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U.S. Department of Health and Human Services

Animal & Veterinary

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Update On Ruminant Reed (BSE) Enforcement Activities

September 30, 2003

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 has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle or other ruminants.

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 April 15, 2002. Since then, FDA has recorded this inspection information in a newly designed database. Throughout the past year, FDA has directed its efforts towards improving the quality of the data available for this report. A new search module for this database is expected to be available in October on the FDA/Center for Veterinary Medicine (CVM) Home Page (l.) NOTE: there may be a difference between the numbers in this CVM UPDATE and what one might obtain by querying the posted BSE data. For this CVM UPDATE, FDA’s CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA’s inspection database as of September 23, 2003. As of September 23, 2003, FDA had received over 25,000 inspection reports. The majority of these inspections (around 71%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment’s lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

A NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.

The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials 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 – 234
  • Number of active firms handling materials prohibited from use in ruminant feed – 157 (67% of those active firms inspected.)
  • Of the 157 active firms handling prohibited materials, their most recent inspection revealed that:

    • 0 firms (0%) were classified as OAI.
    • 7 firms (4.5%) were classified as VAI.

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under 21 CFR 589.2000.

  • Number of active firms whose initial inspection has been reported to FDA – 1,110
  • Number of active firms handling materials prohibited from use in ruminant feed – 300 (27% of those active firms inspected.)
  • Of the 300 active firms handling prohibited materials, their most recent inspection revealed that:

    • 2 firms (0.7%) were classified as OAI.
    • 15 firms (5.0%) 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 – 5,084
  • Number of active firms handling materials prohibited from use in ruminant feed – 579 (11% of those active firms inspected.)
  • Of the 579 active firms handling prohibited materials, their most recent inspection revealed that:

    • 2 firms (0.3%) were classified as OAI.
    • 98 firms (17%) were classified as VAI.

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing a quality feed ingredients that will be used by feed mills.

  • Number of active firms whose initial inspection has been reported to FDA -- 220
  • Number of active firms handling materials prohibited from use in ruminant feed -- 62 (28% of those active firms inspected.)
  • Of the 62 active firms handling prohibited materials, their most recent inspection revealed that:

    • 0 firms (0%) were classified as OAI.
    • 4 firms (6.5%) 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 – 6,905
  • Number of active firms handling materials prohibited from use in ruminant feed – 1,053 (15% of those active firms inspected)
  • Of the 1,053 active firms handling prohibited materials, their most recent inspection revealed that:

    • 3 firms (0.3%) were classified as OAI.
    • 137 firms (13%) were classified as 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 – 11,375
  • Number of active firms handling materials prohibited from use in ruminant feed – 1,664 (15% of those active firms inspected)
  • Of the 1,664 active firms handling prohibited materials, their most recent inspection revealed that:

    • 6 firms (0.4%) were classified as OAI.
    • 171 firms (10%) were classified as VAI.
 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855