Verification Procedures for Enforcement, Investigations and Analysis Officers (EIAOs) for the Listeria monocytogenes (Lm) Regulation and Routine Risk-Based Listeria monocytogenes (RLm) Sampling Program - Revision 3
A. This directive provides Enforcement, Investigations and Analysis Officers (EIAOs) with instructions for collecting samples under the Routine Risk-based Lm (RLm) sampling program. The RLm sampling program includes the collection of product, food contact, and environmental (non-food contact) samples, tested for Lm, in conjunction with a routine Food Safety Assessment (FSA). In addition, this directive provides instructions to District Office (DO) personnel and EIAOs for scheduling RLm sampling.
B. FSIS is revising this directive to provide instructions to EIAOs for collecting environmental samples under the RLMENVC sampling program that will be composited by FSIS laboratories. It also provides EIAOs with instructions for performing RLm sampling in establishments that temporarily alter their routine practices. In addition, this directive provides EIAOs with instructions for collecting product samples under the RLMPRODC sampling program that started in January 2013. Under this program, FSIS has increased the number of product samples from 3 to 5 per unit, and the samples are composited by FSIS laboratories. This directive also provides EIAOs with instructions for verifying that establishments hold or control ready- to-eat (RTE) products that FSIS has tested for pathogens or that have passed over direct food contact surfaces that FSIS has tested for pathogens pending the results of that testing. In addition, this directive provides new instructions for submitting samples when interventions such as high-pressure processing (HPP) are applied.
- DO scheduling of RLm sampling
- EIAO sampling procedures for the RLm Sampling Program
- Actions in establishments that temporarily alter routine practices during sampling
FSIS Directive 10,240.5, Revision 2, Verification Procedures for Enforcement, Investigations, and Analysis Officers (EIAOs) for the Listeria monocytogenes (Lm) Regulation and Routine Risk-Based Listeria monocytogenes (RLm) Sampling Program, dated 2/3/09
A. Under 9 CFR part 430, post-lethality exposed RTE products are adulterated if they test positive for Lm or come into direct contact with a food contact surface that tests positive for Lm. The Agency utilizes microbial testing as a tool to verify the adequacy of an establishment's food safety system, including the measures that the establishment implements for the control of Lm.
B. In the RLm Sampling Program, EIAOs collect intact product samples and food contact and environmental (non-food contact) surface swabs during the production of RTE meat and poultry products that are exposed to the post-lethality environment. In addition, EIAOs assess whether the establishment’s food safety system is controlling Lm by performing an FSA in the establishment.
C. FSIS began compositing RLm environmental samples under the RLMENVC program in 2009 to help meet the Agency’s goal of conducting at least one FSA in each establishment in a 4 year period. This directive provides EIAOs with instructions for collecting samples under this program. In addition, to make FSIS’s sampling programs more consistent with sampling procedures in use internationally, FSIS has also increased the number of products sampled under the RLm sampling program from 3 to 5 and has started compositing the 5 samples under the RLMPRODC program.
D. FSIS has determined that some establishments may temporarily alter their routine production, sanitation, or food safety practices during RLm sampling. By altering routine practices, establishments may make changes that are not consistent with their documented food safety system and that impede FSIS’s ability to assess the safety of the product. This directive provides EIAOs with instructions for taking action in establishments that change practices.
E. On December 10, 2012, FSIS issued a Federal Register notice, Not Applying the Mark of Inspection Pending Certain Test Results, announcing that it is changing its procedures and will withhold its determination as to whether meat and poultry products are not adulterated, and thus eligible to enter commerce, until all test results that bear on the determination have been received. The new procedures went into effect February 8, 2013.
IV. DO AND EIAO RESPONSIBILITIES FOR RLm SCHEDULING
A. DO Responsibilities for RLm Sample Scheduling
1. Districts will receive the Scheduling Memo by e-mail from the Data Analysis and Integration Group (DAIG) as described in FSIS Directive 5100.4. The Scheduling Memo lists:
a. The establishments selected for sampling;
b. The establishment’s HACCP size for sample unit determination; and
c. The FSIS laboratory assigned to analyze the sample.
2. After receiving the scheduling memo, the District Manager (DM) or designee is to assign the RLm sample collection activity to an EIAO trained in Intensified Verification Testing (IVT) (see FSIS Directive 10,300.1).
3. The DM is to schedule a Food Safety Assessment (FSA) at the establishment in conjunction with the RLm sampling so that the EIAO receives the RLm sampling results before he or she completes the FSA, and he or she may share the results with the establishment at the exit conference.
