Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-4 Print Media: 301-827-6242
January 14, 2000
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The Injunction required Van Leeuwen to establish and implement the following systems:
(1) a system for permanently identifying each of his cattle (such as by tag numbers);
(2) a written record-keeping system that prevents him from introducing into interstate commerce any cattle with illegal animal drug residues and that prevents administration of new animal drugs outside the approved and labeled uses for such drugs;
(3) a written record-keeping drug inventory and accountability system;
(4) a system that ensures that each animal intended for slaughter that has been medicated is not introduced into interstate commerce until the applicable withdrawal period for each drug has expired, including a certification that requires each purchaser or other recipient of the cattle to attest to receipt of each animal's medication record; and
(5) a written record-keeping system for quarantining medicated cattle and ensuring that such cattle will not be sold while they contain an illegal drug residue.
The Injunction further prohibited Van Leeuwen from introducing cattle into interstate commerce until FDA inspected the dairy's operations, and FDA notified him in writing that it was satisfied that the dairy's operations comply with the requirements set forth above.
The systems were designed to ensure that cattle sold and consigned for slaughter did not contain illegal (above-tolerance) animal drug residues in their edible tissues, which can cause significant public health consequences. Consumers of the edible tissues of such animals may experience severe allergic reactions as a result of ingesting such food. Such food also poses the hazard of contributing to the creation of antibiotic-resistant strains of bacteria in humans who eat or handle the food. Under the Food, Drug and Cosmetic Act, food is adulterated if it has been prepared, packed or held under insanitary conditions whereby it may be rendered injurious to health. The failure to maintain adequate controls which ensure that animals sold and consigned for slaughter do not contain above-tolerance levels of animal drug residues in their edible tissues constitutes insanitary conditions.
FDA inspected Van Leeuwen's dairy in 1996 and determined that Van Leeuwen had not complied with the Injunction. In November 1996, the Court entered a Stipulation and Order holding Van Leeuwen liable for civil contempt for failing to comply with the terms of the Injunction. In June 1997, on a motion from the government, the Court assessed penalties against Van Leeuwen for his failure to eartag animals and for failure to keep records, in violation of the Injunction and Contempt Order.
In 1997 and 1998, FDA conducted additional inspections and found that Van Leeuwen still had failed to comply with the requirements of the Injunction. Accordingly, during this time period, FDA never authorized Van Leeuwen to resume the sale of cattle. The criminal charges to which Van Leeuwen pled guilty arose from an investigation into his illegal sales of cattle. During 1997 and 1998, Van Leeuwen sold cattle for slaughter at two California livestock auction yards. He sold the cattle using fictitious names, in order to conceal his ownership of the animals.
After subsequent inspections by FDA in June and August, 1999, FDA found the dairy to be in compliance and, as of September 13, 1999, the dairy was authorized to resume the sale of cattle.
Sentencing is set for March 13, 2000.