NOTE: NEW PHIS TASK AND QUESTIONNAIRES AVAILABLE ON: DECEMBER 23, 2024

1. PURPOSE
   This notice instructs inspection program personnel (IPP) on the actions to take to complete two new questionnaires in the Public Health Information System (PHIS): the Physical Plant Modification Profile Questionnaire and the Ready-to-Eat (RTE) Questionnaire. The notice instructs IPP to complete the new Physical Plant Modification Profile Questionnaire one-time in all official establishments. This notice also instructs IPP to schedule and complete a separate Ready-to-Eat (RTE) Questionnaire task on a recurring routine basis in all official establishments with Active RTE Product Groups as entered in the Establishment Profile in PHIS. This notice instructs Frontline Supervisors (FLS) and District Office (DO) personnel of responsibilities and actions to take in response to questionnaire and report findings. FSIS is issuing this notice, and the associated questionnaires, to gather data about potential immediate food safety risk factors in official establishments and for future decision-making.
2. BACKGROUND
   1. FSIS personnel perform routine inspection duties related to establishment facilities and operations as instructed in FSIS Directive 5000.1, Verifying an Establishment's Food Safety System, FSIS Directive 5000.4, Performing The Pre-Operational Sanitation Standard Operating Procedures Verification Task, FSIS Directive 5000.5, Verification of Less Than Daily Sanitation Procedures in Meat and Poultry Processing Operations and Egg Products Establishments, FSIS Directive 7111.1, Verification Procedures for Lethality and Stabilization, FSIS Directive 10240.3, FSIS Ready-To-Eat Sampling Programs, FSIS Directive 10240.4, Listeria Rule Verification Activities, and other applicable policy issuances, in addition to instructions from the Office of Field Operations (OFO) supervisory chain.
   2. The new Physical Plant Modification Profile Questionnaire and new RTE Questionnaire Task do not replace the instructions in FSIS Directive 5000.1, or instructions in any other policy issuances related to documentation of noncompliances, noncompliance record (NR) trend analyses, existing reports, FSIS lab sample results, or instructions from the OFO supervisory chain. Rather, the questionnaire answers will be supplemental information to be used in conjunction with those items for data analysis and decision-making.
   3. For the purposes of this notice and these new questionnaires, physical plant modification includes any modification to the physical establishment that temporarily affects the production environment such as new equipment (removed or installed), air circulation modifiers, new construction, drilling, removal or repair of drains, removal or repair of floor coatings, removal or repair of a wall or ceiling, or exposure of areas not typically accessible for cleaning.
3. AWARENESS MEETINGS
   1. The Inspector-in-Charge (IIC) or designee is to make establishment management aware of this notice at the next weekly meeting. The IIC is to document the discussion about this notice in a Memorandum of Interview (MOI) as instructed in FSIS Directive 5010.1, Food Safety Related Topics for Discussion During Weekly Meetings with Establishment Management.
   2. In official establishments with Active RTE Product Groups, the IIC is to notify the establishment of the RTE Questionnaire task information contained in this notice.
4. IIC RESPONSIBILITIES
   1. IICs, or their designees, are to collect the information for the entire establishment (all shifts) that will be needed to answer the questions in the new one-time Physical Plant Modification Profile Questionnaire and the questions in the new recurring routine RTE Questionnaire task. The respective questionnaire questions are listed in Attachment 1 for reference.
   2. IICs are to complete the one-time Physical Plant Modification Profile Questionnaire in PHIS per establishment for all operating shifts within 30 days of the issuance of this notice. Profile questionnaires are in the Questionnaires tab of the PHIS Establishment Profile. A tutorial on how to complete a questionnaire is located in the following PHISHelp link or through FSIS Applications on an FSIS computer: Questionnaires.
      
      NOTE: Profile questionnaires are completed one-time in PHIS and are not associated with specific PHIS tasks. This one-time questionnaire will generate data for all official establishments that will be available for future analysis as needed.
   3. IICs are to schedule all routine RTE Questionnaire tasks per establishment, per the number and frequency of tasks assigned in PHIS and complete the associated questionnaires to document the data requested for the entire establishment on all shifts. The routine RTE Questionnaire task is located with all other domestic tasks on the PHIS Task Calendar Establishment Task List. The questionnaire is located within the task.
      
