Inspections, Compliance, Enforcement, and Criminal Investigations
CJ Dairy Farm 5/21/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
May 21, 2014
WARNING LETTER NYK-2014-35
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr.Jeff C. Tingue, Co-Owner
Mr. Randy Kessler, Co-Owner
CJ Dairy Farm
2679 Cutting Road
Delevan, New York 14042
Dear Mr. Tingue and Mr. Kessler:
On March 4 - 11, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10051 Hooper Road, Delevan, New York. 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 animals for slaughter as food that were 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 FD&C 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 June 17, 2013, you sold a bob veal calf, identified with tag #(b)(4) and ear tag #(b)(4), for slaughter as food. On or about June 19, 2013, (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 2.1 parts per million (ppm) in the kidney tissue.
In addition, our investigation revealed that on or about June 17, 2013, you sold a bob veal calf, identified with other tag #(b)(4) and ear tag #(b)(4), for slaughter as food. On or about June 18, 2013, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 1.67 ppm in the kidney.
FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113. The presence of this drug in edible tissues from these animals in these amounts 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. For example, you failed to maintain treatment records. 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 (b)(4)(ceftiofurhydrochloride, NADA (b)(4)) sterile suspension. Specifically, our investigation revealed that you did not use the drug as directed by the prescription or approved product labeling. Use of the drug in this manner is an extralabel use. See 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. Part 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 the drug (b)(4) to your dairy cows and the drug subsequently went into your cow's colostrum. You allowed your bob veal calves access to the colostrum from the treated dairy cows without following the prohibition of feeding calves with milk obtained during treatment and during the milk discard period, as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
In addition, you adulterated your dairy cow's medicated colostrum within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351 (a)(6), when you allowed your bob veal calves to ingest this medicated feed. Your use of this medicated feed (colostrum) without following its prohibited use as directed by the approved labeling of (b)(4), caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
We acknowledge a response was received from Mr. (b)(4) on March 14, 2014. However this response is not adequate for the following reasons:
1. The response was not sent, or at a minimum, acknowledged by either party with the authority and responsibility to prevent and/or correct the above listed violations.
2. The response states that your farm no longer uses the drug (b)(4), however does not address the incorrect use of (b)(4) that is also implicated with the illegal tissue residues.
3. The adequacy of your promised corrections will need to be verified with a subsequent inspection to ensure treated cows milk is not being fed to calves and that revised record keeping is adequate.
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.
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 Patricia A.Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at (716) 846-6236 or E-Mail at email@example.com.
Ronald M. Pace
New York District