The Food and Drug Administration (FDA) announced its intention to exercise enforcement discretion for portions of the Food Safety Modernization Act (FSMA) rules. The update on enforcement was announced through a constituent update on January 4. FDA indicated that there are no plans to enforce certain provisions as they currently apply to specific entities or activities.
The enforcement discretion period is designed to provide adequate time for the consideration of changes or alternative approaches to concerns regarding the application of provisions related to certain activities or entities.
“While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated,” FDA Commissioner Scott Gottlieb, M.D. said in a statement.
The discretion announcement pertains to specific provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule, Foreign Supplier Verification Programs rule, and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
Some of the considerations being made are how these rules will apply to facilities that would be considered farms except for certain factors and activities. Other considerations address the written assurances provisions in the rules related to the control of identified hazards or microorganisms that are a potential risk to public health. Animal food preventive control requirements for certain manufacturing or processing activities performed on human food byproducts used as animal food, along with the FSVP requirements for importers of food contact substances will also be receiving a review.
These enforcement discretion policies will remain in place until the FDA takes further action on each of the issues under consideration.