Supporting science to advance the responsible development of nanotechnology

In theory at least, federal nanotechnology programs during the first three years of the Trump administration will be guided by the “National Nanotechnology Initiative Strategic Plan,” (NNI) released on October 31, 2016. The 26 agencies coordinated under the NNI have spent at least $25 billion since 2001 in basic and applied research, in diagnostic and testing infrastructure and in prototype manufacturing to enable start-up firms—often originating in university research—to find investors for their products. The current applications of the atomic to molecular scale nanomaterials are expanding beyond cell phones, semi-conductors and other electronic equipment to nano-encapsulation and more targeted release of medicines and agricultural chemicals, to name just two classes of applications.

In the preface to the NNI Strategic Plan, Dr. John Holdren, President Obama’s chief science advisor wrote, “During this administration, nanotechnology research and development has evolved from a focus on foundational discoveries aimed at understanding and exploiting nanoscale phenomena, to an enabling technology. Revenue from the sale of nanotechnology-enabled products in the United States has grown more than six-fold from 2009 through 2016 and is projected to exceed $500 billion in 2016.” Such sales projections are likely to bedazzle the Trump administration. Regulation of these products on the basis of validated exposure data in humans and the environment was not accomplished during the Obama administration, notwithstanding the recognition of at least one NNI workshop that such data was necessary to ensure the safety of and sustainable markets for nanotechnology enabled products.

Given the knee-jerk reaction that regulation “kills jobs,” and imposes costs to industry without benefits—called the “The $1.75 Trillion Lie” by economist Frank Ackerman and regulatory lawyer Lisa Heinzerling—and the intention of the Trump administration to eviscerate the mandate, staff and budget of the Environmental Protection Agency, will it be possible to realize the NNI’s fourth strategic goal to “Support responsible development of nanotechnology?” This is not a rhetorical question. In a post-fact administration and Congressional majority, it is very, very tempting to believe that more than $500 billion in sales of nanotechnology-enabled products can be achieved only if there are no nanomaterial risk assessments to serve as a basis for regulation.

In the “NNI Supplement to the President [Obama]’s 2017 Budget,” federal investment in agriculture and food applications of nanotechnology is dwarfed by the Department of Defense and the Department of Energy nanotechnology budgets. Nevertheless, in the interdisciplinary world of nanotechnology, fundamental research of nano-biosensors or nanotechnology-enabled coatings may later be applied to food and agriculture products.

IATP’s comment to the draft NNI Strategic Plan noted, “NNI agencies have failed to secure the cooperation of product developers to enable exposure scientists to provide regulators with validated data for Life Cycle Assessment (LCA) based risk assessments of products incorporating ENMs [Engineered Nanoscale Materials].” Without such validated data, regulators cannot determine which applications of nanotechnology require risk assessments and according to which risk metrics.” Past voluntary industry programs, such as the Environmental Protection Agency’s Nanomaterial Stewardship Program, have failed to secure industry cooperation to enable the EPA to know: which nanomaterials, and in which applications, are already in commerce; which are releasing nanomaterials to the environment; and whether it is in the manufacture or product use phase.

The IATP comment also noted the failure of infant manufacture formula makers to consult with the Food and Drug Administration (FDA) before adding ENMs to baby formula, despite the FDA’s voluntary Guidance to Industry on use of nanomaterials in food and beverage products. This is just the most notorious case of the industry’s failure to cooperate with a NNI agency. (For more background on this industry failure to cooperate with FDA’s Guidance document, see “Nanomaterials in baby formula: why?”)

Notwithstanding the failure of many users of nanotechnology and nanomaterials to cooperate with the federal government to enable the “responsible development of nanotechnology,” the U.S. government continues to provide technical support services, seminars, start-up project seed money, and nanomaterial fabrication, detection and characterization infrastructure. At what point does industry’s failure to cooperate endanger the future of public investment and policy for nanotechnology?

In December, Tomo, a Brazilian academic journal, published IATP’s “Rationales for Food and Agriculture Applications of Nanotechnology and Exposure Science Required for Its Regulation.” The article is based on a presentation, given originally in Spanish in October 2015, to a Brazilian Research Network on Nanotechnology Society and Environment (Renanosoma) seminar at the University of Seragipe. The first part of the title is probably self-explanatory. Scientist entrepreneurs explain the relevance of their research to developing food and agriculture products to “feed the world” while doing so without further damaging the natural resource base of agriculture. However, the second part of the title is perhaps less self-explanatory.

Scientists at research alliances such as the Center for the Environmental Implications of Nanotechnologies have developed experiments and mathematical models to track the release and impact of an array of engineered nanoscale materials in water, soil, air and plant life. Life Cycle Analysis quantifies and evaluates ENM release impacts from nanomaterial fabrication to nano—enabled product use to the release of nanomaterials in landfills or in the treated water residues that are applied as a cheap fertilizer on agricultural lands. Other research centers have worked to determine the release of and human exposure to nanomaterials by ingestion, inhalation and via the skin. (A Spanish scientist, who researches how nanomaterials cross biological membranes (lipids), compared the current understanding of nanomaterial risks to the early understanding of radioactive material risk.) In order for the data from such life cycle nanomaterial exposure experiments to have regulatory validity, the data must be gathered as part of a regulatory process.

To that end, on January 12, the Environmental Protection Agency released a long awaited rule on industry reporting and record keeping of nanomaterial manufacture and product use. Jennifer Sass, a toxicologist at the Natural Resources Defense Council, welcomed the rule noting, “This shouldn’t be a big deal for companies.  It’s just one-time reporting for existing nanoscale materials, and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. Companies are only required to disclose what they know!  Consumers deserve to know, too.”

The rule, sought for in a 2008 legal petition joined by IATP, is just a first basic step towards making public what the nanotechnology product developers know about the nanomaterials they are using.  A forward thinking nanotechnology industry will not complain to the incoming EPA administrator that nanomaterial recordkeeping and reporting is “burdensome” or an impediment to “innovation,” or “job-killing.” Rather, the industry will cooperate with this very modest beginning to develop a validated data base and metrics for risk assessment of nanotechnology-enabled products. Only such cooperation will enable scientists to determine which products pose few, if any, risks, and enable product developers to make their products safer and the markets for those products more sustainable.