Framing nanotechnology now: hands-off or hands-on? CIELAP shares elements of a Canadian policy framework for nanotechnology.

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In early 2007, the Canadian Institute for Environmental Law and Policy (CIELAP) held an one-day expert workshop in Toronto to canvass the policy issues involved m nanotechnology. This colloquy resulted in CIELAP's March 2007 report, A Policy Framework for Nanotechnology.

In that document, CIELAP identified 12 key elements for a responsible Canadian approach to policy for this fast-evolving field. Those elements are presented in this article, and this discussion includes new developments that have evolved since that report was first published. Further details on the questions, hazards, and benefits that nanotechnology presents can be found in the original document and the workshop report, both available on CIELAP's Web site at www.cielap.org. In our view, government policy-makers must address each of these 12 elements in detail and in a policy envelope that includes all of them at once. Governments should not be considering potential economic benefits in one context and relegating health and environmental risks, precautionary measures, social impacts, and public involvement to a separate discussion.

The evidence pointing to potential health and environmental risks related to nanomaterials is mounting. At the same time, potential benefits in the health field, renewable energy and energy efficiency, and materials and environmental science and technology are significant. CIELAP supports a context for nanotechnology policy that is based on an explicit recognition and endorsement of sustainable development, with all that implies for equally valuing both human well-being and the environment. The policy challenges for nanotechnology are enormous and are currently dominated by a lack both of scientific information and also of basic policy tools. These tools include definitions and metrology, legal and regulatory frameworks, and structures and resources for public engagement. Despite these large gaps, many parallels with other issues and institutional arrangements exist, and they could be adapted for nanomaterials and technology.

Governments should incorporate a strong sense of urgency about creating policy in this area because of nanotechnology's extraordinarily rapid commercialization and development. A perspective that values prudence, precaution, and the public's input is crucial.

What is policy?

In the CIELAP workshop described above, one participant queried whether it was important to develop a policy on nanotechnology--or a policy process. Policy-making is an intrinsic part of governance since policy is simply the result of decisions in some area that shape its future direction. Sometimes policy can be the result of taking no deliberate action on an issue and thus entrenching the status quo. But for any intentionally created policy, there is always some kind of policy development process. For nanotechnology, both new policy processes and specific policy decisions will be required.

Nanotechnology at present is only partially regulated and policy guidance can be best described as laissez faire. Forming a comprehensive government policy will include making certain substantive decisions and instituting ongoing policy processes. Beyond pointing out the need for priority-setting and speed, CIELAP's recommendations do not address questions of timing or sorting out what should be longer- or shorter-term objectives. At this stage, our proposed policy framework focuses on three things--on the policy goal, on what needs to be attended to, and on how these issues should be addressed.

Filling out that framework into workable policy means assigning actions to the actors involved, assigning accountability, identifying stakeholders and how they should be involved, creating a timeline, and determining what resources are needed and how they will be supplied. Although various stakeholders will have opinions about these matters, the generation of detailed public policy is the responsibility of governments. Right now, government agencies and departments in Canada should be considering what the best options are to tackle these questions, and the implications of different approaches within the context of sustainability.

Elements of a Canadian nanotechnology policy framework

The following points describe CIELAP's perspective on how major areas should be addressed.

1. Goals

The policy framework should include an introductory statement discussing its purpose, which should explicitly be linked to sustainable development and its values.

2. Public education and engagement

Bringing civil society stakeholders into policy discussions very early in the process is the correct and prudent thing to do for the development of robust, publicly acceptable policy. Organizations such as the Action Group on Erosion, Technology and Concentration (ETC Group) and the National Farmers Union are alarmed by the speed of commercialization and the lack of government oversight. They have already called for a moratorium on the technology. Others will probably join their ranks if tangible progress on policy and regulatory action is unable to keep up with commercial activity.

