FDA Extends Several FSMA Compliance Deadlines

The Food and Drug Administration (FDA) recently published a final rule extending several compliance deadlines for specific provisions in four of the seven major FDA Food Safety Modernization Act (FSMA) final rules. The extensions affect provisions of the Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification Program (FSVP), and Produce Safety rules. The extensions each address specific issues that were brought to the agency’s attention by industry. Importantly, these are limited extensions for particular issues, rather than blanket extensions of the compliance date for the entire regulations.
The extensions address the compliance dates for the following:

  1. The requirement to obtain written customer assurances when controls are applied downstream in the distribution chain under the Human and Animal Food Preventive Controls rules, the FSVP rule, and the Produce Safety rule;

  2. Facilities solely engaged in packing and/or holding raw agricultural commodities (RACs) that are produce and/or nut hulls and shells;

  3. Facilities that would qualify as secondary activities farms except for the ownership of the facility;

  4. Certain facilities that color RACs;

  5. Facilities solely engaged in ginning cotton;

  6. Imports of food contact substances;

  7. Current Good Manufacturing Practices (cGMPs) requirements under Part 117 for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO); and

  8. Certain provisions related to agricultural water testing under the Produce Safety rule.

This [below] memorandum explains each of the extended compliance deadlines. Appendix 1 [below] to this memorandum summarizes the previous and revised compliance dates for each of the provisions affected by the final rule.