Inspections, Compliance, Enforcement, and Criminal Investigations

Edgar M. Martin dba Edgar Martin Dairy 12/7/16

  

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

 

December 7, 2016 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                           
Refer to MIN 17 – 03
 
 
Edgar M. Martin, Co-Owner
Martha Martin, Co-Owner
Edgar Martin Dairy
43434 320th Street
Brooten, Minnesota 56316
 
Dear Mr. and Mrs. Martin:
 
On August 22 and 25, 2016, the United States Food and Drug Administration (FDA), conducted an inspection of your dairy operation located at 43434 320th Street, Brooten, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection 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 April 7, 2016, you sold a dairy cow identified with back tag (b)(4) and your farm bangle tag (b)(4) for slaughter as food. On or about April 8, 2016, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples from that cow identified the presence of residues of penicillin at 0.166 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 0.05 ppm penicillin in uncooked, edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (21 CFR), section 556.510(a). The presence of this drug in the uncooked edible tissues 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).
 
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. Specifically, you failed to maintain complete treatment records that included dosage amount and route of administration. 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).
 
We also found that you adulterated the new animal drug (b)(4) penicillin G procaine Injectable Suspension (NADA (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. The use of this drug in this manner is an extralabel use as defined in 21 CFR 530.3(a).
 
The extra-label use of approved animal or human drugs in animals is allowed under the Act only if the extra-label use complies with sections 512(a)(4) and (5) of the 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 40 cc doses of (b)(4) to treat a dairy cow identified with back tag (b)(4) for mastitis, without following the dosage amount and the indications for use as stated in the approved labeling. You stated that this dosage amount of 40 cc is four times the maximum dosage of 10 mL that should have been administered in a single treatment to this animal based on directions on the label.  Additionally, (b)(4) is not approved to treat mastitis. Your extralabel use of (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) resulted in an illegal drug residue in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 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, 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/
Michael Dutcher, DVM
Director
Minneapolis District

Page Last Updated: 12/19/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English