impacts of the european commission’s reach proposal on risk assessment joel a. tickner, scd and...
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Impacts of the European Commission’s REACH Proposal
on Risk Assessment
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 ProblemsEurope 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 ProposalThe 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 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 REACHComponents 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
RegistrationRegistration
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 requirementsRegistration 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
EvaluationEvaluation
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.
AuthorizationAuthorization
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 processRestrictions 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 agencyRole 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 ProcessEU 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 industryImpacts 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 responsibilitiesNew 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 toolsNeed 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 5Rapid 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 REACHInformation 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 assessmentThe 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 methodGoals 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 assessmentA 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 ChemicalsTSCA 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
ConclusionsConclusions
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…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.
Lowell Center for Sustainable Production Chemicals Policy Initiative Website
www.chemicalspolicy.org