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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Green Acres Dairy, L.L.C. 21-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 98021-4l21

Telephone: 425-486-8788

FAX: 425-483-4996

February 21, 2002

VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 02-32

WARNING LETTER

Jason M. Roetcisoender, Owner

Green Acres Dairy, L.L.C.

19605 West Snoqualmie River Road

Duvall, Washington 98019

Dear Mr. Roetcisoender:

An investigation at your dairy located at 19605 West Snoqualmie River Road, Duvall,

Washington, by our investigator on February 1,2002, 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 512 of the Act. On or about November 12, 2001, you sold a bull calf back tag #284 identified on USDA Case #01-1644-01, Form #411358, for slaughter as human food to [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the calf s muscle and kidney tissues at 0.65 parts per million (ppm), and the presence of sulfadimethoxine in the calf s muscle tissue at 0.24 parts per million (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), and 0.1 parts per million (ppm) for residues of sulfadimethoxine (Title 21 Code of Federal Regulations 556.640).

A food is adulterated under Section 402(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 the following conditions on your farm:

1. 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. A system must be

maintained to assure that all treated animals have treatment records to include:

a. the animal?s identity,

b. the date of treatment,

c. the drug administered,

d. the dosage administered, and

e. the drug pre-slaughter withdrawal time. .

2. You lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their labeling.

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. Elrand,

Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 9802 l-442 1. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand, Compliance Officer at (425) 483-4913.

Sincerely,

Charles M. Breen

District Director