South Carolina Code of Regulations
Unannotated
Current through State Register Volume 37, Issue 9, effective September 27, 2013

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CHAPTER 61.

DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL

61-1. Medical and Dental Scholarship Fund.

1. Public Notice: As soon as the initial appropriation to the Fund is approved by the Governor, and at appropriate intervals (at least annually) thereafter, the Office of Communications of the Department of Health and Environmental Control shall send a news release to all news media in South Carolina and nearby communities describing the availability of scholarship funds, the persons eligible, the contractual obligations to be assumed by successful applicants, and the address for application forms and information.

2. Assignment of Responsibility in Department: The Commissioner shall designate an office in the Department to be responsible for distribution of application forms approved by the Board, for collection of completed forms, and for performing other staff functions related to the operation of the Fund.

3. Deadline for Receipt of Applications: The Board may set from time to time appropriate dates after which no more applications will be accepted for a particular granting period. In order that all applicants be given equal consideration, such deadlines will allow adequate time for processing the applications prior to final selection of successful applicants by the Board.

4. Legal Residency in South Carolina: South Carolina residency shall be established in accordance with the principles of Section 59-101-70, S.C. Code, as amended, which currently provides in part as follows: "Persons who have been domiciled in South Carolina for a period no less than twelve months with an intention of making a permanent home therein, including persons in their majority, emancipated minors and unemancipated minors whose parents have been domiciled in this State for no less than twelve months with an intention of making a permanent home herein may be considered South Carolina residents, provided that where the parents of an unemancipated minor are living apart or are separated, divorced, or deceased, the residency of the child shall be determined by the place of domicile of the parent or legal guardian with whom the child normally resides. Students making application for residency status shall have the burden of proving that these requirements are met."

5. Investigation of Fitness of Applicants: The office designated in paragraph 2 shall make a careful and full investigation of the ability, character and qualifications of each applicant to determine his fitness. The office shall submit a written summary of its findings on each applicant to the Board through the Commissioner. This investigation shall include a sharing of information pertaining to the applicant with the medical or dental school(s) which has accepted him for enrollment and a visit to his home community contacting his family, his church, his school, his credit references, law enforcement authorities, and other knowledgeable persons. Each applicant shall be required to sign a release form authorizing any person or agency having information about his ability, character and qualifications to release such information to the Board or its agents.

6. Appearance before Board: The Board may examine each applicant to assist in determining if he is qualified.

7. Duration of Loan or Scholarship: Each loan or scholarship shall be for a period of one year. However, recipients of a loan or scholarship who successfully complete the related year of study shall have first priority on unobligated funds for renewal of the loan or scholarship for the succeeding year.

8. Amount of Loan or Scholarship: Each loan or scholarship shall consist of two parts: (1) Payment of tuition and other school related expenses up to a total of $5000 per year, and (2) an allowance of $100 per month for living expenses.

9. Practice Selection: Each loan or scholarship shall be based upon the condition that on or before six months from the date the applicant completes one year of internship he engage in the general practice of medicine or dentistry in a county within the State which has a doctor ratio of not more than one doctor for each two thousand people or a dentist ratio of not more than one dentist for each four thousand people. The Department shall keep a list of the counties having such ratios and the applicant may choose which of these counties he desires to practice in.

10. Determination of Doctor and Dentist Ratios: The number of doctors and dentists practicing in counties shall be primarily based on the latest data from the State Board of Medical Examiners and the State Board of Dentistry pertaining to practitioners licensed and registered by these Boards. The Board of Health and Environmental Control may also take into consideration the Federal physicians assigned in the counties inasmuch as the people they serve are included in the population of the counties. The population used in calculating the ratios shall be the estimate of the Research and Statistical Services Division of the Budget and Control Board closest to the time of assembly of the information from which the number of professionals is derived.

11. Repayment of Loan or Scholarship: For each year during which an applicant benefits from a loan or scholarship he shall be required to engage in practice as defined in paragraph 9 for one year. Such work shall in addition constitute a repayment of the loan or scholarship. Applicants who receive a scholarship or loan for four years shall only be required to practice in such a county for three years, at the end of which time the loan shall be considered paid in full. Where the Board is convinced that there is justifiable cause which the applicant could not have foreseen, the Board may allow him to repay the loan or scholarship by paying in cash the full amount of the loan or scholarship, plus 7% interest per year compounded semiannually.

12. Contracts with Applicants: Before being granted a loan or scholarship, each applicant shall enter into a contract with the Board, agreeing to the terms and conditions upon which the loan or scholarship shall be granted to him. The contract shall include terms and provisions to carry out the purpose and intent of paragraphs 7 through 10 and 14 of these regulations. It shall be signed by the chairman of the Board, countersigned by the executive secretary of the Board, and signed by the applicant.

13. Contracts with Professional Schools: The Board may make arrangements and execute contracts with approved medical or dental schools for the admission of students granted loans or scholarships by the Board. Such contracts may provide for the payment of tuition and other school related expenses directly to the schools. The Board, upon proper notice, may cancel any contract made with such institutions.

14. Failure of Recipient to Fulfill Contract: If the recipient of a scholarship fails without justifiable cause to practice medicine or dentistry in accordance with the terms of his contract, three times the entire amount of the scholarship benefits received, plus 7% interest per year compounded semiannually shall become due and payable. However, if the Board determines there is justifiable cause for the failure to practice pursuant to the terms of the contract, it may relieve the recipient of the obligation to practice according to the terms of the contract, and shall provide for repayment of the amount received, plus 7% interest per year on any terms it may deem proper. Upon recommendation and request of the Board, the Attorney General shall institute proceedings for the purpose of recovering any amount due the State upon breach of the contract.

15. Receipts and Expenditures: Funds appropriated and all sums received in repayment of loans and scholarships shall be placed in the State Treasury to the credit of the South Carolina Medical and Dental Scholarship Fund. Loan and scholarship payments shall be paid out of this fund upon a voucher to the State Comptroller General signed by the chairman and the executive secretary of the Board.

61-3. The Practice of Selling and Fitting Hearing Aids.

(Statutory Authority: Section 40-25-30 et seq of 1976 Code, as amended.)

Definitions and Interpretations

I. Definitions:

For the purpose of these rules and regulations, the following definitions shall apply:

(a) The Act: The "Fitting and Selling of Hearing Aids Act" enacted June 25, 1971. [1976 Code Sections 40-25-10 et seq.]

(b) The Department: The South Carolina Department of Health and Environmental Control.

(c) The Commission: The State Commission for Hearing Aid Dealers and Fitters.

(d) License: A license issued by the Department under this Act to a hearing aid dealer and fitter.

(e) Temporary Permit: A permit issued by the Department under this Act while the applicant is in training to become a licensed hearing aid dealer and fitter.

(f) Hearing Aid: Any acceptable wearable instrument or device designated for or offered for the purpose of aiding or compensating for impaired human hearing and any parts, attachments or accessories, including earmold, but excluding batteries and cords.

(g) Practice of Fitting and Dealing in Hearing Aids: The measurement of human hearing by means of an audiometer or by any other established means for the purpose of making selections, adaptations or sale of hearing aids. The term also includes the making of impressions for earmolds. Counseling and instruction relative to the above.

(h) Sale of Hearing Aids: Any transfer of title or of the right to use by lease, bailment, or any other contract, excluding wholesale transactions with distributors or representatives.

(i) Otolaryngologist: A licensed physician specializing in diseases of the ear, nose and throat.

(j) Audiologist: An individual completing satisfactory graduate work and holding a Certificate of Clinical Competence and who is actually engaged in audiological practice.

(k) Licensee: The individual authorized to engage in the practice of fitting and selling hearing aids and on whom rests the responsibility for complying with the provisions of the Act and these Rules and Regulations promulgated thereunder.

(l) Application: Application means a form which shall contain all of the prescribed information established by the Department as set forth in the Act.

(m) Examination: Examination means the testing of knowledge and proficiency of an applicant required for fitting and selling hearing aids.

(n) Registrant: Registrant shall be synonymous with licensee, holder of a certificate of registration, trainee and temporary permit holder.

II. Interpretations:

(a) License: A license is issued by the Department pursuant to the provisions of the Act and these Rules and Regulations promulgated thereunder. This license shall be posted in a conspicuous place in his office or place of business at all times in full view at the address specified on the license. A license is not assignable or transferable and is subject to revocation or suspension for a fixed period by the Department for cause as defined within Section 13(2) of the Act [Section 40-25-160(2)].

(b) Term of License:

(1) Each person licensed to fit and sell hearing aids shall annually, on or before January 30, pay to the Department a fee of fifty dollars ($50.00) for issuance or renewal of license.

(2) A thirty (30) day grace period shall be allowed after January 30, during which time licenses may be renewed on payment of a fee of sixty dollars ($60.00) to the Department. After expiration of the grace period, the Department may renew such license upon payment of a fee of seventy-five dollars ($75.00) to the Department. No person who applies for renewal, whose license has expired, shall be required to submit to any examination as a condition to renewal, provided such renewal application is made within a period of two (2) years from the date of such expiration.

(3) A license shall be effective for a twelve (12) month period, beginning January 31 and ending January 30 of the succeeding year.

(c) Temporary Permit: A temporary permit shall be issued to an applicant who fulfills the requirements of the Act but does not meet the experience qualifications and shall entitle applicant to engage in the fitting and selling of hearing aids for a period of one (1) year under the supervision of a licensed hearing aid dealer and fitter.

PART I

CHAPTER I--Management

Section 101.

Application

(a) No person shall fit, or offer for sale, hearing aids in this State unless such person has complied with the requirements hereof as to registration and licensing.

(b) An individual, in making his first registration hereunder, shall write or cause to be written upon the application blank, so furnished by the Department, his full name, business address, residence address and such other facts for identification of the applicant as may be deemed necessary and shall execute and verify the same before a notary public and shall file the same with the Department.

(c) The Department on or before December 1 of each year, after the first registration, shall mail to each licensee or registrant a blank form of application for registration addressed to the last known business of such person.

(d) The Department shall, in accordance with the Act, issue to any individual who has submitted his application for registration complete with the information as may be deemed applicable by the Department, a license or temporary permit under the seal of the Department for the ensuing year.

(1) Any licensee or temporary permit holder must maintain a progressing level of professional competence by participation during each calendar year in educational programs designed to keep such licensee informed of changes, current practices, and developments pertaining to the fitting of hearing aids and rehabilitation as appropriate to hearing aid use.

(2) The licensee shall annually submit to the Commission proof of having participated in a minimum of eight hours of continuing education during the calendar year. A licensee who is granted a license during a calendar year shall not be required to complete such requirements during that year and such requirement shall begin the second full licensing year. The requirement may be fulfilled by attending and participating in training activities approved by the Commission.

(3) Failure to complete the minimum educational requirements shall result in a license suspension until the requirements are met. The Commission, upon sufficient cause shown by the licensee, may allow the licensee to make up the necessary hours during the next calendar year. The make-up allowance shall not waive the full annual requirements for continued education.

(e) Application for Examination Fee: An application for examination shall be accompanied by a check or money order made payable to the South Carolina Department of Health and Environmental Control in the amount of fifty dollars ($50.00). It shall be understood by the applicant that the examination fee shall in no instance be refunded, applied as payment for temporary permit, or transferred to the license fee.

(f) Failure to complete all forms and provide all information required by law may be just cause for the application to be rejected by the Department.

(g) Any person furnishing false information or omitting pertinent information in such application shall be denied the right to the examination, or if the applicant has already been licensed before the falseness of such information has been made known to the Department, such license shall be subject to suspension or revocation.

Section 102. License

A license under this Act shall confer upon the holder the right to select, fit and sell hearing aids.

(a) Licenses or temporary permits shall not by any manner or means be duplicated by the licensee or other persons.

(b) Any change in status of licensee or temporary permit, such as address or name, shall make the license null and void and shall be returned to the Department for proper disposition.

(c) Persons who hold a license or temporary permit shall notify the Department in writing of his regular address, business address, office address or the place where he engages or intends to engage in the fitting or the sale of hearing aids. Notification of any change of status must be made to the Department within fifteen (15) days subsequent to such change.

Section 103. Temporary Permit

An applicant who fulfills the requirements of the Act, and who has not previously applied to take the examination delineated in Section 202 of these Rules and Regulations, may apply to the Department for a temporary permit.

(a) Prior experience or a waiting period shall not be required provided he shall be reasonably supervised and trained for a period of one year by a currently licensed hearing aid dealer.

(b) Annual reports of progress must be maintained on each person with a temporary permit by a licensed dealer verifying adequate personal contact supervision, and training and all such reports shall be kept on file at the Department. The phased training reports shall be submitted quarterly to complete the annual reports of progress.

(c) If any person who holds a temporary permit has not successfully passed the licensing examination within one year from the date of issuance, the temporary permit may, at the discretion of the Department, be renewed or he shall be required to reapply at a date specified by the Department.

Section 104. Display of License/Temporary Permit

The license or temporary permit shall be prominently displayed in his office or place of business in full view of any customer or client. The wallet sized identification shall be in the possession of licensed hearing aid dealers and temporary permit holders at all times and shall be displayed upon request by any customer, client, or agent of the Department, or peace officer.

Where there is more than one office or place of business, duplicate licenses shall be issued by the Department.

Section 105. Fees

(a) All fees shall be made payable to the South Carolina Department of Health and Environmental Control and are not transferable.

(b) Licensing fee or renewal fee established in the Act is fifty dollars ($50.00) and duplicate licenses will be issued where more than one office or place of business is in operation.

(c) Temporary permit fee has been established at twenty-five dollars ($25.00).

(d) Examination fee is set in the amount of fifty dollars ($50.00) and is not refundable.

Section 106. Conduct/Ethics

1. It shall be the responsibility of the licensee or the temporary permit holder, under the Act, to be familiar with and to avoid commission of any acts regarded as unethical conduct including, but not limited to, the following:

(a) The obtaining of any fee or making any sale by fraud or misrepresentation.

(b) Employing directly or indirectly any suspended or unregistered person to perform any work covered by the Act.

(c) Engaging in falsification of name or using an alias with fraudulent intent for the purposes of fitting and selling hearing aids.

(d) Gross incompetence, or negligence shall be considered, in dispensing or selling a hearing aid to a customer, client or person without that person having been given the opportunity of tests utilizing appropriate established procedures and instrumentation to determine the extent or type of hearing impairment: except in cases of selling replacement hearing aids, in which case retesting hearing within 18 months of original purchase except in extenuating circumstances as determined by the Department.

(e) Using or causing or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia, or any other representation, however disseminated or published, which is misleading, deceiving, or untruthful.

(f) Advertising or offering for sale a particular model, type or kind of hearing aid when the offer is not a bonafide effort to sell the product so offered as advertised and at the advertised price. In determining whether there has been a violation of this rule, consideration will be given to actions or practices indicating that the offer was not made in good faith for the purpose of selling the advertised product, but was made for the purpose of contacting prospective purchasers and selling them a product offered.

(g) Violation of any of the provisions of the Act.

2. Actions or procedures which shall be considered for the purpose of determining misrepresentation shall be the following:

(a) The creation, by virtue of the initial offer or advertisement, of a false impression of the product offered in any material respect.

(b) A refusal to show, demonstrate or sell the product offered in accordance with the terms of offer.

(c) To vilify by actions or words, the product offered, credit terms, availability of service, repairs or parts in connection with the offer or advertisement.

(d) To delay, in the event of sale, the delivery of such product or the service of such product offered within a reasonable time thereafter.

(e) Representing, advertising or implying that the hearing aid or repair is guaranteed without complete disclosure of the nature and extent of the guarantee and any conditions or limitations thereof.

3. Representing that the professional services or advice of a physician will be used or made available in the selling or fitting, adjustment, maintenance or repair of hearing aids when that is not true, or using the words "doctor", "clinic", "audiologist", or any similar words, abbreviations, or symbols which tend to connote the audiological or medical profession when such is not the case.

4. Permitting another the use of license or temporary permit.

5. The indulgence in excessive consumption of beverages or drugs for purposes of intoxication shall constitute habitual intemperance.

6. Offering for sale, rent, or lease, by advertisement, a manufacturer's product or using a manufacturer's name or trademark which implies a relationship with the manufacturer(s) that does not exist.

7. Directly or indirectly giving or offering to give, permitting or causing the exchange of anything of value, whether it be money or otherwise, to any person who advises another as an inducement to influence him or others to purchase or contract for purchase products sold or offered for sale by a hearing aid dealer or fitter.

8. Making any statement or implying that the use of any hearing aid will restore or preserve hearing, prevent or regress hearing impairment.

9. To conduct business during any affliction thereby causing to be spread any contagious or infectious disease which may constitute a hazard to the well-being of any client.

10. Committing or contributing to any of the above actions or deeds shall be construed a violation of the Act.

Section 107. Corporation or Like Organizations

Nothing in this Law shall prohibit a corporation, partnership, trust, association or other like organizations from engaging in the business of fitting and selling or offering for sale hearing aids at retail without a license, if it employs licensed persons in the direct sale and fitting of such products. Such corporations, partnerships, trusts, associations, or other like organizations shall also file annually with the Department and Commission a list of all licensed hearing aid dealers, fitters, and holders of temporary permits directly or indirectly employed by it. Corporate officers or agents of such organizations shall file with the Department by affixing their signature(s) to the application and thereby submit themselves to the Rules and Regulations and the provisions of this Act which the Department may deem applicable.

PART II

CHAPTER II--Procedures

Section 201. Procedures/Equipment

1. The following procedure shall be used in the fitting and selling of hearing aids where applicable:

(a) Pure tone audiometric testing by air and bone conduction to determine the level of hearing impairment.

(b) Speech reception threshold, speech discrimination, sound pressure measurement of the speech frequency range for the purpose of determining the best ear(s) for maximal hearing aid benefit and comfort. Selection of the best instrument to compensate for degree of loss.

(c) Only when the above procedures are clearly impractical, then the selection of the best instrument to compensate the loss may be made by trial of several instruments.

The following minimal equipment shall be used in the fitting and selling of hearing aids:

(a) Pure tone audiometer which shall meet with the latest specification standards as determined by the Department.

(b) Speech audiometer or a master hearing aid in order to determine the most comfortable listening level and speech discrimination.

(c) Ear light or an otoscope, for revealing any obstruction of the auditory canal, shall be free of cerumen and maintained in an aseptic manner at all times.

(d) Audiometers shall be checked for proper calibration as often as deemed necessary but not less than once each year. Evidence of calibration shall be furnished with the license renewal application and a copy maintained on file in the office.

1. Calibration shall be conducted by person, or an institution of higher learning equipped with proper instruments for calibrating as determined by the Department.

(e) Maintain or have access to facilities for making ear molds.

(f) A hearing aid office or place of business must have available or access to a selection of hearing aids and supplies and offer services complete enough to accommodate within reasonable limits the various needs of the clientele.

(g) The testing room shall be sufficient in dimensions to accommodate all equipment necessary for the proper testing and evaluation of the client.

(h) Every person who fits and sells hearing aids shall transmit to each person supplied with a hearing aid a receipt which shall contain the licensee's signature, show his business address and the license or temporary permit number together with the make, model and serial number of the hearing aid furnished and full terms of the sale clearly stated thereon. In the event of a used or rebuilt, reconditioned hearing aid, it shall be so specified on said receipt and shall indicate the length of time of the guarantee and by whom guaranteed.

1. The licensee shall advise the purchaser prior to any sale, testing or evaluation by the hearing aid dealer that any examination or representation is not to be construed as a diagnosis, a medical opinion or that such examination imparts to the purchaser a prescription by a person licensed to practice medicine in this State.

2. Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendation within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt.

Section 202. Examination

1. An applicant for license, or holder of a temporary permit who meets all the requirements of the Act, shall appear at a time, place, and before such persons as prescribed by the Department to be examined by written and practical testing. The examination shall be such that it will establish knowledge and proficiency in each of the following categories:

(a) Basic physics of sound.

(b) Anatomy and physiology of the ear.

(c) Basic structure and functions of hearing aids.

(d) Pure tone audiometry, air and bone conduction.

(e) Live voice or recorded speech, speech audiometry including speech reception threshold testing and speech discrimination testing.

(f) Masking (when indicated).

(g) Recording and evaluation of audiograms.

(h) Speech audiometry.

(i) Taking earmold impressions.

2. Examination and Fee:

(a) A fee of fifty dollars ($50.00) has been established for the examination and is not transferable or refundable.

(b) Receipt shall be transmitted to applicant.

(c) Application for examination shall be kept on file by the Department.

(d) Applicant shall be notified within a reasonable time of the results of the prescribed tests.

(e) Examinations for applicants shall be given not less than once each year.

3. The examination shall not constitute criteria or standards nor be conducted in a manner requiring college training in order to pass, or imply that the applicant possess a degree of competence normally expected of physicians or audiologists.

Section 203. Inspections

Inspection(s) shall be conducted periodically by the Department; such inspection(s) shall include but not be limited to the following:

1. Calibration check of audiometric equipment: evidence of calibration check shall be furnished upon request or shall be affixed to audiometer and shall have date and name of person(s) calibrating such equipment.

(a) Calibration shall be conducted on each audiometer as often as deemed necessary but not less than once each year.

(b) Calibration shall be accomplished by the manufacturer or properly trained person or an institution of higher learning equipped with proper instruments for calibrating audiometer as determined by the Department.

(c) Calibration of audiometers and earphones shall be in accordance with the American National Standards and Specification of Audiometers recent edition.

2. Records or receipt applicable to the sale of hearing aid:

(a) Such records or receipts shall contain the signature or initials of licensee, the business address, make, model and serial number of the hearing aid offered.

(b) Full disclosure of the terms of the sale.

(c) The warranty or guarantee and by whom.

(d) Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendations within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt.

(e) These records and receipts shall be retained, by the licensee or dealer, for a period of time not less than ten (10) years in keeping with good practice.

(f) Suggest all employees be required to check in to the owner of the business all pertinent records on termination of association with said owner of business.

3. The facility and individuals who work with, or handle, the equipment shall be clean at all times and all necessary precautions shall be taken to prevent the spread of any communicable disease.

4. Audiograms shall be recorded when applicable, and shall transmit the following information:

(a) Date of evaluation.

(b) Name of customer or client.

(c) Address of customer or client.

(d) Sex.

(e) Age.

(f) Signature of individual conducting test.

(g) Audiogram shall be filed by the dealer, licensee or permit holder at his place of business for a period of ten (10) years or until such time as good practice may dictate.

5. An otoscope or ear light shall be operational and maintained in a clean manner and free of any debris or cerumen at all times.

Section 204. General

Conditions arising which have not been covered in these regulations shall be handled in accordance with the best practices as interpreted by the South Carolina Department of Health and Environmental Control.

Section 205. Continuing Education Programs-Approval

Any person or organization desiring to conduct continuing education training programs must submit such programs to the Commission for approval.

a. Courses which have been approved by the National Institute of Hearing Instruments Studies (NIHIS) of the National Hearing Aid Society will be approved by the Commission under the following conditions:

(1) The organization offering the program furnishes to the Department, not later than thirty days prior to its presentation, an outline which identifies the course content and NIHIS approved hours;

(2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and

(3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one.

b. Courses which do not meet the requirements outlined in "a", above, may be approved by the Commission under the following conditions:

(1) The organization offering the program furnishes to the Department, not later than sixty days prior to its presentation, an outline which includes:

(a) date and location;

(b) a description of each course;

(c) hours of each course; and

(d) biographical data of the instructors.

(2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and

(3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one.

c. The Department will secure Commission approval as appropriate and notify the training organization of the hours approved.

61-4. CONTROLLED SUBSTANCES.

(Statutory Authority: S.C. Code Section 44-53-280(a))

HISTORY: Amended by State Register Volume 21, Issue No. 6, Part 2, eff June 27, 1997; State

Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003.

Table of Contents

PART 100. Purpose and Scope; Definitions, Information, Fees; Certain

Exemptions; Separate Registrations, Out-of-State Dispensing of Prescriptions.

101. Purpose and Scope.

102. Definitions.

103. Information; Special Instructions.

104. Time and Method of Payment of Fees; Refund.

105. Registrants Exempt from Fee.

106. Persons Required to Register.

107. Separate Registration for Independent Activities.

108. Separate Registrations for Separate Locations.

109. Exemption of Agents and Employees; Affiliated Practitioners.

110. Exemption of Certain Military and Other Personnel.

111. Exemption of Law Enforcement Officials.

112. Exemption of Civil Defense Officials.

113. Registration Regarding Ocean Vessels and Aircrafts.

114. Dispensing of Out-of-State Prescriptions and Orders.

PART 200. Application for Registration.

201. Application for Registration.

202. Application Forms; Content; Signature.

203. Research Protocols.

204. Additional Information.

205. Amendments to and Withdrawal of Applications.

PART 300. Action on Application for Registration; Revocation or Suspension of

Registration.

301. Administrative Review Generally.

302. Applications for Research in Controlled Schedule I Substances.

303. Application for Bulk Manufacture of Schedules I and II

Substances.

304. Provisional Registration.

305. Certificate of Registration; Denial of Registration.

306. Suspension or Revocation of Registration.

307. Suspension of Registration Pending Final Order.

308. Extension of Registration Pending Final Order.

309. Order to Show Cause.

310. Hearing Generally.

311. Purpose of Hearing.

312. Waiver and Modification of Rules.

313. Request for Hearing or Appearance; Waiver.

314. Burden of Proof.

315. Time and Place of Hearing.

316. Final Order and Appeals.

317. Modification in Registration.

318. Termination of Registration.

319. Termination of Registration; Partnerships and Corporations;

Other Business Entities.

320. Transfer of Registration.

PART 400. Security Requirements.

401. Security Requirements Generally.

402. Physical Security Controls for Non-practitioners; Storage Areas.

403. Physical Security Controls for Non-practitioners; Manufacturing

Areas.

404. Other Security Controls for Non-practitioners; Narcotic

Treatment Programs and Compounders for Narcotic Treatment

Programs.

405. Physical Security Controls for Practitioners.

406. Other Security Controls of Practitioners.

407. Loss by Diversion Due to Repeated Thefts.

408. Filing of Theft Reports.

409. Employee Screening Procedures.

410. Employee Responsibility to Report Drug Diversion.

411. Illicit Activities by Employees.

412. Separate Registration by Permitted Pharmacies for Installation

and Operation of Automated Storage Machines at Long Term Care

Facilities.

PART 500. Labeling and Packaging Requirements for Controlled Substances.

501. Symbol Required; Exceptions.

502. Location and Size of Symbol on Label.

503. Location and Size of Symbol on Labeling.

504. Effective Dates of Labeling Requirements.

505. Sealing of Controlled Substances.

506. Labeling for Controlled Substances Dispensed Directly to

Ultimate Users.

PART 600. Records and Reports of Registrants.

601. Scope of Part 600.

602. Persons Required to Keep Records and File Reports.

603. Maintenance of Records and Inventories.

PART 700. Inventory Requirements.

701. General Requirements for Inventories.

702. Inventory upon Transfer of Business; Change of

Pharmacist-in-Charge.

703. Annual Inventory Date.

704. Inventories of Manufacturers.

705. Inventories for Distributors.

706. Inventories of Dispensers and Researchers.

707. Inventories of Importers and Exporters.

708. Inventories for Chemical Analysis.

PART 800. Continuing Records.

801. General Requirements for Continuing Records.

802. Records of Manufacture.

803. Records for Distributors.

804. Records for Dispensers and Researchers.

805. Records for Importers.

806. Records of Exporters.

807. Records for Chemical Analysis.

808. Reports.

809. Records for Maintenance Treatment Programs and Detoxification

Treatment Programs.

810. Records for Treatment Programs Which Compound Narcotics for

Treatment Programs and Other Locations.

PART 900. Order Forms.

901. Order Forms.

902. Handling and Filing.

903. Power of Attorney.

PART 1000. Prescriptions.

1001. Persons Entitled to Issue Prescriptions.

1002. Purpose of Issue of Prescription.

1003. Manner of Issuance of Prescription.

1004. Registration Number Required on Prescriptions.

1005. Persons Entitled to Fill Prescriptions.

1006. Information Required for Filled Prescriptions.

1007. Dispensing of Narcotic Drugs for Maintenance Purposes.

1008. Federal Approval of Maintenance Programs Required.

1009. Withdrawal of Drug Dependent Persons by Use of Methadone or

Other Narcotic Controlled Substances.

1010. Approved Uses of Methadone in Hospitals.

1011. Departmental Approval; When Required.

1012. Treatment of Outpatients with Methadone.

PART 1100. Controlled Substances Listed in Schedule II.

1101. Requirement of Prescription.

1102. Limitations on Prescriptions for Schedule II Substances.

1103. Practitioner-Patient Relationship Required.

1104. Refilling Prescription.

1105. Partial Filling of Prescription.

1106. Labeling of Substance.

1107. Filing of Prescriptions.

PART 1200. Controlled Substances Listed in Schedules III, IV and V.

1201. Requirement of Prescription.

1202. Refilling of Prescriptions.

1203. Limitations on Prescriptions for Schedules III, IV, and V

Substances.

1204. Practitioner-Patient Relationship Required.

1205. Partial Filling of Prescriptions.

1206. Labeling of Substances.

1207. Filing Prescriptions.

1208. Controlled Substances Listed in Schedule V - Dispensing Without

Prescription.

PART 1300. Miscellaneous.

1301. Severability.

1302. Application of Other Laws.

1303. Exceptions in Regulations.

PART 1400. Special Exceptions for Manufacture and Distribution of Controlled

Substances.

1401. Distribution by Dispenser to Another Practitioner.

1402. Manufacture and Distribution of Narcotic Solutions and Compounds

by a Pharmacist.

1403. Distribution to Supplier.

1404. Distribution upon Discontinuance or Transfer of Business.

PART 1500. Disposal of Controlled Substances.

1501. Procedure for Disposing of Controlled Substances.

PART 1600. Authority to Make Inspections.

1601. Authority to Make Inspections.

1602. Exclusion from Inspection.

1603. Entry.

1604. Notice of Inspection.

1605. Consent to Inspection.

1606. Application for Administrative Inspection Warrant.

1607. Administrative Probable Cause.

1608. Execution of Warrants.

1609. Refusal to Allow Inspection with an Administrative Warrant.

PART 1700. Protection of Researchers and Research Subjects.

1701. Confidentiality of Research Subjects.

1702. Exemption from Prosecution for Researcher.

PART 1800. Administrative Conferences.

1801. Authority for Administrative Conferences.

1802. Notice; Time and Place.

1803. Conduct of Administrative Conferences.

PART 1900. Handling and Administering Controlled Substances in Hospitals.

1901. Hospital Registration.

1902. Practitioners' Registration.

1903. Residents' Registration.

1904. Responsibility for Controlled Substances.

1905. Prescriptions Not Required on Floor-Stocked Controlled

Substances.

1906. Registry Number.

1907. Telephone Orders.

1908. Verbal Orders.

1909. Controlled Substances Records.

1910. Procedure in Case of Waste, Destruction, Contamination, etc.

1911. Procedures in Case of Loss, Theft, etc.

1912. Controlled Substances of Physician's Office or bag.

1913. Dispensing to Outpatients.

1914. Administering to Outpatients.

1915. Emergency Rooms.

1916. Storage of Controlled Substances.

1917. Availability of Records for Inspectors.

1918. Labeling of Substances. (Schedule II).

1919. Labeling of Substances. (Schedules III, IV, V).

1920. Clarification and Intent.

1921. Consultation Procedure.

PART 100. PURPOSE AND SCOPE; DEFINITIONS, INFORMATION, PAYMENT OF FEES, CERTAIN EXEMPTIONS, SEPARATE REGISTRATIONS, OUT-OF-STATE DISPENSING OF PRESCRIPTIONS.

101. Purpose and Scope.

This regulation implements the provisions of Section 44-53-10, et seq., of the S.C. Code of Laws, 1976, as amended. It establishes the requirements necessary to ensure the appropriate security, authority and accountability with regard to the possession, manufacture, dispensing, administering, use and distribution of controlled substances in South Carolina.

HISTORY: Added by State Register Volume 37, Issue No. 6, eff June 28, 2013.

102. Definitions.

As used in this regulation, the following terms shall have the meaning specified:

(a) Act. Article 3 of Chapter 53 of Title 44 of the 1976 S.C. Code of Laws, including all amendments thereto.

(b) Administration and the Abbreviation DEA. Refer to Drug Enforcement Administration, United States Department of Justice, the successor agency to the Bureau of Narcotics and Dangerous Drugs as defined in the Act.

(c) Automated Storage Machine. A mechanical system that performs operations, other than compounding or administration, that allow medications to be provided to the patient and stored near the point of care while controlling and tracking drug distribution under the control of a licensed pharmacist.

(d) Bureau Director. The Director of the Bureau of Drug Control, DHEC.

(e) Code. The Code of Laws of South Carolina, 1976, including all amendments thereto.

(f) Commercial Container. Any bottle, jar, tube, ampoule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert, or other material kept with or within a commercial container, nor any carton, crate, box, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(g) Compounder. Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage forms of a narcotic drug listed in Schedules II, III, IV, or V for use in maintenance or detoxification treatment by another narcotic treatment program. The term "compounder" as the content requires, includes any lawfully authorized person who changes the dosage forms, mixes, or prepares any controlled substance for use by the ultimate user pursuant to the legitimate and lawful order of a practitioner acting in the regular course of professional practice or by the practitioner personally, if authorized by law to compound and dispense controlled substances.

(h) Controlled Premises:

(1) Places where original or other records or documents required under the Act are required to be kept, and

(2) Places, including factories, warehouses, or other establishments, and conveyances, where persons registered under the Act or exempted from registration under the Act may lawfully hold, manufacture, dispense, distribute, administer, or otherwise dispose of controlled substances.

(i) Controlled Substance. A drug, substance, or immediate precursor in Schedules I through V as described in S.C. Code Sections 44-53-190, 44-53-210, 44-53-230, 44-53-250, and 44-53-270.

(j) DHEC. The South Carolina Department of Health and Environmental Control.

(k) Director. Unless otherwise specified, the Director of the Department of Health and Environmental Control.

(l) Dispenser. An individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

(m) Detoxification Treatment. The dispensing for a period not in excess of twenty-one days, of a narcotic or narcotics drugs in decreasing dosages to an individual in order to alleviate adverse physiological or psychological effects incidental to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. SEE ALSO Sections 1007 through 1011 inclusive.

(n) Emergency Situation. For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the Act, the term "emergency situation" means those situations in which the prescribing practitioner determines:

(1) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and

(2) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and

(3) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

(o) Hearing. Any hearing held pursuant to the provisions of the Act or of this regulation, including, but not limited to, hearings for the granting, denial, revocation, or suspension of a registration pursuant to the Act.

(p) Home Infusion Pharmacy. A pharmacy which compounds solutions for direct administration to a patient in a private residence, Long Term Care Facility or hospice setting by means of parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion.

(q) Individual Practitioner. A physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted by the United States or the State of South Carolina, or by other jurisdiction, or otherwise permitted by the United States or the State of South Carolina, or by any other jurisdiction in which he practices to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacist, a pharmacy, or any institutional practitioner.

(r) Inspector or Drug Inspector. An officer or employee of the Bureau of Drug Control authorized by the Bureau Director to make inspections under the Act, and to conduct audit procedures in relation to controlled substances, and includes the Director of the Bureau of Drug Control.

(s) Institutional Practitioner. A hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States, the State of South Carolina, or other jurisdiction in which it practices, to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacy.

(t) Interested Person. Any person adversely affected or aggrieved by any rule or proposed rule issued or issuable pursuant to the Act.

(u) Long Term Care Facility (LTCF). Nursing home, intermediate care, mental care, or other facility or institution which provides extended health care to resident patients and is licensed as such by DHEC or other appropriate State agency, which may further define the term for licensing and certification purposes.

(v) Name. The official name, common or usual name, chemical name, or brand name of a substance.

(w) Person. Includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(x) Pharmacist. Any pharmacist licensed by a state to dispense controlled substances, and shall include any person (e.g., pharmacy intern) authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State.

(y) Prescription. An order for medication which is dispensed to or for an ultimate user, but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).

(z) Proceeding. All actions taken for the issuance, amendment, or repeal of any rules and regulations issued pursuant to the Act, commencing with the publication by the Bureau Director of the proposed rule, amended rule, or appeal.

(aa) Readily Retrievable. Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some other manner visually identifiable apart from other items appearing on the records; when the term is not applicable to data processing systems, the term also means that a registrant is able to produce controlled substances records in a timely manner (usually within one hour) and that such records are segregated, sorted, or filed in such a manner that the controlled substances information may be derived from the material within a reasonable time (usually with a few hours) by an inspector.

(bb) Register and Registration. Refer only to registration required and permitted by the Act;

(cc) Registrant. Any person who is registered pursuant to the Act.

(dd) Scheduling of a Controlled Substance. Controlled substances are scheduled in accordance with provisions set forth in state law. Changes in the schedule of a controlled substance are made as set forth in S.C. Code Ann. Section 44-53-160.

(ee) Any term not defined in this section shall have the definition set forth in the Act, or amendments thereto.

HISTORY: Formerly R. 61-4.101. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

103. Information; Special Instructions.

Information regarding procedures under these rules and special instructions supplementing these rules will be furnished upon request by writing to the Bureau of Drug Control DHEC, 2600 Bull Street, Columbia, SC 29201.

HISTORY: Formerly R 61-4.102. Renumbered by State Register Volume 37, Issue no. 6, eff June 28, 2013.

104. Time and Method of Payment of Fees; Refund.

Registration and re-registration fees shall be paid at the time when the application for registration is submitted for filing. Payment shall be made in the form of a personal, certified or cashier's check, money order, credit card or online electronic payment, made payable to DHEC. Payments made in the form of stamps, foreign currency, or third party endorsed checks will not be accepted. In the event that the application is not accepted for filing or is denied, the payment shall be refunded to the applicant.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

105. Registrants Exempt from Fee.

(a) Any federal agency, installation or official authorized by law to procure or purchase controlled substances for official use shall be exempt from payment of a fee for registration or re-registration.

(b) In order to claim exemption from the payment of fees for registration or re-registration, the registrant shall have completed the certification on the appropriate application form, wherein the applicant's superior or the agency head certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess or handle controlled substances.

(c) Exemption from payment of a registration fee does not relieve the registrant of any other requirements or duties prescribed by law.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

106. Persons Required to Register.

Every person who manufactures, distributes, prescribes or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a registration unless exempted by law. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

107. Separate Registration for Independent Activities.

(a) The following groups of activities are deemed to be independent of each other:

(1) Manufacturing controlled substances;

(2) Distributing controlled substances;

(3) Dispensing controlled substances listed in schedules II through V;

(4) Conducting research (other than research described in paragraph (a) (6) of this section) with controlled substances listed in schedules II through V;

(5) Conducting instructional activities with controlled substances listed in schedule II through V;

(6) Conducting a narcotic treatment program using any drug listed in Schedules II through V: however, pursuant to Section 109, employees, agents or affiliated practitioners, in programs, need not register separately. Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed shall be separately registered and obtain narcotic drugs by use of order forms pursuant to Sections 901 and 902;

(7) Conducting research and instructional activities with controlled substances listed in schedule I;

(8) Conducting chemical analysis with controlled substances listed in any schedules;

(9) Importing controlled substances;

(10) Exporting controlled substances listed in schedules I through IV;

(11) A compounder as defined by Section 102(g); and

(12) Automated storage machines at long term care facilities.

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities:

(1) A person registered to manufacture or import any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture or import;

(2) A person registered to manufacture any controlled substance listed in schedules II through V shall be authorized to conduct chemical analysis and pre-clinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person registered to conduct research with a basic class of controlled substance listed in schedule I shall be authorized to manufacture or import such class if and to the extent that such manufacture and importation is set forth in the research protocol filed with the application for registration which shall conform with the provisions of 21 CFR Section 1301.33, and to distribute such class to other persons registered or authorized to conduct research with such class, or registered or authorized to conduct chemical analysis with controlled substances;

(4) A person registered to conduct chemical analysis with controlled substances shall be authorized to manufacture and import such substances for analytical or instructional purposes, to distribute such substances to other persons registered to conduct chemical analysis or instructional activities and to persons exempted from registration pursuant to Section 111, to export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries, and to conduct instructional activities with controlled substances;

(5) A person registered or authorized to conduct research (other than research described in paragraph (a)(6) of this section) with controlled substances listed in those schedules in which he or she is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to import such substances for research purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Section 111, and to conduct instructional activities with controlled substances; and

(6) A person registered to dispense controlled substances listed in Schedules II through V may conduct research (other than research described in paragraph (a) (6) of this section) in conformity with the provisions of S.C. Code Ann. Section 44-53-300(c) and conduct instructional activities with those substances.

(c) A single registration to engage in any group of independent activities may include one or more substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he or she has filed and had approved a research protocol.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

108. Separate Registrations for Separate Locations.

(a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registrants other than the registered person or to persons not required to register by the Act;

(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances for display purposes or lawful distribution as samples only nor serves as a distribution point for filling sales orders; and

(3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office and where no supplies of controlled substances are maintained.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

109. Exemption of Agents and Employees; Affiliated Practitioners.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment. (For example, a pharmacist employed by a pharmacy need not be individually registered to conduct lawful business activity in preparing and dispensing of controlled substances if the pharmacy in which he or she is employed is properly registered under the Act; a manufacturer's sales representative may lawfully distribute samples of controlled substances manufactured by his or her employer, provided the manufacturer-employer is lawfully registered and the distribution is made to a registrant authorized to possess controlled substances and not to a non-registrant employee of the recipient of the sample.)

(b) An individual practitioner who is affiliated with one or more other individual practitioners in any legitimate and lawful form of business arrangement (i.e., partnership, professional association, etc.) shall be registered individually with DHEC prior to engaging in any form of controlled substances activity, pursuant to the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). With the written Power of Attorney of another affiliated practitioner within the group, any other affiliate individual practitioner may administer or dispense (other than by prescribing) controlled substances within the regular course of professional practice if and to the extent the practitioner granting the power of attorney has authorized. (For example, Dr. X and Dr. Y are partners; they shall be individually registered in order to utilize controlled substances in their practice; if Dr. X desired, he or she could issue Dr. Y a power of attorney to utilize Dr. X's office stock of controlled substances to administer an injection of product CRx to Dr. Y's Patient, Mrs. A. while she is in the office. Dr. Y may not, however, sign Dr. X's name to prescriptions, nor may Dr. Y use Dr. X's registration number to obtain stocks of controlled substances for himself or herself or his or her own office stock.) Any power of attorney, once granted, may be revoked by the grantor in writing. Nothing in this Section shall be construed to relieve the grantor of any power of attorney of any responsibility for the proper storage, record keeping, handling, or legitimate use of any controlled substances acquired by the grantor; nor shall anything be construed as relieving the grantee practitioner from full and complete responsibility for his or her actions conducted pursuant to the power of attorney or for controlled substances acquired or utilized pursuant to this paragraph.

(c) Pharmacists listed with the S.C. Board of Pharmacy as the "pharmacist-in-charge" of a pharmacy holding a permit issued by that Board to operate as a retail pharmacy, shall be considered as a "registrant" within the meaning of the Act and this Regulation, and shall be primarily responsible for the controlled substances activity at the registered location of the pharmacy. Nothing in this paragraph shall be construed as relieving an owner, partner, corporate officer, or any other person who may be a registrant-in-fact (due to his or her position within the business entity) from any direct or vicarious liability which may be incurred due to unlawful or ultra vires activity, nor shall it be construed to relieve any employee of the business entity from direct responsibility for his or her own unlawful acts.

(d) Individual practitioners permitted under the provisions of Federal Regulation 21 CFR Section 1301.24 to dispense, administer, or prescribe controlled substances under the registration of a hospital or other institution which is registered, in lieu of personal registration, are prohibited from this practice by the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). No prescriptions issued within this State shall be dispensed by any person registered with DHEC unless the individual practitioner issuing the prescription holds a valid individual practitioner registration with DEA. Nothing shall prevent the dispensing of such prescriptions if they are co-signed by an individual practitioner holding a valid individual registration with the DEA and DHEC, providing that the co-signing practitioner has established a valid practitioner-patient relationship as set forth by Sections 1103 and 1204 of this Regulation prior to the dispensing of the controlled substance. Nothing in this paragraph shall preclude any pharmacy or dispensary operated by the Federal government on any property or enclave not subject to State jurisdiction from any act permitted under Federal law or regulation, nor shall it preclude the dispensing of out-of-state prescriptions as permitted by Section 114 of this Regulation.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

110. Exemption of Certain Military and Other Personnel.

(a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service or Bureau of Prisons who is authorized to prescribe, dispense or administer, but not procure or purchase controlled substances in the course of his or her official duties, provided such prescribing, dispensing, and administering of controlled substances takes place upon a military reservation or other Federal enclave. Practitioners who issue prescriptions for controlled substances which are to be dispensed from governmental stocks shall be exempt from registration. Any practitioner who issues prescriptions for controlled substances which are to be dispensed from non-governmental pharmacies or dispensaries shall register with DHEC prior to issuing such prescriptions.

(b) Practitioners who issue prescriptions for controlled substances which are dispensed from non-governmental pharmacies or dispensaries must complete a controlled substances registration application annually;

(c) Practitioners who register annually with DHEC are granted an exemption to the fee requirement pursuant to Section 1303 of this regulation, provided that the request for exemption to the fee requirement is filed in writing with the Bureau Director. The written request must contain a military picture ID of the requestor, as well as documentation of the name and location of the military installation or hospital facility where the practitioner is located.

(d) This registration requirement and fee exemption applies only to practitioners and officials of the United States military service organizations, including the Army, Navy, Marine Corp, Air Force, and Coast Guard, and the Public Health Service, Bureau of Prisons, and Veteran's Administration, who are based on military installations or other Federal hospital facilities, providing healthcare on behalf of the Federal government.

(e) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

111. Exemption of Law Enforcement Officials.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:

(1) Any official or employee of the DEA, U.S. Department of Justice, any officer of the U.S. Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other federal officer who is lawfully engaged in the law enforcement of any federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his or her official duties; and

(2) Any officer or employee of any state, or any political subdivision or agency thereof, who is engaged in the enforcement of any state or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his or her official duties.

(b) Any official exempted by this section may when acting in the course of his or her official duties, possess any controlled substances and distribute any such substance to any other official who is also exempted by this section and acting in the course of his or her official duties.

(c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with the Act or in the course of any criminal investigation involving the person from whom the substance was procured.

(d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use in chemical analysis, such laboratories shall obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described. For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

112. Exemption of Civil Defense Officials.

(a) The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his or her official duties, is authorized to:

(1) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or

(2) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the U.S. General Services Administration and in accordance with the rules of the U.S. Office of Emergency Preparedness.

(b) The requirement of registration is waived for any official of a civil defense or relief organization during a state of emergency or disaster within his or her jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his or her official duties, during such emergency or disaster, is authorized to:

(1) Dispense controlled substances; or

(2) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form" as prescribed in the Federal Regulations (21 CFR Section 1301.27(c)).

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

113. Registration Regarding Ocean Vessels and Aircrafts.

Registration of masters of ocean vessels and aircraft or the medical officers thereof shall be deemed sufficient if they are properly registered with the U.S. Department of Justice, DEA.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

114. Dispensing of Out-of-State Prescriptions and Orders.

(a) Prescriptions or orders for controlled substances from out-of-state practitioners may be filled in good faith by dispensers provided:

(1) The dispenser knows the recipient; or requires proper ID and notes such on the prescription;

(2) The dispenser makes a good faith inquiry concerning whether the order or prescription is legitimate;

(3) The prescription or order meets all of the requirements of this regulation and the Act, including whether the order or prescription is for legitimate medical purposes, and is within the regular course of practice of the practitioner;

(4) The practitioner who issued the prescription would ordinarily be entitled to issue prescriptions under SC law (i.e., physicians, dentists, veterinarians, and podiatrists are authorized to issue prescriptions; chiropractors, psychologists, etc. are not authorized to prescribe drugs); and

(5) The prescribing practitioner holds a valid individual Federal [D.E.A.] controlled substance registration number in the state, district, or territory of origin of the prescription, or is exempt from such registration requirement under the provisions of Federal Regulation 21 CFR Section 1301.24.

(b) Out-of-State prescriptions which do not conform to South Carolina law and which are not otherwise exempted shall not be dispensed.

HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.

115. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

116. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

117. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

118. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

119. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

120. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

121. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

122. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

123. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

124. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

124.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

125. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

126. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

127. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

128. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

129. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

130. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

131. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

132. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

133. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

134. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

135. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

136. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

137. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

138. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

138.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

139. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

140. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

141. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

142. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

143. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

144. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

145. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

146. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

147. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

148. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

149. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

150. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 200. APPLICATION FOR REGISTRATION.

201. Time for Application for Registration; Expiration Date.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Bureau Director to such person.

(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his or her registration.

(c) Fees for registration for a physician shall be from October 2nd of the year until October 1st of the succeeding year. Fees for registration for any other person required to be registered shall be from April 2nd of the year until April 1st of the succeeding year. In the event any physician shall become registered subsequent to October 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed. In the event any other person required to be registered shall become registered subsequent to April 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed.

HISTORY: Formerly R. 61-4.115. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

202. Application Forms; Content; Signature.

(a) If the person is required to be registered, and is not so registered and is applying for registration;

(1) As a practitioner, pharmacy, mid-level practitioner, animal control, animal shelter, health clinic, EMS, rescue squad, or hospice, he or she shall apply on the applicable DHEC form or its electronic equivalent;

(2) As a narcotic treatment program, he or she shall apply on the applicable DHEC form or its electronic equivalent;

(3) As a distributor, canine unit, researcher, exporter, importer, broker, analytical or forensic laboratory, manufacturer or hospital, he or she shall apply on the applicable DHEC form or its electronic equivalent.

(b) Each application for registration to handle any basic class of controlled substances listed in schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in schedule II, or to conduct research with any Narcotic controlled substance listed in schedule II, shall include the Controlled Substances Control Number for each basic class or substance to be covered by such registration.

(c) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.

(d) Each application, attachment, or other document files as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. Another person may be authorized to sign for the applicant, if proof of authority (e.g. general power of attorney) accompanies the application.

HISTORY: Formerly R. 61-4.116. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

203. Research Protocols.

(a) Applicants for "Researcher" registration in Schedule I shall submit a research protocol containing all the information required for Federal Schedule I research protocol set forth under 21 CFR Section 1301.32.

(b) Practitioners registered with DHEC desiring to perform incidental research on or with controlled substances under the provisions of S.C. Code Ann. Section 44-53-300(c) are not required to furnish the formal protocol (except for narcotic substances as is required under Federal law), but shall instead provide a written summary of the proposed research, including the scope, the substance to be utilized, the number of research subjects (and their identity if protection from prosecution is desired), the duration of the research and the estimated usage of the controlled substance. Insofar as is practical, the dispensing of the controlled substance utilized in a valid research project shall be performed by the researcher or a particular dispenser or small group of dispensers in order to maintain adequate control. While not imperative to DHEC, notice of any participating dispensaries or pharmacies should be made to the Bureau of Drug Control in order that inadvertent and unnecessary investigations of normally unusual dispensing practices may be avoided.

(c) DHEC may require additional information or updating of protocols from time to time, but not more often than annually, unless a major change or deviation from previously submitted protocols or summaries is discovered. It is the responsibility of the person conducting the research project to notify to Department prior to any change in a protocol.

HISTORY: Formerly R. 61-4.117. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

204. Additional Information.

The Bureau Director may request an applicant to submit such documents or written statements of fact relevant to the application as he or she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after having been requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Bureau Director in granting or denying the application.

HISTORY: Formerly R. 61-4.120. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

205. Amendments to and Withdrawal of Applications.

(a) An application may be amended or withdrawn without permission of the Bureau Director at any time before the date on which the applicant receives an order to show cause pursuant to Section 309 or before the date on which a notice of hearing on the application is published pursuant to Section 309 whichever is sooner. An application may be amended or withdrawn with permission of the Bureau Director at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.

(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.

HISTORY: Formerly R. 61-4.121. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

206. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

207. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 300. ACTION ON APPLICATIONS FOR REGISTRATION; REVOCATION OR SUSPENSION OF REGISTRATION.

301. Administrative Review Generally.

The Bureau Director may inspect, or cause to be inspected the establishment of an applicant or registrant, pursuant to the Act or this Regulation. The Bureau Director shall review the application for registration and other information gathered by the Bureau of Drug Control regarding an applicant in order to determine whether the applicable standards of the Act have been met by the applicant.

HISTORY: Formerly R. 61-4.122. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

302. Applications for Research in Controlled Schedule I Substances.

(a) In the case of an application for registration to conduct research with controlled substances, the Bureau Director shall refer such application to the Director who shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Bureau Director, in determining the merits of a research protocol, shall consider procedures to effectively safeguard against diversion of such controlled substances from legitimate medical or scientific use. If the Bureau Director finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, he shall register the applicant unless he finds registration should be denied on a ground specified in the Act.

(b) If the Bureau Director is unable to find the applicant qualified or finds that grounds exist for the denial of the application, the Bureau Director shall issue an order to show cause pursuant to Section 309 and, if requested by the applicant, hold a hearing on the application pursuant to Section 310.

HISTORY: Formerly R. 61-4.123. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

303. Application for Bulk Manufacture of Schedules I and II Substances.

The Bureau Director shall coordinate applications for bulk manufacture of schedules I and II controlled substances with the DEA of the U.S. Department of Justice. Applications may be received by the Bureau Director for such bulk manufacture, but shall not be acted upon until tentative or conditional approval is made by the appropriate federal agency, and after such notifications, publications, and other actions required by Chapter II, Title 21, Code of Federal Regulations [21 CFR Section 1301, ff.] are effected by the applicant.

HISTORY: Formerly R. 61-4.124. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

304. Provisional Registration.

(a) The Bureau Director, in his or her discretion, may grant provisional registration as a Researcher, Manufacturer, Distributor, Importer, or Exporter to any applicant, pending such applicant's obtaining a registration under Federal law. The duration of such provisional registration shall not exceed one year, and may not be renewed. Upon the granting of Federal registration, the provisional registration may be converted to a permanent registration by DHEC, which may renew such registration in the same manner as any other regular registration. If the Bureau Director does not find it in the public interest to grant a provisional registration, or to convert a provisional registration into a regular registration in the manner provided above, procedures set forth in S.C. Code Ann. Section 44-53-320 for denial of registration shall be followed.

(b) Provisional registration does not entitle the applicant (i.e., the provisional registrant) to conduct any controlled substances activity within this State until such time as the applicant obtains a valid federal [DEA] registration for the identical activity at the same registered location.

HISTORY: Formerly R. 61-4.124.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

305. Certificate of Registration; Denial of Registration.

(a) The Bureau Director shall issue a Certificate of Registration to an applicant if the issuance of registration or re-registration is required under the applicable provisions of the Act. In the event that the issuance of registration or re-registration is not required, the Bureau Director shall deny the application. Before denying any application, the Bureau Director shall issue an order to show cause pursuant to Section 309 and, if requested by the applicant, shall hold a hearing on the application pursuant to Section 310.

(b) The Certificate of Registration shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Controlled Substances Code Number of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall maintain the Certificate of Registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent or employee of the DEA or of any federal, state, or local agency engaged in enforcement of laws relating to controlled substances.

HISTORY: Formerly R. 61-4.125. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

306. Suspension or Revocation of Registration.

(a) The Bureau Director may suspend any registration pursuant to the Act for any period of time he determines.

(b) The Bureau Director may revoke any registration pursuant to the Act.

(c) Before revoking or suspending any registration, the Bureau Director shall issue an order to show cause pursuant to Section 309 and, if requested by the registrant shall hold a hearing pursuant to Section 310. Notwithstanding the requirements of this section, however, the Director may suspend any registration pending a final order pursuant to Section 307.

(d) Upon service of the order of the Bureau Director suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration and any forms to his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant. Also, upon service of the order of the Bureau Director suspending or revoking registration, the registrant shall:

(1) Deliver all controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or

(2) Place all controlled substances in his or her possession under seal as described in the Act.

(e) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration, when limited to a particular basic class or classes of controlled substances, shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant for such class or classes. Also, upon service of the order of the Bureau Director revoking or suspending registration, the registrant shall:

(1) Deliver to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control all of the particular controlled substances or substances affected by the revocation or suspension which are in his or her possession; or

(2) Place all of such substances under seal as described in the Act.

HISTORY: Formerly R. 61-4.126. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

307. Suspension of Registration Pending Final Order.

(a) The Bureau Director may suspend any registration simultaneously with or at any time subsequent to the service upon the registration of an order to show cause why such registration should not be revoked or suspended, in any case where he or she finds there is an imminent danger to the public health or safety. If the Bureau Director so suspends, he or she shall serve with the order to show cause pursuant to Section 309 an order of immediate suspension, which shall contain a statement of his or her findings regarding the danger in public health or safety.

(b) Upon service of the order of immediate suspension, the registrant shall promptly return his or her Certificate of Registration and any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension of any registration under this section shall suspend any quota fixed for the registrant. Also, upon service of the order of the Bureau Director immediately suspending registration, the registrant shall, as instructed by the Bureau Director:

(1) Deliver all affected controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or

(2) Place all of such substances under seal as described in the Act.

(c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Bureau Director or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his or her registration at a time earlier than specified in the order to show cause pursuant to Section 309, which request shall be granted by the Bureau Director, who shall fix a date for such hearing as early as reasonably possible.

HISTORY: Formerly R. 61-4.127. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

308. Extension of Registration Pending Final Order.

(a) In the event that an applicant for re-registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for re-registration of at least 45 days before the date on which the existing registration is due to expire, and the Bureau Director has issued an order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue to effect until the date on which the Bureau Director so issues his or her order.

(b) The Bureau Director may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for re-registration; at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Bureau Director finds that such extension is not inconsistent with the public health and safety.

HISTORY: Formerly R. 61-4.128. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

309. Order to Show Cause.

(a) If, upon examination of the application for registration from any applicant and other information gathered by the Bureau of Drug Control regarding the applicant, the Bureau Director is unable to make the determinations required by the applicable provisions of the Act to register the applicant, the Bureau Director shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information gathered by the Bureau of Drug Control regarding any registrant, the Bureau Director determines that the registration of such registrant is subject to suspension or revocation to the Act, the Bureau Director shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before a hearing officer at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d) Upon receipt of an order to show cause, the applicant or registrant shall, if he or she desires a hearing, file a request for a hearing in writing. If a hearing is requested, the hearing officer shall hold a hearing at the time and place stated in the order, pursuant to Section 311.

(e) When authorized by the Bureau Director, any agent of the Bureau of Drug Control may serve the order to show cause, or service may be effected by registered or certified mail.

HISTORY: Formerly R. 61-4.129. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

310. Hearing Generally.

(a) In any case where the hearing officer shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth by statute or by the Attorney General's Office.

(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act of any other law of this State or the United States.

HISTORY: Formerly R. 61-4.130. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

311. Purpose of Hearing.

If requested by a person entitled to a hearing the hearing officer shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to manufacture in bulk a basic class of controlled substances listed in schedules I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.

HISTORY: Formerly R. 61-4.131. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

312. Waiver and Modification of Rules.

The Director or the presiding officer (with respect to matters pending before him or her) may modify or waive any rules in this part by notice in advance of the hearing, if he or she determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing.

HISTORY: Formerly R. 61-4.132. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

313. Request for Hearing or Appearance; Waiver.

(a) Any person entitled to a hearing pursuant to Sections 302-306 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause, file with the Director a written notice for a hearing.

(b) Any person entitled to and desiring to participate in a hearing pursuant to Section 309 shall, within 10 days of the date of the hearing, file with the Director a written notice of his or her intention to participate in such hearing.

(c) Any person entitled to a hearing or to participate in a hearing pursuant to Sections 302-306 may, within the period permitted for filing a request for a hearing or a notice of appearance, file with the Director a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his or her position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.

(d) If any person entitled to a hearing or to participate in a hearing pursuant to Sections 302-306 fails to file a request for a hearing or a notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his or her opportunity for the hearing or to participate in the hearing, unless he show good cause for such failure.

(e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Director may cancel the hearing if scheduled, and issue his or her final order pursuant to Section 316 without a hearing.

HISTORY: Formerly R. 61-4.133. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

314. Burden of Proof.

(a) At any hearing on an application to manufacture any controlled substance listed in schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to the Act are satisfied. Any other person participating in the hearing pursuant to Section 313 shall have the burden of proving any proposition of fact or law asserted to him or her in the hearing.

(b) At any hearing on the granting or denial of an application to be registered to conduct a narcotic treatment program or as a compounder, the applicant shall have the burden of proving that the requirements for each registration pursuant to S.C. Code Ann. Section 44-53-290(i) are satisfied.

(c) At any other hearing for the denial of a registration, DHEC shall have the burden of proving that the requirements for such registration pursuant to the Act are not satisfied.

(d) At any hearing for the revocation or suspension of a registration, DHEC shall have the burden of proving that the requirements of the Act for such suspension or revocation are satisfied.

HISTORY: Formerly R. 61-4.134. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

315. Time and Place of Hearing.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing (unless expedited pursuant to Section 307) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.

HISTORY: Formerly R. 61-4.135. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

316. Final Order and Appeals.

(a) Final order. As soon as practicable after the hearing officer has certified the record to the Director, the Director shall certify his or her order on the granting, denial, revocation, or suspension of registration.

(b) Appeals. A Department decision involving the issuance, denial, renewal, suspension, or revocation of a permit, license, certificate or certification may be appealed by an affected person with standing pursuant to applicable law, including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1, Chapter 23. Any person to whom an order is issued may appeal it pursuant to applicable law, including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1, Chapter 23.

HISTORY: Formerly R. 61-4.136. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

317. Modification in Registration.

Any registrant may apply to modify his or her registration to authorize the handling of additional controlled substances or to change his or her name or address, by submitting a letter of request to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. The letter shall contain the registrant's name, address, and registration number as printed on the Certificate of Registration, and the substances and/or schedules to be added to his or her registration or the new name or address and shall be signed in accordance with Section 202(d). If the modification in registration is approved, the Bureau Director shall issue a new Certificate of Registration to the registrant, who shall maintain it with the old Certificate of Registration until expiration.

HISTORY: Formerly R. 61-4.137. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

318. Termination of Registration.

The registration of any person shall terminate if and when such person dies, ceases legal existence, or discontinues business or professional practice. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Bureau Director promptly of such fact.

HISTORY: Formerly R. 61-4.138. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

319 Termination of Registration; Partnerships and Corporations; Other Business Entities.

(a) Upon the transfer of ownership of a controlling interest in any partnership, corporation, holding company, association, or other business entity holding a registration under the Act, which is not a personal registration as an individual or a proprietorship registration involving a single individual registrant, the registration held prior to any transfer of any controlling interest or controlling ownership shall terminate upon the effective date of the transfer, and a new registration shall be obtained if the business entity is to continue controlled substances activity. DHEC may, in its discretion, permit a transferor-registrant to permit the transferee to continue operation pursuant to a written power of attorney for a period of not more than 60 days, during the pendency of obtaining a new registration for the transferee.

(b) If the control of a corporation already registered under the Act shall be acquired by another corporation not registered under the Act, the acquiring corporation need not obtain a separate registration for itself, unless merger takes place; the corporation acquired shall, however, obtain a new registration even if there is no change in corporate officers if it intends to continue controlled substances activity. In the event a merger is effected between the acquiring corporation and the acquired corporation (regardless of the surviving or ensuing name) the acquiring corporation shall obtain a new registration in its own name, or in the name of the successor or ensuing corporation (if different) prior to engaging in controlled substances activity. Successor corporations shall be deemed to be new business entities, and shall obtain new registration prior to conducting controlled substances activity.

HISTORY: Formerly R. 61-4.138.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

320. Transfer of Registration.

No registration or authority conferred thereby shall be assigned or otherwise transferred except upon conditions as the Bureau Director may specifically designate and then only pursuant to his or her written consent.

HISTORY: Formerly R. 61-4.139. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

321. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

322. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 400. SECURITY REQUIREMENTS

401. Security Requirements Generally.

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Bureau Director shall use the security requirements set forth in Sections 402-406 as standards for the physical security controls and operating procedures necessary to diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in Sections 402, 403, and 405 may be used in lieu of the materials and construction described in those sections.

(b) Substantial compliance with the standards set forth in Sections 402-406 may be deemed sufficient by the Bureau Director after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Bureau Director may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements:

(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);

(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or non-usable powders);

(3) The quantity of controlled substances handled;

(4) The location of the premises and the relationship such location bears on security needs;

(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;

(6) The type of vault, safe, and secure enclosures or other storage systems (e.g., automatic storage and retrieval system) used;

(7) The type of closures on vaults, safes, and secure enclosures;

(8) The adequacy of key control systems and/or combination lock control system;

(9) The adequacy of electric detection and alarm systems if any, including use of supervised transmittal lines and standby power sources;

(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

(11) The adequacy of supervision over employees having access to manufacturing and storage area;

(12) The procedures for handling business guests, visitors, maintenance personnel, and non-employees service personnel;

(13) The availability of local police protection or of the registrant's or applicant's security personnel; and

(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.

(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different scientific schedule, or as a result of a non-controlled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Sections 402-406 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.

(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Sections 402-406 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Bureau Director or to the Compliance Investigations Division, DEA, Department of Justice, Washington, DC 20537.

(e) Physical security controls of locations registered under the Harrison Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in Sections 402, 403, and 405. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Bureau of Drug Control, shall not necessarily be deemed to comply substantially with the standards set forth in Sections 402, 403, and 405 notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved.

HISTORY: Formerly R. 61-4.140. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

402. Physical Security Controls for Non-practitioners; Storage Areas.

(a) Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in schedules I and II shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe or steel cabinet:

(i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-minutes against lock manipulation, and 20 man-minutes against radiological techniques.

(ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and

(iii) Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Bureau Director may approve.

(2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system and

(3) A vault constructed after September 1, 1971:

(i) The walls, floors, and ceilings of which vaults are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors and ceilings;

(ii) The door and frame of which vault shall conform to the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against local manipulation, and 20 man-hours against radiological techniques.

(iii) Which vault, if operations require it to remain open for frequent access, is equipped with a "day-gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;

(iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant as the Bureau of Drug Control may approve and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(v) Which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Bureau of Drug Control.

(b) Schedules III, IV and V. Raw materials, bulk materials awaiting further processing and finished products which are controlled substances listed in schedules III, IV, and V shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a)(1) of this section;

(2) A vault which complies with the requirements set forth in either paragraph (a)(2) or (3) of this section; equipped with an alarm system as described in paragraph (b) (4) (v) of this section; or

(3) A building used for storage of Schedules III through V controlled substances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications:

(i) Has an electronic alarm system as described in paragraph (b) (4) (v) of this section;

(ii) Is equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use, and when in use is kept under direct observation of a responsible employee of the agent or registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded, or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination or key lock type and:

(a) In the case of key locks, shall require key control which limits access to a limited number of employees, or;

(b) In the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination;

(4) A cage, located within a building on the premises, meeting the following specifications:

(i) Having walls constructed of not less than No. 10 gauge steel posts, which posts are:

(a) At least one inch in diameter;

(b) Set in concrete or installed with lag bolts that are pinned or brazed; and

(c) Which are placed no more than 10 feet apart with horizontal one and one-half inch reinforcements every sixty inches;

(ii) Having a mesh construction with openings of not more than two and one-half inches across the square;

(iii) Having a ceiling constructed of the same material, or in the alternative, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height;

(iv) Is equipped with a door constructed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects conforms to all of the requirements of subparagraph (b)(3)(ii) of this section; and

(v) Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency, or a local or state police agency, each having a legal duty to respond, or a 24-hour control station operated by the registrant, or to such other source of protection that the Bureau Director may approve;

(5) An enclosure of masonry or other material, approved in writing by the Bureau Director as providing security comparable to a cage;

(6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor, agency, BNDD, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment from DEA (BNDD) has been received for the area in which such building or enclosure is situated;

(7) Such other secure storage areas as may be approved by the Bureau Director after consulting with DEA and the factors listed in Section 401(b)(1) through (14) of this regulation;

(8)(i) Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by paragraph (a) of this section;

(ii) Non-controlled drugs, substances, and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by this section, provided, that permission for such storage of non-controlled substances has been obtained in advance, in writing, from both the Bureau Director and the DEA agent in charge of the area in which such storage area is situated [See 21 CFR Section 1301.72 (b)(8)(ii)]. Any such permission shall be based upon the determination that the storage of such items does not diminish security for the controlled substances.

(c) Multiple store areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g. returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.

(d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

HISTORY: Formerly R. 61-4.141. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

403. Physical Security Controls for Non-practitioners; Manufacturing Areas.

All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following:

(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted, provided, that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his or her knowledge.

(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

HISTORY: Formerly R. 61-4.142. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

404. Other Security Controls for Non-practitioners; Narcotic Treatment Programs and Compounders for Narcotic Treatment Programs.

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the DEA or with the state controlled registration agency to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to alert the registrant of suspicious orders of controlled substances. The registrant shall inform the Bureau of Drug Control of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify the office of the Bureau of Drug Control of any theft or loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the contract or common carrier pursuant to subparagraph (e) of this section, upon discovery of such theft or loss. The registrant shall also complete DEA Form 106 regarding such theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) The registrant shall not distribute any controlled substances in schedules II through V as a complimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the customer and (3) only in reasonable quantities. Such request shall contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substances desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of Part 900 of the Regulation shall be complied with for any distribution of a controlled substance listed in schedule II. For purposes of this paragraph, the term "customer" includes a person to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance to the person.

(e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers, which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in Section 402. In addition, the registrant shall employ precautions (e.g. assuring that shipping containers do not indicate the contents are controlled substances) to guard against storage or in-transit losses.

(f) When distributing controlled substances through agents (e.g., detail men), a registrant is responsible for providing adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.

(g) Before the initial distribution of etorphine hydrochloride and/or diprenorphine to any person, the registrant shall verify that the person is authorized to handle the substance(s) by contacting the Bureau of Drug Control and DEA.

(h) The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual designated in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his or her specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.

(i) Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either (1) the licensed practitioner, (2) a registered nurse under the direction of the licensed practitioner, (3) a licensed practical nurse (LPN) under the direction of the licensed practitioner, or (4) a pharmacist acting under a prescription or an order issued by the licensed practitioner.

(j) Persons enrolled in a narcotic treatment program will be required to wait in an area physically separated from the narcotic storage and dispensing area. This requirement will be enforced by the program physician and employees.

(k) All narcotic treatment programs shall comply with standards established by the appropriate Federal authorities [see 21 CFR Section 1301.74(k)] and the Bureau of Drug Control, and the provisions of S.C. Code Ann. Sections 44-53-710 through 44-53-760 respecting the quantities of narcotic drugs that may be provided to persons enrolled in a narcotic treatment program for unsupervised use.

(l) DEA and the Bureau of Drug Control may exercise discretion regarding the degree of security required in narcotic treatment programs based upon such factors as the location of the program, the number of patients enrolled in a program, and the number of physicians, staff members, and security guards. Similarly, such factors will be taken into consideration when evaluating existing security or requiring new security at a narcotic treatment program.

HISTORY: Formerly R. 61-4.143. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

405. Physical Security Controls for Practitioners.

(a) Controlled substances listed in schedule I shall be stored in a securely locked, substantially constructed cabinet.

(b) Controlled substances listed in schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(c) This section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration.

(d) Etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

HISTORY: Formerly R. 61-4.144. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

406. Other Security Controls of Practitioners.

(a) The registrant shall not knowingly employ as an agent or employee, who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration denied, or has had his or her registration revoked, at any time.

(b) The registrant shall notify the Bureau of Drug Control, DHEC, of the loss or theft of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DEA Form 106 regarding such loss or theft.

(c) The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to 21 CFR Section 1301.74(e), upon discovery of such theft or loss.

(d) Whenever the registrant distributes a controlled substance (without being registered as a distributor, as permitted by Section 107(b) and/or Sections 1401 through 1404 of this Regulation) he or she shall comply with the requirements imposed on non-practitioners in Section 404(a), (b), and (e).

HISTORY: Formerly R. 61-4.145. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

407. Loss by Diversion Due to Repeated Thefts.

(a) Any registrant who suffers repeated losses of controlled substances by theft due to break-ins, employee theft, mysterious disappearance, or other than through an armed robbery shall be deemed to be providing inadequate security for such controlled substances.

(b) Upon the first such diversion, the registrant shall cause such physical security measures to be instituted to prevent reoccurrence.

(c) Upon the second such diversion, the registrant shall be required to appear before the designated hearing officer of DHEC to provide, under oath, the security measures that the registrant has effected and plans to effect in the future to prevent further diversion by theft.

(d) Upon the third such diversion, the registrant shall be cited to show cause, if any he or she may have, why his or her registration under the Controlled Substances Act should not be revoked, suspended, or denied pursuant to the provisions of S.C. Code Ann. Section 44-53-310(e).

HISTORY: Formerly R. 61-4.146. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

408. Filing of Theft Reports.

Theft reports (DEA Form 106) as required by this regulation shall be filed with the Bureau of Drug Control not later than 30 days following the discovery of the theft. Failure to file theft reports within the thirty-day period shall result in the issuance of an order to show cause for revocation or suspension of registration under the Act.

HISTORY: Formerly R. 61-4.147. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

409. Employee Screening Procedures.

Registrants are required to screen all employees for criminal convictions and/or unauthorized use of controlled substances. An employer's comprehensive employee screening program will include the following inquiries:

(1) Within the past five years have you been convicted of a felony or any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses, or military conviction, except by general court martial.) If the answer is yes, furnish details of the conviction, offense, location, date, and sentence.

(2) In the past three years, have you ever knowingly used any narcotic, barbiturates, or amphetamines, other than prescribed to you by a physician or other practitioner? If the answer is yes, furnish details.

Employers should obtain an authorization, in writing, that allows inquires to be made of courts and law enforcement agencies for possible pending charges or convictions. This authorization shall be executed by a person who is allowed to work in an area where access to controlled substances clearly exists. A person shall be advised that any false information or omission of information will jeopardize his or her position with respect to employment. The application for employment should inform a person that information furnished or recovered as a result of any inquiry will not necessarily preclude employment, but will be considered as part of an overall evaluation of the person's qualifications. This person must also be informed that the information contained in the application and any information disclosed as a result of the authorization will be available to the Bureau of Drug Control in the event of inquiry or investigation.

HISTORY: Formerly R. 61-4.148. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

410. Employee Responsibility to Report Drug Diversion.

An employee who has knowledge or suspicion of drug diversion from his or her employer by a fellow employee shall report such information to a responsible security official of the employer, or to a person in a management position with the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area, or with access to controlled substances. The employer shall inform all employees concerning this policy.

HISTORY: Formerly R. 61-4.149. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

411. Illicit Activities by Employees.

Employees who sell, possess, use, or divert controlled substances will subject themselves not only to state and federal criminal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee's violation, the position of responsibility held by the employee, and the past record of employment. in determining whether to suspend, transfer, terminate, or take other action against the employee.

HISTORY: Formerly R. 61-4.150. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

412. Separate Registration by Permitted Pharmacies for Installation and Operation of Automated Storage Machines at Long Term Care Facilities.

(a) A permitted pharmacy may install and operate automated storage machines, as defined in Section 102(c) of this Regulation, at long term care facilities. No person other than a permitted pharmacy may install and operate an automated storage machine at a long term care facility.

(b) Permitted pharmacies installing and operating automated storage machines at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated storage machines are located.

(c) A permitted pharmacy applying for a separate registration to operate automated storage machines which contain controlled substances at a long term care facility is exempt from application fees for any such additional registrations.

HISTORY: Added by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 500. LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES.

501. Symbol Required; Exceptions.

(a) Each commercial container of a controlled substance shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, shall bear a label complying with the requirement of this part.

(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him or her the symbol designating the schedule in which such controlled substance is listed.

(c) The following symbols shall designate the schedule corresponding thereto:

Schedule Symbol

Schedule I I or C-I

Schedule II II or C-II

Schedule III III or C-III

Schedule IV IV or C-IV

Schedule V V or C-V

The word "schedule" need not be used. No distinction need be made between narcotic and non-narcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.

(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.

(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.

(g) The symbol is not required on a commercial container containing, or on labeling of, a controlled substance intended for export from the United States.

HISTORY: Formerly R. 61-4.202. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

502. Location and Size of Symbol on Label.

(a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in schedules I through V. The symbol shall be at least two times as large as the largest type otherwise printed on the label.

(b) In lieu of locating the symbol in the corner of the label, as prescribed in paragraph (a) of this section, the symbol may be overprinted on the label, in which case the symbol shall be printed at least one-half the height of the label and in a contrasting color providing clear visibility against the background color of the label.

(c) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.

HISTORY: Formerly R. 61-4.203. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

503. Location and Size of Symbol on Labeling.

The symbol shall be prominently located on all labeling other than labels covered by Regulation 203. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Section 501.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Section 501.

(c) The Bureau Director may, in the case of any controlled substance, require compliance with the requirements of Section 501 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under federal or state law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

HISTORY: Formerly R. 61-4.204. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

504. Effective Dates of Labeling Requirements.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Section 501.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Section 501.

(c) The Bureau Director may, in the case of any controlled substance, require compliance with the requirements of Section 501 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under federal or state law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

HISTORY: Formerly R. 61-4.205. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

505. Sealing of Controlled Substances.

(a) On each bottle, multiple dose vial, other commercial container of any controlled substance listed in schedules I and/or II, and of any narcotic controlled substance listed in schedule III or IV, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container.

(b) Any seal accepted for use, under federal law prior to July 1, 1971, shall be deemed acceptable for use under this section.

HISTORY: Formerly R. 61-4.206. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

505.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

506. Labeling for Controlled Substances Dispensed Directly to Ultimate Users.

Controlled substances which are dispensed directly to an ultimate user other than by a prescription dispensed by a pharmacy or by direct administration or application of the substance into or upon the person for whom it is intended, shall bear a label or labeling containing the drug name, the quantity dispensed, the name and address of the dispenser, the name of the ultimate user (i.e., the "patient"), specific directions for use, and the date of the dispensing. The label or labeling shall include any necessary cautionary statement, whether customary or required by state or federal law. A serial number may be utilized at the discretion of the dispenser. The act of dispensing controlled substances shall be performed by the registrant, and shall not be delegated to any person other than a pharmacist acting in the regular course of professional activity. Prescriptions shall be labeled pursuant to the provisions of Part 1000 of this Regulation, unless specifically exempted. No practitioner shall directly dispense more than a thirty-one day supply.

