International Bar Association Conference

Health Issues Related to Exposures to Chemicals

Lynn L. BergesonBergeson & Campbell, P.C.http://www.lawbc.comSeptember 15, 2003

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)

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

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

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

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)

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

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

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

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

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

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.

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

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