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U.S. Department of Health and Human Services

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Enforcement Actions

Willow Farms 8/16/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

August 16, 2013
 
WARNING LETTER NO. 2013-NOL-17
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Jerry and Marsha Hobgood, Owners
Willow Farms
91 North Old Military Road
Summertown, Tennessee 38483
 
Dear Mr. and Mrs. Hobgood:
 
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 91 N Old Military Road, Summertown, Tennessee, on April 16-18, 2013.  During the inspection, FDA found your facility had serious 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 United States Code (USC) 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 USC 342(a)(4), because 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. Our investigators’ observations were noted on Form FDA 483, Inspectional Observations, issued to Mrs. Hobgood on April 18, 2013. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s Internet home page at www.fda.gov.
 
During the inspection, two environmental samples were collected and analyzed for Salmonella Enteritidis (SE). Results of analysis documented the presence of SE in Sample 792828, collected from House #4 at your farm. FDA contacted you on May 13, 2013, to notify you of these SE positive results. FDA acknowledges your voluntary action, on or about May 18, 2013, which included the termination of the entire flock of 1050 hens, 1 rooster and 10 guinea, held in House #4 and subsequent disposal/destruction of 345 dozen eggs from the same flock, as witnessed by a representative of the Tennessee Department of Agriculture.
 
We received your firm’s undated response to the Form FDA 483 on May 1, 2013, and your revised written SE prevention plan dated June 11, 2013 on June 14, 2013.  Our evaluation of your responses is discussed below. 
 
Your significant violations are as follows:
 
1.    You failed to have a written SE prevention plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. Specifically, during our inspection your SE prevention plan titled, “Willow Farms SE Prevention Plan,” failed to include the following required SE prevention measures:
 
Pullets
 
Your written SE prevention plan failed to include a requirement that procured pullets are SE monitored or pullets are raised under SE monitored conditions, as required by 21 CFR 118.4(a), and that the pullet environment be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2). You also failed to maintain records documenting pullets were raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2). 
 
Specifically, during the inspection, our investigators learned you have no documentation that chicks purchased from Moyer’s Chicks Inc. were SE monitored and procured from breeder flocks that meet the National Poultry Improvement Plan’s (NPIP) standards for “U.S. S. Enteritidis Clean” status or equivalent standard, as required by 21 CFR 118.10(a)(2). In addition, your firm did not have any supporting records to show that the pullet environment was tested for SE when pullets were 14 to 16 weeks of age, as required by 21 CFR 118.10(a)(2).
 
Your revised SE prevention plan dated June 11, 2013, states you will test all pullets (environment) for SE at 14 to 16 weeks of age, but did not provide for procuring chicks from SE monitored breeder flocks that meet the NPIP’s standards for “U.S. S. Enteritidis Clean” status or equivalent standard, as required by 21 CFR 118.4(a)(1). In addition, in your response received on May 1, 2013, you included a copy of the NPIP form for chicks shipped to you on April 22, 2013. Please note the “S. Enteritidis Clean” box is not marked off on this form.
 
Biosecurity
 
  • Your written SE prevention plan failed to include measures for limiting visitors on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1).
 
Your response received on May 1, 2013, included copies of your visitor forms and your revised SE prevention plan dated June 11, 2013, which included measures for limiting visitors on the farm. During our next inspection, we will verify implementation of these measures and that the visitor forms are accurately maintained.  
 
  • Your written SE prevention plan failed to include practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). 
 
Your revised SE prevention plan dated June 11, 2013, states personnel driving or riding in a vehicle that goes on the farm must have protective boots and anyone who enters poultry houses must wear clean coveralls and shoe covers and use the disinfectant stations provided at the door. We will verify your implementation of this procedure during our next inspection.
 
  • Your written SE prevention plan failed to include measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, and you failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, our investigators observed unscreened roof gables on the northwest and southeast ends of House #2. Wild birds were observed exiting the house through these openings. Additionally, investigators observed apparent bird nests on the ceiling joists of Houses #2 and #4.
 
Your response received on May 1, 2013, indicates you have removed the bird’s nests and installed netting over the eaves of your poultry houses. We will verify these corrective actions during our next inspection.
 
Rodents, Flies, and other Pest Control
 
  • Your written SE prevention plan failed to include procedures to monitor for rodents. Your SE prevention plan must address monitoring for rodents by visual inspection and mechanical traps or glueboards or another appropriate monitoring method, as required by 21 CFR 118.4(c)(1).
 
Your response received on May 1, 2013, contains a revised rodent monitoring form which contains columns for recording rodents present on the farm and an estimate of the rodent population based on visual inspection. Additionally, your revised SE prevention plan dated June 11, 2013, states that rodent monitoring should be done weekly and bait stations to monitor and treat rodent activity should be evaluated. However, your June 11, 2013, revised SE prevention plan does not define what level of rodent activity within your poultry houses is considered unacceptable.  We note that FDA’s December 2011 Guidance for Industry, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity. We recommend in FDA’s guidance 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 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.
 
  • You failed to have and implement a written SE prevention plan which includes an appropriate monitoring method for flies, as required by 21 CFR 118.4(c)(2).  Specifically, your SE prevention plan did not contain fly monitoring procedures, and your Monthly Biosecurity Report records indicated that you monitored for flies by visual inspection on a monthly basis.  Your fly monitoring procedure did not include a method for counting flies or define what level of fly activity is unacceptable.  Your SE prevention plan must address monitoring for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method, as required by 21 CFR 118.4(c)(2). When monitoring indicates unacceptable fly activity within a poultry house, 21 CFR 118.4(c)(2) requires you to use appropriate methods to achieve satisfactory fly control. 
 
