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The National Nanotechnology Initiative (NNI) held a stakeholders’ workshop on August 1-2 about its future, which must be reauthorized by Congress every four years. The NNI is an interagency and interdisciplinary hub for a dozen U.S. federal agencies that research and deploy nanotechnology, as described in the Supplement to the President’s 2019 Budget. The Fiscal Year 2019 budget was $1.4 billion, invested in fundamental science; technological applications (e.g. nanotechnology-enabled fertilizer to reduce nutrient loss and greenhouse gas emissions); infrastructure for physical experiments and computer modeling; prototype manufacturing; and federal assistance for product commercialization. Although the workshop report, an input to the reauthorization process, has yet to be published, the webcast of the workshop plenary sessions have been archived. Workshop presenters highlighted both NNI and nanotechnology enabled achievements of the past 15 years and ambitions for the next 15 years.

The workshop’s keynote speaker, Professor John Rogers of Northwestern University, must have impressed Chloé Kontos of the White House Office of Science and Technology, as well as other participants, with a wide-ranging presentation on the uses of nanoscale (atomic to molecular size) silicon in nano-electronic medical technology. After thanking NNI coordinated funders for supporting his research, Rogers explained how not yet commercialized product prototypes for transient and bio-integrated electronics assisted in neo-natal care, brain surgery and heart surgery. For example, silicon nano-membranes in a flexible heart pacemaker applied during heart surgery would re-absorb into the body after completing its therapeutic functions and without the risks entailed in removing current pacemakers.

IATP attended the plenaries, as well as the breakout sessions on food and agriculture, and environment and water, as described in the workshop agenda. This blog does not attempt to survey or summarize the “Opportunities and challenges for nanotechnology in the agri-tech revolution” or similar research reviews on nano-enabled environmental remediation and water sanitation. Instead we summarize how some participants (IATP included) responded to the workshop’s challenge to imagine what nanotechnology could do by 2035 and what the NNI should do or could do to help the “nanotechnology ecosystem” reach those visionary goals.

First—spoiler alert—it is very unlikely that the Trump administration will terminate research or greatly cut nanotechnology budgets and staff in NNI coordinated agencies, although the NNI mission may be modified. The administration’s attacks on USDA and Environmental Protection Agency science, budgets and staff have concerned research that senior officials and their industry constituents believe will impede new product commercialization and trade. NNI participant agencies are dedicated to assisting the commercialization of nanotechnology enabled products, based on an assumption that possible human and environmental health risks will be anticipated and avoided in product design and manufacture.

The Environment Health and Safety (EHS) and Ethical Legal Societal Issues (ELSI) that preoccupied NNI during its first decade have been sublimated in ‘safe by design’ product development. In “Nanotechnology research directions for societal needs in 2020,” NNI pioneer Miguel Roca wrote (with two co-authors) in 2011, “The focus on EHS hazards and ELSI concerns must be routinely integrated into mainstream nanotechnology research and production activities to support safer and more equitable progress of existing and future generations.” Dr. Roca participated in the Future of the NNI workshop and could witness how EHS and ELSI concerns have been “routinely integrated” into research and manufacturing. Rather than applying or creating normative regulation for nanotechnology products, NNI agencies have worked with industry and European Union counterparts to develop research and production standards for “safe by design” products.

How does “safe by design” de facto self-regulation apply to food and agriculture products? In the U.S., nanotechnology food and food related products (e.g. food packaging, food processing preparation surfaces) are not regulated under nano-specific authority by government agencies.

The Food and Drug Administration (FDA), in its 2014 voluntary Guidance to Industry, advises nanotechnology product developers to consult with the FDA prior to commercial release of their products. IATP commented on the voluntary draft Guidance and agreed with the FDA that producer developers should not self-determine that nanomaterials in their products should be Generally Recognized As Safe (GRAS), just because macro-scale versions of the same materials had been declared GRAS. The FDA reiterated its nanotechnology policy in 2018, noting that for some FDA regulated products, including nanotechnology enabled products, pre-market review is required. However, there is no public record of the voluntary consultations nor of the pre-market reviews and the post-market monitoring of products.

There is no U.S. governmental registry of nanomaterials nor of nanotechnology enabled products. The Center for Food Safety (CFS), which sued the FDA to regulate nanomaterial use in food and food related products in 2011 (IATP was a co-plaintiff), maintains an inventory of products whose manufacturers claim to incorporate nanomaterials. As of July 2019, the inventory included over 400 products, with 121 nano silver and 76 nano titanium dioxide representing the largest number of nanomaterials in products.

