ROSE Agar VIA OVERNIGHT MAIL April 30, 2018 Mr. Derek Price Director, Compliance Branch FDA Atlanta District Of?ce of Human and Animal Foods Division 3 East (Georgia-North Carolina-South Carolina) Of?ce of Regulatory A??airs US. Food and Drug Administration 60 Eighth Street NE. Atlanta, Georgia 30309 Re: Rose Acre Farms Response to FDA 483 Rose Acre Farms takes food safety very seriously. We ?Jlly accept our responsibility to provide a safe and nutritious food product. While we have tried to follow the requirements of the Egg Safety Rule, FSMA and the Federal Food, Drug and Cosmetic Act, it is apparent that, while in many respects we remain in compliance of these regulations and laws, we also fell short in several areas. Since the FDA inspection, we have implemented numerous corrective actions, both 1n the processing areas as well as the chicken houses. We have provided details of what we have done 1n the following FDA 483 Response. We have implemented not only these corrective actions, but other corrective actions that will ensure we achieve regulatory compliance, but will remain in compliance with these regulations and laws as interpreted by FDA and USDA. Following the recall, Hyde County Egg Farm has diverted all eggs away ?-om the table market. We will continue diverting eggs in this manner until we are con?dent that compliance has been achieved. We appreciate the time and e??ort FDA, and its sister agencies, have put into assisting us on our road back to regulatory compliance. .. ce [11 Tony sner, COO Below are speci?c actions Rose Acre Farms is taking in response to the recent FDA inspection and FDA 483 we were provided on 4/1 1/ 18. Currently all shell eggs from The Hyde County Farm are being diverted from the table egg market. We will not put shell eggs from this facility back into commerce until we are con?dent that all necessary corrective actions have been taken. While more details follow below, in summary we have focused on the following important areas: 1. Undertaken a root cause analysis. a. In regard to unacceptable rodent activity we determined that we were not fully implementing the procedures in our rodent control plan. We have retrained our personnel to fully implement the plan, we have added personnel to inspect each house and seal every possible opening we can ?nd where rodents may enter the chicken houses and we have hired Collins Pest Management Company to advise on increased rodent control measures. We will implement these increased measures and will forward to you these increased rodent control measures prior to selling shell eggs into commerce. When the rodent index rose to R2 our increased rodent control measures were not adequate. Since the FDA investigation we have increased our rodent control measures when the index rises to R2, as outlined below. As will be explained below we have hired third party professionals to examine the condensation from the roof area and we have brought in The Acheson Group to assist in a root cause analysis. The root cause analysis is ongoing, and we are assessing our overall environmental control program, and ways in which Salmonella could get into the processing environment. 2. Structural changes a. The chicken houses are being inspected for possible entries by rodents and those possible entrances are being closed. b. Repairs to the processing ?oor are scheduled to be completed by May IStand roof repairs are being scheduled. 3. Recall a. Since the visit, Rose Acre Farms has recalled product and is continuing to divert shell eggs from the table egg market. The Hyde County Farm, plant number P- 1065, has recalled 206,749,248 eggs produced with Julian Dates 011 through 102. A copy of the recall press release is attached. 4. Training a. We have retrained our personnel on fully implementing our rodent control plan. b. When the rodent index reaches R2 we have trained our personnel on the increased rodent control activities we will undertake to bring the index back to R1. These procedures are stated in greater detail below. c. Rose Acres has re-trained our personnel on proper sanitation methods and also implemented new sanitation methods and trained our personnel on these increased sanitation methods. Employees have been retrained on Good Manufacturing Practices with a focus on the areas pointed out by the FDA inspectors. 5. Review and changes to SOPs a. Immediately upon verbal noti?cation of the FDA inspectors Rose Acres changed numerous practices and processes in regard to sanitation procedures. We increased cleaning responsibilities by increasing personnel and instituted procedures such as a rinse down of washers and initial cleaning of the packing lanes on an ongoing basis for our day crew. 6. Full clean and sanitation of the processing area a. Rose Acres is working with Madison Chemical to facilitate improved cleaning and sanitation of the processing area as well as hired a sanitation supervisor. Rose Acres is currently searching for a professional cleaning company to facilitate extra deep cleaning of the plant and another company specializing in facility disinfection has been contacted to sanitize the plant after the deep clean is completed. 7. Revised environmental control and monitoring program a. Collins Pest Management has been brought in to advise on improved pest control measures. b. We have implemented increased rodent control activities when the index hits R2. c. Processing areas that were reported presumptive positive by FDA were cleaned, sanitized, and swabbed again. The plant is continuing with sanitation improvements and additional swabbing is in progress to verify effectiveness of the efforts. Repairs to the ?oor are scheduled to be completed by May IStand roof repairs are being scheduled. d. TUV, the Certi?cation Body for SQF audits has scheduled an audit to take place before the end of May to review that corrective actions implemented are effective and then an unannounced audit will take place in approximately 6 months to ensure corrective actions remain effective. Observation 1: When monitoring indicated unacceptable rodent activity Within a poultry house, appropriate methods were not used to achieve satisfactory rodent control. Resgonse: Rose Acre Farms failed to ?illy implement its written plan on rodent control within poultry houses at this location. We have retrained personnel to fully implement these procedures, have retained the services of Collins Pest Management to advise on increased rodent control measures, and have also made a concerted effort to plug all possible holes in which rodents may enter. We feel by implementing these increased rodent control measures that we will bring rodent activity well within FDA Guidance. At the time of the inspection, Rose Acre Farms was following SOP Rodent Indexing System, version 10, dated March 6, 2018, (Exhibit 1) which is used to determine adequate levels of rodent control in pullet and layer houses. Rose Acre Farms ?rst adopted the rodent indexing system and formula described in ?Guidance for Industry Prevention of Sahnonella 3 Enteritidis in Shell Eggs During Production, Storage, and Transportation,? following the publication of this Guidance in, and after consultations with FDA in 2011 and 2012. The Guidance describes recommended rodent monitoring methods in the ?Monitoring for Rodents? section 8). Rose