Animal & Veterinary
Regulatory Activities - March/April 2005
FDA Veterinarian Newsletter March/April 2005 Volume XX, No II
The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:
- Dennis H. Eldred, Owner, Willet Dairy, LP, Locke, NY
- Sjerp Ysselstein, President, Ysselstein Dairy, Inc., Rock Valley, IA
- Jesse W. Koopman and Anthony Vander Hulst, Partners, West Point Farms, LLC, Wendell, ID
The above violations involved sulfamethazine in a bull calf and a dairy cow, and penicillin and sulfadimethoxine in a culled dairy cow.
A Warning Letter was issued to Dwayne Woody, Owner, W.W. Cattle Company, Poolville, TX, because inspection at his feed manufacturing operation found significant deviations from the requirements sent forth in Title 21, Code of Federal Regulations (CFR), Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The use of protein derived from mammalian tissues, as defined by 21 CFR 589.2000(a)(1), as an animal feed ingredient or in animal feeds must comply with the requirements of 21 CFR 589.2000. The regulations provide that the use of protein derived from mammalian tissues in ruminant feed is prohibited. The definition of “protein derived from mammalian tissues” excludes inspected meat products that have been cooked and offered for human food, and have been further heat processed for use in animal feed.
The inspection of the feed manufacturing operation revealed that whole corn dogs, which contain protein derived from mammalian tissues, were sold by the firm for use in ruminant feed are not subjected to further heat processing, causing them to be adulterated feed under Section 402(a)(2)(C)(i) of the Federal Food, Drug and Cosmetic Act (the Act). In addition, because the whole corn dogs are not subject to further heat processing and are thus not exempt from the regulation, they must bear the caution statement, “Do not feed to cattle or other ruminants.” The inspection revealed that they do not bear this caution statement, which causes them to be misbranded animal feed under Section 403(a)(1) of the Act.
A Warning Letter was issued to -William L. Brown, Owner, Brown Cattle Company, Petrolia, TX, because inspection of his ruminant feeding operation found significant deviations from the requirements set forth in 21 CFR 589.2000. The inspection revealed that prohibited material, as defined by 21 CFR 598.2000(a), was fed to ruminants. The prohibited material consisted of human food processing waste, which is derived from corn dog manufacturing and contains hot dogs and corn dogs. Inspected meat products that have been cooked and offered for human food and further heat processed for animal feed are not prohibited material. However, the human food processing waste used in this operation had not been further heat processed. The failure to further heat process this material causes the feed to be adulterated within the meaning of Section 402(a)(2)(C)(i) of the Act.
A Warning Letter was issued to G. Allen Andreas, Chairman and Chief Executive, Archer Daniels Midland (ADM) Company, Decatur, IL, for -significant deviations from Current Good Manufacturing Practice (cGMP) regulations for medicated feeds at the ADM medicated feed mill operation in Des Moines, IA. The deviations include failure to assure that the equipment used in the manufacture of Type A Medicated Articles is operated in a manner that ensures the integrity of the finished product and failure to adequately store incoming bulk drug components in a manner that assures the maintenance of their identity, strength, quality, and purity.