B. EIAO Responsibilities for RLm Sample Scheduling
1. Within the 6-week timeframe before the month scheduled for sampling, the EIAO is to perform the following items:
a. Randomly select the 1st or 2nd shift Monday through Thursday or the 1st shift Friday for collection of RLm samples within the week identified in the monthly RLm Scheduling Memo; and
b. Inform the Inspector-In-Charge (IIC) at the establishment that an RLm sample collection activity is scheduled in conjunction with an FSA, how the sampling is conducted, and the day when the RLm sampling will occur. The EIAO is to determine the following:
i. The production schedule and types of post-lethality exposed RTE products produced;
ii. The number of production lines producing post-lethality exposed RTE products; and
iii. Whether the establishment uses brine or ice water to chill product. EIAOs are also to determine whether the brine or ice water comes in direct contact with post-lethality exposed product. If it does, the EIAO is to treat the sample as an RLMCONT sample, or if the brine or ice water is used for product in an impermeable casing, the EIAO is to treat it as an RLMENVR sample.
2. When determining the number of sample units to collect, EIAOs are to:
a. Collect samples based on establishment size;
i. Sample a maximum of 3 lines on which post-lethality exposed product is produced (3 sample units) in large establishments.
ii. Sample a maximum of 2 lines on which post-lethality exposed product is produced (2 sample units) in small establishments.
iii. Sample a maximum of 1 line on which post-lethality exposed product is produced (1 sample unit) in very small establishments.
NOTE: Establishment size is based on establishment categories in the HACCP preamble (61 FR 38806). Establishment size is defined based on the number of employees: large establishments – 500 or more employees, small establishments – 10 or more employees but fewer than 500, and very small establishments – fewer than 10 employees or annual sales of less than $2.5 million.
b. Only collect samples on days and shifts when the establishment is producing FSIS- regulated post-lethality exposed meat or poultry products. Generally, an EIAO is to collect 1 sampling unit for each post-lethality exposed RTE line, except in cases when the establishment is not producing on a particular line;
c. If the establishment uses brine or ice water to chill the product, EIAOs are to:
i. Collect RLMCONT brine or ice water samples as one of the 10 food contact samples he or she collects per unit. If the sample is collected as an RLMENVR sample, EIAOs are to collect a separate sample using one RLMENVR form per sample. The brine or ice water samples will not be composited as part of the RLMENVC samples;
ii. Collect 1 brine or ice water sample per unit (e.g., if an EIAO is collecting 3 units and the establishment is only using 2 brine chillers on 2 separate lines, then the EIAO is to collect 2 brine samples); and
iii. Collect a maximum of 3 brine or ice water samples per establishment, if available on the lines sampled.
3. When requesting sampling forms and supplies, EIAOs are to:
a. Send the following information to the FSIS - RLm Sample Scheduling mail box via Outlook at least 2 weeks before the week sampling is scheduled:
i. Sample collection date and production shift;
ii. The number of sample units required based on the establishment size;
iii. Field laboratory designated on the monthly RLm Scheduling Memo;
iv. Establishment number;
v. Contact name and phone number;
vi. Location to send the forms and supplies;
vii. Requests for special supplies (e.g., larger gloves) or large shipping containers, if needed; and
viii. Requests for brine sampling supplies and separate RLMENVR form (if collecting a non food contact surface brine sample). A separate RLMCONT form would not be needed, because the samples are to be collected as one of the 10 RLMCONT samples per unit.
b. Within 2 weeks after submitting the information to the FSIS - RLm Sample Scheduling mailbox, the EIAO should receive the forms and supplies. If the forms are lost, the EIAO can send an e-mail to the FSIS – RLm Sample Scheduling mailbox to request additional forms as needed.
4. At least 1 week before the RLm sample collection date, the EIAO is to notify establishment management that the Agency has scheduled an RLm collection activity at that establishment and document the notification in a Memorandum of Interview (MOI). The EIAO is to perform the following actions:
a. Confirm that the establishment will be producing post-lethality exposed RTE product on the day RLm sampling is scheduled and is planning to implement its documented routine production, Sanitation Standard Operating Procedures (Sanitation SOPs) and food safety practices;
b. Inform the establishment that, if it intends to modify its documented routine production, sanitation, or food safety practices before the RLm sampling, it should inform the EIAO as soon as possible so that the EIAO can determine whether sampling should be rescheduled; and
c. Advise the establishment that if it changes its practices temporarily during the RLm without notifying the EIAO in advance, and cannot provide a justifiable reason for doing so, the sampling may be rescheduled, and further regulatory actions may be taken, which could delay completion of the FSA.
