R & R Holsteins, LLC (Dairy #3) - 525364 - 07/16/2017
- R & R Holsteins, LLC (Dairy #3)
- Issuing Office:
- Seattle District Office
Seattle District Office
July 17, 2017
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 17-18
Edward M. Rosa, Member
Jeffrey M. Rosa, Member
R & R Holsteins, LLC dba Dairy #3
P.O. Box 46
Wendell, Idaho 83355
Dear Messrs. Edward and Jeffrey Rosa:
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 at www.fda.gov.
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.
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 of 0.125 ppm for residues of flunixin in the liver tissues of cattle as codified in 21 C.F.R. § 556.286. The presence of these drugs in edible tissue from this animal in amounts above the tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
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 used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs Excenel RTU EZ (ceftiofur hydrochloride, NADA 141-288) and Vetameg (flunixin meglumine, ANADA 200-308). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, as defined by 21 C.F.R. § 530.3(a).
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.
Our investigation found that you administered Excenel RTU EZ and Vetameg to a cow with Ear Tag (b)(4) and Back Tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Excenel RTU EZ and Vetameg was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and also resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11 (d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501 (a)(5) of the FD&C Act, 21 U.S.C. § 351 (a)(5).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or about October 30, 2008, you submitted a Drug Residues Affidavit and Declaration to (b)(4) that states that none of the livestock picked up or delivered to (b)(4) will have an illegal level of antibiotic or drug residues. On or about August 12, 2016, (b)(4) picked up a cow which contained violative residues of desfuroylceftiofur and flunixin from your farm. Providing such a false guaranty is prohibited by section 301 (h) of the FD&C Act, 21 U.S.C. § 331 (h). You should take appropriate actions to ensure that this violation does not recur.
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.
Your written response should be sent to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian at (425) 302-0444.
Miriam R. Burbach
Debra M. Lawrence, D.V.M.
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707