Bliss Dairy, LLC 5/20/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Denver District Office|
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
May 20, 2014
VIA UPS Overnight
Mr. Michael R. Bliss, Co-Owner
P.O. Box 189
Delta, Utah 84624
Ref: # DEN-13-14-WL
Dear Mr. Bliss:
On March 26 – 27, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 7450 East Harding Way, Delta, Utah. 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, animals for slaughter as food that were 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 revealed that on or about October 11, 2012, you sold a dairy cow, identified with carcass tag (b)(4), for slaughter as food. On or about October 12, 2012, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.177 parts per million (ppm) of flunixin in the liver tissue and 4.53 ppm desfuroylceftiofur in the kidney tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in liver tissue and 0.4 ppm desfuroylceftiofur in kidney tissue as codified in Title 21, Code of Federal Regulations (C.F.R.), Sections 556.286 and 556.113 (21 C.F.R. 556.286, 21 C.F.R. 556.113). Additionally, on or about November 30, 2012, you sold a dairy cow, identified with carcass tag (b)(4), for slaughter as food. On or about November 30, 2012, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.132 ppm penicillin in kidney tissue. FDA has established a tolerance of 0.05 ppm penicillin in uncooked edible tissue of cattle as codified in 21 C.F.R. 556.510. The presence of these drugs in edible tissues from these animals 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 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 complete treatment records. 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).
We also found that you adulterated the new animal drugs (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) to dairy cows without following the withdrawal period as stated in the approved labeling. Our investigation also found that you administered (b)(4) to dairy cows without following the route of administration as stated in the approved labeling. In addition, we also found that you administered (b)(4) to dairy cows without following the dose, amount per injection site and indications for use as stated in the approved labeling. Your extra label use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
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 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 written response should be sent to Matthew R. Dionne, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Matthew R. Dionne at (303) 236-3045 or email at Matthew.Dionne@fda.hhs.gov.
LaTonya M. Mitchell
Mr. Robert Bliss
P.O. Box 189
Delta, Utah 84624
Delta, Utah 84624
Ronald K. Jones, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, Colorado 80225
Mr. Leonard M. Blackham, Commissioner
Utah Department of Agriculture & Food
350 North Redwood Road
P.O. Box 146500
Salt Lake City, Utah 84414-6500