Lawyers, Take Note: Why the Invisible Matters

Over the last two decades, hundreds, if not thousands, of conventional products have been reengineered to improve their performance and/or enhance their consumer appeal. Chalky sunscreens, for example, renowned for the white cast that they left on skin, have been superseded by sheer sunscreens that promise greater reflection of UVA and UVB light. Interior paints, traditionally difficult to clean, now sit alongside stain-resistant and self-cleaning options. And conventional drugs, including cancer drugs, have been reengineered to be effective on a greater number of cancers and at lower doses. Invisible to the human eye, these advances can be directly attributed to advances in nanotechnologies and the greater use of nanomaterials in conventional products.

The increasing use of nanomaterials across all sectors—from agriculture to the auto industry, food to personal care, medicine and biotech and energy to consumer appliances—has, for the most part, occurred with only limited public awareness. That is not to say that terms such as “nano,” “nanotech,” or “nanotechnologies” are absent from the everyday vernacular. Such terms have featured in Hollywood movies and television shows such as Minority Report, Red Dwarf, Transcendence, and the Terminator and Avengers movies. The use of the “nano” term in science fiction and popular culture hasn’t, for the most part, informed the public about the ways in which nanotechnologies and nanoscale materials are being incorporated into products across all sectors—or why. Moreover, there is little understanding about potential future applications and how they could transform the ways in which we, for example, treat cancer, deliver potable water, and generate sustainable energy. And with nanotechnologies likely to be ubiquitous across all sectors, there are just a very few examples of where the public will encounter the technology platform.

The aim of this article is to introduce readers to nanotechnologies by providing an overview of the technology’s history, key drivers, and areas of application. In doing so, the article draws upon the early work of two U.S. law professors, Professor Frederick A. Fiedler and Glenn H. Reynolds, who, in 1994, penned the first law review focused on the legal problems posed by what was then a nascent technology—nanotechnologies.¹ As they predicted, research and commercialization of nanotechnologies has not been without controversy. This article provides an overview of some of these scientific debates and subsequent action by governmental bodies such as the European Parliament and multiple U.S. entities. Acknowledging that the technology hasn’t lived up to the early hype that surrounded it—at least not to date—the article then considers current and future research areas and application. Returning to the groundbreaking work of Fielder and Reynolds, the article concludes by highlighting the many legal questions and issues raised by the technology.

The Early Days of Nanotech Development

It is now more than fifteen years since nanotechnologies made headlines as an “emerging technology,” a ubiquitous technology platform that was simultaneously framed as the “next big thing”² and also an object of significant scientific concern.³ Yet, as scholars such as Toumey are quick to remind us, the history of this technology is much older than that,⁴ with one of the foundational events associated with the development of nanotechnologies being Richard Feynman’s 1959 talk, There’s Plenty of Room at the Bottom.⁵ While Toumey has also sought to remind us that this history is somewhat contested, there are a number of key events that can be said to have advanced the development of the technology and include, for example, the coining of the term “nanotechnology” by Norio Taniguchi in 1974,⁶ the development of the scanning tunneling microscope (STM) in 1981 by IBM researchers Binnig and Rohrer,⁷ and the futuristic writings on nanotechnology and molecular nanotechnology by Eric Drexler (1986).⁸ Collectively, these initiatives have framed the fundamental research and development (R&D) activities that define nanotechnologies of today.

But what are nanotechnologies? And what makes the nanoscale so interesting from a scientific and commercialization perspective? The term “nano” is derived from the Greek word for “dwarf,” and conceptually refers to the scale of one-billionth (or 10⁻⁹). A nanometer (nm) is a unit of length, equal to one-billionth of a meter. And while there is no universally accepted definition of what “nanotechnologies” are, Hodge et al.⁹ suggest five crucial characteristics that define the technology: scale (1–100 nm), heterogenous family of technologies, multidisciplinary approach, the notion of novelty, and the purposeful manipulation of materials at the nanoscale in order to exploit novel properties and functions.¹⁰