HISTORY: Formerly R. 61-4.207. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

506.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507.2. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507.3. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507.4. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

507.5. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

508. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

508.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

508.2. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

509. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

510. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

511. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

512. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

513. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

514. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

514.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

514.2. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

514.3. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

515. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

516. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

517. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

517.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

518. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 600. RECORDS AND REPORTS OF REGISTRANTS.

601. Scope of Part 600.

Inventory and other records and reports required under the Act shall be in accordance with, and contain the information required by, those sections and by the sections of this Part.

HISTORY: Formerly R. 61-4.301. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

602. Persons Required to Keep Records and File Reports.

(a) Each registrant shall maintain the records and inventories and shall file the reports required by this Part, except as exempted by this Section. Any registrant who is authorized to conduct other activities without being registered to conduct these activities, either pursuant to Section 107(b) or to Sections 1401 through 1404, shall maintain the records and inventories and shall file the reports required by this Part for persons registered to conduct such activities. The latter requirement should not be construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Bureau of Drug Control is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. The Bureau of Drug Control does not wish to require separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he or she shall keep a record of the quantity manufactured; when he or she distributes a quantity of the item, he or she shall use and keep invoices or order forms to document the transfer; when he or she imports a substance, he or she keeps as part of his or her records the documentation required to an importer; and when substances are used in chemical analysis, he or she need not keep a record of this because such a record would not be required of him or her under a registration to do chemical analysis. All of those records may be maintained in one consolidated record system. Similarly, the researcher may store all of his or her controlled items in one place, and every year take inventory of all items in hand, regardless of whether the substances were manufactured by him or her, imported by him or her, or purchased domestically by him or her, or whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis.

(b) A registered individual practitioner is not required to keep specific records with respect to controlled substances for which he or she issues prescriptions, or orders for administration within an institutional practitioner setting (e.g., hospital "orders"), in the lawful course of his or her professional practice; provided, that a complete record or memorandum of such prescription or order be maintained upon regular patient records.

(c) A registered individual practitioner is required to maintain a readily retrievable record, separate from patient charts, of all controlled substances acquired, dispensed, administered (other than by the issuance of an institutional order or a prescription) distributed, or otherwise disposed of by the practitioner, his or her employees or agents, whether the controlled substance is separately charged for, included in other charges, or is provided at no charge. Practitioners who personally administer narcotic controlled substances in an emergency need only keep a simple record of the date, kind, quantity, and strength of the controlled substance administered in such emergency, and the name of the recipient. Within 72 hours of the emergency administration, a permanent record shall be constituted and included in the readily retrievable records of dispensing required herein. Repeated or excessive emergency administrations will require the registrant to notify the Bureau of Drug Control of such happenstance.

(d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under Section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) as a registered establishment which maintains records in accordance with either of those sections is not required to keep records if he notified the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records.

(e) A registered person using any controlled substance in pre-clinical research or in teaching at a registered establishment, which maintains records with respect to such substance, is not required to keep records if he notifies the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records.

(f) Notice required by paragraphs (d) and (e) of this section shall be given at the time the person applies for registration or re-registration and shall be made in the form of an attachment to the application, which shall be filed with the application.

HISTORY: Formerly R. 61-4.303. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

603. Maintenance of Records and Inventories.

(a) Every inventory and other record required to be kept under this Part shall be kept by the registrant and be available, for at least two years from the date of such inventory or record, for inspecting and copying by authorized employees of the Bureau of Drug Control, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to 21 CFR Section 1305.13) may be kept at a central location rather than at the registered location if the registrant has notified the Bureau of Drug Control of its intention to keep central records. Written notification shall be submitted by registered or certified mail, return receipt requested, in triplicate to the Bureau Director. Unless the registrant is informed by the Bureau Director that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of the return receipt accompanying the notification. All notifications shall include:

(1) The nature of the records to be kept centrally and the exact location where the records will be kept;

(2) The name, address, state and DEA registration numbers, and type of registration of the registrant whose records are being maintained centrally;

(3) Whether central records will be maintained in a manual, or computer readable form.

(b) Each registered manufacturer, distributor, importer, and exporter shall maintain inventories and records of controlled substances as follows:

(1) Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrants, and

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

(c) Each registered individual practitioner required to keep records and each institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (b) of this section.

(d) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(1) Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained as a separate prescription file.

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.

(3) Prescriptions for controlled substances shall be maintained in separate files from prescriptions for non-controlled substances. Prescriptions for schedule II controlled substances shall be filed separately from prescriptions for schedules III, IV, and V controlled substances. Compliance with this Section will be deemed proper if the pharmacy maintains not less than three files, those being:

File No. 1-Schedule II Controlled Substances only.

File No. 2-Schedules III, IV, and V Controlled Substances only.

File No. 3-Non-controlled Substances.

Sequential numbering systems of the files shall be at the discretion of the dispenser.

(e) All registrants that are authorized to maintain a central record keeping system shall be subject to the following conditions:

(1) The records to be maintained at the central record location shall not include executed order forms, prescriptions, and/or inventories which shall be maintained at each registered location.

(2) If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information) a key to the code shall be provided to make the records understandable.

(3) The registrant agrees to deliver all or any part of such records to the registered location within 2 business days upon receipt of a written request from the Bureau of Drug Control, and if the Bureau of Drug Control chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Bureau of Drug Control to inspect such records at the central location upon request by such employees without a warrant of any kind.

(4) In the event that a registrant fails to comply with these conditions, the Bureau Director may cancel such central record keeping authorization, and all other central record keeping authorization held by the registrant without a hearing or other procedures. In the event of cancellation of central record keeping authorization under this paragraph, the registrant shall, within the time specified by the Bureau Director, comply with the requirements of this section that all records be kept at the registered location.

(f) Original documents shall be maintained in addition to those which are stored in computer media for a period of two years from the date of the origination of the document, or from the last transaction contained therein or entered thereupon, whichever is the later date.

HISTORY: Formerly R. 61-4.304. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

604.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

605. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

606. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

607. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

608. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

609. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 700. INVENTORY REQUIREMENTS.

701. General Requirements for Inventories.

(a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.

(b) A separate inventory shall be made by a registrant for each registered location. In the event controlled substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.

(c) A separate inventory shall be made by a registrant for each independent activity for which he is registered, except as provided in Section 707.

(d) A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business, and the date and time the inventory is taken.

(e) An inventory shall be maintained in an indelibly written, typewritten, or printed form. An inventory taken by use of an oral recording device shall be promptly transcribed. Such inventory shall be signed by a responsible individual, who attests to the completeness and accuracy of the inventory.

HISTORY: Formerly R. 61-4.305. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

702. Inventory upon Transfer of Business; Change of Pharmacist-in-Charge.

(a) Inventory upon transfer of business.

(1) Any registrant transferring his or her business to another person who shall become registered to continue such business shall inventory all controlled substances on hand at the close of business on the day of transfer. The receiving registrant shall either (a) certify the inventory taken as being correct, or (b) shall affect his or her own inventory at the start of business on the date of transfer. Any discrepancy in the inventory shall be reported within 5 days to the Bureau Director.

(2) A new establishment, never before having been registered, and having no prior inventory of controlled substances, shall be deemed to have a zero inventory as of the first day of business.

(3) A registrant discontinuing business shall upon the date of discontinuance inventory all controlled substances and place said controlled substances in sealed containers under adequate protection from theft, until such time as the controlled substances are transferred to another registrant. A copy of this inventory shall be placed with the controlled substances, and a copy retained by the discontinuing registrant.

(b) A complete inventory of all controlled substances on hand shall be performed at the time of a change in pharmacist-in charge.

HISTORY: Formerly R. 61-4.306. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

703. Annual Inventory Date.

Inventories shall be taken on May 1st of each year unless written permission for another date is granted by the Bureau of Drug Control. If permission for another date is granted, the registrant shall maintain documentation of such permission for a period of two (2) years. In the event that a person commences business with no controlled substances on hand, he or she shall record this fact as his or her initial inventory.

HISTORY: Formerly R. 61-4.307. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

704. Inventories of Manufacturers.

Each registered manufacturer shall include the following information in his or her inventory:

(a) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form:

(1) The name of the substance; and

(2) The total quantity of the substance to the nearest metric unit weight consistent with unit size (except that for inventories made in 1971), avoirdupois weights may be utilized where metric weights are not readily available)

(b) For each controlled substance in the process of manufacture on the inventory date:

(1) The name of the substance;

(2) The quantity of the substance in each batch and/or state of manufacture, identified by the batch number of other appropriate identifying number;

(3) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of volume thereof.

(c) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form of the substance (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

(3) The number of units or volume of each finished form in each commercial container (e.g. 100-tablet bottle or 3-milliliter vial); and

(4) The number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials).

(d) For each controlled substance not included in paragraphs (a), (b), or (c) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compounding):

(1) The name of the substance;

(2) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and

(3) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form.

HISTORY: Formerly R. 61-4.308. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

705. Inventories for Distributors.

Each registered distributor shall include in his or her inventory the same information required of manufactures pursuant to Sections 704(c) and (d).

HISTORY: Formerly R. 61-4.309. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

706. Inventories of Dispensers and Researchers.

Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to Section 601 shall include in his or her inventory the same information required of manufacturers pursuant to Sections 704 (c) and (d). In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(a) If the substance is listed in schedule I or II, he or she shall make an exact count or measure of the contents; and

(b) If the substance is listed in schedule III, IV, V, he or she shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he or she shall make an exact count of the contents. If estimated counts are utilized, quantities shall be recorded as number of finished doses per container. Fractions of containers may not be utilized.

(c) It is the responsibility of the registrant to determine that any estimates are accurate, as audit procedures will be based upon the inventories maintained by the registrant. The Bureau of Drug Control utilizes exact counts in all audit procedures, and will allow only minor leeway for estimated inventories.

HISTORY: Formerly R. 61-4.310. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

707. Inventories of Importers and Exporters.

Each registered importer or exporter shall include in his or her inventory the same information required of manufacturers pursuant to Sections 704(a), (c), and (d). Each registered importer or exporter who is also registered as a manufacturer or as a distributor shall include in his or her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his or her stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment).

HISTORY: Formerly R. 61-4.311. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

708. Inventories for Chemical Analysis.

Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers pursuant to Sections 704 (a), (c), and (d) as to substances which have been manufactured, imported, or received by the laboratory conducing the inventory. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in schedule I), or less than 20 grams of a hallucinogenic substance listed in schedule I (other than lysergic acid diethylamide), or less than 0.5 grams of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory.

HISTORY: Formerly R. 61-4.312. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

709. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 800. CONTINUING RECORDS.

801. General Requirements for Continuing Records.

(a) On and after June 17, 1971 every registrant required to keep records pursuant to Section 602 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him or her, except that no registrant shall be required to maintain a perpetual inventory, except as provided in paragraph (e) of this section.

(b) Separate records shall be maintained by a registrant for each registered location except as provided in Section 602. In the event controlled substances are in the possession or under the control of a registrant at a location for which he or she is not registered, the substance shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(c) Separate records shall be maintained by a registrant for each independent activity for which he or she is registered, except as provided in Section 804.

(d) In recording dates of receipt, importation, distribution, exportation or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred shall be used as the date of receipt or distribution of any packing slips.

(e) DHEC, upon a finding that a registrant has maintained inadequate records, or upon a finding that the registrant has a history of poor or inadequate record keeping, may, in its discretion, require perpetual inventories of all or a part on the controlled substances possessed or otherwise utilized or handled by such registrant (or an applicant for new registration having a history of record keeping deficiencies) as a condition for granting or renewing controlled substances registration. DHEC, upon a finding that adequate record keeping has been maintained for two or more years, pursuant to a perpetual inventory requirement, may remove the requirement and permit the registrant to resume standard record keeping activities with or without a probationary period of registration, as DHEC deems proper.

HISTORY: Formerly R. 61-4.313. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

802. Records of Manufacture.

Each registered manufacturer shall maintain records with the following information.

(a) For each controlled substance in bulk form to be used, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substance in finished form:

(1) The name of the substance;

(2) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;

(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;

(4) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him or her, including the date, quantity, and import permit or declaration number for each importation;

(5) The quantity used to manufacture the same substance in finished form, including:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The quantity used in the manufacture;

(iii) The finished form (e.g., 10-milligram tablets or 10 milligram concentrate per fluid ounce or milliliter);

(iv) The number of units of finished form manufactured;

(v) The quantity used in quality control;

(vi) The quantity lost during manufacturing and the causes thereof, if known;

(vii) The total quantity of the substance contained in the finished form;

(viii) The theoretical and actual yields; and

(ix) Such other information as is necessary to account for all controlled substances used in the manufacturing process.

(6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in subparagraph (5) of this paragraph;

(7) The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made;

(8) The quantity exported directly the registrant (under a registration as an exporter), including the date quantity, and export permit or declaration number of each exportation;

(9) The quantity distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed.

(b) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(3) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subparagraph (5) of paragraph (a) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received;

(5) The number of units of finished forms and/or commercial containers imported directly by the registrant (under a registration as an importer), including the date of and the number of units and for commercial containers to each importation;

(6) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The operation performed (e.g., repackaging or re-labeling);

(iii) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and

(iv) Such other information as is necessary to account for all controlled substances used in the manufacturing process;

(7) The number of commercial containers distributed to other persons, including the date and number of containers in each distribution, and the name, address, and registration number of the person to whom the containers were distributed;

(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and

(9) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.

HISTORY: Formerly R. 61-4.314. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

803. Records for Distributors.

Each registered distributor shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) Each finished form (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration of the person from whom the containers were received;

(d) The number of commercial containers of each such finished form imported directly by the registrant (under a registration as an importer), including the date of and the number of containers in each importation;

(e) The number of commercial containers of each such finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;

(f) The number of commercial containers of such finished form exported directly by the registrant (under a registration as an exporter), including the date of and the number of containers of each exportation; and

(g) The number of units or volume of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution as complimentary samples), including the date and manner of distribution or disposal, the name and address, and registration number of the person to whom distributed or disposed.

HISTORY: Formerly R. 61-4.315. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

804. Records for Dispensers and Researchers.

Each person registered to dispense or conduct research with controlled substances required to keep records pursuant to Section 602 shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration number of the person from whom the containers were received;

(d) The number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the dispenser; and

(e) The number of units or volume of such finished form and/or commercial containers disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed.

HISTORY: Formerly R. 61-4.316. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

805. Records for Importers.

Each registered importer shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume), and import permit or declaration number for each importation;

(c) The quantity (or number of units or volume in finished form) distributed to other persons, including the date and quantity (or number of units or volume) of each distribution and the name, address, and registration number of each person to whom a distribution was made; and

(d) The quantity disposed of in any other manner by the registrant, except quantities used for manufacturing by an importer under a registration as a manufacturer, which quantities are to be recorded pursuant to Section 802(a)(4) or (b)(5) including the date and manner of disposal and the quantities disposed.

HISTORY: Formerly R. 61-4.317. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

806. Records of Exporters.

Each registered exporter shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity or number of units (or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address, and registration number of each person from whom the substance was received;

(c) The quantity (or number of units or volume in finished form) exported, including the date, quantity or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to Section 802 (a)(8) or (b)(8); and

(d) The quantity disposed of in any other manner by the registrant including the date and manner of disposal and the quantity disposed.

HISTORY: Formerly R. 61-4.318. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

807. Records for Chemical Analysis.

(a) Each person registered to conduct chemical analysis with controlled substances shall maintain records, with the following information (to the extent known and reasonably ascertainable by him or her) for each controlled substance:

(1) The name of the substance;

(2) The form or forms in which the substance is received, imported, or manufactured by the registrant (e.g., powder, granulation, tablet, capsules, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10-milligram concentration per milliliter);

(3) The total number of the forms received, imported, or manufactured (e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and registration number, if any, of the person from whom the substance was received;

(4) The quantity distributed, exported, or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation or destruction, and the name, address, and registration number, if any, of each person to whom the substance was distributed or exported.

(b) Order forms, import and export permits, import invoices, and export declarations, relating to controlled substances shall be maintained separately from all other records of the registrant.

(c) Records of controlled substances used in chemical analysis or other laboratory work are not required.

(d) Records relating to known or suspected controlled substances received as samples for analysis are not required under paragraph (a) of this section.

HISTORY: Formerly R. 61-4.319. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

808. Reports.

Manufacturers, re-packers, re-labelers, importers, exporters, and distributors who are required to report to ARCOS systems of the DEA, U.S. Department of Justice, need not file copies of such reports with the Bureau of Drug Control, but such registrants shall make copies of the reports available to the Bureau of Drug Control upon its written or oral request. Substantial compliance with the provisions of 21 CFR Sections 1304.31 through 1304.33 shall be deemed sufficient compliance with state reporting requirements.

HISTORY: Formerly R. 61-4.320. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

809. Records for Maintenance Treatment Programs and Detoxification Treatment Programs.

(a) Each person registered or authorized by DHEC to maintain and/or detoxify controlled substances users in a narcotic treatment program shall maintain records with the following information for each narcotic controlled substance:

(1) Name of substance;

(2) Strength of substance;

(3) Dosage form;

(4) Date dispensed;

(5) Adequate identification of the patient (consumer);

(6) Amount consumed;

(7) Amount and dosage form taken home by patient; and

(8) Dispenser's initials.

(b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the narcotic treatment program site and will be maintained in compliance with Section 804 without reference to Section 602.

(c) All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use, shall keep a separate batch record of the compounding.

(d) Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by this regulation and any other state or federal law or regulation.

HISTORY: Formerly R. 61-4.321. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

810. Records for Treatment Programs Which Compound Narcotics for Treatment Programs and Other Locations.

Each person registered or authorized under the provisions of Section 107 of this Regulation to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug:

(a) For each narcotic controlled substance in bulk form to be used in, or capable of being used in, or being used in the compounding of the same or other non-controlled substances in finished form:

(1) The name of the substance;

(2) The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded;

(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;

(4) The quantity imported directly by the registrant (under a registration as an importer) for use in compounding by him or her, including the date, quantity, and import permit or declaration number of each importation;

(5) The quantity used to compound the same substance in finished form, including:

(i) The date and batch or other identifying number of each compounding;

(ii) The quantity used in the compound;

(iii) The finished form (e.g., 10-milligram tablets; 10 mg/ml per fluidounce, etc.);

(iv) The number of units of finished form compounded;

(v) The quantity used in quality control;

(vi) The quantity lost through compounding and the causes therefore, if known;

(vii) The total quantity of the substance contained in the finished form;

(viii) The theoretical and actual yields;

(ix) Such other information as is necessary to account for all controlled substances used in the compounding process;

(6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in paragraph (a) (5) of this section;

(7) The quantity distributed in bulk form to other programs, including the date and quantity of each distribution, and the name, address, and registration number of each program to whom a distribution was made;

(8) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation; and

(9) The quantity disposed of by destruction, including the reason, date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Section 1501.

(b) For each narcotic controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form and the number of units or volume or finished form in each commercial container (e.g., 100-tablet bottle or 3 ml. ampoule, etc.);

(3) The number of containers of each such commercial finished form compounded from bulk form by the registrant, including the information required by paragraph (a) (5) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received;

(5) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;

(6) The number of units and/or commercial containers compounded by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each compounding.

(ii) The operation performed (e.g., repackaging or re-labeling);

(iii) The number of units of finished form used in the compound, the number compounded, and the number lost during compounding, with the causes for such losses, if known;

(iv) Such other information as is necessary to account for all controlled substances used in the compounding process.

(7) The number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address, and registration number of the program to whom the containers were distributed;

(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers, and export permit or declaration number for each exportation; and

(9) The number of units of finished forms and/or commercial containers destroyed in any manner by the registrant, including the reason, the date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Section 1501.

HISTORY: Formerly R. 61-4.322. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

811. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

812. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

814. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

815. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

816. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

817. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

818. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 900. ORDER FORMS.

901. Execution of Order Forms.

DEA Form 222 as issued by the DEA, U.S. Department of Justice, as required by the Federal Controlled Substances Act (21 USC 828) when properly executed and filed will be deemed a sufficient order form as required by the Act.

HISTORY: Formerly R. 61-4.401. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

902. Handling and Filing.

Handling and filing of order forms, and electronic orders, shall be accomplished in the manner provided under Part 1305, 21 C.F.R. (Regulations of the DEA, United States Department of Justice.)

HISTORY: Formerly R. 61-4.402. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

903. Power of Attorney.

Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his or her behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed (or was authorized to sign) the most recent application for registration or re-registration and by the individual being authorized to obtain and execute order forms. The power of attorney shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the most recent application for registration or re-registration, and filing it with the power of attorney being revoked. The forms are available from Director of the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201.

HISTORY: Formerly R. 61-4.403. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

904. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

905. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

906. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

907. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

908. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

909. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

910. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

911. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

912. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

914. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

915. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

916. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

916.1. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

917. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

918. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

919. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

920. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

921. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

922. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

923. Deleted by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1000. PRESCRIPTIONS.

1001. Persons Entitled to Issue Prescriptions.

(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:

(1) Licensed by the S.C. Board of Medical Examiners, S.C. Board of Dentistry, S.C. Board of Veterinary Medicine Examiners, S.C. Board of Nursing, S.C. Board of Examiners in Optometry, or the S.C. Board of Podiatry Examiners, and is authorized to prescribe under the type of license issued by the pertinent Board to the individual practitioner; and

(2) Acting in the regular course of professional practice, e.g., a veterinarian prescribing for a human is not within the regular course of professional practice, nor is a dentist when prescribing for illnesses or disease other than those of the oral cavity and adjacent tissues, nor is a podiatrist when prescribing for treatment of disease other than those manifesting themselves in the foot; and

(3) Registered with DHEC under the provisions of the Act.

(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. The individual practitioner may not delegate the act of prescribing (i.e., the decision-making process whether to issue a prescription, what drug or substance to prescribe, what dosage, what frequency, and whether to refill the prescription) to a person not authorized to issue a prescription in his or her own right as an individual practitioner.

Example: A nurse or other employee of a physician may transmit an oral prescription (if permissible as a Schedule III, IV, or V substance) to a pharmacist if authorized to do so by the prescribing physician; the transmitting person has no authority to make any change whatsoever in the order of the practitioner, nor to add or delete any information to be transmitted.

HISTORY: Formerly R. 61-4.503. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1002. Purpose of Issue of Prescription.

(a) A prescription for a controlled substance to be effective shall be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs whether or not in the course of conducting an authorized clinical investigation in the development of a narcotic rehabilitation program.

HISTORY: Formerly R. 61-4.504. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1003. Manner of Issuance of Prescription.

All prescriptions for controlled substances shall be dated as of the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner.

(a) Written prescriptions. A practitioner shall sign a prescription on the day when issued and in the same manner as he or she would sign a check or legal document (e.g., J. H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter, or other mechanical means of printing, and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this regulation. See also Section 1001(b).

(b) Electronic prescriptions. Existing DEA regulations provide practitioners with the option of transmitting electronic prescriptions for controlled substances in lieu of paper prescriptions. In an effort to ensure the integrity of these electronic prescriptions, the electronic application shall comply with the current DEA regulations prior to use.

HISTORY: Formerly R. 61-4.505. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1004. Registration Number Required on Prescriptions.

All prescriptions for controlled substances, whether written by the practitioner or telephoned and subsequently reduced to writing, shall bear the Federal Controlled Substances Registration Number (DEA Number) of the prescribing practitioner.

HISTORY: Formerly R. 61-4.505.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1005. Persons Entitled to Fill Prescriptions.

A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his or her professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner.

HISTORY: Formerly R. 61-4.506. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1006. Information Required for Filled Prescriptions.

A notation shall be placed upon any prescription for controlled substances when originally filled that shall indicate the date filled, the identity or initials of the pharmacist dispensing the prescription and, if different from the quantity prescribed, the quantity dispensed.

HISTORY: Formerly R. 61-4.506.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1007. Dispensing of Narcotic Drugs for Maintenance Purposes.

The administering or dispensing directly (but not prescribing of) narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his or her professional practice or research" in the Act, provided, that approval is obtained prior to the initiation of such a program by submission of a Notice of Claimed Investigational Exemption for a New Drug to the Food and Drug Administration which will be reviewed concurrently by the Food and Drug Administration for scientific merit and by the DEA for drug control requirements, and that the clinical investigation thereafter accords with such approval.

HISTORY: Formerly R. 61-4.507. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1008. Federal Approval of Maintenance Programs Required.

DHEC will not register any person to conduct an authorized maintenance program for drug dependent persons until approval of such program has been made by the appropriate federal agencies. Upon approval by these agencies, the Bureau of Drug Control shall accept the application for registration as complete.

HISTORY: Formerly R. 61-4.507.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1009. Withdrawal of Drug Dependent Persons by Use of Methadone or Other Narcotic Controlled Substances.

Practitioners desiring to withdraw, but not maintain, drug dependent persons addicted to narcotic controlled substances from such substances by the use of methadone or any other schedule II narcotic controlled substance, may do so provided that all of the following criteria are met:

(a) The drug dependent person shall be a narcotic addict.

(b) The drug dependent person shall be confined to a hospital, clinic, rest home, or other appropriate location that properly segregates the drug dependent person from contact with possible illicit suppliers.

(c) The withdrawal program shall be on a reducing dosage basis, preferably through use of oral administration of the narcotic controlled substance used for withdrawal.

(d) Withdrawal treatment shall not exceed 21 days in length and shall not be available to any drug dependent person more often than once every six months. If, in the opinion of the withdrawing practitioner, longer periods of withdrawal treatment are necessary, application for such longer treatment shall be made to the Director stating the reasons therefore, along with pertinent medical facts including, but not limited to, the following:

(1) Medical condition of subject at onset of withdrawal treatment;

(2) Amount of drug intake and name of drug at onset of treatment;

(3) Initial withdrawal dosage of methadone (or other narcotic controlled substance);

(4) Reduction schedule of withdrawal substance;

(5) Current medical evaluation of withdrawal regimen;

(6) Statement concerning presence or absence from urine sample of drug dependent person of the drug to which he or she was addicted; and

(7) Any other pertinent facts deemed necessary by the withdrawing practitioner or by the Director.

(e) Any maintenance facility shall be approved by DHEC and the appropriate federal agencies.

HISTORY: Formerly R. 61-4.507.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1010 Approved Uses of Methadone in Hospitals. Methadone is Approved for the Following Uses for Inpatients of Hospitals Licensed by DHEC.

(a) Analgesia;

(b) Pertussis;

(c) Detoxification (withdrawal) of drug dependent persons under conditions set forth in Section 1009 of this regulation; or

(d) Temporary maintenance of methadone treatment of a drug dependent person enrolled in a methadone maintenance program licensed by any state or the federal government while such person is institutionalized within a licensed hospital for medical treatment of an illness or malady medically unrelated to drug dependence.

HISTORY: Formerly R. 61-4.507.3. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1011 Departmental Approval; When Required.

(a) Prior approval by DHEC for methadone use as set forth in Section 1010 of this regulation is not required.

(b) Prior approval of DHEC and registration as provided by Title 21, Section 1301.22(a)(6) of the Code of Federal Regulations and S.C. Code Ann. Section 44-53-290(i), is required of all persons desiring to operate a treatment program utilizing methadone (i.e., a "methadone maintenance program").

(c) Prior approval by DHEC in the manner set forth by Section 1012 of this regulation is not required to dispense methadone to outpatients of a hospital licensed by DHEC. Prior approval of DHEC is not required for "take home" methadone preparations which are lawfully dispensed by a methadone maintenance treatment facility.

(d) Approvals by DHEC, as required by Sections 1009 through 1012 of this regulation, may be granted by the Bureau of Drug Control in its discretion. If the Bureau finds that it cannot approve a request, the request shall be submitted to the Director, along with the Bureau's reasons for non-approval. The Director, in his or her discretion, may then approve or deny the request, but if he or she shall deny such request, the person making the request shall be entitled to a hearing to determine the public interest, in the manner provided for "contested cases" in the South Carolina Administrative Procedures Act.

(e) DHEC may require further information from any applicant in order to obtain sufficient information to be utilized in approving or denying any request.

HISTORY: Formerly R. 61-4.507.4. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1012 Treatment of Outpatients with Methadone.

(a) If a physician determines that methadone would be the drug of choice as an analgesic for a particular patient, the physician may issue prescriptions for methadone to the patient. Such prescriptions may be dispensed by any pharmacy that has agreed to perform such dispensing function.

(b) The treating physician shall agree to maintain adequate records to substantiate the use of methadone as an analgesic for the patient and shall make such records available to DHEC upon request.

HISTORY: Formerly R. 61-4.507.5. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1100. CONTROLLED SUBSTANCES LISTED IN SCHEDULE II.

1101. Requirement of Prescription.

(a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the Act, pursuant to one of the following methods:

(1) As a written prescription signed by the prescribing individual practitioner;

(2) As an electronic prescription transmitted in accordance with Section 1003(b); or

(3) As provided in paragraphs (d) through (g) of this section.

(b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to Section 1006.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period shall be pursuant to a written prescription signed by the prescribing individual practitioner);

(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information requested in Section 1003 except for the signature of the prescribing individual practitioner;

(3) If the prescribing individual practitioner is not known to the pharmacist, he or she shall make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his or her phone number as listed in the telephone directory and/or other good faith efforts to insure his or her identity; and

(4) Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Section 1003, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it shall be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Bureau Director if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

(e) A prescription prepared in accordance with Section 1003 written for a Schedule II narcotic controlled substance, to be compounded for the direct administration to a patient by parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion, may be transmitted by the practitioner or the practitioner's agent by facsimile to a home infusion pharmacy. The facsimile serves as the original prescription for the purposes of this paragraph (e) and it shall be maintained in accordance with Section 603. The written, signed prescription shall be maintained in the medical record of the patient.

(f) A prescription prepared in accordance with Section 1003 written for a Schedule II substance for a resident of a long term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with Section 603 (d). The written, signed and voided prescription shall be maintained in the medical record of the patient. This paragraph (f) is not applicable to prescriptions issued for residents of community residential care facilities or assisted living facilities.

(g) A prescription prepared in accordance with Section 1003 written for a Schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII of the Social Security Act, or a hospice program which is licensed by DHEC may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and shall be maintained in accordance with Section 603 (d). The written, signed, and voided prescription shall be maintained in the medical record of the patient.

HISTORY: Formerly R. 61-4.508. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1102. Limitations on Prescriptions for Schedule II Substances.

Prescriptions for schedule II controlled substances shall not be issued for more than a thirty-one day supply of the substance. No prescription for schedule II controlled substances shall be dispensed later than 90 days from the date of issue.

HISTORY: Formerly R. 61-4.508.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1103. Practitioner-Patient Relationship Required.

Prior to the issuance of a prescription for, or the direct dispensing of any schedule II controlled substances, the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule II controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, or with a member of his or her immediate family, due to the likelihood of the loss of or the vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancée, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted.

HISTORY: Formerly R. 61-4.508.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1104. Refilling Prescription.

The refilling of a prescription for a controlled substance listed in schedule II is prohibited.

HISTORY: Formerly R. 61-4.509. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1105. Partial Filling of Prescription.

(a) The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

(b) Prescriptions for schedule II controlled substances issued for patients in long term care facilities (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be dispensed in partial quantities, to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist shall record on the prescription whether the patient is "terminally ill" or LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. For each partial dispensing, the pharmacist shall record on the back of the prescription the date of the partial dispensing, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Prior to any subsequent partial filling the pharmacist is to determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed in all partial dispensings shall not exceed the total quantity prescribed. Schedule II prescriptions, for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. This paragraph (b) is not applicable to prescriptions issued for residents of community residential care facilities or assisted living facilities.

(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF may be maintained in a computerized system if this system has the capability to permit:

(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, identification of LTCF, identification of medication authorized (to include dosage form, strength and quantity), listing of partial dispensings that have been dispensed under each prescription and the information required in paragraph (b) of this section.

(2) Immediate (real time) updating of the prescription record each time a partial dispensing of the prescription is conducted.

(3) Retrieval of partially dispensed Schedule II prescription information is the same as required by Sections 1202(b)(4) and (5) for Schedule III, IV, and V prescription refill information.

HISTORY: Formerly R. 61-4.510. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1106. Labeling of Substance.

The pharmacist filling a written or emergency oral prescription for a controlled substance listed in schedule II shall affix to the package a label showing the drug name, the quantity dispensed, the date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. See also Section 1918.

HISTORY: Formerly R. 61-4.511. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1107. Filing of Prescriptions.

All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Section 603.

HISTORY: Formerly R. 61-4.512. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1200. CONTROLLED SUBSTANCES LISTED IN SCHEDULES III, IV, AND V.

1201. Requirement of Prescription.

(a) A pharmacist may dispense a controlled substance listed in schedule III, IV, or V which is a prescription drug as determined under the Act, only pursuant to one of the following methods:

(1) A written prescription signed by a prescribing individual practitioner;

(2) An electronic prescription transmitted in accordance with Section 1003(b);

(3) An oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Section 1003, except for the signature of the prescribing individual practitioner; or

(4) A facsimile of a written, signed prescription, transmitted by the practitioner or the practitioner's agent to the pharmacy. A prescription transmitted by facsimile must be received at the pharmacy as it was originally transmitted by facsimile and must include the name and address of the practitioner, the phone number for verbal confirmation, the time and date of transmission, and the name of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law.

(b) An individual practitioner may administer or dispense a controlled substance listed in schedule III, IV, or V in the regular course of his or her professional practice without a prescription.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule III, IV, or V pursuant to a written prescription signed by a prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Section 1003 except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

HISTORY: Formerly R. 61-4.513. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1202. Refilling of Prescriptions.

(a) No prescription for a controlled substance listed in schedule III, IV, or V shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription may be refilled more than five times. Additional quantities of controlled substances listed in schedule III, IV, or V may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in Section 1201 which shall be a new and separate prescription.

(b) An automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V, subject to the following conditions:

(1) Any such proposed computerized system shall provide online retrieval (via CRT display or hard-copy printout) information for those prescription orders which are currently authorized for refilling. This shall include, but is not limited to data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.

(2) Any such proposed computerized system shall also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III, IV, or V controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.

(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct shall be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy of each day's controlled substance prescription order refill data, that print-out shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist shall verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a check or legal document (e.g. J.H. Smith or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data shall be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It shall be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown. Such a book or file shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill.

(4) Any such computerized system shall have the capability of producing a print-out of any refill data which the user pharmacy is responsible for maintaining under the Act and its implementing regulation. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both.) Such a print-out shall indicate name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist and the number of the original prescription order. In any computerized system employed by a user pharmacy the central record-keeping location shall be capable of sending the print-out to the pharmacy within 48 hours, and if a DEA Special Agent or compliance Investigator or an Inspector from DHEC requests a copy of such print-out from the user pharmacy it shall, if requested to do so by the Agent, Investigator, or Inspector verify the print-out transmittal capability of its system by documentation (e.g. postmark).

(5) In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy shall have an auxiliary procedure which will be used for the documentation of refills of Schedule III, IV, and V controlled substance prescription orders. This auxiliary procedure shall insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(c) When filing refill information for original prescription orders for Schedule III, IV, or V controlled substances, a pharmacy may use the system described in either paragraph (a) or (b) of this section.

HISTORY: Formerly R. 61-4.514. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1203. Limitations on Prescriptions for Schedules III, IV, and V Substances.

Prescriptions for controlled substances listed in Schedules III, IV, and V shall not be issued for more than a 90 day supply of the substance. If authorized for refill, no prescription shall be refilled sooner than 48 hours prior to the time that the prescription should be consumed if the prescribed daily dosage is divided into the total prescribed amount. (Example: 4 daily divided into 100 dosage units = 25 days.) Carry over time shall not accrue between refills. In the event that the practitioner does not specify an exact daily dosage, the dispenser shall calculate date of refill from the usual daily dosage recommended by the manufacturer of the controlled substance.

HISTORY: Formerly R. 61-4.514.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1204. Practitioner-Patient Relationship Required.

Prior to the issuance of a prescription for controlled substances listed in Schedule III, IV, or V the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule III, IV, or V controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, now with a member of his or her immediate family, due to the likelihood of the loss or vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancée, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted.

HISTORY: Formerly R. 61-4.514.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1205 Partial Filling of Prescriptions.

The partial filling (dispensing) of a prescription for a controlled substance listed in Schedules III, IV, or V is permissible, provided that:

(a) Each partial filling is recorded in the same manner as a refilling;

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(c) No dispensing occurs after six months from the date on which the prescription was issued.

HISTORY: Formerly R. 61-4.514.3. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1206. Labeling of Substances.

The pharmacist filling a prescription for a controlled substance listed in schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the drug name, the quantity dispensed, the serial number of the prescription and the date of the initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescriptions as required by law.

HISTORY: Formerly R. 61-4.515. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1207. Filing Prescriptions.

All prescriptions for controlled substances listed in schedules III, IV, and V shall be kept in accordance with Section 603.

HISTORY: Formerly R. 61-4.516. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1208. Controlled Substances Listed in Schedule V - Dispensing Without a Prescription.

A controlled substance in Schedule V, which is not a prescription drug as determined under the Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:

(a) Such distribution is made only by a pharmacist and not by a non-pharmacist employee even if under the direct supervision of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist):

(b) Not more than 120 ml. (4 ounces) of any controlled substance listed in Schedule V may be distributed at retail to the same purchaser in any given 48-hour period;

(c) The purchaser is at least 18 years of age;

(d) The pharmacist requires every purchaser of a controlled substance listed in Schedule V not known to him or her to furnish suitable identification (including proof of age where appropriate);

(e) A bound record book for distributions of controlled substances listed in Schedule V (other than by prescription) is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who distributed the substance to the purchaser (the book shall be maintained in accordance with the record keeping requirement of Section 603 of this chapter); and

(f) A prescription is not required for distribution or dispensing of the substance pursuant to the Act or any other law.

(g) Repetitive sales without prescription of Schedule V controlled substances without positive determination of medical need by the pharmacist selling the non-prescription controlled substance shall be deemed dispensing for other than medical purposes, and shall be prima facie evidence of detriment to the public health and safety.

HISTORY: Formerly R 61-4.518. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1300. MISCELLANEOUS.

1301. Severability.

If a provision of any section of Part 100 through 1900 of this regulation is held invalid, all valid provisions that are severable shall remain in effect. If a provision of any of this regulation is held invalid in one or more of its applications, the provision shall remain in effect in all its valid applications that are severable.

HISTORY: Formerly R. 61-4.601. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1302. Application of Other Laws.

Nothing in this regulation shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under federal laws or obligations under international treaties, conventions or protocols, or under the law of the state in which he desires to do such act nor shall compliance with such Parts be construed as compliance with other federal or state laws unless expressly provided in such other laws.

HISTORY: Formerly R. 61-4.602. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1303. Exceptions in Regulations.

Any person may apply for an exception to the application of any provision of these regulations by filing a written request stating the reasons for such exception. Requests shall be filed with the Bureau Director. The Bureau Director may grant an exception in his or her discretion, but in no case shall he or she be required to grant an exception to any person which is not otherwise required by law or the regulations cited in this section.

HISTORY: Formerly R. 61-4.603. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1400. SPECIAL EXCEPTIONS FOR MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCES.

1401 Distribution by Dispenser to Another Practitioner.

(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to his or her patients, provided that;

(1) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;

(2) The distribution is recorded by the distributing practitioner in accordance with Section 804(e) of this regulation and by the receiving practitioner in accordance with Section 804(c) of this regulation;

(3) If the substance is listed in Schedule I or II, an order form (DEA Form 222) is used as required by Part 4 of this regulation;

(4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section during any 12 month period does not exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the twelve month period. Registrants in existence less than 12 months shall prorate the time period, and shall not distribute more than five percent of the dispensings for any monthly period.

(b) If, at any time during any consecutive 12 month period during which the practitioner is registered to dispense, there is reason to believe that the total number of dosage units of all controlled substance which will be distributed by him or her pursuant to this section will exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by him or her during the 12 month period, the practitioner shall obtain a registration to distribute controlled substances.

HISTORY: Formerly R. 61-4.604.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1402. Manufacture and Distribution of Narcotic Solutions and Compounds by a Pharmacist.

As an incident to a distribution under Section 1401, a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound, or mixture.

HISTORY: Formerly R. 61-4.605. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1403. Distribution to Supplier.

Any person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he or she obtained it or to the manufacturer of the substance, provided that a written record is maintained which indicates the date of the transaction, the name, form and quantity of the substance, the name, address, and registration number, if any, of the person making the distribution, and the name, address, and registration number, if know, of the supplier or manufacturer. In the case of returning a controlled substance listed in schedule I or II, an order form shall be used in the manner prescribed in Part 900 of these regulations and be maintained as the written record of the transaction.

HISTORY: Formerly R. 61-4.606. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1404. Distribution upon Discontinuance or Transfer of Business.

(a) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his or her South Carolina Controlled Substances Certificate of Registration to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. His or her Federal Controlled Substances Certificate of Registration and any un-executed order forms shall be returned to the DEA, 1835 Assembly Street, Suite 1229, Columbia, SC 29201.

(b) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Bureau Director at least 14 days in advance of the date of the proposed transfer (unless the Bureau Director waives this time limitation in individual instances), the following information:

(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);

(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);

(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in schedule I or II (if so, the basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will occur.

(c) Unless the registrant-transferor is informed by the Bureau Director, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his or her possession to the registrant-transferee in accordance with the following:

(1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with Part 700 of this Regulation. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Bureau of Drug Control unless requested by the Bureau Director. Transfers of any substances listed in schedules I or II shall require the use of order forms in accordance with Part 1305 of the Federal Regulations.

(2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under Parts 600 through 800 of this Regulation, shall be transferred to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.

(3) In the case of registrants required to make reports pursuant to Parts 600 through 800 of this Regulation, a report marked "Final" will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him or her, if no further transactions involving controlled substances are consummated by him or her. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant, and the substances transferred to him or her shall be reported as receipts in his or her initial report.

HISTORY: Formerly R. 61-4.607. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1500. DISPOSAL OF CONTROLLED SUBSTANCES.

1501. Procedure for Disposing of Controlled Substances.

(a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request the Bureau Director for authority and instructions to dispose of such substance.

(b) The Bureau Director shall authorize and instruct the individual in possession to dispose of the controlled substance in one of the following manners:

(1) By transfer to person registered under the Act and authorized to possess the substance;

(2) By destruction in the presence of an agent of the Bureau of Drug Control or other authorized person, or

(3) By such other means as the Bureau Director may determine to assure that the substance does not become available to unauthorized persons.

(c) In the event that a registrant is required regularly to dispose of controlled substances, the Bureau Director may authorize the registrant to dispose of such substances, in accordance with paragraph (b) of this section, without prior approval of the Bureau of Drug Control in each instance, on the condition that the registrant keep records of such disposals and file periodic reports with the Bureau Director summarizing the disposals made by the registrant. In granting such authority, the Bureau Director may place such condition as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports.

HISTORY: Formerly R. 61-4.609. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1600. INSPECTIONS.

1601. Authority to Make Inspections.

In carrying out his or her functions under the Act, the Bureau Director, through his or her inspectors, is authorized in accordance with the Act to enter controlled premises and conduct administrative inspections thereof, for the purpose of:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and any regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to Parts 600 through 800 of this chapter, order form records required to be kept pursuant to Part 900 of this chapter, prescription and distribution records required to be kept pursuant to Part Parts 1000 through 1200 of this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage;

(b) Inspecting within reasonable limits and in a reasonable manner all pertinent equipment, finished and unfinished controlled substances and other substances or materials, containers, and labeling found at the controlled premises relating to this Act;

(c) Making a physical inventory of all controlled substances on hand at the premises;

(d) Collecting samples of controlled substances or precursors (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 84 to the owner, operator, or agent in charge of the premises);

(e) Checking of records and information on distribution of controlled substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled substances increased markedly within the past year, and if so, why); and

(f) Except as provided in Section 1602, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the regulations thereunder.

HISTORY: Formerly R. 61-4.803. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1602. Exclusion from Inspection.

(a) Unless the owner, operator, or agent in charge of the controlled premises so consents, no inspection authorized by the regulations shall extend to:

(1) Financial data;

(2) Sales data other than shipping data; or

(3) Pricing data.

HISTORY: Formerly R. 61-4.804. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1603. Entry.

An inspection shall be carried out by an inspector. Any such inspector, upon:

(a) Stating his or her purpose and

(b) Presenting to the owner, operator, or agent in charge of the premises to be inspected:

(1) Appropriate credentials, or

(2) Written notice of his or her inspection authority under Section 1601 and the Act, or

(c) Receiving informed consent under Section 1605 of this Regulation or through the use of administrative warrant issued under the Act shall have the right to enter such premises and conduct inspections at reasonable times and in a reasonable manner.

HISTORY: Formerly R. 61-4.805. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1604. Notice of Inspection.

The notice of inspection shall contain:

(a) The name and title of the owner, operator, or agent in charge of the controlled premises;

(b) The controlled premises name;

(c) The address of the controlled premises to be inspected;

(d) The date and time of the inspection;

(e) A statement that a notice of inspection is given pursuant to the Act;

(f) A reproduction of the pertinent parts of the Act; and

(g) The signature of the inspector.

HISTORY: Formerly R. 61-4.806. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1605. Consent to Inspection.

(a) An administrative inspection warrant shall not be required if informed consent is obtained from the owner, operator, or agent in charge of the controlled premises to be inspected.

(b) Wherever possible, informed consent obtained by the inspector shall consist of a written statement signed by the owner, operator or agent in charge of the premises to be inspected.

(c) After August 17, 1974, informed consent may be shown by the production of a completed registration application or certificate, which shall contain printed thereon a preamble and conditions of registration.

HISTORY: Formerly R. 61-4.808. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1606. Application for Administrative Inspection Warrant.

(a) An administrative inspection warrant application shall be submitted to any judge or any magistrate and shall contain the following information:

(1) The name and address of the controlled premises to be inspected;

(2) A statement of statutory authority for the administrative inspection warrant, and that the fact that the particular inspection in question is designed to insure compliance with the regulations promulgated under those acts;

(3) A statement relating to the nature and extent of the administrative inspection, including, where necessary, a request to seize specified items and/or to collect samples of finished or unfinished controlled substances;

(4) A statement that the establishment either:

(i) Has not been previously inspected, or

(ii) Was last inspected on a particular date.

(b) The application shall be submitted under oath to an appropriate judge or magistrate.

HISTORY: Formerly R. 61-4.809. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1607. Administrative Probable Cause.

If the judge or magistrate is satisfied that "administrative probable cause" exists, he shall issue an administrative warrant. Administrative probable cause shall not mean criminal probable cause as defined by federal or state statute or case law.

HISTORY: Formerly R. 61-4.810. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1608. Execution of Warrants.

An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of the Act. The inspection shall begin as soon as is practicable after the issuance of the administrative inspection warrant and shall be completed with reasonable promptness. The inspection shall be conducted during regular business hours and shall be completed in a reasonable manner.

HISTORY: Formerly R. 61-4.811. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1609. Refusal to Allow Inspection with an Administrative Warrant.

If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant or impedes the inspector in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of the Act. If the individual persists and the circumstances warrant, he or she shall be arrested and the inspection shall commence or continue.

HISTORY: Formerly R. 61-4.812. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1700. PROTECTION OF RESEARCHERS AND RESEARCH SUBJECTS.

1701. Confidentiality of Research Subjects.

(a) Any person registered to conduct a bona fide research project with controlled substances under the Act who intends to maintain the confidentiality of those persons who are the subjects of such research, shall, upon registration or within a reasonable time thereafter, submit to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201, a separate request for each research project involving controlled substances, which shall contain the following:

(1) The researcher's registration number for that project;

(2) The location of the research project;

(3) A general description of the research or a copy of the research protocol;

(4) A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and

(5) The reasons supporting the request.

(b) Within 60 days from the date of receipt of the request, the Bureau Director shall issue a letter, either granting confidentiality, requesting additional information or denying confidentiality, in which case the reasons for the denial shall be included. A grant of confidentiality shall be limited solely to the specific research project indicated in the request.

(c) Within 30 days after the date of completion of the research project, the researcher shall so notify the Bureau Director.

(d) In addition to the requirements set forth in paragraphs (a), (b), and (c) of this Section, the person requesting confidentiality of research subjects shall also provide the Bureau of Drug Control with a copy of the petition to the Attorney General of the United States required pursuant to the provisions of 21 CFR Section 1316.23. In the event that the federal petition for confidentiality is not granted, or is withdrawn by the Attorney General of the United States, the Bureau of Drug Control shall, after notice to the researcher, remove its grant of confidentiality, if previously granted.

HISTORY: Formerly R. 61-4.814. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1702. Exemption from Prosecution for Researcher.

(a) Upon registration of a practitioner to engage in research in controlled substances under the Act, the Bureau of Drug Control, DHEC, on its own motion or upon request in writing from the Director or from the practitioner, may exempt the registrant when acting within the scope of his or her registration, from prosecution under State or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his or her exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act (21 USC 301, et seq.) or with the Federal Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801, et seq.).

(b) All petitions for Grants of Exemption from Prosecution for the Researcher shall be addressed to the Director, Bureau of Drug Control, SCDHEC, 2600 Bull Street, Columbia, SC 29201, and shall contain the following:

(1) The researcher's registration number, if any, for the project;

(2) The location of the research of the research project;

(3) The qualifications of the principal investigator;

(4) A general description of the research or a copy of the research protocol;

(5) The source of funding for the research project;

(6) A statement as to the risks posed to the research subjects by the research procedures and what measures of protection will be afforded to the research subjects;

(7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society;

(8) A specific request for exemption from prosecution by Federal, State, or local authorities for offenses related to the possession, distribution, and dispensing of controlled substances in accord with the procedures described in the research protocol;

(9) A statement establishing that a grant of exemption from prosecution is necessary to the successful completion of the research project;

(c) Any researcher or practitioner proposing to engage in research requesting both exemption from prosecution and confidentiality of identity of research subjects may submit a single petition incorporating the information required in Sections 1701 and 1702.

(d) The exemption shall consist of a letter issued by the Bureau Director, which shall include:

(1) The researcher's name and address;

(2) The researcher's registration number for the research project;

(3) The location of the research project;

(4) A concise statement of the scope of the researcher's registration; and

(5) The limits of the exemption;

(6) The exemption shall apply to all acts done in the scope of the exemption while the exemption is in effect. The exemption shall remain in effect until completion of the research project or until the registration of the researcher is either revoked or suspended or his or her removal of registration is denied. However, the protection afforded by the grant of exemption from prosecution during the research period shall be perpetual.

(e) Within 30 days of the date of completion of the research project, the researcher shall so notify the Bureau Director. The Bureau Director shall issue another letter including the information required in paragraph (d) of this section and stating the date on which the period of exemption concluded; upon receipt of this letter, the researcher shall return the original letter of exemption.

HISTORY: Formerly R. 61-4.815. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1800. ADMINISTRATIVE CONFERENCES.

1801. Authority for Administrative Conferences.

An administrative conference may be ordered or granted by the Director of the Bureau of Drug Control, at his or her discretion, to permit any person against whom criminal and/or civil action is contemplated under the Act an opportunity to present his or her views and his or her proposals for bringing his or her alleged violations into compliance with the law. Such administrative conference will also permit him or her to show cause why prosecution should not be instituted, or to present his or her views on the contemplated proceeding.

HISTORY: Formerly R. 61-4.816. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1802. Notice; Time and Place.

Appropriate notice designating the time and place for the administrative conference shall be given to the person. Upon request, timely and properly made, by the person to whom notice has been given, the time and place of the administrative conference, or both, may be changed if the request states reasonable grounds for such change. Such request shall be addressed to the Bureau Director who issued the notice.

HISTORY: Formerly R. 61-4.817. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1803. Conduct of Administrative Conferences.

Presentation of views at an administrative conference under this Subpart shall be private and informal. The views presented shall be confined to matters relevant to bringing violations into compliance with the Act or to other contemplated proceedings under the Act. These views may be presented orally or in writing by the person to whom the notice was given, or by his or her authorized representative.

HISTORY: Formerly R. 61-4.818. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

PART 1900. HANDLING AND ADMINISTERING CONTROLLED SUBSTANCES IN HOSPITALS.

1901. Hospital Registration.

All hospitals (except those owned and operated by the federal government) shall be registered with DHEC in controlled substances schedules II through V inclusive.

HISTORY: Formerly R. 61-4.901. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1902. Practitioners' Registration.

Physicians and other practitioners who prescribe or order controlled substances for, or administer controlled substances to, patients in a hospital, shall be registered under the provisions of Article 3 of Chapter 53 of Title 44 of the 1976 Code.

HISTORY: Formerly R. 61-4.902. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1903. Residents' Registration.

A resident may prescribe or order the administration of controlled substances for patients within a hospital or residency training program, provided, that such resident has completed his or her course of study in a recognized college of medicine and has been duly licensed by the Board of Medical Examiners of South Carolina to practice medicine within this state, and has duly registered with DHEC and the DEA under the respective Controlled Substances Acts.

HISTORY: Formerly R. 61-4.903. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1904. Responsibility for Controlled Substances.

The administrative head of the hospital as a registrant under the Controlled Substances Act is responsible for the proper safeguarding and handling of controlled substances within the hospital. Responsibility for storage, accountability, and proper dispensing of controlled substances from the pharmacy may be delegated to a pharmacist employed by the hospital. Likewise, the Director of Nursing is usually delegated the authority for proper storage at nursing stations, and use, as directed by physician orders. However, delegation of authority does not relieve the administrator of the hospital of supervisory responsibility to insure detection and correction or any diversion of mishandling. The administrator shall be certain that all possible control measures are observed, and that any suspected diversion or mishandling of controlled substances is reported immediately to the Bureau of Drug Control for investigation. The administrator is ultimately responsible that all thefts be reported to DHEC pursuant to Sections 410 through 411 of this Regulation.

HISTORY: Formerly R. 61-4.905. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1905. Prescriptions not Required on Floor-Stocked Controlled Substances.

(a) Physicians and other practitioners who may be authorized according to state law, and who may be privileged and credentialed to place orders for patients within the hospital, shall enter such orders in the patient's medical record and no prescription shall be required. The nursing station floor stock used in administering controlled substances in any schedule shall be accounted for in a readily retrievable format. The practitioner's order shall be checked against the medication administration record (MAR) and the controlled substances control sheet or hospital-specific record periodically by pharmacy personnel.

(b) Due to finite limits of nursing unit controlled substances storage areas, controlled substances that are not kept as floor stock will be occasionally ordered. Proper accountability for these controlled substances not included in floor stock require that they be issued on an individual demand basis with an accompanying sign-out control sheet. Any amount of these controlled substances which are not administered to or ingested by the patient shall be returned to the pharmacy within 72 hours after the medication order is discontinued by the individual practitioner treating the patient.

(c) Controlled substances secured from or obtained by prescription from retail sources outside the hospital are to be stored securely with all other controlled substances on the nursing unit. These controlled substances are to be monitored as to their administration to the patient by a supplemental controlled substances disposition sheet. This sheet should be designated with a control number or an identifying mark in order to distinguish it from regular hospital stock. If the patient is discharged before all of these controlled substances are administered, the amount sent home with the patient (if any) shall be noted on the disposition sheet and signed and dated by a registered nurse involved in the discharge process, who shall cause the sheet to be transmitted to the hospital pharmacy. In the event there are controlled substances obtained from outside sources which are not to be sent home with the patient, or if the patient expires and there are unutilized controlled substances from these sources, the balance of the medication shall be noted on the sheet by the Registered Nurse, and the sheet and the medication shall be returned to the hospital pharmacy for disposition.

(d) All non-electronic orders shall be manually signed by the practitioner.

(e) All controlled substances within a hospital that are not located within the hospital pharmacy shall be accompanied by either an electronic documentation, a disposition sheet, or a sign-out sheet upon which to record the administration of the substance, whether the substance originated as hospital stock, from a retail source outside the hospital, or was brought into the hospital by the patient with the consent of the hospital and the patient's practitioner.

HISTORY: Formerly R. 61-4.906. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1906. Registry Number.

The physician's full name shall appear on the physician's order sheet. The physician's registry number is not required on the sheet, but shall be recorded within the pharmacy or drug room.

HISTORY: Formerly R. 61-4.907. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1907. Telephone Orders.

Telephone orders for patients are permissible only in absolute necessity. The nurse receiving the order shall enter it into the patient's medical record, authenticate the practitioner's name, and the nurse's signature. The order for the controlled substance shall be authenticated according to hospital policy.

HISTORY: Formerly R. 61-4.908. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1908. Verbal Orders.

Verbal (oral) orders for hospital patients are permitted in a bona fide emergency. Such orders shall be handled in the same manner as telephone orders.

HISTORY: Formerly R. 61-4.909. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1909. Controlled Substances Records.

All non-electronic orders and non-electronic records of controlled substances shall be in ink, typed, or indelible pencil. Mechanical or electronic systems may be used to collect and store this data. All data shall be kept in a readily retrievable manner as set forth in Sections 601, 602, 603, 801, and 804 of this regulation. Any mechanical or electronic system shall be designed to retrieve data in such a manner as to show individual controlled substance activity per nursing unit as well as individual controlled substance volume in its entirety. This shall include, but is not limited to, control numbers, date dispensed, identity of the controlled substance, strength, quantity dispensed, and location within the hospital.

HISTORY: Formerly R. 61-4.910. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1910. Procedure in Case of Waste, Destruction, Contamination, etc.

(a) Aliquot part of solutions used for drugs: The nurse shall use the proper number of tablets or ampoules from nursing unit stock. The nurse shall record the number of tablets or ampoules used and the dose given in the proper columns of the controlled substances disposition sheet, in the automated storage machine, or in a hospital-specified format. The nurse shall properly dispose of that portion of the solution not used. The aliquot shall be witnessed and recorded by the witness according to hospital policy. This information must be readily retrievable by hospital staff.

(b) Prepared dose refused by patient or canceled by physician: When a dose of a controlled substance has been prepared for a patient but not used due to refusal by the patient or cancellation by the physician, or has been accidentally contaminated during the regular course of administering the drug to the patient for whom it has been ordered (e.g., blood aspirated into a syringe when beginning the administration of an intra-muscular medication) the nurse shall properly dispose of the solution, and record on the back of the disposition sheet, in the automated storage machine, or in a hospital-specified format the reason why the controlled substance was not administered. This information must be readily retrievable by hospital staff.

(c) Accidental destruction of controlled substance: When a solution, tablet, ampoule or substance is accidentally destroyed on a nursing unit, the person responsible shall indicate the accidental loss by writing "wasted; see waste report" on the line allowed for the record on the controlled substances disposition sheet, in the automated storage machine, or in a hospital-specified format. The responsible person shall record a complete report of the accident and sign the statement.

(d) Contaminated or broken hypodermic tablets and contaminated controlled substance solutions: When a controlled substance hypodermic tablet is contaminated or broken or a controlled substance solution is contaminated, the person responsible or the head nurse shall place the tablets, particles, or solution in a suitable container and label. The person responsible, or the head nurse, shall record on the disposition sheet, in the automated storage machine, or in a hospital-specified format the wastage. He or she shall write and sign a complete report, or document the situation electronically with an electronic signature. Regardless of which system is used, a witness shall co-sign the report. The container with the contaminated controlled substance shall be returned to the pharmacy or medication room. The pharmacist or person in charge of the medication room will receive it and note on the controlled substances disposition sheet covering the particular substance that it has been returned. The hospital shall properly dispose of the material.

HISTORY: Formerly R. 61-4.911. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1911. Procedures in Case of Loss, Theft, etc.

(a) Discrepancies in controlled substances count: Those involving small amounts (such as single doses) shall be reported to a responsible supervisory official. An investigation should be made to determine the cause of the loss. A copy of the report of the investigation, signed by the responsible supervisor shall be filed with the hospital controlled substance records, and appropriate action taken to prevent recurrence.

(b) Recurring shortages: In cases of recurring shortages or loss of significant quantities of controlled substances (several doses), a thorough investigation shall be made, making every effort to determine the reason for the shortages, and the person responsible for the shortage, if possible. A complete report of the incident and findings shall be made to the administrative authority of the hospital. Appropriate action shall be taken immediately to prevent recurrence. A copy of the report, including any findings resulting from the local investigations, and a theft report, as required by Section 408, shall be forwarded to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201.

HISTORY: Formerly R. 61-4.912. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1912. Controlled Substances of Physician's Office or Bag.

It is unlawful for a physician to obtain substances for his or her office or bag use from the controlled substances stock of the hospital. A physician may obtain his or her controlled substances from a drug wholesaler by invoice; Schedule II substances shall be acquired through the use of order forms supplied by the DEA, U. S. Department of Justice (DEA Forms 222). Those hospitals maintaining permitted retail pharmacies, or otherwise licensed as a "drug outlet" by the S.C. Board of Pharmacy, may at their option, furnish controlled substances to practitioners pursuant to the provisions of Section 1401 of this Regulation.

HISTORY: Formerly R. 61-4.914. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1913. Dispensing to Outpatients.

It is unlawful for a hospital to dispense controlled substances to outpatients on physicians' orders. Such dispensing shall be done only on the prescription of a duly licensed physician and only from the pharmacy holding a permit as a retail pharmacy of a hospital registered under Article 3 of Chapter 53 of Title 44 of the 1976 Code, and by or under the immediate supervision of a registered pharmacist. With the permission of the hospital, a practitioner may personally dispense limited quantities of controlled substances to their patients for take-home purposes, provided that such substances are properly packaged and labeled as required by provisions elsewhere within this regulation, and in compliance with statutory provisions.

HISTORY: Formerly R. 61-4.915. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1914. Administering to Outpatients.

Controlled substances may be administered to outpatients or emergency patients when admitted to the emergency room of the hospital when ordered by the physician in charge of the case, provided a record is kept showing the name and address of the patient, kind and quantity of controlled substance administered, date and physician's order. Under no conditions may the patient be given controlled substances to take out of the hospital except as provided in Section 1913.

HISTORY: Formerly R. 61-4.916. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1915 Emergency Rooms.

The stock of controlled substances maintained in hospital emergency rooms or outpatient facilities is kept for the use by or at the direction of physicians in the emergency room. Therefore, in order to receive such medication, a patient shall be examined by a physician in the emergency room or outpatient facility and the need for the particular controlled substance determined by such physician. It is not possible under federal requirements for the use of controlled substances for a physician to see a patient outside of the emergency room setting, or talk to the patient over a telephone, and then call the emergency room and order the administration of a stocked controlled substance upon the patient's arrival at the emergency facility. Cf., S.C. Code Ann. Section 44-53-110, "administer" ['...in his presence...']; Sections 1103 and 1204 of this Regulation, requiring personal attendance, etc.

HISTORY: Formerly R. 61-4.916.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1916. Storage of Controlled Substances.

All controlled substances shall be kept in a locked, secure place. Large reserve stocks should be kept in a strong safe, substantial enough to deter entry and heavy enough to prevent being carried away. Other valuable property may be kept in the safe provided adequate security of the controlled substances contained therein is maintained. See also Sections 401 through 406, inclusive.

(a) Nursing station controlled drug box: Responsibility: Only a very limited number of persons should possess the key to the controlled substances on the nursing station. When such person(s) are relieved from duty, the person(s) taking charge should count and transfer the controlled substances in the presence of the person(s) being relieved, and all controlled substances should be accounted for. The responsibility rests with the person(s) assigned to possession of the key on each shift. The administrator shall be responsible for control of these keys. This responsibility may be delegated to the Director of Nursing. Written documentation of accountability of controlled substances (i.e., shift change nurses' signatures) shall be stored in a readily retrievable manner and maintained for a period of not less than two years, after which they may be destroyed.

(b) Responsibility of drug room: In those hospitals not maintaining a pharmacy under the supervision of a registered pharmacist, the drug room shall be restricted to the Director of Nurses, a designated assistant, or a designated registered nurse, not more than one of whom shall be in possession of the key to the drug room at the same time. The nurse in possession of the key to the drug room shall be responsible for all transactions in the drug room on his or her respective shift. (Observance of (a) and (b) does not relieve the Administrator of his or her responsibilities.)

HISTORY: Formerly R. 61-4.917. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1917. Availability of Records for Inspectors.

The administrative head of the hospital shall, upon service of an inspection warrant by an inspector of the Bureau of Drug Control, DHEC, or if such administrative head chooses, voluntarily without inspection warrant, (acting pursuant to the informed consent to inspection delineated as a condition of registration upon the application for registration and the registration certificate issued to the registrant by DHEC) make available to such inspector all dispensing and administering records of controlled substances, for the purpose of audit of said controlled substances, as well as records of receipt and disposition of all controlled substances acquired by the hospital. Inspectors shall not divulge information contained on patient records that do not concern controlled substances or other drugs restricted to prescription use only.

HISTORY: Formerly R. 61-4.919. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1918. Labeling of Substances. (Schedule II)

The requirements of Section 1106 do not apply when a controlled substance listed in schedule II is prescribed for administration to an ultimate user who is institutionalized; Provided, that:

(1) Not more than 7-day supply of the controlled substance listed in schedule II is dispensed at one time;

(2) The controlled substance listed in schedule II is not in the possession of the ultimate user prior to the administration;

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substances listed in schedule II; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

HISTORY: Formerly R. 61-4.920. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1919. Labeling of Substances. (Schedules III, IV, V).

The requirements of Section 1201 do not apply when a controlled substance listed in schedule III or IV is prescribed for administration to an ultimate user who is institutionalized; Provided, that:

(1) Not more than a 30-day supply or 100 dosage units, whichever is less, of the controlled substance listed in schedule III, IV or V is dispensed at one time.

(2) The controlled substance listed in schedule III, IV or V is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing and storage of the controlled substance listed in schedule III, IV or V; and

(4) The system employed by the pharmacist in dispensing a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

HISTORY: Formerly R. 61-4.921. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1920. Clarification and Intent.

These regulations are considered to be a general but minimal required control level in the opinion of the Bureau of Drug Control, DHEC. More stringent control for the institution in question or special interpretations of these regulations may be approved by a special meeting with the Bureau of Drug Control, and the administrator or designated pharmacy and therapeutics committee of the respective hospital every 3 to 5 years when the need is felt for such clarification. The intent of Part 1900 of this regulation is to insure adequate control and accountability of controlled substances utilized in health care without duly hindering or restraining the delivery of such care. Accountability and an accurate audit at periodic intervals are the crux of the adequate control system.

HISTORY: Formerly R. 61-4.922. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

1921. Consultation Procedure.

At the request of the institution under examination and/or the Bureau of Drug Control, DHEC, the S.C. Society of Hospital Pharmacists may furnish a recognized local authority on Institutional Medication Delivery and Control Systems to accompany the agent/or inspector and act as a consultant to the institution in question on rectifying flaws in the system under scrutiny.

HISTORY: Formerly R. 61-4.923. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013.

61-6. Repealed by State Register Volume 36, Issue No. 3, eff March 23, 2012.

61-7. EMERGENCY MEDICAL SERVICES.

(Statutory Authority: S.C. Code Ann. Sections 44-61-30 and 44-78-65 (1976 Code of Laws, as amended))

HISTORY: Added eff March 18, 1975. Amended eff May 22, 1981; eff February 16, 1988; State Register Volume 19, Issue No. 7, eff July 28, 1995; State Register Volume 21, Issue No. 6, Part 2, eff June 27, 1997; State Register Volume 30, Issue No. 6, eff June 23, 2006.

Table of Contents

Section 100. PURPOSE AND SCOPE

Section 101. Scope of ACT 1118 of 1974 as Amended.

Section 200. DEFINITIONS.

Section 201. Definitions as Stated in the Act.

Section 300. ENFORCING REGULATIONS.

Section 301. General.

Section 302. Inspections/Investigations.

Section 303. Enforcement Actions.

Section 304. Violation Classifications.

Section 400. LICENSING PROCEDURES.

Section 401. Application.

Section 402. Medical Control Physician. (I)

Section 403. Licensing Basic Life Support. (II)

Section 404. Licensing Intermediate Life Support. (II)

Section 405. Licensing Advanced Life Support. (II)

Section 406. Licensing Special Purpose Ambulance Providers. (II)

Section 407. Advanced Life Support Information. (II)

Section 408. Advertising Level of Care.

Section 409. Criteria for License Category - EMT First Responder. (II)

Section 500. PERMITS, AMBULANCE. (I)

Section 501. Vehicle and Equipment.

Section 600. STANDARDS FOR AMBULANCE PERMITS.

Section 601. Ambulance Design and Equipment.

Section 700. EQUIPMENT (II).

Section 701. Minimum Ambulance Medical Equipment.

Section 702. Intermediate and Advanced Equipment.

Section 703. Minimum Ambulance Rescue Equipment.

Section 704. Convalescent Transport Units.

Section 705. Special Purpose Ambulance Equipment.

Section 706. EMT First Responder Equipment.

Section 800. SANITATION STANDARDS FOR LICENSED PROVIDERS.

Section 801. Exterior Surfaces.

Section 802. Interior Surfaces - Ambulance.

Section 803. Linen.

Section 804. Oxygen Administration Apparatus. (II)

Section 805. Resuscitation Equipment. (II)

Section 806. Suction Unit.

Section 807. Splints.

Section 808. Stretchers, and Spine Boards.

Section 809. Bandages and Dressings. (II)

Section 810. Obstetrical Kits. (II)

Section 811. Oropharyngeal Appliances. (II)

Section 812. Communicable Diseases. (II)

Section 813. Miscellaneous Equipment.

Section 814. Equipment and Materials Storage Areas.

Section 815. Personnel.

Section 900. TRAINING AND CERTIFICATION

Section 901. Emergency Medical Technician Training Programs. (II)

Section 902. Certification. (I)

Section 903. Application for Certification as an Emergency Medical

Technician-Basic.

Section 904. Application for Certification as an Emergency Medical

Technician-Intermediate or Paramedic.

Section 905. Recertification as an Emergency Medical Technician-Basic.

Section 906. Recertification as an Emergency Medical

Technician-Intermediate or Paramedic.

Section 907. EMT Course Approval. (II)

Section 908. EMT Instructor Training Programs and Certification.

Section 1000. PERSONNEL REQUIREMENTS. (I)

Section 1100. REVOCATION OR SUSPENSION OF CERTIFICATES OF EMTs. (I)

Section 1200. AIR AMBULANCES.

Section 1201. Licensing. (I)

Section 1202. Basic Life Support Air Ambulance, Medical Equipment

Requirements.(II)

Section 1203. Interfacility and Special Purpose Air Ambulance. (II)

Section 1204. Advanced Life Support Air Ambulance Medical Equipment

Requirements. (II)

Section 1205. Medication and Fluids for Advanced Life Support Ambulances.

(II)

Section 1206. Rescue Exception. (II)

Section 1300. PATIENT CARE REPORTS.

Section 1301. Forms Control Officer.

Section 1302. Content.

Section 1303. Report Maintenance.

Section 1400. DO NOT RESUSCITATE ORDER.

Section 1401. Purpose and Authority of Emergency Medical Services Do Not

Resuscitate Order.

Section 1402. Definitions.

Section 1403. General Provisions.

Section 1404. Revocations of EMS DNR Order.

Section 1405. Patient's Assessment and Intervention. (II)

Section 1406. Resuscitative Measures to be Withheld or Withdrawn. (II)

Section 1407. Procedures to Provide Palliative Treatment. (II)

Section 1408. DNR Information for the Patient, the Patient's Family, the

Health Care Provider and EMS Personnel. (II)

Section 1500. SEVERABILITY.

Section 1501 General.

Section 1600. GENERAL.

Section 1601. General.

Section 100. SCOPE AND PURPOSE

Section101. SCOPE OF ACT 1118 OF 1974 AS AMENDED.

A. Establishment of EMS program.

B. General licensing, certification, inspection and training procedures.

C. Establishment of an Emergency Medical Service Council and duties of the Council.

D. Establishment of the Department of Health and Environmental Control authority for enforcement of these rules and regulations.

Section 200. DEFINITIONS

Section 201. Definitions as stated in the Act.

A. Advanced Life Support (ALS): Treatment of life-threatening medical emergencies through the use of techniques such as endotracheal intubation, administration of drugs or intravenous fluids, cardiac monitoring, and electrical therapy by a qualified person pursuant to these regulations.

B. Advanced Life Support Service: A service provider that in addition to basic life support minimum standard, provides at least 2 EMT's, one of which is an EMT-Intermediate or Paramedic and demonstrates the capability to provide IV therapy, advanced airway care, approved drug therapy, cardiac monitoring and electrical therapy on 80% of all emergency calls.

C. Air ambulance: Any aircraft that is intended to be used for and is maintained or operated for transportation of persons who are sick, injured or otherwise incapacitated.

D. Basic Life Support Service: A service provider that meets all criteria for basic life support minimum standard and is able to provide one EMT-Basic to 100% of all calls.

E. Condition Requiring an Emergency Response: The sudden onset of a medical condition manifest by symptoms of such sufficient severity, including severe pain, that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect without medical attention, to result in:

1. Serious illness or disability;

2. Impairment of a bodily function;

3. Dysfunction of the body; or

4. Prolonged pain, psychiatric disturbance, or symptoms of withdrawal.

F. Continuing education: An educational program designed to update the knowledge and skills of its participants by attending conventions, seminars, workshops, educational classes, labs, symposiums, etc. Points toward recertification may be awarded for successful completion of approved activities.

G. Convalescent vehicle: A vehicle that is used for making nonemergency calls such as scheduled visits to a physician's office or hospital for treatment, routine physical examinations, x-rays or laboratory tests, or is used for transporting patients upon discharge from a hospital or nursing home to a hospital or nursing home or residence, or other nonemergency calls.

H. Emergency Transport: Services and transportation provided after the sudden onset of a medical condition manifesting itself by acute symptoms of such severity, including severe pain, that the absence of medical attention could reasonably be expected to result in the following:

1. Placing the patient's health in serious jeopardy;

2. Causing serious impairment to bodily functions; or

3. Causing serious dysfunction of bodily organ or part;

4. A situation that resulted from an accident, injury, acute illness, unconsciousness, or shock, for example, required oxygen or other emergency treatment, required the patient to remain immobile because of a fracture, stroke, heart attack, or severe hemorrhage.

I. EMT: Emergency Medical Technician. An individual possessing a valid basic, intermediate, or paramedic certificate issued by the State pursuant to the provisions of these Regulations.

J. EMT First Responder Service: A licensed agency providing medical care at the EMT-Basic level or above, as a nontransporting first responder.

K. FAA: Federal Aviation Administration. The agency of the federal government that governs aircraft design, operations, and personnel requirements.

L. Fixed Wing: Any aircraft that uses fixed wings to permit it to take off and fly.

M. Flight Nurse: A licensed registered nurse who is trained in all aspects of emergency care except roadside pickups and who has been so designated by the Department.

N. Intermediate Life Support Service: A service provider that, in addition to basic life support minimum standard, provides at least 2 EMT's, one of which is an EMT-Intermediate or EMT-Paramedic and demonstrates the capability to provide IV therapy and advanced airway care on 80% of all emergency calls.

O. Medical Control: Medical Control is usually provided by a unit's physician who is responsible for the care of the patient by the provider's medical attendants. Actual medical control may be direct by two-way voice communications (on-line) or indirect by standing orders or protocols (off-line) control.

P. Moral Turpitude: Behavior that is not in conformity with and is considered deviant by societal standards.

Q. Nonemergency Transport: Services and transportation provided to a patient whose condition is considered stable. A stable patient is one whose condition reasonably can be expected to remain the same throughout the transport and for whom none of the criteria for emergency transport has been met. Prearranged transports scheduled at the convenience of the service or medical facility will be classified as a nonemergency transport.

R. Off-Line Medical Control Physician: A provider's medical control physician who actually takes responsibility for treatment of patients in the prehospital setting, by standing orders or protocols.

S. On-Line Medical Control Physician: The physician who directly communicates with EMT's regarding appropriate patient care procedures en-route. An on-line medical control physician must be available for all EMT's performing procedures designated as such by the Department.

T. Revocation: The Department has permanently voided a license, permit, or certificate and the holder no longer may perform the function associated with the license, permit, or certificate. The Department will not reissue the license, permit, or certificate for a period of two years for a license or permit and three years for a certificate. At the end of this period, the holder may petition the Department for reinstatement.

U. Rotocraft: A helicopter or other aircraft that uses a rotary blade to permit vertical and horizontal flight without the use of wings.

V. Special purpose ambulance: An ambulance equipped and designated to transport only patients in need of specialized types of care. Examples include neonatal ambulances, cardiac-care ambulances, etc.

W. Suspension: The Department has temporarily voided a license, permit, or certificate and the holder may not perform the function associated with the license, permit, or certificate until the holder has complied with the statutory requirements and other conditions imposed by the Department.

X. The Department: The administrative agency known as the South Carolina Department of Health and Environmental Control.

Section 300. ENFORCING REGULATIONS

Section 301. General.

A. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding an EMT, training facility, instructor, or provider in order to enforce these regulations.

B. The Department reserves the right to make exceptions to these regulations where it is determined that the health and welfare of those being served would be compromised.

Section 302. Inspections/Investigations.

A. An inspection shall be conducted prior to initial licensing of a provider and subsequent inspections conducted as deemed appropriate by the Department.

B. All providers, EMTs, training facilities, and instructors are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department.

C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, equipment, and records, and have the authority to require that entity to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings.

Section 303. Enforcement Actions.

When the Department determines that an EMT, provider, instructor, or training facility is in violation of any statutory provision, rule, or regulation relating to the duties therein, the Department may, upon proper notice to that entity, impose a monetary penalty and/or deny, suspend, and/or revoke its certification, license, or authorization.

Section 304. Violation Classifications.

Violations of standards in this regulation are classified as follows:

A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons being served or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods, operations, or lack thereof may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time established by the Department may be considered a subsequent violation.

