Today, the FDA announced that it plans to exercise enforcement discretion on particular provisions of the following FDA Food Safety Modernization Act rules: 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).
In addition to extending the compliance dates for many of the FSMA provisions (see August 2016 compliance date extension), this FDA’s decision of enforcement discretion is meant to allow time to consider changes or approaches to address concerns regarding the implementation of certain FSMA provisions. However, the agency will continue to enforce the current provision against adulterated food.
The following provisions of the previously stated rules will have relaxed enforcement:
- 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.
These enforcement discretion policies will be in place until the 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 and guidance.