Inspections, Compliance, Enforcement, and Criminal Investigations
Beef Northwest Feeders, LLC 21-Aug-07
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
August 21, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-19
Jim Wilson, Partner
John Wilson, Partner
Wesley S. Killion, Feedlot Manager
Beef Northwest Feeders, LLC
66407 Taggares Lane
Boardman, Oregon 97818
Dear Messrs. Wilson and Mr. Killion:
An investigation of your feedlot operation located at 66407 Taggares Lane, Boardman, Oregon, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 19 and 20, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, Albon® S.R. (sulfadimethoxine) sustained release bolus, NADA 093-107, to become adulterated within the meaning of section 501 (a)(5) [21 U.S.C. § 351(a)(5)] of the Act and unsafe under section 512 [21 U.S.C. § 360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about February 27, 2007, you sold a steer, identified with Ear Tag Number [redacted], for slaughter as food to [redacted]. On or about March 1, 2007, this animal was received at and slaughtered for food at [redacted]. United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analyses (USDA Case No. 07-0298-OR, Form No. 471861) of tissue samples collected from that animal identified the presence of 2.13 parts per million (ppm) of sulfadimethoxine in the liver tissue and 1.20 ppm of sulfadimethoxine in the muscle tissue.
In addition, on or about March 6, 2007, you sold a steer, identified with Ear Tag Number [redacted], for slaughter as food to [redacted]. On or about March 8, 2007, this animal was received at and slaughtered as food at [redacted]. USDA/FSIS analyses (USDA Case No. 07-0298-OR, Form No. 471862) of tissue samples collected from that animal identified the presence of 1.36 ppm of sulfadimethoxine in the liver tissue and 1.17 ppm of sulfadimethoxine in the muscle tissue.
A tolerance of 0.1 ppm has been established for negligible residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640(b) [21 C.F.R. 556.640(b)]. The presence of sulfadimethoxine above the established tolerance level in uncooked edible tissues from these two animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
In addition, you adulterated the new animal drug, Albon® S.R. (sulfadimethoxine) sustained release bolus, NADA 093-107, within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, 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. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Albon® S.R. (sulfadimethoxine) sustained release bolus, NADA 093-107, failed to comply with these requirements.
For example, you administered Albon® S.R. (sulfadimethoxine) sustained release bolus, NADA 093-107, without following the pre-slaughter withdrawal time set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351 (a)(5)].
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 ensuring that your overall operation and the food you distribute is 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (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.
Your written response should be sent to Mr. Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. In your reply please refer to Warning Letter SEA 07-19. If you have questions about this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
(w/copy of FDA-483):
Isabel Arrington, Ph.D., D.V.M.
U.S. Department of Agriculture
Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street, Suite 300
Omaha, NE 68102
Oregon State Department of Agriculture
Animal Health and Identification Division
635 Capital St. NE
Salem, OR 97301