FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations
the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA). As we began implementation of these rules, the FDA received questions and comments from stakeholders regarding specific provisions. In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health. As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance.
The enforcement discretion policies announced today are specific to provisions in the following rules:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food,
- Foreign Supplier Verification Program (FSVP),
- Produce Safety (PSR), and
- Intentional Adulteration (IA).
In many instances, this guidance builds upon previously announced enforcement policies.
Extension of Enforcement Discretion Policy for Supply-Chain Program Requirements Applicable to Contract Manufacturers of Human and Animal Food
On November 6, 2019, the agency announced it would continue an enforcement discretion policy described in a November 2017 guidance for certain FSMA supply-chain program requirements applicable to receiving facilities that are contract manufacturers of human and animal foods, while the agency considered issues relating to supplier verification and approval challenges. This guidance formally extends the enforcement discretion policy. While the FDA considers these issues it does not intend to enforce certain supply-chain program requirements for food manufactured for the brand owner by a contract manufacturer/processor.
Enforcement Policy for Certain Entities and Requirements under the Intentional Adulteration Rule
Enforcement Discretion for facilities that conduct farm-related activities
In a January 2018 FSMA guidance, the FDA established an enforcement discretion policy for certain facilities that conduct certain farm-related activities but are not considered farms under the “farm” definition. In this new guidance, the FDA is clarifying that it does not intend to take enforcement action related to the IA rule as it applies to the same facilities and activities, while the agency issues rulemaking that could change the definition of “farm”. Such a change would impact whether the IA provisions apply to these entities.
Enforcement Discretion for the reanalysis provisions in the IA rule in certain circumstances
The IA rule requires reanalysis of a Food Defense Plan (FDP) in certain circumstances, including whenever a mitigation strategy, a combination of strategies, or the FDP as a whole is not properly implemented. The rule also requires that covered entities establish and implement food defense corrective actions procedures that must be taken if mitigation strategies are not properly implemented. To reduce duplication, the FDA plans to exercise enforcement discretion for the requirement for reanalysis when improper implementation of mitigation strategies is addressed through actions that correct the deficiency and reduce the likelihood that the deficiency will happen again.
Enforcement Policy for Supplier Approval and Verification Requirements in the PC Human, PC Animal and FSVP Regulations
This guidance establishes an enforcement discretion policy for a receiving facility or FSVP importer when they are verifying their supplier’s compliance with PC Human Food, PC Animal Food, or Produce Safety requirements covered by an enforcement discretion policy. The FDA will not expect a receiving facility or FSVP importer to verify its supplier’s compliance with requirements that are subject to enforcement discretion for the supplier (e.g., Produce Safety rule requirements for wine grapes, hops, pulse crops, and almonds that are the subject of enforcement discretion for farms that grow and harvest those crops). Receiving facilities and FSVP importers are still expected to conduct other required supplier verification activities.
For More Information
- Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Guidance for Industry (March 2022)
- Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (November 2017)
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (January 2018)
- Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds (March 2019)