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Table 2. EPA activities: a timeline for chemical testing and assay use.
Year Partners # Chemicals # Assays Comments
2005 EPA Toxcast >100 50+ Start of programme at
EPA, NRC expert panel
starts project
2008 EPA Toxcast, NTP,
NCGC
309 200+ Environmental chemicals,
some drugs, some
industrial chemicals
2010 EPA Toxcast, NTP,
NCGC, FDA, NLM
1,000 500+ Dataset storage/
processing needs,
chemical storage &
handling increase
dramatically
NexGen Initiative launched
2012 EPA Toxcast, NTP,
NCGC, FDA, EU,
Corporations
10,000 1,000+ Dataflow now high but due
to increase
A stronger scientific foundation offers the
prospect of improved risk-based regulatory
decisions and greater public confidence
in the decisions. The technology
needed for this transformation is already
available, in advanced development, or understood
conceptually. The primary requisites
to make this transformation are political
willpower and the co-ordination of
substantial public and private resources
that are already allocated to hazard identification
and risk assessment. The goal is
clear, i.e., the replacement of current animal
toxicity testing by mechanistic testing
of cellular-response pathways within a
cheaper and more rapid human health risk
assessment framework that can handle a
much larger number of chemicals than the
current animal-based methods. The NRC
report estimated that the full conversion
of the current system to a toxicity pathway
paradigm would require 10- to 20-years
with an investment of the order of a billion
dollars. The committee emphasised that
a public-private consortium would provide
the greatest opportunity for stakeholder involvement
to insure more rapid acceptance
of these modern approaches for testing
and human health risk assessment.
The EPA is already proceeding to empower
and incorporate elements of the proposed
new approach (Table 2 outlines the
timeline for EPA actions that expand on
the standard hazard identification and risk
evaluation paradigm).
The NexGen goal is to advance risk
assessment by incorporating the advances
in molecular and systems biology to
ensure that health assessment decisions
can be made in a cheaper, faster and more
206 AXLR8-2 WORKSHOP REPORT
Progress Report 2011 & AXLR8-2 Workshop Report