Forecasting Nano Law: Defining Nano

By Ilise L. Feitshans

Law and science have partnered together in the recent past to solve major public health
issues, ranging from asbestos to averting the threat of a nuclear holocaust. This paper
travels to a legal and health policy frontier where no one has gone before, examining
the role of precautionary principles under international law as a matter of codified
international jurisprudence by examining draft terminology from prominent sources
including the Royal Commission on Environmental Pollution (UK), the Swiss
Confederation, the USA (NIOSH) and the OECD. The research questions addressed
are how can the benefits of nanotechnology be realized, while minimizing the risk of
harm? What law, if any, applies to protect consumers (who comprise the general public,
nanotechnology workers and their corporate social partners) and other stakeholders
within civil society from liability? What law, if any, applies to prevent harm?
Keywords: health, law, nanotechnology, regulation, responsible development
I. What is nanotechnology? Sample definitions
The attempt to craft “nano” definitions is still in an embryonic phase at the time of writing.
Many experts are meeting to discuss and define the terms pertaining to nanoparticles and
nanotechnology in small committees, but few large meetings have been convened in order to
critique the definitions collectively, or to combine the views of experts across different
committees, in the hope of using the texts from the variety of available sources to produce one
unified text. In the following paragraphs, several widely quoted definitions of “nanotechnology”
are criticized, noting that none of these are consistent with each other, all are at first blush
1 Prof. Ilise L. Feitshans JD ScM is a bilingual lawyer with a Masters of Science in Public Health from the
Johns Hopkins University, Member of the Bar of the Supreme Court of the United States, former
Member of the Faculty, Columbia University School of Law in the City of New York, and was a student
legal intern in the Office of the Solicitor of the US Department of Labor for OSHA (during the time of the
benzene case). She currently serves as a Faculty Member and a Doctoral Candidate in International
Relations (thesis topic: “Forecasting Nano Law”) at the Geneva School of Diplomacy. Ilise is the
author of “Designing an Effective OSHA Compliance Program” (Westlaw) and “Bringing Health to
Work” (Emalyn Press). ilise@prodigy.net, +41 79 836-3965, +1917 239-9960, forecastingnanolaw.net
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simple but later prove to be overbroad and, most importantly for this analysis, none of these
supposedly respected definitions are actually law!2
The US government offers “Nanotechnology is the understanding and control of matter at
dimensions between approximately 1 and 100 nanometers, where unique phenomena enable
novel applications.”3 There are several other definitions floating around the web, but they are
awkward and have evoked much debate without clear scientific consensus.4 The Woodrow
Wilson Center defines “Nanotechnology is the ability to measure, see, manipulate, and
manufacture things usually between 1 and 100 nanometers. A nanometer is one billionth of a
meter, a human hair is roughly 100,000 nanometers wide.”5
The NanoImpactNet of the European Union suggests words that could become the basis
for a definition in its 2011 annual report. Using the working assumption that objects in the
nanoscale are smaller than one hundred nanometers, the report notes “nanomaterials have
chemical, physical and bioactive characteristics which are different from those of larger entites
of the same substances … nanomaterials can pass through the body’s barriers.”6
The Royal Commission on Environmental Pollution in 2008 tried to posit a method for
evaluating or quantifying the risks associated with emerging nanotechnologies, but failed to
develop clear wording that would be useful for people who are not trained in the hard sciences.
“In trying to assess the potential of manufactured nanoparticles to cause adverse effects in humans
(and indeed other organisms), it is important to understand the relationships between their
physical and chemical structures and their biological effects. Two criteria have been proposed
to identify nanomaterials which may present a unique potential risk to human health: the material
must be able to interact with the body in such a way that its nanostructure is biologically
available; and the material should elicit a biological response associated with its nanostructure
different from that associated with non-nanoscale material of the same composition.”7
From a practical standpoint, these terms lose the clarity of a definition outside the scientific
context, away from the laboratory bench and in the realm of consumer exposure. Few
substances behave the same way in a fine scale of division compared to bulk matter, and this
lack of precision in a definition could bring biological substances also into the regulatory
regime, if the language adopted by a legislature or regulatory body is inept. Simply having more
2 The question whether common use of a term that is widely understood ripens into law, the so-called
“soft law”, and thereby eventually becomes “real” law, has been discussed in several legal contexts,
including. Ilise L. Feitshans, “Applicability of Public Health Principles to the Implementation of ILO
Norms and Related Non-ILO International Standards” at the Séminaire “Responsabilité Sociétale des
Entreprises & Régulations: Quel rôle pour les juristes?” Invited paper at the International Labour
Studies Institute, International Labour Office, Geneva, Switzerland, 9 October 2007.
3 nano.gov
4 See the proceedings of the Second Annual NanoImpactNet conference, sponsored by the EU, the
Council of Europe, the Swiss accident assurance corporation SUVA and many additional private
agencies and international organizations, Lausanne, Switzerland, 9–11 March 2010.
5 www.wilsoncenter.org
6 NanoImpactNet, The European Network on the Health and Environmental Impact of Nanomaterials
(www.nanoimpactnet.eu). Coördinator: Michael Riediker, Institut universitaire romande de santé au
travail, Lausanne. See: Compendium of Projects in the European NanoSafety Cluster (2011), p. 103.
7 Royal Commission on Environmental Pollution. Chairman: Sir John Lawton. Twenty-seventh
Report: Novel Materials in the Environment: The Case of Nanotechnology (November 2008),
paragraph 3.68.
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jurisdiction for a regulatory agency mat be less effective than measured, reserved use of
regulatory power in this situation. Whether an approach that embraces many types of
nanoparticles provides a wise or reasonable basis for jurisdiction is a policy decision. As such,
in the long term, whether the law views nanotechnology and its need for regulation as intended,
good, unwanted or bad is a policy decision that may be derived from political compromise
rather than scientific principles. Unfortunately, it seems prima facie unclear what such a set of
criteria applied to the universe of substances could contain. Some pertinent questions are:
1. What are the components of a working definition of nanotechnology that makes sense, if
there is one?
2. In particular, how can we craft a definition that can accurately distinguish between what the
scientific community calls the “real nano” compared to mundane applications of
nanotechnology and the products or methods that should be deliberately excluded from
regulation or from protection against liability under a regulatory regime?
