1. PROTECTFP6-036425 Work Package 1:- results from questionnaire and overview of tools for chemical assessment

2. PROTECTFP6-036425 WP1 Questionnaire ‘Work in progress’

3. PROTECTFP6-036425 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

4. PROTECTFP6-036425 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

5. PROTECTFP6-036425 Questionnaire responses 34 questionnaire responses received (23/03/07)

6. PROTECTFP6-036425 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’

7. PROTECTFP6-036425 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

8. PROTECTFP6-036425 Tools used in Chemical Risk Assessment

9. PROTECTFP6-036425 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

10. PROTECTFP6-036425 Types of risk assessment RISK ASSESSMENT RetrospectiveProspective 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

11. PROTECTFP6-036425 A generic framework for risk assessment Problem Formulation Risk Characterisation Effects Assessment Exposure Assessment Risk Management

12. PROTECTFP6-036425 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

13. PROTECTFP6-036425 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

14. PROTECTFP6-036425 1. Industrial chemicals

15. PROTECTFP6-036425 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)

16. PROTECTFP6-036425 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

17. PROTECTFP6-036425 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

18. PROTECTFP6-036425 ERA of contaminated land

19. PROTECTFP6-036425 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)

20. PROTECTFP6-036425 ERA framework - overview CONCEPTUAL SITE MODEL SCREENING ASSESSMENT - compare chemical contamination with SSVs PROBLEM FORMULATION CAUSE-EFFECT EXIT DETERMINE Tier 0 Tier 3 Tier 2 Tier 1 DETAILED ASSESSMENT - assess evidence for adverse effects

21. PROTECTFP6-036425 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

22. PROTECTFP6-036425 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 …

23. PROTECTFP6-036425 How do approaches for chemicals and radionuclides compare?

24. PROTECTFP6-036425 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