Inspections, Compliance, Enforcement, and Criminal Investigations
Mark V. Porter d.b.a. MVP Livestock, Inc. 02/11/2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 11, 2009
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-12
Mark V. Porter, Owner
Mark V. Porter dba MVP Livestock, Inc.
P.O. Box 864
Sunnyside, Washington 98944-0864
Dear Mr. Porter:
An inspection of your operation located in Grandview, Washington, by Food and Drug Administration investigators on November 17 and 19, 2008, confirmed cattle purchased and sold by you on or about July 12, 2007, January 23, 2008, March 4, 2008, and April 16, 2008, for slaughter for human food to (b)(4)(b)(4) were in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a)(2)(C)(ii).
United States Department of Agriculture, Food Safety and Inspection Service(USDA/FSIS) analyses of tissues collected from those animals disclosed the presence of drug residues in excess of established safe tolerances. These tissue residue violations are in the following table summarizing the identification of the animals, dates sold and slaughtered, and types and levels of residues found. In reviewing this table please be aware that a tolerance of 0.05 parts per million (ppm) has been established for negligible residues of penicillin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.510); a tolerance of 0.1 ppm has been established for negligible residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in 21 C.F.R. 556.640; and a tolerance of 0.125 ppm has been established for residues of flunixin in the liver tissue of cattle, as codified in 21 C.F.R. 556.286.
|Animal||Back Tag# (Last 3 Digits)||Date Sold||Date Slaughtered/and/or Condemned||Residue Level (ppm) and Tissue where Found|
|Holstein Dairy Cow||(b)(4)||7/12/07||7/12/07||Flunixin 1.35-Liver; 0.046-Muscle|
|Holstein Dairy Cow||(b)(4)||1/23/08||1/23/08||Penicillin 0.18-Kidney|
|Holstein Dairy Cow||(b)(4)||3/4/08||3/4/08||Penicillin 0.20-Kidney|
|Holstein Dairy Cow||(b)(4)||4/16/08||4/16/08||Sulfadimethoxine 4.66-Liver|
You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
In addition, 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 failed to inquire about the medication status of the animals that you purchased and delivered for sale to a slaughter plant when you delivered the cattle on the dates outlined in the table above to (b)(4)(b)(4) You also failed to maintain treatment records for the animals you medicate, such as those that you have treated with the veterinary prescription drug, dexamethasone. 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).
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. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. 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 tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
You should notify this office in writing within 15 working days of the steps you have taken to bring your operation 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 timeframe 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. Michael Donovan at (425) 483-4906.
Charles M. Breen
CC: USDA, FSIS District Office Western Region
Attn: Regional Manager
620 Central Ave. Building 2B
Alameda, California 94501
Food Safety Program
1111 Washington Street
Olympia, Washington 98406