3. If consumers are led to believe that a product is “ nano” because of advertising or use of the
term “nano” in the name of the product, what should civil society and regulators do about it?
Is there a minimum or maximum amount of nanotechnology involved in the definition of a
regulated end-product or technique and, if so, using what criteria? Or, does the mere selfproclamation
that something is “nano” constitute “enough nano” to make it subjected to
regulation?
4. Since there is no such thing as “zero risk”, is there something other than risk that can be used
as the key variable for assessing regulated “nano” criteria?
II. Example: USA FDA definitions for the purpose of “Guidance for Industry”
In its own effort to set forth some definitions as a prelude to future regulaton, the USA Food and
Drug Administration (FDA) published guidelines about nanotechnology in June 2011. The
FDA was cautious in this effort, stating: “These terms are discussed out of context, and without
regard to the role of FDA-proposed guidance as law or as mere suggestions to be followed.8 The
following section discusses the plain meaning of the terms used by the FDA in its draft guidance
document, entitled “Considering Whether an FDA-Regulated Product Involves the Application
of Nanotechnology”.9 Although the role of FDA definitions under law is complex, it cannot be
8 The FDA’s own notice states: “ FDA’s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a
topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word “should” in Agency guidances means that something is
suggested or recommended, but not required. [Regarding scope:] this guidance document does not
establish any regulatory definitions. Rather, it is intended to help industry and others identify when
they should consider potential implications for regulatory status, safety, effectiveness, or public health
impact that may arise with the application of nanotechnology in FDA-regulated products. Public
input on the guidance9 may also inform the development of any regulatory definitions in the future, as
needed. Nor does this guidance document9 address the regulatory status of products that contain
nanomaterials or otherwise involve the application of nanotechnology, which are currently addressed
on a case-by-case basis using FDA’s existing review processes.”
9 Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
Guidance for Industry. Docket number FDA-2010-D-0530.
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overlooked.10 The FDA uses several ambiguous terms in order to create a set of criteria for
defining nanotechnology. These terms include, “Engineered material or end product with ‘at
least one dimension in the nanoscale range’… Exhibits properties or phenomena … that are
attributable to its dimensions … Size range of up to one micrometer”. The recurring theme that
nanoparticles are objects sized 100 nanometers or smaller may be considered to have
consensus, because the phrase appears frequently in articles in reputable scientific journals.11
Another definition views nanotechnology as “Encompassing nanoscale science, engineering,
and technology, nanotechnology involves imaging, measuring, modeling, and manipulating
matter at this length scale. A nanometer is one-billionth of a meter.12 A sheet of paper is about
100,000 nanometers thick; a single gold atom is about a third of a nanometer in diameter.
Dimensions between approximately 1 and 100 nanometers are known as the nanoscale.
Unusual physical, chemical, and biological properties can emerge in materials at the nanoscale,
which therefore differ in important ways from bulk materials and single atoms or molecules.”3
Another regulatory model defines or categorizes chemical substances based on molecular
identity, not on physical properties such as particle size, thereby arguing that jurisdiction
already exists to regulate nanomaterials.13 The various complex regulatory frameworks at the
international level that have been mentioned in this paper are merely the tip of the iceberg.
Countless nanotechnology guides and sets of best practices are available on the web and in
textbooks, which confuse further the question of unknown risks and what is the right course of
action for a well intended employer or an instructor giving training. One thing remains clear:
these matters are relevant for all of civil society.14
10 The FDA’s own notice states: “This draft guidance, when finalized, will represent the Food and Drug
Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.”
11 In general, nanotechnology deals with the application of scientific principles, tools, techniques, and
knowledge gained from multidisciplinary fields of science and engineering in the measurement and
manipulation of structure and properties of matter at length scales greater than 1 nm and, in
nanomedicine, smaller than a few hundred nanometres. Thus, nanotechnology offers the ability to
design, manipulate, and characterize materials at the nanometer length scale (nanoscale), with
properties that can be tailored according to specific biomedical and other applications. This ability has
enabled the development of nanostructured surfaces and engineered nanomaterials, which include
nanoscale-sized objects (e.g., nanoparticles) and nanostructured objects.
12 US billions, i.e. 109, are used here.
13 REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) in the EU and TSCA
(Toxic Substances Control Act) are two examples of regulatory models that categorize chemical
substances based on molecular identity, not on physical properties such as particle size. Many
nanomaterials are composed of chemical substances subject to TSCA. Nanomaterials based on
chemical substances already on the TSCA inventory are considered as existing chemicals. Examples
are metals such as iron and gold, and some metal oxides such as titanium dioxide and silicon dioxide.
Nanomaterials that are not on the TSCA inventory are considered new chemicals; examples are
carbon nanotubes and fullerenes. New chemical substances are subject to reporting and review prior
to commercialization, but nanomaterials based on existing chemical substances are not.
14 Key resources for scientific nano definitions include: guidance on safe handling of nanomaterials
from www.cdc.gov/niosh/topics/nanotech/ and www.GoodNanoGuide.org; nanomaterial characteristics
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An example of what happens when well intended definitions become careless holds lessons for
defining “nanotechnology”, “nanoparticles” and other “nano things” under law. The employment
conditions knowledge network (EMCONET) also cites the mushrooming growth of the
“informal” sector as a major variable reshaping the workforce; a rewport notes: “A feature of
informal employment is the lack of any statutory regulation to protect working conditions,
wages, occupational health and safety or insurance” and, therefore, accidentally includes selfemployed
workers within the definition.15 Thus, a variety of small businesses and self-employed
individuals may find themselves regulated by the same legal apparatus that governs powerful
multinationals, despite the differrence in the ability to handle administrative requirements, if
there is not enough forethought when writing legal definitions for the scope of jurisdiction.
We do not know today whether the redefinition of “work”, “employer”, “employee” and
“occupation” that we will experience as so many telecommuters become independent
contractors will undermine occupational health laws, or bring people into a net of regulation
that requires an infrastructure they cannot support as a self-employed user of nanotechnology or
as a small enterprise.
Some of the definitions from respected sources, such as the Royal Commission on
Environmental Pollution,7 seem very straightforward at first glance, but would easily expand
into unwanted areas of industrial activity if applied in the workplace or to consumer products.
