United States: FDA Finalizes First Two Rules Under FSMA

Last Updated: September 18 2015
Article by Christopher A. Ripple and James F. Neale

New Rules Establish Preventive Controls for Human and Animal Food Manufacturing

On September 10, 2015, the U.S. Food and Drug Administration (FDA) finalized 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 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 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 rules establish standards for the safe manufacturing and production of human and animal food and will have significant implications across the industry. Although the two rules contain provisions specific to human and animal food, respectively, they set forth generally similar requirements regarding hazard analysis and preventive controls. The rules apply to any entity required to register as a "food facility" with FDA. Key features of the 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 rules revise the Current Good Manufacturing Practice (cGMP) regulations for human food for the first time since 1986, and set forth cGMPs for animal food for the first time.
  • The 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 rules.
  • In the commentary accompanying the final rules, FDA has indicated that at least certain provisions of the new rules will apply to activities entirely intrastate in character.
  • The rules provide for staggered compliance dates beginning one year following publication of the final rules, with separate compliance dates for provisions regarding supply-chain programs.

The development of these rules since passage of 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., Case No. C 12-4529 PJH (N.D. Cal. June 21, 2013) (ECF No. 63). 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, M.D., Case No. C 12-4529 PJH (N.D. Cal. February 20, 2014) (ECF No. 82-1).

The Provisions of the Final Preventive Controls Rules

Hazard Analysis and Risk-Based Preventive Controls

The new rules require each food facility to conduct a hazard analysis and implement risk-based preventive controls as part of a written food safety plan. Unless an exemption applies, each facility must identify any known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility, and then implement preventive controls to prevent or mitigate those hazards. Appropriate preventive controls include sanitation and allergen controls, as well as supply-chain controls and recall plans. Food facilities also must monitor the controls and take timely corrective action as appropriate. Verification of the effectiveness of controls, including byproduct testing or environmental monitoring, is not required for all preventive controls, but may be required depending on the food, the facility, and the role of the preventive control in the overall food safety system. Safety plans must be reanalyzed as a whole every three years, and portions of the plans must be reanalyzed in certain other circumstances.

Addressing Distribution Chains and Supply-Chain Programs

The preventive control rules acknowledge the complexities of modern food distribution chains. For example, the rules identify four circumstances in which a food manufacturer or processor need not implement a preventive control and can rely instead on a later entity in the distribution chain to control a particular hazard. The rules also allow a food manufacturer or processor to implement an alternative system that ensures control for a particular hazard at subsequent steps in the distribution chain.

Similarly, the new rules also require a receiving facility to implement a supply-chain program for raw materials or ingredients that require hazard controls. A supply-chain program will be required to include use of approved suppliers, conducting and documenting supplier verification activities, and potentially verifying supply-chain controls applied by an entity other than the receiving facility's supplier of raw materials or ingredients. These supplier-verification activities include onsite audits, sampling and testing of the raw materials, review of the supplier's food safety records, and other activities based on the supplier's performance and the risk associated with the raw material or ingredient.

Consistent with FSMA's goal of creating an integrated national food safety system, FDA has indicated in the commentary accompanying the final rules that it intends for at least certain provisions of the rules to apply to activities that are entirely intrastate in character.

cGMP Regulations

The new regulations revise and update the cGMPs for human food for the first time since 1986. Reflecting FDA's practice to no longer issue guidance within the regulations, previously nonbinding cGMPs for human food have been deleted or made binding. The new cGMPs also address allergen cross-contact.

The animal food rules establish cGMPs for animal food manufacturing and processing for the first time. These requirements cover a broad range of areas, including hygienic practices for personnel; maintenance and sanitation of the plant or grounds where animal food is processed or manufactured; requirements regarding the water supply and plumbing used at the facility; equipment and utensils; and the holding and distribution of animal food (including human food byproducts for use as animal food). The cGMPs for animal food also clarify that human food facilities in compliance with the cGMPs for human food may follow only the specific cGMPs relating to human food byproducts for use as animal food, unless the human food facilities further process the byproduct for use as animal food.

New Definition of "Farm"

Entities that meet the definition of "farm" are not subject to facility registration requirements and thus are not covered by the preventive controls rules. In response to concerns that the previous definition of "farm" was not sufficiently broad, FDA has expanded the definition of "farm" in a way that increases the number of farms exempt from the rules.

The new "farm" definition includes the "primary production" farm that is operated under one manager and devoted to growing and harvesting crops or raising animals, as well as the "secondary activities" farm that consists of operations, such as off-farm packing or the hulling and drying of nuts prior to processing, that are not located on a primary production farm but that are still a part of the farming process. Importantly, farms engaged in the growing, packing and holding of produce will be required to comply with FDA's forthcoming Produce Safety Rule under FSMA, which is due on October 31, 2015.

Other Forthcoming FMSA Regulations

Pursuant to the court-approved settlement regarding deadlines for FSMA regulations, FDA has agreed to finalize the remaining FSMA regulations by the following deadlines:

  • Produce Safety: The new rule will establish standards for the growing, harvesting, packing and holding of produce on both domestic and foreign farms. Deadline: October 31, 2015.
  • Foreign Supplier Verification Program (FSVP): The FSVP rule will require importers to verify that food has been produced under the same level of protections that would apply to domestic food producers. Deadline: October 31, 2015.
  • Third Party Certification: The new rule will establish a program for accrediting third-party auditors. Deadline: October 31, 2015.
  • Sanitary Transportation: The new rule will require food transporters to comply with certain sanitary practices. Deadline: March 31, 2016.
  • Intentional Adulteration: The new rule will require domestic and foreign facilities to address vulnerabilities to actions intended to cause large-scale public harm. Deadline: May 31, 2016.

Additional information on these upcoming rules is available in the Q&A section on FDA's website.


As the first two rules issued under FSMA, the human and animal food preventive controls rules introduce a new era in food regulation in the United States and will have significant implications across the food production industry. Although the new rules purport to provide flexibility to the industry to accommodate the realities of modern food distribution, the industry will be watching to determine how that flexibility is reflected in FDA's enforcement efforts over the months and years ahead.

The food and beverage industry team at McGuireWoods will continue to monitor the rollout of the new FSMA rules. We have extensive experience advising clients in the food and beverage industry regarding regulatory and litigation matters. We can assist companies who are threatened with potential litigation or regulatory enforcement, and we can provide counsel about how to mitigate these threats.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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