B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety or well-being of those being served. The citation of a Class II violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.

C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.

D. The notations "(I)" or "(II)", placed within sections of this regulation, indicate that those standards are considered Class I or II violations, if they are not met, respectively. Standards not so annotated are considered Class III violations.

E. In arriving at a decision to take enforcement actions, the Department shall consider the following factors: specific conditions and their impact or potential impact on the health, safety, or well-being of those being served; efforts by the EMT, provider, training facility or instructor to correct cited violations; behavior of the entity in violation that reflects negatively on that entity's character, such as illegal or illicit activities; overall conditions; history of compliance; and any other pertinent factors that may be applicable to current statutes and regulations.

F. When a decision is made to impose monetary penalties, the following schedule shall be used as a guide to determine the dollar amount:

Frequency of violation of standard within a 36-month period:

MONETARY PENALTY RANGES

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FREQUENCY CLASS I CLASS II CLASS III

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1st $300 - 500 $100 - 300 $50 - 100

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2nd $500 - 1,500 $300 - 500 $100 - 300

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3rd $1,000 - 3,000 $500 - 1,500 $300 - 800

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4th $2,000 - 5,000 $1,000 - 3,000 $500 -1,500

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5th $5,000 - 7,500 $2,000 - 5,000 $1,000 - 3,000

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6th or more $10,000 $7,500 $2,000 - 5,000

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G. Any enforcement action taken by the Department may be appealed pursuant to the Administrative Procedures Act beginning with Section 1-23-310.

Section 400. LICENSING PROCEDURES

Section 401. Application.

A. Application for license shall be made to the Department by private firms, public entities, volunteer groups or non-federal governmental agencies. The application shall be made upon forms in accordance with procedures established by the Department and shall contain the following:

1. The name and address of the owner of the licensed provider or proposed licensed provider;

2. The name under which the applicant is doing business or proposes to do business;

3. A description of each ambulance, including the make, model, year of manufacture or other distinguishing characteristics to be used to designate applicant's vehicle.

4. The location and description of the place or places from which the licensed provider is intended to operate. The Department shall be notified within five (5) working days of any expansion of the service or if the headquarters, director or any substation locations are changed.

5. Personnel roster showing EMT's name, address, certification number and expiration date.

6. Type of license applied for.

7. Name, address, and phone number of medical control physician.

8. Name, fax, e-mail, and phone number of person in charge of day-to-day operations.

9. Number of units and level of service provided from each transporting station.

10. Insurance information, to include name of insurance company, agent, phone number and type of coverage. A copy of insurance policy(s) shall be furnished to the Department upon request. The minimum limits of coverage shall be $1,000,000 liability and $500,000 malpractice per occurrence.

11. A copy of current Drug Enforcement Agency license, when applicable.

12. Such other information as the Department shall deem reasonable and necessary to a fair determination of compliance with this regulation.

B. The Department shall issue a license valid for a period of two (2) years when it is determined that all the requirements of this regulation have been met. If disapproved, the applicant may appeal in a manner pursuant to the Administrative Procedures Act beginning with Section 1-23-310.

C. Subsequent to issuance of any license, the Department shall cause to be inspected each licensed provider (ambulances, equipment, personnel, records, premises, and operational procedures) whenever that service is initially licensed. Thereafter, services will be inspected by the Department on a random basis with a percentage of permitted ambulances inspected. These random inspections will be conducted dependent upon past compliance history.

1. Pursuant to Section 44-61-70 of the Code, the following fine schedule shall be used when a permitted ambulance or licensed first responder service loses points upon reinspection:

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Point Value of Item as Delineated on Inspection Report Fine for Each Item

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2 $15.00

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3 $25.00

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6 $50.00

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9 $75.00

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12 $100.00

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D. The Department is herein authorized, pursuant to Section 44-61-70 of the Code, to suspend or revoke a license so issued at any time it determines that the holder no longer meets the requirements prescribed for operating as a licensed provider.

E. Renewal of any license issued under the provision of this Act shall require conformance with all the requirements of this Act as upon original licensing.

F. The Department shall be notified within five (5) working days when changes of ownership of a licensed provider are impending or occur so that a new license may be issued.

G. The issuance of a license shall not be construed so as to authorize any person, firm, corporation, or association to provide EMT first responder services or ambulance services or to operate any ambulance not in conformity with any ordinance or regulation enacted by any county, municipality or special purpose district or authority.

H. The Department reserves the right to make exceptions to these standards where it is determined that the health and welfare of the community requires the services of the provider. When an "exception" applies to an existing provider, it will continue to meet the standards in effect at the time it was licensed.

I. Conditions which have not been covered in these regulations shall be handled in accordance with the standard practices as interpreted by the Department.

Section 402. Medical Control Physician.(I)

Each licensed provider that provides patient care shall retain a medical control physician to maintain quality control of the care provided, whose functions include the following:

A. Quality assurance of patient care including development of protocols, standing orders, training, policies, and procedures; and approval of medications and techniques permitted for field use by direct observation, field instruction, in-service training or other means including, but not limited to:

1. Patient care report review;

2. Review of field communications tapes;

3. Post-run interviews and case conferences;

4. Investigation of complaints or incident report.

B. The medical control physician shall serve as medical authority for the licensed provider, to perform in liaison with the medical community, medical facilities, and governmental entities.

C. The medical control physician may have disciplinary authority sufficient to oversee the quality of patient care for all EMT's and retain other responsibilities as may be negotiated by agreement with the service.

D. Providers will register their medical control physician with the Department and provide a copy of their current standing orders and authorized drug list signed and dated by medical control physician.

E. The Department must be notified of any change in medical control physician, drug list or standing orders within ten (10) days.

F. The medical control physician may withdraw at his/her discretion, the authorization for personnel to perform any or all patient care procedure(s).

G. All initial Medical Control Physicians must attend a Medical Control Physician Workshop conducted by the Department within 12 months of being designated Medical Control Physician. Failure to attend the above mentioned workshop will result in immediate dismissal from that position.

Section 403. Criteria for License Category of Basic Life Support (Ambulance).(II)

(Minimum Standard):

A. Must have ambulances that are permitted or can be permitted pursuant to these regulations.

B. Shall have no less than five (5) EMT's associated with the provider.

C. Must have staffing patterns, policy and procedure, and if necessary, mutual aid agreements to assure that an ambulance is en route with at least one EMT onboard to all emergent calls within five (5) minutes or the next closest staffed ambulance must be dispatched, excluding prearranged transports. (Minimum crew shall be one driver and one EMT.) Volunteer Services (services not utilizing paid personnel) without on site personnel must have staffing patterns, policy and procedure, and if necessary, mutual aid agreements to assure that an ambulance is en route with at least one EMT onboard to all emergent calls within ten (10) minutes or have the closest staffed ambulance dispatched. (Minimum crew shall be one driver and one EMT.)

1. Non-emergent transport services shall not utilize emergency lights and sirens to a call and shall not utilize lights and sirens from a call unless patient condition deteriorates while on scene or onboard the ambulance.

2. An exception to the above provision regarding utilization of emergency lights and sirens by non-emergent transport services shall be made only when non-emergent transport services are operating under the auspices of a mutual aid agreement with the local emergency transport provider or during a disaster situation.

D. The Department will, upon request, be furnished with staffing patterns, policy and procedure, and mutual aid agreements that assures compliance with the en route times noted in Section 403.C.

E. Industries that provide ambulance service for their employees may exempt the minimum number of EMT's noted in Section 403.B, as long as they meet en route times and staffing requirements of the regulations.

F. The provider maintains records that include, but are not limited to, approved ambulance run reports, employee / member rosters, time sheets, call rosters, training records and dispatch logs that show at least time call received, type call and time unit is en route. Such records are to be available for inspection by the Department with copies furnished upon request.

Section 404. Criteria for License Category - Intermediate Life Support: (Ambulance).(II)

To be categorized as an intermediate life support provider, the provider must meet all criteria established for basic life support, minimum standard. Additionally, the provider must demonstrate sufficient equipping and staffing capability to assure that life support consisting of at least IV therapy and advanced airway care are onboard the ambulance with two EMT's, one of which must be an Intermediate or Paramedic, at least 80% of the time on emergency calls. For initial applicants seeking licensure with no prior call history, category shall be determined by the Department on a case by case basis.

Section 405. Criteria for License Category - Advanced Life Support: (Ambulance).(II)

To be categorized as an advanced life support provider, the provider must meet all criteria established for basic life support, minimum standard. Additionally, the provider must demonstrate sufficient equipping and staffing capability to assure that life support consisting of IV therapy, advanced airway care, cardiac monitoring, electrical therapy and drug therapy, approved by the Department and the unit medical control physician, are onboard the ambulance with a minimum of two EMT's, one of which must be an EMT-Paramedic at least 80% of the time on emergency calls. For initial applicants seeking licensure with no prior call history, category shall be determined by the Department on a case by case basis.

Section 406. Criteria for License Category - Special Purpose Ambulance Provider: (Ambulance).(II)

A. Have an approved vehicle that is in compliance with Section 201.V of these regulations and meets minimum equipment requirements, as delineated in Section 705.

B. Have a medical control physician as delineated in Section 402 of these regulations.

C. Provide the Department with copies of policy and procedure for the operation of the special purpose ambulance.

D. Provide a list of special purpose equipment that is carried on the special purpose ambulance and is approved by the medical control physician for review and approval by the Department.

E. Provide other license information delineated in Section 401 of these regulations.

F. Except during extenuating circumstances, special purpose ambulances shall be used for interfacility transports only.

Section 407. Advanced Life Support Information.(II)

Ambulance service providers professing to provide advanced life support level of care for a patient must at all times transport an ALS patient in an ambulance which is fully equipped as an advanced life support unit, per these regulations, with an EMT-Paramedic, physician or RN, as delineated in these regulations, in the patient compartment.

Section 408. Advertising Level of Care.

Ambulance service providers may not advertise that they provide a level of life support above the category for which they are licensed.

Section 409. Criteria for License Category - EMT First Responder.(II)

A. Personnel assigned to First Responder duty must be currently certified EMT's with no less than five (5) EMT's associated with the provider.

B. Must have staffing patterns, policy and procedure, to assure that a First Responder unit is en route with at least one EMT to all emergent calls within five (5) minutes. Volunteer units (services not utilizing paid personnel) without on site personnel must have staffing patterns, policy and procedure to assure that a First Responder unit is en route with at least one EMT to all emergent calls within ten (10) minutes.

C. The Department will, upon request, be furnished with staffing patterns, policy and procedure to assure compliance with the en route times noted in Section 409.B.

D. The provider maintains records that include, but are not limited to, approved patient care report forms, employee/member rosters, time sheets, call rosters, training records and dispatch logs that show at least time call received, type call and time unit is en route. Such records are to be available for inspection by the Department with copies furnished upon request.

Section 500. PERMITS, AMBULANCE

Section 501. Vehicle and Equipment.

A. Before a permit may be issued for a vehicle to be operated as an ambulance, its registered owner must apply to the Department for an ambulance permit. Prior to issuing an original or renewal permit for an ambulance, the Department shall determine that the vehicle for which the permit is issued meets all requirements as to design, medical equipment, supplies and sanitation as set forth in these regulations of the Department. Prior to issuance of the original permit, if the ambulance does not meet all minimum requirements and loses points during the inspection, no permit will be issued.

B. Permits will be issued for specific ambulances and will be displayed on the lower left-hand corner of the windshield of the ambulance or in the aircraft portfolio, whichever is applicable.

C. No official entry made upon a permit may be defaced, altered, removed or obliterated.

D. Permits may be issued or suspended by the Department.

E. Permits must be returned to the Department when the ambulance or chassis is sold or removed from ambulance service.

Section 600. STANDARDS FOR AMBULANCE PERMIT

Section 601. Ambulance Design and Equipment.

The following designs are hereby established as the minimum criteria for ambulances utilized in South Carolina and are effective with the publication of these regulations. Any emergency ambulance purchased after publication of these requirements must meet the following minimum criteria.

A. Based Unit: Chassis should not be less than three quarter ton. In the case of modular or other type body units, the chassis shall be proportionate to the body unit, weight and size; power train shall be compatible and matched to meet the performance criteria listed in the most current edition of the Federal KKK Specification; maximum effective sized tires; power steering; power brakes; heavy duty cooling system; heavy duty brakes; mirrors; heavy duty front and rear shock absorbers; 70 amp battery; 100 amp alternator; front end stabilizer; driver and passenger seat belts; padded dash; collapsible steering wheel; door locks for all doors; inside mirror; inside control handles on rear and side doors. Four-wheel drive is recommended for operating in mountainous area during winter months where snow and ice is prevalent, in rough terrain and at the seashores where traction in sand is difficult.

B. Color: There shall be no restrictions concerning the painted color of the ambulance.

C. Emblems and Markings: All items in this section shall be of reflective quality and in contrasting color to the exterior painted surface of the ambulance.

1. There shall be a continuous stripe, of not less than 3" on cab and 6" on patient compartment, to encircle the entire ambulance with the exclusion of the hood panel.

2. Emblems and markings shall be of the type, size and location as follows:

a. Front: The word "AMBULANCE", minimum of 4" in height, shall be in mirror image (reverse reading) for mirror identification by drivers ahead, with a "Star of Life", minimum of 3" height, to the left and right of the word "AMBULANCE." If vehicle design permits, there shall be a "Star of Life" of no less than 12" in height on the front section of the patient compartment.

b. Side: Each side of the patient compartment shall have the "Star of Life" not less than 12" in height. The word "AMBULANCE", not less than 6" in height, shall be under or beside each star. The name of the licensee as stated on their provider's license shall be of lettering not less than 3" in height.

c. Rear: The word "AMBULANCE", not less than 6"in height, and two "Star of Life" emblems of not less than 12" in height.

d. Top (roof): There shall be a "Star of Life" of not less than 32" in height as well as the individual provider's ambulance number (example: unit "23") of not less than 12"in height.

3. Prior to private sale of ambulance vehicles to the public, all emblems and markings in Section 601.C must be removed.

D. Interior Patient Compartment Dimensions:

1. Length: The compartment length shall provide a minimum of 25" clear space at the head and 15" at the foot of a 76" stretcher. Minimum inside length will be 116".

2. Width: Minimum inside width is 69 inches.

3. Height: Inside height of patient compartment shall be a minimum dimension of 60" from floor to ceiling.

E. Access to Vehicle:

1. Driver Compartment.

a. Driver's seat will have an adjustment to accommodate the 5th percentile to 95th percentile adult male.*

*Note: This means that the driver's area will accommodate the male drivers who are 90% of the smallest and largest in stature, which includes weight and size.

b. There shall be a door on each side of the vehicle in the driver's compartment.

c. Separation from the patient area is essential to afford privacy for radio communication and to protect the driver from an unruly patient. Provision for both verbal and visual communication between driver and attendant will be provided by a sliding shatterproof glass partition at upper portion of partition. The bulkhead must be strong enough to support an attendant's seat in the patient area at the top of the patient's head and to withstand deceleration forces of the attendant in case of accident.

2. Patient Compartment:

a. There shall be a door on the right side of the patient compartment near the patient's head area of the compartment. The side door must permit a technician to position himself at the patient's head and quickly remove him from the side of the vehicle should the rear door become jammed.

b. Rear doors shall swing clear of the opening to permit full access to the patient's compartment.

c. All patient compartment doors shall incorporate a holding device to prevent the door closing unintentionally from wind or vibration. When doors are open the holding device shall not protrude into the access area. Special purpose ambulances are exempt as long as access/egress is not obstructed due to wheelchair ramps or other specialized equipment.

d. Spare tire storage shall be positioned such that the tire can be removed without disturbing the patient.

F. Interior Lighting:

1. Driver Compartment: Lighting must be available for both the driver and an attendant, if riding in the driving compartment, to read maps, records, etc. There must be shielding of the driver's area from the lights in the patient compartment.

2. Patient Compartment: Illumination must be adequate throughout the compartment and provide an intensity of 40-foot candles at the level of the patient for adequate observation of vital signs, such as skin color and pupillary reflex, and for care in transit. Lights should be controllable from the entrance door, the head of the patient, and the driver's compartment. Reduced lighting level may be provided by rheostat control of the compartment lighting or by a second system of low intensity lights.

G. Illumination Devices:

1. Illumination Devices: Flood and load lights - there shall be at least one flood light mounted not less than 75" above the ground and unobstructed by open doors located on each side of the vehicle. A minimum of one flood light, with a minimum of 150 lumens equivalent, shall be mounted above the rear doors of the vehicle.

2. Warning lights - at a minimum alternating flashing red lights must be on the corners of the ambulance so as to provide 360º conspicuity.

3. Flares: Six red reflectorized or chemically induced illumination devices may be substituted for flares. Combustible type flares are not acceptable.

4. One set battery jumper cables, minimum 04 gauge copper, 600 amp rating.

H. Seats:

1. A seat for both driver and attendant will be provided in the driver's compartment with armrests on each side of driver's compartment.

2. Technician (Patient Compartment): two fixed seats, padded, 18" wide 18" high; to head of patient behind the driver, the other one may be square bench type located on curb (right) side of the vehicle. Space under the seats may be designed as storage compartments.

I. Safety Factors for Patient Compartment:

1. Stretcher Fasteners: Crash-stable fasteners must be provided to secure a primary and secondary stretcher.

2. Stretcher Restraint: If the stretcher is floor supported on its own support wheels, a means shall be provided to secure it in position under all conditions. These restraints shall permit quick attachment and detachment for quick transfer of patient.

3. Patient Restraint: A restraining device shall be provided to prevent longitudinal or transverse dislodgement of the patient during transit, or to restrain an unruly patient to prevent further injury or aggravation to the existing injury.

4. Safety Belts for Drivers and Attendants:

a. Quick-release safety belts will be provided for both driver and attendants, plus all seated patients (squad bench). These safety belts will be retractable and self-adjustable.

5. Mirrors:

a. There shall be two exterior rear view mirrors, one mounted on the left side of the vehicle and one mounted on the right side. Location of mounting must be such as to provide maximum rear vision from the driver's seated position.

b. There shall be an interior rear view mirror to provide the driver with a view of occurrences in the patient compartment.

6. Windshield Wipers and Washers:

a. Vehicle is to be equipped with two electrical windshield wipers and washers in addition to defrosting and defogging systems.

7. Sun Visors:

a. There shall be a sun visor for both driver and attendant.

J. Environmental Equipment: Driver/Patient Compartment.

1. Heating: Shall be capable of heating the compartment to a temperature of 75º F. within a reasonable period while driving in an ambient temperature of 0º F. It must be designed to recirculate inside air, also be capable of introducing 20% of outside air with minimum effect on inside temperature. Fresh air intake shall be located in the most practical contaminant-free air space on the vehicle.

2. Heating Control: Heating shall be thermostatically or manually controlled. The heater blower motors must be at least a three (3) speed design. Separate switches will be installed in patient compartment.

3. Air Conditioning: Air Conditioning shall have a capacity sufficient to lower the temperature in the driver's and patient's compartment to 75º F within a reasonable period and maintain that temperature while operating in an ambient temperature of 95º F. The unit must be designed to deliver 20% of fresh outside air of 95º F. ambient temperature while holding the inside temperature specified. All parts, equipment, workmanship, etc., shall be in keeping with accepted air conditioning practices.

4. Air Conditioning Controls: The unit air delivery control may be manual or thermostatic. The reheat type system is not required in the driver's compartment unit. Switches or other controls must be within easy reach of the driver in his normal driving position. Air delivery fan motor shall be at least a three (3) speed design. Switches and other control components must exceed in capacity the amperage and resistance requirements of the motors.

5. Insulation: The entire body, side, ends, roof, floor, and patient compartment doors shall be insulated to minimize conduction of heat, cold, or external noise entering the vehicle interior. The insulation shall be vermin and mildew-proof, fireproof, non-hygroscopic, non-setting type. Plywood floor when undercoated will be considered sufficient insulation for the floor area.

K. Storage Cabinets: All cabinets must meet the criteria as stated in the most current edition of the Federal KKK Specifications as to types of surfaces, design and storage. Cabinets must be of sufficient size and configuration to store all necessary equipment. All equipment must be accessible to attendant at all times.

L. Two-Way Radio Mobile: Two way radio mobile equipment shall be included which will provide a reliable system operating range of at least a 20 mile radius from the base station antenna. The mobile installation shall provide microphones for transmitting to at least medical control and receiving agencies, at both the driver's position and in the patient's compartment. Selectable speaker outputs, singly and in combination, shall be provided at the driver's position, in the patient's compartment, and through the PA system.

1. All radio frequencies utilized by a licensed service will be provided to the Department.

2. In the event technological advancements render the above components obsolete, the Department shall make determinations as to the efficacy of proposed technology on an individual basis prior to allowing their use.

M. Siren-Public Address: Siren and public address systems shall be provided. If a combined electronic siren and public address system is provided, in siren operation, the power output shall be 100 watts. In voice operation the power output shall be 45 watts through two exterior mounted speakers. The public address amplifier shall be independent of the mobile radio unit.

N. Antenna: Rooftop mounted with coaxial cable.

O. Glass Windows: All windows, windshield and door glass must be shatterproof.

Section 700. EQUIPMENT

Section 701. Minimum Ambulance Medical Equipment.

Effective the date of these Rules and Regulations, all ambulances will be required to be equipped with, but not limited to the following:

A. Minimum of two stretchers.

1. One multilevel, elevating, wheeled stretcher with elevating back. Two patient restraining straps (chest and thigh) minimum, at least two inches wide shall be provided.

2. One secondary patient transport stretcher, with a minimum of two patient restraining straps. Minimum acceptable stretcher is vinyl covered, aluminum frame, folding stretcher.

B. Suction Devices.

1. An engine vacuum operated or electrically powered, complete suction aspiration system, shall be installed permanently on board to provide for the primary patient. It shall have wide bore tubing.

2. A portable suction device, age and weight appropriate, with wide bore tubing and at least a six ounce reservoir.

3. There must be an assortment of suction catheters (minimum of 2 each) on board. Sizes 6 fr, 8 fr, 10 fr, 16 fr, 18 fr. A rigid suction catheter (e.g. Yankaur) will also be carried. Minimum 2 each.

C. Bag Mask Ventilation Units.

1. One adult, hand-operated. Valves must operate in all weather, and unit must be equipped to be capable of delivering 90-100% oxygen to the patient.

2. One pediatric, hand-operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop off mechanism with override capability.

3. One infant, hand-operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

4. The following sized masks will be carried aboard all permitted ambulances to be used in conjunction with the ventilation units above, 0,1,2,3,4,5. Masks must be clear. Either the disposable or non-disposable types are acceptable.

D. Nonmetallic Oropharyngeal (Berman type)/ Nasopharyngeal Airways - adult, child and infant sizes. All airways shall be clean and individually wrapped.

1. Large adult

2. Med. adult

3. Large child

4. Child

5. Infant

E. "S" tube type airways may not be substituted for Berman type airways.

F. Oxygen Equipment.

1. Portable oxygen equipment: Minimum "D" size (360 Liter) cylinder, two required (one full spare cylinder). Liter flow gauges shall be non-gravity, dependent (Bourdon Gauge) type. Additionally, when the vehicle is in motion, all oxygen cylinders shall be readily accessible and securely stored.

2. Permanent On-Board Oxygen Equipment: The ambulance shall have a hospital type piped oxygen system, capable of storing and supplying a minimum of 2400 liters of humidified medical oxygen.

3. Single use, individually wrapped, non-rebreather masks and cannulas in adult and pediatric sizes shall be provided (3 each).

4. A "no smoking" sign will be prominently displayed in the patient compartment.

G. Bite sticks commercially made.(Clean and individually wrapped).

H. Twelve sterile dressings (minimum size 5" x 9").

I. Thirty-six each sterile gauze pads 4"x 4".

J. Twelve each bandages, self-adhering type, minimum three inches by five yards. Bandages must be individually wrapped or in clean containers.

K. A minimum of four commercial sterile occlusive dressings, four inches by four inches.

L. Adhesive Tape, hypoallergenic, one, two and three inches wide.

M. Burn sheets, two, sterile.

N. Splints:

1. Traction type, lower extremity, overall length of splint 43 inches, with limb support slings, padded ankle hitch, traction device and heel stand. Either the Bi-polar or Uni-polar type is acceptable.

2. Padded type, two or more, three feet long, of material comparable to four-ply wood for coadaptation splinting of the lower extremities.

3. Padded wooden type, two or more, 15 inches by three inches, for fractures of the upper extremity.(By local option, commercially available arm or leg splints may be substituted for items N-2,3 above).

O. Spinal immobilization devices:

1. Short spine board, at least 16 inches by 36 inches with appropriate straps. (Commercially available vest type KED, XP1 or other equivalent is acceptable.) Additionally: Child backboard or pedi-board or any type commercially available spinal immobilization device sized for the pediatric patient.

2. Long spine board, at least 16 inches by 72 inches constructed of three-quarter inch plyboard or equivalent material and having at least three quarter inch runners on each side for lifting with appropriate straps. If not equipped with runners, board must be designed so handholds are accessible even with gloves on.

3. Cervical collars to accommodate the infant, child, medium adult and large adult sizes. Collars must be manufactured of semirigid or rigid material.

4. Three, two inches by nine foot patient restraint straps.

5. Head immobilization device, commercially available or towel/blanket rolls.

P. Five each triangular bandages.

Q. Two blankets.

R. Bandage shears, large size.

S. Obstetrical kit, sterile. The kit shall contain gloves, scissors or surgical blades, umbilical cord clamps or tapes, dressings, towels, perinatal pad, bulb syringe and a receiving blanket for delivery of infant.

T. Blood pressure manometer, cuff and stethoscope.

1. Blood pressure set, portable, both pediatric and adult (non mercurial type).

2. Stethoscopes.

U. Emesis basin or commercially available emesis container.

V. Bedpan and urinal.

W. Two dependable flashlights or electric lanterns, minimum size, two-D-cell or six volt lanterns.

X. Minimum of one fire extinguisher, CO2 or dry chemical, five pound capacity, type ABC.

Y. Working gloves, two pair with leather palms and reflective vests for each crew member.

Z. Minimum of 1000 cc of sterile water or normal saline solution for irrigation.

AA. Protective head gear and eye protection devices (minimum two each) must be carried on each ambulance. Standard fire face shield not acceptable.

BB. Personal protective equipment (gloves, masks, gowns and eyeshields).

CC. At the option of the medical control the following equipment may be added:

1. Laryngoscope handle with batteries.

2. Laryngoscope blades, adult, child and infant sizes. Infant sizes shall be 0,1,2 (straight). In addition, a #2 curved blade will be carried.

3. Six disposable endotracheal tubes, sizes to be from 2.5-9.0 with at least one of each size available. An intubation stylette sized for the neonate patient shall also be available (6 fr.).

4. Dual Lumen or LMA airways, age and weight appropriate.

5. Magill Forceps.

a. Adult.

b. Pediatric.

Section 702. Intermediate and Advanced Equipment.

Ambulances providing intermediate and advanced life support must, in addition to meeting all other requirements of Section 701 must have the following equipment:

A. Butterfly or scalp vein needles between 19 and 25 gauge, a total of four.(Medical Control Option)

B. Four each 14, 16, 18, 22 , and 24 gauge IV cannulae.

C. Two Macro drip sets.

D. Two Micro drip sets.

E. Three 21 or 23 and three 25 gauge needles, total six.(Medical Control Option)

F. Three tourniquets.

G. Laryngoscope handle with batteries.

H. Laryngoscope blades, adult, child, and infant sizes. Infant sizes shall be 0,1,2 (straight). In addition, a #2 curved blade will be carried.

I. Six disposable endotracheal tubes sizes to be from 2.5-9.0 with at least one of each size available. An intubation stylette sized for the neonate patient shall also be available (6 fr.).

J. Equipment for drawing blood samples. (Medical Control Option)

K. Syringes, two each 1 ml, 3 ml, 10 ml, 20 ml, and one 50 ml.

L. Twelve (12) alcohol and iodine preps for preparing IV injection sites.

M. One (1) roll of tape, at least 1/2 inch wide.

N. Five (5) band-aids.

O. A minimum of 4 liters of normal saline or other appropriate IV solution.

P. Intraosseous devices.

1. Pediatric - minimum of two sizes.

2. Adult - (Medical Control Option) minimum of one size.

Q. Ambulances providing advanced cardiac life support must be equipped with a battery powered (DC) portable monitor-defibrillator unit, appropriate for both adult and pediatrics with ECG printout. The monitor-defibrillator equipment utilized by the service has the capability of producing hard copy of patient's ECG.

R. Such drugs/fluids as may be approved by the Board for possession and administration by EMT's trained and certified in their use and authorized by the medical control physician, as documented to the Department.

S. Magill Forceps.

1. Adult

2. Pediatric

T. Dual Lumen or LMA airways, age and weight appropriate.

U. Portable sharps container.

V. Pediatric length/weight-based drug dose chart or tape.

Section 703. Minimum Ambulance Rescue Equipment.

The following additional items will be carried by each ambulance:

A. Hammer, one four pound with 15 inch handle.

B. One axe.

C. Wrecking Bar, minimum 24-inch (bar and two preceding items can either be separate or combined as a forcible entry tool).

D. Crowbar, minimum 48", with pinch point.

Section 704. Convalescent Transport Units.(II)

A. Convalescent transport units must meet the requirements of Section 701, minimum ambulance medical equipment, minus items C-3, H, K, M, Y.

B. Convalescent transport units are exempted from Section 703, minimum ambulance rescue/extrication equipment.

C. Convalescent transport units are required to be equipped with a radio that meets the requirements of Section 601-N (minus the PA system) whenever transporting a patient outside of its home county.

D. Convalescent transport units may not have any emergency markings, but shall display the words "Convalescent Transport" and the name of the licensee in letters a minimum of 3" in height, on each side of the ambulance.

Section 705. Special Purpose Ambulance Equipment.

A. All special purpose ambulances will be equipped with at least the following items from Section 701 of these regulations: A-1, B, C(appropriate size), D, F, G, T, U, V, W, X in addition to special purpose equipment that is documented to the Department as delineated in Section 406. Item A-1 can be replaced by a specialized patient transfer device so long as there is a provision to safely secure the device in the special purpose ambulance.

B. Special purpose equipment as documented to the Department as delineated in Section 406 of these regulations must be on the special purpose ambulance when it is in use and is subject to inventory and inspection by the Department as provided for in Section 406 of these regulations.

Section 706. EMT First Responder Equipment.

A. The First Responder Agency's vehicle must be properly marked as to identify the vehicle as an emergency vehicle.

B. The First Responder Agency will provide a minimum of one EMT-Basic for each response.

C. All first responder vehicles will be equipped with at least the following items from Section 701 of these regulations:B-2, B-3, C, D, F-1, F-3, G, H, I, J, K, L, M, N-2, N-3, O, P(3each), Q, R, S, T, W(1each), X, Y, Z, BB, CC.

D. The first responder agency must at all times be able to communicate with (a) on-line medical control, (b) dispatch center and (c) the local transporting service.

E. Equipment In Addition to 706-C To Be Carried By EMT-Intermediate First Responders.

1. Four each, 14, 16, 18 and 22 gauge IV cannulae.

2. Two Macro Drip sets.

3. Two Micro Drip sets.

4. One Sharps type container.

5. A minimum of 4 liters of normal saline or other appropriate IV solution.

6. Three Tourniquets.

7. Twelve each, Alcohol and Betadine Preps for preparing IV injection sites.

8. Five Bandaids.

F. Equipment In Addition To 706.C & E To Be Carried By EMT-Paramedic First Responders.

1. A battery powered Monitor-Defibrillator, appropriate for both adults and pediatrics, capable of producing hard copy of the patient's ECG.

2. Such drugs/fluids as may be approved by the Board for possession and administration by EMT's trained and certified in their use and authorized by the medical control physician, as documented to the Department.

G. All medical and patient care equipment used by a licensed first responder organization shall meet the same standards for cleanliness and communicable diseases as is required of transporting EMS units.

Section 800. SANITATION STANDARDS FOR LICENSED PROVIDERS

Section 801. Exterior Surfaces.

A. The exterior of the vehicle shall have a reasonably clean appearance.

B. All exterior lighting should be kept clear of foreign matter (insects, road grime, etc.) to assure adequate visibility.

Section 802. Interior Surfaces Patient Compartment-Ambulance.

A. Interior surface shall be of a nonporous material to allow ease of cleaning. Carpet-type materials shall not be used on any surface of the patient compartment.

B. Floors shall be free from sand, dirt and other residue that may have been tracked into the compartment.

C. Wall, cabinet, and bench surfaces shall be kept free of dust, sand, grease, or any other accumulated surface matter.

D. Interiors of cabinets and compartments shall be kept free from dust, moisture or other accumulated foreign matter.

E. Bloodstains, vomitus, feces, urine and other similar matter must be cleaned from the unit and all equipment after each call, using an agent or hypochlorite solution described in Section 802.H.

F. Window glass and cabinet doors shall be clean and free from foreign matter.

G. A receptacle shall be provided for the deposit of trash, litter, and all used items, etc.

H. An EPA recommended germicidal/viralcidal agent or a hypochlorite solution of 99 parts water and 1 part bleach must be used to clean patient contact areas. For surfaces where such an EPA solution is not recommended, alcohol or hypochlorite solution can be used.

I. A container specifically for the deposit of contaminated needles or syringes and a second container for contaminated or infectious waste shall be provided and will be easily accessible from the patient compartment.

Section 803. Linen.

A. Storage area for clean linens shall be provided in such configuration so that linens remain dry and clean. (Ambulance)

B. Freshly laundered or disposable linens (minimum of six sets) shall be used on stretchers and pillows, and shall be changed after each patient is transported. (Ambulance)

C. Soiled linen is to be transported in a closed plastic bag or container and removed from the ambulance as soon as possible.

D. Blankets and towels shall be clean and stored in such a manner to assure cleanliness.

1. Towels shall not be used more than once between laundering.

2. Blankets shall be laundered/cleaned as they become soiled. Blankets should preferably be of a hypoallergenic material designed for easy maintenance.

Section 804. Oxygen Administration Apparatus.(II)

A. Oxygen administration devices such as masks, cannulas, and delivery tubing shall be disposable.

B. All masks and cannulas and tubing shall be individually wrapped and not opened until used on a patient.

C. Once used, the masks, cannulas and tubing is to be disposed of and not reused.

D. Oxygen humidifiers should be filled with distilled or sterile water upon use only. Reusable humidifiers must be cleaned after each use. Disposable, single use humidifiers are acceptable in lieu of multiuse types.

Section 805. Resuscitation Equipment.(II)

A. Bag mask assemblies and masks shall be stored in the original container, jump kit, or a closed compartment to promote sanitation of the unit.

B. The bag mask assembly shall be free from dust, moisture and other foreign matter.

C. Masks, valves, reservoirs and other items or attachments for bag mask assemblies shall be cleaned and sanitized after each use. A ten (10) minute sodium hypochlorite soak ninety-nine (99) parts water to one (1) part bleach, or other acceptable method shall be used.

Section 806. Suction Unit.

A. Suction hoses shall be clean and free from foreign matter. Preferably, disposable type hoses should be used.

B. Suction reservoir shall be clean and dry.

C. Suction units shall be clean and free from dust, dirt or other foreign matter.

D. Tonsil tips and suction catheters shall be of the disposable type, stored in sterile packaging until used. Tonsil tips and suction catheters shall not be reused.

E. Suction units with attachments shall be cleaned and sanitized after each use. (See Section 805.C).

Section 807. Splints.

A. Padded splints shall be neatly covered with a nonpermeable material and clean. When the outside cover of the splint becomes soiled, they should be thoroughly cleaned and replaced.

B. Pneumatic trousers, if used, shall be clean and free from dust, dirt or other foreign matter.

C. Commercial splints shall be free of dust, dirt or other foreign matter.

D. Traction splints with commercial supports shall be clean and free from accumulated material.

E. All splinting materials must be stored in such a manner as to promote/maintain cleanliness.

Section 808. Stretchers and Spine Boards.

A. Pillows, mattresses and head immobilization devices (HIDs) shall be covered with a nonpermeable material and in good repair.(Single use items exempt.)

B. Stretchers, pillows, HIDs and spine boards shall be clean and free from foreign material.

C. Canvas or neoprene covers on portable type stretchers shall be in good repair.

D. All restraint straps/devices shall be kept clean and shall be washed immediately if soiled.

E. Wooden spine boards shall be sealed with an appropriate substance to facilitate cleaning.

F. All spine boards shall be free from rough edges/areas that may cause splinters.

Section 809. Bandages and Dressings.(II)

A. Bandages need not be sterile, but they must be clean. They should be individually wrapped, or stored in a closed container or cabinet to insure cleanliness.

B. Dressings must be sterile, individually packaged and sealed, and stored in a closed container or compartment. If the seal is broken or wrap is torn, the dressing is to be discarded.

C. Dressings or burn sheets that are not commercially wrapped must be sterilized in an autoclave or gas sterilizer, with the date of sterilization shown on each item. Items with a sealed plastic dust cover may remain on the unit no longer than six months without being resterilized or rotated with other sterile equipment. Cloth covered items must be resterilized or rotated at least every thirty (30) days.

D. Triangular bandages must be washed after each use if not the disposable type.

E. All bandages or dressings that have been exposed to moisture or otherwise have become soiled must be replaced.

Section 810. Obstetrical Kits.(II)

A. All OB kits must be sterile and wrapped with cellophane or plastic. If the wrapper is torn or the kit is opened but not used, the items in the kit that are not individually wrapped must be resterilized or discarded and replaced.

B. OB kits that are not commercially wrapped must be sterilized in an autoclave or gas sterilizer with a date of sterilization shown on the item. Items with a sealed plastic cover may remain on the unit no longer than six months without being resterilized or rotated at least every thirty (30) days.

Section 811. Oropharyngeal Appliances.(II)

Instruments inserted into a patient's mouth or nose shall be single service, individually wrapped and stored properly. Oropharyngeal airways designed for multi use shall be sterilized in an autoclave or gas sterilizer, Cidex or sodium hypochlorite soak (ninety-nine (99) parts water to one (1) part bleach) and individually wrapped.

Section 812. Communicable Diseases.(II)

A. When an ambulance or transport vehicle has been utilized in the transport of a patient known to have a communicable disease, the vehicle must be taken out of service until cleaning and disinfecting is completed.

B. Linen must be removed from the stretcher and properly disposed of, or immediately placed in a plastic bag or container and sealed until properly cleaned.

C. Patient contact areas, equipment and any surface soiled during the call, must be cleaned in accordance with Section 802.H of these guidelines.

Section 813. Miscellaneous Equipment.

Miscellaneous equipment such as scissors, stethoscopes, BP cuffs and/or other items used for direct patient care should be cleansed as they become soiled. Items should be kept clean and free from foreign matter.

Section 814. Equipment and Materials Storage Areas.

Equipment not used in direct patient care shall be in storage spaces that prevent contamination/damage to direct patient care equipment or materials.

Section 815. Personnel.

A. All personnel functioning on the vehicle shall present themselves in a clean, neat appearance at all times.

B. Hands and forearms should be thoroughly washed according to Standard 1910.1030 set forth by the Occupational Safety and Health Administration (OSHA).

C. Uniforms/clothing should be neat, clean or changed if they become soiled or exposed to vomitus, blood or other foreign matter.

Section 900. TRAINING AND CERTIFICATION

Section 901. Emergency Medical Technician Training Programs.(II)

A. Emergency Medical Technician-Basic Training Program - This program is established by the Department and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices. The curriculum for this training program is the Department of Transportation curriculum for EMT's or any other curriculum approved by the Department.

B. Emergency Medical Technician-Intermediate Training Program - This program is established by the Department to provide a level of care between the basic and Paramedic programs and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices. The curriculum for this training program is the Department of Transportation curriculum for EMT-Intermediate or any other curriculum approved by the Department.

C. The Emergency Medical Technician-Paramedic Training Program - The curriculum for this training program is the Department of Transportation curriculum for EMT-Paramedic or any other EMT-Paramedic training program as developed or established and approved by the Department and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices.

D. Candidates may complete their required refresher training program by one of the following methods:

1. Complete the state approved EMT-Basic, EMT-Intermediate, or EMT-Paramedic refresher course as appropriate to the individual certification level, including the state approved practical and written examination.

2. Complete refresher course requirements by attending state approved C.E. unit lectures and/or seminars that equate to the regular structured refresher courses, including the state approved practical and written examination.

3. Complete the state approved in-service training program that meets the requirements of the Department, including the state approved practical and written examination. In-service training program requirements include, medical control physician participation and supervision of the service's program. Participation includes development of the service's in-service training program to meet the Department requirements and the needs of the individual service.

4. EXCEPTIONS - Candidates may exempt the state written and/or practical examinations if they meet the following criteria:

a. Candidates that complete the state approved in-service program may, if otherwise qualified, exempt the practical examination if the medical control physician signs a statement indicating the individual is competent in all the skills published by the Department for the level of EMT certification the candidate is recertifying. Candidates may also exempt the written examination if the medical control physician signs a statement indicating they are knowledgeable, proficient, and capable of performing all of the duties for the level of EMT certification they are recertifying.

b. Candidates that are nationally reregistered may exempt the state written and practical examinations.

E. Criteria for Special Purpose EMT. In order to be issued a valid special purpose EMT certificate, one must meet all of the following criteria:

1. The special purpose EMT must be a registered nurse.

2. The special purpose EMT must have completed an acceptable training program for delivery of the special area or possess experience in that special care area satisfactory to the Department.

3. The special purpose EMT must be employed by the medical service which utilizes the special purpose ambulance and recommended by the director of the medical service which utilizes a special purpose ambulance.

4. The medical service by which the special purpose EMT is employed must have operational procedures and medical protocols directing the daily operations of the special purpose EMT and special purpose ambulance. These medical protocols must be in written form, approved and signed by the director of the medical service in order for the special purpose EMT to administer medical treatment required by the protocols.

F. Pilot Programs. The Department may authorize providers to initiate pilot programs which provide training in new and innovative procedures that have potential for lifesaving care. Those who wish to initiate a pilot program must provide in writing to the Department a detailed proposal of the program and any supporting materials. Under no circumstances shall pilot programs be initiated without prior approval by the Department. The EMT's who participate in these programs are allowed to perform the pilot procedures, under medical control physician supervision, during the period of the pilot program. At the conclusion of the pilot program a report must be submitted to the Department describing the outcome/results of the program. Research gained from the pilot programs will be used to revise and upgrade existing EMT programs and scope of practice.

G. Department approved Advanced Training Centers in existence prior to the effective date of these regulations shall continue to provide EMT training in accordance with the provisions of this article.

Section 902. Certification.(I)

A. No persons shall act or serve in the capacity of primary patient care attendant in an ambulance without first completing, minimally, an approved Emergency Medical Technician-Basic Training Program and holding a South Carolina certificate as an emergency medical technician-Basic. Emergency medical technician-Basic certificates are in force for three years and are subject to renewal before expiration date if the candidate continues to meet state qualification. Certified emergency medical technician-Basic may perform those functions taught in the approved EMT Basic curriculum. Emergency medical technician-Basic certificates may be issued to eligible personnel, eighteen years of age or older, upon the satisfactory completion of any of the following requirements:

1. Any person completing the Department approved "Emergency Medical Technician-Basic Course" (to include examination), or ...

2. Any person who has successfully passed the written and practical portions of the "National Registry of Emergency Medical Technician-Basic" examination and other requirements established by the Department, and is currently registered, (applies to initial State certification only) "These candidates are exempt from the state practical and written certification examinations," or ...

3. Any person who receives comparable training within three years of their application. Comparable course credit may be determined by submitting copies of course certification and content to the Department for review. Comparable course credit is normally allotted to selected individuals completing extensive emergency courses, such as RNs and United States armed forces medical personnel. These personnel must complete and pass the appropriate state approved refresher course and satisfactorily pass the State or National Registry approved practical and written emergency medical technician examinations.

4. Special Purpose EMT Qualifications. The Department may issue a valid special purpose EMT certificate to those registered nurses who are both extensively trained in a particular special area of care and approved by the Department to attend patients needing that particular care while being transported in special purposes ambulances. These special purpose EMT's may be assisted by other health professionals who are determined qualified and approved by the Department to assist in attendance of the patient during transportation in a special purpose ambulance.

B. Emergency Medical Technician-Intermediate or Paramedic - No person shall act in the capacity of an emergency medical technician-Intermediate or Paramedic without satisfactorily completing an approved emergency medical technician Intermediate or Paramedic training course and holding a South Carolina certificate. EMT-Intermediate or Paramedic certificates are in force for three years and subject to renewal if the candidate continues to meet State qualifications. Appropriate certificates will be issued to candidates who satisfactorily complete an EMT-Intermediate or Paramedic program approved by the Department.

C. Guidance for EMT's - All currently certified emergency medical technicians may only "engage in those practices for which they have been trained" in the state approved curriculum and for which the supervising physician will assume responsibility. In all cases, an EMT will perform procedures under the supervision of a physician licensed in the State of South Carolina. Means of supervision should be direct, by standing orders or by radio and telephone communications.

D. Emergency medical technicians (Intermediate and Paramedic levels only) whose certificates have expired may be reactivated by the candidate completing an appropriate EMT refresher course and submitting an application for certification prior to taking state examinations. Emergency medical technicians at the Basic level whose certificate has expired may only be reactivated by completing all necessary requirements to become Nationally Registered.

E. Emergency medical technician must notify the Department each time they have change of address and furthermore, provider associated EMT's will provide their correct address on the personnel roster required in Section 401.A.5 of these regulations each time their provider submits a license or relicensure application.

F. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

G. The Department may deny certification to applicants with certain past felony convictions and to those who are under felony indictment. Applications for certification of individuals convicted of or under indictment for the following crimes will be denied in all cases*:

1. Felonies involving criminal sexual conduct;

2. Felonies involving the physical or sexual abuse of children, the elderly, or the infirm including, but not limited to, criminal sexual misconduct with a child, making or distributing child pornography or using a child in a sexual display, incest involving a child, assault on a vulnerable adult;

3. A crime in which the victim is a patient or resident of a healthcare facility, including abuse, neglect, theft from, or financial exploitation of a person entrusted to the care or protection of the applicant.

*Applications from individuals convicted of, or under indictment for, other offenses not listed above will be reviewed by the Department on a case by case basis.

Section 903. Application for Certification as an Emergency Medical Technician-Basic.

A. Applications for certification as an Emergency Medical Technician-Basic in South Carolina are to be submitted to the Department, indicating that the student has satisfactorily completed the required curriculum to include any required clinical experience. Reciprocity candidates must provide a copy of their out-of-state certificate that has at least six months remaining on it prior to its expiration date, and have met other requirements as established by the Department. Candidates holding an out of state certificate will be issued a provisional South Carolina certification that expires on the date of their out-of-state certificate, or up to but not exceeding 1 year, whichever is less. During their provisional status, the candidate must become Nationally Registered to be recertified in South Carolina. National Registry candidates requesting initial reciprocity will receive a South Carolina Certification, providing they have a certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department.

B. Upon receipt of the completed application, practical and written examinations will be given at such times as will be scheduled by the Department. An emergency medical technician-Basic certificate will be issued by the Department upon satisfactory completion of the state approved practical and written examinations, and will be effective for three years from the date of issue. A pocket ID card will be issued along with the Basic certificate and must be in the possession of the EMT-Basic at all times that patient care is rendered.

Section 904. Application for Certification as an Emergency Medical Technician-Intermediate or Paramedic.

A. Applications for certification as an EMT-Intermediate or Paramedic in South Carolina are to be submitted to the Department, using forms provided by the Department as follows:

1. Candidates completing a South Carolina approved course must provide a certificate application card that indicates satisfactory completion of the course.

2. Candidates applying for certification by reciprocity must provide a certificate application card along with a copy of their out-of-state certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department. They must also provide statements from a South Carolina licensed provider and the unit medical control physician indicating sponsorship. Candidates holding an out of state certificate will be issued a provisional South Carolina certification that expires on the date of their out-of-state certificate, or up to but not exceeding 1 year, whichever is less. During their provisional status, the candidate must become Nationally Registered to be recertified in South Carolina. National Registry EMT-Intermediate or Paramedic candidates requesting reciprocity, will receive a South Carolina certification providing they have a certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department.

B. Candidates that meet the requirements in "A." above will be permitted to take the state approved examinations. Candidates that pass the state approved examinations will then be issued an intermediate or paramedic EMT certificate as appropriate by the Department which will be effective for three years. A pocket ID card will be issued along with the EMT-Intermediate or Paramedic certificate and must be in the possession of the EMT-Intermediate or Paramedic at all times that patient care is rendered.

Section 905. Recertification as a Emergency Medical Technician-Basic.

A. Recertification as an emergency medical technician-Basic within a 12-month period prior to the expiration date of the EMT-Basic certificate, each emergency medical technician-Basic is required to submit an application for recertification, indicating completion of an approved EMT-Basic refresher course, CEUs or state approved in-service training program, to qualify for recertification. Upon receipt of this application, the Department will schedule and conduct the practical and written examination, as necessary. Upon satisfactory completion of the practical and written examinations, the Department will extend the individual's EMT-Basic certification for another three-year period of time.

B. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

Section 906. Recertification as an EMT-Intermediate or Paramedic.

Each EMT-intermediate or paramedic must do the following prior to their certificate expiring in a three-year period:

A. Submit an application for recertification to the Department requesting recertification. Application to include:

1. Signed statement from licensed provider's medical control physician indicating he will sponsor and supervise the candidate.

2. Signed statement from the licensed provider's director indicating the candidate is a functioning member of the service. Provides documentation that he has the required continuing education points, refresher course completion certificate or in-service EMT training completion record as appropriate.

3. Pass the state practical and written examination. Candidates completing in-service training may with concurrence of the medical control physician, exempt the practical and/or written state examinations.

B. Upon successful completion of the above requirements, the Department will renew the applicant's EMT-intermediate or paramedic certificate, as appropriate, for another three-year period.

C. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

Section 907. Emergency Medical Technician Course Approval Regulations.(II)

A. All EMT courses at all levels, conducted by EMS regional offices or local technical colleges or vocational centers, or colleges must be taught by EMT instructors certified and approved by the Department for the level they are teaching.

B. All EMS training institutions must receive prior approval from the Department prior to starting any course.

C. All licensed providers who wish to conduct approved in-service training program must receive prior approval of the Department and follow the established guidelines of the program.

Section 908. Emergency Medical Technician Instructor Training Programs and Certification.

A. The Department is responsible for the review and approval of all EMT instructor courses. Instructors that meet the requirements and satisfactorily complete the Department approved instructor's course, will be certified by the Department. Certification will coincide with the EMT certification date.

B. Emergency Medical Technician - Basic Instructor Training Program and Authorization. Requirements for authorization as an initial EMT-Basic instructor are as follows:

1. Be twenty-one years of age or older with a high school diploma or GED.

2. Must be currently certified Paramedic with 1 year of experience as an EMT-Paramedic.

3. Complete the Department approved EMS instructor course.

4. Be recommended by a teaching institution that sponsors EMT-Basic courses.

5. Provide the Department with an approved and current CPR instructor card.

6. Meet all other requirements as determined by the Department.

C. The Department is responsible for certification of EMT-Intermediate and Paramedic Instructors who must meet the following qualifications:

1. Be a registered nurse with experience and knowledge in critical care areas; OR be a current South Carolina and Nationally Registered EMT-Paramedic with 5 years experience, high school or GED, and be twenty-one years of age or older.

2. Meet all instructor requirements in areas such as Pediatrics, Trauma and Cardiology as determined by the Department.

3. Be recommended by a teaching institution that sponsors EMT-Intermediate or Paramedic courses.

4. Provide the Department with a copy of an approved and current CPR instructor card.

5. Meet all other requirements as determined by the Department.

6. Complete the Department approved EMS instructor course.

D. Instructor certificates may be renewed as follows:

1. Must provide a letter of endorsement from the teaching institution.

2. Be currently certified as a South Carolina and Nationally Registered EMT-Paramedic.

3. Provide the Department with a copy of an approved and current CPR instructor card.

4. Have met all teaching requirements as determined by the Department.

5. Participate in 12 hours of Department approved continuing education in Instructor Methodology during the 3 year certification period.

6. Meet all other requirements as determined by the Department.

E. An EMT Instructor authorization may be suspended or revoked for any of the following reasons:

1. Any act of misconduct as outlined in Section 1100 of these regulations.

2. Suspension or revocation of the holder's EMT certificate.

3. Failure to maintain required credentials necessary for instructor designation.

4. Any act of proven sexual harassment toward another instructor or candidate.

5. Use of profane, obscene or vulgar language while in the presence of candidates or the EMT program coordinator during the context of class or related functions.

6. Conducting class without the minimum required equipment available and in working condition.

7. The use of any curricula not approved by the Department.

8. Gross or repeated violations of policy pertaining to the EMT training program.

9. Multiple instructor reprimands within a given period of time as established by the Department.

10. Any other actions determined by the Department that compromises the integrity of the program. Those actions may include, but are not limited to the following:

a. An instructor who places himself/herself in a situation which will embarrass or bring unfavorable notoriety to himself/herself or the training institution.

b. Unprofessional behavior in the classroom.

c. Failure to notify the EMT program coordinator when classes must be cancelled or rescheduled.

d. Consistently starting class late or dismissing class early.

e. Conducting classes while under the influence of alcohol.

f. Conducting classes while under the influence of drugs that negatively impair your ability to instruct (prescribed, non-prescribed, or illegal).

g. Falsification of any documents pertaining to the course. (attendance logs, equipment checklists, etc.)

h. Repeated poor class results on the written and/or practical portion(s) of candidate examinations.

Section 1000. PERSONNEL REQUIREMENTS.(I)

A. During the transportation of patients, there shall be an emergency medical technician-Basic, intermediate or paramedic in the patient compartment at all times. The crew member with the highest level of certification shall determine which crew member will attend the patient during transport. If advanced life support procedures are in use, the responsible EMT-intermediate or paramedic shall attend the patient in the patient compartment during transport.

B. Exception: Transferring or receiving medical facilities registered nurses are authorized as ground ambulance attendants when assisting emergency medical technicians in the performance of their duties when all of the following requirements are met:

1. The medical care of the patient is beyond the limit of certification of the EMT.

2. When the ambulance transport is between medical facilities or from medical facility to patient's home.

3. When the responsible physician, transferring or receiving, assumes responsibility of the patient and provides appropriate orders, written preferred, to the registered nurse for patient care.

4. The registered nurse is on duty with the appropriate medical facility during the ambulance transport.

C. No person under the age of eighteen shall operate any emergency vehicle owned or operated by the licensed provider.

D. No person shall act or serve in the capacity of attending a patient while under felony indictment or with certain past felony convictions as listed in Section 902.G of these regulations.

E. All licensed providers must notify the Department immediately should they become aware of a felony indictment or conviction of any person on their roster.

Section 1100. REVOCATION OR SUSPENSION OF CERTIFICATES OF EMERGENCY MEDICAL TECHNICIANS.(I)

A. The Department shall, upon receiving a complaint of misconduct as herein defined, initiate an investigation to determine whether or not suitable cause exists to take action against the holder of an emergency medical technician certificate.

1. The initial complaint shall be in the form of a brief statement, dated and signed by the person making the complaint, which shall identify the person or service who is the subject of the complaint and contain a summary as to the nature of the complaint. The Department is also authorized to initiate an investigation based upon information acquired from other sources.

2. Information received by the Department through inspection, complaint or otherwise authorized under S.C. Code, Section 44-61-10, et.seq., shall not be disclosed publicly except in a proceeding involving the question of licensing, certification or revocation of a license or certificate.

B. "Misconduct," which constitutes grounds for a revocation or suspension or other restriction of a certificate, shall be a satisfactory showing of any of the following:

1. That a false, fraudulent, or forged statement or document has been used, or any fraudulent, deceitful, or dishonest act has been practiced by the holder of a certificate in connection with any of the certification requirements or official documents required by the Department.

2. That, while holding a certificate, the holder is convicted of a felony or any other crime involving moral turpitude, drugs, or gross immorality.

3. That the holder of a certificate is addicted to alcohol or drugs to such a degree as to render him unfit to perform as an EMT.

4. That the holder of a certificate has sustained any physical or mental disability which renders further practice by him dangerous to the public.

5. That the holder of a certificate is guilty of obtaining fees or assisting obtaining such fees under dishonorable, false or fraudulent circumstances.

6. That the holder of a certificate is guilty of disregarding an appropriate order by a physician concerning emergency treatment and transportation.

7. That the holder of a certificate has, at the scene of an accident or illness, refused to administer emergency care on the grounds of age, sex, race, religion, creed or national origin of the patient.

8. That the holder of a certificate has, after initiating care of a patient at the scene of an accident or illness, discontinued such care or abandoned the patient without the patient's consent or without providing for the further administration of care by an equal or higher medical authority.

9. That a holder of a certificate has revealed confidences entrusted to him in the course of medical attendance, unless such revelation is required by law or is necessary in order to protect the welfare of the individual or the community.

10. That the holder of a certificate has, by action or omission and without mitigating circumstance, contributed to or furthered the injury or illness of a patient under his care.

11. That the holder of a certificate is guilty of the careless, or reckless, or irresponsible operation of an emergency vehicle.

12. That the holder of a certificate is guilty of a breach of any section of the Emergency Medical Services Act of South Carolina (Act 1118 of 1974) or any subsequent amendment of the Act or any of the Rules and Regulations published pursuant to the Act.

13. That the holder of a certificate has performed skills above the level for which he was certified or performed skills that he was not trained to do.

14. That the holder of a certificate did allow sub-standard care to be administered by another individual without documenting a supervisor being notified.

15. That the holder of a certificate has, by his actions, or inactions, created a substantial possibility that death or serious physical harm could result therefrom.

16. That the holder of a certificate has not taken or completed remedial training or other courses of action as directed by the Department as a result of an investigation.

17. That the holder of a certificate is found to be guilty of the falsification of any documentation as required by the Department.

C. The suspension or revocation of the emergency medical technician certificate shall include all levels of certification.

Section 1200. AIR AMBULANCES

Section 1201. Licensing.(I)

It shall be unlawful for any ambulance service provider, agent or broker to secure or arrange for air ambulance service originating in the State of South Carolina unless such ambulance service meets the provisions of South Carolina Emergency Medical Services Law and Regulations.

A. Air Ambulance Licensing and Insurance Requirements:

1. Air ambulance licensing procedures are contained in Section 400 of these regulations. Air ambulance permit procedures are contained in Section 500 of these regulations. A permit is required for each aircraft.

2. As part of the licensing procedure, every air ambulance operator shall carry an air ambulance insurance policy. This policy shall cover malpractice, bodily injury and property damage with solvent and responsible insurers licensed to do business in the State of South Carolina. This policy shall provide payment for any loss or damage resulting from any occurrence arising out of or caused by the medical treatment or operation or use of any of the operator's aircraft. Each aircraft shall be insured for the sum of at least $1,000,000 for injuries to or death of any one person arising out of any one incident and the sum of at least $3,000,000 for injuries to or death of more than one person in any one incident. In addition, the provider shall carry at least $500,000 malpractice insurance. Every insurance policy or contract for such insurance shall provide for the payment and satisfaction of any financial judgment entered against the operator and present insured, or any person flying the insured aircraft. All such insurance shall provide for thirty-day cancellation notice to the Department.

B. Out-of-State Air Ambulances.

1. Out-of-state air ambulances transporting patients from locations in South Carolina must be licensed in their home state, if applicable. The medical attendant must be a basic or advanced EMT or have flight nurse who is certified in the home-ported state.

2. Out-of-state air ambulances operating in a state where no license is available must obtain a license in South Carolina and meet all requirements in Section 1200.

C. Air Ambulance Categories:

1. Interfacility Transport. Air ambulance services that transport patients receiving definitive care within the medical care system are those services which provide inter hospital, medical facility to hospital, hospital to other facility, or similar transports where the patients involved are transported from a definitive care medical setting. These transports may be accomplished by fixed-wing or rotary wing aircraft, and range from the transport of a critically ill patient requiring a sophisticated aircraft equipped with special care facilities, staff and supplies to the transport of a patient who has no special medical requirements. It is the responsibility of the medical director to insure that the level of patient care required in any given transport is adequate for that patient's medical needs.

2. Prehospital Transport. Air ambulance services that transport patients in the prehospital setting will be permitted as either an advanced or basic life support service and each prehospital service shall be required to meet the requirements and be licensed accordingly. Each such service shall contract with a medical control physician.

3. Special Purpose Ambulance. Air ambulances that meet the special purpose ambulance requirements.

D. Air Ambulance Aircraft Requirements. The aircraft operator shall, in all operations, comply with all federal aviation regulations which are adopted by reference, Part 135. The aircraft shall meet the following specifications:

1. Be configured in such a way that the medical attendants have adequate access for the provision of patient care within the cabin to give cardiopulmonary resuscitation and maintain patient's life support.

2. Allow loading of a supine patient by two attendants.

3. Have appropriate communication equipment to insure both internal crew and air to ground exchange of information between individuals and agencies appropriate to the mission, including at least medical control, air traffic control, and navigational aids.

4. Be equipped with radio headsets that insure internal crew communications and transmission to appropriate agencies.

5. Have adequate interior lighting, so that patient care can be given and patient status be monitored without interfering with the pilot's vision.

6. Have hooks and/or appropriate devices for hanging intravenous fluid bags.

7. Helicopters must have an external landing light and tail-rotor illumination.

8. Design must not compromise patient stability in either loading, unloading or in-flight operations.

9. Have factory installed or FAA approved add-on air conditioning which has the capacity to lower the temperature in the patient's compartment to 75º F within a reasonable period and maintain that temperature while operating in an ambient temperature of 95º F. All parts, equipment, workmanship, etc., shall be in keeping with accepted air conditioning practices.

E. Aircraft Flight Crew Manning Requirements. The aircraft operator shall, in all operations, comply with all federal aviation regulations which are adopted by reference, Part 135.

1. Rotor craft:

a. The pilot must possess commercial rotor craft certification and a minimum of 1,000 rotor craft flight hours as pilot in command and 50 hours of pilot in command flight time in helicopters within the 12 months prior to application for permitted air ambulance certification. Of this time during which the pilot is in command (referred to as "pilot in command time"), 25 hours must be in the same make and model of aircraft to be used in the proposed air ambulance operation.

b. The pilot must have received factory training or equivalent and must have at least five hours in the specific type of aircraft, before flying as pilot in command on patient missions.

c. The pilot must have received factory training or equivalent in flying over the types of terrain and under the conditions unique to the air ambulance flight program.

d. The pilot must be readily available within a defined call-up time to insure an expeditious and timely response.

e. The helicopter mechanic is vital to mission readiness and, as such, should possess at least two years of experience and must be a certified air frame and power plant mechanic.

f. The mechanic must be properly trained and FAA certified to maintain the aircraft designed by the flight service for its aeromedical program.

2. Fixed-Wing:

a. The pilot must possess a commercial pilot airplane license with a multi-engine land rating and a minimum of 1,000 flight hours as pilot in command and 50 hours of pilot in command flight time in multi-engine airplanes within the 12 months prior to application for permitted air ambulance certification.

b. If flying IFR, the pilot must possess an aircraft instrument rating with a minimum 50 hours of instrument flying time, to include no more than 20 hours in a ground simulator acceptable to the FAA.

c. The pilot must have received factory training or equivalent and must have at least five hours in the specific type of aircraft, before flying as pilot in command on patient missions.

d. The pilot must be readily available within a defined call-up time to insure an expeditious and timely response.

e. The mechanic is vital to mission readiness and must be a certified air frame and power plant mechanic.

f. The mechanic must be properly trained and FAA certified to maintain the aircraft designated by the flight service for its aeromedical program.

F. Off-Line Medical Control Physician (Medical Director). The off-line medical control physician of air ambulance services shall be responsible for:

1. Being knowledgeable of the capabilities and limitations of the aircraft used by his service.

2. Being knowledgeable of the medical staff's capability relative to the patient's needs.

3. Being knowledgeable of the routine and special medical equipment available to the service.

4. Ensuring that each patient is evaluated prior to a flight for the purpose of determining that appropriate aircraft, flight and medical crew and equipment are provided to meet the patient's needs.

5. Ensuring that all medical crew members are adequately trained to perform in-flight duties prior to functioning in an in-flight capacity.

6. All duties and responsibilities listed in these regulations.

G. Aircraft Medical Crew Requirements:

1. Each basic life support air ambulance must be staffed with at least one currently certified EMT.

2. Each advanced life support air ambulance must be staffed with at least one currently certified EMTParamedic or flight nurse as may be required by the patient's condition.

3. Each special purpose air ambulance must be staffed with at least one special purpose EMT, EMTParamedic or RN with specialty training, as approved by the Department.

H. Orientation Program:

1. All medical flight crew members must complete flight orientation program approved by the Department and supervised by the service's medical control physician.

2. The flight orientation program shall be of sufficient duration and substance to cover all patient care procedures, including altitude physiology, and flight crew requirements.

Section 1202. Basic Life Support Air Ambulance Medical Equipment Requirements.(II)

Each prehospital basic life support air ambulance shall be equipped with the following basic life support equipment:

A. There shall be one vinyl covered folding stretcher or acceptable equivalent with at least two patient restraint straps and stretcher fasteners for each patient (spine board is not acceptable). Stretcher fasteners must be bolted directly on the air frame of the aircraft.

B. Suction Device:

1. A portable suction device, age and weight appropriate, with wide bore tubing and at least a six ounce reservoir.

2. There must be an assortment of suction catheters (minimum of two each) on board. Sizes 6 fr, 8 fr, 10 fr, and 14 fr. A rigid suction catheter (e.g. Yankaur) will also be carried. Minimum, 2 each.

C. Bag Valve Ventilation Units:

1. One adult, hand operated. Valves must operate in all weather, and unit must be equipped to be capable of delivering 90-100% oxygen to the patient.

2. One pediatric, hand operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

3. One infant, hand operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

4. The following sized masks will be carried aboard all permitted ambulances to be used in conjunction with the ventilation units above, 0,1,2,3,4,5. Masks must be clear. Either the disposable or nondisposable types are acceptable.

D. Nonmetallic oropharyngeal (Berman type)/Nasopharyngeal airways: adult, child, and infant sizes. All airways shall be clean and individually wrapped.

1. Large adult

2. Medium adult

3. Large child

4. Child

5. Infant

E. "S" tube type airways may not be substituted for Berman type airways.

F. Fixed and portable oxygen equipment - The portable equipment should be: Minimum "D" size (360 liter) cylinder (one required), adequate tubing and semirigid valveless, transparent, single use, individually wrapped nonrebreather masks and nasal cannulas in adult and pediatric sizes, minimum of three each. In addition, a "No Smoking" sign with minimum one inch letter shall be displayed in the patient compartment. When the vehicle is in motion, all oxygen cylinders shall be affixed to a wall or floor with crash stable, quick release fittings. Liter flow gauge shall be non- gravity dependent (Bourdon gauge) type.

G. Bite stick commercially made. (Clean and individually wrapped.)

H. Six sterile dressings (minimum size 5"x 9") compactly folded and packaged.

I. Thirty-six each sterile gauze pads 4"x 4".

J. Four each bandages, self-adhering tape, minimum three inches by five yards. Bandages must be individually wrapped or in clean containers.

K. A minimum of four commercial sterile occlusive dressing, 4"x 4".

L. Adhesive tape, hypoallergenic, one, two, and three inches wide.

M. Burn sheets, two, sterile.

N. Splints:

1. Traction type, lower extremity splint. Uni-polar or bi-polar type is acceptable (Medical Control Option).

2. Padded, wooden type splints, two each, 15"x 3" and 36"x 3", or other approved commercially available splints for arm or leg fractures.

3. Pneumatic splints not acceptable.

O. Spine Boards:

1. Long, at least 16"x 72". (The use of folding backboards is acceptable as a substitute for the long spine board.) (Medical Control Option)

2. Cervical collars. Small, medium, and large. (Each cervical collar should be manufactured with rigid or semi-rigid material) (Medical Control Option)

P. Triangular bandages, four each.

Q. Nine foot straps, three required.

R. Bandage shears, large size.

S. Obstetrical kit, sterile. The kit shall contain gloves, scissors or surgical blades, umbilical cord clamps or tapes, dressing, towels, perinatal pad, bulb syringe and a receiving blanket for delivery of infant. (Medical Control Option)

T. Blood pressure manometer, cuff and stethoscope.

1. Blood pressure set, portable, both adult and pediatric (non mercurial type).

2. Stethoscopes.

U. Emesis basin.

V. Bedpan and urinal. (Medical Control Option)

W. Two dependable flashlights or electric lanterns, minimum size, two "D" cell or six volt lanterns.

X. Minimum of one fire extinguisher, clean agent type, five pound capacity.

Y. Working gloves. (Medical Control Option)

Z. Minimum of 1000 cc of sterile water or normal saline for irrigation.

AA. Dual Lumen or LMA airways, age and weight appropriate.

BB. Magill forceps.

1. Adult.

2. Pediatric.

CC. Flame retardant uniform with reflective striping to be worn by each crew member.

Section 1203. Interfacility and Special Purpose Air Ambulances.(II)

All inter facility and special purpose air ambulances must be equipped with at least the following items from Section 1202:A, B, C, D, F, G, T, U, V, W, and X.

Section 1204. Advanced Life Support Air Ambulance Medical Equipment Requirements.(II)

Air ambulances providing advanced life support in the prehospital, interfacility or special purpose category must have the following equipment and supplies on board in addition to Section 1202:

A. Battery powered (DC) portable monitor-defibrillator unit, appropriate for both adults and pediatrics, with ECG printout. The monitor-defibrillator equipment utilized by the service has the capability of producing hard copy of patient's ECG.

B. Butterfly or scalp vein needles 26 gauge, total of two.

C. Two each 14, 16, 18, and 20 gauge IV cannula.

D. Two macro drip sets.

E. Two micro drip sets.

F. Three 21 or 23 and three 25 gauge needles, total six.

G. Three tourniquets.

H. Laryngoscope handle with batteries.

I. Laryngoscope blades, adult, child, and infant sizes. Sizes must include 0,1,2 straight and #2 curved.

J. Six disposable endotracheal tubes, assorted sizes (2.5-9.0). An intubation stylet sized for the pediatric patient will also be carried (6 fr.).

K. Suitable equipment and supplies for collection and temporary storage of two blood samples (Medical Control Option).

L. Syringes, two 1 ml, 3 ml, 10 ml, 20ml, and one 50 ml.

M. Backup power supply for all patient care devices carried.

N. Twelve (12) alcohol and iodine preps for preparing IV injection sites.

O. One (1) roll of tape.

P. Five (5) Band-Aids.

Q. Intraosseous needles in sizes 14, 18 ga. (1 each).

R. Four liters of normal saline or other appropriate IV solution.

S. Dual lumen or LMA airways, age and weight appropriate.

T. Magill forceps.

1. Adult.

2. Pediatric.

U. Sharps container.

V. Pediatric length/weight-based drug dose chart or tape.

Section 1205. Medication and Fluids for Advanced Life Support Air Ambulances.(II)

Such drugs and fluids approved by the Board for possession and administration by EMT's, and specified by the medical control physician, will be carried on the air ambulance. Drugs not included on the approved drug list for paramedics may be carried on board the air ambulance so long as there is a written protocol which is signed and dated by the medical control physician, for the use of the drug and delineates administration only by a registered nurse or physician.

Section 1206. Rescue Exception.(II)

A non-permitted aircraft may be used for occasional non routine missions, such as the rescue and transportation of victim/patients, who may or may not be ill or injured, from structures, depressions, water, cliffs, swamps or isolated scenes, when in the opinion of the rescuers or EMS provider present at the scene, such is the preferred method of rescue and transportation incident thereto due to the nature of the entrapment, condition of the victim, existence of an immediate life-threatening condition, roughness of terrain, time element and other pertinent factors:

A. Provided that after the initial rescue, an EMT or higher level EMS technician accompanies the victim-patient en-route with the necessary and appropriate EMS supplies needed for the en-route care of the specific injuries or illness involved.

B. Provided the aircraft is of adequate size and configuration to effectively make the rescue and to accommodate the victim-patient, attendant(s) and equipment.

C. Provided reasonable space is available inside the aircraft for continued victim-patient comfort and care.

D. Provided a permitted aircraft is not available within a reasonable distance response time; and

E. Provided the victim-patient is transferred to a higher level of EMS ground transportation for stabilization and transport if such ground unit is available at a reasonably safe landing area.

Section 1300. PATIENT CARE REPORTS

Section 1301. Forms Control Officer.

A. Each licensed provider that provides patient care shall appoint a forms control officer to maintain supplies, ensure safe storage, edit to ensure accuracy, and provide monthly reporting to the Department.

B. The Department must be notified of any change in forms control officer within ten (10) days.

Section 1302. Content.

A. The format/design of the patient care report must be approved by the Department, including medium to be used.

B. Patient care reports shall reflect services, treatment, and care provided directly to the patient by the provider including, but not limited to; information required to properly identify the patient, a narrative description of the call from time of first patient contact to final destination, and other information as determined by the Department.

C. All entries shall be indelibly written, authenticated by the author, and dated.

Section 1303. Report Maintenance.

A. The licensed provider shall provide accommodations, space, supplies, and equipment adequate for the protection, security, and storage of patient care reports.

B. The Department copy of the patient care report shall be maintained by the Department for a period of no less than one (1) year. Licensed providers must maintain their copy of the patient care report for no less than ten (10) years on all adult patients and thirteen (13) years for pediatric patients. Reports shall be destroyed after this time period in accordance with state and federal laws.

C. Prior to closure of business, the licensed provider must arrange for preservation of patient care reports to ensure compliance with these regulations. The provider must notify the Department, in writing, describing these arrangements within ten (10) days of closure.

D. In the event of a change of ownership, all patient care reports shall be transferred to the new owner(s).

E. The patient care report is confidential. Reports containing protected or confidential health information shall be made available only to authorized individuals in accordance with state and federal laws.

F. The Department copy of the patient care report, to include "Page 2" and supplemental forms, shall be sent to the Department on or before the fifteenth (15th) of the month following the close of a month along with a monthly summary as specified by the Department.

G. When patient care is transferred, the receiving agency shall receive their copy of the patient care report within a reasonable amount of time, preferably at the time of transfer, to ensure continuity in quality care.

H. Pursuant to Section 44-61-160 of the S.C. Code, a person who intentionally fails to comply with reporting, confidentiality, or disclosure of requirements in this section is subject to a civil penalty of not more than one hundred dollars for a violation of the first time a person fails to comply and not more than five thousand dollars for a subsequent violation.

Section 1400. DO NOT RESUSCITATE ORDER

Section 1401. Purpose and Authority of Emergency Medical Services Do Not Resuscitate Order.

A. Title 44, Chapter 78 of the 1976 S.C. code as amended directs the Department to promulgate regulations necessary to provide directions to emergency medical personnel in identifying and honoring the wishes of patients who have executed a Do Not Resuscitate Order for Emergency Services. The Do Not Resuscitate Order for Emergency Services is commonly referred to as the EMS DNR law.

B. The EMS DNR law is applicable only to resuscitative attempts by EMS providers in the pre-hospital setting such as the declarant's home, a long-term care facility, during transport to or from a health care facility and in other locations outside of acute care hospitals.

C. Specific statutory authority is found in Section 44-78-65.

Section 1402. Definitions.

A. The definitions contained in S.C. Code Section 44-78-15 are hereby incorporated by reference.

B. Agent or Surrogate means a person appointed by the declarant under a Health Care Power of Attorney, executed or made in accordance with the provisions of Sec. 62-5-504 and/or Sec. 44-77-10.

C. Cardiac Arrest means the cessation of a functional heartbeat.

D. Cardiopulmonary Resuscitation or CPR means the use of artificial respirations to support restoration of functional breathing combined with closed chest massage to support restoration of a functional heart beat following cardiac arrest.

E. Department means the South Carolina Department of Health & Environmental Control.

F. Respiratory Arrest (Pulmonary Arrest) means cessation of functional breathing.

G. Do Not Resuscitate Order for Emergency Medical Services marker is a bracelet or necklace that is engraved with the patient's name, the health care provider's name and telephone number and the words "Do Not Resuscitate" or the letters DNR.

Section 1403. General Provisions.

A. The EMS DNR Form. The document which is to be a "Do Not Resuscitate Order" for EMS purposes must be in substantially the following form:

NOTICE TO EMS PERSONNEL

This notice is to inform all emergency medical personnel who may be called to render assistance to

__________

(Name of patient)

that he/she has a terminal condition which has been diagnosed by me and has specifically requested that no resuscitative efforts including artificial stimulation of the cardiopulmonary system by electrical, mechanical, or manual means be made in the event of cardio-pulmonary arrest.

REVOCATION PROCEDURE

THIS FORM MAY BE REVOKED BY AN ORAL STATEMENT BY THE PATIENT TO EMS PERSONNEL, OR BY MUTILATING, OBLITERATING, OR DESTROYING THE DOCUMENT IN ANY MANNER.

Date:__________

__________

Patient's Signature (or Surrogate or Agent)

__________

Physician's Signature

__________

Physician's Address

__________

Physician's Telephone Number

B. Distribution of the EMS DNR Form. The EMS DNR form, along with instructions for execution and a patient information sheet shall be distributed by the Department to health care providers. Informational pamphlets shall be prepared by the Department and made available to other interested parties upon request.

C. Location of the Executed EMS DNR Form. The executed EMS DNR Form shall be placed in a location where the document is easily observed and recognized by EMS personnel. The form shall be displayed in such a manner that it will be visible and protected at all times.

D. EMS DNR Marker. The DNR marker shall be a bracelet or necklace as approved by the Department. The marker may be worn upon the execution of the EMS DNR Document. Wearing of the marker shall not be mandatory but is encouraged. The marker will alert EMS personnel of the probable existence of the EMS DNR document. The marker shall be of metallic construction and shall be unique and easily recognizable. The marker shall contain the patient's name, the health care provider's name and telephone number and the words "Do Not Resuscitate" or the letters DNR.

Section 1404. Revocation of EMS DNR Order.

The EMS DNR Order may be revoked at anytime by the oral expression of the patient to EMS personnel or by the mutilation, obliteration or destruction of the document in any manner. If the order is revoked, EMS personnel shall perform full resuscitation and treatment of the patient.