For example, “nanoscience” is defined as the study of phenomena and manipulation of
materials at atomic, molecular and macromolecular scales where properties differ significantly
from those at a larger scale (incidentally, the same report7 noted in paragraph 2.5 that “many
terms are used to describe technologies and materials employed at the nanoscale, including
‘nanoscience’, ‘nanotechnology’, ‘nanomaterials’ and ‘nanoparticles’. In evidence we have
been told that it is difficult to point to a single definition that encapsulates ‘nano’. Given the
interdisciplinary nature of nanotechnology, however, a single definition is unhelpful and …
many believe that ‘nanotechnology’ as a term will cease to exist within the next decade because
increasingly researchers and developers will select a material for its functionality, rather than
for its size”). But in reality it is hard to posit a type of substance that does not differ significantly
depending on its size, regardless whether inanimate or biological. Applying this definition in a
model framework, therefore, would include regulation of a wide variety of substances and end
products that may have nothing to do with the expected hazards posed by “true” nanotechnology—
thus forcing many producers to comply with a law whose implementation makes no sense in
and hazard information from the Nanomaterials Registry and from www.nanoparticlelibrary.net;
computational resources for modeling and simulation in nanotechnology from resources such as the
National Science Foundation’s www.nanoHUB.org, the National Cancer Institute’s https://
cabig.nci.nih.gov/tools/caNanoLab, and the Nanomaterial-Biological Interactions knowledge base
(http://nbi.oregonstate.edu/); and information on nanotechnology-related changes in the legal arena
from www.forecastingnanolaw.net.
15 Joan Benach, Carles Muntaner and Vilma Santan (chairs), “Employment Conditions and Health
Inequalities: Final Report to the WHO Commission on Social Determinants of Health (CSDH)”, p. 62.
Published by: Health Inequalities Research Group, Occupational Health Research Unit, Department
of Experimental Sciences and Health, Universitat Pompeu Fabra, Barcelona (Catalonia), Social
Equity and Health Section Center for Addiction and Mental Health, University of Toronto (Ontario)
and Institutes of Collective Health, University of Bahia, Salvador (Brazil), 2007.
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their business or workplace. Overbroad legal terminology therefore runs the risk of clogging the
regulatory system with a litany of inventions and products that would distract regulators,
compliance officers, inspectors and researchers from attacking the major emerging issues in
nanotechnology’s applications.
It is also unclear whether such a definition would treat as outside the regulatory framework
materials that do not “differ significantly from those at a larger scale”, regardless of their impact
upon the environment or human health (including reproductive health). In this important regard,
all the existing working definitions of nanotechnology seem to have one thing in common: at first,
their formulation seems easy to understand and the result of wide consensus. But, upon further
reflexion, any attempt to apply such terms to a broader context than the one originally contemplated
when the definition was written reveals that the consensus soon breaks down. Using scientifically
accepted definitions from key reports emanating from bodies such as the governments of the
United Kingdom or Switzerland or the multinational OECD, when applying a definition that
might include the broad and vague term “atomic, molecular and macromolecular scales” or the
phrase evoking “properties differring significantly from those at a larger scale” another problem
soon becomes clear: such definitions can be meaningless without auxiliary criteria.
III. Simple applications of nanotechnology to daily life
Consumer exposure to nanotechnology is already alive and thriving in the marketplace and in
the medical community—locally and globally. For example, in 2005, the USA’s Food and Drug
Administration (FDA) completed a “proof-of-concept” study of a test that potentially can detect
the presence of anthrax toxin quickly and accurately—“The FDA findings could form the basis
of a test that allows earlier diagnosis of anthrax infection than currently possible,” remarked Dr
Indira Hewlett, the senior author of the study and head of the Laboratory of Molecular Virology
in the Office of Blood Research and Review at the FDA’s Center for Biologics Evaluation and
Research (CBER). “FDA researchers relied on a nanotechnology-based test platform built from
tiny molecular-sized particles. This assay, the europium nanoparticle-based immunoassay
(ENIA), was able to detect the presence of a protein made by the anthrax bacteria known as
protective antigen (PA), which combines with another protein called lethal factor to form
anthrax lethal factor toxin, the protein that enters cells and causes the toxic effects”.16 In the
same year, the USA’s Environmental Protection Agency (EPA) conducted a public meeting on
nanoscale materials (Charts 1 and 2) to discuss a potential voluntary pilot programme for
certain nanoscale materials and the information needed to adequately inform the conduct
of the programme.17 It would appear that there is a small window of opportunity for preventive
use of scientific principles under law to manage risk and protect public health. In the next five to
ten years, when billions of dollars will be spent on research and development funding for the
application of nanotechnology, major policy decisions will be made before there is hard data—
and those decisions may endure for decades.
16 http://www.fda.gov/bbs/topics/NEWS/2009/NEW01975.html
17 http://www.epa.gov/fedrgstr/
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Chart 1. Improved nanomaterials. Sources include CHINANO 2009 (Beijing, September 2009).
Nano-energy and environmental materials
1. Nanomaterials and nanotechnology in energy generation, conversion, storage and saving: fuel cells,
solar cells, thermal-to-electric, renewable power generation, biomass energy, hydrogen storage,
secondary batteries, supercapacitors, thermal storage fluids, intelligent energy-saving materials.
2. Nanomaterials and nanotechnology in environmental detection, protection and governance: energy
consumption reduction, pollution decrease, toxic capture, waste encapsulation, water purification, soil
purification, solid-state sensor nanomaterials and device technology for chemical detection,
characterizing compound semiconductors for environmental and safety studies, and so forth.
3. Nanocatalysts and nanophotocatalysts for energy and environment.
4. Green processes and sustainable processing of environmentally-benign nanomaterials.
Nanodevices and sensors
1. Nanotubes, nanowires, spintronics, quantum dots, molecular electronics, single electron transistors.
2. Photonics, optoelectronic devices.
3. Novel memory technologies: magnetic memory, phase change memory etc.
4. Chemical, gas, optical and mechanical sensors.
5. NEMS (including actuators), nano/micro/macro system integration.
Nanomedicine, nanopharmacy and biomedical engineering
1. Nanomedicine and nanodrugs.
2. Biomedical engineering.
3. Nanobiotechnology.
4. Nanotoxicology, nanosafety assessment and regulations.
5. Nanobiochemical aspects.
Nanofabrication and nanometrology
1. Nanofabrication with top–down and bottom–up approaches, novel nanofabrication methods,
bottom–up and top–down in combination, photon lithography, electron and ion beam lithography,
nanoimprint lithography, maskless lithography, self-assembly and directed self-assembly, scanning
probe techniques, surface engineering in the nanoscale, modelling.
