Inspections, Compliance, Enforcement, and Criminal Investigations
De Boer Dairy 14-Nov-05
Department of Health and Human Services
Public Health Service
November 14, 2005
RETURN RECEIPT REQUESTED
OR Federal Express
In reply refer to Warning Letter SEA 06-13
Sidney C. De Boer, Owner
De Boer Dairy
8426 District Line Road
Burlington, Washington 98233
Dear Mr. De Boer:
An investigation of your dairy operation located at 8426 District Line Road, Burlington, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 20, 25 & May 9, 2005, 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 Terra Vet 100 to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. 360b]. 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 11, 2005, you sold a dairy cow; back tag #3291 identified on USDA Case # 05-0157-WA and further identified on USDA-FSIS lab report #442786 for slaughter as food at [redacted] . On or about January 12, 2005 this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine in the liver at 2.16 parts per million (ppm), and in the muscle at 1.83 ppm, and flunixin in the liver at 3.307 ppm. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in uncooked edible tissues of cattle, and a tolerance of 0.125 ppm has been established for flunixin in cattle liver as codified in Title 21, Code of Federal Regulations. Part 556.640 (21 C.F.R. 556.640) and 21 CFR 556.286. The presence of these drugs in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(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. 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 do not maintain adequate treatment records that include the dosage given, the route of administration, and withdrawal time. 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)].
In addition, you adulterated Terra Vet 100 (100 mg/mI Oxytetracycline HCL) within the meaning of section 501(a)(5) [21 U.S.C. 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 (VCPR). The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Terra Vet 100 failed to comply with these requirements.
Specifically, you use a uterine treatment of mixing Terra Vet 100 and drinking water which is made up on the dairy. You treat dairy cows with 60 ml of this solution by intrauterine administration for uterine infections. The Terra Vet 100 is not approved for intrauterine use; this product is approved for the intravenous treatment of bacterial pneumonia and shipping fever complex. Your use of Terra Vet 100 was not on the lawful order of a licensed veterinarian within the context of a valid VCPR. Because your extralabel use of Terra Vet 100 was not in compliance with 21 CFR Part 530, the drug is unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused it to be 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 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 Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Elrand at 425-483-4913 ; fax is 425-483-4760 ; or email at email@example.com.
Charles M. Breen