International and State Chemical Policy Update

1. International and State Chemical Policy Update Rachel Massey TUR Planners Continuing Education Conference, April 12, 2007

2. Policy Updates 1. Update on REACH 2. China RoHS 3. State level chemicals policy initiatives 4. Canada – DSL categorization 5. Regulation of nanomaterials

3. 1. Update on REACH Registration Evaluation and Authorization of Chemicals

4. Stakeholder consultation Council Conclusions WHITE PAPER Cardiff Council meeting Proposal DG Env DG ENT Parliament’s Opinion 2001 1998 Internet consultation Council Common Position July 2003 COMMISSION PROPOSAL Opinion Commission Parliament’s 1st reading Oct 03 Parliament’s 2nd reading REACH ENTERS INTO FORCE LEGISLATION ADOPTED Conciliation process Dec 06 June 1, 2007 Adapted from: International Chemical Secretariat

5. REGISTRATION • Manufacturers and importers must submit information on health and environmental effects of the chemicals they sell. • Testing requirements depend on annual production volume per company. • Companies join consortia to share testing costs. • Phase-in period of 11 years.

6. REGISTRATION: Time Line Source: International Chemical Secretariat

7. Review of information in registration; completeness check; possible requests to fill data gaps. Dossier evaluation (individual registration) Substance evaluation (per substance) EVALUATION

8. AUTHORIZATION • Substances of Very High Concern (SVHC) cannot be sold without an authorization. • “Adequate control” • Impossible by definition for some chemicals • Socioeconomic benefit • An authorization applies to specific uses.

9. Substances of Very High Concern • Carcinogenic, Mutagenic, Reproductive toxicity (CMR) 1 & 2 • Persistent, Bioaccumulative, and Toxic (PBT) • Very Persistent, very Bioaccumulative (vPvB) • Substances of “equivalent concern,” e.g. endocrine disrupting chemicals

10. RESTRICTION • Safety net • Incorporates current restrictions • Can include conditions for use, or prohibition • Dossier must show risk to health or the environment that needs to be addressed at the European Community level, and explore options for managing risk.

11. SUBSTANCES IN ARTICLES • Registration requirements and deadlines apply to substances in articles > 1 tonne/yr if intended to be released. • If substance is not intended to be released, • for SVHCs, must provide a notification • European Chemicals Agency may request registration of a notified substance in an article if it poses a risk to health or the environment.

12. Substance in Article: Present at > 1 tonne per year? No Yes Substance of Very High Concern? Intended to be released? No Yes No Yes No registration requirement No registration requirement Registration required Notification required Chemicals Agency may request registration if risk posed to health or environment

13. REACH Exemptions • Radioactive materials • Pharmaceuticals • Polymers • Pesticides • Some byproducts • Some minerals, ores, and fuels • Some familiar, commonly used substances

14. What’s Ahead?REACH Time Line • June 1, 2007: REACH enters into force • June 1, 2008: • European Chemicals Agency becomes operational • “New” substances can now be registered; • Preregistration of “phase-in” substances begins (until November 2008)

15. What’s Ahead? REACH Time Line • Dec. 1, 2010: First registration deadline • Substances > 1,000 tonne/yr • Substances classified as very toxic to aquatic organisms > 100 tonne/yr • CMR (category 1 & 2) substances > 1 tonne/yr

16. European Chemicals Agency • The new European Chemicals Agency will be established in Helsinki, Finland. • Executive Director • Secretariat • In charge of administering REACH, including maintaining databases and organizing decision making processes.

17. Substance: Imported to the EU at more than 1 tonne per year? No: No registration requirement. Yes: registration required. Check registration deadline and data requirements for your volume tier. Check any restrictions. Apply for authorization if necessary. Are other companies registering? No Yes Join a consortium Check data availability and carry out any necessary tests, or pay fee to use test data already collected. Communicate with downstream users to identify relevant uses.

18. Submit registration, including chemical safety report Evaluation May need to submit additional data Subject to authorization? Yes No Submit authorization request including analysis of substitutes Product remains on market

19. Submit authorization request including analysis of substitutes Is “adequate control” possible? (Can a safe threshold be defined?) Yes: some CMR No: PBT, vPvB, some CMR Substance adequately controlled? Does a safer alternative exist? No market Yes No Yes No Sell substance for authorized uses only. Socioeconomic importance that outweighs risk? Yes No No market

20. RESOURCES • European Commission • Directorate General for Enterprise: • http://ec.europa.eu/enterprise/reach • Directorate General for Environment • http://ec.europa.eu/environment/chemicals • Lowell Center for Sustainable Production • Chemicals Policy Initiative: • http://chemicalspolicy.org • International Chemical Secretariat (NGO) • http://www.chemsec.org/

