New ECETOC expert report: Advancing OECD TG 309 biodegradation testing
390508

New ECETOC expert report: Advancing OECD TG 309 biodegradation testing

A new expert meeting report is now available on the ECETOC website exploring how OECD TG 309 can be made more robust and environmentally relevant for chemical persistence assessment. The report ref...
We’re Hiring: Join the ECETOC Team as a Trainee!
390494

We’re Hiring: Join the ECETOC Team as a Trainee!

Are you passionate about science, regulatory toxicology, and making a real-world impact at the intersection of industry, academia, and policy? ECETOC is excited to announce that we’re looking for a...
HSSD Tool

HSSD Tool

This software was developed by a consortium of partners to facilitate the uptake of novel approaches to estimate aquatic threshold concentrations (e.g. the concentration at which 5% of the species are exposed above their EC50, HC5).
The Human Exposure Assessment Tools Database (heatDB)

The Human Exposure Assessment Tools Database (heatDB)

heatdb is a public directory of exposure data sources as well as available tools for exposure
NanoApp

NanoApp

ECETOC’s NanoApp is a tool designed to define the boundaries of sets of similar nanoforms and to generate a justification for the REACH registration.
Targeted Risk Assessment (TRA)

Targeted Risk Assessment (TRA)

The Targeted Risk Assessment (TRA) estimates exposures to workers, consumers and the environment that arise during a series of events.
TRA Task Force – Worker branch

TRA Task Force – Worker branch

Why? The Worker TRA Task Force has been active since 2019, delivering projects that advance the scientific basis of the Worker Targeted Risk Assessment (TRA) tool. Its overarching objective is to e...
Immunotoxicity assessment: Addressing Challenges and Advancing Methodologies [Workshop → Task Force]​

Immunotoxicity assessment: Addressing Challenges and Advancing Methodologies [Workshop → Task Force]​

Why?Regulatory assessment of immunotoxic properties of chemicals is a complex and challenging task​ Limited regulatory guidance exists​ Lack of industry and regulatory knowledge​...
Chronic fish case studies towards an IATA

Chronic fish case studies towards an IATA

Why?Hazard and safety assessments for the pelagic compartment often rely on in vivo studies using a single fish species, raising ethical concerns and uncertainty in terms of extrapolation....
Technical Report
29.10.2011

TR 113 – Environmental Impact Assessment for Socio-Economic Analysis of Chemicals: Principles and Practice

TR 113 : Environmental Impact Assessment for Socio-Economic Analysis of Chemicals: Principles and Practice | August 2011

This report describes the requirements for, and illustrates the application of, a methodology for a socio-economic analysis (SEA) especially as it might be adopted in the framework of REACH.

CONTENTS

EXECUTIVE SUMMARY

1. INTRODUCTION

2. WHAT IS SEA AND WHY IS IT IMPORTANT IN DECISION MAKING?

3. ISSUES WITH THE USE OF RISK CHARACTERISATIONS

4. A SYSTEMATIC APPROACH TO COLLECTING DATA FOR A SEA

5. SITE-SPECIFIC IMPACTS ARE EASIER TO HANDLE

6. OTHER POSSIBLE APPROACHES TO MEASURE IMPACT IN VALUE-RELEVANT TERMS

6.1 An example showing how SSD might help

6.2 Smart modelling

6.3 Using the ecosystem services approach

6.4 Using general ecological criteria in the Water Framework Directive

7. CHALLENGES ASSOCIATED WITH AUTHORISATION

7.1 How authorisation works

7.2 Substitution, comparative risk assessment and economic feasibility

7.3 Carrying out cost-benefit analysis on PBT and substances of equivalent concern

8. CONCLUSIONS AND SUMMARY OF MAIN ISSUES

GLOSSARY

ABBREVIATIONS

BIBLIOGRAPHY

APPENDIX A

APPENDIX B

APPENDIX C

APPENDIX D

APPENDIX E

MEMBERS OF THE TASK FORCE

MEMBERS OF THE SCIENTIFIC COMMITTEE

 


EXECUTIVE SUMMARY

· This report describes the requirements for, and illustrates the application of, a methodology for a socio-economic analysis (SEA) especially as it might be adopted in the framework of REACH.

· Socio-economic analysis weighs the costs of any restrictions on the production and use of chemicals against the benefits to human health and the environment.

· The reasons why industry needs to understand the principles and practices of socio-economic analysis are: (1) to carry out, where appropriate, a SEA as an argument for authorisation (this is an industry responsibility), and (2) to be able to contribute as stakeholders in socio-economic discussions with regulatory authorities when a SEA is used as a basis for justifying restrictions.

· The focus of this report is on the ecological impacts of chemicals rather than on their human health impacts. This is where many of the most profound ecological and economic challenges are, and the ECHA guidance for socio-economic analysis associated with both restrictions and authorisation in the REACH process identifies the need for more work in this area.

· The report argues for as much quantification as possible, with the ideal of monetisation so that a cost-benefit analysis can be carried out. Without quantification the ecological benefits of restrictions on chemicals (including failure to authorise) may well be presented in emotive terms that are hard to counter on the basis of the economic benefits that might be lost from restricted use or the banning of a chemical.

· An ecological benefits assessment involves two components. One is the extent to which ecological effects are or may be ameliorated by restrictions on a chemical, and the other is the monetary value that is put on the ecosystems so protected.

· There are enormous challenges in ascribing monetary values, especially to non-marketed ecological goods or services. However, environmental economics has made great strides over recent years in developing appropriate methodologies to enable this to be achieved. This report draws attention to the appropriate sources.

· A substantial part of the challenge for valuation in benefits assessments is in identifying and quantifying the ecological impacts themselves in appropriate terms. The problem is that ecological risk characterisations and assessments do not express effects in terms of 'impacts' that can be valued.

· This report draws attention to a number of possible scenarios whereby the outputs of risk characterisations might be linked to quantified ecological impacts through such methods asspecies-sensitivity analysis, smart modelling, making connections to ecological quality status and using an ecosystem services approach. None of these methods is developed to the extent that they could be applied in case studies. There will be a need for pioneering efforts in these areas.

· The challenge of conducting a socio-economic analysis becomes even harder when only hazard criteria are available as is the case for substances of very high concern. The report takes the view that most of these chemicals will be degradable in the environment and in organisms, and therefore should be amenable to standard risk characterisations. However, the expectation is that the SEA arguments will have to be particularly convincing to allow authorisation.

· Finally, socio-economic analysis needs to bring together risk assessment and economic considerations. This requires that ecologists and economists, scientists and regulators understand each other's needs and languages. The establishment of a forum to facilitate this is to be encouraged.