Inspections, Compliance, Enforcement, and Criminal Investigations
Degrave, Dale and Peggy 1/29/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
January 29, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 07
Dale A. De Grave
Dale and Peggy De Grave Farm
East 2471 County Road X
Casco, Wisconsin 54205
Dear Mr. De Grave:
On November 13 and December 12, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at East 2471 County Road X, Casco, Wisconsin. This letter notifies you of 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 March 11, 2008 you consigned [(b)(4)], to haul a dairy cow identified with back tag [(b)(4)] for slaughter as food. On or about March 11, 2008, [(b)(4)], slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 0.261 parts per million (ppm) in liver tissue, and the presence of sulfamethazine at 29.78 ppm in liver tissue. FDA has established a tolerance of 0.125ppm for residues of flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), 556.286 [21 CFR 556.286]. FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of female dairy cattle 20 months of age or older. The presence of these drugs in edible tissues from this animal in these amounts 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 that include the dosage amount, route of administration, and, the withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. 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 are 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.
We remind you that, as discussed with you during the inspection, sulfamethazine is not approved for use in female dairy cattle 20 months of age or older. The use of sulfamethazine in female dairy cattle 20 months of age or older is an extralabel use. The extralabel use of sulfonamide drugs, which includes sulfamethazine, is prohibited for lactating dairy cattle [21 CFR 530.41(a)(9)].
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat