Getting to Green - Research Progress on Environmental Health and Safety Aspects of Engineered Nanomaterials - page 62

references for better interpretation of results. Time-course studies should initially focus on acute and
subchronic responses to determine whether measurements of early (acute) injury are transitory. It would
be important to have multiple laboratories conduct studies with similar or identical experimental protocols
and end points to demonstrate whether interlaboratory experimental protocols and findings can be
validated for a particular ENM or end point. When a more complete toxicologic profile of an ENM has
been developed, in vitro models that use relevant cell types, end points, doses, and time-course results can
be constructed. Well-designed, in vitro mechanistic studies can provide important insights into relevant
toxicity pathways of a particular ENM response, but only when these criteria are established: there is a
relevant in vivo end point for comparison, time-course studies are undertaken for both in vivo and in vitro
investigations, appropriate doses and dose metrics are relevant for simulating human or ecologic
exposures, temporal (time-course) effects are investigated (that is, not simply acute, high-dose effects),
and appropriate benchmark reference materials are integrated into the experimental design to foster
appropriate interpretation of the data. The successful establishment of adequate in vivo models should be
followed sequentially by corresponding and validated in vitro toxicity tools; only then can the
development of high-throughput toxicity screens informed by in situ and in vitro data represent a realistic
approach.
ANALYSIS OF PROGRESS TOWARD ADDRESSING IMPLEMENTATION NEEDS
Indicators of Progress in Implementation and Their link to the Nanotechnology
Environmental, Health, and Safety Research Enterprise
The committee identified mechanisms to ensure implementation of the EHS research strategy,
including enhancing interagency coordination, providing for stakeholder engagement in the research
strategy, conducting and communicating results of research funded through public-private partnerships,
and managing potential conflicts of interest (NRC 2012, p. 183). Each of those represents a high but
achievable objective, and together they make up the support needed for implementation of a successful
nanotechnology EHS research enterprise (Figure 4-1). For example, without strong and effective
interagency coordination, a comprehensive knowledge commons is compromised. Robust interagency
coordination minimizes overlap in research in the laboratory world and real world and maximizes the
opportunity to identify research gaps and aggressively fund research needed to close them. Closing such
gaps in turn supports the integration of all the elements in Figure 4-1; for example, with more and better
data, modeling efforts can be improved, risk assessment can be enhanced, and decisions can be better
informed.
Engagement of stakeholders in the research enterprise requires participation of all sectors,
including government and academic researchers, nongovernment organizations (NGOs), regulators,
industry, nanotechnology workers, and consumers. Stakeholder involvement maximizes the breadth of
input needed to generate a comprehensive knowledge commons. Perhaps most important, stakeholders
include workers and consumers who make up the populations that have the greatest exposures in the real
world; these stakeholders not only have interest, expertise, and perspective in providing input that may
help to shape research but are the most likely to be affected by the decisions made.
The role of public-private partnerships in the research portfolio for EHS aspects of ENMs has
proved more difficult to define and implement. Funding and policy issues limit formation of such
partnerships in that federal agencies involved in nanotechnology EHS research may have expended their
allocated research budget and industry may have only modest interest in joint funding because of
competitive business concerns. However, there are examples of successful public-private partnerships in
the environmental-health arena. The most notable example has been the congressionally mandated Health
Effects Institute (HEI), which operates through equal cofunding from EPA and the automobile industry.
In the nanotechnology realm, examples include partnerships between the National Institute for
Occupational Safety and Health (NIOSH) and industry, and the multistakeholder Nano Release Initiative,
which provide collaboration and interaction beyond simply joint funding. Such partnerships can support