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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lym-R-Flo Farm 5/11/12

  

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 

May 11,2012

WARNING LETTER NYK-2012-17

VIA UNITED PARCEL SERVICE

Lyman R. White, Owner
Lym-R-Flo Farm
265 Stoner Trail Road
Johnstown, New York 12095-3617

Dear Mr. White:

On March 6, 9, and 12, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 265 Stoner Trail Road, Johnstown, 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 12, 2011, you sold a bob veal calf, identified with sale tag (b)(4), for slaughter as food. On or about July 13, 2011, (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 tulathromycin in the kidney tissue, flunixin in the liver tissue at 0.141 parts per million (ppm), and penicillin in the kidney tissue at 0.11 ppm. FDA has established a tolerance of 5.5 ppm for residues of tulathromycin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.745(b)(1) (21 C.F.R. 556.745(b)(1)). However, this tolerance does not apply to the use of (b)(4) (tulathromycin) (b)(4), in calves to be processed for veal, and there is no acceptable level of residue associated with the use of (b)(4) (tulathromycin) (b)(4), in calves to be processed for veal.  FDA has established a tolerance of 0.125 ppm for residues of flunixin in the uncooked edible tissues of cattle, as codified in 21 C.F.R. 556.286(b)(1).  However, this tolerance does not apply to the use of flunixin in calves to be processed for veal, and there is no acceptable level of residue associated with the use of flunixin in calves to be processed for veal.  FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle, as codified in 21 C.F.R. 556.510.  Therefore, the presence of these drugs in edible tissues from this animal in these amounts 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 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov.

Sincerely,

/s/

Ronald M. Pace
District Director
New York District