Download Ethical perspectives on nanotechnology

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Ethical perspectives on nanotechnology
“NANOTECHNOLOGY could become the most influential force to take hold of the technology
industry since the rise of the Internet. Nanotechnology could increase the speed of memory
chips, remove pollution particles in water and air and find cancer cells quicker. Nanotechnology
could prove beyond our control, and spell the end of our very existence as human beings.
Nanotechnology could alleviate world hunger, clean the environment, cure cancer, guarantee
biblical life spans or concoct super-weapons of untold horror. Nanotechnology could be the new
asbestos. Nanotechnology could spur economic development through spin-offs of the research.
Nanotechnology could harm the opportunities of the poor in developing countries.
Nanotechnology could make the molecules in ice cream more uniform in size. Nanotechnology
could enable a digital camera to work in the dark. Nanotechnology could clean up toxic waste
on the atomic level. Nanotechnology could change the world from the bottom up.
Nanotechnology could become an instrument of terrorism. Nanotechnology could lead to the
next industrial revolution. Nanotechnology could transform the food industry. Nanotechnology
could repair the ozone layer. Nanotechnology could change everything.” UNESCO 2008
Introduction
Nanotechnology is the emerging technology of the 21st century. It has been called the “science
of the very small.” To many people, it may seem inconceivable that humans are able to
manipulate matter at the atomic level, utilizing elements and compounds to form new materials
with size and structure not found in nature and with remarkable new properties. From the
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domain of research to application in consumer products, this technology has moved with
remarkable speed enhanced by substantial government subsidies to the private sector and
academia.
The ethics of new technologies involve multiple considerations, including the social utility of
innovation, impacts on individuals and society, and the political economy of the state. Failures
to acknowledge the importance of engaging these ethical concerns are considered to have
contributed to major economic failures for the biotech industry as well as negative impacts on
US agricultural exports of the products of genetically modified organisms to several countries,
including the EU (Cameron 2006).
There are also ethical concerns about the rights of less developed countries and populations
within countries to access and share in the potential benefits (including economic growth) of a
new technology, which involve but are not limited to legal issues of intellectual property
(UNESCO 2008). The proposect of unequal access to the benefits of nanotechnology is a real
issue, since investments and intellectual production have been dominated by the US, the EU,
China and Japan (see figure 1, from OECD). However, there is evidence that in contrast to
biotechnology, other countries have more rapidly participated in research community through
“early adoption” of nanotechnology in national programs explicitly linking research to economic
growth. In Brazil, nanotechnology policy began in 2001 with a CNPq program to support
“Redes nacionais de nanotecnologia” with support at the level of US$5 million increasing to
US$58.9 million in 2004 for a for year program of development towards production (Kay ND).
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Fig 1. Dominance of US, Japan, and China: publications per year by country of lead
author. Data from OECD (http://www.oecd.org/dataoecd/36/17/42326281.pdf).
I am certainly no expert in bioethics, and it is daunting to enter a field that has its own journal
(Nanoethics). In this paper, I will focus more narrowly on an issue of relevance to my training
and experience in toxicology: the ethical aspects of nanotechnology in the context of
understanding health and environmental impacts. Arguably, this is the responsibility of those
countries in which new technologies are developed, since these are the locations of the largest
economic and human capital resources required for generating a knowledge base for both
technology development and assessment.
A reasonable question at the outset is whether nanotechnology raises novel ethical issues, or
whether an informative ethical analysis can be built upon experience in areas such as applied
biotechnology (Cameron 2006). Nanotechnology is clearly a convergent technology (Roco
2006), in that it is a transformative methodology rather than simply an application. That is, the
ability to synthesize and manipulate matter at the atomic scale is being utilized to serve many
applied and research purposes, including medicine, engineering, materials analysis, electronics,
energy generation and storage, agriculture, biological and chemical sensing, etc. In this way it
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resembles genetic engineering, which is the transformative technology driving applications in
medicine to agriculture. Issues of convergence are of importance in ethics but as Ellul (1968)
has argued, it is difficult if not impossible for any sector in civil society to prevent convergence
due to the force of technology within modern society.
At some level, many issues in new technologies involve the balance between innovation and
caution, which has been a concern in societies since the industrial revolution and of heightened
concern following the chemical revolution of the 1880s and the technical revolutions following
the Second World War. Rosner and Markowitz (1985) illuminated this tension in their history of
the introduction of tetraethyl lead into automotive fuels in the US in the 1920s; the chairman of
Standard Oil referred to this innovation as a “gift of God” in response to concerns voiced by
public health experts. This event is arguably one of the technological innovations that had the
broadest adverse impacts on worker and community health around the world (Silbergeld 1997).
