Feed Ban Compliance Still Outstanding

February 12, 2004 - 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.

Inspections of renderers, feed mills, and other feed manufacturers conducted by FDA or state officials under contract to FDA show a continuing record of compliance. The enforcement report recently released by FDA covers 26,000 inspections conducted through January 23, 2004, and are classified to reflect the compliance status at the time of the inspection. The data summarized below reflect three classifications:

• OAI, or Official Action Indicated, when significant objectionable conditions or practices are 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. OAI violations are promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.

• VAI, or Voluntary Action Indicated, when objectionable conditions or practices are 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. These typically involve minor recordkeeping lapses and conditions involving non-ruminant feeds.

• NAI, or No Action Indicated, 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.

Below are the results to date 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.

• Number of active firms whose initial inspection has been reported to FDA – 235
• Number of active firms handling materials prohibited from use in ruminant feed – 157 (67 percent of firms inspected)
• None of the 157 active firms were classified as OAI
• Three firms (1.9 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.

• Number of active firms whose initial inspection has been reported to FDA – 1,085
• Number of active firms handling materials prohibited from use in ruminant feed – 310 (29 percent of firms inspected)
• None of the 310 firms were classified as OAI
• Seven firms (2.2 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 – 5,071
• Number of active firms handling materials prohibited from use in ruminant feed – 759 (15 percent of firms inspected)
• Four of the 759 firms (0.5 percent) were classified as OAI
• 39 firms (5.1 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.

• Number of active firms whose initial inspection has been reported to FDA -- 252
• Number of active firms handling materials prohibited from use in ruminant feed -- 71 (28 percent of firms inspected.)
• None of the 71 firms were classified as OAI
• Two firms (2.8 percent) were classified as VAI

Renderers, Feed Mills, and 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 utilizing prohibited materials.

• Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA - 6,465
• Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 540 (8.3 percent of firms inspected)
• Five of the 540 firms (0.9 percent) were classified as OAI
• 24 firms (4.4 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 – 9,781
• Number of active firms handling materials prohibited from use in ruminant feed – 1,396 (14 percent of firms inspected)
• Five of the 1,396 firms (0.4 percent) were classified as OAI
• 68 firms (4.9 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.

• Number of active firms whose initial inspection has been reported to FDA – 13,672
• Number of active firms handling materials prohibited from use in ruminant feed – 1,949 (14 percent of firms inspected)
• Five of the 1,949 firms (0.1 percent) were classified as OAI
• 85 firms (4.4 percent) were classified as VAI

For more information, log onto FDA's Center for Veterinary Medicine Web site at www.fda.gov/cvm


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