The June 20, 2005, update shows that out of 15,676 active firms whose initial inspection was reported to FDA, 4,093 companies handling materials prohibited from use in ruminant feed (26 percent of firms inspected) had a compliance rate of 99.8 percent. Ten firms were classified as “official action indicated” (OAI), a classification that 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 of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations are promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.
Among renderers, 263 firms were inspected, with 176 (67 percent) handling prohibited materials. Two of those 176 companies were classified as OAI (1.1 percent). Other inspection results by “segment of industry” are as follows (note: according to FDA, a single firm can operate as more than one firm type, thus the categories of the different industry segments are not mutually exclusive):
• Licensed feed mills – 1,069 firms inspected with 411 (38 percent) handling prohibited materials; one firm (0.2 percent) was classified as OAI.
• Feed mills not licensed by FDA – 5,145 firms inspected with 1,920 (37 percent) handling prohibited materials; two firms (0.1 percent) were classified as OAI.
• Protein blenders – 329 firms inspected with 117 (36 percent) handling prohibited materials; no firms were classified as OAI.
• 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) – 6,550 firms inspected with 553 (8.4 percent) processing with prohibited materials; five firms (0.9 percent) were classified as OAI.
• Other firms inspected (e.g., ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters) – 12,575 firms inspected with 3,288 (26 percent) handling prohibited materials; eight firms (0.2 percent) were classified as OAI.
The latest update can be found on CVM’s Web site at www.fda.gov/cvm/CVM_Updates/bse0605.htm.
August 2005 Render