CONSIDERATION ABOUT PROCESS OF ENVIRONMENTAL RISK ASSESSMENT AND MANAGEMENT

By

Maria Carolina Rivoir VivacquaEnvironmental 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 KomaiInstitute of Geo-resources and Environment AIST, METI

Japan

Gratefulness by

Dr. Mio TakeuchiInstitute of Geo-resources and Environment AIST, METI

Japan

Supported by

Japan International Cooperation Agency (JICA)

June 2007

ABSTRACTThe 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 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. 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. Finally, 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.

I

Table of Contents1 List of Figures________________________________________________________________________________II

2 List of Acronyms_____________________________________________________________________________III

3 Objective_____________________________________________________________________________________1

4 Introduction__________________________________________________________________________________1

5 Methodology of Research_______________________________________________________________________2

6 Results______________________________________________________________________________________36.1 NAS_____________________________________________________________________________________________3

6.2 US EPA__________________________________________________________________________________________36.2.1 Health risk assessment of chemical mixtures___________________________________________________________________46.2.2 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

II

2 List of Acronyms

AIST National Institute of Advanced Industrial Science and TechnologyAs ArsenicBOD Biochemical Oxygen DemandCOD Chemical Oxygen DemandCr ChromiumEcoRA Ecological Risk Assessment and Management, EEA Europe Environmental AgencyEPA U.S. Environmental Protection AgencyERA Environmental Risk Assessment and Management FAO Food and Agriculture Organization of the United NationsHg MercuryHRA Human Health Risk Assessment and ManagementMETI Ministry of Economy Trade and Industry, JapanMOS Margin of SafetyMW Molecular WeightNAEL No Adverse Effect LevelNAS U.S. National Academy of Sciences NF Norme FrançaiseNH3 AmmoniaNOAEL No Observed Adverse Effect LevelNOEC No Observed Effect ConcentrationO&G Oil and GreaseOECD Organisation for Economic Cooperation and DevelopmentOSPAR Oslo and Paris Convention for the protection of the marine environment of the Northeast AtlanticP PersistentPAH Polycyclic Aromatic HydrocarbonPb LeadPBPK Physiologically Based PharmacoKineticsPBPK/PD Physiologically Based PharmacoKinetics and PharmacoDynamicsPBT Persistent, Bioaccumulative and ToxicPBTK Physiologically Based ToxicoKinetic modellingPCB Polychlorinated BiphenylPCDD PolyChlorinated Dibenzo DioxinPCDF PolyChlorinated Dibenzo FuranPEC Predicted Environmental ConcentrationPNEC Predicted No Effect ConcentrationPOM Polycyclic Organic MaterialPOP Persistent Organic PollutantPPE Personal Protective Equipmentppm Parts Per MillionQSAR (Quantitative) Structure-Activity RelationshipR phrases Risk phrases according to Annex III of Directive 67/548/EECRAR Risk Assessment ReportRfC Reference ConcentrationRfD Reference DoseRPF Relative Potency FactorRWC Reasonable Worst CaseS phrases Safety phrases according to Annex III of Directive 67/548/EECS Sulfur

III

SAR Structure-Activity RelationshipsSCE Sister Chromatic ExchangeSETAC Society of Environmental Toxicology and ChemistrySNIF Summary Notification Interchange Format (new substances)SSD Species Sensitivity DistributionSTP Sewage Treatment PlantTEF Toxicity Equivalence FactorTEQ 2,3,7,8-TCDD Toxicity EquivalentsTGD Technical Guidance Document 1TNO The Netherlands Organisation for Applied Scientific ResearchTNsG Technical Notes for Guidance (for Biocides)TOC Total Organic CarbonTSS Total Suspended SolidsTTC Toxicity-Specific ConcentrationTTD Target Organ Toxicity DoseUC Use CategoryUDS Unscheduled DNA SynthesisUF Uncertainty FactorUNEP United Nations Environment ProgrammeUS EPA Environmental Protection Agency, USAvB very BioaccumulativevP very PersistentvPvB very Persistent and very BioaccumulativeWHO World Health OrganizationWOE Weight of Evidence

IV

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.

1

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

2

URUGUAY

JAPAN

Propose a model to apply in Uruguay

Evaluation of risk with different methodologies

Collect data of Uruguay and samples of water contaminated

Classify methodologies (according to environment efficiency)

Analyse data

Collect data about methodologies of management of environmental risk

Various institutions are developing methodologies of management and assessment of environmental risk

Methodologies of management and assessment of environmental risk in the world

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.

3

Risk characterization

Exposure assessment

Dose-response assessment

Hazard identification

RISK ASSESSMENT

Agency decisions and actions

Evaluation of public health, economic, social, political

consequences of regulatory options

Development of regulatory options

RISK MANAGEMENT

Field measurements, estimate exposures, characterization of

populations

Information on extrapolation methods for high to low dose

and animal to human

Laboratory and field observation of adverse health

effects and exposures to particular agents

RESEARCH

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.

