Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit. Ml 48207
May 21, 2015
Trent N. Bowman, Co-Owner
Guy B. Bowman, Co-Owner
Bowman Dairy Farm, LLC
2270 North Country Road 900E
Hagerstown, Indiana 47346
Dear Messrs. Bowman:
On November 21 and December 4, 2014, and February 27, 2015, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2270 North Country Road 900E, Hagerstown, Indiana. This letter notifies you of 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 June 11, 2014, you sold a dairy cow identified with back tag (b)(4) (Ear Tag #(b)(4)) for slaughter as food. On or about June 12, 2014, (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 desfuroylceftiofur at 1.41 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur, the marker residue for ceftiofur, in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113). The presence of this drug in edible tissue from this animal in this amount 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 complete 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 producer 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 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.
Our investigation also revealed that on or about June 11, 2014, you provided (b)(4), with a signed “Livestock Owner’s Certification” stating that none of the livestock supplied to (b)(4) will have an illegal level of drug residues. This signed agreement covers the cow identified with ear tag number “(b)(4)” which was found to contain violative residues of desfuroylceftiofur. Providing such a false guaranty is prohibited by section 301(h) of the Act, [21 U.S.C. § 331(h)]. You should take appropriate actions to ensure that this violation does not recur.
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. Your medication records should include: the ID of the animal, date of treatment, drug(s) used, dosage given, route of administration, withdrawal time for meat and milk, the actual date that the withdrawal period expires, and the initials of the individual treating the animal. Please include copies of any current documentation which demonstrates that corrections have been made. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed.
Your written response should be sent to Tina M. Pawlowski, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Officer Pawlowski at (313) 393-8217.
Art O. Czabanuik
Detroit District Office
James R. Scott, D.V.M., Director
Division of Meat and Poultry Inspection
Board of Animal Health
4154 N. Keystone Avenue
Indianapolis, IN 46205