Inspections, Compliance, Enforcement, and Criminal Investigations
Ellsworth Farm 23-Oct-06
Department of Health and Human Services
Public Health Service
New York District
October 23, 2006
WARNING LETTER NYK 2007-01
RETURN RECEIPT REOUESTED
Donald J. Ellsworth, Owner
1085 County Rt. 3
Ft . Covington, New York 12937
Dear Mr. Ellsworth:
An investigation of your dairy farm operation located 1085 County Rt. 3, Ft. Covington, New York, conducted by representatives of the U.S. Food and Drug Administration (FDA) on June 26 and 27, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under Sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, Durvet brand Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension USP, NADA 65-010, to become adulterated within the meaning of sections 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 [21 U.S.C. 360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about January 17, 2006, you consigned a dairy cow, identified with your farm tag 104, for slaughter as food to cattle dealer and trucker [redacted] Back tag 645 was additionally affixed to this cow by [redacted]. This animal was subsequently shipped to and slaughtered there on or about January 18, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.45 ppm penicillin in kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) [21 USC 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain written treatment records which document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, identity of the individual administering the drug, and withdrawal times for milk and meat. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 USC 342(a)(4)] of the Act.
In addition, you adulterated Durvet brand Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension USP, NADA 65-010, within the meaning of Section 501(a)(5) [21 USC 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use", i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 USC 360b(a)(4)] and 512(a)(5) [21 USC 360b(a)(5)] of the Act and 21 CFR, Part 530. Our investigation found that your extralabel use of Durvet brand Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension USP, NADA 65-010, failed to comply with these requirements. For example, you administered Durvet brand Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension USP, NADA 65-010, without following the dosage level, and you administered this drug for conditions not indicated on the labeling. You did so without the supervision of a licensed veterinarian, in violation of 21 CFR, Part 530.11(a). Specifically, you administered 12 ml of Durvet brand Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension USP, NADA 65-010, to each of three injection sites, for 4-5 days. You did this to treat what you believed to be foot rot or a white-line abscess in the hoof area, a condition not indicated on the labeling. The approved labeling for this drug states no more than 10 ml should be injected at any one site in adult livestock and treatment should not exceed four consecutive days. This drug is indicated for the treatment of pneumonia and shipping fever in cattle.
Furthermore, your extralabel use resulted in an illegal drug residue in violation of 21 C.F.R. Part 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R., Part 530, the drug was unsafe under section 512(a) [21 USC 360b(a)] of the Act, and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 USC 351(a)(5)] of the Act.
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 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 .
Otto D. Vitillo
Director, New York District