Regulation of nanotechnology

Due to the ongoing argument on the implications of nanotechnology, there is significant debate related to the question of whether nanotechnology or nanotechnology-based products merit special government regulation. This debate is related to the circumstances in which it is necessary and appropriate to assess new substances prior to their release into the market, community and environment.

The nanotechnology label is used on an increasing number of commercially available products – from socks and trousers to tennis racquets and cleaning cloths. The emergence of such nanotechnologies, and their accompanying industries, have triggered calls for increased community participation and effective regulatory arrangements.cite paper |author=Katz E, Lovel R, Mee W, Solomon F |title=Social perspectives on nanotechnology research and development: a view from Australia |publisher= Participatory approaches in science and Technology, Edinburgh Scotland |date=2006 |url=http://www.macaulay.ac.uk/PATHconference/PATHconference_proceeding_ps7.html#session7.2.2 |] However, these calls have presently not lead to such comprehensive regulation to oversee research and the commercial application of nanotechnologies, [cite journal |author=Marchant G, and Sylvester D | title=Transnational Models for Regulation of Nanotechnology |journal=The Journal of Law, Medicine & Ethics| volume=34 |issue=4 |pages=714–725 |year=2006 | doi=10.1111/j.1748-720X.2006.00091.x] or any comprehensive labeling for products that contain nanoparticles or are derived from nano-processes.

Regulatory bodies such as the United States Environmental Protection Agency and the Food and Drug Administration in the U.S. or the Health & Consumer Protection Directorate of the European Commission have started dealing with the potential risks posed by nanoparticles. So far, neither engineered nanoparticles nor the products and materials that contain them are subject to any special regulation regarding production, handling or labelling.

Managing risks: human and environmental health and safety

Studies of the health impact of airborne particles are the closest thing we have to a tool for assessing potential health risks from free nanoparticles. These studies have generally shown that the smaller the particles get, the more toxic they become.Fact|date=June 2008 This is due in part to the fact that, given the same mass per volume, the dose in terms of particle numbers increases as particle size decreases.

Based upon available data, it has been argued that current risk assessment methodologies are not suited to the hazards associated with nanoparticles; in particular, existing toxicological and eco-toxicological methods are not up to the task; exposure evaluation (dose) needs to be expressed as quantity of nanoparticles and/or surface area rather than simply mass; equipment for routine detecting and measuring nanoparticles in air, water, or soil is inadequate; and very little is known about the physiological responses to nanoparticles.

Regulatory bodies in the U.S. as well as in the EU have concluded that nanoparticles form the potential for an entirely new risk and that it is necessary to carry out an extensive analysis of the risk.Fact|date=June 2008 The challenge for regulators is whether a matrix can be developed which would identify nanoparticles and more complex nanoformulations which are likely to have special toxicological properties or whether it is more reasonable for each particle or formulation to be tested separately.

The maintains a database and Virtual Journal of scientific papers on environmental, health and safety research on nanoparticles. [ [http://icon.rice.edu/virtualjournal.cfm/ Virtual Journal of Nanotechnology Environment, Health and Safety] ] The database currently has over 2000 entries indexed by particle type, exposure pathway and other criteria. The Project on Emerging Nanotechnologies currently lists 609 products that manufacturers have voluntarily identified that use nanotechnology. [ [http://www.nanotechproject.org/index.php?id=44&action=intro Nanotechnology - Project on Emerging Nanotechnologies ] ] No labeling is required by the FDA [cite web|url = http://www.planetark.com/dailynewsstory.cfm/newsid/43305/story.htm
title = FDA Says No New Labeling For Nanotech Products|accessdate = 2007-10-19|last = Dixon
first = Kim |date = 2007-07-21|format htm|work = Reuters News Service|publisher = Planet Ark ] so that number could be significantly higher. "The use of nanotechnology in consumer products and industrial applications is growing rapidly, with the products listed in the PEN inventory showing just the tip of the iceberg" according to Project on Emerging Nanotechnologies (PEN) Project Director David Rejeski [http://www.nanotechproject.org/news/archive/6697/] . A list of those products that have been voluntarily disclosed by their manufacturers is located here [http://www.nanotechproject.org/inventories/consumer/browse/products/] .

The Material Safety Data Sheet that must be issued for certain materials often does not differentiate between bulk and nanoscale size of the material in question and even when it does these MSDS are advisory only.

