Inspections, Compliance, Enforcement, and Criminal Investigations

Good Earth Egg Company 2/23/16

  

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

Public Health Service
Food and Drug Administration
 Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

 

WARNING LETTER
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
CMS Case # 486994
 
February 23, 2016
 
Mr. John W. David, Jr., Owner
Mrs. Susan E. David, Owner
Mr. John W. David, Sr., Owner
Mrs. Paula K. David, Owner
Good Earth Egg Company
4411 Highway K
Bonne Terre, MO 63628-3533
 
Dear Mr. / Mrs. David:
 
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 4411 Highway K. Bonne Terre, MO 63628 on December 7-9, 2015. We found that you 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 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. Our investigators' observations were noted on form FDA 483, Inspectional Observations, which was issued to you on December 9, 2015. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA's home page at www.fda.gov.
 
We received your written response dated December 27, 2015 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, issued to you at the close of the inspection. Our evaluation of your response is discussed below.
 
Your significant violations are as follows:
 
•    Your firm failed to have a written Salmonella Enteritidis prevention plan ("SE Plan") as required by 21 CFR 118.4. Specifically, on December 7, 2015, your firm stated to our investigators you do not have a written SE Plan for your egg laying farm. Under 21 CFR 118.4 you must have and implement a written SE Plan that includes, at a minimum, the following SE prevention measures:
 
o    Pullets are raised under SE monitored conditions that prevent SE, including environmental testing at 14-16 weeks
o    Biosecurity measures to ensure there is no introduction or transfer of SE into or among poultry houses
o    Rodent, flies and other pest control monitoring
o    Cleaning and disinfection procedures
o    Refrigeration requirements
 
Your firm's December 27, 2015 response states that you plan to develop an SE Plan by March 1, 2016. Your response does not provide sufficient detail for us to determine if your SE Plan will be adequate. As discussed below, it is our understanding that you have temporarily ceased your shell egg operation. You should not resume that operation until you have and are prepared to implement an adequate SE Plan that includes, at a minimum, the SE prevention measures described in 21 CFR 118.4.
 
•    Your firm failed to test your pullet environment for SE when pullets were 14-16 weeks of age as required by 21 CFR 118.4(a)(2)(i). Specifically, on December 7, 2015, you stated to our investigators that you have never tested the pullets raised in your pullet house for SE, and that you have moved approximately (b)(4) flocks of your pullets into your layer houses since 2010, including the laying hens currently housed in House (b)(4) and House (b)(4).
 
Your firm's response states that environmental testing will take place during the time when your next flock of pullets is 14-16 weeks of age (approx. (b)(4)), and that you will develop an SE Plan that will include rearing pullets under SE controlled conditions, including environmental testing at 14-16 weeks. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate.
 
•    Your firm failed to conduct environmental testing for SE when your flocks of laying hens reached 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, on December 7, 2015, you stated to our investigators you have never performed environmental testing in your egg laying houses.
 
Your firm's response states that you will develop an SE Plan that will include environmental testing when a flock is between 40-45 weeks of age. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate.
 
•    Your firm failed to take adequate steps to ensure that there is no introduction or transfer of SE into or among poultry houses as required by 21 CFR 118.4(b). Specifically, your firm does not have any biosecurity measures in place or records associated with biosecurity as evidenced by the following:
 
o    You do not limit visitors on your farm, as required by 21 CFR 118.4(b)(1). On December 7, 2015, our investigators observed two customers enter into your processing area to purchase eggs from your facility. We observed these customers drive to your facility in their own vehicles and observed your firm had no requirement for these customers to sign in or for sanitation of these customers before entering the processing area. Similarly, on December 8, 2015, we observed one customer enter into the processing area to purchase eggs from your facility without any biosecurity measures in place.
 
o    You do not maintain practices that will protect against cross contamination when people move between poultry houses, as required by 21 CFR 118.4(b)(3). On December 8, 2015, our investigators observed that House (b)(4) and House (b)(4) are directly linked by a corridor and employees were observed moving between the two houses via this corridor on December 8 and 9, 2015 without any biosecurity measures in place.
 
o    You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2). On December 7, 2015, you stated to our investigators that your firm does not have designated brooms, scrapers, and other miscellaneous cleaning equipment for each laying house.
 
Your firm's response lists various biosecurity measures that you say will be included in your SE Plan. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate.
 
•    Your firm failed to monitor for the presence of rodents by appropriate monitoring methods as required by 21 CFR 118.4(c)(1). Specifically, on December 7, 2015, you informed our investigators that you have never monitored for the presence of rodents in your egg laying houses.
 
In addition, on December 8, 2015, our investigators observed approximately 10 (ten) apparent rodent excreta pellets along the west wall of House (b)(4). Our investigators also observed numerous openings in House (b)(4) and House (b)(4) that would allow pests entry into your layer houses. Additionally, we observed apparent rodent burrows and feed spillage outside of House (b)(4) along the west perimeter. Harborage conditions were observed between House (b)(4) and the processing building, including numerous sheets of aluminum siding, a pile of dirt and weeds approximately 10' X 10', and standing water. A co-owner of your firm stated the siding and dirt had been there for about one year. Please note that under 21 CFR 118.4(c)(3) you must remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests.
 
