Impacts of the European Commission’s REACH Proposal on Risk Assessment Joel A. Tickner, ScD and Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell Joel A. Tickner, ScD and Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell

Europe and the US – Similar Problems Lack of toxicity/exposure information on chemicals in commerce Unequal treatment of new/existing chemicals Slow chemical by chemical risk assessment process, burden on government Lack of incentives to stimulate development and implementation of safer substitutes Increasing evidence of health effects Lack of integrated and comprehensive approach to chemicals management Lack of toxicity/exposure information on chemicals in commerce Unequal treatment of new/existing chemicals Slow chemical by chemical risk assessment process, burden on government Lack of incentives to stimulate development and implementation of safer substitutes Increasing evidence of health effects Lack of integrated and comprehensive approach to chemicals management

The REACH Proposal In February of 2001, the European Commission issued a White Paper on the Future of Chemicals that proposed a major new policy called REACH REACH: Registration Evaluation Authorization of CHemicals In February of 2001, the European Commission issued a White Paper on the Future of Chemicals that proposed a major new policy called REACH REACH: Registration Evaluation Authorization of CHemicals

The REACH Proposal A duty of care on chemical producers, users, and importers for studying risks and safety A European-wide approach to chemicals policy – protect internal market Substitution of chemicals of very high concern - innovation in safer chemicals Bridge knowledge gap between new and existing chemicals – develop information on all chemicals. Reduction in animal testing Promotion of a non-toxic environment – the “generational goal” A duty of care on chemical producers, users, and importers for studying risks and safety A European-wide approach to chemicals policy – protect internal market Substitution of chemicals of very high concern - innovation in safer chemicals Bridge knowledge gap between new and existing chemicals – develop information on all chemicals. Reduction in animal testing Promotion of a non-toxic environment – the “generational goal”

Components of REACH Registration – testing, data collection, and assessment of all chemicals and supply chain information Evaluation of risks of chemicals used in greatest quantity and of highest concern Accelerated risk management for chemicals of concern Authorization for substances of highest concern. Establishment of a new central administrative agency Registration – testing, data collection, and assessment of all chemicals and supply chain information Evaluation of risks of chemicals used in greatest quantity and of highest concern Accelerated risk management for chemicals of concern Authorization for substances of highest concern. Establishment of a new central administrative agency

Registration Essentially a notification process All producers and importers of substances produced over 1m ton/year (about 30,000 substances) Phased in over 3 yrs, 6 yrs, and 11 yrs Pre-registration, consortia establishment Exemptions for R&D, intermediates, polymers, others Current New Chemicals are considered registered Requirement to submit new data Essentially a notification process All producers and importers of substances produced over 1m ton/year (about 30,000 substances) Phased in over 3 yrs, 6 yrs, and 11 yrs Pre-registration, consortia establishment Exemptions for R&D, intermediates, polymers, others Current New Chemicals are considered registered Requirement to submit new data

Registration requirements Base information – identity, information on manufacture and uses, proposed classification/labeling, Chemical safety assessment/guidance on safe use (over 10 tons) – risk assessment for all identified uses Additional tiered testing/information – requirements – flexibility Requirement to consult database/authorities before testing Required data sharing/compensation – Substance Information Exchange Forum Base information – identity, information on manufacture and uses, proposed classification/labeling, Chemical safety assessment/guidance on safe use (over 10 tons) – risk assessment for all identified uses Additional tiered testing/information – requirements – flexibility Requirement to consult database/authorities before testing Required data sharing/compensation – Substance Information Exchange Forum

Evaluation Essentially a risk screening process Two types: standard and priority Standard: minimize duplicative testing for high production volume substances Priority: review of registration to identify additional information needs (focus on high volume/high concern plus intermediates and randomly selected substances) Requirement to consult other Member States before requiring additional testing Can lead to risk management recommendations. Essentially a risk screening process Two types: standard and priority Standard: minimize duplicative testing for high production volume substances Priority: review of registration to identify additional information needs (focus on high volume/high concern plus intermediates and randomly selected substances) Requirement to consult other Member States before requiring additional testing Can lead to risk management recommendations.

