Inspections, Compliance, Enforcement, and Criminal Investigations
Theo & Cheryl Van Berkum Dairy 25-May-06
Department of Health and Human Services
Public Health Service
May 25, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-33
Theo and Cheryl Van Berkum, Owners
Theo & Cheryl Van Berkum Dairy
8499 Nooksack Road
Everson, WA 98247-9281
Dear Mr. and Mrs. Van Berkum:
An investigation of your dairy farm, located at 8499 Nooksack Road, Everson, Washington, conducted by representatives of the U.S. Food and Drug Administration (FDA) on March 13 and 16, 2006, confirmed that you offered animals for sale for slaughter as food that were 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 Penicillin G Procaine 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 November 4, 2005, you sold a dairy cow, identified with Back Tag Number 5322 and Ear Tag Number 93, for slaughter as food to [redacted]. On or about November 4, 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 Penicillin in the kidney tissue at 3.15 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of Penicillin in the 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 uncooked edible tissue above the established tolerance 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 inspection 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 any treatment records to permit you to systematically review those treatment records prior to offering an animal for slaughter, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed. 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 the drug, Penicillin G Procaine, 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. 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 Penicillin G Procaine failed to comply with these requirements.
You administered the Penicillin G Procaine without following the dosage level set forth in the approved labeling when you administered 40-50 ml of the drug at one injection site rather than administering no more than 10 ml at one injection site, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was 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.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen