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RESTRUCTURING CHEMICALS POLICY:The European Challenge. Ken Geiser, Ph.D. and Joel Tickner, Sc.D. Lowell Center for Sustainable Production Department of Work Environment University of Massachusetts Lowell www.chemicalspolicy.org. Lowell Center for Sustainable Production. SUMMARY.
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RESTRUCTURING CHEMICALS POLICY:The European Challenge Ken Geiser, Ph.D. and Joel Tickner, Sc.D. Lowell Center for Sustainable Production Department of Work Environment University of Massachusetts Lowell www.chemicalspolicy.org Lowell Center for Sustainable Production
SUMMARY • The European Union is proposing a bold restructuring of its entire chemicals policy called REACH • The US is several years behind Europe in addressing chemicals in products and management in general. • There are some positive aspects of the US system that could inform REACH • REACH will provide an important driver to chemicals testing and management in the US.
Defining Chemicals Policy • Regulatory and voluntary policies designed to achieve long-term, integrated and prevention-oriented sustainable use of chemicals in production systems and products • Focus is on industrial chemicals but could also include pesticides, cosmetics, etc.
Basics of chemicals policy • New Chemicals – those coming on the market after regulatory programs came into force in 1979-1980 (about 1% by volume of what is on the market today) • Pre-market vs. pre-manufacture • Subjected to assessment/review • Existing chemicals – everything on the market when regulatory programs came into force (about 99% by volume of what is on the market today)
The Problem • Lack of regulatory programs to address chemical lifecycle risks • Lack of integrated and comprehensive approach to chemicals management • Lack of information on existing chemicals • Concern about chemicals in products • Slow risk assessment process, burden on government
The Problem • Increasing public concerns about types of chemicals (persistent and bioaccumulative and endocrine disruptors) and impacts on health and ecosystems (marine) • Continued use of dangerous chemicals • Policy failures and lack of public confidence • Market pressures for safer chemicals
The Need • The time has come for a broad-based discussion in the United States of a more integrated, preventive and precautious policy on chemicals throughout their lifecycle in synthesis, manufacturing, products, and wastes
Chemicals Policy in the United States Lowell Center for Sustainable Production
SUMMARY • There is no one “US” system of chemicals management • The federal government took an early lead internationally in precautious chemicals policy • National policy basically stalled after 1980 • Since 1980, new, more limited, policy initiatives have appeared at the state and local levels.
History of US Chemicals Policy • Delaney Clause - FFDCA • Great Lakes – International Joint Commission and Great Lakes Water Quality Agreement • Occupational Health • Right-to-Know • Waste Management/ Pollution Prevention/Chemical accident prevention • Green Chemistry/Design for Environment • PBTs and endocrine disruption
Federal Chemicals Legislation in the US • 1960 Hazardous Substances Act • 1970 Occupational Safety and Health Act • 1970 Clean Air Act • 1972 Clean Water Act • 1972 Consumer Product Safety Act • 1976 Resource Conservation and Recovery Act • 1976 Toxic Substances Control Act • 1990 Pollution Prevention Act
Toxics Substances Control Act of 1976 • Regulatory power to require testing • Responsibility on industry to provide data on risks • Regulatory power to restrict chemicals in commerce • Requirement for pre-manufacture notification for New Chemicals • National Inventory update • Deference to other legislation – RCRA, OSHA, CAA, CWA
What about the Toxics Substances Control Act? • “Existing chemicals” – limited results – high burdens on the agency • Industry not proactively providing information/testing • Overuse of Confidential Business Information (CBI) • Use of voluntary initiatives to obtain data or manage chemicals – hard to regulate • “New chemicals” a bright, and understated light
New Chemicals Under TSCA • Pre-Manufacture, not Pre-Market Focus • Low threshold for action – “may present an unreasonable risk or substantial exposure” • Deterrence from potentially harmful chemicals • Guidance towards safer chemicals and syntheses • A precautionary, lifecycle review
Deterrence under the TSCA New Chemicals Program • Informal negotiation with manufacturers • Informal regulatory signals • Establishment of list of “chemicals of concern”/”chemical categories” • Use of conservative assumptions to encourage testing/restricting chemicals
TSCA Guidance Towards Safer Chemicals • Attempt to get safer chemicals to market to replace existing ones • Pre-manufacture pollution prevention review of substances and syntheses • Green chemistry initiatives • Informal discussion with manufacturers • From gatekeeper to encouraging safer chemicals and processes
Precautionary Review of New Chemicals • Multi-disciplinary, multi-step hazard and risk review. • 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 • However: No Testing Requirements
Existing Chemicals under TSCA • Inventory Update Rule generates national inventory of non-polymeric chemicals every four years • Years of delay in seeking health and environmental effects data • 1998 Chemicals Right to Know Challenge generates High Production Volume (HPV) program
High Production Volume Chemicals Program • Initiated from NGO pressure • EPA’s analysis demonstrates basic screening data incomplete for 97% of all existing HPV chemicals • EPA initiates HPV voluntary challenge to chemical industry to provide the basic testing data • Chemical industry agrees to provide screening data for 64% of HPV chemicals • Data in the form of “robust summaries” due by 2005
Right to Know - An Important Driver for Prevention • Toxics Release Inventory and chemical storage and accident scenario data. • Demonstrated inefficiencies in chemicals management • Useful information for workers and communities to promote prevention • Links to hazard/risk data – ie www.scorecard.org
Other Federal Chemicals Policies • Great Lakes Water Quality Agreement (EPA region 5) • PBT initiatives (RCRA focused) • BFR initiative (EPA region 9) • FACA Committee on TSCA
Promoting Chemicals Policy through Pollution Prevention • An important, but indirect route • Sector-based initiatives • Chemical class/use clusters based initiatives (solvents, cleaning agents) • Voluntary reduction programs • Outreach and education • Design for Environment
