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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA HOSTS A FOLLOW-UP WORKSHOP ON BSE FEED REGULATION

by Paul M. Raynes, Deputy Director, Division of Federal-State Relation, FDA Office of Regional Operations
FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

The Fairmont Hotel in Dallas, Texas was the setting for a recent Food and Drug Administration (FDA) sponsored workshop for State veterinarians and feed control officials from all fifty States, Puerto Rico, the U.S. Virgin Islands and Canada, to provide a briefing on the latest developments with the Bovine Spongiform Encephalopathy (BSE) feed regulation. More than 170 State and Federal regulators took part in the two-day workshop that featured speakers from FDA’s Center for Veterinary Medicine (CVM) and Office of Regulatory Affairs (ORA), USDA’s Animal and Plant Health Inspection Service (APHIS) and Canada’s Food Inspection Agency.

The BSE regulation, now in effect for two years, restricts the use of mammalian protein in feeds for cattle and other ruminants. The regulation requires protein renderers, protein blenders, feed manufacturers and distributors to label feeds that contain prohibited material with the following warning statement: "Do not feed to cattle or other ruminants". It was developed to prevent the establishment and amplification through feed of BSE.

This workshop was a follow-up to a 1997 meeting in Kansas City where the regulation was first discussed with an audience of more than 100 Federal and State regulators. As he had done in Kansas City, Dr. John Honstead, a veterinary medical officer with CVM’s Division of Animal Feeds, briefed the Dallas audience on the science related to BSE. He explained that BSE is one type of spongiform encephalopathy while others can be found in sheep, minks, cats and humans. Dr. Honstead reported that, although the BSE epidemic in the United Kingdom continues to abate, there are growing concerns that the incidence of a similar disease in humans called "new variant" Creutzfeldt-Jakob disease (CJD) is increasing. And, unlike its counterpart, sporadic CJD, the "new variant" does not discriminate regarding age. The latest cases have involved victims under the age of 30.

Gloria Dunnavan, Director of CVM’s Division of Compliance, wore several hats during the workshop. She reviewed the Inspection Reporting Checklist, giving the audience the rationale as to why certain questions were being asked. She also led the audience in a question and answer session to gain feedback useful in making needed changes to the checklist. She also shared the program with Ricky Rodriguez from FDA’s Dallas District Office, discussing enforcement issues and reviewing guidance documents.

The States also played an important role in the presentation of this workshop. Two States, Virginia and California, provided detailed accounts of their perspectives and experience with inspections for compliance with the regulation. Similar presentations were then given by FDA personnel from the Denver and Detroit District Offices providing a Federal perspective. The session concluded with a fascinating look at similar efforts "north of the border" from our regulatory counterpart, Mr. Sergio Tolussa, with the Canadian Food Inspection Agency.

Other topics included import activities, future initiatives and the use of a problem solving breakout session to deal with several scenarios involving the use of prohibited materials. Finally, Dr. Linda Detwiler from USDA/APHIS, discussed a memorandum of understanding with USDA and provided some insight as to her agency’s role in the prevention of BSE in this country.

This workshop generated a great deal of interaction among the participants including many questions, solutions to problems, ideas for inspectional techniques, educational initiatives and enforcement approaches. Thanks to the development of this regulation, we can continue to say that there has not been a single case of BSE reported in the United States. Educational efforts such as this with our regulatory partners will help assure that we can continue to make that claim.