Section 1405. Patient's Assessment and Intervention.(II)

When EMS Personnel report to a scene, they shall do a patient assessment. If an EMS DNR bracelet or necklace is found during the assessment, EMS personnel shall make a reasonable effort to determine that a EMS DNR form exists and to assure that the EMS DNR form applies to the person on which the assessment is being made. If no DNR form is found, resuscitative measure will be initiated. If after starting resuscitative measures a EMS DNR form is later found, resuscitative measure must be stopped.

Section 1406. Resuscitative Measures to be Withheld or Withdrawn.(II)

In the event that the patient has a valid EMS DNR order, the following procedures shall be withheld or withdrawn.

A. CPR

B. Endotracheal intubation and other advanced airway management

C. Artificial ventilation

D. Defibrillation

E. Cardiac resuscitation medication

F. Cardiac diagnostic monitoring

Section 1407. Procedures to Provide Palliative Treatment.(II)

The following treatment may be provided as appropriate to patients who have executed a valid EMS DNR order.

A. Suction

B. Oxygen

C. Pain medication

D. Non-cardiac resuscitation medication

E. Assistance in the maintenance of an open airway as long as such assistance does not include intubation or advanced airway management

F. Control of bleeding

G. Comfort care

H. Support to patient and family

Section 1408. DNR Information for the Patient, the Patient's Family, the Health Care Provider and EMS Personnel.(II)

A. Responsibilities of the patient or his/her Surrogate or agent.

The patient and his/her surrogate or agent shall:

1. Make all care givers aware of the location of the EMS DNR Form and ensure that the form is displayed in such a manner that it will be visible and available to EMS personnel.

2. Be aware of the consequences of refusing resuscitative measures.

3. Be aware that if the form is altered in any manner resuscitative measures will be initiated.

4. Understand that in all cases, supportive care will be provided to the patient.

B. Responsibilities of the Health Care Provider (Physician) The patient's physician:

1. Has determined that the patient has a terminal condition.

2. Has completed the patient's EMS DNR Form.

3. Has explained to the patient and family the consequences of withholding resuscitative care; the medical procedures that will be withheld and the palliative and supportive care that will be administrated to the patient.

C. Responsibilities of EMS Personnel

EMS personnel:

1. Will confirm the presence of the EMS DNR Form and the identity of the patient.

2. Upon finding an unaltered EMS DNR Form, will withhold or withdraw resuscitative measures such as CPR, endotracheal intubation or other advanced airway management, artificial ventilation, defibrillation, cardiac resuscitation medication and related procedures.

3. Will provide palliative and supportive treatment such as suctioning the airway, administration of oxygen, control of bleeding, provision of pain and non-cardiac medications, provide comfort care and provide emotional support for the patient and the patient's family.

4. Must have in his possession either the original or a copy of the DNR Order during transport of the patient.

Section 1500. SEVERABILITY

Section 1501. General.

In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations.

Section 1600. GENERAL

Section 1601. General.

Conditions that have not been addressed in these regulations shall be managed in accordance with best practices as interpreted by the Department.

61-8. Vaccination, Screening and Immunization Regarding Contagious Diseases.

I. REQUIREMENTS FOR SCHOOL ADMITTANCE

A. No child shall be admitted to any public, private, or parochial school, grades kindergarten through twelve (K-12), or any child development program under the control of the Department of Education without first presenting a valid South Carolina Certificate of Immunization. To be valid, the South Carolina Certificate of Immunization must be signed by an individual licensed to practice medicine, surgery, or osteopathy or his/her authorized representative. "Admitted" as the term is used in this paragraph shall apply to all students grades kindergarten through twelve. Exemptions to this requirement are authorized in Section II of this regulation.

B. A South Carolina Certificate of Immunization needs to be presented to school officials only once. School officials shall record the immunization data on the student's school health record or attach a copy of the Certificate to the health record. Students who have previously submitted a South Carolina Certificate of Immunization are not required to submit another Certificate. Students previously admitted into any public, private, or parochial school with only a Conditional Certificate of Immunization must present a South Carolina Certificate of Immunization before being readmitted.

C. The standard which must be met to obtain a South Carolina Certificate of Immunization shall be the annually published schedule of required vaccinations, screening and immunizations for school admittance determined by the Department of Health and Environmental Control to be necessary to prevent the spread of contagious diseases. Except during emergency situations, the Department shall seek advice from the appropriate medical associations and academies in development of the schedule of required vaccinations, screening and immunizations. The schedule of required vaccinations, screening and immunizations shall be applicable for any child admitted during the school year immediately following the schedule's publication date unless otherwise stipulated by the Department of Health and Environmental Control in the annually published schedule.

D. Blank forms for the South Carolina Certificate of Immunization will be provided by the Department of Health and Environmental Control.

II. EXEMPTIONS

A. Students may be exempt from the immunization requirements of this regulation for the following reasons:

1. Medical Exemption.

(a) A South Carolina Certificate of Medical Exemption, signed by an individual licensed to practice medicine, surgery, or osteopathy, may be granted to a child when the physician has determined that a particular vaccine(s) required by this regulation is not advisable for the child. When it is determined that this particular vaccine(s) is no longer contraindicated, the child will be required to have the vaccine(s).

(b) A South Carolina Certificate of Medical Exemption, signed by an individual licensed to practice medicine, surgery, or osteopathy or his/her authorized representative, may be granted to a student who meets the requirements for medical exemption as stated in the schedule of required vaccinations, screening and immunizations published annually by the Department of Health and Environmental Control.

2. Religious Exemption. A South Carolina Certificate of Religious Exemption may be granted to any student whose parents, parent, guardian, or person in loco parentis signs the appropriate section of the South Carolina Certificate of Religious Exemption stating they are members of a recognized religious denomination in which the tenets and practices of the religious denomination conflict with immunizations.

3. Special Exemptions. A South Carolina Certificate of Special Exemption, signed by the school principal or his authorized representative, may be issued to transfer students while awaiting arrival of medical records from their former area of residence or to other students who have been unable to secure immunizations or documentation of immunizations already received. A South Carolina Certificate of Special Exemption may be issued only once and shall be valid for only thirty (30) calendar days from date of enrollment. At the expiration of this special exemption, the student must present a valid South Carolina Certificate of Immunization, or a valid South Carolina Certificate of Medical Exemption, or a valid South Carolina Certificate of Religious Exemption.

B. Blank forms for the South Carolina Certificate of Medical Exemption, South Carolina Certificate of Religious Exemption and South Carolina Certificate of Special Exemption will be provided by the Department of Health and Environmental Control.

III. REPORTING REQUIREMENTS.

Forty-five (45) calendar days after the beginning of each school year, school principals must submit to the local health department, on forms provided by the Department of Health and Environmental Control, the name of each student admitted to school with a South Carolina Certificate of Medical Exemption, a South Carolina Certificate of Religious Exemption, and a South Carolina Certificate of Special Exemption as provided in Section II of this regulation.

IV. COMPLIANCE.

Representatives of the Department of Health and Environmental Control shall have the authority to audit school records to insure compliance with this regulation.

V. EFFECTIVE DATE.

This regulation shall become effective upon successful completion of review by the General Assembly.

HISTORY: Amended by State Register Volume 16, Issue No. 4, eff April 24, 1992.

61-9. WATER POLLUTION CONTROL PERMITS

(Statutory Authority: Sections 48-1-10 et seq. and Sections 48-14-10 et seq.)

Table of Contents

61-9.122. The National Pollutant Discharge Elimination System.

61-9.124. Procedures for Decision Making.

61-9.125. Criteria and Standards for the National Pollutant Discharge

Elimination System.

61-9.129. Toxic Pollutant Effluent Standards.

61-9.133. Secondary Treatment Regulation.

61-9.403. General Pretreatment Regulations for Existing and New Sources of

Pollution.

61-9.503. Standards for the Use or Disposal of Sewage Sludge.

61-9.504. Standards for the Use or Disposal of Industrial Sludge.

61-9.505. Land Application Permits and State Permits.

61-9.122. THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM.

(Statutory Authority: The Clean Water Act, 33 U.S.C. 1251 et seq. and the South Carolina Pollution Control Act, S.C. Code Ann. 48-1-10 et. seq.)

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003; State Register Volume 27, Issue No. 12, eff December 26, 2003; State Register Volume 29, Issue No. 2, eff February 25, 2005; State Register Volume 32, Issue No. 5, eff May 23, 2008; State Register Volume 34, Issue No. 11, eff November 26, 2010.

Table of Contents

Part A--Definitions and General Program Requirements

Section

122.1 Purpose and scope.

122.2 Definitions.

122.3 Exclusions.

122.4 Prohibitions.

122.5 Effect of a permit.

122.6 Continuation of expiring permits.

122.7 Confidentiality of information.

Part B--Permit Application and Special NPDES Program Requirements

122.21 Application for a permit.

122.22 Signatories to permit applications and reports.

122.23 Concentrated animal feeding operations.

122.24 Concentrated aquatic animal production facilities.

122.25 Aquaculture projects.

122.26 Storm water discharges.

122.27 Silvicultural activities.

122.28 General permits.

122.29 New sources and new dischargers.

122.30 What are the objectives of the storm water regulations

for small MS4s?

122.31 Indian Tribes.

122.32 Is an operator of a small MS4 regulated under the NPDES

storm water program?

122.33 How does an operator of a regulated, small MS4 apply

for an NPDES permit, and when must be apply?

122.34 As an operator of a regulated, small MS4, what will my

NPDES MS4 storm water permit require?

122.35 May an operator of a regulated small MS4 share the

responsibility to implement the minimum control

measures with other entities?

122.36 As an operator of a regulated small MS4, what happens

if I don't comply with the application or permit

requirements in sections 122.33 through 122.35?

Part C--Permit Conditions

122.41 Conditions applicable to all permits.

122.42 Additional conditions applicable to specified

categories of NPDES permits.

122.43 Establishing permit conditions.

122.44 Establishing limitations, standards and other permit

conditions.

122.45 Calculating NPDES permit conditions.

122.46 Duration of permits.

122.47 Schedules of compliance.

122.48 Requirements for recording and reporting of monitoring

results.

122.50 Disposal of pollutants into publicly-owned treatment

works.

Part D--Transfer, Modification, Revocation and Reissuance, and Termination of

Permits

122.61 Transfer of permits.

122.62 Modification or revocation and reissuance of permits.

122.63 Minor modifications of permits.

122.64 Termination of permits.

APPENDIX A--NPDES Primary Industry Categories

APPENDIX C--Criteria For Determining A Concentrated Aquatic Animal Production

Facility (section 122.24)

APPENDIX D--NPDES Permit Application Testing Requirements (section 122.21)

(Refer to 40 CFR Part 122, Appendix D)

APPENDIX E--Rainfall Zones Of The United States (Refer to 40 CFR Part 122,

Appendix E)

APPENDIX F--Incorporated Places With Populations Greater Than 250,000 According

To The 1990 Decennial Census By Bureau Of Census (Refer to 40 CFR Part 122,

Appendix F)

APPENDIX G--Incorporated Places With Populations Greater Than 100,000 And Less

Than 250,000 According To 1990 Decennial Census By Bureau Of Census (Refer to

40 CFR Part 122, Appendix G)

APPENDIX H--Counties With Unincorporated Urbanized Areas With A Population Of

250,000 Or More According To The 1990 Decennial Census By The Bureau Of

Census (Refer to 40 CFR Part 122, Appendix H)

APPENDIX I--Counties With Unincorporated Urbanized Areas Greater Than 100,000,

But Less Than 250,000 According To The 1990 Decennial Census By The Bureau Of

Census (Refer to 40 CFR Part 122, Appendix I)

APPENDIX J--NPDES Permit Testing Requirements For Publicly Owned Treatment

Works [section 122.21(j)]

PART A. DEFINITIONS AND GENERAL PROGRAM REQUIREMENTS

122.1. Purpose and scope.

(a) Coverage

(1) The regulatory provisions contained in R.61-9.122 and 124 implement the National Pollutant Discharge Elimination System (NPDES) Program under sections 318, 402, and 405 of the Clean Water Act (CWA) (Public Law 92-500, as amended by Pub. L. 95-217, Pub. L. 95-576, Pub. L. 96-483, Pub. L. 97-117, and Pub. L. 100-4; 33 U.S.C. 1251 et seq.) and the South Carolina Pollution Control Act, S.C. Code Ann. 48-1-10, et seq.

(2) These provisions cover basic Department permitting requirements (122) and procedures for Department processing of permit applications and appeals (124).

(3) These provisions also establish the requirements for public participation in State permit issuance and enforcement and related variance proceedings.

(4) The NPDES permit program has separate, additional provisions that are used by the Department to determine what requirements must be placed in permits, if issued. These provisions are located at S.C. R61-9.125, 129, 133, and 503, and 40 CFR 136, 40 CFR subchapter N (parts 400 through 471) and 40 CFR 125.80-89 (Federal Register December 18, 2001 amended June 19, 2003), which are hereby adopted by reference.

(b) Scope of the NPDES permit requirement.

(1) The NPDES program requires permits for the discharge of "pollutants" from any "point source" into "waters of the State" and into "waters of the United States." The terms "pollutant", "point source", "waters of the State", and "waters of the United States" are defined in section 122.2.

(2) The permit program established under this part also applies to owners or operators of any treatment works treating domestic sewage, whether or not the treatment works is otherwise required to obtain an NPDES permit, unless all requirements implementing section 405(d) of the CWA applicable to the treatment works treating domestic sewage are included in a permit issued under the appropriate provisions of subtitle C of the Solid Waste Disposal Act, Part C of the Safe Drinking Water Act, the Marine Protection, Research, and Sanctuaries Act of 1972, or the Clean Air Act, or under a Land Application or State permit issued by the Department under R.61-9.505, as adequate to assure compliance with section 405 of the CWA.

(3) The Department may designate any person subject to the standards for sewage sludge use and disposal as a "treatment works treating domestic sewage" as defined in section 122.2, where it finds that a permit is necessary to protect public health and the environment from the adverse effects of sewage sludge or to ensure compliance with the technical standards for sludge use and disposal developed under CWA section 405(d). Any person designated as a "treatment works treating domestic sewage" shall submit an application for a permit under section 122.21 within 180 days of being notified by the Department that a permit is required. The Department's decision to designate a person as a "treatment works treating domestic sewage" under this paragraph shall be stated in the fact sheet for the permit.

(4) The following are point sources requiring NPDES permits for discharges:

(i) Concentrated animal feeding operations as defined in section 122.23;

(ii) Concentrated aquatic animal production facilities as defined in section 122.24;

(iii) Discharges into aquaculture projects as set forth in section 122.25;

(iv) Discharges of storm water as set forth in sections 122.26 and 122.30 through 36; and,

(v) Silvicultural point sources as defined in section 122.27.

(c) The Department may incorporate the requirements (either directly or by reference), for permits for the Use and Disposal of Sewage Sludge (see R.61-9.503), or the Use and Disposal of Industrial Sludge (see R.61-9.504) into NPDES permit(s) that may be issued to the applicant. A separate Land Application permit (see R.61-9.505) may be issued by the Department for the activities covered under R.61.9-503 or R.61-9.504, unless an NPDES permit is required for the activity.

(d) Relation to other requirements.

(1) Permit application forms. Applicants for permits must submit their applications on permit application forms designated by the Department. The basic information required in the general form (Form 1) and the additional information required by NPDES applications (Forms 2 a through e) are listed in section 122.21.

(2) Technical Regulations. The NPDES permit program has separate additional regulations. These separate regulations are used by the Department to determine what requirements must be placed in permits if they are issued. These separate regulations are located at R.61-9.125, 129, 133, and 403; 40 CFR Part 136; Subchapter N (40 CFR Parts 400 through 402 and 404 through 460); R.61-9.503, R.61-9.504 and R.61-9.505.

(e) Public participation. This part of the regulation (R.61-9.122) establishes the requirements for public participation in NPDES permit issuance and enforcement and related variance proceedings.

(f) [Reserved]

(g) Authority.

(1) Section 48-1-90(a), S.C. Code of Laws (1976), provides that "it shall be unlawful for any person, directly or indirectly, to throw, drain, run, allow to seep, or otherwise discharge into the environment of the State organic or inorganic matter, including sewage, industrial wastes and other wastes, except as in compliance with a permit issued by the Department." Section 301(a) of CWA provides that "Except as in compliance with this section and sections 302, 306, 307, 318, 402, and 404 of this Act, the discharge of any pollutant by any person shall be unlawful."

(2) Section 48-1-100(a), S.C. Code of Laws (1976), provides that "if, after appropriate public comment procedures, as defined by Department regulations, the Department finds that the discharge from the proposed outlet ... will not be in contravention of provisions of Chapter 1, Title 48, S.C. Code of Laws, a permit to construct and a permit to discharge must be issued to the applicant." Section 402(a)(1) of CWA provides in part that "The [Department] may, after opportunity for public hearing, issue a permit for the discharge of any pollutant, or combination of pollutants, ... upon condition that such discharge will meet either all applicable requirements under sections 301, 302, 306, 307, 308, and 403 of this Act, or prior to the taking of necessary implementing actions relating to all such requirements, such conditions as the [Department] determines are necessary to carry out the provisions of this Act."

(3) Section 318(a) of CWA provides that "The [Department] is authorized, after public hearings, to permit the discharge of a specific pollutant or pollutants under controlled conditions associated with an approved aquaculture project under Federal or State supervision pursuant to section 402 of this Act."

(4) Section 405 of CWA provides, in part, that "Where the disposal of sewage sludge resulting from the operation of a treatment works as defined in section 212 of this Act (including the removal of in-place sewage sludge from one location and its deposit at another location) would result in any pollutant from such sewage sludge entering the [waters of the State], such disposal is prohibited except in accordance with a permit issued by the [Department] under section 402 of this Act."

(5) Section 405(d)(4) of the CWA requires the Department, prior to promulgation of standards for sewage sludge use and disposal, to "impose conditions in permits issued to publicly owned treatment works under section 402 of this Act, or take such other measures as the [Department] deems appropriate to protect public health and the environment from any adverse effects which may occur from toxic pollutants in sewage sludge."

(6) Section 405(f) of CWA provides that NPDES permits must include requirements implementing the standards for sludge use and disposal (40 CFR Part 503) "unless such requirements have been included in a permit issued under the appropriate provisions of subtitle C of the Solid Waste Disposal Act, part C of the Safe Drinking Water Act, the Marine Protection, Research, and Sanctuaries Act of 1972, or the Clean Air Act, or under State [NPDES] permit programs approved by the Administrator...." Section 405(f) also authorizes the Department to issue permits with requirements for sludge use or disposal that assure compliance with 40 CFR Part 503 to any treatment works treating domestic sewage that is not subject to NPDES (i.e., has no point source discharge) and has not been issued a permit that includes applicable 40 CFR Part 503 standards under the other permit programs listed in section 405(f)(1) of the CWA.

(7) Sections 402(b), 318(b) and (c), and 405(c) and (f) of CWA authorize EPA approval of State NPDES permit programs for discharges from point sources, discharges to aquaculture projects, and use and disposal of sewage sludge.

(8) Section 304(i) of CWA provides that the Administrator shall promulgate guidelines establishing uniform application forms and other minimum requirements for the acquisition of information from dischargers in approved States and establishing minimum procedural and other elements of approved State NPDES programs.

(9) Section 48-1-40 authorizes the Department "after public hearing as herein provided, [to] adopt standards and determine what qualities of water ... shall indicate a polluted condition and these standards shall be promulgated and made a part of the rules and regulations of the Department." Section 48-1-50(22) authorizes the Department to "[r]equire the owner or operator of any ... disposal system to establish and maintain such operational records; make reports; install, use, and maintain monitoring equipment or methods; sample and analyze ... discharges in accordance with established methods, at locations, intervals, and procedures as the Department shall prescribe; and provide such other information as the Department reasonably may require." Section 48-1-50(23) authorizes the Department to "[a]dopt ... effluent control regulations, standards and limitations that are applicable to the entire State, that are applicable only within specified areas or zones of the State, or that are applicable only when a specified class of pollutant is present." Section 501(a) of CWA provides that "The [Department] is authorized to prescribe such regulations as are necessary to carry out [its] functions under this Act."

(10) Section 48-1-100(a) requires an opportunity for public comment before issuance of permits to discharge. Section 101(e) of CWA provides that "Public participation in the development, revision, and enforcement of any regulation, standard, effluent limitation, plan, or program established by the Administrator or any State under this Act shall be provided for, encouraged, and assisted by the Administrator and the States. The Administrator, in cooperation with the States, shall develop and publish regulations specifying minimum guidelines for public participation in such processes."

122.2. Definitions.

(a) The following definitions apply to this regulation, R.61-9.124, R.61-9.125, R.61-9.129, R.61-9.133, and R.61-9.403. Terms not defined in this section have the meaning given by the Clean Water Act (CWA) or the Pollution Control Act (PCA).

(b) Definitions:

"Administrator" means the Administrator of the Environmental Protection Agency or any employee of the Agency to whom the Administrator may by order delegate the authority to carry out his functions under section 307(a) of the CWA, or any person who shall by operation of law be authorized to carry out such functions.

Note: "Animal feeding operation" is defined at section 122.23.

"Applicable standards and limitations" means all State, interstate, and federal standards and limitations to which a discharge, a sewage sludge use or disposal practice, or a related activity is subject under the CWA, including effluent limitations, water quality standards, standards of performance, toxic effluent standards or prohibitions, best management practices, pretreatment standards, and standards for sewage sludge use or disposal under section 301, 302, 303, 304, 306, 307, 308, 403 or 405 of CWA.

"Applicant" means a person applying to the Department for a State or NPDES permit to discharge wastes into the waters of the State or to operate a treatment works.

"Application" means the uniform NPDES application form, including subsequent additions, revisions, or modifications thereof promulgated by the Administrator of EPA, and adopted for use by the Board or a State permit application form.

Note: "Aquaculture project" is defined at section 122.25.

"Average monthly discharge limitation" means the highest allowable average of daily discharges over a calendar month, calculated as the sum of all daily discharges measured during a calendar month divided by the number of daily discharges measured during that month.

"Average weekly discharge limitation" means the highest allowable average of daily discharges over a calendar week, calculated as the sum of all daily discharges measured during a calendar week divided by the number of daily discharges measured during that week.

"Best management practices" (BMP) means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the State. BMPs also include treatment requirements, operating procedures and practices to control plant site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

"BMP" means best management practices.

"Board" means the Board of Health and Environmental Control for the State of South Carolina and shall be inclusive of any agent designated by the Board to perform any function.

Note: "Bypass" is defined at section 122.41(m).

"CFR" means the Code of Federal Regulations, as amended.

"Class I sludge management facility" means any POTW identified under R.61-9.403.8(a), as being required to have an approved pretreatment program and any other treatment works treating domestic sewage classified as a Class I sludge management facility by the Regional Administrator in conjunction with the Department because of the potential for its sludge use or disposal practices to adversely affect public health and the environment.

"Code" means the South Carolina Code of 1976, as amended.

"Commissioner" means the Commissioner of the S.C. Department of Health and Environmental Control, or his designated representative.

Note: "Concentrated animal feeding operation" is defined at section 122.23.

Note: "Concentrated aquatic animal feeding operation" is defined at section 122.24.

"Contiguous zone" means the entire zone established by the United States under Article 24 of the Convention on the Territorial Sea and the Contiguous Zone.

"Continuous discharge" means a discharge which occurs without interruption throughout the operating hours of the facility, except for infrequent shutdowns for maintenance, process changes, or other similar activities.

"CWA" means the Clean Water Act (formerly referred to as the Federal Water Pollution Control Act or Federal Water Pollution Control Act Amendments of 1972) Pub. L. 92-500, as amended by Pub. L. 95-217, Pub. L. 95-576, Pub. L. 96-483, and Pub. L. 97-117, 33 U.S.C. 1251 et seq. Specific references to sections within the CWA will be according to Pub. L. 92-500 notation.

"CWA and regulations" means the Clean Water Act (CWA) and applicable regulations promulgated thereunder and includes State NPDES program requirements.

"Daily discharge" means the discharge of a pollutant measured during a calendar day or any 24-hour period that reasonably represents the calendar day for purposes of sampling. For pollutants with limitations expressed in units of mass, the daily discharge is calculated as the total mass of the pollutant discharged over the day. For pollutants with limitations expressed in other units of measurement, the daily discharge is calculated as the average measurement of the pollutant over the day.

"Department" means the S.C. Department of Health and Environmental Control and shall also be inclusive of those persons within the Department authorized by the Board to administer the NPDES program or take any action in behalf of the Board.

"Direct discharge" means the discharge of a pollutant.

"Discharge" means any discharge or discharge of any sewage, industrial wastes or other wastes into any of the waters of the State, whether treated or not.

"Discharge of a pollutant"

(1) means:

(i) Any addition of any pollutant or combination of pollutants to waters of the State from any point source, or

(ii) Any addition of any pollutant or combination of pollutants to the waters of the contiguous zone or the ocean from any point source other than a vessel or other floating craft which is being used as a means of transportation.

(2) includes additions of pollutants into waters of the State from: surface runoff which is collected or channelled by man; discharges through pipes, sewers, or other conveyances owned by a State, municipality, or other person which do not lead to a treatment works; and discharges through pipes, sewers, or other conveyances, leading into privately owned treatment works. This term does not include an addition of pollutants by any indirect discharger.

"Discharge Monitoring Report" (DMR) means the EPA uniform national form, including any subsequent additions, revisions, or modifications for the reporting of self-monitoring results by permittees, and modified to substitute the State Agency name, address, logo, and other similar information, as appropriate, in place of EPA's.

"Discharger" means any person who discharges any treated or untreated sewage, industrial wastes, or other wastes into any of the waters of the State.

"DMR" means Discharge Monitoring Report.

"Draft Permit" means a document prepared by the staff of the Department, in accordance with R.61-9.124.6, prior to public notice of an application for a permit by a discharger. This document indicates the Department's tentative decision to issue or deny, modify, revoke and reissue, terminate, or reissue a permit to discharge. It contains proposed effluent standards and limitations, proposed compliance schedules and other proposed conditions or restrictions deemed necessary by the Department for a discharge. A notice of intent to terminate a permit, and a notice of intent to deny a permit, as discussed in R.61-9.124.5, are types of draft permits. A denial of a request for modification, revocation and reissuance, or termination, as discussed in R.61-9.124.5, is not a draft permit. A "proposed permit" is not a draft permit.

"Effluent limitation" means any restriction imposed by the Department on quantities, discharge rates, and concentrations of pollutants which are discharged from point sources into waters of the State, the waters of the contiguous zone, or the ocean.

"Effluent limitations guidelines" means: A regulation published by the Administrator under section 304(b) of CWA to adopt or revise effluent limitations.

"Effluent standards and limitations" means restrictions or prohibitions of chemical, physical, biological, and other constituents which are discharged from point sources into State waters, including but not limited to, effluent limitations, standards of performance, toxic effluent standards and prohibitions, pretreatment standards and schedules of compliance.

"Environmental Protection Agency" (EPA) means the United States Environmental Protection Agency.

"EPA" means the United States Environmental Protection Agency.

"Facility or activity" means any NPDES point source or any other facility or activity (including land or appurtenances thereto) that is subject to regulation under the NPDES program.

"Fact sheet" means a description of a discharge available to the public prepared by the Department staff pursuant to the guidelines, which includes, but is not limited to, information on the location of the discharge, rate of frequency of the discharge, components of the discharge, proposed requirements of the Department regarding the discharge, the location and identification of uses of the receiving waters, water quality standards and procedures for formulation of final requirements on the discharge by the Department.

"Federal Act" means the Federal Water Pollution Control Act (CWA), as amended.

"General permit" means an NPDES permit issued under section 122.28 authorizing a category of discharges or activities under the PCA and CWA within a geographical area.

"Hazardous substance" means any substance designated under 40 CFR Part 116 pursuant to section 311 of CWA.

"Indian country" means:

(1) All land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and, including rights-of-way running through the reservation;

(2) All dependent Indian communities within the borders of the United States whether within the originally or subsequently acquired territory thereof, and whether within or without the limits of a state; and

(3) All Indian allotments, the Indian titles to which have not been extinguished, including rights-of-way running through the same.

"Indirect discharger" means a non-domestic discharge introducing pollutants to a publicly owned treatment works.

"Industry" means a private person, corporation, firm, plant or establishment which discharges sewage, industrial wastes or other wastes into the waters of the State.

"Interstate agency" means an agency of two or more States established by or under an agreement or compact approved by the Congress, or any other agency of two or more States having substantial powers or duties pertaining to the control of pollution as determined and approved by the Administrator under the CWA and regulations.

"Mailing list" means a list of persons requesting notification and information on public hearings, permits and other NPDES forms.

"Major Facility" means any NPDES facility or activity classified as such by the Regional Administrator in conjunction with the Department.

"Management agency" means an area-wide waste treatment management agency designated by the governor pursuant to Section 208(a) of the Federal Act.

"Maximum daily discharge limitation" means the highest allowable daily discharge.

"Minor discharge" means a discharge of wastewater which has a total volume of less than 50,000 gallons on every day of the year, does not closely affect the waters of another state and is not identified by the Department, the Regional Administrator or by the Administrator of EPA in regulations issued by him pursuant to Section 307(a) of the Federal Act, as a discharge which is not a minor discharge, except that in the case of a discharge of less than 50,000 gallons on any day of the year which represents 1 or 2 or more discharges from a single person which in total exceeds 50,000 gallons on any day of the year, then no discharge from the facility is a minor discharge.

Note: "Municipal separate storm sewer system" is defined at sections 122.26 (b).

"Municipality" means a city, town, borough, county, parish, district, association, or other public body created by or under State law and having jurisdiction over disposal of sewage, industrial wastes, or other wastes, or an Indian tribe or an authorized Indian tribal organization, or a designated and approved management agency under section 208 of CWA.

"National Pollutant Discharge Elimination System" means the national program for issuing, modifying, revoking and reissuing, terminating, monitoring and enforcing permits, and imposing and enforcing pretreatment requirements, under sections 307, 402, 318, and 405 of CWA.

"New discharger"

(1) means any building, structure, facility, or installation:

(i) From which there is or may be a discharge of pollutants.

(ii) That did not commence the discharge of pollutants at a particular site prior to August 13, 1979;

(iii) Which is not a new source, and

(iv) Which has never received a finally effective NPDES permit for discharges at that site.

(2) includes an indirect discharger which commences discharging into waters of the State after August 13, 1979. It also includes any existing mobile point source (other than an offshore or coastal oil and gas exploratory drilling rig or a coastal oil and gas developmental drilling rig) such as a seafood processing rig, seafood processing vessel, or aggregate plant, that begins discharging at a site for which it does not have a permit; and any offshore or coastal mobile oil and gas exploratory drilling rig or coastal mobile oil and gas developmental drilling rig that commences the discharge of pollutants after August 13, 1979, at a site under Department's permitting jurisdiction for which it is not covered by an individual or general permit and which is located in an area determined by the Department in the issuance of a final permit to be an area of biological concern. In determining whether an area is an area of biological concern, the Department shall consider the factors specified in section 122(a)(1) through (10). An offshore or coastal mobile exploratory drilling rig or coastal mobile developmental drilling rig will be considered a new discharger only for the duration of its discharge in an area of biological concern.

"New source" means any building, structure, facility, or installation from which there is or may be a discharge of pollutants, the construction of which commenced:

(1) After promulgation of standards of performance under section 306 of CWA which are applicable to such source, or

(2) After proposal of standards of performance in accordance with section 306 of CWA which are applicable to such source, but only if the standards are promulgated in accordance with section 306 within 120 days of their proposal.

"NPDES" means National Pollutant Discharge Elimination System established by the CWA.

"NPDES form" means any issued permit or any uniform national form used by the Department developed for use in the NPDES, including a NPDES application, a Refuse Act permit application and a reporting form.

"NPDES permit" means a permit issued by the Department to a discharger pursuant to regulations adopted by the Board for all point source discharges into surface waters, and shall constitute a final determination of the Board.

"Non-compliance list" means a list of dischargers, prepared by the Department pursuant to this regulation and the guidelines for transmittal to the Regional Administrator, who fail or refuse to comply with a compliance schedule in a NPDES permit issued pursuant to the State law.

"Owner or operator" means the owner or operator of any facility or activity subject to regulation under the NPDES program.

"Permit" means an authorization, license, or equivalent control document issued by the Department to implement the requirements of this regulation, 40 CFR Parts 123, and R.61-9.124. Permit includes an NPDES general permit (section 122.28). Permit does not include any permit which has not yet been the subject of final agency action, such as a draft permit or a proposed permit.

"Person" means any individual, public or private corporation, political subdivision, association, partnership, corporation, municipality, State or Federal agency, industry, copartnership, firm, trust, estate, any other legal entity whatsoever, or an agent or employee thereof.

"Point source" means any discernible, confined, and discrete conveyance, including but not limited to, any pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, vessel, or other floating craft from which pollutants are or may be discharged. This term does not include return flows from irrigated agriculture.

"Point source discharge" means a discharge which is released to the waters of the State by a discernible, confined and discrete conveyance, including but not limited to a pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, vessel, or other floating craft from which waste is or may be discharged.

"Pollutant"

(1) means dredged spoil, solid waste, incinerator residue, filter backwash, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials (except those regulated under the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011 et seq.)), heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water.

(2) does not mean:

(i) Sewage from vessels; or

(ii) Water, gas, or other material which is injected into a well to facilitate production of oil or gas, or water derived in association with oil and gas production and disposed of in a well, if the well used either to facilitate production or for disposal purposes is approved by authority of the State in which the well is located, and if the State determines that the injection or disposal will not result in the degradation of ground or surface water resources.

"Pollution Control Act" (PCA) means the South Carolina Pollution Control Act (PCA), S.C. Code Ann. section 48-1-10 et seq. (1976).

"POTW" means publicly owned treatment works.

"Primary industry category" means any industry category listed in the NRDC settlement agreement (Natural Resources Defense Council et al., v. Train, 8 E.R.C. 2120 (D.D.C. 1976), modified 12 E.R.C. 1833 (D.D.C. 1979)); also listed in Appendix A of this regulation.

"Privately owned treatment works" means any device or system which both is used to treat wastes from any facility whose operator is not the operator of the treatment works and is not a POTW.

"Process wastewater" means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, byproduct, or waste product.

"Proposed permit" means a State NPDES permit prepared after the close of the public comment period (and, when applicable, any public hearing and administrative appeals) which is sent to EPA for review before final issuance by the State. A "proposed permit" is not a draft permit.

"Publicly owned treatment works" or POTW means a treatment works as defined by section 212 of the Clean Water Act, which is owned by a state or municipality (as defined by section 502[4] of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes and other conveyances only if they convey wastewater to a POTW Treatment Plant. The term also means the municipality, as defined in section 502(4) of the CWA, which has jurisdiction over the Indirect Discharges to and the discharge from such a treatment works.

"Recommencing discharger" means a source which recommences discharge after terminating operations.

"Refuse Act permit application" means an application for a permit issued under authority of Section 13 of the United States Rivers and Harbors Act of March 3, 1899.

"Regional Administrator" means the Regional Administrator of Region IV of the Environmental Protection Agency or the authorized representative of the Regional Administrator.

"Reporting form" means the uniform NPDES reporting form, including subsequent additions, revisions or modifications thereof, adopted by the Department for use in administering this regulation, or a State form prescribed by the Department for use in administering this regulation, for reporting data and information to the Department by a discharger on monitoring and other conditions of permits.

"Satellite sewer system" means a sewer system that is owned or operated by one person that discharges to a system that is owned or operated by a different person. Satellite sewer systems depend on a separate person for final wastewater treatment and discharge and include systems approved under R.61-9.505.8.

"Schedule of compliance" means a schedule of remedial measures included in a "permit", including an enforceable sequence of interim requirements (for example, actions, operations, or milestone events) leading to compliance with the CWA and regulations.

"Secondary industry category" means any industry category which is not a primary industry category.

"Secretary" means the Secretary of the Army, acting through the Chief of Engineers.

"Septage" means the liquid and solid material pumped from septic tank, cesspool or similar domestic sewage treatment system, or a holding tank when the system is cleaned or maintained.

"Sewage from vessels" means human body wastes and the wastes from toilets and other receptacles intended to receive or retain body wastes that are discharged from vessels and regulated under section 312 of CWA.

"Sewage Sludge" means any solid, semi-solid, or liquid residue removed during the treatment of municipal waste water or domestic sewage. Sewage sludge includes, but is not limited to, solids removed during primary, secondary, or advanced waste water treatment, scum, septage, portable toilet pumpings, type III marine sanitation device pumpings (33 CFR Part 159), and sewage sludge products. Sewage sludge does not include grit or screenings or ash generated during the incineration of sewage sludge.

"Sewage sludge use or disposal practice" means the collection, storage, treatment, transportation, processing, monitoring, use or disposal of sewage sludge.

"Sewer system" means any system of wastewater collection lines, sewers, interceptors and pump stations, except for service connections, as defined by R.61-67. In this part, a sewer system includes "sewage system" as defined by the Pollution Control Act.

Note: "Silvicultural point source" is defined at section 122.27.

"Site" means the land or water area where any facility or activity is physically located or conducted, including adjacent land used in connection with the facility or activity.

"Sludge-only facility" means any "treatment works treating domestic sewage" whose methods of sewage sludge use or disposal are subject to regulations promulgated pursuant to section 405(d) of the CWA and is required to obtain a permit under section 122.1(b)(2).

"Standards for sewage sludge use or disposal" means the regulations promulgated pursuant to section 405(d) of the CWA which govern minimum requirements for sludge quality, management practices, and monitoring and reporting applicable to sewage sludge or the use or disposal of sewage sludge by any person.

"State" means the State of South Carolina.

"State/EPA Agreement" means an agreement between the Regional Administrator and the State which coordinates EPA and State activities, responsibilities and programs including those under the CWA programs.

"State Law" means the S.C. Pollution Control Act (PCA), specifically 48-1-10 through 48-1-350 of the South Carolina Code of 1976, and any subsequent amendments thereto.

"State permit" See R-61-9.505.2 for definition.

Note: "Storm water" is defined at section 122.26(b)(13).

Note: "Storm water discharge associated with industrial activity" is defined at section 122.26(b)(14).

"Total dissolved solids" (TDS) means the total dissolved (filterable) solids as determined by use of the method specified in 40 CFR Part 136.

"Toxic pollutant" means any pollutant listed as toxic under section 307(a)(1) or, in the case of sludge use or disposal practices, any pollutant identified in regulations implementing section 405(d) of the CWA.

"Trade secret" means the whole or any portion or phase of any manufacturing proprietary process or method, not patented, which is secret, useful in compounding an article of trade having a commercial value, and the secrecy of which the owner has taken reasonable measures to prevent from becoming available to persons other than those selected by the owner to have access thereto to limited purpose. It shall not be construed for purpose of this regulation to include any information relative to the quantity and character of waste products or their constituents discharged into waters of the State.

"Treatment works" means any plant, disposal field, lagoon, constructed drainage ditch or surface water intercepting ditch, incinerator, area devoted to sanitary landfills or other works not specifically mentioned herein, installed for the purpose of treating, neutralizing, stabilizing or disposing of sewage, industrial waste or other wastes.

"Treatment works treating domestic sewage" (TWTDS) means a POTW or any other sewage sludge or waste water treatment devices or system, regardless of ownership (including federal facilities), used in the storage, treatment, recycling, and reclamation of municipal or domestic sewage, including land dedicated for the disposal of sewage sludge. This definition does not include septic tanks or similar devices. For purposes of this definition, domestic sewage includes waste and waste water from humans or household operations that are discharged to or otherwise enter a treatment works. In States where there is no approved State sludge management program under section 405(f) of the CWA, the Regional Administrator may designate any person subject to the standards for sewage sludge use and disposal in 40 CFR Part 503 as a treatment works treating domestic sewage, where he or she finds that there is a potential for adverse effects on public health and the environment from poor sludge quality or poor sludge handling use or disposal practices or where he or she finds that such designation is necessary to ensure that such person is in compliance with 40 CFR Part 503.

"TWTDS" means treatment works treating domestic sewage.

Note: "Upset" is defined at section 122.41(n).

"Variance" means any mechanism or provision under section 301 or 316 of CWA, PCA, or R.61-9.125, or in the applicable effluent limitations guidelines which allows modification to or waiver of the generally applicable effluent limitation requirements or time deadlines of CWA. This includes provisions which allow the establishment of alternative limitations based on fundamentally different factors or on section 301(c), 301(g), 301(h), 301(i), or 316(a) of CWA.

"Vessel" means any contrivance used or capable of being used for navigation upon water, whether or not capable of self-propulsion, including foreign and domestic vessels engaged in commerce upon the waters of this State, passenger or other cargo carrying vessels, privately owned recreational watercraft or any other floating craft.

"Waste" shall be synonymous with sewage, industrial waste, and other wastes.

"Waters of the State" means lakes, bays, sounds, ponds, impounding reservoirs, springs, wells, rivers, streams, creeks, estuaries, marshes, inlets, canals, the Atlantic Ocean within the territorial limits of the State, and all other bodies of surface or underground water, natural or artificial, public or private, inland or coastal, fresh or salt, which are wholly or partially within or bordering the State or within its jurisdiction.

"Waters of the United States" or "waters of the U.S.";

(1) All waters which are currently used, were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide;

(2) All interstate waters, including interstate "wetlands;"

(3) All other waters such as intrastate lakes, rivers, streams (including intermittent streams), mudflats, sand flats, "wetlands," sloughs, prairie potholes, wet meadows, playa lakes, or natural ponds the use, degradation, or destruction of which would affect or could affect interstate or foreign commerce including any such waters:

(i) Which are or could be used by interstate or foreign travelers for recreational or other purposes;

(ii) From which fish or shellfish are or could be taken and sold in interstate or foreign commerce; or

(iii) Which are used or could be used for industrial purposes by industries in interstate commerce;

(4) All impoundments of waters otherwise defined as waters of the United States under this definition;

(5) Tributaries of waters identified in paragraphs (1) through (4) of this definition;

(6) The territorial sea; and

(7) Wetlands adjacent to waters (other than waters which are themselves wetlands) identified in paragraphs (1) through (6) of this definition.

(8) Waste treatment systems, including treatment ponds or lagoons designed to meet the requirements of CWA are not waters of the United States.

"Wetlands" means those areas that are inundated or saturated by surface or groundwater at a frequency and duration sufficient to support, and that under normal circumstances do support, a prevalence of vegetation typically adapted for life in saturated soil conditions. Wetlands generally include swamps, marshes, bogs, and similar areas.

"Whole effluent toxicity" means the aggregate toxic effect of an effluent measured directly by a toxicity test.

122.3. Exclusions.

The following discharges do not require NPDES permits:

(a) Any discharge of sewage from vessels, effluent from properly functioning marine engines, laundry, shower, and galley sink wastes, or any other discharge incidental to the normal operation of a vessel. This exclusion does not apply to rubbish, trash, garbage, or other such materials discharged overboard; nor to other discharges when the vessel is operating in a capacity other than as a means of transportation such as when used as an energy or mining facility, a storage facility or a seafood processing facility, or when secured to a storage facility or a seafood processing facility, or when secured to the bed of the ocean, contiguous zone or waters of the State for the purpose of mineral or oil exploration or development.

(b) Discharges of dredged or fill material into waters of the United States which are regulated under section 404 of CWA.

(c) The introduction of sewage, industrial wastes or other pollutants into publicly owned treatment works by indirect dischargers. Plans or agreements to switch to this method of disposal in the future do not relieve dischargers of the obligation to have and comply with permits until all discharges of pollutants to waters of the State are eliminated. (See also section 122.47(b)). This exclusion does not apply to the introduction of pollutants to privately owned treatment works or to other discharges through pipes, sewers, or other conveyances owned by a State, municipality, or other party not leading to treatment works.

(d) Any discharge in compliance with the instructions of an On-Scene Coordinator pursuant to 40 CFR Part 1510 (The National Oil and Hazardous Substances Pollution Plan) or 33 CFR 153.10(e) (Pollution by Oil and Hazardous Substances).

(e) Any introduction of pollutants from non point-source agricultural and silvicultural activities, including storm water runoff from orchards, cultivated crops, pastures, range lands, and forest lands, but not discharges from concentrated animal feeding operations as defined in section 122.23, discharges from concentrated aquatic animal production facilities defined in section 122.24, discharges to aquaculture projects as defined in section 122.25, and discharges from silvicultural point sources as defined in section 122.27.

(f) Return flows from irrigated agriculture.

(g) Discharges into a privately owned treatment works, except as the Department may otherwise require under section 122.44(m).

122.4. Prohibitions.

No permit may be issued:

(a) When the conditions of the permit do not provide for compliance with the applicable requirements of CWA, State regulations, or regulations promulgated under CWA;

(b) When the applicant is required to obtain a State or other appropriate certification under section 401 of CWA and R.61-9.124.53 and that certification has not been obtained or waived;

(c) By the Department where the Regional Administrator has objected to issuance of the permit under 40 CFR Part 123.44;

(d) When the imposition of conditions cannot ensure compliance with the applicable water quality requirements of all affected States;

(e) When, in the judgment of the Secretary, anchorage and navigation in or on any of the waters of the United States would be substantially impaired by the discharge;

(f) For the discharge of any radiological, chemical, or biological warfare agent or high-level radioactive waste;

(g)(1) For any discharge inconsistent with a plan or plan amendment approved under section 208(b) of CWA, unless the Department finds such variance necessary to protect the public health, safety, and welfare;



(2) In reissuance of a permit which requires connection to a regional sewer system or other treatment facilities under the water quality management plan under section 208 of the CWA, once the permittee is notified by the Department that the regional sewer system is operational.

(h) For any discharge to the territorial sea, the waters of the contiguous zone, or the oceans in the following circumstances;

(1) Before the promulgation of guidelines under section 403(c) of CWA (for determining degradation of the waters of the territorial seas, the contiguous zone, and the oceans) unless the Department determines permit issuance to be in the public interest; or

(2) After promulgation of guidelines under section 403(c) of CWA, when insufficient information exists to make a reasonable judgment whether the discharge complies with them.

(i) To a new source or a new discharger, if the discharge from its construction or operation will cause or contribute to the violation of water quality standards. The owner or operator of a new source or new discharger proposing to discharge into a water segment which does not meet applicable water quality standards or is not expected to meet those standards even after the application of the effluent limitations required by sections 301(b)(1)(A) and 301(b)(1)(B) of CWA, and for which the State or interstate agency has performed a pollutants load allocation for the pollutant to be discharged, must demonstrate, before the close of the public comment period, that:

(1) There are sufficient remaining pollutant load allocations to allow for the discharge; and

(2) The existing dischargers into that segment are subject to compliance schedules designed to bring the segment into compliance with applicable water quality standards. The Department may waive the submission of information by the new source or new discharger required by paragraph (i) of this section if the Department determines that the Department already has adequate information to evaluate the request. An explanation of the development of limitations to meet the criteria of this paragraph (i)(2) is to be included in the fact sheet to the permit under section 124.56(b)(1).

122.5. Effect of a permit.

(a)(1) Except for any toxic effluent standards and prohibitions imposed under section 307 of the CWA and "standards for sewage sludge use or disposal" under 405(d) of the CWA, compliance with a permit during its term constitutes compliance, for purposes of enforcement, with the Pollution Control Act and with sections 301, 302, 306, 307, 318, 403, and 405(a)-(b) of CWA. However, a permit may be modified, revoked and reissued, or terminated during its term for cause as set forth in section 122.62 and section 122.64.



(2) Compliance with a permit condition which implements a particular "standard for sewage sludge use or disposal" shall be an affirmative defense in any enforcement action brought for a violation of that "standard for sewage sludge use or disposal" pursuant to sections 405(e) and 309 of the CWA.

(b) The issuance of a permit does not convey any property rights of any sort, or any exclusive privilege.

(c) The issuance of a permit does not authorize any injury to persons or property or invasion of other private rights, or any infringement of State or local law or regulations.

122.6. Continuation of expiring permits.

(a) The conditions of an expired permit continue in force under S.C. Code section 1-23-370(b) until the effective date of a new permit (see R.61-9.124.15), except when the permit requires connection to a regional sewer system or other treatment facilities under the water quality management plan under section 208 of the CWA and the permittee has been notified by the Department that the regional sewer system is operational, if:

(1) The permittee has submitted a timely application under section 122.21 which is a complete (under section 122.21(e)) application for a new permit; and

(2) The Department, through no fault of the permittee does not issue a new permit with an effective date under R.61-9.124.15 on or before the expiration date of the previous permit (for example, when issuance is impracticable due to time or resource constraints); or

(3) The permittee has submitted a timely application under section 122.21 which is a complete application for a new permit and makes a timely appeal of the new permit.

(b) Effect. Permits continued under this section remain fully effective and enforceable.

(c) Enforcement. When the permittee is not in compliance with the conditions of the expiring or expired permit the Department may choose to do any or all of the following:

(1) Initiate enforcement action based upon the permit which has been continued;

(2) Issue a notice of intent to deny the new permit under section 124.6. If the permit is denied, the owner or operator would then be required to cease the activities authorized by the continued permit or be subject to enforcement action for operating without a permit;

(3) Issue a new permit under R.61-9.124 with appropriate conditions; or

(4) Take other actions authorized by these regulations.

122.7. Confidentiality of information.

(a) [Reserved]

(b) Claims of confidentiality for the following information will be denied:

(1) The name and address of any permit applicant or permittee;

(2) Permit applications, permits, and effluent data.

(c) Information required by NPDES application forms provided by the Department under section 122.21 may not be claimed confidential. This includes information submitted on the forms themselves and any attachments used to supply information required by the forms.

PART B. PERMIT APPLICATION AND SPECIAL NPDES PROGRAM REQUIREMENTS

122.21. Application for a permit.

(a) Duty to apply.

(1) Any person who discharges or proposes to discharge pollutants or who owns or operates a "sludge-only facility" whose sewage sludge use or disposal practice is regulated by R.61-9.503 and who does not have an effective permit, except persons covered by general permits under section 122.28, excluded under section 122.3, or a user of a privately owned treatment works, unless the Department requires otherwise under section 122.44(m), must submit a complete application to the Department in accordance with this section and R.61-9.124. All concentrated animal feeding operations have a duty to seek coverage under an NPDES permit, as described in section 122.23(d).

(2) Applicants for State-issued permits must use State forms which must require at a minimum the information listed in the appropriate paragraphs of this section.

(3) A person discharging or proposing to discharge wastes into the waters of the State shall promptly make application for and obtain a valid NPDES Permit and, if required, a valid State Construction Permit.

(b) [Reserved]

(c) Time to apply.

(1) Any person proposing a new discharge shall submit an application at least 180 days before the date on which the discharge is to commence, unless permission for a later date has been granted by the Department. Facilities proposing a new discharge of storm water associated with industrial activity shall submit an application 180 days before that facility commences industrial activity which may result in a discharge of storm water associated with that industrial activity. Facilities described under section 122.26(b)(14)(x) or (b)(15)(i) shall submit applications at least 90 days before the date on which construction is to commence. Different submittal dates may be required under the terms of applicable general permits. Persons proposing a new discharge are encouraged to submit their applications well in advance of the 90 or 180-day requirements to avoid delay. See also paragraph (k) of this section and section 122.26(c)(1)(i)(G) and (c)(1)(ii).

(2) Permits under section 405(f) of CWA. All "treatment works treating domestic sewage" (TWTDS) whose sewage sludge use or disposal practices are regulated by part 503 of this chapter must submit permit applications according to the applicable schedule in paragraphs (c)(2)(i) or (ii) of this section.

(i) A TWTDS with a currently effective NPDES permit must submit a permit application at the time of its next NPDES permit renewal application. Such information must be submitted in accordance with paragraph (d) of this section.

(ii) Any other TWTDS not addressed under paragraphs (c)(2)(i) of this section must submit the information listed in paragraphs (c)(2)(ii)(A) through (E) of this section to the Department within 1 year after publication of a standard applicable to its sewage sludge use or disposal practice(s), using Form 2S or another form provided by the Department. The Department will determine when such TWTDS must submit a full permit application.

(A) The TWTDS's name, mailing address, location, and status as federal, State, private, public or other entity;

(B) The applicant's name, address, telephone number, and ownership status;

(C) A description of the sewage sludge use or disposal practices. Unless the sewage sludge meets the requirements of paragraph (q)(8)(iv) of this section, the description must include the name and address of any facility where sewage sludge is sent for treatment or disposal, and the location of any land application sites;

(D) Annual amount of sewage sludge generated, treated, used or disposed (estimated dry weight basis); and

(E) The most recent data the TWTDS may have on the quality of the sewage sludge.

(iii) Notwithstanding paragraphs (c)(2)(i) or (ii) of this section, the Department may require permit applications from any TWTDS at any time if the Department determines that a permit is necessary to protect public health and the environment from any potential adverse effects that may occur from toxic pollutants in sewage sludge.

(iv) Any TWTDS that commences operations after promulgation of an applicable "standard for sewage sludge use or disposal" must submit an application to the Department at least 180 days prior to the date proposed for commencing operations.

(3) [Reserved]

(d) Duty to reapply.

(1) Any POTW with a current effective permit shall submit a new application at least 180 days before the expiration date of the existing permit, unless permission for a later date has been granted by the Department. (The Department shall not grant permission for applications to be submitted later than the expiration date of the existing permit).

(2) All other permittees with currently effective permits shall submit a new application 180 days before the existing permit expires, except that the Department may grant permission to submit an application later than the deadline for submission otherwise applicable, but no later than the permit expiration date; and

(3) [Reserved]

(e) Completeness.

(1) The Department shall not issue a permit before receiving a complete application for a permit except for NPDES general permits. An application for a permit is complete when the Department receives an application form and any supplemental information which are completed to its satisfaction. The completeness of any application for a permit shall be judged independently of the status of any other permit application or permit for the same facility or activity.

(2) A permit application shall not be considered complete if a permitting authority has waived application requirements under paragraphs (j) or (q) of this section and EPA has disapproved the waiver application. If a waiver request has been submitted to EPA more than 210 days prior to permit expiration and EPA has not disapproved the waiver application 181 days prior to permit expiration, the permit application lacking the information subject to the waiver application shall be considered complete.

(3) The Department, at its discretion, or upon request of the Regional Administrator, may request of an applicant any additional information deemed necessary to complete or correct deficiencies in a Refuse Act permit application, before processing the application or issuing or denying the issuance of a permit.

(4) The Department may take enforcement action as prescribed by the State law or this regulation against any person who fails to file a complete application, if deficiencies are not corrected or complete information is not supplied within sixty (60) days to the Department following its request.

(f) Information requirements. All applicants for NPDES permits, other than POTW and other TWTDS, must provide the following information to the Department, using the application form provided by the Department. Additional information required of applicants is set forth in paragraphs (g) through (k) of this section.

(1) The activities conducted by the applicant which require it to obtain an NPDES permit.

(2) Name, mailing address, and location of the facility for which the application is submitted.

(3) Up to four SIC codes which best reflect the principal products or services provided by the facility.

(4) The operator's name, address, telephone number, ownership status, and status as Federal, State, private, public, or other entity.

(5) Whether the facility is located on Indian lands.

(6) A listing of all permits or construction approvals received or applied for under any of the following programs:

(i) Hazardous Waste Management program under RCRA.

(ii) UIC program under SDWA.

(iii) NPDES program under CWA.

(iv) Prevention of Significant Deterioration (PSD) program under the Clean Air Act.

(v) Nonattainment program under the Clean Air Act.

(vi) National Emission Standards for Hazardous Pollutants (NESHAPS) preconstruction approval under the Clean Air Act.

(vii) Ocean dumping permits under the Marine Protection Research and Sanctuaries Act.

(viii) Dredge or fill permits under section 404 of CWA.

(ix) Other relevant environmental permits, including State permits.

(7) A topographic map (or other map if a topographic map is unavailable) extending one mile beyond the property boundaries of the source, depicting the facility and each of its intake and discharge structures; each of its hazardous waste treatment, storage, or disposal facilities; each well where fluids from the facility are injected underground; and those wells, springs, other surface water bodies, and drinking water wells listed in public records or otherwise known to the applicant in the map area.

(8) A brief description of the nature of the business, activity, or type project.

(g) Application requirements for existing manufacturing, commercial, mining, and silvicultural dischargers. Existing manufacturing, commercial, mining, and silvicultural dischargers applying for NPDES permits, except for those facilities subject to the requirements of section 122.21(h), shall provide the following information to the Department, using application forms provided by the Department.

(1) Outfall location. The latitude and longitude to the nearest 15 seconds and the name of the receiving water.

(2) Line Drawing. A line drawing of the water flow through the facility with a water balance, showing operations contributing wastewater to the effluent and treatment units. Similar processes, operations, or production areas may be indicated as a single unit, labeled to correspond to the more detailed identification under paragraph (g)(3) of this section. The water balance must show approximate average flows at intake and discharge points and between units, including treatment units. If a water balance cannot be determined (for example, for certain mining activities), the applicant may provide instead a pictorial description of the nature and amount of any sources of water and any collection and treatment measures.

(3) Average flows and treatment. A narrative identification of each type of process, operation, or production area which contributes wastewater to the effluent for each outfall, including process wastewater, cooling water, and stormwater runoff; the average flow which each process contributes; and a description of the treatment the wastewater receives, including the ultimate disposal of any solid or fluid wastes other than by discharge. Processes, operations or production areas may be described in general terms (for example, "dye-making reactor", "distillation tower." For a privately owned treatment works, this information shall include the identity of each user of the treatment works. The average flow of point sources composed of storm water may be estimated. The basis for the rainfall event and the method of estimation must be indicated.

(4) Intermittent flows. If any of the discharges described in paragraph (g)(3) of this section are intermittent or seasonal, a description of the frequency, duration and flow rate of each discharge occurrence (except for stormwater runoff, spillage or leaks).

(5) Maximum production. If an effluent guideline promulgated under section 304 of CWA applies to the applicant and is expressed in terms of production (or other measure of operation), a reasonable measure of the applicant's actual production reported in the units used in the applicable effluent guideline. The reported measure must reflect the actual production of the facility as required by section 122.45(b)(2).

(6) Improvements. If the applicant is subject to any present requirements or compliance schedules for construction, upgrading or operation of waste treatment equipment, an identification of the abatement requirement, a description of the abatement project, and a listing of the required and projected final compliance dates.

(7) Effluent characteristics.

(i) Information on the discharge of pollutants specified in this paragraph (g)(7) (except information on storm water discharges which is to be provided as specified in section 122.26). When "quantitative data" for a pollutant are required, the applicant must collect a sample of effluent and analyze it for the pollutant in accordance with analytical methods approved under 40 CFR Part 136. When no analytical method is approved the applicant may use any suitable method but must provide a description of the method. When an applicant has two or more outfalls with substantially identical effluents, the Department may allow the applicant to test only one outfall and report that the quantitative data also apply to the substantially identical outfalls. The requirements in paragraphs (g)(7)(vi) and (vii) of this section that an applicant must provide quantitative data for certain pollutants known or believed to be present do not apply to pollutants present in a discharge solely as the result of their presence in intake water; however, an applicant must report such pollutants as present. Grab samples must be used for pH, temperature, cyanide, total phenols, residual chlorine, oil and grease, fecal coliform, and fecal streptococcus. For all other pollutants, 24-hour composite samples must be used. However, a minimum of one grab sample may be taken for effluents from holding ponds or other impoundments with a retention period greater than 24 hours. In addition for discharges other than storm water discharges, the Department may waive composite sampling for any outfall for which the applicant demonstrates that the use of an automatic sampler is infeasible and that the minimum of four (4) grab samples will be a representative sample of the effluent being discharged.

(ii) Storm water discharges. For storm water discharges, all samples shall be collected from the discharge resulting from a storm event that is greater than 0.1 inch and at least 72 hours from the previously measurable (greater than 0.1 inch rainfall) storm event. Where feasible, the variance in the duration of the event and the total rainfall of the event should not exceed 50 percent from the average or median rainfall event in that area. For all applicants, a flow-weighted composite shall be taken for either the entire discharge or for the first three hours of the discharge. The flow-weighted composite sample for a storm water discharge may be taken with a continuous sampler or as a combination of a minimum of three sample aliquots taken in each hour of discharge for the entire discharge or for the first three hours of the discharge, with each aliquot being separated by a minimum period of fifteen minutes (applicants submitting permit applications for storm water discharges under section 122.26(d) may collect flow weighted composite samples using different protocols with respect to the time duration between the collection of sample aliquots, subject to the approval of the Department). However, a minimum of one grab sample may be taken for storm water discharges from holding ponds or other impoundments with a retention period greater than 24 hours. For a flow-weighted composite sample, only one analysis of the composite of aliquots is required. For storm water discharge samples taken from discharges associated with industrial activities, quantitative data must be reported for the grab sample taken during the first thirty minutes (or as soon thereafter as practicable) of the discharge for all pollutants specified in section 122.26(c)(1). For all storm water permit applicants taking flow-weighted composites, quantitative data must be reported for all pollutants specified in section 122.26 except pH, temperature, cyanide, total phenols, residual chlorine, oil and grease, fecal coliform, and fecal streptococcus. The Department may allow or establish appropriate site-specific sampling procedures or requirements, including sampling locations, the season in which the sampling takes place, the minimum duration between the previous measurable storm event and the storm event sampled, the minimum or maximum level of precipitation required for an appropriate storm event, the form of precipitation sampled (snow melt or rain fall), protocols for collecting samples under 40 CFR Part 136, and additional time for submitting data on a case-by-case basis. An applicant is expected to "know or have reason to believe" that a pollutant is present in an effluent based on an evaluation of the expected use, production, or storage of the pollutant, or on any previous analyses for the pollutant. (For example, any pesticide manufactured by a facility may be expected to be present in contaminated storm water runoff from the facility.)

(iii) Reporting requirements. Every applicant must report quantitative data for every outfall for the following pollutants:

(A) Biochemical oxygen demand, 5-day (BOD5)

(B) Chemical oxygen demand

(C) Total organic carbon

(D) Total suspended solids

(E) Ammonia (as N)

(F) Temperature (both winter and summer)

(G) pH

(iv) The Department may waive the reporting requirements for individual point sources or for a particular industry category for one or more of the pollutants listed in paragraph (g)(7)(iii) of this section if the applicant has demonstrated that such a waiver is appropriate because information adequate to support issuance of a permit can be obtained with less stringent requirements.

(v) Each applicant with processes in one or more primary industry category (see appendix A to this regulation) contributing to a discharge must report quantitative data for the following pollutants in each outfall containing process wastewater:

(A) The organic toxic pollutants in the fractions designated in Table I of Appendix D for the applicant's industrial category or categories unless the applicant qualifies as a small business under paragraph (g)(8) of this section. Table II of Appendix D lists the organic toxic pollutants in each fraction. The fractions result from the sample preparation required by the analytical procedure which uses gas chromatography/mass spectrometry. A determination that an applicant falls within a particular industrial category for the purposes of selecting fractions for testing is not conclusive as to the applicant's inclusion in that category for any other purposes. [See Notes 2, 3, and 4 of 40 CFR 122.21.]

(B) The pollutants listed in Table III of Appendix D (the toxic metals, cyanide, and total phenols).

(vi)(A) Each applicant must indicate whether it knows or has reason to believe that any of the pollutants in Table IV of appendix D of this part (certain conventional and nonconventional pollutants) is discharged from each outfall. If an applicable effluent limitations guideline either directly limits the pollutant or, by its express terms, indirectly limits the pollutant through limitations on an indicator, the applicant must report quantitative data. For every pollutant discharged which is not so limited in an effluent limitations guideline, the applicant must either report quantitative data or briefly describe the reasons the pollutant is expected to be discharged.

(B) Each applicant must indicate whether it knows or has reason to believe that any of the pollutants listed in Table II or Table III of appendix D of this part (the toxic pollutants and total phenols) for which quantitative data are not otherwise required under paragraph (g)(7)(v) of this section is discharged from each outfall. For every pollutant expected to be discharged in concentrations of 10 ppb or greater the applicant must report quantitative data. For acrolein, acrylonitrile, 2,4 dinitrophenol, and 2-methyl-4,6 dinitrophenol, where any of these four pollutants are expected to be discharged in concentrations of 100 ppb or greater the applicant must report quantitative data. For every pollutant expected to be discharged in concentrations less than 10 ppb, or in the case of acrolein, acrylonitrile, 2,4 dinitrophenol, and 2-methyl-4,6 dinitrophenol, in concentrations less than 100 ppb, the applicant must either submit quantitative data or briefly describe the reasons the pollutant is expected to be discharged. An applicant qualifying as a small business under paragraph (g)(8) of this section is not required to analyze for pollutants listed in Table II of Appendix D (the organic toxic pollutants).

(vii) Each applicant must indicate whether it knows or has reason to believe that any of the pollutants in Table V of appendix D (certain hazardous substances and asbestos) are discharged from each outfall. For every pollutant expected to be discharged, the applicant must briefly describe the reasons the pollutant is expected to be discharged, and report any quantitative data it has for any pollutant.

(viii) Each applicant must report qualitative data, generated using a screening procedure not calibrated with analytical standards, for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) if it:

(A) Uses or manufactures 2,4,5-trichlorophenoxy acetic acid (2,4,5,-T); 2-(2,4,5-trichlorophenoxy) propanoic acid (Silvex, 2,4,5,-TP); 2-(2,4,5-trichlorophenoxy) ethyl, 2,2-dichloropropionate (Erbon); O,O-dimethyl O-(2,4,5-trichlorophenyl) phosphorothioate (Ronnel); 2,4,5-trichlorophenol (TCP); or hexachlorophene (HCP); or

(B) Knows or has reason to believe that TCDD is or may be present in an effluent.

(8) Small business exemption. An applicant which qualifies as a small business under one of the following criteria is exempt from the requirements in paragraph (g)(7) (v)(A) or (g)(7)(vi)(A) of this section to submit quantitative data for the pollutants listed in Table II of Appendix D (the organic toxic pollutants):

(i) For coal mines, a probable total annual production of less than 100,000 tons per year.

(ii) For all other applicants, gross total annual sales averaging less than $100,000 per year (in second quarter 1980 dollars).

(9) Used or manufactured toxics. A listing of any toxic pollutant which the applicant currently uses or manufactures as an intermediate or final product or byproduct. The Department may waive or modify this requirement for any applicant if the applicant demonstrates that it would be unduly burdensome to identify each toxic pollutant and the Department has adequate information to issue the permit.

(10) [Reserved]

(11) Biological toxicity tests. An identification of any biological toxicity tests which the applicant knows or has reason to believe have been made within the last 3 years on any of the applicant's discharges or on a receiving water in relation to a discharge.

(12) Contract analyses. If a contract laboratory or consulting firm performed any of the analyses required by paragraph (g)(7) of this section, the identity of each laboratory or firm and the analyses performed.

(13) Additional information. In addition to the information reported on the application form, applicants shall provide to the Department upon request such other information as the Department may reasonably require to assess the discharges of the facility and to determine whether to issue an NPDES permit. The additional information may include additional quantitative data and bioassays to assess the relative toxicity of discharges to aquatic life and requirements to determine the cause of the toxicity.

(h) Application requirements for manufacturing, commercial, mining and silvicultural facilities which discharge only non-process wastewater. Except for stormwater discharges, all manufacturing, commercial, mining and silvicultural dischargers applying for NPDES permits which discharge only non-process wastewater not regulated by an effluent limitations guideline or new source performance standard shall provide the following information to the Department, using application forms provided by the Department.

(1) Outfall location. Outfall number, latitude and longitude to the nearest 15 seconds, and the name of the receiving water.

(2) Discharge date (for new dischargers). Date of expected commencement of discharge.

(3) Type of waste. An identification of the general type of waste discharged, or expected to be discharged upon commencement of operations, including sanitary wastes, restaurant or cafeteria wastes, or noncontact cooling water. An identification of cooling water additives (if any) that are used or expected to be used upon commencement of operations, along with their composition if existing composition is available.

(4) Effluent characteristics.

(i) Quantitative data for the pollutants or parameters listed below, unless testing is waived by the Department. The quantitative data may be data collected over the past 365 days, if they remain representative of current operations, and must include maximum daily value, average daily value, and number of measurements taken. The applicant must collect and analyze samples in accordance with 40 CFR Part 136. Grab samples must be used for ph, temperature, oil and grease, total residual chlorine, and fecal coliform. For all other pollutants, 24-hour composite samples must be used. New dischargers must include estimates for the pollutants or parameters listed below instead of actual sampling data, along with the source of each estimate. All levels must be reported or estimated as concentration and as total mass, except for flow, ph, and temperature.

(A) Biochemical Oxygen Demand (BOD5).

(B) Total Suspended Solids (TSS).

(C) Fecal Coliform (if believed present or if sanitary waste is or will be discharged).

(D) Total Residual Chlorine (if chlorine is used).

(E) Oil and Grease.

(F) Chemical Oxygen Demand (COD) (only if non-contact cooling water is or will be discharged).

(G) Total Organic Carbon (TOC) (only if non-contact cooling water is or will be discharged).

(H) Ammonia (as N).

(I) Discharge Flow.

(J) pH.

(K) Temperature (Winter and Summer).

(ii) The Department may waive the testing and reporting requirements for any of the pollutants or flow listed in paragraph (h)(4)(i) of this section if the applicant submits a request for such a waiver before or with his application which demonstrates that information adequate to support issuance of a permit can be obtained through less stringent requirements.

(iii) If the applicant is a new discharger, he must complete and submit Item IV of Form 2e (see section 122.21(h)(4)) by providing quantitative data in accordance with that section no later than two years after commencement of discharge. However, the applicant need not complete those portions of Item IV requiring tests which he has already performed and reported under the discharge monitoring requirements of his NPDES permit.

(iv) The requirements of parts i and iii of this section that an applicant must provide quantitative data or estimates of certain pollutants do not apply to pollutants present in a discharge solely as a result of their presence in intake water. However, an applicant must report such pollutants as present. Net credit may be provided for the presence of pollutants in intake water if the requirements of section 122.45(g) are met.

(5) Flow. A description of the frequency of flow and duration of any seasonal or intermittent discharge (except for stormwater runoff, leaks, or spills).

(6) Treatment system. A brief description of any system used or to be used.

(7) Optional information. Any additional information the applicant wishes to be considered, such as influent data for the purpose of obtaining "net" credits pursuant to section 122.45(g).

(8) Certification. Signature of certifying official under section 122.22.

(i) Application requirements for new and existing concentrated animal feeding operations and aquatic animal production facilities. New and existing concentrated animal feeding operations (defined in section 122.23) and concentrated aquatic animal production facilities (defined in section 122.24) shall provide the following information to the Department, using the application form provided by the Department:

(1) For concentrated animal feeding operations:

(i) The name of the owner or operator;

(ii) The facility location and mailing addresses;

(iii) Latitude and longitude of the production area (entrance to production area);

(iv) A topographic map of the geographic area in which the CAFO is located showing the specific location of the production area, in lieu of the requirements of paragraph (f)(7) of this section;

(v) Specific information about the number and type of animals, whether in open confinement or housed under roof (beef cattle, broilers, layers, swine weighing 55 pounds or more, swine weighing less than 55 pounds, mature dairy cows, dairy heifers, veal calves, sheep and lambs, horses, ducks, turkeys, other);

(vi) The type of containment and storage (anaerobic lagoon, roofed storage shed, storage ponds, under-floor pits, above ground storage tanks, below ground storage tanks, concrete pad, impervious soil pad, other) and total capacity for manure, litter, and process wastewater storage (tons/gallons);

(vii) The total number of acres under control of the applicant available for land application of manure, litter, or process wastewater;

(viii) Estimated amounts of manure, litter, and process wastewater generated per year (tons/gallons);

(ix) Estimated amounts of manure, litter, and process wastewater transferred to other persons per year (tons/gallons); and

(x) For CAFO that must seek coverage under a permit after December 31, 2006, certification that a nutrient management plan has been completed and will be implemented upon the date of permit coverage.

(2) For concentrated aquatic animal production facilities:

(i) The maximum daily and average monthly flow from each outfall.

(ii) The number of ponds, raceways, and similar structures.

(iii) The name of the receiving water and the source of intake water.

(iv) For each species of aquatic animals, the total yearly and maximum harvestable weight.

(v) The calendar month of maximum feeding and the total mass of food fed during that month.

(j) Application requirements for new and existing POTWs. Unless otherwise indicated, all POTW and other dischargers designated by the Department must provide, at a minimum, the information in this paragraph to the Department, using Form 2A or another application form provided by the Department. Permit applicants must submit all information available at the time of permit application. The information may be provided by referencing information previously submitted to the Department. The Department may waive any requirement of this paragraph if he or she has access to substantially identical information. The Department may also waive any requirement of this paragraph that is not of material concern for a specific permit, if approved by the Regional Administrator. The waiver request to the Regional Administrator must include the State's justification for the waiver. A Regional Administrator's disapproval of a State's proposed waiver does not constitute final Agency action, but does provide notice to the State and permit applicant(s) that EPA may object to any State-issued permit issued in the absence of the required information.

(1) Basic application information. All applicants must provide the following information:

(i) Facility information. Name, mailing address, and location of the facility for which the application is submitted;

(ii) Applicant information. Name, mailing address, and telephone number of the applicant, and indication as to whether the applicant is the facility's owner, operator, or both;

(iii) Existing environmental permits. Identification of all environmental permits or construction approvals received or applied for (including dates) under any of the following programs:

(A) Hazardous Waste Management program under the Resource Conservation and Recovery Act (RCRA), Subpart C;

(B) Underground Injection Control program under the Safe Drinking Water Act (SDWA);

(C) NPDES program under Clean Water Act (CWA);

(D) Prevention of Significant Deterioration (PSD) program under the Clean Air Act;

(E) Nonattainment program under the Clean Air Act;

(F) National Emission Standards for Hazardous Air Pollutants (NESHAPS) preconstruction approval under the Clean Air Act;

(G) Ocean dumping permits under the Marine Protection, Research, and Sanctuaries Act;

(H) Dredge or fill permits under section 404 of the CWA; and

(I) Other relevant environmental permits, including State permits.

(iv) Population. The name and population of each municipal entity served by the facility, including unincorporated connector districts. Indicate whether each municipal entity owns or maintains the collection system and whether the collection system is separate sanitary or combined storm and sanitary, if known;

(v) Indian country. Information concerning whether the facility is located in Indian country and whether the facility discharges to a receiving stream that flows through Indian country;

(vi) Flow rate. The facility's design flow rate (the wastewater flow rate the plant was built to handle), annual average daily flow rate, and maximum daily flow rate for each of the previous 3 years;

(vii) Collection system. Identification of type(s) of collection system(s) used by the treatment works (i.e., separate sanitary sewers or combined storm and sanitary sewers) and an estimate of the percent of sewer line that each type comprises; and

(viii) Outfalls and other discharge or disposal methods. The following information for outfalls to waters of the State and/or of the United States and other discharge or disposal methods:

(A) For effluent discharges to waters of the State and/or of the United States, the total number and types of outfalls (e.g., treated effluent, combined sewer overflows, bypasses, constructed emergency overflows);

(B) For wastewater discharged to surface impoundments:

(1) The location of each surface impoundment;

(2) The average daily volume discharged to each surface impoundment; and

(3) Whether the discharge is continuous or intermittent;

(C) For wastewater applied to the land:

(1) The location of each land application site;

(2) The size of each land application site, in acres;

(3) The average daily volume applied to each land application site, in gallons per day; and

(4) Whether land application is continuous or intermittent;

(D) For effluent sent to another facility for treatment prior to discharge:

(1) The means by which the effluent is transported;

(2) The name, mailing address, contact person, and phone number of the organization transporting the discharge, if the transport is provided by a party other than the applicant;

(3) The name, mailing address, contact person, phone number, and NPDES permit number (if any) of the receiving facility; and

(4) The average daily flow rate from this facility into the receiving facility, in millions of gallons per day; and

(E) For wastewater disposed of in a manner not included in paragraphs (j)(1)(viii)(A) through (D) of this section (e.g., underground percolation, underground injection):

(1) A description of the disposal method, including the location and size of each disposal site, if applicable;

(2) The annual average daily volume disposed of by this method, in gallons per day; and

(3) Whether disposal through this method is continuous or intermittent;

(2) Additional Information. All applicants with a design flow greater than or equal to 0.1 mgd must provide the following information:

(i) Inflow and infiltration. The current average daily volume of inflow and infiltration, in gallons per day, and steps the facility is taking to minimize inflow and infiltration;

(ii) Topographic map. A topographic map (or other map if a topographic map is unavailable) extending at least one mile beyond property boundaries of the treatment plant, including all unit processes, and showing:

(A) Treatment plant area and unit processes;

(B) The major pipes or other structures through which wastewater enters the treatment plant and the pipes or other structures through which treated wastewater is discharged from the treatment plant. Include outfalls from bypass piping, if applicable;

(C) Each well where fluids from the treatment plant are injected underground;

(D) Wells, springs, and other surface water bodies listed in public records or otherwise known to the applicant within 1/4 mile of the treatment works' property boundaries;

(E) Sewage sludge management facilities (including on-site treatment, storage, and disposal sites); and

(F) Location at which waste classified as hazardous under RCRA enters the treatment plant by truck, rail, or dedicated pipe;

(iii) Process flow diagram or schematic.

