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Statement of Need: FDA last updated its food CGMP regulations for manufacturing, packing or holding of human food in 1986. Modernizing these food CGMP regulations to more explicitly address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces, as well as risk-based preventive controls, would be a critical step in raising the standards for food production and distribution. By amending 21 CFR 110 to modernize good manufacturing practices, the agency could focus the attention of food processors on measures that have been proven to significantly reduce the risk of food-borne illness. An amended regulation also would allow the agency to better focus its regulatory efforts on ensuring industry compliance with controls that have a significant food safety impact.

Summary of the Legal Basis: FDA's legal authority to amend its CGMP regulations derives in part from sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the Act, a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Under section 701(a) of the Act, FDA is authorized to issue regulations for the efficient enforcement of the Act. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: An alternative to this rulemaking is not to update the CGMP regulations, and instead to issue guidance on best practices regarding environmental pathogens, food allergens, mandatory employee training, sanitation of food contact surfaces, and risk-based preventive controls. However, guidance is voluntary and unenforceable. FDA believes a regulation containing clear, enforceable standards would be more effective in ensuring protection of public health.

Anticipated Costs and Benefits: FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food safety plans, setting up training programs, implementing allergen controls, and purchasing new tools and equipment) and recurring costs (e.g., auditing and monitoring suppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduced risk of foodborne illness and deaths from processed foods and from a reduction in the number of safety related recalls.

Risks: This regulation will directly and materially advance the federal government's substantial interest in reducing the risks for illness and death associated with foodborne infections. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborne illness in the U.S.