NOTE: DO NOT IMPLEMENT THIS NOTICE UNTIL JANUARY 17, 2025

1. PURPOSE
   1. This notice instructs inspection program personnel (IPP) at establishments that prepare, process, or import ready-to-eat (RTE) meat, poultry or egg products to notify the establishments that starting on January 17, 2025, FSIS is changing its laboratory method to include testing for non-Listeria monocytogenes Listeria species (non-Lm Listeria spp.) in all sampling projects that currently test for Listeria monocytogenes (Lm). This notice applies to all sampling projects that currently test product, food contact surface, or environmental non-food contact surface samples for Lm.
   2. This notice also instructs IPP on the actions to take in response to a non-Lm Listeria spp. positive in a RTE meat, poultry, or egg product sample, including samples of imported RTE meat, poultry, or egg products. 
   3. This notice also instructs Enforcement, Investigations and Analysis Officers (EIAOs) on the actions to take in response to a non-Lm Listeria spp. positive in a RTE meat or poultry product, food contact surface, or non-food contact surface environmental sample.
2. BACKGROUND
   1. Lm is one of several different species within the Listeria genus. Starting on January 17, 2025, FSIS is changing its laboratory method to add testing for non-Lm Listeria spp. in addition to Lm. FSIS will report Lm as well as the names of non-Lm Listeria spp. identified by the method when any of the following more common spp. are detected: Listeria aquatica, Listeria booriae, Listeria cornellensis, Listeria costaricensis, Listeria fleischmannii, Listeria floridensis, Listeria grandensis, Listeria grayi, Listeria innocua, Listeria ivanovii, Listeria newyorkensis, Listeria riparia, Listeria rocourtiae, Listeria seeligeri, Listeria weihenstephanesis, and Listeria welshimeri. When FSIS identifies a non-Lm Listeria spp. but the method can’t confirm the name of the species, it will report the result as indeterminant. 
   2. FSIS is testing for non-Lm Listeria spp. in addition to Lm because these results provide more information about the effectiveness of the establishment’s sanitation program. If sanitation is effective, no type of Listeria spp. should be found in product, on food contact surfaces, or on environmental, non-food contact surfaces in the post-lethality exposed RTE environment. Sanitation is the foundation for an effective Lm control program. 
      
      NOTE:  FSIS will continue to test for Salmonella in RTE meat, poultry, or egg product samples, including samples of imported RTE meat, poultry, or egg products.  
   3. When FSIS finds a sample is positive for non-Lm Listeria spp. but negative for Lm, IPP and EIAOs are to be aware that establishments must take corrective actions per 9 CFR 416.15 because a finding of non-Lm Listeria spp. in a product, food contact surface, or environmental non-food contact surface indicates that the sanitation program is ineffective at preventing conditions where contamination with Lm may occur and may have failed to prevent direct contamination of product resulting in adulteration. Therefore, establishments must take corrective actions (e.g., intensified cleaning and sanitation) even when Listeria spp. other than Lm are found on environmental, non-food contact surfaces to ensure that conditions are addressed to prevent harborage of Lm and cross-contamination to product. Conditions that allow Listeria spp. other than Lm to occupy and thrive in various sites in a production facility, such as on floors, in drains, or in standing water are the same conditions that allow Lm to occupy and thrive in those sites. In addition, if sanitation and employee hygiene practices allow Listeria spp. other than Lm to cross-contaminate processing equipment, gloves or aprons of employees, and product then those same practices may allow Lm contamination.
   4. Repetitive non-Lm Listeria spp. findings from FSIS testing indicate a trend and could indicate that the establishment’s Listeria control program is not effective in controlling the presence of Lm in the establishment’s post-lethality processing environment and indicate the need to evaluate the Sanitation SOPs according to 9 CFR 416.14. 
