Trout Brothers Dairy

Department of Health and Human Services	Public Health Service Food and Drug Administration
	900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215·597·4390

 

WARNING LETTER

10-PHI-12
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 17, 2010
 

Mr. Jeffery A. Trout, Co-Owner
Trout Brothers Farm, LLC
508 Red Rock Road
Loysville, Pennsylvania 17047

Dear Mr. Trout:

On May 27 and June 4,2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 508 Red Rock Road, Loysville, Pennsylvania. 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 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 16, 2009, you sold two veal calves, identified with back tag (b)(4) and (b)(4) for slaughter as food. On or about September 16, 2009, (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of (b)(4) parts per million (ppm) and (b)(4) ppm, respectively, of neomycin residues in the kidney tissues. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430(b)(1) (21 C.F.R. 556.430(b)(1)).

In addition, our investigation revealed that on or about October 8, 2009, you sold a dairy cow, identified with back tag (b)(4) or slaughter as food. On or about October 8, 2009, (b)(4) located in (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of flunixin in the liver at (b)(4) FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissues of cattle, as codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissues from these animals in this amount causes the food to be adulterated within the meaning of section 402(a)(2) of the Act, 21 U.S.C. § 342(a)(2).

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).

We found that you adulterated the new animal drug flunixin. Specifically, our investigation revealed that you did not use flunixin as directed by its approved labeling. Use of this drug 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 veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered flunixin to a dairy cow without following the withdrawal time as stated in the approved labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of flunixin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug(s) 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).

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, U.S. Food and Drug Administration, US Customs House, Room 900, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076. 

Sincerely yours,
/S/
Kirk D. Sooter
District Director
Philadelphia District
 

cc: Mr. David M. Trout, Co-Owner
Trout Brothers Farm, LLC
508 Red Rock Road
Loysville, Pennsylvania 17047

Dr. David R. Griswold, Acting Director
PA Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, PA 17120

Dr. Isabel Arrington, Director TAlC
United Stated Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Office of Policy, Program and Employee Development
Suite 300 Landmark Center
1299 Farnam Street
Omaha, Nebraska 68102

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