The FDA announced today that the agency does not intend to enforce certain provisions of FSMA, at least until additional rulemaking can take place. The enforcement discretion applies to four rules:

  • Preventive Controls (PC) for Human Food
  • Preventive Controls for Animal Food
  • Foreign Supplier Verification Program (FSVP)
  • Produce Safety

FDA Commissioner Scott Gottlieb said in a statement: “We value the feedback we’ve received on the new rules and understand manufacturers, farmers and other stakeholders have faced certain challenges as they work to implement the new rules. We’re actively working to pursue permanent fixes to some of these remaining issues through rulemaking or other means, but this will take time.”

The agency released guidance on the four areas where they plan to exercise enforcement discretion:

1. Certain facilities conducting farm-related activities that are subject to the preventive controls requirements

Farms are exempt from FSMA’s preventive controls rules, but some facilities that aren’t considered farms still conduct farm-related activities. The FDA plans further rulemaking that could change the way the requirements in the PC rules apply to these facilities.

2. Written assurances in the “customer provisions” in the PC Human Food, PC Animal Food, FSVP, and Produce Safety rules.

These rules require manufacturers, processors, importers, and farmers to provide their customers with written assurances that food will be processed to control for hazards. The FDA said that it underestimated the complexity of some product distribution chains, and, thus, the resources required to comply with the rules.

3. Importation of food contact substances under FSVP

The FDA doesn’t provide many details here, except to say that “after considering the issue, including comments and information provided by stakeholders,” they decided not to require importers of food contact substances to comply with FSVP requirements. The agency will continue to follow the existing Food Contact Notification and food additive petition processes.

4. Certain manufacturing/processing activities for human food byproducts for use as animal food

Human food facilities that separate byproducts for use in animal food may or may not be subject to the full requirements of the PC for Animal Food rule, depending on whether or not they further process those byproducts. The FDA will not enforce these requirements for activities that don’t affect the safety profile of the byproducts, specifically activities to reduce weight, bulk, or volume (e.g., drying/dehydrating, evaporating, pressing, chopping) and activities to combine ingredients or separate components (e.g., mixing, centrifuging).

For more information and to learn whether this enforcement discretion applies to you, read the fact sheet or download the full guidance.

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