With leading scientific commentators and policymakers heralding nanotechnologies as a key driver for the next industrial revolution and promising everything from sustainable energy solutions to revolutionary cancer treatments,¹¹ high levels of public-sector interest should be no surprise. The formal establishment of the National Nanotechnology Initiative (NNI) by the Clinton administration in 2001, which sought to coordinate R&D efforts across U.S. federal agencies, was the first of now more than thirty national government nano-focused initiatives around the world.¹² Significant investment in these initiatives has helped to catalyze fundamental R&D efforts, provide infrastructure, and accelerate innovation. The U.S. government, in 2019 alone, allocated $1.4 billion to the NNI. With global consulting firm BCC Investments suggesting that the value of the global nanotech market is likely to exceed $90 billion by 2021,¹³ such levels of investment in bringing nano-enabled products and applications into the market appears likely to continue.

Catalyst for Concerns?

The emergence of nanotechnologies and the increasing use of nanomaterials in consumer goods such as personal care products and foods, however, have not been without controversy. The commercialization of such products has occurred in parallel to significant scientific debate regarding potential risks, scientific uncertainties, and broad debate over the potential social, ethical, and legal issues raised by the technology.¹⁴ The landmark report by the Royal Society and Royal Academy of Engineering (RS-RAE) in 2004 provided the first comprehensive analysis of the scientific state of the art, potential risks to human and environmental health and safety, and known scientific unknowns.¹⁵ This report also identified numerous regulatory issues relating to the ability of existing legislative regimes to effectively regulate, for example, the production and entry of nanomaterials and nano-based products into the market. It is therefore not surprising that in response to these uncertainties associated with nanotechnologies, a number of nongovernmental organizations, including the ETC Group and Friends of the Earth, called for moratoriums on the use of certain families of nanomaterials in, for example, the agri-food and personal care sectors.¹⁶ However, such calls gained little traction.

Efforts to address the scientific and regulatory uncertainties have shaped national and international research agendas, culminating in a significant number of legislative reviews, regulatory activities, and soft-law initiatives over the past fifteen years. These have included comprehensive regulatory reviews by the European Commission¹⁷ and the Australian Government,¹⁸ voluntary data call-ins by the United Kingdom’s government and the U.S. Environmental Protection Agency (EPA),¹⁹ the passage of nano-specific legislative provisions in the European Union (EU) and New Zealand, rulemaking by the EPA, publication of guidance materials by the U.S. Food and Drug Administration (FDA), and the publication of a number of codes of conduct/risk management frameworks by entities such as the European Commission (EC), BASF, and DuPont-Environmental Defense.²⁰ The proactive approach to technology governance here is arguably unique, with Levi-Faur and Comaneshter noting that “[p]robably for the first time ever, the attempt to develop a regulatory framework for a new technology is emerging on the public agenda hand in hand with the development of the technology itself.”²¹

While a myriad of questions still remain over potential risks posted by the technology, an impressive body of scientific research now exists on the potential toxicity, routes of exposure, biological interactions, and environmental impacts of many nanomaterial families. Significant advances have also been made in the applicability of conventional risk assessment protocols, standards, metrology, test methods, reference materials, and nomenclature.²²

Despite this greater depth and breadth of knowledge, headlines such as “Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study”²³ have the potential to fuel public concern over the technology—as did the news that Dunkin’ Donuts used nano-scale titanium dioxide (TiO2) as an ingredient in its powdered-sugar donuts—despite TiO2 being approved by the FDA as a color additive.²⁴ In regards to the former, significant debate over whether carbon nanotubes (CNTs) are the next asbestos has generated worldwide attention, helped shape national and multinational regulatory agendas and scientific studies, and given rise to a “safety-by design” approach to CNT production.²⁵ In regards to the latter, public outrage against Dunkin’ Donuts’s use of nanomaterials within its foods led to the subsequent removal of nano-TiO2 in its much-loved donut. While such high-profile incidents have been rare, given the ubiquitous nature of nanotechnologies, similar adverse reports likely will recur.