   5. Although eggs products are not currently subject to the requirements in 9 CFR part 430, Control of Listeria monocytogenes in Post-lethality Exposed Ready-to-Eat Products (Listeria Rule), FSIS currently tests egg products for Lm; therefore, egg products are subject to the additional testing for non-Lm Listeria spp.
   6. When non-Lm Listeria spp. are found in imported RTE meat, poultry, or egg product samples, no further actions are required by the import establishment or Importer of Record (IOR). However, FSIS will notify the foreign country central competent authority of the results as appropriate.
3. AWARENESS MEETINGS
   1. IPP at establishments that prepare, process, or import RTE meat, poultry or egg products are to make establishment management aware of this notice at the next weekly meeting. IPP are 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. IPP are to share that starting on January 17, 2025, FSIS testing will begin identifying non-Lm Listeria spp. in addition to Lm in RTE meat, poultry, and egg product samples collected by IPP, as well as RTE meat and poultry product samples, food contact, and environmental, non-food contact samples collected by EIAOs for the most common species listed above in Section II.A. When FSIS identifies another non-Lm Listeria spp. but can’t confirm the name of the species it will report the result as indeterminant.  IPP are also to share that:
      1. Establishments will continue to receive FSIS sample results by e-mail, including when FSIS finds Lm or a non-Lm Listeria spp.
      2. Although non-Lm Listeria spp. will be reported as “positive” and require corrective actions as described below, the analysis result for the sample will be reported in PHIS and by e-mail as “acceptable” and the lot can be released if other results for Lm and Salmonella are negative.
      3. The establishment must take corrective actions as required by 9 CFR 416.15 when a product, food contact surface, or environmental, non-food contact sample is positive for a non-Lm Listeria spp. (even if not identified by name and reported as indeterminant) because the results indicate the sanitation program is ineffective at preventing conditions where contamination with Lm may occur. However, the establishment can determine and be able to support that parts of 9 CFR 416.15(b) such as ensuring appropriate disposition of product do not apply because product can be released if other results for Lm and Salmonella are negative.
   3. IPP are to share with import establishments that starting on January 17th, FSIS testing will begin identifying the most common non-Lm Listeria spp. listed above in Section II.A in addition to Lm in samples of imported meat, poultry, or egg products. When FSIS identifies another non-Lm Listeria spp. but can’t confirm the name of the species it will report the result as indeterminant.  IPP are also to share that:
      1. Import establishments will continue to receive FSIS sample results by e-mail, including when FSIS finds Lm or non-Lm Listeria spp.
      2. Although non-Lm Listeria spp. will be reported as “positive,” the analysis result for the sample will be reported in PHIS and by e-mail as “acceptable” and the lot can be released if other results for Lm and Salmonella are negative and no further actions are required.
4. IPP RESPONSIBILITIES FOR RTE MEAT, POULTRY, AND EGG PRODUCT SAMPLING PROJECTS
   1. IPP are to schedule and collect samples of RTE meat and poultry products following instructions in FSIS Directive 10240.3, FSIS Ready-to-Eat Sampling Programs and to schedule and collect samples of RTE egg products  following instructions in FSIS Directive 10230.3, FSIS Verification Testing of Domestic Egg Products. Instructions for scheduling and collecting samples have not changed.
   2. Sampling results, including Lm and non-Lm Listeria spp. results, will be reported to IPP through PHIS.
   3. IPP are to monitor PHIS for sample results and inform the establishment of the results as soon as they are available, according to FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System. If a RTE meat, poultry, or egg product sample collected by IPP is positive for a non-Lm Listeria spp. but negative for Lm and Salmonella IPP are also to inform the establishment that it must take corrective actions according to 9 CFR 416.15. IPP are to document the discussion in an MOI.
