Inspections, Compliance, Enforcement, and Criminal Investigations
Orth Farms LLC 2/3/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
February 3, 2014
WARNING LETTER NYK-2014-18
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Paul Orth, Co-Owner
Mr. David Orth, Co-Owner
Orth Farms LLC
2861 Evans Road
Eaton, New York 13334
Dear Messer’s Orth:
On October 10, 2013 through October 29, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2861 Evans Road, Eaton, 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 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 within the meaning of 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 May 22, 2013, you sold a bob veal calf, identified with sale tag (b)(4), for slaughter as food. On or about May 24, 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 dihydrostreptomycin in the kidney tissue at 6.31 parts per million (ppm). The FDA has established a tolerance of 2.0 parts per million (ppm) for residues of dihydrostreptomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.00 (21 C.F.R. 556.200). However, this tolerance does not apply to the use of (b)(4) (penicillin-dihydrostreptomycin in oil), NADA (b)(4) in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) (penicillin-dihydrostreptomycin in oil), NADA (b)(4) in bob veal calves (pre-ruminating calves ). Therefore, the presence of this drug in kidney tissue from this animal 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 drug (b)(4) (penicillin-dihydrostreptomycin in oil), NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by the prescription or approved labeling. Use of this 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.
Furthermore, our investigation found that you administered (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 to not use as food the milk taken from treated animals within 96 hours (eight milkings) after calving, as stated in the approved labeling. Your extralabel use of (b)(4) was in or on feed, in violation of 21 C.F.R. 530.11(b), and it resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with the approved labeling and your servicing veterinarian’s prescription 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.
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 are 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 LCDR Frank Verni, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact LCDR Frank Verni, Compliance Officer at (718) 662-5702 or by email at email@example.com.
Ronald M. Pace
New York District