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CONSIDERATION ABOUT PROCESS OF ENVIRONMENTAL RISK ASSESSMENT AND MANAGEMENT
By
Maria Carolina Rivoir Vivacqua
Environmental Engineering Department of IMFIA
Republica Oriental del Uruguay
Submitted in partial fulfillment of the requirements for the requirements for the Training on Environmental
Technology
(July 2006 – June 2007)
Dr. Takeshi Komai
Institute of Geo-resources and Environment AIST, METI
Japan
Gratefulness by
Dr. Mio Takeuchi
Institute of Geo-resources and Environment AIST, METI
Japan
Supported by
Japan International Cooperation Agency (JICA)
June 2007
I
ABSTRACT
The objective of this research is developing a methodology of risk management and assessment to apply in Uruguay. In search of
this objective this research was divided into 6 steps: (a) collect data, (b) analyse methodologies, (c)classify methodologies
(according to environment efficiency), (d) collect data of Uruguay and samples of water contaminated, (e) evaluation of risk with
different methodologies, (f) propose a methodology to apply in Uruguay. Here in Japan was developed three first steps. Human
being and earth’s ecosystems form a symbiotic relationship such that the impacts to one entity ultimately reflect upon the other. As
human influence upon the environment has been intensified in response to increasing population and technological reliance, the
environment has become increasingly more stressed. To minimize or curtail environmental degradation, individual or organizations
are given the responsibility to make decisions and take action to reduce adverse human impact without unduly hindering the
economic, social, or political progress of their countries. Environmental management problems are complex because of the
involvement of several and diverse stakeholder groups whose values are often conflicting. The effort to recognize, assess, and
mitigate environmental problems has been largely led by developed Countries. The methodology of risk management has been
developed to integrate the stakeholders concerns, population opinion, and technical analyses (risk assessment). In pursuit of the
objective of this research was done a survey of guidelines and methodologies about risk management and assessment in sites of
Internet of institutions. The next steps will be analyzing and classify the methodologies find. There are three line of research of risk
assessment and management: human health (HRA), ecological (EcoRA), and environmental (ERA). For each line of research can
be used different methodologies and model. In the scientific literature the model developed in USA by National Academy of
Sciences (NAS) which looks at chemical risk to human health is widely used and accepted but excludes any of the social aspects of
risk that make risk assessment such a complex task. Many international institutions developed risk assessment methodologies a nd
procedures for exposure from specific source follow the NAS model using a complement. EcoRA involves the assessment of the
risk posed by presence of substances released to the environment on all living organisms in the variety of ecosystems that make
up the environment. EcoRA has a trend to focus on the risk from chemicals and genetically modified organisms. Some address
physical risk such as temperature risks caused by cooling water releases from industry. Many organizations are involved in the
development of methods and applications of EcoRA. Within the precept what human being and earth’s ecosystems form a
symbiotic relationship the concept of ERA was born. This method is also based on NAS method but involves much more steps and
embrace human health, ecological system, aspects of socio-economics, culture, and politics. US EPA is developing a new
methodology, cumulative risk assessment (CRA), which could be used on risks to health or environment. CRA is combined risks
from aggregate exposures to multiple agents or stressors (chemicals, biological or physical agents, or the absence of a necessity
such as habitat). All institutions researched make emphasize of risk managers may have to scientifically assess risk and use
formalized risk management procedures to choose the most satisfactory course of action in response to that risk. For EEA this
means reducing risk to an “acceptable” level at an “acceptable” cost. By any means, the most common of formal analysis
techniques for alternative risk management options are cost-benefit, cost-risk-benefit, and decision analysis. Complex problems are
broken down into manageable components that can be studied individually and then combined to make an overall assessment.
Strongly prescriptive decision rules are used. These components are combined according to formalized procedures. Final ly, there
has to be a common unit to compare different consequences and make trade -offs between conflicting objectives. ERA is a process
by which environmental risk can be examined and a qualitative or quantitative measure of risk derived by using scientific data and
this kind of process can be applied in any country.
Keywords: methodology, risk management, risk assessment, health, ecological, environmental.
II
Table of Contents
1 List of Figures______________________________________________________________________________ II
2 List of Acronyms ____________________________________________________________________________III
3 Objective ___________________________________________________________________________________ 1
4 Introduction_________________________________________________________________________________ 1
5 Methodology of Research ______________________________________________________________________ 2
6 Results _____________________________________________________________________________________ 3
6.1 NAS ____________________________________________________________________________________ 3
6.2 US EPA _________________________________________________________________________________ 3
6.2.1 Health risk assessment of chemical mixtures ______________________________________________________________ 4
6.2.2 Cumulative Risk Assessment__________________________________________________________________________ 7
6.3 EEA___________________________________________________________________________________ 12
6.4 European Chemicals Bureau ________________________________________________________________ 12
6.5 Institute of Geo-resources and Environment AIST, METI__________________________________________ 15
7 Discussions ________________________________________________________________________________ 16
8 Conclusion_________________________________________________________________________________ 21
9 References _________________________________________________________________________________ 22
10 Acknowledgement ___________________________________________________________________________ 25
1 List of Figures
Fig. 1. Methodology of research ___________________________________________________________________ 2
Fig. 2. NAS method _____________________________________________________________________________ 3
Fig. 3. Risk assessment approach for chemical mixtures _______________________________________________ 5
Fig. 4. NAS Risk Assessment Paradigm Modified for Cumulative Risk, with Concepts Beyond Issues for Single
Chemicals or Mixtures ____________________________________________________________________________ 7
Fig. 5. Approach for cumulative risk assessment ______________________________________________________ 8
Fig. 6. Elements of risk assessment for EEA ________________________________________________________ 12
Fig. 7. Risk assessment of new substances, existing substances and biocidal active substances and substances of
concern present in a biocidal product: general principles._______________________________________________ 14
Fig. 8. Risk assessment and risk management for soil and groundwater. _________________________________ 15
Fig. 9. Strategy of environment risk management.____________________________________________________ 15
III
2 List of Acronyms
AIST National Institute of Advanced Industrial Science and Technology
As Arsenic
BOD Biochemical Oxygen Demand
COD Chemical Oxygen Demand
Cr Chromium
EcoRA Ecological Risk Assessment and Management,
EEA Europe Environmental Agency
EPA U.S. Environmental Protection Agency
ERA Environmental Risk Assessment and Management
FAO Food and Agriculture Organization of the United Nations
Hg Mercury
HRA Human Health Risk Assessment and Management
METI Ministry of Economy Trade and Industry, Japan
MOS Margin of Safety
MW Molecular Weight
NAEL No Adverse Effect Level
NAS U.S. National Academy of Sciences
NF Norme Française
NH3 Ammonia
NOAEL No Observed Adverse Effect Level
NOEC No Observed Effect Concentration
O&G Oil and Grease
OECD Organisation for Economic Cooperation and Development
OSPAR Oslo and Paris Convention for the protection of the marine environment of the Northeast Atlantic
P Persistent
PAH Polycyclic Aromatic Hydrocarbon
Pb Lead
PBPK Physiologically Based PharmacoKinetics
PBPK/PDPhysiologically Based PharmacoKinetics and PharmacoDynamics
PBT Persistent, Bioaccumulative and Toxic
PBTK Physiologically Based ToxicoKinetic modelling
PCB Polychlorinated Biphenyl
PCDD PolyChlorinated Dibenzo Dioxin
PCDF PolyChlorinated Dibenzo Furan
PEC Predicted Environmental Concentration
PNEC Predicted No Effect Concentration
POM Polycyclic Organic Material
POP Persistent Organic Pollutant
PPE Personal Protective Equipment
ppm Parts Per Million
QSAR (Quantitative) Structure-Activity Relationship
R phrases Risk phrases according to Annex III of Directive 67/548/EEC
RAR Risk Assessment Report
RfC Reference Concentration
RfD Reference Dose
RPF Relative Potency Factor
RWC Reasonable Worst Case
S phrases Safety phrases according to Annex III of Directive 67/548/EEC
S Sulfur
IV
SAR Structure-Activity Relationships
SCE Sister Chromatic Exchange
SETAC Society of Environmental Toxicology and Chemistry
SNIF Summary Notification Interchange Format (new substances)
SSD Species Sensitivity Distribution
STP Sewage Treatment Plant
TEF Toxicity Equivalence Factor
TEQ 2,3,7,8-TCDD Toxicity Equivalents
TGD Technical Guidance Document 1
TNO The Netherlands Organisation for Applied Scientific Research
TNsG Technical Notes for Guidance (for Biocides)
TOC Total Organic Carbon
TSS Total Suspended Solids
TTC Toxicity-Specific Concentration
TTD Target Organ Toxicity Dose
UC Use Category
UDS Unscheduled DNA Synthesis
UF Uncertainty Factor
UNEP United Nations Environment Programme
US EPA Environmental Protection Agency, USA
vB very Bioaccumulative
vP very Persistent
vPvB very Persistent and very Bioaccumulative
WHO World Health Organization
WOE Weight of Evidence
1
3 Objective
The objective of this research is essaying to draw a methodology of risk management and assessment of
groundwater contamination to apply in Uruguay.
4 Introduction
Human being and earth’s ecosystems form a symbiotic relationship such that the impacts to one entity
ultimately reflect upon the other. As human influence upon the environment has been intensified in response
to increasing population and technological reliance, the environment has become increasingly more stressed.
To minimize or curtail environmental degradation, individual or organizations are given the responsibility to
make decisions and take action to reduce adverse human impact without unduly hindering the economic,
social, or political progress of their countries. Environmental management problems are complex because of
the involvement of several and diverse stakeholder groups whose values are often conflicting. The effort to
recognize, assess, and mitigate environmental problems has been largely led by developed countries.
Therefore, the methodology of risk management has been developed to integrate the stakeholders concerns,
population opinion, and technical analyses (risk assessment). In pursuit of the objective of this research was
done a survey of guidelines and methodologies about risk management and assessment in sites of Internet of
institutions. In addition, was analyzing and classify the methodologies found.
Analyzing consist in try understand how work each methodology and why do what each one do. To
summarize, there are three line of research of risk assessment and management: human health (HRA),
ecological (EcoRA), and environmental (ERA). For each line of research can be used different methodologies
and models.
In the scientific literature the model developed in USA by National Academy of Sciences (NAS) which looks at
chemical risk to human health is widely used and accepted but excludes any of the social aspects of risk that
make risk assessment such a complex task. Many international institutions developed risk assessment
methodologies and procedures for exposure from specific source follow the NAS model using a complement.
EcoRA involves the assessment of the risk posed by presence of substances released to the environment on
all living organisms in the variety of ecosystems that make up the environment. EcoRA has a trend to focus
on the risk from chemicals and genetically modified organisms. Some address physical risk such as
temperature risks caused by cooling water releases from industry. Many organizations are involved in the
development of methods and applications of EcoRA.
2
Within the precept what human being and earth’s ecosystems form a symbiotic relationship the concept of
ERA was born. This method is also based on NAS method but involves much more steps and embrace
human health, ecological system, aspects of socio-economics, culture, and politics.
US EPA is developing a new methodology, cumulative risk assessment (CRA), which could be used on risks
to health or environment. CRA is combined risks from aggregate exposures to multiple agents or stressors
(chemicals, biological or physical agents, or the absence of a necessity such as habitat).
All institutions researched make emphasize of risk managers may have to scientifically assess risk and use
formalized risk management procedures to choose the most satisfactory course of action in response to that
risk. For EEA this means reducing risk to an “acceptable” level at an “acceptable” cost. By any means, the
most common of formal analysis techniques for alternative risk management options are cost-benefit, cost-
risk-benefit and decision analysis.
In most methodologies, complex problems broken down into manageable components that can be studied
individually and then combined to make an overall assessment. Strongly prescriptive decision rules are used.
These components are combined according to formalized procedures. Finally, there has to be a common unit
to compare different consequences and make deals between conflicting objectives.
5 Methodology of Research
In search of the objective, this research was divided as you can see from the figure 1. In Japan was done
search of methodology in various institutions like: AIST, US EPA, EEA, FAO, OECD, WHO, UNEP, European
Chemicals Bureau, and others institutions. Also in Japan was analyse and classify the methodology found
according environment efficiency.
