Challenges and opportunities for effective implementation
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Transcript Challenges and opportunities for effective implementation
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.
Source: www.epa.gov/chemrtk
Source: www.epa.gov/chemrtk
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 - 2002
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?