As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Lathem Family Farms, Inc.
A food firm in Georgia is on notice from the FDA after an inspection at its egg processing facility found the presence of Salmonella, flies, rodents and more violations of federal regulation.
In an Oct. 5, 2023, warning letter, the FDA described an April 17-21, 2023, inspection of Lathem Family Farms Inc.’s shell egg farm and egg processing facility, where eggs are washed, graded and packed, in Pendergrass, GA.
The FDA’s inspection found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation). Additionally, FDA collected environmental samples from the firm’s poultry houses and detected the presence of Salmonella as further described in this letter.
At the conclusion of the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.
The significant violations are as follows:
FDA’s analytical findings indicate that the firm has a resident strain of Salmonella Enteritidis in its poultry houses and within its processing facility environment.
FDA laboratory analysis of environmental samples collected during the April 2023 inspection from house (redacted), house (redacted), house (redacted), house (redacted), and house (redacted) were confirmed positive for Salmonella Enteritidis. This was not the first time Salmonella Enteritidis was detected in the company’s poultry houses and egg processing environment.
- In Oct. 2021, FDA detected Salmonella Enteritidis from house (redacted) and from a (redacted) and a (redacted) of the egg processing facility.
- In Nov. 2019, FDA detected Salmonella Enteritidis from house (redacted).
Additionally, the FDA has detected other Salmonella serovars including, Salmonella Typhimurium from a swab collected from the packer (redacted) within the egg processing facility in Oct. 2021, and Salmonella Braenderup from environmental swabs collected from house (redacted) during the April 2023 inspection.
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 (redacted) of their poultry houses during the April 2023 inspection matched isolates derived from swabs collected from their poultry house and egg processing environment during the Oct. 2021 inspection, and from (redacted) of their poultry houses during the Nov. 2019 inspection. The presence of these isolates across multiple years indicates a resident pathogen on their 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 their processing environment in Oct. 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). FDA notes that the 2012 raw egg isolates were collected from a breaking facility with which they have a business relationship and demonstrate the ability of this pathogen to contaminate eggs. Another strain representing one Salmonella Enteritidis isolate from Oct. 2021 processing environment did not match any other isolates in the database. FDA advised them 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 they have not implemented an effective Salmonella Enteritidis Prevention Plan (SE Prevention Plan) to control Salmonella Enteritidis in their 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 their 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. FDA notes that these serovars are not explicitly addressed in the shell egg regulation; 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.
The firm’s May 2, 2023, response to FDA’s positive environmental samples stated that houses (redacted) 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.
The company further stated that it would follow “Daily Operating Procedures” for a “SE Positive Environment” and eggs would be diverted from the table market from the affected flock while they initiated egg testing. Additionally, the company stated that house (redacted) was in molt and egg testing would begin once the flock began laying eggs and house (redacted) 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.” FDA acknowledges that they provided four negative egg test results for houses (redacted).
Further, their May 12, 2023, response stated that they will re-evaluate their SE Prevention Plan to determine if modifications are needed and conduct any necessary personnel training by Sept. 1, 2023. The firm also stated that following FDA’s review, they conducted environmental testing to verify the effectiveness of cleaning and sanitation for Salmonella Enteritidis positive houses; however, they did not specify when the testing was conducted, indicate the outcome of the environmental testing, or provide the environmental test results.
Shell Egg Rule:
1. The firm did not have and implement a written Salmonella Enteritidis prevention plan (SE Prevention Plan) that includes, at minimum, the SE prevention measures required.
a) They did not take steps to ensure that there is no introduction or transfer of SE into or among poultry houses, as required. Specifically, their biosecurity program within their SE Prevention Plan dated Jan. 6, 2022, and signed as reviewed on Aug. 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. During the inspection, investigators observed animals, including a live fox and live cat in the manure pit of house (redacted) and multiple signs of ingress on the exterior perimeter of their poultry houses, as follows:
i. A 1-inch door gap on the northern wall and four 2×4-inch holes on the southern and eastern walls connecting the feed lines into house (redacted). Six burrows were also observed along the perimeter of house (redacted). 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 (redacted), a gap in the foundation along the southern wall, and a 4×6-inch hole in the wall, a 3×3-inch hole in the wall with feeder auger, and a 2×4-inch gap around plumbing pipes leading into the house. Seven burrows were also observed along the perimeter of the house.
iii. In house (redacted), a 2×6-inch door gap in the back doorway and a 3×3-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 (redacted), and one burrow outside the house.
v. Two large holes in the back of house (redacted) near the manure pit.
vi. A 3×3-inch hole on the left side of house (redacted).
b) The firm did not implement their SE Prevention Plan to clean and disinfect their 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. The specific procedures required 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, they must not only follow the specific SE prevention measures set forth in the section, but also must have and implement a written SE prevention plan that is specific to their farm. The firm SE Prevention Plan dated Jan. 6, 2022, and signed as reviewed on Aug. 23, 2022, states as part of their cleaning procedures for an environmentally positive poultry house that they will “remove all manure from the pit”, “sanitize house following disinfection procedures”, and “conduct swab sampling to verify cleaning effectiveness”. However, they did not follow their cleaning and disinfection procedures, or the specific requirements, as follows:
i. An environmental test was reported positive for Salmonella Enteritidis in house (redacted) on March 22, 2022, when the flock was approximately 89 weeks of age. Their cleaning and disinfection records dated Aug. 17-24, 2022, state that they conducted a “washdown with disinfectant.” However, a representative of their firm informed investigators that all of the manure was not removed from this house. Further, they did not conduct any post sanitation environmental sampling to verify the effectiveness of their cleaning and disinfection procedures per their 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 (redacted) on Jan/ 3, 2022, when the flock was approximately 70 weeks of age. The firm’s cleaning and disinfection records dated Jan. 29, 2023, to Feb. 3, 2023, state “dry cleaning only” and do not reference that disinfection occurred. Additionally, a representative of their firm informed investigators that all of the manure was not removed from this house. Further, they did not conduct any post sanitation environmental sampling to verify the effectiveness of their cleaning and disinfection procedures per their SE Prevention Plan. At the time of the inspection, the current flock placed in this house was approximately 29 weeks of age.
c) The firm did not remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests, as required. They also did not implement written SE prevention plan with regard to their plan’s “Requirements for Vegetation and Debris Management” section. Their SE Prevention Plan dated Jan. 6, 2022, and signed as reviewed on Aug. 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 (redacted) 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 (redacted).
iii. Insect activity in and around the unused equipment stored around house (redacted).
iv. A deceased rodent outside in a large pile of apparent spilled feed outside house (redacted).
Additionally, they converted house (redacted) to a storage building which is located approximately (redacted) from another populated house on their farm. During the inspection, house (redacted) 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). FDA is 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 their poultry houses, despite records indicating satisfactory control. The importance of a robust rodent and pest control program is critically important at their 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. Their rodent and pest control program and its implementation will play a critical role in addressing the resident Salmonella strain at their farm.
The full warning letter can be viewed here.
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