Fig. 1. Methodology of research
Methodologies ofmanagementand assessmentof environmental risk in the world
Various institutions are developing methodologies ofmanagementand assessment of environmental risk
Collect data about methodologies of management of environmental risk
Analyse data
Classify methodologies (according to environment efficiency)
Collect data of Uruguay and samples of water contaminated
Evaluation of risk with different methodologies
Propose a model to apply in Uruguay
JAPAN
URUGUAY
3
6 Results
There are numerous methodologies of risk assessment and management work out by several institutions
from developed countries but the selected to analyze was: NAS, US EPA, EEA, European Chemicals Bureau,
Radiation Risk Assessment Methodologies, Institute of Geo-resources and Environment AIST, METI.
6.1 NAS
U.S. National Academy of Sciences worked out a model called NAS.
Because of the widespread use of this model in regulatory and policy terms for human health protection in
several countries is very important know its paradigm, as can been see in figure 2.
Fig. 2. NAS method
6.2 US EPA
The EPA guidelines for human health risk assessment incorporate the four parts of the NAS paradigm. EPA
regularly publishes guidelines to provide for consistency of application and communication of risk
assessment. Guidelines were published in 1986 on assessment of the following areas: exposure,
developmental effects, germ cell mutagenecity, carcinogenic effects, and chemical mixtures. Since that time,
the Agency has revised some of these Guidelines and published new Guidelines. These include Guidelines
on developmental toxicity, exposure assessment, cancer (proposed revisions), reproductive toxicity,
neurotoxicity, chemical mixtures, supplemental, and review purposes for cumulative risk.
It is beyond the scope of this report analyze and discuss aspects of guideline for chemical mixtures,
supplemental, and review purposes for cumulative risk since this guidelines incorporating the paradigm of the
others.
RESEARCH
Laboratory and field
observation of adverse health
effects and exposures to
particular agents
Information on extrapolation
methods for high to low dose
and animal to human
Field measurements, estimate
exposures, characterization of
populations
RISK MANAGEMENT
Development of regulatory
options
Evaluation of public health,
economic, social, political
consequences of regulatory
options
Agency decisions and actions
RISK ASSESSMENT
Hazard identification
Dose-response assessment
Exposure assessment
Risk characterization
4
6.2.1 Health risk assessment of chemical mixtures
For this supplemental guidance on the risk assessment of chemical mixtures, the four parts of the paradigm
are interrelated and will be found within the assessment techniques. For some methods described herein,
assessment of dose-response relies on decisions in the area of hazard identification and on assessment of
potential human exposures.
For mixtures, the use of pharmacokinetics data and models in particular differs from single chemical
assessment, where they are often part of the exposure assessment. For mixtures, the dominant mode of
toxicologic interaction is the alteration of pharmacokinetic processes, which strongly depends on the
exposure levels of the mixture chemicals. In this guidance, there has been no effort to categorize methods
strictly or arbitrarily into one part of the paradigm. The methods are organized instead according to the type of
available data. In general, risk characterization takes into account both human health and ecological effects,
and assesses multiroute exposures from multiple environmental media. This guidance focuses only on the
human health risk assessment for chemical mixtures and only discusses multiroute exposures in terms of
conversions from dermal to oral.
EPA justify the importance to developed risk assessment of chemical mixtures is although some potential
environmental hazards involve significant exposure to only a single compound, most instances of
environmental contamination involve concurrent or sequential exposures to a mixture of compounds that may
induce similar or dissimilar effects over exposure periods ranging from short-term to lifetime.
This guidance is organized according to the type of data available to the risk assessor, ranging from data rich
to data poor situations. It is recommended that the risk assessor implement several of the approaches that
are practical to apply and evaluate the range of health risk estimates that are produced.
EPA suggests that the selection of a chemical mixture risk assessment method follow the outline in the flow
chart shown in Figure 3, which begins with an assessment of data quality and then leads the risk assessor to
selection of a method through evaluation of the available data.
5
Fig. 3. Risk assessment approach for chemical mixtures
Summarizes few important concepts related to chemical mixtures exposure assessment. Once a chemical
mixture is released to the environment, its concentration and composition may change through partitioning
into abiotic and biotic compartments and through transformation mediated by the environment and biota. The
physical/chemical properties of each component of the mixture (or the properties of the mixture as a whole)
and the condition of the microenvironment into which the components are partitioned may change the
magnitude and the routes of human exposure. Partitioning and transformation of the mixture components will
affect the routes of exposure. Ideally, chemical mixture exposures through different routes can be integrated
through measurement data or a validated physiologically based pharmacokinetic (PBPK) model; at this time,
approaches are still evolving, particularly for combining inhalation and oral exposures. The sequence of
exposures to different chemical agents is clearly important for some responses.
This guideline considers risk assessment may be based on the toxic or carcinogenic properties of the
components in the mixture. When quantitative information on toxicologic interaction exists, even if only on
chemical pairs, it should be incorporated into the component-based approach. When there is no adequate
interactions information, dose- or response-additive models are recommended. Several studies have
demonstrated that dose (or concentration) addition often predicts reasonably well the toxicities of mixtures
composed of a substantial variety of both similar and dissimilar compounds, although exceptions have been
noted.
yes
No yes
If sufficient quantitative data are available
on the interactions of 2 or more
components in the mixture
1 Assess the quality
of the data on
interaction, health
ef f ects, and exposure
14 Qualitativ ely
assess thenature of
any potential hazard
and detail the ty pes
of additional data
necessary to support
risk assessment
Inadequate
data
Adequate
data
3 Risk assessment on the
mixture of concern based
on health ef fects using the
same procedures as those
f or single compounds
7 Compile health ef f ects
and exposure inf ormation
12 Compare Risk
assessment conducted in
steps 5, 8 and 9. Identif y
and justif y the pref erred
assessment, and quantif y
uncertain, if possible
No
Ifsufficiently
similar
6 Conduct Risk assessment
8 Deriv e appropriate
indices of
acceptable
exposure and/or risk
on the indiv idual
components in the
mixture
9 Assess
data on
interactions
components
in the
mixture
11 Dev elop a risk
assessment based on
an addiv ity approach
f or all compounds data
on interactions
components in the
mixture
If sufficient quantitative data are not
available use whatever information
to qualitatively indicate the nature of
potential interactions
13 Dev eloped an integrated
summary of the qualitativ e
and quantitative assessment
with special emphasis on
uncertainties an
assumption. Classif y the
ov erall quality of the risk
assessment
Ifnot
sufficiently
similar
4 Health ef f ects
inf ormation is available
on a mixture that’s is
similar to the mixture of
concern
10 Use an appropriate
interaction model to
combine risk assessment
data on compounds f or
which data are adequate,
and use an additiv ity
assumption f or the
remaining compounds
5 Assess the similarity of the mixture on
health ef fects data are available that’s is
similar to the mixture of concern, with
emphasis on any dif f erences in
components or proportions of components,
as well as the ef fects that such differences
would hav e on biological activ ity
2 Health
ef f ects
inf ormation
is av ailable
6
Three component methods are discussed in this guideline that are based on dose addition: the RPF method,
the TEF method, which is a special case of the RPF method, and the HI method. They differ in the required
knowledge about toxicologic processes and in the extent over which toxicologic similarity is assumed. In each
method, the exposure levels are added after being multiplied by a scaling factor that accounts for differences
in toxicologic potency (also called toxic strength or activity).
The RPF method uses empirically derived scaling factors that are based on toxicity studies of the effect and
exposure conditions of interest in the assessment. When extensive mechanistic information shows that all the
toxic effects of concern share a common mode of action, then one scaling factor is derived for each chemical
that represents all toxic effects and all exposure conditions. This special case is the TEF method, where
actual toxicologic equivalence between the component chemicals is assumed once the scaling factor is
applied. When data are conflicting or missing, or indicate that different modes of action may apply to different
effects or exposure conditions, separate factors may be derived for each effect or exposure condition, which
are distinguished from the special TEFs by being called RPFs. In the general RPF and specific TEF methods,
the scaling factor represents the toxicity relative to the toxicity of one of the chemical components, called the
index chemical, which is usually the best-studied chemical. The mixture exposure, given by the sum of the
scaled exposure levels, is then the equivalent exposure in terms of the index chemical. This equivalent
exposure is the exposure level of the index chemical that elicits the same response as the mixture exposure.
The risk assessment then evaluates the equivalent index chemical exposure on that chemical’s dose-
response curve in order to predict the mixture response.
The Hazard Index method has weaker assumptions and data requirements, is more generally applicable, and
has more uncertainty in the resulting assessment. Instead of requiring knowledge of similar mode of action,
the Hazard Index method requires only similarity in target organ. As with the general RPF me thod, a separate
Hazard Index is determined for each target organ of concern. Instead of converting the component exposure
levels into an equivalent index chemical exposure, the scaling factors are standardized so that the resulting
sum is dimensionless, and the Hazard Index is interpreted by whether or not it is greater than 1. The scaling
factors for the Hazard Index are based only on each component’s toxicity, preferably related to the target
organ being assessed so that the interpretation of the Hazard Index value can be tied to the target organ risk.
Similarly, if some estimate of a practical threshold exists for each component, then HI=1 indicates that the
mixture is at its practical threshold. In previous EPA applications of the Hazard Index method, the Hazard
Index has served only as a decision index, where HI>1 leads to more investigation or to remedial action. If
enough information becomes available on the components to assume a similar toxic mode of action, then
RPFs could be developed instead.
7
Approaches for risk assessment strategy are based on the mixture’s chemical components are recommended
for relatively simple, identified mixtures with approximately a dozen or fewer chemical constituents. For
exposures at low doses with low component risks, the likelihood of significant interaction is usually
considered low. Interaction arguments based on saturation of metabolic pathways or competition for cellular
sites usually imply an increasing interaction effect with dose, so that the importance at low doses is probably
small. The default component procedure at low exposure levels is then to assume response addition when
the component toxicological processes are assumed to act independently, and dose (or concentration)
addition when the component toxicological processes are similar. For dose (concentration) addition, a specific
Hazard Index procedure is recommended. For higher exposure levels, or when adequate data on interactions
suggest other than dose or response additivity at low doses, such information must be incorporated into the
assessment.
6.2.2 Cumulative Risk Assessment
Public interest in the environment continues to grow as more information is shared about multiple chemicals
in air, water, and soil from different sources, with health risks being a major concern. The U.S. EPA has
responded to increasing requests for a way to understand and evaluate the combined impacts of these
conditions by preparing a set of reports on various aspects of cumulative risk assessment.
Technical topics in cumulative risk assessment included in this approach are showed in the figure 4.
Fig. 4. NAS Risk Assessment Paradigm Modified for Cumulative Risk, with Concepts Beyond Issues
for Single Chemicals or Mixtures
To summarize, the purpose is to provide a structured collection of approaches for addressing the chemical
interactions and joint toxicity issues in cumulative health risk assessment by describing key concepts and
illustrating steps that can be taken to more explicitly evaluate cumulative risks. This approach builds on
8
recent U.S. EPA documents to extend their concepts into a first phase of implementation that addresses the
joint and interactive impacts of multiple chemicals, exposures and effects. Chemical and toxicologic
interactions are a primary focus because these are areas where methodological advances allow the
traditional process (evaluating chemicals individually) to be enhanced. Approaches for grouping are
presented in order to simplify complexities and combine components for joint analysis, so attention can be
focused on the factor combinations that could contribute most to adverse cumulative health risks.
EPA studying in develops the guideline of cumulative risk assessment method follow the outline in the flow
chart shown in Figure 5.
Fig. 5. Approach for cumulative risk assessment
1) Planning, Scoping and Problem Formulation
Planning and Scoping
 Team:
 risk
assessors,
 risk managers
and
 stakeholders
 Goals,
 Breadth,
 Depth, and
 Focus
 Approach,
 Resources,
 Past
Experiences.
