Inspections, Compliance, Enforcement, and Criminal Investigations
Boles Livestock 5/29/09
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
May 29, 2009
RETURN RECEIPT REQUESTED
Mr. Beau T. Boles, Owner
Clovis, New Mexico 88101-1022
Ref: DEN-09-07 WL
Dear Mr. Boles:
On January 20-21, 23, and 28, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 950 Cr G, Clovis, New Mexico, 88101-1022. 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 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 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 the dates of May 13, 2008, July 8, 2008, and August 14, 2008 you sold a cow each day identified with ear tag numbers (b)(4) and (b)(4) respectively, for slaughter as food at (b)(4). On or about the same date the animals were sold, these animal were slaughtered at (b)(4) United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from each of these animals identified the presence of the following drugs in parts per million (ppm):
|Cow Ear Tag||Back Tag|
|Flunixin||Liver Muscle||Liver Muscle|
|(b)(4)||(b)(4)||5/13/2008||1.241 0.042||0.125 0.025|
|Sulfadimethoxine||Liver Muscle||Liver Muscle|
|(b)(4)||(b)(4)||5/13/2008||2.03 1.02||0.1 0.01|
A tolerance of 0.125 ppm in the liver and 0.025 ppm in the muscle has been established for residues of flunixin in the edible tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.FR. § 556.286). A tolerance of 0.4 ppm in the kidney has been established for residues of desfuroylceftiofur in the edible tissue of cattle as codified in 21 C.F.R. § 556.113. A tolerance of 0.1 ppm in the liver and in the muscle has been established for residues of sulfadimethoxine in the edible tissue of cattle as codified in 21 C.F.R. § 556.640.The presence of these drugs in edible tissue from these animals in these amounts cause the food to be adulterated under 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. Specifically, you lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. 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).
The violations listed above are not intended to be an all-inclusive list. As a dealer 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. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
2. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
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 frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303)-236-3024.
H. Thomas Warwick, Jr.
Denver District Director