The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Use of Material From Deer and Elk in Animal Feed.” When finalized, this draft guidance will describe FDA’s recommendations regarding the use in all animal feed of all material from deer and elk that are positive, or at high risk, for Chronic Wasting Disease (CWD).

The potential risks from CWD to humans or non-cervid animals such as poultry and swine are not well understood. However, because of recent recognition that CWD is spreading rapidly in white-tailed deer, and because CWD’s route of transmission is poorly understood, FDA is recommending that any material from CWD-positive animals, or deer and elk considered to be at high risk for CWD, not be used in any animal feed or feed ingredients. High risk deer and elk are those from 1) areas declared by state officials to be endemic for CWD and/or to be CWD eradication zones and 2) those that at some time during the 60-month period before the time of slaughter were part of a captive herd with a CWD-positive animal.

CWD is a neurological (brain) disease of farmed and wild deer and the elk that belong in the cervidae animal family (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. TSEs are very rare, but are always fatal.

There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for CWD that can be used to test live animals for the disease.

FDA’s guidance documents are not regulations and are not mandatory. They set forth voluntary recommendations from FDA. They do not create or confer any rights for, or on, any person and do not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations.

This draft guidance is being distributed for comment purposes only. Written comments comments on the draft guidance may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Comments should be identified with the full title of the draft guidance and Docket number 03D-0186. Written comments on the draft guidance may be submitted at any time; however, comments should be submitted by June 16, 2003, to ensure their adequate consideration in preparation of the final document.

Additional information on the draft guidance document may be found in the May 16, 2003, Federal Register and from Dr. Burt Pritchett, Center for Veterinary Medicine (HFV-222) Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0177. E-mail: [email protected] The draft guidance is posted at http://www.fda.gov/cvm/guidance/dguide158.pdf.