The history of TEL also illuminates some aspects common to the introduction of new
technology, which characterize the development of nanotechnology as well (Table 1).
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Table 1 THE TAXONOMY OF NEW TECHNOLOGIES – 20th AND 21st CENTURY
Government-industrial-academic partnerships in research
Government subsidies for developing new technology
Promises of major social benefits from technology
Economic benefits (jobs, national economy) promoted by government and industry
Assertions that benefits will outweigh any reasonably anticipated risks or impacts
Applications introduced with minimal assessment of risks
Early applications have marginal social utility or benefits
Concealment of the presence of new technological products in consumer goods
The strategic engagement of academia in the development of new technologies over the past
60 years began in the US with the development of nuclear weapons during the Second World
War, and has been critical to the subsequent development of microelectronics, biotechnology,
and nanotechnology. In the US the origins of this national strategy goes farther back, to the socalled land grant state university system, established by federal and state government to
support institutions of higher education with the goal of strengthening American agriculture.
The modern era of massive investments in higher education and academic research in the US
began after the Second World War, based upon the vision of Vannevar Bush, who connected
support for education and research with economic growth. This not only fostered the growth of
the modern American research universities, such as Johns Hopkins, but, as argued by Krimsky
(1999) and many others, compromised the independence of academic scholars as critics of
technology. This compromise can be lessened when governments also invest in the production
of knowledge relevant to the safe development and application of technology, but this rarely
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happens on a scale or time course sufficient to provide relevant and timely information to
government, industry, and the public on the risks and benefits of a new technology.
Because of the importance of timely and accessible information about new technologies, I
propose to examine the ethical aspects of nanotechnology in the context of the control of
knowledge, that is, the ethics of ensuring adequate knowledge on risks and benefits prior to
introducing innovations in the workplace, marketplace, and environment. The generation of
information and access to that information are the first ethical requirements for an informed
social debate among parties at interest, for governments to make decisions and for the public to
participate in the process. Among others, William Ruckelshaus (twice administrator of the US
EPA) noted the adverse impact of complicated decision making tools (such as risk assessment)
because of their impact on the ability of the public to participate in democratic processes (1983).
It is relevant that the proposed Safe Chemicals Act of 2010, introduced in the US Senate,
requires that risk assessments be “understandable.” NGOs and others have challenged its
efficacy as a regulatory tool as well as the increasing suspicion of the public that it is a
malleable tool for political and economic purposes (Silbergeld 1993).
Barriers to information on technological risks in the US
Before discussing the problem of information as an ethical issue in nanotechnology, it is
important to recognize that there are general impediments to information on technological risks
in many countries. These include barriers to accessing information when it exists and the
obstacles to requiring the generation of new information. The former set of barriers are
embedded in economic policy and law in many countries, establishing the concept of
“confidential business information” or the right of industry to keep information away from the
public on the grounds of its economic value to competitors. Ethically, adoption of such policies
places a higher value on the interests of the private sector than on the value of an informed
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public. This deference is not restricted to capitalist economies: in many countries, as
catalogued by the OECD Environment Program, even state-owned industries enjoy protection
from public disclosure of information on health and safety. With the rise of regulatory agencies
with mandates to register (approve) chemicals and technologies, this deference has been
reduced to some extent, but these agencies accede to claims of confidential business
information in terms of the extent of data collection and public access to this information (in the
case of pharmaceuticals and pesticides in the US, for example). Confidential business
information will be maintained in the new REACH legislation in the EU.
The second set of barriers are more complex and in many ways raise more systematic
problems as they prevent the generation of information ab initio, and without information, the
right of access is irrelevant. For chemicals there are major barriers in current laws and
regulations in the US to requiring the production of information on the products of new
technology. Unlike drugs and pesticides, new industrial chemicals (which are how
nanomaterials may be defined; see below), are not required to be tested prior to their production
and use. Under the current Toxic Substances Control Act (TSCA) for existing chemicals the
procedural obstacles to government requesting information are difficult to surmount, such that it
is now universally accepted that chemicals are assumed to enjoy the Anglo-Saxon right of
innocence until proven guilty. As a result, the majority of existing chemicals (even high
production volume chemicals) have little or no information to support an assumption of safety
about their presence in the environment or their use by workers and consumers. For new
chemicals, the burden is placed on the EPA to demonstrate a need for information, rather than
on the producer to supply this information. This has resulted in a policy of “don’t tell, don’t ask”
in the US, in which industry is not required to tell and government is unable to ask.
