Inspections, Compliance, Enforcement, and Criminal Investigations
Thomas, Allan 06-May-04
Department of Health and Human Services
Public Health Service
May 6, 2004
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 04-26
Allan B. Thomas, Owner
123 East Roosevelt
Enumclaw, Washington 98022
Dear Mr. Thomas:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of an illegal drug residue in a veal calf that originated from your dairy farm located at 123 East Roosevelt, Enumclaw, Washington 98022. As a follow-up to USDA’s finding, an investigation of your dairy farm was conducted by a FDA investigator on March 24, 2004, and confirmed that you offered an animal for sale for slaughter as food which was adulterated, in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You also caused the adulteration of an animal drug because the drug was used in a manner that does not conform to its approved uses or the extraiabel use regulations at Title 21, Code of Federal Remlations, Part 530 (21 CFR Part 530). This caused the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(S) of the Act.
On or about November 24, 2003, you sold a veal calf with back tag number 473 identified on USDA-FSIS Lab Form #23340. This calf was sold for slaughter as human food to [redacted] who operates a cattle hauling business, who in tum sold the calf to [redacted]. USDA analysis of a tissue sample collected from that calf identified the presence of neomycin at 1.60 parts per million (PPM) in the kidney. The use of neomycin in the treatment of veal calves is not allowed, per 21 CFR Part 520.1485. A copy of Part 520.1485 is enclosed for your review. The presence of this drug in edible tissue of this animal caused the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
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 that are inadequate to prevent animals bearing potentially harmful drug residues from entering 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.
2. You lack an adequate system for assuring that drugs are not used in a manner contrary to the directions contained in their approved labeling.
3. You lack an adequate system for assuring that expired drugs are discarded and not used.
4. You failed to identify and/or segregate animals that are receiving drug treatments.
The investigation also determined that you adulterated an animal drug within the meaning of Section 501(a)(5) of the Act when you failed to use the drug in conformance with its approved conditions of use or the extralabel use regulations at 21 CFR Part 530. Specifically, you used Neomycin & Oxytetracycline Scours Control 2 Medicated Calf Milk Replacer in a manner contrary to its labeling, which states this product is not approved for use on veal calves. Your use of this drug on a calf contrary to the labeling is considered extralabel use. Extralabel drug use is permitted only on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and in conformance with all other criteria set forth in 21 CFR Part 530, includingthat there may be no residue above established tolerance levels. Your use of neomycin failed to comply with the extralabel use regulations, which caused the drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.
You should be aware that it is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal for sale that was shipped in interstate commerce to be a slaughterhouse is sufficient to make you responsible for violations of the Act.
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for sale for use as food, you are responsible for ensuring that your 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 occur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond within fifteen (15) days of receipt of this letter and notify this office in writing of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421, In addition, if you have questions regarding any issue in this letter, please contact Lisa Elrand, Compliance Officer, (425) 483-4913.
Charles M. Breen
Form FDA 483