1. 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

2. 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.

3. Lowell Center for Sustainable 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.

4. 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 into force (about 99% by volume of what is on the market today)

5. Lowell Center for Sustainable Production 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

6. 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

7. 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

8. Chemicals Policy in the United States Lowell Center for Sustainable Production

9. 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.

10. 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

11. 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  1990 Pollution Prevention Act

12. Lowell Center for Sustainable 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  Deference to other legislation – RCRA, OSHA, CAA, CWA

13. Lowell Center for Sustainable Production 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

14. 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

15. 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

16. 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 chemicals and processes

17. Lowell Center for Sustainable 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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)  Understand costs of chemical use

25. Lowell Center for Sustainable 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)

26. 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

27. 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 responsibility/ accident prevention  Movement at the state/regional level is likely to influence federal policy

28. New Directions in European Chemicals Policies Lowell Center for Sustainable Production

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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 and Development (OECD)

37. Lowell Center for Sustainable 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)

38. 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

39. 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 impact, workability, etc.

40. Lowell Center 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”

41. 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.  Establishment of a new central administrative agency

42. Lowell Center for Sustainable Production 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

43. Lowell Center for Sustainable Production 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

44. 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

45. 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.

46. 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  Can be subject to conditions/time limited  Community/Member State authorizations

47. Lowell Center for Sustainable Production 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

48. 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 1m ton/yr) in articles unless not registered

49. 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

50. 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

51. 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

52. 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

53. 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  Better metrics for evaluation

54. Lowell Center for Sustainable 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

55. 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 amongst advocates and others (more involvement of users/retailers)  Need to promote global chemicals policies.

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