Nanotechnology Today and Tomorrow

There can be little doubt that nanotechnologies have not lived up to the original hype and promises that were sold to policymakers and the public nearly two decades ago. Today’s nano-based products and applications are, for the most part, conventional products that have been reengineered to include nanomaterials for the purpose of exploiting specific unique properties. And while a space elevator made out of CNTs remains squarely in the realm of science fiction, innovative nano-based solutions for treating cancer and HIV, generating cheap energy, and creating advanced materials that can be deployed on the battlefield are being tested and deployed in many different forms today. A quick review of scientific journals such as Nature, Nature Nanotechnology, and Science is suggestive of the cutting-edge research being undertaken by the global researcher community using nanotechnologies and the paradigm-changing nature of their discoveries and inventions.

While nanotechnologies alone may not be the panacea for addressing the United Nations Sustainable Development Goals, many of the solutions for addressing climate change, creating sustainable energy networks, promoting economic growth, providing access to potable water, and creating innovative industries and infrastructure will—by design and by necessity—incorporate nanotechnologies in one way or another. As this issue’s theme highlights, the law will play a central role in helping to bring the products and applications into the market in a way that balances innovation with protecting human and environmental health and safety.

Fiedler and Reynold’s early writings on the governance of nanotechnologies did exactly what they intended it to do: It was more of a “wakeup call than a road map, . . . rais[ing] far more questions than it answer[ed].”²⁶ While some of these questions have now been answered, many of the questions that they raised some twenty-five years ago relating to legislative fit, legal lag, property rights, and liability remain relevant today—and will continue to be tomorrow—and beyond.

Endnotes

1. F.A. Fiedler & G.H. Reynolds, Legal Problems of Nanotechnology: An Overview, 3 S. Cal. Interdisc. L.J. 593 (1993).

2. D. Newberry & J. Uldrich, The Next Big Thing Is Really Small: How Nanotechnology Will Change the Future of Your Business (Random House 2010).

3. A.D. Maynard, Nanotechnology: Assessing the Risks, 1 Nano Today, no. 2, 2006, at 22–33.

4. C. Toumey, Tracing and Disputing the Story of Nanotechnology, in International Handbook on Regulating Nanotechnologies 46–59 (G.A. Hodge, D.M. Bowman & A.D. Maynard eds., 2010).

5. Richard P. Feynman, There’s Plenty of Room at the Bottom, Paper presented to the Annual Meeting of the American Physical Society, California Institute of Technology (Dec. 29, 1959), available at http://www.phy.pku.edu.cn/~qhcao/resources/class/QM/Feynman’s-Talk.pdf..

6. N. Taniguchi, On the Basic Concept of Nanotechnology, Paper presented at the Proceedings of the International Congress on Production Engineering, Tokyo (1974).

7. Gerd Binnig & Heinrich Rohrer, Scanning Tunneling Microscope, U.S. Patent No. 4,343,993 (issued Aug. 10, 1982).

8. K.E. Drexler, Engines of Creation: The Coming Era of Nanotechnology (Anchor Books, 1986). See, also, K.E. Drexler, Machine-Phase Nanotechnology, 285 Sci. Am., no. 3, 2001, at 74–75; K.E. Drexler, Nanosystems: Molecular Machinery, Manufacturing and Computation (Wiley 1992).

9. Graeme A. Hodge, Diana M. Bowman & Karinne Ludlow, Introduction: Big Questions for Small Technologies, in New Global Frontiers in Regulation: The Age of Nanotechnology (Graeme A. Hodge, Diana Bowman & Karinne Ludlow eds., Edward Elgar Publishing, 2007).

10. Id.

11. See, e.g., D.M. Berube, Nano-hype: The Truth Behind the Nanotechnology Buzz (Prometheus Books 2006); C. Lok, Nanotechnology: Small Wonders, 467 Nature News, no. 7311, 2010, at 18–21.

12. M.C. Roco, International Perspective on Government Nanotechnology Funding in 2005, 7 J. Nanoparticle Res. 707–12 (2005).

13. BCC Research, The Maturing Nanotechnology Market: Products and Applications (2016), available at https://www.bccresearch.com/market-research/nanotechnology/nanotechnology-market-products-applications-report.html. This figure represents the suggested market value for all nanotechnology products and applications, including, for example, nanomaterials.

14. See, e.g., Andrew D. Maynard, Nanotechnology: The Next Big Thing, or Much Ado About Nothing?, 51 Annals of Ooccupational Hygiene 1 (2006): 1-12; International Handbook on Regulating Nanotechnologies, supra note 4.