In a breakout session, CFS Director of Policy Jaydee Hanson responded to an industry participant who said that regulation should take place only after there was a “mature market” for nanotechnology enabled products. Mr. Hanson advised against this viewpoint, noting that in the absence of regulation, tort law would function both to seek compensation for any harm that might result from use of those unregulated products and to remove the products from the market.

Norman Scott of Cornell University recalled the first U.S. government sponsored agri-nanotechnology meeting of 80 researchers in 2002. He said the aim of that meeting and subsequent meetings was to reduce waste in the conventional agri-food supply chain and to interface nanotechnology with biotechnology and cognitive science. After more than 15 year of nanotechnology enabled agri-food applications, he asked whether these applications could become accepted by consumers and avoid the resistance that has met genetically engineered foods.

A 2014 journal article referring to that 2002 meeting summarized challenges faced by agri-nanotechnology researchers: “Nanotechnology in agriculture might take a few decades to move from laboratory to land, especially since it has to avoid the pitfalls experienced with biotechnology. For this to happen, sustained funding and understanding on the part of policy planners and science administrators, along with reasonable expectations, would be crucial for this nascent field to blossom.” To judge by the food applications of nanotechnology now on the market, agri-nanotechnology products very likely will be on the market in the next decade.

One of the NNI’s scientific entrepreneurship strategies has been to request that federal and academic researchers propose projects to NNI Signature Initiatives, e.g. nanotechnology enabled water sustainability, and Office of Science and Technology Policy’s “Grand Challenges.” In that context, Dawn Bonnell of the University of Pennsylvania concluded her remarks on the first 15 years of NNI achievements by contending that “nanotechnology is best positioned to address global challenges in the next 10 to 15 years.” How should researchers and policy makers meet such challenges and which challenges should be prioritized?

The plenary audience offered more proposals than can be summarized here to respond to both the “how” and the “which” questions. “How” responses included Bonnell’s call for the use of artificial intelligence in nanotechnology research and several proposals on how to reduce the time frame from laboratory research to scaled up production by designing and employing one set of infrastructure tools for research and another for manufacture. Surprising, to me at least, regarding the prioritization of challenges to be met, climate change was most frequently cited, despite Trump administration hostility towards climate change science.

I had joined the plenary queue to respond to the prioritization question with “climate change,” when my response would have been redundant. Instead, I gave a “how” response about nanotechnology application prioritization for the marketplace. In 2014, IATP participated in a NNI workshop on bio-sensors that included a session on how companies and technology bankers analyzed the value added of a particularly nanotechnology application, relative to their company’s and customers’ needs. For example, a John Deere engineer explained how his company determined the economic and technological viability of incorporating biosensors in their farm machinery to test for soil moisture, fertilizer residues and other agronomically relevant data.

Any nanotechnology application to respond to climate change that reaches proto-type production will have to pass through a John Deere type value proposition analysis first. A comparative technology assessment would be a part of value proposition analysis. For example, since USDA research had already demonstrated that planting a cover crop could reduce nitrate runoff from nitrogen fertilizer more than a nanotechnology enabled controlled release fertilizer, wouldn’t it be more climate change effective to invest more in cover crop research?

On the other hand, the nanotechnology fertilizer technique might be applied effectively to reducing the phosphorus fertilizer runoff that results in toxic algae and marine dead zones. In any event, a nanotechnology application should not be assumed to be the best application for a given problem. Unfortunately, the White House Office of Technology Assessment was discontinued in 1995, but a bill has been proposed in the House of Representatives to revive it.

According to one of the report-backs from the workshop breakout sessions, there was concern that fundamental scientific research could not be done with non-U.S. scientists because of national security concerns about purloined research with possible military uses. When the closing session posed the final question, “what is your moonshot achievement for nanotechnology in 2030?” one panelist said, “to provide potable water everywhere” in response to the extreme water crisis confronting about a quarter of the planet’s population today. Nanotechnology may have the potential to contribute to solving such global problems, but if national security concerns are going to impede basic scientific cooperation, it will be difficult to realize that potential. The NNI goal of making the U.S. the world leader in nanotechnology may well conflict with the international scientific collaboration required to realize ‘moonshot’ goals.

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