Acre speci?cally follows the recommended RI monitoring method, which is based on the total number of rodents caught in a house in 7 days using 12 live catch traps and is used to estimate the rodent population. The formula standardizes the Index by adjusting for periods of time longer or shorter than 7 days and using more or fewer traps: Number or rodents for R1 [total number of rodents in trans divided bv woridnu traps set} x12 7 number of days traps are set The rodent population is then estimated by applying the number of rodents as determined using the formula above to the RI table below. An RI of 1 is likely to indicate satisfactory rodent control. A R1 of higher than 1 requires additional investigation to determine the source of the rodents. Number of Rodents caught in 7 days with 12 traps RI Description of RI 0-10 1 Low 1 1-25 2 Moderate 26 or more 3 High Rose Acre adopted this RI method, recommended and developed by FDA, in consultation with FDA and with our implementation of its Egg Safety Program to prevent Salmonella Enteritidis in shell eggs during production, storage and transportation. Guidance, including the RI method, was developed as a measure to prevent Salmonella Enteritidis from contaminating eggs on the farm by controlling the presence of rodents in the layer houses, and ?achieving satisfactory rodent control.?The RI index developed by FDA establishes levels that are indicative of satisfactory rodent control, and levels that indicate unacceptable monitoring activity. For example, the RI allows for up to 10 mice to be caught in 12 live traps per week to estimate a larger population of rodents that might be present in the house, and deem it ?Satisfactory control?. In order to understand how these rodent control measures are implemented at Rose Acre Farms, we brie?y describe the laying houses: 0 There are 12 laying houses located on the Hyde County Egg farm. 0 The laying houses that are present at this farm site are 100 feet wide by 670 feet long. The birds are housed in cages in the upper level of the house. 0 Manure is collected daily by automated scrapers that deposit and store the manure in the lower level of the house that is 9 feet tall. The scrapers create long wind rows of dry manure that builds up until it is time to be removed and sold as fertilizer. The ?oor for the manure storage is a concrete slab. Fresh air for the birds comes in from the top of the house, through the birds and over the manure storage before exiting out of the house. This serves as proper ventilation for the birds and aids in keeping the manure piles dried until removal is scheduled. 0 These 12 laying houses on site are some of the largest in our company, or in the industry in general. Each house represents 67,000 square feet of manure storage. In accordance with our Egg Safety Program and following the RI method described above, rodent monitoring and reading of the live traps is carried out weekly for each of the 12 laying houses. For the period referred to in the Form FDA-483, from September 2017 to March 26, 2018 there were weekly readings for some of the twelve layer houses that indicated houses were at a RI level of 2 (moderate activity). When rodent monitoring and readings establish a R1 of greater than 1, our company plan states that corrective measures will be implemented in order to reduce the rodent population back into low 1evels(RI 1). Our plan dictates that some of the correctional measures include the following procedures: (1) Use of rodent bait in the bait stations; (2) placing extra bait stations outside of the chicken house and also down walkways of the chicken houses (We used a total of 22 live traps in the bird areas to decrease the intervals between trap locations, well in excess to the FDA plan with a standard of 12 live traps); (3) having personnel walk around the outside of the chicken house and place steel wool, and then foaming, all visible holes where rodents may enter into the structure; (4) Placing rodent bait in holes in the manure in the lower level of the structure; (5) placing soft bait stations in both the front and the back of the structure; and (6) removing the manure from the lower level of the chicken house. Additionally, we rotated the different types of rodenticides so as to minimize resistance to the bait. While some of these steps were implemented when any particular chicken house rose to a R2 we implemented more of these steps immediately after the FDA inspection. For instance, as is discussed in more detail below we are removing the manure from the buildings that have an R2 index and are implementing the additional procedures to minimize rodent entry to bring the chicken house back to R1. Speci?cally, a review of your pest control records from September 2017 to present indicate an ongoing rodent infestation. The corrective actions taken by your ?rm have not been effective at reducing the rodent levels within your poultry houses to an acceptable level that is below the threshold established in your SE Prevention Plan. Response: Below is a table summarizing the pest control records made available to the FDA investigators, with a breakdown of the weekly rodent control, depicting the RI description (low 1; medium 2; high 3)for each House for each week from September 7, 2017 to the date of the inspection (March 26, 2018): ]For comparison a football field with end zones represents 57,600 square feet. 5 Rodent Numbers with 22 If/ House Yellow Moderate Acti?ty - Rodent Index 1le of 2 Requiring a Corrective Action Heavy Activity - Rodent Indra: of 3- Requ?rring a CorrEC?vE Acting! At the time of the inspection, there were four layer houses with heavy rodent activity 3) for a one week period. Layer houses #5 and #11 recorded a high R1 (R1 3) at the time of the inspection due to the increased employee activity in areas of the house. As explained below, Spring is a time of increased activity as we begin the process of moving manure out of the houses and increase repairs done on the chicken houses. Additionally, just prior to the FDA inspection (due to the Spring repair timeline for our company) employees were checking perimeters for rodent harborage and working on ventilation exhaust fans located in the perimeter wall the length of the manure storage area on both sides of the house. Rose Acre Farms determined that this heavy rodent activity was due to increased activity in the house that caused the mice to change their normal activity in and around the live traps. While we implemented some of the corrective actions stated above to control the increased rodent activity it was not enough. Since the inspection we have implemented the following procedures to get the RI down. Spring is the busiest time to move manure from our layer house storage to our composting site for future fertilizer sales. As a corrective action, Rose Acre will remove the manure from the storage area of the laying houses in order to achieve satisfactory rodent control, since most rodent activity is in this area of the laying houses. The clean out process, using heavy machinery, will take approximately one week per manure storage area. Rose Acre Farms has developed and implemented the following schedule for these cleaning activities: Layer House Number Begin Clean out of manure storage 4/16/2018 4/30/2018 5/01/2018 5/08/2018 5/14/2018 