1. International Bar Association Conference Health Issues Related to Exposures to Chemicals Lynn L. Bergeson Bergeson & Campbell, P.C. http://www.lawbc.com September 15, 2003

2. Bergeson & Campbell, P.C. 2 Historical Overview Toxic Substances Control Act (TSCA)  Principal law regulating chemical substances  Enacted in 1976; largely unchanged in key respects  Administered by U.S. Environmental Protection Agency (EPA)

3. Bergeson & Campbell, P.C. 3 Historical Overview (cont’d) TSCA’s Roots Go Back To 1971  CEQ determined existing statutory measures were inadequate  Several well publicized events hastened TSCA’s enactment: Vinyl chloride Asbestos PCBs

4. Bergeson & Campbell, P.C. 4 Historical Overview (cont’d) TSCA Title I -- Core Provisions  Data development (Section 4)  Premarket review (Section 5)  Inventory (Section 8)  CBI (Section 14) Other TSCA Titles  Title II -- Asbestos  Title III -- Radon  Title IV -- Lead-based paint

5. Bergeson & Campbell, P.C. 5 TSCA Today Successes  TSCA Inventory process works well  IUR/IURA reporting Challenges  Data development is difficult and often contentious  CBI is difficult to implement  TSCA Section 5 new chemical reviews can be protracted

6. Bergeson & Campbell, P.C. 6 Other Federal Chemical Programs Emergency Planning and Community Right-to- Know Act (EPCRA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

7. Bergeson & Campbell, P.C. 7 EPA Policy Initiatives TSCA -- Expanding Jurisdictional Reach Voluntary Initiatives  Voluntary Children’s Chemical Evaluation Program (VCCEP)  High Production Volume (HPV) Other Targeted Initiatives  PBT  Endocrine disruption  Asbestos/durable fibers

8. Bergeson & Campbell, P.C. 8 Emerging Pollutants EPA Agenda  Triclosan  Perfluoro octane compounds  Toxic chemicals resulting from the disposal of electronic equipment  Bisphenol A and phthalate esters

9. Bergeson & Campbell, P.C. 9 Emerging Pollutants (cont’d)  Pharmaceuticals and personal care products  Endocrine disrupting chemicals  Asbestos and related durable fibers  Biotechnology  Environmental “futures”: nanotechnology and genomics

10. Bergeson & Campbell, P.C. 10 Drivers Private Sector -- accountability/responsibility, precaution/prevention Government Sector -- accountability/ responsibility/enhanced sensitivity to NGO pressures and greater reliance on policy directives and guidance

11. Bergeson & Campbell, P.C. 11 Trends/Developments Volunteerism -- HPV, VCCEP Transparency -- EPCRA, TRI, CERHR Hazard Management vs. Risk Management -- enhanced need to manage based on hazard as opposed to risk due largely to perception of risk from hazard

12. Bergeson & Campbell, P.C. 12 Trends/Developments (cont’d) Product Substitution -- the logical consequences of both hazard and risk management Enhanced Awareness of Sensitive Subpopulations -- CDC National Exposure Report, children’s health issues, consumer applications of products with chemical components, etc.

13. Bergeson & Campbell, P.C. 13 Trends/Developments (cont’d) Global Management of Risks/Data Development -- private sector increasingly taking the long view toward product management Integrated Data Development -- growing awareness across statutes, FIFRA/TSCA cross over

14. Bergeson & Campbell, P.C. 14 Trends/Developments (cont’d) Enhanced awareness of end use applications, particularly as they relate to consumer uses, and potential for product attack Tort Liability -- REACH and related initiatives pick up steam Toxicogenomics will have increasing influence in chemical product development, maintenance, defense Biotechnology/Nanotechnology