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In the US, there is argument as to whether current laws could empower agencies to act on
nanomaterials as new chemicals. The US chemicals law defines existing chemicals based on
chemical composition nomenclature from the Chemical Abstracts Service (CAS); as titanium
dioxide or carbon are already listed on the TSCA inventory, these substances in nanoform
would have to be regulated as an existing chemical. The newly proposed Safe Chemicals Act
redefines the scope of regulation to include “chemical substances and materials,” which is
recognition of the issues involved in defining nanomaterials. TSCA does provide EPA with the
powers to initiate new regulations under conditions of a “significant new use”, but this has in the
past been interpreted as a mass-based criterion of significance. Since the total mass of any
nano-based use of titanium or carbon would be very small, “significant new use” would need to
be interpreted as a use involving a different form, properties, and purpose. Those countries that
have adopted principles of chemical regulation from US law and practice have similar barriers.
Recent advances in regulation and law, starting in the EU with the REACH legislation, have
dramatically shifted the burden to producers to provide evidence of safety for existing and new
chemicals, rather than governments having to justify a request for information. The feasibility of
implementing REACH remains hotly debated in terms of the resources ot time, expertise, and
animals that will be required (e.g. Hartung et al 2009; Williams et al 2009). Moreover, it is not
yet clear if REACH can “reach” nanomaterials; as with TSCA its requirements for information
are based upon volume (mass) of production and use. Even for carbon nanotubes, a
nanomaterial with increasing uses in consumer products and industrial processes, growth in
production is still below the threshold that triggers submission of comprehensive information on
health and ecological impacts.
Other regulatory agencies in the US are similarly limited when information is lacking. The
Consumer Product Safety Commission, which has the power to regulate products (under
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current US law the EPA only regulates chemicals), is not able to undertake independent
analysis of constituents in products; it acts upon findings from EPA or other agencies with
respect to risk assessment. At the FDA, nanomaterials have so far fallen into the large loophole
for evaluation and action related to the concept of GRAS (generally recognized as safe), a
designation created decades ago on the basis of expert judgment that results in an assumption
of safety without the need for additional data or de novo hazard or risk evaluation. Discussions
at the FDA have centered on whether a substance that has been considered GRAS, or safe at
the macroscale should also be considered safe at the nanoscale. Michael Taylor, newly
appointed deputy director of the Center for Food Safety at FDA has stated that nanoparticles
with novel properties should be deemed to be new substances for purposes of safety evaluation
but up to the present, FDA has undertaken no actions to restrict use of nanomaterials or to
require safety evaluations.
In terms of worker health, the US Occupational Safety and Health Administration (OSHA) can
promulgate standards for agents in the workplace, but the resource constraints on this agency
are such that most of its standards were adopted from old analyses conducted by an outside
organization with very few new workplace standards completed over the 40 years of OSHA’s
existence. OSHA regulations also tend of focus on work activities and industries rather than on
specific substances, which is efficient but may not work for a technology already in use in
multiple industries. In terms of access to information in the US workers can obtain information
relevant to health and safety through “right to know” and Material Safety Data Sheets (MSDS).
However, the information in the MSDS is provided is produced by the employer and is limited by
CBI (as discussed above) as well as by the decision of the employer. They are generally
uninformative as to the full list of chemicals present in commercial or industrial commodities;
they consist of summary information based upon the judgment of the employer who has the
prerogative to determine which hazards are to be communicated. An example of a
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manufacturer’s MSDS is shown in Figure 2 for cadmium-selenide quantum dots; note the
contradictions in the material presented in terms of hazard as well as the overall paucity of
information. The useful content of these documents largely consists of preventive measures
that workers should take, such as protective equipment and appropriate responses to spills and
other unintended contact. Since protective equipment is usually supplied by the employer, the
worker has limited autonomy in evaluation or response.