5/21/2018 5/28/2018 The schedule will be accelerated if houses take less than the week needed to completely clean out. Removing manure is one of the most effective rodent control measures available in that it removes harborage. In addition to manure removal we believe that by fully implementing the FDA Guidance on rodent control and implement the recommendations of Collins Pest Management that rodent activity will be properly controlled to a R1. Additionally, the following conditions were observed in the poultry houses: On 03/26/2018: House 9 - one (1) live apparent rodent in manure pit while swabbing about hallway down row two (2) in the pit, and one (1) live apparent rodent observed running across the upper level ?oor law row 19; two (2) dead apparent rodents observed on the ground, 10+ feet from the front of the houses; daylight observed through an area with spray foam creating a potential pest entrance in the manure pits around the closed roll up door at the front of the house near row four (4). Response: We have implemented the following corrective actions on House 9: I Placed black boxes with snap traps added down every aisle in bird area week of 4/ 16/ 1 8-4/20/ 1 8 I Placed trays of rodenticide in pit beams 4/4/ 8/ 1 8 I Mechanical monitoring devices added in barn 9 on 4/26/18, went from 22 to 42 to help us monitor more closely for potential rodent activity due the large house size, I Daylight observed around closed door at front of house (pit area) was checked and it was a thinner area of foam, no hole found, but the area had additional foam added 3/26/18, area was more permanently sealed with metal on 4/20/18 0 House 13 - multiple live apparent rodents running around the staging area in pit, and burrowing in and out of manure piles; ?ve (5) live apparent rodents observed in the manure pits. Response: We have implemented the following corrective actions on House 13: Mechanical devices were placed in bird area down the aisles on 4/4/18 Pit beams were baited on 4/4/18 Black boxes with snap traps added down every aisle in bird area week of 4/16/18-4/20/18 Trays with rodenticide placed throughout pit area between the rows of manure on 4/17/1 8 Mechanical monitoring devices were added to barn 13. Placed 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/26/ 18 On 03/27/2018:House 2 - one (1) live apparent rodent, downstairs in row 4, pit area. Response: We have implemented the following corrective actions on House 2: Pit beams were baited on 4/3/18 - Trays of bait were added to pit between rows of manure 0114/14/18 0 Black boxes with snap traps were added down every aisle in bird area week of 4/16/18-4/20/18 0 Mechanical monitoring devices were added to barn 2. Placed from 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/25/18 0 House 6 - one (1) live apparent rodent, in row 1, pit area. Response: We have implemented the following corrective actions on House 6: - Mechanical devices were placed in bird area down the aisles on 4/4/1 8 - Pit beams were baited on 4/4/18 . Black boxes with snap traps added down every aisle in bird area week of 4/16/1 8-4/20/1 8 . Trays with rodenticide placed throughout pit area between the rows of manure on 4/17/18 Mechanical monitoring devices were added to barn 13. Placed 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/26/18 0 House 10 - approximately 4-5 apparent live rodents in the pit were observed near the staging table and several were observed while dragging swabs, in the pit area; more than 10 apparent rodents observed in the pit staging area including baby mice. Response: We have implemented the following corrective actions on House 10: 0 Mechanical devices were placed in bird area down the aisles on 4/4/18 Pit beams were baited on 4/4/18 0 Black boxes with snap traps added down every aisle in bird area week of 4/16/18-4/20/18 Trays with rodenticide placed throughout pit area between the rows of manure on 4/17/1 8 0 Mechanical monitoring devices were added to barn l3. Placed 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/26/18 Approximately five (5) apparent rodents seen while walking rows during swab collection; also, a large spill/pile of what appeared to be feed with large ?ying insects too numerous to count between house numbers 10 and 11, directly beside canal. Response: As can be seen by exhibits 2 and 3 the feed spill was cleaned up. The picture below (Exhibit 2) depicts the area mentioned at the time of discovery. The outside area of our laying houses has a feed delivery system in an auger pipe that runs over head of this area. It had developed a small leak allowing feed to fall to the ground below the pipe. On 3/28/18 we repaired the pipe that had a leak so that it will not leak again and also removed the spilled feed. Exhibit 2 taken 3/27/2018 shows the site during the FDA inspection and Exhibit 3, taken on 3/28/ 18 shows the cleaned up area. (Exhibits 2 and 3 are attached below). Cleaning up the feed resolved the ?y problem that was observed during the FDA inspection. House 11 - one (1) live apparent rodent in manure pit while swabbing approximately halfway down row 5; possible apparent rodent burrows observed in the manure piles; apparent dead rodent carcass on row 5; possible apparent rodent hole/burrow observed in the large grave] in the front of the house; and 1 apparent live rodent on the bird platform. Response: We have implemented the following corrective actions on House 11: On 03/28/2018: Mechanical devices were placed in bird area down the aisles on 4/4/18 Pit beams were baited on 4/4/18 Black boxes with snap traps added down every aisle in bird area week of 4/16/18-4/20/18 Trays with rodenticide placed throughout pit area between the rows of manure on 4/1 7/1 8 Mechanical monitoring devices were added to barn 13. Placed 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/26/18 House 5 three (3) live apparent rodents were observed downstairs, in rows 4 5. Response: We have implemented the following corrective actions on House 5: Mechanical devices were placed in bird area down the aisles on 4/4/18 Pit beams were baited on 4/4/18 Black boxes with snap traps added down every aisle in bird area week of 4/16/18-4/20/18 Trays with rodenticide placed throughout pit area between the rows of manure on 4/ 1 7/ 1 8 Mechanical monitoring devices were added to barn 13. Placed 22 to 42 monitoring devices to help monitor for potential rodent activity due to the large house size on 4/26/18 House 8 two (2) live apparent rodents were observed downstairs, in rows 4 1. 