4

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.

5

2 Health effects

information is available

5 Assess the similarity of the mixture on health effects data are available that’s is

similar to the mixture of concern, with emphasis on any differences in

components or proportions of components, as well as the effects that such differences

would have on biological activity

10 Use an appropriate interaction model to

combine risk assessment data on compounds for

which data are adequate, and use an additivity assumption for the

remaining compounds

4 Health effects information is available on a mixture that’s is

similar to the mixture of concern

If not sufficiently

similar

13 Developed an integrated summary of the qualitative

and quantitative assessment with special emphasis on

uncertainties an assumption. Classify the overall quality of

the risk assessment

If sufficient quantitative data are not available use whatever information to qualitatively indicate the nature of

potential interactions

11 Develop a risk assessment based on an addivity approach

for all compounds data on interactions

components in the mixture

9 Assess data on

interactions components

in the mixture

8 Derive appropriate indices of

acceptable exposure and/or risk on the

individual components in the

mixture

6 Conduct Risk assessment

If sufficiently similar

No

12 Compare Risk assessment conducted in steps 5, 8 and 9. Identify and justify the preferred

assessment, and quantify uncertain, if possible

7 Compile health effects and exposure information

3 Risk assessment on the mixture of concern based on health effects using the same procedures as those

for single compounds

Adequate data

Inadequate data

14 Qualitatively assess the nature of any potential hazard

and detail the types of additional data

necessary to support risk assessment

1 Assess the quality of the data on

interaction, health effects, and exposure

If sufficient quantitative data are available on the interactions of 2 or more

components in the mixture

yesNo

yes

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 method, 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.

6

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 7

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

8

1) Planning, Scoping and Problem FormulationPlanning 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

Chemicalconcentrations

Triggers

Data Elements

Sources,releases

Population illness

multiple-chemical

fate

public health data

mixtures toxicity

multi-route exposures

Combined characterization

population subgroup features

Chemicalconcentrations

Triggers

Data Elements

9

5) Identify Links between Chemicals & Subpopulations

7) Quantify Dose-Response for Initial Toxicity-Based Chemical Grouping

6) Quantify Exposure for General Population and Subpopulations

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.

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.

OUTPUTS

Population Profile

List of Chemicals

of Concern

10

Chemical Groups By Toxicity Chemical Groups By Media & TimeOUTPUTS6) 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 MediaSame Different

Same Group 1 Group 3Different Group 2 Group 4

Exposure GroupsBecause of

Exposure GroupSame 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 GroupsKidney Group 1,1 Group 2,1 Group 3,1 Group 4,1Liver 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 Cumulative

RA

Integrated Chemical Groups

OUTPUTS

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 European Chemicals 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.

12

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.13

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.

14

RISK CHARACTERIZATIONHUMAN HEALTH

Evaluation of effects data and comparison with exposure dataENVIRONMENT

Evaluation of effects data and comparison with exposure data

EXPOSURE ASSESSMENT Human exposure assessment (Workers, consumers, via the

environment) Environmental exposure assessment (water, soil, air)

EFFECTS ASSESSMENT Hazard identification Dose (concentration) – Response (effect) Assessment

INFORMATION GATHERING

6.5 Institute of Geo-resources and Environment AIST, 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.

15

DETAILED ASSESSMENTClean–up and remediationEstimation of risk levelTrade–off analysisAnalysis of risk reductionCost–benefit analysis

SITE ASSESSMENTIntake of contaminated soilIntake of contaminated GroundwaterExposure assessmentSurvey and monitoringUncertainty analysis

COMPREHENSIVE ASSESSMENTScale of soil contaminationGroundwater contaminationKind of contaminationConcentration of chemicalsCondition of acceptor

RISK ASSESS

RISK MANAGEMENT

Phase 1

Phase 2

Phase 3Control of Risk

Analysis of Risk

Characterization of Risk

Monitoring•Remedial options•

Making decision•Risk reduction/control

Options analysis•

Exposure and risk assessment•Risk assessment

Risk estimation•

Risk and hazard characterization•Risk identification

costMinimize

techniqueseffectiveness

-Selection of cost

Simulation

Comprehensive risk assessment from health risk and social risk

Soil and GW contamination

Survey

Planning

Risk Scenario

Risk Assessment Risk estimation

reductiontrade off and risk

Realistic approach of

Options

CharacterizationRisk

Risk reduction

Exposure Risk assessment by

Stakeholders

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.16

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

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Milk and dairy products → cream, butter, yoghurt, ice cream, and cheese drinks → juices, and alcoholic drinks 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.

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Enable input level of groundwater 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.

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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.

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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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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 encouraging words and actions. I would especially like 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.

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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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