      
      NOTE: The testing FSIS performs is different than the Listeria spp. testing of food contact surfaces establishments perform during the production of post-lethality exposed RTE meat or poultry products.  Establishments often use screen tests for Listeria spp. and do not follow a screen positive Listeria spp. test result on a food contact surface with cultural confirmation like FSIS does because cultural confirmation is not required for this type of establishment testing. A positive result from a screening test conducted by an establishment could mean Lm is present but it was not confirmed by the test. Corrective actions are required in this situation according to how the establishment addresses Lm in its Hazard Analysis and Critical Control Point (HACCP) system (9 CFR 417.3(a), 9 CFR 417.3(b), or 9 CFR 416.15) because a positive result could mean that Lm is present, just not confirmed by the test. For more information on IPP responsibilities in response to establishment test results for post-lethality exposed RTE meat or poultry products see FSIS Directive 10240.4, Listeria Rule Verification Activities.
   4. IPP are to be aware that test results for Lm and non-Lm Listeria spp. are reported at the same time and that a sample may be positive for multiple Listeria spp. For example, a result could indicate that the sample is positive for Lm, a non-Lm Listeria spp., or both Lm and a non-Lm Listeria spp. If the sample confirms positive for a non-Lm Listeria spp., the specific species detected will be listed unless listed as indeterminant.
   5. IPP are to be aware that the analysis result for the sample will be reported as “acceptable” or “non-acceptable” after all sample analyses are completed. The sample analysis result will be reported as “acceptable” if results for Lm and Salmonella are negative, regardless of the result for a non-Lm Listeria spp.  Although the sample analysis result will be reported as “acceptable” when results for Lm and Salmonella are negative but positive for a non-Lm Listeria spp., the establishment is required to take corrective actions according to 9 CFR 416.15. The sample analysis result will be reported as “non-acceptable” if the results for either Lm or Salmonella are positive, regardless of the result for a non-Lm Listeria spp. Below are some examples of how these results will appear in PHIS:
      
      
   6. If the meat, poultry, or egg product is positive for Lm or Salmonella, product from the sampled lot is considered adulterated. IPP are to follow the instructions in FSIS Directive 5000.1 to take regulatory action in response to positive sampling results. IPP are to follow the instructions in FSIS Directive 10240.3 Documenting Noncompliance, Chapter IV, Sampling Results from RTEPROD, Section II., and Verifying Product Disposition, Chapter V, in response to RTE meat or poultry product positive results for Lm or Salmonella and are to follow the instructions in  FSIS Directive 10230.3, Sample Results Reporting and FSIS Actions, Section IX,  in response to product positive results for Lm or Salmonella in an egg product sample.
   7. Generally, if the product is negative for Lm and Salmonella but positive for a non-Lm Listeria spp., product can move in commerce, and IPP are not to issue a noncompliance record (NR) solely based on the positive result. IPP may issue an NR based on an establishment’s compliance with 9 CFR 416.15 as described below. 
   8. If the product is negative for Lm and Salmonella but positive for a non-Lm Listeria spp., IPP are to be aware that corrective actions are required by 9 CFR 416.15 because the results indicate the sanitation program is ineffective at preventing conditions where contamination with Lm may occur. IPP are to be aware that:
      1. At a minimum, the establishment is required to restore sanitary conditions of surfaces associated with the positive test in order to comply with 9 CFR 416.15(b);
      2. Intensified cleaning and sanitation is an example of a measure an establishment can take to restore sanitary conditions; and
      3. FSIS recommends but does not require that the establishment conduct follow-up testing to verify corrective actions have been effective.
   9. IPP are to be aware that if the product is negative for Lm but positive for a non-Lm Listeria spp., then corrective actions under 9 CFR 417.3(a) or 9 CFR 417.3(b) are not typically required unless the establishment determines in its hazard analysis that Listeria spp. are food safety hazards reasonably likely to occur and has a Critical Control Point (CCP) for Listeria spp.   