Problem Formulation
 Conceptual model establishes:
 stressors
 health or environmental effects to be evaluated,
 relationships among various stressor exposures and potential
effects
 Analysis plan lays out:
 data needed,
 the approach to be taken, and
 the types of results expected during the analysis phase
2) Identify “Trigger”
Sources,
releases
Population
illness
multiple-
chemical
fate
public health
data
mixtures
toxicity
multi-route
exposures
Combined
characterization
population
subgroup
features
Chemical
concentrations
Triggers
Data
Elements
Sources,
releases
Population
illness
multiple-
chemical
fate
public health
data
mixtures
toxicity
multi-route
exposures
Combined
characterization
population
subgroup
features
Chemical
concentrations
Triggers
Data
Elements
9
List of
Chemical
s of
Concern
Population
Profile
OUTPUTS
4) Generate Chemical List
 Initiating the Exposure Assessment when Health Endpoint is the Trigger,
 Initiating the Exposure Assessment when Elevated Chemical Concentrations are the Trigger,
 Initiating the Exposure Assessment when One or More Sources is the Trigger,
 characterize the source(s) by compiling basic facility information
 determine the spatial bounds of the assessment
 examine the fate of the released pollutants
 determine whether (and which) individuals in the community could be exposed and
 quantify such exposures.
3) Characterize Population based on Trigger
 Population in that study area,
 Population defined by the health endpoint
 Population defined by chemical concentrations,
 Population defined by multiple sources.
6) Quantify Exposure for General Population and
Subpopulations
7) Quantify Dose-Response for Initial Toxicity-
Based Chemical Grouping
5) Identify Links between Chemicals & Subpopulations
10
Chemical Groups By ToxicityChemical Groups By Media & TimeOUTPUTS
6) Quantify Exposure for General Population
and Subpopulations
* Transformation refers to a group of
processes that can act to change the
composition of a mixture.
** Intracompartment transport refers to the
processes that move a mixture through an
individual compartment (e.g., turbulence and
wind will move a mixture through the
atmosphere) and intercompartment transport
refers to processes that move a chemical
mixture from one medium to another.
7) Quantify Dose-Response for Initial Toxicity-Based Chemical Grouping
Chemical Groupings by Co-occurrence in Media/Time
Time
Media
Same Different
Same Group 1 Group 3
Different Group 2 Group 4
Exposure Groups
Because of
Exposure Group
Same Media;
Same Time
Same Media; Different
Time
Different Media; Same Time Different Media; Different Time
Consider These
Factors to Form
Toxicity Groups
Similar effects
or metabolites
Similar effects or
metabolites; Body
burden; Persistence of
effects
Similar effects or
metabolites;
Pharmacokinetics; Multi-
route exposures
Similar effects or metabolites; Body
burden, Pharmacokinetics;
Persistence of effects; Multi-route
exposures
Target Organ Specific Toxicity Groups
Kidney Group 1,1 Group 2,1 Group 3,1 Group 4,1
Liver Group 1,2 Group 2,2 Group 4,2 Group 4,2
…
…
…
…
…
Lung Group 1,n Group 2,n Group 4,n Group 4,n
9) Conduct Risk Characterization
8) Integrate Exposure & Dose
Response; Refine Exposure and
Toxicity Assessments
11
9) Conduct Risk Characterization
8) Integrate Exposure & Dose Response; Refine Exposure and Toxicity Assessments
Final
Cumulativ
e RA
Integrated
Chemical
Groups
OUTPUTS
12
6.3 EEA
The European Environmental Agency – EEA guidelines for human health, ecologic and environment risk
assessment incorporate the NAS paradigm with some improvement. The figure 6 shows the elements of risk
assessment of EEA.
Fig. 6. Elements of risk assessment for EEA
The institution responsible for develop guidelines of chemicals risk for EEA is European Chemicals Bureau.
6.4 EuropeanChemicals Bureau
The European Chemicals Bureau attending the Directive 93/67, Regulation 1488/94 and Directive 98/8 whom
require that an environmental risk assessment be carried out on notified new substances, on priority existing
substances and active substances and substances of concern in a biocidal product, respectively, created the
Technical Guidance Document – TGD.
13
The environmental risk assessment approach outlined in this guideline attempts to address the concern for
the potential impact of individual substances on the environment by examining both exposures resulting from
discharges and/or releases of chemicals and the effects of such emissions on the structure and function of
the ecosystem. Three approaches are used for this examination:
 Quantitative PEC/PNEC estimation for environmental risk assessment of a substance comparing
compartmental concentrations (PEC) with the concentration below which unacceptable effects on
organisms will most likely not occur (predicted no effect concentration (PNEC). This includes also an
assessment of food chain accumulation and secondary poisoning;
 The qualitative procedure for the environmental risk assessment of a substance for those cases where a
quantitative assessment of the exposure and/or effects is not possible;
 The PBT assessment of a substance consisting of an identification of the potential of a substance to
persist in the environment, accumulate in biota and be toxic combined with an evaluation of sources and
major emissions.
In principle, human beings as well as ecosystems in the aquatic, terrestrial and air compartment are to be
protected. At present, the environmental risk assessment methodology has been developed for the following
compartments:
 For inland risk assessment:
 aquatic ecosystem (including sediment);
 terrestrial ecosystem;
 top predators;
 microorganisms in sewage treatment systems;
 atmosphere.
 For marine risk assessment:
 aquatic ecosystem (including sediment);
 top predators.
In addition to the three primary environmental compartments, effects relevant to the food chain (secondary
poisoning) are considered. Also effects on the microbiological activity of sewage treatment systems are
considered. The latter is evaluated because proper functioning of sewage treatment plants (STPs) is
important for the protection of the aquatic environment.
The methodologies implemented have as aim the identification of acceptable or unacceptable risks. This
identification provides the basis for the regulatory decisions, which follow from the risk assessment. In some
cases the uncertainties in carrying out the standard assessment become unacceptably high. The
methodologies implemented in these cases are based on identifying the emission sources in order to identify
where exposures should be minimised.
The risk assessment process, in relation to both human health and the environment, entails a sequence of
actions which is outlined in the figure 7 below.
14
Fig. 7. Risk assessment of new substances, existing substances and biocidal active substances and
substances of concern present in a biocidal product: general principles.
The effects assessment address eight toxic effects
 Acute toxicity
 Irritation
 Corrosivity
 Sensitization
 Repeated dose toxicity
 Mutagenecity
 Carcinogenicity and
 Toxicity for reproduction
Human population liable to the contaminants is divided in:
 Workers
 Consumers and
Humans exposed directly via environmental:
 Inhalation,
 Oral and
 Dermal
Principle of the assessment is to compare concentrationexposed × concentrationno adverse effects
The way to perform a quantitative analysis of uncertainties of the risk assessment process is based on
probabilistic techniques. Using a probabilistic technique (e.g. Monte-Carlo simulation), simultaneous
uncertainties in the model inputs can be propagated through the model to determine their combined effect on
model outputs.
INFORMATION GATHERING
EFFECTS ASSESSMENT
 Hazard identification
 Dose (concentration) – Response (effect) Assessment
EXPOSURE ASSESSMENT
 Human exposure assessment (Workers, consumers, via the
environment)
 Environmental exposure assessment(water,soil,air)
RISK CHARACTERIZATION
HUMAN HEALTH
Evaluation of effects data and comparison with exposure data
ENVIRONMENT
Evaluation of effects data and comparison with exposure data
15
6.5 Institute of Geo-resources and EnvironmentAIST, METI
The Institute of Geo-resources and Environment consider very important to assess exposure an risk caused
by contaminated soil and groundwater. Risk based assessment makes it possible to realize the quantitative
analysis of environment risk for health and ecology as well as the cost–effectiveness analysis and socio–
economical analysis. In general lines the risk management and the risk assessment follow the figure 8.
Fig. 8. Risk assessment and risk management for soil and groundwater.
The strategy of environment risk management of the institute is represented in the figure 9.
Fig. 9. Strategy of environment risk management.
Risk identification
•Risk and hazard characterization
•Risk estimation
Risk assessment
•Exposure and risk assessment
•Options analy sis
Risk reduction/control
•Making decision
•Remedial options
•Monitoring
Characterization of Risk
Analy sis of Risk
Control of Risk
Phase 3
Phase 2
Phase 1
R
RISKASSESSMENT
COMPREHENSIVE ASSESSMENT
Scale of soil contamination
Groundwater contamination
Kind of contamination
Concentration of chemicals
Condition of acceptor
SITE ASSESSMENT
Intake of contaminated soil
Intake of contaminated Groundwater
Exposure assessment
Survey and monitoring
Uncertainty analysis
DETAILED ASSESSMENT
Clean–up and remediation
Estimation of risk level
Trade–off analysis
Analysis of risk reduction
Cost–benefit analysis
Stakeholders
Risk assessment by
Exposure
Risk reduction
Risk
Characterization
Options
Realistic approachof
trade of f and risk
reduction
Risk estimationRisk Assessment
Risk Scenario
Planning
Surv ey
Soil and GW contamination
Comprehensive risk
assessment from health
risk and social risk
Simulation
Selection of cost-
ef f ectiveness
techniques
Minimize
cost
16
7 Discussions
According to current guidelines in different part of the world risk assessment, have to be carried out for all
kinds of substances, pesticides, including agricultural and non–agricultural pesticides, new and existing
chemicals not being pesticides, soil contaminant, accidental pollution, etc.
Several models and modeling system were having been developed based the guidelines showed in this
report:
 FOCUS–activities, of the European Union, directorate-general Health, and consumer Protection,
concerning the determination of PECs in different environmental compartment like soil, groundwater and
surface water; the models included here are e.g. PRZM, MACRO, TOXSWA.
 EUSES, of the European Union, for new and existing chemical.
 USES incorporating EUSES and Netherland evaluation system for pesticides.
 CSOIL model was developed to calculate (reverse-calculation) for serious soil contamination
concentration (SCC) at which a human toxicological maximum permissible risk (MPR) is exceeded.
Beside this program are uses in Netherland also the programs SEDISOIL, VOLASOIL, RISK Human, and
HESP.
 CLEA is developed in UK for deriving guidelines, but this model also can be used for site–specific risk
assessments.
 UMS was developed for the detailed assessment of abandoned contaminated sites in Germany.
 CalTOX RISK–human was developed in Finland.
 CalTOX is a model developed by California Environment Protection Agency, department of Toxic
Substances Control from US EPA.
 Exposure models used in the USA, particularly at Environment Protection Agency, including screening
models like SCI-GROW and GENEEC, but also more sophisticated models as there are PRZM, TIGEM,
and EXAMS.
 MACRO–model is specific model for pesticide leaching were dealt with in more detail used for estimating
the concentration in groundwater or drainage water in cracked soils (heterogeneous flow).
 EHIPS model from Russia for environmental health and operator exposure calculations using the
EUROPOEM databases.
 Canadian Environment Modelling Center at Trent University, Ontario, Canada had developed some
multimedia fugacity models with different levels of complexity with increasing level introducing new data
input requirements, and providing a more complete description of environmental fate.
 GIS (geographic information systems) is explored in several model applications, e.g. USA, Russia, as well
as in Italy and Germany.
 GERAS, this model was developed by Institute of Geo-resources and Environment to assess exposure a
risk caused by contaminated soil and groundwater.
In general, the concepts of these models and guidelines found have many aspects in common but have
different deepness in the analysis between them. Added to this, the approaches are lightly different and all
have important strengths. Consequently is not possible compare them to classify by then environment
efficiency.
17
In the words of Linders, is not recommended use a model A for some specific compartment or contaminant
and another for other compartment for them sum of all results. However, the best solution is develop a new
model, which combines the strengths of models.
It would be appropriate to conclude this section of discussions with collections of considerations in the
construction of one new model able to apply in a developing country:
 Possibility to mathematically mass balance estimation concentration of the contaminant in the air, water,
and soil through by frequency of interactions: physical (photolysis, fugacity, dissolution, erosion, leach,
and runoff) chemical (oxidation, reduction, and reactions between contaminants, and others compounds),
and biological (biodegradation, absorption, transpiration, bioaccumulation, and others).
 Enable to choose which interactions will be considered in the mass balance estimation concentration of
the contaminant in the air, water, soil.
 Consider influence of depth, number of layers, thickness, and type of soil in the dynamic of movement of
the contaminant in the soil, fugacity, groundwater, superficial water, absorption of the roots, and
degradation of the contaminant.
 Enable to input several layers of soils with different percents of each type of soil (rock, gravel, sand, silt,
organic clay or not), thickness, porosity, density, humidity, and chemical characteristics.
