Animal & Veterinary
Regulatory Activities - July/August 2004
by Marilyn Broderick, CVM Communications Staff
FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV
The following individuals and firms received warning letters for offering animals for slaughter that contained illegal tissue residues:
- Andrew E. Brown, Owner, Brown’s Livestock, Winchester, Va.
- John and Rusty Eaker, Co-Owners, Eaker Dairy, Cherryville, N.C.
- Albert J. Huizenga, Owner, Fir Crest Hauling, Lynden, Wash.
- Jake A. and Lori A. Slegers, Co-Owners, Jake Slegers Jr. Dairy, Pixely, Calif.
- Juan Manuel Barreto, Owner, J.M. Dairy Corporation, Arecibo, P.R.
- Kenneth Deputy, Owner, Mammoth Cave Dairy Auction, Inc., Smiths Grove, Ky.
- Manuel F. and Mary F. Barcelos, Co-Owners, M & M Barcelos Dairy, Chowchilla, Calif.
- William F. Nickle, North East, Md.
- Perry T. Dewey, Owner, Perry Dewey Farm, Clymer, N.Y.
- John C. Reynolds, Swanton, Vt.
- Michael J. Arambel, Manager, Sunstar Dairy, Rupert, Idaho
- Duaine E. and Kenneth D. Walker, Co-Owners, Walker Farms, Minerva, Ohio
The above violations involved neomycin in bob veal calves, penicillin in dairy cows, neomycin and sulfadimethoxine in a cow, gentamicin in dairy cows and sulfadimethoxine in a dairy cow.
Warning Letters were issued to the following because investigations into illegal tissue residues in animals sold for slaughter as human food revealed serious deviations from the regulations for Extralabel Drug Use in Animals. These deviations caused an animal drug to be used in a manner that was unsafe and adulterated under the Federal Food, Drug, and Cosmetic Act.
- Jack Davis, President, Idacrest Farms, Inc., Kuna, Idaho
- Mike Loy, Columbia, Ky.
- Charles H. Stewart, Owner, Stewart’s Dairy, Addison, N.Y.
- Timothy Devine, Co-Owner, Devine Farms, LLC, Canastota, N.Y.
- Allan B. Thomas, Owner, Enumclaw, Wash.
- James J. Ostrom, President and CEO, Milk Source, LLC, Kaukauna, Wis.
- David J. Boor, Owner, Boor Crest Farm, Horseheads, N.Y.
- Allen L. Van Nurden, Co-Owner, Allen & Dale Van Nurden Farm, Rice, Minn.
The above violations involved penicillin and sulfadimethoxine in a culled dairy cow, gentamicin in a dairy cow, neomycin in a bob veal calves, flunixin and sulfonamide in dairy cows and sulfadimethoxine in a dairy cow.
A Warning Letter was sent to Henry M. Nelson, President, Nelsons Premix Service, Inc., Storm Lake, Iowa, because an inspection of the veterinary health products sales facility revealed the firm purchased and further distributed prescription drug products for animal use without an order from a licensed veterinarian and without adequate directions for use. Selling new animal drugs with “adequate directions for use” means adequate directions for which the layman can use a drug safely and for the purposes for which it was intended. Such adequate directions for use by laypersons cannot be written for prescription drugs because the drugs can be used safely only at the direction of, and under the supervision of, a licensed veterinarian. Dispensing of a prescription drug other than by or upon the lawful written or oral order of a licensed veterinarian results in the drug being misbranded.
Warning Letters were received by Dwight Armstrong, President and CEO, North American Nutritional Companies, Inc., Lewisburg, Ohio; and by Ronald M. Foster, Randall C. Boyce, Trevor O. Foster and George P. Foster, Managers, Fresno Farming LLC, Livingston, Calif., for significant deviations from the requirements set 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. The inspection at American Nutritional Companies, Inc., revealed that the firm failed to maintain written procedures for separating products that may contain protein derived from mammalian tissues from all other protein products from the time of receipt until the time of shipment. Specifically, the firm received poultry digest that listed a prohibited ingredient and that contained the label statement, “Warning: Do Not Feed to Cattle or Other Ruminants,” but had no written procedures to ensure that ruminant feed was not cross-contaminated with prohibited material. The inspection at Fresno Farming, LLC, revealed failure to provide for measures to avoid commingling or cross-contamination of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants; failure to maintain written procedures specifying the clean-out procedures and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products; and failure to maintain records sufficient to track prohibited materials throughout their distribution.
A Warning Letter was issued to Randall Copeland, Executive Vice-President of Operations, Menu Foods, Inc., Pennsauken, N.J., because an inspection of the animal feed manufacturing operation found a failure to label canned animal food that contains protein sources of bovine origin including beef lung with the cautionary statement “Do Not Feed to Cattle or Other Ruminants” in violation of Title 21 CFR Part 589.2000.
A Warning Wetter was issued to David W. Bernauer, CEO and Chairman of the Board, Walgreen Company, Deerfield, Ill., because an inspection of the firm’s warehouse in Mt. Vernon, Ill., revealed numerous insanitary conditions that caused the food and drug products there to be adulterated and pet food products that contain or may contain animal protein prohibited ruminant feed were salvaged, repackaged, and donated without bearing the cautionary statement “Do Not Feed to Cattle or Other Ruminants.”