Inspections, Compliance, Enforcement, and Criminal Investigations
Jonathan S. Allgyer 3/17/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100FAX: (612) 334-4142
March 17, 2014
Via UPS Overnight Delivery
Refer to MIN 14 – 10
Jonathan S. Allgyer
21472 Ames Branch Road
Shullsburg, Wisconsin 53586-9713
Dear Mr. Allgyer:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 21472 Ames Branch Road, Shullsburg, Wisconsin, on September 23 and 26, 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 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 September 26, 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 fully implement your written SE prevention plan, as required by 21 CFR 118.4. Specifically, our investigators made the following observations:
A. 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 - 45 weeks of age, as required by 21 CFR 118.5(a) and as set forth in your SE prevention plan. Specifically, your records indicate that the flock was hatched on March 20, 2012, which made the flock approximately 50 weeks of age on March 1, 2013, when you performed your environmental sampling.
Your response, received on September 30, 2013, states that you will have environmental tests done at the correct time. We will verify this correction during our next inspection.
B. You failed to fully implement the “Biosecurity Measures” portion of your SE prevention plan, which requires that persons entering the barn area wear protective clothing, boots, and masks, and that they have not had contact with any other poultry within the last 72 hours. Furthermore, you failed to take steps to ensure that there is no introduction or transfer of SE into the poultry house, as required by 21 CFR 118.4(b). Specifically, you informed our investigators that at times your neighbors and family enter your barn to acquire poultry feed, including sometimes when you are not present. You explained that these visitors have poultry in their own barns and will enter your barn without protective clothing or boots as required under your SE prevention plan. You indicated that in lieu of protective clothing you provide foot sanitizer near the entrance of your barn. However, you were unable to provide the name of the sanitizer or the labeling for the product; and you indicated that your visitors enter the barn without properly sanitizing their boots. Please note that in addition to implementing adequate biosecurity measures as required by 21 CFR 118.4(b), you are also required to document that these measures were taken, as required by 21 CFR 118.10(a)(3)(i).
Your response indicates that you will leave feed out for your neighbors in a completely separate building. We note that this may introduce a rodent harborage or attractant for wild birds and recommend you monitor this activity. Alternatively, you can instruct and ensure that any visitors to your egg laying facility follow the biosecurity measures specified in your written SE prevention plan.
Your response further indicates that you will provide the foot bath ingredient label. However, you did not include that label as part of your response. Please note that under 21 CFR 118.4(b), your biosecurity measures, including any foot baths, must be sufficient to ensure that there is no introduction or transfer of SE into or among poultry houses. You should take this into consideration in selecting your foot bath ingredients. We note that, provided the foot bath ingredients are appropriate to prevent cross-contamination, this measure would be an acceptable alternative to the use of protective clothing under your current SE prevention plan. If you decide to change your biosecurity measures (for example, by using foot baths), you should update your SE prevention plan accordingly.
C. You failed to fully implement the “Pest Control” portion of your SE prevention plan which states that rodent traps are checked weekly and that fly monitoring takes place weekly. Specifically, Pest Control Logs collected during the inspection show that fly and rodent monitoring were documented on a monthly basis rather than weekly.
In your response you indicate that you will improve fly and rodent monitoring. However, you did not provide any supporting documentation demonstrating implementation of this corrective action. We will evaluate the adequacy of your fly and rodent monitoring activities during our next inspection.
D. You failed to fully implement the “Biosecurity Plan” section of your written SE prevention plan, which specifies that weeds be kept 2-4 inches high around the poultry houses. Specifically, our investigators observed that vegetation around your poultry house was approximately 2-3 feet high. Under 21 CFR 118.4(c)(3), you must remove vegetation and debris outside a poultry house that may provide harborage for pests.
In your response you indicate that you will improve on the vegetation situation outside the poultry house. We will evaluate this during our next inspection.
