December 2, 2008 | On November 26, 2008, the Food and Drug Administration (FDA) published in the Federal Register a draft guidance document for renderers in response to questions received since the April 25, 2008, announcement of a final rule that strengthens regulations regarding animal feed.
The purpose of the guidance document is to help rendering firms comply with the rule that becomes effective April 27, 2009. The guidance should also help slaughter facilities and farms supplying offal and dead livestock to the renderers understand their obligations under the rule. A copy of the draft guidance can be found at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0597-gdl.pdf.
Written comments on the guidance document must be submitted by January 26, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0597-gdl.pdf. Identify all submissions to the docket with the docket number 2008-D-0597.
For questions regarding this draft document, contact Shannon Jordre at FDA’s Center for Veterinary Medicine, (240) 276-9229, e-mail firstname.lastname@example.org.
FDA has also released updated enforcement activities related to the feed rule put in place August 4, 1997, which prohibits the use of most mammalian protein in feeds for ruminant animals. FDA’s Center for Veterinary Medicine has assembled data from the over 66,000 inspections that have been conducted and recorded in the FDA’s inspection database as of November 15, 2008. The majority of these inspections (approximately 71 percent) were conducted by state feed control officials, with 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 – either 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 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. Inspections classified with OAI violations are 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 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. Inspections classified with VAI violations are more technical violations of the feed ban and can 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.
The results to date are reported 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.
The number of renderers whose initial inspection has been reported to FDA is 267, with 155 (58 percent) of these firms handling materials prohibited from use in ruminant feed. Of the 155 firms, none were classified as OAI and three (two percent) were classified as VAI.
FDA licenses certain feed mills to produce medicated feed products. This licensing has nothing to do with handling prohibited materials under the feed ban regulation and is not required to handle materials prohibited under the ruminant feed ban.
The number of licensed feed mills whose initial inspection has been reported to FDA is 1,075, with 494 (46 percent) of these firms handling materials prohibited from use in ruminant feed. Of these companies recent inspections show that no firms were classified as OAI ,and four (0.8 percent) were classified as VAI.
There were 5,290 feed mills not licensed by the FDA to produce medicated feeds inspected, with 2,685 (51 percent) firms handling materials prohibited from use in ruminant feed. Of these firms, none were classified as OAI, and 29 (1.1 percent) were classified as VAI.
These firms blend rendered animal proteins to produce quality feed ingredients that will be used by feed mills. The number of active firms whose initial inspection has been reported to FDA is 387, with 196 (51 percent) of these firms handling materials prohibited from use in ruminant feed. All had a perfect compliance rate.
This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients. The total number of these renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA is 6,712, with 506 (7.5 percent) of those processing with prohibited materials. Of these 506 firms, their most recent inspection revealed that none were classified as OAI, and 11 (2.2 percent) were classified as VAI.
Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters. The number of active firms whose initial inspection has been reported to FDA is 21,865, with 7,295 (33 percent) of these firms handling materials prohibited from use in ruminant feed. Of the 7,295 firms handling prohibited materials, zero were classified as OAI, and 113 (1.5 percent) were classified as VAI.
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. There are 24,065 active firms whose initial inspection has been reported to FDA, with 7,876 (33 percent) handling materials prohibited from use in ruminant feed. Of the 7,876 active firms handling prohibited materials, none were were classified as OAI, and 121 (1.5 percent) were classified as VAI.