UNEP POPS BATBEP GUID POPs 03 202106.en
UNEP POPS BATBEP GUID POPs 03 202106.en
Table of contents
1 Introduction ............................................................................................................................... 2
2.5 What data are needed to perform a Tier 1, 2 and 3 risk assessment? ............................ 10
5.5 Advanced research methods for assessing adverse human health effects..................... 33
6 References .............................................................................................................................. 37
BAT/BEP Guidance for POPs contaminated sites
1. Introduction
1.1 General
Persistent Organic Pollutants, known as POPs, are chemical substances which are extremely
stable (Persistent), are known to accumulate in biological tissue (Bioaccumulate) and are Toxic. Because
of these PBT properties, these substances thereby pose a risk of adverse effects to human health and the
environment. Many of the characteristics that make POPs ideal for agricultural and industrial applications
create problems when they are released into the environment. The negative effects on humans primarily
follow long-term (chronic) exposure although acute effects can also occur because of high-level exposures.
Ecological impacts are known to include food web contamination and reproductive disorders (Turrio-
Baldassarri et al. 2007; Malisch et al.1999; Holmes et al. 1994; Weber et al. 2008).
1.2 Objectives
The scope of the guidelines is to describe the Best Available Techniques (BAT) and Best Environmental
Practice (BEP) hereafter on the management of POPs contaminated sites. This module focuses on
capacity building of environmental management professionals. This module describes the best practice of
risk assessment Tier 1, Tier 2, and Tier 3 as part of the sustainable management of contaminated sites. In
this context a contaminated site is a site with any type of contaminant including POPs in soil and/ or
contaminated groundwater and/ or bottom sediments. This module should build the capacity in the above-
mentioned professionals on risk assessment for the sustainable management of contaminated sites by
answering the following questions:
• What is a Tier 1, 2 and 3 risk assessment? (see Chapter 2)
• When do you perform a Tier 1, 2 and 3 risk assessment? (see Chapter 2)
• What are the objectives of a Tier 1, 2 and 3 risk assessment? (see Chapter 2)
• What data are needed to perform a Tier 1, 2 and 3 risk assessment? (see Chapters 3-5)
• How are Tier 1, 2 and 3 risk assessments carried out? (see Chapters 3-5)
• What models are available for a Tier 3 risk assessment? (see Chapter 5)
• What is the most appropriated Tier 3 risk assessment model to be used? (see Chapter 5)
According to common practice, a risk assessment for a contaminated site should include:
1. Human health risk (using generic land use specific exposure scenarios) Examples of such generic
exposure scenarios are:
a. Residential
b. Industrial
c. Recreational
d. Agricultural
2. Ecological risk. This typically includes one or more of the following aspects:
a. Direct ecotoxicological effects (adverse effects for individual species)
b. Bioaccumulation/biomagnification (secondary poisoning) in food webs
c. Effects on nutrient cycling function
3. Contaminant migration risk. Mostly related to groundwater migration.
An environmental risk assessment is used to estimate or calculate the impact on humans and the
ecosystem by soil and/ or groundwater and/ or soil gas contamination and the contaminant’s potential
migration in the soil and/ or groundwater and/ or vapor intrusion in buildings and ambient air emission. This
is called forward mode risk assessment or baseline risk calculation.
An environmental risk assessment can also be used to determine the desired clean up target levels
(RBTL 1/ SSTL 2) in soil, groundwater and freshwater sediments that are protective for human health and the
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receptors of the ecosystem. This is called backward mode risk assessment or clean up level calculation.
1
RBTL: Risk Based Target Level. Usually this involves generic target levels for certain land-use scenarios for instance
residential and commercial/industrial land use
2
SSTL: Site-Specific Target Level. This level is derived for site specific land use and the exposure parameters are tailored to
the site-specific land use
The principles of forward-mode and backward mode risk assessment are illustrated in the following Figure
2.1 (adapted from GSI Environmental, 2007).
Figure 2.1 Difference between forward and backward mode risk modelling (adjusted from GSI Environmental, 2007)
Below the same content as Figure 2.1 taken from the Guidance Document of the Interstate Technology and
Regulatory Council (see https://itrcweb.org/risk-3/Content/Resources/ITRC2015RISK-3.pdf).
Internationally it is best practice to perform the risk assessment as a Tiered approach. An example of a
widely used Tiered approach is the Risk Based Corrective Action (RBCA) methodology, which originates
from the United States. This RBCA approach is described in detail in American Society for Testing and
Materials (ASTM) standard guides E2081 3 & E1739 4.
2F 3F
3
Standard Guide for Risk-Based Corrective Action, ASTM E2081, 2015
4
Risk-Based Corrective Action applied at Petroleum Release Sites, ASTM E17393F, 2015
Generally, three levels or ‘Tiers’ of risk assessment are used to sustainably manage sites with
contaminated soil and/ or groundwater and/ or bottom sediments, hereafter referred to as contaminated
sites. These three levels are:
• Tier 1 - A qualitative or preliminary environmental risk assessment based on general site assessment
information
• Tier 2 - A semi-quantitative environmental risk assessment based on more site-specific data
• Tier 3 - A quantitative environmental risk assessment based on numerical or highly detailed Fate and
Transport (F&T) and/ or exposure models and site-specific conditions
Internationally the terminology of the Tiers differs. Tier 1 for instance can be fully qualitative (multicriteria
analysis based on expert judgement) or semi-quantitative risk screening using generic screening levels.
Tier 2 varies from semi-quantitative risk screening using generic screening levels to exposure calculation
with risk models using generic exposure parameters. Tier 3 involves the most site specific and quantitative
risk calculation. Figure 2.2 and 2.3 show two example specific applications of the RBCA approach.