Your firm's response states that you will develop an SE Plan that includes rodent monitoring and baiting procedures in an effort to keep the rodent population within a "low" rodent index. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate. Your response also states that you will make various repairs by March 1, 2016, and that you will address harborage conditions by May 1, 2016. We will evaluate the adequacy of these corrections at our next inspection.
 
•    Your firm failed to monitor for the presence of flies by appropriate monitoring methods as required by 21 CFR 118.4(c)(2). Specifically, on December 7, 2015, you informed our investigators that you have never monitored for the presence of flies in your egg laying houses.
 
Your firm's response states that you will develop an SE Plan that includes fly monitoring and control procedures in an effort to keep fly activity in the laying houses at an acceptable level. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate.
 
•    You failed to have qualified supervisory personnel who are responsible for development and implementation of an SE Plan that is appropriate for your farm, as required by 21 CFR 118.9. Specifically, on December 8, 2015, you stated to our investigators that you have not identified a supervisory person to be responsible for monitoring the development and implementation of an SE Plan.
 
Your written response identifies Susan David as the supervisory person who will be responsible for monitoring the development and implementation of your SE Plan. Your response does not address whether or not Mrs. David is qualified for this role under 21 CFR 118.9, which states that the person in this role must have successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by FDA or must be otherwise qualified through job experience to administer the SE prevention measures. Job experience qualifies a person to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. We recognize that Mrs. David is a (b)(4)% owner of your firm who is responsible for the firm's recordkeeping. However, you stated to our investigators that Mrs. David does not currently oversee or participate in the daily egg laying operation. Furthermore, your firm has been operating without an SE Plan. It is therefore not clear that Mrs. David has job experience that qualifies her to administer SE prevention measures. You have not stated whether or not Mrs. David plans to enroll in a training course on SE prevention measures or whether she is otherwise qualified under 21 CFR 118.9.
 
•    You failed to maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation as required by 21 CFR 118.10(a)(3 )(iii). Specifically, on December 7, 2015, you stated to our investigators that you clean and disinfect your laying houses in between every flock, but that you do not have written procedures or records showing the cleaning and disinfection of your laying houses has been completed between flocks.
 
Your written response states that you will develop an SE Plan that will outline procedures for the cleaning and disinfection performed at depopulation. Your response does not provide sufficient detail for us to determine if this portion of your SE Plan will be adequate. Your response further states that you will keep records in accordance with FDA requirements. We will evaluate the adequacy of this corrective action at our next inspection.
 
The above violations are not meant to be an all-inclusive list of deficiencies 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 future violations of these statutes and regulations.
 
In addition to the above violations, we also have the following comments:
 
We are concerned about the presence of Salmonella Oranienberg (SO) in your poultry house environment. During the most recent inspection, SO was identified in both House (b)(4) and House (b)(4) from environmental samples we collected. In addition, the same strain of SO was implicated in a recent outbreak resulting in many cases of human illness. Shell eggs that have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, for example through contamination with pathogens, are adulterated under section 402(a)(4) of the FD&C Act.
 
We acknowledge that you have been working with FDA and the State of Missouri to address this situation, including recalling your shell eggs; however, we remain concerned about the cleaning and disinfecting of your (b)(4) houses once birds are depopulated. Although FDA's Shell Egg Rule pertains to the prevention of SE, FDA considers SO in a poultry house environment to be a public health threat since all serovars of Salmonella are considered human pathogens. According to your firm's management, your cleaning procedure in between flocks includes a step where the manure belts are run for removal of all manure, dust, dirt, and feathers prior to being sprayed with disinfectant. However, it is not clear if you remove manure from other surfaces. In situations where a poultry house has tested positive for SE, 21 CFR 118.4(d)(l) requires the removal of all visible manure, including from the floor and other surfaces. Although your poultry house tested positive for SO, not SE, FDA strongly recommends following this procedure.
 
We also note that your firm's recent correspondence with FDA's Kansas City District Office, dated January 16, 2016, indicates that you contracted with a chemical company to sanitize and disinfect both houses after removal of the birds. In addition, you state that you will conduct follow up environmental testing to show that all Salmonella-related contamination has been eliminated and that you will continue to treat, sanitize and disinfect until satisfactory negative results are achieved. Lastly, you state that you are moving forward indefinitely without any birds on the property and plan to continue business strictly as an egg broker, bringing in graded product and selling it to customers. We acknowledge your intentions to change your business operation; however, we are concerned about potential future use of these houses. As stated above, should you choose to repopulate your layer houses, you must develop a comprehensive SE prevention plan as required by 21 CFR 118.4, and implement this plan prior to population.
 
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).
 
Please notify this office, in writing, within fifteen ( 15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved, such as an SE Prevention Plan. lf you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.
 
Please send your reply to the attention:
 
Miguel Hernandez
Director, Compliance Branch
U.S. Food and Drug Administration
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214
 
If you have any questions regarding any issue in this letter, please contact Dania) S. Hutchison, Compliance Officer at 913-495-5154.
 
Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District
 
Cc:
Mark Buxton
Rapid Response Team Coordinator
Missouri Department of Health and Senior Services
912 Wildwood, PO Box 570
Jefferson City, MO 65102-0570
 
Linda Hickman
State Veterinarian
Missouri Department of Agriculture
PO Box 630
Jefferson City, MO 65102
 
Eric Hueste
Bureau Chief
Missouri Department of Health and Senior Services
912 Wildwood, PO Box 570
Jefferson City, MO 65102-0570
 

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