Inspections, Compliance, Enforcement, and Criminal Investigations

Emerald Dairy, LLC and Emerald Dairy II, LLC 12/8/14

  

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 8, 2014
 
 
Via UPS Overnight Delivery                                 
Refer to MIN 15 - 03
 
 
John H. Vriese
Owner
Emerald Dairy II, LLC.
2487 County Road G
Emerald, Wisconsin 54013-8126
 
Dear Mr. Vriese:
 
On September 17, 19, and October 1, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, Emerald Dairy II, LLC, located at 1450 250th Street, Emerald, 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 June 3, 2014, you sold a dairy cow identified with backtag #(b)(4), corresponding to your farm tag #(b)(4), for slaughter as food. On or about June 3, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of edible tissue from that cow identified the presence of 0.653 parts per million (ppm) of residues of penicillin in kidney tissue, and 0.199 ppm of residues of flunixin in liver 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, section 556.510(a), 21 CFR 556.510(a), and a tolerance of 0.125 ppm flunixin in uncooked edible liver tissue of cattle, as codified in 21 CFR 556.286(b)(1)(i). The presence of these drugs in these edible tissues from this animal in these amounts 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 fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply. For example, you failed to have a system to control administration of drug treatments to your animals, and you failed to maintain complete treatment records. These observations were identified on the form FDA 483 issued to your herdsman, Rafael Orta‑Rodriguez, on October 1, 2014. 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).
 
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.
 
We remind you of the corrective actions that Mr. Orta-Rodriguez, Herd Manager, committed to implementing in his July 15, 2014, letter in response to the form FDA 483 issued on July 14, 2014, after FDA’s investigation of residues of 0.176 ppm penicillin in kidney tissue of a cow sold by you on or about November 12, 2013, from your Baldwin Dairy, Inc., operation located at 2038 County Highway E, Baldwin, Wisconsin. Our investigator observed similar violations at Emerald Dairy II, LLC, under your same managerial oversight of your three dairy operations.
 
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 timeframe 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 listed on this 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

 

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