 Enable input average, maximum and minimum of wind velocity, humidity, rainfall, and temperature of air,
water, and soil for each season of year or monthly.
 Possibility to estimate contamination from traffic of vehicles by combustion of fuel, wear and tear of brake
(cadmium), tire, lost oil.
 Enable input type of traffic (car, trunk, bus, persons, animals), average, maximum, and minimum intensity
of traffic for each season of year or monthly.
 Enable input characteristics of traffic emissions by car, trunk, bus, persons, and animals.
 Possibility to estimate the transport of contaminant and products of degradation by:
 Air flow like prevailing winds (general circulation of the atmosphere), synoptic winds (winds associated
with large-scale events such as warm and cold fronts), mesoscale winds (higher boundary of what is
considered to be "forecastable" wind), microscale winds (short durations of time – seconds to minutes –
and spatially over only ten to hundreds of meters) carrying gas, vapor, water, fog, smoke, smog, haze,
dust, soil.
 Superficial, and ground water flow and rain runoff
 Leaching
 Enable to choose which transport will be considered in the mass balance estimation concentration of the
contaminant in the air, water, soil.
 Possibility to estimate the contamination by:
 Intake of contaminants by:
 Vegetables → grains (rice, wheat, soya, bean, corn), fruits (apple, orange, banana, grape, tomato,
cucumber, eggplant, pumpkin), leaves (lettuce, cabbage, arugula, alfalfa, pasture), bulb (Onion, garlic,
leek), tuber(potato), steam (ginger), roots (beet, carrot, manioc), and others
 Meat → bovine, swine, sheep, ram, goats, chickens, fish
 Seafood → fish, algae, and shellfish
 Milk and dairy products → cream, butter, yoghurt, ice cream, and cheese
 drinks → juices, and alcoholic drinks
18
 Water → potable, groundwater, surface
 Soil → itself, in the food
 Inhalation of contaminants in:
 Out door → could be in the form of gas, vapor, solid particle, aerosols. The origin could be from
industries, plant of water or wastewater treatment, wasteland, sea, lakes, rivers, groundwater,
pavement, water or air of soil pore, where this pore could be in superficial, zone of roots, depth layer of
soil. Also, have to be pondering about evapotranspiration of plants and animals, sludge application in
the surface or in root zone, and irrigation by superficial, sub superficial and in root zone with water
reuse, or ground water, or storm water, or superficial water, or potable. Beside could be interesting
considerate, the contaminations come from vehicle traffic.
 In door →could be in the form of gas, vapor, solid particle, aerosols. The origin could be from outdoor,
shower, bath, tap, pavement, ground, water or air of soil pore, groundwater, superficial soil, and depth
layer of soil
 Dermal contact
 Water →potable, groundwater, surface, storm water
 Soil → working, life style
 Dust
 Possibility to enter data from socials studies like: social classes, density of population, percent of male
and female, percent of each age group, life expectancy, life style, kind of residences, tall of the building,
use of land (agriculture, industrial, commercial, residential), managing plans of the area by the
municipalities, and services from the municipalities available in the area.
 Enable input percent of age and sex group related with social class.
 Enable input data about life style: percent of students, workers, employ and unemployed, and retired,
percent of time spend and area of residence, industrial, commercial, agriculture, parks, theaters, cinemas,
shopping centers, schools, street, parks, lakes, rivers, beaches and in case don`t have data consider
international recommendation.
 Enable input percent of age and sex group related with life style.
 Enable to choose the numbers of age group, and activities of the life style.
 Enable input percent of time working, type of work (agriculture, industry, commercial, hospital, laboratory),
type of place (outdoor agriculture or urban area, indoor, line of production, office, hangar, building, house),
and type of ventilation (with or without air conditioning).
 Enable input residence standard size (area, numbers and size of rooms, kitchens, bathrooms), height of
building, number and height of floors, number of apartment per floor, number and size of apertures,
impermeability of floors, walls, number of floors underground (with or without windows), height of crow
space and in case don`t have data input consider international recommendation.
 Enable input number of taps, showers, toilets, in residence standard and in case don`t have data input
consider international recommendation related with the number of rooms, kitchens, bathrooms.
 Enable input distance, superficial area, depth, and frequency of application of sludge and irrigation.
Furthermore, enable choose the chemical characteristic of the sludge and water used.
 Enable input distance, superficial area, and depth median for lakes, rivers, sediments and the changes for
each season. Furthermore, enable choose the chemical characteristic of the water.
 Enable input level of groundwater
19
 Consider influence in intake percent of principals vegetables, meat, milk and dairy products, drinks by:
 Social class →each social class have different amount of intake of each group of food and drinks.
 The interaction between compartment (air, water, and soil) and vegetables (root, stem, leaf) could be as
form sediment from air over plans, evapotranspiration, rain splash, soil suspended, osmotic press, wind.
 Season of year →each season of year have available different kind of vegetables and the amount of
intake of each group of food and drinks is different and the way of eat the food change (percent of
cooked or raw). Beside the metabolism of the plants, animals, and the velocity of degradation change
according with the temperature. In addition, the weather influences formation of sediment from air over
plans, evapotranspiration, rain splash, soil suspended, evaporation, transpiration, metabolism, and
osmotic press.
 Influence of different absorption, transport, and bioaccumulation of contaminants by each group of
vegetable, and inside the plant (root, stem, leaf).
 Age and sex → each age and sex group has different weight, amount of intake of each group of food
and drinks, and have different metabolism.
 Water → the water intake could occur in the shower, swimming, and type of irrigation (sprinkle, dripping,
and underground, and water used to do it) and natural disasters (inundation, tsunamis).
 Use of land → land used for agriculture usually don`t have service of municipalities for potable water so
usually they had well to take groundwater or use superficial water or rain water and usually in this area
have orchard and vegetable garden. Beside, master plan of the city, guide the house standard for each
zone this information is useful for determine the type of residence (house, apartment, condominium), the
use of land (percent of area appropriate to agriculture, industrial, commercial, residential) and the
existence and the numbers of wells. Also is important know the use of land for calculation of transport
and the type of contaminant. In addition, the intake of food is different in rural area than urban area.
 Type of residence → depend of type of residence has the possibility to plant in the garden vegetables
and had well to take groundwater.
 Enable change infiltration in the net pipes of potable water (age of the net of pipes to distribution) and
efficiency of treatment (age of the plant), and percent of soil intake in the food, itself and dust over
 Enable to choose which type of food in each group, and source of the contaminant will be considered in
the mass balance estimation concentration of the contaminant in the air, water, soil.
 Enable change the percent for each group of food, drinks and way of eat (cooked or raw) but when don`t
have data use international recommendation of international organism for nutrition.
 Possibility of estimate soil intake by percent of ingestion each type of vegetables.
 Enable change the percent for each use of land (agriculture, industrial, commercial, residential).
 Enable choose the water supply.
 Consider influence in inhalation by:
 Social class → each social class has different type of residence standard. In addition, each social class
is building with different material and the quality. Therefore, change the impermeability of floors, walls or
any structure.
 Type of residence → each type of residence has a different height, size, structure impermeability,
number, and size of apertures consequently has different law of wind (transport of contaminant inside).
Beside the existence or not of craw space, floors underground (with or without windows), garage
underground (with or without windows), and the distance to groundwater is very meaningful for the
fluxes of volatiles compounds, and humidity. Furthermore, the existence or not of garden, type of
pavement around the building could influence in fluxes of contaminants inhalation.
20
 Use of land → the land used is related with the distance of industry, plant of treatment for water or
wastewater, wasteland, sea, lake, river, groundwater, sludge application, areas irrigated, and traffic
ways.
 Life style → the life style is not just related with not only with the time but also with the way of outdoor or
indoor. For instance time worked and type work (agriculture, industry, commercial, hospital, laboratory,
line of production, office, on street) so this will change the distance of source of contaminants. In the
same way time spend in theaters, cinemas, shopping centers, schools, parks, beaches, lakes, rivers will
have the same influence.
 Age and sex →each age and sex group have a different breathing volume, weight as well as influence in
life style.
 Season of year → each season have different weather conditions (temperature, humidity, rainfall, wind
velocity) and this could influence chemicals reactions, evaporation, transpiration, viscosity, fugacity,
velocity of degradation. Moreover, the season has influence in life style.
 The flux interaction in and between compartment (air, water, and soil)
 Enable input national limits standard for contaminants concentrations and in case don`t have data input
consider international recommendation.
 Enable to choose international recommendation for contaminants concentrations for intake, inhalation,
and dermal contact.
 Estimate the limit of exposition based on relation pathway of exposition, capacity of absorption by dermal
contact, ingestion, and inhalation, capacity of elimination contaminant and limits standard for
contaminants concentrations.
 Estimate an index of hazard based on relation dose response for each contaminant and the way of
exposition (dermal contact, ingestion, and inhalation) and calculation of risk and uncertain using statistical
models.
 Enable input alternative of treatment for risk reduction, with efficiency, and cost of each one, and compare
risk with cost and efficiency using statistical models.
21
8 Conclusion
Decision making in environmental projects is typically a complex and confusing exercise, characterize by
trade–offs between socio–political, environmental, and economic impacts. Cost–benefit analyses often are
used, occasionally in concert with comparative risk assessment, to choose between competing projects.
Risk assessment develops choices that risk managers can rank according to risk–cost–benefit analysis or
other criteria, and implement, monitoring and change as new knowledge becomes accepted.
In most of the countries, the risk assessment process uses basic scientific information to evaluate potential
risk to human and the environment. Typically, these scientific evaluations of potential risk to human health
and the environment are used to determine if remedial action or cleanup is necessary and if so, how much
needed. In addition, the quantitative results of these risk assessments are often used to determine cleanup
goals for restoration of a waste site. Given that countries of European community, USA and Japan has
developed extensive guidance and has established numerous policies for the use of risk assessment in
environment problem solving, it is not surprising for methodologies in other countries to be similar. In addition,
the scientific database created for risk assessments produce similarities among countries.
In search of the objective, this research was collect information about technologies with low cost or
implementation with low cost. Since, the principal barrier for the developing countries is the height cost
associated with implementation of restrictive politic for environment protection.
In the item about discussion, was made some considerations with intention of would have done contribution
for implement risk assessment and management by simulation understand this way is the most low cost.
For this was proposing use in calculation data used in several activities and with low cost like: socials studies,
soil profile used in construction, standards used for building popular residences, international standards for
inhalation, intake, and dermal contact of contaminant.
Beside was proposing have flexibility in the model for permit apply in several sites with different characteristic
and by this way do not be limited a just one site and consequently making low the cost of the simulation.
Offering by this way, offer to decision-making using a tool of environmental management based on risk
management and assessment to be able to apply in Uruguay
22
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Protection Agency,Office of Emergency and Remedial Response,Washington.
___. 1989b. Interim Procedures for Estimating Risks Associated with Exposures to Mixtures of Chlorinated Dibenzo-p-dioxins and -
dibenzofurans (CDDs and CDFs) and 1989 Update. U.S. Environmental Protection Agency,Risk Assessment Forum, Washington.
___. 1991. Guidelines for Developmental Toxicity Risk Assessment. Washington.
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24
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Environmental Assessment,Washington.Available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=55145.
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25
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Protection Agency, National Risk Management Research Laboratory, Cincinnati, OH. March. EPA/625/R-02/004. Available at
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___. 2003d. Developing Relative Potency Factors for Pesticide Mixtures: Biostatistical Analyses of Joint Dose-Response. U.S.
Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Cincinnati, OH.
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___. 2003f. Region/ORD Workshop on Inhalation Risk Assessment: A Superfund Focus: Summary Report. U.S. Environmental Protection
Agency,Washington,DC. September 9-12, 2003. Available at http://intranet.epa.gov/ospintra/scienceportal/htm/complete.htm#inhale.
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Washington DC. June 19. Available at http://www.epa.gov/superfund/programs/risk/airmodel/guide.pdf.
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National Center for Environmental Assessment, Research Triangle Park, NC. EPA/600/P-99/002aF. Available at
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___. 2004c. Health-based Short-term Advisory Levels: Pilot Guide. National Homeland Security Research Center, Cincinnati, OH.