2. Pattern transfer, nanoscale etching, lift-off technology, sputtering and beam etching/deposition,
modelling.
3. Nanofabrication applications in nanodevices, nanofabrication and characterization for
nanostructures in nanoelectronics, nanomechanical devices, nanooptics/nanophotonics,
nanomagnetics, data storage, molecular devices, nanofluidics, microbiodevices, nanomedical devices.
4. Nanometrology: novel methods, testing and process measurements, reference materials,
standardization.
Nano-optics and plasmonics
1. Nanophotonics and near-field optics.
2. Plasmonics.
3. Subwavelength photon lithography.
4. Nano-optical storage and applications of ultrafast lasers.
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Chart 2. Areas of application of nanotechnology. Nanotechnology’s revolution for the global
economy can also revolutionize public health!
New medical treatments3
• Nanomedicine is focused on diagnosing and treating diseases and creating new drug delivery
techniques with fewer side effects. Many nanomedical devices are now undergoing clinical trials
and could soon be available to the public.
• Nanotech-enabled sensors may be able to “smell” cancer. Researchers have mapped the odour
profile of certain skin cancers and are looking into ways to sense the airborne chemical patterns of
other skin ailments.
• Gold nanoparticles can be used to detect early stage Alzheimer’s disease. Other nanomaterials can
recognize diseased cells and deliver drugs to cancerous tumours without harming healthy cells or
organs. New nanoparticles to improve biomedical imaging are being designed.
• Research is underway to use nanotechnology to engineer a gel that spurs the growth of nerve cells.
The gel fills the space between existing cells and encourages new cells to grow. This process could
be used to regrow lost or damaged spinal cord and brain cells.
Cheap and clean energy3
• Prototype solar panels incorporating nanotechnology are overall more efficient than standard designs in
converting sunlight to electricity, promising cheap solar power in the near future.
• Nanotechnology is already in use in new batteries, and nanostructured materials may improve the
hydrogen storage materials and catalysts needed to realize fuel cells for alternative transportation.
Clean water3
• Inexpensive water purification; rapid, low-cost detection of impurities.
• Magnetic interactions between ultrasmall specks of rust (magnetite nanoparticles) can help remove
arsenic and possibly other impurities from drinking water.
Pollution reduction and environmental progress3
• Lighter cars and machinery that requires less fuel; alternative fuel and energy sources; “smart”
materials that detect and clean up environmental contaminants.
• Nanosilver as an antimicrobial reagent to clean up oil spills and certain hazardous chemicals.
• Nanotech-enabled sensors to detect and identify harmful chemical and microbiological species in
the environment.
IV. Defining nanotechnology: the nano that everybody knows
According to the European Union NanoImpactNet,18 “nanotechnology” and “nanomaterials” refer
to materials “that have at least one structural dimension in the nanoscale; that is, between 1 to
100 nanometres.19 Nanomaterials often have chemical, physical and bioactive characteristics
that are different from those of larger pieces of material with the same nominal chemical
composition, and from molecular forms where they exist”. This description closely parallels
that offered by an agency in the USA in 2005.19, 20
18 NanoImpactNet.6 See: Compendium of Projects in the European NanoSafety Cluster 2011,
pp. 102–114, esp. p. 103.
19 This definition is consistent with that of the USA Environmental Protection Agency (EPA):
“Nanoscale materials are chemical substances containing structures in the length scale of
approximately 1 to 100 nanometers, and may have different molecular organizations and properties
than the same chemical substances in a larger size.”
20 The definition19 continues with “Some of the nanoscale materials are new chemical substances
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Summarizing public information about nanotechnology on the web reveals these key
features:
1. Many nanostructured materials can be harder, yet less brittle than comparable bulk materials
with the same composition because of certain interface and confinement effects.
Nanoparticles or nanograins are too small to have surface defects and are harder because of
the surface energy so they can be used to make very strong composite materials.
2. Nanoscale components have very high surface areas, making them ideal for use as catalysts
and other reacting systems and adsorbents, and for drug delivery, energy storage and
even cosmetics.
3. The internal transit times between interacting nanostructures is much faster than in
microstructures because the dimensions involved are orders of magnitude smaller. Much
faster and more energy efficient systems are, therefore, envisioned.
4. Electronic and atomic interactions inside matter are influenced by variations at the
nanometre scale.
5. Patterning matter in the nanometre length scale will make it possible to control the
fundamental properties of materials (such as magnetization, charge capacity, catalytic
activity) without changing their chemical composition. For example, nanoparticles of
different sizes emit light at different frequencies so they have different colours, and nanosize
single magnetic domains can lead to vastly improved magnetic devices.
6. Nanotechnology will place artificial components and assemblies inside cells and make
new structurally organized materials by mimicking nature. These new nanomaterials
should, therefore, be more biocompatible. In summary, then, nanotechnology will leave no
corner of the global economy untouched, cutting across almost every industry,21 including
food processing for retail markets, cosmetics, paint and other coatings, agriculture,
pesticides, equipment and packaging.
subject to notification requirements under Section 5 of the Toxic Substances Control Act (TSCA) and,
therefore, are subject to review for potential human health and environmental risks before they are
manufactured and enter commerce. Other nanoscale materials are existing chemical substances that
may enter commerce without notification to EPA.”
