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U.S. Department of Health and Human Services

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Enforcement Actions

Evergreen Acres 10/9/09

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142

 

October 9,2009

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Keith L. Schaeffer
Owner
Evergreen Acres Dairy, LLC
26162 240th Street
Paynesville, Minnesota 56362

Dear Mr. Schaeffer:

Refer to MIN 10 - 01

On April 23 and May 4,2009, the Minnesota Department of Agriculture conducted an investigation of your dairy operation located at 26162 240th Street, Paynesville, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were found during the 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.

The investigation 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, the investigation revealed that on or about September 16, 2008, you sold a dairy cow identified with your farm ear tag #(b)(4)for slaughter as food. On or about September 17,  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 neomycin at 31.05 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 7.2 ppm neomycin residue in kidney tissue as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1), 21 C.F.R. 556.430(b)(1). The presence of this drug in kidney tissue from this animal in this amount 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).

The 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. 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 investigation also found that you adulterated the new animal drugs neomycin sulfate, sulfadimethoxine oral solution, oxytetracycline injection, oxytetracycline hydrochloride injection, ceftiofur hydrochloride, ceftiofur crystalline free acid, ceftiofur sodium, penicillin G procaine aqueous suspension, florfenicol, tetracycline hydrochloride soluble powder, and tylosin. Specifically, the investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs contrary to their approved labeling is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/ client/patient relationship.

The investigation found that you administered neomycin sulfate to lactating dairy cows contrary to the approved indication of use. Neomycin sulfate is not approved for the treatment and control of Salmonella infections. Your extralabel use of neomycin sulfate was not in compliance with 21 C.F.R. 530, and your extralabel use of neomycin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).

The investigation also found that you administered the following new animal drugs contrary to the conditions of use set forth in their approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a):

1. Neomycin sulfate (b)(4) - You administered neomycin sulfate to a lactating dairy cow without following the approved indication of use. Neomycin Sulfate (Neomycin Liquid) is not approved for the treatment and control of Salmonella infections.

2. Sulfadhnethoxine oral solution (b)(4) - You administered sulfadimethoxine oral solution to lactating dairy cows without following the approved route of administration, indications for use, and animal class. Sulfadimethoxine oral solution is not approved for intravenous injection, not approved to treat peritonitis, and not approved for use in lactating dairy cows. Furthermore, sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9).

3. Oxytetracycline injection (b)(4)  - You administered oxytetracycline injection to lactating dairy cows without following the approved dose per injection site. Oxytetracycline injection is not approved for use at more than 10 mL per injection site.

4. Oxytetracycline hydrochloride injection (b)(4) - You administered oxytetracycline hydrochloride injection to lactating dairy cows without following the approved animal class and indications for use. Oxytetracycline hydrochloride injection is not approved for use in lactating dairy cattle, or to treat peritonitis.

5. Ceftiofur hydrochloride (b)(4) - You administered ceftiofur hydrochloride to lactating dairy cows without following the approved indications for use. Ceftiofur hydrochloride is not indicated for treating watery mastitis in cattle, or for post-surgical use.

6. Ceftiofur crystalline free acid (b)(4) - You administered ceftiofur crystalline free acid to lactating dairy cows without following the approved indications of use. Ceftiofur crystalline free acid is not indicated for treating watery mastitis, foot rot, or metritis in cattle, nor is it approved for postsurgical use.

7. Ceftiofur sodium (b)(4) - You administered ceftiofur sodium to lactating dairy cows without following the approved indications for use. Ceftiofur sodium is not indicated for treating watery mastitis or metritis in cattle, nor is it approved for post-surgical use.

8. Penicillin G procaine (b)(4) - You administered penicillin G procaine aqueous suspension to lactating dairy cows without following the approved indications for use, dosage amount, or dosage amount per injection site. Penicillin G procaine aqueous suspension is not indicated for treating mastitis in cattle, not approved at a dose more than 1 mLI100 pounds of body weight, and not approved for use at the rate of more than 10 mL per injection site.

9. Florfenicol (b)(4) - You administered florfenicol to lactating dairy cows without following the approved animal class. Florfenicol is not approved for use in female dairy cattle 20 months of age or older.

10.Tetracycline hydrochloride soluble powder (b)(4) - You administered tetracycline hydrochloride soluble powder to lactating dairy cows without following the approved animal class and indications for use. Tetracycline hydrochloride soluble powder is not approved for treating dairy cows or for treatment of uterine infections.

11. Tylosin (b)(4) - You administered tylosin to dairy calves without following the approved route of administration and indications for use.Tylosin is not approved for oral administration, nor is the drug approved for preventing scours (bacterial enteritis) in dairy calves.  Furthermore, the extralabel use of approved new animal or human drugs in or on an animal feed (milk) is prohibited by 21 C.F.R. 530.11(b).

Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 50 1(a)(5) of the Act, 21 U.S.C. § 351(a)(5).

In addition, you adulterated animal feed (milk) within the meaning of section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). You administered tylosin to dairy calves to prevent Escherichia coli (E. colI) scours by mixing the drug in milk. This caused the animal feed (milk) to which the drug was added to be unsafe within the meaning of section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).

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.

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 to 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.

Sincerely,

/s/

W. Charles Becoat
Director
Minneapolis District

 


BDG/ccl
 

(b)(4)

Doug Leuders
Minnesota Department of Agriculture
625 North Robert Street
St. Paul, Minnesota 55155


District Manager, USDA-FSIS
Butler Square West, Suite 989-C
100 North Sixth Street
Minneapolis, Minnesota 55403