NOTE: See section VI below for instructions for EIAOs in establishments that alter routine practices during RLm sampling.
d. EIAOs are to document in the MOI whether the establishment is holding or controlling product when FSIS collects samples of product of food contact surfaces.
V. EIAO SAMPLING PROCEDURES UNDER THE RLm SAMPLING PROGRAM
B. EIAOs are to conduct the RLm testing as early in the FSA as possible to facilitate receiving the results and the completion of the FSA report without unnecessary delay.
C. In conjunction with performing the RLm sampling, EIAOs are to conduct an FSA in accordance with FSIS Directive 5100.1.
NOTE: EIAOs may find useful information in this link: FSIS Compliance Guideline: Controlling Listeria monocytogenes in Post Lethality Exposed Ready-to-Eat Meat and Poultry Products.
D. For product samples, EIAOs are to:
1. Collect 5 separate product samples per sampling unit from a particular line and processing lot following the instructions in this directive;
2. Collect products from the highest risk alternative and the highest risk post-lethality exposed RTE product category using the instructions in a and b below;
a. Select product from the highest-risk alternative (Risk: Alternative 3 > Alternative 2 > Alternative 1);
i. For each sampling unit, select product from only one Lm control alternative. For example, if an EIAO is collecting one unit, and the establishment produces products under all three alternatives, then the EIAO is to select Alternative 3 product;
ii. If the EIAO is collecting more than one unit, then the EIAO may select product from more than one alternative (if all the products selected within a given unit are produced under a single alternative).
b. Collect product from the highest risk level, according to Product Sampling Priority List in Attachment 5. Products from multiple product categories/groups may be collected as part of the same sampling unit; however, all the samples in each unit must be from the same production lot, processing line, and control alternative;
3. Collect enough product in the final intact package so that at least ONE pound of meat or poultry per sample is submitted to the lab for analysis. The samples may be collected on a different day than the food contact and environmental samples, as long as the same production lot is represented by all three sample types, and each unit is composed of product samples from the same lot, line, and alternative. If an intact sample of product is too large to submit to the lab, ask the establishment to slack-fill or short-weight a package to one pound without making any changes to its processing operations. If the establishment is not able to do so, contact the lab to see if a larger shipping container is available;
4. Use only one RLMPRODC form per 5-sample unit;
5. Fill in the following fields for block 28 of FSIS Form 10,210-3 for each unit collected:
a. Line ID: Use the line ID in use by the establishment. If no line ID is available, leave blank;
b. Product Line Alternative: Include products from only one alternative;
c. Product Type: Select a product type number from block 18;
d. Product Name: Use the product name in use by the establishment; and
e. Lot Code: Use the lot code in use by the establishment.
f. Time Collected: Use the time that the product is collected. Product should be collected over the production shift, if possible.
6. Use a separate sample seal set (FSIS form 7355-A/B) for each individual sample collected. Place one separately numbered identification label on each sample, and place a corresponding identification label in block 33 of the form;
7. Include a completed FSIS Form 10,210-3 with the five product samples. If it is necessary to send a unit of product samples in multiple boxes, EIAOs are to include a copy of the completed RLMPRODC form in each box. Write “photocopy” on each copy of the original form and number each box (e.g., 1 of 2 and 2 of 2). The original form must be included in one of the boxes; and
8. The laboratory will composite the five RLMPRODC samples submitted per RLm unit and will post one result on LEARN, or the results will be made available through the PHIS, when this function is activated.
C. For food contact surface samples, EIAOs are to:
1. Collect 10 food contact samples per unit. Collect samples starting closest to the product areas and then move further out (i.e., collect food contact surfaces first and then environmental samples);
2. Collect most swabs during operations, ideally at the start of routine breaks scheduled by the establishment. EIAOs are to follow “lock-out, tag-out” procedures for equipment. “Lock-out, tag- out” is controlling energy sources while working on or around equipment.
NOTE: Food contact and environmental samples may be collected on different days from the product samples as long as the same product lot is represented by all three sample types.
a. EIAOs may collect some swabs at the end of pre-operational sanitation activities, before the start of production. Doing so will allow EIAOs to sample areas that are hard to reach or unsafe to sample during operations (e.g., slicer blades); and
b. EIAOs are to take post-operation samples as quickly after operations end as practical and before the implementation of establishment sanitation procedures.