Figure 2.2 Example of a three Tier RBCA approach (Naval Facilities Engineering Service Centre, 1998)
Figure 2.3 Example of a three Tier RBCA approach (Israel Risk-Based Corrective Action abbreviated as IRBCA, 2020)
In this guidance, a specific elaboration of the Tiers in the risk assessment process for POPs is proposed.
This approach focuses on the application of Tier 1 risk assessment, which first requires limited information
of the site-specific contamination situation and exposure parameters. Therefore, this approach is well
suited to quickly prioritize and select contaminated sites for further site assessment including a Tier 2 and
possibly a Tier 3 risk assessment. Parties with limited resources can conduct Tier 1 assessments across
their inventory of suspected and confirmed contaminated sites to prioritise those that present the highest
immediate risk. Limited resources can then be most efficiently deployed to conduct Tier 2 and 3
assessments on those high-risk sites.
A Tier 1 risk assessment is executed when the results of a preliminary site assessment are available and
the decision to stop or to enter to the next phase of site assessment needs to be taken.
The objective of a Tier 3 risk assessment is to provide more justification for major investments and/ or to
focus mitigation measures on the most critical risks (cost-benefit analysis). In this Tier the risk assessment
can be based on (a combination of):
Human health:
• Measured contamination concentration in soil/ groundwater and expert human health modelling
• Direct contact media sampling (crops, drinking water, surface water, dust, soil gas/indoor air) and
comparison with human health-based guidance values (HBGV)
Ecology:
• Ecological risk modelling (for instance Potential Affected Fraction and/or food web modelling)
• Qualitative observations or measuring/monitoring of fate and transport:
o Ecological surveying
o Biota monitoring (for instance fish)/Bioaccumulation/biomagnification testing
• Quantitative methods to assess adverse ecological effects for ecological impact of POPs
o Ecotoxicological lab testing
o In-vivo/In-vitro bioassays such as BDS DR CALUX® bioassay (Besselink H
2004) of dioxin-like activity in eggs etc.
5
RBTL: Risk Based Target Levels
For executing the quantitative Tier 3 risk assessment, various expert (human or ecological) exposure/ risk
models exist. It is mentioned that a human health and an ecological risk assessment are separate
exercises, using different models.
As previously stated, the Risk Based Corrective Action or RBCA Risk Assessment methodology of the US
ASTM (ASTM E2081) is one of the most widely used methods. This methodology is implemented in several
expert models, which can be used such as:
• RBCA Toolkit for Chemical Releases (Provider: GSI Environmental)
• RISC (Risk Implemented Software for site Clean-up)-model (provider: GroundwaterSoftware.com)
Background information on various quantitative risk assessment guidelines/tools can be consulted on the
websites of the United States -Environmental Protection Agency (US EPA and US EPA CLU-IN, Interstate
Technology Regulatory Council (ITRC):
General overview
o https://www.epa.gov/risk/risk-tools-and-databases
Human health:
o https://www.epa.gov/risk/human-health-risk-assessment
o https://www.epa.gov/risk/guidelines-human-exposure-assessment
o https://www.epa.gov/risk/superfund-risk-assessment-human-health-topics
o https://itrcweb.org/risk-3/Content/Resources/ITRC2015RISK-3.pdf
Ecological risks:
o https://www.epa.gov/risk/ecological-risk-assessment
o https://www.epa.gov/risk/superfund-risk-assessment-ecological-risk-topics
Sediments:
o https://www.epa.gov/superfund/superfund-contaminated-sediments-guidance-and-technical-support
o https://clu-in.org/issues/default.focus/sec/Sediments/cat/Risk_Assessment/
In a Tier 3 risk assessment, a detailed exposure assessment is carried out in which receptors and
exposure pathways and parameters are identified in detail in accordance with reference manuals from for
example US EPA (see Figure 2.3). An experienced risk assessor should be involved in this exposure
assessment.
Figure 2.3 Three steps of the Exposure assessment process (USEPA, 1989a) of a Tier 3 risk assessment
The quantified human exposure (usually in mg/kg bodyweight/day) is then compared to a toxicological
threshold value 6. There are two types of toxicological thresholds:
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Usually, these toxicological threshold values are derived by expert organizations such as the World Health
Organisation (WHO), environmental protection agencies (such as US-EPA), Food Safety Authorities (such
as European Food Safety Authority - EFSA) and/ or national public health organizations, such as the Dutch
National Institute for Public Health and the Environment (RIVM). The derivation requires expert
toxicological knowledge (an experienced human health toxicologist), an extensive dataset with human
toxicological test results (for several endpoints), thorough quality assurance procedures according to
international best practices and peer review. Once toxicological threshold values for the COC are available
the comparison of the calculated exposure with the toxicological threshold values can be performed by
experienced risk assessors using quantitative risk models.
It should be mentioned that these derived toxicological threshold values and related screening levels,
although derived by well respected organizations like US EPA should always be used carefully since they
might be specifically derived/suited for national populations with significantly different physiological
properties (such as bodyweight) and or intake rates since these are often closely related to cultural
differences in diets.
A Tier 3 risk assessment requires physical and chemical data for the present COC, the soils, underlying
rock, and ground- and surface waters. In addition, detailed information on the land-use and the related
receptors and exposure parameters is required. In other words, the CSM must be completed.