10 Response: We have implemented the following corrective actions on House 8: 0 Mechanical devices were placed in bird area down the aisles on 4/4/18 - Pit beams were baited on 4/4/18 0 Black boxes with snap traps added down every aisle in bird area week of 4/16/18-4/20/18 0 Trays with rodenticide placed throughout pit area between the rows of manure discussed above, Rose Acre Farm utilizes the RI method, recommended and developed by FDA, in order to monitor rodent activity in the layer houses. We have discussed the past corrective actions taken (from September 2017 March 2018) in response to (prior) unacceptable rodent activity above and realize that these, as implemented, were not effective. As discussed above, we have since implemented several additional procedures to bring the rodent activity to acceptable levels. Below, we address the additional, speci?c observations regarding rodents, insects and potential pest entrances. In addition, an independent third party Pest management company has been hired to come in and evaluate the corrective actions being used when layer house indexing indicates their need. They arrived 4/21/2018 to begin their review and will report on the plans effectiveness or recommendations to improve or add any corrective actions. We will share any new approaches to our pest control program with FDA once they are ?nalized. Potential Pest Entrances On 3/26/2018, in Layer house it was noted that daylight was observed through an area with spray foam creating a potential pest entrance in the manure pits around the closed roll up door at the front of the house near row four (4). This spot on the door was an area where insulating foam sealant was used to seal and insulate an irregular area where the t0p of a 9 foot door meets the frame. As seen in the picture below, taken on 3/26/2018 (Exhibit 4.), the area of the foam was still intact, but thin at that point showing the illumination of sunlight, but no actual hole to the outside was present. The area was foamed again on that same day (Exhibit 5). It is evident that the top of the door is 9 feet above the ground and clad with a smooth metal siding (Exhibit 6). For reference the area is represented with a picture from the outside (Exhibit 7) of the building. 11 Observation 2: There were insanitary conditions and poor employee practices observed in the egg processing facility that create an environment that allows for the harborage, proliferation and spread of filth and pathogens throughout the facility that could cause the contamination of egg processing equipment and eggs. Rose Acre Farms has been in regular communication with food and shell egg industry subject matter experts, such as Oscar Garrison from Dr. David Acheson, Peymon Fatemi, and others from The Acheson Group; Trena Beaty, Terry Willis, and others from Madison Chemical; Dan Collins from Collins Pest Management, to better understand how to incorporate the changes needed into the shell egg packing facility. All employees at the farm are involved with the improvement process and all are focused on the goals at hand. Training performed since the inspection has been well received by employees and the extra efforts put forth by all are evident. Sample records of training are attached as Exhibit 8. Since the inspection, as part of this culture change, Rose Acre Farms has established a Corporate Sanitation Manager to oversee and audit cleaning and sanitation at the farm level; in addition, Corporate Quality Personnel are receiving additional training on sanitation as part of the checks and balances of this program. As a reminder as we implement changes all eggs from The Hyde County Farm are being diverted to either a land?ll or to off-line breaking plants and no eggs from the farm are entering commerce as table shell eggs at this time. We will not put shell eggs into commerce from this facility until we are con?dent that all necessary corrective actions have been taken. On 03/28/18, a review of the firm?s sanitation procedure, Cleaning Procedure for Egg Orientor Belt, Form 6.7.0 Version found that the procedure for cleaning the Orientor in the egg processing facility was not being implemented by management and followed by sanitation employees. Employees were observed bypassing the degreaser step, and observed spraying on the detergent and immediately whipping off, not allowing the detergent to soak for the prescribed 10-15 minutes. Reslionse: Representatives from our Chemical supplier, Madison Chemical, visited the Hyde County Egg Packing Plant the weeks of April 2nd, April 16th, and April 23rd. During the visits, cleaning procedures were reviewed and updated. 6.7.0 F-5 Moba Omnia FT 500 Packer was updated to include a clean water rinse after cleaning and a sanitizing step. 6.7.0 F-6 Moba Omnia FT 500 Transfer was updated to include a clean water rinse after cleaning and a sanitize step. 6.7.0 F-7 Egg Orientor Belts and Dividers was updated to provide the use of two new chemicals and BIOREM for cleaning and a sanitizing step was added after cleaning and rinsing. 6.7.0 F-S Mechanical Egg Washer was updated to require a rinse at the end of production to facilitate cleaning and a sanitizing step added after cleaning and rinsing. 6.7.0 -9 Acid Cleaning was updated to use SOAR or ACID on areas not completely descaled during the acid wash step and a sanitizing step was added after the cleaning and rinsing. 6.7.0 F-10 12 Moba Omnia FT 500 Overhead Carriers is a newly written procedure to provide written instructions for cleaning the overhead carriers. It includes application of a sanitizer. A copy of the updated procedures approved 4/23/18 is attached as Exhibit 9. Employees have been thoroughly trained on updated procedures. To ensure that cleaning procedures are being followed, the facility quality manager is currently scheduled to work a split shift covering the end of sanitation and beginning of the packing shift. After 1 month, the progress of the sanitation crew will be evaluated by Corporate Personnel. Once the facility passes Corporate inspection, the Quality Manager will schedule 1 night every other week, eventually reducing to 1 night per month to inspect cleaning operations. On 3/28/18, during a review of the ?rm?s cleaning procedures and a walk through of the cleaning procedures we observed that the ?rm did not have in their procedures or use a sanitizing step following the wash step. Response: A sanitization step using Madison 75 at a concentration of 150?400ppm has been added to the cleaning procedures following the cleaning step in 6.7.0 F-S Moba Omnia FT 500 Packer procedure, 6.7.0 F-6 Moba Omnia FT 500 Transfer procedure, 6.7.0 F-7 Egg Orientor Belts and Dividers procedure, 6.7.0 F-8 Mechanical Washer procedure, 6.7.0 F-9 Acid Cleaning procedure, and 6.7.0 f?lO Overhead Carriers Procedure. The Overhead Carrier procedure has the option of using ALPET D2 to clean and sanitize in one step. A copy of the cleaning and sanitizing procedures is attached as Exhibit 9. A form for recording sanitizer strength from the dispensing system was created and implemented. Copies of the completed form is attached as Exhibit 10. All appropriate personal are now trained on the new procedure and the cleaning procedures will be inspected by the Quality Manager and by the Corporate Sanitation Manager. The Quality Manager'will work a split shift with part of the shift with the sanitation crew and part of the shift with the packing crew until Corporate inspection con?rms sanitation procedures are suf?ciently followed. Upon approval by Corporate, the Quality Manager will inspect sanitation operations on a basis. As part of the checks and balances, a Corporate Sanitation Manager will oversee the cleaning and sanitation program and Corporate Quality will increase inspections. Visits to the facility will be scheduled by Corporate Personnel to ensure the items listed above remain properly implemented and that they are effective. A swab program consisting of weekly swabbing using ATP or similar technology for Zone 1 and 2 and swabs for Salmonella analysis for Zone 3 is under development and will be implemented before