FDA guidance explains enforcement discretion related to FSMA provisions

The US Food and Drug Administration (FDA) announced that it intends to exercise enforcement discretion for certain provisions in four of the rules that implement the 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.

This 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

•FSVP requirements for importers of food contact substances

In general, the FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding 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.

For more information, see the fact sheet, constituent update and guidance available at www.fda.gov/fsma.

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