In cases where site-specific data is not available for all parameters, generic values from books, the internet
or other reference documents such as the US-EPA Exposure factors Handbook (USEPA, 2011 and see
6
These values are internationally also referred to as Health Based Guidance Values (HBGV)
7
Usually a Tolerable Daily Intake (TDI value) or Reference Dose: RfD
8
For these substances there are no safe levels (without risk levels) every exposure level can result in adverse effects.
Therefore, an acceptable risk levels is chosen. Usually, an accepted excess lifetime cancer risk is used
(for instance, 1 in 100 000 of 1 in 1 000 000)
specifically the EPA Expobox website9) might be used. When choosing data, the most conservative values
(the most protective of the environment) should be used or the data needs to be verified with specific
sampling/ measuring (for instance contact media sampling). The parameters that have the greatest impact
on the results of the risk assessment should be chosen very carefully. To identify the impact of these
parameters, a sensitivity analysis10 can be conducted.
2.5 What data are needed to perform a Tier 1, 2 and 3 risk assessment?
To perform any of the different Tiers of an environmental risk assessment the source of the contamination,
the source- receptor pathway (exposure pathway) for the contamination and the receptor of the
contaminants should be known. The receptor can be human, sensitive sub-groups of humans (e.g.,
children), highly exposed groups such as site workers or different types of biota (fish, birds, mammals or
even plants) or a combination of all of these. The type and sensitivity of the receptor to specific POPs can
influence the Safe Threshold level or Acceptable Risk Threshold determinations in the final assessment.
The understanding and the reporting of the source of the contamination, the source- receptor pathway for
the contaminants and the receptor of the contaminants together are the Conceptual site Model or CSM.
Figure 2.4 (TAUW 2018) gives an example of a CSM. The CSM is a necessary gateway to perform an
environmental risk assessment.
Figure 2.4 Example Conceptual Site Model with source, source- receptor pathways, potential risks, and receptors
presented 11
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A CSM typically is developed from the start of the process of the sustainable management of a
contaminated site. The CSM is refined and updated throughout each phase of the sustainable
management of a contaminated site. The phases to be recognized in the process of the sustainable
management of contaminated site are:
1. The preliminary site assessment
2. The detailed site assessment
3. The site remediation assessment
4. The site remediation management
5. The site monitoring and after care
9
https://www.epa.gov/expobox/about-exposure-factors-handbook
10
An analysis of the amount of error an output holds when it is generated from other data that may also have errors or
inaccurate data.
11
In situ soil and groundwater remediation: theory and practice TAUW 2018
The updating and refining of the CSM must take place in each phase of the sustainable management of
contaminated sites. The first two phases are known as the site assessment phases and have the objective
to construct a complete CSM. Presenting the full understanding of the source(s) of contamination, the
source-receptor pathway(s) and the receptor(s).
A completed CSM is the precondition for the next phase, the site remediation assessment including, the
selection and design of the best remedial option based on risk reduction, the environmental merits, and the
costs. Also, in this phase and the last two phases of the site management (the site remediation
management and the site monitoring and after care) the CSM should be updated.
Table 2.1 provides a summary of the role a CSM has in the sustainable management of contaminated
sites.
Site assessment
1 Preliminary site Initial Limited data such as data from a site walkover, interviews, a photo report,
assessment sketches, and possible limited analyses
2 Site assessment Completed Detailed data on the contaminants including soil description, analytical
data and exposure and migration assessment
Site remediation
3 Site remediation Detailed Detailed data needed for remediation such as a hydrological model
assessment
4 Site remediation Updated Results of the carried-out remediation such as the replaced contaminated
management soil by clean soil
Site monitoring and after care
5 Site monitoring and Updated Results of the monitoring and aftercare such as the analytical date of the
after care groundwater
Figure 3.1 and 3.2 are examples12 of illustrations belonging to the ICSM of a DDT contaminated site in Viet
Nam. This example is the same as used in Module 2 Site Investigation, Assessment and Conceptual Site
Model. This section summarizes the results of the ICSM and the results of the Tier 1 Risk Assessment. For
details on the ICSM and the Tier 1 risk assessment results refer to Appendix 1.
Based on the information collected during preliminary site assessment it is concluded that remains of DDT
are present at nine spots. The total quantity of pure DDT is estimates to be around 40 tons. Because of the
years of exposure to rain and rainwater run-off the soil at and surrounding of these hot spots is expected to
be impacted by the DDT. The total estimated amount of DDT impacted soil is around 50 tons. The example
of this ICSM is made with limited site information but based on expert judgement. The objective of the
ICSM is to clearly illustrate the known/ potential soil and groundwater contamination situation in relation to
former and current site-use without extensive (costly) site survey. The ICSM provides an overview:
• Of the potential source area(s) for the soil and groundwater contamination
• Of the potential source-receptor pathway(s) for the soil and groundwater contamination
• Of the potential receptor(s) for the contaminants (current and future)
The ICSM should give an instant overview of the suspected contamination situation, then identify all likely
source(s), source-receptor pathway(s), and receptor(s). The preliminary site assessment results, reported
in an ICSM, are the input for a Tier 1 risk assessment. The objective of a Tier 1 risk assessment is to obtain
a site risk profile with the limited available site data collected during a preliminary site assessment.
