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WARNING LETTER

Milo’s Poultry Farms, LLC MARCS-CMS 693647 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Milo E. Borntrager
Recipient Title
Owner
Milo’s Poultry Farms, LLC

N3873 Valley Rd
Bonduel, WI 54107
United States

Issuing Office:
Human Foods Program

United States

WARNING LETTER

May 22, 2025

CMS # 693647

Dear Mr. Bontrager, Owner:

The United States Food and Drug Administration (FDA) conducted a joint inspection with Wisconsin Department of Agriculture, Trade, and Consumer Protection (WDATCP) of your shell egg farm and egg processing facility, where shell eggs are washed, graded, and packed, located at N3873 Valley Rd, Bonduel, WI from August 15, 2024, through September 10, 2024. The inspection was initiated as part of a Salmonella Enteriditis (SE) multi-state outbreak investigation,1 which CDC has since declared as over. During the inspection, FDA collected samples and detected the presence of SE in environmental samples (i.e., swabs) collected from your poultry house and shell egg processing facility. Whole Genome Sequence (WGS) analysis of these SE isolates revealed they were genetically identical clinical isolates and matched the SE outbreak strain, as further described below. Additionally, FDA investigators also observed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the Shell Egg Regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the deviations found at your farm.

Based on FDA’s inspectional and analytical findings, we have determined that the shell eggs produced on your farm do not comply with the provisions of 21 CFR Part 118. Failure to comply with the provisions of 21 CFR Part 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 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 www.fda.gov.

Salmonella Enteriditis
As described above, FDA collected environmental swabs from your poultry house and shell egg processing facility during the referenced inspection. FDA laboratory analysis of these environmental swabs detected the presence of SE within (b)(4) manure sub samples collected from your poultry house (FDA Sample (b)(4)) and within (b)(4) environmental swabs collected from various food contact and non-food contact surfaces within your shell egg processing facility environment (FDA Sample (b)(4)). These SE positive areas within the processing environment included, but were not limited to, the roller conveyor, brushes, panel control buttons, hose handles, and pallet jack wheels.

WGS was conducted on the SE isolates derived from the referenced samples. Based on the results of the WGS analysis, (b)(4) environmental isolates collected from FDA samples (b)(4) (total of (b)(4) isolates; environmental samples from poultry house) and (b)(4) (total of (b)(4) isolates; environmental swabs from processing area) were a single strain and matched clinical isolates. We advised you of the importance of these WGS results on September 4, 2024.

These SE findings in your poultry house environment, processing facility, and within your shell eggs indicate that your SE prevention plan and implementation are not adequate. SE is among the leading bacterial causes of foodborne illness in the United States and shell eggs are the primary source of human SE infections.

We acknowledge the immediate corrective actions you took in response to these findings, which included conducting a voluntary recall (initial recall on August 20, 2024; further expanded on September 5, 2024) of approximately (b)(4) dozen shell eggs distributed to the table market, ceasing operations within your processing facility, holding remaining shell eggs stored on site, and sending shell eggs intended to be processed on your farm (from other supplier farms) for treatment. Additionally, on or around August 28, 2024, you initiated environmental testing of your poultry house environment and detected the presence of Salmonella. In response, you submitted shell eggs produced within your poultry house for egg testing, as described in 21 CFR 118.6(b)-(e). On September 7, 2024, you received notice of a positive SE egg test in your first sample. You voluntarily provided this Salmonella positive isolate to FDA for further identification, including serotype confirmation and genome sequencing (FDA Sample (b)(4)). This shell egg sample was found positive for SE and matched the isolates collected from your processing environment, poultry house, and clinical isolates. We provided the updated WGS report to you on September 23, 2024. We further acknowledge your subsequent actions, including depopulating your poultry house. It is our understanding that you plan to repopulate your poultry house in the future.

We received your faxed responses dated September 16, 2024, September 25, 2024, September 26, 2024, October 1, 2024, October 2, 2024, October 10, 2024, October 17, 2024, and October 31, 2024, which described additional corrective actions taken by your farm. The responses included information on the cleaning and disinfection of your poultry house and processing facility, an environmental sampling procedure for your processing facility (and subsequent results), a Food Safety Plan, and a summary of training provided to your suppliers on the Shell Egg Rule. We also recognize your continued efforts in coordination with WDATCP and corrective actions for your processing area. However, despite your corrective actions to date, we continue to be concerned with your farm’s actions to address the Salmonella Enteriditis contamination on your farm and within your poultry house.

Shell Egg Rule (21 CFR Part 118)
Your significant violations are as follows:
1. You did not have and implement a written Salmonella Enteritidis prevention plan (SE Plan) that includes, at minimum, the SE prevention measures required by 21 CFR 118.4. At the initiation of the inspection, you had an SE Plan dated December 15, 2014, and your poultry house contained approximately (b)(4) laying hens at (b)(4) weeks of age. However, as further described below, this SE Plan is inadequate in that it does not address all required SE prevention measures. In addition, you were not fully implementing your SE Plan as written. In your response, you provided a Food Safety Plan which primarily focuses on audits for supplier farms and for your processing area, and further indicated that you would write and implement a new SE Plan. However, to date, we have not received this document.

A. Biosecurity:
You did not have and implement a written SE prevention plan that includes, at a minimum, the biosecurity measures required by 21 CFR 118.4(b). Specifically,

i. Your 2014 SE Plan states, “(b)(4)” and “(b)(4).” However, your (b)(4) had not been used since January 4, 2020. You were therefore not implementing your written SE prevention plan as required by 21 CFR 118.4. Note that under 21 CFR 118.4(b)(1), your written SE prevention plan must include, among other things, biosecurity measures to limit visitors on the farm and in the poultry house.

ii. Your 2014 SE Plan states, “(b)(4)”; and “(b)(4).” However, at the initiation of the inspection you did not have or utilize any (b)(4) on your farm and therefore you were not implementing your written SE prevention plan as required by 21 CFR 118.4. This element of your SE Plan was a key part of maintaining practices that will protect against cross contamination when persons move between poultry houses, as required per 21 CFR 118.4(b)(3). We acknowledge that you began using (b)(4) on or around September 9, 2024, which was prior to depopulating your flock.

iii. Your 2014 SE Plan states, “(b)(4)”. During the inspection, you explained to investigators that some of your employees have flocks at their home farms, but to your knowledge, they are not involved in the care or maintenance of those flocks. During the closeout discussion you further stated that to your knowledge, only one of your employees has a flock at their residence, and this employee works in the packing house and does not enter the poultry house. In addition, you reported that your consultant also owns a personal flock of birds. Per 21 CFR 118.4(b)(5), employees are not allowed to keep birds at home.

We are concerned that employees that have birds at their residence, even if not directly involved in the care of those flocks or of your flocks, may be a source of SE contamination on your farm. Your response of September 16, 2024, stated you will hold an in-house employee training and further stated that no employees may own a flock of chickens of their own or have pet birds. We will verify this correction at our next inspection.

B. Rodents, Flies, and Other Pest Control
i. You did not comply with the rodent monitoring requirements that are stated in 21 CFR 118.4(c)(1). Under that provision, you must have and implement an SE prevention plan that includes monitoring for rodents by visual inspection and mechanical traps or glue boards (or another appropriate monitoring method) and, when monitoring indicates unacceptable rodent activity within a poultry house, use appropriate methods to achieve satisfactory rodent control. Your 2014 SE Plan has a handwritten comment, dated August 30, 2023, stating, “I don’t use traps, only bait stations” and “I check bait stations monthly”. Your SE Plan also states, “A visual inspection of the facility for rodent activity should be performed weekly.” However, your plan does not indicate a threshold for acceptable or unacceptable rodent activity that relates to bait stations (or that relates to the visual inspection), nor does it identify corrective actions to take if unacceptable activity is observed. Your SE Plan references FDA’s Rodent Index calculation (based on rodent traps) for determining if a corrective action should be taken. However, as indicated by your handwritten comment and as we observed during the inspection, you do not utilize rodent traps; you utilize bait stations. Since you were not utilizing rodent traps, the rodent index is not an effective method to determine if corrective actions are required. Further, you did not document weekly visual inspections.

Your September 16, 2024, response stated that you will use the appropriate number of rodent traps, and that a visual inspection will be done weekly for rodent activity along with checking the rodent traps and recording the activity/amounts for each trap. Your response further states that you will have an appropriate number of bait stations around the outside of the chicken barn and poultry house, which will be checked monthly and documented. You have not provided a revised SE prevention plan that incorporates these measures, and it is unclear if you are now adhering to the relevant aspects of your 2014 SE Plan, such as the use of FDA’s Rodent Index calculation.

ii. You did not comply with the fly monitoring requirements that are stated in 21 CFR 118.4(c)(2). Under that provision, you must have and implement an SE prevention plan that includes monitoring for flies by spot cards, Scudder grills, or sticky traps (or another appropriate monitoring method) and, when monitoring indicates unacceptable fly activity within a poultry house, use appropriate methods to achieve satisfactory fly control. Your 2014 SE Plan has a handwritten comment, dated August 30, 2023, stating “(b)(4)”, and “(b)(4)”. This does not appear to be an appropriate monitoring method. You do not describe a specific, objective approach to monitoring for flies, nor do you identify an objective threshold for unacceptable fly activity. Furthermore, we are concerned that fly tape alone will not achieve satisfactory fly control in a situation where monitoring has indicated unacceptable fly activity.

Your September 16, 2024, response indicated you will monitor the fly population using spot cards on a weekly basis throughout the year. However, you did not provide any further details and therefore we are unable to verify the adequacy of this approach. Further, your SE Plan must reflect the current monitoring method and identify the appropriate threshold for acceptable or unacceptable activity, for you to identify and take corrective actions if unacceptable activity is observed. Prior to being changed through your handwritten notes, your 2014 SE Plan stated (b)(4). You have not provided a revised SE prevention plan that incorporates your plan to monitor the fly population using spot cards, or that identifies the threshold for acceptable or unacceptable activity under this (b)(4) method, or that identifies corrective actions to take if unacceptable activity is observed.

iii. You did not 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). Although your 2014 SE Plan stated, “(b)(4),” during the inspection there were several observations indicating that you were not implementing this portion of your SE Plan and were not acting in accordance with 21 CFR 118.4(c)(3). Specifically, horse and goat manure were observed in the outdoor access areas on the east and south sides of the poultry house and horse manure was observed on the concrete apron on the (b)(4) side of the poultry house. Further, uncut weeds and grass were noted along the (b)(4) side of the poultry house. Unused fencing, live animal traps, and pallets were also observed near the (b)(4) grain bin on the (b)(4) side of the poultry house, which is adjacent to the (b)(4) side poultry access area.

Your September 16, 2024, response stated the horses and goats will no longer have access to the laying hens’ outdoor area and horse manure will be cleaned. Also, you stated that you plan to monitor the outside areas. You further stated the weeds will be cut and any unused fencing, live animal traps, and pallets will be removed and put into storage, and that potential areas of rodent harborage in and around the poultry house will be appropriately dealt with, including removing all items that attract or harbor rodents and monitoring on a monthly basis. We will verify the adequacy of your corrective actions during the next inspection.

Food, Drug, and Cosmetic Act (FD&C Act)
Your eggs were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health within the meaning of section 402(a)(4) of the FD&C Act. Specifically, during the inspection, we observed the following insanitary conditions and practices within your processing environment that allow for the harborage, proliferation, and spread of filth and pathogens (including SE) throughout the processing facility. Further, this is a concern based on the number of environmental sample positives detected from your shell egg processing facility environment, as described above.

For example:

  • Post-cleaning residue buildup was observed on the food contact surfaces on the unloading, washing, grading, and packaging equipment including conveyor belts, conveyor belt guides, rollers, brush fringe, flaps, metal plates, and plastic egg guides. These conditions were also observed on non-food contact surfaces including electrical boxes, motor housing, control buttons/panels, hoses, buckets, overhead fan and heating elements, shelf holding cleaning equipment, carts, and pallet jacks. Further, you did not use sanitizer to clean the equipment or processing area.
  • An employee placed a plastic flat divider, which includes direct food contact surfaces, on the floor near the egg packaging stations and proceeded to rinse it with hose water. Overspray was observed hitting the floor and a pallet of nest run eggs. An employee was also observed standing on the plastic flat divider while completing this operation.
  • Previously used pulp trays are used to pack washed bulk eggs. Broken shells, dried yolk and apparent mold were observed on the exterior of the stacked trays.
  • Pallets holding wrapped stacks of plastic nest run trays were also stored outside the processing facility. A green residue was observed on the edges of the trays.
  • An employee was observed handling and removing crushed eggs at the egg unloading station just prior to egg washing. This employee rinsed their hands using a hose and immediately returned to packaging washed eggs into cartons.

As discussed, we acknowledge that you ceased operations in your processing facility after being notified of the sample results and have since cleaned and sanitized your production facility. Your September 16, 2024, response detailed several steps you plan to take to address the conditions within your processing facility, including providing food safety/GMP training for all employees and cleaning and sanitizing your equipment regularly. We will verify the adequacy of your corrective actions during the next inspection.

This letter is not intended to be an all-inclusive statement of the violations that may exist at your farm or in connection with your shell eggs. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your shell egg production practices are conducted in compliance with federal law, including the FD&C Act, the PHS Act, and the Shell Egg regulation.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).

In addition to the above violations, we also offer the following comment:

During the inspection, investigators noted that when the outdoor access area is not in use by the chickens, horses and goats are allowed to graze in this area. Your response indicated that horses and goats would no longer have access to this area. Please note that when there is movement of hens between the poultry house and an area outside the poultry house, this movement can lead to the transfer of SE between the two areas. In this situation, to ensure that there is no introduction or transfer of SE into the poultry house, you should take appropriate steps to prevent other animals, including but not limited to horses and goats, from entering the outdoor access area.

Further, resources are available on our website at www.fda.gov/eggs that address various aspects of shell egg regulation, including some of the topics addressed in this letter. For example, the December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” addresses topics such as rodent monitoring; the August 2022 Guidance for Industry “Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House)” provides information specific to operations where layers have access to areas that are outside the poultry house; and the July 2015 Guidance for Industry “Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” provides answers to common questions about the Shell Egg regulation.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting information for our consideration.

Your response should be sent electronically to HFPOCEConventionalFoods@fda.hhs.gov, copying Lisa Thursam, Compliance Officer, at Lisa.Thursam@fda.hhs.gov or via mail to the Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. Your reply may also be submitted via eFax at (301) 837-6314. If you have any questions regarding any issues in this letter, please contact Lisa Thursam via email at Lisa.Thursam@fda.hhs.gov, or at the phone number that FDA previously provided you. Please refer to Unique Identification Number, CMS #693647 in any submissions and within the subject line of any correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

__________________

1 Outbreak Investigation of Salmonella: Eggs | FDA

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