3. If an establishment does not produce product on a particular line on the day an EIAO conducts an RLm, the EIAO can still sample that line, as long as the establishment is producing some FSIS post- lethality exposed RTE product that day. If the EIAO collects samples of equipment that is not in operation, he or she is to:
a. Sample food contact surfaces under the RLMCONT and environmental surfaces under the RLMENVC project code and record that the line is not in use under block 28;
b. Collect the 5 product samples from the unit under the RLMPRODC project code from another line that is in operation at the establishment. The contact and environmental samples may be collected from a different line than the one from which the product samples were taken, as long as all of the product samples are collected from the same line and alternative, and all three sample types (product, food contact, and environmental) represent the same production lot; and
c. If the equipment tests positive, the EIAO is not to recommend that inspection program personnel (IPP) issue a non-compliance record (NR) because the equipment was not in operation at the time the sample was collected, and there is no reason to consider the product to be adulterated. However, if the establishment later decides to use the equipment and does not conduct a full cleaning and sanitizing per its Sanitation SOP before using the equipment, the EIAO is to recommend that IPP issue an NR. The NR would be appropriate because the positive result would establish that the equipment was not maintained in sanitary condition and the product would be considered adulterated (cite 9 CFR 416.3(a) and 430.4(a)).
D. For environmental samples, EIAOs are to:
- Collect environmental (non-food contact surface) samples in areas of the establishment where products are being processed, stored, or held, including smokehouses, coolers, and production rooms;
- Collect 5 separate environmental swabs per sampling unit following the instructions in FSIS Directive 10,300.1. Use only one RLMENVC form per unit;
- In block 28 of FSIS Form 10,210-3, under question 3, state the number of swabs submitted for each site category. The 5 swabs may be from the same sites or different sites. If a sample site swabbed does not fit any of the site categories listed in question 3, then next to choice “J-Other/Details,” the EIAO is to state the number of swabs, along with a short written description (not to exceed 50 characters in the space provided next to that option) of the sites swabbed;
- Place each swab in a separate whirl-pak bag. The EIAO is to use a separate sample seal set (FSIS form 7355-A/B) for each individual swab sample collected. Place one separately numbered identification label on each swab sample and place a corresponding identification label on the form. Place all 5 bar-coded labels side-by-side in block 33 of the RLMENVC form;
NOTE: Environmental (non-contact) brine samples will not be composited. Environmental brine samples are still to be collected using the RLMENVR form. The EIAO needs to request a separate RLMENVR form, along with special supplies for brine collection. RLMCONT forms will still be used for the collection of brine samples that contact product.
5. For each sampling unit, place all 5 of the swab samples, which will be in separate whirl-pak bags, and a single RLMENVC form in a separate large Ziploc bag. Fold over the top of the bag and seal it with a bar-coded identification label (FSIS Form 7355-2B); and
6. Submit all 5 swabs in the sampling unit with a single RLMENVC form. The laboratory will composite the 5 swab samples and post 1 result on the Laboratory Electronic Application for Results Notification (LEARN) (or the Public Health Information System (PHIS) when the function is activated). The description of the sites will be a coding of the information provided in question 3 from block 28 (e.g., 2A1E2J: On-off switch/supply air duct).
NOTE: In situations where a ‘for cause’ FSA is conducted, such as during an IVT, FSIS laboratory personnel will not composite environmental swab samples.
VI. EIAO ACTIONS IN ESTABLISHMENTS THAT ALTER ROUTINE PRACTICES DURING AN RLm
A. FSIS has determined that establishments may temporarily alter their routine production, sanitation, or food safety practices during RLm sampling. By altering routine practices, establishments may make changes that are not consistent with their documented food safety system and that impede FSIS’s ability to assess the safety of the product.
B. Examples of an establishment altering their routine practices may include:
- Temporarily increasing the use or concentration of a sanitizer, or changing the type of sanitizer during the RLm;
- Drastically reducing the typical production time (e.g., by more than 2 hours in a typical 8-hour shift or other significant reduction);
- Reducing the production lot size (except to facilitate holding the product, see the note below);
- Reducing the number of employees handling post-lethality exposed product; or
- Selectively not producing higher risk post-lethality product (e.g., sliced deli product); and not using particular equipment that previously has tested positive.
C. Such practices can interfere with FSIS’s assessment of routine conditions or corrective actions at the establishment and may limit FSIS’s ability to determine whether post-lethality exposed RTE meat and poultry products are not adulterated as required by the Federal Meat Inspection Act and Poultry Products Inspection Act. In addition, such changes may not have been considered in the establishment’s hazard analysis or accompanied by supporting documentation in accordance with 9 CFR 417.2(a) and 417.5(a)(1).