      NOTE: At this time, the routine RTE Questionnaire task is to be completed at a frequency of weekly during an assigned performance period of one month; that is, a scheduled frequency of 4 times in 20 working days. See FSIS Notice 12-24, Task Distributor Updates in the Public Health Information System, for instructions on how the information in the Establishment Profile may impact task distribution. The Task Distributor (TD) calculates the number of routine tasks assigned based on expected operating days for the shifts during the month. The scheduled number and frequency of the RTE Questionnaire task is subject to change over time as necessary, and this will be reflected in the PHIS Task Calendar Establishment Task List and in the questionnaire itself. FSIS Notice 12-24 also includes information on tasks assigned with zero planned so that they are available to add as directed tasks.
   4. IICs are to complete the RTE Questionnaire task and associated questionnaire at the frequency assigned in PHIS within the performance period. The performance period begins with the “Start Date” and ends with the “End Date” as viewed in the PHIS Task Calendar Establishment Task List.
   5. When the establishment operates two shifts under inspection, but only produces RTE products on one shift, the IIC is to manually exclude the task from the shift that never produces RTE products. IICs are to discuss concerns about when or if to manually exclude the RTE Questionnaire task with their supervisor.
   6. The RTE Questionnaire task questions are risk based, and IICs are to notify their supervisor immediately if concerns arise, including but not limited to when the answer to any of the questions suggest vulnerabilities in the food safety system that may result in increased food safety risks, as instructed in FSIS Directive 5000.1. IICs are to continue to follow the instructions related to RTE products in FSIS Directive 5000.1, FSIS Directive 5000.4, FSIS Directive 5000.5, FSIS Directive 7111.1, FSIS Directive 10240.3, FSIS Directive 10240.4, any other applicable policy issuances, along with those from their immediate supervisor.
5. IPP RESPONSIBILITIES
   1. IPP are to use the PHIS tutorials and user guides that are maintained in PHIS Help or provided through supervisory instruction as well as the instructions in FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, for additional information on maintaining the Establishment Profile. IPP are to refer to FSIS Directive 13,000.1, Scheduling In-Plant Inspection Tasks in PHIS, for additional information about managing inspection tasks in PHIS.
   2. If there are multiple IPP in an establishment that produces RTE products on multiple shifts, the immediate supervisor is to coordinate the work among the available IPP so that each of the RTE Questionnaire tasks to be completed is assigned to only one IPP during the assigned performance period in PHIS. In multiple-shift establishments, the routine RTE Questionnaire task will appear on the PHIS task list for all shifts during each assigned performance period. The immediate supervisor is to coordinate the work among the shifts so that each routine RTE Questionnaire task is only performed on one of the shifts during the assigned performance period, but that the questionnaire responses include aggregated data from all shifts in the responses. IPP not scheduled to perform the RTE Questionnaire task during the assigned performance period are to schedule and then mark the RTE Questionnaire task as “not performed” with the justification “task assigned to another inspector.” The immediate supervisor is to ensure that, over time, all inspectors have equal opportunities to perform the RTE Questionnaire task.
   3. IPP are to notify their supervisor when the task has already been completed for the assigned performance period, but IPP subsequently observe vulnerabilities in the food safety system that may result in increased food safety risks and these observations change the information in the most recently completed questionnaire. In such cases IPP are to add and complete directed RTE Questionnaire tasks as instructed by their supervisor or D O personnel.
   4. IPP are to review the Products page of the Establishment Profile by scheduling the next routine Update Establishment Profile task or by scheduling a directed Update Establishment Profile task if the monthly routine task has already been completed in the month when this notice publishes:
      1. In the Product Groups tab on the Products page, IPP are to verify that the Finished Product Category, Average Daily Volume (LB), and Days of Production/Month data fields are entered accurately with the Active box selected for any RTE products currently produced by the establishment;