the facility returns to packing eggs for the table egg market. Attached as Exhibit 11. Throughout the inspection we observed condensation dripping from the ceiling, pipes, and down walls, onto production equipment (i.e crack detector, egg grader) and pooling on the ?oors in food traf?c and forklift pathways. Resgonse: Contractors visited the plant the week of April 23Tdto inspect the roof and ceiling in the plant. A projected completion date for repairs will be provided when available. The facility will be inspected by Corporate personnel for condensation and standing water to insure it is not present 13 inspected by Corporate personnel for condensation and standing water to insure it is not present prior to returning to packing for the table egg market. Plant and Corporate Quality Personnel will monitor for water condensation and standing water and insure it is not present during routine inspections. On 3/28/18, we observed maintenance and sanitation employees placing buffers (food contact) and metal covers to the egg packer with buffers (non-food contact) onto the ?oor, pallets, and equipment that was visibly dirty with accumulated grime and food debris, before placing the equipment into service. Additionally, throughout the inspection several production and maintenance employees were observed touching non-food contact surfaces face, hair, intergluteal cleft, production equipment with accumulated grime and food debris, ?oor, boxes, trash cans, inedible transport cans) and then touch shell eggs and food contact surfaces buffers, rollers, etc.) without changing gloves or washing hands. We also observed maintenance employees dragging non? food contact equipment black electrical conduit with accumulated grime and dried food debris) on top of food contact surfaces conveyors and rollers). Response: Employees have been trained on equipment handling and GMPs focusing on the items pointed out during the visit by FDA. Employees will be required to wear disposable sanitary gloves when handling food or food contact equipment before returning to the table egg market. Training on the proper use of disposable gloves will be provided for individuals handling product or product contact equipment post sanitation or during packing operations prior to returning to packing for the table egg market. Quality Personnel will monitor effectiveness and enforce proper use of disposable gloves. Corporate Quality and the Corporate Sanitation Manager will monitor for proper use of disposable gloves during routine visits. The facility will be visited by Corporate personnel at least to inspect for these items and insure the practices are being implemented properly. The sanitation crew has been provided with new carts to handle product contact equipment during cleaning and sanitation. Employees have been trained on proper equipment handling and GMPs such as hand washing and sanitation. These aspects will be reviewed and improved upon during visits from Corporate Personnel. Throughout the inspection we observed equipment conveyor belts, chains, rail guards, buffers, egg transport arms, egg clappers, production computers and exterior of production equipment surfaces) with accumulated food debris dried egg and shells) and grime, post sanitation. The same areas of accumulated debris were observed uncleaned on multiple days during the inspection pre? and post-sanitation. The overall culture of the facility is changing to higher expectations for the packing plant. Cleaning and sanitation procedures have been updated with the assistance of Madison Chemical. The updated procedures include use of new cleaning agents and sanitizing steps. The updated 14 cleaning procedures are attached as Exhibit 9. A Corporate Sanitation Manager will oversee the cleaning and sanitation moving forward. Auditing will be performed by both plant and corporate quality personnel. The plant will receive visits from Corporate personnel to ensure programs remain effective. Personnel from other facilities are working at the Hyde County Packing Plant to assist and work with the cleaning and sanitation crew. Additional cleaning and sanitation personnel were hired to provide more hours of cleaning each sanitation shift. A ?illy revised and updated environmental monitoring program (EMP) focused on all zones including zone 1 food contact surfaces is under development and will be implemented before the facility starts back into packing eggs for the table market. Attached as Exhibit 11. On 03/28/18, we observed a sanitation employee on the right line, packing area, lanes 1-11 utilizing a steel wool scrubber to scrub debris off egg buffers in service, post sanitation. The steel wool scrubber was stored on a cart in a dustpan that had a pool of water and egg mix with ?oating food debris and grime. Reslionse: Employees received training instruction to not use any equipment or utensils for ?oor contact on equipment or in contact with cleaning utensils used for food contact surfaces. This will be observed and addressed during Corporate Personnel visits and by the plant Quality Manager. The Quality Manager and Corporate Personnel will monitor and retrain as necessary during their respective inspections. A revised environmental monitoring program is currently under development and will be implemented prior to returning to the table egg market and results trended to monitor the sanitation programs effectiveness. Any deviations will result in a reassessment of the program and training as necessary. Throughout the inspection weobserved at least 25 ?ying insects throughout the egg processing facility. The insects were observed landing on food, food contact surfaces, and food production equipment. Response: A pest control service company, Collins Pest Management, visited the plant on April 21-22 to review the pest management program and to provide a report with recommendations for improvements. We will consult with the pest management provider to have a documented corrective action plan completed within 2 weeks after receipt of the report. Follow up inspections by Collins Pest Management for program review will be scheduled regularly to ensure pest control programs are maintained and effective. On 03/28/18, we observed an employee mix and use a sanitizer on food contact equipment that was not prepared according to the manufacturer instructions. When tested with a quaternary ammonia test strip, the sanitizer was found to be 1500ppm, outside the acceptable range of 150-400ppm. 15 Res;nonse: The quaternary ammonia sanitizer dispensing system was corrected immediately after the above observation and by the evening of 3/28/18 prior to that evening?s sanitation step. Employees have been trained on checking and documenting chemical concentrations. A copy of sanitizer concentration records is attached as Exhibit 10. Quality personnel have been instructed to monitor records and ensure concentrations are checked accurately. The Quality Manager at the plant is verifying records to ensure concentrations are Within limits. This will be reviewed during Corporate Personnel inspections as well. 16 EXHIBIT 1 Rose Acre Farms I ma: Rodent mam swam ?m ymno Mama? I mama-Flor: ?Purpolc: Who Where When Action Reference Records Layla-and Pl?lntand Weekly Pullat?tm layu- employees Houses back to twelve mp5. RCB ({(TamIMmber ofRodmn' 1' Rita! Number of?ups??jj [Nimbu- afDa?uX?) mdninuoh huildingdminglwukhelm?l)orabm. magma-mow) Rodent 1-an 21.1mm 0-10 1 Law 11-25 2 Moduli: (om-motive lotion . 