21 In 2000, the USA National Science and Technology Council’s Committee on Technology’s
Subcommittee on Nanoscale Science, Engineering and Technology’s Report to the President of the
USA (National Nanotechnology Initiative: The Initiative and Its Implementation Plan) predicted:
“Biotechnology and agriculture. The molecular building blocks of life—proteins, nucleic acids,
lipids, carbohydrates and their nonbiological mimics—are examples of materials that possess unique
properties determined by their size, folding and patterns at the nanoscale. Biosynthesis and
bioprocessing offer fundamentally new ways to manufacture new chemicals and pharmaceutical
products. Integration of biological building blocks into synthetic materials and devices will allow the
combination of biological functions with other desirable material properties. Imitation of biological
systems provides a major area of research in several disciplines. For example, the active area of
biomimetic chemistry is based on this approach. Nanoscience will contribute directly to
advancements in agriculture in a number of ways: molecular-engineered biodegradable chemicals for
nourishing plants and protecting against insects; genetic improvement for animals and plants;
delivery of genes and drugs to animals; and nanoarray-based testing technologies for DNA. For
example, such array-base technologies will allow a plant scientist to know which genes are expressed
in a plant when it is exposed to salt or drought stress. The application of nanotechnology in agriculture has
only begun to be appreciated.”
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V. International scientific concerns regarding unknown risks
According to the Royal Commission on Environmental Pollution’s 27th report7 (paragraph 1.43),
“the governance of emerging technologies [is subject to] two conditions that pose serious
constraints on any regulator. First is the condition of ignorance about the possible environmental
impacts in the absence of any kind of track record for the technology. Second is the condition of
ubiquity—the fact that new technologies no longer develop in a context of local
experimentation but emerge as globally pervasive systems—which challenges both trial-anderror
learning and attempts at national regulation … International scientific consensus points
towards major risks to public health and the health and well-being of workers and the families
who depend upon their wages from the unfettered application of nanotechnology, even though
there is also consensus that the state of the art is such that those risks cannot be easily
quantified.” When such reports22 conclude that the state of the art of scientific research
promoting safety and health in the workplace lags behind the implementation of new
technologies in commerce, there may be cause for alarm, because as noted in the same report7
(paragraph 1.39) “by the time problems emerge, the technology is too entrenched to be changed
without major disruptions” and (paragraph 1.40) “the solution to this dilemma is not simply to
impose a moratorium that stops development, but to be vigilant with regard to inflexible
technologies that are harder to abandon or modify than more flexible ones …”. These limits on
the present state of the art for quantifying risk sharpen the edge of the dilemma that regulators,
industrial stakeholders and all members of civil society must courageously examine.
Consistent with such concerns, the Swiss National Science Foundation warns that “physically
confining materials at the nanoscale alters the behaviour of electrons within them, which in turn
can change the way they conduct electricity and heat, and interact with electromagnetic radiation.
Moreover, materials engineered at the nanoscale can enter into places that are inaccessible to
larger materials, and can therefore be used in new ways. These behaviours also have potential
consequences on the abilities of synthetic nanomaterials to cause harm in novel ways.23
Despite some strong efforts to rely on the opinions of scientific experts and codify their
views about risk, there have been significantly few coördinating projects among global social
partners. This may change with the widespread global implementation of nanotechnology. The
Royal Commission on Environmental Pollution’s report, already cited,7 notes regarding
“Trans-science, world views and the control dilemma” that (paragraph 1.31) “the policy
challenge posed by novel materials is a specific instance of the more general dilemma of how to
govern the emergence of new technologies which, by definition, cannot be fully characterized
with respect to their potential benefits and drawbacks. As such it is a classic case of what the
American physicist Alvin Weinberg described as a ‘trans-scientific’ problem.” The same report
continues with (paragraph 1.37): “As we have noted, history is replete with instances … such
22 See also: UK Department for Environment, Food, and Rural Affairs. 2010. Research into the
likelihood and possible pathways of human exposure via inhalation arising throughout the life cycle
of a selection of commercially available articles containing carbon nanotubes (document CB0423).
23 Swiss National Science Foundation, Opportunities and Risks of Nanomaterials. Implementation Plan
of the National Research Programme NRP 64. Berne, 6 October 2009. This plan is notable because it
succinctly reaches the main points in current policy dilemmas.
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assumptions were shown to be flawed too late to avoid serious consequences. The second
approach assumes that the state of the science is up to the job of detecting problems
unambiguously and at an early enough stage to prevent widespread damage, which we have not
found to be the case here. The third view would deny citizens and consumers the real lifestyle
and health benefits that technologies based on novel materials might provide. In any case, we
know that science can never definitively prove that something is safe.”24
Echoing this sentiment, and edging towards international scientific consensus, the leading
occupational health research agency for the federal US government held hearings regarding
occupational exposure to carbon nanotubes (CNT) and nanofibres (CNF), expressing
trepidation about the impact of unknown variables on human health:25 “given the low density
and small diameters of individual CNT and CNF structures, a mass-based sampling method
may not be sufficiently sensitive to detect all CNT and CNF structures in the air at low mass
concentrations. Thus, research is needed to determine the most sensitive dose metrics for
estimating various health risks of exposures to CNT and CNF and to develop sampling and
analytical methods corresponding to those metrics. CNT are widely accepted to be durable due
to the process they undergo during synthesis in which contaminating catalytic metals are
frequently removed either by high temperature vaporization or acid treatment. Neither
treatment is found to significantly alter the physical structure of CNT.”
The Royal Commission on Environmental Pollution in the UK, the Swiss National Science
Foundation, the OECD and the USA’s NIOSH have surveyed the state of the art of nanotechnology
and, each acting independently, have determined that the potential for risk exists, even though the
precise nature and scope of risk within nanotechnology cannot presently be quantified.26
24 The Royal Commission has been criticized for failing to take a clear position favoring any of the three
approaches it advocated, but there is no denying that choosing one of these approaches in 2008 would
have been premature. It stated in paragraphs 1.35 and 1.36: “We heard at least three distinctive
approaches to the problem of the governance of novel technologies under conditions of what we
consider to range from high uncertainty to profound ignorance. One optimistic view was that no
regulatory attention to novel materials could be justified unless and until there were clear indications that
harm is being caused. Those expressing such a position were generally more concerned to forestall any
unjustified regulatory intervention that might stifle innovation. A less optimistic version was the
argument that any attempts to devise governance arrangements for novel materials should be ‘risk
based’. This usually means that the technology should be controlled only to the extent that there are
clearly articulated (preferably quantified) scientific reasons for concern, and only then where the cost of
risk reduction is deemed proportionate to the probability and extent of danger. Reasons for concern
might include detection of empirical disease clusters, the articulation of theoretically plausible exposure
pathways, or plant or animal disease mechanisms that might be associated with particular novel materials.
