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HHS/FDA RIN: 0910-AC21 Publication ID: Spring 2002 
Title: Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations 
Abstract: The Food and Drug Administration (FDA) is proposing to prohibit the use of cervids (deer, elk) for food, including dietary supplements, and cosmetics if the cervids have been exposed to chronic wasting disease (CWD). FDA is proposing this regulation because of potential risks to health. CWD is a type of transmissible spongiform encephalopathy (TSE), a group of fatal, neurodegenerative diseases that include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep, and Creutzfeldt-Jakob disease (CJD) in humans. CWD affects cervids in the United States and Canada. CWD is endemic in cervid populations in certain areas of Colorado, Nebraska, and Wyoming. The disease has been identified in wild and farmed elk and wild deer populations. At least one published scientific article has reported that infectious CWD prion proteins in vitro can convert normal, non-infectious human prion proteins into abnormal, infectious forms. These data suggest that the agent of CWD could be transmitted to humans. Currently, there are no validated analytical tests to identify animals in the pre-clinical phase of CWD, or any other TSE. CWD typically exhibits a long incubation period, during which time animals appear normal but are likely to be infectious. Therefore, FDA is proposing to require that food or cosmetic products derived from animals exposed to CWD not enter into commerce. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 USC 264    21 USC 301 et seq   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2003    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306, Center for Food Safety and Applied Nutrition (HFS-316), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1486
Fax:301 436-2632

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