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U.S. Department of Health and Human Services

Animal & Veterinary

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Consent Decrees of Permanent Injunction Signed to Correct Illegal Drug Residues

by Walt D. Osborne, M.S., J.D.
FDA Veterinarian Newsletter 2007 Volume XXII, No IV

The presence of illegal drug residues in the tissues of dairy cows offered for slaughter as food is the basis for two recent court actions taken by the Department of Justice and the Food and Drug Administration.

Case in Iowa

In the first case, an Order of Consent Decree of Permanent Injunction was signed by a U.S. District Court Judge in the Northern District of Iowa, Western Division, against Ysselstein Dairy, Inc., Rock Valley, IA, and its owner and president, Sjerp W. Ysselstein. Ysselstein Dairy produces milk for human consumption and dairy cows for slaughter as human food.

The permanent injunction is based on nine illegal residues in the edible tissues of seven dairy cows sampled by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) between July 1992 and March 2006. The drug residues found by FSIS included antibiotics, such as tetracycline, sulfadimethoxine, flunixin, oxytetracycline, and penicillin at levels exceeding the tolerances set by FDA; no residue of tetracycline is permitted in the edible tissues of dairy cattle. The presence of the high levels of drugs in the tissues of the cows sold for slaughter as food rendered them adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA).

In the seven different animals offered for sale by the Ysselstein Dairy from 1992 to 2006, the concentrations of antibiotic drugs demonstrated that the dairy and its owner did not administer the drugs consistent with the dosage, withdrawal period, species limitations, or other use requirements set forth in the drugs’ labeling. The violations continued over an extensive period, despite the issuance by FDA of several “findings of inspections” (Form 483s) and several Warning Letters. Pursuant to the Court’s order, the dairy and Mr. Ysselstein must implement systems for identifying animals, keeping records, drug control, drug accountability, and drug residue withdrawal control. In addition, if FDA informs them about not being in compliance with the terms of the Consent Decree or the FFDCA, the agency may require them to cease operations until they are in compliance. The Decree also provides for the dairy and Mr. Ysselstein to pay a fine for each day they fail to comply with the Decree and for each animal that they sell or deliver for sale in violation of the Decree.

Case in Puerto Rico

In the second case, the U.S. District Court for the District of Puerto Rico issued an Order of Permanent Injunction on August 8, 2007, against J.M. Dairy, Inc., Las Martas, Inc., and Juan Manuel Ginorio, the owner of both dairies, after illegal drug residues were found in cows offered for slaughter as food. The court order follows a civil complaint filed against all of the parties in September 2006, based on FDA’s investigations into the dairies and their practices.

The injunction is based, in part, on five illegal residues in the edible tissue of three dairy cows sampled by FSIS between August 2003 and September 2005. These residues included antibiotics, such as sulfamethazine, sulfathiazole, sulfadimethoxine, and penicillin at levels not permitted by FDA. Inspections conducted more recently by FDA confirmed that the two dairies continued to use animal drugs in a manner contrary to the label directions, without the benefit of a veterinarian’s oversight. In addition, the dairies failed to maintain record-keeping systems to ensure that they did not sell milk or animals for slaughter for human food with illegal new drug residues. The court order requires that these conditions be rectified. The order also stipulated that the defendants may resume selling or delivering food (milk or animals for slaughter for human food) in interstate commerce only after they are notified by FDA that they are in compliance with the terms of the court order.