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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - May and June 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No II

A Warning Letter was sent to -Kenneth L. Wagler, Wagler Farms, Morgantown, IN, for offering a bull for sale for slaughter as food that was adulterated because of the presence of illegal tissue residues. Analysis of tissue samples collected from the animal identified the presence of gentamicin and flunixin. No tolerance has been established for residues of gentamicin in the edible tissues of cattle as codified in Title 21 of the Code of Federal Regulations (21 CFR). The amount of flunixin found exceeded the tolerance of 125 parts per billion established for residues of flunixin in the liver tissue of cattle as codified in 21 CFR 556.286. The presence of these drug residues in the edible tissues of this animal causes the food to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (FFDCA).

The following individuals and firms received Warning Letters for offering animals for slaughter as food that was adulterated because of the presence of illegal tissue residues:

  • William G. Vandenberg, owner, -Vandenberg Dairy, Caldwell, ID
  • Ronald J. Vander Poel and Joseph M. Vander Poel, co-owners, Bar VP Dairy, Pixley, CA
  • Edward Imsand, owner, Meadowbrook Dairy, Phelan, CA
  • Theo and Cheryl Van Berkum, owners, Theo & Cheryl Van Berkum Dairy, Everson, WA
  • Edward DeRuyter, owner, Desertland Dairy, Mesquite, NM
  • David B. Van Heel, owner, Swanville, MN

Animals at these facilities were held under conditions so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. For example, each operation lacked an adequate system to ensure that animals medicated by the operation were withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. In addition, new animal drugs were adulterated when each of the operations failed to use a drug in conformance with its approved labeling. “Extralabel use,” i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is permitted only if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the FFDCA and 21 CFR Part 530. FDA investigations found that the extralabel use of new animal drugs at these operations failed to comply with these requirements and resulted in illegal drug residues. Because the extralabel uses of the drugs were not in compliance with Part 530, the drugs were caused to be unsafe and adulterated. The above violations involved sulfadimethoxine, penicillin G procaine, flunixin, penicillin, and gentamicin in dairy cows.

Warning Letters were issued to the following individuals and firms because investigations of their operations revealed that they offered animals for slaughter as food that was adulterated because of the presence of illegal tissue residues:

  • Benjamin Byma, Ilion, NY
  • Richard S. Hunter, owner, H & H Farms, Baileyton, AL
  • Rodger W. Camping, president, Eagle Livestock, Inc., Chino, CA

Animals were held under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The operations lack an adequate system to ensure that animals medicated by the facilities are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. The above violations involved sulfadimethoxine in a cow; gentamicin in a beef cow; and neomycin, flunixin, sulfamethazine, and gentamicin in a culled calf.

A Warning Letter was issued to David C. Timmermann, president, J.B. -Timmermann Farms, Limited, Breese, IL, because an investigation of the dairy operation revealed that a dairy cow was offered for sale for slaughter as food that was adulterated because of the presence of illegal tissue residues. The amount of sulfadimethoxine found exceeded the tolerance of 0.1 parts per million established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in 21 CFR 556.640. The presence of these drug residues in the edible tissues of this animal causes the food to be adulterated within the meaning of the FFDCA. In addition, new animal drugs Terra-Vet 100 (oxytetracycline hydrochloride injection) and Sulfadimethoxine Injection 40% were adulterated when the operation failed to use the drugs in conformance with their approved labeling. For example, the facility administered a mixture of oxytetracycline and sulfadimethoxine to a dairy cow without the supervision of a licensed veterinarian, and the extralabel use of these drugs resulted in illegal drug residues. Extralabel use is permitted only if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the FFDCA and 21 CFR Part 530. FDA investigations found that the extralabel use of new animal drugs at these operations failed to comply with these requirements and resulted in illegal drug residues. Because the extralabel use of the drugs were not in compliance with Part 530, the drugs were caused to be unsafe and adulterated.

A Warning Letter was issued to Ed M. Pomeroy, Ferndale, WA, because an investigation of the dairy operation in Custer, WA, revealed that it caused the new animal drug Neomycin 325 (neomycin sulfate power packet) and the medicated feed Instant Amplifier Max NT Medicated Dairy Herd & Beef Calf Milk Replacer (containing neomycin) to become adulterated within the meaning of sections 501(a)(5) and (a)(6) of the FFDCA and unsafe under section 512 of the FFDCA. The drug Neomycin 325 was adulterated within the meaning of section 501(a)(5) of the FFDCA when the dairy operation used it in a calf to be processed for veal, which is contrary to the warning on the label. Specifically the operation administered the drug Neomycin 325 by adding it to Instant Amplifier Max NT Medicated Dairy Herd & Beef Calf Milk Replacer, the liquid milk replacer supplement the operation feeds its calves, contrary to the directions set forth in the approved labeling that states it is not for use in liquid supplements and contrary to the label statement that it is not to be used in calves to be processed for veal. Because the FFDCA does not permit the extralabel use of drugs in or on medicated feeds, the actions caused the neomycin to be unsafe under Section 512(a) of the FFDCA and adulterated within the meaning of Section 501(a)(5) of the FFDCA. In addition, the operation caused the adulteration of an animal feed bearing or containing a new animal drug under Section 501(a)(6) of the FFDCA when it failed to use the milk replacer in conformance with its approved labeling by feeding it to calves to be processed for veal and adding the drug neomycin to it.

