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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Scarrow Dairy 08-Aug-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-496-9798
FAX: 425-493-4996




August 8, 2003
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 03-26

Jimmy D. Scarrow, Owner
Scarrow Dairy
2128 East 3200 South
Wendell, Idaho 83355

WARNING LETTER

Dear Mr. Scarrow:

On March 24-25, 2003, our investigator inspected your dairy located at 2128 East 3200 South, Wendell, Idaho. This inspection confirmed that you offered an animal for sale for slaughter as food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) (21 U.S.C. 342(a)(2)(C)(ii) and (a)(4)) of the Federal Food, Drug, and Cosmetic Act (the Act), and you caused a new animal drug to become adulterated within the meaning of section 501(a)(5) (21 U.S.C. 351(a)(5)).

On or about March 11, 2003, you sold a calf heifer with back tag ##4725 identified on USDA Case #03-0367-ID, From #433500, for slaughter as human food to [redacted] USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 1.52 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 Rerzulations, section 556.510. The excess residue of this drug in the edible tissues of these animals 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)). A new animal drug is adulterated under section 501(a)(5) of the Act (21 U.S.C. 351(a)(5)) if it is administered in a manner other than in accordance with the directions specified in the labeling, thereby making it unsafe within the meaning of section 5 12(a)(l)(B) (21 U.S.C. 360b(a)(1)(B)). A food is adulterated under section 402(a)(2)(C)(ii) of the Act (21 U.S.C. 342(a)(2)(C)(ii)) if it contains a new animal drug that is unsafe within the meaning of section 512 of the Act (21 U.S.C. 5 360b(a)(1)(B)). A food is adulterated under section 402(a)(4) (21 U.S.C. 342(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
possibly harmful drug residues may enter the food supply.

For example, our investigator noted the following conditions on your farm:

1. You lack an adequate system for determining the medication status of animals you offer for slaughter.
2. You lack an adequate system for ensuring that medicated animals have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous drug residues.
3. You lack an adequate system for ensuring that drugs are used in a manner not contrary to the directions contained in their labeling.

You should be aware that it is not necessary for you to have personally shipped an adulterated animal into interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal to be slaughtered into food for human consumption where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act.

For your information, in October 1994, Congress passed the Animal Medicinal Drug Use Clarification Act, which permits extra-label use of drugs under certain controlled conditions as specified in 21 CFR Part 530. “Extra-label use” means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. Extra-label use is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship and in conformance with criteria set forth in the regulation. Such extra-label use would include, for example, the use of Penicillin at
30-35cc‘s when the label indicates a dose of 1 See’s in dairy cattle.

The above is not intended to be an all-inclusive list of violations. As a producer of animals that are offered for use as food, you are responsible for ensuring that your overall operations and the food 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.

Within fifteen (15) working days of the receipt of this letter, please advise this office 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 written reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Lisa M. Elrand, Compliance Officer at (425) 483-4913.

Sincerely,

/s/
Charles M. Breen
District Director