12
Environmental Management Plan Lâm Hoá site, Viet Nam PHASE 1 The Preliminary Site Assessment Lâm Hoá commune,
Tuyên Hoá district, Quang Binh province Draft, 26 October 2015. UNDP, GEF and MONRE (TAUW Reference R008-
1217441BFF-beb-V01-NL see Appendix 1)
Table 3.1 Identified environmental risks based on the ICSM presented in Figure 3.2 and 3.3 (example)
No. Environmental risks Sources Pathways Receptors
1.1 human exposure to pure remains of DDT in the direct contact farmers collecting bat manure in
DDT present in the cave cave cave
1.2 ecosystem exposed to pure direct contact ecosystem inside the cave
DDT in the cave
1.3 migration of pure DDT percolating rainwater ecosystem inside and outside in
present in the cave to the run-off front of the cave
surrounding
1.4 migration of pure DDT percolating rainwater groundwater
present in the cave in rock in cave bottom
bottom
2.1 human exposure to DDT DDT contaminated soil Direct contact farmers collecting bat manure in
contaminated soil present in in the cave cave
the cave
2.2 ecosystem exposed to DDT Direct contact ecosystem inside the cave
contaminated soil present in
the cave
2.3 migration of DDT Percolated rainwater ecosystem inside and outside in
contaminated soil present in run-off front of the cave
the cave to the surrounding
2.4 migration of DDT Percolating rainwater groundwater
contaminated soil present in cave bottom
the cave in the cave rock
bottom
3.1 human exposure to pure Remains of DDT Direct contact villagers (including women &
DDT present at varies spots outside the cave children) hunting, collecting
outside fruits and leaves
3.2 ecosystem exposed to pure Direct contact surrounding spots with
DDT present at varies spots DDT
outside
3.3 migration of pure DDT Rainwater run-off surrounding spots with
present at varies spots DDT
outside to the surrounding
3.4 migration of pure DDT Percolating rainwater Groundwater
present at varies spots
outside in the soil/
groundwater
4.1 human exposure to DDT DDT contaminated soil Direct contact villagers (including women &
contaminated soil present at outside the cave children) hunting, collecting
varies spots outside fruits and leaves
4.2 ecosystem exposed to DDT Direct contact ecosystem surrounding spots
contaminated soil present at with DDT contaminated soil
varies spots outside
4.4 migration of DDT Rainwater run-off ecosystem surrounding spots
contaminated soil present at with DDT contaminated soil
varies spots outside to the
surrounding
4.4 migration of DDT Percolating rainwater groundwater
contaminated soil present at
• The ecosystem is not in direct contact with the contaminants, but if the situation is not actively
maintained, it can change to a situation where there is direct contact, and this may have minor
impact to the ecosystem
• Contaminants are not migrating, but if the situation is not actively maintained, it can change to a
situation where contaminants migrate, and this may have some impact on the surroundings
To evaluate the potential environmental risks in a structured way, the identified risks are evaluated by
giving for each identified risk a score for the likelihood and a score for the expected impact. The five
classes of Tier 1 risk assessment with the scores are given in Table 3.2.
Table 3.2 The five classes for the likelihood and impact to be used for the Tier 1 Risk Assessment
Classes Likelihood Score Classes Impact Score
These scores are given for each identified risk, regarding human health, ecosystem, and migration of the
contaminants, as shown in the example of Table 3.3. The sixteen risks given in Table 3.1 related to the
ICSM from Figure 3.1 and 3.2 are listed in the first column of Table 3.3. In the other columns, the scores
from Table 3.2 for the likelihood and impact are given to assess these risks.
Table 3.3 The risks scores given for the identified risks (example)
Human exposure
exposure Ecosystem Migration
13 14
No Risk L I10 L I L I
13
L: likelihood score
14
I: Impact score
Human exposure
exposure Ecosystem Migration
13 14
No Risk L I10 L I L I
human exposure to DDT contaminated soil present at varies
4.1 2.0 2.5
spots outside
ecosystem exposed to DDT contaminated soil present at
4.2 6.0 3.0
varies spots outside
migration of DDT contaminated soil present at varies spots
4.3 6.0 2.0
outside to the surrounding
migration of DDT contaminated soil present at varies spots
4.4 1.0 1.0
outside in the soil/ groundwater
Risks related to the DDT contaminated groundwater
5.1 human exposure to DDT contaminated groundwater 1.0 2.0
human exposure by consumption of DDT contaminated animal
5.2 1.0 4.0
products
5.3 human exposure by consumption of DDT contaminated crops 1.0 2.0
5.4 ecosystem exposed to DDT contaminated groundwater 1.0 1.0
5.5 migration of DDT contaminated groundwater 1.0 1.0
Table 3.4 Calculating the Total Risk Score and Total Site Risk Score for the identified risks (example)
Human health Ecosystem Migration
No L I L I L I Total Risk Score
Figure 3.3 Tier 1 Risk Assessment results: human health risks example site
Figure 3.4 Tier 1 Risk assessment results: ecological risks example site
The updated or completed CSM confirms or rejects the identified potential risks of the Tier 1 risk
assessment by establishing the presence or non-presence of the source, the source- receptor pathway(s)
and the receptor(s). When present the CSM gives the extent and the magnitude (concentration) of the
Contaminants of Concern (hereafter referred as COC) of the source(s) and the extent and magnitude of the
source-receptor pathway(s) using the mapping results and the results of the sample analyses. Finally, the
updated or completed CSM also describes the receptor(s). When all three, source, pathway(s) and the
receptor(s) are there, the risk is real.
These reference values are mostly underpinned by an environmental risk study and apply to individual
COC or groups of contaminants, for instance, DDT/DDE/DDD (sum), Per- and polyfluoroalkyl substances
(PFAS), Hexachlorocyclohexane (HCH), or Polychlorobiphenyls (PCB).
