| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
May 25, 2010
WARNING LETTER NYK 2010-17
VIA UNITED PARCEL SERVICE
Andrew T. Schantz, Farm Manager
Thomas Schantz Farm
d/b/a Riverview Dale Farm
8841 Van Amber Road
Castorland, New York 13620
Dear Mr. Schantz:
On February 10-12, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 8841 Van Amber Road, Castorland, NewYork. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
We found that you offered an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 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 6, 2009, you shipped a dairy cow, identified with tag (b)(4) to an auction house, (b)(4). This dairy cow was subsequentiy slaughtered for human food on or about August 7, 2009, at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of phenylbutazone in the kidney at 8888.0 parts per million (ppm). FDA has not established a tolerance for phenylbutazone in animals intended for human consumption, and its use is prohibited from extralabel use in female dairy cattle 20 months of age, or older as codified in Title 21, Code of Federal Regulations (C.F.R.), 530.41(a)(12) [21 CFR 530.41(a)(12)]. The presence of this drug in tissue of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs Phenylbute Injection 20% (Phenylbutazone), ANADA 200-371 and Penicillin G Procaine Injectable Suspension USP, NADA 65-010. Specifically, our investigation revealed that you did not use phenylbutazone and penicillin G procaine as directed by their approved labeling. Use of these drugs in this matter is an extralabel use as defined in 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 phenylbutazone to a female dairy cow approximately 58 months old without following the animal species as stated in the approved labeling. Phenylbutazone is prohibited for extralabel use in female dairy cattle 20 months or older by 21 CFR, Part 530.41(a)(12) and your extralabel use of phenylbutazone resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Our investigation also found that you administered penicillin G procaine to a dairy cow without following the conditions of use stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs were 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 Act, 21 U.S.C.§ 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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.
In your signed affidavit dated February 10, 2010, you stated it has been your practice to feed all of your calves, including bull calves intended for slaughter, a medicated milk replacer containing the drugs neomycin and oxytetracycline. You further stated, the medicated milk replacer you use has a thirty (30) day withdrawal for meat and you have been feeding this milk replacer for years without holding the calves for the thirty (30) day withholding time. Not following the appropriate withdrawal time for a drug product (medicated feed) constitutes extralabel use. The extralabel use of an approved new animal drug (neomycin and oxytetracycline) in or on an animal feed (milk replacer) is not permitted in accordance with 21 C.F.R. 530.11(b).
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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.
Sincerely yours,
/s/
Ronald M. Pace
District Director
NewYork District
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