Inspections, Compliance, Enforcement, and Criminal Investigations
De Bruin Farm 06-Apr-04
Department of Health and Human Services
Public Health Service
April 6, 2004
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 04-22
Gary De Bruin, Owner
De Bruin Farm
716 E. Front Street
Lynden, WA 98264-1614
Dear Mr. De Bruin:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residue in a calf that originated from your calf raising/buying farm located at 716 East Front Street Lynden, WA, 95324. As a follow-up to USDAs finding, an investigation of your calf raising/buying farm was conducted by a Food and Drug Administration (FDA) investigator on March 2 and 3, 2004, and confumed 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 extralabel use regulations at Title 21, Code of Federal Repulations, 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)(5) of the Act.
On or about October 22, 2003, you sold a calf with back tag number 5663 identified on USDA/FSIS Lab Form #4417266. This calf was sold for slaughter as human food to [redacted] who in turn sold the calf to [redacted] United States Department of Agriculture (USDA) analysis of a tissue sample collected from that calf identified the presence of Neomycin at 0.45 parts per million (PPM) in the kidney. There is no established tolerance for residues of Neomycin in the kidney tissue of calves. Therefore, the presence of neomycin in the edible tissues 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 fiorn 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 withheId 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
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 the drug neomycin in a manner contrary to its labeling in that: 1) the labebng states to mix the product with water only; 2) the labeling instructs the user to stop treatment 30 days prior to slaughter; and 3) the 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, including that there may be no residue above established tolerance levels. Your use of neomycin failed to comply with the extralabel use regulations, causing 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: Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have questions regarding any issue in this letter, please contact Bruce Williamson, Compliance Officer, (425) 483-4976.
Charles M. Breen