Late last week, two Upstate New York dairies received warning letters from the U.S. Food and Drug Administration (FDA) over their misuse of animal antibiotics.  Both dairies were found to be in violation of the Federal Food, Drug, and Cosmetic Act during investigations of their operations.

Both farms, located in Cato, NY and Lyons, NY was found to be in violation by offering an animal for sale or slaughter, as food that was adulterated.  

Under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342 (a)(2)(C)(ii)), a food is determined ‘adulterated’ if it bears or contains a new animal drug that is unsafe under section 512 of the Act [21 U.S.C. 360b).  Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

The investigation of the operation located in Cato, NY found that in June 2009 the dairy sold and slaughtered a bob veal calf that contained 4.40 parts per million (ppm) of an florfenicol in the liver and 0.73 ppm in the muscle tissue.  Florfenicol is usually used as a treatment for bovine respiratory disease.  The presence of the florfeincol in the edible tissue of the animal caused the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)).

The same investigation also found that the dairy holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.  Investigators also found that the dairy failed to maintain treatment records or segregate treated animals.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C.342(a)(4)].

Other violations were also found at the Cato, NY dairy including unapproved adulterated use of the new animal drug florfenicol (b)(4), (b)(4).  The dairy has fifteen working days to amend the violations and respond to the FDA in writing explaining what steps have been taken to correct the violations.

The Lyons, NY operation was cited for adulteration violations under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

The investigation of the operation found that in July of 2009, a bob veal calf was sold and slaughtered for food with a 1.83 ppm presence of penicillin in the kidney tissue.  The presence of the drug in edible tissue from the animal caused the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

Additionally, the investigation found that the dairy holds animals under conditions that are so inadequate that medicated animals are bearing potentially harmful drug residues that are likely to enter the food supply.  This dairy also failed to keep treatment records, and thus, animals held under such conditions are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

Further, the investigation found that the dairy adulterated the new animal drug penicillin G procaine (Penicillin Injection), (b)(4) by not using the Penicillin Injection as directed by its approved labeling, which is in violation of Title 21, Code of Federal Regulations, Section 530.3(a) (21 C.F.R. 530.3(a)).

The Lyons, NY dairy also has fifteen working days to amend the violations and respond to the FDA in writing explaining what steps have been taken to correct the violations.