FDA Hearing Focuses on BSE

The Food and Drug Administration will hold a public hearing to solicit information and views on whether and how to strengthen a regulation designed to help prevent the occurrence, through animal feed, of bovine spongiform encephalopathy (BSE) in U.S. cattle herds.

Since 1997, when the regulation "Animal Proteins Prohibited in Ruminant Feed" (available at http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr589_01.html) went into effect, new information on BSE and variant Creutzfeldt-Jakob Disease (vCJD) has emerged. FDA said this information needs to be considered for its possible effect on the risk the diseases pose to human and animal health.

FDA is requesting information and views from individuals and organizations on the present rule and whether changes in the rule or other additional measures are necessary. The agency is interested especially in soliciting comments and views from individuals, industry, consumer groups, health professionals, and researchers with expertise in BSE and related animal and human diseases.

The hearing will be held on Oct.30 from 9 a.m. to 5 p.m. central time at the Westin Crowne Center Hotel, 1 Pershing Road, Kansas City, MO. The hearing will be open to the public, and FDA will reserve one hour from 4-5 p.m. for oral presentations from those who have not previously registered.

Individuals or organizations that wish to address the hearing should register by 4:30 p.m. eastern time on Oct. 23 and submit a written notice of participation to Linda Grassie at Center for Veterinary Medicine (HFV-12), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855 (fax no. 301-827-4065). To ensure timely handling, the outer envelope should be clearly marked with Docket No. 01N-0423 and the statement "Animal Feed Rule Hearing."

The official record of the hearing will remain open to receive written comments until Nov. 21. Comments identified with Docket No. 01N-0423 can be submitted (in one copy by an individual and two copies by organizations) to the Dockets Management Branch, HFA-305, Food and Drug Administration 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. Comments can be submitted also electronically to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.

Additional information about the hearing is available in the Oct. 5 Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/100501b.htm) and from Linda Grassie at 301-827-3796 or via email at lgrassie@cvm.fda.gov.