Authorization Essentially a use restrictions process Applies to chemicals of very high concern – CMRs 1&2, PBTs, VPVBs, and other high concern substances Requirement to request authorization for high concern chemicals – timelines (includes use and incorporation into articles) Consideration of socio-economic benefits, alternatives, controls in place (safe use) Can be subject to conditions/time limited Community/Member State authorizations Essentially a use restrictions process Applies to chemicals of very high concern – CMRs 1&2, PBTs, VPVBs, and other high concern substances Requirement to request authorization for high concern chemicals – timelines (includes use and incorporation into articles) Consideration of socio-economic benefits, alternatives, controls in place (safe use) Can be subject to conditions/time limited Community/Member State authorizations

Restrictions process A “safety net” – for Community wide protection Member State proposal for restriction Preparation of risk assessment and socio- economic assessment Commission decision Can specify types of restrictions Time limited process A “safety net” – for Community wide protection Member State proposal for restriction Preparation of risk assessment and socio- economic assessment Commission decision Can specify types of restrictions Time limited process

Role of new chemicals agency Database on chemicals under registration/ authorization Completeness check of registration dossiers Risk assessment/socio-economic analysis for Community authorizations Risk and socio-economic analysis for restrictions Forum for exchange of information on enforcement Maintenance of much expertise in Member States Database on chemicals under registration/ authorization Completeness check of registration dossiers Risk assessment/socio-economic analysis for Community authorizations Risk and socio-economic analysis for restrictions Forum for exchange of information on enforcement Maintenance of much expertise in Member States

EU Legislative Process White Paper Draft legislation Comment Period Final Commission proposal First Reading Parliament/Council Second Reading Council/Parliament (time limited) with Commission debate Conciliation (time limited) White Paper Draft legislation Comment Period Final Commission proposal First Reading Parliament/Council Second Reading Council/Parliament (time limited) with Commission debate Conciliation (time limited)

Impacts of REACH on Risk Assessment – new data and initial burden on industry Burden on industry to come up with test data or equivalent information Availability of test data for most existing substances Ability to use surrogates (QSAR, category approach, alternatives) if satisfactory Burden on industry to provide risk assessment and risk management recommendations for all identified uses according to guidance New supply chain use and exposure data Burden on industry to come up with test data or equivalent information Availability of test data for most existing substances Ability to use surrogates (QSAR, category approach, alternatives) if satisfactory Burden on industry to provide risk assessment and risk management recommendations for all identified uses according to guidance New supply chain use and exposure data

New government risk assessment responsibilities Development of good IT system for collecting, analyzing, and public access to data Data on some 11,000 chemicals over 11 years Protecting CBI Spot checks of dossiers for completeness Member States perform evaluation of risk assessments for certain higher concern substances (high volume, toxicity concerns) For additional data/risk assessment needs For risk management recommendations Determination of new chemicals of concern for which registration is warranted – intermediates Development of good IT system for collecting, analyzing, and public access to data Data on some 11,000 chemicals over 11 years Protecting CBI Spot checks of dossiers for completeness Member States perform evaluation of risk assessments for certain higher concern substances (high volume, toxicity concerns) For additional data/risk assessment needs For risk management recommendations Determination of new chemicals of concern for which registration is warranted – intermediates

Need for rapid screening and assessment tools Need for tools to rapidly characterize chemical hazards, exposures and risks Traditional risk assessment methods won’t be quick enough Need effective prioritization schemes Need indicators of which chemicals seem to be of higher concern One option is establishment of list of “chemical categories” Opportunities to reduce registrations by encouraging non-registration of chemicals of concern. Need tools that can be given to industry to help then internalize good assessment practices Need for tools to rapidly characterize chemical hazards, exposures and risks Traditional risk assessment methods won’t be quick enough Need effective prioritization schemes Need indicators of which chemicals seem to be of higher concern One option is establishment of list of “chemical categories” Opportunities to reduce registrations by encouraging non-registration of chemicals of concern. Need tools that can be given to industry to help then internalize good assessment practices

Rapid chemicals review under TSCA Section 5 Multi-disciplinary, multi-step hazard and risk review throughout lifecycle Rapid chemical assessment using available data (SAR, surrogates, etc.) Conservative assumptions in face of data gaps Build on database/experience of 30,000 new chemicals analyzed Multi-disciplinary, multi-step hazard and risk review throughout lifecycle Rapid chemical assessment using available data (SAR, surrogates, etc.) Conservative assumptions in face of data gaps Build on database/experience of 30,000 new chemicals analyzed

