Public Health Service
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Street
Philadelphia, PA 19106
Telephone: 215 597-4390
RETURN RECEIPT REQUESTED
November 14, 2014
Mr. Curvin R. Martin, Owner
Martin Star Dairy
870 Mount Airy Road
Stevens, PA 17578
Dear Mr. Martin:
On July 24, 2014, and September 9, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 870 Mount Airy Road, Stevens, Pennsylvania. 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 December 3, 2013 you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about December 5, 2013, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the bob veal calf with back tag (b)(4) identified the presence of sulfamethazine at 13.101 parts per million (ppm) in the liver tissue and 8.345 (ppm) in the muscle tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). However, this tolerance does not apply to the use of sulfamethazine in bob veal calves (pre-ruminating calves). There is no acceptable level of residue associated with the use of sulfamethazine in veal calves (pre-ruminating calves). The presence of this drug in edible tissue from this animal in the amount noted above 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 identify and segregate animals. 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 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 Ms. Yvette Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Johnson at (215)717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.