2. You failed to maintain records documenting your environmental sampling procedures and the results of SE testing you performed on those environmental samples, as required by 21 CFR 118.10(a)(3)(v) and 118.10(a)(3)(vi), respectively. Specifically, while you did provide documentation that you sampled the environment of your “old barn” on March 1, 2013, you were unable to provide documentation of the sampling procedure you followed or of the results of the SE testing of the samples. We acknowledge that, upon request from FDA, your lab subsequently provided documentation of SE test results from environmental samples taken on March 1, 2013.
Your response states that you will place a report in your records relating to your environmental testing. We will verify this correction during our next inspection. Please note that 21 CFR 118.10(a)(3)(v) and 118.10(a)(3)(vi) set forth specific requirements for records you must maintain that relate to sampling procedures and test results.
3. As the SE prevention plan administrator, you failed to sign and date the written SE prevention plan, as required by 21 CFR 118.10(b)(3).
Your response stated that the SE prevention plan has been signed and dated. However, you did not provide any supporting documentation demonstrating you made these revisions to your written SE prevention plan.
4. You failed to sample the environment using a sampling plan appropriate to the poultry house layout, as required by 21 CFR 118.7(a). Specifically, the laboratory worksheets for the March 1, 2013, environmental tests conducted at the “old barn” indicate that only (b)(4) swabs were collected at the barn. The “old barn” consists of two distinct areas measuring (b)(4) feet and (b)(4) feet respectively, and is a cage-free style poultry house. FDA finds that given the size of your barn, (b)(4) swabs does not provide for a representative sample of the entire environment of your poultry house. We note that FDA’s December 2011 “Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” provided to you during the inspection, recommends procedures for collecting representative environmental samples. We recommend sampling cage-free poultry houses based on the width of the house. For a house that is more than 55 feet wide, such as yours, we recommend collecting 12 swabs. While you are not required to follow the procedures set forth in the December 2011 guidance, which are just recommendations, you do need to use a sampling plan that is appropriate to your poultry house layout, as required by 21 CFR 118.7(a).
Your written response states that you will take the correct amount of swabs per sample. We will verify this correction at our next inspection.
5. The portion of your SE prevention plan that addresses pest control (rodents, flies) does not include items required to be part of your SE plan under 21 CFR 118.4(c). Specifically, your plan does not include appropriate monitoring methods for rodents and flies, and appropriate methods to achieve satisfactory rodent and fly control if your monitoring indicates unacceptable rodent or fly activity within a poultry house, as required under 21 CFR 118.4(c)(1) (rodents) and 118.4(c)(2) (flies). 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 an index of rodent activity. The December 2011 Guidance also recommends several fly monitoring methods, along with methods for characterizing levels of fly activity.
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 operations are in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have a 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 initiation of administrative enforcement procedures under 21 CFR 118.12(a).
In addition to the above violations, we also have the following comment:
The lack of detail in your written SE prevention plan may influence a lack of compliance with the rule. Some examples of the types of details that you may want to consider providing are as follows:
- Include a statement regarding when your last collection of the day occurs in order to establish the time of lay, to ensure that eggs are held at or below 45ºF ambient temperature beginning 36 hours after time of lay, as required under 21 CFR 118.4(e). Define what you consider to be the end of the molting process. This will help ensure that you conduct environmental testing of your poultry house at 4 - 6 weeks after the end of the molting process to comply with 21 CFR 118.5(b).
- Revise your written SE prevention plan to clarify the specific SE prevention measures your firm is taking to comply with 21 CFR 118.4(a). The “Pullets” section of your SE prevention plan references the National Poultry Improvement Plan (NPIP) and also references your intent to reject pullets in the event of SE positive testing. This seems to be a reference to the requirement in 21 CFR 118.4(a) that you either procure pullets that are SE monitored or raise pullets under SE monitored conditions. As is further set forth in 21 CFR 118.4(a)(1) and 118.4(a)(2), this includes, among other things, requirements that chicks are procured from flocks that meet certain NPIP standards or equivalent standards, and that the pullet environment is tested for SE when pullets are 14 - 16 weeks of age.
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 ensure that similar violations do not occur. You should include in your response 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 time within which the remaining corrections will be completed.
Please send your reply to the 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.
Michael Dutcher, DVM