At the other extreme was the view that novel materials should not be permitted until they had been given
a clean bill of health, i.e. they had been demonstrated beyond any reasonable doubt to be safe.”
25 NIOSH (National Institute for Occupational Safety and Health) Current Intelligence Bulletin:
Occupational Exposure to Carbon Nanotubes and Nanofibers (draft document for public review and
comment). Docket number NIOSH-161.
26 See the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee
on Technology, National Science and Technology Council (NSTC), Strategy for Nanotechnology-
Related Environmental, Health, and Safety Research, describing the National Nanotechnology
Imitative (NNI)’s strategy for addressing priority research on environmental, health, and safety (EHS)
aspects of nanomaterials. Research on workplace exposure to nanomaterials is a high priority. The
broad implications of nanotechnology for society can be grouped into two categories, namely
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Switzerland has a precautionary matrix that was prepared by its government. This pathbreaking
document is leading the way in voluntary compliance because it gives manufacturers and some
industrial users of nanoproducts and nanotechnologies a matrix in which to plug in key
variables, and then determine internally how important are the risks and whether they can be
prioritized compared to other dangers.27
VI. The illusion of scientific consensus regarding risk
So many different sources have used similar language to define engineered or manufactured
nanomaterials that it becomes deceptively simple to conclude that “everybody” agrees “what
nano is supposed to be”. At first blush nanotechnology policy questions seem to be easy to
answer. “Everybody” knows them or, at least “everybody in the scientific community”, because
many of the substances used at the molecular level are already regulated because they are
dangerous. No one knows, however, what dangers lurk in the new use at the nano level and,
conversely, the possibility exists that some substances may be safer at the new level. Thus, fear
exists, but empirical data to justify the use of law does not. Consequently, even with an
abundance of caution, crafting workable regulations is very difficult.
At first, there may appear to be an immediately clear difference regarding “truly scientific”
discussion of nanotechnology and nanoparticles, compared to commercial usage when the term
“nano” sometimes appears for things that are just called nano but aren’t really. As the discussion
slowly evolves to focus on precise concepts and, eventually, precise language to give these
terms meaning, however, the difficulty of the task becomes remarkably clear. To break these
terms down into workable definitions, one might suggest that the term nanoparticle refers only
to “free nanoparticles”. There are presently no clear criteria for explaining this term, however,
nor for differentiating it from other uses of the term “nano”.
Consider for example, whether it is appropriate or enforceable to have laboratory-quality
carbon nanotubes treated in the same way as a car or a toy under nanotechnology laws. Consider
the car called “Nano” and the Migros grocery store toy called “Nano mania”. Few scientists
would consider these products to be a “pure” example of nano and, therefore, society might
reject the idea of labelling them accordingly. Such a policy decision in practice is more
problematic than it seems intuitively. For example, from the standpoint of risk, it could not be
argued that a car is without risk to the consumer population or society overall, or that the risk is
not potentially lethal regardless of dose or time of exposure. From the standpoint of percentage
of nanoparticles used in the product, it is not clear whether the combined presence of nanotubes in
paint coatings, fabric protection, headlights and a variety of other parts of the car might
constitute a total percentage that exceeded a possible threshold for nano regulation. Thus,
drafting text can become a legislative nightmare and a regulatory burden even to industries that
do not consider themselves to be using nanotechnology, unless the criteria are clear and there is a
flexible regulatory framework.
environmental, health, and safety implications and societal dimensions. See also: the NNI strategy for
nanotechnology-related environmental, health, and safety research in coördination with the OECD.
27 Federal Office of Public Health (FOPH) and Federal Office for the Environment (FOEN) Guidelines
on a Precautionary Matrix for Synthetic Nanomaterials (Version 1.0). Berne, 2008. http://
www.bag.admin.ch/themen/chemikalien/00228/00510/05626/index.html?lang’en
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But, this policy dilemma of what to do if manufacturers or retailers call a product “nano”
merely to make it appealing to consumers has deeper implications. If a product is merely called
“nano” and not regulated, there is the possibility that it will offer any purchaser—whether a
large corporation or an individual consumer—a false illusion of being safer than it is, because
purchasers know that “nano” products are subject to a vast apparatus of regulatory oversight. At
the same time, some consumers might not want every product to be burdened with regulation,
but the criteria are not at all clear how to treat products that are self-proclaimed as “nano” but
are not genuinely nano according to scientific consensus. In fact, crafting text that draws such
distinctions is almost impossible.
VII. Translating scientific consensus into workable text for law governing nanomaterials
Should tyres be treated the same as paints or coatings or research nanofibres? The notion that a
definition that is widely accepted can or should become law is problematic. Not every
government utterance is law. Nor should every guideline, request for data, voluntary compliance,
summary in an annual report or draft legislation be accorded the weight of real law!
The issue of what weight to accord a specific government definition becomes an important
question when crafting definitions in any area of science that attempts to describe new
technology because the authors of a definition will typically search for authority for the terms
they finally choose. If a definition represents the collective will of scientific consensus, it may
someday become law, but cannot be accorded the weight given to a legislative or executive
proclamation of the definition under law. In sum, the experts may not have power. Conversely
and more importantly, the powerful lawgivers may not have expertise.
Beyond the superficial question, whose definition? or, in other words, which stakeholders
interested will have primacy? and which interests will be subsumed when others are served?
there is a much deeper question concerning legitimacy and governance. In brief, does
nanotechnology provide an excuse for government agencies to usurp power, by claiming that
their laws already cover chemcials even if their properties are different at the nanoscale? Is it
fair to demand that these same agencies regulate materials below an agreed-upon, regulatory
threshold level? Must civil society await, as the Royal Commission feared (referring to
pharmaceutical disasters in the 1950s in the UK) a “nightmare scenario” despite good will? Or,
can civil society muster political will to take the time and think through draft legislaiton in order
to control risks that are important and unquantified, without at the same time engulfing every
product that uses nanotechnology in science laboratories or at home?
