Guidance on

Pathogen Environmental
Monitoring Programs (PEMP)

GMI QRO-Microbiology
May 2017

-1
 Outline
• Facility and product specific plans to identify target organisms
• Zoning definitions
• GMI PEMP requirements
• Identification of swabbing locations and frequency
• Number of sites to be sampled based upon facility size and risk assessment
• Routine environmental sampling
• Use of approved methods for environmental monitoring
• Additional monitoring during special events
• Response to positive results
• Internal annual review for effectiveness
• Documented sampling procedures

2
GMI Supplier Ingredient Manual

3
 Product Recall Examples:
• The plant environment can harbor microorganisms
• Cross-contamination of product or product contact
zones from environment is possible on most systems
• Control and verification are critical!

• Examples:
• Cereal- 1998, 2008
• Peanuts- 2007 or 2008
• Frozen waffles - 2016
• Sunflower seeds- 2016
• Frozen breakfast products - 2017

4
 Goals of a Pathogen Environmental Monitoring
Program (PEMP)

• Identify and eliminate harborage areas in the

production facility.
• Prevent the growth and spread of pathogenic
microorganisms.
• Prevent environmental pathogens from
contaminating finished product.
• Prevent transient microorganisms from becoming
established residents.

5
Pathogen Environmental Monitoring (PEM)

Verification that sanitation and

GMPs control the growth and
spread of environmental
pathogens

Opportunity to improve programs to

prevent future issues

6
Documented PEMP

7
 Target Microorganisms
Environmental Pathogens

Listeria monocytogenes Salmonella

• Known to survive in processing
plant environments
• Associated with foodborne
disease outbreaks

Valid indicator: • Use a scientifically valid indicator

Listeria spp. organism, if available No valid indicator

*Other organisms known to persist in specific types of production facilities

shall also be included where appropriate

8
 Listeria species
• Ubiquitous
• L. monocytogenes - only human pathogen
• Survives and grows in wet, cool environments
– Note: also survives in dry environments
• Zero tolerance for L. monocytogenes in U.S.

Why not monitor for L. monocytogenes? Look in :

• Listeria spp. indicator casts a broader net to • Cool, wet areas,
catch potential L. monocytogenes •Wet areas near exposed RTE
harborage sites early. product
•Wet areas in high traffic
zones

9
 Salmonella species

• All Salmonella species are potentially pathogenic

• Survives in dry environments for extended periods of
time

Why not use a Salmonella spp. indicator

Look in :
group?
• Dry areas that get wet
• There is no known indicator group that occasionally
consistently represents potential Salmonella •Dry and wet areas near
harborage sites. exposed RTE product
•Dry and wet areas in high
traffic zones

10
Indicator and Spoilage Organism Monitoring

Indicator organisms Spoilage organisms

– Enterobacteriaceae • Yeast and Mold
– Coliforms • Lactic acid bacteria
– Aerobic Plate Count

• Quantitative data for trending

• Way to get routine product contact zone information without
product holding
• Assessment of intervention efficacy
• Indicator/spoilage organism monitoring is NOT a
replacement for pathogen monitoring

11
Target Microorganism by Site
• In mostly dry areas, Salmonella should be
emphasized. If there are specific locations that get
wet, then also sample for Listeria species.

• In mostly wet and cold areas such as freezers and

coolers, Listeria species should be emphasized.

• In mostly wet and ambient areas, both Listeria spp.

and Salmonella should be monitored equally.

