Inspections, Compliance, Enforcement, and Criminal Investigations
Stanton Brothers 1/22/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
Ref. KAN 2014-06
January 22, 2014
Mr. Dustin Stanton and Mr. Andrew Stanton
21101 North Tri City Lake Road
Centralia, MO 65240
Dear Messrs. Stanton:
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility located at 21101 North Tri City Lake Road Centralia, Missouri, between August 27 and 28, 2013. During the inspection, FDA found that 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 U.S.C. § 264(a). In addition, these violations also 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 August 28, 2013. 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.
Your significant violations are as follows:
1. You failed to conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, you have never performed environmental testing of your poultry houses. In addition, your firm does not have any supporting evidence to demonstrate that the pullets or hens you procure have had their pullet environment tested for SE when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). Documentation that pullets were SE monitored, or were raised under SE monitored conditions is required by 21 CFR 118.10(a)(2); this includes records of the above-mentioned environmental testing of the pullet environment that is required by 21 CFR 118.4(a)(2)(i). You stated that you had purchased all of your hens when they were past production age and you were not sure if any of the pullet or laying hen environments were ever tested for SE. You informed the investigators that laying hens are of varying ages, with the oldest hens being approximately 10 years old, and that there is no way to determine the age of each laying hen. It is important to note that environmental testing of the poultry houses is required during specific time periods (specifically, when pullets are 14 to 16 weeks of age, under 21 CFR 118.4(a)(2)(i); when laying hens are 40 to 45 weeks of age, under 21 CFR 118.5(a); and 4 to 6 weeks after the end of any molting process, under 21 CFR 118.5(b)).
Please note that your sampling plan used to sample the environment must be appropriate to the poultry house layout as required by 21 CFR 118.7(a). Under 21 CFR 118.10(a)(3)(v), you must maintain records documenting the environmental sampling procedures you perform under 21 CFR 118.7. Additionally, as required by 21 CFR 118.8(a), testing to detect SE in environmental samples must be conducted by the April 2008 method that is cited in 21 CFR 118.8(a), or by a method equivalent in accuracy, precision, and sensitivity in detecting SE. Under 21 CFR 118.10(a)(3)(vi), you must maintain records documenting the results of SE testing that you perform under 21 CFR 118.8.
We acknowledge your September 16, 2013 response, where you state that you "will use the (b)(4) when birds are at 14-16 weeks old, 40 - 45 weeks old, or come back with a laying percentage of at least (b)(4)% after a molt," and that you will "make sure the birds have been tested under these conditions, if we are to purchase new chickens." Your response is inadequate in that it does not address how you will ensure that the poultry house environment is tested during these timeframes, in light of the fact that you are unable to determine the age of your laying hens. Furthermore, your response states that you will consider (b)(4)% production to be the end of the molt; however, you did not indicate how you will know when hens reach this stage of production. We will verify the implementation of your environmental testing procedures, sampling plan, and schedule for testing at the appropriate times during our next inspection.
2. You failed to take 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). This includes taking appropriate steps to prevent animals that can be vectors of SE from causing the introduction or transfer of SE into or among poultry houses. During our inspection, we observed approximately three pigeons and eight dogs co-mingling with the laying hens, all which were freely roaming. You had not taken steps to ensure that your hens would not mingle with these animals and then enter the poultry house, which could lead to the introduction of SE into the poultry house. You can find questions and answers related to the management of farms that provide laying hens with access to the outdoors at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/eggs/ucm360028.htm
In your September 16, 2013 response you stated that you will depopulate stray animals on the farm. We will verify your corrective actions at our next inspection.
3. You failed to remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, we observed debris leaning against the outside of Barn (b)(4) and inside Barn (b)(4). The debris included metal scraps, wood, concrete blocks, hollow plastic tubing, and old metal tanks.
In your firm's September 16, 2013 response, you state that the harborage outside of Barn (b)(4) and inside Barn (b)(4) would be removed; however, you did not indicate a timeframe for this action. We will verify your corrective actions during our next inspection. In addition, we note that your written SE Prevention Plan includes measures to rid your free range area of trash and tall grass. We recommend revising your plan to include removal of all debris that may provide harborage for pests..
