By: F.C. Faries, Jr.
Federal regulations exist to ensure the proper distribution and usage of veterinary drugs and to prevent adulteration of the food supply with illegal drug residues through drug misuse in food producing animals.
The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) enforce regulatory laws under the Food, Drug and Cosmetic (FDC) Act, enacted in 1906 with subsequent amendments. Anyone who causes, by an act of omission or commission, violative residues in livestock and poultry (by irresponsible and illegal distribution and use of drugs) violates state and federal laws. When FSIS inspectors detect violative drug residues in food products derived from animals, they report the violation to the FDA, the producer and the state authorities. FDA then initiates an on-site investigation of the suspect producer. If the evidence shows a flagrant violation of the law, the producer may face criminal charges. The convicted producer can be fined and possibly imprisoned for this crime. Animals with residues above established tolerances are condemned by FSIS.
To be in compliance with the law, a producer must follow precisely the instructions on the drug or chemical label. This means the producer must use only those veterinary drugs, chemicals or feed additives approved by the FDA and administer them only by the recommended route, at the approved dosage rate, and for the specific usage(s) or treatment of condition(s) indicated on the label.
Even the use of approved drugs and chemicals within the established withdrawal times prior to marketing is illegal. Drug and chemical residues are human health hazards. There is no question that producers must be more judicious in the use of chemicals and drugs in food animals. Producers are advised to read and follow directions on all drug labels with respect to dosage and withdrawal recommendations as mandated by federal law. This will ensure that consumers receive safe, high quality animal food products.
Extra-label distribution, prescription and use of veterinary drugs in food producing animals are regulated by FDA. The FDA policy requires all extra- label drug usage to be under the control of a licensed veterinarian. Extra-label usage must be in accordance with a veterinarian/client/patient relationship; a careful medical diagnosis; and a determination by the attending veterinarian that available labeled products have been found clinically ineffective. There must be assurances that treated animals have been adequately identified and that extended withdrawal periods have been established before marketing. There must also be a procedure to ensure that these policies will be met. A legitimate veterinarian/client/patient relationship exists when the veterinarian has assumed the responsibility of making medical judgments, and the client has agreed to follow the instructions of the veterinarian.
Use of an unapproved drug in food animals by a producer without a legitimate veterinarian/client/ patient relationship is extra-label drug usage and is illegal. Use of an approved drug via a route of administration not specified on the label, or at a dosage rate not specified on the label, or for treatment of a condition not specified on the label without a legitimate veterinarian/client/patient relationship, is illegal.
An important role of the Texas Agricultural Extension Service is to educate and advise food animal producers on correct usage of drugs and chemicals, problems of drug and chemical residues, and the litigation that may result from intentional or unintentional abuse or misuse of these substances in food producing animals. All persons involved in the industry must work together to bring about proper usage of drugs and chemicals in food animals.
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