|Company:||Northwest Order Buyers, Inc.|
|Subject:||Illegal Drug Residue|
|Issuer:||Kansas City District Office|
|Issued:||Oct. 26, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Kansas City District
October 26, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2007-O1
Mr. Marvin J. Rietema, President
Northwest Order Buyers, Inc. (AKA Value Added Pork Market, LLC)
1375 North Main Street
Sioux Center, Iowa 51250
Dear Mr. Rietema:
An investigation of your swine buyer/order operation located at 1375 North Main Street, Sioux Center, Iowa, conducted by representatives of the United States Food and Drug Administration (FDA) concluding, on August. 2, 2006, confirmed that you offered two hogs for slaughter for human food t that were adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] 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's web page at www.fda.gov .
On or about May 9, 2006, you sold a hog for slaughter to [redacted] . On or about May 11, 2006, this animal as slaughtered. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 2.53 parts-per-million (ppm) in the liver and 0.89 ppm in the muscle of the hog.
On or about May 21, 2006, you sold a hog for slaughter to [redacted] . On or about May 23, 2006, this animal was slaughtered. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 0.31 ppm in the liver and 0.11 ppm in the muscle of the hog.
A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the uncooked edible tissues of swine as codified in Title 21, Code of Federal Regulations , Section 556.670 (21 CFR 556.670). The presence of this drug in these amounts in edible tissue(s) from these animals 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.
The above is not intended to be an all-inclusive list of violations. As a dealer and 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. To avoid future illegal residue violations, you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug (s); and
3 . If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.
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 Ralph J. Gray, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have any questions about this letter, please contact Mr. Gray at the above address or by phone at (913) 752-2105.
John W. Thorsky
Kansas City District