Leland Bruce Shaw 8/18/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District Food & Drug Administration 158-15 Liberty Avenue Jamaica, NY 11433

August 18, 2011
 

WARNING LETTER NYK 2011-30

VIA UNITED PARCEL SERVICE

Leland Bruce Shaw
40920 State Route 12
Clayton, NY 13624

Dear Mr. Shaw:

On March 31 and April 4 & 12, 2011 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 40920 State Route 12, Clayton, NY. 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 the FDA's web page at www.fda.gov.

We found that you offered an animal for sale 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 December 13, 2010 you transported a bob veal calf to (b)(4) where, upon arrival, it was identified with tag (b)(4). On or about December 14, 2010, (b)(4),slaughtered this animal for human food. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the cow bearing farm tag (b)(4) identified the presence of flunixin in the liver at 0.0926 ppm. FDA has not established a tolerance for residues of flunixin in the edible tissue of veal calves. The presence of this drug in tissue from this animal causes 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).

Additionally, we 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 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 above violations and to establish procedures whereby such 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, 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 Patricia A. Clark, 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 Patricia A. Clark at 716-5514461, extension 3168.

Sincerely yours,

/S/
Ronald M. Pace
District Director
New York

cc:

Dr. David Smith, Acting Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, NY 12235

Mr. Haroon Miam, District Manager
US Department of Agriculture/Food Safety and Inspection Service
230 Washington Ave. Extension
Albany, NY 12203-5369

Julie A. Cornett, D.V.M.
Senior Veterinary Officer
Technical Assistance/Correlation
US Department of Agriculture/ Food Safety and Inspection Service
Technical Service Center
Landmark Center
1299 Farnam Street
Omaha, NE 68102

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