| Public Health Service Food and Drug Administration |
New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 587-7500 FAX: (781) 587-7556 |
Department of Health and Human ServicesWARNING LETTER
NWE-24-11W
VIA UPS
August 5, 2011
Rudolf K. Vorsteveld, Co-owner
Vorsteveld Farm, LLP
168 Spaulding Road
Vergennes, Vermont 05491
Dear Mr. Vorsteveld:
On February 1, 2 and March 23, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4530 Jersey Street, Panton, Vermont. 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 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 the dates referenced in the table below you sold five (5) calves, as identified in same table, for slaughter as food. On or about the dates referenced in the table, the identified slaughterhouse slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from these animals identified the presence of neomycin in the kidney tissue in which illegal residues were reported.
Date Sold | Farm Tag | Back Tag | Date Slaughtered | Slaughter House | Drug Residue | Residue Level Found in Kidney Tissue (ppm) |
8/12/10 | N/A (calf) | (b)(4) | 8/13/10 | Ohio Farms Packing Co., Creston, OH | Neomycin | 13.63 |
9/2/10 | N/A (calf) | (b)(4) | 9/3/10 | Gold Medal Packing Inc., Rome, NY | Neomycin | 9.56 |
9/13/10 | N/A (calf) | (b)(4) | 9/14/10 | Gold Medal Packing Inc., Rome, NY | Neomycin | 9.56 |
9/27/10 | N/A (calf) | (b)(4) | 9/28/10 | Ohio Farms Packing Co., Creston, OH | Neomycin | 9.56 |
A tolerance of 7.2 ppm has been established for residues of neomycin in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, 556.430 (21 CFR 556.430). However, this tolerance does not apply to use of (b)(4) in veal calves, and there is no acceptable level of residue associated with use of (b)(4) in veal calves.
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).
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 Penicillin G Procaine Injectable Suspension U.S.P. to your dairy cows without following the dose, duration of treatment, route of administration, and frequency of treatment stated in the approved labeling. Your extralabel use of Penicillin G Procaine Injectable Suspension U.S.P. 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 this 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 the medicated feed (b)(4), which contains the drugs neomycin sulfate and oxytetracycline hydrochloride, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the class of animal as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b and adulterated within the meaning of 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 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 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.
We received your response dated March 30, 2011; however, no documentation was provided to verify the corrective actions taken.
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 Bruce R. Ota, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Compliance Officer Mr. Ota at 781-587-7487.
Sincerely yours,
/S/
Mutahar S. Shamsi
District Director
New England District
cc: Hans H. Vorsteveld
Co-Owner
Vorsteveld Farm, LLP
168 Spaulding Road
Vergennes, Vermont 05491
Gerald J. Vorsteveld
Co-Owner
Vorsteveld Farm, LLP
168 Spaulding Road
Vergennes, Vermont 05491
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