(A) A diagram showing the processes of the treatment plant, including all bypass piping and all backup power sources or redundancy in the system. This includes a water balance showing all treatment units, including disinfection, and showing daily average flow rates at influent and discharge points, and approximate daily flow rates between treatment units; and

(B) A narrative description of the diagram; and

(iv) Scheduled improvements, schedules of implementation. The following information regarding scheduled improvements:

(A) The outfall number of each outfall affected;

(B) A narrative description of each required improvement;

(C) Scheduled or actual dates of completion for the following:

(1) Commencement of construction;

(2) Completion of construction;

(3) Commencement of discharge; and

(4) Attainment of operational level;

(D) A description of permits and clearances concerning other Federal and/or State requirements;

(3) Information on effluent discharges. Each applicant must provide the following information for each outfall, including bypass points, through which effluent is discharged, as applicable:

(i) Description of outfall. The following information about each outfall:

(A) Outfall number;

(B) State, county, and city or town in which outfall is located;

(C) Latitude and longitude, to the nearest second;

(D) Distance from shore and depth below surface;

(E) Average daily flow rate, in million gallons per day;

(F) The following information for each outfall with a seasonal or periodic discharge:

(1) Number of times per year the discharge occurs;

(2) Duration of each discharge;

(3) Flow of each discharge; and

(4) Months in which discharge occurs; and

(G) Whether the outfall is equipped with a diffuser and the type (e.g., high-rate) of diffuser used;

(ii) Description of receiving waters. The following information (if known) for each outfall through which effluent is discharged to waters of the state and or of the United States:

(A) Name of receiving water;

(B) Name of watershed/river/stream system and United States Soil Conservation Service 14-digit watershed code;

(C) Name of State Management/River Basin and United States Geological Survey 8-digit hydrologic cataloging unit code; and

(D) Critical flow of receiving stream and total hardness of receiving stream at critical low flow (if applicable);

(iii) Description of treatment. The following information describing the treatment provided for discharges from each outfall to waters of state and/or the United States:

(A) The highest level of treatment (e.g., primary, equivalent to secondary, secondary, advanced, other) that is provided for the discharge for each outfall and:

(1) Design biochemical oxygen demand (BOD5 or CBOD5) removal (percent);

(2) Design total suspended solids (TSS) removal (percent); and, where applicable;

(3) Design phosphorus (P) removal (percent);

(4) Design nitrogen (N) removal (percent); and

(5) Any other removals that an advanced treatment system is designed to achieve.

(B) A description of the type of disinfection used, and whether the treatment plant dechlorinates (if disinfection is accomplished through chlorination);

(4) Effluent monitoring for specific parameters.

(i) As provided in paragraphs (j)(4)(ii) through (x) of this section, all applicants must submit to the Department effluent monitoring information for samples taken from each outfall through which effluent is discharged to waters of the United States, except for CSOs. The Department may allow applicants to submit sampling data for only one outfall on a case-by-case basis, where the applicant has two or more outfalls with substantially identical effluent. The Department may also allow applicants to composite samples from one or more outfalls that discharge into the same mixing zone;

(ii) All applicants must sample and analyze for the pollutants listed in Appendix J, Table 1A of this part;

(iii) All applicants with a design flow greater than or equal to 0.1 mgd must sample and analyze for the pollutants listed in Appendix J, Table 1 of R.61-9.122. Facilities that do not use chlorine for disinfection, do not use chlorine elsewhere in the treatment process, and have no reasonable potential to discharge chlorine in their effluent may delete chlorine from Table 1;

(iv) The following applicants must sample and analyze for the pollutants listed in Appendix J, Table 2 of R.61-9.122, and for any other pollutants for which the State or EPA have established water quality standards applicable to the receiving waters:

(A) All POTW with a design flow rate equal to or greater than one million gallons per day;

(B) All POTW with approved pretreatment programs or POTW required to develop a pretreatment program;

(C) Other POTW, as required by the Department;

(v) The Department should require sampling for additional pollutants, as appropriate, on a case-by-case basis.

(vi) Applicants must provide data from a minimum of three samples taken within four and one-half years prior to the date of the permit application. Samples must be representative of the seasonal variation in the discharge from each outfall. Existing data may be used, if available, in lieu of sampling done solely for the purpose of this application. The Department should require additional samples, as appropriate, on a case-by-case basis.

(vii) All existing data for pollutants specified in paragraphs (j)(4)(ii) through (v) of this section that is collected within four and one-half years of the application must be included in the pollutant data summary submitted by the applicant. If, however, the applicant samples for a specific pollutant on a monthly or more frequent basis, it is only necessary, for such pollutant, to summarize all data collected within one year of the application.

(viii) Applicants must collect samples of effluent and analyze such samples for pollutants in accordance with analytical methods approved under 40 CFR part 136 unless an alternative is specified in the existing NPDES permit. Grab samples must be used for pH, temperature, cyanide, total phenols, residual chlorine, oil and grease, and fecal coliform. For all other pollutants, 24-hour composite samples must be used. For a composite sample, only one analysis of the composite of aliquots is required.

(ix) The effluent monitoring data provided must include at least the following information for each parameter:

(A) Maximum daily discharge, expressed as concentration or mass, based upon actual sample values;

(B) Average daily discharge for all samples, expressed as concentration or mass, and the number of samples used to obtain this value;

(C) The analytical method used; and

(D) The threshold level (i.e., method detection limit, minimum level, or other designated method endpoints) for the analytical method used.

(x) Unless otherwise required by the Department, metals must be reported as total recoverable.

(5) Effluent monitoring for whole effluent toxicity.

(i) All applicants must provide an identification of any whole effluent toxicity tests conducted during the four and one-half years prior to the date of the application on any of the applicant's discharges or on any receiving water near the discharge.

(ii) As provided in paragraphs (j)(5)(iii)-(ix) of this section, the following applicants must submit to the Department the results of valid whole effluent toxicity tests for acute or chronic toxicity for samples taken from each outfall through which effluent is discharged to surface waters, except for combined sewer overflows:

(A) All POTW with design flow rates greater than or equal to one million gallons per day;

(B) All POTW with approved pretreatment programs or POTW required to develop a pretreatment program;

(C) Other POTW, as required by the Department, based on consideration of the following factors:

(1) The variability of the pollutants or pollutant parameters in the POTW effluent (based on chemical-specific information, the type of treatment plant, and types of industrial contributors);

(2) The ratio of effluent flow to receiving stream flow;

(3) Existing controls on point or non-point sources, including total maximum daily load calculations for the receiving stream segment and the relative contribution of the POTW;

(4) Receiving stream characteristics, including possible or known water quality impairment, and whether the POTW discharges to a coastal water or a water designated as an outstanding natural resource water; or

(5) Other considerations (including, but not limited to, the history of toxic impacts and compliance problems at the POTW) that the Department determines could cause or contribute to adverse water quality impacts.

(iii) Where the POTW has two or more outfalls with substantially identical effluent discharging to the same receiving stream segment, the Department may allow applicants to submit whole effluent toxicity data for only one outfall on a case-by-case basis. The Department may also allow applicants to composite samples from one or more outfalls that discharge into the same mixing zone.

(iv) Each applicant required to perform whole effluent toxicity testing pursuant to paragraph (j)(5)(ii) of this section must provide:

(A) Results of a minimum of four quarterly tests for a year, from the year preceding the permit application; or

(B) Results from four tests performed at least annually in the four and one half year period prior to the application, provided the results show no appreciable toxicity using a safety factor determined by the permitting authority.

(v) Applicants must conduct tests with multiple species (no less than two species; e.g., fish, invertebrate, plant), and test for acute or chronic toxicity, depending on the range of receiving water dilution. EPA recommends that applicants conduct acute or chronic testing based on the following dilutions:

(A) Acute toxicity testing if the dilution of the effluent is greater than 1000:1 at the edge of the mixing zone;

(B) Acute or chronic toxicity testing if the dilution of the effluent is between 100:1 and 1000:1 at the edge of the mixing zone. Acute testing may be more appropriate at the higher end of this range (1000:1), and chronic testing may be more appropriate at the lower end of this range (100:1); and

(C) Chronic testing if the dilution of the effluent is less than 100:1 at the edge of the mixing zone.

(vi) Each applicant required to perform whole effluent toxicity testing pursuant to paragraph (j)(5)(ii) of this section must provide the number of chronic or acute whole effluent toxicity tests that have been conducted since the last permit reissuance.

(vii) Applicants must provide the results using the form provided by the Department, or test summaries if available and comprehensive, for each whole effluent toxicity test conducted pursuant to paragraph (j)(5)(ii) of this section for which such information has not been reported previously to the Department.

(viii) Whole effluent toxicity testing conducted pursuant to paragraph (j)(5)(ii) of this section must be conducted using methods approved under 40 CFR part 136.

(ix) For whole effluent toxicity data submitted to the Department within four and one-half years prior to the date of the application, applicants must provide the dates on which the data were submitted and a summary of the results.

(x) Each POTW required to perform whole effluent toxicity testing pursuant to paragraph (j)(5)(ii) of this section must provide any information on the cause of toxicity and written details of any toxicity reduction evaluation conducted, if any whole effluent toxicity test conducted within the past four and one-half years revealed toxicity.

(6) Industrial discharges. Applicants must submit the following information about industrial discharges to the POTW:

(i) Number of significant industrial users (SIU) and categorical industrial users (CIU) discharging to the POTW; and

(ii) POTW with one or more SIU shall provide the following information for each SIU, as defined at R.61-9.403.3(o), that discharges to the POTW:

(A) Name and mailing address;

(B) Description of all industrial processes that affect or contribute to the SIU's discharge;

(C) Principal products and raw materials of the SIU that affect or contribute to the SIU's discharge;

(D) Average daily volume of wastewater discharged, indicating the amount attributable to process flow and non-process flow;

(E) Whether the SIU is subject to local limits;

(F) Whether the SIU is subject to categorical standards, and if so, under which category(ies) and subcategory(ies); and

(G) Whether any problems at the POTW (e.g., upsets, pass through, interference) have been attributed to the SIU in the past four and one-half years.

(iii) The information required in paragraphs (j)(6)(i) and (ii) of this section may be waived by the Department for POTW with pretreatment programs if the applicant has submitted either of the following that contain information substantially identical to that required in paragraphs (j)(6)(i) and (ii) of this section.

(A) An annual report submitted within one year of the application; or

(B) A pretreatment program;

(7) Discharges from hazardous waste generators and from waste cleanup or remediation sites. POTW receiving Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or RCRA Corrective Action wastes or wastes generated at another type of cleanup or remediation site must provide the following information:

(i) If the POTW receives, or has been notified that it will receive, by truck, rail, or dedicated pipe any wastes that are regulated as RCRA hazardous wastes pursuant to 40 CFR Part 261, the applicant must report the following:

(A) The method by which the waste is received (i.e., whether by truck, rail, or dedicated pipe) and

(B) The hazardous waste number and amount received annually of each hazardous waste;

(ii) If the POTW receives, or has been notified that it will receive, wastewaters that originate from remedial activities, including those undertaken pursuant to CERCLA and sections 3004(u) or 3008(h) of RCRA, the applicant must report the following:

(A) The identity and description of the site(s) or facility(ies) at which the wastewater originates;

(B) The identities of the wastewater's hazardous constituents, as listed in Appendix VIII of 40 CFR part 261, if known; and

(C) The extent of treatment, if any, the wastewater receives or will receive before entering the POTW.

(iii) Applicants are exempt from the requirements of paragraph (j)(7)(ii) of this section if they receive no more than fifteen kilograms per month of hazardous wastes, unless the wastes are acute hazardous wastes as specified in 40 CFR 261.30(d) and 261.33(e).

(8) Combined sewer overflows. Each applicant with combined sewer systems must provide the following information:

(i) Combined sewer system information. The following information regarding the combined sewer system:

(A) System map. A map indicating the location of the following:

(1) All CSO discharge points;

(2) Sensitive use areas potentially affected by CSO (e.g., beaches, drinking water supplies, shellfish beds, sensitive aquatic ecosystems, and outstanding national resource waters); and

(3) Waters supporting threatened and endangered species potentially affected by CSO; and

(B) System diagram. A diagram of the combined sewer collection system that includes the following information:

(1) The location of major sewer trunk lines, both combined and separate sanitary;

(2) The locations of points where separate sanitary sewers feed into the combined sewer system;

(3) In-line and off-line storage structures;

(4) The locations of flow-regulating devices; and

(5) The locations of pump stations.

(ii) Information on CSO outfalls. The following information for each CSO discharge point covered by the permit application:

(A) Description of outfall. The following information on each outfall:

(1) Outfall number;

(2) State, county, and city or town in which outfall is located;

(3) Latitude and longitude, to the nearest second;

(4) Distance from shore and depth below surface;

(5) Whether the applicant monitored any of the following in the past year for this CSO:

(i) Rainfall;

(ii) CSO flow volume;

(iii) CSO pollutant concentrations;

(iv) Receiving water quality;

(v) CSO frequency; and

(6) The number of storm events monitored in the past year;

(B) CSO events. The following information about CSO overflows from each outfall:

(1) The number of events in the past year;

(2) The average duration per event, if available;

(3) The average volume per CSO event, if available; and

(4) The minimum rainfall that caused a CSO event, if available, in the last year.

(C) Description of receiving waters. The following information about receiving waters:

(1) Name of receiving water;

(2) Name of watershed/stream system and the United States Soil Conservation Service watershed (14-digit) code (if known); and

(3) Name of State Management/River Basin and the United States Geological Survey hydrologic cataloging unit (8-digit) code (if known); and

(D) CSO operations. A description of any known water quality impacts on the receiving water caused by the CSO (e.g., permanent or intermittent beach closings, permanent or intermittent shellfish bed closings, fish kills, fish advisories, other recreational loss, or exceedance of any applicable State water quality standard);

(9) Contractors. All applicants must provide the name, mailing address, telephone number, and responsibilities of all contractors responsible for any operational or maintenance aspects of the facility; and

(10) Signature. All applications must be signed by a certifying official in compliance with section 122.22.

(k) Application requirements for new sources and new discharges.

New manufacturing, commercial, mining, and silvicultural dischargers applying for NPDES permits (except for new discharges of facilities subject to the requirements of paragraph (h) of this section or new discharges of storm water associated with industrial activity which are subject to the requirements of section 122.26(c)(1) and this section (except as provided by section 122.26(c)(1)(ii)) shall provide the following information to the Department, using application forms provided by the Department.

(1) Expected outfall location. The latitude and longitude to the nearest 15 seconds and the name of the receiving water.

(2) Discharge dates. The expected date of commencement of discharge.

(3) Flows, sources of pollution, and treatment technologies.

(i) Expected treatment of wastewater. Description of the treatment that the wastewater will receive, along with all operations contributing wastewater to the effluent, average flow contributed by each operation, and the ultimate disposal of any solid or liquid wastes not discharged.

(ii) Line drawing. A line drawing of the water flow through the facility with a water balance as described in section 122.21(g)(2).

(iii) Intermittent flows. If any of the expected discharges will be intermittent or seasonal, a description of the frequency, duration and maximum daily flow rate of each discharge occurrence (except for storm water runoff, spillage, or leaks).

(4) Production. If a new source performance standard promulgated under section 306 of CWA or an effluent limitation guideline applies to the applicant and is expressed in terms of production (or other measure of operation), a reasonable measure of the applicant's expected actual production reported in the units used in the applicable effluent guideline or new source performance standard as required by section 122.45(b)(2) for each of the first three years. Alternative estimates may also be submitted if production is likely to vary.

(5) Effluent characteristics. The requirements in paragraphs (h)(4)(i), (ii), and (iii) of this section that an applicant must provide estimates of certain pollutants expected to be present do not apply to pollutants present in a discharge solely as a result of their presence in intake water; however, an applicant must report such pollutants as present. Net credits may be provided for the presence of pollutants in intake water if the requirements of section 122.45(g) are met. All levels (except for discharge flow, temperature, and pH) must be estimated as concentration and as total mass.

(i) Each applicant must report estimated daily maximum, daily average, and source of information for each outfall for the following pollutants or parameters. The Department may waive the reporting requirements for any of these pollutants and parameters if the applicant submits a request for such a waiver before or with his application which demonstrates that information adequate to support issuance of the permit can be obtained through less stringent reporting requirements.

(A) Biochemical Oxygen Demand (BOD).

(B) Chemical Oxygen Demand (COD).

(C) Total Organic Carbon (TOC).

(D) Total Suspended Solids (TSS).

(E) Flow.

(F) Ammonia (as N).

(G) Temperature (winter and summer).

(H) pH.

(ii) Each applicant must report estimated daily maximum, daily average, and source of information for each outfall for the following pollutants, if the applicant knows or has reason to believe they will be present or if they are limited by an effluent limitation guideline or new source performance standard either directly or indirectly through limitations on an indicator pollutant: all pollutants in Table IV of Appendix D (certain conventional and nonconventional pollutants).

(iii) Each applicant must report estimated daily maximum, daily average and source of information for the following pollutants if he knows or has reason to believe that they will be present in the discharges from any outfall:

(A) The pollutants listed in Table III of Appendix D (the toxic metals, in the discharge from any outfall; total cyanide, and total phenols);

(B) The organic toxic pollutants in Table II of Appendix D (except bis chloromethyl) ether, dichlorofluoromethane and trichlorofluoromethane). This requirement is waived for applicants with expected gross sales of less than $100,000 per year for the next three years, and for coal mines with expected average production of less than 100,000 tons of coal per year.

(iv) The applicant is required to report that 2,3,7,8 Tetrachlorodibenzo-P-Dioxin (TCDD) may be discharged if he uses or manufactures one of the following compounds, or if he knows or has reason to believe that TCDD will or may be present in the effluent:

(A) 2,4,5-trichlorophenoxy acetic acid (2,4,5-T) (CAS #93-76-5);

(B) 2-(2,4,5-trichlorophenoxy)propanoic acid (Silvex, 2,4,5-TP) (CAS #93-72-1);

(C) 2-(2,4,5-trichlorophenoxy) ethyl 2,2,-dichloropropionate (Erbon) (CAS #136-25-4);

(D) O,O-dimethyl O-(2,4,5-trichlorophenyl) phosphorothioate (Ronnel) (CAS #299-84-3);

(E) 2,4,5-trichlorophenol (TCP) (CAS #95-95-4); or

(F) Hexachlorophene (HCP) (CAS #70-30-4);

(v) Each applicant must report any pollutants listed in Table V of Appendix D (certain hazardous substances) if he believes they will be present in any outfall (no quantitative estimates are required unless they are already available).

(vi) No later than two years after the commencement of discharge from the proposed facility, the applicant is required to complete and submit Items V and VI of NPDES application Form 2c (see section 122.21(g)). However, the applicant need not complete those portions of Item V requiring tests which he has already performed and reported under the discharge monitoring requirements of his NPDES permit.

(6) Engineering Report. Each applicant must report the existence of any technical evaluation concerning his wastewater treatment, along with the name and location of similar plants of which he has knowledge.

(7) Other information. Any optional information the permittee wishes to have considered.

(8) Certification. Signature of certifying official under section 122.22.

(l) [Reserved]

(m) Variance requests by non-POTWs. A discharger which is not a publicly owned treatment works (POTW) may request a variance from otherwise applicable effluent limitations under any of the following statutory or regulatory provisions within the times specified in this paragraph:

(1) Fundamentally different factors.

(i) A request for a variance based on the presence of "fundamentally different factors" from those on which the effluent limitations guideline was based shall be filed as follows:

(A) For a request from best practicable control technology currently available (BPT) by the close of the public comment period under R.61-9.124.10.

(B) For a request from best available technology economically achievable (BAT) and/or best conventional pollutant control technology (BCT), by no later than:

(1) July 3, 1989, for a request based on an effluent limitation guideline promulgated before February 4, 1987, to the extent July 3, 1989 is not later than that provided under previously promulgated regulations; or

(2) 180 days after the date on which an effluent limitation guideline is published in the Federal Register for a request based on an effluent limitation guideline promulgated on or after February 4, 1987.

(ii) The request shall explain how the requirements of the applicable regulatory and/or statutory criteria have been met.

(2) Non-conventional pollutants. A request for a variance from the BAT requirements for CWA section 301(b)(2)(F) pollutants (commonly called "non-conventional" pollutants) pursuant to section 301(c) of CWA because of the economic capability of the owner or operator, or pursuant to section 301(g) of the CWA (provided, however, that a section 301(g) variance may only be requested for ammonia; chlorine; color; iron; total phenols (4AAP) (when determined by the Department to be a pollutant covered by section 301(b)(2)(F)) and any other pollutant which the Administrator lists under section 301(g)(4) of the CWA) must be made as follows:

(i) For those requests for a variance from an effluent limitation based upon an effluent limitation guideline by:

(A) Submitting an initial request to the Regional Administrator as well as to the Department, stating the name of the discharger, the permit number, the outfall number(s), the applicable effluent guideline, and whether the discharger is requesting a section 301(c) or section 301(g) modification or both. This request must have been filed not later than:

(1) September 25, 1978, for a pollutant which is controlled by a BAT effluent limitation guideline promulgated before December 27, 1977; or

(2) 270 days after promulgation of an applicable effluent limitation guideline for guidelines promulgated after December 27, 1977, and

(B) Submitting a completed request no later than the close of the public comment period under section 124.10 demonstrating that the requirements of section 124.13 and the applicable requirements of R.61-9.125 have been met.

(C) Notwithstanding this provision, the complete application for a request under section 301(g) shall be filed 180 days before EPA must make a decision.

(ii) For those requests for a variance from effluent limitations not based on effluent limitation guidelines, the request need only comply with paragraph (m)(2)(i)(B) of this section and need not be preceded by a initial request under paragraph (m)(2)(i)(A) of this section.

(3) [Reserved]

(4) [Reserved]

(5) Water quality related effluent limitations. A modification under section 302(b)(2) of requirements under section 302(a) for achieving water quality related effluent limitations may be requested no later than the close of the public comment period under R.61-9.124.10 on the permit from which the modification is sought.

(6) Thermal discharges. A variance under CWA section 316(a) for the thermal component of any discharge must be filed with a timely application for a permit under this section, except that if thermal effluent limitations are established under CWA Section 402(a)(1) or are based on water quality standards, the request for a variance may be filed by the close of the public comment period under R.61-9.124.10. A copy of the request as required under R.61-9.125, Part H, shall be sent simultaneously to the appropriate State or interstate certifying agency as required under R.61-9.125. (See 40 CFR 124.66 for special procedures for thermal variances in accordance with section 316(a) of the CWA.)

(n) Variance requests by POTWs. A discharger which is a publicly owned treatment works (POTW) may request a variance from otherwise applicable effluent limitations under any of the following statutory provisions as specified in this paragraph:

(1) Discharges into marine waters. A request for a modification under CWA section 301(h) of requirements of CWA section 301(b)(1)(B) for discharges into marine waters must be filed in accordance with the requirements of R.61-9.125 Part G.

(2) [Reserved]

(3) Water quality based effluent limitation. A modification under CWA section 302(b)(2) of the requirements under section 302(a) for achieving water quality based effluent limitations shall be requested no later than the close of the public comment period under section 124.10 on the permit from which the modification is sought.

(o) Expedited variance procedures and time extensions.

(1) Notwithstanding the time requirements in paragraphs (m) and (n) of this section, the Department may notify a permit applicant before a draft permit is issued under section 124.6 that the draft permit will likely contain limitations which are eligible for variances. In the notice the Department may require the applicant as a condition of consideration of any potential variance request to submit a request, explaining how the requirements of R.61-9.125 applicable to the variance have been met and may require its submission within a specified reasonable time after receipt of the notice. The notice may be sent before the permit application has been submitted. The draft or final permit may contain the alternative limitations which may become effective upon final grant of the variance.

(2) A discharger who cannot file a timely complete request required under paragraph (m)(2)(i)(B) or (m)(2)(ii) of this section may request an extension. The extension may be granted or denied at the discretion of the Department. Extensions shall be no more than 6 months in duration.

(p) Record keeping. Except for information required by paragraph (q) of this section, which shall be retained for a period of at least five years from the date the application is signed (or longer as required by R.61-9.503 or R.61-9.504), applicants shall keep records of all data used to complete permit applications and any supplemental information submitted under this section for a period of at least 3 years from the date the application is signed.

(q) Sewage sludge management. All TWTDS subject to paragraph (c)(2)(i) of this section must provide the information in this paragraph to the Department, using Form 2S or another application form approved by the Department. New applicants must submit all information available at the time of permit application. The information may be provided by referencing information previously submitted to the Department. The Department may waive any requirement of this paragraph if he or she has access to substantially identical information. The Department may also waive any requirement of this paragraph that is not of material concern for a specific permit, if approved by the Regional Administrator. The waiver request to the Regional Administrator must include the State's justification for the waiver. A Regional Administrator's disapproval of a State's proposed waiver does not constitute final Agency action, but does provide notice to the State and permit applicant(s) that EPA may object to any State-issued permit issued in the absence of the required information.

(1) Facility information. All applicants must submit the following information:

(i) The name, mailing address, and location of the TWTDS for which the application is submitted;

(ii) Whether the facility is a Class I Sludge Management Facility;

(iii) The design flow rate (in million gallons per day);

(iv) The total population served; and

(v) The status of the TWTDS as Federal, State, private, public, or other entity.

(2) Applicant information. All applicants must submit the following information:

(i) The name, mailing address, and telephone number of the applicant; and

(ii) Indication whether the applicant is the owner, operator, or both.

(3) Permit information. All applicants must submit the facility's NPDES permit number, if applicable, and a listing of all other Federal, State, and local permits or construction approvals received or applied for under any of the following programs:

(i) Hazardous Waste Management program under the Resource Conservation and Recovery Act (RCRA);

(ii) UIC program under the Safe Drinking Water Act (SDWA);

(iii) NPDES program under the Clean Water Act (CWA);

(iv) Prevention of Significant Deterioration (PSD) program under the Clean Air Act;

(v) Nonattainment program under the Clean Air Act;

(vi) National Emission Standards for Hazardous Air Pollutants (NESHAPS) preconstruction approval under the Clean Air Act;

(vii) Dredge or fill permits under section 404 of CWA;

(viii) Other relevant environmental permits, including State or local permits.

(4) Indian country. All applicants must identify any generation, treatment, storage, land application, or disposal of sewage sludge that occurs in Indian country.

(5) Topographic map. All applicants must submit a topographic map (or other map if a topographic map is unavailable) extending one mile beyond property boundaries of the facility and showing the following information:

(i) All sewage sludge management facilities, including on-site treatment, storage, and disposal sites and

(ii) Wells, springs, and other surface water bodies that are within 1/4 mile of the property boundaries and listed in public records or otherwise known to the applicant.

(6) Sewage sludge handling. All applicants must submit a line drawing and/or a narrative description that identifies all sewage sludge management practices employed during the term of the permit, including all units used for collecting, dewatering, storing, or treating sewage sludge, the destination(s) of all liquids and solids leaving each such unit, and all processes used for pathogen reduction and vector attraction reduction.

(7) Sewage sludge quality. The applicant must submit sewage sludge monitoring data for the pollutants for which limits in sewage sludge have been established in R.61-9.503 for the applicant's use or disposal practices on the date of permit application.

(i) The Department may require sampling for additional pollutants, as appropriate, on a case-by-case basis.

(ii) Applicants must provide data from a minimum of three samples taken within four and one-half years prior to the date of the permit application. Samples must be representative of the sewage sludge and should be taken at least one month apart. Existing data may be used in lieu of sampling done solely for the purpose of this application.

(iii) Applicants must collect and analyze samples in accordance with analytical methods approved under SW-846 unless an alternative has been specified in an existing sewage sludge permit.

(iv) The monitoring data provided must include at least the following information for each parameter:

(A) Average monthly concentration for all samples (mg/kg dry weight), based upon actual sample values;

(B) The analytical method used; and

(C) The method detection level.

(8) Preparation of sewage sludge. If the applicant is a "person who prepares" sewage sludge, as defined at R.61-9.503.9(r), the applicant must provide the following information:

(i) If the applicant's facility generates sewage sludge, the total dry metric tons per 365-day period generated at the facility;

(ii) If the applicant's facility receives sewage sludge from another facility, the following information for each facility from which sewage sludge is received:

(A) The name, mailing address, and location of the other facility;

(B) The total dry metric tons per 365-day period received from the other facility; and

(C) A description of any treatment processes occurring at the other facility, including blending activities and treatment to reduce pathogens or vector attraction characteristics.

(iii) If the applicant's facility changes the quality of sewage sludge through blending, treatment, or other activities, the following information:

(A) Whether the Class A pathogen reduction requirements in R.61-9.503.32(a) or the Class B pathogen reduction requirements in R.61-9.503.32(b) are met, and a description of any treatment processes used to reduce pathogens in sewage sludge;

(B) Whether any of the vector attraction reduction options of R.61-9.503.33(b)(1) through (b)(8) are met, and a description of any treatment processes used to reduce vector attraction properties in sewage sludge; and

(C) A description of any other blending, treatment, or other activities that change the quality of sewage sludge.

(iv) If sewage sludge from the applicant's facility meets the ceiling concentrations in R.61-9.503.13(b)(1), the pollutant concentrations in section 503.13(b)(3), the Class A pathogen requirements in section 503.32(a), and one of the vector attraction reduction requirements in section 503.33(b)(1) through (b)(8), and if the sewage sludge is applied to the land, the applicant must provide the total dry metric tons per 365-day period of sewage sludge subject to this paragraph that is applied to the land.

(v) If sewage sludge from the applicant's facility is sold or given away in a bag or other container for application to the land, and the sewage sludge is not subject to paragraph (q)(8)(iv) of this section, the applicant must provide the following information:

(A) The total dry metric tons per 365-day period of sewage sludge subject to this paragraph that is sold or given away in a bag or other container for application to the land and

(B) A copy of all labels or notices that accompany the sewage sludge being sold or given away.

(vi) If sewage sludge from the applicant's facility is provided to another "person who prepares," as defined at R.61-9.503.9(r), and the sewage sludge is not subject to paragraph (q)(8)(iv) of this section, the applicant must provide the following information for each facility receiving the sewage sludge:

(A) The name and mailing address of the receiving facility;

(B) The total dry metric tons per 365-day period of sewage sludge subject to this paragraph that the applicant provides to the receiving facility;

(C) A description of any treatment processes occurring at the receiving facility, including blending activities and treatment to reduce pathogens or vector attraction characteristic;

(D) A copy of the notice and necessary information that the applicant is required to provide the receiving facility under R.61-9.503.12(g); and

(E) If the receiving facility places sewage sludge in bags or containers for sale or give-away to application to the land, a copy of any labels or notices that accompany the sewage sludge.

(9) Land application of bulk sewage sludge. If sewage sludge from the applicant's facility is applied to the land in bulk form, and is not subject to paragraphs (q)(8)(iv), (v), or (vi) of this section, the applicant must provide the following information:

(i) The total dry metric tons per 365-day period of sewage sludge subject to this paragraph that is applied to the land;

(ii) If any land application sites are located in States other than the State where the sewage sludge is prepared, a description of how the applicant will notify the permitting authority for the State(s) where the land application sites are located;

(iii) The following information for each land application site that has been identified at the time of permit application:

(A) The name (if any), and location for the land application site;

(B) The site's latitude and longitude to the nearest second, and method of determination;

(C) A topographic map (or other map if a topographic map is unavailable) that shows the site's location;

(D) The name, mailing address, and telephone number of the site owner, if different from the applicant;

(E) The name, mailing address, and telephone number of the person who applies sewage sludge to the site, if different from the applicant;

(F) Whether the site is agricultural land, forest, a public contact site, or a reclamation site, as such site types are defined under R.61-9.503.11;

(G) The type of vegetation grown on the site, if known, and the nitrogen requirement for this vegetation;

(H) Whether either of the vector attraction reduction options of R.61-9.503.33(b)(9) or (b)(10) is met at the site, and a description of any procedures employed at the time of use to reduce vector attraction properties in sewage sludge; and

(I) Other information that describes how the site will be managed, as specified by the permitting authority.

(iv) The following information for each land application site that has been identified at the time of permit application, if the applicant intends to apply bulk sewage sludge subject to the cumulative pollutant loading rates in R.61-9.503.13(b)(2) to the site:

(A) Whether the applicant has contacted the permitting authority in the State where the bulk sewage sludge subject to section 503.13(b)(2) will be applied, to ascertain whether bulk sewage sludge subject to section 503.13(b)(2) has been applied to the site on or since July 20, 1993, and if so, the name of the permitting authority and the name and phone number of a contact person at the permitting authority;

(B) Identification of facilities other than the applicant's facility that have sent, or are sending, sewage sludge subject to the cumulative pollutant loading rates in section 503.13(b)(2) to the site since July 20, 1993, if, based on the inquiry in paragraph (q)(iv)(A), bulk sewage sludge subject to cumulative pollutant loading rates in section 503.13(b)(2) has been applied to the site since July 20, 1993;

(v) If not all land application sites have been identified at the time of permit application, the applicant must submit a land application plan that, at a minimum:

(A) Describes the geographical area covered by the plan;

(B) Identifies the site selection criteria;

(C) Describes how the site(s) will be managed;

(D) Provides for advance notice to the Department of specific land application sites and reasonable time for the permit authority to object prior to land application of the sewage sludge; and

(E) Provides for advance public notice of land application sites in the manner prescribed by State and local law. When State or local law does not require advance public notice, it must be provided in a manner reasonably calculated to apprise the general public of the planned land application.

(10) Surface disposal. If sewage sludge from the applicant's facility is placed on a surface disposal site, the applicant must provide the following information:

(i) The total dry metric tons of sewage sludge from the applicant's facility that is placed on surface disposal sites per 365-day period;

(ii) The following information for each surface disposal site receiving sewage sludge from the applicant's facility that the applicant does not own or operate:

(A) The site name or number, contact person, mailing address, and telephone number for the surface disposal site and

(B) The total dry metric tons from the applicant's facility per 365-day period placed on the surface disposal site;

(iii) The following information for each active sewage sludge unit at each surface disposal site that the applicant owns or operates:

(A) The name or number and the location of the active sewage sludge unit;

(B) The unit's latitude and longitude to the nearest second, and method of determination;

(C) If not already provided, a topographic map (or other map if a topographic map is unavailable) that shows the unit's location;

(D) The total dry metric tons placed on the active sewage sludge unit per 365-day period;

(E) The total dry metric tons placed on the active sewage sludge unit over the life of the unit;

(F) A description of any liner for the active sewage sludge unit, including whether it has a maximum permeability of 1 x 10-7 cm/sec;

(G) A description of any leachate collection system for the active sewage sludge unit, including the method used for leachate disposal, and any Federal, State, and local permit number(s) for leachate disposal;

(H) If the active sewage sludge unit is less than 150 meters from the property line of the surface disposal site, the actual distance from the unit boundary to the site property line;

(I) The remaining capacity (dry metric tons) for the active sewage sludge unit;

(J) The date on which the active sewage sludge unit is expected to close, if such a date has been identified;

(K) The following information for any other facility that sends sewage sludge to the active sewage sludge unit:

(1) The name, contact person, and mailing address of the facility and

(2) Available information regarding the quality of the sewage sludge received from the facility, including any treatment at the facility to reduce pathogens or vector attraction characteristics;

(L) Whether any of the vector attraction reduction options of R.61-9.503.33(b)(9) through (b)(11) is met at the active sewage sludge unit, and a description of any procedures employed at the time of disposal to reduce vector attraction properties in sewage sludge;

(M) The following information, as applicable to any ground water monitoring occurring at the active sewage sludge unit:

(1) A description of any ground water monitoring occurring at the active sewage sludge unit;

(2) Any available ground-water monitoring data, with a description of the well locations and approximate depth to ground water;

(3) A copy of any ground-water monitoring plan that has been prepared for the active sewage sludge unit;

(4) A copy of any certification that has been obtained from a qualified ground-water scientist that the aquifer has not been contaminated; and

(N) If site-specific pollutant limits are being sought for the sewage sludge placed on this active sewage sludge unit, information to support such a request.

(11) Incineration. If sewage sludge from the applicant's facility is fired in a sewage sludge incinerator, the applicant must provide the following information:

(i) The total dry metric tons of sewage sludge from the applicant's facility that is fired in sewage sludge incinerators per 365-day period;

(ii) The following information for each sewage sludge incinerator firing the applicant's sewage sludge that the applicant does not own or operate:

(A) The name and/or number, contact person, mailing address, and telephone number of the sewage sludge incinerator and

(B) The total dry metric tons from the applicant's facility per 365-day period fired in the sewage sludge incinerator;

(iii) The following information for each sewage sludge incinerator that the applicant owns or operates:

(A) The name and/or number and the location of the sewage sludge incinerator;

(B) The incinerator's latitude and longitude to the nearest second, and method of determination;

(C) The total dry metric tons per 365-day period fired in the sewage sludge incinerator;

(D) Information, test data, and documentation of ongoing operating parameters indicating that compliance with the National Emission Standard for Beryllium in 40 CFR part 61 will be achieved;

(E) Information, test data, and documentation of ongoing operating parameters indicating that compliance with the National Emission Standard for Mercury in 40 CFR part 61 will be achieved;

(F) The dispersion factor for the sewage sludge incinerator, as well as modeling results and supporting documentation;

(G) The control efficiency for parameters regulated in R.61-9.503.43, as well as performance test results and supporting documentation;

(H) Information used to calculate the risk specific concentration (RSC) for chromium, including the results of incinerator stack tests for hexavalent and total chromium concentrations, if the applicant is requesting a chromium limit based on a site-specific RSC value;

(I) Whether the applicant monitors total hydrocarbons (THC) or carbon monoxide (CO) in the exit gas for the sewage sludge incinerator;

(J) The type of sewage sludge incinerator;

(K) The maximum performance test combustion temperature, as obtained during the performance test of the sewage sludge incinerator to determine pollutant control efficiencies;

(L) The following information on the sewage sludge feed rate used during the performance test:

(1) Sewage sludge feed rate in dry metric tons per day;

(2) Identification of whether the feed rate submitted is average use or maximum design; and

(3) A description of how the feed rate was calculated;

(M) The incinerator stack height in meters for each stack, including identification of whether actual or creditable stack height was used;

(N) The operating parameters for the sewage sludge incinerator air pollution control device(s), as obtained during the performance test of the sewage sludge incinerator to determine pollutant control efficiencies;

(O) Identification of the monitoring equipment in place, including (but not limited to) equipment to monitor the following:

(1) Total hydrocarbons or Carbon Monoxide;

(2) Percent oxygen;

(3) Percent moisture; and

(4) Combustion temperature; and

(P) A list of all air pollution control equipment used with this sewage sludge incinerator.

(12) Disposal in a municipal solid waste landfill. If sewage sludge from the applicant's facility is sent to a municipal solid waste landfill (MSWLF), the applicant must provide the following information for each MSWLF to which sewage sludge is sent:

(i) The name, contact person, mailing address, location, and all applicable permit numbers of the MSWLF;

(ii) The total dry metric tons per 365-day period sent from this facility to the MSWLF;

(iii) A determination of whether the sewage sludge meets applicable requirements for disposal of sewage sludge in a MSWLF, including the results of the paint filter liquids test and any additional requirements that apply on a site-specific basis; and

(iv) Information, if known, indicating whether the MSWLF complies with criteria set forth in 40 CFR part 258.

(13) Contractors. All applicants must provide the name, mailing address, telephone number, and responsibilities of all contractors responsible for any operational or maintenance aspects of the facility related to sewage sludge generation, treatment, use, or disposal.

(14) Other information. At the request of the Department, the applicant must provide any other information necessary to determine the appropriate standards for permitting under R.61-9.503, and must provide any other information necessary to assess the sewage sludge use and disposal practices, determine whether to issue a permit, or identify appropriate permit requirements.

(15) Signature. All applications must be signed by a certifying official in compliance with section 122.22.

122.22. Signatories to permit applications and reports.

(a) Applications. All permit applications shall be signed as follows:

(1) For a corporation: by a responsible corporate officer. For the purpose of this section, a responsible corporate officer means:

(i) A president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation, or

(ii) The manager of one or more manufacturing, production, or operating facilities, provided, the manager is authorized to make management decisions which govern the operation of the regulated facility including having the explicit or implicit duty of making major capital investment recommendations, and initiating and directing other comprehensive measures to assure long term environmental compliance with environmental laws and regulations; the manager can ensure that the necessary systems are established or actions taken to gather complete and accurate information for permit application requirements; and where authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures.

(2) For a partnership or sole proprietorship: by a general partner or the proprietor, respectively; or

(3) For a municipality, State, Federal, or other public agency or public facility: By either a principal executive officer, mayor, or other duly authorized employee or ranking elected official. For purposes of this section, a principal executive officer of a Federal agency includes:

(i) The chief executive officer of the agency, or

(ii) A senior executive officer having responsibility for the overall operations of a principal geographic unit of the agency (e.g., Regional Administrator, Region IV, EPA).

(b) All reports required by permits, and other information requested by the Department, shall be signed by a person described in paragraph (a) of this section, or by a duly authorized representative of that person. A person is a duly authorized representative only if:

(1) The authorization is made in writing by a person described in paragraph (a) of this section;

(2) The authorization specifies either an individual or a position having responsibility for the overall operation of the regulated facility or activity such as the position of plant manager, operator of a well or a well field, superintendent, position of equivalent responsibility, or an individual or position having overall responsibility for environmental matters for the company. (A duly authorized representative may thus be either a named individual or any individual occupying a named position.) and,

(3) The written authorization is submitted to the Department.

(c) Changes to authorization. If an authorization under paragraph (b) of this section is no longer accurate because a different individual or position has responsibility for the overall operation of the facility, a new authorization satisfying the requirements of paragraph (b) of this section must be submitted to the Department prior to or together with any reports, information, or applications to be signed by an authorized representative.

(d) Certification. Any person signing a document under paragraph (a) or (b) of this section shall make the following certification: "I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations."

122.23. Concentrated animal feeding operations.

(a) Permit requirement for CAFO. Concentrated animal feeding operations, as defined in paragraph (b) of this section, are point sources that require NPDES permits for discharges or potential discharges. Once an operation is defined as a CAFO, the NPDES requirements for CAFO apply with respect to all animals in confinement at the operation and all manure, litter, and process wastewater generated by those animals or the production of those animals, regardless of the type of animal.

(b) Definitions applicable to this section:

(1) "Animal feeding operation (AFO)" means a lot or facility (other than an aquatic animal production facility)

(i) where the following conditions are met:

(A) Animals (other than aquatic animals) have been, are, or will be stabled or confined and fed or maintained for a total of 45 days or more in any 12-month period and

(B) Crops, vegetation, forage growth, or post-harvest residues are not sustained in the normal growing season over any portion of the lot or facility.

(ii) Two or more AFO under common ownership are considered to be a single AFO for the purposes of determining the number of animals at an operation if they adjoin each other or if they use a common area or system for the disposal of wastes.

(2) "Concentrated animal feeding operation (CAFO)" means an AFO that is defined as a Large CAFO or as a Medium CAFO by the terms of this paragraph, or that is designated as a CAFO in accordance with paragraph (c) of this section.

(3) The term "land application area" means land under the control of an AFO owner or operator, whether it is owned, rented, or leased, to which manure, litter, or process wastewater from the production area is or may be applied.

(4) "Large concentrated animal feeding operation (Large CAFO)". An AFO is defined as a Large CAFO if it stables or confines as many as or more than the numbers of animals specified in any of the following categories:

(i) 700 mature dairy cows, whether milked or dry;

(ii) 1,000 veal calves;

(iii) 1,000 cattle other than mature dairy cows or veal calves. The term cattle includes but is not limited to heifers, steers, bulls, and cow/calf pairs;

(iv) 2,500 swine, each weighing 55 pounds or more;

(v) 10,000 swine, each weighing less than 55 pounds;

(vi) 500 horses;

(vii) 10,000 sheep or lambs;

(viii) 55,000 turkeys;

(ix) 30,000 laying hens or broilers, if the AFO uses a liquid manure handling system;

(x) 125,000 chickens (other than laying hens), if the AFO uses other than a liquid manure handling system;

(xi) 82,000 laying hens, if the AFO uses other than a liquid manure handling system;

(xii) 30,000 ducks, if the AFO uses other than a liquid manure handling system; or

(xiii) 5,000 ducks, if the AFO uses a liquid manure handling system.

(5) The term "manure" is defined to include manure, bedding, compost, and raw materials or other materials commingled with manure or set aside for disposal.

(6) "Medium concentrated animal feeding operation (Medium CAFO)". The term Medium CAFO includes any AFO with the type and number of animals that fall within any of the ranges listed in paragraph (b)(6)(i) of this section and which has been defined or designated as a CAFO. An AFO is defined as a Medium CAFO if:

(i) The type and number of animals that it stables or confines falls within any of the following ranges:

(A) 200 to 699 mature dairy cows, whether milked or dry;

(B) 300 to 999 veal calves;

(C) 300 to 999 cattle other than mature dairy cows or veal calves. The term cattle includes but is not limited to heifers, steers, bulls and cow/calf pairs;

(D) 750 to 2,499 swine each weighing 55 pounds or more;

(E) 3,000 to 9,999 swine each weighing less than 55 pounds;

(F) 150 to 499 horses;

(G) 3,000 to 9,999 sheep or lambs;

(H) 16,500 to 54,999 turkeys;

(I) 9,000 to 29,999 laying hens or broilers, if the AFO uses a liquid manure handling system;

(J) 37,500 to 124,999 chickens (other than laying hens), if the AFO uses other than a liquid manure handling system;

(K) 25,000 to 81,999 laying hens, if the AFO uses other than a liquid manure handling system;

(L) 10,000 to 29,999 ducks, if the AFO uses other than a liquid manure handling system; or

(M) 1,500 to 4,999 ducks, if the AFO uses a liquid manure handling system; and

(ii) Either one of the following conditions is met:

(A) Pollutants are discharged into waters of the State through a man-made ditch, flushing system, or other similar man-made device; or

(B) Pollutants are discharged directly into waters of the State which originate outside of the facility and pass over, across, or through the facility or otherwise come into direct contact with the animals confined in the operation.

(7) "Process wastewater" means water directly or indirectly used in the operation of the AFO for any or all of the following: spillage or overflow from animal or poultry watering systems; washing, cleaning, or flushing pens, barns, manure pits, or other AFO facilities; direct contact swimming, washing, or spray cooling of animals; or dust control. Process wastewater also includes any water which comes into contact with any raw materials, products, or byproducts including manure, litter, feed, milk, eggs, or bedding.

(8) "Production area" means that part of an AFO that includes the animal confinement area, the manure storage area, the raw materials storage area, and the waste containment areas. The animal confinement area includes but is not limited to open lots, housed lots, feedlots, confinement houses, stall barns, free stall barns, milk rooms, milking centers, cowyards, barnyards, medication pens, walkers, animal walkways, and stables. The manure storage area includes but is not limited to lagoons, runoff ponds, storage sheds, stockpiles, under-house or pit storages, liquid impoundments, static piles, and composting piles. The raw materials storage area includes but is not limited to feed silos, silage bunkers, and bedding materials. The waste containment area includes but is not limited to settling basins and areas within berms and diversions which separate uncontaminated storm water. Also included in the definition of production area is any egg washing or egg processing facility and any area used in the storage, handling, treatment, or disposal of mortalities.

(9) "Small concentrated animal feeding operation (Small CAFO)". An AFO that is designated as a CAFO and that is not a Medium CAFO.

(c) How may an AFO be designated as a CAFO? The appropriate authority (i.e., the Department or Regional Administrator, or both, as specified in paragraph (c)(1) of this section) may designate any AFO as a CAFO upon determining that it is a significant contributor of pollutants to waters of the State.

(1) Who may designate? In South Carolina, CAFO designations may be made by the Department. The Regional Administrator may also designate CAFO in South Carolina, but only where the Regional Administrator has determined that one or more pollutants in the AFO's discharge contributes to an impairment in a downstream or adjacent state or Indian country water that is impaired for that pollutant.

(2) In making this designation, the Department or the Regional Administrator shall consider the following factors:

(i) The size of the AFO and the amount of wastes reaching waters of the State;

(ii) The location of the AFO relative to waters of the State;

(iii) The means of conveyance of animal wastes and process wastewaters into waters of the State;

(iv) The slope, vegetation, rainfall, and other factors affecting the likelihood or frequency of discharge of animal wastes, manure, and process waste waters into waters of the State; and

(v) Other relevant factors.

(3) No AFO shall be designated under this paragraph unless the Department or the Regional Administrator has conducted an on-site inspection of the operation and determined that the operation should and could be regulated under the permit program. In addition, no AFO with numbers of animals below those established in paragraph (b)(6) of this section may be designated as a CAFO unless:

(i) Pollutants are discharged into waters of the State through a manmade ditch, flushing system, or other similar manmade device or

(ii) Pollutants are discharged directly into waters of the State which originate outside of the facility and pass over, across, or through the facility or otherwise come into direct contact with the animals confined in the operation.

(d) Who must seek coverage under an NPDES permit?

(1) All CAFO owners or operators must apply for a permit. All CAFO owners or operators must seek coverage under an NPDES permit, except as provided in paragraph (d)(2) of this section. Specifically, the CAFO owner or operator must either apply for an individual NPDES permit or submit a notice of intent for coverage under an NPDES general permit. If the Department has not made a general permit available to the CAFO, the CAFO owner or operator must submit an application for an individual permit to the Department.

(2) Exception. An owner or operator of a Large CAFO need not seek coverage under an NPDES permit otherwise required by this section once the owner or operator has received from the Department notification of a determination under paragraph (f) of this section that the CAFO has "no potential to discharge" manure, litter, or process wastewater.

(3) Information to submit with permit application. A permit application for an individual permit must include the information specified in section 122.21. A notice of intent for a general permit must include the information specified in sections 122.21 and 122.28.

(e) Land application discharges from a CAFO are subject to NPDES requirements. The discharge of manure, litter, or process wastewater to waters of the State from a CAFO as a result of the application of that manure, litter, or process wastewater by the CAFO to land areas under its control is a discharge from that CAFO subject to NPDES permit requirements, except where it is an agricultural storm water discharge as provided in 33 U.S.C. 1362(14). For purposes of this paragraph, where the manure, litter or process wastewater has been applied in accordance with site-specific nutrient management practices that ensure appropriate agricultural utilization of the nutrients in the manure, litter, or process wastewater, as specified in section 122.42(e)(1)(vi) through (ix), a precipitation-related discharge of manure, litter, or process wastewater from land areas under the control of a CAFO is an agricultural storm water discharge.

(f) "No potential to discharge" determinations for Large CAFO.

(1) Determination by the Department. The Department, upon request, may make a case-specific determination that a Large CAFO has "no potential to discharge" pollutants to waters of the State. In making this determination, the Department must consider the potential for discharges from both the production area and any land application areas. The Department must also consider any record of prior discharges by the CAFO. In no case may the CAFO be determined to have "no potential to discharge" if it has had a discharge within the 5 years prior to the date of the request submitted under paragraph (f)(2) of this section. For purposes of this section, the term "no potential to discharge" means that there is no potential for any CAFO manure, litter, or process wastewater to be added to waters of the State under any circumstance or climatic condition. A determination that there is "no potential to discharge" for purposes of this section only relates to discharges of manure, litter, and process wastewater covered by this section.

(2) Information to support a "no potential to discharge" request. In requesting a determination of "no potential to discharge", the CAFO owner or operator must submit any information that would support such a determination, within the time frame provided by the Department and in accordance with paragraphs (g) and (h) of this section. Such information must include all of the information specified in sections 122.21(f) and (i)(1)(i) through (ix). The Department has discretion to require additional information to supplement the request and may also gather additional information through on-site inspection of the CAFO.

(3) Process for making a "no potential to discharge" determination. Before making a final decision to grant a "no potential to discharge" determination, the Department must issue a notice to the public stating that a "no potential to discharge" request has been received. This notice must be accompanied by a fact sheet which includes, when applicable, a brief description of the type of facility or activity which is the subject of the "no potential to discharge" determination; a brief summary of the factual basis upon which the request is based for granting the "no potential to discharge" determination; and a description of the procedures for reaching a final decision on the "no potential to discharge" determination. The Department must base the decision to grant a "no potential to discharge" determination on the administrative record, which shall include all information submitted in support of a "no potential to discharge" determination and any other supporting data gathered by the permitting authority. The Department must notify any CAFO seeking a "no potential to discharge" determination of its final determination within 90 days of receiving the request.

(4) What is the deadline for requesting a "no potential to discharge" determination? The owner or operator must request a "no potential to discharge" determination by the applicable permit application date specified in paragraph (g) of this section. If the Department's final decision is to deny the "no potential to discharge" determination, the owner or operator must seek coverage under a permit within 30 days after the denial.

(5) The "no potential to discharge" determination does not relieve the CAFO from the consequences of an actual discharge. Any unpermitted CAFO that discharges pollutants into the waters of the State is in violation of the Clean Water Act and PCA even if it has received a "no potential to discharge" determination from the Department. Any CAFO that has received a determination of "no potential to discharge", but who anticipates changes in circumstances that could create the potential for a discharge, should contact the Department and apply for and obtain permit authorization prior to the change of circumstances.

(6) The Department retains authority to require a permit. Where the Department has issued a determination of "no potential to discharge", the Department retains the authority to subsequently require NPDES permit coverage if circumstances at the facility change, if new information becomes available, or if there is another reason for the Department to determine that the CAFO has a potential to discharge.

(g) When must a CAFO seek coverage under an NPDES permit?

(1) Operations defined as CAFO prior to the effective date of this regulation. For operations that are defined as CAFO under regulations that are in effect prior to the effective date of this regulation, the owner or operator must have or seek to obtain coverage under an NPDES permit as of the effective date of this regulation and comply with all applicable NPDES requirements, including the duty to maintain permit coverage in accordance with paragraph (h) of this section.

(2) Operations defined as CAFO as of the effective date of this regulation, who were not defined as CAFO prior to that date. For all CAFO, the owner or operator of the CAFO must seek to obtain coverage under an NPDES permit by a date specified by the Department, but no later than February 13, 2006.

(3) Operations that become defined as CAFO after the effective date of this regulation, but which are not new sources. For newly constructed AFO and AFO that make changes to their operations that result in becoming defined as CAFO for the first time, after the effective date of this regulation, but that are not new sources, the owner or operator must seek to obtain coverage under an NPDES permit, as follows:

(i) For newly constructed operations not subject to effluent limitations guidelines, 180 days prior to the time CAFO commences operation or

(ii) For other operations (e.g., resulting from an increase in the number of animals), as soon as possible, but no later than 90 days after becoming defined as a CAFO; except that

(iii) If an operational change that makes the operation a CAFO would not have made it a CAFO prior to the effective date of this regulation, the operation has until April 13, 2006, or 90 days after becoming defined as a CAFO, whichever is later.

(4) New sources. New sources must seek to obtain coverage under a permit at least 180 days prior to the time that the CAFO commences operation.

(5) Operations that are designated as CAFO. For operations designated as a CAFO in accordance with paragraph (c) of this section, the owner or operator must seek to obtain coverage under a permit no later than 90 days after receiving notice of the designation.

(6) No potential to discharge. Notwithstanding any other provision of this section, a CAFO that has received a "no potential to discharge" determination in accordance with paragraph (f) of this section is not required to seek coverage under an NPDES permit that would otherwise be required by this section. If circumstances materially change at a CAFO that has received a NPTD determination, such that the CAFO has a potential for a discharge, the CAFO has a duty to immediately notify the Department and seek coverage under an NPDES permit within 30 days after the change in circumstances.

(h) Duty to Maintain Permit Coverage. No later than 180 days before the expiration of the permit, the permittee must submit an application to renew its permit in accordance with section 122.21(g). However, the permittee need not continue to seek continued permit coverage or reapply for a permit if:

(1) The facility has ceased operation or is no longer a CAFO and

(2) The permittee has demonstrated to the satisfaction of the Department that there is no remaining potential for a discharge of manure, litter or associated process wastewater that was generated while the operation was a CAFO, other than agricultural storm water from land application areas.

122.24. Concentrated aquatic animal production facilities.

(a) Permit requirement. Concentrated aquatic animal production facilities, as defined in this section, are point sources subject to the NPDES permit program.

(b) Definition. "Concentrated aquatic animal production facility" means a hatchery, fish farm, or other facility which meets the criteria in Appendix C of this regulation, or which the Department designates under paragraph (c) of this section.

(c) Case-by-case designation of concentrated aquatic animal production facilities.

(1) The Department may designate any warm or cold water aquatic animal production facility as a concentrated aquatic animal production facility upon determining that it is a significant contributor of pollution to waters of the State. In making this designation the Department shall consider the following factors:

(i) The location and quality of the receiving waters of the State;

(ii) The holding, feeding, and production capacities of the facility;

(iii) The quantity and nature of the pollutants reaching waters of the State; and

(iv) Other relevant factors.

(2) A permit application shall not be required from a concentrated aquatic animal production facility designated under this paragraph until the Department has conducted on-site inspection of the facility and has determined that the facility should and could be regulated under the permit program.

122.25. Aquaculture projects.

(a) Permit requirement. Discharges into aquaculture projects, as defined in this section, are subject to the NPDES permit program through section 318 of CWA, and in accordance with R.61-9.125 Part B.

(b) Definitions.

(1) "Aquaculture project" means a defined managed water area which uses discharges of pollutants into that designated area for the maintenance or production of harvestable freshwater, estuarine, or marine plants or animals.

(2) "Designated project area" means the portions of the waters of the State within which the permittee or permit applicant plans to confine the cultivated species, using a method or plan or operation (including, but not limited to, physical confinement) which, on the basis of reliable scientific evidence, is expected to ensure that specific individual organisms comprising an aquaculture crop will enjoy increased growth attributable to the discharge of pollutants, and be harvested within a defined geographic area.

122.26. Storm water discharges.

(a) Permit requirement.

(1) Prior to October 1, 1992, a permit shall not be required for a discharge composed entirely of storm water, except:

(i) A discharge with respect to which a permit has been issued prior to February 4, 1987;

(ii) A discharge associated with industrial activity (see section 122.26(a)(4));

(iii) A discharge from a large municipal separate storm sewer system;

(iv) A discharge from a medium municipal separate storm sewer system;

(v) A discharge which the Department or the EPA Regional Administrator determines to contribute to a violation of a water quality standard or is a significant contributor of pollutants to waters of the State. This designation may include a discharge from any conveyance or system of conveyances used for collecting and conveying storm water runoff or a system of discharges from municipal separate storm sewers, except for those discharges from conveyances which do not require a permit under paragraph (a)(2) of this section or agricultural storm water runoff which is exempted from the definition of point source at section 122.2. The Department may designate discharges from municipal separate storm sewers on a system-wide or jurisdiction-wide basis. In making this determination the Department may consider the following factors:

(A) The location of the discharge with respect to waters of the State as defined at section 122.2;

(B) The size of the discharge;

(C) The quantity and nature of the pollutants discharged to waters of the State; and

(D) Other relevant factors.

(2) The Department may not require a permit for discharges of storm water runoff from mining operations or oil and gas exploration, production, processing or treatment operations or transmission facilities, composed entirely of flows which are from conveyances or systems of conveyances (including but not limited to pipes, conduits, ditches, and channels) used for collecting and conveying precipitation runoff and which are not contaminated by contact with or that has not come into contact with, any overburden, raw material, intermediate products, finished product, byproduct or waste products located on the site of such operations.

(3) Large and medium municipal separate storm sewer systems.

(i) Permits must be obtained for all discharges from large and medium municipal separate storm sewer systems.

(ii) The Department may either issue one system-wide permit covering all discharges from municipal separate storm sewers within a large or medium municipal storm sewer system or issue distinct permits for appropriate categories of discharges within a large or medium municipal separate storm sewer system including, but not limited to: all discharges owned or operated by the same municipality; located within the same jurisdiction; all discharges within a system that discharge to the same watershed; discharges within a system that are similar in nature; or for individual discharges from municipal separate storm sewers within the system.

(iii) The operator of a discharge from a municipal separate storm sewer which is part of a large or medium municipal separate storm sewer system must either:

(A) Participate in a permit application (to be a permittee or a co-permittee) with one or more other operators of discharges from the large or medium municipal storm sewer system which covers all, or a portion of all, discharges from the municipal separate storm sewer system;

(B) Submit a distinct permit application which only covers discharges from the municipal separate storm sewers for which the operator is responsible; or

(C) A regional authority may be responsible for submitting a permit application under the following guidelines:

(1) The regional authority together with co-applicants shall have authority over a storm water management program that is in existence, or shall be in existence at the time part 1 of the application is due:

(2) The permit applicant or co-applicants shall establish their ability to make a timely submission of part 1 and part 2 of the municipal application;

(3) Each of the operators of municipal separate storm sewers within the systems described in paragraphs (b)(4)(i), (ii) and (iii) or (b)(7)(i), (ii), and (iii) of this section, that are under the purview of the designated regional authority, shall comply with the application requirements of paragraph (d) of this section.

(iv) One permit application may be submitted for all or a portion of all municipal separate storm sewers within adjacent or interconnected large or medium municipal separate storm sewer systems. The Department may issue one system-wide permit covering all, or a portion of all municipal separate storm sewers in adjacent or interconnected large or medium municipal separate storm sewer systems.

(v) Permits for all or a portion of all discharges from large or medium municipal separate storm sewer systems that are issued on a system-wide, jurisdiction-wide, watershed or other basis may specify different conditions relating to different discharges covered by the permit, including different management programs for different drainage areas which contribute storm water to the system.

(vi) Co-permittees need only comply with permit conditions relating to discharges from the municipal separate storm sewers for which they are operators.

(4) Discharges through large and medium municipal separate storm sewer systems. In addition to meeting the requirements of paragraph (c) of this section, an operator of a storm water discharge associated with industrial activity which discharges through a large or medium municipal separate storm sewer system shall submit to the operator of the municipal separate storm sewer system receiving the discharge no later than May 15, 1991, or 180 days prior to commencing such discharge: the name of the facility; a contact person and phone number; the location of the discharge; a description, including Standard Industrial Classification, which best reflects the principal products or services provided by each facility; and any existing NPDES permit number.

(5) Other municipal separate storm sewers. The Department may issue permits for municipal separate storm sewers that are designated under paragraph (a)(1)(v) of this section on a system-wide basis, jurisdiction-wide basis, watershed basis or other appropriate basis, or may issue permits for individual discharges.

(6) Non-municipal separate storm sewers. For storm water discharges associated with industrial activity from point sources which discharge through a non-municipal or non-publicly owned separate storm sewer system, the Department, in its discretion, may issue: a single NPDES permit, with each discharger a co-permittee to a permit issued to the operator of the portion of the system that discharges into waters of the State; or, individual permits to each discharger of storm water associated with industrial activity through the non-municipal conveyance system.

(i) All storm water discharges associated with industrial activity that discharge through a storm water discharge system that is not a municipal separate storm sewer must be covered by an individual permit, or a permit issued to the operator of the portion of the system that discharges to waters of the State, with each discharger to the non-municipal conveyance a co-permittee to that permit.

(ii) Where there is more than one operator of a single system of such conveyances, all operators of such conveyances, all operators of storm water discharges associated with industrial activity must submit applications.

(iii) Any permit covering more than one operator shall identify the effluent limitations or other permit conditions, if any, that apply to each operator.

(7) Combined sewer systems. Conveyances that discharge storm water runoff combined with municipal sewage are point sources that must obtain NPDES permits in accordance with the procedures of section 122.21 and are not subject to the provisions of this section.

(8) Whether a discharge from a municipal separate storm sewer is or is not subject to regulation under this section shall have no bearing on whether the owner or operator of the discharge is eligible for funding under Title II, Title III or Title IV of the Clean Water Act. See 40 CFR Part 35, subpart I, Appendix A(b)H.2.j.

(9) (i) On and after October 1, 1994, for discharges composed entirely of storm water, that are not required by paragraph (a)(1) of this section to obtain a permit, operators shall be required to obtain a NPDES permit only if:

(A) The discharge is from a small MS4 required to be regulated pursuant to section 122.32;

(B) The discharge is a storm water discharge associated with small construction activity pursuant to paragraph (b)(15) of this section;

(C) Either the Department or the EPA Regional Administrator determines that storm water controls are needed for the discharge based on wasteload allocations that are part of "total maximum daily loads" (TMDLs) that address the pollutant(s) of concern; or

(D) Either the Department or the EPA Regional Administrator determines that the discharge, or category of discharges within a geographic area, contributes to a violation of a water quality standard or is a significant contributor of pollutants to waters of the United States.

(ii) Operators of small MS4s designated pursuant to paragraphs (a)(9)(i)(A), (a)(9)(i)(C), or (a)(9)(i)(D) of this section shall seek coverage under an NPDES permit in accordance with sections 122.33 through 122.35. Operators of non-municipal sources designated pursuant to paragraphs (a)(9)(i)(B), (a)(9)(i)(C), or (a)(9)(i)(D) of this section shall seek coverage under an NPDES permit in accordance with paragraph (c)(1) of this section.

(iii) Operators of storm water discharges designated pursuant to paragraph (a)(9)(i)(C) or (a)(9)(i)(D) of this section shall apply to the Department for a permit within 180 days of receipt of notice, unless permission for a later date is granted by the Department (see section 124.52[c] of this chapter).

(b) Definitions.

(1) "Co-permittee" means a permittee to an NPDES permit that is only responsible for permit conditions relating to the discharge for which it is operator.

Note: "General permit application" is defined at 122.28(b)(4).

(2) "Illicit discharge" means any discharge to a municipal separate storm sewer that is not composed entirely of storm water except discharges pursuant to an NPDES permit (other than the NPDES permit for discharges from the municipal separate storm sewer) and discharges resulting from fire fighting activities.

(3) "Incorporated place" means a city, town, township, or village that is incorporated under the laws of the State of South Carolina.

(4) "Large municipal separate storm sewer system" means all municipal separate storm sewers that are either:

(i) Located in an incorporated place with a population of 250,000 or more as determined by the 1990 Decennial Census by the Bureau of the Census (Appendix F of this part); or

(ii) Located in the counties listed in appendix H, except municipal separate storm sewers that are located in the incorporated places, townships or towns within such counties; or

(iii) Owned or operated by a municipality other than those described in paragraph (b)(4)(i) or (ii) of this section and that are designated by the Department as part of the large or medium municipal separate storm sewer system due to the interrelationship between the discharges of the designated storm sewer and the discharges from municipal separate storm sewers described under paragraph (b)(4)(i) or (ii) of this section. In making this determination the Department may consider the following factors:

(A) Physical interconnections between the municipal separate storm sewers;

(B) The location of discharges from the designated municipal separate storm sewer relative to discharges from municipal separate storm sewers described in paragraph (b)(4)(i) of this section;

(C) The quantity and nature of pollutants discharged to waters of the State;

(D) The nature of the receiving waters; and

(E) Other relevant factors; or

(iv) The Department may, upon petition, designate as a large municipal separate storm sewer system, municipal separate storm sewers located within the boundaries of a region defined by a storm water management regional authority based on a jurisdictional, watershed, or other appropriate basis that includes one or more of the systems described in paragraph (b)(4)(i), (ii), and (iii) of this section.

(5) "Major municipal separate storm sewer outfall" (or "major outfall") means a municipal separate storm sewer outfall that discharges from a single pipe with an inside diameter of 36 inches or more or its equivalent (discharge from a single conveyance other than circular pipe which is associated with a drainage area of more than 50 acres); or for municipal separate storm sewers that receive storm water from lands zoned for industrial activity (based on comprehensive zoning plans or the equivalent), an outfall that discharges from a single pipe with an inside diameter of 12 inches or more or from its equivalent (discharge from other than a circular pipe associated with a drainage area of 2 acres or more).

(6) "Major outfall" means a major municipal separate storm sewer outfall.

(7) "Medium municipal" separate storm sewer system means all municipal separate storm sewers that are either:

(i) Located in an incorporated place with a population of 100,000 or more but less than 250,000, as determined by the 1990 Decennial Census by the Bureau of the Census (Appendix G); or

(ii) Located in the counties listed in appendix I, except municipal separate storm sewers that are located in the incorporated places, townships or towns within such counties; or

(iii) Owned or operated by a municipality other than those described in paragraph (b) (7)(i) or (ii) of this section and that are designated by the Department as part of the large or medium municipal separate storm sewer system due to the interrelationship between the discharges of the designated storm sewer and the discharges from municipal separate storm sewers described under paragraph (b)(7)(i) or (ii) of this section. In making this determination the Department may consider the following factors:

(A) Physical interconnections between the municipal separate storm sewers;

(B) The location of discharges from the designated municipal separate storm sewer relative to discharges from municipal separate storm sewers described in paragraph (b)(7)(i) of this section;

(C) The quantity and nature of pollutants discharged to waters of the State;

(D) The nature of the receiving waters; or

(E) Other relevant factors; or

(iv) The Department may, upon petition, designate as a medium municipal separate storm sewer system, municipal separate storm sewers located within the boundaries of a region defined by a storm water management regional authority based on a jurisdictional, watershed, or other appropriate basis that includes one or more of the systems described in paragraphs (b)(7)(i), (ii), and (iii) of this section.

(8) "Municipal separate storm sewer" means a conveyance or system of conveyances (including roads with drainage systems, municipal streets, catch basins, curbs, gutters, ditches, man-made channels, or storm drains):

(i) Owned or operated by a State, city, town, borough, county, parish, district, association, or other public body (created by or pursuant to State law) having jurisdiction over disposal of sewage, industrial wastes, storm water, or other wastes, including special districts under State law such as a sewer district, flood control district or drainage district, or similar entity, or an Indian tribe or an authorized Indian tribal organization, or a designated and approved management agency under section 208 of the CWA that discharges to waters of the State;

(ii) Designed or used for collecting or conveying storm water;

(iii) Which is not a combined sewer; and

(iv) Which is not part of a Publicly Owned Treatment Works (POTW) as defined at section 122.2.

Note: "Notice of Intent" is defined at 122.28(b)(4).

(9) "Outfall" means a point source as defined by section 122.2 at the point where a municipal separate storm sewer discharges to waters of the State and does not include open conveyances connecting two municipal separate storm sewers, or pipes, tunnels or other conveyances which connect segments of the same stream or other waters of the State and are used to convey waters of the State.

(10) "Overburden" means any material of any nature, consolidated or unconsolidated, that overlies a mineral deposit, excluding topsoil or similar naturally-occurring surface materials that are not disturbed by mining operations.

(11) "Runoff coefficient" means the fraction of total rainfall that will appear at a conveyance as runoff.

(12) "Significant materials" includes, but is not limited to: raw materials; fuels; materials such as solvents, detergents, and plastic pellets; finished materials such as metallic products; raw materials used in food processing or production; hazardous substances designated under section 101(14) of CERCLA; any chemical the facility is required to report pursuant to section 313 of Title III of SARA; fertilizers; pesticides; and waste products such as ashes, slag and sludge that have the potential to be released with storm water discharges.

(13) "Storm water" means storm water runoff, snow melt runoff and surface runoff and drainage.

(14) "Storm water discharge associated with industrial activity" means the discharge from any conveyance that is used for collecting and conveying storm water and that is directly related to manufacturing, processing or raw materials storage areas at an industrial plant. The term does not include discharges from facilities or activities excluded from the NPDES program under this regulation. For the categories of industries identified in this section, the term includes, but is not limited to, storm water discharges from industrial plant yards; immediate access roads and rail lines used or traveled by carriers of raw materials, manufactured products, waste material, or by-products used or created by the facility; material handling sites; refuse sites; sites used for the application or disposal of process waste waters (as defined at 40 CFR Part 401); sites used for the storage and maintenance of material handling equipment; sites used for residual treatment, storage, or disposal; shipping and receiving areas; manufacturing buildings; storage areas (including tank farms) for raw materials and intermediate and final products; and areas where industrial activity has taken place in the past and significant materials remain and are exposed to storm water. For the purposes of this paragraph, material handling activities include storage, loading and unloading, transportation, or conveyance of any raw material, intermediate product, final product, by-product or waste product. The term excludes areas located on plant lands separate from the plant's industrial activities, such as office buildings and accompanying parking lots as long as the drainage from the excluded areas is not mixed with storm water drained from the above described areas. Industrial facilities (including industrial facilities that are federally, State, or municipally owned or operated that meet the description of the facilities listed in paragraphs (b)(14)(i) through (xi) of this section) include those facilities designated under the provisions of paragraph (a)(1)(v) of this section. The following categories of facilities are considered to be engaging in "industrial activity" for purposes of paragraph (b)(14):

(i) Facilities subject to storm water effluent limitations guidelines, new source performance standards, or toxic pollutant effluent standards under 40 CFR subchapter N (except facilities with toxic pollutant effluent standards which are exempted under category (xi) in paragraph (b)(14) of this section);

(ii) Facilities classified as Standard Industrial Classifications 24 (except 2434), 26 (except 265 and 267), 28 (except 283), 29, 311, 32 (except 323), 33, 3441, 373;

(iii) Facilities classified as Standard Industrial Classifications 10 through 14 (mineral industry) including active or inactive mining operations (except for areas of coal mining operations no longer meeting the definition of a reclamation area under 40 CFR 434.11(1) because the performance bond issued to the facility by the appropriate SMCRA authority has been released, or except for areas of non-coal mining operations which have been released from applicable State or Federal reclamation requirements after December 17, 1990) and oil and gas exploration, production, processing, or treatment operations, or transmission facilities that discharge storm water contaminated by contact with or that has come into contact with, any overburden, raw material, intermediate products, finished products, byproducts or waste products located on the site of such operations; (inactive mining operations are mining sites that are not being actively mined but which have an identifiable owner/operator; inactive mining sites do not include sites where mining claims are being maintained prior to disturbances associated with the extraction, beneficiation, or processing of mined materials, nor sites where minimal activities are undertaken for the sole purpose of maintaining a mining claim);

(iv) Hazardous waste treatment, storage, or disposal facilities, including those that are operating under interim status or a permit under subtitle C of RCRA;

(v) Landfills, land application sites, and open dumps that receive or have received any industrial wastes (waste that is received from any of the facilities described under this subsection) including those that are subject to regulation under subtitle D of RCRA;

(vi) Facilities involved in the recycling of materials, including metal scrapyards, battery reclaimers, salvage yards and automobile junkyards, including but limited to those classified as Standard Industrial Classification 5015 and 5093;

(vii) Steam electric power generating facilities, including coal handling sites;

(viii) Transportation facilities classified as Standard Industrial Classifications 40, 41, 42 (except 4221-25), 43, 44, 45, and 5171 which have vehicle maintenance shops, equipment cleaning operations, or airport deicing operations. Only those portions of the facility that are either involved in vehicle maintenance (including vehicle rehabilitation, mechanical repairs, painting, fueling, and lubrication), equipment cleaning operations, airport deicing operations, or which are otherwise identified under paragraphs (b)(14)(i)-(vii) or (ix)-(xi) of this section are associated with industrial activity;

(ix) Treatment works treating domestic sewage or any other sewage sludge or wastewater treatment device or system, used in the storage treatment, recycling, and reclamation of municipal or domestic sewage, including land dedicated to the disposal of sewage sludge that are located within the confines of the facility, with a design flow of 1.0 mgd or more, or required to have an approved pretreatment program under R.61-9.403. Not included are farm lands, domestic gardens or lands used for sludge management where sludge is beneficially reused and which are not physically located in the confines of the facility, or areas that are in compliance with section 405 of the CWA;

(x) Construction activity including clearing, grading, and excavation, except operations that result in the disturbance of less than five acres of total land area. Construction activity also includes the disturbance of less than five acres of total land area that is a part of a larger common plan of development or sale if the larger common plan will ultimately disturb five acres or more;

(xi) Facilities under Standard Industrial Classifications 20, 21, 22, 23, 2434, 25, 265, 267, 27, 283, 285, 30, 31 (except 311), 323, 34 (except 3441), 35, 36, 37 (except 373), 38, 39, and 4221-25;

(15) Storm water discharge associated with small construction activity means the discharge of storm water from:

(i) Construction activities including clearing, grading, and excavating that result in land disturbance of equal to or greater than one acre and less than five acres and, in coastal counties within one-half (1/2) mile of a receiving water body (but not for single-family homes which are not part of a subdivision development), that result in any land disturbance less than five acres. Small construction activity also includes the disturbance of less than one acre of total land area that is part of a larger common plan of development or sale if the larger common plan will ultimately disturb equal to or greater than one and less than five acres. Small construction activity does not include routine maintenance that is performed to maintain the original line and grade, hydraulic capacity, or original purpose of the facility. The Department may waive the otherwise applicable requirements in a general permit for a storm water discharge from construction activities that disturb less than five acres where:

(A) The value of the rainfall erosivity factor ("R" in the Revised Universal Soil Loss Equation) is less than five during the period of construction activity. The rainfall erosivity factor is determined in accordance with Chapter 2 of Agriculture Handbook Number 703, Predicting Soil Erosion by Water: A Guide to Conservation Planning With the Revised Universal Soil Loss Equation (RUSLE), pages 21-64, dated January 1997. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from EPA's Water Resource Center, Mail Code RC4100, 401 M St. S.W., Washington, DC 20460. A copy is also available for inspection at the U.S. EPA Water Docket , 401 M Street S.W., Washington, DC. 20460, or the Office of the Federal Register, 800 N. Capitol Street N.W. Suite 700, Washington, DC. An operator must certify to the Department that the construction activity will take place during a period when the value of the rainfall erosivity factor is less than five; or

(B) Storm water controls are not needed based on a "total maximum daily load" (TMDL) approved or established by EPA that addresses the pollutant(s) of concern or, for non-impaired waters that do not require TMDLs, an equivalent analysis that determines allocations for small construction sites for the pollutant(s) of concern or that determines that such allocations are not needed to protect water quality based on consideration of existing in-stream concentrations, expected growth in pollutant contributions from all sources, and a margin of safety. For the purpose of this paragraph, the pollutant(s) of concern include sediment or a parameter that addresses sediment (such as total suspended solids, turbidity or siltation) and any other pollutant that has been identified as a cause of impairment of any water body that will receive a discharge from the construction activity. The operator must certify to the Department that the construction activity will take place, and storm water discharges will occur, within the drainage area addressed by the TMDL or equivalent analysis.

(ii) Any other construction activity designated by the Department, or in States with approved NPDES programs either the Department or the EPA Regional Administrator, based on the potential for contribution to a violation of a water quality standard or for significant contribution of pollutants to waters of the United States.

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Exhibit 1 to Section 122.26(b)(15) - Summary of Coverage of Storm Water

Discharges Associated with Small Construction Activity Under the NPDES Storm

Water Program

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Automatic Designation: Construction activities that result in a land

Required Nationwide disturbance of equal to or greater than one acre

Coverage and less than five acres.

Construction activities disturbing less than one

acre if part of a larger common plan of

development or sale with a planned disturbance

of equal to or greater than one acre and less

than five acres. (See Section 122.26(b)(15)(i).)

Potential Designation: Construction activities that result in a land

Optional Evaluation and disturbance of less than one acre based on the

Designation by the NPDES potential for contribution to a violation of a

Permitting Authority or water quality standard or for significant

EPA Regional contribution of pollutants. (See Section

Administrator. 122.26(b)(15)(ii).)

