Livestock producers who fail to correct asserted violations of the Food, Drug, & Cosmetic Act face serious repercussions that may result in the permanent or temporary cessation of their operations.

Illegal residues of drugs in meat, milk, or eggs, identified by USDA and/or FDA are serious offenses that require the immediate attention of, and response by, the alleged violator.  When these acts are repeated, particularly egregious, or the response is deemed inadequate, the government may take additional measures, including filing complaints for permanent injunctions, to permanently restrain and enjoin producers from continuing operations that introduce or deliver into interstate commerce any article of food consisting of animals and their edible tissues.  Violators may also have to pay for the costs of any related investigations, in addition to any fines ordered by the court.

Needless to say, livestock producers should take extraordinary measures to remain squarely out of the cross-hairs of such government actions.  Those who do not may be accused of the following offenses:

• Failing “to have a system to control drug administration,” specifically, failing “to document the drug usage or the withdrawal time,” resulting in “animals with illegal drug residues offered for slaughter for use as food.”[1]
• Failing “to systematically review treatment records prior to offering an animal for slaughter for human food, to ensure that drugs have been used only as directed and that appropriate withdrawal times have been observed.”
• Failing to maintain adequate medical records, including the treatment dosages, route of administration and withdrawal times.
• Using a prescription drug in a manner not specified by the label, and without a prescription from a veterinarian, thereby resulting in illegal extra-label drug use.  The drugs used in this manner are considered unsafe and the food produced from the livestock treated is considered adulterated.

FDA and USDA ordinarily warn livestock producers, sometimes repeatedly, whose management practices are found to be deficient, in order to ensure compliance with the laws governing the medical treatment of livestock raised for food.  However, even without proof of actual harm to humans, those agencies will take remedial and punitive action to protect consumers from potential public health risks resulting from the consumption of food containing above-tolerance levels of antibiotics and other drugs.

[1] Representative offenses specified in U.S. v. Metzler & Sons, L.L.C., Case No. 3:13-cv-00283-KRG, (W.D. Pa. Dec. 18, 2013)