Information Needs in REACH Need for good process/facility/supply chain level materials accounting information Materials not efficiently managed (what you can’t measure you can’t manage) Identifies opportunities for greater efficiency and supply chain uses and places for exposure reduction and substitution Need good metrics to measure progress Need good information on alternatives to problem substances Market pressures from good information on alternatives Need for good process/facility/supply chain level materials accounting information Materials not efficiently managed (what you can’t measure you can’t manage) Identifies opportunities for greater efficiency and supply chain uses and places for exposure reduction and substitution Need good metrics to measure progress Need good information on alternatives to problem substances Market pressures from good information on alternatives

The big risk assessment challenge in REACH – alternatives assessment Chemical changes mean process changes Potential for risk trade-offs (community, occupational) Defeats goals of REACH if companies switch to other problem substances No clear cut tools for comparative assessments P2OASys – UMASS Lowell German, Swedish, OSPAR, Nordic Substitution methodologies University of TN Risk Ranking tool/CTSA method PBT Profiler A challenge to develop procedures for substitution assessment Chemical changes mean process changes Potential for risk trade-offs (community, occupational) Defeats goals of REACH if companies switch to other problem substances No clear cut tools for comparative assessments P2OASys – UMASS Lowell German, Swedish, OSPAR, Nordic Substitution methodologies University of TN Risk Ranking tool/CTSA method PBT Profiler A challenge to develop procedures for substitution assessment

Goals of a substitution assessment method Compare toxicity, physical hazards and other trade-offs at process and lifecycle levels Identify key criteria for avoidance (ie PBT) Allow flexibility to adapt to particular chemical, use Allow use of expert judgment Number scores are easy but hide information Be simple and clear enough so that firms and regulators can use Outline a clear process/guidelines for “substitution thinking” Compare toxicity, physical hazards and other trade-offs at process and lifecycle levels Identify key criteria for avoidance (ie PBT) Allow flexibility to adapt to particular chemical, use Allow use of expert judgment Number scores are easy but hide information Be simple and clear enough so that firms and regulators can use Outline a clear process/guidelines for “substitution thinking”

A possible process for substitution assessment Problem Identification Identification and development of a range of alternatives (chemical, non-chemical) Identification of the consequences of the alternatives Comparison of the alternatives Decision Implementation Evaluation of the results/reevaluation Problem Identification Identification and development of a range of alternatives (chemical, non-chemical) Identification of the consequences of the alternatives Comparison of the alternatives Decision Implementation Evaluation of the results/reevaluation

TSCA Section 5: Guidance Towards Safer Chemicals Attempt to get safer chemicals to market to replace existing problem ones Pre-manufacture pollution prevention review of substances and syntheses Green chemistry initiatives Informal discussion with manufacturers Agency going from gatekeeper to encouraging safer chemicals and processes Attempt to get safer chemicals to market to replace existing problem ones Pre-manufacture pollution prevention review of substances and syntheses Green chemistry initiatives Informal discussion with manufacturers Agency going from gatekeeper to encouraging safer chemicals and processes

Conclusions REACH will require development of new risk assessment tools For rapid assessment For alternatives assessment Without these will have collection of data REACH will require development of clear guidance on how to assess chemicals, substitutes, and trade-offs REACH will require tools to understand risk reduction activities/progress towards goals To be more effective, REACH needs to include more data on process level use and exposure REACH will require development of new risk assessment tools For rapid assessment For alternatives assessment Without these will have collection of data REACH will require development of clear guidance on how to assess chemicals, substitutes, and trade-offs REACH will require tools to understand risk reduction activities/progress towards goals To be more effective, REACH needs to include more data on process level use and exposure

Final thoughts… If REACH internalizes holistic consideration of chemical lifecycle risks and alternatives then it has achieved some measure of success Too little attention has been paid to substitution and analysis of alternatives Equally applicable with what to do about HPV/VCCEP in the US An opportunity to guide manufacturers towards safer chemicals and syntheses. If REACH internalizes holistic consideration of chemical lifecycle risks and alternatives then it has achieved some measure of success Too little attention has been paid to substitution and analysis of alternatives Equally applicable with what to do about HPV/VCCEP in the US An opportunity to guide manufacturers towards safer chemicals and syntheses.

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