Democratic governance

Many argue that government has a responsibility to provide opportunities for the public to be involved in the development of new forms of science and technology). [cite paper |title=Democratic Technologies? Final Report of the Nanotechnology Engagement Group |url=http://www.involve.org.uk/negreport |] Community engagement can be achieved through various means or mechanisms.(2005)cite journal |author=Rowe G, Horlick-Jones T, Walls J, Pidgeon N, |title= Difficulties in evaluating public engagement initiatives: reflections on an evaluation of the UK GM Nation? |journal=Public Understanding of Science |volume=14 |pages=331–352 |url=http://pus.sagepub.com/cgi/content/abstract/14/4/331 |year=2005 |doi= 10.1177/0963662505056611] identify traditional approaches such as referenda, consultation documents, and advisory committees that include community members and other stakeholders. Other conventional approaches include public meetings and “closed” dialog with stakeholders. More contemporary engagement processes that have been employed to include community members in decisions about nanotechnology include citizens' juries and consensus conferences. Leach and Scoones (2006, p. 45)cite paper |author=Melissa Leach and Ian Scoones |title=The Slow Race: Making Technology Work for the Poor |publisher=Demos |url=http://www.demos.co.uk/publications/theslowrace |year=2006] argue that since that “most debates about science and technology options involve uncertainty, and often ignorance, public debate about regulatory regimes is essential.”

It has been argued that limited nanotechnology labeling and regulation may exacerbate potential human and environmental health and safety issues associated with nanotechnology, [cite journal |author=Bowman D, and Hodge G |title=A Small Matter of Regulation: An International Review of Nanotechnology Regulation |journal=Columbia Science and Technology Law Review |volume=8 |pages=1–32 |year=2007] and that the development of comprehensive regulation of nanotechnology will be vital to ensure that the potential risks associated with the research and commercial application of nanotechnology do not overshadow its potential benefits. [cite journal |author=Bowman D, and Fitzharris, M |title=Too Small for Concern? Public Health and Nanotechnology |journal=Australian and New Zealand Journal of Public Health |volume=31 |issue=4 | pages=382–384 |year=2007 |doi=10.1111/j.1753-6405.2007.00092.x] Regulation may also be required to meet community expectations about responsible development of nanotechnology, as well as ensuring that public interests are included in shaping the development of nanotechnology.cite journal |author=Bowman D, and Hodge G | title=Nanotechnology: Mapping the Wild Regulatory Frontier |journal=Futures |volume=38 |pages=1060–1073 |year=2006 | doi=10.1016/j.futures.2006.02.017]

Community education, engagement and consultation tend to occur “downstream”: once there is at least a moderate level of awareness, and often during the process of disseminating and adapting technologies. “Upstream” engagement, by contrast, occurs much earlier in the innovation cycle and involves: “dialogue and debate about future technology options and pathways, bringing the often expert-led approaches to horizon scanning, technology foresight and scenario planning to involve a wider range of perspectives and inputs.” Daniel Sarewitz Director of Arizona State University’s Consortium on Science, Policy and Outcomes, argues that “by the time new devices reach the stage of commercialization and regulation, it is usually too late to alter them to correct problems.” [cite paper |author=Brainard J. | title=A More Social Science |url=http://cspo.org/home/newatcspo/sarewitz_chronicle.htm |year=2005]

The stance that the research, development and use of nanotechnology should be subject to control by the public sector is sometimes referred to as nanosocialism.

Newness

The question of whether nanotechnology represents something ‘new’ must be answered to decide how best nanotechnology should be regulated. The Royal Societycite paper |author=Royal Society and Royal Academy of Engineering |title=Nanoscience and nanotechnologies: opportunities and uncertainties |date=2004 |url=http://www.nanotec.org.uk/finalReport.htm |accessdate=2008-05-18] recommended that the UK government assess chemicals in the form of nanoparticles or nanotubes as new substances. Subsequent to this, in 2007 a coalition of [http://www.icta.org/global/actions.cfm?page=15&type=366&topic=8 over forty groups] called for nanomaterials to be classified as new substances, and regulated as such.

Despite these recommendations, chemicals comprising nanoparticles that have previously been subject to assessment and regulation may be exempt from regulation, regardless of the potential for different risks and impacts. In contrast, nanomaterials are often recognised as ‘new’ from the perspective of intellectual property rights (IPRs), and as such are commercially protected via patenting laws. There is an inconsistency here; nanomaterials are legally defined as ‘new’ via IPRs, however they are not recognized as such from the perspective of health and safety regulations.Fact|date=June 2008

New regulatory framework, or adapt existing arrangements?

