Inspections, Compliance, Enforcement, and Criminal Investigations
Chris & Tracey Elbe Dairy Farm 28-Aug-07
Department of Health and Human Services
Public Health Service
Minneapolis District Office
August 28, 2007
RETURN RECEIPT REQUESTED
Refer to MIN 07-21
Christopher J. Elbe
Chris & Tracey Elbe Dairy Farm
8262 Orchard Valley Road
West Bend, Wisconsin 53090
Dear Mr. Elbe:
An investigation of your dairy operation located in West Bend, Wisconsin, was conducted by an investigator from the U.S. Food and Drug Administration (FDA), on July 12-13, 2007. That investigation 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). 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 February 6, 2007, you shipped a dairy cow, identified with back tag #35PL6690, for slaughter at [redacted]. On or about February 7, 2007, this animal was slaughtered. 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 0.49 parts per million (ppm) of the drug penicillin in kidney tissue.
A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 CFR 556.510). The presence of this drug in kidney tissue 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. 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, your firm failed to maintain animal treatment records.
Further, your operation lacks an adequate inventory system for determining the quantities of drugs used to medicate your livestock. 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)].
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 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 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.
Your written response should be sent to Timothy G. Philips, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
W. Charles Becoat