January 10, 2001
UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
Bovine spongiform encephalopathy (BSE) is a type of “transmissible spongiform encephalopathy” disease that infects cattle. After the first case in 1986 in the United Kingdom, BSE quickly became an epidemic in cattle herds there. No cases of BSE have been found in U.S. cattle, despite active monitoring.
Rendered feed ingredients contaminated with an infectious agent are believed to be the source of BSE infection in cattle. Some of the feed given to cattle includes remnants of the slaughtering process, such as the brain and spinal cord, which may harbor the agent that causes BSE. Although the material is cooked during the rendering process, the BSE agent can survive.
To prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the feeding of mammalian protein to ruminant animals in most cases. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
FDA developed an enforcement plan with the goal of 100% compliance with this rule. For the first two years it was in effect, the enforcement plan included education as well as inspections with FDA taking compliance actions for egregious actions or repeated non-compliance. As part of the enforcement plan, an assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and feed mills and some ruminant feeders to determine compliance.
FDA's Center for Veterinary Medicine (CVM) has assembled data from the inspections conducted thus far, and presented the following data in a conference call FDA held with Federal and State feed control officials on January 9, 2001.
To date, there have been a total of 9,947 inspections. The majority of these inspections (around 80%) were conducted by State officials and the remainder by FDA. Various segments of the feed industry had different levels of compliance.
For Renderers, who are at the "top of the pyramid" since they are the first to handle rendered protein, and who send materials to feed mills and other ruminant feeders:
Total number of inspections -- 239. Firms handling prohibited material -- 180
Firms whose products were labeled with the required caution statement -- 84%
Had a system to prevent commingling -- 72%
Followed recordkeeping regulations -- 96-98%
For FDA Licensed Feed Mills -- 1,240 total -- Inspected -- 846. Of those feed mills inspected, 347 were handling prohibited material:
Firms whose products were labeled with the required caution statement -- 80%
Had a system to prevent commingling -- 91%
Followed recordkeeping regulations -- 98
For Non-FDA Licensed Feed Mills -- 4,344 inspected (FDA does not know the total number since they are not required to be licensed by the Agency, but it could be 6,000 - 8,000.) Of those feed mills inspected, 1,593 were handling prohibited material:
Firms whose products were labeled with the required caution statement -- 59%
Had a system to prevent commingling -- 74%
Followed recordkeeping regulations -- 91%
FDA is continuing its enforcement efforts to achieve the goals of 100% inspection of all renderers and feed mills and some ruminant feeders and 100% compliance with the ruminant feed regulations. FDA Field offices have an assignment to re-inspect 700 firms that were not in full compliance with the rule but have committed to implementing the regulation. In addition, FDA is seeking assistance from State feed control officials to identify non-FDA licensed feed mills and to conduct additional inspections in all categories. FDA anticipates higher levels of compliance after completion of follow-up inspections.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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