Inspections, Compliance, Enforcement, and Criminal Investigations
David Montanez Calf Farm 5/21/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
May 21, 2010
RETURN RECEIPT REQUESTED
David Montanez, Owner
David Montanez Calf Farm
3850 County Road 382
Carlton, Texas 76436
Dear Mr. Montanez:
On January 19 - 21, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf farm operation located at 3850 County Road 382, Carlton, Texas 76436. 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 September 28, 2009, you sold four calves, identified with back tag numbers (b)(4)and (b)(4) for slaughter as food. On or about September 29, 2009, (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of Sulfamethazine at 0.307 ppm in the liver and at 0.21 ppm in the muscle for the calf identified with back tag number (b)(4) 0.195 ppm in the liver and at 0.17 ppm in the muscle for the calf identified with back tag number (b)(4) 0.11 ppm in the liver of the calf identified with back tag number (b)(4) and 0.229 ppm in the liver and at 0.13 ppm in the muscle of the calf identified with back tag number (b)(4) . FDA has established a tolerance level of 0.1 ppm for residues of Sulfamethazine in the edible tissue of calf as codified in Title 21 Code of Federal Regulations(C.F.R.), 556.670. The presence of this drug 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 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 records regarding the identity of the animals that you purchased and delivered for sale at an auction yard, and failed to inquire about the medication status of the animals that you purchased and delivered for sale at an auction yard. 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 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 Ronda Loyd-Jones, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Ste. 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ronda Loyd-Jones at 214-253-5242.
Reynaldo R. Rodriguez , Jr.