4/11/2023
Good Practices in Food Chains
Environmental Monitoring Program
untuk Verifikasi Good Practices
Harsi D. Kusumaningrum
Department of Food Science and Technology
Faculty of Agricultural Technology,
IPB University
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Introduction
• Microorganisms are generally
introduced into the food
processing environment
through raw materials, pests,
air, water, and employees.
• Various pathogenic
microorganisms, such as
Escherichia coli O157:H7,
Listeria monocytogenes, and
Salmonella spp., are common
contaminants found in food-
handling environments.
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Introduction
Food Safety Modernization Act - Product Testing and
Environmental Monitoring (FSMA-FDA, 2011):
“Scientifically valid” environmental monitoring and product
testing must conducted if :
• A ready-to-eat (RTE) food product is exposed to the
environment before it is packaged
• The packaged food does not receive a treatment (e.g., kill
step) that would significantly minimize environmental
pathogens that could contaminate the food
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Environmental monitoring program
(EMP):
will assess the effectiveness of the overall
hygienic practices in a facility and provide
necessary information to prevent possible
microbial contamination of food products
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A properly established environmental monitoring
program:
• will act as an early warning system for potential
microbial hazards in a food manufacturing plant and
• confirm that sanitary designs, personnel practices, and
operational methods already in place are, in fact,
effective.
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To reduce the risk of microbial product contamination,
one must:
• have insight into implementing an effective EMP in a
food facility and
• properly interpreting the data to initiate appropriate
corrective actions.
EMP does not make food safe, but it provides valuable
data (source and concentration) on indicator
organisms, spoilage organisms, and pathogens of
concern in a timely manner.
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EMP BENEFITS
• Measures the overall effectiveness of sanitary design,
personnel practices, and operational methods.
• Provides information (source and concentration) about
indicator organisms, spoilage organisms, and/or pathogens
of concern in a timely manner, so that appropriate
corrective actions can be initiated to prevent potential
microbial outbreaks.
• Acts as an early warning system for microbiological hazards
in both the production and post-production environment
when well-developed and effectively implemented as an
integral component of prerequisite programs.
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EMP BENEFITS
• Helps to identify harborage niches and hot spots in a plant
that may act as a source of contamination.
• Is a critical aspect of documenting the overall sanitary state
of the facility.
• Validates the sanitation program and helps in determining
the frequency required for cleaning and sanitation.
EMP is not designed to validate the effectiveness of cleaning
and sanitizing methods, but is more focused on validating
cleaning and sanitizing frequencies, and all the programs of
the Good Manufacturing Practices (21 CFR).
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DESIGNING AND IMPLEMENTING AN EMP
• Different types of food processing facilities (e.g., plant versus
animal products, dry versus wet processing, etc.) handling
different food products may require different EMPs.
• There is no universal EMP that can be used effectively in all
food processing facilities.
• The design of an effective EMP is specific to the individual
food facility and to the individual operations within the
facility.
• A tailored EMP with a baseline/target will be more effective
in assessing the overall sanitary conditions of a specific
facility.
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KEY COMPONENTS OF AN EMP
An EMP should be carefully designed after evaluating a facility
and its products. Some key components that should be included
in a program are:
• An environmental monitoring team
• A zoning concept
• Sampling procedures
• Selection of indicator and pathogenic
microorganisms
• Sampling tools
• Labeling and shipping
• Baseline/target
• Trends and corrective actions
• Documentation and mapping
• Monitoring
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AN EFFECTIVE EMP
• The first task in the implementation of an EMP is to bring together
individuals familiar with the operation to help identify potential
areas of risk and concern in a facility.
• This group will be the EMP team and may include the plant quality
manager, the plant or corporate microbiologist, line supervisors or
operators, and sanitation supervisors or workers.
• If the facility does not have a food safety microbiology expert
experienced in the development and implementation of an EMP, it
is strongly recommended that the facility contact an experienced
outside expert for guidance.
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AN EFFECTIVE EMP
• An EMP should be carefully designed after evaluating the facility
and its products.
• Different food plants (e.g., plant vs. animal products, dry vs. wet
processing facility) with various food products may require
different EMPs.
• An EMP is specific to a facility and to the individual operations
within a facility.
• A tailored environmental monitoring program with a
baseline/target will be more specific as well as more effective in
assessing the overall sanitary conditions of the facility.
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AN EFFECTIVE EMP
• It is critical for the EMP team to define what constitutes highest
risk areas (zone 1) to lowest risk areas (zone 4) for product
contamination in a facility.
• Also, it is important to choose the right testing tools and
methods before beginning to collect samples.
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AN EFFECTIVE EMP
• It also is critical for food manufacturers to develop a science-
based environmental testing and verification program that
effectively monitors the overall hygiene quality of the facility.
