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

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

1. Update on REACH Registration Evaluation and Authorization of Chemicals Final regulation published December 2006 Replaces or incorporates about 40 pieces of existing legislation New regulatory structure for chemicals

REACH ENTERS INTO FORCE LEGISLATION ADOPTED 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 Final regulation published December 2006 At this point, emphasize that many of the materials and specifics are still in progress, so you’ll probably have some questions that don’t yet have answers. … REACH ENTERS INTO FORCE LEGISLATION ADOPTED Conciliation process Dec 06 June 1, 2007 Adapted from: International Chemical Secretariat

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. Applies to chemicals produced or imported at > 1 tonne/year per producer/importer. For chemicals > 10 tpa, requires a Chemical Safety Report documenting hazard classification of a substance and whether it’s PBT or vPvB. For chemicals classified as dangerous, PBTs, or vPvBs, manufacturer must explain how risks from known uses can be ‘adequately controlled’.

REGISTRATION: Time Line Source: International Chemical Secretariat

EVALUATION Review of information in registration; completeness check; possible requests to fill data gaps. Dossier evaluation (individual registration) Substance evaluation (per substance) Substance evaluation applies when there is reason to believe a substances presents a risk to health or the environment. Dossier evaluation (individual registration) Prevent unnecessary animal testing and require additional tests Compliance check (5%) Substance evaluation (per substance) Agency / Member State will evaluate safety data for certain chemicals, especially those at high volumes and those of particular concern. This may lead to: Requests for further information to clarify risks, or ensure compliance with the requirements Substance proposed for ‘authorisation’ or ‘restrictions’

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. Socioeconomic value that outweighs the risks. [OR: Submit a case for continued use based on risks, socio economic impacts, alternatives and substitutes] No set schedule for authorization - chemicals will be added on a chemical by chemical basis but the list of chemicals potentially subject will be published earlier.

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

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. Safety net: chemicals that pose “unacceptable risks” to human health or the environment that need to be addressed at a community level. Similar to current EU restrictions process, but faster. Existing EU marketing and use restrictions are brought forward into REACH.

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. If present above 1 tonne per M/I per year, If substance is not intended to be released, for SVHCs, must provide a notification to the European Chemicals Agency

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

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

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)

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

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. Secretariat is planned to grow in a year from around 80 to 220, and then gradually to a full staff of about 450.

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.

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

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

RESOURCES European Commission Lowell Center for Sustainable Production 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/

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

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 Review the basics of RoHS in the EU before going into details

CHINA RoHS Lead Mercury Cadmium Hexavalent chromium PBBs PBDEs “other toxic and hazardous substances or elements specified by the State” Review information about EU RoHS: The EU directive covers the same six classes of substances. It specifies that NEW EQUIPMENT SHALL NOT CONTAIN MORE THAN THE MAXIMUM SPECIFIED CONCENTRATIONS OF THESE TOXIC SUBSTANCES AS OF JULY 1, 2006.

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

Also mention the need for a check-box showing which chemicals are present.

Phase 2 Catalog Laboratory testing Prohibition on sales

Comparison: EU vs. China Labeling provisions Catalog Laboratory testing vs. self-declaration Testing may be required for every part, down to homogeneous materials Exemptions EU RoHS exempts medical equipment, servers and networking equipment. It allows mercury lamps (in laptop computers) because they’re highly energy efficient. Also: The EU directive applies to NEW equipment, whereas the Chinese legislation applies to ALL equipment. Other differences: The concept of "Put on the market" is different The penalties are different Material testing may be required in every part you use to build your product, down to the homogeneous materials Firms must design labels and issue change orders in order to comply Finalized standards just became available

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

STATE POLICY INITIATIVES Right to Know Chemical restrictions Procurement policies TUR/safer alternatives Right to Know (labeling, toxics use data collection, biomonitoring) Chemical restrictions (PBTs, mercury, PBDEs, Perc) Procurement policies TUR/safer alternatives

Source: Center for International Environmental Law

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!

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. The Legislature is considering a proposal from the state Department of Environmental Protection to ban the sale of televisions and other electronics equipment containing Deca beginning in 2012. Maine already has banned two related flame retardants.Research conducted by staff at the Maine Center for Disease Control and Prevention and the University of Southern Maine found that newborn lab mice exposed to Deca exhibited brain development problems, including lower grip strength, decreased thyroid levels and learning problems

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

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.

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

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.

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

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

Source: Environment Canada

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

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