Critical Elements for a Successful

Pathogen Environmental Monitoring

Program
Timothy Freier, Ph.D.
Food Hazards Virtual Conference
June 1, 2018
Why Conduct a PEMP?
◼ For RTE (Instant) Foods: Major impact on food
safety and quality
◼ Pathogens and spoilage organisms can live in any
food manufacturing plant
◼ Water, food, time
◼ VERIFICATION
◼ Sanitation, sanitary design of equipment and
facility, employee practices, HACCP, hygienic
zoning
◼ PROACTIVE
Different Ways to Achieve the Same Goal

◼ The goal is pathogen-free finished product

◼ Start with a validated kill step
◼ Keep it out of the product after the kill step
◼ How to verify this?
◼ Finished product testing
◼ Intensive environmental monitoring
Problems With Finished Product Sampling

◼ Statistical weakness
◼ Even if 1/100 bags positive for Salmonella,
would need to sample 300 bags for a 95%
probability of finding a positive

◼ Regulatory risk
◼ What is a lot?
◼ It is prudent to hold the lot that is being tested
◼ Costs of product storage
◼ Complications of hold and release
◼ Short shelf life product difficult to hold

◼ Despite problems, still good reasons

 Seek & Destroy Maturity Model
Evolution of Listeria Control in Processed Meats
Stage 1 Stage 2 Stage 3 Stage 4 Stage 5
Doubt Awareness Enlightenment Preventive Predictive
(Know of) (React to)
No testing or only Initially sampled finished Growth niches Interventions Comprehensive indicator
testing as required product, then some contact recognized in both developed and applied site process controlling
to meet regulatory surfaces and equipment and to manage growth facility and equipment
requirements environmental sites facilities niches. Sanitary design growth niches combined
applied to eliminate. with hurdles and barriers
Environmental sampling to control transfer
and corrective action pathways.
resulted in giving the Indicator sites used to
drains to Listeria. measure risk and signal
when to apply intervention
or strengthen hurdle
Seven Most Critical Elements
1. Management Commitment
2. Determination of the Need
3. Risk Evaluation
4. The Sampling Plan
5. The Sampling Methods
6. Data Management
7. Corrective Actions
Management Commitment

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Management Commitment
◼ Corporate and facility management must understand and
support
◼ Appropriate resources must be provided
◼ Employee training
◼ Employee time
◼ Sampling and testing costs

◼ Buteven more important – support corrective actions and

potential actions on product
◼ Sanitary design of equipment and facility – may
require significant $$$
◼ May have to put product on hold
◼ May need to reject, destroy and/or reprocess
impacted product
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Determination of the Need for
PEMP

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Determination of The Need For PEMP
◼ Most pathogen EMP’s are either Listeria or Salmonella
◼ Not every food manufacturing facility will need to do a PEMP
◼ Canned food
◼ Inherent product properties that kill the pathogen

◼ Trend is that more facilities are doing multiple targets

◼ Decision Tree

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http://www.foodquality.com/SpringboardWebApp/userfiles/fqu/image/CorrectedDecisionTree.png
Risk Evaluation

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Risk Evaluation
◼ Properties of the product
◼ Intrinsic and extrinsic properties
◼ History
◼ Where do pathogen reduction steps occur?
◼ How complex is the production operation?
◼ How often does sanitation occur?
◼ Expert input
◼ Not only whether or not to have PEMP, but how
stringent
◼ How many samples taken at each sampling time?
◼ How often to sample?

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Sources of Microorganisms
◼ Raw materials (and rework)
◼ Water (consider re-circulated water)
◼ Workers
◼ Maintenance workers and tools
◼ Animals, pests
◼ Others?
◼ Air
◼ Pallets
◼ Growth in harborage sites
The Sampling Plan

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The Sampling Plan
◼ Each facility needs its own science-based sampling program
◼ What to test for
◼ Number of samples
◼ Which area or zone
◼ How often
◼ Exactly where to sample

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What To Test For?
Facilities producing low water activity foods:
◼ There is no suitable indicator for Salmonella
◼ Supplemented but not replaced by:
◼ Enterobacteriaceae
◼ Salmonella is not a coliform!
◼ EB testing – best to develop a quantitative base line, use statistical process
control to develop upper limits
◼ Many do EB on Zone 1
What To Test For?
Facilities producing wet, perishable foods:
◼ Testing for Listeria spp. can be an excellent indicator for growth niches
that could also harbor Listeria monocytogenes
◼ This can be supplemented by indicator testing, such as APC or ATP
◼ Sanitation verification at pre-op
◼ Use statistical process control
◼ These generic assays can supplement EMP but do not replace
Every Facility is Unique

