Today, the U.S. Food and Drug Administration (FDA) issued guidance that summarizes enforcement discretion for certain areas of the agency’s Food Safety Modernization Act (FSMA) rules.

Specifically, FDA will carry out enforcement discretion for parts of some specific FSMA rules. During the enforcement discretion period, FDA has no plans to enforce certain provisions as they currently apply to certain entities or activities.

This guidance is meant to allow additional time to consider changes or alternative ways 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 but is now exercising enforcement discretion.

The enforcement discretion applies to the following FSMA rules:

  • Current Good Manufacturing Practice
  • Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food)
  • Foreign Supplier Verification Programs rule (FSVP)
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety)

The provisions within these rules that will experience enforcement changes are:

  • 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 the FDA has taken to ensure that the 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 the FDA takes further action on each of these issues.

To find out if this new guidance applies to your food facility, you can refer to FDA's fact sheet. You can also view and download the full guidance document at FDA.gov. If you have questions, you can refer to FDA's FSMA Technical Assistance Network.

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Author(s): Staff