1. Chemicals Management in a Transatlantic Perspective Henrik Selin selin@bu.edu November 10, 2008

2. The Chemicals Issue Modern chemistry provides many benefits Modern chemistry provides many benefits Industrial production; agriculture; public health Industrial production; agriculture; public health Rachel Carson’s Silent Spring in 1962 Rachel Carson’s Silent Spring in 1962 Persistence; toxicity; bioaccumulation; biomagnification Persistence; toxicity; bioaccumulation; biomagnification Regulating chemicals in an effective and socially acceptable way Regulating chemicals in an effective and socially acceptable way Competing political, economic, and social interests under conditions of scientific uncertainty Competing political, economic, and social interests under conditions of scientific uncertainty Maintaining benefits while controlling risks Maintaining benefits while controlling risks

3. US Chemicals Law and Policy I Toxic Substances Control Act (TSCA) of 1976 Toxic Substances Control Act (TSCA) of 1976 “Existing” and “new” chemicals 1978; requires pre- manufacture notification of “new” “Existing” and “new” chemicals 1978; requires pre- manufacture notification of “new” Covers over 80,000 chemicals including 61,000 “existing” Covers over 80,000 chemicals including 61,000 “existing” Federal Insecticide, Fungicide and Rodenticide Act of 1947 Federal Insecticide, Fungicide and Rodenticide Act of 1947 Requires registering and labeling of pesticides Requires registering and labeling of pesticides Federal Food, Drug and Cosmetic Act of 1906 Federal Food, Drug and Cosmetic Act of 1906 Sets maximum residue levels of pesticides in food and products Sets maximum residue levels of pesticides in food and products

4. US Chemicals Law and Policy II EPA prove harm before regulation; high threshold EPA prove harm before regulation; high threshold Detailed process-oriented approach to assessment and regulation Detailed process-oriented approach to assessment and regulation Lower requirements for “existing” chemicals than for “new” chemicals Lower requirements for “existing” chemicals than for “new” chemicals Lack of assessment data for most chemicals Lack of assessment data for most chemicals Use of the legal system to challenge regulatory decisions Use of the legal system to challenge regulatory decisions

5. EU Chemicals Law and Policy I Old EU system reminiscent of US legislation Old EU system reminiscent of US legislation Multitude of Directives and Regulations Multitude of Directives and Regulations Separating “existing” and “new” chemicals (1979); over 100.000 “existing” Separating “existing” and “new” chemicals (1979); over 100.000 “existing” Slow assessment and regulatory processes Slow assessment and regulatory processes Inadequate environmental and human health protection Inadequate environmental and human health protection Growing political and public pressure for change in the 1990s Growing political and public pressure for change in the 1990s

6. EU Chemicals Law and Policy II The 2007 regulation on the Registration, Evaluation and Authorization of Chemicals (REACH) The 2007 regulation on the Registration, Evaluation and Authorization of Chemicals (REACH) Multi-tiered process covering both “existing” and “new” chemicals to be implemented over a decade-long period Multi-tiered process covering both “existing” and “new” chemicals to be implemented over a decade-long period The creation of a new European Chemicals Agency working with the European Commission and member states’ regulatory agencies The creation of a new European Chemicals Agency working with the European Commission and member states’ regulatory agencies

7. Key Principles of REACH Abolishes the distinction between “existing” and “new” chemicals; large assessment effort Abolishes the distinction between “existing” and “new” chemicals; large assessment effort Reversing the burden of proof; firms to show data that a chemical does not pose a risk Reversing the burden of proof; firms to show data that a chemical does not pose a risk Identifies generic characteristics of concern Identifies generic characteristics of concern Carcinogenic and mutagenic affecting reproduction Carcinogenic and mutagenic affecting reproduction Persistence, bioaccumulation, toxicity Persistence, bioaccumulation, toxicity Operationalizing the precautionary principle Operationalizing the precautionary principle Promotes substitution and innovation Promotes substitution and innovation

8. Transatlantic Disagreements Much US lobbying against REACH (federal agencies and the chemical industry) Much US lobbying against REACH (federal agencies and the chemical industry) Growing EU-US policy divergence Growing EU-US policy divergence Regulatory opposition focusing on data generation, precaution and basis for regulation Regulatory opposition focusing on data generation, precaution and basis for regulation Financial opposition arguing that costs outweigh benefits for industry and regulatory agencies Financial opposition arguing that costs outweigh benefits for industry and regulatory agencies Market-based opposition relating to issues of standard setting and trade Market-based opposition relating to issues of standard setting and trade

9. EU’s Global Influence EU-27 500 million people with a market the value of that of the US EU-27 500 million people with a market the value of that of the US The EU trading-up regional standards to the global level The EU trading-up regional standards to the global level Political and technical importance of global standard setting (soft power) Political and technical importance of global standard setting (soft power) Other countries (China and Japan) and sub- national jurisdictions (CA and MA) are copying EU policy ideas Other countries (China and Japan) and sub- national jurisdictions (CA and MA) are copying EU policy ideas

10. US Federal Policy Change? In 2005, the Child, Worker and Consumer Safe Chemicals Act proposed by Senators Lautenberg (D-NJ) and Jeffords (I-V) – Not passed In 2005, the Child, Worker and Consumer Safe Chemicals Act proposed by Senators Lautenberg (D-NJ) and Jeffords (I-V) – Not passed In 2008, the Kid Safe Chemical Act proposed by Senator Lautenberg and Representatives Solis (D-CA) and Waxman (D-CA) – Not passed In 2008, the Kid Safe Chemical Act proposed by Senator Lautenberg and Representatives Solis (D-CA) and Waxman (D-CA) – Not passed Explicitly based on same principles as REACH Explicitly based on same principles as REACH Generating more risk assessment data Generating more risk assessment data Reversing the burden of proof Reversing the burden of proof Targeting more chemicals for restrictions and bans Targeting more chemicals for restrictions and bans