RESTRUCTURING CHEMICALS POLICY The European Challenge Ken Geiser

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 Center § REACH will provide an important driver to for. Lowell Sustainable chemicals testing and management in the US. Production

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. Lowell Center for Sustainable Production

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 Lowell Center into force (about 99% by volume of for Sustainable Production 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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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. Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable § 1990 Pollution Prevention Act Production

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 Lowell Center § Deference to other legislation – RCRA, for Sustainable Production 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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable chemicals and processes Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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) Lowell Center for Sustainable § Understand costs of chemical use Production

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) Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center responsibility/ accident prevention for Sustainable Production 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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable and Development (OECD) Production

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) Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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 Lowell Center impact, workability, etc. for Sustainable Production

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” Lowell Center for Sustainable Production

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. Center Establishment of a new central administrative for. Lowell Sustainable Production 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 Lowell Center for Sustainable Production

Registration § Essentially a notification process § All producers and importers of substances § § § produced over 1 m 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 Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

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. Lowell Center for Sustainable Production

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 Lowell Center Can be subject to conditions/time limited for Sustainable Production 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 Lowell Center for Sustainable Production

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 1 m ton/yr) in articles unless not registered Lowell Center for Sustainable Production

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 Lowell Center for Sustainable Production

Key issues § Workability § Flexibility in requirements § Prioritization/overloading § Enforcement § Access to information/protection of CBI § Centralization of system § Maximizing benefits/minimizing costs Lowell Center for Sustainable Production

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) § Comitology Lowell Center for Sustainable Production

Responses to REACH proposal § Many countries and downstream users are supportive, offering important input § Serious concerns raised by the chemical industry § Serious concerns raised by the United States Lowell Center for Sustainable Production

Strengthening REACH § Greater linkage to technical support and R&D § Greater focus on safer processes and green § § chemistry Greater linkage with innovative Member State tools Greater focus on public information and right to know Improved rapid assessment Lowell Center for Sustainable Better metrics for evaluation Production

Lessons learned § Major European restructuring of chemicals policy is happening § REACH responds to problems of current system § Policies at the Member State level are more integrated and diversified § Will have significant impacts on global chemicals markets Lowell Center for Sustainable Production

Conclusions for the US § Need policies to make it easier to act – use § § § variety of tools and markets Need to move focus from study to solutions – have studied many chemicals enough. An opportunity to stimulate dialogue on chemicals management in the US. An opportunity to innovate in the US to meet REACH goals. Need for greater Trans-Atlantic dialogue Lowell Center amongst advocates and others (more for Sustainable Production involvement of users/retailers) Need to promote global chemicals policies.

Chemicals Policy Initiative Website § www. chemicalspolicy. org Lowell Center for Sustainable Production