March 23, 2001
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
This is more recent information on ruminant feed (BSE) enforcement activities. FDA previously provided information on this issue in a January 10, 2001, CVM UPDATE (Active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle.
To prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
FDA's enforcement plan for the ruminant feed rule includes 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 as of February 27, 2001.
As of that date, there had been a total of 10,240 inspections of 10,065 firms. 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 the first to handle rendered protein, and who send materials to feed mills and other ruminant feeders:
Estimated number of rendering firms in the U.S. - 260
Number of firms inspected - 227
Number of firms handling material prohibited for use in ruminant feed - 177 (77% of those firms inspected).
Of the 177 renderers handling prohibited material:
Those whose products were labeled with the required caution statement -- 96%
Had a system to prevent commingling -- 86%
Followed recordkeeping regulations -- 97%
For FDA Licensed Feed Mills:
Estimated number of licensed feed mills - 1,240
Number of licensed feed mills inspected - 1,069
Number of licensed feed mills handling material prohibited for use in ruminant feed -- 397 (37% of those licensed feed mills inspected).
Of the 397 handling prohibited material:
Those whose products were labeled with the required caution statement -- 85%
Had a system to prevent commingling -- 87%
Followed recordkeeping regulations -- 99%
For Non-FDA Licensed Feed Mills:
Estimated number of non-FDA licensed feed mills - 6,000-8,000 (FDA does not know the total number since they are not required by the Agency to be licensed).
Number of non-FDA licensed feed mills inspected - 5,064
Number of non-FDA licensed feed mills handling material prohibited for use in ruminant feed -- 1,829 (36% of those non-FDA licensed feed mills inspected).
Of the 1,829 handling prohibited material:
Those whose products were labeled with the required caution statement -- 67%
Had a system to prevent commingling -- 82%
Followed recordkeeping regulations -- greater than 99%
The rule requiring a firm to have a system to prevent commingling is triggered when the firm is manufacturing products that contain prohibited material in the same facility it is manufacturing products that do not contain prohibited material.
In January 2001, FDA field offices were issued an assignment to re-inspect 834 firms that were not in full compliance with the rule. As FDA anticipated, because many of these firms had committed to implementing the regulation, there have been higher levels of compliance after completion of follow-up inspections. Of the 157 re-inspections of renderers, feed mills, and other facilities that had been conducted by February 27, only one firm, a rendering firm, continued to be out of compliance. FDA continues to conduct these re-inspections, and FDA and State feed control officials continue conducting initial 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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