Inspections, Compliance, Enforcement, and Criminal Investigations
Vierstra Dairy 10-May-02DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
May 10, 2002
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 02-47
Mike G. Vierstra, Owner
2588 East 3500 North
Twin Falls, Idaho 83301
Dear Mr. Vierstra:
An investigation at your dairy located at 2588 East 3500 North, Twin Falls, Idaho, by our investigators on March 27, 2002, confirmed that you offered an animal for sale for slaughter as food in violation of Section 402(a)(2)(C)(ii), and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 5 12 of the Act.
On or about January 3, 2001, you sold a dairy cow identified with back tag #7639 and listed as USDA Case #8-0375-00, Form #407287, for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of tilmicosin in the liver at 25.70 parts per million (ppm). A tolerance of 1.20 ppm has been established for residues of tilmicosin in the liver tissue of cattle (Title 21 Code of Federal Regulations 556.735). USDA analysis also identified 1.60 ppm in the muscle and 29.90 ppm in the kidney. There is no established tolerance for tilmicosin in these edible tissues.
On or about June 12, 2001, you sold a dairy cow identified with back tag #3431 and listed as USDA Case #8-0375-00, Form #407296, for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the liver at 00.29 ppm and in the kidney at 0.33 ppm. A tolerance of 0.05 ppm has been established for residues of penicillin in edible tissues of cattle (Title 21 Code of Federal Regulations 556.510).
On or about February 5, 2002, you sold a dairy cow identified with back tag #5977 and listed as USDA Case #8-0375-00, Form #439522, for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the liver at 00.47 ppm and in the kidney at 1.19 ppm. As stated above, a tolerance of 0.05 ppm has been established for residues of penicillin in edible tissues of cattle (Title 21 Code of Federal Regulations 556.510).
A food is adulterated under Section 102(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions . . .whereby it may have been rendered injurious to health." As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, our investigator noted that you lack an adequate system for assuring that animals to which you administer medication have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs from edible tissues. Although you do maintain treatment records, your system failed in that you did not identify these animals and assure that they were not prematurely offered for sale for slaughter.
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 assuring that your overall operations and the foods 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.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug, and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
You should notify this office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to bring your firm into compliance with the law. 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.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Aithar, Compliance Officer at (425) 483-4940.