One outgrowth of the history is the 20th century’s development of three types of
international legal systems:
• multilateral international public law, reflected in the United Nations charter and its
accompanying documents, including the World Health Organization (WHO) Constitution,
which is one component of an impressive cluster of fundamental human rights documents
that were born in the aftermath of World War II;
• international labour standards, reflecting a mission among member nations to promulgate
social change at the end of World War I, as reflected in the work of the International Labour
Organization (ILO); and
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• regional multilateral treaties, tied to other treaties binding the contracting parties, such as the
trade and tariff agreements that are also part of the European Union (EU).28
Unfortunately, there has been little interaction between these parallel structures during the
time of their further development in the late twentieth century. Both the demands of globalized
governance and commerce, and the plethora of laws and regulations that govern its otherwise
free flow, however, require that these structures interact and generate coöperative programmes,
perhaps for the first time. Examples of such interaction are found in the United Nations, the
WHO and a host of other international organizations that have agreed to work together in order
to foster the Globally Harmonized System for the Classification and Labeling of Chemicals
(GHS).29 GHS is consistent with the current trend for international coöperation to bring together
rival agencies whose jurisdiction overlaps, in order to avoid the confusion that inevitably follows
multiple governmental involvement in regulatory structures. Parallel developments to unify
training and danger warnings are underway in the European Union, in tandem with GHS, using
the Registration, Evaluation, Authorization and Restriction of Chemical Substances30
(REACH) programme, which requires registration of information in a central database
established and maintained by the European Chemicals Agency (EChA) in Helsinki.
VIII. Regulatory criteria for coverage by law
The hallmark of clear law involves the use sharp, line-drawing definitions. Careful use of
language makes obvious the criteria for sorting out which is which: is an activity, process,
person, place or thing covered by the law? Or, is it outside the jurisdiction of the statute? What
would be covered by the proposed law—and what is outside the scope of the regulatory reach
contemplated by the legislation?
Despite the reality that scientific reports use the one to one hundred nanometre scale as a
definition of nanotechnology, it is not practical to put into the text of laws specific numerical
limits. What if some major, potentially catastrophic harm occurs due to the use of engineered
nanomaterials one hundred and one nanometres in size? Why regulate the eighty or ninety
nanometre use of technology that after scrutiny using reliable, established testing seems to do
28 Council Directive 92/85/ on safety and health of pregnant workers and a rather sweeping regulation
of so-called “minimum” standards for workplace safety and health are just a few of the many
pioneering aspects of EU directives. These activities in the legal realm are supplemented by a variety
of programmes, including the establishment of the office for safety and health in Spain, and a wide
variety of publications and newsletters.
29 Over 25 United Nations agencies and regional groups such as the EU, governments and individual
trade organizations participate in GHS to promote consistency among hazard and risk assessment
within the global system for hazard classification, with a view to implementing GHS at the national
level. This includes preparation of risk assessments for specific chemicals and developing and
harmonizing hazard and risk assessment methods as well as preparing concise international chemical
risk assessment documents, international chemical safety cards, pesticide data sheets and poisons
information monographs. The official text of the GHS, which was adopted on 27 June 2007, is
available on the web at: http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html
30 The REACH (EC 1907/2006) regulation went into effect on 1 June 2007. The aim of REACH is to
protect human health and the environment through better and earlier identification of the intrinsic
properties of chemical substances and to require manufacturers and importers to gather information
on the properties of their chemicals.
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no harm? And, legislative history has taught theorists that the application of any numberbased
standard is easily subjected to a numbers game; some applications will be developed
that expressly avoid the number-based criteria in the legislation, whether the regulators write
about nanoparticles or taxable limits on salaries! Therefore, the most important criteria for
defining the jurisdiction of regulations or rules governing nanotechnology may not be
particularly scientific at all, because they will be contextual. How is the material used, and
who is placed at risk by its use?
The Royal Commission on Environmental Pollution called this approach “functional
anlaysis”. After taking testimony from experts in many walks of life, the Commission was
baffled whether nanotechnology is so new and novel that it requires new laws. It could be, as the
USA’s Environmental Protection Agency asserted in 2005, that existing materials already
regulated need not be subjected to a new round of regulatory scrutiny—even though the
threshold levels for safe exposure were conceived when the materials were well above the
nanoscale. Or, it could be that there were so many new materials constantly being synthesized
and so many innovative ways of using them that had never been envisioned by humanity and so
many risks that were never imagined either, that the existing law had to be modified, or, indeed
new laws to cover nanotechnology’s new developments had to be created. The Royal
Commission was evidently unclear about resolving the question whether anyone needs new
law, but it was clear that some type of law should govern the new industry. Out of all the criteria
for regulation, the Commission favoured regulation based on function in commerce and society.
This basis also takes into account the views of stakeholders, because who will use the products
and how they will be trained is part of the functional analysis. Thus the same product may have
a different regulatory outcome on the shelf of a grocery store or a pharmacy, compared to the
blanket applicability of workplace exposure limits in industry.
The Royal Commission was wise to choose this approach. Legislators frequently follow
such a path when the decisions to be made at the time of the writing the legislation is full of
uncertainty. Typically, this is accomplished by avoiding defining the key term in the law
entirely. For example, both the United Nations Convention on the Prevention of Discrimination
Against Persons With Disabilities (2006) and the USA Americans with Disabilities Act (ADA)
that formed the model pattern for the international law, do not define disability. Instead, these
laws define a host of contexts in which people are treated as disabled— regardless what disease
or illness they have and, in some cases, regardless whether they are healthy or not. This enables
the people writing the law to craft criteria for determining which problems are important
enough to merit the bureaucratic resources and attention of the legislation, without
inadvertently also regulating minor situations that would distract implementation of the law. In
addition to avoiding the political compromises inherent in determining “who is in, who is out?”
under the law, which can stall passage of a law or its implementation, this approach has the
added benefit of creating a flexible framework that can address new problems, especially
problems that could not be anticipated at the time when the law was written.
IX. Labelling
The legislative drafting question whether labelling is important has two possible answers:
1. Labels are important because of consumer perception of risk.
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2. Labels are designed to actually inform consumers about their personal risk from
nanomaterials so that they can make informed choices when purchasing cosmetics, food and
a variety of wholly manufactured nanotechnology products.