Your response received on May 1, 2013, contains a revised fly control evaluation form that has columns for recording fly counts from sticky traps and an estimate of the fly population. Additionally, your revised SE prevention plan dated June 11, 2013, states that fly control logs will be monitored weekly and when fly numbers reach a “high” indication appropriate pesticides will be administered. However, your June 11, 2013, revised plan does not define what level of fly activity is considered “high,” or unacceptable, such that these corrective actions would be taken. 
 
  • You failed to take steps to ensure there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). Specifically, our investigators observed that a portion of the fence was missing that separates the free range area for hens outside House #4 from an adjacent cow pasture. Our investigators observed hens commingling with cows and hens walking near cow fecal material in the cow pasture adjacent to the free range area. To ensure there is no introduction or transfer of SE into the poultry house, you must take appropriate steps to prevent hens from commingling with cows, such as repairing the fence separating the free range area from the adjacent cow pasture.  
 
Cleaning and Disinfection
 
Your written SE prevention plan failed to include measures addressing the cleaning and disinfection of poultry houses after an environmental test or an egg test is positive for SE, as required by 21 CFR 118.4(d). We note that in response to FDA informing you of a positive SE environmental sample in House #4, you destroyed the flock on May 14, 18, and 20, 2013. However, your revised SE prevention plan dated June 11, 2013, did not specify that cleaning and disinfection measures be conducted before new laying hens are added to any house an environmental test or an egg test was positive for SE at any point during the life of a flock, as required by 21 CFR 118.4(d).
 
2.    You failed to perform environmental testing for SE in a poultry house when any group of laying hens constituting the flock within the poultry house was 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, during the inspection our investigators learned that you did not perform environmental testing for SE in poultry House #2 or House #4 when hens were 40 to 50 weeks of age. 
 
Your revised SE prevention plan dated June 11, 2013, states you will test all pullets (environment) for SE at 14 to 16 weeks of age and again at 40-45 weeks of age.  FDA will verify your implementation of this required testing during our next inspection. Please note that under 21 CFR 118.7(a), environmental testing must utilize a sampling plan appropriate to the poultry house layout. Furthermore, under 21 CFR 118.8(a), testing to detect SE in environmental samples must be conducted 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. Within 21 CFR 118.10(a)(3)(v) you are required to maintain records documenting compliance with environmental and egg sampling procedures, when applicable, performed under 21 CFR 118.7. 
 
3.    You failed to fully implement your written SE prevention plan, as required by 21 CFR 118.4.  Specifically, your written SE prevention plan states refrigeration temperatures of your processing facility’s cooler and delivery truck will be monitored daily and weekly, respectively. However, your Monthly Biosecurity Report records contained only one temperature check per month for the processing facility coolers and the refrigerated truck.  Additionally, you routinely deliver smaller shipments of eggs using an unrefrigerated delivery van and do not maintain records documenting compliance with the refrigeration SE prevention measures under 21 CFR 118.4(e) to ensure the eggs are held and transported at or below 45˚F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.10(a)(3)(iv). 
 
Your response received on May 1, 2013, stated you will not use the unrefrigerated van for shell egg deliveries and have a new cooler truck which has a “temperature log.” In your response you include a weekly monitoring record for Cooler Truck #1 and Cooler Truck #2. We will verify the implementation of your weekly temperature monitoring for shell egg transport during our next inspection.
 
4.    You failed to maintain records documenting compliance with SE prevention measures, including biosecurity measures, as required by 21 CFR 118.10(a)(3)(i). During the inspection, our investigators observed that you do not maintain records addressing the limiting of visitors on the farm and in the poultry houses; records to document implementation of practices to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses; and records to show employees are not permitted to keep birds at home.
 
Your response received on May 1, 2013, included copies of your “Employee Disclaimer” and “Visitors Disclaimer” forms wherein employees and visitors attest to not keeping birds at home. Your “Visitors Disclaimer” form is also a record of biosecurity measures to limit visitors on the farm and in the poultry houses. However, records to document implementation of practices to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, were not included as part of your May 1 or June 11, 2013 responses. 
 
The above violations are not meant to be an all-inclusive list of deficiencies at your facility. You are responsible for ensuring 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 future 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 seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
 
In addition to the above violations, we also have the following comment:
 
  • Please be aware your hours of operation may lead to a failure of holding eggs at or below 45˚F ambient temperature beginning 36 hours after time of lay, as required under 21 CFR 118.4(e).  During the inspection you informed our investigators that generally you collect eggs at 10:00 a.m. and 2:00 p.m. on Monday through Friday. However, some of the eggs laid on Saturday and Sunday may not be held at or below 45˚Fambient temperature within 36 hours after time of lay.
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations and prevent their recurrence.  You should include in your response a revised written SE prevention plan and  other documentation or information which 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 timeframe within which you will complete the remaining corrections.
 
Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response to this letter should be directed to Compliance Officer Kari L. Batey, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Ms. Batey at (615) 366-7808.
                                                                        
Sincerely,
/S/ 
Patricia K. Schafer
District Director
New Orleans District