In addition to the FD&C Act, FDA's legal authority for the proposed CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act for the proposed regulations is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as "are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State" (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.) Many provisions in the proposed rule are necessary to prevent animal food from being contaminated with microorganisms of human health significance, such as Salmonella, and therefore to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the United States, or from one state in the United States to another. As discussed in section II.E and X.C.6, lack of adequate sanitation in food establishments can lead to the contamination of food with pathogens, increasing the likelihood of illness in humans consuming products derived from animals (such as milk and eggs) and illness in humans handling animal food, particularly in the household setting. The Agency tentatively concludes that the proposed CGMPs are necessary to prevent the spread of communicable disease and to prevent animal food from containing filthy, putrid, or decomposed substances, being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
B. Hazard Analysis and Risk-Based Preventive Controls
Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms "small business" and "very small business," taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act.
In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is, in relevant part, to prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act. In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include hazard analysis ( SEC 418(b)), preventive controls ( SEC 418(c)), monitoring ( SEC 418(d)), corrective actions ( SEC 418(e)), verification ( SEC 418(f)), recordkeeping ( SEC 418(g)), a written plan and documentation ( SEC 418(h)), and reanalysis of hazards ( SEC 418(i)). Proposed requirements (proposed subparts C and F) that would implement these provisions of section 418 of the FD&C Act are discussed in sections X and XII.
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