FDA finally finalizes animal food safety rule under FSMA

The FDA issued new regulations for animal food safety under the Food Safety Modernization Act (FSMA) (P.L. 111-353), including new requirements for current good manufacturing practices (CGMP), hazard analysis, and risk-based preventive controls, through an advance release of a Final rule. The regulations are the agency’s attempt to interpret new statutory provisions in the FSMA which are designed to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals. The Final rule attempts to develop a modern, preventive, and risk-based approach to food safety regulation through new manufacturing standards and new food facility safety prevention requirements. The Final rule is set to publish in the Federal Register on September 17, 2015.

Background

The FSMA was signed into law on January 4, 2011 and was aimed at improving public human and animal health “by helping to ensure the safety and security of the food supply.” The FSMA requires the passage of seven foundational rules which provide the regulatory framework for the FDA’s implementation of the new FSMA programs. In 2012, the FDA was sued for failing to meet the FSMA’s requirement to promulgate the foundational rules within 18 months of the law’s effective date (see Federal court orders the FDA to promulgate food safety regulations required by the Food Safety and Modernization Act of 2010, Health Law Daily, April 24, 2013).

Deadlines

The court then set deadlines for the FDA to publish all proposed regulations concerning food safety by November 30, 2013, with subsequent final regulations to be published by June 30, 2015. Subsequently, the FDA requested extensions on the publication deadlines for some of the rules. The court denied those requests (see Court declines to allow additional FDA delays on implementation of food safety regulations, Health Law Daily, August 15, 2013). The rulemaking litigation was subsequently settled, and a consent decree established a timeline containing new deadlines for the publication of the Final rules (see FDA, food safety advocates settle rulemaking litigation, Health Law Daily, February 21, 2014).

Final rule

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Final rule is one of the foundational rules required under the FSMA. On September 29, 2014, the FDA supplemented a 2013 Proposed rule (78 FR 64736) on the topic (see FDA takes another proposed bite at manufacturing requirements for animal food, Health Law Daily, September 29, 2014). Now, four-and-a-half years after the FSMA was signed into law, the FDA is finalizing two of those rules, the animal food rule and one pertaining to human food.

CGMPs

The animal food Final rule establishes CGMP requirements under 21 C.F.R. Sec. 507 for the manufacturing, processing, packing and holding of animal food. The Final rule explains that the CGMP regulations “are necessary 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.” The Final rule establishes specific CGMPs for the following areas: Personnel; Plant and grounds; Sanitation; Water supply and plumbing; Equipment and utensils; Plant operations; Holding and distribution; and Holding and distribution of human food by-products for use as animal food. The CGMPs are designed to serve as baseline standards that take into account the unique aspects of the animal food industry.

Preventive controls

Section 103 of the FSMA required the FDA to issue regulations establishing “science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls.” The Final rule includes requirements for the establishment of a Written food safety plan; Hazard analysis; Preventive controls; Monitoring; Corrective actions and corrections; Verification; Supply-chain program; Recall plan; and Associated records. Although they are not identical, the FDA explains that the animal food safety requirements are similar to the requirements of the Hazard Analysis and Critical Control Point (HACCP) systems.

Under the Final rule, “a facility must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are any hazards requiring preventive controls.” Those preventive controls must be implemented to “provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by the facility will not be adulterated.”

Risk assessment

The FDA was also required by the FSMA to conduct a science-based risk analysis and to consider the results of that analysis as part of the rulemaking process. Accordingly, the FDA also issued an advance release of a Qualitative Risk Assessment of activities related to animal food. The risk assessment is also scheduled to publish in the Federal Register on September 17, 2015.