Potential Waiver: Waiver Any automatically designated construction activity

from Requirements as where the operator certifies: (1) A rainfall

Determined by the NPDES erosivity factor of less than five or (2) that

Permitting Authority. the activity will occur within an area where

controls are not needed based on a TMDL or, for

non-impaired waters that do not require a TMDL,

an equivalent analysis for the pollutants of

concern. (See Section 122.26(b)(15)(i).)

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(16) Small municipal separate storm sewer system means all separate storm sewers that are:

(i) Owned or operated by the United States, a State, city, town, borough, county, parish, district, association, or other public body (created by or pursuant to State law) having jurisdiction over disposal of sewage, industrial wastes, storm water, or other wastes, including special districts under State law such as a sewer district, flood control district, or drainage district, or similar entity, or an Indian tribe or an authorized Indian tribal organization, or a designated and approved management agency under section 208 of the CWA that discharges to waters of the United States and

(ii) Not defined as "large" or "medium" municipal separate storm sewer systems pursuant to paragraphs (b)(4) and (b)(7) of this section, or designated under paragraph (a)(1)(v) of this section.

(iii) This term includes systems similar to separate storm sewer systems in municipalities, such as systems at military bases, large hospital or prison complexes, and highways and other thoroughfares. The term does not include separate storm sewers in very discrete areas, such as individual buildings.

(17) Small MS4 means a small municipal separate storm sewer system.

(18) Municipal separate storm sewer system means all separate storm sewers that are defined as "large" or "medium" or "small" municipal separate storm sewer systems pursuant to paragraphs (b)(4), (b)(7), and (b)(16) of this section, or designated under paragraph (a)(1)(v) of this section.

(19) MS4 means a municipal separate storm sewer system.

(20) Uncontrolled sanitary landfill means a landfill or open dump whether in operation or closed, that does not meet the requirements for runon or runoff controls established pursuant to subtitle D of the Solid Waste Disposal Act.

(21) "Storm water point source" means a conveyance or system of conveyances (including but not limited to pipes, conduits, ditches and channels) primarily used for collecting and conveying storm water runoff and that:

(i) Is located in an urbanized area as designated by the Bureau of the Census;

(ii) Discharges from lands of facilities used for industrial or commercial activities; or

(iii) Is referenced under section 122.26 (Storm Water Discharges).

(c) Application requirements for storm water discharges associated with industrial activity and storm water discharges associated with small construction activity;

(1) Individual application. Dischargers of storm water associated with industrial activity and with small construction activity are required to apply for an individual permit or seek coverage under a promulgated storm water general permit. Facilities that are required to obtain an individual permit, or any discharge of storm water which the Department is evaluating for designation (see R.61-9.124.52(c)) under paragraph (a)(1)(v) of this section and is not a municipal storm sewer, shall submit an NPDES application in accordance with the requirements of section 122.21 as modified and supplemented by the provisions of the remainder of this paragraph. Applicants for discharges composed entirely of storm water shall submit Form 1 and Form 2F. Applicants for discharges composed of storm water and non-storm water shall submit Form 1, Form 2C and Form 2F. Applicants for new sources or new discharges (as defined in section 122.2 of this regulation) composed of storm water and non-storm water shall submit Form 1, Form 2D, and Form 2F.

(i) Except as provided in section 122.26(c)(1)(ii)-(iv), the operator of a storm water discharge associated with industrial activity subject to this section shall provide:

(A) A site map showing topography (or indicating the outline of drainage areas served by the outfall(s) covered in the application if a topographic map is unavailable) of the facility including: each of its drainage and discharge structures; the drainage area of each storm water outfall; paved areas and buildings within the drainage area of each storm water outfall, each past or present area used for outdoor storage or disposal of significant materials; each existing structural control measure to reduce pollutants in storm water runoff, materials loading and access areas, areas where pesticides, herbicides, soil conditioners and fertilizers are applied, each of its hazardous waste treatment, storage or disposal facilities (including each area not required to have a RCRA permit which is used for accumulating hazardous waste under R.61-79.262.34); each well where fluids from the facility are injected underground; springs, and other surface water bodies which receive storm water discharges from the facility;

(B) An estimate of the area of impervious surfaces (including paved areas and building roofs) and the total area drained by each outfall (within a mile radius of the facility) and a narrative description of the following: Significant materials that in the three years prior to the submittal of this application have been treated, stored or disposed in a manner to allow exposure to storm water; method of treatment, storage or disposal of such materials; materials management practices employed, in the three years prior to the submittal of this application, to minimize contact by these materials with storm water runoff; materials loading and access areas; the location, manner and frequency in which pesticides, herbicides, soil conditioners and fertilizers are applied; the location and a description of existing structural and non-structural control measures to reduce pollutants in storm water runoff; and a description of the treatment the storm water receives, including the ultimate disposal of any solid or fluid wastes other than by discharge;

(C) A certification that all outfalls that should contain storm water discharges associated with industrial activity have been tested or evaluated for the presence of non-storm water discharges which are not covered by a NPDES permit; tests for such non-storm water discharges may include smoke tests, fluorometric dye tests, analysis of accurate schematics, as well as other appropriate tests. The certification shall include a description of the method used, the date of any testing, and the onsite drainage points that were directly observed during a test;

(D) Existing information regarding significant leaks or spills of toxic or hazardous pollutants at the facility that have taken place within the three years prior to the submittal of this application;

(E) Quantitative data based on samples collected during storm events and collected in accordance with section 122.21 of this regulation from all outfalls containing a storm water discharge associated with industrial activity for the following parameters:

(1) Any pollutant limited in an effluent guideline to which the facility is subject;

(2) Any pollutant listed in the facility's NPDES permit for its process wastewater (if the facility is operating under an existing NPDES permit);

(3) Oil and grease, pH, BOD5, COD, TSS, total phosphorus, total Kjeldahl nitrogen, and nitrate plus nitrite nitrogen;

(4) Any information on the discharge required under section 122.21(g)(7) (vi) and (vii) of this regulation;

(5) Flow measurements or estimates of the flow rate, and the total amount of discharge for the storm event(s) sampled, and the method of flow measurement or estimation; and

(6) The date and duration (in hours) of the storm event(s) sampled, rainfall measurements or estimates of the storm event (in inches) which generated the sampled runoff and the duration between the storm event sampled and the end of the previous measurable (greater than 0.1 inch rainfall) storm event (in hours);

(F) Operators of a discharge which is composed entirely of storm water are exempt from the requirements of section 122.21(g)(2), (g)(3), (g)(4), (g)(5), (g)(7)(iii), (g)(7)(iv), (g)(7)(v), (g)(7)(viii); and

(G) Operators of new sources or new discharges (as defined in section 122.2 of this regulation) which are composed in part or entirely of storm water must include estimates for the pollutants or parameters listed in paragraph (c)(1)(i)(E) of this section instead of actual sampling data, along with the source of each estimate. Operators of new sources or new discharges composed in part or entirely of storm water must provide quantitative data for the parameters listed in paragraph (c)(1)(i)(E) of this section within two years after commencement of discharge, unless such data has already been reported under the monitoring requirements of the NPDES permit for the discharge. Operators of a new source or new discharge which is composed entirely of storm water are exempt from the requirements of section 122.21(k)(3)(ii), (k)(3)(iii), and (k)(5).

(ii) An operator of an existing or new storm water discharge that is associated with industrial activity solely under paragraph (b)(14)(x) of this section or is associated with small construction activity solely under paragraph (b)(15) of this section, is exempt from the requirements of section 122.21(g) and paragraph (c)(1)(i) of this section.

(A) The location (including a map) and the nature of the construction activity;

(B) The total area of the site and the area of the site that is expected to undergo excavation during the life of the permit;

(C) Proposed measures, including best management practices, to control pollutants in storm water discharges during construction, including a brief description of applicable State and local erosion and sediment control requirements;

(D) Proposed measures to control pollutants in storm water discharges that will occur after construction operations have been completed, including a brief description of applicable State or local erosion and sediment control requirements;

(E) An estimate of the runoff coefficient of the site and the increase in impervious area after the construction addressed in the permit application is completed, the nature of fill material and existing data describing the soil or the quality of the discharge; and

(F) The name of the receiving water.

(iii) The operator of an existing or new discharge composed entirely of storm water from an oil or gas exploration, production, processing, or treatment operation, or transmission facility is not required to submit a permit application in accordance with paragraph (c)(1)(i) of this section, unless the facility:

(A) Has had a discharge of storm water resulting in the discharge of a reportable quantity for which notification is or was required pursuant to 40 CFR 117.21 or 40 CFR 302.6 at anytime since November 16, 1987; or

(B) Has had a discharge of storm water resulting in the discharge of a reportable quantity for which notification is or was required pursuant to 40 CFR 110.6 at any time since November 16, 1987; or

(C) Contributes to a violation of a water quality standard.

(iv) The operator of an existing or new discharge composed entirely of storm water from a mining operation is not required to submit a permit application unless the discharge has come into contact with any overburden, raw material, intermediate products, finished product, byproduct or waste products located on the site of such operations.

(v) Applicants shall provide such other information the Department may reasonably require under section 122.21(g)(13) of this regulation to determine whether to issue a permit and may require any facility subject to paragraph (c)(1)(ii) of this section to comply with paragraph (c)(1)(i) of this section.

(2) [Reserved]

(d) Application requirements for large and medium municipal separate storm sewer discharges. The operator of a discharge from a large or medium municipal separate storm sewer or a municipal separate storm sewer that is designated by the Department under paragraph (a)(1)(v) of this section, may submit a jurisdiction-wide or system-wide permit application. Where more than one public entity owns or operates a municipal separate storm sewer within a geographic area (including adjacent or interconnected municipal separate storm sewer systems), such operators may be a co-applicant to the same application. Permit applications for discharges from large and medium municipal storm sewers or municipal storm sewers designated under paragraph (a)(1)(v) of this section shall include:

(1) Part 1. Part 1 of the application shall consist of:

(i) General information. The applicant's name, address, telephone number of contact person, ownership status, and status as a State or local government entity.

(ii) Legal authority. A description of existing legal authority to control discharges to the municipal separate storm sewer system. When existing legal authority is not sufficient to meet the criteria provided in paragraph (d)(2)(i) of this section, the description shall list additional authorities as will be necessary to meet the criteria and shall include a schedule and commitment to seek such additional authority that will be needed to meet the criteria.

(iii) Source identification.

(A) A description of the historic use of ordinances, guidance or other controls which limited the discharge of non-storm water discharges to any Publicly Owned Treatment Works serving the same area as the municipal separate storm sewer system.

(B) A USGS 7.5 minute topographic map (or equivalent topographic map with a scale between 1:10,000 and 1:24,000 if cost effective) extending one mile beyond the service boundaries of the municipal storm sewer system covered by the permit application. The following information shall be provided:

(1) The location of known municipal storm sewer system outfalls discharging to waters of the State:

(2) A description of the land use activities (e.g. divisions indicating undeveloped, residential, commercial agricultural and industrial uses) accompanied with estimates of population densities and projected growth for a ten year period within the drainage area served by the separate storm sewer. For each land use type, an estimate of an average runoff coefficient shall be provided;

(3) The location and a description of the activities of the facility of each currently operating or closed municipal landfill or other treatment, storage or disposal facility for municipal waste;

(4) The location and the permit number of any known discharge to the municipal storm sewer that has been issued an NPDES permit;

(5) The location of major structural controls for storm water discharge (retention basins, detention basins, major infiltration devices, etc.); and

(6) The identification of publicly owned parks, recreational areas, and other open lands.

(iv) Discharge characterization.

(A) Monthly mean rain and snow fall estimates (or summary of weather bureau data) and the monthly average number of storm events.

(B) Existing quantitative data describing the volume and quality of discharges from the municipal storm sewer, including a description of the outfalls sampled, sampling procedures and analytical methods used.

(C) A list of water bodies that receive discharges from the municipal separate storm sewer system, including downstream segments, lakes and estuaries, where pollutants from the system discharges may accumulate and cause water degradation and a brief description of known water quality impacts. At a minimum, the description of impacts shall include a description of whether the water bodies receiving such discharges have been:

(1) Assessed and reported in section 305(b) reports submitted by the State, the basis for the assessment (evaluated or monitored), a summary of designated use support and attainment of Clean Water Act (CWA) goals (fishable and swimmable waters) and causes of nonsupport of designated uses;

(2) Listed under section 304(l)(1)(A)(i), section 304(l)(1)(A)(ii) or section 304(l)(1)(B) of the CWA that is not expected to meet water quality standards or water quality goals;

(3) Listed in State Nonpoint Source Assessments required by section 319(a) of the CWA that, without additional action to control nonpoint sources of pollution, cannot reasonably be expected to attain or maintain water quality standards due to storm sewers, construction, highway maintenance and runoff from municipal landfills and municipal sludge adding significant pollution (or contributing to a violation of water quality standards);

(4) Identified and classified according to eutrophic condition of publicly owned lakes listed in State reports required under section 314(a) of the CWA (include the following: a description of those publicly owned lakes for which uses are known to be impaired; a description of procedures, processes and methods to control the discharge of pollutants from municipal separate storm sewers into such lakes; and a description of methods and procedures to restore the quality of such lakes);

(5) [Reserved]

(6) Designated estuaries under the National Estuary Program under section 320 of the CWA;

(7) Recognized by the applicant as highly valued or sensitive waters;

(8) Defined by the State or U.S. Fish and Wildlife Service's National Wetlands Inventory as wetlands; and

(9) Found to have pollutants in bottom sediments, fish tissue or biosurvey data.

(D) Field screening. Results of a field screening analysis for illicit connections and illegal dumping for either selected field screening points or major outfalls covered in the permit application. At a minimum, a screening analysis shall include a narrative description, for either each field screening point or major outfall, of visual observations made during dry weather periods. If any flow is observed, two grab samples shall be collected during a 24 hour period with a minimum period of four hours between samples. For all such samples, a narrative description of the color, odor, turbidity, the presence of an oil sheen or surface scum as well as any other relevant observations regarding the potential presence of non-storm water discharges or illegal dumping shall be provided. In addition, a narrative description of the results of a field analysis using suitable methods to estimate pH, total chlorine, total copper, total phenol, and detergents (or surfactants) shall be provided along with a description of the flow rate. Where the field analysis does not involve analytical methods approved under 40 CFR Part 136, the applicant shall provide a description of the method used including the name of the manufacturer of the test method along with the range and accuracy of the test. Field screening points shall be either major outfalls or other outfall points (or any other point of access such as manholes) randomly located throughout the storm sewer system by placing a grid over a drainage system map and identifying those cells of the grid which contain a segment of the storm sewer system or major outfall. The field screening points shall be established using the following guidelines and criteria:

(1) A grid system consisting of perpendicular north-south and east-west lines spaced 1/4 mile apart shall be overlaid on a map of the municipal storm sewer system, creating a series of cells;

(2) All cells that contain a segment of the storm sewer system shall be identified; one field screening point shall be selected in each cell; major outfalls may be used as field screening points;

(3) Field screening points should be located downstream of any sources of suspected illegal or illicit activity;

(4) Field screening points shall be located to the degree practicable at the farthest manhole or other accessible location downstream in the system, within each cell; however, safety of personnel and accessibility of the location should be considered in making this determination;

(5) Hydrological conditions; total drainage area of the site; population density of the site; traffic density; age of the structures or buildings in the area; history of the area; and land use types;

(6) For medium municipal separate storm sewer systems, no more than 250 cells need to have identified field screening points; in large municipal separate storm sewer systems, no more than 500 cells need to have identified field screening points; cells established by the grid that contain no storm sewer segments will be eliminated from consideration; if fewer than 250 cells in medium municipal sewers are created, and fewer than 500 in large systems are created by the overlay on the municipal sewer map, then all those cells which contain a segment of the sewer system shall be subject to field screening (unless access to the separate storm sewer system is impossible); and

(7) Large or medium municipal separate storm sewer systems which are unable to utilize the procedures described in paragraphs (d)(1)(iv)(D)(1) through (6) of this section, because a sufficiently detailed map of the separate storm sewer systems is unavailable, shall field screen no more than 500 or 250 major outfalls respectively (or all major outfalls in the system, if less); in such circumstances, the applicant shall establish a grid system consisting of north-south and east-west lines spaced 1/4 mile apart as an overlay to the boundaries of the municipal storm sewer system, thereby creating a series of cells; the applicant will then select major outfalls in as many cells as possible until at least 500 major outfalls (large municipalities) or 250 major outfalls (medium municipalities) are selected; a field screening analysis shall be undertaken at these major outfalls.

(E) Characterization plan. Information and a proposed program to meet the requirements of paragraph (d)(2)(iii) of this section. Such description shall include: the location of outfalls or field screening points appropriate for representative data collection under paragraph (d)(2)(iii)(A) of this section, a description of why the outfall or field screening point is representative, the seasons during which sampling is intended, a description of the sampling equipment. The proposed location of outfalls or field screening points for such sampling should reflect water quality concerns (see paragraph (d)(1)(iv)(C) of this section) to the extent practicable.

(v) Management Programs.

(A) A description of the existing management programs to control pollutants from the municipal separate storm sewer system. The description shall provide information on existing structural and source controls, including operation and maintenance measures for structural controls, that are currently being implemented. Such controls may include, but are not limited to: procedures to control pollution resulting from construction activities; floodplain management controls; wetland protection measures; best management practices for new subdivisions; and emergency spill response programs. The description may address controls established under State law as well as local requirements.

(B) A description of the existing program to identify illicit connections to the municipal storm sewer system. The description should include inspection procedures and methods for detecting and preventing illicit discharges and describe areas where this program has been implemented.

(vi) Fiscal resources. A description of the financial resources currently available to the municipality to complete part 2 of the permit application. A description of the municipality's budget for existing storm water programs, including an overview of the municipality's financial resources and budget, including overall indebtedness and assets, and sources of funds for storm water programs.

(2) Part 2. Part 2 of the application shall consist of:

(i) Adequate legal authority. A demonstration that the applicant can operate pursuant to legal authority established by statute, ordinance or series of contracts which authorizes or enables the applicant at a minimum to:

(A) Control through ordinance, permit, contract, order or similar means, the contribution of pollutants to the municipal storm sewer by storm water discharges associated with industrial activity and the quality of storm water discharged from sites of industrial activity;

(B) Prohibit through ordinance, order or similar means, illicit discharges to the municipal separate storm sewer;

(C) Control through ordinance, order or similar means the discharge to a municipal separate storm sewer of spills, dumping, or disposal of materials other than storm water;

(D) Control through interagency agreements among co-applicants the contribution of pollutants from one portion of the municipal system to another portion of the municipal system;

(E) Require compliance with conditions in ordinances, permits, contracts or orders; and

(F) Carry out all inspection, surveillance and monitoring procedures necessary to determine compliance and noncompliance with permit conditions including the prohibition on illicit discharges to the municipal separate storm sewer.

(ii) Source identification. The location of any major outfall that discharges to waters of the State that was not reported under paragraph (d)(1)(iii)(B)(1) of this section. Provide an inventory, organized by watershed of the name and address, and a description (such as SIC codes) which best reflects the principal products or services provided by each facility which may discharge to the municipal separate storm sewer, storm water associated with industrial activity;

(iii) Characterization data. When "quantitative data" for a pollutant are required under paragraph (d)(2)(iii)(A)(3) of this paragraph, the applicant must collect a sample of effluent in accordance with section 122.21(g)(7) and analyze it for the pollutant in accordance with analytical methods approved under 40 CFR Part 136. When no analytical method is approved, the applicant may use any suitable method but must provide a description of the method. The applicant must provide information characterizing the quality and quantity of discharges covered in the permit application, including:

(A) Quantitative data from representative outfalls designated by the Department (based on information received in part 1 of the application, the Department shall designate between five and ten outfalls or field screening points as representative of the commercial, residential and industrial land use activities of the drainage area contributing to the system, or where there are less than five outfalls covered in the application, the Department shall designate all outfalls) developed as follows:

(1) For each outfall or field screening point designated under this subparagraph, samples shall be collected of storm water discharges from three storm events occurring at least one month apart in accordance with the requirements at section 122.21(g)(7) (the Department may allow exemptions to sampling three storm events when climatic conditions create good cause for such exemptions);

(2) A narrative description shall be provided of the date and duration of the storm event(s) sampled, rainfall estimates of the storm event which generated the sampled discharge and the duration between the storm event sampled and the end of the previous measurable (greater than 0.1 inch rainfall) storm event;

(3) For samples collected and described under paragraphs (d)(2)(iii)(A)(1) and (A)(2) of this section, quantitative data shall be provided for: the organic pollutants listed in Table II; the pollutants listed in Table III (toxic metals, cyanide, and total phenols) of appendix D, and for the following pollutants;

(a) Total suspended solids (TSS)

(b) Total dissolved solids (TDS)

(c) COD

(d) BOD5

(e) Oil and grease

(f) Fecal coliform

(g) Fecal streptococcus

(h) pH

(i) Total Kjeldahl nitrogen

(j) Nitrate plus nitrite

(k) Dissolved phosphorus

(l) Total ammonia plus organic nitrogen

(m) Total phosphorus

(4) Additional limited quantitative data required by the Department for determining permit conditions (the Department may require that quantitative data shall be provided for additional parameters, and may establish sampling conditions such as the location, season of sample collection, form of precipitation (snow melt, rainfall) and other parameters necessary to insure representativeness);

(B) Estimates of the annual pollutant load of the cumulative discharges to waters of the State from all identified municipal outfalls and the event mean concentration of the cumulative discharges to waters of the State from all identified municipal outfalls during a storm event (as described under section 122.21(g)(7)) for BOD5, COD, TSS, dissolved solids, total nitrogen, total ammonia plus organic nitrogen, total phosphorus, dissolved phosphorus, cadmium, copper, lead, and zinc. Estimates shall be accompanied by a description of the procedures for estimating constituent loads and concentrations, including any modelling, data analysis, and calculation methods;

(C) A proposed schedule to provide estimates for each major outfall identified in either paragraph (d)(2)(ii) or (d)(1)(iii)(B)(1) of this section of the seasonal pollutant load and of the event mean concentration of a representative storm for any constituent detected in any sample required under paragraph (d)(2)(iii)(A) of this section; and

(D) A proposed monitoring program for representative data collection for the term of the permit that describes the location of outfalls or field screening points to be sampled (or the location of instream stations), why the location is representative, the frequency of sampling, parameters to be sampled, and a description of sampling equipment.

(iv) Proposed management program. A proposed management program covers the duration of the permit. It shall include a comprehensive planning process which involves public participation and where necessary intergovernmental coordination, to reduce the discharge of pollutants to the maximum extent practicable using management practices, control techniques and system, design and engineering methods, and such other provisions which are appropriate. The program shall also include a description of staff and equipment available to implement the program. Separate proposed programs may be submitted by each co-applicant. Proposed programs may impose controls on a system-wide basis, a watershed basis, a jurisdiction basis, or on individual outfalls. Proposed programs will be considered by the Department when developing permit conditions to reduce pollutants in discharges to the maximum extent practicable. Proposed management programs shall describe priorities for implementing controls. Such programs shall be based on:

(A) A description of structural and source control measures to reduce pollutants from runoff from commercial and residential areas that are discharged from the municipal storm sewer system that are to be implemented during the life of the permit, accompanied with an estimate of the expected reduction of pollutant loads and a proposed schedule for implementing such controls. At a minimum, the description shall include:

(1) A description of maintenance activities and a maintenance schedule for structural controls to reduce pollutants (including floatables) in discharges from municipal separate storm sewers;

(2) A description of planning procedures including a comprehensive master plan to develop, implement and enforce controls to reduce the discharge of pollutants from municipal separate storm sewers which receive discharges from areas of new development and significant redevelopment. Such plan shall address controls to reduce pollutants in discharges from municipal separate storm sewers after construction is completed. (Controls to reduce pollutants in discharges from municipal separate storm sewers containing construction site runoff are addressed in paragraph (d)(2)(iv)(D) of this section;

(3) A description of practices for operating and maintaining public streets, roads and highways and procedures for reducing the impact on receiving waters of discharges from municipal storm sewer systems, including pollutants discharged as a result of deicing activities;

(4) A description of procedures to assure that flood management projects assess the impacts on the water quality of receiving water bodies and that existing structural flood control devices have been evaluated to determine if retrofitting the device to provide additional pollutant removal from storm water is feasible;

(5) A description of a program to monitor pollutants in runoff from operating or closed municipal landfills or other treatment, storage or disposal facilities for municipal waste, which shall identify priorities and procedures for inspections and establishing and implementing control measures for such discharges (this program can be coordinated with the program developed under paragraph (d)(2)(iv)(C) of this section); and

(6) A description of a program to reduce to the maximum extent practicable, pollutants in discharges from municipal separate storm sewers associated with the application of pesticides, herbicides and fertilizer which will include, as appropriate, controls such as educational activities, permits, certifications and other measures for commercial applicators and distributors, and controls for application in public right-of-ways and at municipal facilities;

(B) A description of a program, including a schedule, to detect and remove (or require the discharger to the municipal separate storm sewer to obtain a separate NPDES permit for) illicit discharges and improper disposal into the storm sewer. The proposed program shall include:

(1) A description of a program, including inspections, to implement and enforce an ordinance, orders or similar means to prevent illicit discharges to the municipal separate storm sewer system; this program description shall address all types of illicit discharges; however, the following category of non-storm water discharges or flows shall be addressed where such discharges are identified by the municipality as sources of pollutants to waters of the State:; water line flushing, landscape irrigation, diverted stream flows, rising ground waters, uncontaminated ground water infiltration (as defined at 40 CFR 35.2005(20)) to separate storm sewers, uncontaminated pumped ground water, discharges from potable water sources, foundation drains, air conditioning condensation, irrigation water, springs, water from crawl space pumps, footing drains, lawn watering, individual residential car washing, flows from riparian habitats and wetlands, dechlorinated swimming pool discharges, and street wash water (program descriptions shall address discharges or flows from fire fighting only where such discharges or flows are identified as significant sources of pollutants to waters of the State);

(2) A description of procedures to conduct on-going field screening activities during the life of the permit, including areas or locations that will be evaluated by such field screens;

(3) A description of procedures to be followed to investigate portions of the separate storm sewer system that, based on the results of the field screen, or other appropriate information, indicate a reasonable potential of containing illicit discharges or other sources of non-storm water (such procedures may include: sampling procedures for constituents such as fecal coliform, fecal streptococcus, surfactants (MBAS), residual chlorine, fluorides, and potassium; testing with fluorometric dyes; or conducting in storm sewer inspections where safety and other considerations allow. Such description shall include the location of storm sewers that have been identified for such evaluation);

(4) A description of procedures to prevent, contain, and respond to spills that may discharge into the municipal separate storm sewer;

(5) A description of a program to promote, publicize, and facilitate public reporting of the presence of illicit discharges or water quality impacts associated with discharges from municipal separate storm sewers;

(6) A description of educational activities, public information activities, and other appropriate activities to facilitate the proper management and disposal of used oil and toxic materials; and

(7) A description of controls to limit infiltration of seepage from municipal sanitary sewers to municipal separate storm sewer systems where necessary;

(C) A description of a program to monitor and control pollutants in storm water discharges to municipal systems from municipal landfills, hazardous waste treatment, disposal and recovery facilities, industrial facilities that are subject to section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA), and industrial facilities that the municipal permit applicant determines are contributing a substantial pollutant loading to the municipal storm sewer system. The program shall:

(1) Identify priorities and procedures for inspections and establishing and implementing control measures for such discharges;

(2) Describe a monitoring program for storm water discharges associated with the industrial facilities identified in paragraph (d)(2)(iv)(C) of this section, to be implemented during the term of the permit, including the submission of quantitative data on the following constituents: any pollutants limited in effluent guidelines subcategories, where applicable; any pollutant listed in an existing NPDES permit for a facility; oil and grease, COD, pH, BOD5, TSS, total phosphorus, total Kjeldahl nitrogen, nitrate plus nitrite nitrogen, and any information on discharges required under section 122.21(g)(7)(vi) and (vii).

(D) A description of a program to implement and maintain structural and non-structural best management practices to reduce pollutants in storm water runoff from construction sites to the municipal storm sewer system, which shall include;

(1) A description of procedures for site planning which incorporate consideration of potential water quality impacts;

(2) A description of requirements for nonstructural and structural best management practices;

(3) A description of procedures for identifying priorities for inspecting sites and enforcing control measures which consider the nature of the construction activity, topography, and the characteristics of soils and receiving water quality; and

(4) A description of appropriate educational and training measures for construction site operators.

(v) Assessment of controls. Estimated reductions in loadings of pollutants from discharges of municipal storm sewer constituents from municipal storm sewer systems expected as the result of the municipal storm water quality management program. The assessment shall also identify known impacts of storm water controls on ground water.

(vi) Fiscal analysis. For each fiscal year to be covered by the permit, a fiscal analysis of the necessary capital and operation and maintenance expenditures necessary to accomplish the activities of the programs under paragraphs (d)(2)(iii) and (iv) of this section. Such analysis shall include a description of the source of funds that are proposed to meet the necessary expenditures, including legal restrictions on the use of such funds.

(vii) Where more than one legal entity submits an application, the application shall contain a description of the roles and responsibilities of each legal entity and procedures to ensure effective coordination.

(viii) Where requirements under paragraph (d)(1)(iv)(E), (d)(2)(ii), (d)(2)(iii)(B) and (d)(2)(iv) of this section are not practicable or are not applicable, the Department may exclude any operator of a discharge from a municipal separate storm sewer which is designated under paragraph (a)(1)(v), (b)(4)(ii) or (b)(7)(ii) of this section from such requirements. The Department shall not exclude the operator of a discharge from a municipal separate storm sewer identified in Appendix F, G, H, or I from any of the permit application requirements under this paragraph, except where authorized under this section.

(e) Application deadlines. Any operator of a point source required to obtain a permit under paragraph (a)(1) of this section that does not have an effective NPDES permit covering its storm water outfalls shall submit an application in accordance with the following deadlines;

(1) Storm water discharges associated with industrial activity.

(i) Except as provided in paragraph (e)(1)(ii) of this section, for any storm water discharge associated with industrial activity identified in paragraphs (b)(14)(i) through (xi) of this section, that is not part of a group application as described in paragraph (c)(2) of this section or which is not authorized by a storm water general permit, a permit application made pursuant to paragraph (C) of this section shall be submitted to the Department by October 1, 1992;

(ii) For any storm water discharge associated with industrial activity from a facility that is owned or operated by a municipality with a population of less than 100,000 that is not authorized by a general or individual permit, other than an airport, power plant, or uncontrolled sanitary landfill, the permit application must be submitted to the Department by March 10, 2003.

(2) For any group application submitted in accordance with paragraph (c)(2) of this section:

(i) Part 1.

(A) Except as provided in paragraph (e)(2)(i)(B) of this section, part 1 of the application shall be submitted to the Department by September 30, 1991;

(B) Any municipality with a population of less than 250,000 shall not be required to submit a part 1 application before May 18, 1992.

(C) For any storm water discharge associated with industrial activity from a facility that is owned or operated by a municipality with a population of less than 100,000 other than an airport, powerplant, or uncontrolled sanitary landfill, permit applications requirements are reserved.

(ii) Based on information in the part 1 application, the Department will approve or deny the members in the group application within 60 days after receiving part 1 of the group application.

(iii) Part 2.

(A) Except as provided in paragraph (e)(2)(iii)(B) of this section, part 2 of the application shall be submitted to the Department by October 1, 1992;

(B) Any municipality with a population of less than 250,000 shall not be required to submit a part 2 application before May 17, 1993.

(C) For any storm water discharge associated with industrial activity from a facility that is owned or operated by a municipality with a population of less than 100,000 other than an airport, powerplant, or uncontrolled sanitary landfill, permit applications requirements are reserved.

(iv) Rejected facilities.

(A) Except as provided in paragraph (e)(2)(iv)(B) of this section, facilities that are rejected as members of the group shall submit an individual application (or obtain coverage under an applicable general permit) no later than 12 months after the date of receipt of the notice of rejection or October 1, 1992, whichever comes first.

(B) Facilities that are owned or operated by a municipality and that are rejected as members of part 1 group application shall submit an individual application no later than 180 days after the date of receipt of the notice of rejection or October 1, 1992, whichever is later.

(v) A facility listed under paragraph (b)(14)(i)-(xi) of this section may add on to a group application submitted in accordance with paragraph (e)(2)(i) of this section at the discretion of the Department, and only upon a showing of good cause by the facility and the group applicant; the request for the addition of the facility shall be made no later than February 19, 1992; the addition of the facility shall not cause the percentage of the facilities that are required to submit quantitative data to be less than 10%, unless there are over 100 facilities in the group that are submitting quantitative data; approval to become part of group application must be obtained from the group or the trade association representing the individual facilities.

(3) For any discharge from a large municipal separate storm sewer system;

(i) Part 1 of the application shall be submitted to the Department by November 18, 1991;

(ii) Based on information received in the part 1 application, the Department will approve or deny a sampling plan under paragraph (d)(1)(iv)(E) of this section within 90 days after receiving the part 1 application;

(iii) Part 2 of the application shall be submitted to the Department by November 16, 1992.

(4) For any discharge from a medium municipal separate storm sewer system;

(i) Part 1 of the application shall be submitted to the Department by May 18, 1992.

(ii) Based on information received in the part 1 application, the Department will approve or deny a sampling plan under paragraph (d)(i)(iv)(E) of this section within 90 days after receiving the part 1 application.

(iii) Part 2 of the application shall be submitted to the Department by May 17, 1993.

(5) A permit application shall be submitted to the Department within 180 days of notice, unless permission for a later date is granted by the Department [see R.61-9.124.52(c)], for:

(i) A storm water discharge that either the Department or the EPA Regional Administrator determines that the discharge contributes to a violation of a water quality standard or is a significant contributor of pollutants to waters of the United States [see paragraphs (a)(1)(v) and (b)(15)(ii) of this section];

(ii) A storm water discharge subject to paragraph (c)(1)(v) of this section.

(6) Facilities with existing NPDES permits for storm water discharges associated with industrial activity shall maintain existing permits. New applications shall be submitted in accordance with the requirements of sections 122.21 and 122.26(c) 180 days before the expiration of such permits. Facilities with expired permits or permits due to expire before May 18, 1992, shall submit applications in accordance with the deadline set forth under paragraph (e)(1) of this section.

(7) The Department shall issue or deny permits for discharges composed entirely of storm water under this section in accordance with the following schedule:

(i)(A) Except as provided in paragraph (e)(7)(i)(B) of this section, the Department shall issue or deny permits for storm water discharges associated with an industrial activity no later than October 1, 1993, or, for new sources or existing sources which fail to submit a complete permit application by October 1, 1992, one year after receipt of a complete permit application;

(B) For any municipality with a population of less than 250,000 which submits a timely Part I group application under paragraph (e)(2)(i)(B) of this section, the Department shall issue or deny permits for storm water discharges associated with an industrial activity no later than May 17, 1994, or, for any such municipality which fails to complete a Part II group permit application by May 17, 1993, one year after receipt of a complete permit application;

(ii) The Department shall issue or deny permits for large municipal separate storm sewer systems no later than November 16, 1993, or, for new sources or existing sources which fail to submit a complete permit application by November 16, 1992, one year after receipt of a complete permit application;

(iii) The Department shall issue or deny permits for medium municipal separate storm sewer systems no later than May 17, 1994, or, for new sources or existing sources which fail to submit a complete permit application by May 17, 1993, one year after receipt of a complete permit application.

(8) For any storm water discharge associated with small construction activity identified in paragraph (b)(15)(i) of this section, see section 122.21(c)(1). Discharges from these sources require permit authorization by March 10, 2003, unless designated for coverage before then.

(9) For any discharge from a regulated small MS4, the permit application made under section 122.33 must be submitted to the Department by:

(i) March 10, 2003 if designated under section 122.32(a)(1) unless your MS4 serves a jurisdiction with a population under 10,000 and the NPDES permitting authority has established a phasing schedule under section 40 CFR 123.35(d)(3) (see section 122.33(c)(1)); or

(ii) Within 180 days of notice, unless the NPDES permitting authority grants a later date, if designated under section 122.32(a)(2). (See section 122.33(c)(2)).

(f) Petitions.

(1) Any operator of a municipal separate storm sewer system may petition the Department to require a separate NPDES permit for any discharge into the municipal separate storm sewer system.

(2) Any person may petition the Department to require a NPDES permit for a discharge which is composed entirely of storm water which contributes to a violation of a water quality standard or is a significant contributor of pollutants to waters of the State.

(3) The owner or operator of a municipal separate storm sewer system may petition the Department to reduce the Census estimates of population served by such separate system to account for storm water discharged to combined sewers as defined by 40 CFR 35.2005(b)(11) that is treated in a publicly owned treatment works. In municipalities in which combined sewers are operated, the Census estimates of population may be reduced proportional to the fraction, based on estimated lengths, of the length of combined sewers over the sum of the length of combined sewers and municipal separate storm sewers where an applicant has submitted the NPDES permit number associated with each discharge point and a map indicating areas served by combined sewers and the location of any combined sewer overflow discharge point.

(4) Any person may petition the Department for the designation of a large, medium, or small municipal separate storm sewer system as defined by paragraph (b)(4)(iv), (b)(7)(iv), or (b)(16) of this section.

(5) The Department shall make a final determination on any petition received under this section within 90 days after receiving the petition with the exception of petitions to designate a small MS4 in which case the Department shall make a final determination on the petition within 180 days after its receipt.

(g) Conditional exclusion for "no exposure" of industrial activities and materials to storm water. Discharges composed entirely of storm water are not storm water discharges associated with industrial activity if there is "no exposure" of industrial materials and activities to rain, snow, snowmelt and/or runoff, and the discharger satisfies the conditions in paragraphs (g)(1) through (g)(4) of this section. "No exposure" means that all industrial materials and activities are protected by a storm resistant-shelter to prevent exposure to rain, snow, snowmelt, and/or runoff. Industrial materials or activities include, but are not limited to, material handling equipment or activities, industrial machinery, raw materials, intermediate products, by-products, final products, or waste products. Material handling activities include the storage, loading and unloading, transportation, or conveyance of any raw material, intermediate product, final product or waste product.

(1) Qualification. To qualify for this exclusion, the operator of the discharge must:

(i) Provide a storm resistant shelter to protect industrial materials and activities from exposure to rain, snow, snowmelt, and runoff;

(ii) Complete and sign (according to section 122.22) a certification that there are no discharges of storm water contaminated by exposure to industrial materials and activities from the entire facility, except as provided in paragraph (g)(2) of this section;

(iii) Submit the signed certification to the NPDES permitting authority once every five years;

(iv) Allow the Department to inspect the facility to determine compliance with the "no exposure" conditions;

(v) Allow the Department to make any "no exposure" inspection reports available to the public upon request; and

(vi) For facilities that discharge through an MS4, upon request, submit a copy of the certification of "no exposure" to the MS4 operator, as well as allow inspection and public reporting by the MS4 operator.

(2) Industrial materials and activities not requiring storm resistant shelter. To qualify for this exclusion, storm resistant shelter is not required for:

(i) Drums, barrels, tanks, and similar containers that are tightly sealed, provided those containers are not deteriorated and do not leak ("Sealed" means banded or otherwise secured and without operational taps or valves);

(ii) Adequately maintained vehicles used in material handling; and

(iii) Final products, other than products that would be mobilized in storm water discharge (e.g., rock salt).

(3) Limitations.

(i) Storm water discharges from construction activities identified in paragraphs (b)(14)(x) and (b)(15) are not eligible for this conditional exclusion.

(ii) This conditional exclusion from the requirement for an NPDES permit is available on a facility-wide basis only, not for individual outfalls. If a facility has some discharges of storm water that would otherwise be "no exposure" discharges, individual permit requirements should be adjusted accordingly.

(iii) If circumstances change and industrial materials or activities become exposed to rain, snow, snowmelt, and/or runoff, the conditions for this exclusion no longer apply. In such cases, the discharge becomes subject to enforcement for un-permitted discharge. Any conditionally exempt discharger who anticipates changes in circumstances should apply for and obtain permit authorization prior to the change of circumstances.

(iv) Notwithstanding the provisions of this paragraph, the Department retains the authority to require permit authorization (and deny this exclusion) upon making a determination that the discharge causes, has a reasonable potential to cause, or contributes to an instream excursion above an applicable water quality standard, including designated uses.

(4) Certification. The no exposure certification must require the submission of the following information, at a minimum, to aid the Department in determining if the facility qualifies for the no-exposure exclusion:

(i) The legal name, address and phone number of the discharger [see section 122.21(b)];

(ii) The facility name and address, the county name, and the latitude and longitude where the facility is located;

(iii) The certification must indicate that none of the following materials or activities are, or will be in the foreseeable future, exposed to precipitation:

(A) Using, storing, or cleaning industrial machinery or equipment, and areas where residuals from using, storing, or cleaning industrial machinery or equipment remain and are exposed to storm water;

(B) Materials or residuals on the ground or in storm water inlets from spills/leaks;

(C) Materials or products from past industrial activity;

(D) Material handling equipment (except adequately maintained vehicles);

(E) Materials or products during loading/unloading or transporting activities;

(F) Materials or products stored outdoors (except final products intended for outside use, e.g., new cars, where exposure to storm water does not result in the discharge of pollutants);

(G) Materials contained in open, deteriorated or leaking storage drums, barrels, tanks, or similar containers;

(H) Materials or products handled/stored on roads or railways owned or maintained by the discharger;

(I) Waste material (except waste in covered, non-leaking containers, e.g., dumpsters);

(J) Application or disposal of process wastewater (unless otherwise permitted); and

(K) Particulate matter or visible deposits of residuals from roof stacks/vents not otherwise regulated, i.e., under an air quality control permit, and evident in the storm water outflow;

(iv) All "no exposure" certifications must include the following certification statement, and be signed in accordance with the signatory requirements of section 122.22: "I certify under penalty of law that I have read and understand the eligibility requirements for claiming a condition of "no exposure" and obtaining an exclusion from NPDES storm water permitting; and that there are no discharges of storm water contaminated by exposure to industrial activities or materials from the industrial facility identified in this document (except as allowed under paragraph (g)(2)) of this section. I understand that I am obligated to submit a no exposure certification form once every five years to the Department and, if requested, to the operator of the local MS4 into which this facility discharges (where applicable). I understand that I must allow the Department, or MS4 operator where the discharge is into the local MS4, to perform inspections to confirm the condition of no exposure and to make such inspection reports publicly available upon request. I understand that I must obtain coverage under an NPDES permit prior to any point source discharge of storm water from the facility. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gathered and evaluated the information submitted. Based upon my inquiry of the person or persons who manage the system, or those persons directly involved in gathering the information, the information submitted is to the best of my knowledge and belief true, accurate, and complete. I am aware there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations."

122.27. Silvicultural activities.

(a) Permit requirement. Silvicultural point sources, as defined in this section, are point sources subject to the NPDES permit program.

(b) Definitions.

(1) "Silvicultural point source" means any discernible, confined and discrete conveyance related to rock crushing, gravel washing, log sorting, or log storage facilities which are operated in connection with silvicultural activities and from which pollutants are discharged into waters of the State. The term does not include non-point source silvicultural activities such as nursery operations, site preparation, reforestation and subsequent cultural treatment, thinning, prescribed burning, pest and fire control, harvesting operations, surface drainage, or road construction and maintenance from which there is natural runoff. However, some of these activities (such as stream crossing for roads) may involve point source discharges of dredged or fill material which may require a CWA section 404 permit (See 33 CFR 209.120 and Part 233).

(2) "Rock crushing and gravel washing facilities" means facilities which process crushed and broken stone, gravel, and riprap (See 40 CFR Part 436, Subpart B, including the effluent limitations guidelines).

(3) "Log sorting and log storage facilities" means facilities whose discharges result from the holding of unprocessed wood, for example, logs or roundwood with bark or after removal of bark held in self-contained bodies of water (mill ponds or log ponds) or stored on land where water is applied intentionally on the logs (wet decking). (See 40 CFR Part 429, Subpart I, including the effluent limitations guidelines).

122.28. General permits.

(a) Coverage. The Department may issue a general permit in accordance with the following:

(1) Area. The general permit shall be written to cover one or more categories or subcategories of discharges or sludge use or disposal practices or facilities described in the permit under paragraph (a)(2)(ii) of this section, except those covered by individual permits, within a geographic area. The area shall correspond to existing geographic or political boundaries such as:

(i) Designated planning areas under sections 208 and 303 of CWA:

(ii) Sewer districts or sewer authorities;

(iii) City, county, or State political boundaries;

(iv) State highway systems;

(v) Standard metropolitan statistical areas as defined by the Office of Management and Budget;

(vi) Urbanized areas as designated by the Bureau of the Census according to criteria in 30 FR 15202 (May 1, 1974); or

(vii) Any other appropriate division or combination of boundaries.

(viii) Watershed boundaries.

(2) Sources. The general permit may be written to regulate one or more categories or subcategories of discharges or sludge use or disposal practices or facilities within the area described in paragraph (a)(1) of this section, where the sources within a covered subcategory of discharges are either:

(i) Storm water point sources; or

(ii) One or more categories or subcategories of point sources other than storm water point sources, or one or more categories or subcategories of "treatment works treating domestic sewage", if the sources or "treatment works treating domestic sewage" within each category or subcategory all:

(A) Involve the same or substantially similar types of operations;

(B) Discharge the same types of wastes or engage in the same types of sludge use or disposal practices;

(C) Require the same effluent limitations, operating conditions, or standards for sewage sludge use or disposal;

(D) Require the same or similar monitoring; and

(E) In the opinion of the Department are more appropriately controlled under a general permit than under individual permits.

(3) Water quality-based limits. Where sources within a specific category or subcategory of dischargers are subject to water-quality-based limits imposed pursuant to 40CFR122.44, the sources in that specific category or subcategory shall be subject to the same water-quality-based effluent limitations.

(4) Other requirements.

(i) The general permit must clearly identify the applicable conditions for each category or subcategory of dischargers or treatment works treating domestic sewage covered by the permit.

(ii) The general permit may exclude specified sources or areas from coverage.

(b) Administration.

(1) In general. General permits may be issued, modified, revoked and reissued, or terminated in accordance with applicable requirements of R61-9.124. Special procedures for issuance are found at 40 CFR 123.44.

(2) Authorization to discharge or authorization to engage in sludge use and disposal practices.

(i) Except as provided in paragraphs (b)(2)(v) and (b)(2)(vi) of this section, dischargers (or treatment works treating domestic sewage) seeking coverage under a general permit shall submit to the Department a written notice of intent to be covered by the general permit. A discharger (or treatment works treating domestic sewage) who fails to submit a notice of intent in accordance with the terms of the permit is not authorized to discharge (or in the case of sludge disposal permit, to engage in a sludge use or disposal practice), under the terms of the general permit unless the general permit, in accordance with paragraph (b)(2)(v) of this section, contains a provision that a notice of intent is not required or the Department notifies a discharger (or treatment works treating domestic sewage) that it is covered by a general permit in accordance with paragraph (b)(2)(vi) of this section. A complete and timely notice of intent (NOI) to be covered in accordance with general permit requirements, fulfills the requirements for permit applications for purposes of sections 122.6, 122.21 and 122.26.

(ii) The contents of the notice of intent shall be specified in the general permit and shall require the submission of information necessary for adequate program implementation, including at a minimum, the legal name and address of the owner or operator, the facility name and address, type of facility or discharges, and the receiving stream(s). General permits for storm water discharges associated with industrial activity from inactive mining, inactive oil and gas operations, or inactive landfills occurring on Federal lands where an operator cannot be identified may contain alternative notice of intent requirements. All notices of intent shall be signed in accordance with section 122.22. Notices of intent for coverage under a general permit for concentrated animal feeding operations (CAFO) must include the information specified in section 122.21(i)(1), including a topographic map.

(iii) General permits shall specify the deadlines for submitting notices of intent to be covered and the date(s) when a discharger is authorized to discharge under the permit.

(iv) General permits shall specify whether a discharger (or treatment works treating domestic sewage) that has submitted a complete and timely notice of intent to be covered in accordance with the general permit and that is eligible for coverage under the permit, is authorized to discharge (or in the case of a sludge disposal permit, to engage in a sludge use or disposal practice) in accordance with the permit either upon receipt of the notice of intent by the Department, after a waiting period specified in the general permit, on a date specified in the general permit, or upon receipt of notification of inclusion by the Department. Coverage may be terminated or revoked in accordance with paragraph (b)(3) of this section.

(v) Discharges other than discharges from publicly owned treatment works, combined sewer overflows, municipal separate storm sewer systems, primary industrial facilities, and storm water discharges associated with industrial activity may, at the discretion of the Department, be authorized to discharge under a general permit without submitting a notice of intent where the Department finds that a notice of intent requirement would be inappropriate. In making such a finding, the Department shall consider: the type of discharge; the expected nature of the discharge; the potential for toxic and conventional pollutants in the discharges; the expected volume of the discharges; other means of identifying discharges covered by the permit; and the estimated number of discharges to be covered by the permit. The Department shall provide in the public notice of the general permit the reasons for not requiring a notice of intent.

(vi) The Department may notify a discharger (or treatment works treating domestic sewage) that it is covered by a general permit, even if the discharger (or treatment works treating domestic sewage) has not submitted a notice of intent to be covered. A discharger (or treatment works treating domestic sewage) so notified may request an individual permit under paragraph (b)(3)(iii) of this section.

(3) Requiring an individual permit.

(i) The Department may require any person authorized by a general permit to apply for and obtain an individual NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements). An applicant, any affected state, or interstate agency, the Regional Administrator, or any other interested person may petition the Department to take action under this paragraph. The petition shall indicate specific reasons why an individual permit is requested and the interest in or relationship of the petitioner to the applicant. Cases where an individual NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements) may be required include the following:

(A) The discharger or "treatment works treating domestic sewage" is not in compliance with the conditions of the general NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements);

(B) A change has occurred in the availability of demonstrated technology or practices for the control or abatement of pollutants applicable to the point source or treatment works treating domestic sewage;

(C) Effluent limitation guidelines are promulgated for point sources covered by the general NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements);

(D) A Water Quality Management plan containing requirements applicable to such point sources is approved;

(E) Circumstances have changed since the time of the request to be covered so that the discharger is no longer appropriately controlled under the general permit, or either a temporary or permanent reduction or elimination of the authorized discharge is necessary;

(F) Standards for sewage sludge use or disposal have been promulgated for the sludge use and disposal practice covered by the general NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements); or

(G) The discharge(s) is a significant contributor of pollutants. In making this determination, the Department may consider the following factors:

(1) The location of the discharge with respect to waters of the State;

(2) The size of the discharge;

(3) The quantity and nature of the pollutants discharged to waters of the State; and

(4) Other relevant factors.

(ii) [Reserved]

(iii) Any owner or operator authorized by a general permit may request to be excluded from the coverage of the general permit by applying for an individual permit. The owner or operator shall submit an application under section 122.21, with reasons supporting the request, to the Department no later than 90 days after the publication of the general permit in the State Register. The request shall be processed in accordance with R.61-9.124. The request shall be granted by issuing of an individual permit if the reasons cited by the owner or operator are adequate to support the request.

(iv) When an individual NPDES permit, Land Application permit, or State permit (See R.61-9.505 for Land Application permit and State permit requirements) is issued to an owner or operator otherwise subject to a general NPDES, Land Application, or State permit, the applicability of the general permit to the individual NPDES, Land Application, or State permittee is automatically terminated on the effective date of the individual permit.

(v) A source excluded from a general permit solely because it already has an individual permit may request that the individual permit be revoked, and that it be covered by the general permit. Upon revocation of the individual permit, the general permit shall apply to the source.

(4) Definitions:

(i) "General Permit Application" means an application filed by a potential permittee with the Department for a general permit.

(ii) Notice of Intent" (NOI) means a form used by potential permittees to notify the Department, within a specified time, that they intend to comply with the general permit or that they do not wish to be covered by the general permit and wish an individual permit.

(c) Degree of Waste Treatment Required. All pollutants shall receive such treatment or corrective action so as to insure compliance with the terms and conditions of the issued permit and with the following, whenever applicable:

(1) Effluent limitations established by the EPA pursuant to Sections 301, 302, 303, 306, 307, 308, 318, and 405 of the Federal CWA;

(2) Criteria and standards for Best Management practices established by EPA pursuant to Section 304(e) of the Federal CWA;

(3) Notwithstanding the above, more stringent effluent limitations may be required as deemed necessary by the Department (i) to meet any other existing federal laws or regulations, or (ii) to insure compliance with any applicable State water quality standards, effluent limitations, or treatment standards; and

(4) Calculations and specifications of effluent limits and standards shall be made in accordance with the provisions of section 122.45.

(d) Submittals and Signatory Requirements.

(1) An NOI shall be on forms as may be prescribed and furnished from time to time by the Department. A NOI shall be accompanied by all pertinent information as the Department may require in order to establish effluent limitations in accordance with this regulation, including, but not limited to, complete engineering reports, schedule of progress, plans, specifications, maps, measurements, quantitative and qualitative determinations, records, and all related materials.

(2) Engineering reports, plans, specifications, and other material submitted to the Department's NPDES or State permitting (See R.61-9.505 for Land Application permit and State permit requirements) divisions shall be signed by a Professional Engineer registered in State of South Carolina and competent in the field of sewage and industrial waste treatment.

(3) Material submitted shall be complete and accurate.

(4) Any NOI form submitted to the Department shall be signed in accordance with this Regulation.

(5) All other reports or requests for information required by the Department shall be signed by a person designated in section 122.22 or a duly authorized representative of such person, if:

(i) The representative so authorized is responsible for the overall operation of the facility from which the discharge originates, e.g., a plant manager, superintendent or person of equivalent responsibility;

(ii) The authorization is made in writing by the person designated under section 122.22; and

(iii) The written authorization is submitted to the Department.

(6) Any changes in the written authorization submitted to the Department which occur after the issuance of a permit shall be reported to the Department by submitting a copy of a new written authorization that meets the requirements of (5) above.

(7) Any person signing any document under (d) above shall make the following certification: "I certify under penalty of law that I have personally examined and am familiar with the information submitted in the attached document; and based on my inquiry of those individuals immediately responsible for obtaining the information, I believe the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment."

(e) Other Requirements.

(1) Notice and Public Participation. Public notice and participation requirements shall be in accordance with this Regulation.

(2) Terms and Conditions of Permits. General permits issued shall be subject to the terms and conditions contained in this Regulation.

(3) Monitoring, Recording and Reporting Requirements. Monitoring, recording, and reporting requirements shall be in accordance with the permit and this Regulation.

(4) Duration, Continuation, and Transferability of Permits. General permits shall be issued for a fixed term in accordance with this Regulation.

122.29. New sources and new dischargers.

(a) Definitions.

(1) "New source" and "new discharger" are defined in section 122.2.

(2) "Source" means any building, structure, facility, or installation from which there is or may be a discharge of pollutants.

(3) "Existing source" means any source which is not a new source or a new discharger.

(4) "Site" is defined in section 122.2;

(5) "Facilities or equipment" means buildings, structures, process or production equipment or machinery which form a permanent part of the new source and which will be used in its operation, if these facilities or equipment are of such value as to represent a substantial commitment to construct. It excludes facilities or equipment used in connection with feasibility, engineering, and design studies regarding the source or water pollution treatment for the source.

(b) Criteria for new source determination.

(1) Except as otherwise provided in an applicable new source performance standard, a source is a "new source" if it meets the definition of "new source" in section 122.2, and

(i) It is constructed at a site at which no other source is located; or

(ii) It totally replaces the process or production equipment that causes the discharge of pollutants at an existing source; or

(iii) Its processes are substantially independent of an existing source at the same site. In determining whether these processes are substantially independent, the Department shall consider such factors as the extent to which the new facility is integrated with the existing plant; and the extent to which the new facility is engaged in the same general type of activity as the existing source.

(2) A source meeting the requirements of paragraphs (b)(1)(i), (ii), or (iii) of this section is a new source only if a new source performance standard is independently applicable to it. If there is no such independently applicable standard, the source is a new discharger. See section 122.2.

(3) Construction on a site at which an existing source is located results in a modification subject to section 122.62 rather than a new source (or a new discharger) if the construction does not create a new building, structure, facility, or installation meeting the criteria of paragraphs (b)(1)(ii) or (iii) of this section but otherwise alters, replaces, or adds to existing process or production equipment.

(4) Construction of a new source as defined under section 122.2 has commenced if the owner or operator has:

(i) Begun, or caused to begin as part of a continuous on-site construction program:

(A) Any placement, assembly, or installation of facilities or equipment; or

(B) Significant site preparation work including clearing, excavation, or removal of existing buildings, structures, or facilities which is necessary for the placement, assembly, or installation of new source facilities or equipment; or

(ii) Entered into a binding contractual obligation for the purchase of facilities or equipment which are intended to be used in its operation within a reasonable time. Options to purchase or contracts which can be terminated or modified without substantial loss, and contracts for feasibility, engineering, and design studies do not constitute a contractual obligation under the paragraph.

(c) [Reserved]

(d) Effect of compliance with new source performance standards. (The provisions of this paragraph do not apply to existing sources which modify their pollution control facilities or construct new pollution control facilities and achieve performance standards, but which are neither new sources or new dischargers or otherwise do not meet the requirements of this paragraph.)

(1) Except as provided in paragraph (d)(2) of this section, any new discharger, the construction of which commenced after October 18, 1972, or new source which meets the applicable promulgated new source performance standards before the commencement of discharge, may not be subject to any more stringent new source performance standards or to any more stringent technology-based standards under section 301(b)(2) of CWA for the soonest ending of the following periods:

(i) Ten years from the date that construction is completed;

(ii) Ten years from the date the source begins to discharge process or other non-construction related wastewater; or

(iii) The period of depreciation or amortization of the facility for the purposes of section 167 or 169 (or both) of the Internal Revenue Code of 1954.

(2) The protection from more stringent standards of performance afforded by paragraph (d)(1) of this section does not apply to:

(i) Additional or more stringent permit conditions which are not technology based; for example, conditions based on water quality standards, or toxic effluent standards or prohibitions under section 307(a) of CWA; or

(ii) Additional permit conditions in accordance with section 125.3 controlling toxic pollutants or hazardous substances which are not controlled by new source performance standards. This includes permit conditions controlling pollutants other than those identified as toxic pollutants or hazardous substances when control of these pollutants has been specifically identified as the method to control the toxic pollutants or hazardous substances.

(3) When an NPDES permit issued to a source with a "protection period" under paragraph (d)(1) of this section will expire on or after the expiration of the protection period, that permit shall require the owner or operator of the source to comply with the requirements of section 301 and any other then applicable requirements of CWA immediately upon the expiration of the protection period. No additional period for achieving compliance with these requirements may be allowed except when necessary to achieve compliance with requirements promulgated less than 3 years before the expiration of the protection period.

(4) The owner or operator of a new source, a new discharger which commenced discharge after August 13, 1979, or a recommencing discharger shall install and have in operating condition, and shall "start-up" all pollution control equipment required to meet the conditions of its permits before beginning to discharge. Within the shortest feasible time (not to exceed 90 days), the owner or operator must meet all permit conditions. The requirements of this paragraph do not apply if the owner or operator is issued a permit containing a compliance schedule under section 122.47(a)(2).

(5) After the effective date of new source performance standards, it shall be unlawful for any owner or operator of any new source to operate the source in violation of those standards applicable to the source.

122.30. What are the objectives of the storm water regulations for small MS4s?

(a) Sections 122.30 through 122.36 are written in a "readable regulation" format.

(b) Under the statutory mandate in section 402(p)(6) of the Clean Water Act, the purpose of this portion of the storm water program is to designate additional sources that need to be regulated to protect water quality and to establish a comprehensive storm water program to regulate these sources. (Because the storm water program is part of the National Pollutant Discharge Elimination System (NPDES) Program, you should also refer to section 122.1 which addresses the broader purpose of the NPDES program.)

(c) Storm water runoff continues to harm the nation's waters. Runoff from lands modified by human activities can harm surface water resources in several ways including changing natural hydrologic patterns and elevating pollutant concentrations and loadings. Storm water runoff may contain or mobilize high levels of contaminants, such as sediment, suspended solids, nutrients, heavy metals, pathogens, toxins, oxygen-demanding substances, and floatables.

(d) EPA and the Department strongly encourage partnerships and the watershed approach as the management framework for efficiently, effectively, and consistently protecting and restoring aquatic ecosystems and protecting public health.

122.31. Indian Tribes. As a Tribe, what is my role under the NPDES storm water program?

As a Tribe you may:

(a) Be authorized to operate the NPDES program including the storm water program, after EPA determines that you are eligible for treatment in the same manner as a State under sections 123.31 through 123.34. (If you do not have an authorized NPDES program, the Department implements the program for discharges on your reservation.);

(b) Be classified as an owner of a regulated small MS4, as defined in section 122.32. (Designation of your Tribe as an owner of a small MS4 for purposes of this part is an approach that is consistent with U.S. EPA's 1984 Indian Policy of operating on a government-to-government basis with EPA looking to Tribes as the lead governmental authorities to address environmental issues on their reservations as appropriate. If you operate a separate storm sewer system that meets the definition of a regulated small MS4, you are subject to the requirements under sections 122.33 through 122.35. If you are not designated as a regulated small MS4, you may ask EPA to designate you as such for the purposes of this part.); or

(c) Be a discharger of storm water associated with industrial activity or small construction activity under sections 122.26(b)(14) or (b)(15), in which case you must meet the applicable requirements. Within Indian country, the NPDES permitting authority is the Department, unless you are authorized to administer the NPDES program.

122.32. Is an operator of a small MS4 regulated under the NPDES storm water program?

(a) Unless you qualify for a waiver under paragraph (c) of this section, you are regulated if you operate a small MS4, including but not limited to systems operated by federal, State, Tribal, and local governments, including State departments of transportation, and:

(1) Your small MS4 is located in an urbanized area as determined by the latest Decennial Census by the Bureau of the Census (If your small MS4 is not located entirely within an urbanized area, only the portion that is within the urbanized area is regulated.); or

(2) You are designated by the Department, including where the designation is pursuant to 40 CFR 123.35(b)(3) or (b)(4) or is based upon a petition under section 122.26(f).

(b) You may be the subject of a petition to the NPDES permitting authority to require an NPDES permit for your discharge of storm water. If the NPDES permitting authority determines that you need a permit, you are required to comply with sections 122.33 through 122.35.

(c) The Department may waive the requirements otherwise applicable to you if you meet the criteria of paragraph (d) or (e) of this section. If you receive a waiver under this section, you may subsequently be required to seek coverage under an NPDES permit in accordance with section 122.33(a) if circumstances change. (See also section 123.35(b) of 40CFR123.)

(d) The Department may waive permit coverage if your MS4 serves a population of less than 1,000 within the urbanized area and you meet the following criteria:

(1) Your system is not contributing substantially to the pollutant loadings of a physically interconnected MS4 that is regulated by the NPDES storm water program (see section 123.35(b)(4) of 40CFR123) and

(2) If you discharge any pollutant(s) that have been identified as a cause of impairment of any water body to which you discharge, storm water controls are not needed based on wasteload allocations that are part of an EPA-approved or established total maximum daily load (TMDL) that addresses the pollutant(s) of concern.

(e) The Department may waive permit coverage if your MS4 serves a population under 10,000 and you meet the following criteria:

(1) The Department has evaluated all waters of the U.S., including small streams, tributaries, lakes, and ponds, that receive a discharge from your MS4;

(2) For all such waters, the Department has determined that storm water controls are not needed based on wasteload allocations that are part of an EPA-approved or established TMDL that addresses the pollutant(s) of concern or, if a TMDL has not been developed or approved, an equivalent analysis that determines sources and allocations for the pollutant(s) of concern;

(3) For the purpose of this paragraph (e), the pollutant(s) of concern include biochemical oxygen demand (BOD), sediment or a parameter that addresses sediment (such as total suspended solids, turbidity or siltation), pathogens, oil and grease, and any pollutant that has been identified as a cause of impairment of any water body that will receive a discharge from your MS4; and

(4) The Department has determined that future discharges from your MS4 do not have the potential to result in exceedances of water quality standards, including impairment of designated uses, or other significant water quality impacts, including habitat and biological impacts.

(f) Process for designating small MS4 to require storm water NPDES permitting. The Department will designate small MS4s according to the following criteria as a determination that a storm water discharge results in or has the potential to result in exceedances of water quality standards, including impairment of designated uses, or other significant water quality impacts, including habitat and biological impacts.

(1) The Department will make initial designations on a watershed basis but no later than December 8, 2004 [except see the phasing considerations in (h)(3) for MS4 with population less than 10,000], as follows:

(i) All MS4 which are located within an urbanized area as defined by the U.S. Bureau of the Census are to be designated and must obtain permits, unless a waiver is granted. (Many of the municipalities and counties which are small MS4 covered by this requirement are listed in Appendix 6 of 64FR68722, December 8, 1999.)

(ii) Consider all small MS4 with a population density of at least 1000 persons per square mile and a population of at least 10,000 located outside urban areas, according to the criteria. (Six municipalities which meet these descriptions are listed in Appendix 7 of 64FR68722.)

(iii) Consider small MS4 which are adjacent to and impact a designated MS4, according to criteria.

(iv) Consider other government entities which are MS4 relevant to criteria (e.g., military installations, prisons, and state, county, or municipal school, or hospital campuses).

(v)(A) Consider MS4 for which petitions are received requesting that permitting be required.

(B) See section 122.26(f)(5) as to the period for making a determination on designation.

(2) The Department will designate small MS4 to require permitting, as follows:

(i) Small MS4 within urbanized areas;

(ii) Entire municipalities which meet the criteria;

(iii) Counties, military installations, prisons, and state, county, or municipal school or hospital campuses, giving consideration to whether solely the urbanized areas should be designated;

(iv) Small MS4 physically interconnected with and substantially affecting regulated MS4, according to the criteria.

(3) In the process of designating small MS4, the Department will inform entities of the waiver requirements of 40 CFR 123.35(d) and evaluate any requested waiver in making a designation decision.

(4) The Department will evaluate any entity for which a petition is received requesting that a permit be required, based on criteria.

(5) The Department will reevaluate to designate appropriate, additional MS4 whenever the 303(d) list is revised.

(6) The Department will reevaluate at each census only to designate additional small MS4.

(g) Criteria for Designating Small MS4 for Storm Water NPDES Permitting

(1) Any small MS4 with a population of 10,000 or more and a population density of 1000 persons per square mile meeting any criterion will be designated, unless one or more of the exceptions in (1)(i) below applies. For smaller or less-densely populated MS4, the following criteria will be used in any evaluation of whether they should be designated to require a permit.

(i) Any water body receiving storm water from the MS4 is on the South Carolina |303(d)f list of impaired waters for a pollutant discharged in the storm water of the entity or a pollutant contributing to the standards violation leading to listing, unless the MS4 shows that it meets one of the following exceptions:

(A) The runoff from the MS4 caused by a 2-inch rainstorm would be less than one (1) percent of the annual average flow of each receiving stream on the 303(d) list;

(B) The MS4 has excellent BMP in place and presents data showing exemplary quality storm water runoff;

(C) The MS4 has a low ratio of runoff to rainfall (e.g., sandy soil) and moderate (that is, not high) water table; or

(D) The MS4 is shown to have a significantly lower percentage of impermeable area than would be expected for its level of development.

(ii) Any water body receiving storm water from the MS4 is classed ONRW, ORW, or Freshwater-Trout or is open for shellfish harvesting.

(iii) Population growth in the MS4 between the 1990 and 2000 (or the two most-recent) censuses has been 10 percent or more or growth has been 2 percent or more in each of the three (3) most-recent years.

(iv) The MS4 is located within 3 miles of an urbanized area, and the MS4 under consideration discharges storm water to one or more of the water bodies which receive storm water from the urbanized area.

(v) An MS4 which has been partly (at least 25%) designated (e.g., part lying within an urbanized area). Consideration will be give to designating only the portion of a county, military installation, prison, or state, county, or municipal school or hospital campus which is in the relevant urbanized area or, for the more extensively developed counties, designating areas up to three (3) miles from the boundary of the urbanized area.

(vi) The population density of the MS4 is at least 1500 persons per square mile.

(2) The following matters may also be considered in deciding whether a permit is required.

(i) The storm water discharge of an MS4 is causing or contributing to a violation of a water quality standard.

(ii) An MS4 is subject to activity contributing or expected to contribute to storm water contamination; for example, frequent military training exercises.

(iii) An MS4 includes industries with significant particulate emissions (such as battery manufacturing |e.g., leadf, steel manufacturing, etc.)

(iv) An MS4 includes a high percentage of impermeable area (pavement, roof).

(v) An MS4 owns or operates a wastewater treatment facility which has a history of being on the NPDES "Significant Non-compliance List" for effluent violations.

(vi) An MS4 approaches but does not reach two or more of the criteria in (1) above.

(3) Government-owned educational institutions, hospital and prison complexes, and military bases outside of urban areas will be considered in the same manner as municipalities outside urban areas. That is, if they have a population of 10,000 or more and a population density of 1500 persons per square mile, they will be designated. If they are less populated or less-densely populated, they will be considered based on the criteria, if a petition requests that a permit be required.

(4) As an initial decision, designate any small MS4 which has either greater than 2000 total population with a density of at least 1500 persons per square mile or greater than 4000 total population with a density of at least 1000 persons per square mile and which is within the boundaries of or whose boundaries touch, and which drains to at least one basin which receives drainage from, a permitted or designated MS4. However, consider exceptions and "other considerations" stated elsewhere in these criteria.

(h) Waivers and Phasing. The Department may waive or phase in the requirements otherwise applicable to regulated small MS4s, as defined in Sec. 122.32(a)(1) and (2) of this item, under the following circumstances:

(1) The Department may waive permit coverage for each small MS4 in jurisdictions with a population under 1,000 within the urbanized area according to section 122.32(d).

(2) The Department may waive permit coverage for each small MS4 in jurisdictions with a population under 10,000 according to section 122.32(e).

(3) The Department may phase in permit coverage for small MS4s serving jurisdictions with a population under 10,000 on a schedule consistent with a State watershed permitting approach. Under this approach, the Department will permit coverage for small MS4s that qualify for such phased-in coverage during the year assigned for permitting in the basin where it is located. Under this option, all regulated small MS4s are required to have coverage under an NPDES permit no later than March 8, 2007.

(4) The Department will periodically review any waivers granted in accordance with paragraph (h)(2) of this section to determine whether any of the information required for granting the waiver has changed. At a minimum, the reviews will be conducted once every five years during pertinent years for basin permit issuance. In addition, the Department will consider any petition to review any waiver when the petitioner provides evidence that the information required for granting the waiver has substantially changed.

122.33. How does an operator of a regulated, small MS4 apply for an NPDES permit, and when must he apply?

(a) If you operate a regulated, small MS4 under section 122.32, you must seek coverage under a NPDES permit issued by the Department. As South Carolina is an NPDES authorized State, then the State is your NPDES permitting authority.

(b) You must seek authorization to discharge under a general or individual NPDES permit, as follows:

(1) If the Department has issued a general permit applicable to your discharge and you are seeking coverage under the general permit, you must submit a Notice of Intent (NOI) that includes the information on your best management practices and measurable goals required by section 122.34(d). You may file your own NOI, or you and other municipalities or governmental entities may jointly submit an NOI. If you want to share responsibilities for meeting the minimum measures with other municipalities or governmental entities, you must submit an NOI that describes which minimum measures you will implement and identify the entities that will implement the other minimum measures within the area served by your MS4. The general permit will explain any other steps necessary to obtain permit authorization.

(2)(i) If you are seeking authorization to discharge under an individual permit and wish to implement a program under section 122.34, you must submit an application to the Department that includes the information required under sections 122.21(f) and 122.34(d), an estimate of the area in square miles served by your small MS4, and any additional information that your NPDES permitting authority requests. A storm sewer map that satisfies the requirement of section 122.34(b)(3)(i) will satisfy the map requirement in section 122.21(f)(7).

(ii) If you are seeking authorization to discharge under an individual permit and wish to implement a program that is different from the program under section 122.34, you will need to comply with the permit application requirements of section 122.26(d). You must submit both Parts of the application requirements in sections 122.26(d)(1) and (2) by March 10, 2003. You do not need to submit the information required by sections 122.26(d)(1)(ii) and (d)(2) regarding your legal authority, unless you intend for the permit writer to take such information into account when developing your other permit conditions.

(iii) If allowed by the Department, you and another regulated entity may jointly apply under either paragraph (b)(2)(i) or (b)(2)(ii) of this section to be co-permittees under an individual permit.

(3) If your small MS4 is in the same urbanized area as a medium or large MS4 with an NPDES storm water permit and that other MS4 is willing to have you participate in its storm water program, you and the other MS4 may jointly seek a modification of the other MS4 permit to include you as a limited co-permittee. As a limited co-permittee, you will be responsible for compliance with the permit's conditions applicable to your jurisdiction. If you choose this option you will need to comply with the permit application requirements of section 122.26, rather than the requirements of section 122.34. You do not need to comply with the specific application requirements of section 122.26(d)(1)(iii) and (iv) and (d)(2)(iii) (discharge characterization). You may satisfy the requirements in section 122.26 (d)(1)(v) and (d)(2)(iv) (identification of a management program) by referring to the other MS4's storm water management program.

(c) If you operate a regulated, small MS4:

(1) Designated under section 122.32(a)(1), you must apply for coverage under an NPDES permit, or apply for a modification of an existing NPDES permit under paragraph (b)(3) of this section by March 10, 2003, unless your MS4 serves a jurisdiction with a population under 10,000 and the Department has established a phasing schedule under 40CFR123.35(d)(3).

(2) Designated under section 122.32(a)(2), you must apply for coverage under an NPDES permit, or apply for a modification of an existing NPDES permit under paragraph (b)(3) of this section, within 180 days of receiving the notice of designation, unless the Department grants a later date.

122.34. As an operator of a regulated, small MS4, what will my NPDES MS4 storm water permit require?

(a) Your NPDES MS4 permit will require at a minimum that you develop, implement, and enforce a storm water management program designed to reduce the discharge of pollutants from your MS4 to the maximum extent practicable (MEP), to protect water quality, and to satisfy the appropriate water quality requirements of the Clean Water Act. Your storm water management program must include the minimum control measures described in paragraph (b) of this section unless you apply for a permit under section 122.26(d). For purposes of this section, narrative effluent limitations requiring implementation of best management practices (BMP) are generally the most appropriate form of effluent limitations when designed to satisfy technology requirements (including reductions of pollutants to the maximum extent practicable) and to protect water quality. Implementation of best management practices consistent with the provisions of the storm water management program required pursuant to this section and the provisions of the permit required pursuant to section 122.33 constitutes compliance with the standard of reducing pollutants to the "maximum extent practicable." The Department will specify a period of up to 5 years from the date of permit issuance for you to develop and implement your program.

(b) Minimum control measures:

(1) Public education and outreach on storm water impacts. You must implement a public education program to distribute educational materials to the community or conduct equivalent outreach activities about the impacts of storm water discharges on water bodies and the steps that the public can take to reduce pollutants in storm water runoff.

(2) Public involvement/participation. You must, at a minimum, comply with State and local public notice requirements when implementing a public involvement/participation program.

(3) Illicit discharge detection and elimination.

(i) You must develop, implement and enforce a program to detect and eliminate illicit discharges [as defined at section 122.26(b)(2)] into your small MS4.

(ii) You must:

(A) Develop, if not already completed, a storm sewer system map, showing the location of all outfalls and the names and locations of all waters of the United States that receive discharges from those outfalls;

(B) To the extent allowable under State or local law, effectively prohibit, through ordinance, or other regulatory mechanism, non-storm water discharges into your storm sewer system and implement appropriate enforcement procedures and actions;

(C) Develop and implement a plan to detect and address non-storm-water discharges, including illegal dumping, to your system; and

(D) Inform public employees, businesses, and the general public of hazards associated with illegal discharges and improper disposal of waste.

(iii) You need address the following categories of non-storm water discharges or flows (i.e., illicit discharges) only if you identify them as significant contributors of pollutants to your small MS4: water line flushing, landscape irrigation, diverted stream flows, rising ground waters, uncontaminated ground water infiltration [as defined at 40 CFR 35.2005(20)], uncontaminated, pumped ground water, discharges from potable water sources, foundation drains, air conditioning condensate, irrigation water, springs, water from crawl space pumps, footing drains, lawn watering, individual residential car washing, flows from riparian habitats and wetlands, dechlorinated swimming pool discharges, and street wash water (discharges or flows from fire fighting activities are excluded from the effective prohibition against non-storm water and need only be addressed where they are identified as significant sources of pollutants to waters of the United States).

(4) Construction site storm water runoff control.

(i) You must develop, implement, and enforce a program to reduce pollutants in any storm water runoff to your small MS4 from construction activities that result in a land disturbance of greater than or equal to one acre. Reduction of storm water discharges from construction activity disturbing less than one acre must be included in your program if that construction activity is part of a larger common plan of development or sale that would disturb one acre or more. If the Department waives requirements for storm water discharges associated with small construction activity in accordance with section 122.26(b)(15)(i), you are not required to develop, implement, and/or enforce a program to reduce pollutant discharges from such sites.

(ii) Your program must include the development and implementation of, at a minimum:

(A) An ordinance or other regulatory mechanism to require erosion and sediment controls, as well as sanctions to ensure compliance, to the extent allowable under State or local law;

(B) Requirements for construction site operators to implement appropriate erosion and sediment control best management practices;

(C) Requirements for construction site operators to control waste such as discarded building materials, concrete-truck washout, chemicals, litter, and sanitary waste at the construction site that may cause adverse impacts to water quality;

(D) Procedures for site plan review which incorporate consideration of potential water quality impacts;

(E) Procedures for receipt and consideration of information submitted by the public; and

(F) Procedures for site inspection and enforcement of control measures.

(5) Post-construction storm water management in new development and redevelopment.

(i) You must develop, implement, and enforce a program to address storm water runoff from new development and redevelopment projects that disturb greater than or equal to one acre, including projects less than one acre that are part of a larger common plan of development or sale, that discharge into your small MS4. Your program must ensure that controls are in place that would prevent or minimize water quality impacts.

