ROPES & GRAY LLP Chemical Policy Reform: State/Federal Approaches Mark Greenwood

ROPES & GRAY Agenda Federal Initiatives –EPA plans to expand existing program –Congress is contemplating major changes to the TSCA statutory framework Contrast with California Green Chemistry Program Common Challenges Shared by Both Programs

ROPES & GRAY Federal Initiatives Information collection –EPA High production volume chemical testing Inventory Update Rule expansion Greater use of subpoenas –Congress Minimum data set for new, existing chemicals Declarations on use, exposure information Broad authorities to require testing by order

ROPES & GRAY Federal Initiatives (con.) Identifying Chemicals of Concern –EPA Action Plan list; Section 5(b)(4) list –Congress Expedited Action Chemical list Safety Standard Priority List (300+ chemicals)

ROPES & GRAY Federal Initiatives (con.) Risk Management –EPA Action Plans –Congress Safety Determination on Priority Chemicals Imposition of Conditions to Meet Standard –Critical use exemptions

ROPES & GRAY Federal Initiatives (con.) New Chemicals –EPA Use of Significant New Use Rules to expand use of new chemical review program (e.g., Nano SNUR) –Congress New chemical review for substances and mixtures Review of new uses not covered by Declarations

ROPES & GRAY Contrasts in Programs Locus of regulation –California: consumer products –Feds: chemicals in commerce –Significance Addressing the most significant risks (e.g., what if the important exposures are upstream?) Alignment with expertise (e.g., who is best able to identify alternatives?) What products are covered (e.g. articles)?

ROPES & GRAY Program Contrasts (con.) Standard of protection –California: Take “action that will, to the extent feasible, mitigate the adverse impact so that, on balance, there is no significant adverse impact on public health or the environment” –Feds: Current TSCA: “unreasonable risk”; Congress: “reasonable certainty of no harm” –Significance Consideration of comparative safety and cost? Review of aggregate risk?

ROPES & GRAY Program Contrasts (con.) Process Transparency –California: multiple opportunities for comment –Feds: Existing TSCA is mainly through rulemaking; Congress has not clarified process for most major EPA actions under bills –Significance Who has a seat at the table in major decisions? Tension between expedited action and open government objectives

ROPES & GRAY Program Contrasts (con.) Implementation of Risk Management –California: Compliance certification to authorize sale, distribution, manufacture, import –Feds: Focus on regulation of manufacturers, importers, processors; no clear mechanism –Significance Transaction costs for wide range of parties? Tradeoff: Value of predictable implementation vs. flexible but uncertain implementation mechanism

ROPES & GRAY Program Contrasts (con.) Approach to Alternatives –California: Industry conducts alternative assessments with 3 rd party certification –Feds: Process for alternative assessment not clear; up to EPA, stakeholders to address –Significance Importance of alternative assessment in steering path to a greener solution Will 3 rd party certifiers bring expertise and value?

ROPES & GRAY Common Program Challenges State of exposure assessment –Limited data and undeveloped tools (e.g., life cycle assessment methodology) –Requires quantum jump in agency capabilities Framework for choosing among risk management options –How to assess effectiveness of qualitatively different approaches (e.g., labeling vs. use ban) –When to wait for more information?

ROPES & GRAY Common Challenges (con.) Pragmatic Approach to Transition –Drop-in substitutes are very rare –When are options not available? –What is a reasonable time for transition? Approach to Transparency –More chemical information should be available –But what aspects of program (e.g., new technology assessment) needs protection