FDA CVM GFI #239 Human Food By-Products For Use As Animal Food

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Draft – Not for Implementation Draft Guidance for Industry Human Food By-Products For Use As Animal Food This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency). It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION 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 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. Resources on whether a facility is required to register and how to complete the registration process can be found online at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. In this guidance, “Agency” and the pronouns “we” and “our” are used to refer to FDA. II. BACKGROUND On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). This law enables FDA to better protect public health by helping to ensure the safety and security of the human and animal food supply by focusing on prevention of

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