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U.S. Department of Health and Human Services

Animal & Veterinary

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Indiana Cattle/Dairy Operation Signs Consent Decree in Drug Residue Case

FDA Veterinarian Newsletter 2006 Volume XXI, No III

Two co-owners of a cattle dealership and dairy operation in Indiana that had sold animals containing illegal drug residues signed a consent decree in June that requires the owners to take several steps to prevent residue violations in animals they sell.

The court Consent Decree of Permanent Injunction was filed June 13, 2006, against Chris Parker and Ted Parker, as individuals, and against their company, Jay Parker and Sons, LLC, Silver Lake, IN.

The Food and Drug Administration’s (FDA) Detroit District Office, working with FDA’s Center for Veterinary Medicine, conducted the investigations that led to the Consent Decree.

The U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), which samples animals at slaughter for illegal drug residues, reported 23 illegal drug residues in nine cows and one veal calf sold by the defendants during a period beginning in 1999 and ending in 2005. USDA inspectors reported finding illegal residues of several antibiotics—streptomycin, neomycin, gentamicin, oxytetracycline, flunixin, and sulfadimethoxine—at levels exceeding FDA-permitted tolerances or for which FDA has assigned no tolerance level.

The farm managers had previously received letters from USDA/FSIS advising them of the problem. In 2004, FDA investigators visited the farm and found problems severe enough in the drug administration and recordkeeping system that FDA issued the firm a Warning Letter citing specific violations. A follow-up inspection in 2005 found that the firm had not addressed the problems cited in the Warning Letter.

The Consent Decree places several requirements on the defendants if they are to stay in business.

The defendants must establish and implement a system that identifies by a tag number each animal they control.

The defendants must establish a written recordkeeping system that will help prevent the sale of any animal that contains illegal drug residues.

The firm is prohibited from using drugs in an extralabel manner (in a way not specified on the label) without a written order from a licensed veterinarian who has firsthand knowledge of the animals to be treated—otherwise known as a valid-client-patient relationship. (See article: “FDA Permits Extralabel Drug Use Under Certain Conditions” on page 6.) The defendants must implement a system that will prevent the defendants from using new animal drugs that are not in conformance with FDA approved labeling.

The defendants must establish and implement an inventory system for drugs that prevents them from selling or delivering animals containing violative drug residues and prevents medicated animals from being sold during a drug’s withdrawal period.

The Consent Decree requires the defendants to explain in writing how they will comply with these requirements. In addition, the defendants must send a copy of the decree to all of their agents, employees, and other representatives that purchase animals from this firm.

Whenever it deems necessary, FDA can come onto the Jay Parker and Sons dairy farm to inspect the facilities to be sure that animal drugs are being properly used and documented. In accordance to the decree, the defendants “shall reimburse FDA for the costs of conducting and evaluating all inspectional, laboratory, analytical, and other work that FDA deems necessary to evaluate the defendants’ compliance….” The fees will be charged at a standard rate.

USDA/FSIS inspectors often found multiple residue violations in one violative animal from Jay Parker and Sons, LLC. For example, a violative animal reported in April 2005 had residues of sulfadimethoxine in the kidney and liver. Because FDA has not established a tolerance for the drug in either organ, each of the two findings is one violation. In some violative cows, USDA/FSIS found illegal residues in three or more tissues, and in some cases found illegal residues of more than one drug.

Besides FDA’s Detroit District Office and CVM’s Division of Compliance, FDA’s Office of the Chief Counsel, the U.S. Department of Justice’s Office of Consumer Litigation, and the U.S. Attorney’s Office in the Northern District of Indiana worked on the case.