R & R Holsteins, LLC (Dairy #3) FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records. Specifically, you do not record the amount of medication administered, route of administration, amount of drug administered per injection site, withdrawal times for milk and meat, who administered the treatment, and the condition treated. Further, you lack an adequate inventory system for determining the quantities of drugs

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Potential Health Risks

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C 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.

Regulatory Context

On April 7, 10, and 13, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2924 South 2100 East, Wendell, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page atwww.fda.gov.

Specifically, our investigation revealed that on or about August 12, 2016, you sold a cow identified with Ear Tag(b)(4)and Back Tag(b)(4)for slaughter as food. On or about August 12, 2016,(b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 17.78 parts per million (ppm) in the kidney tissue and the presence of flunixin at 1.59 ppm in the liver tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.113 (21 C.F.R. § 556.113). FDA has established a tolerance

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. § 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.