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To read the full submission to the White House Office of Science and Technology Policy (OSTP), National Science and Technology Council, National Nanoscale Science Engineering and Technology (NSET) Subcommittee, please click here

The Institute for Agriculture and Trade Policy (IATP) is pleased to have the opportunity to provide information to assist the NSET Subcommittee in the development of the 2021 draft Strategic Plan. IATP commented on the previous draft Strategic Plan and responded to the OSTP “Grand Challenges” for nanotechnology. We have been the beneficiary of participation in several excellent NNI sponsored webinars and workshops, a few of which we have reported on.

Responsible development of nanotechnology

Of the many questions posed in the RFI, IATP will first respond to that concerning the NNI goal of the “responsible development of nanotechnology.” The RFI asks, “As concepts surrounding responsible development have evolved over the past twenty years, what factors may contribute to the responsible development of nanotechnology going forward?”

In the 2016 NNI Strategic Plan, an important objective to realizing responsible development was to “Support the creation of a comprehensive knowledge base for evaluation of the potential risks and benefits of nanotechnology to the environment and to human health and safety.” (Goal 4.1, p. 22) The National Nanotechnology Coordinating Office (NNCO) has organized or hosted dozens of activities over the past five years in support of this goal and associated sub-goals. Perhaps the most ambitious of these activities is the U.S. EU Communities of Research work on a nano-informatics platform to standardize and systematize the reporting of nanotechnology and nano-science research. The application of nano-informatics data and methodology to EHS risk assessment and to “safer by design capabilities” has been demonstrated and should become an objective of the 2021 Strategic Plan. How can the nano-informatics platforms, built thus far on a budgetary shoestring and the pro bono contributions of mostly academic scientists, be scaled up for use across NNI agencies?

One of the benefits of the process of developing nano-informatics platforms is the interdisciplinary convergence that has been an NNI hallmark. However, to scale up the building and applications of such platforms for EHS application, a more comprehensive framework is needed to formulate NNI consensus nano-EHS questions and technically and financially support EHS research beyond what is accessed and standardized in the nano-informatic categories. NNI agencies have not published a collective EHS strategy since 2011. The draft Strategic Plan should commit NNI agencies to review the EHS literature of the past decade towards contributing to an EHS Research Strategy that anticipates EHS research and associated infrastructure that will be needed over the next decade.

Although NNI continues to publish reports from its excellent EHS workshops and to present a broad array of EHS studies in its webinar series, the 2011 NNI EHS Research Strategy has not been reviewed since 2014. Some individual NNI agencies have published summaries of their EHS research. However, the convergence of NNI agencies to develop a research strategy for the next decade would have the budgetary advantage of reducing duplicative research and infrastructure needs and expense.

A new NNI EHS Research Strategy would include a review of what was accomplished and what was intended but not accomplished in federally funded EHS research since the 2014 review of the 2011 EHS Research Strategy. NNI EHS research funds have been historically concentrated in a few agencies, above all Health and Human Services, National Science Foundation and Environmental Protection Agency, so a survey of EHS research in the NNI agencies would not show uniform scale of results. However, all NNI agencies might benefit from a process to identify EHS research accomplishments and needs. One way to focus a new Strategy would be to determine any EHS research needs, including any new infrastructure, for achieving current and prospective NNI Signature Initiatives. Because each Signature Initiative involves research and development in more than one agency, developing EHS Research Strategy for those Initiatives could engage multiple agencies.

IATP strongly prefers that a new NNI EHS Research Strategy be a stand-alone process and a stand-alone document. However, if the NSET Subcommittee decides that the objectives of a new EHS Research Strategy should become part of the 2021 Strategic Plan, we urge the NSET Subcommittee to propose launching a separate NNI EHS Research Strategy by the end of 2021.

The “Supporting Information for the NNI Strategic Planning” identifies “potential ethical legal and societal implications” (ELSI) of nanotechnology as crucial, along with EHS research, to achieving the goal of “responsible development.” However, there are no budget lines or program components for ELSI research in the “NNI Supplement to the President’s 2021 Budget.” IATP has not reviewed all the past NNI budgets, but to judge by the titles of NNI workshops dating back to 2003, there have been no ELSI workshops and just one on “public engagement” (2012) that could concern societal implications.

If the 2021 Strategic Plan is to retain the “responsible development” goal, the NSET Subcommittee should outline how ELSI research has been used and might be used in the future to achieve that and other Strategic Plan goals. The NSET Subcommittee could propose that the NNI organize one or more workshops to consider how ELSI research could advance realization of the NNI Signature Initiatives. For example, regarding the Food and Agriculture Signature Initiative, ELSI researchers could evaluate industry consultations with the Food and Drug Administration concerning FDA voluntary guidance documents on engineered nanomaterials in food, food ingredients and food contact surfaces. In its most recent nanotechnology report, FDA explains that it applies a “science-based product-focused regulatory policy” to regulating nanotechnology products. A sample research question: have such consultations about specific products resulted in responsible development of food related products that incorporate engineered nanoscale materials? Or regarding the Nano-biosensor Initiative, ELSI researchers might report on ethical and legal issues arising from the development and use of such sensors, e.g., concerning how and when sensor-generated data should be anonymized.

If the NSET Subcommittee decides that ELSI research is no longer necessary to achieving the “responsible development” goal, it should state so clearly and explain the reasons in support of such a determination.

To continue reading the submission, click here