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  5. Imer Barton - 07/29/2014
  1. Compliance Actions and Activities

WARNING LETTER

Imer Barton

Product:
Animal & Veterinary

Recipient:
Imer Barton


United States

Issuing Office:
New York District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433 

 

July 29, 2014
 
WARNING LETTER NYK-2014-49
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Imer W. Barton
5724 State Route 30
Schoharie, New York 12157-0311
 
Dear Mr. Barton:
 
On April 10 and 18, 2014 and May 16, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle dealer operation located at 5724 State Route 30, Schoharie, New York. 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 July 9, 2013, you purchased and sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about July 10, 2013 (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 penicillin at 0.084 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulation (C.F.R.), Section 556.510 (21 C.F.R. 556.510). 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. 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). Specifically, you lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow them to be withheld from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. Also, you failed to identify and record the existing identification of animals that you purchased, transported and delivered for sale.
 
The above is not intended to be an all-inclusive list of violations. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduce or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the FD&C Act.
 
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 residue violations you should take precautions such as:
 
1.    Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
 
2.    Implementing a system to determine from the source of the animal whether the animal has been medicated, with what drug(s), and the date the withdrawal period (if any) terminates; and
 
3.    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;
 
4.    Obtaining signed statements from the source of the animals(s), if you are told the animal is not medicated.
 
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 Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or by e-mail at Lillian.Aveta@fda.hhs.gov.
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District