• In general, most environmental swab samples should be taken
from zones 2 to 3, and fewer samples should be taken from
zone 4.
• The frequency and number of samples per zone should be
modified after reviewing the results and effectiveness of
corrective actions.
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All direct food contact surfaces in the plant (e.g.,
blenders, conveyors, utensils, work tables, etc.).
Nonfood contact areas in the plant that are closely
adjacent to product contact surfaces. In general, this is
the area where environmental contamination is most likely
to affect the safety of the product (e.g., equipment
framework, maintenance tools, drip shields, housings, etc.).
Nonfood contact surfaces that are not close to zone 1. If
zone 3 is contaminated with a pathogen, it could lead to
contamination of zone 2 through employees’ actions or
movement of machinery (e.g., walls, floor, drains, etc.).
Areas remote from the product processing areas. If zone 4
is not maintained in a good sanitary condition, it can lead
to cross contamination of zones 1, 2, and 3 (e.g., office
areas, locker rooms, maintenance room, etc.).
(Channaiah, 2013)
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INDICATOR MICROORGANISMS
• Indicators are non-pathogenic microorganisms that may be
naturally present in food or the environment.
• These indicator organisms are used to assess the overall
sanitation or environmental condition that may signal or
indicate the potential presence of pathogens that may cause
significant health risks to consumers.
• Zone 1 is tested for indicator organisms, and zones 2 to 4 are
tested for indicators and pathogens.
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The following reasons explain some of the advantages of using
indicator organisms in an EMP:
• They are less expensive and save time compared to pathogens.
• Low prevalence of pathogenic microorganisms limits the practical
significance of direct pathogen testing.
• Indicator microorganisms are high in numbers and can be easily
enumerated.
• Indicator microorganisms are a valid representative of pathogens
of concern since indicators use nearly the same pH, nutrients,
temperature, water, etc. as that of pathogens.
• They are non-pathogenic, so there is not a need for sophisticated
containment facilities/labs (e.g., Bio Safety Level-2) for sample
analysis.
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• Indicator organisms are not a substitute for testing for
pathogens. A positive result indicates possible
contamination and a risk of foodborne disease.
• Examples of some of the indicator microorganisms that
can be used to monitor hygienic conditions are total
aerobic plate count, total coliforms, fecal coliforms, and
Enterococcus spp. of fecal origin.
• It is recommended that food manufacturing facilities customize
their EMPs after careful evaluation of microbial risks
associated with their products and in compliance with the
regulatory guidance/standards.
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The sampling frequency, type of indicator microorganism, and number of
samples per zone can be modified after reviewing the results and
assessing the effectiveness of corrective actions.
Example 1
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Example 2:
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MAPPING
• A map of all sampling locations on a facility design diagram is
an effective way of identifying hot spots to take appropriate
corrective actions.
• Map the locations of any negative (green color flag), increasing
trend (yellow color flag), and positive samples/results (red
color flag) on a facility design diagram to help define the scope
of the problem.
• Mapping helps in identifying harborage niches and hot spots
that may act as a source of contamination.
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ESTABLISHING A BASELINE
AND CORRECTIVE ACTIONS
• Historical data, such as the previous six to 12 months of
consecutive data, is needed to establish a baseline/target. For
example, if a site tests <50 cfu for a year with two or three spike
readings, then 50 cfu would be set as the baseline.
• The environmental monitoring program and the target/baseline
are unique for each plant and for each type of products.
• It is different for different zones (1 to 4).
• Since the reasons for a positive finding are likely to be plant
specific, the corrective action will differ from plant to plant
based on final food products.
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ESTABLISHING A BASELINE
AND CORRECTIVE ACTIONS
• It is important to compare the environmental sampling results
against a target level or a baseline.
• Any increase in microorganisms or pathogen number should be
monitored.
• These results signal a possible deviation in the sanitary
conditions.
• An appropriate corrective action (e.g., change of sanitizers,
change in sanitizing frequencies, etc.) should be initiated to
bring the values close to or below the target/baseline.
• It requires monitoring to check the indicator or pathogenic
microorganism level in the plant.
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TYPICAL CORRECTIVE ACTIONS
FOR PATHOGEN POSITIVES
Scenario I: Positive zone 1
1. Stop production in the affected line.
2. Stop product.
3. Thoroughly examine the area, both visually and through vector
swabbing.
4. Breakdown production lines for inspection and take appropriate
corrective actions (e.g., leakage, employee traffic, etc.).
5. Thoroughly clean affected site (50-foot radius) and swab site and
adjacent areas (zones 2 and 3).
6. Increase sampling frequency (e.g., from weekly to daily) until you
get three consecutive negative results.