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Fig 2. An example of a Material Safety Data Sheet form for cadmium-selenide quantum
dots (from Evident Technologies, prepared in 2005)
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The “ethical crisis” of nanotechnology
Nanotechnology has moved from the research laboratory into production and consumer
products with great speed over the past 20 years, with relatively little oversight by government
or awareness on the part of the public. This process has been substantially supported by
national governments in anticipation of its potential contribution to national economies. In the
US, the federal government has spent over $6 billion through the National Nanotechnology
Initiative (NNI), and many states have emulated the NNI with their own programs of public
investment. Over 25 federal agencies are involved in nanoresearch, ranging from defense to
health and environment. In 2006, the NNI estimated that by 2015 nano-based industries will
generate over $1 trillion and employ at least 2 million workers. In the context of the current
world wide recession and general loss of industrial jobs in many countries, these predictions are
extraordinarily attractive.
The publicly stated promises of nanotechnology have been equally remarkable: as noted by
UNESCO in the introductory quotation, its proponents have claimed that nanotechnology will
support new energy and information technologies, transformations in medical diagnosis and
treatment, advancements in agriculture, protection against terrorism, and even environmental
cleanup
However, consistent with the taxonomy of Table 1, most of the commercialized
products of NT have been mundane and of marginal social benefit: cosmetics, sunscreens,
fabric and other surface treatments, and food container coatings. A website at the Woodrow
Wilson National Center (www.wilsoncenter.org/net) provides relatively frequent updates on
nanotechnology applications and products in commerce.
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Figure 3. Growth in nano-based products for sale in the US from 2005 to 2011 (estimated). Data
from WWNC Project in Emerging Technologies, 2010.
Over the past five years during which nano-based products have entered the marketplace,
governmental responses around the world have been complaisant, if not complicit. The amount
of government investment in health and safety research related to nanotechnology has been
very small compared to overall subsidization of this technology, as shown in Figure 4. More
forward plans have been published by the National Nanotechology Initiative since 2006, but the
stated timelines for funding research on health and environmental risks will not be completed for
at least 10 years, according to the NNI (2008), which will not enable information-based policies
to take effect in a reasonable time frame in the context of exponential growth in nanobased
products (figure 3).
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Figure 4. National and sectoral investments in nanotechnology, 2004 and 2006. During this
period, in the US only $44 million (or less than 2%) was allocated for research on health and
environmental impacts. Data from UN.
No government has required any meaningful assessment of any of these introductions on the
basis of data specific to the nanomaterial. Some regulatory agencies justified this inaction,
without any empirical basis, on the assumption that hazards can be inferred from the macro
form of the compounds to the nano form. For example, the US FDA determined that additions
of nano titanium dioxide to cosmetics could be considered harmless based upon the lack of
harm associated with vastly larger titanium implants. This is a priori untenable, since the
rationale for deliberately engineering new materials at the nanoscale is the acquisition of novel
properties that confer new applications. Moreover, emerging data indicates that this is not a
reliable approach; for example the ecotoxic effects of nanosilver are not found with silver in a
crude form (Powers et al 2010). It has also been claimed that nanomaterials are not a risk
because they are embedded in the product, despite a long list of chemicals supposedly
embedded in products that were later shown to be released under conditions of normal use
(such as bisphenol A and PBDEs in plastics). The performance of some nanomaterials (such
as nanowhiskers as surface treatments) depends upon their exposure to the external
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environment to repel liquids. Other currently allowed (and unreviewed) applications are overtly
dispersive, such as nanosilver in washing machines (as a biocide) or cerium oxide as an
additive to automotive fuels. Even for these uses governments have not required production of
data on environmental fate or ecotoxicity, which is usually required for biocides and persistent
chemicals.
Public engagement in nanotechnology
In most countries, public concern is an essential driver for policy debate and action (Walt 1994).
In the case of nanotechnology, the public is notably absent from this discourse, which is an
important factor in the absence of debate as this new technology has moved from research to
development to application. The lack of public notice or engagement is striking in comparison
with some other technologies, such as nuclear power and biotechnology. The trend towards
public passivity in the face of new technology was noted in 1954 by the French philosopher and
sociologist Jacques Ellul (1968).
A focus group survey in 2007 involving 1800 adults in the US found that over 90% expressed
favorable opinions about nanotechnology (www.nanotechproject.org). A 2009 national survey in
the US found that 68% of the public had heard little or nothing about nanotechnology and, as
shown in figure 4, knowledge of nano has increased only slightly over the past 4 years.
