RESTRUCTURING%20CHEMICALS%20POLICY:The%20European%20Challenge

1
RESTRUCTURING CHEMICALS POLICYThe 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
High Production Volume Chemicals Program

• Initiated from NGO pressure
• EPAs 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
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
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
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
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
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
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
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
Conclusions

• New Chemicals policy has been moderately
  successfulprecautious 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 childrens 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 RD, intermediates, polymers,
  others
• Current New Chemicals are considered registered
• Requirement to submit new data

44
Registration requirements

• Base information identity, information on
  manufacture and uses, proposed classification/labe
  ling, 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
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
Authorization

• Essentially a use restrictions process
• Applies to chemicals of very high concern CMRs
  12, 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
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
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
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
Key issues

• Workability
• Flexibility in requirements
• Prioritization/overloading
• Enforcement
• Access to information/protection of CBI
• Centralization of system
• Maximizing benefits/minimizing costs

51
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
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
Strengthening REACH

• Greater linkage to technical support and RD
• 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
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
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
Chemicals Policy Initiative Website

• www.chemicalspolicy.org