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 classification occurs 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 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 classification occurs 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. VAI violations are more technical violations of the feed ban and include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.
An NAI classification occurs when no objectionable conditions or practices are found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results are reported both by “segment of industry” and “in total.” Note that 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 send these processed materials to feed mills and/or protein blenders for use as a feed ingredient. The number of renderers whose initial inspection has been reported to FDA is 274, with 185 (68 percent of those inspected) handling materials prohibited from use in ruminant feed. Recent inspections revealed that one firm (0.5 percent) was classified as OAI and 11 firms (5.9 percent) were classified as VAI.
Licensed Feed Mills
The FDA licenses these firms 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.
There were 1,079 firms whose initial inspection has been reported to FDA, with 426 (39 percent) handling materials prohibited from use in ruminant feed. Of the 426 firms, recent inspections revealed that no firms were classified as OAI and eight (1.9 percent) were classified as VAI.
Feed Mills Not Licensed by FDA
The number of feed mills not licensed by the FDA to produce medicated feeds whose initial inspection has been reported to FDA is 5,165, with 2,036 (39 percent) handling materials prohibited from use in ruminant feed. Of those firms handling prohibited materials, recent inspections show that two firms (0.1 percent) were classified as OAI and 24 (1.2 percent) 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. FDA reports that 340 firms were inspected, with 147 (43 percent) handling materials prohibited from use in ruminant feed. Of the firms handling prohibited materials, recent inspections revealed that no firms were classified as OAI and seven (4.8 percent) were classified as VAI.
Renderers, Feed Mills, and Protein Blenders
This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients. The number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA is 6,576, with 539 (8.2 percent) processing with prohibited materials. Of these 539, recent inspections confirm that three firms (0.6 percent) were classified as OAI and 23 (4.3 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, with FDA reporting 13,477 firms inspected. The number of these handling materials prohibited from use in ruminant feed is 3,748 (28 percent), with recent inspections revealing eight firms (0.2 percent) were classified as OAI and 95 (2.5 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. The number of firms whose initial inspection has been reported to FDA is 16,476, with 4,553 (27 percent of firms inspected) handling materials prohibited from use in ruminant feed. Of the 4,553 firms, recent inspections revealed that nine (0.2 percent) were classified as OAI and 107 (2.4 percent) were classified as VAI.
February 2006 Render