   10. IPP are to verify that the establishment performs the appropriate corrective actions using a scheduled ‘Operational Sanitation Standard Operating Procedure (SSOP) Review and Observations’ task in PHIS if they have one scheduled for the day the positive result is received but that has not yet been completed. Alternatively, if the ‘Operational SSOP Review and Observations’ task scheduled for that day has already been completed, IPP are to schedule an additional directed ‘Operational SSOP Review and Observations’ task to confirm the establishment’s corrective actions. The task can’t be completed until the establishment has implemented all corrective actions. IPP are to review FSIS Directive 5000.1, Chapter II, Part III Sanitation SOPs when performing the ‘Operational SSOP Review and Observations’ task.  IPP are also to review the Sanitation SOP Task Job Aid for RTE Establishments available in IPP Help when performing the task in response to RTE meat or poultry product positives.
   11. When verifying corrective actions, IPP are to review Sanitation SOPs records and, when possible, observe establishment employees implementing corrective actions, such as intensified cleaning and sanitation and follow-up sampling (although sampling is not required), to verify that establishment corrective actions meet all the applicable requirements of 9 CFR 416.15. IPP are also to review sanitation NRs from the week prior to the positive to determine if there were any sanitation noncompliances that could have contributed to the finding of a positive non-Lm Listeria spp. result. In addition to reviewing sanitation NRs from the week prior to the positive, IPP are to correlate with the in-plant inspection team, including their supervisor, to consider information they have gathered in the context of past findings and to look for any patterns or trends in the findings.
   12. If the establishment does not restore sanitary conditions of surfaces associated with the non-Lm Listeria spp. positive test, then IPP are to document an NR for failure to comply with 9 CFR 416.15(b).
   13. When IPP are observing conditions and operations in the establishment as part of their verification or other duties, they are to be aware of the sanitary conditions and verify that the establishment is meeting the Sanitation Performance Standard (SPS) requirements by maintaining the facilities, equipment, and utensils in a sanitary manner and by following practices that protect product from adulteration.
   14. IPP are to document the results of their verification during the performance of the ‘Operational SSOP Review and Observations’ task, including any noncompliance, following the instructions in Chapter V of FSIS Directive 5000.1. IPP are to document the establishment’s corrective actions. This can be done in the findings tab of the task.
   15. If the establishment produces products under Alternative 3 and relies on sanitation alone to control Lm, then IPP are also to perform a directed Hazard Analysis Verification (HAV) task as described in FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) Task, to verify the establishment can continue to support the decisions in its hazard analysis. If the establishment produces products under Alternatives 1 or 2, IPP may also perform a directed HAV task as described in FSIS Directive 5000.6 to verify the establishment can continue to support its decisions in its hazard analysis because sanitation is the foundation for an effective Lm Control Program. IPP are to discuss with their supervisor as to whether a directed HAV task should be performed.
   16. IPP are also to consider whether a trend is developing, for example because the establishment has had repetitive non-Lm Listeria spp. results from FSIS testing and the establishment’s corrective actions do not prevent repetitive findings. Repetitive non-Lm Listeria spp. findings from FSIS testing indicate a trend and could indicate that the establishment’s Listeria control program is not effective in controlling the presence of Lm in the establishment’s post-lethality processing environment and indicate the need to evaluate the Sanitation SOPs according to 9 CFR 416.14. IPP are to discuss concerns about the establishment’s history with their supervisor to determine if noncompliance with 9 CFR 416.14 exists, whether the assistance of an EIAO is needed, or whether a Food Safety Assessment should be recommended.
5. IPP RESPONSIBILITIES FOR IMPORTED RTE MEAT, POULTRY, AND EGG PRODUCT SAMPLING PROJECTS
   1. IPP are to schedule and collect samples under the RTE imported meat, poultry, and egg product sampling programs following instructions in FSIS Directive 9900.6, Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products when collecting and submitting samples and when taking action in response to results.