The situation regarding consumer exposure remains equally unclear in either case. If
consumers demand a type of information, the market is likely to provide that information,
regardless of regulatory requirements. Yet, if there are genuine risks to health, it is not clear
what information can or should be disclosed as a matter of law. Therefore, any meaningful
criterion requiring disclosure under law must also explain, to some extent, how much risk is
acceptable in order to determine which products fall under the regulations.
X. How big is nano, how small is not nano?
According to the strategy set forth by the European Commission of the EU, “originating from
the Greek word meaning ‘dwarf’, in science and technology the prefix nano signifies 10–9; that
is one thousand millionth, hence one nanometre is one thousand billionth of a metre … the term
nanotechnology (for the purposes of the EU strategy) as a collective term, encompassing the
various branches of nanosciences and nanotechnologies.”31, 12
Although fascinating, it is not clear that one could apply the rest of the European
Commission’s strategic definition to a specific place or operation in manufacturing as a matter
of law: “Conceptually, nanotechnology refers to science and technology at the nanoscale—of
atoms and molecules—and to the scientific principles and new properties that can be
understood and mastered when operating in this domain. Such properties can then be observed
and exploited at the micro- or macroscale; for example, for the development of materials and
devices with novel functions and performance”.31 If international regulations were to apply this
definition and the types of uses covered, there is hardly any operation of life that one could
exclude from the coverage of the corresponding laws!
For the purposes of a law, several sources demand flexible criteria that take into account:
1. Properties that are important compared to properties that are of no consequence from the
standpoint of risk.
2. Criteria for determining how such priorities regarding consequences are to be weighed in
their natural context.
3. A policy determination that clarifies at what temporal moment (epoch) does the regulatory
framework or the law capture the data that is used to make these determinations, ignoring
later developments?
So-called “functionalization of nanoparticles” is typically achieved by different linkage
methods such as covalent (e.g., amide linkage, disulfide linkage), encapsulation or
entrapment. Nanoparticle formulations exist in some physical state (e.g., emulsion, hydrogel
or powder) and can be generally characterized as multicomponent systems containing
nanoparticles, functionalizing agents and the associated medium in which these components
are contained. The same nanoparticle formulation can contain one or more different types of
nanoparticles that vary in their structure, function and chemical composition; examples
31 Towards a European Strategy for Nanotechnology, p. 4. Luxembourg: Office for Official Publications
of the European Communities (2004).
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include liposomes, nanoshells, metal oxides, quantum dots, nanocrystals and polymer-based
nanoparticles.32 Formulations using such nanoparticles are already in clinical development or
in the marketplace.18–20
One local municipality has attempted to protect its citizens, but in the process has joined
the fray of regulatory dilemmas: According to the survey broadcast by the Cambridge (Mass.)
City Council, “engineered nanoscale materials” includes materials composed of particles or
structures with at least one dimension between one and one hundred nanometres. These
materials are referred to as “engineered” because they are manufactured and used purposefully
to make use of size-related properties” (an appendix at the end of the survey includes a list of
some common engineered nanoscale materials presently in commerce).
In particular, what if there is a major breakthrough in the state of the art of measurement or
the state of the art regarding understanding of empirically based risk between the time that the
law is written and the time that the law will be applied?
Such concerns can be built into a flexible framework under law, but implementation is a
matter of political will beyond the laboratory, crossing impermeable borders into the hearts and
minds of people throughout civilian society.
XI. Conclusions: regulating the real nano
Governmental structures at all levels of society presently face a situation in which there is
potential risk to public health, but insufficient data exists about actual risk in order to make key
policy judgments. Consequently, the regulatory picture of the legal landscape presently looks
like a scene from the wild, wild west of the USA in the 19th century: large gaps in the law
where there is undisputed uncertainty about the magnitude of risk, and many different sources
of law clustered around tangible, established practices for any toxic or hazardous materials,
such as medical surveillance through employer-based occupational health services and global
sharing of chemical hazard information using engineering controls.
Big risks have been successfully addressed by governments in the past to enable industry
and commerce to flourish by promoting useful but potentially dangerous technology, by creating
flexible frameworks for oversight and by providing placeholder space in final legislation for new
methodologies. As a result, society has won the benefits when it gambled with regulated risk.
The Royal Commission on Environmental Pollution would like regulators to focus on
“functionality”. Their proposed criteria for whether a chemical is regulated as nanotechnology
depend not only on size (considered as a nanoparticle) or form but, more importantly, on how
the nanomaterial is used. As discussion of “functionality” drills down it soon becomes clear that
the answer to this question must be examined on a case-by-case basis, and that the answer may
even be different with each use of the same substance, thus giving the impression that even
nanolaws must function in the nanoscale! This also brings into the debate an important question
about the meaning and purposes of labels for consumer use in society. In a context where the
functionality impacts thousands or millions of people, or where people believe that a product
32 Thomas, D.G., Klaessig, F., Harper, S.L., Fritts, M., Hoover, M.D., Gaheen, S., Stokes, T.H., Reznik-
Zellen, R., Freund, E.T., Klemm, J.D., Paik, D.S. and Baker, N.A. Informatics and standards for
nanomedicine technology. Wiley Interdiscip. Rev. Nanomed. Nanobiotechnol. 3 (2011) 511–532.
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incorporates nanotechnology even when it does not, it soon becomes possible that nanoregulations
will envelope everything! In such a context, the difference between the genuine scientific use of
“nano” and the popular use of the term can become meaningless.
Application of the law to relatively harmless uses of nanotechnology is wasteful. Conversely,
a miscalculation regarding risk that excludes harmful applications of nanotechnology can mean
the difference between life and death.
Therefore, there is probably no single criterion that will suffice to define “nano”, and the
use of no term defining nanotechnology and its related sciences may be the wisest use of
language for all. This has been accomplished in major national and international legislation, in
which the key terms of the law are never defined at all. For example, both the United Nations
Convention on the Prevention of Discrimination Against Peoples With Disabilities (“PWA”)
and the Americans with Disabilities Act (ADA) nowhere define disability. And, in the USA’s
Occupational Safety and Health Act of 1970, neither “safety” nor “health” is ever defined.
Hence, there is no law requiring nanotechnology laws to define “nano” terms!