Inspections, Compliance, Enforcement, and Criminal Investigations
Brann Farms 3-10-2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
March 10, 2009
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-13
Ronald A. Brann, Owner
9106 Northwood Road
Lynden, Washington 98264
Dear Mr. Brann:
An inspection of your dairy operation located at 9106 Northwood Road, Lynden, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 14-15, 2009, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food Drug, and Cosmetic Act (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 July 29, 2008, you sold a dairy cow with Ear Tag number (b)(4)for slaughter as food to (b)(4) (b)(4) (b)(4) identified the animal with Back Tag (b)(4). On July 30, 2008,(b)(4) sold the animal for slaughter to (b)(4)(b)(4). The animal identified with Back Tag (b)(4) was subsequently slaughtered by (b)(4) on July 30, 2008. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.49 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510(a) [21 C.F.R. 556.510(a)]. The presence of this drug in the kidney of this animal in an amount exceeding the established tolerance 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.
Our inspection also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records and you lack an adequate inventory system for determining the quantity of drugs used-to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.
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 Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Elrand at (425) 483-4913.
Charles M. Breen
cc: United States Department of Agriculture
Food Safety and Inspection Service
665 South Broadway
Boulder, Colorado 80303