FDA takes action against Iowa Dairy

Aug 11 2007

A Complaint and Consent Decree of Permanent Injunction were filed Wednesday, August 8 in the U.S. District Court for the Northern District of Iowa, Western Division, against Ysselstein Dairy Inc., Rock Valley, Iowa, and its owner and president, Sjerp W. Ysselstein, after illegal drug residues were found in the dairy's cows.

The permanent injunction will not become effective against Ysselstein Dairy until the Court signs and enters the Consent Decree. The action follows FDA investigations into the dairy and its practices.

The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. The FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans.

Ysselstein Dairy produces milk for human consumption and sells dairy cows for slaughter for human consumption. The injunction is based on nine illegal residues in the edible tissue of seven dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between July 21, 1992, and March 10, 2006. The drug residues found by FSIS included antibiotics such as tetracycline, sulfadimethoxine, flunixin, oxytetracycline, and penicillin at levels not permitted by the FDA.

Under the terms of the Consent Decree, the dairy and Ysselstein must implement systems for identifying animals, keeping records, drug control, drug accountability, and drug residue withdrawal control. Furthermore, if the FDA informs the defendants of their not being in compliance with the terms of the Decree or the Federal Food, Drug, and Cosmetic Act, the FDA may require them to cease operations until they are in compliance. The Decree also provides for the dairy and 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.

FDA's Kansas City District Office conducted the investigations that led to the Consent Decree. FDA's Center for Veterinary Medicine Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Attorney's Office in the Northern District of Iowa processed and filed the case.