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Fig 5. Results of a national poll (Hart Assoc) commissioned by the Woodrow Wilson National
Center on public knowledge of nanotechnology, US.
http://www.nanotechproject.org/process/assets/files/8286/nano_synbio.pdf)
The OECD commissioned an analysis of blog postings about nanotechnology in 2006. As
shown in Figure 6, these are strikingly positive; health and environment were the areas of most
negative blogs but even in these areas, negative comments were less than 10% of the total.
Fig. 6. Analysis of blog postings in 2006 concerning nanotechnology. Data from
(http://www.oecd.org/dataoecd/36/17/42326281.pdf; it is not clear how this analysis was carried out).
Several reasons have been proposed for this lack of engagement: lack of public
disclosure by industry or governments on nanotechnology; the complexity of the topic;
increasing scientific illiteracy; lack of leadership by independent experts and
organizations; “burnout” over environmental issues; pre-eminent concerns such as
climate change, economics and terrorism. The issue of leadership is demonstrable.
Most major environmental nongovernment organizations (NGOs) have not taken activist
stances. Friends of the Earth (FOE), an international green NGO, is an exception; FOE
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has produced materials on nanotechnology and convened conferences for activists and
has requested companies to disclose use of nanomaterials in products, such as
cosmetics. In 2009 FOE called for an immediate ban on the use of nanosilver
(http://www.foe.org/healthy-people/nanosilver). The Environmental Defense Fund, one
of the major environmental NGOs in the US, has taken a deliberate strategy of working
with industry to develop proposals that will increase information about potential health
and environmental impacts without impeding the industry (Balbus et al 2005; 2007). A
quotation from EDF’s website exemplifies this approach:
We see our role as guiding people to carefully consider and manage the
potential implications of nanotechnology. We are advocating for a
proactive approach, both by working with companies to establish
standards of care and by seeking to enhance government regulations
to identify and address risks, even as more is learned about the various
exciting possibilities of this emerging science.
http://www.edf.org/article.cfm?contentID=4449
Actions in the absence of information
Absence of evidence on hazard is not evidence of absence of hazard. Despite the obvious
ethical import of this adage, there appears to be general acceptance that it is not possible to
prevent the introduction of nanotechnology into the workplace and consumer products, or the
environmental releases that can be expected to accompany production, consumption, and
disposal. This is not a most satisfactory option in ethical terms, but without public concern the
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likelihood of political support for interdiction or bans is very low. The promises of the technology
are extreme, such that some may be tempted to accept the premise that even very large risks
would be outweighed by the benefits. Thus at this point, an ethical analysis must consider
actions that can be taken in the absence of information and of the compulsion to generate
information in the short term. Several of these are discussed below.
1. The best practices approach and product stewardship
Regulatory agencies have developed strategies to formulate and promulgate recommendations
based on a “control banding” approach that relies on inferences or general knowledge
concerning likely health risks. Control banding is widely used in the UK to regulate occupational
exposures through actions that achieve specific levels (or bands) of exposure reduction using
best practices relevant to the known or assumed nature of the hazard. An example is shown in
Table 2 for control bands related to inhalation exposures and the presence of dusts in the
workplace (http://www.cdc.gov/niosh/topics/ctrlbanding/pdfs/CBFAQ.pdf).
A similar qualitative approach is utilized for recommendations related to environmental as well
as occupational hazards in the Globally Harmonized System for Chemicals. Like control
banding, these are relatively straightforward methods of risk management that do not require
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extensive or quantitative risk assessment, and is largely driven by hazard characterization and
use of available control technologies. The Globally Harmonized System for Chemicals was
developed by the UN Economic Commission for Europe and has been widely used in the EU
and recommended for global use by the OECD
(http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html) The GHS is also
incorporated as a decision matrix by REACH
(http://ec.europa.eu/environment/chemicals/ghs/index_en.htm) . The GSH uses simple
pictograms to convey the nature of the hazard (see figure 2) and risk management actions, as
with control banding are based upon the hazard and a “band” or range of anticipated toxicity,
rather than more precise quantification of dose:response as in risk assessment.
While these approaches do not support specific standards, such as ambient air
concentrations in the environment or permissible exposure levels in the workplace, they
at least provide notice of potential hazard along with recommendations for feasible
actions to reduce exposures. This approach has the advantage of being able to be
implemented quickly, thus reducing the need for extensive information and analysis, but
it is necessarily limited to the extent the hazard is correctly identified. In the case of
nanotechnology exposures, it has been proposed that the occupational health hazards will be
similar to those associated with inhalation of small particles (Maynard and Keumpel 2005).
