Animal & Veterinary
Regulatory Activities - September/October 2005
FDA Veterinarian Newsletter September/October 2005 Volume XX, No V
The following individuals and firms received Warning Letters for offering animals for sale for slaughter as food that contained illegal drug residues:
- Abel Villalpando, Sr., owner, Dexter Dairy, Dexter, NM
- Robert Lawson, owner, Lawsons Farm, Irasburg, VT
- Calvin W. Pareo, co-owner, Milk Flow Dairy, Portales, NM
The above violations involved penicillin, flunixin, and sulfadimethoxine in dairy cows.
The presence of the illegal drug residues in edible tissues caused the food to be adulterated.
A Warning Letter was issued to Jerome Fitzgerald, president, Clement Fitzgerald, vice president, and Andrew W. Fitzgerald, secretary-treasurer, Four Brothers Dairy, Inc., Shoshone, ID, because an investigation revealed the presence of illegal drug residues of penicillin in a dairy cow offered for sale for slaughter as food. The penicillin was found to be above the tolerance of 0.05 parts per million established for residues of penicillin in the edible tissues of cattle, which caused the food to be adulterated. The investigation also showed the adulteration of the new animal drug because it was used in a manner that did not conform with its approved labeling. Further there were deviations from the regulations for Extralabel Drug Use in Animals. For example, the penicillin was administered without following the dosage level of treatment or the methods for injecting the drug set forth in the approved labeling and was done so without the supervision of a licensed veterinarian. Also, the drug was administered without following the recommended withdrawal time for the drug set forth in the approved labeling, and was done so without the supervision of a licensed veterinarian. Extralabel use of an approved animal drug that is not in compliance with the regulations renders the drug unsafe under Section 512 and thus adulterated under Section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act).
A Warning Letter was issued to Walter E. Newton, III, president, WaJa Farms, Inc., New Albany, PA, because an inspection of the veal calf operation confirmed that a veal calf owned by the firm was shipped from a contract grower for sale for slaughter as food that was adulterated because of the presence of neomycin in kidney tissue. Neomycin is not approved for use in veal calves. The inspection also revealed that the firm caused the new animal drugs neomycin and penicillin to become adulterated and unsafe, when in accordance with the firm’s -instructions a contract grower failed to use the drugs in conformance with their 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 investigation found the extralabel use of Neomycin 325 Soluble Powder in starter formula fed to veal calves, and the extralabel use of Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension in the treatment of veal calves did not comply with the Extralabel Use in Animals regulations.
A Warning Letter was issued to -Michael Mumbulo, Edmeston, NY, because an investigation into his veal calf operation confirmed that he offered an animal for sale for slaughter as food that contained illegal drug residues of neomycin. Neomycin is not approved for use in veal calves. The extralabel use of neomycin without complying with the Extralabel Drug Use in Animals regulations causes the drug to be unsafe and adulterated. The presence of this unsafe drug in edible tissue from the animal causes the food to be adulterated. The investigation also found animals were held under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
Warning Letters were issued to several dairy operations and a cattle operation because investigations confirmed the operations were offering animals for sale for slaughter as food that contained illegal drug residues. The presence of the illegal drug residues in edible tissues caused the food to be adulterated. The investigations also revealed the adulteration of new animal drugs because they were used in a manner that did not conform with their approved labeling. Further, there were serious deviations from the regulations for Extralabel Drug Use in Animals. These deviations caused animal drugs to be used in a manner that was unsafe and adulterated under the Act. In addition, the investigation also found animals were held under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The Warning Letters were issued to the following:
- Chuck H. Hilt, owner, C & M Hilt Dairy, Gooding, ID
- Gregory S. Vierstra, owner, Vierstra & Son, Inc. dba Classic Dairy, Twin Falls, ID
- Fritz Balsiger, partner/manager, -Balsiger, Greiner, Rohweder Dairy, LLP, Lake Park, MN
- Edgar M. Martin, owner, Edgar -Martin Dairy, Brooten, MN
- Richard Leyendekker, farm manager, SLI Dairy, Sunnyside, WA
- Sidney C. De Boer, owner, De Boer Dairy, Burlington, WA
- Tom B. De Groot, partner, De Groot Dairy, LLC, Lynden, WA
- Laverne Morrell, owner, Morrell Farm, Franklin, NY
- Merle R. Buss, dba Rancho, Inc., Shawnee, OK
The above violations involved penicillin, tilmicosin, neomycin, oxytetracycline, sulfadimethoxine, and flunixin in cows.
A Warning Letter was issued to David J. Wright, DVM, partner, Buffalo Equine and Large Animal Clinic, LLP, Buffalo, MN, because an investigation involving the use of drugs in the veterinary practice revealed that an animal drug was caused to be unsafe and adulterated because it was used in a manner that did not conform with its approved uses or the regulations for Extralabel Drug Use in Animals. A brand of sulfadimethoxine injection - 40% was administered to treat peritonitis and mastitis in lactating dairy cattle, which is not an approved use of this drug. The extralabel use of an approved animal or human drug in animals is permitted only if it complies with the regulations set forth in 21 CFR 530. The regulations prohibit the extralabel use of sulfadimethoxine in lactating dairy cattle, except for approved uses. The use by Dr. Wright was not one of the approved uses of sulfadimethoxine injection.
