TRFA Regulatory Affairs Committee Update

1. 14 September 2009 TRFA Regulatory Affairs Committee Update

2. TRFA Regulatory Affairs Committee • Who we are • Glenn House, Pro-Set Inc. • Julie O’Brien*, Air Products and Chemicals, Inc. • Calvin Patten, ITW Devcon • Our mission • Identifying and communicating regulatory issues that could impact TRFA members • Our deliverables • Regulatory summaries (fact sheets) • Issue advisories (issue alerts) • For more information visit our webpage on the TRFA website *Chairman

3. Current Regulatory Issues • REACH • Bisphenol A • TSCA Reform • And more – please take our survey

4. EU REACH Regulation • Registration, Evaluation and Authorization of Chemicals • Largest chemical registration program in the world • Requires manufacturers and importers to register substances on the EU market at 1 tonne/yr or more • Substances pre-registered by 1 December 2008 could be registered over 10 year period • 2010: >1,000 tpa, CMRs, R50/53 at >100 tpa • 2013: 100 – 1000 tpa • 2018: 1 – 100 tpa • New substances require registration within 6 months of reaching 1 tpa • Late pre-registration of some substances still possible

5. Registration • Registration dossiers prepared by Substance Information Exchange Forums (SIEFs) or consortia • Chemical hazards, uses and exposures • Phys/chem and hazard data according to tonnage band – share existing data but compensate for it • Test cost per substance of €50,000 – > €2 million depending on volume • Registration fees of €1,200 – €50,000 depending on volume and type of registration • Administrative fees vary widely • Registration package checked by European Chemicals Agency (ECHA) for completeness then passed to Member State Competent Authorities for review • Substance uses can be restricted or banned

6. Other REACH Impacts • SIEFs must agree to substance classification based on Global Harmonized System (GHS) rules by 1 December 2010; companies must apply this classification to substances • MSDSs must be updated • Swap sections 2 and 3 so hazards information appears before compositional information • Exposure scenarios must be appended for substances at >10 tpa • Companies must report to ECHA volumes of substances manufactured in or imported into EU on an annual basis • Suppliers may decide not to register their substances • Enforcement (fines/penalties) expected

7. Actions • Understand activities of or get involved in SIEFs / consortia for substances • Collect use information for products/downstream users • If relying on supplier registration, confirm uses will be covered • Determine what data is available and needed • Prepare for SDS changes • Prepare for volume tracking

8. Bisphenol A (BPA) • Raw material for polycarbonate plastics and epoxy resins • Clear, rigid plastic water bottles, baby bottles, re-usable food containers and plastic wraps • Food can lining • Some dental sealants • Significant toxicity testing data available • Conflicting data on hormonal impact of exposure to low doses of BPA

9. Developments in 2008 • January – Energy and Commerce Committee began investigation into BPA use for infant/children’s products • February – European Commission issued BPA risk assessment – no additional information needed • April – National Toxicology Program (NTP) released draft assessment showing significant risk to human development • April – Environment/Health Canada announced BPA would be classified as dangerous and proposed measures to reduce exposure to infants / young children • August – FDA reaffirmed BPA did not pose health threat for adults or children • October – Environment/Health Canada released final screening assessment and imposed use restrictions on BPA

10. More Developments • 2009 example restrictions and bans • Minnesota – food and drink containers for children • Chicago – baby bottles and sippy cups • Schenectady County, NY – baby bottles • French Parliament – all uses • Looking forward • More scrutiny of BPA by regulators, NGOs, public • Watch for additional bans and use restrictions

11. US TSCA Reform • Toxic Substances Control Act is the chemical control regulation for substances manufactured in or imported into the US • Significant number of chemicals grandfathered • Pre-market approval for new chemicals • Calls to revamp TSCA have increased driven by • Regulatory developments – e.g., REACH • Chemical safety concerns – e.g., BPA, phthalates, PFOS/PFOA, etc. • Kid-Safe Chemicals Act (S.3040 and HR.6100) introduced in May 2008

12. Kid-Safe Chemicals Act • Require Basic Data on Industrial Chemicals • Place the Burden on Industry to Demonstrate Safety • Restrict the Use of Dangerous Chemicals Found in Newborn Babies • Use New Scientific Evidence to Protect Health • Establish National Program to Assess Human Exposure • Expand the Public Right to Know on Toxic Chemicals • Invest in Long-Term Solutions

13. EPA Developments • March 2008 – EPA launched Chemical Assessment and Management Program ("ChAMP") to develop screening level hazard, exposure, and risk characterizations for 6,750 moderate production volume (MPV) chemicals • MPV > 25,000 PPY • December 2008 – EPA announced plans to enhance ChAMP by resetting the TSCA inventory and adding inorganics to high production volume (HPV) challenge • Spring 2009 – EPA announced it was refocusing ChAMP

14. Coming Soon • EPA announcement on TSCA reform expected. Anticipate: • TSCA reset to remove chemicals no longer being manufactured or imported • Chemical manufacturers and importers will be engaged to determine the current commercial status of existing chemicals • Continued evaluation of substance risks and calls for more toxicity and use/exposure data • Kid-Safe Chemicals Act will be re-introduced

15. Thank You