Inspections, Compliance, Enforcement, and Criminal Investigations
De Groot Dairy, L.L.C. 15-Nov-05
Department of Health and Human Services
Public Health Service
November 15, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-14
Tom B. De Groot, Partner
De Groot Dairy, L.L.C.
569 Birch Bay-Lynden Road
Lynden, Washington 98264
Dear Mr. De Groot:
On July 29 and August 2, 2005, our investigator inspected your dairy farm located at 569 Birch Bay- Lynden Road, Lynden, Washington. This inspection confirmed that you offered an animal for sale for slaughter as food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(ii) and 342(a)(4)], and you caused a new animal drug to be unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
You sold a dairy cow on February 8, 2005, identified with back tag #8410 and USDA Case # 8-0222-05, and further identified as USDA-FSIS lab report # 443265, for slaughter as human food to [redacted] who in turn sold the dairy cow with back tag #8410 to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.13 parts per million (ppm). The tolerance for penicillin in edible tissues of dairy cattle is 0.05 ppm as specified in Title 21, Code of Federal Regulations (CFR), section 556.510. The presence of this drug inedible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [(21 U.S.C. 342(a)(2)(C)(ii)].
Our investigation also found that you hold animals, which are ultimately offered for sale for slaughter as food, 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 for assuring that the medicated animals 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 lack adequate written treatment records for animal drugs administered to your herd. Your treatment records do not specify the dosage administered, route of administration, or the withdrawal time.
In addition, you adulterated Pen-G Max' Procaine Penicillin G within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] 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 Pen-G Max Procaine Penicillin G failed to comply with these requirements. For example, you,administered the drug in excess of the dosage level 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(c). 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. 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 also be aware that it is not necessary for you to have personally shipped an animal into interstate commerce to 6e responsible for a violation of the Act. The fact that you offered an animal for sale, through a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.
Within fifteen (15) days of the receipt of this letter, you should notify this office of the specific steps you have taken to correct these violations and prevent their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made.
Please send your written reply to the Food and Drug Administration, Attention : Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Althar at (425) 483-4940.
Charles M. Breen