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U.S. Department of Health and Human Services

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Enforcement Actions

Maunesha River Dairy 21-Feb-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142


 



February 21, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 07-13

Dennis E. Ballweg
Owner
Maunesha River Dairy
6790 Twin Lane Road
Sun Prairie, Wisconsin 53590

Dear Mr. Ballweg:

An inspection of your dairy operation located in Sun Prairie, Wisconsin, conducted by a representative of the U.S. Food and Drug Administration (FDA), on November 14 and -16, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402{a)(2)(C){u) (21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food; Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs oxytetracycline hydrochloride and sulfadimethoxine to become unsafe under section 512 [21 U.S.C. 360b] of the Act and adulterated within the meaning of section 501.(a)(5) [21 U.S.C. 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.

On or about July 20, 2006, you consigned [redacted], a livestock trucker to transport; a dairy identified with your farm ear tag #2899 for slaughter as food. [redacted], applied back tag #35 PE7344 to this cow and delivered the cow to [redacted] where it was slaughtered on or about July 20, 2006. The United States Department of Agriculture Food Safety and inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of oxytetracycline at 244.82 parts per muscle (ppm) in kidney tissue, 10.31 ppm in liver tissue, and 10.89 ppm in muscle tissue. Sulfadimethioxine was also found in this same animal at 12.23 ppm in liver tissue and 21.44 ppm in muscle tissue.

A tolerance of 12 ppm in kidney tissue, 6 ppm in liver tissue, and 2 ppm in muscle tissue has been established for residues of oxytetracycline in cattle as codified in Title 21, Code of Federal Regulations, ( CFR 556.500). A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in uncooked edible tissue of cattle as codified in 21 CFR 556.640. The presence of these drugs in excess of these amounts in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a){2)(C)(u )[21 U.S.C. 342(a)(2)(C)(ii)] of the Act.

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 any treatment records for some of the animals that you medicated, and you failed 'to maintain complete treatment records for other animals that you medicated. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act.

In addition, you adulterated oxytetracycline hydrochloride and sulfadimethoxine within the meaning of section 501{a)(5) [21 U.S.C. 351(a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is riot in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(S) [21 U.S.C. 360b(a)(4) and 21 U.S.C. 360b(a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of oxytetracycline hydrochloride and sulfadimethoxine failed to comply with these requirements.

For example, you administered oxytetracycline hydrochloride without following the animal class set forth in the approved labeling. Your extralabel use of oxytetracycline hydrochloride was without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, you administered sulfadimethoxine without following the. slaughter withdrawal time set forth in the approved labeling. Sulfadimethoxine is prohibited from extralabel use in lactating dairy cattle [21 CFR 530.41(a)(9)]. Your extralabel use of oxytetracycline hydrochloride and sulfadimethoxine resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 CFR 530, your use caused the drugs to be unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and adulterated within the meaning of section 50i(a)(5) [21 U.S.C. 351(a)(5)] of the Act.

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 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.

Additionally, our investigation found you use a medicated milk replacer (feed) containing oxytetracycline and neomycin in calves that may be sold for bob veal. Please be aware that the use of this medicated milk replacer in calves to be sold for veal is contrary to its approved use. The label of this medicated milk replacer contains the statements, "Withdraw from feed 30 days prior to slaughter" and "Do not use in calves to be processed for veal." Since the Act does not permit the extralabel use of medicated feeds, using the; medicated milk replacer in calves intended for veal would cause this medicated feed to be adulterated within the meaning of section 501(a)(6) [21 U.S.C. 351(a)(6)] and unsafe under section 512.(a)(2) [21 U.S.C. 360(b)] of the Act.

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, 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 Brian D. Garthwaite, Ph.D., Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (6i2} 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District
 

[redacted]

Dr. Isabel Arrington
USDA-FSIS
Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, NE 68102