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TYPICAL CORRECTIVE ACTIONS
FOR PATHOGEN POSITIVES
Scenario I: Positive zone 1 (cont’d)
Zone 1 is normally tested for indicator microorganisms. Testing zone 1 for
pathogens such as Salmonella is normally done only for special situations.
If zone 1 tests positive for a pathogen, then the product made on that line
must be held until further confirmative test results are available, and it
will most likely initiate a recall situation.
It is important to have a predetermined action plan that would be
implemented in case of a Salmonella (or any pathogen) positive zone 1.
The response team and appropriate management should make a careful
decision on disposition of finished product, which is put on hold as a
result of zone 1 positive. If possible, the product should be reworked or
condemned according to all legal and regulatory procedures.
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Scenario II: Positive zone 2
1. Breakdown production lines for inspection.
2. Restrict traffic flow in these areas to the extent possible.
3. Thoroughly examine the area, both visually and through
vector swabbing.
4. Take appropriate corrective actions (e.g., leakage, employee
traffic, etc.).
5. Collect swabs after thorough cleaning (zones 2 and 3) in a 50-
foot radius
6. Increase sampling frequency (e.g., from weekly to daily) until
you get three consecutive negative results.
7. Zone 1 swabbing and/or finished product testing may need to
be initiated or intensified in the event of persistent zone 2
positives.
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Scenario III: Positive zone 3 and negative zone 2
This is an early indication that the cleaning and sanitation
programs need to be more robust or redesigned.
1. Restrict traffic flow in these areas to the extent possible.
2. Thoroughly examine the area.
3. Collect swabs after thorough cleaning (zone 3) in a 50-foot
radius.
4. Increase sampling frequency (e.g., from weekly to daily)
until you get three consecutive negative results.
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Scenario IV: Positive zones 2 and 3
1. Break down production lines for inspection.
2. Restrict traffic flow in these areas to the extent possible.
3. Thoroughly examine the area both visually and through vector
swabbing.
4. Take appropriate corrective actions (e.g., leakage, employee
traffic, etc.).
5. Collect swabs after thorough cleaning (zones 2 and 3) in a 50-
foot radius.
6. Increase sampling frequency (e.g., from weekly to daily) until
you get three consecutive negative results in zones 2 and 3.
7. Zone 1 swabbing and/or finished product testing may need to
be initiated or intensified in the event of persistent zone 2
positives.
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POSITIVE RESULTS - ACTION PLAN PROCEDURES
1. Reassemble your team.
2. Initiate root-cause investigation. (What happened?)
3. Use the team’s findings to improve operations, such as:
• Thoroughly examine the area, both visually and through vector
swabbing.
• Increase cleaning and sanitation frequencies or modify method.
• Reexamine employee traffic patterns and redirect, if feasible.
• Make repairs (e.g., leaks, cracks etc.).
• Audit production handling practices (e.g., product and material
handling, etc.).
• Redesign and/or perform equipment maintenance as needed to
eliminate harborage niches that may act as a source of
contamination or facilitate cleaning access.
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POSITIVE RESULTS - ACTION PLAN PROCEDURES
3. Use the team’s findings to improve operations, such as: (cont’d)
• Conduct indirect cleaning such as floor scrubbing and sanitation or
cleaning of overhead equipment, A/C ducts and pipes, etc.
• Increase the swab frequencies.
• Verify the effectiveness.
• Monitor and document.
In a rare and extreme situation, where a “hot zone” cannot be
eliminated, the area should be physically quarantined from the rest of the
plant until a permanent solution
can be found.
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Resume
Develop Environmental Monitoring Program (EMP)
• Determine pathogen(s) of concern and/or or relevant test
microorganisms (surrogate, indicators)
• Review
- all available steps to prevent entry of pathogens
- all hygiene control programs
- historical data, conduct investigative sampling
• Establish sampling methods, sampling points (‘in-process’ or
‘environmental samples’) and their Microbiological Criterion
• Establish testing frequency and testing methods
• Establish corrective action
• Periodical review of the data
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References
• L. Channaiah, C.E. Anderson, A. Bianchini, T.H. Black, G.M. Clapper, E.B. Gay,
J.M. Levenhagen, and Y. Li. 2016. Environmental Monitoring Programs.
Cereals Food World, 61(4): 158-159. http://dx.doi.org/10.1094/CFW-61-4-
0158
• L. Channaiah. 2013. Environmental Monitoring Program: An Early Warning
System for Microbiological Hazards. AIB Update, Nov/Dec: 8-13. Retreived
from https://www.aibinternational.com/aibonline_/
www.aibonline.org/newsletter/Magazine/Nov_Dec2013/EPMEarlyWarningH
azards.pdf [15/4/2021]
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Terima kasih
Safety and Quality is never an accident,
It is always the results of intelligent efforts
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