26 or more 3 High (ml-rod!? action W) 17 magma: .icw. TH. n. .. .. ma EXHIBIT 4 Hm EXHIBIT 6 EXHIBIT 7 EXHIBIT 8 Employee Training Checklist Lista de Entrenamiento del Empieado have been trained by Rose Acre Farms in the following Areas: Yo, he side cntrenadu per Rose Acres Farms en las siguientes Areas: Topim?ehia Date?! Feeha Team Member i?l?iiaer Initials I Iniciales de] 5 dc! Miembro del Entrenador I rm Equipo :Fond Quality and Safety Policies 1.- - 7 [pains d?e Calidnd de Aliment: 31: Seguridad - jinnd Manufacturing Practices 5) Buemg Pr?c?cas de Manufacture - Control of Physical Contaminants I pentrol dc Contaminantes Fisieos ?1 7? :Pood Defense green dealesgenfen?f} cea__ - 1? . . aanmg an em on re ures _Procedimien_tus de Limyiezn de Levado I Allergen Awareness -24 . - Qeneeimianm de Al?rgenos" IPest Control Awareness !Cnnocimiento de gont'rql de Plagas 1'1! ?24 - IWork LocationfDepMment: 35' rahajo: i?au- Team Member Signature: Fim'm del? Miembro del Equipo: 1 ;Trainer Signature: lErma dc! 7 - Trainer Signature: Fm deleemgsaor sTrainer Signature: EFin-ma del Entrenador: Veri?ed By (Veri?cado 11002;? Date (Fecha): Z. Form [Fame Ii!) 6.3.0A I Version (Vet-slain) 9 Dale (Fechn) I mm 24 EXHIBIT 8.1 MADISON CHEMICAL Co" Inc; .?il-H L??j'?rfw - Mam. ammurzm - . - Bm?ualulimti?mh?nmuwn . w?mm?mkm?m?m EMPLOYEE REGULATORY TRAINING LOG EMPLOYER: (cuahl ??rm DATE: 5? I . SUBJECT: 77+ (cw Hum?; INSTRUCTOR: [mm bf?oh 4 WM EMPLOYEE .V. - I -- _b 25 EXHIBIT 8.2 MADISON CHEMIC Co., Inc. 3m thb?ih?iiu - Madam. hulinm-WZEO ?2.211.611! ills - - HAZARD COMMUNICATION QUIZ 1. Before starting any job with a chemical, you should: a. a manufacturer?s booklet on the chemical end the chemicnl's label and 5335 0. Put on a respirator and protective suit 2. You eon be exposed to a chemical by skin or contact, inhaling or swzw- 11;. True is. False 3. Every hazardous substance in the workplace must have a safety data sheei (SDS). True 13. False Ii. The corrosion pietogram indieotes: Explosiire Skin corrosioniburns e. Flammable 5. To prevent splashes or boiling you should: a. Add chemicals to water quickly Add chemicals to water slowly c. Have someone else add chemieals to water aura.- ,Lp. .. Name: ?15:3: new: 49g 26 6. ?chlorinated products and acid products mix: Toxic chlorine gas is created h. Nothing happens e. They explode You should report missing or unreadable labels so they can be cell. True b. False 8. When working with sanitizers: a. You must follow instructions on the label 1). You should always wear PPE All of the above 9. You should neVer mix a chemical will another chemical unless sp- cally instructed lode so. ?a True b. False Ill. The health hazard pietogram in les: (3 Carcinogen b. Self-heating e. Selfiroactive ?1 .. -- Signature: EXHIBIT 8.3 E11519 helm! hav'abaeriwainedmthew mm (QSOPJ. an: mm a: the Hyde W9 ?3559 mound 27 EXHIBIT 9 Rose Acre Farms- Hyde County Grader Plant PROGRAM I CLEANING PROCEDURES Claimed #35531 Am- Sheli Egg Processing Panor- Quali?od Sanltor, Operator or Responsible Properly Trained Designea Person Senliation Supanmor' Aununlable Personal Palmolive Boats. Safety limes. WW Gloves. Apron Frequency Daily. following production Lockout-TIM May be required for lire SSOP. follow company guidelines. 5m (?31742: Illa important in understand the poleniiai risks associated with allergens. Quality Assurance must vlwaiiy and analyiioely Requirements Cloning Mutation: 3-696 bywl. Gomenua?an: 150-400 4-8 ozI1 gel water 1-2.61 on gel water Guinean-alien: 4-856 by vol. 5-8 oz" gal water 28 EXHIBIT 9.1 Wit Date Issued Daio? Indeed ?F?age?iaf?z [am Hi 4:23:13 4:23:13 Pack-r I Frossr-Lure NOTE: Don all required PPE per: company policy prior to chemical use. . '35 5?13?. iiz?gf?ijhi W. ?Remove all linished product trash and debris frorn area. 2)Prepare a bucketof?.? 12323111.:- ?1 rid-.3 s34"; - ?1 i :3 1:33 213? mi. . 3)Remove and empty all drip trays and pans into the inedible barrels. Rinse hayslpans and wipe with damp cloth of cleaning solution if needed. then rinse with fresh water. 4)Use compressed air to blow down the packer. This' Is approved by Mobs. Blow dust and debris from areas which are dif?cult to reach using air hose with pistol. 5)Use damp cloth to wrpe down surfaces of the packer for general cleaning. Use cleaning solution of .. or .. . w} ?needed- 6)Wipe off packer chains. guides. carton bed. and take away rollers or belt with a danip cloth. (MUST KEEP WATER TO A MINIMUM). Use cleaning soiulionof 31;- .- .. LJ {?32 .Borif - 7; z?tiifneeded. 7)Use a clean cloth and clear waierto wipe all surfaces deaned' In steps 5 and B. 8)Wipe packer side guards with damp cloth using plain water or cleaning solution it needed. These guards can be removed and rinsed and washed with cleaning solution if needed 9)When cleaning floor under and around packerpart g? me eg?er with water. 10) Use damp cloth to wipe down surfaces of the packer for sanitizing. A spray application is also acceptable using spray patties or a garden sprayer. Use sanitizing soiution of Aid 7'5 (11? (if . 29 EXHIBIT 9.2 Rose Acre Fanns- Hyde County Grader Plant SANITATION PROGRAM I CLEANING PROCEDURES W: 0.1an ran-mm Page1ef2 5.1.0 F-e mus we we; may? =way3arm Enlarger Area Shell Egg Parson Quali?ed Sanitur. Operator or ?will!" Properly Trained Designee Person Sanitation Supervisor Accountable Personal We Boots, Safely Glasses. Gloves. Apron Frequency Daily. following produellon Lockout Jason: May be required fur the SSDP, guidelines. Bpeelal 13:31:33: It Is Important to understand the potential risks associated with enemas. Quality Assurance must visually and analy?eelly R?mm?? validate the cleaning of Ibis arm prior to rel-aha lo ?nnTag Canaan?tron: by? . Concentration: 150400 4-3 am gel was a, 1-2.6? oz? gal weler Coneewmion: 443% by vol. 5-8 0211 gal water 30 EXHIBIT 9.3 summer IayTam ill-W imam 8.7.0 F-E 4:23"! Transfer . Procedure NOTE: Don all required FPE par comm poilcy prior to chemical use. equal: i! if": 3? ii! .: 1gp..an ?r '(J??LflLihip Co: ?Remove and empty all drip trays and pans into the inedible barrels Rinse trayslpans and wiperwith damp cloth of cleaning solutionifneedad. thenrinsewithfreshwater. 2)Use compressed air to blow down the transfer. This is approved by Mobs. Blow dust and debris from areas which are dif?cult to reach using air hose with pistol. 3)Preparea bucket ofG?i 3.31% (3. 31 {53:23. iormi ?Use: damp cloth to W93 down surfaces of the transfer for general cleaning. Use deaning solution of . mi}; LIAN. Eblfneeded. 5)W'pa off transfer bars with a damp clam (MUST KEEP WATER TO A MINIMUM) Use cleaning solution a i? 33!. 15': . 33? 5.3.) or siix "11 [f :3 :m .-.llfneecled. cleaned. Binapeat step 5 as needed to completely clean transfer bars. TlUse a clean cloth and clear water to wipe all surfaces cleaned in steps 4 and 5. 8)Usa compressed air to blow down the transfer again as done in step 2 to ensure all debris has been removed. 9)Use damp cloth to wipe down all transfer bars for sanitizing. Use sanitizing solution of (toe-son ppm). Jog the grader as needed to ensure all transfer bars are sanitized 31 EXHIBIT 9.4 Rose Acre Farms- Hyde County Grader Plant SANITATION PROGRAM I CLEANING PROCEDURES bun-ma mm mm Page 1 of2 9 mm: Bolt. and ?2311! 