Inspections, Compliance, Enforcement, and Criminal Investigations

Jeff Mlsna 1/10/14

  

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 

 

January 10, 2014
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                  
Refer to MIN 14 – 05
 
 
Jeffrey E. Mlsna
Owner
Jeff Mlsna
12022 Oklahoma Avenue
Cashton, Wisconsin  54619-6219
 
Dear Mr. Mlsna:
 
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility located at 12153 Oklahoma Avenue, Cashton, Wisconsin, on June 10-11, 2013. During the inspection, FDA found that your facility had significant violations of the Prevention of Salmonella Enteritidis [SE] in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at http://www.fda.gov
 
Your significant violations are as follows:
 
1.    You failed to conduct environmental testing for SE in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, your testing records indicated that in October 2012 you performed environmental tests of your poultry house when the laying hens were approximately 32 weeks of age.
 
2.    You failed to fully implement your written SE prevention plan, as required by 21 CFR 118.4. Specifically, the Fly Control section of your written SE prevention plan states that you are to “hang a sticky trap in the front of the poultry house and at the back of the poultry house. At the end of each week count the number of flies on the sticky traps. A weekly count number of 50 or less is considered to be an acceptable level of flies. If there are more than 50 flies caught, more sticky traps should be hung up.”  However, your fly monitoring records show that you conducted monthly visual observations in August, October, and June.
 
3.    You failed to monitor for rodents by appropriate methods, as required by 21 CFR 118.4(c)(1). Your rodent monitoring procedure does not include counting or tracking of the level of rodents observed in your facility. Without tracking the level of rodents in your facility, you cannot determine whether you have unacceptable rodent activity within a poultry house, which is a required component of 21 CFR 118.4(c)(1). Your House Diagram for Rodent Control document also does not set a threshold level for unacceptable rodent activity at which you would take corrective action or define what corrective action(s) you would take. Additionally, to the extent that your written SE prevention plan incorporates FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” we note that your rodent monitoring procedure does not follow the procedures recommended in the guidance.  In the guidance, FDA recommends a procedure for obtaining a rodent index of rodent activity.  We recommend that a rodent index of one or less is likely to indicate satisfactory rodent control.  The guidance further recommends that if a rodent index greater than one (1) is obtained, the producer should investigate to find out where rodents are entering the house.  Our guidance is available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm.
 
4.    You failed to maintain records documenting your rodent and fly monitoring activities, as required by 21 CFR 118.10(a)(3)(ii). Specifically, you did not routinely document monitoring of your pest control measures.
 
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent further violations of these statutes and regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as the initiation of administrative enforcement procedures under 21 CFR 118.12(a), or—insofar as you are introducing adulterated eggs into interstate commerce or otherwise violating any of the prohibited acts listed in Section 301 of the FD&C Act, 21 U.S.C. § 331—seizure and injunction.
 
In addition to the above violations, we also have the following comments:
 
  • You are required under 21 CFR 118.8(a) to conduct testing to detect SE in environmental samples by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. Your Environmental Sampling Method states (b)(4) may be used for collecting the sample, rather than sterile gauze pads as indicated by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses.”  If you intend to continue using a sampling protocol other than that which is described in the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” we encourage you to submit additional documentation to FDA so that we can determine if your sampling protocol allows for a testing methodology that is equivalent in accuracy, precision, and sensitivity in detecting SE.
  • We recommend that you reconsider the (b)(4) Egg Temperature Policy in your written SE prevention plan which permits the temperature in your coolers to reach (b)(4)˚F for up to (b)(4) hours.  While temperature fluctuations in a cooler are expected, due to the cooler door being opened and closed repeatedly to load eggs, we consider allowing the temperature to remain above 45˚F for up to (b)(4) hours to be excessive. 
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations noted above and to prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the time frame within which the remaining corrections will be completed.
 
Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at the number listed in this letter’s header.
 
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District

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