Inspections, Compliance, Enforcement, and Criminal Investigations
Grandview Dairy LLC 31-Oct-06
Department of Health and Human Services
Public Health Service
October 31, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-01
Jake Bosma, Owner
Grandview Dairy LLC
318 Spring Cove Road
Bliss, Idaho 83314
Dear Mr. Bosma:
An investigation of your dairy farm located at 318 Spring Cove Road, Bliss, Idaho, conducted by a representative of the U.S. Food and Drug Administration (FDA) on August 22 and 24, 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). 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 June 19, 2006, you sold a dairy cow identified with back tag # [redacted] 4928 and ear tag #1302 for slaughter as human food to [redacted] who in turn sold the dairy cow to [redacted]. This cow is further identified by USDA Case # 06-0631-ID and by USDA-FSIS lab report # 473378. On June 20, 2006, 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 muscle at 0.17 parts per million (ppm), and in the liver at 0.31 ppm. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as specified in Title 21, Code of Federal Regulations (CFR), part 556 .640. The presence of this drug in this amount in the edible tissues of 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)] 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 for ensuring 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 drug administered, the dosage administered, the route of administration, or the withdrawal time.
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 also note that it appears you use Oxy-Biotic 100 Injection (oxytetracycline) in a manner that is not in accordance with its approved labeling. Please be aware that 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 and otherwise complies with 21 CFR Part 530.
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 corrections will be completed . Please include with your response copies of any documentation demonstrating that corrections have been made.
Your response should be sent to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Elrand at (425) 483-4913.
Charles M. Breen