18 Mr. was; By: was: 3am mm Area Shall Egg Processing Mon Quali?ed Samar. Operator or Pm?y Traimd Dosignae Parson Sanitation Supervisor While Personal Protective 3001:. Safety Glasses. Equimm Gloves. Apron Floquancy Daily. following produdon Lockout - Tammi May be mquh?ed for the Maw company guidelines. Special ?sksassociatedwimaiiergm. validate the cleaning uf?is ama pliorto releasing to produdion. aiming Oom?un: 4-896 by vai. Comm: 0.54.099 byvol. Ghonlicais 13-26me momma-8% by vol. mm?hyvd. +8on aaiwater Commutation: 150-4009pm NOTE: MbIEnzyinamandBiorem 1-2.6702I493Iwalm CDZDIn?JWgalionsofwaterlo lill??iemna?onfoawwimone 32 EXHIBIT 9.5 @1321} 04151.13qu :Deta Em 5.7.0 F-T NOTE: Don all required PPE per company policy prior to chemical use. 1) Remove all ?nished product. trash and debris from area. 2) Cover all electrical panels and boxes with plastic. 3) Pro-rinse area. High PressureIBoosted Pressure Rinsing is the preferred method in removing shell and egg soil residues. Note: When rinsing. be nrefui not to spray directly onto any bearings. 4) Use foamer station to apply . g, consistingof . .- _?and .soiutlon. reaching as far toward the middle as possible. Use hand brush or part to manually clean all areas. 5) Rinse equipment of cleaning solution with fresh water. High PressureIBooeted Pressure Rinsing is the preferred method. Ensure the interior of the belts and intemai pieces are rinsed as well. 6) Remove plastic from electrical paneislboxes. 7) Using pump up sprayer and cover all surfaces of equipth with sanitizing solution from bottom to top. I,or2parlfoam 33 mns . EXHIBIT 9.6 Rose Acre Farms- Hyde County Grader Plant SANITATION PROGRAM I CLEANING PROCEDURES Dootmmii mm fem 'pagudz Mechanical Egg 6.7.0 F-B #23118 4123118 Wa_shef Approved By: Imam By Review By: sum limp! or Area Shell Egg Processing Person Quali?ed Sanitor. Operator or Responsible Properly Trained Designee Person Accountable Sanitation Supervisor Personal Protective Boots. Safety Glasses. Eqalpment Gloves. Apron Dally-following Frequency production Lockout - Tagout May be required for the 880?. follow company guidelines. Special Allergen: ii is Important to understand the potential risks associated with allergens. Quality Assurance must visually and analytically Requirements validate the cleaning of this area prior to releasing to production. Cleanlng ENVIRD CLEAN 444 Concentration: 4-696 by vol. 76 Concentration: 150-400 Chemicals 58 ozi1 gal water (Sanitizer) 1-2.6? 02/4 get water GREEN CLEANER MPO 3-65 by vol. 4-8 0211 gal water 34 EXHIBIT 9.7 nomads 1mm *oarmmT_ *Fm [Pa9e2ofz ?:sr.o F-B Mechanical Egg Washer I ?23:13 man?s NOTE: Don all required PPE per company policy prior to chemical use. 1) Remove all ?nished product. trash and debris from area. 2) immediately following the days production. rinse down the top lids and thoroughly rinse down the inside covers and all washer distribution pipes. support bars and mechanical brushes. Note: Brushes can sustain water up to for rinsing. Water at this temperature may be used safely (per Mobs) if applied back and forth across the brushes intermittently. 3) When the upper cabinet is completely rinsed and cleaned. pull the washer screens and rinse off thoroughly. Drain the wash tank solution and rinse out inside of washer tank thoroughly. 4) Use foamer station to apply ENVIRO CLEAN 444 1 or GREEN CLEANER MPD - solution from bottom to top. Use hand brush or pad to manually clean all intemal and extemal areas of the washer. Rinse the washer inside to outside. top to bottom with fresh water. Replace washer screens and leave the washer lids open to dry and air out machine. 5) Using pump up sprayer and MADISAN 75 cover all surfaces of equipment with sanitizing solution from bottom to top. 35 EXHIBIT 9.8 Rose Acre Farms- Hyde County Grader Plant SANITATION PROGRAM I CLEANING PROCEDURES comm il? Dateisaued Datelewaad? WTJY2 6.1.0 F-O 4123118 #23118 Acid Clotting-Washer Approved By: Approved Bic Revisited By My aim hams?_ Area Shell Egg Processing Person Quali?ed Sanitor. Operator or Responsible Properly Trained Designee Person Accountable Sanitation Supervisor Personal Protective Boots. Safety Glasses, Equipment Gloves. Apron Weekly or more Frequency frequently if necessary Lockout - Tagout May be mouired for the SSOP. follow company guidelines. Alieegan: It is important to understand the potential risks associated with allergens. Quality Assurance must visually and analytically Special Requirements validate the cleaning of this ama prior to releasing to production Cleaning SOAR Concentration: 0.64% byvol. Medium 75 Concentration: 150-400 Chemicals (Add Detergent) 1 oz" get water (for ?rst application) . Sanitizer; 1-2.6? ozl4 gal water SOAR Concentration: 20-25% hyvol. ACID Concentration: 20-25% by vol. {Acid Detergent) 32 0211 gal water (for second (Add Detergent) 32 ozl'l gal water (for second application) application) 36 EXHIBIT 9.9 JDaislssued ?ioaemveed 15W i 6.7.0 F-9 4123118 1 4123118 1 Acid Cleaning-Washer Procedure NOTE: Don all required PPE per company policy prior to chemical use. 1) Remove all ?nished product. trash and debris from area. 2] Ensure that the egg washer has been drained and completely rinsed down. 3} Start the washer to start water circulation and heating of the water. Add SCAR (ms-1.0% by vol.) to the water one tank at a time using the control panel and chemical wand installed at the wash tanks. Slow speed of washer down so that we can have maximum contact time with the egg spools. 4) Wash sotution temperature should be approximately Clrculate the hot acid solution for one hour. It washers and egg spools have excessive buiid-up. you may need to add a little more by vol.) and run for another Ya-t hour. The acid solution should maintain a pH range of 2-3. 5) Drain the washer tanks of acid solution. As the tanks are draining, foam the insideloutside of the washer with a solution of SOAR (20-25% by vol.) or ACID (20-25% by vol.) using a foam or spray applicator. 6) Thoroughly rinse the inside and outside of the washers. Rinse washer from top down to the bottom; ensure all traces of acid are removed from system. ?Do not spray directly onto any bearings. Check that all spray nozzles are open and spraying properly. 7) Using pump up sprayer and MADISAN 75 (150400 ppm) cover all surfaces of equipment with sanitizing solution from bottom to top. 37 EXHIBIT 9.10 Rose Acre Fanne- Hyde County Grader Plant SANITATION PROGRAM I CLEANING PROCEDURES Decimal! iDalarevisad Equinurl' Pagelolz Moba Omnla FT 500 8.1.0 F-10 4:23:18 M23113 Ova I Ca I ?r Approved 350 mm as mm mm Comm ?nger Area Shall Egg Processing Person Quali?ed Sanilor. Operator or Responsible Pmperiy Trained Daeignae Person Accountable Sanitation Supervisor Personal Premium Boole. Safety Glasses. Equipment Gloves. Apron Dally, following Frequency production Lockout - ?layout May be required for the SSOP. follow company guldalines. special Allergen: It is important to understand the potential risks associabd with allergens. Quality Assurance must visually and analytically Requirement- validate the cleaning of this area prior to releasing la production. Cleaning GREEN CLEANER MPO Canaan?h-a?on: seas by vol. Concentration: 150-400 Chemicals 4-3 ozll gal ureter 1-2.6? ozl4 gal water ENVIROCLEAN ?4 Concentration: til-6% by vol. 5-0 02" gal water 38 EXHIBIT i name-rm ioarermd Inseam lea-um Page2oi2 I 6.7.0 mm .1 Overhead Carriers Procedure NOTE: Don all required PPE per company policy prior to chemical use. CAUTION: This is NOT a wash down NEVER at any time hose down any part of the overhead carriers! Due to sensitive parts on the carriers. do NOT use compressed air on any part of the overhead carriers! Option 1 1) Prepare a bucket of ALPET DZ (100% by vol.). 