      2. When there is a change in Product Groups, or other parameters as identified in FSIS Directive 5300.1, IPP are to make that update in the establishment profile as soon the change occurs. For example, if the establishment is not currently producing a specific RTE Product Group, IPP are to uncheck the Active box. Conversely, if the establishment resumes production of a specific RTE Product Group, IPP are to check the Active box. IPP can access a PHISHelp tutorial here: Mark a Product Group Active or Inactive; and
      3. IPP are only to delete products if the establishment notifies IPP that the products will no longer be produced in the establishment on any shift.
   5. IPP are to observe the conditions in the establishment during routine Sanitation Performance Standards (SPS) tasks and use these observations, and any documented noncompliance, to inform the questionnaire responses. Specifically, IPP are to observe routine traffic flow of products, equipment, machinery, and personnel to verify if the establishment always maintains separation between RTE and Raw areas. This sanitation can be achieved by time or space, but IPP are to carefully evaluate if the separation is effective and consult their supervisor if there is a concern. IPP are to observe overhead structures, walkways, automated/robotic machinery, conveyors, chains, sanitation crews, trash disposal, and maintenance to consider if these areas are the source of insanitary conditions or cross contamination.
   6. IPP are to observe RTE operations and compare their observations to establishment programs to inform questionnaire responses and verify that the establishment has identified all possible post-lethality Food Contact Surfaces (FCSs) for sampling as required in 9 CFR 430.4(b)(2)(iii)(D) and 9 CFR 430.4(b)(3)(i)(D) and using the instructions in FSIS Directive 10240.4. A list of common FCSs is included in Attachment 2. As indicated in FSIS Directive 10240.4:
      1. IPP are to be aware that an establishment using Alternative 2b or 3 is required to identify and sample all possible post-lethality FCSs; however, the establishment is not required to sample them at the same frequency. The establishment may sample the sites based on risk, although all sites should be sampled over time; and
      2. If the establishment has not identified all possible FCSs for sampling, IPP are to evaluate whether the establishment can provide supporting documentation to show why the product or FCS would not be contaminated. If the establishment has not identified all possible FCSs and can't support that the other sites would not be contaminated, then the establishment would not be in compliance with 9 CFR 430.4(b)(2)(iii)(A) or 9 CFR 430.4(b)(3)(i)(A), and IPP are to issue an NR.
   7. If physical plant modification has occurred in the last week in the interior production and packaging areas, as indicated in FSIS Directive 10240.4, IPP are to verify:
      1. That the establishment controls sanitation during physical plant modifications so that product does not become contaminated; and
      2. That the establishment increases verification sampling in response to physical plant modifications or other conditions that could increase risk in the establishment.
   8. If the establishment does not control Lm during physical plant modifications or does not increase its verification sampling in response to the modifications, IPP are to issue an NR (cite only pertinent regulations, which may include 9 CFR 416.12(a), 9 CFR 416.13, 9 CFR 416.14, 9 CFR 430.4(b), and 9 CFR 430.4(c)(3)).
   9. When answering the RTE Questionnaire task questions regarding establishment testing, IPP are to be aware that FSIS considers presumptive positive results for Listeria spp. to be positive. For ANY samples the establishment collects and analyzes, IPP are to enter the total number of sample results received in the questionnaire box. These results may originate from single samples, aggregate samples, or pooled samples, as possible examples, but the focus is on the results reported by the establishment testing. The results may be for Listeria spp., Lm, or a combination of both Listeria spp. and Lm. IPP are to report the total number and results for whatever organism is reported in the establishment sample results for their Listeria sampling program.
   10. If the establishment has Listeria spp. positive test results on a FCS, as indicated in FSIS Directive 10240.4, IPP are to verify the establishment takes corrective actions using a scheduled Hazard Analysis and Critical Control Point (HACCP) Verification task or Sanitation Standard Operating Procedure (Sanitation SOP) task if they have one scheduled for that day. Alternatively, if no HACCP Verification task or Sanitation SOP task is scheduled for that day, IPP are to schedule a directed HACCP Verification task or Sanitation SOP task to verify the establishment takes corrective actions.
       
