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U.S. Department of Health and Human Services

Animal & Veterinary

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RUMINANT FEED ENFORCEMENT ACTIVITIES

FDA Veterinarian Newsletter November/December 2001 Volume XVI, No VI

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 three CVM UPDATEs, most recently one on July 6, 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 October 26, 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 October 26, 2001, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,018 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 — 232
  • Number of firms handling materials prohibited for use in ruminant feed — 174 (75% of those firms inspected/reported).
  • Of the 174 renderers handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

    • 8 (5%) had products that were not labeled as required
    • 6 (3%) did not have adequate systems to prevent co-mingling
    • 2 (1%) did not adequately follow record keeping regulations
    • 13 (7%) 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.)

  • Number of FDA licensed feed mills in the U.S. as of October 26, 2001 — 1,231
  • Number of firms that have received an initial inspection —1,240
  • Number of firms whose initial inspection has been reported to CVM — 1,181
  • Number of firms handling materials prohibited for use in ruminant feed — 406 (34% of those firms inspected/reported)
  • Of the 406 licensed feed mills handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

    • 24 (6%) had products that were not labeled as required
    • 25 (6%) did not have adequate systems to prevent co-mingling
    • 3 (1%) did not adequately follow record keeping regulations
    • 42 (10%) 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 — 4,835
  • Number of firms handling materials prohibited for use in ruminant feed —1,439 (30% of those firms inspected/reported
  • Of the 1,439 feed mills not licensed by FDA handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

    • 133 (9%) had products that were not labeled as required
    • 78 (5%) did not have adequate systems to prevent co-mingling
    • 82 (6%) did not adequately follow record keeping regulations
    • 228 (16%) 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 — 4,237
  • Number of firms handling materials prohibited for use in ruminant feed — 629 (15% of those firms inspected/reported)
  • Of the 629 such firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

    • 56 (9%) had products that were not labeled as required
    • 21 (3%) did not have adequate systems to prevent co-mingling
    • 27 (4%) did not adequately follow record keeping regulations
    • 81 (13%) 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 October 26, 2001)

  • Number of firms whose initial inspection has been reported to CVM — 10,018
  • Number of firms handling materials prohibited for use in ruminant feed — 2,501 (25% of those firms inspected/reported)
  • Of the 2,501 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection):

    • 204 (8%) had products that were not labeled as required
    • 116 (5%) did not have adequate systems to prevent co-mingling
    • 106 (4%) did not adequately follow record keeping regulations
    • 333 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule. These 333 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 October 26, 2001, reports of 1,719 re-inspections have been submitted to CVM. On re-inspection of these 1,719 firms, 108 (6%) 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.