| Public Health Service Food and Drug Administration |
900 U.S. Customhouse |
Department of Health and Human Services
WARNING LETTER
11-PHI-02
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
December 1, 2010
Myron J. Diller, Owner
Myron J. Diller Farm
2203 Walnut Bottom Road
Carlisle, Pennsylvania 17015-7932
Dear Mr. Diller:
On August 25-26, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2203 Walnut Bottom Road, Carlisle, Pennsylvania. 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 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 November 24, 2009, you consigned a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about November 25, 2009, this animal was slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal with back tag (b)(4), identified the presence of the following residues in parts per million (ppm):
DRUG LEVELS TISSUE TOLERANCE
Neomycin 16.36 ppm Kidney 7.2 ppm
Sulfadimethoxine 1.511 ppm Liver 0.1 ppm
Sulfadimethoxine 1.21 ppm Muscle 0.1 ppm
FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430) and 0.1 ppm for residues of sulfadimethoxine in the edible tissue of cattle as codified in 21 C.F.R. 556.640. However, these tolerances do not apply to the use of Neomycin 200 (neomycin sulfate ANADA 200-379) and Albon Bolus (sulfadimethoxine NADA 031-715) in veal calves (pre-ruminating calves). Therefore, the presence of these drugs in the tissues from this animal causes the food to be adulterated within the meaning 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 Neomycin 200 (neomycin sulfate ANADA 200-379) and Albon Bolus (sulfadimethoxine NADA 031-715). Specifically, our investigation revealed that you did not use Neomycin 200, and Albon Bolus as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 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 Neomycin 200, and Albon Bolus to a bob veal calf with back tag (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of Neomycin 200 and Albon Bolus was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extralabel use of Neomycin 200, and Albon Bolus, resulted in illegal drug residue(s), in violation of 21 C.F.R. § 530.11 (c). 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 drug(s) 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 the animal feed (milk replacer) within the meaning of section 501(a)(6), 21 U.S.C. § 351(a)(6) when you added neomycin to milk replacer and you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). 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 feed.
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 above violations and to establish procedures whereby such 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, 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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions regarding this letter, please contact Compliance Officer, Robin M. Rivers at 215-717-3076 or via e-mail at Robin.Rivers@FDA.HHS.GOV.
Sincerely,
Kirk D. Sooter
District Director
Philadelphia District Office
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