There is significant debate about who is responsible for the regulation of nanotechnology. While some non-nanotechnology specific regulatory agencies currently cover some products and processes (to varying degrees) – by “bolting on” nanotechnology to existing regulations – there are clear gaps in these regimes. This enables some nanotechnology applications to literally “slip through the cracks” without being covered by any regulations. An example of this has occurred in the US, and involves nanoparticles of titanium dioxide for use in sunscreen. In this case, the Federal Drug Administration reviewed the immediate health effects of exposure to nanoparticles of titanium dioxide for consumers. However, they did not review its impacts for aquatic ecosystems when the sunscreen rubs off, nor did the EPA, or any other agency. Such gaps in regulation are likely to continue alongside the development and commercialization of increasingly complex second and third generation nanotechnologies.

The Self-policing wiki notes that self-regulation attempts may well fail, due to the inherent conflict of interest in asking any organization to police itself. If the public becomes aware of this failure, an external, independent organization is often given the duty of policing them, sometimes with highly punitive measures taken against the organization.The Food and Drug Administration note that they only regulate on the basis of voluntary claims made by the product manufacturer. If no claims are made by a manufacturer, then the FDA may be unaware of nanotechnology being employed.

Yet regulations world-wide still fail to distinguish between materials in their nanoscale and bulk form. This means that nanomaterials remain effectively unregulated; there is no regulatory requirement for nanomaterials to face new health and safety testing or environmental impact assessment prior to their use in commercial products, if these materials have already been approved in bulk form. The health risks of nanomaterials are of particular concern for workers who may face occupational exposure to nanomaterials at higher levels, and on a more routine basis, than the general public.

International law

There is no international regulation of nanoproducts or the underlying nanotechnology.cite paper |title= FDA and Nanotechnology Products: Frequently asked questions |publisher= Food and Drug Administration |url= http://www.fda.gov/nanotechnology/faqs.html |year=2007 ] Nor are there any internationally agreed definitions or terminology for nanotechnology, no internationally agreed protocols for toxicity testing of nanoparticles, and no standardized protocols for evaluating the environmental impacts of nanoparticles. [cite paper |title= International Standardisation for Nanotechnologies |publisher=Institute for Food and Agricultural Standards |url=http://www.ifas.msu.edu/keyprojects.htm ]

Since products that are produced using nanotechnologies will likely enter international trade, it is argued that it will be necessary to harmonize nanotechnology standards across national borders. There is concern that some countries, most notably developing countries, will be excluded from international standards negotiations. The [http://www.ifas.msu.edu/keyprojects.htm Institute for Food and Agricultural Standards] note that “developing countries should have a say in international nanotechnology standards development, even if they lack capacity to enforce the standards". (p. 14)..cite paper |title= An Issues Landscape for Nanotechnology Standards. Report of a Workshop | publisher=Institute for Food and Agricultural Standards, Michigan State University, East Lansing |year=2007 [http://ifas.msu.edu/NSWorkshopReport.pdf] ]

Concerns about monopolies and concentrated control and ownership of new nanotechnologies were raised in community workshops in Australia in 2004.

Arguments against regulation

A major argument against special regulation of nanotechnology is that the projected applications with the greatest impact are far in the future, and it is unclear how to regulate technologies whose feasability is speculative at this point. In the meantime, it has been argued that the immediate applications of nanomaterials raise challenges not much different than those of introducing any other new material, and can be dealt with by minor tweaks to existing regulatory schemes rather than sweeping regulation of entire scientific fields.Fact|date=June 2008

A truly precautionary approach to regulation could severely impede development in the field of nanotechnology if we require safety studies for each and every nanoscience application. While the outcome of these studies can form the basis for government and international regulations, a more reasonable approach might be development of a risk matrix that indentifes likely culprits.

Response from governments

United Kingdom

In its seminal 2004 report "Nanoscience and Nanotechnologies: Opportunities and Uncertainties", the United Kingdom's Royal Society concluded that:

:"Many nanotechnologies pose no new risks to health and almost all the concerns relate to the potential impacts of deliberately manufactured nanoparticles and nanotubes that are free rather than fixed to or within a material.... We expect the likelihood of nanoparticles or nanotubes being released from products in which they have been fixed or embedded (such as composites) to be low but have recommended that manufacturers assess this potential exposure risk for the lifecycle of the product and make their findings available to the relevant regulatory bodies.... It is very unlikely that new manufactured nanoparticles could be introduced into humans in doses sufficient to cause the health effects that have been associated with [normal air pollution] ."

but have recommended that nanomaterials be regulated as new chemicals, that research laboratories and factories treat nanomaterials "as if they were hazardous", that release of nanomaterials into the environment be avoided as far as possible, and that products containing nanomaterials be subject to new safety testing requirements prior to their commercial release.