___. 2004d. Benchmark Dose Software. U.S. Environmental Protection Agency, Washington, DC. Available at
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Agency, Office of Solid Waste and Emergency Response (5305W), Washington, DC. EPA/520/R-05/006. Available at
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___.2005b. Human Health Medium-Specific Screening Levels. U.S. Environmental Protection Agency, Region 6, Dallas, TX. November.
Available at http://www.epa.gov/earth1r6/6pd/rcra_c/pd-n/r6screenbackground.pdf.
___.2005c. Guidelines for Carcinogen Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC.
EPA/630/P-03/001B.
___.2005d. Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. U.S. Environmental Protection
Agency,Risk Assessment Forum, Washington,DC. EPA/630/R-03/003F.
___.2005e. All-Ages Lead Model (AALM) Version 1.05 (External Review Draft). U.S. Environmental Protection Agency, Washington, DC.
EPA/600/C-05/013. Available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=139314.
___. 2006. Considerations for Developing Alternative Health Risk Assessment Approaches for Addressing Multiple Chemicals,
Exposures and Effects (External Review Draft). Cincinnati.
World Health Organization (WHO) and Agencia Internacional para la Investigación sobre el Cáncer (IARC). 1982. IARC Monographs on the
Evaluation of the Carcinogenic Risk of Chemicals to Humans. Lyon.
World Health Organization (WHO) and Oficina de Medicina del Trabajo. 1989. Occupational Exposure Limit for Asbestos. Ginebra.
World Health Organization (WHO). 2004. Principles for Modelling Dose-Response for the Risk Assessment of Chemicals. Ginebra.
World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO). 2006. A Model for Establishing
Upper Levels of Intake for Nutrients and Related Substances. Ginebra.
10 Acknowledgement
There are many persons that in different ways have contributed to this thesis with knowledge, ideas, and fruitful discussions,
but not the least with encouragingwords and actions.I would especiallylike to thank the following persons:
Dr. Takeshi KOMAI for the valuable teachings, for the opportunity for my professional development and by friendship
resulting of our convivial.
Dra. Mio TAKEUCHI, who, in this months of convivial teach me a lot, contributed for my scientific, intellectual,
professional,and personal growth, and for her friendship result of our convivial.
Dra. Junko HARA for her friendship, technical and personal support, and change of knowledge fact that contributed for my
scientific, intellectual, professional growth.
Dr. Yoshishige KAWABE contributed for my scientific, intellectual,professional growth.

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FINAL report - RIVOIR

  • 1. CONSIDERATION ABOUT PROCESS OF ENVIRONMENTAL RISK ASSESSMENT AND MANAGEMENT By Maria Carolina Rivoir Vivacqua Environmental Engineering Department of IMFIA Republica Oriental del Uruguay Submitted in partial fulfillment of the requirements for the requirements for the Training on Environmental Technology (July 2006 – June 2007) Dr. Takeshi Komai Institute of Geo-resources and Environment AIST, METI Japan Gratefulness by Dr. Mio Takeuchi Institute of Geo-resources and Environment AIST, METI Japan Supported by Japan International Cooperation Agency (JICA) June 2007
  • 2. I ABSTRACT The objective of this research is developing a methodology of risk management and assessment to apply in Uruguay. In search of this objective this research was divided into 6 steps: (a) collect data, (b) analyse methodologies, (c)classify methodologies (according to environment efficiency), (d) collect data of Uruguay and samples of water contaminated, (e) evaluation of risk with different methodologies, (f) propose a methodology to apply in Uruguay. Here in Japan was developed three first steps. Human being and earth’s ecosystems form a symbiotic relationship such that the impacts to one entity ultimately reflect upon the other. As human influence upon the environment has been intensified in response to increasing population and technological reliance, the environment has become increasingly more stressed. To minimize or curtail environmental degradation, individual or organizations are given the responsibility to make decisions and take action to reduce adverse human impact without unduly hindering the economic, social, or political progress of their countries. Environmental management problems are complex because of the involvement of several and diverse stakeholder groups whose values are often conflicting. The effort to recognize, assess, and mitigate environmental problems has been largely led by developed Countries. The methodology of risk management has been developed to integrate the stakeholders concerns, population opinion, and technical analyses (risk assessment). In pursuit of the objective of this research was done a survey of guidelines and methodologies about risk management and assessment in sites of Internet of institutions. The next steps will be analyzing and classify the methodologies find. There are three line of research of risk assessment and management: human health (HRA), ecological (EcoRA), and environmental (ERA). For each line of research can be used different methodologies and model. In the scientific literature the model developed in USA by National Academy of Sciences (NAS) which looks at chemical risk to human health is widely used and accepted but excludes any of the social aspects of risk that make risk assessment such a complex task. Many international institutions developed risk assessment methodologies a nd procedures for exposure from specific source follow the NAS model using a complement. EcoRA involves the assessment of the risk posed by presence of substances released to the environment on all living organisms in the variety of ecosystems that make up the environment. EcoRA has a trend to focus on the risk from chemicals and genetically modified organisms. Some address physical risk such as temperature risks caused by cooling water releases from industry. Many organizations are involved in the development of methods and applications of EcoRA. Within the precept what human being and earth’s ecosystems form a symbiotic relationship the concept of ERA was born. This method is also based on NAS method but involves much more steps and embrace human health, ecological system, aspects of socio-economics, culture, and politics. US EPA is developing a new methodology, cumulative risk assessment (CRA), which could be used on risks to health or environment. CRA is combined risks from aggregate exposures to multiple agents or stressors (chemicals, biological or physical agents, or the absence of a necessity such as habitat). All institutions researched make emphasize of risk managers may have to scientifically assess risk and use formalized risk management procedures to choose the most satisfactory course of action in response to that risk. For EEA this means reducing risk to an “acceptable” level at an “acceptable” cost. By any means, the most common of formal analysis techniques for alternative risk management options are cost-benefit, cost-risk-benefit, and decision analysis. Complex problems are broken down into manageable components that can be studied individually and then combined to make an overall assessment. Strongly prescriptive decision rules are used. These components are combined according to formalized procedures. Final ly, there has to be a common unit to compare different consequences and make trade -offs between conflicting objectives. ERA is a process by which environmental risk can be examined and a qualitative or quantitative measure of risk derived by using scientific data and this kind of process can be applied in any country. Keywords: methodology, risk management, risk assessment, health, ecological, environmental.
  • 3. II Table of Contents 1 List of Figures______________________________________________________________________________ II 2 List of Acronyms ____________________________________________________________________________III 3 Objective ___________________________________________________________________________________ 1 4 Introduction_________________________________________________________________________________ 1 5 Methodology of Research ______________________________________________________________________ 2 6 Results _____________________________________________________________________________________ 3 6.1 NAS ____________________________________________________________________________________ 3 6.2 US EPA _________________________________________________________________________________ 3 6.2.1 Health risk assessment of chemical mixtures ______________________________________________________________ 4 6.2.2 Cumulative Risk Assessment__________________________________________________________________________ 7 6.3 EEA___________________________________________________________________________________ 12 6.4 European Chemicals Bureau ________________________________________________________________ 12 6.5 Institute of Geo-resources and Environment AIST, METI__________________________________________ 15 7 Discussions ________________________________________________________________________________ 16 8 Conclusion_________________________________________________________________________________ 21 9 References _________________________________________________________________________________ 22 10 Acknowledgement ___________________________________________________________________________ 25 1 List of Figures Fig. 1. Methodology of research ___________________________________________________________________ 2 Fig. 2. NAS method _____________________________________________________________________________ 3 Fig. 3. Risk assessment approach for chemical mixtures _______________________________________________ 5 Fig. 4. NAS Risk Assessment Paradigm Modified for Cumulative Risk, with Concepts Beyond Issues for Single Chemicals or Mixtures ____________________________________________________________________________ 7 Fig. 5. Approach for cumulative risk assessment ______________________________________________________ 8 Fig. 6. Elements of risk assessment for EEA ________________________________________________________ 12 Fig. 7. Risk assessment of new substances, existing substances and biocidal active substances and substances of concern present in a biocidal product: general principles._______________________________________________ 14 Fig. 8. Risk assessment and risk management for soil and groundwater. _________________________________ 15 Fig. 9. Strategy of environment risk management.____________________________________________________ 15
  • 4. III 2 List of Acronyms AIST National Institute of Advanced Industrial Science and Technology As Arsenic BOD Biochemical Oxygen Demand COD Chemical Oxygen Demand Cr Chromium EcoRA Ecological Risk Assessment and Management, EEA Europe Environmental Agency EPA U.S. Environmental Protection Agency ERA Environmental Risk Assessment and Management FAO Food and Agriculture Organization of the United Nations Hg Mercury HRA Human Health Risk Assessment and Management METI Ministry of Economy Trade and Industry, Japan MOS Margin of Safety MW Molecular Weight NAEL No Adverse Effect Level NAS U.S. National Academy of Sciences NF Norme Française NH3 Ammonia NOAEL No Observed Adverse Effect Level NOEC No Observed Effect Concentration O&G Oil and Grease OECD Organisation for Economic Cooperation and Development OSPAR Oslo and Paris Convention for the protection of the marine environment of the Northeast Atlantic P Persistent PAH Polycyclic Aromatic Hydrocarbon Pb Lead PBPK Physiologically Based PharmacoKinetics PBPK/PDPhysiologically Based PharmacoKinetics and PharmacoDynamics PBT Persistent, Bioaccumulative and Toxic PBTK Physiologically Based ToxicoKinetic modelling PCB Polychlorinated Biphenyl PCDD PolyChlorinated Dibenzo Dioxin PCDF PolyChlorinated Dibenzo Furan PEC Predicted Environmental Concentration PNEC Predicted No Effect Concentration POM Polycyclic Organic Material POP Persistent Organic Pollutant PPE Personal Protective Equipment ppm Parts Per Million QSAR (Quantitative) Structure-Activity Relationship R phrases Risk phrases according to Annex III of Directive 67/548/EEC RAR Risk Assessment Report RfC Reference Concentration RfD Reference Dose RPF Relative Potency Factor RWC Reasonable Worst Case S phrases Safety phrases according to Annex III of Directive 67/548/EEC S Sulfur
  • 5. IV SAR Structure-Activity Relationships SCE Sister Chromatic Exchange SETAC Society of Environmental Toxicology and Chemistry SNIF Summary Notification Interchange Format (new substances) SSD Species Sensitivity Distribution STP Sewage Treatment Plant TEF Toxicity Equivalence Factor TEQ 2,3,7,8-TCDD Toxicity Equivalents TGD Technical Guidance Document 1 TNO The Netherlands Organisation for Applied Scientific Research TNsG Technical Notes for Guidance (for Biocides) TOC Total Organic Carbon TSS Total Suspended Solids TTC Toxicity-Specific Concentration TTD Target Organ Toxicity Dose UC Use Category UDS Unscheduled DNA Synthesis UF Uncertainty Factor UNEP United Nations Environment Programme US EPA Environmental Protection Agency, USA vB very Bioaccumulative vP very Persistent vPvB very Persistent and very Bioaccumulative WHO World Health Organization WOE Weight of Evidence
  • 6. 1 3 Objective The objective of this research is essaying to draw a methodology of risk management and assessment of groundwater contamination to apply in Uruguay. 4 Introduction Human being and earth’s ecosystems form a symbiotic relationship such that the impacts to one entity ultimately reflect upon the other. As human influence upon the environment has been intensified in response to increasing population and technological reliance, the environment has become increasingly more stressed. To minimize or curtail environmental degradation, individual or organizations are given the responsibility to make decisions and take action to reduce adverse human impact without unduly hindering the economic, social, or political progress of their countries. Environmental management problems are complex because of the involvement of several and diverse stakeholder groups whose values are often conflicting. The effort to recognize, assess, and mitigate environmental problems has been largely led by developed countries. Therefore, the methodology of risk management has been developed to integrate the stakeholders concerns, population opinion, and technical analyses (risk assessment). In pursuit of the objective of this research was done a survey of guidelines and methodologies about risk management and assessment in sites of Internet of institutions. In addition, was analyzing and classify the methodologies found. Analyzing consist in try understand how work each methodology and why do what each one do. To summarize, there are three line of research of risk assessment and management: human health (HRA), ecological (EcoRA), and environmental (ERA). For each line of research can be used different methodologies and models. In the scientific literature the model developed in USA by National Academy of Sciences (NAS) which looks at chemical risk to human health is widely used and accepted but excludes any of the social aspects of risk that make risk assessment such a complex task. Many international institutions developed risk assessment methodologies and procedures for exposure from specific source follow the NAS model using a complement. EcoRA involves the assessment of the risk posed by presence of substances released to the environment on all living organisms in the variety of ecosystems that make up the environment. EcoRA has a trend to focus on the risk from chemicals and genetically modified organisms. Some address physical risk such as temperature risks caused by cooling water releases from industry. Many organizations are involved in the development of methods and applications of EcoRA.