D. Prior to the RLm, if an establishment informs the EIAO that it no longer plans to produce post-lethality exposed RTE product, or that it has modified its production, sanitation, or food safety practices, the EIAO is to document in the MOI the date of the notification, and the reason the change was made. The EIAO is to consider and document the following issues in the MOI:
- If the establishment can provide a supportable rationale for not producing the product (such as intermittent production to fill customer orders), then the EIAO is to collect similar post-lethality exposed RTE product (e.g., produced using equipment that has previously tested positive for Lm) during the RLm sampling, if available. If similar product is not available, the EIAO is to reschedule the RLm as in paragraph VI.D.3 below;
- Likewise, if the establishment can support that the production, sanitation, or food-safety practices were implemented as part of reasonable program modifications that the establishment intends to make permanent, the EIAO is to assess the program changes as part of the RLm, if possible. If the EIAO is unable to assess the program changes, he or she is to reschedule the RLm; and
- If the establishment can provide a supportable rationale for not producing the product, or for modifying the production, sanitation, or food safety practices, the EIAO is to work with the designated FSIS laboratory to reschedule RLm sampling to the next time in which the product or production practice of interest can be assessed by the EIAO. The EIAO is to reschedule the sampling for a time when the FSA is underway at the establishment, if possible.
E. On the day of the RLm sampling, if the EIAO determines that the establishment has temporarily decided not to produce post-lethality exposed RTE product or has altered its documented routine production, sanitation, or food-safety practices, and the establishment can not provide a supportable rationale for doing so, then the EIAO is not to perform sampling and is to contact the DO through his or her supervisory chain.
F. If the EIAO finds that the establishment has made changes in its food safety systems (e.g., changing its supplier of RTE product only during the RLm) and does not have documents supporting the appropriateness of the changes, the EIAO is to recommend to supervisory personnel that the in-plant inspection team issue an NR. The NR would be recommended because the establishment did not consider the changes in its hazard analysis in accordance with 9 CFR 417.2(a), or did not support the changes to its hazard analysis as in 9 CFR 417.5(a)(1). When recommending the issuance of an NR, the EIAO is to follow the instructions in chapters 3, 13, and 15 in FSIS Directive 5100.1. Likewise, if the EIAO finds that the establishment has made changes in its sanitation practices (e.g., temporarily increasing the use of sanitizer during the RLm) and did not revise its Sanitation SOP to reflect these changes, he or she is to recommend to supervisory personnel that the in-plant inspection team issue an NR under 9 CFR 416.14.
NOTE: If an establishment decides to limit its product lot size solely to facilitate holding of the product during the RLm sampling, it would not be considered to have significantly altered its production practices, as long as the EIAO can collect samples that accurately represent routine production. If the EIAO has questions about whether an establishment is altering routine production, sanitation, or food-safety practices, he or she can submit them through askFSIS.
G. If the EIAO is unable to collect RLm samples as in paragraph VI.E and is therefore unable to assess whether the establishment is controlling Lm on its FCS and is preventing the product from becoming adulterated in accordance with 9 CFR 430.4(a), the DO may determine that further actions are warranted. These may include the following:
- The DO may initiate product sampling or schedule an IVT with a “for cause” FSA; and
- The DO may issue a Notice of Intended Enforcement or Notice of Suspension in situations where FSIS personnel have found insanitary conditions at the establishment, or where FSIS personnel have found that the food safety system is inadequate, in accordance with 9 CFR 500.4(a) or (b) or 9 CFR 500.3(a)(4).
VII. EIAO SAMPLE SUBMISSION RESPONSIBILITITES
A. For sample submission, the EIAO is to:
- Follow the instructions in FSIS Directive 10,300.1.
- Ship the sample after the establishment has completed the production lot (as defined by the establishment) and applied all of the interventions for Lm control. EIAOs are to:
- Submit samples the same day if collected during 1st shift Monday through Friday; or
- Submit samples as soon as possible if collected during 2nd shift, Monday through Thursday. Samples should not be sent on Saturday or a day before a holiday. EIAOs are to store the samples refrigerated when holding the samples overnight for shipping; and
- If the product is sent to another establishment for a Listeria control intervention (e.g., HPP), the EIAO is not to ship the sample until the intervention is complete. If the product will not be returned to the establishment, the EIAO is to sample another product (if possible). If the process is being applied to extend the shelf life of the product, and not as a Listeria control intervention, the EIAO is to collect the sample and ship the product before the process is applied.