12
Monitored Plant Areas &
Hygienic Areas

-13
 Hypothetical Plant Scenario

Raw materials Finished product Process flow

Waste Main personnel entrances/exits
14
Monitored Plant Areas

15
 Hygienic Area Definitions

Production area with higher risk of environmental cross-

contamination to a RTE product
Primary Pathogen
Control (PPC) Area  Areas where RTE products or RTE product contact surfaces
are exposed to the environment after the last validated
pathogen lethality step

Production area with lower risk of environmental cross-

contamination to a RTE product
 Non-RTE production areas
Basic GMP Area  Sites before validated pathogen lethality step for RTE
products
 Sites where product is not exposed to environment (e.g.
after it is packaged or where equipment is completely closed
to the environment)

Non-production Area Monitored non-production areas

*GMI definitions
16
 Hygienic Areas on Plant Floor Plan
Primary Pathogen Production area with higher risk of environmental cross-contamination to a RTE product
 Areas where RTE products or RTE product contact surfaces are exposed to the environment after
Control (PPC) Area the last validated pathogen lethality step

17
 Hygienic Areas on Plant Floor Plan
Production area with lower risk of environmental cross-contamination to a RTE product
Basic GMP ● Non-RTE production areas; ● Sites before validated pathogen lethality step for RTE products; ● Sites
Area where product is not exposed to environment (e.g. after it is packaged or where equipment is completely
closed to the environment)

18
 Hygienic Areas on Plant Floor Plan
Non-production Area Monitored non-production areas

19
Hygienic Area Example
Ready To Eat (RTE) Process Flow*

Ingredient Cooking– Packing /

Mixing Enrobing Oven Packaging
handling validated kill Whse

PPC area
Basic GMP area
Monitored non-production area
*Note: Block flow diagram used to simplify the example. 20
 Hygienic Area Examples
Dry Mix (not RTE) Process Flow

Ingredient Packing /
Mixing Packaging
handling Whse

PPC area
Basic GMP area
Monitored non-production area
*Note: Block flow diagram used to simplify the example. 21
Sites more concentrated in PPC Area

22
Sampling Zones

-23
 Sampling Zones: Definitions and Examples

Direct food contact surfaces and surfaces directly above

Increasing risk of product contamination

food contact surfaces where the effects of gravity or

Zone 1 normal air flow could cause contamination to the contact
surface (Before testing, consider implications to product run before and after
sampling. Zone 1 samples are equivalent to testing finished product. Product control
required pending pathogen test results.)

Non-Product Contact Surfaces in Close Proximity to product

Zone 2
contact surfaces

Zone 3 Peripheral Areas of Production

Zone 4 Non-Production Areas

24
 Sampling Zone Examples
Direct food contact surfaces and surfaces directly above food contact surfaces
Zone 1 where the effects of gravity or normal air flow could cause contamination to
the contact surface

-25
 Sampling Zone Examples
Zone 2 Non-product contact surfaces in close proximity to product contact surfaces

-26
 Sampling Zone Examples
Zone 3 Peripheral areas of production

-27
 Sampling Zone Examples
Zone 4 Non-production areas

-28
 Sampling Zone Review
Air handling
unit above line

Bottom of
Zone 1
catch pan
Conveyor
belt
Rail
Zone 1 Zone 2

Conduit Crack in
Zone 2 floor
Zone 3
Gear box Drain Equipment
Zone 2 Zone 3 support
Zone 2 -29
Sampling Sites (Locations)

-30
 Sampling Sites (Locations)

• List of routinely monitored sites

• Non-routines sites
• For each site, record the following:
– Plant area
– Hygienic area
– Sampling zone

31
 Sample Site Selection
Moisture, leaks, standing water, or water stains

32
 Sample Site Selection
Moisture, leaks, standing water, or water stains

33
 Sample Site Selection
Look for…
• Cracks, gaps, mated surfaces, damaged surfaces – “hiding
places”

34
 Sample Site Selection
Look for…
• Hard to clean areas. (Ex. equipment undersides)

35
 Sample Site Selection
Look for…
• High traffic areas, mobile equipment, and thresholds

36
 Sample Site Selection
Look for…
• Previously untested areas – no history
• Something unusual, off – odor, out of place, or abnormal.

Look for
the
goo!

