Human Food By-Products For Use As Animal Food; Draft Guidance for Industry; Availability

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) regarding draft guidance for industry #239, Human Food By-Products for Use as Animal Food. 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. Our members produce frozen foodsfrom fruits and vegetables, to mixed dishes, to pizza and frozen potatoesfor human consumption. Many AFFI members distribute by-products from their human food production for use in animal food. We commend the agency for issuing guidance on this important issue. It is important that the regulatory framework governing by-products sent for animal consumption provides a practical way for surplus food materials to get put to good use. Our members send by-products to animal consumption for a number of practical, economic, and environmental reasons that we have set forth in our prior comments. / We are encouraged that FDA's Preventive Controls for Animal Food final rule recognizes this practice and sets up a common-sense approach to regulating by-products under current Good Manufacturing Practices (cGMPs). The goal for this guidance document should be to provide additional details and flexibility for manufacturers, rather than to place any new restrictions on sending human food by-products for use as animal food. In the comments that follow, we offer several recommendations to clarify the draft guidance, as well as to preserve the flexibility needed to ensure our members have the continued ability to engage in this important practice. To summarize our main messages: FDA's guidance should clarify that an entity other than the food company (e.g., a downstream customer) may make the determination of whether a human food by-product with a human food safety concern also poses an animal food safety concern. The guiding principle for determining a common or usual name should be that the name provides adequately descriptive terms that identify the contents to the purchaser. The guidance should not recommend labeling discarded by-products as "Not for Animal Food." The discussion of the regulatory status of ingredients as GRAS or food additives should be moved to separate guidance. FDA should not consider "mixing" to be a manufacturing activity in this context. FDA should ensure that draft guidance # 235, Current Good Manufacturing Practice Requirements for Food for Animals is consistent with this guidance. We address each of these points in the attached document.