• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Sulphur Springs Dairy Auction, Inc. 5/1/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

May 1, 2012
 
2012-DAL-WL-19
 
WARNING LETTER
 
UPS OVERNIGHT
RETURN RECEIPT REQUESTED  
 
David M. Fowler, Co-owner and President
Sulphur Springs Dairy Auction, Inc.
P.O. Box 480
Sulphur Springs, Texas 75484-0480
 
Dear Mr. Fowler:
 
On January 19 and 23, and February 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your auction facility located at 1910 South Broadway Street, Sulphur Springs, Texas. 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 revealed that on or about October 6, 2011, you purchased and sold a calf, identified with back tag (b)(4), for slaughter as food to (b)(4), located in (b)(4). On or about October 7, 2011, (b)(4), located in (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of tulathromycin in the kidney tissue and sulfamethazine in the liver tissue at 0.273 parts per million (ppm) and in the muscle tissue at 0.154 ppm. FDA has established a tolerance of 5.5 parts per million (ppm) for residues of tulathromycin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.745(b)(1) (21 C.F.R. 556.745(b)(1)). However, this tolerance does not apply to the presence of tulathromycin in tissues of calves to be processed for veal. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in 21 C.F.R. 556.670. Therefore, the presence of these drugs in edible tissues from this animal 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. 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). 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 them to be withheld from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.
 
The above is not intended to be an all-inclusive list of violations. As a distributor 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. To avoid future residue violations you should take precautions such as:
 
  1. Implementing a system to determine whether animals you receive for auction have been medicated, with what drug(s), and the date the withdrawal period (if any) terminates: and
  2. Obtaining signed statements from the source of the animals(s), if you are told the animal is not medicated.
 
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 Rose Ashley, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ashley at 210-541-9450, Ext. 1118.
 
Sincerely yours,
/S/
Reynaldo R. Rodriguez, Jr.
District Director
Dallas District
 
 
cc:      
Mr. Joe Don Pogue, Co-owner
Sulphur Springs Dairy Auction, Inc.
P.O. Box 480
Sulphur Springs, Texas 75484-0480
 
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean
District Manager
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598
 
Texas Department of State Health Services
Attn: Julie W. Lorea, Manager
1100 W. 49th Street
Austin, Texas 78756