Inspections, Compliance, Enforcement, and Criminal Investigations
Bar VP Dairy 05-Jun-06
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 3003371220
June 5, 2006
Ronald J. Vander Poel, Co-owner
Joseph M. Vander Poel, Co-owner
Bar VP Dairy
8001 Road 104
Pixley, CA 93256
Dear Messrs. Vander Poel:
An investigation of your dairy operation located at 8001 Road 104, Pixley, California, conducted by U.S. Food & Drug Administration (FDAJ Investigators on February 17, 21, and 23, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under Section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(ax4) j21 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 (Pen-Aqueous brand) to become adulterated within the meaning of Section 501(a)(5) [21 U.S.C. §351(a)(5)] of the Act and unsafe within the meaning of 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 December 28, 2005, you consigned a dairy cow, identified with back tag number [redacted] to be sold through [redacted]. On December 28, 2005, this cow was sold through the sales yard and subsequently slaughtered by [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDAIFSIS) analysis of tissue samples collected (USDA laboratory report number 442988) from that animal identified the presence of penicillin in the kidney at 1.07 parts per million (ppm) and in the liver at 0.16 ppm. A tolerance level has been established in the uncooked edible tissues of cattle for residues of penicillin at 0.05 ppm 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 tissues from this dairy cow above the established tolerance 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 period of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records; you failed to review treatment records prior to offering an animal for slaughter for human food; and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 (Agripharm brand of Pen- Aqueous) 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) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(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.
For example, you administered penicillin G procaine (Agripharm brand of Pen-Aqueous) without following the withdrawal period set forth in the approved labeling 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 C.F.R. 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)]. In addition, our investigation revealed you administered 100cc's of penicillin G procaine (Agripharm brand of Pen-Aqueous), 50cc's per injection site, for four days to one of your dairy cows, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a). Your veterinarian's prescription for penicillin G procaine (Agripharm brand of Pen-Aqueous) specifies a dosage of 40cc's per cow and no more than 10cc's per injection site.
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. We note that since 1997, FSIS has identified 16 other illegal tissue residues from 9 dairy cows from your operation.
You should take prompt action to correct the violations specified in this letter 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 specified 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 correctives have been made.
Your reply should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions about this letter, please contact Karen Robles at (916) 930-3674 ext 14.
Barbara J. Cassens
San Francisco District