Report Shows Renderers in Full Compliance with Feed Ban

October 2, 2003 - To help prevent the establishment and amplification of bovine spongiform encephalopathy (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, became effective on August 4, 1997. To date, active monitoring by the U.S. Department of Agriculture has found no cases of BSE in U.S. cattle or other ruminants.

FDA recently released the results of enforcement activities regarding the ruminant feed regulation. As of September 23, 2003, the agency had received over 25,000 inspection reports, with the majority of these inspections (around 71 percent) conducted by state officials under contract to FDA, and the remainder conducted by FDA officials. Inspections 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 feed ban 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.

FDA reported their results 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 animal proteins and to send these processed materials to feed mills and or protein blenders for use as a feed ingredient. The number of active firms whose initial inspection was reported to FDA is 234, of which 157 (67 percent) handle materials prohibited from use in ruminant feed. Of the companies handling prohibited materials, the most recent inspection revealed that no renderers were classified as OAI and seven firms (4.5 percent) 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.

The number of licensed feed mills whose initial inspection was reported to FDA is 1,110, with 300 (27 percent) of these firms handling materials prohibited from use in ruminant feed. Of the companies handling prohibited materials, FDA's most recent inspection revealed that two firms (0.7 percent) were classified as OAI and 15 firms (five percent) were classified as VAI.

Feed Mills Not Licensed by FDA

The number of these companies whose initial inspection was reported to FDA is 5,084, with 579 (11 percent) handling materials prohibited from use in ruminant feed. Of the firms handling prohibited materials, the most recent inspection revealed that two firms (0.3 percent) were classified as OAI and 98 firms (17 percent) were classified as VAI.

Protein Blenders

These firms blend rendered animal protein for the purpose of producing a quality feed ingredient that will be used by feed mills. The number of active firms whose initial inspection was reported to FDA is 220, with 62 (28 percent) handling prohibited materials. Of the firms handling prohibited materials, the recent inspection showed that no protein blenders were classified OAI and four (6.5 percent) were classified as VAI.

Other Firms Inspected

Examples of these firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters. The number of these firms whose initial inspection was reported to FDA is 6,905, with 1,053 (15 percent) of these companies handling materials prohibited from use in ruminant feed. Of these, FDA's most recent inspection revealed that three firms (0.3 percent) were classified as OAI and 137 firms (13 percent) 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.

The number of active firms whose initial inspection was reported to FDA is 11,375, with 1,664 (15 percent of those firms inspected) handling materials prohibited from use in ruminant feed. Of these companies, the recent inspection revealed that six firms (0.4 percent) were classified as OAI and 171 firms (10 percent) were classified as VAI.


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