Inspections, Compliance, Enforcement, and Criminal Investigations
Dan VanGrouw Dairy 25-Apr-07
Department of Health and Human Services
Public Health Service
April 25, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-12
Daniel S. VanGrouw, Owner
Dan VanGrouw Dairy
5655 South Black Cat Road
Meridian, Idaho 83642
Dear Mr. VanGrouw:
An investigation of your dairy operation conducted by a representative of the U.S. Food and Drug Administration (FDA) on February 22-23, 2007, 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 September 18, 2006, you sold a dairy cow with farm ear tag 90001 and assigned back tag [redacted] 4544 for slaughter as food to [redacted]. On or about September 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 at 5.69 parts per million (ppm) in the muscle. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.640. The presence of this drug in the edible tissue 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)] 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 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 complete treatment records to include the dosage given and route of administration. Further, you lack an adequate inventory system for determining the quantities of drugs used to medicate your animal(s). Food from animals held under such conditions are adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.
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 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. Althar, 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 Lisa M. Althar at 425-483-4940.
Charles M. Breen
cc: Celia R. Gould, Director
Idaho State Department of Agriculture
P.O. Box 790
Boise, Idaho 83701-0791
Dr. Julie Cornett, USDA-FSIS, Technical Service Center
Landmark Center, Suite 300,
1299 Farnam Street
Omaha, Nebraska 68102