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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Borkholder Farms 4/22/09

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 4820
Telephone: 313-393-8100
FAX: 313-393-8139


 

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

 

Warning Letter
2009- DT-11

April 22, 2009

Lyle J. Borkholder, Owner
Borkholder Farms
9457 West 1050 North
Nappanee, Indiana 46550-8624
 

Dear Mr . Borkholder,

On December 16, 2008, January 9, 2009, and February 17, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9457 West 1050 North, Nappanee Indiana. 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 July 19, 2008, you sold a dairy cow, identified with back tag number (b)(4) for slaughter as food. On July 21, 2008, (b)(4) slaughtered this animal. The United Sates Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.78 parts per million (ppm) of sulfadimethoxine in the liver and 0.95 ppm sulfadimethoxine in the muscle. FDA as established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified Title 21, Code of Federal Regulations (C.F.R.), 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissues from this animal in this amount 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).
 

In addition, on or about September 17, 2008, you sold a dairy cow, identified with back tag number (b)(4) slaughter as food. On September 18, 2008 (b)(4) slaughtered this animal. The USDA/FSIS analysis of tissue samples, collected from this animal identified the presence of 0.68 this ppm of sulfadimethoxine in the liver. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 556.640. The presence of this drug in edible tissues from this animal in this amount 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 is 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 new animal drug sulfadimethoxine. Specifically, our investigation revealed that you did not use sulfadimethoxine 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 sulfadimethoxine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).

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. art 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of valid veterinarian/client/patient relationship.

Our investigation found that in July 2008 you administered sulfadimethoxine to a dairy cow, identified with back tag number (b)(4) without following the route of administration and withdrawal period as stated in the approved labeling. Additionally, our investigation found that in September 2008 you administered sulfadimethoxine to a dairy cow, identified with back tag number (b)(4) without following the withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Further, your extralabel use of this drug resulted in illegal drug residues in these animals, 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 to be unsafe under section 51 (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 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 had 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 directed to Anastasia M. Piliafas-Brown, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions bout this letter, please contact Compliance Officer Piliafas-Brown at 313-393-8270; fax 313-393-8139; email anastasia.brown@fda.hhs.gov.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office