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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Double Aught Dairy 3/9/12


Department of Health and Human Services logoDepartment 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
Telephone: 303-236-3000
FAX:         303-236-3100 


March 9, 2012
Mr. Jason A. Flores
Double Aught Dairy, LLC
181 East Darby Road
Dexter, NM 88230
Ref. #: DEN-12-12-WL
Dear Mr. Flores:
On January 10 – 12, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 222 East Darby Road, Dexter, New Mexico. 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 animals for sale for slaughter as food that were 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 September 6, 2011, you sold a Holstein dairy cow, identified with ear tag (b)(4), for slaughter as food, to (b)(4). The dairy cow was purchased by (b)(4) and slaughtered on September 8, 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 0.17 parts per million (ppm) Penicillin in the kidney tissue.
FDA has established a tolerance of 0.05 ppm for residues of Penicillin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510, (21 CFR 556.510).The presence of this drug in the edible tissues 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 which 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)].
FDA has previously warned you regarding the causing of illegal drug residues in dairy cows sold for slaughter as food. A Warning Letter was issued to you as owner of Dan Dee Dairy, LLC, Dexter, New Mexico, on October, 19, 2007, citing your failure to comply with sections 402(a)(2)(C)(ii), 402(a)(4), and 501(a)(5) of the Act, [21 U.S.C. § 342(a)(2)(C)(ii)], [21 U.S.C. § 342(a)(4)] and [21 U.S.C. § 351(a)(5)], due to illegal residues of Flunixin in a dairy cow your dairy sold for food.
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 at all of your dairies 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, state the reason for the delay and the timeframe 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: U.S. Food and Drug Administration, P.O. Box 25087, (6th Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at william.sherer@fda.hhs.gov
Latonya M. Mitchell
Denver District Director
cc:        via USPS
Ronald C. Nelson, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005