  • 7. 2 Within the precept what human being and earth’s ecosystems form a symbiotic relationship the concept of ERA was born. This method is also based on NAS method but involves much more steps and embrace human health, ecological system, aspects of socio-economics, culture, and politics. US EPA is developing a new methodology, cumulative risk assessment (CRA), which could be used on risks to health or environment. CRA is combined risks from aggregate exposures to multiple agents or stressors (chemicals, biological or physical agents, or the absence of a necessity such as habitat). All institutions researched make emphasize of risk managers may have to scientifically assess risk and use formalized risk management procedures to choose the most satisfactory course of action in response to that risk. For EEA this means reducing risk to an “acceptable” level at an “acceptable” cost. By any means, the most common of formal analysis techniques for alternative risk management options are cost-benefit, cost- risk-benefit and decision analysis. In most methodologies, complex problems broken down into manageable components that can be studied individually and then combined to make an overall assessment. Strongly prescriptive decision rules are used. These components are combined according to formalized procedures. Finally, there has to be a common unit to compare different consequences and make deals between conflicting objectives. 5 Methodology of Research In search of the objective, this research was divided as you can see from the figure 1. In Japan was done search of methodology in various institutions like: AIST, US EPA, EEA, FAO, OECD, WHO, UNEP, European Chemicals Bureau, and others institutions. Also in Japan was analyse and classify the methodology found according environment efficiency. Fig. 1. Methodology of research Methodologies ofmanagementand assessmentof environmental risk in the world Various institutions are developing methodologies ofmanagementand assessment of environmental risk Collect data about methodologies of management of environmental risk Analyse data Classify methodologies (according to environment efficiency) Collect data of Uruguay and samples of water contaminated Evaluation of risk with different methodologies Propose a model to apply in Uruguay JAPAN URUGUAY
  • 8. 3 6 Results There are numerous methodologies of risk assessment and management work out by several institutions from developed countries but the selected to analyze was: NAS, US EPA, EEA, European Chemicals Bureau, Radiation Risk Assessment Methodologies, Institute of Geo-resources and Environment AIST, METI. 6.1 NAS U.S. National Academy of Sciences worked out a model called NAS. Because of the widespread use of this model in regulatory and policy terms for human health protection in several countries is very important know its paradigm, as can been see in figure 2. Fig. 2. NAS method 6.2 US EPA The EPA guidelines for human health risk assessment incorporate the four parts of the NAS paradigm. EPA regularly publishes guidelines to provide for consistency of application and communication of risk assessment. Guidelines were published in 1986 on assessment of the following areas: exposure, developmental effects, germ cell mutagenecity, carcinogenic effects, and chemical mixtures. Since that time, the Agency has revised some of these Guidelines and published new Guidelines. These include Guidelines on developmental toxicity, exposure assessment, cancer (proposed revisions), reproductive toxicity, neurotoxicity, chemical mixtures, supplemental, and review purposes for cumulative risk. It is beyond the scope of this report analyze and discuss aspects of guideline for chemical mixtures, supplemental, and review purposes for cumulative risk since this guidelines incorporating the paradigm of the others. RESEARCH Laboratory and field observation of adverse health effects and exposures to particular agents Information on extrapolation methods for high to low dose and animal to human Field measurements, estimate exposures, characterization of populations RISK MANAGEMENT Development of regulatory options Evaluation of public health, economic, social, political consequences of regulatory options Agency decisions and actions RISK ASSESSMENT Hazard identification Dose-response assessment Exposure assessment Risk characterization
  • 9. 4 6.2.1 Health risk assessment of chemical mixtures For this supplemental guidance on the risk assessment of chemical mixtures, the four parts of the paradigm are interrelated and will be found within the assessment techniques. For some methods described herein, assessment of dose-response relies on decisions in the area of hazard identification and on assessment of potential human exposures. For mixtures, the use of pharmacokinetics data and models in particular differs from single chemical assessment, where they are often part of the exposure assessment. For mixtures, the dominant mode of toxicologic interaction is the alteration of pharmacokinetic processes, which strongly depends on the exposure levels of the mixture chemicals. In this guidance, there has been no effort to categorize methods strictly or arbitrarily into one part of the paradigm. The methods are organized instead according to the type of available data. In general, risk characterization takes into account both human health and ecological effects, and assesses multiroute exposures from multiple environmental media. This guidance focuses only on the human health risk assessment for chemical mixtures and only discusses multiroute exposures in terms of conversions from dermal to oral. EPA justify the importance to developed risk assessment of chemical mixtures is although some potential environmental hazards involve significant exposure to only a single compound, most instances of environmental contamination involve concurrent or sequential exposures to a mixture of compounds that may induce similar or dissimilar effects over exposure periods ranging from short-term to lifetime. This guidance is organized according to the type of data available to the risk assessor, ranging from data rich to data poor situations. It is recommended that the risk assessor implement several of the approaches that are practical to apply and evaluate the range of health risk estimates that are produced. EPA suggests that the selection of a chemical mixture risk assessment method follow the outline in the flow chart shown in Figure 3, which begins with an assessment of data quality and then leads the risk assessor to selection of a method through evaluation of the available data.
  • 10. 5 Fig. 3. Risk assessment approach for chemical mixtures Summarizes few important concepts related to chemical mixtures exposure assessment. Once a chemical mixture is released to the environment, its concentration and composition may change through partitioning into abiotic and biotic compartments and through transformation mediated by the environment and biota. The physical/chemical properties of each component of the mixture (or the properties of the mixture as a whole) and the condition of the microenvironment into which the components are partitioned may change the magnitude and the routes of human exposure. Partitioning and transformation of the mixture components will affect the routes of exposure. Ideally, chemical mixture exposures through different routes can be integrated through measurement data or a validated physiologically based pharmacokinetic (PBPK) model; at this time, approaches are still evolving, particularly for combining inhalation and oral exposures. The sequence of exposures to different chemical agents is clearly important for some responses. This guideline considers risk assessment may be based on the toxic or carcinogenic properties of the components in the mixture. When quantitative information on toxicologic interaction exists, even if only on chemical pairs, it should be incorporated into the component-based approach. When there is no adequate interactions information, dose- or response-additive models are recommended. Several studies have demonstrated that dose (or concentration) addition often predicts reasonably well the toxicities of mixtures composed of a substantial variety of both similar and dissimilar compounds, although exceptions have been noted. yes No yes If sufficient quantitative data are available on the interactions of 2 or more components in the mixture 1 Assess the quality of the data on interaction, health ef f ects, and exposure 14 Qualitativ ely assess thenature of any potential hazard and detail the ty pes of additional data necessary to support risk assessment Inadequate data Adequate data 3 Risk assessment on the mixture of concern based on health ef fects using the same procedures as those f or single compounds 7 Compile health ef f ects and exposure inf ormation 12 Compare Risk assessment conducted in steps 5, 8 and 9. Identif y and justif y the pref erred assessment, and quantif y uncertain, if possible No Ifsufficiently similar 6 Conduct Risk assessment 8 Deriv e appropriate indices of acceptable exposure and/or risk on the indiv idual components in the mixture 9 Assess data on interactions components in the mixture 11 Dev elop a risk assessment based on an addiv ity approach f or all compounds data on interactions components in the mixture If sufficient quantitative data are not available use whatever information to qualitatively indicate the nature of potential interactions 13 Dev eloped an integrated summary of the qualitativ e and quantitative assessment with special emphasis on uncertainties an assumption. Classif y the ov erall quality of the risk assessment Ifnot sufficiently similar 4 Health ef f ects inf ormation is available on a mixture that’s is similar to the mixture of concern 10 Use an appropriate interaction model to combine risk assessment data on compounds f or which data are adequate, and use an additiv ity assumption f or the remaining compounds 5 Assess the similarity of the mixture on health ef fects data are available that’s is similar to the mixture of concern, with emphasis on any dif f erences in components or proportions of components, as well as the ef fects that such differences would hav e on biological activ ity 2 Health ef f ects inf ormation is av ailable
  • 11. 6 Three component methods are discussed in this guideline that are based on dose addition: the RPF method, the TEF method, which is a special case of the RPF method, and the HI method. They differ in the required knowledge about toxicologic processes and in the extent over which toxicologic similarity is assumed. In each method, the exposure levels are added after being multiplied by a scaling factor that accounts for differences in toxicologic potency (also called toxic strength or activity). The RPF method uses empirically derived scaling factors that are based on toxicity studies of the effect and exposure conditions of interest in the assessment. When extensive mechanistic information shows that all the toxic effects of concern share a common mode of action, then one scaling factor is derived for each chemical that represents all toxic effects and all exposure conditions. This special case is the TEF method, where actual toxicologic equivalence between the component chemicals is assumed once the scaling factor is applied. When data are conflicting or missing, or indicate that different modes of action may apply to different effects or exposure conditions, separate factors may be derived for each effect or exposure condition, which are distinguished from the special TEFs by being called RPFs. In the general RPF and specific TEF methods, the scaling factor represents the toxicity relative to the toxicity of one of the chemical components, called the index chemical, which is usually the best-studied chemical. The mixture exposure, given by the sum of the scaled exposure levels, is then the equivalent exposure in terms of the index chemical. This equivalent exposure is the exposure level of the index chemical that elicits the same response as the mixture exposure. The risk assessment then evaluates the equivalent index chemical exposure on that chemical’s dose- response curve in order to predict the mixture response. The Hazard Index method has weaker assumptions and data requirements, is more generally applicable, and has more uncertainty in the resulting assessment. Instead of requiring knowledge of similar mode of action, the Hazard Index method requires only similarity in target organ. As with the general RPF me thod, a separate Hazard Index is determined for each target organ of concern. Instead of converting the component exposure levels into an equivalent index chemical exposure, the scaling factors are standardized so that the resulting sum is dimensionless, and the Hazard Index is interpreted by whether or not it is greater than 1. The scaling factors for the Hazard Index are based only on each component’s toxicity, preferably related to the target organ being assessed so that the interpretation of the Hazard Index value can be tied to the target organ risk. Similarly, if some estimate of a practical threshold exists for each component, then HI=1 indicates that the mixture is at its practical threshold. In previous EPA applications of the Hazard Index method, the Hazard Index has served only as a decision index, where HI>1 leads to more investigation or to remedial action. If enough information becomes available on the components to assume a similar toxic mode of action, then RPFs could be developed instead.
