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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ed Fields & Sons, Inc 4/3/14

  

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 

 

April 3, 2014
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                 
Refer to MIN 14 – 15
 
 
James E. Fields
President
Ed Fields & Sons, Inc.
15421 Round Lake Boulevard NW
Andover, Minnesota 55304-3034
 
Dear Mr. Fields:
 
We inspected your vegetable farm on February 3-5 and 11, 2014, as a result of analytical findings of the pesticide Linuron in your parsnips at levels exceeding the tolerance established by regulation. The Environmental Protection Agency establishes these tolerances in Title 40, Code of Federal Regulations, specifically section 180.184 for Linuron (40 CFR 180.184). As such, your parsnips are adulterated within the meaning of section 402(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21 of the United States Code, section 342(a)(2)(B), 21 U.S.C. § 342(a)(2)(B), in that they are a raw agricultural commodity within the meaning of 21 U.S.C. § 321(r) which bears and contains a pesticide chemical, namely Linuron, which is unsafe within the meaning of 21 U.S.C. § 346a since the quantity of such pesticide chemical exceeds the limits of the tolerance granted for the use of such pesticide chemical in or on the article pursuant to 40 CFR 180.
 
Samples of your parsnips obtained and analyzed by FDA on November 21, 2013, and January 3, 2014, were found to contain the pesticide Linuron at limits exceeding the 0.05 ppm levels permitted by 40 CFR 180.184. The November sample was found to contain 0.191 ppm and 0.265 ppm, original and check analysis, respectively. The January sample was found to contain 0.098 ppm and 0.114 ppm, original and check analysis, respectively. 
 
This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct this violation. Failure to promptly correct this violation may result in regulatory action, including seizure and/or injunction, without further notice.
 
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violation and prevent its recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.
 
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address on the letterhead. If you have questions regarding the issues in this letter, please contact Ms. Wisecup at
(612) 758-7114.
 
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District
 
 
xc: Charles P. Fields
      Vice President
      Ed Fields & Sons, Inc.
      15421 Round Lake Boulevard NW
      Andover, MN 55304-3034