| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT 900 U.S. Customhouse |
Department of Health and Human Services
WARNING LETTER
11-PHI-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 12, 2011
Mr. Roman J. Bem
15000 Route 8
Union City, PA 16438-9044
Dear Mr. Bem:
On February 18, 2011 through March 2, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 15000 Route 8, Union City, PA. 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, an animal for slaughter as food that was 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 October 25, 2010, you sold a dairy cow, identified with ear tag #(b)(4), sale tag # (b)(4), and farm tag/ticket #(b)(4) for slaughter as food. On or about October 26, 2010, (b)(4) slaughtered this animal. (b)(4) services customers through interstate trade. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.11 parts per million (ppm) Penicillin, and Gentamicin residues in the kidney. FDA has established a tolerance of 0.05 ppm for Penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510(a) (21 C.F.R. 556.510(a)). FDA has not established a tolerance for residues of Gentamicin in dairy cows. The presence of these drugs in edible tissues from this animal in these amounts cause 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 treatment records. 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 Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, United States Customs House, Room 900, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076.
Sincerely,
/S/
Kirk D. Sooter
District Director
Philadelphia District Office
cc: Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Office of Policy and Program Development
1616 Capitol Avenue, Suite 260
Omaha, NE 68102
Dr. David R. Griswold, Acting Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, Pennsylvania 17120
Dr. Anthony LaBarbera
Chief of Regulation and Compliance
Pennsylvania Department of Agriculture
Bureau of Animal Health
Room 408
2301 North Cameron Street
Harrisburg, Pennsylvania 17110
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