4. You failed to monitor for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method, as required by 21 CFR 118.4(c)(2). Specifically, no fly monitoring is performed within the poultry houses and we observed fly activity in the houses during the inspection. Furthermore, your written SE Prevention Plan fails to include fly monitoring measures for your poultry houses and fails to define what level of fly activity is unacceptable. Under 21 CFR 118.4(c)(2), your written SE Prevention Plan must include your fly monitoring procedures.
Your September 16, 2013 response includes measures for fly monitoring that appear to be adequate. However, details of the procedures or a revised written SE Prevention Plan were not included in your response. We will verify your corrective actions and the necessary changes to your written SE Prevention Plan during the next inspection.
5. You failed to use appropriate monitoring method for rodents, as required by 21 CFR 118.4(c)(1). Specifically, your method of rodent monitoring (one tin cat per house) is insufficient to provide a true representation of the rodent population in that environment. In addition, your written SE Prevention Plan fails to address how frequently you will monitor, what your threshold for acceptable or unacceptable rodent activity is, and what your corrective actions will be if the threshold is exceeded.
Your September 16, 2013 response includes measures for rodent monitoring that appear to be adequate. However, details of the procedures or a revised written SE Prevention Plan were not included in your response. Additionally, your response indicates that you will consider a Rodent Index of (b)(4) or less to be satisfactory, and that you will consider a Rodent Index of (b)(4) to be unsatisfactory; however, you failed to indicate how the Rodent Index will be calculated. We will verify your corrective actions and your calculation of your Rodent Index during our next inspection.
6. You failed to have a written SE Prevention Plan that includes the SE prevention measures required by 21 CFR 118.4. Specifically, your written SE Prevention Plan does not address limiting visitors on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1); maintaining practices that will protect against cross contamination when equipment and persons move between poultry houses, as required by 21 CFR 118.4(b)(2) and (b)(3); and cleaning and disinfection of poultry houses, as required by 21 CFR 118.4(d). Please note that under 21 CFR 118.10(a)(3), you are also required to maintain records documenting compliance with these SE prevention measures.
In your September 16, 2013 response, you state that you will revise your plan to include the following measures:
- use biosecurity practices to prevent the introduction or transfer of SE by (b)(4) on the farm and in the poultry houses
- prevent cross contamination caused by equipment and persons, including by (b)(4) poultry houses and (b)(4) the buildings
- clean and disinfect a poultry house if an environmental sample is positive by using (b)(4).
Please be advised that (b)(4) may not be an adequate disinfectant, especially when the surface to be cleaned contains organic matter. The floors in your farm are all dirt floors and (b)(4) would be completely ineffective as a disinfectant. We will verify these corrective actions and your firm's implementation and maintenance of records for these control measures during our next inspection.
7. You failed to maintain records documenting compliance with biosecurity measures, as required by 21 CFR 118.10(a)(3)(1). Specifically, during the inspection, our investigator observed that you do not maintain records addressing the limiting of visitors on the farm; records to document implementation of practices to protect against cross contamination when equipment is moved between poultry houses and when persons move between poultry houses; and records to document implementation of practices to prevent stray poultry, wild birds, cats, and other animal from entering poultry houses.
In your September 16, 2013 response, you state that you "will keep records of visitors on the farm, practices of preventing cross contamination with equipment, practices of preventing cross contamination with people, and stray animals entering the poultry houses ....All records will have a title, name of Stanton Brothers as the producer, address, date of activity, time of activity, and signature/initials of the person performing the operation."
We will verify all of these corrective actions during our next inspection.
This letter is not meant 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 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 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.
You should respond in writing within fifteen (15) working days of your 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 updated written SE prevention plan and monitoring records. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Your written response to this letter should be directed to Miguel Hernandez, Director, Compliance Branch, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Suite 205, Lenexa KS 66214. If you have any questions regarding any issue in this letter, please contact Danial S. Hutchison, Compliance Officer at 913-495-5154.
Kansas City District
U.S. Food and Drug Administration