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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jerland Farm 3/6/13

  

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) 334-4100
FAX: (612) 334-4142

 

March 6, 2013
 
 
WARNING LETTER
                                                         
 
Via UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                      
Refer to MIN 13 - 13
 
 
Lawrence Jerome
Owner
Jerland Farms
1483-14 ½ Street
Barron, Wisconsin  54812
 
Dear Mr. Jerome:
 
On January 17 and 25, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1483-14½ Street, Barron, Wisconsin. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 October 3, 2012, you sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about October 3, 2013, (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 1.1 parts per million (ppm) of desfuroylceftiofur residue in the kidney and 0.303 ppm of flunixin in the liver. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.113 (21 CFR 556.113). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle as codified in 21 CFR 556.286. The presence of these drugs in the specified tissues from this animal in these amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
We also found that you adulterated the new animal drugs (b)(4) (ceftiofur sodium) Sterile Powder, NADA (b)(4), and (b)(4) (flunixin meglumine) Injectable Solution, NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) (ceftiofur sodium) Sterile Powder, NADA (b)(4), and (b)(4) (flunixin meglumine) Injectable Solution, NADA (b)(4), as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under 21 CFR 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR Part 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.
 
Our investigation found that you administered (b)(4)(ceftiofur sodium) Sterile Powder, NADA (b)(4), to your dairy cow, identified with ear tag (b)(4) and back tag (b)(4), without following the indications for use and withdrawal period as stated in the approved labeling. Your extralabel use of (b)(4) (ceftiofur sodium) Sterile Powder, NADA (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of (b)(4) (ceftiofur sodium) Sterile Powder, NADA (b)(4), resulted in an illegal residue, in violation of 21 CFR 530.11(d).
 
Our investigation also found that you administered (b)(4) (flunixin meglumine) Injectable Solution, NADA (b)(4), to your cows without following the route of administration and withdrawal period as stated in the approved labeling. Your extralabel use of (b)(4) (flunixin meglumine) Injectable Solution, NADA (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of (b)(4) (flunixin meglumine) Injectable Solution, NADA (b)(4), resulted in an illegal residue, in violation of 21 CFR 530.11(d).
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
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 is 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 prevent their recurrence. If corrective actions 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 Pamela B. Schweikert, Director, Compliance Branch, U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Ms. Schweikert at (612) 758-7112.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District
 
 
xc: Michael F. Johnson
      Herdsman
      Jerland Farms
      1483-14½ Street
      Barron, WI  54812
 
      (b)(4)
 
      Steven Ingham, Ph.D.
      Administrator, Food Safety
      Wisconsin Department of Agriculture,
          Trade and Consumer Protection
      2811 Agriculture Drive, P.O. Box 8911
      Madison, WI  53708-8911