  • 12. 7 Approaches for risk assessment strategy are based on the mixture’s chemical components are recommended for relatively simple, identified mixtures with approximately a dozen or fewer chemical constituents. For exposures at low doses with low component risks, the likelihood of significant interaction is usually considered low. Interaction arguments based on saturation of metabolic pathways or competition for cellular sites usually imply an increasing interaction effect with dose, so that the importance at low doses is probably small. The default component procedure at low exposure levels is then to assume response addition when the component toxicological processes are assumed to act independently, and dose (or concentration) addition when the component toxicological processes are similar. For dose (concentration) addition, a specific Hazard Index procedure is recommended. For higher exposure levels, or when adequate data on interactions suggest other than dose or response additivity at low doses, such information must be incorporated into the assessment. 6.2.2 Cumulative Risk Assessment Public interest in the environment continues to grow as more information is shared about multiple chemicals in air, water, and soil from different sources, with health risks being a major concern. The U.S. EPA has responded to increasing requests for a way to understand and evaluate the combined impacts of these conditions by preparing a set of reports on various aspects of cumulative risk assessment. Technical topics in cumulative risk assessment included in this approach are showed in the figure 4. Fig. 4. NAS Risk Assessment Paradigm Modified for Cumulative Risk, with Concepts Beyond Issues for Single Chemicals or Mixtures To summarize, the purpose is to provide a structured collection of approaches for addressing the chemical interactions and joint toxicity issues in cumulative health risk assessment by describing key concepts and illustrating steps that can be taken to more explicitly evaluate cumulative risks. This approach builds on
  • 13. 8 recent U.S. EPA documents to extend their concepts into a first phase of implementation that addresses the joint and interactive impacts of multiple chemicals, exposures and effects. Chemical and toxicologic interactions are a primary focus because these are areas where methodological advances allow the traditional process (evaluating chemicals individually) to be enhanced. Approaches for grouping are presented in order to simplify complexities and combine components for joint analysis, so attention can be focused on the factor combinations that could contribute most to adverse cumulative health risks. EPA studying in develops the guideline of cumulative risk assessment method follow the outline in the flow chart shown in Figure 5. Fig. 5. Approach for cumulative risk assessment 1) Planning, Scoping and Problem Formulation Planning and Scoping  Team:  risk assessors,  risk managers and  stakeholders  Goals,  Breadth,  Depth, and  Focus  Approach,  Resources,  Past Experiences. Problem Formulation  Conceptual model establishes:  stressors  health or environmental effects to be evaluated,  relationships among various stressor exposures and potential effects  Analysis plan lays out:  data needed,  the approach to be taken, and  the types of results expected during the analysis phase 2) Identify “Trigger” Sources, releases Population illness multiple- chemical fate public health data mixtures toxicity multi-route exposures Combined characterization population subgroup features Chemical concentrations Triggers Data Elements Sources, releases Population illness multiple- chemical fate public health data mixtures toxicity multi-route exposures Combined characterization population subgroup features Chemical concentrations Triggers Data Elements
  • 14. 9 List of Chemical s of Concern Population Profile OUTPUTS 4) Generate Chemical List  Initiating the Exposure Assessment when Health Endpoint is the Trigger,  Initiating the Exposure Assessment when Elevated Chemical Concentrations are the Trigger,  Initiating the Exposure Assessment when One or More Sources is the Trigger,  characterize the source(s) by compiling basic facility information  determine the spatial bounds of the assessment  examine the fate of the released pollutants  determine whether (and which) individuals in the community could be exposed and  quantify such exposures. 3) Characterize Population based on Trigger  Population in that study area,  Population defined by the health endpoint  Population defined by chemical concentrations,  Population defined by multiple sources. 6) Quantify Exposure for General Population and Subpopulations 7) Quantify Dose-Response for Initial Toxicity- Based Chemical Grouping 5) Identify Links between Chemicals & Subpopulations
  • 15. 10 Chemical Groups By ToxicityChemical Groups By Media & TimeOUTPUTS 6) Quantify Exposure for General Population and Subpopulations * Transformation refers to a group of processes that can act to change the composition of a mixture. ** Intracompartment transport refers to the processes that move a mixture through an individual compartment (e.g., turbulence and wind will move a mixture through the atmosphere) and intercompartment transport refers to processes that move a chemical mixture from one medium to another. 7) Quantify Dose-Response for Initial Toxicity-Based Chemical Grouping Chemical Groupings by Co-occurrence in Media/Time Time Media Same Different Same Group 1 Group 3 Different Group 2 Group 4 Exposure Groups Because of Exposure Group Same Media; Same Time Same Media; Different Time Different Media; Same Time Different Media; Different Time Consider These Factors to Form Toxicity Groups Similar effects or metabolites Similar effects or metabolites; Body burden; Persistence of effects Similar effects or metabolites; Pharmacokinetics; Multi- route exposures Similar effects or metabolites; Body burden, Pharmacokinetics; Persistence of effects; Multi-route exposures Target Organ Specific Toxicity Groups Kidney Group 1,1 Group 2,1 Group 3,1 Group 4,1 Liver Group 1,2 Group 2,2 Group 4,2 Group 4,2 … … … … … Lung Group 1,n Group 2,n Group 4,n Group 4,n 9) Conduct Risk Characterization 8) Integrate Exposure & Dose Response; Refine Exposure and Toxicity Assessments
  • 16. 11 9) Conduct Risk Characterization 8) Integrate Exposure & Dose Response; Refine Exposure and Toxicity Assessments Final Cumulativ e RA Integrated Chemical Groups OUTPUTS
  • 17. 12 6.3 EEA The European Environmental Agency – EEA guidelines for human health, ecologic and environment risk assessment incorporate the NAS paradigm with some improvement. The figure 6 shows the elements of risk assessment of EEA. Fig. 6. Elements of risk assessment for EEA The institution responsible for develop guidelines of chemicals risk for EEA is European Chemicals Bureau. 6.4 EuropeanChemicals Bureau The European Chemicals Bureau attending the Directive 93/67, Regulation 1488/94 and Directive 98/8 whom require that an environmental risk assessment be carried out on notified new substances, on priority existing substances and active substances and substances of concern in a biocidal product, respectively, created the Technical Guidance Document – TGD.
  • 18. 13 The environmental risk assessment approach outlined in this guideline attempts to address the concern for the potential impact of individual substances on the environment by examining both exposures resulting from discharges and/or releases of chemicals and the effects of such emissions on the structure and function of the ecosystem. Three approaches are used for this examination:  Quantitative PEC/PNEC estimation for environmental risk assessment of a substance comparing compartmental concentrations (PEC) with the concentration below which unacceptable effects on organisms will most likely not occur (predicted no effect concentration (PNEC). This includes also an assessment of food chain accumulation and secondary poisoning;  The qualitative procedure for the environmental risk assessment of a substance for those cases where a quantitative assessment of the exposure and/or effects is not possible;  The PBT assessment of a substance consisting of an identification of the potential of a substance to persist in the environment, accumulate in biota and be toxic combined with an evaluation of sources and major emissions. In principle, human beings as well as ecosystems in the aquatic, terrestrial and air compartment are to be protected. At present, the environmental risk assessment methodology has been developed for the following compartments:  For inland risk assessment:  aquatic ecosystem (including sediment);  terrestrial ecosystem;  top predators;  microorganisms in sewage treatment systems;  atmosphere.  For marine risk assessment:  aquatic ecosystem (including sediment);  top predators. In addition to the three primary environmental compartments, effects relevant to the food chain (secondary poisoning) are considered. Also effects on the microbiological activity of sewage treatment systems are considered. The latter is evaluated because proper functioning of sewage treatment plants (STPs) is important for the protection of the aquatic environment. The methodologies implemented have as aim the identification of acceptable or unacceptable risks. This identification provides the basis for the regulatory decisions, which follow from the risk assessment. In some cases the uncertainties in carrying out the standard assessment become unacceptably high. The methodologies implemented in these cases are based on identifying the emission sources in order to identify where exposures should be minimised. The risk assessment process, in relation to both human health and the environment, entails a sequence of actions which is outlined in the figure 7 below.
  • 19. 14 Fig. 7. Risk assessment of new substances, existing substances and biocidal active substances and substances of concern present in a biocidal product: general principles. The effects assessment address eight toxic effects  Acute toxicity  Irritation  Corrosivity  Sensitization  Repeated dose toxicity  Mutagenecity  Carcinogenicity and  Toxicity for reproduction Human population liable to the contaminants is divided in:  Workers  Consumers and Humans exposed directly via environmental:  Inhalation,  Oral and  Dermal Principle of the assessment is to compare concentrationexposed × concentrationno adverse effects The way to perform a quantitative analysis of uncertainties of the risk assessment process is based on probabilistic techniques. Using a probabilistic technique (e.g. Monte-Carlo simulation), simultaneous uncertainties in the model inputs can be propagated through the model to determine their combined effect on model outputs. INFORMATION GATHERING EFFECTS ASSESSMENT  Hazard identification  Dose (concentration) – Response (effect) Assessment EXPOSURE ASSESSMENT  Human exposure assessment (Workers, consumers, via the environment)  Environmental exposure assessment(water,soil,air) RISK CHARACTERIZATION HUMAN HEALTH Evaluation of effects data and comparison with exposure data ENVIRONMENT Evaluation of effects data and comparison with exposure data
  • 20. 15 6.5 Institute of Geo-resources and EnvironmentAIST, METI The Institute of Geo-resources and Environment consider very important to assess exposure an risk caused by contaminated soil and groundwater. Risk based assessment makes it possible to realize the quantitative analysis of environment risk for health and ecology as well as the cost–effectiveness analysis and socio– economical analysis. In general lines the risk management and the risk assessment follow the figure 8. Fig. 8. Risk assessment and risk management for soil and groundwater. The strategy of environment risk management of the institute is represented in the figure 9. Fig. 9. Strategy of environment risk management. Risk identification •Risk and hazard characterization •Risk estimation Risk assessment •Exposure and risk assessment •Options analy sis Risk reduction/control •Making decision •Remedial options •Monitoring Characterization of Risk Analy sis of Risk Control of Risk Phase 3 Phase 2 Phase 1 R RISKASSESSMENT COMPREHENSIVE ASSESSMENT Scale of soil contamination Groundwater contamination Kind of contamination Concentration of chemicals Condition of acceptor SITE ASSESSMENT Intake of contaminated soil Intake of contaminated Groundwater Exposure assessment Survey and monitoring Uncertainty analysis DETAILED ASSESSMENT Clean–up and remediation Estimation of risk level Trade–off analysis Analysis of risk reduction Cost–benefit analysis Stakeholders Risk assessment by Exposure Risk reduction Risk Characterization Options Realistic approachof trade of f and risk reduction Risk estimationRisk Assessment Risk Scenario Planning Surv ey Soil and GW contamination Comprehensive risk assessment from health risk and social risk Simulation Selection of cost- ef f ectiveness techniques Minimize cost
  • 21. 16 7 Discussions According to current guidelines in different part of the world risk assessment, have to be carried out for all kinds of substances, pesticides, including agricultural and non–agricultural pesticides, new and existing chemicals not being pesticides, soil contaminant, accidental pollution, etc. Several models and modeling system were having been developed based the guidelines showed in this report:  FOCUS–activities, of the European Union, directorate-general Health, and consumer Protection, concerning the determination of PECs in different environmental compartment like soil, groundwater and surface water; the models included here are e.g. PRZM, MACRO, TOXSWA.  EUSES, of the European Union, for new and existing chemical.  USES incorporating EUSES and Netherland evaluation system for pesticides.  CSOIL model was developed to calculate (reverse-calculation) for serious soil contamination concentration (SCC) at which a human toxicological maximum permissible risk (MPR) is exceeded. Beside this program are uses in Netherland also the programs SEDISOIL, VOLASOIL, RISK Human, and HESP.  CLEA is developed in UK for deriving guidelines, but this model also can be used for site–specific risk assessments.  UMS was developed for the detailed assessment of abandoned contaminated sites in Germany.  CalTOX RISK–human was developed in Finland.  CalTOX is a model developed by California Environment Protection Agency, department of Toxic Substances Control from US EPA.  Exposure models used in the USA, particularly at Environment Protection Agency, including screening models like SCI-GROW and GENEEC, but also more sophisticated models as there are PRZM, TIGEM, and EXAMS.  MACRO–model is specific model for pesticide leaching were dealt with in more detail used for estimating the concentration in groundwater or drainage water in cracked soils (heterogeneous flow).  EHIPS model from Russia for environmental health and operator exposure calculations using the EUROPOEM databases.  Canadian Environment Modelling Center at Trent University, Ontario, Canada had developed some multimedia fugacity models with different levels of complexity with increasing level introducing new data input requirements, and providing a more complete description of environmental fate.  GIS (geographic information systems) is explored in several model applications, e.g. USA, Russia, as well as in Italy and Germany.  GERAS, this model was developed by Institute of Geo-resources and Environment to assess exposure a risk caused by contaminated soil and groundwater. In general, the concepts of these models and guidelines found have many aspects in common but have different deepness in the analysis between them. Added to this, the approaches are lightly different and all have important strengths. Consequently is not possible compare them to classify by then environment efficiency.