◼ Sampling locations are unique to the facility and to

the processing line
◼ Sampling sites and frequency will change based on
results over time
◼ A product may differ from similar competitor
products
◼ Available resources will create differences between
facilities
Sanitary Sampling Zones
◼ Zone 1 – Product Contact Surfaces
◼ Zone 2 – Immediately adjacent to Zone 1
◼ Zone 3 – The remainder of the exposed RTE
product area
◼ Zone 4 – Outside the exposed RTE product
area

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Sampling
◼ How many samples?
◼ Varies from 15-100 or more samples/month
◼ Very dependent on the risk evaluation
◼ Sampling may be increased as part of an investigation
◼ When to take the samples?
◼ The frequency will be facility specific
◼ Can be daily, weekly, biweekly, monthly, quarterly
◼ Try to hit each site on a regular basis (annually, twice a year, etc.)
◼ If EM is required for FSMA you will need to document (and explain)
the frequency
Where to Sample - Salmonella
◼ Focus on Non Product Contact Surfaces (NPCS)
◼ Routine monitoring focus on high risk areas
◼ Primary Salmonella Control Area – more frequent
◼ Non – Primary Salmonella Control Area – less frequent (or not at all)
◼ Wet processing/blending

◼ Raw area

◼ Warehousing

◼ Monitoring provides insight to:

◼ Potential for Salmonella presence
◼ Potential for transport though facility

Hunt for moisture!

Salmonella
◼ Strong survivor
◼ May persist in dry state for prolonged periods of time
◼ Difficult to eradicate once established in facility
◼ Heat resistance increases as water activity decreases
◼ Post-process contamination
◼ Sanitation practices
◼ Facility design / maintenance
◼ Moisture control
◼ Ingredient control
Seek Out Moisture Events

Condensate from air conditioner

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Seek Out Moisture Events

Window leaks – may not be this obvious

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Sources of Moisture
◼ Condensation

◼ Roof leaks and drains

◼ Overspray or drainage from wet (raw) areas
◼ Explosion panels around dryers
◼ Wall leaks
◼ Window leaks
◼ Door leaks
◼ Drinking fountains
◼ Hand wash stations

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Where to Sample - Listeria
◼ Focus on Non Product Contact Surfaces (NPCS), but also more
important to do Zone 1
◼ Routine monitoring focus on high risk areas
◼ Primary Listeria Control Area – more frequent
◼ Non – Primary Listeria Control Area – less frequent (or not at all)
◼ Raw area
◼ Warehousing

◼ Monitoring provides insight to:

◼ Potential for Listeria growth niches
◼ Potential for transport though facility

Dig deep!
Environmental Monitoring
Sampling Food Contact Surfaces
◼ Hygienic qualification (hold and test)
◼ Special cause investigation (hold and test)
◼ Verification (hold and test)
◼ Always understand the impact results will have on product
◼ Sampling Zone 1 for Salmonella can implicate all the product
produced on that line since the last sanitary break point
◼ Remember – a sponge picks up < 1 gm of residue, why not test 375 gm
of finished product?
◼ Sampling Zone 1 for L. monocytogenes can also implicate all product
produced on that line from complete clean-up to complete clean-up
Designing a Routine Monitoring Program

◼ Should not be limited to sites easily cleaned & sanitized

◼ Should include collection of residue from inaccessible or neglected
niches
◼ Seek and Destroy
◼ Will be different depending on the target pathogen
◼ Make a list of all zone 2 and 3 sites in the PSCA, choose from this list
randomly but get complete coverage
◼ Leave room for “creative” samples
The Sampling Method

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Sampling Method
◼ Samples can be composited
◼ Not recommended for new programs or investigational sampling
◼ Do not composite sponges from different zones
◼ Sponges should be held refrigerated and
◼ Tested within 24-48 h
◼ Use a method validated for environmental testing
◼ Some methods do not perform as well for environmental samples
Sampling
◼ No rules on the size that should be sampled
◼ The bigger the better
◼ Ideally 10 x 10 or 12 x 12
◼ Not all surfaces are flat squares
◼ When to test?
◼ Listeria – Sample after running several hours
◼ Salmonella – may be difficult to sample during production, can do more
complete break-down and sampling when production down
Data Management

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Environmental Data Management

"The goal is to turn data into information,

and information into insight."
-Carly Fiorina

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Environmental Data Management

Mapping Results

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Corrective Actions

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Evaluation of Results and Corrective Actions

PEMP should be clear on handling pathogen findings

◼ A finding in a Zone 1, 2 or 3 typically will need to be addressed by
corrective action
◼ FSMA requires corrective actions
◼ Identify and correct the problem
◼ Evaluate the food for safety
◼ Finding a pathogen on a zone 1 food contact surface implicates a RTE
product
◼ Prevent from entering commerce if you cannot assure the safety of the
food
Corrective Action Key Points

◼ Finding
a pathogen-positive sample in the exposed RTE product
area should be:
◼ Rare
◼ A really big deal

◼ Form a multidisciplinary investigation team

◼ Production, QA, Maintenance, Sanitation, Procurement
◼ Review all records, interview employees -- try to find the smoking
gun!

