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 17, 2014
Marvin J. Te Velde, Owner
Te Velde Holsteins, LLC
7678 Weld County Rd 17
Fort Lupton, Colorado 80621
Ref. #: DEN-14-07-WL
Dear Mr. Te Velde:
On March 10-20, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy and heifer raising operation located at 8604 East County Rd 18, Johnstown, Colorado. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 found that on or about August 30, 2013, you sold a dairy cow identified with ear tag (b)(4) for slaughter as food. On or about August 30, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) collected tissue samples from your dairy cow with ear tag (b)(4) and RetainTAG: (b)(4). The tissue samples from this animal tested positive for the presence of desfuroylceftiofur of 3.48 parts per million (ppm) in the kidney tissue and for the presence of flunixin of 0.549 ppm in the liver tissue (b)(4). FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue and 0.125 ppm for flunixin in liver tissue as codified in Title 21, Code of Federal Regulations (C.F.R.), Sections 556.113 and 556.286, 21 C.F.R. 556.113, 21 C.F.R. 556.286. The presence of this drug in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you held 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 maintain treatment records for animals that you medicate. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(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 food 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 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 of receiving this letter, 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 corrections have been made.
Your response should be sent to U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: Thomas R. Berry, PharmD, Compliance Officer. If you have any questions about this letter, please contact Dr. Berry at (303) 236-3028.