A Warning Letter was sent to Allen M. Petro, owner, Ana-Tech, Monroe, WI, which manufactures and distributes multiple products for both human and animal consumption. The Warning Letter was sent for marketing and distributing several products not covered by an approved New Animal Drug Application (NADA). Section 201(g)(1)(B) of the Act defines a drug as any article intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Section 201(v) of the Act defines a new animal drug as one in which the composition is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. New animal drugs may not be marketed in the absence of an approved NADA demonstrating the safety and effectiveness of the product. The representations on the labeling for the firm’s products, i.e., X-IT(W) and NO MORE, indicate that they are intended for use in the prevention and treatment of disease in animals. The firm also offers several direct-fed microbial products, which they refer to as “probiotics,” which are identified on the firm’s internet site as “naturally occurring beneficial organisms that inhibit disease causing organisms.” The representations on the website for these direct-fed microbial products establish their intended use in the treatment and prevention of disease in animals. Because none of these products is covered by an approved NADA, the products are unsafe, and thus are adulterated. The Warning Letter also includes violations of the Act and FDA regulations concerning several of the firm’s products for human consumption.
A Warning Letter was sent to Paul Rasmussen, president, Gold Eagle Cooperative Board of Directors, Corwith, IA, because inspections of the animal feed manufacturing operations in Goldfield, IA, revealed 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 investigation found a failure to label one of the company’s products, “ISLACT – IS LACTATION,” a swine feed, with the statement “Do Not Feed to Cattle or Other Ruminants,” as required by Part 589.2000. Although the swine feed is not formulated with protein derived from mammalian tissues, which is prohibited in ruminant feed, the facility’s production practices may cause the finished product to contain such material. The investigator found that the firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material. As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. The failure to label the swine feed with the above-mentioned statement causes it to be misbranded under the Act.
A Warning Letter was issued to G. Allen Andreas, chairman and chief executive, Archer Daniels Midland Company (ADM), Decatur, IL, for significant deviations from Current Good Manufacturing Practice (cGMP) regulations for medicated feeds at its medicated feed mill in Higginsville, MO. The deviations include a failure to perform assays on representative samples of medicated feeds requiring a medicated feed mill license, the drug inventory records do not accurately reflect the current inventory, the storage of drugs in the mixing area without properly identifying, storing, handling, and controlling the drugs to maintain their integrity and identity.
A Warning Letter was issued to -Lawrence S. Hoblik, chief executive officer, J.R. Simplot Company, Boise, ID, for significant deviations from cGMP regulations for medicated feeds at its licensed medicated feed mill Western Stockmen’s, Caldwell, ID. FDA’s cGMP regulations state that for feeds requiring an approved license for their manufacture and marketing (such as medicated feed containing amprolium) at least three representative samples of medicated feed containing each drug or drug combination used in the establishment shall be collected and assayed by approved methods, at periodic intervals during the calendar year. The FDA investigator observed Western Stockmen’s manufactured medicated feed containing amprolium, a Category II, Type A medicated article, without performing any assays. In addition, the Corid 25% Amprolium found at the feed mill was labeled only for the manufacture of medicated feed for calves, however, the firm is also using it to manufacture a Type B medicated feed, called Amprolium Premix, which is labeled for use in chickens, turkeys, and pheasants, in addition to calves. If the firm wants to continue to manufacture medicated feed for these other species, it should use a drug product that is labeled for use in these other species.
A Warning Letter was issued to Larry D. Smith, president, Custom Feed Services Corporation, Norfolk, NE, for significant deviations from cGMP regulations for medicated feeds at its medicated feed mill. The deviations found include master records files and product records are deficient, there is no record the mineral oil scale is calibrated once a year, the facility is not maintained in a reasonably clean and orderly manner, and a proper receipt record for each lot of drug received is not maintained. In addition, the investigation revealed feeds manufactured and distributed by the firm that contain carbon black. Carbon black is a color additive. According to the Act, color additives are deemed to be unsafe unless they are used in accordance with a color additive regulation that specifies the conditions under which the color additive may be safely used, including the purposes for which it may be used and the product category or categories to which it may be added. There is no color additive regulation currently allowing for the use of carbon black in food, including animal feeds. Animal feeds containing carbon black are thus unsafe and adulterated. Also, the labels for feeds containing monensin intended for use in dairy cattle are not in conformance with the approved application. Approval provides for feed to contain 11- 22 g of monensin per ton, but the firm’s labels instead state the amount as mg/head/day.
A Warning Letter was issued to Ron Curtis, owner, Cache Commodities, Inc., Ogden UT, because an inspection of the medicated feed mill revealed that the facility manufactured Type C medicated feeds from a Category II, Type A medicated article on several occasions without a FDA medicated feed mill license. According to the Act and FDA regulations, this feed cannot be manufactured without a FDA medicated feed mill license. Because these feeds were manufactured at a facility without a medicated feed mill license, these feeds are considered unsafe and therefore adulterated. Facilities manufacturing solely medicated feeds for which an approved medicated feed mill license is not required must comply with cGMP requirements. FDA investigation revealed that the facility no longer manufactures any medicated feeds that require a medicated feed mill license. Therefore, the facility is subject to the cGMP requirements. An inspection noted the following deviations: failure to establish and use adequate procedures for all equipment used in the production of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds; failure to establish adequate procedures to aid in assuring the identity, strength, quality, and purity of the Type A medicated articles; the buildings and grounds are not constructed and maintained in such a manner to minimize vermin and pest infestations; and failure to maintain, on the premises, records identifying the formulation, date of mixing, and date of shipment of medicated feeds for one year following the date of last -distribution.