USDA Food Safety and Inspection Service 

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Purpose of Presentation. 

overview 

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• The RTE WG is concerned that the RLm collection rate has decreased significantly

over time. This presentation will convey the importance and purpose of RLm

sampling program.

• Data analyses have shown that for cause IVT sampling has been done in instances

when routine, risk-based Rlm sampling should have been performed.

• This presentation will review RLm scheduling guidance and using OPARM’s

scheduling spreadsheet to decrease confusion and increase the number of RLms

performed.

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• History of FSIS Lm testing and Listeriosis

• Health impacts of Lm vs. other pathogens

• Purpose of the RLm Sampling Program

• WGS and Outbreak Investigations

• RLm Collection Rate and Results

• RLm Scheduling Allocation

• Scheduling Guidance

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FSIS Testing for Lm in RTE Products & Listeriosis Incidence 

bv Calendar Year 

• FSIS Lm Product Testing, Percent Positive I ~ est 

11111111111111 ■■ ••------------ Calendar Year 

Health Impacts vs. Other Pathogens 

Who is most at risk of Listeriosis? 

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*Source: USDA-FSIS regulatory testing results in RTE meat and poultry products (1990-2020)

**Source: Foodnet, Centers for Disease Control and Prevention (1996-2019), includes all Listeriosisinfections in

the U.S. from all food sources.

Bacteria Cases/Year Deaths/Year*

L. monocytogenes 1,591 255

Salmonella 1,027,561 378

E. coli O157:H7 63,153 20

• Compare the number of cases vs. number of deaths.

• Very high hospitalization rate for Lm. 

• Very high mortality rate for Lm. 

• The FDA estimates that Listeriosis has a mortality rate of 20%

to 30%, even in patients taking antibiotics.

• Lm has a disproportionately high impact and cost.

*Estimate of overall cases/deaths per year in the U.S from Scallan, Et al. 2011.

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• The elderly

• Pregnant women

• Pre-nates

• Neonates

• The immunocompromised

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Purpose of the RLm Program 

WGS and Listeriosis outbreaks 

RLm Collection Rate and Results 

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• Intended to detect Lm presence that product verification activities cannot. 

• Listeria forms biofilms which can’t be seen. 

• Establishments that have a good compliance history may still have Lm harborage

and contamination. 

• May help proactively verify that establishments are controlling Lm before

adulterated production lots lead to outbreaks or recalls.

• FSIS sampling verification activities are spot checks and are not intended to

support lot by lot safety. All RLm negative results do not mean that there is no Lm

present.

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• FSIS transitioned fully to Whole Genome Sequencing (WGS) in January of

2018.

• Since then, we have investigated seven listeriosis outbreaks, three were linked

to FSIS regulated products:

• 2018 Cooked Country-cured Ham Outbreak (4 cases, 1 death)

• 2018 Pork Roll Outbreak (4 cases, 0 deaths)

• 2021 Ready-to-eat Chicken Outbreak (3 cases, 1 death)

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RLms continue to be an effective means for verifying

Lm control and prioritizing establishments that do not

have Lm under control for more follow-up (e.g., IVT).

The data supports that routine NFCS sampling is very

effective for detecting Lm in the establishment’s

environment.

NOTE: There were fewer RLm samples collected in FY20 due to restrictions put in place due to the COVID-19 pandemic

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RLm Scheduling 

Update of District RLm Scheduling Allocation 

Why is Using All of the Allocation Each Month 

Iiai.ii3-~Wii.'t? 

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• Unlike most other sampling projects, RLm annual targets are based on an

estimate of the number of eligible lg, sm., and v. sm. establishments and the

number of units that will be collected per establishment. 

• Each District receives between 1 to 3 establishment RLm slots per month. 

• The number of slots assigned to each District has been revised to be

proportional to the number of PLE, RTE producing establishments in each

District. This change was implemented in June 2021.

• It is important for DOs to fulfill the monthly RLm sampling allocation.

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Revision of RLm Scheduling to Ensure 23 Establishments are Sampled per

Month Across All Districts.

District

#

# RLm

Eligible

Est. in FY

21

% of All

RLm

Eligible

Est. in

District

# Ests.

OPARM

Schedules

Monthly

(2019-21)

% of

Monthly

Scheduling

Total

# Ests.

OPARM

Schedule

s

Monthly

(Revised

5/21)

% of

Monthly

Scheduling

Total

5 278 13% 2 8% 3 13%

15 259 12% 3 12% 3 13%

25 237 11% 3 12% 2 9%

35 99 4% 2 8% 1 4%

40 219 10% 3 12% 2 9%

50 313 14% 3 12% 3 13%

60 326 15% 3 12% 3 13%

80 216 10% 3 12% 2 9%

85 146 7% 2 8% 2 9%

90 116 5% 2 8% 1 4%

Total 2209 100% 26 100% 23 100% 11

• The FY 2022 FSIS target is to perform RLm sampling in 23 eligible

establishments each month, for a total of 276 establishments sampled

annually.

• 1 single establishment missed represents 4.35% of the monthly goal.