21. Policy Updates 1. Update on REACH 2. China RoHS 3. State level chemicals policy initiatives 4. Canada – DSL categorization 5. Regulation of nanomaterials

22. CHINA RoHS • “Measures for the Administration of the Control of Pollution Caused by Electronic Information Products” • Promulgated February 2006 • In force as of March 1, 2007

23. CHINA RoHS • Lead • Mercury • Cadmium • Hexavalent chromium • PBBs • PBDEs • “other toxic and hazardous substances or elements specified by the State”

24. CHINA RoHS • Phase 1 • Labelling • Compliant • Noncompliant • Phase 2 • Catalog • Testing by accredited laboratories • Prohibition on sale of non-compliant products

27. Phase 2 • Catalog • Laboratory testing • Prohibition on sales

28. Comparison: EU vs. China • Labeling provisions • Catalog • Laboratory testing vs. self-declaration • Testing may be required for every part, down to homogeneous materials • Exemptions

29. Policy Updates 1. Update on REACH 2. China RoHS 3. State level policy initiatives 4. Canada – DSL categorization 5. Regulation of nanomaterials

30. STATE POLICY INITIATIVES • Right to Know • Chemical restrictions • Procurement policies • TUR/safer alternatives

31. Source: Center for International Environmental Law

32. State level initiatives:Recent examples • Connecticut: Mercury; proposals re: deca and safer alternatives • Illinois: BFRs; Governor’s letter to Illinois EPA re: Deca • Maryland: Mercury; BFRs; phthalates, bisphenol A in toys • Michigan: Mercury; BFRs; Executive order: Green Chemistry • New Hampshire: Mercury; Dioxin • New York: BFRs; Executive order on deca submitted 12/06; new Pollution Prevention & Green Chemistry Institute proposed • Plus: Buffalo: PBTs; Erie County & NYC: environmentally preferable purchasing; proposed state action on phthalates, lead paint & jewelry, EPP, & environmental health tracking. • Rhode Island: Mercury; BFRs • … and more!

33. CHEMICAL RESTRICTIONS • Example: Brominated flame retardants • Maine - 2004 • Bans sale of products containing >1% penta- and octa-BDEs as of January 2006. • Products containing BFRs must be registered with the state. • Specify type and amount. • Products containing BFRs must be labeled, with a summary of health hazards.  • Ban deca-BDE by 2008 if safer alternatives are available. • New deca bill pending • Tetrabromobisphenol-A or hexabromocyclododecane or any other brominated flame retardant is banned as of January 1, 2010.

34. CHEMICAL RESTRICTIONS • Example: Brominated flame retardants • Washington –first deca ban, April ’07 • Prohibits use in mattresses starting 2008 • Prohibits use in TVs, computers and residential upholstered furniture starting 2011 • Contingent on safer substitute

35. SAFER ALTERNATIVES • Executive orders • Example: Maine, February 2006 • Outlines need for information on safer alternatives; • Names lead, mercury, BFRs, and pesticides as priorities; • Commits to environmentally preferably preferable purchasing; • Creates task force to promote safer chemicals in consumer products.

36. California • Proposition 65 • Biomonitoring • BFRs • Hazardous Chemicals: Testing Methods • Mercury • Right to Know • Phase-out of perc; + South Coast Air Quality Management District perc regulation • Municipal: • Berkeley: Precautionary principle and environmentally preferable purchasing • Berkeley: Nanoparticles • Oakland: Dioxin • San Francisco: Bisphenol A, phthalates • San Francisco: Precautionary principle and environmentally preferable purchasing

37. Massachusetts • TURA • Mercury • Boston: Dioxin • Proposed: Asthma/Cleaning Products • Proposed: Act for a Healthy Massachusetts • Safer Alternatives to Toxic Chemicals • Initial focus on: lead, formaldehyde, TCE, Perc, dioxins and furans, hexavalent chromium, organophosphate pesticides, PBDEs, DEHP, and 2,4-D.

38. Policy Updates 1. Update on REACH 2. China RoHS 3. State level policy initiatives 4. Canada – DSL Categorization 5. Regulation of nanomaterials

39. CANADA • Domestic Substances List (DSL) Categorization, mandated by law in 1999 • Examined information available on about 23,000 chemicals in commerce • Identified more than 4,300 warranting further scrutiny

40. Source: Environment Canada

41. Regulation of Nanomaterials • Special characteristics of nanomaterials • Challenges for regulation • Government initiatives – first steps • EPA – intention to regulate nanosilver • Voluntary programs • US EPA • UK • Municipal • Berkeley • Cambridge

42. Environmental Defense and DuPont Nanorisk Framework • Describe material and application. • Profile lifecycle(s). • Evaluate risks. • Assess risk management. • Decide, Document, and Act. • Review and adapt. http://nanoriskframework.com