| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7133 FAX: (612) 334-4142 |
Department of Health and Human Services
June 30, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 17
Keith and Patricia Haldiman
N9035 Harvestore Road
Hilbert, Wisconsin 54129
Dear Mr. and Mrs. Haldiman:
On February 1 and March 11, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N9035 Harvestore Road, Hilbert, 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 June 22, 2009, you consigned (b)(4) to haul your dairy cow #(b)(4) identified with back tag #(b)(4), for slaughter as food. On or about June 22, 2009, (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 sulfamethazine at 37.280 parts per million (ppm) in liver tissue and 65.57 ppm in muscle tissue. The USDA/FSIS analysis also identified the presence of phenylbutazone in kidney tissue. The FDA has established a tolerance of 0.1 ppm for sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 [21 CFR 556.670]. However, this tolerance does not apply to sulfamethazine in lactating dairy cattle. There is no acceptable level of sulfamethazine residue in lactating dairy cattle. There is also no acceptable level of phenylbutazone residue in lactating dairy cattle. The presence of these drugs in edible tissues from this animal 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 withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. You also failed to maintain an inventory system for determining the quantities of drugs used to medicate your 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 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 are aware that your veterinarian, (b)(4) DVM, has discussed these matters with you. Specifically, he discussed the appropriate use of prescription medications and the use of medications that are prohibited for certain uses. We refer you to 21 CFR 530.41(a)(9) which prohibits the extralabel use of sulfonamide drugs (such as sulfamethazine) in lactating dairy cattle. Similarly, 21 CFR 530.41(a)(12) prohibits the extralabel use of phenylbutazone in female dairy cattle 20 months of age or older. (b)(4) also reviewed appropriate drug use record keeping and supplied you with appropriate forms.
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 Timothy G. Philips, 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 Mr. Philips at (612) 758-7133.
Sincerely,
/S/
Howard E. Manresa
Acting Director
Minneapolis District
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