Inspections, Compliance, Enforcement, and Criminal Investigations
Elder Grove Dairy Farm 11-Mar-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
Telephone: (612) 334-4100
Fax (612) 334-4134
March 11, 2005
RETURN RECEIPT REQUESTED
Refer to MIN 05-10
James G. Rankel
Elder Grove Dairy Farm
W1110 Colby Factory Road
Colby, Wisconsin 54421-9020
Dear Mr. Rankel:
Our investigator conducted an inspection at your dairy farm located at W1110 Colby Factory Road, Colby, Wisconsin, on January 24-27, 2005 . This inspection confirmed that you offered a dairy cow for sale for slaughter as food in violation of Section 402(a)(2)(C)(ii) and Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(ii) and 21 U.S.C. 342(a)(4)] and that you caused a new animal drug to be unsafe under Section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of Section 501(a)(5) of the Act [21 U.S.C . 351(a)(5)].
A food is adulterated under Section 402(a)(2)(C)(ii) of the Act [21 U.S .C. 342(a)(2)(C(ii)] if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act (21 U.S.C. 360b).
On or about October 6, 2004, you sold a dairy cow, back tag [redacted] for slaughter as human food to [redacted] USDA analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine in the liver at 5.82 parts per million (ppm) and in the muscle at 3.65 ppm. The tolerance for sulfadimethoxine in edible tissues of cattle is 0.10 ppm (21 CFR 556.640).
A food is adulterated under Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] "if it has been prepared, packed, or held under insanitary conditions-whereby it may have been rendered injurious to health ." As it applies in this case, "insanitary conditions" means that you hold animals, which are ultimately offered for sale for slaughter as food, under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues may enter the food supply. Under Section 402(a)(2)(C)(ii) of the Act (21 U.S .C. 342(a)(2)(C)(ii)] a food is also adulterated if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act (21 U.S.C. 360b).
A new animal drug is adulterated under Section 501(a)(5) of the Act [21 U .S .C. 351(a)(5)] if its use does not conform to its approved labeling, thereby making it unsafe within the meaning of Section 512(a)(1)(B) of the Act [21 U.S.C. 360b(a)(1)(B)].
Our investigation noted the following conditions at your farm:
You lack an adequate system for determining the medication status of animals you offer for slaughter;
You lack an adequate system for assuring that animals to which you administer medication have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs; and
You lack an adequate system for assuring that drugs are used in accordance with their labeling.
You should be aware that it is not necessary for you to have personally shipped an adulterated animal into interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal to be slaughtered into food for human consumption where the cow was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act. See 21 U.S .C. 331(k).
The above is not intended to be an all-inclusive list of violations. 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. This letter constitutes official notification under the law and provides you an opportunity to correct. Within fifteen (15) days of the receipt of this letter, notify this office in writing of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Please include copies of any available documentation that corrections have been made.
Your reply should be sent to Brian D . Garthwaite, Ph.D., Compliance Officer, Food and Drug Administration, Minneapolis District Office, 212 Third Avenue South,
Minneapolis, Minnesota 55401.
W. Charles Becoat