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Posted: May 25, 2009
Nanotechnology regulation - international approaches
(Nanowerk Spotlight) A recent report ("International Approaches to the Regulatory Governance of Nanotechnology") from the School of Public Policy and Administration at Carleton University in Canada gives an overview of how five jurisdictions (US, UK, EU, Australia and Canada) reacted to the recent emergence of nanotechnology-based products in the marketplace and it describes how this triggered activities in three domains: (a) public and stakeholder debate, (b) development of initial policy options, and (c) the management of regulatory development in a situation of scarce data.
The bulk of the report describes the current situation (up to March 2009) in the five jurisdictions and this part doesn't contain information that hasn't already been covered elsewhere. In analyzing this data, however, the authors (Jennifer Pelley and Marc Saner from the Regulatory Governance Initiative at Carleton University) make some interesting observations and attempt to develop a set of six key regulatory governance principles that they propose for consideration by regulators.
It appears that the jurisdictional approach to nanotechnology policy development is pretty consistent across the covered geographies: "A first step in policy development taken in the majority of jurisdictions was the release of a strategy (or policy statement) on nanotechnology. A draft document produced by the OECD Working Party on Nanotechnology indicates that as of 2008, seventeen of twenty-four OECD countries surveyed (71%) had developed dedicated strategies for nanotechnology at either the national government and/or agency level. The US, EU, and Australia all have named nanotechnology strategies; the UK also has a dedicated, though unnamed strategy."
A majority of the jurisdictions examined have additionally issued policy statements on nanotechnology regulation. Pelley and Saner argue that these statements are designed to serve a dual purpose: "On one hand, they signal to industry that the jurisdiction in question is committed to the continued development of nanotechnology, and that it is therefore safe for companies to invest in that jurisdiction. On the other hand, they signal to consumers that jurisdictional governments are committed to ensuring the continued health and safety of its citizens and of the environment."
They also caution that the importance of such policy statements should not be trivialized. "They are a key aspect of ensuring the transparency of the policy development process, and help to signal to all interested parties – the general public, industry, and civil society organizations alike – that jurisdictional governments are aware of the issues and committed to working with stakeholders toward the development of solutions."
Not surprisingly, these statements have been remarkably consistent across jurisdictions:
"1. Such statements first note the potential benefits of nanotechnology, and state the government‘s intention to pursue nanotechnology research and development with a view to future economic benefits.
2. Next, it is generally noted in such statements that the benefits of nanotechnology are, however, accompanied by potential risks, the extent of which we do not yet fully appreciate.
3. Jurisdictions then stress that until such a time as there is more information available regarding the potential risks of nanotechnology, existing regulatory frameworks are sufficiently rigorous to ensure the continued health and safety of consumers and the viability of the environment.
4. Next, jurisdictions tend to note the current lack of information pertaining to the novel properties of nanomaterials, and a lack of metrics, methodologies, and standards to deal with hazard and exposure evaluation and overall risk assessment.
5. Finally, jurisdictions note that they will review the need for nano-specific regulatory frameworks in the future, and update existing regulatory frameworks as required."
There also appear to be a number of commonalities with regard to how regulators tale a stepwise approach to developing policy options for regulating nanotechnology:
1. Formal statement of policy on nanotechnology, or preparation of a jurisdictional strategy;
2. Attempt to gain more knowledge of the potential risks associated with nanotechnology;
3. Perform or commission a regulatory gaps analysis; and
4. Make use of current regulations to 'indirectly' regulate nanotechnology.
The authors caution that it may be premature to evaluate what works and what does not in the regulation of nanotechnology, especially given that regulations in the strictest sense of the word are only just beginning to emerge. "The perspective of regulatory governance, however, allows us to adopt a very wide perspective and to include all activities that have a regulatory aim – including public debate, policy announcements, data management approaches, voluntary schemes, industry self-regulation, etc.".
Based on the descriptive evidence collected for their report, Pelley and Saner observe six key regulatory governance principles that they propose for consideration by regulators:
1. The regulatory response should be coordinated. This should include coordination at the international level, between states, provinces or member states, as well as coordination at the inter-departmental and inter-agency level in individual jurisdictions.
2. Regulatory approaches to nanotechnology should be flexible and adaptive.
3. Information gathering initiatives, a key first step in an adaptive regulatory system, should be designed with the endpoints in mind, should offer incentives for participation, and should involve both industry and academic researchers.
4. Risk management approaches should strive to be comprehensive, by incorporating a lifecycle approach to govern the potential risks of nanotechnology, and should be designed with the importance of scope and timing horizons in mind.
5. Risk management approaches should strive for balance and proportionality between the costs and benefits of regulating. The regulatory impact of mandatory versus 'indirect' approaches versus an absence of regulation should be considered.
6. An understanding of the profile of the beneficiaries of nanotechnology and the risk bearers in concert with who is accountable would go a long way toward ensuring the appropriate deployment of both technology and regulatory oversight. Stakeholders should be engaged appropriately and regulatory systems should be transparent.