These soil target values for the various substances are in several countries related to national or regional
background concentrations. The groundwater target values provide an indication of the benchmark for
environmental quality if there are negligible risks for the ecosystem in the long term. For parameters like
metals, a distinction is often made between deep and shallow groundwater. This is because deep and
shallow groundwater contain different background concentrations. For instance, in the Netherland an
arbitrary limit of 10 meters has been adopted to define ‘deep’ groundwater15.
The intervention values indicate when human, plants and animals using the soil and/ or groundwater are
(potentially) seriously impacted by the contaminants in the soil and/ or groundwater. They are
representative of the level of soil and groundwater contamination above which a serious case of soil and/ or
groundwater contamination is deemed to exist. A serious case has concentrations above which risks are
15
https://www.rivm.nl/bibliotheek/rapporten/680721005.pdf
expected for long-term (chronic) exposures to the contaminant. Besides the concentration, a volume
criterion is also often applied. A serious environmental contamination is defined when, for instance, more
than 25 m³ of soil and/ or when more than 100 m³ groundwater is contaminated above one of the
intervention values. In some countries, the target values are soil specific so are in the Dutch system the
target values for soil adjusted for the organic matter (humus) content and the soil fraction with a particle
seize smaller than 0.2 µm, as this part of the soil has the capacity to absorb the contaminants.
The analytical results of the sampling evaluated against the reference values are the first input for the Tier
2 risk assessment. In addition, the CSM providing other site assessment information, such as the land-use
status, groundwater, and soil characteristics, should be used for the Tier 2 risk assessment. In case of a
complex contaminant situation (e.g., unexpected contaminants present on the site), consultation from an
experienced toxicologist or another qualified expert is strongly recommended to assess if there are any
significant risks.
The risks assessed during a Tier 2 can also be categorized into the same four categories used in the Tier 1
(see Section 3.3). Now, the ‘likelihood’ is established by the completed CSM and the ‘impact’ is assessed
by the evaluation of concentrations measured. The definitions of the four (4) Tier 2 risk categories are now:
1. Direct risks having a high likelihood and a high impact as the concentration is above the
intervention value:
• Humans having direct contact with the contaminant through the food chain and in their daily lives,
which severely impact their health
• Ecosystem is in direct contact with the contaminants and has a direct negative effect on the
ecosystem
• Contaminants migrating and have a direct negative effect on the site surroundings
2. Potential risks having a low to medium likelihood and a high impact as the concentration is
above the intervention value:
• Humans have no direct contact with the contaminants, but if the situation is not actively maintained,
it can change to a situation that there is direct contact, and this will severely impact their health.
• The ecosystem is not in direct contact with the contaminants, but if the situation is not actively
maintained, it can change to a situation that there is direct contact, and this will have a negative
effect on the ecosystem.
• Contaminants are not migrating, but if the situation is not actively maintained, it can change to a
situation where contaminants migrate, and this will have a negative effect on the site surroundings
3. Probable risks having a high likelihood and a low to medium impact as the concentration is
below the intervention value but above the background value:
• Humans having direct contact with the contaminants in their daily lives, and this has an impact on
their health
• The ecosystem is in direct contact with the contaminants, and this has some impact to the
ecosystem
• Contaminants are migrating and this has some impact on the surroundings.
4. Latent risks having a low to medium likelihood and a low to medium impact as the
concentration is below the intervention value but above the background value:
• Humans have no direct contact with the contaminants, but if the situation is not actively maintained,
it can change to a situation that there is direct contact and will impact their health
• The ecosystem is not in direct contact with the contaminants, but if the situation is not actively
maintained, it can change to a situation that there is direct contact, and this will have some impact
to the ecosystem is expected
• Contaminants are not migrating, but if the situation is not actively maintained, it can change to a
situation where contaminants migrate, and this will have some impact on the surroundings
Below the same example as presented in Figure 3.3 and 3.4 is used as an example of the Tier 2 risk
assessment.
Now more information is available from the detailed site assessment, Phase 2 of the sustainable
management of this contaminated site. The results of the detailed site assessment are reported in the
Phase 2 report16. An example of a Phase 2 report is the Phase 2 report of the Lâm Hoá site, in Viet Nam
provided Module 9 of these guidelines.
It should be mentioned that this Tier 2 risk assessment is not assessing the risks related to the remains of
the pure DDT. Based on the Tier 1 risk assessment results, all DDT remaining outside and inside the cave
(including the contaminated soil inside the cave) was removed before the Phase 2 (soil mapping and
sampling) was carried out. The risks related to the potentially contaminated groundwater are based on the
soil type (loamy clay), the observations made during the Phase 2 fieldwork (very low infiltration rate and
most of the rainwater runs off) are considered not to be present. Instead, the sediment in the creek
receiving the sediments from the run-off is sampled from five places. All sediment samples had DDT levels
below the detection limit and therefor the run-off pathway and the potential risks related to ground and
surface water are not confirmed.
The Tier 2 risk assessment for contaminated soil applied a project-specific reference frame that is based on
the Vietnamese limit values for land-use as provided in Table 4.1.