       NOTE: Establishments that use a screen test for Listeria spp. for FCSs or product are not required to culturally confirm the presence of Lm. A finding of Listeria spp. by an establishment on a FCS indicates conditions where Lm may be present, but the product is not considered adulterated. However, establishments are required to take corrective action, according to their Listeria control alternative (defined in FSIS Directive 10240.4), to address Listeria spp. positives so that product does not become adulterated.
   11. If the establishment has Listeria spp. positive test results in a product, as indicated in FSIS Directive 10240.4, FSIS may determine that the product is adulterated because the product was produced under insanitary conditions or the establishment cannot demonstrate the product is not positive for Lm. A finding of Listeria spp. in the product can indicate that the Sanitation SOP is inadequate or that corrective actions taken in response to a previous sanitation failure may not be effective to prevent product contamination. IPP are to review the establishment's documentation in response to the positive Listeria spp. result to determine whether it can support that the product is not adulterated. This documentation may include testing data demonstrating that the original isolate is not positive for Lm, or documentation showing that the product has been reprocessed using a process validated to achieve at least a 5-log reduction in Lm.
   12. If the establishment tests for Lm and receives positive Lm FCS or product results, IPP are to verify the establishment takes corrective actions under 9 CFR 417.3(a) or 9 CFR 417.3(b).
   13. When IPP document SPS NRs, including but not limited to any of the examples from the questionnaire, such as roof leak, condensation, rust/peeling paint, standing water/puddling/pooling/backed up drains, cracked floors, cracked walls, damaged equipment, footbaths/foamers, pre-operational, operational, or other sanitation issues, they are to follow the instructions in FSIS Directive 5000.1 Chapter V, Section III. Documentation of SPS Verification Results including:
       1. If an establishment has not complied with a SPS regulation, but product is not directly contaminated, IPP need to determine whether the noncompliance requires a regulatory control action to prevent contamination or adulteration of product; and
       2. If there is an imminent probability that the noncompliance will result in product adulteration if not addressed immediately, IPP are to take a regulatory control action such as retaining product or rejecting equipment and complete an NR.
   14. After documenting noncompliance with SPS or Sanitation SOP regulations, IPP are to follow the instructions in FSIS Directive 5000.1, Chapter V, Section VII. Trends of Noncompliance including:
       1. Consider whether the noncompliance is associated with previous noncompliances at that establishment; and
       2. Associate two or more NRs when they indicate an ongoing trend of related noncompliances or systemic problems with the establishment's food safety system.
       EXAMPLE: IPP documented noncompliance with 9 CFR 416.13(b) this week at Establishment A when they observed condensation dripping from the ceiling onto product in the processing room. Upon reviewing the NR history prior to the weekly meeting, IPP noted another noncompliance with 9 CFR 416.13(b) last week that also documented condensation dripping onto product in the same area. After reviewing the establishment's proposed preventive measures from the previous noncompliance, IPP find that the establishment did not implement their proposal to add another ventilation fan in the area. IPP concluded that the establishment failed to implement the preventive measures resulting in the recurrence, so they associate the two NRs.
   15. IPP are to notify their supervisor immediately if concerns arise, including but not limited to when the answer to any of the questions indicates vulnerabilities in the food safety system that may result in increased food safety risks, as instructed in FSIS Directive 5000.1. IPP are to continue to follow the instructions for RTE product in FSIS Directive 5000.1, FSIS Directive 5000.4, FSIS Directive 5000.5, FSIS Directive 7111.1, FSIS Directive 10240.3, FSIS Directive 10240.4, any other applicable policy issuances, along with those from their immediate supervisor.
