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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - May/June 2005

FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:

  • James G. Rankel, owner, Elder Grove Dairy Farm, Colby, WI
  • Art R. Mills and Roger A. Mills, co-owners, Bar-B-R Farm, Andover, NY
  • Horton Mitchell, owner, Mitchell Farms, Adairsville, GA
  • Arthur H. Chickering, III, cattle dealer, Westmoreland, NH
  • David Galton, principal owner, Ridgecrest Dairy, LLC, Genoa, NY
  • Douglas B. Handley, owner, Do-Rene Dairy, Clovis, NM
  • Paul S. Weber, president, Idyl Wild Farms, Inc., Loundonville, OH
  • Eric W. Daale, owner/partner, Heritage Dairy, Clovis, NM
  • Barney G. Prince, Hamilton, NY
  • ames M. Klever, part-owner, Klever Holstein Farms, Ltd., Fredricktown, OH

The above violations involved neomycin in bob veal calves, sulfadimethoxine in dairy cows, gentamicin in a bull calf, penicillin in cows, and tilmicosin in a cow.

A Warning Letter was issued to -Priscilla D. Shaw, owner, A & A Serv-ices, Kapolei, HI, because inspection at this animal feed distribution operation found 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 (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. Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants." The inspection found that the operation was not labeling the products distributed to swine farms that contain food waste from restaurants and hospital cafeterias with this caution statement. The inspection also found that the same containers were being used to hold both prohibited materials to be used for feed for non-ruminants and non-prohibited materials to be used for feed ruminants. However, the firm failed to provide written procedures specifying clean-out procedures or other measures to avoid cross-contamination of the feed products to be used for ruminants.

A Warning Letter was issued to Don Cloud, CEO, West Feeds, Inc., Billings, MT, because an inspection conducted at his medicated feed mill located at Miles City, MT, found significant deviations from Current Good Manufacturing Practice (cGMP) regulations for medicated feeds. The deviations included a failure to possess a medicated feed license for the use of Category II, Type A medicated articles amprolium, sulfamethazine, and chlortetracycline in the manufacture of medicated feeds at the Miles City facility; and the failure to conduct on an annual basis periodic assays on at least three samples of medicated feeds requiring a medicated feed mill license for each drug or drug combination used. Specifically, the facility in Miles City has manufactured medicated supplements containing the Category II, Type A medicated articles amprolium, sulfamethazine, and chlortetracycline since October 2003 without performing the required annual assays.

A Warning Letter was issued to Jose M. Homen and -Durvalina Homen, co-owners, Homen Dairy Farms, LP, Merced, CA, because investigations found they were offering animals for slaughter that contained illegal tissue residues. This violation involved the drug penicillin in dairy cows. In addition, their extralabel use of Penicillin G Procaine and Oxytetracycline Hydrochloride caused these drug products to become adulterated within the meaning of Section 501(a)(5) of the Food, Drug, and Cosmetic Act, because they failed to use the drugs in conformance with their approved labeling.

A Warning Letter was issued to Francisco Torres Quijano, president of the Board, Asociación de Productores de Leche Camuy-Quebradillas, Camuy, PR, for selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian, which caused the products to be misbranded within the meaning of Section 503(f)(1)(C) of the Act. -Examples of veterinary prescription drugs dispensed without the order from a licensed veterinarian include gonadorelin diacetate tetrahydrate sterile solution, dinoprost tromethamine injection, and isoflupredone acetate sterile aqueous suspension. In addition, these prescription veterinary drugs were misbranded within the meaning of 502(f)(1) because they did not bear adequate directions for use, and they do not fall into an exception to that requirement. FDA has defined “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended.”

A Warning Letter was issued to -Michael J. Langenhorst, president, Anamax Corporation, Green Bay, WI, because inspection at his rendering plant in South St. Paul, MN, found 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 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. Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, “Do not feed to cattle or other ruminants.” The inspection found that the operation failed to provide for measures to prevent commingling or cross-contamination in that the plant failed to maintain written procedures or to use clean-out procedures adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants. The inspection also found failure to label products with the cautionary statement, “Do not feed to cattle or other ruminants.” For example, the company’s Feather Meal and Stabilized Poultry By-Product Meal lacked this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues.