WARNING LETTER

Lathem Family Farms, Inc. MARCS-CMS 660924 — October 05, 2023

Delivery Method:: UPS Overnight
Product:: Food & Beverages

Recipient:: Recipient Name

Mr. David Lathem; Recipient Title

President/Owner; Lathem Family Farms, Inc.; 1236 Wayne Poultry Road
Pendergrass, GA 30567
United States

Issuing Office:: Division of Human and Animal Food Operations East III; United States

October 5, 2023

Reference: CMS Case 660924

WARNING LETTER

Dear Mr. Lathem:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your eggs are washed, graded, and packed, both of which are located at 1236 Wayne Poultry Road, Pendergrass, GA from April 17, 2023, through April 21, 2023. During our inspection, FDA investigators found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation) found at Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Additionally, FDA collected environmental samples (i.e., swabs) from your poultry houses and detected the presence of Salmonella as further described in this letter.

Based on FDA’s inspectional 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 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 United States Code (U.S.C.) § 264(a). In addition, these violations and analytical findings 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. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA's homepage at www.fda.gov.

At the conclusion of the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations. You provided a response to the sample results dated May 2, 2023¹ and to the inspectional findings dated May 12, 2023, describing your corrective actions. Based on our review of the inspectional findings, the analytical findings, and your responses, we are issuing this letter to advise you of FDA’s continued concerns and to provide detailed information describing the findings at your farm.

Salmonella findings:
FDA’s analytical findings indicate that you have a resident strain of Salmonella Enteritidis in your poultry houses and within your processing facility environment.

FDA laboratory analysis of environmental samples collected during the April 2023 inspection from house (b)(4) (FDA sample 1217500), house (b)(4) (FDA sample 1217501), house (b)(4) (FDA sample 1193535), house (b)(4) (FDA sample 1216084), and house (b)(4) (FDA sample 1216083) were confirmed positive for Salmonella Enteritidis. This was not the first time Salmonella Enteritidis was detected in your poultry houses and your egg processing environment.

In October 2021, FDA detected Salmonella Enteritidis from house (b)(4) (FDA sample 1173545) and from a (b)(4) and a (b)(4) of your egg processing facility (FDA sample 1136001)
In November 2019, FDA detected Salmonella Enteritidis from house (b)(4) (FDA sample 1115428).

Additionally, FDA has detected other Salmonella serovars including, Salmonella Typhimurium from a swab collected from the packer (b)(4) within your egg processing facility in October 2021 (FDA sample 1136002), and Salmonella Braenderup from environmental swabs collected from house (b)(4) during the April 2023 inspection (FDA sample 1212290).

Whole genome sequencing (WGS) was conducted on the above referenced isolates. Based on the results of the WGS analysis, 101 isolates represent four strains of Salmonella enterica, of which three of these strains are of particular significance. The first significant strain represents 98 Salmonella Enteritidis isolates. Isolates derived from the swabs collected from (b)(4) of your poultry houses during the April 2023 inspection matched isolates derived from swabs collected from your poultry house and egg processing environment during the October 2021 inspection, and from (b)(4) of your poultry houses during the November 2019 inspection. The presence of these isolates across multiple years indicates a resident pathogen on your farm. Further, these isolates matched one 2023 clinical isolate which demonstrates that this strain is capable of causing human illness. The second significant strain consists of one Salmonella Typhimurium isolate collected from your processing environment in October 2021 that matches 26 clinical isolates from 2020 through 2022, demonstrating that this strain is also capable of causing human illness. A third significant strain, representing one Salmonella Braenderup isolate, matches two USDA/FSIS chicken isolates (dated 2017 and 2021) and two egg isolates (dated 2012). We note that the 2012 raw egg isolates were collected from a breaking facility with which you have a business relationship and demonstrate the ability of this pathogen to contaminate eggs. Another strain representing one Salmonella Enteritidis isolate from October 2021 processing environment did not match any other isolates in the database. We advised you of the importance of these WGS results via a conference call on May 26, 2023.

The reoccurring presence of Salmonella Enteritidis is significant in that it demonstrates you have not implemented an effective Salmonella Enteritidis Prevention Plan (SE Prevention Plan) to control Salmonella Enteritidis in your egg production environment. The presence of a resident strain of Salmonella Enteritidis is of particular concern in that it represents an increased risk of contamination for eggs produced at your farm. Salmonella Enteritidis is among the leading bacterial causes of foodborne illness in the United States and shell eggs are a primary source of human Salmonella Enteritidis infections. Additionally, other Salmonella serovars including Salmonella Typhimurium and Salmonella Braenderup have been implicated in multiple egg-associated outbreaks. We note that these serovars are not explicitly addressed in the shell egg regulation (21 CFR 118); however, they are human pathogens that can cause food to be adulterated under the FD&C Act. Further, the proper implementation of an effective SE Prevention Plan can help to mitigate and reduce the risk of contamination of eggs from these other serovars.

Your May 2, 2023, response to FDA’s positive environmental samples stated that houses (b)(4) would each be segregated, employee traffic will be limited as much as possible, and footbaths and hand sanitizer would be added at the entrance and exit to the houses and employees would be required to use both.

You further stated that you would follow your “Daily Operating Procedures” for a “SE Positive Environment” and eggs would be diverted from the table market from the affected flock while you initiated egg testing. Additionally, you stated that house (b)(4) was in molt and egg testing would begin once the flock began laying eggs and house (b)(4) was near depopulation, therefore, the shell eggs from this house would all be sent “to the breaker for treatment in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f)”. We acknowledge that you provided four negative egg test results for houses (b)(4).

Further, your May 12, 2023, response stated that you will re-evaluate your SE Prevention Plan to determine if modifications are needed and conduct any necessary personnel training by September 1, 2023. You also stated that following FDA’s review, you conducted environmental testing to verify the effectiveness of cleaning and sanitation for Salmonella Enteritidis positive houses; however, you did not specify when the testing was conducted, indicate the outcome of the environmental testing, or provide the environmental test results. We will verify the effectiveness of your corrective actions during our next inspection.

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 Prevention Plan) that includes, at minimum, the SE prevention measures required by 21 CFR 118.4.

a) You did not 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). Specifically, your biosecurity program within your SE Prevention Plan dated January 6, 2022, and signed as reviewed on August 23, 2022, identifies measures for preventing wild birds, but does not include any measures for the prevention of stray poultry, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). During the inspection, investigators observed animals, including a live fox and live cat in the manure pit of house (b)(4) and multiple signs of ingress on the exterior perimeter of your poultry houses, as follows:

i. A 1-inch door gap on the northern wall and four 2x4-inch holes on the southern and eastern walls connecting the feed lines into house (b)(4). Six burrows were also observed along the perimeter of house (b)(4). Additionally, two shell eggs were located outside of the house on top of the burrows located on the northern side of the house.
ii. In house (b)(4), a gap in the foundation along the southern wall, and a 4x6-inch hole in the wall, a 3x3-inch hole in the wall with feeder auger, and a 2x4-inch gap around plumbing pipes leading into the house. Seven burrows were also observed along the perimeter of the house.
iii. In house (b)(4), a 2x6-inch door gap in the back doorway and a 3x3-inch wall gap around the plumbing leading into the house. Further, black tape was used to seal four holes on the outside western wall.
iv. A large gap in the foundation along the southern wall of house (b)(4), and one burrow outside the house.
v. Two large holes in the back of house (b)(4) near the manure pit.
vi. A 3x3-inch hole on the left side of house (b)(4).

Your May 12, 2023, response states that you will have an employee walk the exterior and the pit of each house every two weeks to look for building maintenance items such as holes and gaps, the presence of any wildlife, and rodent burrows. You also stated that any temporarily maintained items will be permanently repaired. You indicated that these corrections, including building maintenance issues, will occur by November 1, 2023. You further stated that burrows will be covered and “checked the following day” to determine if the burrow is active and apply tracking powder if active; however, you did not provide any corrections that have been implemented to date. You state that you will contact a pest control service to evaluate your current pest control program; however, you did not provide a timeframe within which you will have the initial evaluation conducted. We remain concerned regarding how you will address the potential ingress points within and around your poultry houses, as this was a repeat observation from previous inspections conducted in November 2019 and October 2021, and your previous promised corrections included you contracting with a professional integrated pest management (IPM) service company and that you would bait, cover, and fill burrow holes and repair gaps in your poultry houses. We will verify the adequacy of your corrective actions during a future inspection.

b) You did not implement your SE Prevention Plan to clean and disinfect your poultry houses before new laying hens were added to the house, when there was an environmental test that was positive for Salmonella Enteritidis at any point during the life of a flock that was housed in the poultry house prior to depopulation, as required by 21 CFR 118.4(d). The specific procedures required by 21 CFR 118.4(d) include removing all visible manure from the positive poultry house, and (following cleaning) disinfecting the positive poultry house with spray, aerosol, fumigation, or another appropriate disinfection method. More generally, 21 CFR 118.4 states that you must not only follow the specific SE prevention measures set forth in the section, but also that you must have and implement a written SE prevention plan that is specific to your farm. Your SE Prevention Plan dated January 6, 2022, and signed as reviewed on August 23, 2022, states as part of your cleaning procedures for an environmentally positive poultry house that you will “remove all manure from the pit", “sanitize house following disinfection procedures”, and “conduct swab sampling to verify cleaning effectiveness”. However, you did not follow your cleaning and disinfection procedures, or the specific requirements of 21 CFR 118.4(d), as follows:

