Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
May 10, 2010
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-21
Dennis D. Lenssen, Owner
9179 Bloom Road
Lynden, Washington 98264-9509
Dear Mr. Lenssen:
On March 23, and 26, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9179 Bloom Road, Lynden, Washington. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about December 4, 2009, you sold a dairy cow, identified with Back Tag number (b)(4) for slaughter as food to (b)(4), where it was subsequently slaughtered on that same day. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of Sulfadimethoxine at 1.160 parts per million (ppm) in the liver. FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640).
The presence of Sulfadimethoxine in edible tissues from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation 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 complete drug treatment records. Specifically, your drug treatment records lack information about the manner in which animal drugs are being administered by your dairy. Your treatment records lack:
• The reason for drug use (disease condition treated);
• The route of administration;
• The person administering the drug;
• The drug withdrawal timeframe from the last treatment date and/or the date the
milk/meat of the treated cow can be marketed.
Additionally, you failed to have an adequate inventory system for determining the quantities of drugs used to medicate your cows. Specifically, you do not maintain a written accountability of the animal drugs used by your dairy. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
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 violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or about December 4, 2009, that an employee acting as your agent, provided to (b)(4) a signed Drug Residue Affidavit certifying that the cattle are drug residue free in accordance with the regulations of the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA). This signed affidavit covered the dairy cow identified with back tag #(b)(4) (retain tag (b)(4)), which was found to have a violative residue of sulfadimethoxine. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 of receiving this letter, 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 Brenda L. Reihing, 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 Reihing at (425)483-4899.
Charles M. Breen