• 10 single establishments missed represent 3.62% of the annual goal.

• Each time an RLm that is not completed puts FSIS significantly farther from

the targeted number.

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Difference Between RLm and IVT Sampling 

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OPARM PHRE Scheduling Spreadsheet 

Using the RLm Tab 

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RLm and IVT sampling projects are not interchangeable. Examples of

the differences include:

Never performed due to for-cause criteria

in the PLE, RTE production area Routine,risk-based criteria, not for-cause

All results reported individually. Exact location of all positives is identified. 

RLm

IVT

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Very small establishments - 1 unit

collected, based on establishment size.

Predetermined number of sampling units

Small establishments - up to 2 units

Large establishments - up to 3 units

Product and NFCS samples composited by the

laboratories.

Results reported collectively for composited sample types.

Only conducted for-cause

Greater flexibility in number of sample units. Collect 1 unit per line

Up to maximum of 5 units

No sample compositing. Greater sensitivity for detecting very low levels.

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•Ranked list of establishments which do not produce a PLE, RTE product

•Not subjectto 9 CFR 430 “The Listeria Rule” Non-430 Tab •Not eligible for RLm sampling

•Ranked list of establishments which produce at least one PLE, RTE product

•Subjectto 9 CFR 430 “The Listeria Rule” RLm Tab* •Eligible for RLm sampling

*Thistab includesestablishmentswith other processessuch as raw slaughter and further processing. These establishmentsmay have

for cause criteria not related to RTE production and are eligiblefor a PHRE/FSA that may only be focused on non-RTE areas.

The focus of this part of the presentation is on how to

schedule RLms using the RLm tab of the spreadsheet

Every month, OPARM provides each DO with a PHRE Scheduling

Spreadsheet, as described in FSIS Directive 5100.4. The PHRE Scheduling

Spreadsheet is divided into two tabs.

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The RLm tab of PHRE Scheduling spreadsheet ranks establishments eligible for PHREs in

the following order. The “schedule type” column in the spreadsheet corresponds to the

basis for selection and risk type in Table 1 of FSIS Directive 5100.4.

1. PLE, RTE establishmentswith for-cause criteria. Top priority for a

PHRE related to the for-cause criteria. For-cause criteria related to RTE

processtypically triggers IVT sampling.

For-cause RTE criteria = IVT

2. New establishments(risk based). Second priority for PHREs. RLm

sampling is optional, depending on risk factors, the PHRE outcome, or to

inform the PHRE.

3. The “routine” portion (risk-based). Currently sequenced by the last FSA

date. Plan to sequence with the Lm risk algorithm. RLm sampling may be

performed depending on additional risk factors, the PHRE outcome, or to

inform the PHRE.

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Routine, risk-based = RLm

Routine, risk-based = RLm

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Using the RLm Tab 

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Scheduling of Risk-based PHREs (Directive 5100.4) 

Summary 

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The RLm tab of PHRE Scheduling spreadsheet ranks

establishments eligible for PHREs in the following order;

For cause criteria = top priority for PHREs

For-cause criteria not related to RTE does

not justify IVT or RLm sampling in the RTE

area.

For-cause criteria related to RTE may

justify IVT sampling (but not RLm).

Routine, risk-based. Currently sequenced based on

when last FSA was performed. Other risk factors

through correlation with IPP should always be

considered.

Routine, risk-based. 430

establishments that have never had

an FSA – next priority for PHREs. RLm

sampling optional, dependent on all

risk factors and the PHRE outcome.

Optionally, to inform the PHRE.

1. Consider IPP input/concerns.

2. Schedule Rlm allocation even

if PHRE shows no significant

risk factors.

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Indications

for a PHRE

or RLm

Sampling

A change in the

establishment’s

HACCP plan or the

addition of a new

HACCP plan

An increase in Lm,

or indicator

organism positives, 

obtained through

establishment

sampling and

testing.

Conditions that negatively impact sanitation or increase

the probability of Lm contamination such as:

Recent or ongoing construction activities.

Condensation issues. 

Use of high-pressure hoses in the PLE, RTE area.

Worn out, old equipment, roof leaks, or other events that

increase the probability of Lm contamination.

Addition by the

establishment of a

new product. 

Indicators that the

establishment may

be having sanitation

issues such as

repetitive sanitation

related NRs,

increased ATP or

APC values, etc.

• RLm sampling is important because:

• This is our only routine sampling program which includes FCSs, NFCSs, and

product samples. Positives from NFCS locations have proven to be important. 

• The rate Listeria infections and outbreaks has remained steady.

• Listeriosis has a disproportionate human health impact and is deadly for the

at-risk population.

• It’s important to fulfill the monthly RLm allocation.

• RLm sampling is risk based, not for cause. 

• Many of the best Lm related risk factors are not recorded in PHIS and must be

obtained from IPP, e.g., condensation, construction, high pressure hoses, etc.

• NFCS, FCS, and product data together can show evidence of cross contamination

or harborage.

• Past and current isolates may indicate that previous corrective actions were not

effective. 18

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fsis.usda.gov

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