(ii) You must:

(A) Develop and implement strategies which include a combination of structural and/or non-structural best management practices (BMP) appropriate for your community;

(B) Use an ordinance or other regulatory mechanism to address post-construction runoff from new development and redevelopment projects to the extent allowable under State, Tribal, or local law; and

(C) Ensure adequate long-term operation and maintenance of BMP.

(6) Pollution prevention/good housekeeping for municipal operations. You must develop and implement an operation and maintenance program that includes a training component and has the ultimate goal of preventing or reducing pollutant runoff from municipal operations. Using training materials that are available from EPA, your State, Tribe, or other organizations, your program must include employee training to prevent and reduce storm water pollution from activities such as park and open space maintenance, fleet and building maintenance, new construction and land disturbances, and storm water system maintenance.

(c) If an existing, qualifying local program requires you to implement one or more of the minimum control measures of paragraph (b) of this section, the Department may include conditions in your NPDES permit that direct you to follow the Department's requirements rather than the requirements of paragraph (b) of this section. A qualifying local program is a local storm water management program that imposes, at a minimum, the relevant requirements of paragraph (b) of this section.

(d)(1) In your permit application (either a notice of intent for coverage under a general permit or an individual permit application), you must identify and submit to the Department the following information:



(i) The best management practices (BMP) that you or another entity will implement for each of the storm water minimum control measures at paragraphs (b)(1) through (b)(6) of this section;

(ii) The measurable goals for each of the BMP including, as appropriate, the months and years in which you will undertake required actions, including interim milestones and the frequency of the action; and

(iii) The person or persons responsible for implementing or coordinating your storm water management program.

(2) If you obtain coverage under a general permit, you are not required to meet any measurable goal(s) identified in your notice of intent in order to demonstrate compliance with the minimum control measures in paragraphs (b)(3) through (b)(6) of this section unless, prior to submitting your NOI, EPA or the Department has provided or issued a menu of BMP that addresses each such minimum measure. Even if no regulatory authority issues the menu of BMP, however, you still must comply with other requirements of the general permit, including good faith implementation of BMP designed to comply with the minimum measures.

(e) You must comply with any more stringent effluent limitations in your permit, including permit requirements that modify, or are in addition to, the minimum control measures based on an approved total maximum daily load (TMDL) or equivalent analysis. The Department may include such more stringent limitations based on a TMDL or equivalent analysis that determines such limitations are needed to protect water quality.

(f) You must comply with other applicable NPDES permit requirements, standards and conditions established in the individual or general permit, developed consistent with the provisions of sections 122.41 through 122.49, as appropriate.

(g) Evaluation and assessment:

(1) Evaluation. You must evaluate program compliance, the appropriateness of your identified best management practices, and progress towards achieving your identified measurable goals.

Note to Paragraph (g)(1): The Department may determine monitoring requirements for you in accordance with State/Tribal monitoring plans appropriate to your watershed. Participation in a group monitoring program is encouraged.

(2) Recordkeeping. You must keep records required by the NPDES permit for at least 3 years. You must submit your records to the Department only when specifically asked to do so. You must make your records, including a description of your storm water management program, available to the public at reasonable times during regular business hours (see section 122.7 for confidentiality provision). (You may assess a reasonable charge for copying. You may require a member of the public to provide advance notice.)

(3) Reporting. Unless you are relying on another entity to satisfy your NPDES permit obligations under section 122.35(a), you must submit annual reports to the Department for your first permit term. For subsequent permit terms, you must submit reports in year two and four unless the Department requires more frequent reports. Your report must include:

(i) The status of compliance with permit conditions, an assessment of the appropriateness of your identified best management practices and progress towards achieving your identified measurable goals for each of the minimum control measures;

(ii) Results of information collected and analyzed, including monitoring data, if any, during the reporting period;

(iii) A summary of the storm water activities you plan to undertake during the next reporting cycle;

(iv) A change in any identified best management practices or measurable goals for any of the minimum control measures; and

(v) Notice that you are relying on another governmental entity to satisfy some of your permit obligations (if applicable).

122.35. May an operator of a regulated small MS4 share the responsibility to implement the minimum control measures with other entities?

(a) You may rely on another entity to satisfy your NPDES permit obligations to implement a minimum control measure if:

(1) The other entity, in fact, implements the control measure;

(2) The particular control measure, or component thereof, is at least as stringent as the corresponding NPDES permit requirement; and

(3) The other entity agrees to implement the control measure on your behalf. In the reports you must submit under section 122.34(g)(3), you must also specify that you rely on another entity to satisfy some of your permit obligations. If you are relying on another governmental entity regulated under section 122 to satisfy all of your permit obligations, including your obligation to file periodic reports required by section 122.34(g)(3), you must note that fact in your NOI, but you are not required to file the periodic reports. You remain responsible for compliance with your permit obligations if the other entity fails to implement the control measure (or component thereof). Therefore, EPA encourages you to enter into a legally binding agreement with that entity if you want to minimize any uncertainty about compliance with your permit.

(b) In some cases, the Department may recognize, either in your individual NPDES permit or in an NPDES general permit, that another governmental entity is responsible under an NPDES permit for implementing one or more of the minimum control measures for your small MS4 or that the Department itself is responsible. Where the Department does so, you are not required to include such minimum control measure(s) in your storm water management program. (For example, if a State or Tribe is subject to an NPDES permit that requires it to administer a program to control construction site runoff at the State or Tribal level and that program satisfies all of the requirements of section 122.34(b)(4), you could avoid responsibility for the construction measure, but would be responsible for the remaining minimum control measures.) Your permit may be reopened and modified to include the requirement to implement a minimum control measure if the entity fails to implement it.

122.36. As an operator of a regulated small MS4, what happens if I don't comply with the application or permit requirements in sections 122.33 through 122.35?

NPDES permits are federally enforceable. Violators may be subject to the enforcement actions and penalties described in Clean Water Act sections 309 (b), (c), and (g) and 505, or under applicable State, Tribal, or local law. Compliance with a permit issued pursuant to section 402 of the Clean Water Act is deemed compliance, for purposes of sections 309 and 505, with sections 301, 302, 306, 307, and 403, except any standard imposed under section 307 for toxic pollutants injurious to human health. If you are covered as a co-permittee under an individual permit or under a general permit by means of a joint Notice of Intent you remain subject to the enforcement actions and penalties for the failure to comply with the terms of the permit in your jurisdiction except as set forth in section 122.35(b).

PART C. PERMIT CONDITIONS

122.41. Conditions applicable to all permits.

The following conditions apply to all NPDES permits. Additional conditions applicable to NPDES permits are in section 122.42. All conditions applicable to NPDES permit shall be incorporated into the permits either expressly or by reference. If incorporated by reference, a specific citation to the federal regulations (or the corresponding approved State regulations) must be given in the permit.

(a) Duty to comply. The permittee must comply with all conditions of the permit. Any permit noncompliance constitutes a violation of the Clean Water Act and the Pollution Control Act and is grounds for enforcement action; for permit termination, revocation and reissuance, or modification; or denial of a permit renewal application. The Department's approval of wastewater facility Plans and Specifications does not relieve the permittee of responsibility to meet permit limits.

(1) The permittee shall comply with effluent standards or prohibitions established under section 307(a) of the Clean Water Act for toxic pollutants and with standards for sewage sludge use or disposal established under section 405(d) of the CWA within the time provided in the regulations that establish these standards or prohibitions or standards for sewage sludge use or disposal, even if the permit has not yet been modified to incorporate the requirement.

(2) Failure to comply with permit conditions or the provisions of this regulation may subject the permittee to civil penalties under S.C. Code Section 48-1-330 or criminal sanctions under S.C. Code Section 48-1-320. Sanctions for violations of the Federal Clean Water Act may be imposed in accordance with the provisions of 40 CFR Part 122.41(a)(2) and (3).

(3) A person who violates any provision of this regulation, a term, condition or schedule of compliance contained within a valid NPDES permit, or the State law is subject to the actions defined in the State law.

(b) Duty to reapply. If the permittee wishes to continue an activity regulated by this permit after the expiration date of this permit, the permittee must apply for and obtain a new permit. (But see 122.4(g)(2)).

(c) Need to halt or reduce activity not a defense. It shall not be a defense for a permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the conditions of this permit.

(d) Duty to mitigate. The permittee shall take all reasonable steps to minimize or prevent any discharge or sludge use or disposal in violation of this permit which has a reasonable likelihood of adversely affecting human health or the environment.

(e)(1) Proper operation and maintenance. The permittee shall at all times properly operate and maintain in good working order and operate as efficiently as possible all facilities and systems of treatment and control (and related appurtenances) which are installed or used by the permittee to achieve compliance with the terms and conditions of this permit. Proper operation and maintenance includes effective performance based on design facility removals, adequate funding, adequate operator staffing and training and also includes adequate laboratory controls and appropriate quality assurance procedures. This provision requires the operation of back-up or auxiliary facilities or similar systems which are installed by a permittee only when the operation is necessary to achieve compliance with the conditions of the permit.



(2) The permittee shall develop and maintain at the facility a complete Operations and Maintenance Manual for the waste treatment facilities and/or land application system. The manual shall be made available for on-site review during normal working hours. The manual shall contain operation and maintenance instructions for all equipment and appurtenances associated with the waste treatment facilities and land application system. The manual shall contain a general description of the treatment process(es), the operational procedures to meet the requirements of (e)(1) above, and the corrective action to be taken should operating difficulties be encountered.

(3)(i) Except as stated in (ii) below, the permittee shall provide for the performance of daily treatment facility inspections by a certified operator of the appropriate grade as defined in the permit for the facility. The inspections shall include, but should not necessarily be limited to, areas which require visual observation to determine efficient operation and for which immediate corrective measures can be taken using the O & M manual as a guide. All inspections shall be recorded and shall include the date, time, and name of the person making the inspection, corrective measures taken, and routine equipment maintenance, repair, or replacement performed. The permittee shall maintain all records of inspections at the permitted facility as required by the permit, and the records shall be made available for on-site review during normal working hours.

(ii) The Department may make exceptions to operating requirements, if stated in the permit, as follows:

(A) Attendance by the certified operator of the appropriate grade ("the operator") is normally required only on days when treatment or discharge occurs.

(B) For performance of daily inspections, permits may allow a reduced grade of operator for limited time periods under specific circumstances when justified by the permittee in a staffing plan and approved by the Department.

(C) Reduced inspection frequency, but in no case less than weekly, may be suitable when specified in the permit, if there is complete telemetry of operating data and there is either a simple treatment system with a low potential for toxicity but requiring pumps or other electrical functions or the ability to stop the discharge for an appropriate period when necessary.

(D) In other circumstances where the permittee demonstrates the capability to evaluate the facility in an alternative manner equivalent to the inspection requirements in subparagraph 3(i).

(E) Any exceptions allowed under (A), (B), (C), and (D) above may be subject to compliance with the permit conditions.

(4)(i) Purpose. This regulation establishes rules for governing the operation and maintenance of wastewater sewer systems, including gravity or pressure interceptor sewers. It is the purpose of this rule to establish standards for the management of sewer systems to prevent and/or minimize system failures that would lead to public health or environmental impacts.

(ii) Authority and applicability. Under Section 48-1-30 of the Code of Laws of South Carolina (1976 as amended), the Department is authorized to adopt such rules and regulations as may be necessary to implement the Pollution Control Act. This regulation applies to all sewer systems that have been or would be subject to a DHEC construction permit under Regulation 61-67 and whose owner owns or operates the wastewater treatment system to which the sewer discharges and which discharges under NPDES. Nothing in this regulation supersedes a more stringent requirement that may be imposed by sewer system owners that manage wastewater from satellite systems. This regulation (122.41(e)(4)) is effective when published in the State Register.

(iii) General requirements. The requirements to properly operate and maintain sewer systems are the responsibility of the system owner. General Standards. The sewer system owner must:

(A) Properly manage, operate, and maintain at all times all parts of its sewer system(s), to include maintaining contractual operation agreements to provide services, if appropriate;

(B) Provide adequate capacity to convey base flows and peak flows for all parts of the sewer system or, if capital improvements are necessary to meet this standard, develop a schedule of short and long term improvements;

(C) Take all reasonable steps to stop and mitigate the impact of releases of wastewater to the environment; and

(D) Notify the Department within 30 days of a proposed change in ownership of a sewer system.

(iv) [Reserved]

(f) Permit actions. This permit may be modified, revoked and reissued, or terminated for cause. The filing of a request by the permittee for a permit modification, revocation and reissuance, or termination, or a notification of planned changes or anticipated noncompliance does not stay any permit condition.

(g) Property rights. This permit does not convey any property rights of any sort, or any exclusive privilege.

(h) Duty to provide information. The permittee shall furnish to the Department, within a reasonable time, any information which the Department may request to determine whether cause exists for modifying, revoking and reissuing, or terminating this permit or to determine compliance with this permit. The permittee shall also furnish to the Department upon request, copies of records required to be kept by this permit.

(i) Inspection and entry. The permittee shall allow the Department, or an authorized representative (including an authorized contractor acting as a representative of the Department), upon presentation of credentials and other documents as may be required by law, to:

(1) Enter upon the permittee's premises where a regulated facility or activity is located or conducted, or where records must be kept under the conditions of this permit;

(2) Have access to and copy, at reasonable times, any records that must be kept under the conditions of this permit;

(3) Inspect at reasonable times any facilities, equipment (including monitoring and control equipment), practices, or operations regulated or required under this permit; and

(4) Sample or monitor at reasonable times, for the purposes of assuring permit compliance or as otherwise authorized by the Clean Water Act and Pollution Control Act, any substances or parameters at any location.

(j) Monitoring and records.

(1)(i)(A) Samples and measurements taken for the purpose of monitoring shall be representative of the monitored activity.

(B) Samples shall be reasonably distributed in time, while maintaining representative sampling.

(C) No analysis, which is otherwise valid, shall be terminated for the purpose of preventing the analysis from showing a permit or water quality violation.

(ii) Flow Measurements.

(A) Where primary flow meters are required, appropriate flow measurement devices and methods consistent with accepted scientific practices shall be present and used to ensure the accuracy and reliability of measurements of the volume of monitored discharges. The devices shall be installed, calibrated, and maintained to ensure that the accuracy of the measurements is consistent with the accepted capability of that type of device. Devices selected shall be capable of measuring flows with a maximum deviation of not greater than 10 percent from the true discharge rates throughout the range of expected discharge volumes. The primary flow device, where required, must be accessible to the use of a continuous flow recorder.

(B) Where permits require an estimate of flow, the permittee shall maintain at the permitted facility a record of the method(s) used in "estimating" the discharge flow (e.g., pump curves, production charts, water use records) for the outfall(s) designated on limits pages to monitor flow by an estimate.

(C) Records of any necessary calibrations must be kept.

(iii) The Department may designate a single, particular day of the month on which any group of parameters listed in the permit must be sampled. When this requirement is imposed in a permit, the Department may waive or alter compliance with the permit requirement for a specific sampling event for extenuating circumstances.

(iv) The Department may require that a permittee monitor parameters in the stream receiving his permitted discharge as necessary to evaluate the need for and to establish limits and conditions and to insure compliance with water quality standards (i.e., R.61-68).

(2) Except for records of monitoring information required by this permit related to the permittee's sewage sludge use and disposal activities, which shall be retained for a period of at least five years (or longer as required by R.61-9.503 or R.61-9.504); the permittee shall retain records of all monitoring information, including all calibration and maintenance records and all original strip chart recordings for continuous monitoring instrumentation, copies of all reports required by this permit, and records of all data used to complete the application for this permit, for a period of at least 3 years from the date of the sample, measurement, report or application. This period may be extended by request of the Department at any time.

(3) Records of monitoring information shall include:

(i) The date, exact place, and time of sampling or measurements;

(ii) The individual(s) who performed the sampling or measurements;

(iii) The date(s) analyses were performed;

(iv) The individual(s) who performed the analyses;

(v) The analytical techniques or methods used; and

(vi) The results of such analyses.

(4) Analyses for required monitoring must be conducted according to test procedures approved under 40 CFR Part 136 unless other test procedures have been specified in the permit or, in the case of sludge use or disposal, unless otherwise specified in R.61-9.503 or R.61-9.504.

(5) The PCA provides that any person who falsifies, tampers with, or knowingly renders inaccurate any monitoring device or method required to be maintained under this permit shall, upon conviction, be punished by a fine of not more than $25,000 or by imprisonment for not more than 2 years, or both. If a conviction of a person is for a violation committed after a first conviction of such person under this paragraph, punishment provided by the Clean Water Act is also by imprisonment of not more than 4 years.

(k) Signatory requirement.

(1) All applications, reports, or information submitted to the Department shall be signed and certified (See section 122.22).

(2) The PCA provides that any person who knowingly makes any false statement, representation, or certification in any record or other document submitted or required to be maintained under this permit, including monitoring reports or reports of compliance or non-compliance shall, upon conviction, be punished by a fine of not more than $25,000 per violation, or by imprisonment for not more than two years per violation, or by both.

(l) Reporting requirements.

(1) Planned changes. The permittee shall give notice to the Department as soon as possible of any planned physical alterations or additions to the permitted facility. Notice is required only when:

(i) The alteration or addition to a permitted facility may meet one of the criteria for determining whether a facility is a new source in section 122.29(b); or

(ii) The alteration or addition could significantly change the nature or increase the quantity of pollutants discharged. This notification applies to pollutants which are subject neither to effluent limitations in the permit, nor to notification requirements under section 122.42(a)(1).

(iii) The alteration or addition results in a significant change in the permittee's sewage sludge or industrial sludge use or disposal practices, and such alteration, addition, or change may justify the application of permit conditions that are different from or absent in the existing permit, including notification of additional use or disposal sites not reported during the permit application process or not reported pursuant to an approved land application plan (included in the NPDES permit directly or by reference);

(2) Anticipated noncompliance. The permittee shall give advance notice to the Department of any planned changes in the permitted facility or activity which may result in noncompliance with permit requirements.

(3) Transfers. This permit is not transferable to any person except after notice to the Department. The Department may require modification or revocation and reissuance of the permit to change the name of permittee and incorporate such other requirements as may be necessary under the Pollution Control Act and the Clean Water Act. (See section 122.61; in some cases, modification or revocation and reissuance is mandatory.)

(4) Monitoring reports. Monitoring results shall be reported at the intervals specified in the permit.

(i) Monitoring results must be reported on a Discharge Monitoring Report (DMR) or forms provided or specified by the Department for reporting results of monitoring of sludge use or disposal practices.

(ii) If the permittee monitors any pollutant more frequently than required by the permit using test procedures approved under 40 CFR Part 136 or, in the case of sludge use or disposal, approved under 40 CFR Part 136 unless otherwise specified in R.61-9.503 or R.61-9.504, or as specified in the permit, the results of this monitoring shall be included in the calculation and reporting of the data submitted in the DMR or sludge reporting form specified by the Department.

(iii) Calculations for all limitations which require averaging of measurements shall utilize an arithmetic mean unless otherwise specified by the Department in the permit.

(5) Compliance schedules. Reports of compliance or noncompliance with, or any progress reports on, interim and final requirements contained in any compliance schedule of this permit shall be submitted no later than 14 days following each schedule date.

(6) Twenty-four hour reporting.

(i) The permittee shall report any noncompliance which may endanger health or the environment. Any information shall be provided orally within 24 hours from the time the permittee becomes aware of the circumstances. A written submission shall also be provided within 5 days of the time the permittee becomes aware of the circumstances. The written submission shall contain a description of the noncompliance and its cause; the period of noncompliance, including exact dates and times, and if the noncompliance has not been corrected, the anticipated time it is expected to continue ; and steps taken or planned to reduce, eliminate, and prevent reoccurrence of the noncompliance.

(ii) The following shall be included as information which must be reported within 24 hours under this paragraph.

(A) Any unanticipated bypass which exceeds any effluent limitation in the permit. (See section 122.44(g)).

(B) Any upset which exceeds any effluent limitation in the permit.

(C) Violation of a maximum daily discharge limitation for any of the pollutants listed by the Department in the permit to be reported within 24 hours (See section 122.44(g)).

(iii) The Department may waive the written report on a case-by-case basis for reports under paragraph (l)(6)(ii) of this section if the oral report has been received within 24 hours.

(7) Other noncompliance. The permittee shall report all instances of noncompliance not reported under paragraphs (l)(4), (5), and (6) of this section, at the time monitoring reports are submitted. The reports shall contain the information listed in paragraph (l)(6) of this section.

(8) Other information. Where the permittee becomes aware that it failed to submit any relevant facts in a permit application, or submitted incorrect information in a permit application or in any report to the Department, it shall promptly submit such facts or information.

(m) Bypass.

(1) Definitions.

(i) "Bypass" means the intentional diversion of waste streams from any portion of a treatment facility.

(ii) "Severe property damage" means substantial physical damage to property, damage to the treatment facilities which causes them to become inoperable, or substantial and permanent loss of natural resources which can reasonably be expected to occur in the absence of a bypass. Severe property damage does not mean economic loss caused by delays in production.

(2) Bypass not exceeding limitations. The permittee may allow any bypass to occur which does not cause effluent limitations to be exceeded but only if it also is for essential maintenance to assure efficient operation. These bypasses are not subject to the provisions of paragraph (m)(3) and (m)(4) of this section.

(3) Notice.

(i) Anticipated bypass. If the permittee knows in advance of the need for a bypass, it shall submit prior notice, if possible, at least ten days before the date of the bypass.

(ii) Unanticipated bypass. The permittee shall submit notice of an unanticipated bypass as required in paragraph (l)(6) of this section (24-hour notice).

(4) Prohibition of bypass

(i) Bypass is prohibited, and the Department may take enforcement action against a permittee for bypass, unless:

(A) Bypass was unavoidable to prevent loss of life, personal injury, or severe property damage;

(B) There were no feasible alternatives to the bypass, such as the use of auxiliary treatment facilities, retention of untreated wastes, or maintenance during normal periods of equipment downtime. This condition is not satisfied if adequate back-up equipment should have been installed in the exercise of reasonable engineering judgment to prevent a bypass which occurred during normal periods of equipment downtime or preventive maintenance; and

(C) The permittee submitted notices as required under paragraph (m)(3) of this section.

(ii) The Department may approve an anticipated bypass, after considering its adverse effects, if the Department determines that it will meet the three conditions listed above in paragraph (m)(4)(i) of this section.

(n) Upset.

(1) Definition. "Upset" means an exceptional incident in which there is unintentional and temporary noncompliance with technology based permit effluent limitations because of factors beyond the reasonable control of the permittee. A upset does not include noncompliance to the extent caused by operational error, improperly designed treatment facilities, inadequate treatment facilities, lack of preventive maintenance, or careless or improper operation.

(2) Effect of an upset. An upset constitutes an affirmative defense to an action brought for noncompliance with such technology based permit effluent limitations if the requirements of paragraph (n)(3) of this section are met. No determination made during administrative review of claims that noncompliance was caused by upset, and before an action for noncompliance, is final administrative action subject to judicial review.

(3) Conditions necessary for a demonstration of upset. A permittee who wishes to establish the affirmative defense of upset shall demonstrate, through properly signed, contemporaneous operating logs, or other relevant evidence that:

(i) An upset occurred and that the permittee can identify the cause(s) of the upset;

(ii) The permitted facility was at the time being properly operated; and

(iii) The permittee submitted notice of the upset as required in paragraph (l)(6)(ii)(B) of this section (24 hour notice).

(iv) The permittee complied with any remedial measures required under paragraph (d) of this section.

(4) Burden of proof. In any enforcement proceeding, the permittee seeking to establish the occurrence of an upset has the burden of proof.

(o) Misrepresentation of Information.

(1) Any person making application for a NPDES discharge permit or filing any record, report, or other document pursuant to a regulation of the Department, shall certify that all information contained in such document is true. All application facts certified to by the applicant shall be considered valid conditions of the permit issued pursuant to the application.

(2) Any person who knowingly makes any false statement, representation, or certification in any application, record, report, or other documents filed with the Department pursuant to the State law, and the rules and regulations pursuant to that law, shall be deemed to have violated a permit condition and shall be subject to the penalties provided for pursuant to 48-1-320 or 48-1-330.

122.42. Additional conditions applicable to specified categories of NPDES permits.

The following conditions, in addition to those set forth in section 122.41, apply to all NPDES permits within the categories specified below:

(a) Existing manufacturing, commercial, mining, and silvicultural dischargers. In addition to the reporting requirements under section 122.41(1), all existing manufacturing, commercial, mining, and silvicultural dischargers must notify the Department as soon as they know or have reason to believe:

(1) That any activity has occurred or will occur which would result in the discharge on a routine or frequent basis, of any toxic pollutant which is not limited in the permit, if that discharge will exceed the highest of the following "notification levels":

(i) One hundred micrograms per liter (100 ug/l);

(ii) Two hundred micrograms per liter (200 ug/l) for acrolein and acrylonitrile; five hundred micrograms per liter (500 ug/l) for 2,4-dinitrophenol and for 2-methyl-4,6-dinitrophenol; and one milligram per liter (1 mg/l) for antimony;

(iii) Five (5)times the maximum concentration value reported for that pollutant in the permit application in accordance with section 122.21(g)(7); or

(iv) The level established by the Department in accordance with section 122.44(f).

(2) That any activity has occurred or will occur which would result in any discharge, on a non-routine or infrequent basis, of a toxic pollutant which is not limited in the permit, if that discharge will exceed in the highest of the following "notification levels":

(i) Five hundred micrograms per liter (500 ug/l);

(ii) One milligram per liter (1 mg/l) for antimony;

(iii) Ten (10) times the maximum concentration value reported for that pollutant in the permit application in accordance with section 122.21(g)(7).

(iv) The level established by the Department in accordance with section 122.44(f).

(b) Publicly owned treatment works. All POTWs must provide adequate notice to the Department of the following:

(1) Any new introduction of pollutants into the POTW from an indirect discharger which would be subject to sections 301 or 306 of CWA if it were directly discharging those pollutants; and

(2) Any substantial change in the volume or character of pollutants being introduced into that POTW by a source introducing pollutants into the POTW at the time of issuance of the permit.

(3) For purposes of this paragraph, adequate notice shall include information on:

(i) The quality and quantity of effluent introduced into the POTW, and

(ii) Any anticipated impact of the change on the quantity or quality of effluent to be discharged from the POTW.

(c) Municipal separate storm sewer systems. The operator of a large or medium municipal separate storm sewer system or a municipal separate storm sewer that has been designated by the Department under section 122.26(a)(1)(v) of this regulation must submit an annual report by the anniversary of the date of the issuance of the permit for such system. The report shall include:

(1) The status of implementing the components of the storm water management program that are established as permit conditions;

(2) Proposed changes to the storm water management programs that are established as permit conditions. Such proposed changes shall be consistent with section 122.26(d)(2)(iii); and

(3) Revisions, if necessary, to the assessment of controls and the fiscal analysis reported in the permit application under section 122.26(d)(2)(iv) and (d)(2)(v);

(4) A summary of data, including monitoring data, that is accumulated throughout the reporting year;

(5) Annual expenditures and budget for year following each annual report;

(6) A summary describing the number and nature of enforcement actions, inspections, and public education programs;

(7) Identification of water quality improvements or degradation.

(d) Storm water discharges. The initial permits for discharges composed entirely of storm water issued pursuant to section 122.26(e)(7) of this regulation shall require compliance with the conditions of the permit as expeditiously as practicable, but in no event later than three years after the date of issuance of the permit.

(e) Concentrated animal feeding operations (CAFO). Any permit issued to a CAFO must include:

(1) Requirements to develop and implement a nutrient management plan. At a minimum, a nutrient management plan must include best management practices and procedures necessary to implement applicable effluent limitations and standards. Permitted CAFO must have their nutrient management plans developed and implemented by December 31, 2006. CAFO that seek to obtain coverage under a permit after December 31, 2006 must have a nutrient management plan developed and implemented upon the date of permit coverage. The nutrient management plan must, to the extent applicable:

(i) Ensure adequate storage of manure, litter, and process wastewater, including procedures to ensure proper operation and maintenance of the storage facilities;

(ii) Ensure proper management of mortalities (i.e., dead animals) to ensure that they are not disposed of in a liquid manure, storm water, or process wastewater storage or treatment system that is not specifically designed to treat animal mortalities;

(iii) Ensure that clean water is diverted, as appropriate, from the production area;

(iv) Prevent direct contact of confined animals with waters of the United States;

(v) Ensure that chemicals and other contaminants handled on-site are not disposed of in any manure, litter, process wastewater, or storm water storage or treatment system unless specifically designed to treat such chemicals and other contaminants;

(vi) Identify appropriate site-specific conservation practices to be implemented, including as appropriate buffers or equivalent practices, to control runoff of pollutants to waters of the State;

(vii) Identify protocols for appropriate testing of manure, litter, process wastewater, and soil;

(viii) Establish protocols to land apply manure, litter, or process wastewater in accordance with site-specific nutrient management practices that ensure appropriate agricultural utilization of the nutrients in the manure, litter, or process wastewater; and

(ix) Identify specific records that will be maintained to document the implementation and management of the minimum elements described in paragraphs (e)(1)(i) through (e)(1)(viii) of this section.

(2) Recordkeeping requirements.

(i) The permittee must create, maintain for five years, and make available to the Department upon request, the following records:

(A) All applicable records identified pursuant to paragraph (e)(1)(ix) of this section;

(B) In addition, all CAFO subject to 40 CFR 412 must comply with record keeping requirements specified in sections 412.37(b) and (c) and sections 412.47(b) and (c).

(ii) A copy of the CAFO's site-specific nutrient management plan must be maintained on site and made available to the Department upon request.

(3) Requirements relating to transfer of manure or process wastewater to other persons. Prior to transferring manure, litter, or process wastewater to other persons, Large CAFO must provide the recipient of the manure, litter, or process wastewater with the most current nutrient analysis. The analysis provided must be consistent with the requirements of 40 CFR 412. Large CAFO must retain for five years records of the date, recipient name and address, and approximate amount of manure, litter, or process wastewater transferred to another person.

(4) Annual reporting requirements for CAFO. The permittee must submit an annual report to the Department. The annual report must include:

(i) The number and type of animals (beef cattle, broilers, layers, swine weighing 55 pounds or more, swine weighing less than 55 pounds, mature dairy cows, dairy heifers, veal calves, sheep and lambs, horses, ducks, turkeys, other), whether in open confinement or housed under roof;

(ii) Estimated total amount of manure, litter, and process wastewater generated by the CAFO in the previous 12 months (tons/gallons);

(iii) Estimated total amount of manure, litter, and process wastewater transferred to other person(s) by the CAFO in the previous 12 months (tons/gallons);

(iv) Total number of acres for land application covered by the nutrient management plan developed in accordance with paragraph (e)(1) of this section;

(v) Total number of acres under control of the CAFO that were used for land application of manure, litter, and process wastewater in the previous 12 months;

(vi) Summary of all manure, litter, and process wastewater discharges from the production area that have occurred in the previous 12 months, including date, time, and approximate volume; and

(vii) A statement indicating whether the current version of the CAFO's nutrient management plan was developed or approved by a certified nutrient management planner.

(f) Easements. Easements for Storm Water NPDES Permits or Leaking Underground Storage Tank Groundwater Remediation NPDES Permits. Easements for ditch discharges from either a storm water point source or a leaking underground storage tank groundwater remediation project will not be required to be submitted to the Department as a prerequisite for obtaining an individual NPDES permit or for coverage under a general permit. The permittee must ensure that all easements necessary for the discharge are obtained prior to the discharge occurring.

122.43. Establishing permit conditions.

(a) In addition to conditions required in all permits (sections 122.41 and 122.42), the Department shall establish conditions, as required on a case-by-case basis, to provide for and assure compliance with all applicable requirements of CWA and PCA and regulations. These shall include conditions under section 122.46 (duration of permits), section 122.47(a) (schedules of compliance), and section 122.48 (monitoring).

(b)(1) An "applicable requirement" is a State statutory or regulatory requirement which takes effect prior to final administrative disposition of a permit. An applicable requirement is also any requirement which takes effect prior to the modification or revocation and reissuance of a permit, to the extent allowed in section 122.62.



(2) New or reissued permits, and to the extent allowed under section 122.62 modified or revoked and reissued permits, shall incorporate each of the applicable requirements referenced in section 122.44 and section 122.45.

(c) Incorporation. All permit conditions shall be incorporated either expressly or by reference. If incorporated by reference, a specific citation to the applicable regulations or requirements must be given in the permit.

122.44. Establishing limitations, standards, and other permit conditions.

In addition to the conditions established under section 122.43(a), each NPDES permit shall include conditions meeting the following requirements when applicable.

(a)(1) Technology-based effluent limitations and standards based on effluent limitations and standards promulgated under section 301 of the CWA, new source performance standards promulgated under section 306 of CWA, or case-by-case effluent limitations determined under section 402(a)(1) of CWA, or a combination of the three, in accordance with section 125.3. For new sources or new dischargers, these technology based limitations and standards are subject to the provisions of section 122.29(d) (protection period).



(2) Monitoring waivers for certain guideline-listed pollutants.

(i) The Department may authorize a discharger subject to technology-based effluent limitations guidelines and standards in an NPDES permit to forego sampling of a pollutant found at 40 CFR Subchapter N if the discharger has demonstrated through sampling and other technical factors that the pollutant is not present in the discharge or is present only at background levels from intake water and without any increase in the pollutant due to activities of the discharger.

(ii) This waiver is good only for the term of the permit and is not available during the term of the first permit issued to a discharger.

(iii) Any request for this waiver must be submitted when applying for a reissued permit or modification of a reissued permit. The request must demonstrate through sampling or other technical information, including information generated during an earlier permit term that the pollutant is not present in the discharge or is present only at background levels from intake water and without any increase in the pollutant due to activities of the discharger.

(iv) Any grant of the monitoring waiver must be included in the permit as an expressed permit condition and the reasons supporting the grant must be documented in the permit's fact sheet or statement of basis.

(v) This provision does not supersede certification processes and requirements already established in existing effluent limitations guidelines and standards.

(b)(1) Other effluent limitations and standards under sections 301, 302, 303, 307, 318 and 405 of CWA. If any applicable toxic effluent standard or prohibition (including any schedule of compliance specified in such effluent standard or prohibition) is promulgated under section 307(a) of CWA for a toxic pollutant and that standard or prohibition is more stringent than any limitation on the pollutant in the permit, the Department shall institute proceedings under these regulations to modify or revoke and reissue the permit to conform to the toxic effluent standard or prohibition. See also section 122.41(a).

(2) Standards for sewage sludge use or disposal under section 405(d) of the CWA unless those standards have been included in a permit issued under the appropriate provisions of subtitle C of the Solid Waste Disposal Act, Part C of Safe Drinking Water Act, the Marine Protection, Research, and Sanctuaries Act of 1972, or the Clean Air Act, or under State NPDES permit programs approved by the Administrator. When there are no applicable standards for sewage sludge use or disposal, the permit may include requirements developed on a case-by-case basis to protect public health and the environment from any adverse effects which may occur from toxic pollutants in sewage sludge. If any applicable standard for sewage sludge use or disposal is promulgated under section 405(d) of the CWA and that standard is more stringent than any limitation on the pollutant or practice in the permit, the Department may initiate proceedings under these regulations to modify or revoke and reissue the permit to conform to the standard for sewage sludge use or disposal.

(c) Reopener clause:

(1) For any permit issued to a treatment works treating domestic sewage (including "sludge-only facilities"), the Department shall include a reopener clause to incorporate any applicable standard for sewage sludge use or disposal promulgated under section 405(d) of the CWA. The Department may promptly modify or revoke and reissue any permit containing the reopener clause required by this paragraph, if the standard for sewage sludge use or disposal is more stringent than any requirements for sludge use or disposal in the permit or controls a pollutant or practice not limited in the permit.

(2) A permit may include a reopener referring to a permit modification reasonably foreseen based on expected revision to law or regulation or based on the expectation of receipt of information when either of these would be the basis for a modification under R.61-9.122.62.

(d) Water quality standards and State requirements: any requirements in addition to or more stringent than promulgated effluent limitations guidelines or standards under sections 301, 304, 306, 307, and 318, and 405 of CWA necessary to:

(1) Achieve water quality standards established under section 303 of the CWA, including State narrative criteria for water quality.

(i) Limitations must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Department determines are or may be discharged at a level which will cause, have the reasonable potential to cause, or contribute to an excursion above any State water quality standard, including State narrative criteria for water quality.

(ii) When determining whether a discharge causes, has the reasonable potential to cause, or contributes to an in-stream excursion above a narrative or numeric criteria within a State water quality standard, the permitting authority shall use procedures which account for existing controls on point and nonpoint sources of pollution, the variability of the pollutant or pollutant parameter in the effluent, the sensitivity of the species to toxicity testing (when evaluating whole effluent toxicity), and where appropriate, the dilution of the effluent in the receiving water.

(iii) When the permitting authority determines, using the procedures in paragraph (d)(1)(ii) of this section, that a discharge causes, has the reasonable potential to cause, or contributes to an in-stream excursion above the allowable ambient concentration of a State numeric criteria within a State water quality standard for an individual pollutant, the permit must contain effluent limits for that pollutant.

(iv) When the permitting authority determines, using the procedures in paragraph (d)(1)(ii) of this section, that a discharge causes, has the reasonable potential to cause, or contributes to an in-stream excursion above the numeric criterion for whole effluent toxicity, the permit must contain effluent limits for whole effluent toxicity.

(v) Except as provided in this subparagraph, when the permitting authority determines, using the procedures in paragraph (d)(1)(ii) of this section, toxicity testing data, or other information, that a discharge causes, has the reasonable potential to cause, or contributes to an in-stream excursion above a narrative criterion within an applicable State water quality standard, the permit must contain effluent limits for whole effluent toxicity. Limits on whole effluent toxicity are not necessary where the permitting authority demonstrates in the fact sheet or statement of basis of the NPDES permit, using the procedures in paragraph (d)(1)(ii) of this section, that chemical-specific limits for the effluent are sufficient to attain and maintain applicable numeric and narrative State water quality standards.

(vi) Where the Department has not established a water quality criterion for a specific chemical pollutant that is present in an effluent at a concentration that causes, has the reasonable potential to cause, or contributes to an excursion above a narrative criterion within an applicable State water quality standard, the permitting authority must establish effluent limits using one or more the following options:

(A) Establish effluent limits using calculated numeric water quality criterion for the pollutant which the permitting authority demonstrates will attain and maintain applicable narrative water quality criteria and will fully protect the designated use. Such a criterion may be derived using a proposed State criterion, or an explicit State policy or regulation interpreting its narrative water quality criterion, supplemented with other relevant information which may include: EPA's Water Quality Standards Handbook, October 1983, risk assessment data, exposure data, information about the pollutant from the Food and Drug Administration, and current EPA criteria documents; or

(B) Establish effluent limits on a case-by-case basis, using EPA's water quality criteria, published under section 307(a) of the CWA, supplemented where necessary by other relevant information; or

(C) Establish effluent limitations on an indicator parameter for the pollutant of concern, provided:

(1) The permit identifies which pollutants are intended to be controlled by the use of the effluent limitation;

(2) The fact sheet required by R.61-9.124.56 sets forth the basis for the limit, including a finding that compliance with the effluent limit on the indicator parameter will result in controls on the pollutant of concern which are sufficient to attain and maintain applicable water quality standards;

(3) The permit requires all effluent and ambient monitoring necessary to show that during the term of the permit the limit on the indicator parameter continues to attain and maintain applicable water quality standards; and

(4) The permit contains a reopener clause allowing the permitting authority to modify or revoke and reissue the permit if the limits on the indicator parameter no longer attain and maintain applicable water quality standards.

(vii) When developing water quality-based effluent limits under this paragraph, the permitting authority shall ensure that:

(A) The level of water quality to be achieved by limits on point sources established under this paragraph is derived from, and complies with all applicable water quality standards; and

(B) Effluent limits developed to protect a narrative water quality criterion, a numeric water quality criterion, or both, are consistent with the assumptions and requirements of any available wasteload allocation for the discharge prepared by the State and approved by EPA pursuant to 40 CFR 130.7.

(2) Attain or maintain a specified water quality through water quality related effluent limits established under section 302 of CWA;

(3) Conform to the conditions to a State certification under R.61-101 and section 401 of the CWA.

(4) Conform to applicable water quality requirements under section 401(a)(2) of CWA when the discharge affects a State other than the certifying State:

(5) Incorporate any more stringent limitations, treatment standards, or schedule of compliance requirements established under Federal or State law or regulations in accordance with section 301(b))(1)(C) of CWA;

(6) Ensure consistency with the requirements of a Water Quality Management plan approved by EPA under section 208(b) of CWA;

(7) Incorporate section 403(c) criteria under R.61-9.125 Part M, for ocean discharges;

(8) Incorporate alternative effluent limitations or standards where warranted by "fundamentally different factors," under R.61-9.125 Part D;

(9) [Reserved]

(e) Technology-based controls for toxic pollutants. Limitations established under paragraphs (a), (b), or (d) of this section, to control pollutants meeting the criteria listed in paragraph (e)(1) of this section. Limitations will be established in accordance with paragraph (e)(2) of this section. An explanation of the development of these limitations shall be included in the fact sheet under R.61-9.124.56(b)(1)(i).

(1) Limitations must control all toxic pollutants which the Department determines (based on information reported in a permit application under section 122.21(g)(7) or in a notification under section 122.42(a)(1) or on other information) are or may be discharged at a level greater than the level which can be achieved by the technology-based treatment requirements appropriate to the permittee under R.61-9.125.3(c); or

(2) The requirement that the limitations control the pollutants meeting the criteria of paragraph (e)(1) of this section will be satisfied by:

(i) Limitations on those pollutants; or

(ii) Limitations on other pollutants which, in the judgement of the Department, will provide treatment of the pollutants under paragraph (e)(1) of this section to the levels required by 125.3(c).

(f) Notification level. A "notification level" which exceeds the notification level of section 122.42(a)(1)(i), (ii) or (iii), upon a petition from the permittee or on the Department's initiative. This new notification level may not exceed the level which can be achieved by the technology-based treatment requirements appropriate to the permittee under R.61-9.125.3(c).

(g) Twenty-four hour reporting. Pollutants for which the permittee must report violations of maximum daily discharge limitations under section 122.41(l)(6)(ii)(C) (24-hour reporting) shall be listed in the permit. This list shall include any toxic pollutant or hazardous substance, or any pollutant specifically identified as the method to control a toxic pollutant or hazardous substance.

(h) Durations for permits, as set forth in section 122.46.

(i) Monitoring requirements. In addition to section 122.48, the following monitoring requirements:

(1) To assure compliance with the permit and protection of the environment, requirements to monitor:

(i) The mass (or other measurement specified in the permit) for each pollutant limited in the permit and as necessary to characterize any other pollutant, which may be in the wastewater, which has a significant potential to have an effect on the environment or operation of treatment or disposal facilities,

(ii) The volume of effluent discharged from each outfall;

(iii) Other measurements as appropriate including pollutants in internal waste streams under section 122.45(h), pollutants in intake water for net limitations under section 122.45(g); frequency, rate of discharge, etc., for noncontinuous discharges under section 122.45(e); pollutants subject to notification requirements under section 122.42(a); and pollutants in sewage sludge or other monitoring as specified in R.61-9.503 or R.61-9.504; or as determined to be necessary on a case-by-case basis pursuant to section 405(d)(4) of the CWA.

(iv) According to test procedures approved under 40 CFR Part 136 for the analyses of pollutants having approved methods under that part, and according to a test procedure specified in the permit for pollutants with no approved methods.

(2) Except as provided in paragraphs (i)(4) and (i)(5) of this section, requirements to report monitoring results shall be established on a case-by-case basis with a frequency dependent on the nature and effect of the discharge but in no case less than once a year. For sewage sludge use or disposal practices, requirements to monitor and report results shall be established on a case-by-case basis with a frequency dependent on the nature and effect of the sewage sludge use or disposal practice; minimally this shall be as specified in R.61-9.503 (where applicable) but in no case less than once a year.

(3) Requirements to report monitoring results for storm water discharges associated with industrial activity which are subject to an effluent limitation guideline shall be established on a case-by-case basis with a frequency dependent on the nature and effect of the discharge, but in no case less than once a year.

(4) Requirements to report monitoring results for storm water discharges associated with industrial activity (other than those addressed in paragraph (i)(3) of this section) shall be established on a case-by-case basis with a frequency dependent on the nature and effect of the discharge. At a minimum, a permit for such a discharge must require:

(i) The discharger to conduct an annual inspection of the facility site to identify areas contributing to a storm water discharge associated with industrial activity and evaluate whether measures to reduce pollutant loadings identified in a storm water pollution prevention plan are adequate and properly implemented in accordance with the terms of the permit or whether additional control measures are needed;

(ii) The discharger to maintain for a period of three years a record summarizing the results of the inspection and a certification that the facility is in compliance with the plan and the permit, and identifying any incidents of non-compliance.

(iii) Such report and certification be signed in accordance with section 122.22 and

(iv) Permits for storm water discharges associated with industrial activity from inactive mining operations may, where annual inspections are impracticable, require certification once every three years by a Registered Professional Engineer that the facility is in compliance with the permit, or alternative requirements.

(5) Permits which do not require the submittal of monitoring result reports at least annually shall require that the permittee report all instances of noncompliance not reported under section 122.41(l)(1), (4), (5) and (6) at least annually.

(j) Pretreatment program for POTWs. Requirements for POTWs to:

(1) Identify, in terms of character and volume of pollutants, any Significant Industrial Users discharging into the POTW subject to Pretreatment Standards under section 307(b) of CWA and R.61-9.403.

(2)(i) Submit a local program when required by and in accordance with R.61-9.403 to assure compliance with pretreatment standards to the extent applicable under section 307(b). The local program shall be incorporated into the permit as described in R.61-9.403. The program must require all indirect dischargers to the POTW to comply with the reporting requirements of R.61-9.403.

(ii) Provide a written technical evaluation of the need to revise local limits under R.61-9.403.5(c)(1), following permit issuance or reissuance.

(3) For POTWs which are "sludge-only facilities," a requirement to develop a pretreatment program under R.61-9.403 when the Department determines that a pretreatment program is necessary to assure compliance with section 405(d) of the CWA.

(k) Best management practices (BMP) to control or abate the discharge of pollutants when:

(1) Authorized under section 304(e) of CWA for the control of toxic pollutants and hazardous substances from ancillary industrial activities;

(2) Authorized under section 402(p) of the CWA for the control of storm water discharges;

(3) Numeric effluent limitations are infeasible; or

(4) The practices are reasonably necessary to achieve effluent limitations and standards or to carry out the purposes and intent of the CWA.

(l) Reissued permits.

(1) Except as provided in paragraph (l)(2) or (l)(3) of this section when a permit is renewed or reissued, interim effluent limitations, standards or conditions must be at least as stringent as the final effluent limitations, standards, or conditions in the previous permit (unless the circumstances on which the previous permit was based have materially and substantially changed since the time the permit was issued and would constitute cause for permit modification or revocation and reissuance under section 122.62).

(2) In the case of effluent limitations established on the basis of Section 402(a)(1)(B) of the CWA, a permit may not be renewed, reissued, or modified on the basis of effluent guidelines promulgated under section 304(b) subsequent to the original issuance of such permit, to contain effluent limitations which are less stringent than the comparable effluent limitations in the previous permit.

(i) Exceptions -- A permit with respect to which paragraph (l)(2) of this section applies may be renewed, reissued, or modified to contain a less stringent effluent limitation applicable to a pollutant, if --

(A) Material and substantial alterations or additions to the permitted facility occurred after permit issuance which justify the application of a less stringent effluent limitation;

(B)(1) Information is available which was not available at the time of permit issuance (other than revised regulations, guidance, or test methods) and which would have justified the application of a less stringent effluent limitation at the time of permit issuance; or

(2) The Department determines that technical mistakes or mistaken interpretations of law were made in issuing the permit under section 402(a)(1)(b);

(C) A less stringent effluent limitation is necessary because of events over which the permittee has no control and for which there is no reasonably available remedy;

(D) The permittee has received a permit modification under section 301(c), 301(k), 301(n), or 316(a); or

(E) The permittee has installed the treatment facilities required to meet the effluent limitations in the previous permit and has properly operated and maintained the facilities but has nevertheless been unable to achieve the previous effluent limitations, in which case the limitations in the reviewed, reissued, or modified permit may reflect the level of pollutant control actually achieved (but shall not be less stringent than required by effluent guidelines in effect at the time of permit renewal, reissuance, or modification.

(ii) Limitations. In no event may a permit with respect to which paragraph (l)(2) of this section applies be renewed, reissued, or modified to contain an effluent limitation which is less stringent than required by effluent guidelines in effect at the time the permit is renewed, reissued, or modified. In no event may such a permit to discharge into waters be renewed, reissued, or modified to contain a less stringent effluent limitation if the implementation of such limitation would result in a violation of a water quality standard under section 303 of the CWA applicable to such waters.

(3) In the event this section (section 122.44(l)) of the regulations conflicts with the provisions of the Clean Water Act, the CWA will apply.

(m) Privately owned treatment works. For a privately owned treatment works, any conditions expressly applicable to any user, as a limited co-permittee, that may be necessary in the permit issued to the treatment works to ensure compliance with applicable requirements under this part. Alternatively, the Department may issue separate permits to the treatment works and to its users, or may require a separate permit application from any user. The Department's decision to issue a permit with no conditions applicable to any user, to impose conditions on one or more users, to issue separate permits, or to require separate applications, and the basis for that decision, shall be stated in the fact sheet for the draft permit for the treatment works.

(n) Grants. Any conditions imposed in grants made by the Department to POTWs under sections 201 and 204 of CWA which are reasonably necessary for the achievement of effluent limitations under Section 301 of CWA.

(o) Sewage sludge. Requirements under section 405 of CWA governing the disposal of sewage sludge from publicly owned treatment works or any other treatment works treating domestic sewage for any use for which regulations have been established, in accordance with any applicable regulations.

(p) Coast Guard. When a permit is issued to a facility that may operate at certain times as a means of transportation over water, a condition that the discharge shall comply with any applicable regulations promulgated by the Secretary of the Department in which the Coast Guard is operating, that establish specifications for safe transportation, handling, carriage, and storage of pollutants.

(q) Navigation. Any conditions that the Secretary of the Army considers necessary to ensure that navigation and anchorage will not be substantially impaired, in accordance with R61-9.124.59.

(r) [Reserved]

(s) Qualifying State, Tribal, or local programs.

(1) For storm water discharges associated with small construction activity identified in section 122.26(b)(15), the Director may include permit conditions that incorporate qualifying State, Tribal, or local erosion and sediment control program requirements by reference. Where a qualifying State, Tribal, or local program does not include one or more of the elements in this paragraph (s)(1), then the Director must include those elements as conditions in the permit. A qualifying State, Tribal, or local erosion and sediment control program is one that includes:

(i) Requirements for construction site operators to implement appropriate erosion and sediment control best management practices;

(ii) Requirements for construction site operators to control waste such as discarded building materials, concrete truck washout, chemicals, litter, and sanitary waste at the construction site that may cause adverse impacts to water quality;

(iii) Requirements for construction site operators to develop and implement a storm water pollution prevention plan. (A storm water pollution prevention plan includes site descriptions, descriptions of appropriate control measures, copies of approved State, Tribal or local requirements, maintenance procedures, inspection procedures, and identification of non-storm water discharges); and

(iv) Requirements to submit a site plan for review that incorporates consideration of potential water quality impacts.

(2) For storm water discharges from construction activity identified in section 122.26(b)(14)(x), the Director may include permit conditions that incorporate qualifying State, Tribal, or local erosion and sediment control program requirements by reference. A qualifying State, Tribal or local erosion and sediment control program is one that includes the elements listed in paragraph (s)(1) of this section and any additional requirements necessary to achieve the applicable technology-based standards of "best available technology" and "best conventional technology" based on the best professional judgment of the permit writer.

122.45. Calculating NPDES permit conditions.

(a) Outfalls and discharge points. All permit effluent limitations, standards and prohibitions shall be established for each outfall or discharge point of the permitted facility, except as otherwise provided under section 122.44(k) (BMPs where limitations are infeasible) and paragraph (h) of this section (limitations on internal waste streams).

(b) Production-based limitations.

(1) In the case of POTWs, permit effluent limitations, standards, or prohibitions shall be calculated based on design flow.

(2)(i) Except in the case of POTWs or as provided in paragraph (b)(2)(ii) of this section, calculation of any permit limitations, standards, or prohibitions which are based on production (or other measure of operation) shall be based not upon the designed production capacity but rather upon a reasonable measure of actual production of the facility. For new sources or new dischargers, actual production shall be estimated using projected production. The time period of the measure of production shall correspond to the time period of the calculated permit limitations; for example, monthly production shall be used to calculate average monthly discharge limitations.

(ii)(A)(1) The Department may include a condition establishing alternate permit limitations, standards, or prohibitions based upon anticipated increased (not to exceed maximum production capability) or decreased production levels.

(2) For the automotive manufacturing industry only, the Department may establish a condition under paragraph (b)(2)(ii)(A)(1) of this section if the applicant satisfactorily demonstrates to the Department at the time the application is submitted that its actual production, as indicated in paragraph (b)(2)(i) of this section, is substantially below maximum production capability and that there is a reasonable potential for an increase above actual production during the duration of the permit.

(B) If the Department establishes permit conditions under paragraph (b)(2)(ii)(A) of this section:

(1) The permit shall require the permittee to notify the Department at least two business days prior to a month in which the permittee expects to operate at a level higher than the lowest production level identified in the permit. The notice shall specify the anticipated level and the period during which the permittee expects to operate at the alternate level. If the notice covers more than one month, the notice shall specify the reasons for the anticipated production level increase. New notice of discharge at alternate levels is required to cover a period or production level not covered by prior notice or, if during two consecutive months otherwise covered by a notice, the production level at the permitted facility does not in fact meet the higher level designated in the notice.

(2) The permittee shall comply with the limitations, standards, or prohibitions that correspond to the lowest level of production specified in the permit, unless the permittee has notified the Department under paragraph (b)(2)(ii)(B)(1) of this section, in which case the permittee shall comply with the lower of the actual level of production during each month or the level specified in the notice.

(3) The permittee shall submit with the DMR the level of production that actually occurred during each month and the limitations, standards, or prohibitions applicable to that level of production.

(c) Metals. All permit effluent limitations, standards, or prohibitions for a metal shall be expressed in terms of "total recoverable metal" as defined in 40 CFR Part 136 unless:

(1) An applicable effluent standard or limitation has been promulgated under the CWA or under R.61-68 and specifies the limitation for the metal in the dissolved or valent or total form; or

(2) In establishing permit limitations on a case-by-case basis under R.61-9.125.3, it is necessary to express the limitation on the metal in the dissolved or valent or total form to carry out the provisions of the CWA; or

(3) All approved analytical methods for the metal inherently measure only its dissolved form (e.g. hexavalent chromium).

(d) Continuous discharges. For continuous discharges all permit effluent limitations, standards, and prohibitions, including those necessary to achieve water quality standards, shall unless impracticable be stated as:

(1) Maximum daily and average monthly discharge limitations for all dischargers other than publicly owned treatment works; and

(2) Average weekly and average monthly discharge limitations for POTWs.

(e) Non-continuous discharges. Discharges which are not continuous, as defined in section 122.2, shall be particularly described and limited, considering the following factors, as appropriate:

(1) Frequency (for example a batch discharge shall not occur more than once every 3 weeks);

(2) Total mass (for example, not to exceed 100 kilograms of zinc and 200 kilograms of chromium per batch discharge);

(3) Maximum rate of discharge of pollutants during the discharge (for example, not to exceed 2 kilograms of zinc per minute); and

(4) Prohibition or limitation of specified pollutants by mass, concentration, or other appropriate measure (for example, shall not contain at any time more than 0.1 mg/l zinc or more than 250 grams ( 1/4 kilogram) of zinc in any discharge).

(f) Mass limitations.

(1) All pollutants limited in permits shall have limitations, standards, or prohibitions expressed in terms of mass except:

(i) For pH, temperature, radiation, or other pollutants which cannot appropriately be expressed in mass:

(ii) When applicable standards and limitations are expressed in terms of other units of measurement; or

(iii) If in establishing permit limitations on a case-by-case basis under R.61-9.125.3, limitations expressed in terms of mass are infeasible because the mass of the pollutant discharged cannot be related to a measure of operation (for example, discharges of TSS from certain mining operations), and permit conditions ensure that dilution will not be used as a substitute for treatment.

(2) Pollutants limited in terms of mass additionally may be limited in terms of other units of measurement, and the permit shall require the permittee to comply with both limitations.

(g) Pollutants in intake water.

(1) Upon request of the discharger, technology-based effluent limitations or standards shall be adjusted to reflect credit for pollutants in the discharger's intake water if;

(i) The applicable effluent limitations and standards contained in 40 CFR Subchapter N specifically provide that they shall be applied on a net basis; or

(ii) The discharger demonstrates that the control system it proposes or uses to meet applicable technology-based limitations and standards would, if properly installed and operated, meet the limitations and standards in the absence of pollutants in the intake waters.

(2) Credit for generic pollutants such as biochemical oxygen demand (BOD) or total suspended solids (TSS) should not be granted unless the permittee demonstrates that the constituents of the generic measure in the effluent are substantially similar to the constituents of the generic measure in the intake water or unless appropriate additional limits are placed on process water pollutants either at the outfall or elsewhere.

(3) Credit shall be granted only to the extent necessary to meet the applicable limitation or standard, up to a maximum value equal to the influent value. Additional monitoring may be necessary to determine eligibility for credits and compliance with permit limits.

(4) Credit shall be granted only if the discharger demonstrates that the intake water is drawn from the same body of water into which the discharge is made. The Department may waive this requirement if it finds that no environmental degradation will result.

(5) This section does not apply to the discharge of raw water clarifier sludge generated from the treatment of intake water.

(h) Internal waste streams.

(1) When permit effluent limitations or standards imposed at the point of discharge are impractical or infeasible, effluent limitations or standards for discharges of pollutants may be imposed on internal waste streams before mixing with other waste streams or cooling water streams. In those instances, the monitoring required by section 122.48 shall also be applied to the internal waste streams.

(2) Limits on internal waste streams will be imposed only when the fact sheet under R.61-9.124.56 sets forth the exceptional circumstances which make such limitations necessary, such as when the final discharge point is inaccessible (for example, under 10 meters of water), the wastes at the point of discharge are so diluted as to make monitoring impracticable, or the interferences among pollutants at the point of discharge would make detection or analysis impracticable.

(i) Disposal of pollutants into wells, into POTWs. Permit limitations and standards shall be calculated as provided in section 122.50.

122.46. Duration of permits.

(a) An NPDES permit issued pursuant to State law and this regulation shall be effective for a fixed term not to exceed 5 years. A person who wishes to continue to operate under such permit shall apply for re-issuance of a permit pursuant to this regulation.

(b) Except as provided in section 122.6, the term of a permit shall not be extended by modification beyond the maximum duration specified in this section.

(c) The Department may issue any permit for a duration that is less than the full allowable term under this section.

(d) A permit may be issued to expire on or after the statutory deadline set forth in section 301(b)(2)(A), (C), and (E), if the permit includes effluent limitations to meet the requirements of section 301(b)(2) (A), (C), (D), (E) and (F), whether or not applicable effluent limitations guidelines have been promulgated or approved.

(e) A determination that a particular discharger falls within a given industrial category for purposes of setting a permit expiration date under paragraph (d) of this section is not conclusive as to the discharger's inclusion in that industrial category for any other purposes, and does not prejudice any rights to challenge or change that inclusion at the time that a permit based on that determination is formulated.

122.47. Schedule of compliance.

(a) General. The NPDES permit may, when appropriate, specify a schedule of compliance leading to compliance with CWA, PCA, and regulations.

(1) Time for compliance. Any schedules of compliance under this section shall require compliance as soon as possible, but not later than the applicable statutory deadline under the CWA or as provided for under section 122.47(c).

(2) The first NPDES permit issued to a new source or a new discharger shall contain a schedule of compliance only when necessary to allow a reasonable opportunity to attain compliance with requirements issued or revised after commencement of construction but less than three years before commencement of the relevant discharge. For recommencing dischargers, a schedule of compliance shall be available only when necessary to allow a reasonable opportunity to attain compliance with requirements issued or revised less than three years before recommencement of discharge.

(3) Interim dates. Except as provided in paragraph (b)(1)(ii) of this section, if a permit establishes a schedule of compliance which exceeds nine (9) months from the date of permit issuance, the schedule shall set forth interim requirements and the date for their achievement.

(i) The time between interim dates shall not exceed nine (9) months, except that in the case of a schedule for compliance with standards for sewage sludge use and disposal, the time between interim dates shall not exceed six months.

(ii) If the time necessary for completion of any interim requirement (such as the construction of a control facility) is more than nine (9) months and is not readily divisible into stages for completion, the permit shall specify interim dates for the submission of reports of progress toward completion of the interim requirements and indicate a projected completion date.

(4) Reporting. The permit shall be written to require that no later than 10 days following each interim date and the final date of compliance, the permittee shall notify the Department in writing of its compliance or noncompliance with the interim or final requirements, or submit progress reports if paragraph (a)(3)(ii) is applicable.

(b) Alternative schedules of compliance. An NPDES permit applicant or permittee may cease conducting regulated activities (by terminating of direct discharge for NPDES sources) rather than continuing to operate and meet permit requirements as follows:

(1) If the permittee decides to cease conducting regulated activities at a given time within the term of a permit which has already been issued:

(i) The permit may be modified to contain a new or additional schedule leading to timely cessation of activities; or

(ii) The permittee shall cease conducting permitted activities before non-compliance with any interim or final compliance schedule requirement already specified in the permit.

(2) If the decision to cease conducting regulated activities is made before issuance of a permit whose term will include the termination date, the permit shall contain a schedule leading to termination which will ensure timely compliance with applicable requirements no later than the statutory deadline.

(3) If the permittee is undecided whether to cease conducting regulated activities, the Department may issue or modify a permit to contain two schedules as follows:

(i) Both schedules shall contain an identical interim deadline requiring a final decision on whether to cease conducting regulated activities no later than a date which ensures sufficient time to comply with applicable requirements in a timely manner if the decision is to continue conducting regulated activities;

(ii) One schedule shall lead to timely compliance with applicable requirements, no later than the statutory deadline;

(iii) The second schedule shall lead to cessation of regulated activities by a date which will ensure timely compliance with applicable requirements no later than the statutory deadline.

(iv) Each permit containing two schedules shall include a requirement that after the permittee has made a final decision under paragraph (b)(3)(i) of this section it shall follow the schedule leading to compliance if the decision is to continue conducting regulated activities, and follow the schedule leading to termination if the decision is to cease conducting regulated activities.

(4) The applicant's or permittee's decision to cease conducting regulated activities shall be evidenced by a firm public commitment satisfactory to the Department, such as a resolution of the board of directors of a corporation.

(c) Terms and Conditions of Permits: Schedules of Compliance.

(1) A person issued an NPDES permit by the Department who is not in compliance with applicable effluent standards and limitations or other requirements contained therein at the time the permit is issued, shall be required to achieve compliance within a period of time as set forth by the Department, with effluent standards and limitations, with water quality standards, or with specific requirements or conditions set by the Department. The Department shall require compliance with terms and conditions of the permit in the shortest reasonable period of time as determined thereby or within a time schedule for compliance which shall be specified in the issued permit.

(2) If a time schedule for compliance specified in an NPDES permit which is established by the Department pursuant to Subpart (1) above, exceeds nine (9) months, the time schedule shall provide for interim dates of achievement for compliance with certain applicable terms and conditions of the permit.

(d) Terms and Conditions of Permits: Compliance Reports by Dischargers.

(1) Within ten (10) days after an interim date of compliance or the final date of compliance specified in an NPDES permit, a permittee shall provide the Department with written notice of his compliance or noncompliance with the requirements or conditions specified to be completed by that date.

(2) Failure to submit the written notice to the Department is just cause for the Department to pursue enforcement action against the discharger pursuant to the State law or this regulation.

(e) Noncompliance. A discharger who fails or refuses to comply with an interim or final date of compliance specified in an NPDES permit, may be deemed by the Department to be in violation of the permit and may be subject to enforcement action prescribed in the State law or this regulation.

122.48. Requirements for recording and reporting of monitoring results.

(a) All permits shall specify:

(1) Requirements concerning the proper use, maintenance, and installation, when appropriate, of monitoring equipment or methods (including biological monitoring methods when appropriate);

(2) Monitoring shall include type, intervals, and frequency sufficient to yield data which are representative of the monitored activity including, when appropriate, continuous monitoring;

(3) Applicable reporting requirements based upon the impact of the regulated activity and as specified in section 122.44. Reporting shall be no less frequent than specified in the above regulation.

(4) That a permittee required to monitor a waste discharge shall maintain records of all information resulting from such monitoring, including the date, place and time of sampling; the dates analyses were performed; the person performing the analyses; the analytical techniques, procedures or methods used; and the results of such analyses. All records and results of monitoring activities and calibration and maintenance records shall be retained by the permittee a minimum of three (3) years unless otherwise required or extended by the Department.

(b) Any person who falsifies, tampers with, or knowingly renders inaccurate any monitoring device or method required by the Department to be maintained as a condition in a permit, or who alters or falsifies the results obtained by such devices or methods, shall be deemed to have violated a permit condition and shall be subject to the penalties provided for pursuant to 48-1-320 and 48-1-330 of the Code.

122.50. Disposal of pollutants into publicly-owned treatment works.

(a) When part of a discharger's process wastewater is not being discharged into waters of the State or contiguous zone because it is disposed into a POTW, thereby reducing the flow or level of pollutants being discharged into waters of the State, applicable effluent standards and limitations for the discharge in an NPDES permit shall be adjusted to reflect the reduced raw waste resulting from such disposal. Effluent limitations and standards in the permit shall be calculated by one of the following methods:

(1) If none of the waste from a particular process is discharged into waters of the State, and effluent limitations guidelines provide separate allocation for wastes from that process, all allocations for the process shall be eliminated from calculation of permit effluent limitations or standards.

(2) In all cases other than those described in paragraph (a)(1) of this section, effluent limitations shall be adjusted by multiplying the effluent limitation derived by applying effluent limitation guidelines to the total waste stream by the amount of wastewater flow to be treated and discharged into waters of the State, and dividing the result by the total wastewater flow. Effluent limitations and standards so calculated may be further adjusted under R.61-9.125 Part D to make them more or less stringent if discharges to publicly owned treatment works change the character or treatability of the pollutants being discharged to receiving waters. This method may be algebraically expressed as:

P = E x N

-----------------------------------

T

where P is the permit effluent limitation, E is the limitation derived by applying effluent guidelines to the total wastestream, N is the wastewater flow to be treated and discharged to waters of the State, and T is the total wastewater flow.

(b) Paragraph (a) of this section does not apply to the extent that promulgated effluent limitations guidelines:

(1) Control concentrations of pollutants discharged but not mass; or

(2) Specify a different specific technique for adjusting effluent limitations to account for well injection, or disposal into POTWs.

(c) Paragraph (a) of this section does not alter a discharger's obligation to meet any more stringent requirements established under sections 122.41, 122.42, 122.43, and 122.44.

PART D. TRANSFER, MODIFICATION, REVOCATION, AND REISSUANCE AND TERMINATION OF PERMITS

122.61. Transfer of permits.

(a) Transfers by modification. Except as provided in paragraph (b) of this section, a permit may be transferred by the permittee to a new owner or operator only if the permit has been modified or revoked and reissued (under section 122.62(e)(2)), or a minor modification made (under section 122.63(d)), to identify the new permittee and incorporate such other requirements as may be necessary under CWA.

(b) Other transfers. As an alternative to transfers under paragraph (a) of this section, any NPDES permit may be transferred to a new permittee if:

(1) The current permittee notifies the Department at least 30 days in advance of the proposed transfer date in paragraph (b)(2) of this section;

(2) The notice includes a written agreement between the existing and new permittees containing a specific date for transfer of permit responsibility, coverage, and liability between them; and

(3) Permits are non-transferable except with prior consent of the Department. A modification under this subparagraph may also be a minor modification under section 122.63.

122.62. Modification or revocation and reissuance of permits.

(a) When the Department receives any information (for example, inspects the facility, receives information submitted by the permittee as required in the permit (see section 122.41), receives a request for modification or revocation and reissuance under section 124.5, or conducts a review of the permit file), it may determine whether or not one or more of the causes listed in paragraph (d) and (e) of this section for modification or revocation and reissuance or both exist.

(b) If cause exists, the Department may modify or revoke and reissue the permit accordingly, subject to the limitations of R.61-9.124.5(c), and may request an updated application if necessary. When a permit is modified, only the conditions subject to modification are reopened. If a permit is revoked and reissued, the entire permit is reopened and subject to revision and the permit is reissued for a new term. See R.61-9.124.5(c)(2).

(c) If cause does not exist under this section or section 122.63, the Department shall not modify or revoke and reissue the permit. If a permit modification satisfies the criteria in section 122.63 for "minor modifications" the permit may be modified without a draft permit or public review. Otherwise, a draft permit must be prepared and other procedures in R.61-9.124 followed.

(d) Causes for modification. The following are causes for modification but not revocation and reissuance of permits except when the permittee requests or agrees.

(1) Alterations. There are material and substantial alterations or additions to the permitted facility or activity (including a change or changes in the permittee's sludge use or disposal practice) which occurred after permit issuance which justify the application of permit conditions that are different or absent in the existing permit.

(2) Information. The Department has received new information. Permits may be modified during their terms for this cause only if the information was not available at the time of permit issuance (other than revised regulations, guidance, or test methods) and would have justified the application of different permit conditions at the time of issuance. For NPDES general permits (section 122.28) this cause includes any information indicating that cumulative effects on the environment are unacceptable. For new source or new discharger NPDES permits (sections 122.21, 122.29), this cause shall include any significant information derived from effluent testing required under section 122.21(k)(5)(vi) or section 122.21(h)(4)(iii) after issuance of the permit.

(3) New regulations. The standards or regulations on which the permit was based have been changed by promulgation of amended standards or regulations or by judicial decision after the permit was issued. Permits may be modified during their terms for this cause, only as follows:

(i) For promulgation of amended standards or regulations, when:

(A) The permit condition requested to be modified was based on a promulgated effluent limitation guideline, EPA approved or promulgated water quality standards, or the Secondary Treatment Regulations under R.61-9.133; and

(B) EPA has revised, withdrawn, or modified that portion of the regulation or effluent limitation guideline on which the permit condition was based, or has approved a State action with regard to a water quality standard on which the permit condition was based; and

(C) A permittee requests modification in accordance with R.61-9.124.5 within ninety (90) days after Federal Register notice of the action on which the request is based.

(ii) For judicial decisions, a court of competent jurisdiction has remanded and stayed promulgated regulations or effluent limitation guidelines, if the remand and stay concern that portion of the regulations or guidelines on which the permit condition was based and a request is filed by the permittee in accordance with R.61-9.124.5 within ninety (90) days of judicial remand.

(iii) For changes based upon modified State certifications of NPDES permits, see R.61-9.124.55(b).

(4) Compliance schedules. The Department determines good cause exists for modification of a compliance schedule or terms and conditions of a permit, such as an act of God, strike, flood, or materials shortage or other events over which the permittee has little or no control and for which there is no reasonably available remedy. However, in no case may an NPDES compliance schedule be modified to extend beyond an applicable CWA statutory deadline. See also section 122.63(c) (minor modifications) and paragraph (d)(13) of this section (NPDES innovative technology).

(5) When the permittee has filed a request for a variance under CWA section 301(c), 301(k), or 316(a) or for "fundamentally different factors" within the time specified in section 122.21.

(6) 307(a) toxics. When required to incorporate an applicable 307(a) toxic effluent standard or prohibition (see section 122.44(b)).

(7) Reopener. When required by the "reopener" conditions in a permit, which are established in the permit under section 122.44(b) (for CWA toxic effluent limitations and standards for sewage sludge use or disposal, see also section 122.44(c)) or R.61-9. 403.18(e) (Pretreatment program).

(8)(i) Net limits. Upon request of a permittee who qualifies for effluent limitations on a net basis under section 122.45(g).

(ii) When a discharger is no longer eligible for net limitations, as provided in section 122.45(g)(1)(ii).

(9) Pretreatment. As necessary under R.61-9.403.8(e) (compliance schedule for development of pretreatment program).

(10) Failure to notify. Upon failure of an approved State to notify, as required by section 40 CFR 402(b)(3), another State whose waters may be affected by a discharge from the approved State.

(11) Non-limited pollutants. When the level of discharge of any pollutant which is not limited in the permit exceeds the level which can be achieved by the technology-based treatment requirements appropriate to the permittee under R.61-9.125.3(c).

(12) Notification levels. To establish a "notification level" as provided in section 122.44(f).

(13) Compliance schedules. To modify a schedule of compliance to reflect the time lost during construction of an innovative or alternative facility, in the case of a POTW which has received a grant under section 202(a)(3) of CWA for 100% of the costs to modify or replace facilities constructed with a grant for innovative and alternative wastewater technology under section 202(a)(2). In no case shall the compliance schedule be modified to extend beyond an applicable CWA statutory deadline for compliance.

(14) For a small MS4, to include an effluent limitation requiring implementation of a minimum control measure or measures as specified in section 122.34(b) when:

(i) The permit does not include such measure(s) based upon the determination that another entity was responsible for implementation of the requirement(s); and

(ii) The other entity fails to implement measure(s) that satisfy the requirement(s).

(15) To correct technical mistakes, such as errors in calculation, or mistaken interpretations of law made in determining permit conditions.

(16) When the discharger has installed the treatment technology considered by the permit writer in setting effluent limitations imposed under 402(a)(1) of the CWA and has properly operated and maintained the facilities but nevertheless has been unable to achieve those effluent limitations. In this case, the limitations in the modified permit may reflect the level of pollutant control actually achieved (but shall not be less stringent than required by a subsequently promulgated effluent limitations guideline).

(17) [Reserved]

(18) Land application plans. When required by an NPDES permit condition to incorporate a land application plan for beneficial reuse of sewage sludge, to revise an existing land application plan, or to add a land application plan.

(e) Causes for modification or revocation and reissuance. The following are causes to modify or, alternatively, revoke and reissue a permit:

(1) Cause exists for termination under section 122.64, and the Department determines that modification or revocation and reissuance is appropriate.

(2) The Department has received notification (as required in the permit, see section 122.41(l)(3)) of a proposed transfer of the permit. A permit also may be modified to reflect a transfer after the effective date of an automatic transfer (section 122.61(b)) but will not be revoked and reissued after the effective date of the transfer except upon the request of the new permittee.

(3) There is a violation of any terms or conditions of the permit.

(4) The permittee has obtained a permit by misrepresentation or has failed to disclose all relevant facts to the Department.

122.63. Minor modifications of permits.

Upon the consent of the permittee, the Department may modify a permit to make the corrections or allowances for changes in the permitted activity listed in this section, without following the procedures of R.61-9.124. Any permit modification not processed as a minor modification under this section must be made for cause and with R.61-9.124 draft permit and public notice as required in section 122.62. Minor modifications may only:

(a) Correct typographical errors;

(b) Require more frequent monitoring or reporting by the permittee;

(c) Change an interim compliance date in a schedule of compliance, provided the new date is not more than 120 days after the date specified in the existing permit and does not interfere with attainment of the final compliance date requirement; or

(d) Approve permit transfer for a Change in Ownership, as follows:

(1) Allow for a change in ownership or operational control of a facility where the Department determines that no other change in the permit is necessary, provided that a written agreement containing a specific date for transfer of permit responsibility, coverage, and liability between the current and new permittees has been submitted to the Department.

(2) Whenever there occurs a change in the ownership of treatment works which are the subject of a NPDES permit the new owner shall notify the Department of this change in ownership within thirty (30) days thereof and shall be bound by all the terms and conditions of said permit or permits.

(3) Change the name of the facility.

(4) Permits are non-transferable except with the prior consent of the Department.

(e)(1) Change the construction schedule for a discharger which is a new source. No such change shall affect a discharger's obligation to have all pollution control equipment installed and in operation prior to discharge under section 122.29.

(2) Delete a point source outfall when the discharge from that outfall is terminated and does not result in discharge of pollutants from other outfalls except in accordance with permit limits.

(f)(1) Add or revise requirements for certification under section 208 of CWA.

(2) [Reserved]

(3) Change sludge disposal sites from one approved landfill to another.

(g) Incorporate conditions of a POTW pretreatment program that has been approved in accordance with the procedures in R.61-9.403.11 (or a modification thereto that has been approved in accordance with the procedures in R.61-9.403.18) as enforceable conditions of the POTW's permits.

(h)(1) Change the operator grade or other operator requirements, including revision to frequency of operator visits.

(2)(i) Change a sampling date stated in the permit or add a sampling date,

(ii) Add specific sample locations if unclear in the issued permit,

(iii) Reduce sampling frequency after some period of time, if specifically allowed in an issued permit.

(3) Add the treatment system reliability classification.

(4) Require submittal of closure plans.

(5) Change page numbers of the issued permit.

122.64. Termination of permits.

(a) The following are causes for terminating a permit during its term, or for denying a permit renewal application:

(1) Noncompliance by the permittee with any condition of the permit:

(2) The permittee's failure in the application or during the permit issuance process to disclose fully all relevant facts, or the permittee's misrepresentation of any relevant facts at any time;

(3) A determination that the permitted activity endangers human health or the environment and can only be regulated to acceptable levels by permit modification or termination; or

(4)(i) A change in any condition that requires either a temporary or permanent reduction or elimination of any discharge or sludge use or disposal practice controlled by the permit (for example, plant closure or termination of discharge by connection to a POTW).

(ii) Cessation of substantially all manufacturing operations, which are a basis for effluent limits or which contribute to a discharge, for a period of 180 days or longer.

(5) A permittee with a permit which requires connection to a regional sewer system or other treatment facilities under the water quality management plan under section 208 of the CWA is ineligible for reissuance of a permit once notified by the Department that the regional sewer system is operational.