16
Phase 2 - Detailed Site Assessment Report Lâm Hoá site, Viet Nam, Viet Nam POPs and Sound Harmful
Chemicals Management (Project ID 91381) August 16, 2018. UNDP, GEF and MONRE (TAUW Reference R003-1260864BFF-
V02-ihu-NL see Appendix 2)
Table 4.1 Vietnamese limit values (mg/kg dw)** for DDT in soil
Limit value
Class 2
Background Class 1 Perennial Class 3 Class 4
Contaminant of Concern limit value* Agriculture agriculture Public Industrial
The used project specific reference frame for the DDT/DDE/DDD (sum) concentration in soil (in milligram
per kilogram dry matter referred to as mg/kg dw) is as follows:
• < 0.002 (detection limit) - 0.01 mg/kg dw - No restriction on land use
• 0.01 - 1.10 mg/kg dw Class 1 - Limit value for agricultural land
• 1.10 - 16.5 mg/kg dw Class 2 - Limit value perennial crops
• > 16.5 mg/kg dw - Restricted for any use
The results of the Tier 2 risk assessment for the soil at the Lâm Hoá site are summarized in Table 4.2
below. For the details on the CSM and the Tier 2 risk assessment results refer to Module 9 . The risks are
discussed based on the layout of the sites. For this site, the two following parts of the site are used to
describe the site:
1. The Northern part of the Lâm Hoá site
2. The Southern part of the Lâm Hoá site
Northern part
Southern part
*dry weight
1. Northern part
A small portion (157 m2) of the Northern part, spread over the five different hotspots, is based on the
analytical results for DDT, is not suitable for agricultural and perennial crops such as Eucalyptus and
Acacias. Based on the analytical results for DDT a larger part (489 m2) of the Northern part is not suitable
for agricultural use. Since the Northern part is the habitat for the scarce wildlife and villagers hunt and
collect forest products to supplement their diet, the contaminated soil above the land-use Class 1
(agricultural use) for DDT, are not suitable for the current land-use. Humans having direct contact with the
contaminant through the food web and in their daily lives and will could severely impact their health. The
Ecosystem is in direct contact with the contaminants and has a direct negative effect on the ecosystem.
Contaminants are migrating and have a direct negative effect on the site surroundings. Risk reduction/
mitigations measures at the five different hotspots should be taken to minimize the current environmental
risks related to the land-use.
2. Southern part
A small portion (75 m2) of the Southern part, spread over the four hotspots, is based on the analytical
results for DDT, is not suitable for agricultural and perennial crops such as Eucalyptus and Acacias. Based
on the analytical results for DDT, a larger part (164 m2) of the Southern part is not suitable for agricultural
use. As the Southern part is the habitat for the scarce wildlife and villagers hunt and collect forest products
to supplement their diet, the contaminated soil above the land-use Class 1 (agricultural use) for DDT, is not
suitable for this land-use type. One hotspot, hotspot 10, is located outside the strip of secondary forest but
is in an agricultural field. The soil in this hotspot is not suitable for agricultural use. Also, here humans
having direct contact with the contaminant through the food web and in their daily lives and could severely
impact their health. The ecosystem is in direct contact with the contaminants and has a direct negative
effect on the ecosystem. Contaminants are migrating and have a direct negative effect on the site
surroundings. Risk reduction/ mitigations measures at the three of these hotspots should be taken to
minimize the current environmental risks and at hotspot 10, risk reduction/ mitigations measures should be
taken to minimize the current environmental risks relate to the agricultural use.
There are detailed international guidelines available with exposure factors, for instance, the extensive
documents from the US-EPA Also, other sources like the International Programme on Chemical Safety
1F .
(IPCS) from the World Health Organisation (WHO) and the Agency for Toxic Substances and Disease
Registry (ATSDR) can provide useful information regarding relevant exposure pathways and parameters.
Table 5.1 provides a selection of guidance on assessing and managing human health risks from
contaminated sites.
Table 5.1 A selection of available guidance on assessing and managing risk from contaminated sites
Country/ and Title (Year) Website link Language
organisation
International organisations
Ecology risks
Ecological criteria need to be established through an extensive review of existing ecotoxicological data
including, if necessary, specific ecotoxicity testing and/ or ecological observations of the site in question
(and surrounding habitat) by an experienced ecologist can be applied. During Tier 3, you will need to have
determined that the receptor is present and have undertaken an extensive review and field survey to
assess its habitat conditions, behaviour, sensitive life stages and its diet.
Having determined how the receptor might be exposed (e.g., dermal, inhalation, ingestion, etc.), the
exposure assessment should focus on the predicted level of exposure. For example, where diet is the
primary pathway for exposure, the potential body burden of a sensitive life stage (e.g., juvenile fish) will be
determined based on the likely number/ weight of prey (e.g., aquatic insect larvae) it is likely to eat, and the
amount of contaminant present in the prey.
For ecological risks, a distinction needs to be made between direct ecological effects and the potency of
indirect ecological effects via bioaccumulation/ biomagnification 17. To assess whether these indirect
12F
ecological effects are relevant a thorough understanding of the present ecological receptors which are
directly exposed (for instance earthworms) in the contaminated area in relation to the surrounding habitat
and the food web is needed. Since modelling of site-specific bioaccumulation is complex, sampling of
potential bio accumulative contaminants in higher organisms such as predator birds, fish, mammals can be
a more practical and conclusive way to assess this complex aspect. For POPs, this is an especially
important step due to the persistent and bioaccumulate nature of these chemicals.
17
Bioaccumulation refers to the accumulation of substances, such as pesticides, or other chemicals in an organism.
Biomagnification is the increasing concentration of a substance, such as a toxic chemical, in the tissues of organisms at
successively higher levels in a food chain
communities and/ or ecosystems from contaminants. This may also include estimates of effects associated
with a range of control options from no mitigation (i.e., no action) to maximum control (e.g., complete clean
up). It is mentioned that the F&T of PFAS, including PFOS and PFOA, are very complex and unusual,
compared to most substances normally found at contaminated sites. Therefore, the applicability of these
models to PFAS should not be assumed at this point. At this time, a good reference is the ITRC
(https://pfas-1.itrcweb.org/), as they have dedicated resources to update this information. Several risk
models18 are already specifically updated for PFAS.