There are many good models for consultative involvement in Canada, and government officials must accept that citizen groups will require resources to participate effectively. Government-run forums in which information flows mainly from government experts to the public are an outmoded and unproductive approach. The same is true for government information ads that attempt to minimize public concerns about jobs, safety, or the environment. The Internet has made an enormous difference in the ability of a motivated public to become informed about a topic, and the best motivator is the opportunity to have real input in shaping policy decisions. A comprehensive, well designed, and easy-to-use Web site is a very useful approach, though not so easy to achieve. Consideration should be given to building on the single information window used for biotechnology--especially since future nanotechnology applications are likely to include bioengineered components.

3. Inventory of activities and information sources

Despite the establishment of several government-funded centres for nanotechnology research such as the National Research Council's Alberta-based National Institute for Nanotechnology (NINT) and NanoQuebec in Montreal, it is still surprisingly difficult to get a comprehensive overview of nanotechnology activities in Canada. This is especially true for up-to-date developments in policy and related government initiatives. A Web-based inventory that is updated and maintained by a government agency would be useful in a variety of ways. Transparency about government planning and action must be recognized as vital.

4. Lead agencies

A fast-tracked process to designate lead agencies for various areas of specific responsibility, to name lead contacts, and to identify the role of the main lead government agency should be quickly established. For the latter, Health Canada and Environment Canada jointly may be most appropriately positioned to lead progress overall. These decisions should be part of the information inventory.

5. Terminology, metrology, and related technical issues

These need to be resolved as soon as possible, preferably through international collaboration. Canada should continue its existing involvement in such efforts with the International Standards Organization, the EU, and others through agencies such as the Canadian Standards Association and the National Research Council Canada. Canada should press for speed and practical results from these deliberations.

6. Regulatory approach--science, risk assessment, and stakeholder involvement

Much of Canada's regulatory system for different types of products and chemicals can probably be adapted to address nanomaterials. Indeed, Environment Canada posted an Advisory Note (signed in June 2007) to manufacturers or importers of nanomaterials that have "unique structures or molecular arrangements" and are not on the Domestic Substances List (DSL) of materials already in commercial use. Such nanomaterials will now be subject to the New Substances Regulations under the Canadian Environmental Protection Act (CEPA). (1) This is one of the first general regulatory initiatives for nanomaterials that has been put in place, but. it is not comprehensive. The Advisory notes that this requirement would apply to materials like fullerenes, which have a novel molecular structure. But it would not affect the use of substances like nanoparticles of titanium dioxide particles, which, despite their novel properties at this scale, do not have a different molecular structure from ordinary, macroscale titanium dioxide that is already on the DSL. Clearly, additional triggers for regulation of synthetic nanomaterials will need to be phased in, particularly since nanoparticles of some materials now in use, such as copper or silver, may be particularly toxic at this scale. (2)

A more difficult area for regulation is convergent technologies involving nanomaterials and biotechnology, especially self-assembling biological "machines" and products. The challenges for these may be more like containing the spread of antimicrobial resistance or infectious diseases, rather than regulating toxic chemicals, and different models for regulation will probably be needed.

Last year in the U.S., the Environmental Protection Agency stepped in under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), to regulate a Samsung washing machine that generated antibacterial nanosilver particles. That legislation, however, is applicable only to products claiming efficacy for those uses. It is unclear at this time whether the Toxic Substances Control Act (U.S. legislation comparable to CEPA) will also be used or adapted to apply to nanomaterials.

It is unrealistic to expect comprehensive regulations to be created immediately, since much is still unknown about a long list of crucially important factors. These factors include the potential human health hazards, exposure routes, mechanisms of action, and nanomaterial properties, behaviour, environmental fate, including bioaccumulation and transport, dispersion, and sensitive species and ecosystems. Using a life cycle approach, every effort must be made to prioritize what needs to be known and to acquire that information quickly. An appropriate risk assessment model, such as that developed jointly by DuPont and Environmental Defense in the U.S., could assist in determining priorities for a defensible regulatory system and, in the immediate future, for voluntary and precautionary action. An interim approach to assessing risks and developing appropriate controls is needed right now for medical uses, consumer products, laboratory, medical, and industrial wastes and other items in the waste stream with nanomaterials that come in direct contact with humans or can enter the environment.

