To help prevent the establishment and amplification of Bovine Spongiform Encephalophathy (BSE) through feed in the United States, the Food and Drug Administration (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, here called the Ruminant Feed Ban, became effective on August 4, 1997.

A second rule, Title 21 Part 589.2001 of the Code of Federal Regulations, here called the Enhanced Feed Ban, became effective on April 27, 2009. This rule prohibits the use of certain cattle-derived materials in all animal feed. The BSE inspection report form has been revised and is being used for determining compliance with both the ruminant feed ban and the enhanced feed ban. The inspection results summarized below reflect the compliance status for both rules.

The following is an update on FDA enforcement activities regarding the ruminant feed ban. FDA's Center for Veterinary Medicine (CVM) has summarized results of those inspections that have been entered into FDA's inspection database as of January 8, 2011. As of January 8, 2011, FDA had received over 83,000 inspection reports since 1997. Approximately 73% of these inspections have been conducted by State feed control officials, 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. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

An 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. A firm’s compliance status and whether the firm handles prohibited material is based on its most recent inspection.

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 inspected – 276

• Number of active firms handling materials prohibited from use in ruminant feed – 149 (54% of those active firms inspected)

• Of the 149 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 12 firms (8.1%) 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 the Ruminant Feed Ban.

• Number of active firms inspected – 1047

• Number of active firms handling materials prohibited from use in ruminant feed – 472 (45% of those active firms inspected)

• Of the 472 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 10 firms (2.1%) were classified as VAI

Feed millls not licensed by FDA

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

• Number of active firms inspected – 5210

• Number of active firms handling materials prohibited from use in ruminant feed – 2722 (52% of those active firms inspected)

• Of the 2722 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 33 firms (1.2%) were classified as VAI

Protein blenders

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

• Number of active firms inspected – 303

• Number of active firms handling materials prohibited from use in ruminant feed – 132 (44% of those active firms inspected)

• Of the 132 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 1 firm (0.8%) was classified as VAI

Renderers, feed mills, and protein blenders manufacturing with prohibited material

This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.

• Total number of active renderers, feed mills, and protein blenders inspected – 6606

• Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 467 (7.1%)

• Of the 467 active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 21 firms (4.5%) 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 inspected – 26,392

• Number of active firms handling materials prohibited from use in ruminant feed – 8802 (33% of those active firms inspected)

• Of the 8802 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 140 firms (1.6%) 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 – 31,188

• Number of active firms handling materials prohibited from use in ruminant feed – 9285 (30% of those active firms inspected)

• Of the 9285 active firms handling prohibited materials, their most recent inspection revealed that:

• 0 firms (0%) were classified as OAI

• 151 firms (1.6%) were classified as VAI