Inspections, Compliance, Enforcement, and Criminal Investigations
VL Livestock Company, Inc. 29-Aug-08
Department of Health and Human Services
Public Health Service
August 29, 2008
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-33
Joel Van Lith, President
VL Livestock Company, Inc.
P.O. Box 490
Parma, Idaho 83660
Dear Mr. Van Lith:
An inspection of your cattle feed lot operation located at 3010 1st Lane East, Parma, Idaho, conducted by a representative of the U.S. Food and Drug Administration (FDA) on July 30 and 31, 2008, 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 21 U.S.C. § 342(a)(4)]. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
On or about June 3, 2008, you sold a steer, identified with Ear Tag Number [(b)(4)] for slaughter as food to [(b)(4)] Idaho. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of a tissue sample collected from the animal with Ear Tag Number [(b)(4)] on that same date identified the presence of sulfamethazine in the liver tissue at 8.23 parts per million (ppm). A tolerance of 0.10 ppm has been established for negligible residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 (21 C.F.R. § 556.670).
The presence of this drug in this amount in edible tissues of 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. § 42(a)(2)(C)(ii)].
FDA's recent inspection also found that 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, you failed to systematically review treatment records prior to offering an animal for slaughter as human food to assure that appropriate withdrawal times have been observed, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 overall operations and the food you distribute from any and all facilities 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 comply 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 Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
CC: FSIS District Office Western Region
Attn: Regional Manager
620 Central Ave. Building 2B
Alameda, California, 94501
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707