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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 August 5, 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No III

As of August 5, 2006, the Food and Drug Administration (FDA) had received more than 47,000 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 68 percent of the inspections were conducted by State officials under contract to 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 re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether adequate corrective actions have been -implemented.
  • 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 establishment 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 August 5, 2006.)

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 – 275
  • Number of active firms handling materials prohibited from use in ruminant feed – 177 (64 percent of those active firms inspected)
    Of those 177 firms:
    • 2 (1.1 percent) were classified as OAI
    • 1 (0.6 percent) was 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 – 1,086
  • Number of active firms handling materials prohibited from use in ruminant feed – 438 (40 percent of those active firms inspected)
    Of those 438 firms:
    • 1 (0.2 percent) was classified as OAI
    • 5 (1.1 percent) were classified as VAI

Feed mills not licensed by FDA

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

  • Number of active firms whose initial inspection has been reported to FDA – 5,138
  • Number of active firms handling materials prohibited from use in ruminant feed – 2,270 (44 percent of those active firms inspected)
    Of those 2,270 firms:
    • 2 (0.1 percent) were classified as OAI
    • 49 (2.2 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 – 345
  • Number of active firms handling materials prohibited from use in ruminant feed – 176 (51 percent of those active firms inspected)
    Of those 176 firms:
    • 1 (0.6 percent) was classified as OAI
    • 1 (0.6 percent) was classified as VAI

Renderers, feed mills, protein blenders

This category includes any firm that is represented by any of the above four categories, but 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 to FDA – 6,572
  • Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 487 (7.4 percent of those active firms inspected)
    Of those 487 firms:
    • 4 (0.8 percent) were classified as OAI
    • 15 (3.1 percent) were classified as 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 – 15,544
  • Number of active firms handling materials prohibited from use in ruminant feed – 4,712 (30 percent of those active firms inspected)
    Of those 4,712 firms:
    • 5 (0.1 percent) were classified as OAI
    • 127 (2.7 percent) were classified as VAI

Total firms

  • Number of active firms whose initial inspection has been reported to FDA – 18,231
  • Number of active firms handling materials prohibited from use in ruminant feed – 5,476 (30 percent of those active firms inspected)
    Of those 5,476 firms:
    • 8 (0.1 percent) were classified as OAI
    • 137 (2.5 percent) were classified as VAI

(NOTE: A single firm that has more than one function can be listed in different industry segments, which also means that the total presented here may be less than a combination of all the segments listed above.)

Comings and Goings

New Hires

Office of Surveillance and Compliance

  • Diana Bargo, Consumer Safety -Officer

Office of New Animal Drug Evaluation

  • Trudie Willis, Legal Instruments -Examiner

Departures

Office of New Animal Drug Evaluation

  • Sabine Ladd, Veterinary Medical Officer, Staff Fellow
  • Anna Caponiti, Project Management Specialist