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HHS/FDA

RIN: 0910-AC21

Publication ID: Fall 2003

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. In addition to this proposed rule, FDA intends to issue guidance within the next few months on the use in animal feed or material from deer and elk that are positive for CWD or are at high risk of CWD. 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 goats, and Creutzfeldt-Jakob disease (CJD) in humans. The disease has been identified in wild and farmed elk and wild deer populations. CWD has been found in cervid populations in certain areas of Wisconsin, Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, New Mexico, Minnesota, and Canada. In 1999, the World Health Organization said there is no evidence that CWD transmits to humans. However, it also suggested any part of a deer or elk believed to be diseased should not be eaten. Results of some studies using in vitro techniques have suggested that transmission to humans could possibly occur. However, if it does occur, it is likely to be through a very inefficient process. Currently, there are no validated analytical tests to identify animals in the preclinical phase of CWD, or any other TSE. In addition, no test exists to ensure food safety. CWD typically exhibits a long incubation period, during which time animals appear normal but are potentially 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

Timetable:

Action	Date	FR Cite
NPRM	09/00/2004

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 Email: rebecca.buckner@fda.hhs.gov