(b) The Department shall follow the applicable procedures in R.61-9.124 in terminating any NPDES permit under this section, except that if the entire discharge is permanently terminated by elimination of the flow or by connection to a POTW (but not by land application or disposal into a well), the Department may terminate the permit by notice to the permittee. Termination by notice shall be effective 30 days after notice is sent, unless the permittee objects within that time. If the permittee objects during that period, the Department shall follow R.61-9.124 procedures for termination. Expedited permit termination procedures are not available to permittees that are subject to pending State and/or Federal enforcement actions including citizen suits brought under State or Federal law. If requesting expedited permit termination procedures, a permittee must certify that it is not subject to any pending State or Federal enforcement actions including citizen suits brought under State or Federal law. State-authorized NPDES programs are not required to use 40 CFR 22 procedures for NPDES permit terminations.

APPENDIX A NPDES Primary Industry Categories

APPENDIX A. NPDES Primary Industry Categories



Any permit issued after June 30, 1981 to dischargers in the following categories shall include effluent limitations and a compliance schedule to meet the requirements of section 301(b)(2)(A), (C), (D), (E) and (F) of CWA, whether or not applicable effluent limitations guidelines have been promulgated. See section 122.44 and section 122.46.

Industry Category

Adhesives and sealants

Aluminum forming

Auto and other laundries

Battery manufacturing

Coal mining

Coil coating

Copper forming

Electrical and electronic components

Electroplating

Explosives manufacturing

Foundries

Gum and wood chemicals

Inorganic chemicals manufacturing

Iron and steel manufacturing

Leather tanning and finishing

Mechanical products manufacturing

Nonferrous metal manufacturing

Ore mining

Organic chemicals manufacturing

Paint and ink formulation

Pesticides

Petroleum refining

Pharmaceutical preparations

Photographic equipment and supplies

Plastics processing

Plastic and synthetic materials manufacturing

Porcelain enameling

Printing and publishing

Pulp and paper mills

Rubber processing

Soap and detergent manufacturing

Steam electric power plants

Textile Mills

Timber Products Processing

APPENDIX C Criteria for Determining a Concentrated Aquatic Animal Production Facility (section 122.24)

APPENDIX C. Criteria for Determining a Concentrated Aquatic Animal Production Facility (section 122.24)

A hatchery, fish farm, or other facility is a concentrated aquatic animal production facility for purposes of section 122.24 if it contains, grows, or holds aquatic animals in either of the following categories:

(a) Cold water fish species or other cold water aquatic animals in ponds, raceways, or other similar structures which discharge at least 30 days per year but does not include:

(1) Facilities which produce less than 9,090 harvest weight kilograms (approximately 20,000 pounds) of aquatic animals per year; and

(2) Facilities which feed less than 2,272 kilograms (approximately 5,000 pounds) of food during the calendar month of maximum feeding.

(b) Warm water fish species or other warm water aquatic animals in ponds, raceways, or other similar structures which discharge at least 30 days per year, but does not include:

(1) Closed ponds which discharge only during periods of excess runoff; or

(2) Facilities which produce less than 45,454 harvest weight kilograms (approximately 100,000 pounds) of aquatic animals per year.

"Cold water aquatic animals" include, but are not limited to, the Salmonidae family of fish; e.g., trout and salmon.

"Warm water aquatic animals" include, but are not limited to, the Ictaluridae, Centrarchidae, and Cyprinidae families of fish; e.g., respectively, catfish, sunfish, and minnows.

HISTORY: Amended by State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003.

APPENDIX D - NPDES PERMIT APPLICATION TESTING REQUIREMENTS (Section 122.21) (Refer to 40 CFR Part 122, Appendix D)

APPENDIX D. NPDES PERMIT APPLICATION TESTING REQUIREMENTS (Section 122.21) (Refer to 40 CFR Part 122, Appendix D)



APPENDIX E - RAINFALL ZONES OF THE UNITED STATES (Refer to 40 CFR Part 122, Appendix E)

APPENDIX E. RAINFALL ZONES OF THE UNITED STATES (Refer to 40 CFR Part 122, Appendix E)



APPENDIX F - INCORPORATED PLACES WITH POPULATIONS GREATER THAN 250,000 ACCORDING TO THE 1990 DECENNIAL CENSUS BY BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix F)

APPENDIX F. INCORPORATED PLACES WITH POPULATIONS GREATER THAN 250,000 ACCORDING TO THE 1990 DECENNIAL CENSUS BY BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix F)

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001.

APPENDIX G. - INCORPORATED PLACES WITH POPULATIONS GREATER THAN 100,000 AND LESS THAN 250,000 ACCORDING TO 1990 DECENNIAL CENSUS BY BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix G)

APPENDIX G. INCORPORATED PLACES WITH POPULATIONS GREATER THAN 100,000 AND LESS THAN 250,000 ACCORDING TO 1990 DECENNIAL CENSUS BY BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix G)

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001.

APPENDIX H. - COUNTIES WITH UNINCORPORATED URBANIZED AREAS WITH A POPULATION OF 250,000 OR MORE ACCORDING TO THE 1990 DECENNIAL CENSUS BY THE BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix H)

APPENDIX H. COUNTIES WITH UNINCORPORATED URBANIZED AREAS WITH A POPULATION OF 250,000 OR MORE ACCORDING TO THE 1990 DECENNIAL CENSUS BY THE BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix H)

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001.

APPENDIX I. - COUNTIES WITH UNINCORPORATED URBANIZED AREAS GREATER THAN 100,000, BUT LESS THAN 250,000 ACCORDING TO THE 1990 DECENNIAL CENSUS BY THE BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix I)

APPENDIX I. COUNTIES WITH UNINCORPORATED URBANIZED AREAS GREATER THAN 100,000, BUT LESS THAN 250,000 ACCORDING TO THE 1990 DECENNIAL CENSUS BY THE BUREAU OF CENSUS (Refer to 40 CFR Part 122, Appendix I)

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001.

APPENDIX J. - NPDES PERMIT TESTING REQUIREMENTS FOR PUBLICLY OWNED TREATMENT WORKS [section 122.21(j)]

APPENDIX J. NPDES PERMIT TESTING REQUIREMENTS FOR PUBLICLY OWNED TREATMENT WORKS [section 122.21(j)]

Table 1A--Effluent Parameters for All POTWS

Biochemical oxygen demand (BOD5 or CBOD5), 5-day

Fecal coliforms

Design Flow Rate

pH

Temperature

Total suspended solids

Table 1--Effluent Parameters for All POTWS With a Flow Equal to or Greater Than 0.1 MGD

Ammonia (as N)

Chlorine (total residual, TRC)

Dissolved oxygen

Nitrate/nitrite

Kjeldahl nitrogen

Oil and grease

Phosphorus

Total dissolved solids

Table 2--Effluent Parameters for Selected POTWS

Cyanide

Hardness

Metals (total recoverable), cyanide and total phenols

Antimony

Arsenic Beryllium

Cadmium Chromium

Copper Lead

Mercury Nickel

Selenium Silver

Thallium Zinc

Phenolic compounds, total

Volatile organic compounds

Acrolein Acrylonitrile

Benzene Bromoform

Carbon tetrachloride Chlorobenzene

Chlorodibromomethane Chloroethane

2-chloroethylvinyl ether Chloroform

Dichlorobromomethane 1,1-dichloroethane

1,2-dichloroethane Trans-1,2-dichloroethylene

1,1-dichloroethylene 1,2-dichloropropane

1,3-dichloropropylene Ethylbenzene

Methyl bromide Methyl chloride

Methylene chloride 1,1,2,2-tetrachloroethane

Tetrachloroethylene Toluene

1,1,1-trichloroethane 1,1,2-trichloroethane

Trichloroethylene Vinyl chloride

Acid-extractable compounds

P-chloro-m-cresol 2-chlorophenol

2,4-dichlorophenol 2,4-dimethylphenol

4,6-dinitro-o-cresol 2,4-dinitrophenol

2-nitrophenol 4-nitrophenol

Pentachlorophenol Phenol

2,4,6-trichlorophenol

Base-neutral compounds:

Acenaphthene Acenaphthylene

Anthracene Benzidine

Benzo(a)anthracene Benzo(a)pyrene

3,4-benzofluoranthene Benzo(ghi)perylene

Benzo(k)fluoranthene Bis (2-chloroethoxy) methane

Bis (2-chloroethyl) ether Bis (2-chloroisopropyl) ether

Bis (2-ethylhexyl) phthalate 4-bromophenyl phenyl ether

Butyl benzyl phthalate 2-chloronaphthalene

4-chlorophenyl phenyl ether Chrysene

Di-n-butyl phthalate Di-n-octyl phthalate

Dibenzo(a,h)anthracene 1,2-dichlorobenzene

1,3-dichlorobenzene 1,4-dichlorobenzene

3,3'-dichlorobenzidine Diethyl phthalate

Dimethyl phthalate 2,4-dinitrotoluene

2,6-dinitrotoluene 1,2-diphenylhydrazine

Fluoranthene Fluorene

Hexachlorobenzene Hexachlorobutadiene

Hexachlorocyclo-pentadiene Hexachloroethane

Indeno(1,2,3-cd)pyrene Isophorone

Naphthalene Nitrobenzene

N-nitrosodi-n-propylamine N-nitrosodimethylamine

N-nitrosodiphenylamine Phenanthrene

Pyrene 1,2,4 -trichlorobenzene

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001.

61-9.124. PROCEDURES FOR DECISION MAKING.

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003; State Register Volume 32, Issue No. 5, eff May 23, 2008; State Register Volume 34, Issue No. 11, eff November 26, 2010.

Table of Contents

Part A - General Program Requirements

Section

124.1 Purpose and scope.

124.2 Definitions.

124.3 Application for a permit.

124.5 Modification, revocation and reissuance, or termination of permits.

124.6 Draft permits.

124.8 Fact sheet.

124.10 Public notice of permit action and public comment period.

124.11 Public comments and requests for public hearings.

124.12 Public hearings.

124.13 Obligation to raise issues and provide information during the public

comment period.

124.15 Issuance and effective date of permit.

124.17 Response to comments.

Part D - Specific Procedures Applicable to NPDES Permits.

124.51 Purpose and scope.

124.52 Permits required on a case-by-case basis.

124.56 Fact Sheets.

124.57 Public notice.

124.59 Conditions requested by the Corps of Engineers and other government

agencies.

124.62 Decision on variances.

PART A. GENERAL PROGRAM REQUIREMENTS

124.1. Purpose and scope.

This part contains the Department's procedures for issuing, modifying, revoking and reissuing, or terminating all NPDES, Land Application, and State permits (including "sludge-only" permits issued pursuant to R.61-9.122.1(b)(2)).

124.2. Definitions.

In addition to the definitions given in R.61-9.122.2, R.61-9.503.9, R.61-9.503.11, R.61-9.503.21, R.61-9.503.31, R.61-9.503.41, R.61-9.504.9, R.61-9.504.11, R.61-9.504.21, R.61-9.504.31, R.61-9.505.2 and 40 CFR 501.2 (sludge management), the following definitions apply to this regulation. Terms not defined in this section have the meaning given by the Clean Water Act (CWA) or Pollution Control Act (PCA).

(a) "Appropriate Act and regulations" means the Clean Water Act (CWA); the Pollution Control Act (PCA); the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (RCRA); or Safe Drinking Water Act (SDWA), whichever is applicable; and applicable regulations promulgated under those statutes. Appropriate Act and regulations includes program requirements.

(b) [Reserved]

(c) "Interstate Agency" means an agency of two or more States established by or under an agreement or compact approved by the Congress, or any other agency of two or more States having substantial powers or duties pertaining to the control of pollution as determined and approved by the Administrator under the "appropriate Act and regulations."

(d) "RCRA" means the Solid Waste Disposal Act as amended by the Resource Conservation and Recovery Act of 1976 (Pub. L. 94-580, as amended by Pub. L. 95-609, 42 U.S.C. Section 6901 et seq.).

(e) "SDWA" means the Safe Drinking Water Act (Pub. L. 95-523, as amended by Pub. L. 95-1900; 42 U.S.C. 300f et seq.; and the 1986 Amendments Pub. L.99-339.

(f) "Schedule of compliance" means a schedule of remedial measures included in a permit, including an enforceable sequence of interim requirements (for example, actions, operations, or milestone events) leading to compliance with the appropriate Act and regulations.

(g) "Section 404 permit" means a permit to regulate the discharge of dredged material and the discharge of fill material under Section 404 of the Clean Water Act in the waters of the State.

(h) "UIC" means the Underground Injection Control program under Part C of the Safe Drinking Water Act, including an "approved program."

124.3. Application for a permit.

(a)(1)Any person who requires a permit under the NPDES program shall complete, sign, and submit to the Department an application for each permit required under R.61-9.122.1. Applications are not required for NPDES general permits under R.61-9.122.28.

(2) The Department shall not begin the processing of a permit until the applicant has fully complied with the application requirements for that permit.

(3) Permit applications must comply with the signature and certification requirements of R.61-9.122.22.

(4) A person discharging waste from more than one (1) location shall file a separate application for each discharge location. A single application may be filed for multiple outfalls discharging from a single location, except that the discharge from each outfall shall be described separately in the application.

(b)(1) Any person who requires a permit under the Land Application or State program shall complete, sign, and submit to the Department an application for each permit required under R 61-9.503, R.61-9.504 or R.61-9.505. Applications are not required for General permits under R.61-9.505.23. Notices of Intent are required for General permits. See R.61-9.505.23.

(2) The Department shall not begin the processing of a permit until the applicant has fully complied with the application requirements for that permit.

(3) Permit applications must comply with the signature and certification requirements of R.61-9.505.22.

(4) A person discharging waste from more than one (1) location shall file a separate application for each discharge location. A single application may be filed for multiple sites discharging from a single location, except that the discharge from each site shall be described separately in the application.

124.6. Draft permits.

(a) Once an application is complete, the Department shall tentatively decide whether to prepare a draft permit or to deny the application.

(b) If the Department tentatively decides to deny the permit application, it shall issue a notice of intent to deny. A notice of intent to deny the permit application is a type of draft permit which follows the same procedures as any other draft permit prepared under this section. See section 124.6(e). If the Department's final decision (section 124.15) is that the tentative decision to deny the permit application was incorrect, it shall withdraw the notice of intent to deny and proceed to prepare a draft permit under paragraph (d) of this section.

(c) If the Department tentatively decides to issue an NPDES, Land Application, State, or general permit, it shall prepare a draft NPDES, Land Application, State, general or 404 general permit under paragraph (d) of this section.

(d) If the Department decides to prepare a draft permit, it shall prepare a draft permit that contains the following information:

(1) For permits under R.61-9.122, all conditions under R.61-9.122.41 and R.61-9.122.43;

(2) For permits under R.61-9.122, all compliance schedules under R.61-9.122.47;

(3) For permits under R.61-9.122, all monitoring requirements under R.61-9.122.48;

(4)(i) For permits under R.61-9.505, all applicable conditions under R.61-9.505.41; and R.61-9.505.43;

(ii) For permits under R.61-9.505, all compliance schedules under R.61-9.505.47; and

(iii) For permits under R.61-9.505, all applicable monitoring requirements under R.61-9.505.48;

(iv) For Land Application, State or sludge disposal permits, effluent limitations, standards, prohibitions, standards for sewage sludge use or disposal, and conditions under R.61-9.503; R.61-9.504; or R.61.9.505 including R.61-9.505.41, R.61-9.505.42, R.61-9.505.44, and any applicable conditions as determined by the Department;

(v) For NPDES permits, effluent limitations, standards, prohibitions, standards for sewage sludge use or disposal, and conditions under R.61-9.122.41, R.61-9.122.42, and R.61-9.122.44, including when applicable any conditions certified by a State agency under section 124.55 and all variances that are to be included under section 124.63.

(e) Draft NPDES, Land Application, State or general permits prepared by the State shall be accompanied by a fact sheet if required under section 124.8.

124.8. Fact sheet.

(a) A fact sheet shall be prepared for every draft permit for a major NPDES facility or activity, for every Class I sludge management facility, for every NPDES general permit (R.61-9.122.28), for every NPDES draft permit that incorporates a variance or requires an explanation under section 124.56(b), for every draft permit that includes a sewage sludge land application plan under 40 CFR 501.15(a)(2)(ix), and for every draft permit which the Department finds is the subject of wide-spread public interest or raises major issues. The fact sheet shall briefly set forth the principal facts and the significant factual, legal, methodological and policy questions considered in preparing the draft permit. The Department shall send this fact sheet to the applicant and, on request, to any other person. A fact sheet may be prepared by the Department for draft permits under R.61-9.505.

(b) The fact sheet shall include, when applicable:

(1) A brief description of the type of facility or activity which is the subject of the draft permit;

(2) The type and quantity of wastes, fluids, or pollutants which are proposed to be treated, stored, disposed of, injected, emitted, or discharged;

(3) [Reserved]

(4) [Reserved]

(5) Reasons why any requested variances or alternatives to required standards do or do not appear justified;

(6) A description of the procedures for reaching a final decision on the draft permit including:

(i) The beginning and ending dates of the comment period under section 124.10 and the address where comments will be received;

(ii) Procedures for requesting a hearing and the nature of that hearing; and

(iii) Any other procedures by which the public may participate in the final decision.

(7) Name and telephone number of a person to contact for additional information.

(8) For NPDES permits, provisions satisfying the requirements of section 124.56.

(9) Justification for waiver of any application requirements under section 122.21(j) or (q) of this chapter.

124.10. Public notice of permit actions and public comment period.

(a) Scope.

(1) The Department shall give public notice of NPDES or Land Application permits that the following actions have occurred:

(i) A permit application has been tentatively denied under section 124.6(b);

(ii) A draft permit has been prepared under section 124.6(d);

(iii) A hearing has been scheduled under section 124.12;

(iv) [Reserved]

(v) [Reserved]

(vi) An NPDES new source determination has been made under R.61-9.122.29.

(2) No public notice is required when a request for permit modification, revocation and reissuance, or termination is denied under section 124.5(b). Written notice of that denial shall be given to the requester and to the permittee.

(3) Public notices may describe more than one permit or permit actions.

(b)(1) Public notice of the preparation of a draft NPDES or Land Application permit (including a notice of intent to deny a permit application) required under paragraph (a) of this section shall allow at least 30 days for public comment.

(2) Public notice of a public hearing shall be given at least 30 days before the hearing. (Public notice of the hearing may be given at the same time as public notice of the draft permit and the two notices may be combined).

(c) Methods. Public notice of activities described in paragraph (a)(1) of this section shall be given by the following methods:

(1) By mailing a copy of a notice to the following persons (any person otherwise entitled to receive notice under this paragraph may waive his or her rights to receive notice for any classes and categories of permits);

(i) The applicant (except for NPDES or Land Application general permits when there is no applicant);

(ii) Any other agency which the Department knows has issued or is required to issue a RCRA, UIC, PSD (or other permit under the Clean Air Act), NPDES, 404, sludge management permit, or ocean dumping permit under the Marine Research Protection and Sanctuaries Act for the same facility or activity (including EPA when a draft NPDES permit is prepared by the State);

(iii) Federal and State agencies with jurisdiction over fish, shellfish, and wildlife resources and over coastal zone management plans, the Advisory Council on Historic Preservation, State Historic Preservation Officers, including any affected States.

(iv) Any State agency responsible for plan development under CWA section 208(b)(2), 208(b)(4) or 303(e) and the U.S. Army Corps of Engineers, the U.S. Fish and Wildlife Service and the National Marine Fisheries Service;

(v) Any user identified in the permit application of a privately owned treatment works;

(vi) [Reserved]

(vii) [Reserved]

(viii) [Reserved]

(ix) Persons on a mailing list developed by:

(A) Including those who request in writing to be on the list;

(B) Soliciting persons for "area lists" from participants in past permit proceedings in that area; and

(C) Notifying the public of the opportunity to be put on the mailing list through periodic publication in the public press and in such publications as Regional and State funded newsletters, environmental bulletins, or State law journals. (The Department may update the mailing list from time to time by requesting written indication of continued interest from those listed. The Department may delete from the list the name of any person who fails to respond to such a request).

(x)(A) To any unit of local government having jurisdiction over the area where the facility is proposed to be located; and

(B) To each State agency having any authority under State law with respect to the construction or operation of such facility.

(2)(i) For major NPDES permits, NPDES general permits, and permits that include sewage sludge land application plans under 40 CFR 501.15(a)(2)(ix), publication of a notice in a daily or weekly newspaper within the area affected by the facility or activity.

(ii) [Reserved]

(3) In a manner constituting legal notice to the public under State law; and

(4) Any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

(d) Contents.

(1) All public notices. All public notices for NPDES and Land Application permits issued under this regulation shall contain the following minimum information:

(i) Name and address of the office processing the permit action for which notice is being given;

(ii) Name and address of the permittee or permit applicant and, if different, of the facility or activity regulated by the permit, except in the case of NPDES and 404 draft general permits under R.61-9.122.28 and 40 CFR 233.37;

(iii) A brief description of the business conducted at the facility or activity described in the permit application or the draft permit, for NPDES or 404 general permits when there is no application.

(iv) Name, address and telephone number of a person from whom interested persons may obtain further information, including copies of the draft permit or draft general permit, as the case may be, statement of basis or fact sheet, and the application; and

(v) A brief description of the comment procedures required by section 124.11 and section 124.12 and the time and place of any hearing that will be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled) and other procedures by which the public may participate in the final permit decision.

(vi) [Reserved]

(vii) For NPDES permits only (including those for "sludge-only facilities"), a general description of the location of each existing or proposed discharge point and the name of the receiving water and the sludge use and disposal practice(s) and the location of each sludge treatment works treating domestic sewage and use or disposal sites known at the time of permit application. For draft general permits, this requirement will be satisfied by a map or description of the permit area.

(viii) [Reserved]

(ix) Requirements applicable to cooling water intake structures under section 316(b) of the CWA, in accordance with 40 CFR 125, subpart I.

(x) Any additional information considered necessary or proper.

2. Public notices for hearings. In addition to the general public notice described in paragraph (d)(1) of this section, the public notice of a hearing under section 124.12 shall include the following information:

(i) Reference to the date of previous public notices relating to the permit;

(ii) Date, time, and place of the hearing;

(iii) A brief description of the nature and purpose of the hearing, including the applicable rules and procedures; and

(e) In addition to the general public notice described in paragraph (d((1) of this section, all persons identified in paragraphs (c)(1)(i)(ii), (iii), and (iv) of this section shall be mailed a copy of the fact sheet, the permit application (if any) and the draft permit (if any).

124.11. Public comments and requests for public hearings.

During the public comment period provided under section 124.10, any interested person may submit written comments on the draft permit and may request a public hearing, if no hearing has already been scheduled. A request for a public hearing shall be in writing and shall state the nature of the issues proposed to be raised in the hearing. All comments shall be considered in making the final decision and shall be answered as provided in section 124.17.

124.12. Public hearings.

(a) Determinations and Scheduling.

(1) Within the thirty (30) day comment period or other applicable comment period provided after posting or publishing of a public notice, an applicant, any affected state or interstate agency, the Regional Administrator or any other interested person or agency may file a petition with the Department for a public hearing on an application for a permit. A petition for a public hearing shall indicate the specific reasons why a hearing is requested, the existing or proposed discharge identified therein and specifically indicate which portions of the application or other permit form or information constitutes necessity for a public hearing. If the Department determines that a petition constitutes significant cause or that there is sufficient public interest in an application for a public hearing, it may direct the scheduling of a hearing thereon.

(2) A hearing shall be scheduled not less than four (4) nor more than eight (8) weeks after the Department determines the necessity of the hearing in the geographical location of the applicant or, at the discretion of the Department, at another appropriate location, and shall be noticed at least thirty (30) days before the hearing. The notice of public hearing shall be transmitted to the applicant and shall be published in at least one (1) newspaper of general circulation in the geographical area of the existing or proposed discharge identified on the permit application and shall be mailed to any person or group upon request therefor. Notice shall be mailed to all persons and governmental agencies which received a copy of the notice or the fact sheet for the permit application.

(3) The Department may hold a single public hearing on related groups of permit applications.

(4) The Department may also hold a public hearing at its discretion, whenever, for instance, such a hearing might clarify one or more issues involved in the permit decision;

(5) Public notice of the hearing shall be given as specified in section 124.10.

(b) [Reserved]

(c) Any person may submit oral or written statements and data concerning the draft permit. Reasonable limits may be set upon the time allowed for oral statements, and the submission of statements in writing may be required. The public comment period under section 124.10 shall automatically be extended to the close of any public hearing under this section. The hearing officer may also extend the comment period by so stating at the hearing.

(d) A tape recording or written transcript of the hearing shall be made available to the public.

124.13. Obligation to raise issues and provide information during the public comment period.

All persons, including applicants, who believe any condition of a draft permit is inappropriate or that the Department's tentative decision to deny an application, terminate a permit, or prepare a draft permit is inappropriate, must raise all reasonably ascertainable issues and submit all reasonably available arguments supporting their position by the close of the public comment period (including any public hearing) under section 124.10. No issue shall be raised during an appeal by any party that was not submitted to the administrative record as part of the preparation and comment on a draft permit, unless good cause is shown for the failure to submit it. Any supporting materials which are submitted shall be included in full and may not be incorporated by reference, unless they are already part of the administrative record in the same proceeding, or consist of State or Federal statutes and regulations, Department and EPA documents of general applicability, or other generally available reference materials. Commenters shall make supporting materials not already included in the administrative record available. (A comment period longer than 30 days may be necessary to give commenters a reasonable opportunity to comply with the requirements of this section. Additional time shall be granted under section 124.10 to the extent that a commenter who requests additional time demonstrates the need for such time).

124.15. Issuance and effective date of permit.

(a) After the close of the public comment period under section 124.10 on a draft permit, the Department shall issue a final permit decision. The Department shall notify the applicant and each person who has submitted written comments or requested notice of the final permit decision. This notice shall include reference to the procedures for appealing a decision on a permit. For the purposes of this section, a final permit decision means a final decision to issue, deny, modify, revoke and reissue, or terminate a permit.

(b) A final permit decision shall become effective 30 days after the service of notice of the decision unless:

(1) A later effective date is specified in the decision; or

(2) [Reserved]

(3) No comments requested a change in the draft permit, in which case the permit shall become effective on the effective date shown in the issued permit.

124.17. Response to comments.

(a) The Department is only required to issue a response to comments when a final permit is issued. This response shall:

(1) Specify which provisions, if any, of the draft permit have been changed in the final permit decision, and the reasons for the change; and

(2) Briefly describe and respond to all significant comments on the draft permit raised during the public comment period, or during any hearing.

(b) [Reserved]

(c) The response to comments shall be available to the public.

124.19. Appeal of NPDES and State Permits.

a. A Department decision involving issuance, denial, renewal, modification, suspension, or revocation of an NPDES, Land Application, or State permit may be appealed by an affected person with standing pursuant to applicable law, including S.C. Code Title 1, Chapter 23 and Title 44, Chapter 1.

b. Any person to whom an order, related to an NPDES, Land Application, or State permit, is issued may appeal it pursuant to applicable law, including S.C. Code Title 1, Chapter 23 and Title 44, Chapter 1.

PART D. SPECIFIC PROCEDURES APPLICABLE TO NPDES PERMITS

124.51. Purpose and scope.

(a) This part sets forth additional requirements and procedures for decision making for the NPDES program. Part D applies only to NPDES permits prepared under R.61-9.122.

(b) Decisions on NPDES variance requests ordinarily will be made during the permit issuance process. Variances and other changes in permit conditions ordinarily will be decided through the same notice-and-comment and hearing procedures as the basic permit.

124.52. Permits required on a case-by-case basis.

(a) Various sections of R.61-9.122 Part B allow the Department to determine, on a case-by-case basis, that certain concentrated animal feeding operations (R.61-9.122.23), concentrated aquatic animal production facilities (R.61-9.122.24) storm water discharges (R.61-9.122.26) and certain other facilities covered by general permits (R.61-9.122.28) that do not generally require an individual permit may be required to obtain an individual permit because of their contributions to water pollution.

(b) Whenever the Department decides that an individual permit is required under this section, except as provided in paragraph (c) of this section, the Department shall notify the discharger in writing of that decision and the reasons for it, and shall send an application form with the notice. The discharger must apply for a permit under R.61-9.122.21 within 60 days of notice, unless permission for a later date is granted by the Department. The question whether the designation was proper will remain open for consideration during the public comment period under section 124.11 and in any subsequent hearing.

(c) Prior to a case-by-case determination that an individual permit is required for a storm water discharge under this section (see R.61-9.122.26(a)(1)(v), (a)(9)(iii), and (c)(1)(v)), the Department may require the discharger to submit a permit application or other information regarding the discharge under section 308 of the CWA. In requiring such information, the Department shall notify the discharger in writing and shall send an application form with the notice. The discharger must apply for a permit within 180 days of notice, unless permission for a later date is granted by the Department. The question whether the initial designation was proper will remain open for consideration during the public comment period under section 124.11 and in any subsequent hearing.

124.56. Fact sheets.

In addition to meeting the requirements of section 124.8, NPDES fact sheets shall contain the following:

(a) Any calculations or other necessary explanation of the derivation of specific effluent limitations and conditions or standards for sewage sludge use or disposal, including a citation to the applicable effluent limitation guideline, performance standard, or standard for sewage sludge use or disposal as required by R.61-9.122.44 and reasons why they are applicable or an explanation of how the alternate effluent limitations were developed.

(b)(1) When the draft permit contains any of the following conditions, an explanation of the reasons why such conditions are applicable:

(i) Limitations to control toxic pollutants under R.61-9.122.44(e);

(ii) Limitations on internal waste streams under R.61-9.122.45(h);

(iii) Limitations on indicator pollutants under R.61-9.125.3(g);

(iv) Limitations set on a case-by-case basis under R.61-9.125.3(c)(2) or (c)(3), or pursuant to section 405(d)(4) of the CWA;

(v) Limitations to meet the criteria for permit issuance under R61-9.122.4(i); or

(vi) Waivers from monitoring requirements granted under R61-9.122.44(a).

(2) For every permit to be issued to a treatment works owned by a person other than a State or municipality, an explanation of the Department's decision on regulation of users under R.61-9.122.44(m).

(c) When appropriate, a sketch or detailed description of the location of the discharge or regulated activity described in the application; and

(d) [Reserved]

(e) [Reserved].

124.57. Public notice.

(a) Section 316(a) requests. In addition to the information required under section 124.10(d)(1), public notice of an NPDES draft permit for a discharge where a CWA section 316(a) request has been filed under section R.61-9.122.21(l) shall include:

(1) A statement that the thermal component of the discharge is subject to effluent limitations under CWA sections 301 or 306 and a brief description, including a quantitative statement, of the thermal effluent limitations proposed under section 301 or 306;

(2) A statement that a section 316(a) request has been filed and that alternative less stringent effluent limitations may be imposed on the thermal component of the discharge under section 316(a) and a brief description, including a quantitative statement, of the alternative effluent limitations, if any, included in the request; and

(b) [Reserved]

124.59. Conditions requested by the Corps of Engineers and other government agencies.

(a) If during the comment period for an NPDES draft permit, the District Engineer advises the Department in writing that anchorage and navigation of any waters of the State would be substantially impaired by the granting of a permit, the permit shall be denied and the applicant so notified. If the District Engineer advised the Department that imposing specified conditions upon the permit is necessary to avoid any substantial impairment of anchorage or navigation, then the Department shall include the specified conditions in the permit. Review or appeal of denial of a permit or of conditions specified by the District Engineer shall be made through the applicable procedures of the Corps of Engineers, and may not be made through the procedures provided in this regulation. If the conditions are stayed by a court of competent jurisdiction or by applicable procedures of the Corps of Engineers, those conditions shall be considered stayed in the NPDES permit for the duration of that stay.

(b) If during the comment period the U.S. Fish and Wildlife Service, the National Marine Fisheries Service, or any other State or Federal agency with jurisdiction over fish, wildlife, or public health advises the Department in writing that the imposition of specified conditions upon the permit is necessary to avoid substantial impairment of fish, shellfish, or wildlife resources, the Department may include the specified conditions in the permit to the extent they are determined necessary to carry out the provisions of R.61-9.122.49 and of the CWA.

(c) In appropriate cases, the Department may consult with one or more of the agencies referred to in this section before issuing a draft permit and may reflect their views in the fact sheet, or the draft permit.

124.62. Decision on variances.

(a) The Department may grant or deny requests for the following variances (subject to EPA objection under 40 CFR Part 123.44 for State NPDES permits);

(1) [Reserved]

(2) After consultation with the Regional Administrator, extensions under CWA section 301(k) based on the use of innovative technology; or

(3) Variances under CWA section 316(a) for thermal pollution.

(b) The Department may deny, or forward to the Regional Administrator with a written concurrence, or submit to EPA without recommendation a completed request for:

(1) [Reserved]

(2) A variance based on water quality related effluent limitations under CWA section 302(b)(2) or PCA.

(c) The Regional Administrator may deny, forward, or submit to the Office Director for Water Enforcement and Permits with a recommendation for approval, a request for a variance listed in paragraph (b) of this section that is forwarded by the Department.

(d) The EPA Office Director for Water Enforcement and Permits may approve or deny any variance request submitted under paragraph (c) of this section. If the Office Director approves the variance, the Department may prepare a draft permit incorporating the variance.

(e) The Department may deny or forward to the Administrator (or his delegate) with a written concurrence a completed request for:

(1) A variance based on the presence of "fundamentally different factors" from those on which an effluent limitations guideline was based;

(2) A variance based upon certain water quality factors under CWA section 301(g).

(f) The Administrator (or his delegate) may grant or deny a request for a variance listed in paragraph (e) of this section that is forwarded by the Department. If the Administrator (or his delegate) approves the variance, the Department may prepare a draft permit incorporating the variance.

61-9.125. CRITERIA AND STANDARDS FOR THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM.

HISTORY: Amended by State Register Volume 25, Issue No. 7, eff July 27, 2001; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003; State Register Volume 29, Issue No. 2, eff February 25, 2005.

Table of Contents

Part A--Criteria and Standards for Imposing Technology-Based Treatment

Requirements Under Sections 301(b) and 402 of the Clean Water Act

Section

125.1 Purpose and scope.

125.2 Definitions.

125.3 Technology-based treatment requirements in permits.

Part B--Criteria for Issuance of Permits to Aquaculture Projects

125.10 Purpose and scope.

125.11 Criteria.

Part D--Criteria and Standards for Determining Fundamentally Different Factors

Under Sections 301(b)(1)(A), 301(b)(2)(A) and (E) of the CWA

125.30 Purpose and scope.

125.31 Criteria.

125.32 Method of application.

Part H--Criteria for Determining Alternative Effluent Limitations Under Section

316(a) of the CWA

125.70 Purpose and scope.

125.71 Definitions.

125.72 Early screening of applications for variances under

section 316(a) of the CWA.

125.73 Criteria and standards for the determination of

alternative effluent limitations under section

316(a) of the CWA.

PART A. CRITERIA AND STANDARDS FOR IMPOSING TECHNOLOGY-BASED TREATMENT REQUIREMENTS UNDER Sections 301(B) AND 402 OF THE CLEAN WATER ACT

125.1. Purpose and scope.

This part establishes criteria and standards for the imposition of technology-based treatment requirements in permits under section 48-1-90 of the South Carolina Pollution Control Act and section 301(b) of the Federal Clean Water Act, including the application of EPA promulgated effluent limitations and case-by-case determinations of effluent limitations under this regulation and section 402(a)(1) of the Clean Water Act.

125.2. Definitions.

Unless otherwise noted, the definitions in R.61-9.122, 40 CFR Part 123, and R.61-9.124 apply to this part.

125.3. Technology-based treatment requirements in permits.

(a) General. Technology-based treatment requirements under section 301(b) of the CWA represent the minimum level of control that must be imposed in an NPDES permit issued under section 402 of the CWA. (See R.61-9.122.41, 122.42, and 122.44 for a discussion of additional or more stringent effluent limitations and conditions.) NPDES permits shall contain the following technology-based treatment requirements in accordance with the following statutory deadlines:

(1) For POTW's, NPDES permit effluent limitations based upon:

(i) Secondary treatment - from date of permit issuance; and

(ii) The best practicable waste treatment technology; and

(2) For dischargers other than POTWs except as provided in R. 61-9.122.29(d), NPDES permit effluent limitations requiring:

(i) The best practicable control technology currently available (BPT).

(A) [Reserved]

(B) [Reserved]

(C) For all other BPT effluent limitations compliance is required from the date of permit issuance.

(ii) For conventional pollutants, the best conventional pollutant control technology (BCT).

(iii) For all toxic pollutants referred to in Committee Print No. 95-30, House Committee on Public Works and Transportation, the best available technology economically achievable (BAT).

(iv) For all toxic pollutants other than those listed in Committee Print No. 95-30, effluent limitations based on BAT.

(v) For all pollutants which are neither toxic nor conventional pollutants, effluent limitations based on BAT.

(b) Statutory variances and extensions.

(1) The following variances from technology-based treatment requirements are authorized by the CWA and may be applied for under R.61-9.122.21;

(i) [Reserved]

(ii) For dischargers other than POTW's;

(A) [Reserved]

(B) [Reserved]; and

(C) A section 316(a) thermal variance from BPT, BCT and BAT (Part H).

(2) The following extensions of deadlines for compliance with technology-based treatment requirements are authorized by the CWA and may be applied for under R.61-9.124.53:

(i) [Reserved]

(ii) For dischargers other than POTW's:

(A) [Reserved]

(B) A section 301(k) extension of the BAT deadline.

(c) Methods of imposing technology-based treatment requirements in permits. Technology-based treatment requirements may be imposed through one of the following three methods;

(1) Application of EPA-promulgated effluent limitations developed under section 304 of the CWA to dischargers by category or subcategory. These effluent limitations are not applicable to the extent that they have been remanded or withdrawn. However, in the case of a court remand, determinations underlying effluent limitations shall be binding in permit issuance proceedings where those determinations are not required to be reexamined by a court remanding the regulations. In addition, dischargers may seek fundamentally different factors variances from these effluent limitations under R.61-9.122.21 and Part D of this regulation.

(2) On a case-by-case basis under section 402(a)(1) of the CWA, to the extent that EPA-promulgated effluent limitations are inapplicable. The permit writer shall apply the appropriate factors listed in section 125.3(d) and shall consider:

(i) The appropriate technology for the category or class of point sources of which the applicant is a member, based upon all available information; and

(ii) Any unique factors relating to the applicant.

(3) Through a combination of the methods in paragraphs (d)(1) and (d)(2) of this section. Where promulgated effluent limitations guidelines only apply to certain aspects of the discharger's operation, or to certain pollutants, other aspects or activities are subject to regulation on a case-by-case basis in order to carry out the provisions of the CWA and Pollution Control Act.

(4) Limitations developed under paragraph (d)(2) of this section may be expressed, where appropriate, in terms of toxicity (e.g., "the LC50 for fat head minnow of the effluent from outfall 001 shall be greater than 25%"), provided that it is shown that the limits reflect the appropriate requirements (for example, technology-based or water-quality-based standards) of the CWA.

(d) In setting case-by-case limitations pursuant to section 125.3(c), the permit writer must consider the following factors:

(1) For BPT requirements:

(i) The total cost of application of technology in relation to the effluent reduction benefits to be achieved from such application;

(ii) The age of equipment and facilities involved;

(iii) The process employed;

(iv) The engineering aspects of the application of various types of control techniques;

(v) Process changes; and

(vi) Non-water quality environmental impact (including energy requirements).

(2) For BCT requirements:

(i) The reasonableness of the relationship between the costs of attaining a reduction in effluent and the effluent reduction benefits derived;

(ii) The comparison of the cost and level of reduction of such pollutants from the discharge from publicly owned treatment works to the cost and level of reduction of such pollutants from a class or category of industrial sources;

(iii) The age of equipment and facilities involved;

(iv) The process employed;

(v) The engineering aspects of the application of various types of control techniques;

(vi) Process changes; and

(vii) Non-water quality environmental impact (including energy requirements).

(3) For BAT requirements:

(i) The age of equipment and facilities involved;

(ii) The process employed;

(iii) The engineering aspects of the application of various types of control techniques;

(iv) Process changes;

(v) The cost of achieving such effluent reduction; and

(vi) Non-water quality environmental impact (including energy requirements).

(e) Technology-based treatment requirements are applied prior to or at the point of discharge.

(f) Technology-based treatment requirements cannot be satisfied through the use of "non-treatment" techniques such as flow augmentation and in-stream mechanical aerators. However, these techniques may be considered as a method of achieving water quality standards on a case-by-case basis when:

(1) The technology-based treatment requirements applicable to the discharge are not sufficient to achieve the standards;

(2) The discharger agrees to waive any opportunity to request a variance under section 301(c), (g) or (h) of the CWA; and

(3) The discharger demonstrates that such a technique is the preferred environmental and economic method to achieve the standards after consideration of alternatives such as advanced waste treatment, recycle and reuse, land disposal, changes in operating methods, and other available methods.

(g) Technology-based effluent limitations shall be established under this part for solids, sludges, filter backwash, and other pollutants removed in the course of treatment or control of wastewaters in the same manner as for other pollutants.

(h)(1) The Department may set a permit limit for a conventional pollutant at a level more stringent than the best conventional pollution control technology (BCT), or a limit for a nonconventional pollutant which shall not be subject to modification under section 301(c) or (g) of the CWA where:



(i) Effluent limitations guidelines specify the pollutant as an indicator for a toxic pollutant, or

(ii)(A) The limitation reflects BAT-level control of discharges of one or more toxic pollutants which are present in the waste stream, and a specific BAT limitation upon the toxic pollutant(s) is not feasible for economic or technical reasons;

(B) The permit identifies which toxic pollutants are intended to be controlled by use of the limitation; and

(C) The fact sheet required by R.61-9.124.56 sets forth the basis for the limitation, including a finding that compliance with the limitation will result in BAT-level control of the toxic pollutant discharges identified in paragraph (h)(1)(ii)(B) of this part, and a finding that it would be economically or technically infeasible to directly limit the toxic pollutant(s).

(2) The Department may set a permit limit for a conventional pollutant at a level more stringent than BCT when;

(i) Effluent limitations guidelines specify the pollutant as an indicator for a hazardous substance, or

(ii)(A) The limitation reflects BAT-level control of discharges (or an appropriate level determined under section 301(c) or (g) of the CWA) of one or more hazardous substance(s) which are present in the waste stream, and a specific BAT (or other appropriate) limitation upon the hazardous substance(s) is not feasible for economic or technical reasons;

(B) The permit identifies which hazardous substances are intended to be controlled by use of the limitation; and

(C) The fact sheet required by R.61-9.124.56 sets forth the basis for the limitation, including a finding that compliance with the limitations will results in BAT-level (or other appropriate level) control of the hazardous substances discharges identified in paragraph (h)(2)(ii)(B) of this section, and a finding that it would be economically or technically infeasible to directly limit the hazardous substance(s).

(iii) Hazardous substances which are also toxic pollutants are subject to paragraph (h)(1) of this section.

(3) The Department may not set a more stringent limit under the preceding paragraphs if the method of treatment required to comply with the limit differs from that which would be required if the toxic pollutant(s) or hazardous substance(s) controlled by the limit were limited directly.

(4) Toxic pollutants identified under paragraph (h)(1) of this section remain subject to the requirements of R.61-9.122.42(a)(1) (notification of increased discharges of toxic pollutants above levels reported in the application form).

PART B. CRITERIA FOR ISSUANCE OF PERMITS TO AQUACULTURE PROJECTS

125.10. Purpose and scope.

(a) These regulations establish guidelines under sections 318 and 402 of the CWA for approval of any discharge of pollutants associated with an aquaculture project.

(b) The regulations authorize, on a selective basis, controlled discharges which would otherwise be unlawful under the PCA, section 48-1-90, and the CWA in order to determine the feasibility of using pollutants to grow aquatic organisms which can be harvested and used beneficially.

(c) Permits issued for discharges into aquaculture projects under this part are NPDES permits and are subject to the applicable requirements of R.61-9.122 and 124 and 40 CFR Part 123. Any permit shall include such conditions (including monitoring and reporting requirements) as are necessary to comply with those regulations. Technology-based effluent limitations need not be applied to discharges into the approved project except with respect to toxic pollutants.

125.11. Criteria.

(a) No NPDES permit shall be issued to an aquaculture project unless:

(1) The Department determines that the aquaculture project:

(i) Is intended by the project operator to produce a crop which has significant direct or indirect commercial value (or is intended to be operated for research into possible production of such a crop); and

(ii) Does not occupy a designated project area which is larger than can be economically operated for the crop under cultivation or than is necessary for research purposes.

(2) The applicant has demonstrated, to the satisfaction of the Director, that the use of the pollutant to be discharged to the aquaculture project will result in an increased harvest of organisms under culture over what would naturally occur in the area;

(3) The applicant has demonstrated, to the satisfaction of the Department that if the species to be cultivated in the aquaculture project is not indigenous to the immediate geographical area, there will be minimal adverse effects on the flora and fauna indigenous to the area, and the total commercial value of the introduced species is at least equal to that of the displaced or affected indigenous flora and fauna;

(4) The Department determines that the crop will not have a significant potential for human health hazards resulting from its consumption;

(5) The Department determines that migration of pollutants from the designated project area to water outside of the aquaculture project will not cause or contribute to a violation of water quality standards or a violation of the applicable standards and limitations applicable to the supplier of the pollutant that would govern if the aquaculture project were itself a point source. The approval of an aquaculture project shall not result in the enlargement of a pre-existing mixing zone area beyond what had been designated by the State for the original discharge.

(b) No permit shall be issued for any aquaculture project in conflict with a plan or an amendment to a plan approved under section 208(b) of the CWA.

(c) No permit shall be issued for any aquaculture project located in the territorial sea, the waters of the contiguous zone, or the oceans, except in conformity with guidelines issued under section 403(c) of the CWA.

(d) Designated project areas shall not include a portion of a body of water large enough to expose a substantial portion of the indigenous biota to the conditions within the designated project area. For example, the designated project area shall not include the entire width of a watercourse, since all organisms indigenous to that watercourse might be subjected to discharges of pollutants that would, except for the provisions of section 318 of the CWA, violate section 301 of the CWA.

(e) Any modifications caused by the construction or creation of a reef, barrier or containment structure shall not unduly alter the tidal regimen of an estuary or interfere with migrations of unconfined aquatic species.

(f) Any pollutants not required by or beneficial to the aquaculture crop shall not exceed applicable standards and limitations when entering the designated project area.

PART D. CRITERIA AND STANDARDS FOR DETERMINING FUNDAMENTALLY DIFFERENT FACTORS UNDER Sections 301(B)(1)(A), 301(B)(2)(A) AND (E) OF THE CWA

125.30. Purpose and scope.

(a) This part establishes the criteria and standards to be used in determining whether effluent limitations alternative to those required by promulgated EPA effluent limitations guidelines under sections 301 and 304 of the CWA (hereinafter referred to as "national limits") should be imposed on a discharger because factors relating to the discharger's facilities, equipment, processes or other factors related to the discharger are fundamentally different from the factors considered by EPA in development of the national limits. This part applies to all national limitations promulgated under sections 301 and 304 of the CWA, except for the BPT limits contained in 40 CFR 423.12 (steam electric generating point source category).

(b) In establishing national limits, EPA takes into account all the information it can collect, develop and solicit regarding the factors listed in sections 304(b) and 304(g) of the CWA. In some cases, however, data which could affect these national limits as they apply to a particular discharge may not be available or may not be considered during their development. As a result, it may be necessary on a case-by-case basis to adjust the national limits, and make them either more or less stringent as they apply to certain dischargers within an industrial category or subcategory. This will only be done if data specific to that discharger indicates it presents factors fundamentally different from those considered by EPA in developing the limit at issue. Any interested person believing that factors relating to the discharger's facilities, equipment, processes or other facilities related to the discharger are fundamentally different from the factors considered during development of the national limits may request a fundamentally different factors variance under R.61-9.122.21(l)(1). In addition, such a variance may be proposed by the Department in the draft permit.

125.31. Criteria.

(a) A request for the establishment of effluent limitations under this part (fundamentally different factors variance) shall be approved only if:

(1) There is an applicable national limit which is applied in the permit and specifically controls the pollutant for which alternative effluent limitations or standards have been requested; and

(2) Factors relating to the discharge controlled by the permit are fundamentally different from those considered by EPA in establishing the national limits; and

(3) The request for alternative effluent limitations or standards is made in accordance with the procedural requirements of R.61-9.124.

(b) A request for the establishment of effluent limitations less stringent than those required by national limits guidelines shall be approved only if:

(1) The alternative effluent limitation or standard requested is no less stringent than justified by the fundamental difference; and

(2) The alternative effluent limitation or standard will ensure compliance with section 208(e) and 301(b)(1)(C) of the CWA; and

(3) Compliance with the national limits (either by using the technologies upon which the national limits are based or by other control alternatives) would result in:

(i) A removal cost wholly out of proportion to the removal cost considered during development of the national limits; or

(ii) A non-water quality environmental impact (including energy requirements) fundamentally more adverse than the impact considered during development of the national limits.

(c) A request for alternative limits more stringent than required by national limits shall be approved only if:

(1) The alternative effluent limitation or standard requested is no more stringent than justified by the fundamental difference; and

(2) Compliance with the alternative effluent limitation or standard would not result in:

(i) A removal cost wholly out of proportion to the removal cost considered during development of the national limits; or

(ii) A non-water quality environmental impact (including energy requirements) fundamentally more adverse than the impact considered during development of the national limits.

(d) Factors which may be considered fundamentally different are:

(1) The nature or quality of pollutants contained in the raw waste load of the applicant's process wastewater;

(2) The volume of the discharger's process wastewater and effluent discharged;

(3) Non-water quality environmental impact of control and treatment of the discharger's raw waste load;

(4) Energy requirements of the application of control and treatment technology;

(5) Age, size, land availability, and configuration as they relate to the discharger's equipment or facilities; processes employed; process changes; and engineering aspects of the application of control technology;

(6) Cost of compliance with required control technology.

(e) A variance request or portion of such a request under this section shall not be granted on any of the following grounds;

(1) The infeasibility of installing the required waste treatment equipment within the time the CWA allows.

(2) The assertion that the national limits cannot be achieved with the appropriate waste treatment facilities installed, if such assertion is not based on factor(s) listed in paragraph (d) of this section;

(3) The discharger's ability to pay for the required waste treatment; or

(4) The impact of a discharge on local receiving water quality.

(f) Nothing in this section shall be construed to impair the right of the State or locality under section 510 of the CWA to impose more stringent limitations than those required by Federal law.

125.32. Method of application.

(a) A written request for a variance under this part D shall be submitted in duplicate to the Department in accordance with R61-9.122.21(m)(1) and R61-9.124.3.

(b) The burden is on the person requesting the variance to explain that:

(1) Factor(s) listed in section 125.31(b) regarding the discharger's facility are fundamentally different from the factors EPA considered in establishing the national limits. The requester should refer to all relevant material and information, such as the published guideline regulations development document, all associated technical and economic data collected for use in developing each national limit, all records of legal proceedings, and all written and printed documentation including records of communication, etc., relevant to the regulations which are kept on public file by the EPA;

(2) The alternative limitations requested are justified by the fundamental difference alleged in paragraph (b)(1) of this section; and

(3) The appropriate requirements of section 125.31 have been met.

PART H. CRITERIA FOR DETERMINING ALTERNATIVE EFFLUENT LIMITATIONS UNDER Section 316(A) OF THE CWA

125.70. Purpose and scope.

(a) Section 316(a) of the CWA provides that: "With respect to any point source otherwise subject to the provisions of section 301 or section 306 of this ACT, whenever the owner or operator of any such source, after opportunity for public hearing, can demonstrate to the satisfaction of ... the State that any effluent limitation proposed for the control of the thermal component of any discharge from such source will require effluent limitations more stringent than necessary to assure the protection and propagation of a balanced, indigenous population of shellfish, fish and wildlife in and on the body of water into which the discharge is to be made, the ...State may impose an effluent limitation under such sections on such plant, with respect to the thermal component of such discharge (taking into account the interaction of such thermal component with other pollutants), that will assure the protection and propagation of a balanced indigenous population of shellfish, fish and wildlife in and on that body of water."

(b) This part describes the factors, criteria and standards for establishment of alternative thermal effluent limitations under section 316(a) of the CWA in permits issued under section 402(a) of the CWA.

125.71. Definitions.

For the purpose of this part:

(a) "Alternative effluent limitations" means all effluent limitations or standards of performance for the control of the thermal component of any discharge which are established under section 316(a) of the CWA, this section, and the State Water Quality Standard R.61-68.

(b) "Representative important species" means species which are representative, in terms of their biological needs, of a balanced, indigenous community of shellfish, fish and wildlife in the body of water into which a discharge of heat is made.

(c) The term "balanced, indigenous community" is synonymous with the term "balanced, indigenous population" in the CWA and means a biotic community typically characterized by diversity, the capacity to sustain itself through cyclic seasonal changes, presence of necessary food chain species and by a lack of domination by pollution tolerant species. Such a community may include historically non-native species introduced in connection with a program of wildlife management and species whose presence or abundance results from substantial, irreversible environmental modifications. Normally, however, such a community will not include species whose presence or abundance is attributable to the introduction of pollutants that will be eliminated by compliance by all sources with section 301(b)(2) of the CWA; and may not include species whose presence or abundance is attributable to alternative effluent limitations imposed pursuant to section 316(a) of the CWA.

125.72. Early screening of applications for variances under section 316(a) of the CWA.

(a) Any initial application for a section 316(a) variance shall include the following early screening information:

(1) A description of the alternative effluent limitation requested;

(2) A general description of the method by which the discharger proposes to demonstrate that the otherwise applicable thermal discharge effluent limitations are more stringent than necessary;

(3) A general description of the type of data, studies, experiments and other information which the discharger intends to submit for the demonstration; and

(4) Such data and information as may be available to assist the Department in selecting the appropriate representative important species.

(b) After submitting the early screening information under paragraph (a) of this section, the discharger shall consult with the Department at the earliest practicable time (but not later than 30 days after the application is filed) to discuss the discharger's early screening information. Within 60 days after the application is filed, the discharger shall submit for the Department's approval a detailed plan of study which the discharger will undertake to support its section 316(a) demonstration. The discharger shall specify the nature and extent of the following type of information to be included in the plan of study; Biological, hydrographical and meteorological data; physical monitoring data; engineering or diffusion models; laboratory studies; representative important species; and other relevant information. In selecting representative important species, special consideration shall be given to species mentioned in applicable water quality standards. After the discharger submits its detailed plan of study, the Department shall either approve the plan or specify any necessary revisions to the plan. The discharger shall provide any additional information or studies which the Department subsequently determines necessary to support the demonstration, including such studies or inspections as may be necessary to select representative important species. The discharger may provide any additional information or studies which the discharger feels are appropriate to support the demonstration.

(c) Any application for the renewal of a section 316(a) variance shall include only such information described in paragraph (a) and (b) of this section and section 125.73(c)(1) as the Department requests within 60 days after receipt of the permit application.

(d) [Reserved]

(e) In making the demonstration the discharge shall consider any information or guidance published by EPA to assist in making such demonstrations.

(f) If an applicant desires a ruling on a section 316(a) application before the ruling on any other necessary permit terms and conditions, it shall so request upon filing its application under paragraph (a) of this section. This request shall be granted or denied at the discretion of the Department.

125.73. Criteria and standards for the determination of alternative effluent limitations under section 316(a) of the CWA.

(a) Thermal discharge effluent limitations or standards established in permits may be less stringent than those required by applicable standards and limitations if the discharger demonstrates to the satisfaction of the Department that such effluent limitations are more stringent than necessary to assure the protection and propagation of a balanced, indigenous community of shellfish, fish and wildlife in and on the body of water into which the discharge is made. This demonstration must show that the alternative effluent limitation desired by the discharger, considering the cumulative impact of its thermal discharge together with all other significant impacts on the species affected, will assure the protection and propagation of a balanced indigenous community of shellfish, fish and wildlife in and on the body of water into which the discharge is to be made.

(b) In determining whether or not the protection and propagation of the affected species will be assured, the Department may consider any information contained or referenced in any applicable thermal water quality criteria and thermal water quality information published by the Administrator under section 304(a) of the CWA, or any other information it deems relevant.

(c)(1) Existing dischargers may base their demonstration upon the absence of prior appreciable harm in lieu of predictive studies. Any such demonstrations shall show:



(i) That no appreciable harm has resulted from the normal component of the discharge (taking into account the interaction of such thermal component with other pollutants and the additive effect of other thermal sources to a balanced, indigenous community of shellfish, fish and wildlife in and on the body of water into which the discharge has been made; or

(ii) That despite the occurrence of such previous harm, the desired alternative effluent limitations (or appropriate modifications thereof) will nevertheless assure the protection and propagation of a balanced, indigenous community of shellfish, fish and wildlife in and on the body of water into which the discharge is made.

(2) In determining whether or not prior appreciable harm has occurred, the Department shall consider the length of time in which the applicant has been discharging and the nature of the discharge.

61-9.129. TOXIC POLLUTANT EFFLUENT STANDARDS.

HISTORY: Amended by State Register Volume 29, Issue No. 2, eff February 25, 2005.

Table of Contents

Part A. Toxic Pollutant Effluent Standards and Prohibitions

Section

129.1 Scope and purpose.

129.2 Definitions.

129.3 Abbreviations.

129.4 Toxic Pollutants.

129.5 Compliance.

129.6 Adjustment of effluent standard for presence of toxic pollutant in the

intake water.

129.7 Requirement and procedure for establishing a more stringent effluent

limitation.

129.8 Compliance Date

129.100 Aldrin/dieldrin.

129.101 DDT, DDD, and DDE.

129.102 Endrin.

129.103 Toxaphene.

129.104 Benzidine.

129.105 Polychlorinated Biphenyls (PCBs).

PART A. TOXIC POLLUTANT EFFLUENT STANDARDS AND PROHIBITIONS

129.1. Scope and Purpose.

(a) The provisions of this Part apply to owners or operators of specified facilities discharging into waters of the State.

(b) The effluent standards or prohibitions for toxic pollutants established in this Part shall be applicable to the sources and pollutants hereinafter set forth, and may be incorporated in any NPDES permit, modification or renewal thereof, in accordance with the provisions of this Part.

(c) The provisions of R.61-9.124 and R.61-9.125 shall apply to any NPDES permit proceedings for any point source discharge containing any toxic pollutant for which a standard or prohibition is established under this Part.

129.2. Definitions.

All terms not defined herein shall have the meaning given them R.61-9.122 or R.61-9.124. As used in this regulation, the term:

(a) "Air emissions" means the release or discharge of a toxic pollutant by an owner or operator into the ambient air either (1) by means of a stack or (2) as a fugitive dust, mist, or vapor as a result inherent to the manufacturing or formulating process.

(b) "Ambient water criterion" means that concentration of a toxic pollutant in the waters of the State that, based upon available data, will not result in adverse impact in important aquatic life, or on consumers of such aquatic life, after exposure of that aquatic life for periods of time exceeding 96 hours and continuing at least through one reproductive cycle; and will not result in a significant risk of adverse health effects in a large human population based on available information such as mammalian laboratory toxicity data, epidemiological studies of human occupational exposures, or human exposure data, or any other relevant data.

(c) "Construction" means any placement, assembly, or installation of facilities or equipment (including contractual obligations to purchase such facilities or equipment) at the premises where such equipment will be used, including preparation work at such premises.

(d) "Effluent standard" means, for purposes of 307, the equivalent of effluent limitation as that term is defined in section 502(11) of the CWA with the exception that it does not include a schedule of compliance.

(e) "Existing Source" means any source which is not a new source as defined in this section.

(f) "Fugitive dust, mist, or vapor" means dust, mist or vapor containing a toxic pollutant regulated under this Part which is emitted from any source other than through a stack.

(g) "Manufacturer" means any establishment engaged in the mechanical or chemical transformation of materials or substances into new products including but not limited to the blending of materials such as pesticidal products, resins, or liquors.

(h) "New Source" means any source discharging a toxic pollutant, the construction of which is commenced after proposal of an effluent standard or prohibition applicable to such source if such effluent standard or prohibition is thereafter promulgated in accordance with section 307 of CWA.

(i) "Owner or operator" means any person who owns, leases, operates, controls, or supervises a source as defined above.

(j) "Permit" means a permit for the discharge of pollutants into waters of the State under the National Pollutant Discharge Elimination System established by Section 402 of the CWA, the PCA, and implemented in regulations in R.61-9.124 and R.61-9.125.

(k) "Process Wastes" means any designated toxic pollutant, whether in wastewater or otherwise present, which is inherent to or unavoidably resulting from any manufacturing process, including that which comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product or waste product and is discharged into the waters of the state.

(l) "Prohibited" means that the constituent shall be absent in any discharge subject to these standards, as determined by any analytical method.

(m) "Source" means any building, structure, facility, or installation from which there is or may be the discharge of toxic pollutants designated as such by the Administration under section 307(a)(1) of the CWA.

(n) "Stack" means any chimney, flue, conduit, or duct arranged to conduct emissions to the ambient air.

(o) "Ten year 24-hour rainfall event" means the maximum precipitation event with a probable recurrence interval of once in 10 years as defined by the National Weather Service in technical paper No. 40, "Rainfall Frequency Atlas of the United States," May 1961, and subsequent amendments or equivalent regional or State rainfall probability information developed therefrom.

(p) "Working day" means the hours during a calendar day in which a facility discharges effluents subject to this regulation.

129.3. Abbreviations.

The abbreviations used in this Part represent the following terms:

lb = pound (or pounds)

g = gram

ug/l = micrograms per liter (1 one-millionth gram/liter)

kg = kilogram(s)

kkg = 1000 kilogram(s)

129.4. Toxic pollutants.

The following are the pollutants subject to regulation under the provisions of this part:

(a) Aldrin/Dieldrin-"Aldrin" means the compound aldrin as identified by the chemical name, 1,2,3,4,10,10 -hexachloro -1,4,4a,5,8,8a -hexahydro -1,4 -endo -5,8 -exo -dimethanonaphthalene; "Dieldrin" means the compound dieldrin as identified by the chemical name 1,2,3,4,10,10 -hexachloro-6,7 -epoxy -1,4,4a,5,6,7,8,8a -octahydro -1,4 -endo -5,8 -exo -dimethanonaphthalene.

(b) DDT-"DDT" means the compounds DDT, DDD, and DDE as identified by the chemical names; (DDT) -1,1,1 -trichloro -2,2 -bis(p-chlorophenyl) ethane and some o,p' -isomers; (DDD) or (TDE) -1,1 -dichloro -2,2 -bis(p-chlorophenyl) ethane and some o,p' -isomers; (DDE) -1,1 -dichloro -2,2, -bis(p -chlorophenyl) ethylene.

(c) Endrin-"Endrin" means the compound endrin as identified by the chemical name 1,2,3,4,10,10 -hexachloro -6,7 -epoxy -1,4,4a,5,6,7,8, 8a -octahydro -1,4, -endo -5,8, -endo -dimethanonaphthalene.

(d) Toxaphene-"Toxaphene" means the material consisting of technical grade chlorinated camphene having the approximate formula of C10H10Cl8 and normally containing 67-69 percent chlorine by weight.

(e) Benzidine-"Benzidine" means the compound benzidine and its salts as identified by the chemical name 4,4'-diaminobiphenyl.

(f) Polychlorinated Biphenyls (PCBs) -"Polychlorinated biphenyls (PCBs)" means a mixture of compounds composed of the biphenyl molecule which has been chlorinated to varying degrees.

129.5. Compliance.

(a)(1) Within 60 days from the date of promulgation of any toxic pollutant effluent standard or prohibition, each owner or operator with a discharge subject to that standard or prohibition must notify the Department, of such discharge. Such notification shall include such information and follow such procedures as the Department may require.

(2) Any owner or operator who does not have a discharge subject to any toxic pollutant effluent standard at the time of such promulgation but who thereafter commences or intends to commence any activity which would result in such a discharge shall first notify the Department, in the manner herein provided, at least 60 days prior to any such discharge.

(b) Upon receipt of any application for issuance or reissuance of a permit or for a modification of an existing permit for a discharge subject to a toxic pollutant effluent standard or prohibition, the permitting authority shall proceed thereon in accordance with R.61-9.124 or R.61-9.125, whichever is applicable.

(c)(1) Every permit which contains limitations based upon a toxic pollutant effluent standard or prohibition under this Part is subject to revision following the completion of any proceeding revising such toxic pollutant effluent standard or prohibition regardless of the duration specified on the permit.

(2) For purposes of this section, all toxic pollutants for which standards are set under this Part are deemed to be injurious to human health within the meaning of section 402(k) of the CWA, unless otherwise specified in the standard established for any particular pollutant.

(d)(1) Upon the compliance date for any section 307(a) toxic pollutant effluent standard or prohibition, each owner or operator of a discharge subject to such standard or prohibition shall comply with such monitoring, sampling, recording, and reporting conditions as the Department may require for that discharge. Notice of such conditions shall be provided in writing to the owner or operator.

(2) In addition to any conditions required pursuant to paragraph (d)(1) and to the extent not required in conditions contained in NPDES permits, within 60 days following the close of each calendar year, each owner or operator of a discharge subject to any toxic standard or prohibition shall report to the Department concerning the compliance of such discharges. Such report shall include, as a minimum, information concerning

(i) Relevant identification of the discharger such as name, location of facility, discharge points, receiving waters, and the industrial process or operation emitting the toxic pollutant;

(ii) Relevant conditions (pursuant to paragraph (d)(1) or to an NPDES permit) as to flow, section 307(a) toxic pollutant concentrations, and section 307(a) toxic pollutant mass emission rate;

(iii) Compliance by the discharger with such conditions.

(3) When samples collected for analysis are composited, such samples shall be composited in proportion to the flow at time of collection and preserved in compliance with requirements of the Department, but shall include at least five samples collected at approximately equal intervals throughout the working day.

(e)(1) [Reserved]

(2) Nothing in these regulations shall preclude the Department from requiring in any permit a more stringent effluent limitation or standard pursuant to section 301(b)(1)(C) of the CWA and implemented in R.61-9.124.42 and other related provisions of R.61-9.124.

(f) Any owner or operator of a facility which discharges a toxic pollutant to the waters of the State and to a publicly owned treatment system shall limit the summation of the mass emissions from both discharges to the less restrictive standard, either the direct discharge standard or the pretreatment standard; but in no case will this Subsection allow a discharge to the waters greater than the toxic pollutant effluent standard established for a direct discharge to the waters of the State.

(g) [Reserved]

129.6. Adjustment of effluent standard for presence of toxic pollutant in the intake water.

(a) Upon the request of the owner or operator of a facility discharging a pollutant subject to a toxic pollutant effluent standard or prohibition, the Department shall give credit and shall adjust the effluent standard(s) in such permit to reflect credit for the toxic pollutant(s) in the owner's or operator's water supply if

(1) the source of the owner's or operator's water supply is the same body of water into which the discharge is made and if

(2) it is demonstrated to the satisfaction of the Department that the toxic pollutant(s) present in the owner's or operator's intake water will not be removed by any wastewater treatment systems whose design capacity and operation were such as to reduce toxic pollutants to the levels required by the applicable toxic pollutant effluent standards in the absence of the toxic pollutant in the intake water.

(b) Effluent limitations established pursuant to this section shall be calculated on the basis of the amount of section 307(a) toxic pollutant(s) present in the water after any water supply treatment steps have been performed by or for the owner or operator.

(c) Any permit which includes toxic pollutant effluent limitations established pursuant to this section shall also contain conditions requiring the permittee to conduct additional monitoring in the manner and locations determined by the Department for those toxic pollutants for which the toxic pollutant effluent standards have been adjusted.

129.7. Requirement and procedure for establishing a more stringent effluent limitation.

(a) In exceptional cases

(1) where the Department determines that the ambient water criterion established in these standards is not being met or will not be met in the receiving water as a result of one or more discharges at levels allowed by these standards, and

(2) where the Department further determines that this is resulting in or may cause or contribute to significant adverse effects on aquatic or other organisms usually or potentially present, or on human health, he may issue to an owner or operator a permit or a permit modification containing a toxic pollutant effluent limitation at a more stringent level than that required by the standard set forth in these regulations. Any such action shall be taken pursuant to the procedural provisions of R.61-9.124 and R.61-9.125, as appropriate.

(3) [Reserved]

(b) Any effluent limitation in an NPDES permit which the Department proposes to issue which is more stringent than the toxic pollutant effluent standards promulgated by the Administrator is subject to review by the Administrator under section 402(d) of the CWA. The Administrator may approve or disapprove such limitation(s) or specify another limitation(s) upon review of any record of any proceedings held in connection with the permit issuance or modification and any other evidence available to him. If he takes no action within ninety days of his receipt of the notification of the action of the permit issuing authority and any record thereof, the action of the Department's permit issuing authority shall be deemed to be approved.

129.8. Compliance date.

(a) The effluent standards or prohibitions set forth herein shall be complied with not later than one year after promulgation unless an earlier date is established by the Administrator for an industrial subcategory in the promulgation of the standards or prohibitions.

(b) Toxic pollutant effluent standards or prohibitions set forth herein shall become enforceable under sections 307(d) and 309 of the CWA on the date established in subsection (a) regardless of proceedings in connection with the issuance of any NPDES permit or application therefor, or modification or renewal thereof.

129.100. Aldrin/Dieldrin.

(a) Specialized definitions.

(1) "Aldrin/Dieldrin Manufacturer" means a manufacturer, excluding any source which is exclusively an aldrin/dieldrin formulator, who produces, prepares or processes technical aldrin or dieldrin or who uses aldrin or dieldrin as a material in the production, preparation or processing of another synthetic organic substance.

(2) "Aldrin/Dieldrin Formulator" means a person who produces, prepares or processes a formulated product comprising a mixture of either aldrin or dieldrin and inert materials or other diluents, into a product intended for application in any use registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135, et seq.).

(3) The ambient water criterion for aldrin/dieldrin in navigable waters is 0.003 ug/l or the State Standard as identified in SC Regulation R.61-68, whichever is more stringent.

(b) Aldrin/Dieldrin manufacturer.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the manufacturing areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by aldrin/dieldrin as a result of the manufacturing process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of aldrin/dieldrin; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable. Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standard.

(i) Existing Sources. Aldrin or dieldrin is prohibited in any discharge from any aldrin/dieldrin manufacturer.

(ii) New Sources. Aldrin or dieldrin is prohibited in any discharge from any aldrin/dieldrin manufacturer.

(c) Aldrin/Dieldrin Formulator.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the formulating areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by aldrin/dieldrin as a result of the formulating process, including but not limited to:

(1) Stormwater and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of aldrin/dieldrin; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable. Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standard.

(i) Existing Sources. Aldrin or dieldrin is prohibited in any discharge from any aldrin/dieldrin formulator.

(ii) New Sources. Aldrin or dieldrin is prohibited in any discharge from any aldrin/dieldrin formulator.

129.101. DDT, DDD and DDE.

(a) Specialized Definitions.

(1) "DDT Manufacturer" means a manufacturer, excluding any source which is exclusively a DDT formulator, who produces, prepares or processes technical DDT, or who uses DDT as a material in the production, preparation or processing of another synthetic organic substance.

(2) "DDT Formulator" means a person who produces, prepares or processes a formulated product comprising a mixture of DDT and inert materials or other diluents into a product intended for application in any use registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135, et seq.).

(3) The ambient water criterion for DDT in navigable waters is 0.001 ug/l, or the State Standard as identified in S.C. Regulation R.61-68, whichever is more stringent.

(b) DDT Manufacturer.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the manufacturing areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by DDT as a result of the manufacturing process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of DDT; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable. Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standard.

(i) Existing Sources. DDT is prohibited in any discharge from any DDT manufacturer.

(ii) New Sources. DDT is prohibited in any discharge from any DDT manufacturer.

(c) DDT Formulator.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the formulating areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by DDT as a result of the formulating process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of DDT; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable. Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standard.

(i) Existing Sources. DDT is prohibited in any discharge from any DDT formulator.

(ii) New Sources. DDT is prohibited in any discharge from any DDT formulator.

129.102. Endrin.

(a) Specialized definitions.

(1) "Endrin Manufacturer" means a manufacturer, excluding any source which is exclusively an endrin formulator, who produces, prepares or processes technical endrin or who uses endrin as a material in the production, preparation or processing of another synthetic organic substance.

(2) "Endrin Formulator" means a person who produces, prepares or processes a formulated product comprising a mixture of endrin and inert materials or other diluents into a product intended for application in any use registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C 135, et seq.).

(3) The ambient water criterion for endrin in waters of the State is 0.004 ug/l, or the State Standard as identified in S.C. Regulation R.61-68, whichever is more stringent.

(b) Endrin manufacturer.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the manufacturing areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by endrin as a result of the manufacturing process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of endrin; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable -Environmental Protection Agency method specified in 40 CFR Part 136.

(3) Effluent Standard.

(i) Existing Sources - Discharges from an endrin manufacturer shall not contain endrin concentrations exceeding an average per working day of 1.5 ug/l calculated over any calendar month; and shall not exceed a monthly average daily loading of 0.0006 kg/kkg of endrin produced; and shall not exceed 7.5 ug/l in a sample(s) representing any working day.

(ii) New Sources - Discharges from an endrin manufacturer shall not contain endrin concentrations exceeding an average per working day of 0.1 ug/l calculated over any calendar month; and shall not exceed a monthly average daily loading of 0.00004 kg/kkg of endrin produced; and shall not exceed 0.5 ug/l in a sample(s) representing any working day.

(iii) Mass Emission Standard During Shutdown of Production - In computing the allowable monthly average daily loading figure required under the preceding subparagraphs (i) and (ii), for any calendar month for which there is no endrin being manufactured at any plant or facility which normally contributes to the discharge which is subject to these standards, the applicable production value shall be deemed to be the average monthly production level for the most recent preceding 360 days of actual operation of the plant or facility.

(c) Endrin Formulator.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the formulating areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by endrin as a result of the formulating process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of endrin; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable -Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standard.

(i) Existing Sources - Endrin is prohibited in any discharge from any endrin formulator.

(ii) New Sources - Endrin is prohibited in any discharge from any endrin formulator.

(d) The standards set forth in this Section shall apply to the total combined weight or concentration of endrin, excluding any associated element or compound.

129.103. Toxaphene.

(a) Specialized definitions.

(1) "Toxaphene Manufacturer" means a manufacturer, excluding any source which is exclusively a toxaphene formulator, who produces, prepares or processes toxaphene or who uses toxaphene as a material in the production, preparation or processing of another synthetic organic substance.

(2) "Toxaphene Formulator" means a person who produces, prepares or processes a formulated product comprising a mixture of toxaphene and inert materials or other diluents into a product intended for application in any use registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135, et seq.).

(3) The ambient water criterion for toxaphene in navigable waters is 0.005 ug/l or the State Standard as identified in S.C. Regulation 61-68, whichever is more stringent.

(b) Toxaphene manufacturer.

(1) Applicability.

(i) These standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the manufacturing areas, loading and unloading areas, storage areas and other areas which are subject to direct contamination by toxaphene as a result of the manufacturing process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of toxaphene; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable -Environmental Protection Agency method specified in 40 CFR Part 136.

(3) Effluent Standard.

(i) Existing Sources - Discharges from a toxaphene manufacturer shall not contain toxaphene concentrations exceeding an average per working day of 1.5 ug/l calculated over any calendar month; and shall not exceed a monthly average daily loading of 0.00003 kg/kkg of toxaphene produced, and shall not exceed 7.5 ug/l in a sample(s) representing any working day.

(ii) New Sources - Discharges from a toxaphene manufacturer shall not contain toxaphene concentrations exceeding an average per working day of 0.1 ug/l calculated over any calendar month; and shall not exceed a monthly average daily loading of 0.000002 kg/kkg of toxaphene produced, and shall not exceed 0.5 ug/l in a sample(s) representing any working day.

(iii) Mass Emission During Shutdown of Production - In computing the allowable monthly average daily loading figure required under the preceding subparagraphs (i) and (ii), for any calendar month for which there is no toxaphene being manufactured at any plant or facility which normally contributes to the discharge which is subject to these standards, the applicable production value shall be deemed to be the average monthly production level for the most recent preceding 360 days of actual operation of the plant or facility.

(c) Toxaphene Formulator.

(1) Applicability.

(i) The standards or prohibitions apply to:

(A) All discharges of process wastes; and

(B) All discharges from the formulating areas; loading and unloading areas, storage areas and other areas which are subject to direct contamination by toxaphene as a result of the formulating process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in subparagraph (ii); and

(2) Water used for routine cleanup or cleanup of spills.

(ii) These standards do not apply to storm water runoff or other discharges from areas subject to contamination solely by fallout from air emissions of toxaphene; or to storm water runoff that exceeds that from the ten year 24-hour rainfall event.

(2) Analytical method acceptable -Environmental Protection Agency method specified in 40 CFR Part 136, except that a 1-liter sample size is required to increase the analytical sensitivity.

(3) Effluent Standards.

(i) Existing Sources - Toxaphene is prohibited in any discharge from any toxaphene formulator.

(ii) New Sources - Toxaphene is prohibited in any discharge from any toxaphene formulator.

(d) The standards set forth in this Section shall apply to the total combined weight or concentration of toxaphene, excluding any associated element or compound.

129.104. Benzidine.

(a) Specialized definitions.

(1) "Benzidine Manufacturer" means a manufacturer who produces benzidine or who produces benzidine as an intermediate product in the manufacture of dyes commonly used for textile, leather and paper dyeing.

(2) "Benzidine-Based Dye Applicator" means an owner or operator who uses benzidine-based dyes in the dyeing of textiles, leather or paper.

(3) The ambient water criterion for benzidine in navigable waters is 0.1 ug/l or the State Standard as identified in S.C. Regulation 61-68 whichever is more stringent.

(b) Benzidine manufacturer.

(1) Applicability.

(i) These standards apply to:

(A) All discharges into the waters of the State of process wastes, and

(B) All discharges into the waters of the State of wastes containing benzidine from the manufacturing areas, loading and unloading areas, storage areas, and other areas subject to direct contamination by benzidine or benzidine-contaminated product as a result of the manufacturing process, including but not limited to:

(1) Storm water and other runoff except as hereinafter provided in paragraph (b)(1)(ii) of