机构: 

美国食品药品管理委员会（Food and Drug Administration）
卫生与人类服务部（Health and Human Services）
21 CFR Part 589 [Docket No. 96N–0135] RIN 0910–AA91

提要: 

The Food and Drug Administration (FDA) is proposing to amend the regulations to provide that animal protein derived from ruminant and mink tissues is not generally recognized as safe (GRAS) for use in ruminant feed, and is a food additive subject to certain provisions of the Federal Food, Drug, and cosmetic Act (the act). The proposed regulations would establish a flexible system of controls, designed to ensure that ruminant feed does not contain animal protein derived from ruminant and mink tissues in a manner that encourages innovation. FDA is also considering alternatives to this proposed ruminant-to-ruminant prohibition, and is requesting comment on the relative merits and disadvantages of the alternatives. FDA is proposing this action because the feeding to ruminants of protein derived from potentially transmissible spongiform encephalopathy (TSE)-infective tissues may cause TSE in animals. TSE’s are progressively degenerative central nervous system (CNS) diseases of man and animal that are fatal. Epidemiologic evidence gathered in the United Kingdom (U.K.) 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, scientists have postulated that there is an epidemiologic association between BSE and a form of human TSE, new variant Creutzfeldt-Jakob disease (nv-CJD) reported recently in England. BSE has not been diagnosed in the United States. However, this proposed rule is intended to prevent the establishment and amplification of BSE in cattle in the United States, and thereby minimize any risk which might be faced by animals and humans. proposal become effective 60 days after the date of its publication in the Federal Register.