6. SUPERVISORY PERSONNEL RESPONSIBILITIES<
   1. Supervisors are to inform IPP of their availability to assist if IPP have questions or concerns while completing the RTE Questionnaire task. The supervisor is to play a key role in ensuring that accurate decisions are made by IPP completing the questionnaires and tasks.
   2. Supervisors are to routinely review task completion reports to monitor RTE Questionnaire task completion for each establishment to ensure that these tasks are performed in a timely and complete manner and as instructed in this notice.
   3. Supervisors are to verify that IPP are following the instructions in Section V. IPP Responsibilities of this notice.
   4. The Frontline Supervisor (FLS) is to follow the instructions in FSIS Directive 5000.1, including Chapter V, Section VII. Trends of Noncompliance to determine whether IPP are correctly identifying and documenting any trends of noncompliance and whether a Food Safety Assessment (FSA) should be recommended.
7. DO RESPONSIBILITIES
   1. Each week the DO is to run and evaluate the report generated based on IPP completion of the RTE questionnaire.
   2. The DO is to consider whether the establishment has had an increased frequency of Listeria spp. or Lm positives through its own testing.
   3. In addition to Sanitation SOP and SPS noncompliances in RTE Post-Lethality Exposed (PLE) areas, the following responses would indicate an increased risk for Lm contamination:
      1. Use of high pressure hoses;
      2. No positive air pressure movement or air flow out of the RTE room into the Raw or other processing areas then to outside;
      3. No separation between Raw and RTE products;
      4. No separation between equipment, personnel, and tools for Raw and RTE, PLE processing areas;
      5. No color coding for equipment in production areas; or
      6. No identification to maintain separation between equipment, personnel, and tools for Raw and RTE PLE production areas.
   4. When the DO becomes aware that an establishment may be associated with an increased risk of producing product of public health concern, either through discussions with the FLS, or through reviewing PHIS reports related to the results of this questionnaire, including findings related to B. and C. above, they are to consider options for taking immediate action. Next steps could include conducting a Public Health Risk Evaluation (PHRE) as described in FSIS Directive 5100.4, Public Health Risk Evaluation Methodology, conducting a FSA as described in FSIS Directive 5100.1, Food Safety Assessment Methodology, or taking other actions as appropriate for the situation as described in FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology.
8. DATA ANALYSIS AND USE
   1. The data collected through the questionnaire will be initially used for the following purposes:
      1. Within two weeks of the publication date of this notice, the Office of Planning Analysis and Risk Management (OPARM) will make a PHIS report available to provide the DOs with results of questionnaire responses. DO personnel are to review the one-time physical plant modification questionnaire report once it is available and thereafter as needed. DO personnel are to review the ongoing weekly questionnaire reports on a weekly basis to inform PHRE and other decision-making; and
      2. OPARM will consult with OFO and develop criteria for automated PHIS alerts.
   2. Longer term analysis of the data will be conducted to inform other FSIS activities:
      1. OPARM will consult with other FSIS program areas, as needed, to evaluate the data produced to inform FSIS activities;
      2. Such as:
         1. Updates or enhancements to the questionnaire;
         2. Updates to sampling algorithms; and
         3. Creation of new or revision of existing PHIS reports.
9. QUESTIONS
   1. Refer to FSIS Directive 13000.7, Public Health Information System Support, for instructions on PHIS assistance.
   2. Refer questions regarding this notice to your supervisor as needed or to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select General Inspection Policy as the Inquiry Type.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

