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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.
Control of Communicable Diseases
21 CFR Part 1240 establishes FDA regulations for controlling communicable diseases through sanitation and quarantine measures. The regulation defines key terms including communicable diseases, contamination, conveyances, garbage, incubation periods, and milk/milk products. It specifies requirements for interstate traffic involving conveyances and persons, and sets minimum heat treatment standards (boiling for 30+ minutes) for garbage in food-handling establishments including houses, restaurants, hotels, and kitchens.
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.
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.
Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589 establishes prohibitions on substances in animal food and feed that present potential health risks or lack adequate safety data. The regulation prohibits gentian violet in all animal feed and propylene glycol in cat food, and restricts mammalian proteins in ruminant feed to prevent disease transmission. Violations render animal feed adulterated under the Federal Food, Drug, and Cosmetic Act.
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.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Food Additive Petitions
21 CFR Part 571 establishes the procedure for submitting food additive petitions to the FDA under the Federal Food, Drug, and Cosmetic Act. Petitioners must submit applications in triplicate with detailed information on the food additive's chemical identity, composition, manufacturing methods, analytical controls, stability data, and proposed uses. The regulation specifies content requirements including physical/chemical/biological properties, specifications, impurities, and manufacturing details for each entity involved in production.
Regulations Under the Federal Import Milk Act
21 CFR Part 1210 establishes regulatory requirements for imported milk and cream under the Federal Import Milk Act. It defines milk, cream, and related dairy products; specifies pasteurization standards (minimum 143°F for 30 minutes or 161°F for 15 seconds); and requires dairy farms and processing plants to undergo sanitary inspections scoring at least 50 out of 100 points and be available for examination by authorized agents. The rules apply to all milk and cream offered for import into the continental United States.
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.