A Warning Letter was issued to Paul M. Kalmbach, president and owner, Kalmbach Feeds, Inc, Upper Sandusky, OH, because an investigation of the licensed medicated feed mill found significant violations of the FFDCA. His firm uses the new animal drug Coban 60 (a Type A medicated article) in an extralabel manner. The extralabel use of a new animal drug in or on animal feed is prohibited by section 512(a)(4)(A) of the FFDCA and 21 CFR 530.11(b). The extralabel use of Coban 60 to produce feed for cattle causes the new animal drug to be deemed unsafe and adulterated within the meaning of the FFDCA. In addition, the use of Coban 60 to produce medicated feed for cattle causes the medicated feed to be unsafe and adulterated within the meaning of the FFDCA. In addition, the feed mill failed to conduct potency assays on at least three representative samples at periodic intervals during the calendar year of each feed required to be manufactured by a licensed feed mill, which is a failure to comply with current Good Manufacturing Practice (cGMP) regulations for medicated feeds. Such deviations cause medicated feeds manufactured at this facility to be adulterated under of the FFDCA.

A Warning Letter was issued to John Johnson, president and CEO, CHS, Incorporated, Invergrove Heights, MN, because an investigation of the medicated feed mill located in Great Falls, MT, found significant deviations from cGMP regulations for medicated feeds. Such deviations cause the medicated feeds manufactured at this facility to be adulterated. The investigation found the firm was not conducting potency assays on at least three representative samples at periodic intervals during the calendar year of each feed required to be manufactured by a licensed medicated feed mill. Specifically, during calendar year 2005, the medicated feed mill manufactured batches of medicated feed containing a Category II, Type A medicated article with chlortetracycline and sulfamethazine and batches of medicated feed containing a Category II, Type A medicated article with amprolium, without performing any of the required assays.

A Warning Letter was issued to Gil Carrier, president, West Feeds, Inc., Billings, MT, because an inspection of the licensed medicated feed mill located in Great Falls, MT, found significant violations of the FFDCA. The feed mill used the Category II, Type A medicated article amprolium in Type B or Type C medicated feeds containing bentonite. Amprolium is not approved for use in Type B or Type C medicated feeds that contain bentonite. This use causes the new animal drug amprolium to be deemed unsafe and adulterated. In addition, this use of amprolium to produce medicated feed causes the medicated feed to be unsafe and adulterated. Also, the firm failed to conduct potency assays on at least three representative samples at periodic intervals during the calendar year of each feed required to be manufactured by a licensed feed mill. Specifically, the facility manufactured batches of medicated feed containing amprolium, a Category II, Type A medicated article, during calendar year 2005 without performing the required assays. This failure to comply with the cGMP regulations for medicated feeds causes medicated feeds manufactured at this facility to be adulterated.

A Warning Letter was issued to Bart Krisle, CEO, Tennessee Farmers Cooperative, LaVergne, TN, because an inspection of the medicated feed mill located in Rockford, TN, revealed significant violations of the FFDCA. Samples of the mill’s equine feed, formula 93638, 10% Grain Mix, lot number 4287593638, collected during the investigation were analyzed by FDA’s Forensic Chemistry Center (FCC). Analytical results reported by FCC revealed the samples contained monensin. Monensin is not approved for use in equine feed. The manufacture of equine feed containing monensin causes the feed to be deemed unsafe and adulterated. In addition, FDA is aware the mill conducted recalls of the following products due to monensin contamination: 10% Grain Mix, formula 93638, with the lot numbers 4276593638, 4283593638, 4287593638, and 4290593638; and 11% Sweet Horse Feed Course, lot number 43125327. Also recalled were 16% Pelleted Goat Ration, lot number 4313593840, because the quantity of detectable decoquinate was below specifications; Co-op Chick Starter/Grower, Medicated, lot number 43045104 and 43055104, because the quantity of detectable amprolium was below specifications; and Dairy Cattle Rumensin Premix 10000, Medicated Type B Premix, lot number 4287592997, because the amount of detectable rumensin was below specifications.

A Warning Letter was issued to -Jeffrey Burton, president, Boesl Packing Company, Inc., Baltimore, MD, because an inspection of this producer of animal food determined that the facility is subject to the registration requirement in section 415 of the FFDCA. The failure to register a facility as required is a prohibited act under section 301(dd) of the FFDCA. In addition, FDA reviewed the firm’s product labels and a brochure entitled “What Does Your Dog Krave.” The therapeutic claims contained in the product brochure for K-9 Kraving Dog Food establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of a disease. The product K-9 Kraving Dog Food is a drug as defined in section 201(g) of the FFDCA and a new animal drug as defined in section 201(v) of the FFDCA. The product is adulterated within the meaning of section 501(a)(5) of the FFDCA, in that it is a new animal drug that is unsafe within the meaning of section 512(a)(1)(A) of the FFDCA. Under sections 512(a)(1)(A) of the FFDCA, a new animal drug is considered to be unsafe unless there is an approved New Animal Drug Application (NADA) for the product. FDA advised this producer of animal food that it must cease marketing K-9 Kraving Dog Food and file a NADA, or remove the therapeutic claims from the product brochures. Furthermore, the food manufacturing facility needs to register with FDA.

A Warning Letter was issued to William Shirley, Jr., owner, Louisiana Proteins, dba Riegel By-Products, Dallas, TX, because inspection of the rendering plant located in Shreveport, LA, revealed significant deviations from the requirements sent forth in Title 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. The inspection found that the rendering plant failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures as required by 21 CFR 589.2000(e). The plant failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants. For example, the facility uses the same equipment to process mammalian and poultry tissues. However, it uses only hot water to clean the cookers between processing tissues from each species, and does not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues. Also, the facility failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants. As a result, the poultry meal the facility manufactures may contain protein derived from mammalian tissues prohibited in ruminant. Any product containing or that may contain protein derived from mammalian tissues must be labeled “Do not feed to cattle or other ruminants.” Because the facility failed to label their product with the required cautionary statement, the protein meal is misbranded under the FFDCA.