FDA announces some FSMA regulations will have enforcement discretion
Enforcement discretion will apply to provisions in four rules
FDA has announced that it will exercise enforcement discretion for certain provisions of four FSMA rules.
The enforcement discretion will apply to specific provisions in the following four rules: Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food; CGMP and HARPC for Food for Animals; Foreign Supplier Verification Programs (FSVP); and the Standard for the Growing, Harvesting, and Holding of Produce for Human Consumption.
The enforcement discretion will be exercised according to how those four rules apply to:
- Facilities that would be farms except for certain factors and activities
- Written assurances provision 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 and processing activities performed on human food by-products used as animal food
- FSVP requirements for importers of food contact substances.