The 2004 report by the UK Royal Society and Royal Academy of Engineers noted that existing UK regulations did not require additional testing when existing substances were produced in nanoparticulate form. The Royal Society recommended that such regulations were revised so that “chemicals produced in the form of nanoparticles and nanotubes be treated as new chemicals under these regulatory frameworks” (p.xi). They also recommended that existing regulation be modified on a precautionary basis because they expect that “the toxicity of chemicals in the form of free nanoparticles and nanotubes cannot be predicted from their toxicity in a larger form and… in some cases they will be more toxic than the same mass of the same chemical in larger form.”

The Better Regulation Commission's earlier 2003 report [cite paper |title=Scientific Research: Innovation with Controls |publisher= Better Regulation Task Force |url=http://archive.cabinetoffice.gov.uk/brc/upload/assets/www.brc.gov.uk/scientificresearch.pdf] had recommended that the UK Government:
# enable, through an informed debate, the public to consider the risks for themselves, and help them to make their own decisions by providing suitable information;
# be open about how it makes decisions, and acknowledge where there are uncertainties;
# communicate with, and involve as far as possible, the public in the decision making process;
# ensure it develops two-way communication channels; and
# take a strong lead over the handling of any risk issues, particularly information provision and policy implementation.

These recommendations were accepted in principle by the UK Government. Noting that there was “no obvious focus for an informed public debate of the type suggested by the Task Force”, the UK government's [http://archive.cabinetoffice.gov.uk/brc/upload/assets/www.brc.gov.uk/scienceresponse.pdf response] was to accept the recommendations.

The Royal Society's 2004 report identified two distinct governance issues:
# the “role and behaviour of institutions” and their ability to “minimise unintended consequences” through adequate regulation and
# the extent to which the public can trust and play a role in determining the trajectories that nanotechnologies may follow as they develop.

United States

Rather than adopt a new nano-specific regulatory framework, the United States’ Food and Drug Administration (FDA) convenes an ‘interest group’ each quarter with representatives of FDA centers that have responsibility for assessment and regulation of different substances and products. This interest group ensures coordination and communication. [cite paper |title= Task Force Report |publisher= FDA Nanotechnology Task Force |url=http://www.fda.gov/nanotechnology/ |year=2007 ]

The Bush administration has recently decided that no special regulations or labeling of nanoparticles are required [http://www.planetark.com/dailynewsstory.cfm/newsid/43305/story.htm] . This decision strikes many familiar with the issue as inexplicable and a sign of the influence of corporations over individuals, "The consumer is being made the guinea pig" says George Kimbrell of The International Center for Technology Assessment [http://www.icta.org/nanotech/index.cfm] see also [http://www.icta.org/press/release.cfm?news_id=26] . "'Consumers are not aware of what's on the market. They are not aware that a substantial amount of consumer products are being sold to them, there's no labelling, there's no information getting to them,' says Elizabeth Nielsen, a consultant for the Consumers Council of Canada (CCC) and author of a report released April 1, [http://www.consumerscouncil.com/index.cfm?pid=14903 Nanotechnology and Its Impact on Consumers] ... the biggest concern is that consumers are unaware they are buying products that contain nanoparticles. 'Consumers should be informed to make their own judgments of the risks of using these products'" says Troy Benn of Arizona State University who along with Paul Westerhoff studied the stability of silver nanoparticles in socks with widely varying results [http://thetyee.ca/News/2008/04/07/NanoParticles/] .

Berkeley, CA is currently the only city in the United States to regulate nanotechnology. Cambridge, MA in 2008 considered enacting a similar law, but the committee it instituted to study the issue Cambridge recommended against regulation in [http://www.nanolawreport.com/Cambridge.pdf its final report] , recommending instead other steps to facilitate information-gathering about potential effects of nanomaterials.

European Union

The European Union has formed a group to study the implications of nanotechnology called [http://ec.europa.eu/health/opinions2/en/nanotechnologies/about-nanotechnologies.htm#7 The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)] [http://ec.europa.eu/health/opinions2/en/nanotechnologies/index.htm#1] . One can find their list of risks [http://ec.europa.eu/health/opinions2/en/nanotechnologies/l-2/6-health-effects-nanoparticles.htm#0 Here] .

