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Overall Description of Deadline: The FDA Food Safety Modernization Act (FSMA) mandates that FDA promulgate final regulations to establish preventive controls not later than 18 months after the date of enactment of FSMA. Certain requirements regarding standards for pet food and other animal feeds mandated by the FDA Amendment Act of 2007 will be subsumed in the FSMA rulemaking. Per consent decree, FDA will submit the final rule to the Federal Register for publication by 08/30/2015.

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 problems that remain unaddressed potentially affecting animal health. The massive pet food recall due to adulteration with melamine and cyanuric acid in 2007 is an example. Actions taken by two protein suppliers in China affected a large number of pet food manufacturers 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 had resulted in the adulteration of millions of individual servings of pet food sickening and killing pets. Salmonella contaminated pet food has been the cause of illness in humans: in 2007 people became ill handling pet food contaminated with a rare Salmonella serotype; over 200 people in the United Kingdom and United States became ill from handling Salmonella contaminated frozen mice (used for pet food) that came from a U.S. facility; and people were infected with Salmonella in 2012 that originated from contaminated dog and cat food. Other animal food recalls have resulted from contamination with aflatoxins, dioxins excessive vitamin D, and insufficient thiamine. 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 hazard analysis and preventive controls to significantly minimize or prevent the occurrence of hazards and help prevent adulteration of food.

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. FDA is also issuing this rule under the certain provisions of section 402 of the FD&C Act (21 U.S.C. 342) regarding 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. To the extent the regulations are related to communicable disease, FDA's legal authority also derives from sections 311, 361, and 368 of the Public Health Services Act (42 U.S.C. 243, 264, and 271). Finally, FDA is acting under the direction of section 1002(a) of title X of FDAAA of 2007 (21 U.S.C. 2102) which requires the Secretary to establish processing standards for pet food.

Alternatives:

The Food Safety Modernization Act requires FDA to promulgate regulations to establish hazard analyses and risk-based preventive controls.

Anticipated Costs and Benefits:

The benefits of the proposed rule would be fewer cases of contaminated animal food. 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, reduced loss of market value of livestock, reduced loss of animal companionship, and reduced loss in value of animal food. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal food, 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 food from becoming contaminated, and implement the current good manufacturing practice regulations.

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. 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 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 reduce the risk of serious illness and death to animals.