RESTRUCTURING CHEMICALS POLICY:The European Challenge Ken Geiser, Ph.D. and Joel Tickner, Sc.D....

RESTRUCTURING CHEMICALS POLICY:The European Challenge

Ken Geiser, Ph.D. and Joel Tickner, Sc.D.Lowell Center for Sustainable ProductionDepartment of Work EnvironmentUniversity of Massachusetts Lowellwww.chemicalspolicy.org

Lowell Center for Sustainable

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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.


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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.


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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)


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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


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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


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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


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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.


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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)


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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


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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


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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


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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


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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


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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


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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


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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


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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


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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)


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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)


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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


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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.


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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”


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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


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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


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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


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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


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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.


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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


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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


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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


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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


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Key issues Workability

Flexibility in requirements Prioritization/overloading Enforcement

Access to information/protection of CBI

Centralization of system Maximizing benefits/minimizing costs


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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


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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


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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


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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


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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.


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Chemicals Policy Initiative Website

www.chemicalspolicy.org

RESTRUCTURING CHEMICALS POLICY:The European Challenge Ken Geiser, Ph.D. and Joel Tickner, Sc.D....

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