Inspections, Compliance, Enforcement, and Criminal Investigations
Van Raay Dairy Farm 7/14/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
July 14, 2009
VIA FEDERAL EXPRESS
Sybrand T.C. Van Raaj, Owner and Manager
Van Raay Dairy Farm
12471 Thomas Road
South Charleston, OH 45368
Dear Mr. Van Raaj:
On April 23, 24, and 27, May 7 and 19, and June 18,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12471 Thomas Road, South Charleston, Ohio 45368. 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 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 June 30, 2008, you sold ten calves, one of which was a bull calf that was given back tag (b)(4) by the hauler and sold for slaughter as food. On or about July 1, 2008, (b)(4) of (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDAJFSIS) analysis of tissue samples collected from this animal identified the presence of 10.95 ppm neomycin in the kidney. FDA has established a tolerance of 7.2 ppm of neomycin in the kidney of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430 (21 C.F.R. 556.430). The presence of this drug in the edible tissue 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. For example, you failed to maintain complete treatment records and failed to identify treated animals. 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.
You should notify this office in writing of the steps you have taken to bring your film 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 Gina M. Brackett, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Gina Brackett at (513) 679-2700 Ext. 167.
Teresa C. Thompson