Inspections, Compliance, Enforcement, and Criminal Investigations
Dairyland Farm, LLC 08-Jul-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
July 8, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 - 15
Larry J. Dufek
Dairyland Farm, LLC.
5420 Gauthier Road
New Franken, Wisconsin 54229-9306
Dear Mr. Dufek:
An inspection of your dairy operation located at 2647 Mercier Road, New Franken, Wisconsin, conducted by a representative of the U.S. Food and Drug Administration (FDA), on April 8, 15, and 28, 2008, confirmed that you offered animals for sale for slaughter. as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4)]. The inspection revealed also that you caused the new animal drug flunixin meglumine to be unsafe under section 512 of the Act (21 U.S.C. § 360b) and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On or about January 14, 2008, you consigned [redacted] to haul a dry dairy cow identified with your farm ear tag [redacted] for slaughter as food. [redacted] applied back tag [redacted] to this cow and delivered the cow to [redacted]. On or about January 14, 2008, this cow was slaughtered at [redacted] United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 4.779 parts per million (ppm) flunixin in the liver.
On or about February 5, 2008, you consigned [redacted] to haul a dairy cow identified with your farm ear tag for slaughter as food. [redacted] applied back tag #027 to this cow and delivered the cow to [redacted]. On or about February 5, 2008, this cow was slaughtered at [redacted] The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 1.331 ppm flunixin 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(b)(1)(i). [21 CFR 556.286(b)(1)(i)]. The presence of this drug in excess of this amount in the liver from these animals 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. 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 that include the dosage amount, route of administration, identity of the person administering the drug, and the withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. 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 flunixin meglumine within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use this drug 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 [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)] and 21 CFR Part 530. Our investigation found that your extra-label use of flunixin meglumine failed to comply with these requirements.
For example, you administered flunixin meglumine to a dry dairy cow, contrary to the animal class set forth in the 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 of flunixin meglumine 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 121 U.S.C. § 360b(a)] and your use caused the drug to be 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 a11-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 are 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 to prevent their recurrence. If corrective action cannot be completed within 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.
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612)758-7132.
W. Charles Becoat
xc: Dr. Craig White
2810 Crossroads Drive, Suite 3500
Madison, WI 53718-7969
Dr. James Kile
Director, Policy Development Division
Landmark Center, Suite 300
1299 Farnam Street
Omaha, NE 68102
Robert Ehlenfeldt, DVM
Acting State Veterinarian
WDA Division of Animal Health
P.O. Box 8911
Madison, WI 53708-8911
Supervisor of Attorneys
State of Wisconsin Department of
Regulation and License
P.O. Box 8935
Madison, WI 53708-8935