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Showing 101–107 of 107 regulations
Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals
This regulation affirms certain food substances as generally recognized as safe (GRAS) for use in animal feed and drinking water. Specific substances listed include ethyl alcohol with ethyl acetate as an energy source in ruminant supplements, hydrophobic silicas as anticaking agents in vitamin preparations (limited to 5%), and 25-hydroxyvitamin D3 as a vitamin D3 source in broiler chicken feed and water (not exceeding 69 ppb in feed or 34.5 ppb in water), each with defined purity and usage specifications.
Food Additives Permitted in Feed and Drinking Water of Animals
21 CFR Part 573 establishes permitted food additives for animal feed and drinking water. Regulations cover acrylamide-acrylic acid resin as a thickener/suspending agent in aqueous feed suspensions, aminoglycoside 3'-phosphotransferase II enzyme for genetic modification of crops, ammoniated cottonseed meal as a protein source in ruminant feed (max 20% of ration), and ammoniated rice hulls as fiber and nonprotein nitrogen source in beef cattle feed (max 20% of ration). Each additive includes specifications, approved uses, and labeling requirements for safe application.
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
21 CFR Part 630 establishes minimum criteria for blood and blood component donations intended for transfusion or further manufacturing. Blood establishments must determine donor eligibility, assess donation suitability, and notify deferred donors. The regulation defines key terms including blood, blood components, donors, and relevant transfusion-transmitted infections (HIV, HBV, HCV, HTLV, syphilis, West Nile virus, Chagas disease, CJD, vCJD, and malaria). Requirements apply to establishments manufacturing blood and blood components.
Intentional Genomic Alterations in Animals
21 CFR Part 528 establishes regulatory pathways for intentional genomic alterations in animals, including rabbits producing recombinant human Factor VII in milk for hemophilia treatment, genetically modified Atlantic salmon with enhanced growth rates in contained freshwater facilities, pigs with CD163 gene deletion conferring PRRSV resistance, pigs with modified GGTA1 gene for use as food or therapeutic sources, and chickens producing human lysosomal acid lipase for medical treatment. Food and feed restrictions apply to certain lineages.
Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food
21 CFR Part 579 establishes safety standards for using ionizing radiation in animal feed and pet food production. Facilities may use gamma rays (cobalt-60, cesium-137) or electrons (up to 10 MeV) to treat complete animal diets and ingredients. For poultry feed, additional X-ray sources are permitted. Minimum effective dose for salmonella control is 2.0 kGy; maximum is 25 kGy. Facilities must comply with Part 507 and incorporate applicable Part 179 food irradiation regulations.
Interstate Conveyance Sanitation
21 CFR Part 1250 establishes sanitation standards for interstate conveyances (land, air, and water carriers) to prevent transmission of communicable diseases. It defines key terms including contamination, potable water, food service utensils, and shellfish, and references CDC quarantine requirements. The regulation covers bactericidal treatment, waste management, and sanitation practices for vessels and conveyances engaged in interstate traffic.
Substances Generally Recognized as Safe
21 CFR Part 582 establishes the regulatory framework for substances generally recognized as safe (GRAS) for use in food and animal feed. The regulation defines GRAS status, outlines good manufacturing and feeding practices including restrictions on quantities, and authorizes the FDA Commissioner to maintain lists of approved substances such as spices, essential oils, natural seasonings, and flavorings. Substances must be of appropriate grade and prepared as food ingredients, with quantities limited to what is reasonably necessary to accomplish their intended effect.