Inspections, Compliance, Enforcement, and Criminal Investigations
Dutch Cowboy Dairy 6/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office |
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
June 22, 2012
Mr. Paul P. Byl, Co-Owner
Mr. Steven Byl, Co-Owner
Dutch Cowboy Dairy, LLC
6215 North West Frontage Road
Paragonah, UT 84760
Ref. #: DEN-12-17-WL
Dear Messrs. Byl:
On April 24 – May 7, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6215 North West Frontage Road, Paragonah, Utah. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act, and its associated regulations, on the Internet through links on the FDA’s web page at www.fda.gov.
We found that you offered an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, [21 U.S.C. § 342(a)(2)(C)(ii)] a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, [21 U.S.C. § 360b]. Further, under section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about December 16, 2011, you delivered for slaughter as food, a dairy cow identified with (b)(4). The cow was slaughtered on or about December 19, 2011. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 4.12 parts per million (ppm) Dihydrostreptomycin in the kidney tissue.
FDA has established a tolerance of 2.0 ppm for residues of Dihydrostreptomycin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.200, (21 CFR 556.200). The presence of this drug in the edible tissue of this animal in this amount 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 under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain 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. In addition, you failed to maintain and review complete treatment records for medicated animals that are sold for food. 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)].
We acknowledge receipt of your letter dated May 5, 2012 in which you assert that the dairy cow with head tag (b)(4) was not your cow. However, based on the information obtained during our investigation, we disagree. Your response has been placed in your permanent file. We also acknowledge that during our inspection you made the decision to stop using (b)(4), the Penicillin and Dihydrostreptomycin containing product most likely responsible for the illegal drug residue.
With respect to the USDA/FSIS illegal residue report, (b)(4), our investigation found no evidence that your firm was responsible for the illegal Gentamicin residue in the dairy cow identified with retain tag (b)(4).
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 foods you distribute are in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these 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 within fifteen (15) working days of receiving this letter of any additional steps you have taken to bring your firm into compliance with the law. 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 timeframe within which the corrections will be completed. Please include copies of any available documentation, such as written procedures, and inventory records, demonstrating that corrections have been made.
Your written response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, (6th Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at firstname.lastname@example.org
LaTonya M. Mitchell
Denver District Director
Ronald C. Nelson, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Mr. Leonard M. Blackham, Commissioner
Utah Department of Agriculture and Food
350 N Redwood Road
PO Box 146500
Salt Lake City UT 84114-6500
PO Box 146500
Salt Lake City UT 84114-6500