15. Royal Soc’y & Royal Acad. of Eng’g, Nanoscience and Nanotechnologies: Opportunities and Uncertainties (July 29, 2004), available at http://www.nanotec.org.uk/finalReport.htm.

16. News Release, ETC Grp. (2004), Nanotech: Unpredictable and Un-Regulation: New Report from the ETC Group (July 8, 2004); G. Miller & K. Senjen, Friends of the Earth Australia, Europe & U.S.A, Out of the Laboratory and on to Our Plates: Nanotechnology in Food & Agriculture (Mar. 2008).

17. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Regulatory Aspects of Nanotechnologies, COM(2008) 366 final (June 17, 2008), https://ec.europa.eu/research/industrial_technologies/pdf/policy/comm_2008_0366_en.pdf; Accompanying Document to the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Regulatory Aspects of Nanomaterials: Summary of Legislation in Relation to Health, Safety and Environment Aspects of Nanomaterials, Regulatory Research Needs and Related Measures, SEC (2008) 2036 (June 17, 2008), http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/sec/2008/2036/COM_SEC(2008)2036_EN.pdf; Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Second Regulatory Review on Nanomaterials, COM (2012) 572 final (October 3, 2012), https://ec.europa.eu/research/industrial_technologies/pdf/policy/communication-from-the-commission-second-regulatory-review-on-nanomaterials_en.pdf.

18. Karinne Ludlow, Diana M. Bowman & Graeme A. Hodge, A Review of Possible Impacts of Nanotechnology on Australia’s Regulatory Framework (September 2007) (final report, Monash University Law), https://www.researchgate.net/profile/Graeme_Hodge/publication/265997359_A_Review_of_Possible_Impacts_of_Nanotechnology_on_Australia%27s_Regulatory_Framework/links/54b511d00cf28ebe92e4b974/A-Review-of-Possible-Impacts-of-Nanotechnology-on-Australias-Regulatory-Framework.pdf.

19. Dep’t of Env’t Food & Rural Affairs (DEFRA), UK Voluntary Reporting Scheme for Engineered Nanoscale Materials (Sept. 2006), http://www.defra.gov.uk/ENVIRONMENT/nanotech/policy/pdf/vrs-nanoscale.pdf; Press Release, EPA, EPA Invites Public Participation in Development of Nanotechnology Stewardship Program (Oct. 18, 2006), http://www.epa.gov/.

20. See, generally, D.M. Bowman & LM Tournas, Science–Democracy–Industry: Who Is in Charge of Regulating Nanomaterials?, in Nanotechnology: Regulation and Public Discourse (I. Eisenberger, A. Kallhoff & C. Schwarz-Plaschg eds., Rowman & Littlefield International 2019).

21. David Levi-Faur & Hanna Comaneshter, (2007). The Risks of Regulation and the Regulation of Risks: The Governance of Nanotechnology, in New Global Frontiers in Regulation: The Age of Nanotechnology 149–65 (Graeme A. Hodge, Diana Bowman & Karinne Ludlow eds., Edward Elgar Publishing 2007).

22. See, generally, Nanotechnology Environmental Health and Safety: Risks, Regulation, and Management (Matthew S. Hull & Diana M. Bowman eds., 2018).

23. C.A. Poland et al., Carbon Nanotubes Introduced into the Abdominal Cavity of Mice Show Asbestos-like Pathogenicity in a Pilot Study, 3 Nature Nanotechnology 423 (2008).

24. A. Gergely, D.M. Bowman & Q. Chaudhry, (2017). Infinitesimal Ingredients: An Analysis of the Regulatory Dimensions of Nanotechnologies in Foods and Food Contact Materials, in Nanotechnologies in Food 228–51 (Qasim Chaudhry, Laurence Castle & Richard Watkins eds., 2d ed. 2017).

25. K. Donaldson et al., Identifying the Pulmonary Hazard of High Aspect Ratio Nanoparticles to Enable Their Safety-by-Design, 6 Nanomedicine 143 (2011).

26. Fiedler & Reynolds, supra note 1, at 593.