Ken Corscadden

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

August 17, 2010

WARNING LETTER NYK-2010-26

VIA UNITED PARCEL SERVICE

Kenneth C. Corscadden
Corscadden Family Farm
1334 River Road
Richville, New York 13681

Dear Mr. Corscadden:

On April 20, 22, 27, May 26, June 22, and August 12, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 1334 River Road, Richville, New York. 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 for sale animals for slaughter as food that were 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 September 24, 2009 and October 29, 2009, you sold a bob veal calf each day, identified with tags (b)(4) and (b)(4) respectively, for slaughter as food. On or about September 25, 2009 and October 30, 2009, (b)(4) located in (b)(4) slaughtered these animals. Our investigation revealed that on or about October 15, 2009, you sold two (2) bob veal calves, identified with tags (b)(4), and (b)(4) for slaughter as food. On or about October 16, 2009, (b)(4) located in (b)(4) slaughtered these animals. Our investigation revealed that on or about February 8, 2010, you sold a dairy cow, identified with farm tag (b)(4) back tag (b)(4) for slaughter as food. On or about February 9, 2010, (b)(4) located in (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from each of these animals identified the presence of the following residues:

TAG ID:	Slaughter Date	Residue	Tolerance	Drug
Calf (b)(4)	09/25/09	8.26 ppm Liver 3.76 ppm Muscle 13.88 ppm Kidney	6 ppm Liver  2 ppm Muscle 12 ppm Kidney	Tetracycline Tetracycline Tetracycline
Calf (b)(4)	10/16/09	2.35 ppm Muscle	2 ppm Muscle	Tetracycline
Calf (b)(4)	10/16/09	57.24 ppm Kidney 10.27 ppm Muscle	12 ppm Kidney 2 ppm Muscle	Tetracycline Tetracycline
Calf (b)(4)	10/30/09	6.58 ppm Liver 2.42 ppm Muscle	6 ppm Liver  2 ppm Muscle	Tetracycline Tetracycline
Cow (b)(4)	02/09/10	1.96 ppm Kidney	0.05 ppm	Penicillin

Note:

FDA has established the following tolerances for residues of tetracycline in the tissue of calves: 2 parts per million (ppm) in the muscle; 6 ppm in the liver; and 12 ppm in the kidney as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.720 (21 C.F.R. 556.720), and for residues of penicillin in uncooked edible tissue of cattle at 0.05 ppm as codified in 21 C.F.R. 556.510. The presence of these drugs in edible tissues from these animals in these amounts 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).

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 are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the following new animal drugs: 1) (b)(4); and, 2) (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinary within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered (b)(4) to bull calves intended to be slaughtered as veal without following the extralabel use directions of a licensed veterinarian. Your extralabel use of tetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered (b)(4) to a dairy cow without following the approved indication for use, dose, and injection site limitation. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).

We acknowledge your decision to stop using the medicated milk replacer (containing Lasalocid) in veal calves because the directions for use state not to use this product in veal calves.

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 Email at dean.rugnetta@fda.hhs.gov.

Sincerely,
/S/
Ronald M. Pace
District Director
New York District

cc: Lorrie Corscadden, Kylie Corscadden, and Gilbert Gotham
1334 River Road
Richville, New York 13681

cc: Dr. John P. Huntley, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235

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