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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Reports BSE Inspection Figures as of November 15, 2008

FDA Veterinarian Newsletter 2008 Volume XXIII, No IV

As of November 15, 2008, the Food and Drug Administration had received more than 66,000 reports of inspections done under the ruminant feed rule designed to prevent the establishment and spread of bovine spongiform encephalopathy (BSE) in the United States.

Approximately 71 percent of the inspections were conducted by State officials under contract or other arrangement with FDA, with the remainder conducted by FDA officials.

Inspections conducted by State and FDA investigators are classified to reflect the compliance status at the time of the inspection, based upon whether objectionable conditions were documented. Based on the conditions found, inspection results are recorded in one of three classifications:

  • OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly reinspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions.
  • VAI (Voluntary Action Indicated) when inspectors find objectionable conditions or practices that do not meet the threshold of regulatory significance, but warrant an advisory to inform the establishments that inspectors found conditions or practices that should be voluntarily corrected. VAI violations are typically technical violations of the 1997 BSE Feed Rule. These violations include minor recordkeeping lapses or conditions involving non-ruminant feeds.
  • NAI (No Action Indicated) when inspectors find no objectionable conditions or practices or, if they find objectionable conditions, those conditions are of a minor nature and do not justify further actions.
    (Note: The following figures are as of November 15, 2008.)

(Note: The following figures are as of November 15, 2008.)

Renderers

These firms are the first to handle and process (i.e., render) animal proteins. After they process the material, they send it to feed mills and/or protein blenders for use as a feed ingredient.

  • Number of active firms whose initial inspection has been reported to FDA – 267
  • Number of active firms handling materials prohibited from use in ruminant feed – 155 (58 percent of those active firms inspected)
    Of those 155 firms:
    • 0 firms were classified as OAI
    • 3 firms (2.0 percent) were classified as VAI

Licensed feed mills

In the inspection report database, FDA lists medicated feed licensed feed mills separately from non-licensed feed mills. But the licensing has nothing to do with handling prohibited materials under the feed ban regulation. FDA requires feed mills to have medicated feed licenses to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time, to produce certain medicated feed products.

  • Number of active firms whose initial inspection has been reported to FDA – 1,075
  • Number of active firms handling materials prohibited from use in ruminant feed – 494 (46 percent of those active firms inspected)
    Of those 494 firms:
    • 0 firms were classified as OAI
    • 4 firms (0.8 percent) were classified as VAI

Feed mills not licensed by FDA

These feed mills are not licensed by FDA to produce medicated feeds.

  • Number of active firms whose initial inspection has been reported to FDA – 5,290
  • Number of active firms handling materials prohibited from use in ruminant feed – 2,685 (51 percent those active firms inspected)
    Of the 2,685 firms:
    • 0 firms were classified as OAI
    • 29 firms (1.1 percent) were classified as VAI

Protein blenders

These firms blend rendered animal protein for the purpose of producing feed ingredients used by feed mills.

  • Number of active firms whose initial inspection has been reported to FDA – 387
  • Number of active firms handling materials prohibited from use in ruminant feed – 196 (51 percent of those active firms inspection)
    Of those 196:
    • 0 firms were classified OAI
    • 0 firms were classified VAI

Renders, feed mills, protein blenders

This category includes only those firms that manufacture, process, or blend animal feed or feed ingredients using prohibited materials.

  • Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported for FDA – 6,712
  • Number of active renders, feed mills, and protein blenders processing with prohibited materials – 506 (7.5 percent)
    Of those 506 firms:
    • 0 firms were classified OAI
    • 11 firms (2.2 percent) were classified VAI

Other firms inspected

Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.

  • Number of active firms whose initial inspection has been reported to FDA – 21,865
  • Number of active firms handling materials prohibited from use in ruminant feed – 7,295 (33 percent of those active firms inspected)
    Of those 7,295:
    • 0 firms were classified OAI
    • 113 firms (1.5 percent) were classified VAI

Total firms

(Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.)

  • Number of active firms whose initial inspection has been reported to FDA – 24,065
  • Number of active firms handling materials prohibited from use in ruminant feed – 7,876 (33 percent of those active firms inspected)
    Of those 7,876:
    • 0 firms were classified OAI
    • 121 firms (1.5 percent) were classified VAI