37
 Number of Sampling Sites
How many sites should I routinely monitor?
“It depends”
Size of Facility Complexity Circumstances
Bigger facilities will • Equipment layout •Age and condition
have more sites due • Traffic patterns of infrastructure
to…. • Larger or more PPC and equipment
•More total area areas = more sites •Weather
•More processing • Wet vs. dry sanitation conditions
systems, more • Does the product •Planned and
potential harborage support the growth of unplanned events
points, more foot pathogens if (non-routine
and vehicle traffic temperature abused? sampling)

38
 Sampling Sites Review
For each site, the record the following:
• Plant area
• Hygienic area
• Sampling zone

When choosing sampling sites look for the following

• Evidence of water – standing water or stains from past water
• Cracks, gaps, mated surfaces, damaged surfaces – “hiding
places”
• Areas that are hard to clean
• Previously untested area – no history
• Areas where something doesn’t seem “right” – use your
senses!

How many areas should I test??

“It depends”
39
Sampling Plans

-40
 Example of GMI Sampling Plans
(Why is the sample being taken?)
Routine Fixed  Sites sampled routinely on a monthly or quarterly basis
 Sites likely to harbor or transfer microorganisms
 Sites that have been positive 2 or more times in the past
12 months

Routine Variable  Exploratory sites in the spirit of "find it, fix it”
 Sites selected at the sampling team’s discretion
Non-Routine  Swabs taken during mitigation and investigation of a
Positive positive finding. This includes repeat swabs of the
Mitigation positive site and additional swabs from related sites for
investigative purposes.
Non-Routine  Sites selected in response to specific activity or special
Event Driven event in the plant that poses a potential risk

41
 GMI Routine Sampling Frequency

Sampling
PPC Area Basic GMP Area
Plan

Quarterly
Monthly
(all sites sampled once per
Fixed (all sites sampled once per
Zones 2 quarter with some sites sampled
month)
and 3 every month)

Variable Monthly (some variable sites sampled each month)

Fixed or
Zone 4 Optional. Frequency to be determined by plant QRO Manager.
Variable

! PPC Area, Zone 3 = Monthly

42
Sample Collection Timing Definitions

The timing of sample collection in production areas with

respect to production and sanitation activities should be
recorded. Sample timing categories for production areas
include:

• During production: to assess the area under normal operating conditions

• Before start-up: To assess effectiveness of sanitation procedures
• Not running: to monitor containment procedures or investigate an event

43
 Sampling Device

Sterile cellulose or polyurethane sponge

• pre-moistened with a neutralizing buffer
• on a stick or with sterile gloves

Use cotton-tipped swabs for small locations only

(cracks, holes, etc.)

44
Separate Device for Each Test at One Site

Salmonella Listeria spp.

45
 Compositing Samples
(a) Up to 5 sponges
(b) Separate sponge for each location

(c) Site selection for compositing

• Same plant area, hygienic area, sampling zone and sampling timing
• Do not composite samples from Zone 2 in PPC areas
• Do not composite samples from sites with a history of positives
• Compositing is not recommended during investigation / mitigation

46
 Composites
• Up to 5 swabs may be combined for one test to
save on testing costs.

• If a composite sample results in a positive

finding, re-swabs of each location individually
should be done prior to corrective actions to
increase the odds of being able to identify the
actual location of the positive.

47
 Sample Analysis
• Samples shall be refrigerated (32-40°F / 0-4.4°C)
for <48 hours prior to testing. Not frozen.

• The test method must be validated for detection

of the target organism in environmental swabs.

• The test method should be performed by an

accredited laboratory with a Quality
Management System and stringent safety
measures.

48
 Test Methodology
• Method must be validated for environmental samples – individual
or composite (Facility QRO Manager responsible)
Example validation credentials:

• Direct plating methods without an

enrichment step are not acceptable
due to lower test sensitivity.

• For rapid screening methods, respond to suspect positive results.

