The U.S. Food and Drug Administration (FDA) has issued five FDA Food Safety Modernization Act (FSMA) final and draft guidance documents relating to supplier verification under both the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF) rule.
We briefly summarize the issues addressed in each of the following documents:

  • FSVP Draft Guidance;
  • Chapter 15 (Supply-Chain Program) of the Hazard Analysis and Risk-Based Preventive Controls for Human Food Draft Guidance;
  • Guidance on the Application of FSVP Regulation to Importers of Grain Raw Agricultural Commodities;
  • Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 Draft Guidance;
  • FSVP Small Entity Compliance Guide (SECG); and,
  • Hazard Analysis and Risk-Based Preventive Controls for Animal Food Draft Guidance.

We encourage a close review of each of the documents, as they address important issues affecting compliance with the major FSMA regulations. Note that comments can be submitted at any time on guidance documents. FDA has established dates by when comments are requested to be submitted on the draft guidance document

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