   2. Sampling results, including Lm and non-Lm Listeria spp. results, will be reported to IPP through PHIS.
   3. IPP are to monitor PHIS for sample results.
   4. If the imported meat, poultry, or egg product is positive for Lm or Salmonella, results will be reported as “non-acceptable” regardless of the result for a non-Lm Listeria spp. and product from the sampled lot is considered adulterated. IPP are to follow the instructions in FSIS Directive 9900.6.
   5. If the imported meat, poultry, or egg product is negative for Lm and Salmonella, results will be reported as “acceptable” regardless of the result for a non-Lm Listeria spp. and IPP are to release the shipment. IPP are to release the shipment even if a non-Lm Listeria spp. is detected IPP are to notify the import establishment management the sampling test results are positive for a non-Lm Listeria spp, and request that they notify the IOR, but that no further actions are required.
6. SUPERVISORY PERSONNEL RESPONSIBILITIES
   1. Supervisors are to inform IPP of their availability to assist if IPP have questions or concerns while performing the ‘Operational SSOP Review and Observations’ task and HAV task.
   2. Supervisors play a key role in ensuring that decisions made by IPP are consistent with FSIS statutory authority and Agency policy, and that duties are performed in accordance with prescribed inspection methods and procedures addressed in this notice. Supervisory responsibilities are described in FSIS Directive 5000.1 including ensuring that IPP are correctly applying the inspection methodology, are making informed decisions, are properly documenting findings, and are taking the appropriate actions as instructed in FSIS Directive 5000.1 and FSIS Directive 5,000.6.
   3. Supervisors are to verify that IPP are following the instructions in Section IV. IPP Responsibilities for RTE Meat, Poultry, and Egg Products Sampling Projects and Section V. IPP Responsibilities for Imported RTE Meat, Poultry, and Egg Products Sampling Projects of this notice.
   4. The supervisor may determine that it is necessary to request the assistance of an EIAO.  If needed, the supervisor is to ask the DO to assign an EIAO to review the establishment’s corrective actions.
   5. The supervisor 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 related to the establishment’s corrective actions in response to non-Lm Listeria spp. positives and whether a Food Safety Assessment should be recommended.
7. EIAO RESPONSIBILITIES
   1. EIAOs are to follow instructions in FSIS Directive 5100.4, Public Health Risk Evaluation Methodology, FSIS Directive 10240.5, Verification Procedures for Enforcement, Investigations, and Analysis Officers for the Listeria Monocytogenes Regulation and Routine Risk-Based Listeria monocytogenes Sampling Program, and FSIS Directive 10300.1, Intensified Verification Testing (IVT) Protocol for Sampling of Product, Food Contact Surfaces and Environmental Surfaces for Listeria Monocytogenes when scheduling and collecting RLm and IVT samples.  Instructions for scheduling and collecting samples have not changed.
   2. Sampling results, including Lm and non-Lm Listeria spp. results, will be reported in PHIS. The laboratories will report the results for Lm and non-Lm Listeria spp. results for each sample. 
   3. After the RLm or IVT sampling is completed, during the in-plant portion of the food safety assessment (FSA), EIAOs are to monitor the testing results in PHIS. EIAOs are to inform the establishment of the results and required actions if applicable, including that if the product is negative for Lm but positive for a non-Lm Listeria spp. the establishment must take corrective actions according to 9 CFR 416.15.  EIAOs are to document the discussion in an MOI.
      
      NOTE:  Presumptive and confirmed positive Lm test results will continue to be sent by e-mail to the District Office (DO) Biological Information Transfer and E-mail System (BITES) Distribution list in addition to reporting in PHIS; however, presumptive and confirmed positive results for a non-Lm Listeria spp. will not be sent through BITES and will only be available in PHIS. In addition, FSIS is not currently performing Whole Genome Sequencing on non-Lm Listeria spp.
   4. If the product or food contact surface is positive for Lm or Salmonella, product from the sampled lot is considered adulterated. EIAOs are to follow instructions in FSIS Directive 10240.5 and FSIS Directive 10300.1 in response to positive Lm or Salmonella sampling results.