2) Using a damp cloth or damp brush wipe down all overhead carriers for cleaning and sanitizing. Use ALPET DZ (100% by vol.) Option 2 1) Prepare a bucket of GREEN CLEANER MP9 by vol.) or ENVIROCLEAN 444 (ll-6% by vol.). 2) Use damp cloth or damp brush to wipe down the carriers individually. (MUST KEEP WATER TO A MINIMUM). Use cleaning solution of GREEN CLEANER MPO (36% by vol.) or ENVIROCLEAN 444 (4-696 by vol.) if needed. Jog the grader as needed to ensure all overhead carriers are cleaned. 3) Use a clean cloth and clear water to nine all surfaces cleaned In step 2. 4) Use damp cloth to wipe down all overhead carriers for aan'rti?ng. Use sanitiz?ng solution of MADISAN 75 (150-400 ppm). This should be done alter each individual center is cleaned then wiped with water (steps 2 and 3) to minimize jogging of the grader. 39 EXHIBIT 10 Rose Acre I Title: Sanitizer Concentration I I 'Farms Inc. I?m-slum: I Date: 3128118 Page NIL: Page 1 cf] Hyde County ?53 an I559 ?we Cm, Rd Purpose: Provide documentation of samilmer concentration Sanl?zerUsed: M131 7 Range Desired: 150-400 mm Day Date Time {Summation (ppm) Initials Monday lg? 09 33.6, (L46 . '771'013 1% WM ma WQLO g, ?My j?oo ?Va (2135; 3-05 215' am Saturday 4-;qu grab Ann/g 13f; . . . . Sunday .. gr; 3'0 275/ I t: Veri?ed By: Fri? Date: .J 40 EXHIBIT 10.1 r? . 7 . Rose Acre Title: Sanitizer Concentration Ewiett?m 6'10 F4 Farms Inc I . I Page No: Pug: ofl Hyde County 933 Pm i . l560 Hyd: Pm: Canal Rd. Puma-n, NC 27860 Purpose: Provide of sanitizer concen?ation um: "5 75 concentratlon Range Doslred: I Day Date 'l'lme Gonnammlun (ppm) lnl?ab Mon-daft 3?31"! LOO 'l 9.00 W55 @223: 200 we 459% ..- 133?? '4 in; ME) 21% lsw?-. I fly? 225: Sunday (ff/14F; f: 4/3" ma 2.3.5 2 VerifiedBy: DEW: 1 41 EXHIBIT 10.2 I Rose Acre Title: Sanitller Concentration . W"mt NW G-?l?j Farms Inc Version: I _msns . Pig: NIL: Fag: I of I Purpose: Provide documantnulion onucemralian Sanitizu Used: 5 7 7 Concentration Range Deslred: Mm m, commu.mm{ mm Mm.? . mm Tuesday V. AWPM- Rm ?mm? yer/43> a" ..- '71" M/i? . 50 300 :mcez? PM _3/50/ f?roo 390 . 5mm, 3174118 ?4 mm 260 I am I Sunday 3/31/18? I W53 900 ?61: (lib t-V Ila! ?agrarian! 1? M053 Veri?ed By: Date: (775/? 42 ?0chan EXHIBIT 11 6.7.2A \aill: mt mm Fm?oulo? When Weekly . Signature: Auk-hm Anatmhahhmb-Wm?h mdomloa?nm?om?mmoblist - Wan. Limillwill - mum mi - normative-06mm? maxim Wmhuwl?g?oHnuddI-h. - ?min-hp?u?mdmhu?-hn?nm?h Mandi?) 40in}. - Jim?hi nmpling. - anneativeactimsaremty. - inmaa?onmdconec?vem?ommnw. Contact datumination of nonnative lotions. Docummteonec?ve lotion: mm. :m 43 "timing I Procedures A ?uid: to ATP Emilia Ewin- 4A.S.D F1 Cmctiu . Adan Lug Grader (if Applicable): Individual Collectine Samnle Date Collected Swab Lo1# EXHIBIT 11.1 Time Collected Swab Exniration Date Swab Area Tested Result (RLUlarea swabbed) u?d Id b) Hl?l ON p?n on p?n Action Limit- To Be Dete?nined. Veri?ed By: Date: 44 FOR IMMEDIATE RELEASE Gene Grabowski 202-270-6560 April 13, 2018 ROSE ACRE FARMS RECALLS SHELL EGGS DUE TO POSSIBLE HEALTH RISK Through an abundance of caution Rose Acre Farms of Seymour, Indiana is voluntarily recalling 206,749,248 eggs because they have the potential to be contaminated with Salmonella Breendemp. an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people. and others with weakened immune systems. Healthy individuals infected with Salmonella Braendemp can experience fever, diarrhea. nausea. vomlting and abdominal pain. In rare circumstances, infection with Salmonella Braenderup can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections infected endocarditis and arthritis. The eggs were distributed from the farm in Hyde County, North Carolina and reached consumers in the following states: Colorado, Florida, New Jersey, New York, North Carolina. South Carolina, Virginia. and West Virginia through retail stores and restaurants via direct delivery. 22 illnesses have been reported to date. The affected eggs, from plant number P-1065with the Julian date range of 011 through data of 102 printed on either the side portion or the principal side of the carton or package, as follows: LOT CODES 011 102 Item Description Carton UPC COUNTRY DAWALARGEXBODOZEN 077236000302 DAYBREAKALARGE x15 DDZEN (?1236000302 COUNTRY 077236000500 COUNTRY DAYBRBAKAMEDIUM 1130 13021111 077230000203 COUNTRY DOZEN 077236000401 OOUNTRY 077236000500 FOOD LION Ammo 12 oozes: 035826089618 FOOD LION AMEDIOMXIS DOZEN 035826089649 FOOD LION AXIARGBX 15 Dozen 035825039625 FOOD LIONA 035826059601 FOOD LION ALAROEXH DOZBN 0351125000533 FOOD LIONAGPKLARGEX 15 DOZEN 035826089632 IDOSEAUSDASMALLXSO Dom NIA x30 DDZEN N113 LOOSEAXLARGE NIA LOOSEAMGE x30 DOZEN NIA LOOSEAMEDTUMX 15 DOZEN NIA 45 LOOSE A MEDIUM 330 DOZEN LOOSE USDA AA XLARGE x30 DOZEN NIA LOOSE USDA AA XLARGE X15 DOZEN NIA LOOSE USDA AA LARGE X30 DOZEN NIA LOOSE USDA AA LARGE X15 DOZEN NIA LOOSE x30 DOZBN NIA LOOSE AA MGE x30 DOZEN NIA LOOSE USDA AA LARGE PEG 30 DOZEN LOOSE USDA AA LARGE 15 DOZENV NIA LOOSE USDA A XLARGE X30 DUZEN NELMS 634181000018 WAFFIE HOUSE LOOSE USDA A LARGE 30DOZBN FARMS A.N.1EDIUM x30 077235000203 FARMS A 18PK NIEDIUM 30 077236000258 FARMS A 2.5 DOZ MEDIUM 25 077236000124 COUNTRY DAYEREAK A XLARGE X15 DOZEN, 077236000401 COUNTRY DAYBREAK USDA. GRADE A XLARGE 240 DOZEN PULP 077236700400 COUNTRY DAYBREAK USDA GRADE A LARGE RACK 240 DOZBN 07723 6700301 COEURN FARMS A MEDIUMW 30 DOZEN 7 051933182603 COBURN FARMS A LARGE 30 DOZEN 051933190801 VCQBURN FARMS A ISPK. LARGE 30 DOZEN 051933182509 A JUMBO 12 Dam 804879457336 GLENVIEW USDA AA LOOSE LARGE (5-2.5 15 DOZEN NIA LOOSE LARGE FLATS) 30 DOIEN USDA AA LOOSE MEDIUM {6-2.5 15 DDZEN NIA GIMW USDA AA LOOSE XLARGE (6-2.5 15 DOZEN USDA AA LOOSE MEDIUM {12-25 FLATS) 30 DOZEN NIA GLENVIEW USDA AA LOOSE XLARGE (12-15 FLATS) 30 DDZEN NIA GREAT VALUE GRADE A USDA ISPK XLARGF. MC 078742127132 GREAT VALUE GRADE A USDA IZPK XLARGE 24 DOZEN RPC 078742127128 GRADE AUSDA TWIN ISPK LARGEX 24 DOZEN RPC 078742127101 GREAT VALUE GRADE A USDA GPK LARGE 15 DOZEN 078742127095 GREAT VALUE GRADE A USDA IZPK mm 15 DOE-EN 078742127224 GREAT VALUE GRADE AUSDA 12px LARGE 24 DUZEN RFC 078742127071 GREAT VALUE GRADE A USDA 18PK. LARGE 24 DDZEN RPC @127088 GREAT VALUE GRADE A IZPK JUMBO 22 DDZEN RPC 078742127149 GREAT VALUE GRADE A USDA SDZ LARGE 5 DOZEN 070742127113 The voluntary recall was a result of some illnesses reported on the U3. East Coast. which led to extensive interviews and eventually a thorough FDA inspection of the Hyde County farm, which produces 2.3 million eggs a day. The facility includes 3 million laying hens with a USDA inspector on?site daily. Consumers who have purchased shells eggs are urged to immediately discontinue use of the recalled eggs and to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (855) 215-5730 between the hours of 8 am. to 5 pm. Eastern Standard time. 46