• Confirmation of positive results not required except under
some circumstances

49
 Special Event Management

• Atypical events may increase food safety risk

(biological, chemical, and physical)

• Biological risks: Additional environmental

and/or product surveillance may be needed to
verify safe operating conditions

50
 Microbiological Food Safety Event Management
Events that increase the risk of microbiological contamination in production areas
Examples:
Planned events: Unplanned events:
 Construction projects  Roof leaks

 New line installation  Backed-up drains/flooded floors

 Repairs and maintenance  Excessive condensation in

normally dry areas

 Unknown use of contaminated

ingredient

Non-routine event-based environmental sampling required

• Target organism(s) may be different than during routine sampling

51
Actions for Salmonella or
Listeria spp. Positive Sites

-52
Immediate Actions for Positive Result

• Clean and sanitize the positive site and immediate area.

o Composite samples
o Freezers
• Prevent cross-contamination until fully mitigated.
• Inspect. Repair or remove potential niches.
• Escalate, if necessary.

53
 Follow-up Swabs and Investigation

• After corrective action has been performed, follow-

up sampling should be done to obtain three
consecutive negative results.
• Follow-up samples should be done in a short time
frame (within 7 days of each other), independent
of the routine monitoring frequency.
• Continued positive results should lead to a more
extensive investigation of the area to locate the
root cause.

54
 Vectoring: Investigative Tool
Vectoring = sampling sites surrounding a positive
site in a systematic manner to identify niches
and/or cross-contamination patterns.

- -- -
-- + ++++ +
+
- -
- -

If possible, vector samples shall be taken before cleaning and sanitizing.

55
Vectoring: Example

- -
- -
+
- + -
+ + + -
+ + + -

56
 Vectoring: Follow-up Sampling
NOTE: When vectoring identifies the source of contamination,
the original positive site and the source site must have 3
consecutive negative results

Positive sites in between the original and source sites must have
one negative test result, but are exempt from the 3 consecutive
negative result requirement

If no source is identified, then all positive sites must meet 3 consecutive

negatives
57
 Risk-based Escalation Plan
Number of positive results at the same site within a rolling 12 month period
Hygienic regardless if it is a routine, event-based, or mitigation sample
Zone
Area
1st Positive 2nd Positive 3rd Positive
2 • Root cause investigation and corrective action required

• Continue vectoring and

Primary root cause investigation
• Vector to Zone 2 and 3
Pathogen and corrective action
in immediate area
Control • Confirm presumptive • Continue root cause investigation
3 • Root cause investigation
Area positive results and corrective action
and corrective action
• Contact your Micro
required
department or sanitation
manager
• Vector to zone 2 and 3 in expanded
• Vector to Zone 2 and 3 in area
2
immediate area Root • Continue root cause investigation
Basic
Vectoring considered, but cause investigation and and corrective action
GMP
may not be chosen corrective action • Confirm presumptive positive
Area
required results
3 • Contact Microbiology personnel or
sanitation manager

58
 Correction vs. Corrective Action
Correction Corrective Action
Action taken to prevent a The steps taken to eliminate
detected contamination the root cause of
source from contamination source
continuing to to prevent recurrence.
contaminate the
area. Corrections
do not address Example corrective actions:
root cause. • Repair floor to remove niches

Example corrections:
• Increase sanitation frequency
• Intensify sanitation chemical and
effort
• Reduce/restrict traffic flow
• Shoe sanitation upon exit • Permanent changes to SSOP
that prevent recurrence.
59
 PEM Program Review

Annually or as needed Plant-based team Implement changes

60
 Rate of Positive Incidence

• Don’t worry about percent positives found.

• The idea is to identify and eliminate harborage locations.
• Find it and Fix it!

• Keep track of repeat positives, or those sites that yield a

positive result after you think you have mitigated it.

• Do an annual internal review for effectiveness

– This will give a better idea of the efficacy of the EMP Program.
– Over time, the total incidence will drop.

61
PEMP Personnel Training
Plant-specific training on:
• Facility PEMP
• Related procedures

Including topics such as sampling locations,

naming convention, sampling materials,
where to send samples, recordkeeping
specifics, how to communicate and respond
to positive findings, etc.

For people directly involved in:

• Collecting swabs
• Submitting swabs for testing
• Recordkeeping
• Responding to positive findings
• Evaluating data

62
 Summary

PEMPs are preventive and proactive

programs that help identify and eliminate
risks before they become a problem.

Questions?

63