  • 22. 17 In the words of Linders, is not recommended use a model A for some specific compartment or contaminant and another for other compartment for them sum of all results. However, the best solution is develop a new model, which combines the strengths of models. It would be appropriate to conclude this section of discussions with collections of considerations in the construction of one new model able to apply in a developing country:  Possibility to mathematically mass balance estimation concentration of the contaminant in the air, water, and soil through by frequency of interactions: physical (photolysis, fugacity, dissolution, erosion, leach, and runoff) chemical (oxidation, reduction, and reactions between contaminants, and others compounds), and biological (biodegradation, absorption, transpiration, bioaccumulation, and others).  Enable to choose which interactions will be considered in the mass balance estimation concentration of the contaminant in the air, water, soil.  Consider influence of depth, number of layers, thickness, and type of soil in the dynamic of movement of the contaminant in the soil, fugacity, groundwater, superficial water, absorption of the roots, and degradation of the contaminant.  Enable to input several layers of soils with different percents of each type of soil (rock, gravel, sand, silt, organic clay or not), thickness, porosity, density, humidity, and chemical characteristics.  Enable input average, maximum and minimum of wind velocity, humidity, rainfall, and temperature of air, water, and soil for each season of year or monthly.  Possibility to estimate contamination from traffic of vehicles by combustion of fuel, wear and tear of brake (cadmium), tire, lost oil.  Enable input type of traffic (car, trunk, bus, persons, animals), average, maximum, and minimum intensity of traffic for each season of year or monthly.  Enable input characteristics of traffic emissions by car, trunk, bus, persons, and animals.  Possibility to estimate the transport of contaminant and products of degradation by:  Air flow like prevailing winds (general circulation of the atmosphere), synoptic winds (winds associated with large-scale events such as warm and cold fronts), mesoscale winds (higher boundary of what is considered to be "forecastable" wind), microscale winds (short durations of time – seconds to minutes – and spatially over only ten to hundreds of meters) carrying gas, vapor, water, fog, smoke, smog, haze, dust, soil.  Superficial, and ground water flow and rain runoff  Leaching  Enable to choose which transport will be considered in the mass balance estimation concentration of the contaminant in the air, water, soil.  Possibility to estimate the contamination by:  Intake of contaminants by:  Vegetables → grains (rice, wheat, soya, bean, corn), fruits (apple, orange, banana, grape, tomato, cucumber, eggplant, pumpkin), leaves (lettuce, cabbage, arugula, alfalfa, pasture), bulb (Onion, garlic, leek), tuber(potato), steam (ginger), roots (beet, carrot, manioc), and others  Meat → bovine, swine, sheep, ram, goats, chickens, fish  Seafood → fish, algae, and shellfish  Milk and dairy products → cream, butter, yoghurt, ice cream, and cheese  drinks → juices, and alcoholic drinks
  • 23. 18  Water → potable, groundwater, surface  Soil → itself, in the food  Inhalation of contaminants in:  Out door → could be in the form of gas, vapor, solid particle, aerosols. The origin could be from industries, plant of water or wastewater treatment, wasteland, sea, lakes, rivers, groundwater, pavement, water or air of soil pore, where this pore could be in superficial, zone of roots, depth layer of soil. Also, have to be pondering about evapotranspiration of plants and animals, sludge application in the surface or in root zone, and irrigation by superficial, sub superficial and in root zone with water reuse, or ground water, or storm water, or superficial water, or potable. Beside could be interesting considerate, the contaminations come from vehicle traffic.  In door →could be in the form of gas, vapor, solid particle, aerosols. The origin could be from outdoor, shower, bath, tap, pavement, ground, water or air of soil pore, groundwater, superficial soil, and depth layer of soil  Dermal contact  Water →potable, groundwater, surface, storm water  Soil → working, life style  Dust  Possibility to enter data from socials studies like: social classes, density of population, percent of male and female, percent of each age group, life expectancy, life style, kind of residences, tall of the building, use of land (agriculture, industrial, commercial, residential), managing plans of the area by the municipalities, and services from the municipalities available in the area.  Enable input percent of age and sex group related with social class.  Enable input data about life style: percent of students, workers, employ and unemployed, and retired, percent of time spend and area of residence, industrial, commercial, agriculture, parks, theaters, cinemas, shopping centers, schools, street, parks, lakes, rivers, beaches and in case don`t have data consider international recommendation.  Enable input percent of age and sex group related with life style.  Enable to choose the numbers of age group, and activities of the life style.  Enable input percent of time working, type of work (agriculture, industry, commercial, hospital, laboratory), type of place (outdoor agriculture or urban area, indoor, line of production, office, hangar, building, house), and type of ventilation (with or without air conditioning).  Enable input residence standard size (area, numbers and size of rooms, kitchens, bathrooms), height of building, number and height of floors, number of apartment per floor, number and size of apertures, impermeability of floors, walls, number of floors underground (with or without windows), height of crow space and in case don`t have data input consider international recommendation.  Enable input number of taps, showers, toilets, in residence standard and in case don`t have data input consider international recommendation related with the number of rooms, kitchens, bathrooms.  Enable input distance, superficial area, depth, and frequency of application of sludge and irrigation. Furthermore, enable choose the chemical characteristic of the sludge and water used.  Enable input distance, superficial area, and depth median for lakes, rivers, sediments and the changes for each season. Furthermore, enable choose the chemical characteristic of the water.  Enable input level of groundwater
  • 24. 19  Consider influence in intake percent of principals vegetables, meat, milk and dairy products, drinks by:  Social class →each social class have different amount of intake of each group of food and drinks.  The interaction between compartment (air, water, and soil) and vegetables (root, stem, leaf) could be as form sediment from air over plans, evapotranspiration, rain splash, soil suspended, osmotic press, wind.  Season of year →each season of year have available different kind of vegetables and the amount of intake of each group of food and drinks is different and the way of eat the food change (percent of cooked or raw). Beside the metabolism of the plants, animals, and the velocity of degradation change according with the temperature. In addition, the weather influences formation of sediment from air over plans, evapotranspiration, rain splash, soil suspended, evaporation, transpiration, metabolism, and osmotic press.  Influence of different absorption, transport, and bioaccumulation of contaminants by each group of vegetable, and inside the plant (root, stem, leaf).  Age and sex → each age and sex group has different weight, amount of intake of each group of food and drinks, and have different metabolism.  Water → the water intake could occur in the shower, swimming, and type of irrigation (sprinkle, dripping, and underground, and water used to do it) and natural disasters (inundation, tsunamis).  Use of land → land used for agriculture usually don`t have service of municipalities for potable water so usually they had well to take groundwater or use superficial water or rain water and usually in this area have orchard and vegetable garden. Beside, master plan of the city, guide the house standard for each zone this information is useful for determine the type of residence (house, apartment, condominium), the use of land (percent of area appropriate to agriculture, industrial, commercial, residential) and the existence and the numbers of wells. Also is important know the use of land for calculation of transport and the type of contaminant. In addition, the intake of food is different in rural area than urban area.  Type of residence → depend of type of residence has the possibility to plant in the garden vegetables and had well to take groundwater.  Enable change infiltration in the net pipes of potable water (age of the net of pipes to distribution) and efficiency of treatment (age of the plant), and percent of soil intake in the food, itself and dust over  Enable to choose which type of food in each group, and source of the contaminant will be considered in the mass balance estimation concentration of the contaminant in the air, water, soil.  Enable change the percent for each group of food, drinks and way of eat (cooked or raw) but when don`t have data use international recommendation of international organism for nutrition.  Possibility of estimate soil intake by percent of ingestion each type of vegetables.  Enable change the percent for each use of land (agriculture, industrial, commercial, residential).  Enable choose the water supply.  Consider influence in inhalation by:  Social class → each social class has different type of residence standard. In addition, each social class is building with different material and the quality. Therefore, change the impermeability of floors, walls or any structure.  Type of residence → each type of residence has a different height, size, structure impermeability, number, and size of apertures consequently has different law of wind (transport of contaminant inside). Beside the existence or not of craw space, floors underground (with or without windows), garage underground (with or without windows), and the distance to groundwater is very meaningful for the fluxes of volatiles compounds, and humidity. Furthermore, the existence or not of garden, type of pavement around the building could influence in fluxes of contaminants inhalation.
  • 25. 20  Use of land → the land used is related with the distance of industry, plant of treatment for water or wastewater, wasteland, sea, lake, river, groundwater, sludge application, areas irrigated, and traffic ways.  Life style → the life style is not just related with not only with the time but also with the way of outdoor or indoor. For instance time worked and type work (agriculture, industry, commercial, hospital, laboratory, line of production, office, on street) so this will change the distance of source of contaminants. In the same way time spend in theaters, cinemas, shopping centers, schools, parks, beaches, lakes, rivers will have the same influence.  Age and sex →each age and sex group have a different breathing volume, weight as well as influence in life style.  Season of year → each season have different weather conditions (temperature, humidity, rainfall, wind velocity) and this could influence chemicals reactions, evaporation, transpiration, viscosity, fugacity, velocity of degradation. Moreover, the season has influence in life style.  The flux interaction in and between compartment (air, water, and soil)  Enable input national limits standard for contaminants concentrations and in case don`t have data input consider international recommendation.  Enable to choose international recommendation for contaminants concentrations for intake, inhalation, and dermal contact.  Estimate the limit of exposition based on relation pathway of exposition, capacity of absorption by dermal contact, ingestion, and inhalation, capacity of elimination contaminant and limits standard for contaminants concentrations.  Estimate an index of hazard based on relation dose response for each contaminant and the way of exposition (dermal contact, ingestion, and inhalation) and calculation of risk and uncertain using statistical models.  Enable input alternative of treatment for risk reduction, with efficiency, and cost of each one, and compare risk with cost and efficiency using statistical models.
  • 26. 21 8 Conclusion Decision making in environmental projects is typically a complex and confusing exercise, characterize by trade–offs between socio–political, environmental, and economic impacts. Cost–benefit analyses often are used, occasionally in concert with comparative risk assessment, to choose between competing projects. Risk assessment develops choices that risk managers can rank according to risk–cost–benefit analysis or other criteria, and implement, monitoring and change as new knowledge becomes accepted. In most of the countries, the risk assessment process uses basic scientific information to evaluate potential risk to human and the environment. Typically, these scientific evaluations of potential risk to human health and the environment are used to determine if remedial action or cleanup is necessary and if so, how much needed. In addition, the quantitative results of these risk assessments are often used to determine cleanup goals for restoration of a waste site. Given that countries of European community, USA and Japan has developed extensive guidance and has established numerous policies for the use of risk assessment in environment problem solving, it is not surprising for methodologies in other countries to be similar. In addition, the scientific database created for risk assessments produce similarities among countries. In search of the objective, this research was collect information about technologies with low cost or implementation with low cost. Since, the principal barrier for the developing countries is the height cost associated with implementation of restrictive politic for environment protection. In the item about discussion, was made some considerations with intention of would have done contribution for implement risk assessment and management by simulation understand this way is the most low cost. For this was proposing use in calculation data used in several activities and with low cost like: socials studies, soil profile used in construction, standards used for building popular residences, international standards for inhalation, intake, and dermal contact of contaminant. Beside was proposing have flexibility in the model for permit apply in several sites with different characteristic and by this way do not be limited a just one site and consequently making low the cost of the simulation. Offering by this way, offer to decision-making using a tool of environmental management based on risk management and assessment to be able to apply in Uruguay
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IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Lyon. World Health Organization (WHO) and Oficina de Medicina del Trabajo. 1989. Occupational Exposure Limit for Asbestos. Ginebra. World Health Organization (WHO). 2004. Principles for Modelling Dose-Response for the Risk Assessment of Chemicals. Ginebra. World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO). 2006. A Model for Establishing Upper Levels of Intake for Nutrients and Related Substances. Ginebra. 10 Acknowledgement There are many persons that in different ways have contributed to this thesis with knowledge, ideas, and fruitful discussions, but not the least with encouragingwords and actions.I would especiallylike to thank the following persons: Dr. Takeshi KOMAI for the valuable teachings, for the opportunity for my professional development and by friendship resulting of our convivial. Dra. Mio TAKEUCHI, who, in this months of convivial teach me a lot, contributed for my scientific, intellectual, professional,and personal growth, and for her friendship result of our convivial. Dra. Junko HARA for her friendship, technical and personal support, and change of knowledge fact that contributed for my scientific, intellectual, professional growth. Dr. Yoshishige KAWABE contributed for my scientific, intellectual,professional growth.