Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

The Food and Drug Administration (FDA) is amending its regulations to provide that animal protein derived from mammalian tissues for use in ruminant feed is a food additive subject to certain provisions in the Federal Food, Drug, and Cosmetic Act (the act). The final rule establishes a flexible system of controls designed to ensure that ruminant feed does not contain animal protein derived from mammalian tissues and to encourage innovation in such controls. FDA is taking this action because ruminants have been fed protein derived from animals in which transmissible spongiform encephalopathies (TSE's) have been found. Such proteins may cause TSE's in ruminants. TSE's are progressively degenerative central nervous system diseases of man and other animals that are fatal. Epidemiologic evidence gathered in the United Kingdom suggests an association between an outbreak of a ruminant TSE, specifically bovine spongiform encephalopathy (BSE), and the feeding to cattle of protein derived from sheep infected with scrapie, another TSE. Also, there may be an epidemiologic association between BSE and a form of human TSE known as new variant Creutzfeldt- Jakob disease (nv-CJD) reported in England. BSE has not been diagnosed in the United States, and the final rule is intended to prevent the establishment and amplification of BSE in the United States through feed and thereby minimize any risk to animals and humans.