Biomedical Engineering Reference
In-Depth Information
that “to the extent possible, the Director of OSTP coordinate the development by the NNI member
agencies of estimates of the costs and types of resources necessary to meet the EHS research needs”
(p. 52).
In summary, as illustrated above with examples from several recent reports, a number of
consistent themes have emerged. They include the need for rigor in identifying the most critical questions
to be addressed by federal funding through cooperative efforts and with stakeholder engagement.
Increased networking among all sectors of the scientific community should be sought. Standards for
analysis and reference materials will be critical for this effort; the use of uniform terminology, data
descriptions, and approaches to data capture will underpin this broader engagement. Production of not just
data but knowledge that can be applied in the construction of decision-support tools and risk assessments
will be needed to inform decision-making around EHS issues as we move toward the future. In Chapter 4
of this report, the committee presents a diagram for the EHS nanotechnology research enterprise that
builds on those characteristics. It describes the interrelated and interdependent aspects of the enterprise.
Although aspirational and relatively simple, it is founded on the key principles for a successful EHS
research program that are articulated in the three reports described above and the first report of the present
committee.
EUROPEAN UNION EFFORTS
Research on nanotechnology funded through the EC—including EHS research—has been guided
since 2004 by a broad strategy. Published in 2004, the
Communication from the Commission: Towards a
European Strategy for Nanotechnology
(EC 2004, pp. 21-22)
outlined key elements of research
investment related to commercial and societal progress. Actions toward identifying and addressing
potential human and environmental risks included
Identifying and addressing safety concerns at the earliest possible stage.
Reinforcing support for the integration of health, environmental, risk, and other related aspects
into research and development (R&D) activities.
Supporting the generation of toxicology and ecotoxicology data (including dose-response
information) and the evaluation of potential human and environmental exposure.
Adjustment, if necessary, of risk-assessment procedures to account for issues associated with
nanotechnology applications.
Application of risk assessment to consumers, workers, and the environment at all stages of the
life cycle of ENMs (including design, R&D, manufacturing, distribution, use, and disposal).
The strategy was influential in guiding ENM safety projects funded under the current and
previous research framework programs (FP6 and FP7).
The first implementation report on the strategy, published in 2007 (EC 2007), highlighted a
number of steps toward addressing potential risks of nanotechnologies. The steps included expanding the
pan-European research program, work by the European Joint Research Center on harmonized methods of
characterizing and evaluating the toxicity of ENMs, scientific reviews of research needs and opportunities
by the Scientific Committee on Emerging and Newly Identified Risks, and a focus on regulatory review.
A number of international collaboration initiatives with the OECD Working Party on Manufactured
Nanomaterials, the International Organization for Standardization (ISO), and specific US federal agencies
were also highlighted.
The second implementation report on the strategic plan (EC 2009) also emphasizes those themes.
Specifically, the EC concluded that from a regulatory perspective there was an urgent need for more
action on increasing and consolidating risk-related research funding to keep pace with the development
and marketing of new applications; adjusting, validating, and harmonizing available methods for risk
assessment for ENMs to ensure the generation of relevant data; improving, developing, and validating
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