WARNING LETTER
Rise N’ Shine Farm, Inc.
MARCS-CMS 672629 —
October 25, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
William Mitch Lawson
Recipient Title
President/Owner
Rise N’ Shine Farm, Inc.
4307 Roland Hayes Parkway SW
Calhoun
,
GA
30701
United States
Issuing Office:
Human Foods Program
United States
October 25, 2024
WARNING LETTER
Reference: CMS Case 672629
Dear Mr. Lawson:
The United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your eggs are washed and packed, located at 4307 Roland Hayes Parkway SW in Calhoun, Georgia, between October 23, 2023, and October 27, 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), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118), as well as sanitation concerns in your egg processing facility. Additionally, FDA collected environmental samples (i.e., swabs) from your farm and detected the presence of
Salmonella
Enteritidis (SE) 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 though links on FDA’s homepage at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued you a Form FDA 483 (FDA-483), Inspectional Observations. You provided written responses to the inspectional findings dated November 10, 2023, December 4, 2023, December 12, 2023, and multiple updates throughout January 2024 describing additional corrective actions. We are issuing this letter to advise you of FDA‘s continued concerns based on the inspectional findings, sample and analytical results, and our review of your responses.
Salmonella Enteritidis findings:
During the October 2023 inspection, FDA collected environmental swabs from your poultry house and processing facility environment. FDA laboratory analysis of these environmental swabs detected the presence of SE in manure samples from your poultry house (FDA Sample 1231468), dust samples from your poultry house (FDA Sample 1231467), and from a drain located below your egg candler in your processing environment (FDA Sample 1240106).
Whole Genome Sequencing (WGS) was conducted on the SE isolates derived from the referenced samples. Based on the results of the WGS analysis, 19 isolates from the three samples represent two strains of
Salmonella
enterica. The first strain includes 17 isolates derived from swabs collected from your poultry house (FDA Sample 1231486) that match 57 clinical isolates and demonstrates that this strain is capable of causing human illness. This strain also matches an isolate obtained from a chicken sample collected in Georgia in 2021. The second strain consisted of two environmental isolates derived from swabs collected from your poultry house (FDA Sample 1231467) and your egg processing environment (FDA Sample 1240106) that match 23 clinical isolates, demonstrating that this strain is also capable of causing human illness. This strain also matches five isolates obtained from chicken samples collected in Georgia and Illinois in 2023. We advised you of the importance of these WGS results on November 20, 2023.
In response to these sample results, you initiated egg testing, as described in 21 CFR 118.6(b)-(e). On January 11, 2024, you notified FDA of a positive SE egg test in your fourth consecutive egg test. We acknowledge that you voluntarily held your shell eggs while conducting egg testing, diverted these eggs for treatment, and further depopulated the group of laying hens. You also provided information on how you plan to clean and disinfect and resample the poultry house environment prior to placing a new group of laying hens. However, these SE findings within your poultry house environment, processing area, and within your shell eggs is an indicator that your SE prevention measures 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 are concerned that the corrective actions you have initiated are not adequate to address the Salmonella contamination on your farm, as further described below.
Your significant violations are as follows:
Shell Egg Regulation (21 CFR Part 118)
1. You did not have and implement a written
Salmonella
Enteritidis prevention plan (SE plan) that was specific to your farm and includes the minimum SE prevention measures as required under 21 CFR 118.4. At the initiation of the October 2023 inspection, your house contained
(b)(4)
flock of
(b)(4)
hens at
(b)(4)
weeks of age, and
(b)(4)
flock of
(b)(4)
chicks at
(b)(4)
old. You are required to have an SE prevention plan that includes, at minimum, the SE prevention measures outlined in 21 CFR 118.4 (a) – (e), which include (but are not limited to):
a. Procurement of pullets that are SE monitored or raising of pullets under SE monitored conditions, as required under 21 CFR 118.4(a);
b. Biosecurity measures to help ensure that there is no introduction or transfer of SE into or among poultry houses, as required under CFR 118.4(b);
c. Rodent and pest control measures as required under 21 CFR 118.4(c)(1) through (3);
d. Cleaning and disinfection procedures as required under 21 CFR 118.4(d);
e. Refrigeration requirements as required under 21 CFR 118.4(e)
Your response stated
(b)(4)
. Your response did not indicate a timeframe for completion, and to date, we have not received a copy of your SE plan and are unable to assess or evaluate your preventive measures.
2. You did not conduct environmental testing of the pullet environment at 14-16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). Specifically, we note that your firm received and raised pullets from day-old chicks. At the time of the inspection a group of layers in your poultry house were over 60 weeks of age, but you had not tested the pullet environment for SE when the pullets were 14 to 16 weeks of age.
Your response indicated
(b)(4)
. Further, we acknowledge that you provided an environmental sampling record for your second group of hens currently populated in your house that were tested for SE on January 17, 2024. However, this group was approximately 12 weeks of age on January 17, 2024, and their environment was not sampled when they were 14-16 weeks.
3. You did not conduct environmental testing for SE in your poultry house when each group of laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, your current flock was
(b)(4)
weeks of age during the inspection; however, you had not conducted environmental testing for SE when the hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a).
Your response indicated
(b)(4)
. We will verify the adequacy of the corrective action during our next establishment inspection.
4. You did not prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, during the inspection three dogs were observed inside your poultry house, where they also had access to the pasture area outside the poultry house.
In your response you stated
(b)(4)
. The presence of the dogs within the poultry house is a violation of 21 CFR 118.4(b)(4), and we are concerned about the presence of the dogs within the pastures to which the laying hens have access. As a producer, you must take appropriate 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).
5. You did not register your farm as shell egg producer, as required per 21 CFR 118.11(a). At the initiation of the inspection, your farm had 3,000 or more laying hens, was producing shell eggs for the table market, and was not selling all the eggs directly to consumers.
Your response stated
(b)(4)
. However, if you maintain a flock size above 3,000 or more laying hens and further meet the definition of persons covered under 21 CFR 118.1, you are required to register as a shell egg producer. To date, you are not registered with FDA as a shell egg producer, and we are not aware that you have decreased your flock size to under 3,000 laying hens.
FD&C Act
6. 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, our investigators observed the following conditions and practices at your farm during the processing of shell eggs:
Leftover product grime was observed on the egg candling line before processing.
Rust observed on areas adjacent to food contact surface points on your processing line.
Egg line brushes used to clean eggs were observed with an apparent substance after cleaning.
Porous wood was used as a brace on a portion of the processing line.
Duct tape was used as a repair on the egg packing line in areas that come into direct contact with shell eggs.
Your response stated
(b)(4)
. We acknowledge that you submitted photographs detailing the implemented corrective actions and will verify the adequacy of the corrective action during our next establishment 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 (15) 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 via email to Lakisha N. Morton, Compliance Officer at Lakisha.Morton@fda.hhs.gov or to the U.S. Food and Drug Administration, Attention: Lakisha N. Morton, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement (HFS-607) at 5001 Campus Drive, College Park, MD 20740. Please reference #672629 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
11/26/2024
Regulated Product(s)
Food & Beverages