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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lost Trail Dairy, LLC 15-Mar-06

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, TX 75204-3145



March 15, 2006

2006-DAL-WL-16

Certified Mail
Return Receipt Requested

WARNING LETTER

Pete Tuls, Co-Owner
Brian Hemann, Co-Owner
Lost Trail Dairy, LLC
RR#1-Box 166-A
Liberal, KS 67901

Dear Mr. Tuls and Mr. Hemann:

An investigation of your dairy operation located at HC1 Box 3A, Boise City, Oklahoma, that was conducted by a representative of the U.S. Food and Drug Administration on December 9-21, 2005, confirmed that you offered an animal for sale as food that was adulterated within the meaning of sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, [redacted] (Sulfamethazine [redacted]), to be unsafe under section 512 of the Act [21 U.S.C. § 360b] and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

On or about August 4, 2005, you offered for sale an adult dairy cow identified with dairy flap tag number 2772 and ear tag 73SKA8980 for slaughter for human food. On or about August 5, 2005, this animal was slaughtered at [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfarnethazine at 1.09 parts per million (ppm) in liver tissue and 0.59 ppm in muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (CFR,) , Part 556.670 (21 CFR 556.670). The presence of this drug in the edible tissues of this animal at the reported level causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)].

Our investigation also found that you hold animals under conditions 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 drugs from edible tissues. For example, you failed to maintain complete treatment records (i.e., your records do not include the dose administered, the route of administration, or the associated withdrawal time) and you lacked an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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)].

In addition, you adulterated [redacted] (Sulfamethazine [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved animal or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530.

Our investigation found that our extralabel use of [redacted] (Sulfamethazine [redacted]) failed to comply with these requirements. For example you administered the [redacted] (Suffamethazine[redacted] without following the dosage level and withdrawal period set forth in its approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, your use caused the drug 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. § 301(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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. This may include 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 (95) 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 timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be sent to Sherrie L. Kroiczyk, Compliance Officer at the above letterhead address. If you have any questions about this letter, please contact Compliance Officer Sherrie L. Krolczyk at (214) 253-5312.

Sincerely yours,

/S/

Michael A. Chappell
District Director
Dallas District