On September 10, 2015, FDA issued a prepublication notice of its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food (“Human Food Rule”) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Food for Animals (“Animal Food Rule”) (collectively referred to as “the New FSMSA Rules”) are the first two of seven major rules that will be finalized under FSMA, and represent a historic shift toward a preventive approach to foodborne illness and safety across the U.S. food supply.
The New FSMA Rules establish standards for the safe manufacturing and production of human and animal food and will have significant implications across the industry. Although the New FSMA Rules contain provisions specific to human and animal food, respectively, they set forth generally similar requirements regarding hazard analysis and preventive controls. The New FSMA Rules apply to any entity required to register as a “food facility” with FDA. Key features of the New FSMA Rules include the following:
The development of FDA’s rules since passage of the FSMA in 2011 has been controversial. In June 2013, in response to a lawsuit filed by the Center for Food Safety and the Center for Environmental Health, the Northern District of California ordered FDA to publish all regulations required under FSMA by June 2015. See Order Granting Injunctive Relief, Center for Food Safety v. Margaret A. Hamburg, M.D. In February 2014, FDA reached a settlement with the two groups, agreeing to finalize regulations according to a staggered schedule beginning with the preventive controls rules. See Consent Decree, Center for Food Safety v. Margaret A. Hamburg.
The first two rules issued under FSMA introduce a new era in food regulation in the United States and will have significant implications across the food production industry. Although the New FSMA Rules purport to provide flexibility to the industry to accommodate the realities of modern food distribution, industry will be watching to determine how that flexibility is reflected in FDA’s enforcement efforts over the months and years ahead.
We will continue to monitor the rollout of the new FSMA rules and provide additional updates as they become available.