   5. Generally, if the product, food contact surface, or environmental, non-food contact surface is negative for Lm but positive for a non-Lm Listeria spp., product can move in commerce and EIAOs are not to recommend issuing an NR solely based on the positive result. An NR may be issued based on an establishment’s compliance with 9 CFR 416.15.   
   6. EIAOs are to inform IPP and the FLS of the sampling results so that the IPP verify that the establishment performs the appropriate corrective actions according to 9 CFR 416.15 using the ‘Operational SSOP Review and Observations’ task in PHIS as instructed in Section IV of this notice. The EIAO is to communicate with the IPP and FLS throughout the course of the assessment. 
   7. In addition to taking corrective actions in response to individual FSIS and establishment test results, repeated Listeria spp. positives (either from establishment screen positive test results or FSIS testing that confirms a Lm or non-Lm Listeria spp.) on product, food contact, or environmental, non-food contact indicate positive Listeria trends in the establishment. The finding of Listeria trends could indicate that the establishment’s Listeria control program is not effective in controlling the presence of Lm in the establishment’s post-lethality processing environment and indicate the need to evaluate the Sanitation SOPs according to 9 CFR 416.14.
   8. When an FSA is performed with the RLm or IVT sampling, as indicated in FSIS Directive 5100.1, the EIAO is to consider sampling results and any sanitation noncompliance identified when determining the FSA outcome, including that non-Lm Listeria spp. positives indicate the sanitation program is ineffective at preventing conditions where Lm may be present. In some limited circumstances (e.g., there are unanticipated sampling delays or presumptive positives), results may not be available within the seven-day FSA timeframe. If sampling results are delayed, the DO may elect to delay the start of the FSA or delay the exit meeting until sampling results are received.
   9. EIAOs are to be aware that as indicated in section VIII. DO Responsibilities, a positive non-Lm Listeria spp. in a product, food contact surface, or an environmental, non-food contact surface from one sampling event, does not meet either a risk-based or for-cause risk criteria for a PHRE. However, trends in FSIS sampling results over time such as recurring non-Lm Listeria spp. positives and other information as indicated in section VIII is to be taken into account when determining whether a PHRE is warranted.
8. DO RESPONSIBILITIES
   1. If an establishment has positive non-Lm Listeria spp. in a product, food contact surface, or an environmental, non-food contact surface samples from one sampling event, DOs are to be aware that this alone does not meet either a risk-based or for-cause risk criteria for a PHRE in FSIS Directive 5100.4; however, the DO is to take this information into account along with trends in FSIS sampling results over time and other information from the RTE questionnaire report, such as sanitation and SPS noncompliance and establishment test results, to determine whether a PHRE is warranted.
   2. If DO personnel recommend an enforcement action associated with FSIS sampling, the DO personnel may include positive non-Lm Listeria spp. findings including for RLm or IVT sampling in the enforcement letter (FSIS Directive 5100.1 and FSIS Directive 5100.3, Administrative Enforcement Action Decision-Making and Methodology) in addition to specific compliance history and any FSA findings.  The non-Lm Listeria spp. findings may be included along with other information because the finding indicates the sanitation program is ineffective at preventing conditions where Lm may be present. FSIS may determine based on other findings (e.g., compliance history and FSA findings) that the establishment’s food safety system (i.e., the HACCP plan, prerequisite program, or Sanitation SOP depending on where the Lm control measures are included) is inadequate to control Lm in the post-lethality environment, the Sanitation SOP is not properly implemented or maintained, or the establishment has not maintained sanitary conditions to prevent Lm product adulteration (9 CFR 500). The enforcement letter is to include the specific compliance history in addition to the non-Lm Listeria spp. findings.
9. QUESTIONS
   Refer questions regarding this notice to your immediate 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 Sampling as the Inquiry Type.

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