Animal & Veterinary
Regulatory Activities - January/February 2002
by Karen A. Kandra
FDA Veterinarian Newsletter January/February 2002 Volume XVII, No 1
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
- Mike Bidart, Owner, Loyola Dairy, Chino, CA
- Charles F. Woodward, DVM, Concho Dairy Consulting, Onalaska, WI
- Shaye G. Pope, President, Pope Dairy Enterprises, Stetsonville, WI
- Anthony R. Dinitto, Rome, NY
- Randy J. Winner, Four Star Dairy, Yorkshire, OH
These violations involved illegal residues of penicillin in a dairy cow; extra-label treatment resulting in flunixin meglumine residues in a cow; illegal residues of gentamicin in a cow; illegal residues of sulfadimethoxine in two cows; and, neomycin in a cow.
A warning letter was issued to the following firms for violations related to 21 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) through feed.
- Kenneth Roy Tufly, Owner, Dixon Feeds, Inc., Dixon, MT
- Gregory M. Sostak, President, Finlayson Ag Center, Finlayson, MN
Violations included failure to separate the receipt, processing, and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system to avoid commingling and cross-contamination of common equipment; failure to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of products; and, failure to label products with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants." For example, the common scoop used to transfer prohibited material from 50-pound bags to smaller brown bags is not cleaned between prohibited and non-prohibited material uses. Also, opened bags of prohibited materials were reported to be stored next to other open feed ingredient bags.
Ray Winn, President, Winn, Inc., Smithfield, UT, received a warning letter for manufacturing a free choice feed containing the Category II Type A Medicated Article, Lasalocid/Bovatec 68, for use in cattle and sheep. This firm failed to have an approved formula, and failed to possess a valid FDA Medicated Feed Mill License. In addition, the firm's product labels contained numerous errors.
Mr. LaMar G. Clements, President, Walton Feeds West, Inc., Cache Junction, UT, received a warning letter for selling and shipping a Type A Medicated Article (Lasalocid/Bovatec 68) to the above firm which does not possess a valid FDA Medicated Feed Mill License. As a manufacturer of materials intended for animal feed use, feed mills are responsible for assuring that the overall operation and the products manufactured and distributed are in compliance with the law. This includes assuring that each site where the firm handles Type A Medicated Articles adheres to the requirement not to ship to unlicensed or unauthorized parties.
Mr. Louis A. Rodriguez, Vice President, Pet Magic, Inc., Detroit, MI, received a warning letter for releasing pig ear dog treats that had been detained by the Detroit District Office into commerce without the proper release from the FDA. The samples tested positive for Salmonella.