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COMMITTEE REPORT
February 25, 2016
S. 284
S. Printed 2/25/16--S.
Read the first time January 13, 2015.
To whom was referred a Bill (S. 284) to amend Section 39-25-180(H) of the 1976 Code, relating to the adoption of federal regulations for food and cosmetics, to provide that very small, etc., respectfully
That they have duly and carefully considered the same and recommend that the same do pass with amendment:
Amend the bill, as and if amended, by striking SECTION 1 and inserting:
/ SECTION 1. Section 39-25-180(H) of the 1976 Code is amended to read:
"Section 39-25-180. (H) Good manufacturing practice regulations and their amendments now or hereafter adopted pursuant to the authority of the federal Food, Drug, and Cosmetic Act are the good manufacturing regulations of this State. However, the commissioner may adopt a regulation that prescribes conditions under which good manufacturing processes may be used in this State whether or not in accordance with regulations promulgated pursuant to the federal act.
(1) The commissioner shall exclude qualified exempt human food facilities, as defined in the federal Food, Drug and Cosmetic Act and its implementing regulations, from the requirements of Subparts C and G of Title 21, Part 117 of the Code of Federal Regulations; such qualified exempt human food facilities will continue to be subject to all other applicable good manufacturing practice regulations enforced pursuant to this Section.
(2) The commissioner shall exclude qualified exempt animal feed facilities, as defined in the federal Food, Drug and Cosmetic Act and its implementing regulations, from the requirements of Subparts C and E of Title 21 Part 500 of the Code of Federal Regulations; such qualified exempt animal feed facilities will be subject to all other applicable good manufacturing practice regulations enforced pursuant to this Section.
(3) In the event that a human food or animal feed facility loses its qualified exempt facility status under the federal Food, Drug and Cosmetic Act, the commissioner shall enforce all applicable good manufacturing practice regulations to that facility." /
Renumber sections to conform.
Amend title to conform.
DANIEL B. VERDIN III for Committee.
TO AMEND SECTION 39-25-180(H) OF THE 1976 CODE, RELATING TO THE ADOPTION OF FEDERAL REGULATIONS FOR FOOD AND COSMETICS, TO PROVIDE THAT VERY SMALL BUSINESSES AND QUALIFIED EXEMPT FACILITIES ARE NOT REQUIRED TO COMPLY WITH ANY REQUIREMENT TO IMPLEMENT HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS UNDER THE FEDERAL GOOD MANUFACTURING PRACTICES REGULATIONS, BUT WILL CONTINUE TO BE SUBJECT TO ALL OTHER GOOD MANUFACTURING PRACTICE REGULATIONS.
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Section 39-25-180(H) of the 1976 Code is amended to read:
"Section 39-25-180. (H) Good manufacturing practice regulations and their amendments now or hereafter adopted pursuant to the authority of the federal Food, Drug, and Cosmetic Act are the good manufacturing regulations of this State. However, the commissioner may adopt a regulation that prescribes conditions under which good manufacturing processes may be used in this State whether or not in accordance with regulations promulgated pursuant to the federal act. Very small businesses and qualified exempt facilities, as defined in the federal Food Drug and Cosmetic Act and its implementing regulations, are not required to comply with any requirement to implement hazard analysis and risk-based preventive controls under the federal good manufacturing practices regulations, but will continue to be subject to all other good manufacturing practice regulations."
SECTION 2. This act takes effect upon approval by the Governor.
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