What is Sustainable Futures?
On December 11, 2002, EPA announced in the Federal Register [PDF] a voluntary pilot project, entitled Sustainable Futures. The goal of this pilot project is to
encourage the application of pollution prevention principles and
the development of inherently low hazard new chemicals submitted
as premanufacture notices (PMNs) under Section 5 of the Toxic Substances
Control Act (TSCA). The Agency seeks to gain
additional data and experience regarding the pollution prevention,
risk reduction, and source reduction benefits of the use of hazard,
exposure, and risk screening methodologies such as EPA's Pollution Prevention (P2) Framework in new product development efforts.
To encourage industry participation in this voluntary pilot project,
the Agency will consider providing regulatory flexibility in the
form of certain expedited PMN review.
For purposes of this voluntary pilot project, EPA will implement
a program leading to the opportunity for simultaneous submissions
of Test Market Exemption applications and PMNs on chemical substances
for which the submitter demonstrates the application and use of
the P2 Framework or other scientifically acceptable hazard and exposure
screening methodologies. This regulatory flexibility will
have the effect of reducing the time to market for select new chemicals
from 90 to 45 days.
In order to qualify for this pilot project, and associated expedited
review, companies subject to TSCA section 5 reporting requirements
must demonstrate experience and competence with the P2 Framework
or other scientifically acceptable approaches to chemical risk screening.
In order to do this, companies will need to:
Take necessary training;
Use hazard and exposure screening tools and demonstrate to EPA that model results were used to inform corporate decision-making. EPA wants submitters to use these tools to select safer new chemical alternatives to submit as new chemical notifications (and, where appropriate, to identify opportunities
to eliminate or control exposures through process controls); and
Submit 5-10 successful (i.e., not regulated by EPA) PMNs or PMN
exemption notices which have been developed using chemical hazard
and exposure screening tools. These submissions should also
include documentation of chemicals evaluated, models used, endpoints
on which decisions were based, and the submitter's perspectives
on the extent to which the screening tools provided useful information
to compare alternatives and select safer chemicals.
The Federal Register notice provides additional detail relating to the expedited review available under this pilot project and discusses criteria or factors EPA will consider to determine eligibility for the pilot project and associated expedited review.
Note: PMN submitters who want to participate in Sustainable Futures, please clearly state this fact in capital letters at the top of the cover letter for the PMN submission -- for example, SUSTAINABLE FUTURES or ATTN: SUSTAINABLE FUTURES. Thank you.
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