For a Tier 3 risk assessment various models are available. Two widely used models are listed below and
shortly presented in this section:
• Risk-Based Corrective Action Toolkit (RBCA Toolkit): for detailed info see https:/ / www.gsi-net.com/
en/ software/ rbca-software-tool-kit-for-chemical-releases-version-2-6.html
• Risk Integrated Software for Clean-ups (RISC): for detailed info see http:/ /
www.groundwatersoftware.com/ risc5.htm
18
For instance the Belgian (Flanders) S-Risk model (https://www.s-risk.be/) and CSOIL2020 model from Dutch RIVM.
Figure 5.1 Example of exposure pathway flowchart (GSI Environmental Inc., 2007)
• F&T Models: F&T models for all exposure pathways address a wide array of chemicals, including
petroleum hydrocarbons, including Total Petroleum Hydrocarbons (TPH), metals, chlorinated solvents,
pesticides including POPs, and more. Multiple Points Of Exposure (POEs) allow analysis of actual
versus potential points of exposure in the same run. An array of default transport parameters is
provided for various soil types. F&T models include:
− Soil and groundwater source depletion
− ASTM and USEPA (SSG) outdoor air volatilization
− Johnson & Ettinger and Groundwater Mass Flux indoor air models
− ASTM soil leaching model, with decay options
− Dual-equilibrium desorption
− Point-source air dispersion
− Domenico groundwater solute transport, with decay options
The modelling results, in the (forward mode) calculation of the baseline risk (see Figure 5.2), are tested
against:
• Non carcinogenic risk indexes
• Carcinogenic risk levels
Figure 5.2 Example of baseline risk summary (GSI Environmental Inc., 2007
The backward calculation of site-specific clean-up levels (target levels) can also be performed (see Figure
5.3).
Figure 5.3 Example of calculated clean up levels (GSI Environmental Inc., 2007)
• Human health risk assessment: RISC5 includes the following nine exposure pathways to estimate the
potential for adverse human health impacts:
19
http://www.groundwatersoftware.com/risc5.htm#RISC5
1. Ingestion of soil
2. Dermal contact with soil
3. Ingestion of groundwater
4. Dermal contact with groundwater
5. Inhalation in the shower
6. Inhalation of outdoor air
7. Inhalation of indoor air
8. Ingestion of surface water
9. Dermal contact with surface water
RISC5 offers F&T models to estimate receptor point concentrations in both air and groundwater. The model
can be used for soil and groundwater contamination and surface water and sediment contamination from
impacted groundwater and direct comparison with relevant national standards for these media. The
modelling, such as with the RBCA toolkit, results in the calculation of the baseline risk (forward mode):
• Non carcinogenic risk indexes and
• Carcinogenic risk levels
Additionally, site specific clean-up levels (target levels) can be calculated using backward calculation.
The sampling and or measurements require experienced field technicians and specific sampling/
measuring protocols (including robust verification protocols and quality assurance/ control procedures since
often guidelines from the International Organization for Standardization (ISO guidelines) are lacking).
To obtain the concentration of contaminants in the sampled contact media often specific laboratory
analyses are needed. For air sampling, several mobile measuring techniques are available and can be
applied. Such as with the field sampling, the analyses require specialized laboratories, specific analytical
guidelines, and equipment. Also, the detection and quantification limits of the chemical analysis are
important to obtain useful and reliable results that can be used in the risk calculation. An extensive
5.5 Advanced research methods for assessing adverse human health effects
In complex situations where risk modelling, in combination with contact media sampling, does not lead to
conclusive results because the exposure assessment or the human health criteria (health-based guidance
values) have a high degree of uncertainty (for instance when high uncertainty factors are applied to
calculate the health-based guidance values) more advanced methods can be applied to assess the amount
of exposure of receptors or actual adverse human health effects.
Some of these methods can also be applied to monitor the exposure of receptors over time or to monitor
the actual effect of mitigation measures to reduce the exposure of contaminants. In vitro or in vivo bio-
indicators and biomarkers (bioassays) can also be used to assess potential ecological risks in detail.
20
GUIDANCE MANUAL FOR ENVIRONMENTAL SITE CHARACTERIZATION IN SUPPORT OF ENVIRONMENTAL AND
HUMAN HEALTH RISK ASSESSMENT - VOLUME 1 GUIDANCE MANUAL, CCME, 2016 See:
https://www.ccme.ca/en/files/Resources/csm/Volume%201-Guidance%20Manual-
Environmental%20Site%20Characterization_e%20PN%201551.pdf
21
Epidemiology is the study of the distribution of diseases and other health-related conditions in populations, and the
application of this study to control health problems. The purpose of epidemiology is to understand what risk factors are
associated with a specific disease, and how disease can be prevented in groups of individuals; due to the observational nature
of epidemiology, it cannot provide answers to what caused a disease to a specific individual. Epidemiologic studies can be
used for many reasons, commonly to estimate the frequency of a disease and find associations suggesting potential causes of
a disease. (Source: National Center for Biotechnology Information, U.S. National Library of Medicine)
22
ISO 19204:2017 Soil quality -- Procedure for site-specific ecological risk assessment of soil contamination (soil quality TRIAD
approach)
23
https://www.rivm.nl/bibliotheek/rapporten/711701047.html
24
Ecological risk assessment guidance document, CCME (2020) see https://ccme.ca/en/res/eraguidance_e.pdf
25
An ecological risk assessment framework for contaminants in soil UK Environment Agency (2008) see
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964467/An-Ecological-Risk-
Assessment-Framework-for-contaminants-in-soil.pdf
26
British Columbia Guidance documents for ecological risk assessment Ecological Risk Assessment. Several documents see:
https://www2.gov.bc.ca/gov/content/environment/air-land-water/site-remediation/guidance-resources/risk-
assessment/guidance-for-risk-assessment
27
Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments Interim Final EPA 540-R-97-
006 June 1997 (USEPA, 1997a) See: https://www.epa.gov/risk/ecological-risk-assessment-guidance-superfund-process-
designing-and-conducting-ecological-risk
28
Guidelines for Ecological Risk Assessment. USEPA/630/R-95/002F. April 1998 (USEPA, 1998). See:
https://www.epa.gov/sites/production/files/2014-11/documents/eco_risk_assessment1998.pdf
Figure 5.4 Schematic presentation of the integration of three (3) fields of research according to a Triad (RIVM, 2006)
For each of the lines of evidence several tools can be used to gather specific information regarding risks/
adverse effects. There are dozens of tools that can be applied to assess certain effects for certain species.
