April 15, 2002
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
To help 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. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle.
This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA previously provided information on this issue in four CVM UPDATEs, most recently one on October 30, 2001.
FDA’s enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non-compliance. FDA’s Center for Veterinary Medicine (CVM) has assembled data from the inspections that have been conducted AND whose final inspection report has been submitted to CVM (i.e., “inspected/reported”) as of March 11, 2002. There is a lag time between the completion of an inspection and the submission of a final inspection report to CVM. This lag period includes the time required to conduct quality assurance on the report and to evaluate the findings before a final report is submitted.
As of March 11, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,458 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials.
Various segments of the feed industry had different levels of compliance with this feed ban regulation. The results to date are reported here both by “segment of industry” and “in total”.
RENDERERS:
(These firms are the first to handle rendered protein and send materials to feed mills and ruminant feeders.)
Number of firms whose initial inspection has been reported to CVM -- 239
Number of firms handling materials prohibited for use in ruminant feed -- 171 (72% of those firms inspected/reported).
Of the 171 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
4 (2%) had products that were not labeled as required
3 (2%) did not have adequate systems to prevent co-mingling
(1%) did not adequately follow record keeping regulations
4 (2%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)
(FDA licenses these mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban rule: 21 CFR 589.2000. A license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.)
Number of firms whose initial inspection has been reported to CVM -- 1,203FDA LICENSED FEED MILLS:
Number of firms handling materials prohibited for use in ruminant feed -- 370 (31% of those firms inspected/reported)
Of the 370 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
8 (2%) had products that were not labeled as required
2 (1%) did not have adequate systems to prevent co-mingling
3 (1%) did not adequately follow record keeping regulations
10 (3%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)
FEED MILLS NOT LICENSED BY FDA:
Number of firms whose initial inspection has been reported to CVM -- 4,867
Number of firms handling materials prohibited for use in ruminant feed -- 1,224 (25% of those firms inspected/reported)
Of the 1,224 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
55 (4%) had products that were not labeled as required
28 (2%) did not have adequate systems to prevent co-mingling
28 (2%) did not adequately follow record keeping regulations
86 (7%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)
OTHER FIRMS INSPECTED:
(Examples of such firms include: ruminant feeders, on-farm mixers, protein blenders, and distributors.)
Number of firms whose initial inspection has been reported to CVM -- 4,710
Number of firms handling materials prohibited for use in ruminant feed -- 565 (12% of those firms inspected/reported)
Of the 565 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
17 (3%) had products that were not labeled as required
2 (less than 1%) did not have adequate systems to prevent co-mingling
7 (1%) did not adequately follow record keeping regulations
25 (4%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)
TOTALS (as of March 11, 2002):
Number of firms whose initial inspection has been reported to CVM -- 10,458
Number of firms handling materials prohibited for use in ruminant feed -- 2,153 (21% of those firms inspected/reported)
Of the 2,153 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
77 (4%) had products that were not labeled as required
34 (2%) did not have adequate systems to prevent co-mingling
35 (2%) did not adequately follow record keeping regulations
113 (5%) firms were found to be out of compliance
RE-INSPECTIONS:
When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of March 11, 2002, reports of 2,185 re-inspections have been submitted to CVM. On re-inspection of these 2,185 firms, 32 (1%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations.
DATABASE CHANGE
After March 11, 2002, FDA discontinued the database that was used to compile these numbers. The Agency is starting a new database on April 15, 2002, and future updates on BSE enforcement will draw from it.
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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