Scientists and government officials should also recognize that risk assessment alone does not provide automatic answers to many regulatory questions. Many of these issues bring forth a range of legitimately differing ethical and social perspectives, and there must be mechanisms to include many different opinions and stakeholders in the regulatory process.

7. Labelling and consumer worker safety

Especially in the absence of a comprehensive regulatory regime, legal requirements to label consumer products with nanomaterials that can come in contact with humans, animals, or enter the environment directly should be imposed. Similarly, protocols for the protection of workers and researchers must be put in place at once, and updated as soon as possible as more information is available.

8. Liability and intellectual property regimes

Producer responsibility and legislated strict liability should be considered as essential principles for commercial applications of nanotechnology and a process to institute them should be put in place. Intellectual property rules should, as much as possible, encourage open access to scientific information.

9. Science and research support

Much more science in support of regulatory action is clearly needed. Granting councils should emphasize safety and the environment as design requirements in each project from its inception, along with supporting work on so-called N[E.sup.3]LS, i.e., nanotechnology and ethical, environmental, economic, legal, and social concerns.

10. Commercialization and social and economic benefits

Most of the public discussion to date has focused on nanotechnology's potential for generating economic benefits, on how best to position Canada's industry in that regard, and on how to encourage research that leads to commercial developments. It is generally assumed that Canadian efforts will be in particular applications, such as information/ communication technology, health, energy, biotechnology, and environment-related niches. Should Canadian governments take a handsoff approach and let research develop where it happens to go, or should there be more support for targeted niches? How should these decisions be determined? There are also questions about whether research should be deliberately supported for particular social or environmental ends. The EPA, for example, is especially interested in supporting work in nanotechnology on environmental sensors and environmental remediation applications. There must be a discussion and decision process about which of these paths to follow to maximize Canadian economic benefits, and about what social and environmental needs and opportunities exist in Canada that should be supported.

11. Training

Increased support for and expansion of training in this new field, with a particular emphasis on worker health and safety, is essential.

12. Security concerns

There are many potential military applications of nanotechnology. For example, a centre for such research was established at Massachusetts institute of Technology in 2002. It is possible to imagine criminal and terrorist possibilities for nanotechnology. Understanding these potential threats and determining ways to avoid them and to prepare for and minimize their consequences should be a part of the policy agenda. As with land mines, Canada should be prepared to lead international efforts to outlaw military uses that create environmental damage and civilian casualties.

At present, for its insiders, the world of nanotechnology is full of enthusiasm and promise. Outside, dark clouds of public suspicion and concern can be seen gathering. Environmentalists will rightly point out that many scientific and technological innovations that were at first optimistically hailed as modern wonders have ultimately impacted us in varying ways. Some technologies become so widely employed that they are embedded in the very fabric of society. Managing their negative effects can become an intensely difficult problem, as with the internal combustion engine and the use of fossil fuels. If nanotechnology is to fulfill its positive potential, governments must make an unprecedented effort to bring precautionary foresight, speed, and open dialogue into policy development for this fascinating field.

References

(1.) Information posted on Environment Canada's New Substances Web site at www.ec.gc.ca/substances/ nsb/eng/home_e.shtml (August 20, 2007).

(2.) Gunter Oberdorster, "Nanoparticle Toxicology: Into the Respiratory Tract, Across the Skin, and Beyond?," Keynote Plenary Lecture, Symposium 3, Canadian Federation of Biological Societies 51st Scientific Conference/5th Northern Lights Summer Conference, University of Waterloo, Waterloo, ON, June 21, 2007.

Susan Holtz is the senior policy analyst at the Canadian Institute for Environmental Law and Policy (CIELAP). Founded in 1970, CIELAP is an independent, not-for-profit policy research organization, focusing particularly on emerging and less publicized environmental issues.