Response from advocacy groups

In January 2008, a coalition of over 40 civil society groups endorsed a statement of principles [cite paper |title=Principles for the Oversight of Nanotechnologies and Nanomaterials |publisher=International Center for Technology Assessment |date=2008 |url=http://www.icta.org/global/actions.cfm?page=15&type=366&topic=8 ] calling for precautionary action related to nanotechnology. The coalition called for strong, comprehensive oversight of the new technology and its products in the International Center for Technology Assessment's report "Principles for the Oversight of Nanotechnologies and Nanomaterials",cite press release| title = Broab international coalition issues urgent call for strong oversight of nanotechnology| publisher = International Center for Technology Assessment|date=2007-07-31|url = http://www.icta.org/press/release.cfm?news_id=26 |accessdate = 2007-10-19] which states:

:"Hundreds of consumer products incorporating nanomaterials are now on the market, including cosmetics, sunscreens, sporting goods, clothing, electronics, baby and infant products, and food and food packaging. But evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards. In addition, the profound social, economic, and ethical challenges posed by nano-scale technologies have yet to be addressed ... 'Since there is currently no government oversight and no labeling requirements for nano-products anywhere in the world, no one knows when they are exposed to potential nanotech risks and no one is monitoring for potential health or environmental harm. That's why we believe oversight action based on our principles is urgent' ... This industrial boom is creating a growing nano-workforce which is predicted to reach two million globally by 2015. 'Even though potential health hazards stemming from exposure have been clearly identified, there are no mandatory workplace measures that require exposures to be assessed, workers to be trained, or control measures to be implemented,' explained Bill Kojola of the AFL-CIO. 'This technology should not be rushed to market until these failings are corrected and workers assured of their safety'" also [http://www.icta.org/nanotech/index.cfm] .

The group has urged action based on eight principles. They are 1) A Precautionary Foundation 2) Mandatory Nano-specific Regulations 3) Health and Safety of the Public and Workers 4) Environmental Protection 5) Transparency 6) Public Participation 7) Inclusion of Broader Impacts and 8) Manufacturer Liability.

Some NGOs, including [http://www.foe.org.au/nano-tech/ Friends of the Earth] , are calling for the formation of a separate nanotechnology specific regulatory framework for the regulation of nanotechnology. In Australia, Friends of the Earth propose the establishment of a Nanotechnology Regulatory Coordination Agency, overseen by a Foresight and Technology Assessment Board. The advantage of this arrangement is that it could ensure a centralized body of experts that are able to provide oversight across the range of nano-products and sectors. It is also argued that a centralized regulatory approach would simplify the regulatory environment, thereby supporting industry innovation. A National Nanotechnology Regulator could coordinate existing regulations related to nanotechnology (including intellectual property, civil liberties, product safety, occupation health and safety, environmental and international law). Regulatory mechanisms could vary from "hard law at one extreme through licensing and codes of practice to ‘soft’ self-regulation and negotiation in order to influence behaviour." The formation of national nanotechnology regulatory bodies may also assist in establishing global regulatory frameworks.

In early 2008, The UK's largest organic certifier, [http://www.soilassociation.org/ the Soil Association] , announced that its organic standard would exclude nanotechnology, recognizing the associated human and environmental health and safety risks. It is likely that other organic certifiers will also follow suit. The Soil Association was also the first to declare organic standards free from genetic engineering.

Technical aspects

ize

Regulation of nanotechnology will require a definition of the size, in which particles and processes are recognized as operating at the nano-scale. The size-defining characteristic of nanotechnology is the subject of significant debate, and varies to include particles and materials in the scale of at least 100 to 300 nanometers (nm). [http://www.foe.org.au/nano-tech/ Friends of the Earth Australia] recommend defining nanoparticles up to 300 nanometers (nm) in size. They argue that “particles up to a few hundred nanometers in size share many of the novel biological behaviours of nanoparticles, including novel toxicity risks”, and that “nanomaterials up to approximately 300nm in size can be taken up by individual cells”. The [http://www.soilassociation.org/web/sa/saweb.nsf/a71fa2b6e2b6d3e980256a6c004542b4/444ed4dee8649ee18025739c003d0a49!OpenDocument&Highlight=2,nanotechnology UK Soil Association] define nanotechnology to include manufactured nanoparticles where the mean particle size is 200 nm or smaller. The [http://www.nano.gov U.S. National Nanotechnology Initiative] define nanotechnology as “the understanding and control of matter at dimensions of roughly 1 to 100 nm.

Mass thresholds

Regulatory frameworks for chemicals tend to be triggered by mass thresholds. This is certainly the case for the management of toxic chemicals in Australia through the National pollutant inventory. However, in the case of nanotechnology, nanoparticle applications are unlikely to exceed these thresholds (tonnes/kilograms) due to the size and weight of nanoparticles. As such, the [http://www.wilsoncenter.org/index.cfm?fuseaction=news.item&news_id=165552 Woodrow Wilson International Centre for Scholars] question the usefulness of regulating nanotechnologies on the basis of their size/weight alone. They argue, for example, that the toxicity of nano-participles is more related to surface area than weight, and that emerging regulations should also take account of such factors.

References