July 7, 2001
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 CVM UPDATEs on January 10 and March 23, 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. As part of the enforcement plan, an initial inspection assignment was issued to all FDA District Offices in 1998 to conduct inspections of 100% of all renderers and known feed mills to determine compliance. Additional assignments have been issued to FDA District Offices regarding (1) further initial inspections of previously unknown firms potentially handling materials prohibited in ruminant feed and (2) re-inspections of firms found on initial inspection to be out of compliance with this regulation.
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 June 12, 2001. 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 June 12, 2001, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 9,867 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.)
Estimated number of rendering firms in the U.S. -- 264
Number of firms that have received an initial inspection -- 264
Number of firms whose initial inspection has been reported to CVM -- 241
Number of firms handling materials prohibited for use in ruminant feed -- 183 (76% of those firms inspected/reported).
Of the 183 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
17 (9%) had products that were not labeled as required
8 (4%) did not have adequate systems to prevent co-mingling
3 (2%) did not adequately follow record keeping regulations
25 (14%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule)
FDA LICENSED FEED MILLS:
(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.)
Estimated number of FDA licensed feed mills in the U.S. -- 1,240
Number of firms that have received an initial inspection -- 1,240
Number of firms whose initial inspection has been reported to CVM -- 1,176
Number of firms handling materials prohibited for use in ruminant feed -- 435 (37% of those firms inspected/reported)
Of the 435 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
47 (11%) had products that were not labeled as required
45 (10%) did not have adequate systems to prevent co-mingling
8 (2%) did not adequately follow record keeping regulations
76 (17%) 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:
(FDA does not know the total number of these feed mills because they are not required to be licensed by FDA.)
Estimated number of feed mills not licensed by FDA in the U.S. -- 6,000-8,000
Number of firms whose initial inspection has been reported to CVM -- 4,783
Number of firms handling materials prohibited for use in ruminant feed -- 1,580 (33% of those firms inspected/reported)
Of the 1,580 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
312 (20%) had products that were not labeled as required
169 (11%) did not have adequate systems to prevent co-mingling
85 (5%) did not adequately follow record keeping regulations
421 (27%) 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.)
Estimated number of such firms in the U.S. -- unknown
Number of firms whose initial inspection has been reported to CVM -- 4,094
Number of firms handling materials prohibited for use in ruminant feed -- 621 (15% of those firms inspected/reported)
Of the 621 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
84 (14%) had products that were not labeled as required
25 (4%) did not have adequate systems to prevent co-mingling
29 (5%) did not adequately follow record keeping regulations
110 (18%) 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 June 12, 2001):
Number of firms whose initial inspection has been reported to CVM -- 9867
Number of firms handling materials prohibited for use in ruminant feed -- 2,653 (27% of those firms inspected/reported)
Of the 2,653 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):
431 (16%) had products that were not labeled as required
222 (8%) did not have adequate systems to prevent co-mingling
112 (4%) did not adequately follow record keeping regulations
591 (22%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule. These 591 firms will be re-inspected in the near future.)
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 June 12, 2001, reports of 1,251 re-inspections have been submitted to CVM. On re-inspection of these 1,251 firms, 106 (8%) 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.
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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