Pollution Prevention at the State Level • Most state programs are voluntary and poorly funded • A few states (Massachusetts, New Jersey, Maine) have mandatory planning programs, with materials accounting and planning requirements • Goals for waste reduction • Education • Technical assistance and research for prevention • Tax credits and other incentives
Example: Massachusetts Toxics Use Reduction Program • Goal: 50% reduction in toxic waste • Focus on ways to reduce waste and chemical use rather than on “acceptable exposures” • Chemical List based on evidence but not proof of toxicity of chemicals • Quantify materials used (why and how) • Understand costs of chemical use
Example: Massachusetts Toxics Use Reduction Program • Examine alternatives • Innovation and technical support • Measure progress and re-evaluate • Results: 1990-2000 • 60% reduction in waste • 40% reduction in use • 80% reduction in emissions • Benefits to industry $15 million (not considering health/environmental benefits)
Other State Initiatives • Labeling – Prop 65 in California • PBDE ban - California • PBTs – Washington, Oregon • Local procurement programs • Mercury bans at local, state, regional level • High Hazard Chemicals program in Massachusetts/Act for a Healthy MA
Conclusions • New Chemicals policy has been moderately successful—precautious and preventive • Existing Chemicals policy has been inadequate – based on voluntary initiatives and data collection, with little focus on chemical management or restrictions • Focus on pollution prevention and getting safer chemicals to market. • Important drivers: children’s health/corporate responsibility/ accident prevention • Movement at the state/regional level is likely to influence federal policy
New Directions in European Chemicals Policies Lowell Center for Sustainable Production
Summary • European Union moving forward with a major restructuring of chemicals policy the result of several years of public debate • Centerpiece is the REACH proposal • Over the past 10 years, Member States have initiated a variety of programs/tools for integrated chemicals management • These European initiatives provide an opportunity for broad-scale US discussions on the effectiveness of current chemical management policies and potential for changes
The European Union • 15 Member States (inc. 13 more in June 2004) • Environmental legislation is developed through Directives or Regulations • Technical expertise/implementation in Member States • European Parliament and Council of Ministers enacts laws while the European Commission acts as an administrative body
European Member State Approaches • Constraints of the Common Market • Ability of Member States to go beyond EU policy is constrained, particularly for chemicals • Impetus for new policy has come from Germany, UK, the Netherlands and the Nordic states
Differing National Approaches • Member States tend to use an array of tools ranging from regulations, economics, taxes to education • Nordic States: Regulatory • Netherlands: Cooperative • United Kingdom: Voluntary • Other nations are less innovative
Nordic Approaches - Regulatory • Multiple regulatory and voluntary tools – action plan/long-term goal-oriented • Lists of “chemicals of concern” and criteria for problem substances • Focus on products and product lifecycles – product registers • Demonstration projects and research support for safer technologies and substances • Public education • Taxes, eco-labeling, procurement • Integrate chemicals management throughout regulatory and business structures
The Dutch Approach – Cooperative • Rapid screening to prioritize high concern/low concern chemicals – Quick Scan • Tripartite process (SOMS) with inclusion of occupational health authorities • Agreements with industry sectors – covenants • Sector demonstration projects • Project chain responsibility of industry – communication
The UK Approach - Voluntary • 1999 Chemicals Strategy • Stakeholder forum • Department of Trade and Industry Downstream Users group and Chemicals Innovation Growth Team • Health and Safety Executive • UK Royal Commission 2003 Report • Market-based approaches – retail, users
International efforts on chemicals influencing EU process • Stockholm Convention on Persistent Organic Pollutants • North Sea Conventions • Oslo and Paris Conventions • Intergovernmental Forum on Chemical Safety • Organization for Economic Cooperation and Development (OECD)
Existing European policies • Dangerous Substances Directive (1967) • Limitations Directive (1976) • Dangerous Preparations Directive (1988) • Existing Substances Regulation (1993) • Cosmetic Products Directive (1976, 2003) • Occupational Health regulations (1990,1998) • Biocides Directive (1998) • Water Framework Directive (2000) • Waste from Electronic Products/ Restrictions on Hazardous Substances (2003)
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
A long and transparent process leading to REACH • 1998 Council of Ministers concern/request for report on status of chemicals policy • 1999 stakeholder conferences and additional consultations • 2001 Comments by Council and Parliament • Stakeholder working groups • Other stakeholder conferences, Member State meetings and informal discussions– business impact, workability, etc.
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”
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
Chemical safety assessment • Part of duty of care for all manufacturers, importers and downstream users and producers of articles • Applied to all chemicals manufactured and used • To be based on available data only • Identification of hazards and potential exposures, and risk management measures • Responsibility to pass information along supply chain
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
Registration requirements • Base information – identity, information on manufacture and uses, proposed classification/labeling, guidance on safe use, safety assessment • 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.
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 • 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
Requirements for downstream users/substances in products • Incentive for downstream users to place responsibility on producers • Requirement to complete downstream user chemical safety assessment • Limited registration/authorization requirements • Similar limited requirements for substances (contained over 1m ton/yr) in articles unless not registered
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
Key issues • Workability • Flexibility in requirements • Prioritization/overloading • Enforcement • Access to information/protection of CBI • Centralization of system • Maximizing benefits/minimizing costs