The Food and Drug Administration has released a guidance document to assist FDA and state investigators in determining compliance with the agency's regulation prohibiting the use of most animal proteins in ruminant feeds.
"BSE/Ruminant Feed Ban Inspection" provides comprehensive instructions for investigators, to help ensure that inspections are conducted in a uniform manner and are of high quality. These inspections are important in the agency's efforts to help prevent the establishment and amplification of BSE through feed in the United States, should the disease ever be found in this country. The guidance is not binding, and alternative methods may be used, as long as they satisfy the requirements of the applicable statutes and regulations.
Because of the FDA's urgent need to assist inspectors, the level 1 guidance is being implemented immediately, without prior public comment. The agency requests comments on the guidance, however, and will consider revising the document.
The program can be found at www.fda.gov/cvm/index/bse/bse_guidance.htm. Single copies of the document may be obtained from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. The agency asks that individuals send a self-addressed, adhesive label to assist in processing their request.
Written comments may be submitted to the Dockets Management Brach (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted at www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Comments should be identified with the full title of the guidance document and docket number, 2003D-0498.
Technical questions about the guidance may be directed to Dr. Neal Bataller, Center for Veterinary Medicine, HFV-230, Food and Drug Administration, 7500 Standish Place, Rm. E441, Rockville, MD 20855; phone, (301) 827-0163, or firstname.lastname@example.org.