FSMA Rules for Preventive Controls for Human and Animal Food Manufacturing Finalized

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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:

  • Food facilities must implement hazard analysis and risk-based preventive controls as part of their written food safety plans to prevent or mitigate identified food safety hazards.
  • The Human Food Rule revises the Current Good Manufacturing Practice (cGMP) regulations for human food for the first time since 1986, and the Animal Food Rule sets forth cGMPs for animal food for the first time.
  • The New FSMA Rules address food safety across the distribution chain, allowing food manufacturers and processors in some circumstances to rely on entities later in the distribution chain but requiring receiving facilities to create supply-chain programs that implement preventive controls.
  • An expanded definition of “farm” will reduce the number of farms subject to the New FSMA Rules.
  • In the commentary accompanying the New FSMA Rules, FDA has indicated that at least certain provisions of the New FSMA Rules will apply to activities entirely intrastate in character.
  • The New FSMA Rules provide for staggered compliance dates beginning one year following publication of the New FSMA Rules (September 17, 2016), with separate compliance dates for provisions regarding supply-chain programs.

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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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