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Overall Description of Deadline: The legal deadline for FDA under the Food Safety and Modernization Act to promulgate regulations is July 2012.

Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a few known safety issues, so there could be potential human and animal health problems that remain unaddressed. The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid in 2007 is a prime example. The actions taken by two protein suppliers in China affected a large number of pet food suppliers in the United States and created a nationwide problem. By the time the cause of the problem was identified, melamine and cyanuric acid contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Congress passed FSMA which the President signed into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA, Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety, emphasizing prevention. Section 418 of the FD&C Act requires owners, operators, or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section.

Summary of the Legal Basis: FDA's authority for issuing this rule is provided in FSMA (Pub. L. 111-353), which amended the FD&C Act by establishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of the FD&C Act to add 301(uu) that states 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 is a prohibited act. Further authority comes from section 1002(a) of title X of the FDAAA of 2007 (21 U.S.C. 2102) requiring the Secretary to update standards for the processing of pet food. FDA is also issuing this rule under the general requirements of section 402 of the FD&C Act (21 U.S.C. 342) for adulterated food. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act.

Alternatives: The 2011 FSMA limited the Agency's flexibility to exclude many requirements. It described in detail its requirements for subpart C, concerning the hazard analysis and risk-based preventive controls part of the proposed rule. Alternatives include certain requirements listed in subpart B concerning operations and practices.

Anticipated Costs and Benefits: The benefits of the proposed rule would result from fewer cases of contaminated animal food ingredients or finished animal food products. Discovering contaminated food ingredients before they are used in a finished product would reduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs for animals and humans, reduced loss of market value of live animals, reduced loss of animal companionship, and reduced loss in value of animal food products. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal foods and protect animal and human health. FDA lacks sufficient data to quantify the benefits of the proposed rule. The compliance costs of the proposed rule would result from the additional labor and capital required to perform the hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take corrective actions if preventive controls fail to prevent feeds from becoming contaminated, and implement requirements from the operations and practices section.

Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe and will not cause illness or injury to animals or humans. This rule would implement a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the food supply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases of animal food contamination would (1) reduce the risk of serious illness and death to animals, (2) reduce the risk of adverse health effects to humans handling animal food, and (3) reduce the risk of consuming human food from animals that consumed contaminated food.