FDA Issues Guidance on FSMA Enforcement Discretions
FDA will be exercising enforcement discretion for specific provisions in four FSMA rules, which means that the agency doesn’t expect to enforce the provisions as they apply to certain entities or activities. The agency made the announcement yesterday.
“In general, the 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 but is now exercising enforcement discretion.”
According to an FDA release, the enforcement discretion applies to provisions in: 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). The applications is as follows:
- Facilities that would be farms except for certain factors and activities
- Written assurances provisions in the four rules related to the control of identified hazards or microorganisms that could be a risk to public health
- Animal food PC requirements for certain manufacturing/processing activities performed on human food by-products used as animal food
- FSVP requirements for importers of food contact substances