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U.S. Department of Health and Human Services

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Enforcement Actions

Lanners, Rogers 28-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: (812) 758-7132
FAX: (812) 334-4142


 



February 28, 2007

WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 07-14


Roger A. Lanners
Julie A. Lanners
Owners
18576 83rd Street
Royalton, Minnesota 56373

Dear Mr. and Mrs. Lanners:

An investigation of your dairy operation located in Royalton, Minnesota, was conducted by investigators from the Minnesota Department of Agriculture, acting on behalf of the U.S. Good and Drug Administration (FDA), on October 26, 2006. This investigation confirmed that you offered animals for sale for slaughter as food that were 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 sulfadimethoxine, oxytetracycline hydrochloride; penicillin G procaine, amoxicillin, and isoflupredone acetate to be unsafe under section 512 [21 U.S.C. 360b] of the Act and adulterated within the meaning of section 501(a){S) [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 August 18, 2006, you sold to [redacted] a dairy cow identified with your ear tag #905 and cross-referenced to back tag #4747 for slaughter as food. On or about August 18, 2006, this animal was slaughtered at [redacted].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 27 parts per million (ppm) oxytetracycline in kidney tissue, 0.30 ppm sulfadimethoxine in liver tissue, and. 0.82 ppm sulfadimethoxine in muscle tissue.

On or about August. 28, 2006, you sold to [redacted] a dairy cow identified with your ear tag #488 and cross-referenced to back tag #5327 for slaughter as food. On or about August 29, 2006, this animal was slaughtered at [redacted].The USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.11 ppm ampicillin in kidney tissue.

On or about September 7, 2006, you sold to [redacted] a dairy cow identified with your ear tag #881 and cross-referenced to back tag #5828 for slaughter as food. On or about September 7, 2006, this animal was slaughtered at [redacted]. The USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 20.98 ppm oxytetracycline in kidney tissue, 6.97 ppm sulfadimethoxine in liver tissue, and 3.88 ppm sulfadimethoxine in muscle tissue.

A tolerance of 12 ppm has been established for residues of oxytetracycline in kidney tissues of cattle as codified in Title 21, Code of Federal Regulations, 556.500 {21 CFR 556.500). A tolerance of 0.01 ppm has been established for residues of ampicillin in uncooked edible tissues of cattle as codified in 21 CFR 556.40. 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 these tissues from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [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 in your treatment records a reliable system 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) [21 U.S.C. 342(a){4)] of the Act.

In addition, you adulterated sulfadimethoxine, oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate 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 not 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) [21 U.S.C. 360b(a)(4)] and 512(a)(5) [21 U.S.C.360b(a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of sulfadimethoxine, oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate failed to comply with these requirements.

For example, you administered the sulfadimethoxine to treat an indication (mastitis} not set forth in the approved labeling, and you failed to follow the labeled slaughter withdrawal time. Sulfadimethoxine is prohibited from extralabel use in food producing animals by 21 CFR 530.41(a)(9). In addition, you administered oxytetracycline hydrochloride without following the animal class set forth in the approved labeling, you administered penicillin G procaine without following the dosage amount per injection site and for an indication (metritis) that is not set, forth in the approved labeling, and you failed to observe the slaughter withdrawal time for animals treated with amoxicillin. Furthermore, you failed to follow the extralabel use directions for the route of administration of isoflupredone acetate prescribed by your veterinarian.

Your use of sulfadimethoxine in an extralabel manner, when such use is prohibited by 21 CFR 530.41(a)(9), caused the drug to be unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act. In addition, your extralabel use of oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate was without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use of sulfadimethoxine; oxytetracycline, and ampicillin resulted in drug residues above an established safe level, safe concentration, or tolerance, in violation of 21 CFR 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 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 501(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.

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 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 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 (612) 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

BDG/ccl