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FDA announces enforcement discretion policy for certain FSMA regulations

The agency is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions.

FDA intends to exercise enforcement discretion for certain provisions in four of the rules that implement the FDA Food Safety Modernization Act (FSMA). This means that during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities.

In general, FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance (see August 2016 compliance date extension) but is now exercising enforcement discretion.

The enforcement discretion  pertains to specific provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:

  • facilities that would be farms except for certain factors and activities,
  • written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health
  • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
  • FSVP requirements for importers of food contact substances.

Issuing this enforcement discretion guidance is consistent with other actions FDA has taken to ensure that FSMA rules are as effective as possible while providing flexibility where necessary and appropriate to support compliance. These enforcement discretion policies will be in place until FDA takes further action on each of these issues. To learn more about whether this guidance applies to your facility please see the fact sheet (PDF: 79KB) and guidance.

Resources:

Questions can be directed to the FSMA Technical Assistance Network

Federal Register Notice Announcing the Guidance

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