However, there are data emerging to indicate that carbon nanotubes (of specific size and
structure) may possess asbestos-like hazards in terms of fibrosis and pleural carcinogenesis
(Bonner 2010). If this is the case, then a disastrous error may have made in terms of the long
term costs of chronic diseases with long latency (EEA 2001); for asbestos, it has been
estimated that total industry liability in the US along may reach $200 billion (Balbus et al 2005).
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There have also been attempts to develop “best practice” recommendations for sate production
and use of nanotechnology. Some of these have been compiled by the US National
Nanotechnology Inititative and are available at the NNI website
http://www.nano.gov/html/society/occupational_safety/. In 2006, the German government and
chemical industry association jointly developed recommendations based on current practices in
occupational safety and health within industry (Heinemann and Schafer 2009). These included
reducing contact with nanomaterials in power or aerosolized form, using contained work stations
as much as feasible, purifying air before discharge through ventilation systems, provision of
protective clothing (work clothes, goggles, gloves, and respirators depending upon job), and
evaluation of these safety measures.
Whether these recommendations are in practice is not known. Because recommendations are
not enforceable, implementation depends upon voluntary actions by industry, in the spirit of
product stewardship. Results from a survey of 40 German and Swiss companies working with
nanomaterials, conducted in late 2005-early 2006, are not encouraging (Heiland et al 2009).
The results indicated a lack of concern and action: 65% of the companies did not perform any
risk assessment and 75% had not established limits for exposure concentrations or time. The
majority did not anticipate any risks of exposures over the lifecycle of production and use. This
anticipation is directly contradicted by a recent study by Johnson et al (2010) documenting the
relatively high concentrations of airborne nanomaterials measured in laboratories working with
nanomaterials. These findings challenge the assumption that industries will self-regulate worker
protection.
The disclosure approach
In both the absence and presence of information-based regulation, labels can be an important
mode of risk management by altering user and/or consumer behavior. Disclosure has been
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utilized to accomplish several goals (1) reduce risks by stipulating conditions of use and
disposal (household cleansers or batteries), (2) reduce use of products that are not regulated
(transfats in food or cigarettes), to empower the public to make choices (recycled material
content or organic food labeling in the US),, and to provide incentives to producers to take
actions that are either not regulated or deemed safe under regulation (California’s Proposition
64 or the US EPA Toxics Release Inventories).
The power of labeling is evident from the vociferous resistance by industry to labeling proposals
in the US and elsewhere. It is generally argued that the presence of a label discourages use
despite the use of positive labels (such as country of origin or organic food labels). For this
reason, labeling unregulated products generates considerable opposition. On the other hand,
labeling can generate misleading labels (such as “natural”, a food label without specific meaning
in the US, or “contains no trans fats” on food that contain and have never contained fats).
Labeling is not necessarily an effective substitute for regulation; consumers can be overloaded
by information such that their content is ignored (Magat et al 1988)
No government has required labeling of products for the presence of nanomaterials. The US
FDA in 2007 determined that a label could be misleading without sufficient basis to conclude
that the presence of nanomaterials in a product affected its safety or effectiveness
(http://www.reuters.com/article/idUSN2514226320070725) . Industry has taken a cautious
approach to disclosure or labeling, after years of promoting this new technology for its vast
social benefits. This strategy of nondisclosure may have been partly inspired by the publicity
surrounded a reported incident of human intoxication to a product that was later reported not to
contain nanomaterials. The Foresight website (an organization generally promoting new
technologies) posted a blog in 2006 entitled “Think twice before labeling nanotechnology
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products” and calling for a “precautionary approach to the strong version of the precautionary
principle” (http://www.foresight.org/nanodot/?p=2339).
The failure of precaution
The current status of ignorance on the risks of nanotechnology would seem to represent exactly
the situation that the precautionary principle was meant to redress, to prevent repetitions of the
case studies evoked forcefully by EEA (2001), in which technological innovations (including lead
in gasoline) were introduced without requiring adequate information for their safe use. The
precautionary principle has been officially codified in the EU and the proposed Safe Chemicals
Act introduced into the US Congress in 2010 makes extensive reference to this principle as well.
