Inspections, Compliance, Enforcement, and Criminal Investigations
Stephen A. Langmaid 5/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 1, 2012
RETURN RECEIPT REQUESTED
Stephen A. Langmaid, Grower
P.O. Box 767
Sulphur Springs, Texas 75484-0767
Dear Mr. Langmaid:
On January 27 and February 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy cattle grower operation located at 2204 U.S. Interstate Highway 30 West, 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 sold a calf, identified with back tag (b)(4), for slaughter as food. 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 this animal identified the presence of tulathromycin in the kidney tissue and sulfamethazine at 0.273 parts per million (ppm) in the liver tissue and at 0.154 ppm in the muscle tissue. 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 use of (b)(4) (tulathromycin) Injectable Solution, NADA (b)(4), in calves to be processed for veal, and there is no acceptable level of residue associated with the use of (b)(4) (tulathromycin) Injectable Solution, NADA (b)(4), in 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. For example, you failed to maintain 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).
The above is not intended to be an all-inclusive list of violations. As a grower/dealer 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. To avoid future illegal residue violations you should take precautions such as:
- Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
- Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and,
- 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 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.
Reynaldo R. Rodriguez, Jr.
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean
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