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Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance is intended for domestic and foreign facilities that are required to register under section 415 the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and its implementing regulations because they manufacture, process, pack, or hold human food for consumption in the United States and their human food production also provides by-products for use as animal food in the US. This guidance contains information for these facilities to determine what requirements to follow for their human food by-products for use as animal food. The regulations applicable to human food by-product for use as animal food were established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (the final rule). (80 FR 56170).
This guidance explains what requirements human food facilities must follow when they are providing by-products for use as animal food. It also explains what requirements facilities performing off-farm packing and holding of raw agricultural commodities (RACs) subject to the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety rule) in 21 CFR part 112 must follow when they are providing by-products for use as animal food.
This guidance applies only to by-products of human food processing and not to by-products from other types of processing. Examples of by-products of other types of processing that are sometimes used for animal food include spent grains from fuel ethanol production, glycerin from biodiesel production, lignin sulfonate and kraft lignin from wood pulp production or paper-making, or hemicellulose extracted from wood. Facilities that are not producing human food but are producing by-products for use as animal food are required to register and comply with all of 21 CFR part 507, unless they meet the criteria for an exemption.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1220.