B. When submitting collected samples, the EIAO is submit the type of sample collected (e.g., food contact) with a FSIS Form 10,210-3 having the appropriate corresponding sample project code in block 14, (e.g., RLMCONT) to the laboratory; and
C. The EIAO is to complete all requested information in Part II as specified in block 18 of FSIS Form 10,210-3. The laboratory will discard samples with incomplete forms.
D. The EIAO is to safeguard the security of samples during preparation, storing, packaging, and submission of samples for testing (see FSIS Directive 7355.1.
VII. SAMPLING RESULTS AND ENFORCEMENT
A. When checking the sampling results, EIAOs are to:
- Follow FSIS Directive 10,200.1, or PHIS when the function is activated; and
- Immediately report test results to establishment management.
B. If any RTE product sample collected by the EIAO tests positive for Lm, product in the sampled lot is adulterated.
C. If a post-lethality exposed RTE food contact surface sample collected by the EIAO tests positive for Lm, any product in direct contact with the surface is adulterated.
NOTE: If the establishment treats the product that passed over the food contact surface with a post- lethality treatment (e.g., HPP) that has been validated to achieve at least a 5-log reduction of Lm, the product would not be considered to be adulterated. EIAOs are to consider all processing steps before making a determination of adulteration.
D. If a post-lethality exposed RTE environmental (non-food contact) surface sample collected by the EIAO tests positive for Lm, the EIAO is to consider whether product may have been produced under insanitary conditions before recommending the issuance of an NR. EIAOs are to recommend that IPP issue an NR if there is evidence of insanitary conditions that could lead to product contamination.
EXAMPLE: A drain tests positive for Lm. The EIAO observes an establishment employee spraying a high pressure hose in the drain. Water droplets landed on a conveyor belt and exposed RTE product. The positive results from the drain, taken along with the observation of possible cross contamination, would be adequate to support the issuance of an NR. The drain positive alone, without any further observations of conditions that could lead to insanitary conditions, would not warrant the issuance of an NR.
E. EIAOs are to follow the instructions in FSIS Directive 5100.1 when making recommendations to the DM or designee regarding enforcement actions. In addition, EIAOs are to take the following into consideration when making recommendations:
- If FSIS finds the product or food contact surface positive, and the establishment tested the product or food contact surface under its documented sampling programs, EIAOs are to check the establishment’s Lm testing results to determine whether the establishment also found the sampled product or food contact surface positive for Lm;
- EIAOs are to determine whether the establishment held the product or maintained control of the product (e.g., the establishment moved the product off site but did not complete pre-shipment review or transfer ownership of the product to another entity) pending its own test results. Establishments are required to hold or control shipments of RTE products containing meat or poultry products pending the results of FSIS product and food contact surface testing.
- If the EIAO finds that the establishment did not hold or maintain control of product when FSIS collects product or food contact surface samples, he or she is to recommend to the in-plant supervisory personnel that the inspection team issue an NR. The NR would be recommended because the establishment shipped product before FSIS found that the product was not adulterated, and because the establishment did not complete pre-shipment review following availability of all relevant test results, as set out in 9 CFR417.5(c). When recommending the issuance of an NR, the EIAO is to follow the instructions in chapters 3, 13, and 15 in FSIS Directive 5100.1; and
- Generally, if FSIS finds the product or food contact surface positive for Lm, EIAOs are to recommend that IPP issue an NR (cite 9 CFR 417.4(a)). However, if the establishment also found the product or food contact surface to be positive for Lm and held the product, EIAOs are not to recommend the issuance of an NR. They are to verify that the establishment performs the appropriate corrective actions as part of the FSA.
IX. DATA ANALYSIS
The Office of Public Health Science (OPHS), the Office of Data Integration and Food Protection (ODIFP), and the Office of Policy and Program Development (OPPD) will analyze data from the RLm Sampling Program on a quarterly basis. OPHS will evaluate the results from the RLm Sampling Program for incorporation into the Lm risk assessment model. In addition, OPHS will report results on the FSIS OPHS Microbiology Data Collection and Report internet site. OPPD will evaluate the program to assist the Agency in informing future policy decisions. ODIFP will perform analyses as needed to evaluate trends in the data or inform agency decision-making. OPPD, ODIFP, and OPHS will collaborate as needed.
Refer questions regarding this directive to the Risk, Innovations, and Management Division through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:
Subject Field: Enter Directive 10240.5
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