For each contaminated site, a selection of applicable tools must be made. Often the applicability of a tool
depends on the land-use (and associated ecosystem) and the constituents of concern. Table 5.2 presents
an overview of tools that can be used and the suitability for certain land-uses.
Table 5.2 Overview of applicability of tools for ecological risk assessment (RIVM, 2006)
Indicator Tier* Nature Agricultural Parks Garden- Garden Industrial
(instrument) etc. food
Chemistry
Site-Specific benchmarks 1 • •• •• •• ••• •••
Toxic pressure, combi-PAF 1 •• •• •• •• ••• •••
Toxic pressure, multi-substance 1-2 •• •• •• •• •• •••
PAF
Toxic pressure, specific target 1-2 ••• •• •• •• • •
species PAF
Toxic pressure, specific soil 1-2 ••• ••• •• ••• •• •
functions PAF
Modelling bioavailability 3-4 ••• •• •• ••• • •
Modelling bioaccumulation 3-4 ••• •• • ••• • •
Modelling effects on populations 4 ••• •• • • • •
Bioaccumulation measurements 4 ••• ••• • ••• • •
Toxicology
Microtox (elutriate) 1 •• •• ••• •• ••• •••
Rotoxkit (elutriate) 1 •• •• ••• •• ••• •••
PAM-algae test (elutriate) 1 •• •• ••• •• ••• •••
Emergence test with plant seeds 2 • • • • • ••
Earthworm: avoidance test, 2 •• ••• ••• ••• ••• •••
acute toxicity test
Plant growth test 3-4 ••• ••• •• ••• ••• ••
Nematodes: survival, growth, 3-4 ••• ••• •• •• •• •
reproduction
To compare the results of the different tests and lines of evidence the results for each line are scaled and
added in a decision matrix. Figure 5.6 is an example of such a decision matrix.
Table 5.3 is an example of a triad decision matrix used for a site in Denmark.
Table 5.3 Example of Triad decision matrix of the Skagen site in Denmark (RIVM, 2006)
Tier 1
Tier 2 + 3
Chemistry Skagen M Skagen H
Sum TP soil (C1) 0.94 1.00
TP porewater (SPME) (C3) 0.06 0.66
Risk number 0.76 0.98
Toxicology
Microtox solid phase (T1) 0.05 0.05
Ostracodtoxkit mortality (T1) 0.14 0,86
Springtail reproduction test (T3) 0.18 0.37
Daphnia survival (T3) 0.43 0.43
Risk number 0.21 0.53
Ecology
Microarthropods (E3) 0.13 0.30
Plant community analyses (E3) 0.17 0.34
Biolog (CLPP) (E3) 0.19 0.18
Risk number 0.16 0.28
Final assessment
Risk number - Chemistry 0.76 0.98
Risk number - Toxicology 0.21 0.53
Risk number - Ecology 0.16 0.28
Integrated risk number 0.46 0.82
Deviation 0.58 0.62
Risk Indicators: 0.00 < IR < 0.20 no risk
(IR = Integrated Risk) 0.21 < IR < 0.50 low risk
0.51 < IR < 0.75 moderate risk
0.76 < IR < 1.00 high risk
6. References
ASTM standard guide E2081 (2015) Standard Guide for Risk-Based Corrective Action
2
ASTM standard guide E1739 (2015) Risk-Based Corrective Action applied at Petroleum Release Sites
Besselink H, J. A., Pijnappels M, Swinkels A, Brouwer B (2004). "Validation of extraction, clean-up and DR
CALUX® bioanalysis. Part II: foodstuff." Organohalog Compd 66: 677-681.
GSI Environmental (2007) Software Guidance Manual RBCA Tool Kit for Chemical Releases, Risk Based
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Holmes SJ, Green N, Lohmann R, Jones KC (1998) Concentrations of PCDD/PCDFs in soil around a point
source. Organohalog Compd 39:257–260
Israel Risk-Based Corrective Action (IRBCA, 2020). Technical Guidance Version 2. Available online:
https://www.gov.il/BlobFolder/guide/irbca/he/contaminated_soil_documents_irbca_guidance.pdf
ITRC (2015) Decision making at contaminated sites – Issues and options in human health risk assessment.
Available online: https://itrcweb.org/risk-3/
Malisch R, Gleadle A, Wright C (1999) PCDD/F in meat samples from domestic farm animals and game.
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Naval Facilities Engineering Service Center (NFESC) (1998) Risk-Based Corrective Action (RBCA) A cost
effective and practical strategy to manage site clean-up. Available online :
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www.rivm.nl/ bibliotheek/ rapporten/ 711701047.pdf
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