In practice, the precautionary principle has not been applied to nanotechnology even by its
strongest proponents in the European Union. There are at least three reasons for the failure of
precaution as a basis for policy with respect to nanotechnology: first, many of the governments
endorsing the precautionary principle in the EU and elsewhere have large financial stakes in the
development of nanotechnology; second, as indicated above, there is no clear statement of the
precautionary principle within EU legislation; and third, the precautionary principle is not clearly
applicable to conditions where no information is available to raise a flag of concern. The
European Union, like the US and Brazil, has made major investments in the development of
nanotechnology. Several major producers of nanomaterials – such as BASF and Bayer, are EU
corporations. Statements on nanorisk from the EU are weak and lack clear statements on the
need for information prior to any approval process. Finally, a careful reading of the principle
indicates that it is not free of the same problems that impede the US chemicals laws from acting
without information (Silbergeld 2004; Merchant et al 2008). There are several formulations of
the precautionary principle, but all include similar language along these lines: “actions should be
taken even in the absence of scientific certainty when there is evidence that significant risks are
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likely to occur” (emphasis added). These are the same words that have impeded US chemicals
policy for three decades under TSCA, where the burden remains on government to establish
that there is “evidence” and that the risks are both “significant” and “likely to occur.” The
examples of missed opportunities for precaution described in EEA (2001) are misleading, as
each involves issues in which much was known of the nature of the hazard as well as
exposures. Thus both the precautionary principle and risk assessment policies depend upon
information, although they may appear to differ in terms of the amount of certainty required for
action and on the assumption of innocence or guilt at the outset. In the context of
nanotechnology and the almost total lack of information on either hazard or likelihood, neither
approach is of assistance to regulatory agencies.
What are we to do in 2010
We are in a political, scientific, and ethical quandary. The elements of an ethical response to
nanotechnology, as to any new technology, include access to information and a commitment to
the generation of information relevant to public expectations of safety in the workplace and the
environment. The ethical right of access to information still holds in the absence of relevant
data, as discussed below.
The need for an immediate response is urgent. Economic forecasters trumpet the arrival of
nanotechnology in terms of its potential for stimulating national growth, supporting new industrial
development, increasing employment, and provided new solutions to old problems as well as
new products in a range of areas. We have increasing reason to expect a growing presence of
nanomaterials in the workplace, in our products, and in our environment. Many of the properties
deliberately engineered into nanomaterials – stability, surface reactivity, ability to penetrate
biological systems – can reasonably be anticipated to cause unintended problems throughout
the lifecycle of production, use, and disposal of these materials. Inevitably, nanomaterials will
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enter the environment and some currently approved uses are unavoidably dispersive.
Information on environmental fate and transport are very limited and potentially different from
what is known from studies of other types of pollutants. While the range of knowledge related to
nanotoxicology is still far behind the development of the technology, there are sufficient signals
to suggest that nanomaterials will behave differently from the same compounds at the macro
scale (Powers et al 2010).
Regulators appear unprepared for the arrival of this technology. As discussed above, existing
tools for decision making have not been utilized and many contain inherent limitations (see Lin
2007 for full discussion of US policy options). In addition, the scientific community has not
responded to the urgency of developing strategic approaches needed to catch up with the
production and use of nanomaterials. We have developed no strategy for testing or evaluating
nanomaterials and at present it is unknown as to what characteristics of nanomaterials may be
predictive of hazard, or whether and to what extent these characteristics may inform
scientifically based assessments that can reduce the requirements for extensive testing of
thousands of materials. There is an urgent need to resolve this issue; some have suggested
use of existing test batteries (Balbus et al 2007); others have proposed increased reliance on .
rapid methodologies that may include in vitro or alternative methods (Nyland and Silbergeld
2009). However, this requires investments in further development of in vitro methods and their
interpretation (Park et al 2010). Others have recommended development of relational
databases, such as structure-activity relationships, to infer hazard from more limited datasets
(Clark et al in preparation).
In the absence of information, the ethical requirement of disclosure and access at a minimum
involves disclosure of the presence of nanomaterials in products or the workplace, through
notification of governments and other institutions, such as labor unions, and in other settings
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such as transportation, storage, consumption, and disposal. Lin (2007) has argued for
additional actions for what he calls “free nanomaterials”, but this assumes that nanomaterials in
products will not become “free” during the course of use and disposal. Experience indicates
that many chemicals are released from products during their lifecycle, including formaldehyde
from plywood, mercury from paints, PFOAs from teflon, lead from crystal and glazes, bisphenol
A from plastics. Inherently dispersive uses, such as pesticides and fuel additives (Stadler et al
2010) should be reviewed on an expedited basis In addition, a burden should be placed on
producers to develop methods for detecting nanomaterials prior to use so that increases in
exposure can be detected as quickly as possible. The inability to measure lead, for example, in
urban air and dusts impeded recognition of its widespread contamination until some 50 years
after its approval as a gasoline additive.