Attachment 1

One-Time Physical Plant Modification Profile Questionnaire Questions:

1. In what year was the establishment built? Enter date physical plant modifications were completed (enter date as MM/DD/YYYY)
2. In what year did FSIS production/processing begin in this establishment? Enter date (enter date as MM/DD/YYYY)
3. In the time since the original building construction, have any production areas (areas within the official premises for production of inspected products) been modified? (Yes/No)
   1. If No: Next Question
   2. If Yes: 3a: Enter most recent date production areas were modified (enter date in MM/DD/YYYY)

Weekly RTE Questionnaire Task Questions

1. Has any physical plant modification occurred on the premises within the last week? (Yes/No)
   1. If No: Next Question
   2. If Yes: 1a: What areas of the establishment were part of the physical plant modifications in the last week? (select all that apply to the most recent physical plant modifications)
      Exterior of the buildings/outside premises- no interior/indoor production area directly involved
      FSIS Raw product production area
      FSIS RTE product production area
      FSIS product production area for HACCP category products other than Raw or RTE
      FSIS product ingredients, packaging materials, or other product-handling or processing equipment storage areas
      FDA/non-FSIS production areas
      Interior Non-production related area (for example, an office)
2. Have there been any physical plant modifications involving the INTERIOR of the building, indoor spaces/rooms in the last week? Consider the below list when answering (Yes/No)
   • Equipment (including addition, removal or repair, relocation)
   • Opening of structure (including floor drilling, opening wall drywall, holes in the ceiling, roof repair)
   • Resurface (including sanding/sandblasting anywhere)
   • Surface patch/paint/wax/caulk/tar
   • Plumbing (including drains, pipes, pipe insulation)
   • Asbestos mitigation
   • Other physical plant modifications with interior involvement
   1. If No: Next Question
   2. If Yes: 2a: What was part of the physical plant modifications in the last week? (select all that apply to the most recent interior physical plant modifications)
      Equipment (including addition, removal or repair, relocation)
      Opening of structure (including floor drilling, opening wall drywall, holes in the ceiling, roof repair)
      Resurface (including sanding/sandblasting anywhere)
      Surface patch/paint/wax/caulk/tar
      Plumbing (including drains, pipes, pipe insulation)
      Asbestos mitigation
      Other physical plant modifications with interior involvement
   3. If Yes: 2b: How well is the area where physical plant modifications are being performed kept isolated from the production areas of the establishment? (select one)
      Completely isolated
      Somewhat isolated
      Not at all isolated
3. Does the establishment use high pressure hoses to clean in Ready-to-Eat, post-lethality exposed (PLE) areas at any time, including during preoperational sanitation or during production shifts? (Yes/No)
4. Select the items/procedures the establishment uses/implements during production of RTE products. (select all that apply)
   Separate dedicated equipment, personnel, and tools for RTE, PLE processing areas
   Color coding for equipment in production areas
   Other form of identification to maintain separation between equipment, personnel, and tools for Raw and RTE production areas
   Separation of Raw and RTE products by space, without a physical barrier
   Separation of Raw and RTE products by time with implementation of sanitation procedures in between
   Use of a physical barrier with separation of Raw and RTE products by space
   Other method of separation between Raw and RTE
   No separation between Raw and RTE production
5. In the last week, were any NRs documented in this establishment citing Sanitation Performance Standards or Sanitation Standard Operating Procedures issues (this includes any 9 CFR part 416 regulations) for observations IN THE RTE PLE AREAS OF THE ESTABLISHMENT: (Yes/No)
   1. If No: Next Question
   2. If Yes: 5a: Select the total number of NRs in the last week documented in this establishment citing Sanitation Performance Standards or Sanitation Standard Operating Procedures issues (this includes any 9 CFR part 416 regulations) for observations IN THE RTE, PLE AREAS OF THE ESTABLISHMENT: (select one that applies)
      0
      1
      2-3
      4-5
      6+
   3. If Yes: 5b: Select the observations related to the NRs documented in this establishment citing Sanitation Performance Standards or Sanitation Standard Operating Procedures issues (this includes any 9 CFR part 416 regulations) IN THE RTE PLE AREAS OF THE ESTABLISHMENT: (select all that apply to the NRs documented)
      Roof leak
      Condensation
      Rust/peeling paint
      Standing water/puddling/pooling/backed up drains
      Cracked floors
      Cracked walls
      Damaged equipment
      Footbaths/foamers
      Pre-operational
      Operational
      Other sanitation issues
6. Does the routine traffic flow of products, equipment, machinery, and personnel always maintain separation between RTE and Raw areas? (Yes/No)
7. Does the establishment implement measures to direct air flow FROM RTE TO Raw and FROM Raw TO outside (or from RTE TO outside or TO other processing areas then TO outside if no Raw processing)? (Yes/No)
8. Does the establishment use filtration devices on air entering the RTE areas? (Yes/No)
