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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Liberty Dairy LLC 10-Jan-07

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

Public Health Service
Food and Drug Administration


Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483~4996




January 10, 2007


In reply refer to Warning Letter SEA 07-06

Henry M. Bosma, Co-owner
Henry W. Bosma, Co-owner
Steve Bosma, Co-owner
Liberty Dairy LLC
5860 East Zillah Drive
Zillah, Washington 98953


Dear Messrs. Bosma:

An investigation of your dairy operation located at 5860 East Zillah Drive, Zillah, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on October 31 and November 1 and 3, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under 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 investigation also revealed that you caused the new animal drugs, sulfadimethoxine and flunixin meglumine, to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about August 3, 2006, you offered for sale for food a dairy cow, subsequently identified with back tag number 904. This cow was transported by, [redacted] a cattle hauler in [redacted] to [redacted]. The animal was sold [redacted] to where it was slaughtered on August 4, 2006. 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 flunixin at 0.54 ppm in the liver. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver of cattle, as codified in Title 21, Code of Federal Regulations, section 556.286(21 C.F.R. 556.286.)

The presence of this drug above the established tolerance level in the liver from this animal 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)] of the Act.

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. 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 of the animals you medicate. Specifically, the treatment records that you maintained did not contain the drug dosage, route of administration, or the withdrawal period. In addition, you did not systematically review your medication/treatment records prior to delivering animals for slaughter as food. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [2.1 U.S.C. § 342 (a)(4)] of the Act.

In addition, you adulterated the new animal drugs sulfadimethoxine and flunixin within the meaning of section 501(a)(5) [21 U.S.C. §351 (a)(5)] of the Act when you failed to use the drugs, in conformance with the 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 veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of suifadimethoxine and flunixin failed to comply with these requirements.

For example, you administered sulfadimethoxine to a dairy cow without following the dosage level set forth in the approved labeling. Sulfadimethoxine is prohibited from extralabel use in lactating dairy cattle and your administration of this drug was in violation of 21 C.F.R. 530.41(a)(9). In addition, you administered flunixin to a dairy cow and failed to follow the labeled withdrawal time. Specifically, your veterinarian's prescription label stated a seven day withdrawal period before sending an animal to slaughter. You offered the animal for slaughter for food after a two day withdrawal period. Your extralabel use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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.

We.note that these are not the first tissue residue violations associated with cattle from your farm. Since October 1995, USDA/FSIS has reported six additional violative tissue; residues in cattle from your farm. In one instance in 2005, USDA/FSIS notified you of an illegal tissue residue of sulfadimethoxine from a dairy cow identified as originating at your dairy. It appears that this drug residue violation was caused by your use of the drug in a manner-contrary to the labeling. As discussed above, this drug is prohibited from extralabel use in lactating dairy cattle by 21 CFR 530.41(a)(9).

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.

Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23d Drive SE, Bothell; Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Mr.
Donovan at (425) 483-4906.



Charles M. Breen
District Director,

(w/copy, of FDA-483):

CC: Dr. Julie Cornett, USDA-FSIS, Technical Service Center Landmark Center; Suite 300, 1299 Farnam Street, Omaha, NE 68102

Washington State Department of Agriculture, Food Safety Program
P.O. Box 42560, Olympia, Washington 98504-2560