An additional proposal that has been advanced in other contexts of uncertain risk and untested
technologies is that of insurance, or bonding. Lin (2007) proposes a time limited bond, based
upon a “worst case scenario” of possible impacts, which could be lifted when the producer
supplies appropriate information to characterize the hazards more precisely (sufficient to
support risk management actions). The fund could also be utilized to compensate workers with
health impairments associated with nanomaterial exposures. This approach has been used in
the nuclear power industry (where the government funds the insurance fund) and in mining
(where companies are required to establish a fund for eventual site remediation). A publicprivate hybrid has been advocated by Takhlin (2008). The challenge is to determine a fee that
avoids being prohibitive (in which case an outright ban on nanotechnology would be more
honest) and at the same presents a realistic estimate of potential unforeseen damage.
There are ethical issues in the insurance solution; fundamentally, insurance is another form of
subsidization for technology development, particularly if public funds are involved in its support.
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Insurance for new technology raises other issues that are familiar to over 100 years of
experience in compensation systems in occupational health and safety First, these approaches
accept the likelihood of injury or impact and are designed not to prevent but to provide
compensation that may or may not be adequate but is certainly not preventive or capable of
making injured parties whole. Compensation for black lung disease or asbestosis does not cure
the disease or prevent premature death. Second, insurance systems inherently spread risk
(Rakhlin 2008) and thus treat responsible and nonresponsible parties equally. This can result in
discouraging exemplary behavior, such as the decision by an industry to investigate the
potential hazards of its products (such as BASF and its published research on carbon
nanotubes), unless there are discounts for “good behavior” (analogous to lower health
insurance fees for nonsmokers, for example, in the US). Third, there is little evidence to
suggest that insurance or compensation systems are ever adequately funded; the existence of a
$75 million “cap” on liability in the ongoing oil spill in the Gulf of Mexico indicates the problem of
incommensurability. A thought experiment demonstrates this: suppose in 1925, the US
government had required industry to fund an insurance program in return for permitting the
addition of tetraethyl lead to gasoline. Given the state of knowledge at the time about lead
toxicity (which was substantially greater than present knowledge of nanotoxicology), the fund
would not have been adequate to cover the unanticipated impacts of lead on the
neurodevelopment of children, cardiovascular disease risks in adults, or the cleanup of the
parks, school yards, and neighborhoods of every city in the US.
The need for international approaches
Ethical and practical arguments can be made for the need for international consensus on
actions with respect to nanotechnology. Experience suggests that chemicals in widespread use
contribute to transboundary pollution after environmental releases and through international
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transfers of wastes. International coordination ensures equal protection from such risk
transfers. Practically, international consensus may be more persuasive to national governments
that focusing on country-by-country actions. Those governments that have made investments
in the R&D phases of growing this technology on the order of billions of dollars are unlikely to
block applications that might cost them in terms of competitive economic advantage in terms of
international trade.
Recognizing this, Merchant and Sylvester (2006) have proposed new
models for transnational regulation of nanotechnology, a strategy that can speed research on
risk, share resources in regulation, and avoid what they term “nano divides” which may favor
certain nations in terms of technological and regulatory advantage.
Roco M (2006) Ann NY Sci 1093: 1-23
Roco has outlined the components of a transnational process as shown in figure 5 that include
civil society. These processes could include international consensus standards, conventions,
framework approaches, codes of conduct, and above all the full participation of informed civil
society. At the end, their success will depend upon meeting the most urgent ethical need in
nanotechnology -- the obligation to generate and disclose information relevant to decisions by
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industry, workers, consumers, and governments on the acceptability and priorities of this new
technology.
In conclusion, it is worth noting the prescient ending of Jacque Ellul’s prescient critique of
technology, written in 1954:
“…In the decades to come, technology will become stronger and its
pace will be accelerated through the agency of the state. The state and
technology – increasingly interrelated – are becoming the most important
forces in the modern world; they buttress and reinforce each other in their
aims to produce an apparently indestructible, total civilization.” (Ellul 1968).
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