On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), Produce Safety, and Foreign Supplier Verification Programs (FSVP) regulations issued under the FDA Food Safety Modernization Act (FSMA). This post provides an overview of the situations in which FDA will exercise enforcement discretion, specifically:
- Written assurance provisions in all four rules related to the downstream control of identified hazards or microorganisms that are a potential risk to public health;
- FSVP requirements for importers of food contact substances (FCS);
- PCAF requirements for certain manufacturing/processing activities performed on human food by-products for use as animal food; and
- Certain facilities that are similar to farms, but that do not meet the “farm” definition.