Substances Prohibited From Use in Animal Food or Feed; Specified Offal From Adult Sheep and Goats Prohibited in Ruminant Feed; Scrapie

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The Food and Drug Administration (FDA) proposes to declare that specified offal from adult (more than 12 months of age) sheep and goats is not generally recognized as safe (GRAS) for use in ruminant feed and is an unapproved food additive when added to ruminant feed. Accordingly, in the absence of an approved food additive regulation or investigational exemption, the use in ruminant feed of ingredients containing specified offal from adult sheep or goats will cause the feeds to be considered adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). FDA is proposing this action because the specified offal may contain the agent that causes scrapie, a transmissible spongiform encephalopathy (TSE) of sheep and goats. In the United Kingdom scrapie has been epidemiologically associated with the occurrence of bovine spongiform encephalopathy (BSE), another TSE. Because FDA cannot positively rule out a direct association between scrapie, BSE and human TSE's, FDA is proposing this action to protect the health of animals and humans.