An Iowa dairy is on notice from the Food and Drug Administration for offering for sale an animal for slaughter as food that was adulterated. According to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), “a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe.”

In a July 9 warning letter to owners Larry Roorda, Scott Roorda and Lance Roorda, the FDA described violations observed during inspection visits on April 17 and 23 at the Roorda Dairy LLC operation in Paullina, IA.

First, investigators found the presence of the drug tetracycline in edible tissue of the animal offered for sale in amounts above the tolerance, causing the meat to be adulterated.

On or about Jan. 2, the firm sold a cow for slaughter as food. On or about Jan. 3 that animal was slaughtered. According to the warning letter, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) analysis of tissue samples identified the presence of tetracycline at 65.05 parts per million (ppm) in the kidney tissue, and tetracycline at 6.73 ppm in the muscle tissue.

“FDA has established a tolerance of 12 ppm for residues of tetracycline in the kidney tissues of cattle,” meaning the dairy establishment demonstrated levels over 5 times the legal limit; “FDA has established a tolerance of 2 ppm for residues of tetracycline in the muscle tissues of cattle,” meaning the dairy establishment demonstrated levels over 3 times the legal limit.

Additionally, FDA investigators found that the firm’s extralabel use of the new animal drug Vetrimycin 100 was not used “as directed by its approved labeling.” Vetrimycin 100 — oxytetracycline hydrochloride, ANADA 200-452 — must be adminstered under the supervision of a licensed veterinarian, however:

“You stated in your affidavit that the animal identified with ear tag “(b)(4)” was treated with Vetrimycin™ 100 as an intrauterine infusion, wheras the drug is labeled for intravenous use only. Use of this drug in this manner is an extralabel use.”

Futhremore, the extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the use is “by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.”

In a signed affidavit, Larry Roorda stated the decision to use oxytetracycline in an off-label manner as an intrauterine infusion was based on advice that the firm’s herdsman had obtained from a colleague in the dairy industry, according the FDA.

The FDA said there is no evidence to suggest that the extralabel use was authorized by a veterinarian, and because the firm’s use of this drug was not in conformance with its approved labeling, the firm caused the drug to be unsafe and adulterated.

Lastly, the FDA’s investigation noted that on or about July 11, 2013, Larry Roorda provided to a (confidential) buyer “a Livestock Owner Certificate that states that the animals presented for slaughter do not have an illegal level of drug residues.” On or about Jan. 2 Larry Roorda delivered a dairy cow which contained violative residues of tetracycline.

“Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act,” the FDA said, “You should take appropriate actions to ensure that this violation does not recur.”

FDA investigators added that the above is not intended to be an “all-inclusive list of violations,” and that as a producer of animals offered for use as food, the firm is responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.

Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

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