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Corrective Action Key Points
◼ Document

◼ History has a way of repeating itself

◼ Cleaning and sanitizing the effected area usually just temporary
◼ Use extreme caution with wet clean-ups in dry plants
◼ Some corrective actions require significant capital
◼ Do follow-up testing to ensure you were effective and that you “hold
the gains”

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Corrective Actions
◼ Depends on single or reoccurring positive
◼ Investigational sampling may (should) be included as part of the
corrective action to determine the source of contamination
◼ Sampling & testing equipment
◼ Measuring microbial loads in finished product
◼ Collect & test samples from food processing environment
◼ Test the area again
◼ Vector out
◼ Keep it on higher sampling rotation
Investigation and Corrective Actions
Key Point - Persistence
◼ Listeria
monocytogenes illness and death linked to hotdogs. Eleven
years later, exact strain from a connected plant linked to RTE turkey
outbreak
◼ Salmonella Agona in dry breakfast cereal, caused an outbreak, exact
strain reappeared in a second outbreak 10 years later
◼ Value of strain tracking
◼ Ribotyping, serotyping, WGS
◼ Can help zero in on root cause
◼ House pets vs house pests
Conclusions
◼ PEMP is a verification tool to assess condition of plant environment
◼ In general
◼ Listeria spp. in refrigerated foods, wet environments
◼ Salmonella in dry foods
◼ The aim of the program is to seek and destroy
◼ Sampling is only the first step. Data management and corrective
actions are key!
Resources
◼ GMA Salmonella Guidance
http://www.gmaonline.org/downloads/technical-guidance-and-
tools/SalmonellaControlGuidance.pdf
◼ FDA Draft Listeria Guidance
https://www.fda.gov/RegulatoryInformation/Guidances/ucm073110.htm
Components in a Pathogen Environmental Monitoring Program
http://www.foodqualityandsafety.com/article/components-for-an-
effective-pathogen-environmental-monitoring-program/4/
◼ Environmental Monitoring Decision Tree
http://www.foodqualityandsafety.com/article/letters-to-the-editor-2

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Our Ambition

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deliver a wide range of testing and consulting services to the food &
nutrition industries and help our customers increase their own
customer’s loyalty with tastier, healthier and safer products.

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Supporting Manufacturing is our Core
Business

Product Sourcing Production Distribution Consumer

development Experience

1 2 3 4 5
Program Preventative In-line Testing Production
Development Controls
 Consulting  Environmental Anaysis  Test Calibration  Finished Product Testing
 Risk Analysis  EnviroMap®  Testing  Food Safety (microbiology,
allergens, contaminants)
 Specification  Laboratory Audits
Development  Digital Solutions
 Training
 Sampling Plan Design
and Optimization 50
Other Activities
Product Consumer
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◼ Thermal Validations ◼ Raw Material ◼ Distribution Center ◼ Sensory Studies

Specification Audits
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EnviroMap Is Tackling Your Concerns

A secure cloud-based system that allows you to

automate your environmental monitoring
program and assist with entire sampling life cycle

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 Building Value through Data
Solutions: EnviroMap
Cloud based software to automate environmental monitoring program

◼ Scheduling : Applies your customized program

◼ Task Manager. Automated communication of tasks as prescribed in the
program
◼ Notification System. Various levels of notification for Tasks and
Results, including corrective action response
◼ Reporting. Flexible and easy to use reporting tools to present, analyze,
and share results, including historical data traceability and data analysis

Set up Schedule Print

Monitoring sampling plan Labels Sampling
plan
Generat Submit Edit
Send e SARF samples samples
samples and Edit
SARF resu
to an external Download lts Mitigation Analyse results
laboratory results if necessary 53
 EnviroMap & Env. Life Cycle
May 2016

Set up Schedule Print

monitoring plan sampling plan labels
Sampling

Generate Submit Edit

SARF samples samples
Send
samples
and SARF Edit
to an results
external
laboratory
Download Mitigation Analyse
results if necessary results
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 The Power of a Global Network

Repartition of revenues*:
Europe

36%
North America

41%
South America

We are not just a collection of 13%

laboratories but an highly MEA-ASPAC

integrated network of laboratories.

*September FY17
10% 55
QUESTIONS?

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