9. Did the establishment collect and analyze non-food contact surface (non-FCS) samples in the RTE PLE areas for Listeria spp. or for Listeria monocytogenes (Lm) or both? (Yes/No)
   1. If No: Next Question
   2. If Yes: 9a: Which one did the establishment collect and analyze? (Select one)
      Listeria spp. only
      Lm only
      Both
10. If the establishment collected and analyzed non-food contact surface (non-FCS) samples for Listeria spp. or for Listeria monocytogenes (Lm) or both in RTE PLE areas in the last week, please select Collected to enter the number of samples collected and the total positive. Select one (Not collected, Collected)
    Not collected
    Collected
    1. If Not Collected: Next question
    2. If Collected: 10a: How many results were received by the establishment (both positive and negative) in the last week that the establishment collected and submitted for analysis? Enter total (free text, enter whole number)
    3. If Collected: 10b: How many of the results received by the establishment in the last week from samples collected and submitted for analysis from RTE PLE areas were positive (presumptive or confirmed)? Enter total (free text, enter whole number)
11. Did the establishment collect and analyze food contact surface (FCS) samples in RTE PLE areas in the last week for Listeria spp. or for Lm or for both? (Yes/No)
    1. If No: Next Question
    2. If Yes: 11a: Which one did the establishment collect and analyze? (Select one)
       Listeria spp. only
       Lm only
       Both
12. If the establishment collected and analyzed FCS samples for Listeria spp. or for Listeria monocytogenes (Lm) or both in RTE PLE areas in the last week, please select Collected to enter the number of samples collected and the total positive.  Select one
    Not collected
    Collected
    1. If Not collected: Next question
    2. If Collected: 12a: How many results were received by the establishment (both positive and negative) in the last week that the establishment collected and submitted for analysis? Enter total (free text, enter whole number)
    3. If Collected: 12b: How many of the results received by the establishment in the last week from samples collected and submitted for analysis from RTE PLE areas were positive (presumptive or confirmed)? Enter total (free text, enter whole number)
13. Are there any food contact surfaces (FCSs) that the establishment has missed or left out of their FCS sampling program? Including but not limited to brines, solutions, racks, baskets, employee hands, and other surfaces that contact product directly. (Yes/No)
14. Did the establishment collect and analyze product samples in the last week for Listeria spp. or for Lm or for both? (Yes/No)
    1. If No: Next Question
    2. If Yes: 14a: Which one did the establishment collect and analyze? (Select one)
       Listeria spp. only
       Lm only
       Both
15. If the establishment collected and analyzed product samples for Listeria spp. or for Listeria monocytogenes (Lm) or both in the last week, please select Collected to enter the number of samples collected and the total positive. Select one (Not collected, Collected)
    Not collected
    Collected
    1. If Not collected: next question
    2. If Collected: 15a: How many results were received by the establishment (both positive and negative) in the last week that the establishment collected and submitted for analysis? Enter total (free text, enter whole number)
    3. If Collected15b: How many of the results received by the establishment in the last week from samples collected and submitted for analysis of product were positive (presumptive or confirmed)? Enter total (free text, enter whole number)
16. Does the establishment use microbial testing to monitor sanitation process control (including, but not limited to, ATP (Adenosine triphosphate), APC (Aerobic plate count), and indicator organisms other than Listeria spp.)? (Yes/No)
    1. If No: End Questionnaire
    2. If Yes: 16a: In the last week have any process control testing results (including, but not limited to, ATP (Adenosine triphosphate), APC (Aerobic plate count), and indicator organisms other than Listeria spp.), based on the criteria incorporated into the establishment's written programs, indicated that established criteria were not met? (Yes/No)
    3. If Yes: 16b: In the last week has the establishment taken any corrective actions as a result of process control test results received? (Yes/No)

Attachment 2

The below table provides examples of possible Food Contact Surfaces (FCS) and non-Food Contact Surfaces (non-FCS) sites. The below list is not all-inclusive. FCS and non-FCS are defined as follows:

Food Contact Surface (FCS): An area in the post-lethality processing environment that comes in direct contact with post-lethality exposed RTE product (see FSIS Directive 10240.4).

Non-Food Contact Surface (non-FCS): An area that does not contact product. Non-FCS samples may be collected from any area where RTE product is held in the establishment (e.g., coolers, freezers, loading docks, and trucks). Non-FCS samples may also be collected in areas associated with post-lethality processing, such as equipment storage and washrooms, spice rooms, and ingredient rooms.
Table of Possible Food Contact and Non-Food Contact Sampling Sites

*Could be considered either a food contact surface (FCS) or a non-food contact surface (non-FCS), depending on if the surface comes in direct contact with the product.