Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on Chapter 15 of FDA's draft Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry (Chapter 15) and draft Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry (FSVP Guidance). As the voice of the U.S. frozen food industry, AFFI is the national trade association that represents the interests of all segments of the frozen food industry. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI represents a broad group of companies that are subject to the FDA Food Safety Modernization Act (FSMA) regulations, including food producers, distributors, and retailers. AFFI and its members are grateful to FDA for its ongoing efforts to develop guidance and other tools to assist industry in complying with these groundbreaking regulations. Robust and thoughtful guidance will be essential for understanding and complying with the new FSMA regulations, especially for small businesses. AFFI is particularly appreciative of the obvious time and resources FDA invested in developing these supplier verification guidance documents. Both documents provide additional information and clarification that will assist industry in crafting and implementing their compliance strategies, leading to quicker compliance with the regulations and improving food safety. Due to the significant overlap in the documents, AFFI has prepared these shared comments addressing both documents. First, AFFI recognizes and expresses its support for several sections in the documents that either clarify the rules or provide additional flexibility for firms in their compliance with the supplier verification regulations. Second, AFFI offers suggestions for changes to the documents to address areas where FDA's expectations for compliance exceed what firms are able to achieve due to practical constraints of common industry practices. Finally, we also identify additional opportunities to improve the documents by addressing additional questions and concerns from industry, including in particular areas where additional flexibility would facilitate compliance. Further discussion of these and other topics are detailed in the attached document.