116 Baker Drive Redwood Falls, MN56283-1809 United States
Minneapolis District Office
Office of Human and Animal Foods - Division 1 West
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
August 30, 2017
Via UPS Overnight Delivery Refer to MIN 17 – 08
Barry J. Paskewitz
Jim Paskewitz Livestock
116 Baker Drive
Redwood Falls, Minnesota 56283-1809
Dear Mr. Paskewitz:
On May 25 and June 15, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of Jim Paskewitz Livestock, a cattle buying business located at 815 East Meadow Lane, Redwood Falls, Minnesota, for which you are currently the Manager. This inspection confirmed that you offered an animal 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). 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. You can find the Act and its associated regulations on the internet through links on the FDA web site www.fda.gov.
On or about November 15, 2016, you consigned (b)(4), a livestock hauler out of (b)(4), to transport a cow identified with orange ear tag number (b)(4) from your feedlot in (b)(4), to (b)(4). On or about November, 16, 2016, this cow was slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from that animal identified the presence of 0.242 parts per million (ppm) penicillin in kidney tissue.
A tolerance of 0.05 ppm has been established for residues of pencillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510 (21 CFR 556.510). The presence of this drug in excess of this amount in uncooked edible tissues from this animal 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 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. 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. It is your responsibility to ensure that your operations are in compliance with the law. As a buyer, feeder, and seller of animals intended for slaughter as food, you are frequently the individual who introduces or offers for introduction into interstate commerce the adulterated animal. As such, you share responsibility for violating the Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations, you should take precautions such as implementing a system or systems to determine and record the source of the animal, to determine whether the animal has been medicated and with what drug(s), and to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.
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 within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and 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 Demetria Lueneburg, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Ms. Lueneburg at (612) 758-7210.
Michael Dutcher, DVM
Office of Human and Animal Foods – Division 1 West