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Work Package 1:- results from questionnaire and overview of tools for chemical

assessment

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WP1 Questionnaire

‘Work in progress’

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Background

• WP1 aims to gather information on approaches for protecting the environment from radioactive and non-radioactive substances

• Questionnaires were used to help gather information

• Two questionnaires were developed:-– regulatory/advisory bodies– industry

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Main areas where a response was invited

• The questionnaire covered the following issues:-– Protection goals– Methodology– Criteria (thresholds)– Future changes in regulation– Comparison of radionuclide and chemical

regulation

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Questionnaire responses

Regulators (44%)Advisory bodies (20%)NGOs or international organisations (12%)Industry (24%)

34 questionnaire responses received (23/03/07)

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Protection goals for radionuclides

Typically … ‘protection of ecosystems’ ‘pollution prevention’ ‘protection of animals, plants and diversity’ ‘the aquatic environment’

Some more specific e.g. ‘species at population level - some at individual level’ ‘maintenance of habitats with reasonable species populations’

‘aspirational’

Technically measurable

Many respondents focussed on risks to health and workers.

Protection of flora and fauna to be ‘considered’ or ‘general duty to protect’

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Protection goals for chemicals

• ‘Aspirational’ aims also feature in legislation but accompanying technical guidance usually translates these into more tangible measurement endpoints

• Implicit protection goal is protection of populations rather than individuals

• Ecological function features in soil thresholds but not aquatic (entirely structural protection)

• May also consider risks from secondary poisoning (biomagnification) and risks to operation of wastewater treatment plants

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Tools used in Chemical Risk Assessment

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Structure of presentation

• Overarching principles of chemical risk assessment

• Examples of risk assessment schemes• Examples of tools • How do these schemes and tools link to

assessment of radioactive substances?• Conclusions

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Types of risk assessment

RIS

K

AS

SES

SM

EN

T

Retrospective Prospective

•Contaminants already present

•Site-specific

•Focus is on classification, remediation or abatement

e.g. New Chemicals,

Pesticide Approval

• Anticipates possible risks

• ‘Imaginary’ exposure scenario e.g. standard application regime, standard receiving environment

•Risk mitigation through release, approved uses

e.g. ERA of contaminated land

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A generic framework for risk assessment

Problem

Formulation

Risk

Characterisation

Effects

Assessment

Exposure Assessment

Risk Management

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Tools

• Exposure – Emission-estimating

tools– dispersion models– food chain models– run-off models– leaching models– soil/cropping models

• Effects– QSARs– Biotic Ligand Model– Data analysis

(bioassays)– SSDs

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Examples of chemical risk assessment schemes

RETROSPECTIVE

• UK (?)Part IIa Environmental Risk Assessment for Contaminated Soils

• IPPC Directive

PROSPECTIVE

• New and Existing Industrial Chemicals

• Biocides Directive• Pesticides - Plant Protection

Product Directive

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1. Industrial chemicals

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Industrial chemicals and biocides

• The EU Technical Guidance Document (TGD) for risk assessment provides technical detail for undertaking risk assessments required for:-– new substances (Directive 93/67)– priority existing substances (Regulation

1488/94)– biocides (Directive 98/8)

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Risk assessment of industrial chemicals and biocides

• Requires understanding of exposure and effects• Basic minimum data set required to undertake

assessment• Encourages use of additional data where

available to refine the assessment for existing substances

• Provides option to refine exposure and effects if adverse risk indicated

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Risk assessment of industrial chemicals and biocides

• TGD is supported by EUSES• Computer-based models which predict

environmental concentrations and effect concentrations based on available data

• Models cover:– emission estimates– environmental distribution models for various

environmental scales– food chain modelling– species sensitivity distributions

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ERA of contaminated land

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ERA of contaminated land

• Part IIa of Environment Act requires Local Authorities to classify designated sites (nature reserves etc) that might be at risk from chemical contamination

• May be requirement to clean up where unacceptable risk

• Scheme at advanced stage of development (EA with Conservation Agencies)

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ERA framework - overviewCONCEPTUAL SITE MODEL

SCREENING ASSESSMENT - compare chemical contamination with SSVs

PROBLEM FORMULATION

CAUSE-EFFECT

EXIT

EXIT

EXIT

EXITDETERMINE

Tier 0

Tier 3

Tier 2

Tier 1

DETAILED ASSESSMENT - assess evidence for adverse effects

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• Use of SSVs (effectively chemical thresholds) as a screening tool

– compare monitored concs with SSV (equivalent to PEC/PNEC)

– need to consider background concentrations

– consider factors that affect availability (e.g. [OC], pH)

• Suite of biological methods - are there impacts?

– ecological surveys

– bioassays

– models to predict risks from biomagnification?

• Tools to link impacts to causes under consideration

ERA Tools

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Links to radioactive substances

• Assessment of environmental impact of radioactive substances involves a similar generic risk assessment approach

• Tools required to undertake such assessments are often similar, e.g. determination of contaminant exposure

• However there are some differences …

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How do approaches for chemicals and radionuclides compare?

Problem Formulation

Scoping and protection goals common to both approaches. A priori definition of ecosystems and reference organisms in radionuclide RA

Exposure Assessment

Environmental transfer of contaminants is a common feature but attention to interactions between ambient environment and biological receptors different

Dosimetry Major differences; significant feature of radionuclide RA but not chemical assessments. Possible internal and external exposure from radionuclides

Effects Assessment

Significant differences; assessment of chemicals based on pragmatic assessment of available ecotox data whilst assessment of radionuclides dominated by dose issues

Risk Characterisation

Details of radionuclide RA have to be resolved but likely to be major differences

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Conclusions• Chemical risk assessment invariably involves exposure

and effect assessment• Typically a tiered approach

– to allow for risk assessment to be refined– to structure use of different lines of evidence

• Numerous tools are available to help at each stage of the risk assessment process

• For large risk assessment schemes, technical guidance advises choice of which tool is to be used

• Similarities between the risk assessment of radioactive and chemical substances indicate need for some common tools but fundamental differences e.g. risks from external irradiation call for other tools in addition