i. An environmental test was reported positive for Salmonella Enteritidis in house (b)(4) on March 22, 2022, when the flock was approximately 89 weeks of age. Your cleaning and disinfection records dated August 17, 2022, to August 24, 2022, state that you conducted a “washdown with disinfectant”. However, a representative of your firm informed investigators that all of the manure was not removed from this house. Further, you did not conduct any post sanitation environmental sampling to verify the effectiveness of your cleaning and disinfection procedures per your SE Prevention Plan. At the time of the inspection, the current flock placed in this house was approximately 51 weeks of age.
ii. An environmental test was reported positive for Salmonella Enteritidis in house (b)(4) on January 3, 2022, when the flock was approximately 70 weeks of age. Your cleaning and disinfection records dated January 29, 2023, to February 3, 2023, state “dry cleaning only” and do not reference that disinfection occurred. Additionally, a representative of your firm informed investigators that all of the manure was not removed from this house. Further, you did not conduct any post sanitation environmental sampling to verify the effectiveness of your cleaning and disinfection procedures per your SE Prevention Plan. At the time of the inspection, the current flock placed in this house was approximately 29 weeks of age.

During a regulatory meeting held with your firm on August 12, 2020, we previously communicated our concerns regarding your cleaning and disinfection procedures and emphasized the significance of adhering to the procedures outlined in your SE Prevention Plan. Your May 12, 2023, response states that your SE Prevention Plan will be reviewed, and any necessary changes and training will be conducted to include your “cleaning, sanitizing and environmental testing” procedures by September 1, 2023. We will verify the adequacy of your corrective actions during a future inspection.

c) 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). You also did not implement your written SE prevention plan (as required under 21 CFR 118.4) with regard to your plan’s “Requirements for Vegetation and Debris Management” section. Your SE Prevention Plan dated January 6, 2022, and signed as reviewed on August 23, 2022, states to “[k]eep the exterior of poultry houses free of high vegetation, debris, and feed.” It further states, “With the exception of required fans, feed storage, and similar equipment that are part of the layer operation, do not store or mount equipment within (b)(4) of the layer houses”; “[r]emove all debris around layer houses”; and “[a]ll feed that is exposed to wild birds or potentially has rodent contact is to be disposed of immediately.” However, during the inspection, investigators observed the following:
i. Numerous flies swarming near spent grain and discarded food in a trash can on the exterior of houses #9 and #10.
ii. Spilled feed (approximately three feet wide) located at the front of house (b)(4).
iii. Insect activity in and around the unused equipment stored around house (b)(4).
iv. A deceased rodent outside in a large pile of apparent spilled feed outside house (b)(4).

Additionally, you converted house (b)(4) to a storage building which is located approximately (b)(4) from another populated house on your farm. During the inspection, house (b)(4) was observed without a back wall, gaps in the side netting, and filled with accumulated and unused equipment, trash, and debris (i.e., siding, wooden boards, racks, egg cartons, and egg crates). We are concerned that this house is an attractant or harborage for rodents and pests, which are known vectors of pathogens. Further, investigators observed numerous live (and dead) rodents and flies within and around your poultry houses, despite records indicating satisfactory control. The importance of a robust rodent and pest control program is critically important at your farm, particularly in light of the repeat isolation of Salmonella serovars given that both flies and rodents are primary mechanisms of Salmonella spread throughout a farm. Your rodent and pest control program and its implementation will play a critical role in addressing the resident Salmonella strain at your farm.

Your May 12, 2023, response stated you will have an employee conduct walkthroughs (b)(4) to look for trash and debris, as well as using (b)(4) on the exterior of the houses to control the flies around the houses. Additionally, you stated in your response that the rodent traps you have previously utilized for rodent monitoring within the houses are “not an effective method due to their size” and would be replaced with snap traps to obtain a “more accurate record of activity levels”. You stated that these corrective actions will be completed by November 1, 2023, however, you did not provide any corrections that have been implemented to date. We will verify the adequacy of your corrective actions during a future 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. It is your responsibility to investigate and determine the cause of the violations identified above and for preventing their reoccurrence 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 FDA’s egg safety rule (21 CFR 118).

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If corrective actions cannot be completed within fifteen (15) working days of receipt of this letter, please state the reason for the delay and the timeframe within which the corrections will be completed. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting documentation for our consideration.

Please send your written response to Lakisha N. Morton, Compliance Officer via email (preferred method) at Lakisha.Morton@fda.hhs.gov. Alternatively, you may send hardcopy documentation to the attention of Mrs. Morton at the U.S. Food and Drug Administration; 60 8th Street, NE; Atlanta, GA 30309. Please notify Mrs. Morton via email if you choose to send hardcopy documentation through the mail system.

If you have any questions about this letter, please contact Mrs. Morton at 404-253-1285 or at Lakisha.Morton@fda.hhs.gov.

Sincerely,
/S/

Heather A. McCauley
Acting Program Division Director
Office of Human and Animal Foods
Division East III (Georgia, North Carolina, and South Carolina)
Office of Regulatory Affairs
U.S. Food and Drug Administration

_________________________

1 We received your first response to the sample results on May 3, 2023, and a secondary response on May 10, 2023, via email; however, each of these responses were documented on company letterhead dated May 2, 2023.