Challenges and opportunities for effective implementation of TSCA Joel A. Tickner, ScD School of Health and Environment, UMASS Lowell US EPA National Pollution Prevention and Toxics Advisory Committee, July, 2004

What most people think  The government wouldn’t allow chemicals on the market if they weren’t tested for safety  Industry demonstrates the safety of their chemical products before they are allowed in everyday products and emitted into the environment.

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General premises  Section 5 of TSCA has been fairly successful in preventing new hazardous chemicals from getting to market (which represent less than 1% by volume of what is on the market today)  EPA has done a good job with data collection on HPV’s through the HPV challenge but still as many as 250 orphans and 700 new HPVs.  For non-HPVs Section 4 of TSCA is burdensome and the agency has had to resort to voluntary initiatives to collect major data sets for multiple chemicals  Due to high administrative and scientific hurdles, EPA is unable to utilize Section 6 of TSCA for risk management

Movement Internationally, in Europe, and in States provides a good opportunity to reevaluate U.S. federal toxics policy  A lack of data on many chemicals in commerce  A disconnect between policies for new and existing chemicals;  A slow and resource intensive chemical-by-chemical risk assessment process with the burden on regulatory authorities;  A lack of incentives for innovation in safer chemicals

Goal – What are opportunities for EPA now  Given current statute  If EPA had adequate resources  Taking successes and lessons from existing programs  Most options for existing chemicals are voluntary but the agency could be redirecting resources and taking some bolder steps particularly in risk management

TSCA Section 5  Pre-Manufacture, not Pre-Market Focus – an important distinction  Low threshold for action – “may present an unreasonable risk or substantial exposure” with a shifting burden from agency to regulated entity.  Opportunity for regulatory handle before chemicals become existing chemicals  But: covers small part of chemical universe

The TSCA New Chemicals Review Process  Multi-disciplinary, multi-step hazard and risk review.  Rapid chemical assessment using available data (SAR, surrogates, etc.)  Conservative assumptions in face of data gaps  Build on database/experience of 30,000 new chemicals analyzed  Given international movement – some data requirements will ultimately be needed

Proposal  Take the successful EPA new chemicals review process and apply to all existing chemicals, reviewing within three-five years all chemicals on the TSCA inventory using SAR and other data  Allow industry to submit additional data  Prioritize for additional data collection  Prioritize for risk management – voluntary initiatives, etc.

Dutch Quick Scan

Deterrence under the TSCA New Chemicals Program  Informal negotiation with manufacturers  Informal regulatory signals  Establishment of “chemical categories” list to guide PMN process  Use of conservative assumptions to encourage testing/restricting potentially problem chemicals

Proposal  EPA should take the chemical categories list and turn it into a “chemicals of concern” or “observation” outlining chemicals, classes, and uses that may present high risk. This list should be widely disseminated to industry and publicly published  EPA could also publish a list of environmentally preferable substances for specific uses  An information stimulus for development of alternatives – many companies already doing  The new chemicals category for PBTs reflects this idea.

TSCA Guidance Towards Safer Chemicals  Attempt to get safer chemicals to market – provide tools to industry  Pre-manufacture pollution prevention review of substances and syntheses (SMART review)  P2 Framework/PBT profiler  Informal discussion with manufacturers  From gatekeeper to encouraging safer chemicals and processes  Small but crucial part of EPA’s work – needs to apply to both existing and new chemicals

Proposal  EPA should greatly increase budget for DfE, Green Chemistry, BFR work, green purchasing and P2 Framework efforts which have the potential to stimulate innovation and significantly reduce risks  EPA should set up challenge grants and projects to develop alternatives to problem substances  EPA should develop and provide guidance on chemical substitution planning to ensure adequate analysis and minimization of trade-off risks

More effectively use TSCA provisions for risk assessment and management  Volume or use-based SNURs (or 5e consent orders) for all new chemicals (ensure don’t end up in same boat as existing chemicals) to ensure testing with increased production and new uses of existing chemicals (a big concern)  Use TSCA S. 5b4 – risk list – which would shift burden onto manufacturers to show that the new substance or new use “will not present an unreasonable risk of injury”

Other opportunities for EPA  Expand TRI to include chemical use data (or at least pilots)  Enhance enforcement for failure to file Section 8e notices  More voluntary agreements with companies or industry sectors to substitute problem chemicals (PFOA, penta/octa-BDEs)  Use Inventory Update Rule to more effectively collect supply chain data on chemicals  Revise CBI guidelines for agency so agency can focus more on risk management

More opportunities  Strengthen Great Lakes bi-national program work to more aggressively move towards goals of Great Lakes Water Quality Agreement (a legislative mandate)  Strengthen PBT program efforts – a priority for many states, localities, and businesses

On the horizon  State level chemical management initiatives (WA, CA, HI)  International efforts UN PTS, POPs, SAICM  European efforts – WEEE/RohS, REACH, cosmetics, etc.  An opportunity to engage a broad public discussion in US on integrated chemicals assessment and management

Concluding thoughts  “The goal should be to use TSCA to promote a dialogue about safer materials and about the development of new materials”  How can limited agency resources be more effectively used to understand and reduce chemical risks?