- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory Affairs
The Federal Food, Drug, and Cosmetic Act (the Act) regulates the marketing of drugs for use in animals and the presence of residues of such drugs that may occur in the products of treated animals marketed for food (meat, milk and eggs). Failure to observe label withdrawal periods before slaughter is the principal cause of illegal drug residues. Other causes may include failure to observe other label directions, poor feed manufacturing practices and mix-ups. Illegal drug residues in the edible products of treated animals can constitute a hazard to the health of persons consuming such food.
In determining responsibility for illegal residues the concept of "causing," as expressed in Section 301 of the Act must be developed. Acts under the "causing" concept may be committed by one or more individuals in the production and marketing chain when illegal residues occur and, if justified by the facts, charges should be considered against these individuals. Therefore, all investigations of illegal residues should determine the culpability of any and all individuals who may have acted (or failed to act) in such a way as to be responsible for illegal residues.
Such individuals could include farmers, feedmill operators, veterinarians, livestock producers, animal dealers, brokers, etc. In one instance, a veterinarian administered a drug calling for a 30-day withdrawal time but recommended marketing the treated animal within 5 days. Another investigation disclosed purchase of a cow at an auction by an animal vendor who then sold the animal to a slaughter house without determining whether the animal had been treated with drugs, and, if so, whether a withdrawal time was required and followed. Sick or injured animals may be marketed before a drug withdrawal period has expired. Poultry are sometimes double dosed in both feed and drinking water.
Our policy is to hold responsible any individual in the production and marketing chain who can be shown to have been responsible for having "caused" (by any act of commission or omission) illegal drug residues in edible animal products.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0646.