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Posted: Jul 26, 2010

Stakeholder preferences in regulating nanotechnology

(Nanowerk Spotlight) How to regulate nanotechnology and the application of nanomaterials has been quite a controversial issue in recent years. A good example of opposing positions could be found in last year's comprehensive review of existing legislation on nanotechnology, conducted by the FramingNano project. This report documents variations in governance structures across the world and disagreement over whether voluntary codes of conduct will be enough to regulate nanomaterials.
While for instance non-governmental organizations (NGOs) like Greenpeace and Friends of the Earth consider the existing regulatory situation to be inadequate and are urging a strictly precautionary approach, industry representatives are instead seeking the development of specific guidance and standards to support implementation of existing regulations, which are generally seen as adequate.
Steffen Foss Hansen, a postdoc at the Technical University of Denmark, Department of Environmental Engineering and NanoDTU Environment & Health, has now used Multicriteria Mapping (MCM) to study why some regulatory options – bans, moratoriums, voluntary measures, etc. – are deemed to be acceptable/unacceptable by various stakeholders in the U.S. and the criteria they use to evaluate the different regulatory options.
Multicriteria Mapping is a computer-based decision analysis technique that provides a way of appraising a series of different potential ways forward on a complex and controversial policy problem. Like other multicriteria approaches, it involves developing a set of criteria, evaluating the performance of each option under each criterion, and weighting each criterion according to its relative importance.
Hansen interviewed 26 stakeholders, including academics, public civil servants, corporate lawyers, and representatives from worker unions, industrial companies, and trade association. The MCM interviews were performed face-to-face and completed in a 3-month period between May and August 2007, prior to the U.S. Environmental Protection Agency's initiation of the it's voluntary Nanoscale Materials Stewardship Program.
His findings have been published in the June 30, 2010 online issue of Journal of Nanoparticle Research ("Multicriteria mapping of stakeholder preferences in regulating nanotechnology").
"Adopting an incremental approach and implementing a new regulatory framework have been evaluated as the best options whereas a complete ban and no additional regulation of nanotechnology were the least favorable" Hansen explains the key findings to Nanowerk.
Participants described their idea of an 'incremental approach' as "...launching an incremental process using existing legislative structures—e.g., dangerous substances legislation, classification and labeling, cosmetic legislation, etc.—to the maximum, revisiting them, and, when appropriate only, amending them..." and a 'new regulatory framework' as "...launching a comprehensive, in-depth regulatory process specific to nanotechnologies that aims at developing an entirely new legislative framework that tries to take all the widely different nanomaterials and applications into consideration."
Hansen notes that comparing the ranking of the various options by the stakeholder groups reveals that an incremental approach was ranked highest by a majority of the various stakeholder groups e.g. civil servants, public interest groups, industrial company representatives and corporate lawyers.
The option of forming and implementing a new regulatory framework was ranked highest by the worker union representative, academics and environmental NGOs under whereas industrial company and trade association representatives evaluated it to be only the third/fourth best option.
The option of relying on voluntary measures generally ranked high as well and was ranked first by the trade association representative; second by the industrial company representatives and the corporate lawyers; and third by the civil servants. In contrast, academics and the environmental NGOs evaluated this option either worst or second to worst.
"The largest difference in ranking of the policy options can be observed between environmental NGOs and the representatives from the industrial companies and the trade association," says Hansen. "The option of relying on voluntary measures and having no additional regulation are evaluated to be most favorable by the representative from the trade association, but the least favorable by the environmental NGOs whereas the three options ranked as most favorable by industrial company representatives were the options ranked the least favorable by the environmental NGOs."
He points out that the criteria used by NGOs and the trade association representative to evaluate the various policy options differed widely – which could help explain their dissimilar ranking of the options. Several NGOs put most weight on criteria that fell into the categories of health and environmental concerns and regulatory, legal, social and ethical issues, the trade association representative used criteria that fell into the categories of proportionality and benefits.
During the MCM exercise, a total of 97 different criteria were used by the interviewees with Protection of human health and environment being mentioned most often, followed by Practicality and Transparency in the decision-making process. Criteria predominately fall into health and environmental concerns (27%) followed by concerns about efficacy (14%) and criteria that could be classified as benefits, economical, social, regulatory, and legal issues (10–13%).
Hansen points out that the expressed opinions about future regulation appear far less polarized than originally expected. " We observed a high level of agreement among stakeholders on the most favorable policy options: the reliance on voluntary measures; an incremental approach; and forming and implementation of a new regulatory framework. Several stakeholders actually suggested the possibility of implementing a combination of these three options."
"This would also be a potential compromise between the two most extreme stakeholder positions, i.e., environmental NGOs versus the trade association representative" says Hansen. "The first step of such a potential future process, i.e., relying on voluntary measures, was evaluated highest by the trade association representative whereas combining this with an incremental approach was evaluated second overall. Environmental NGOs ranked relying on voluntary measures very low, but evaluated an incremental approach and forming and implementing a new regulatory framework highest."
Hansen notes that at the time of the interviews – in the summer of 2007 – there was a lot of discussion about the US EPA's voluntary Nanoscale Materials Stewardship Program (NMSP)and one might wonder if environmental NGOs might had been willing to accept relying on voluntary measures for a certain time-period while knowing that an incremental approach was being prepared.
The U.S. EPA's voluntary NMSP was implemented despite numerous limitations (see "Implementing successful voluntary nanotechnology environmental programs appears to be a challenge" and "EPA Nanotechnology Voluntary Program risks becoming a 'black hole'") and is now generally believed to have been a failure (see "Too small to overlook").
Hansen concludes that the time seems ripe to move to a full implementation of an incremental approach and the initiation of discussions about the forming of a new regulatory framework. Attempts to address elements of an incremental approach already have been made such as for instance recommendation and guidelines published by the U.S. National Institute for Occupational Safety and Health ("Approaches to Safe Nanotechnology – Managing the Health and Safety Concerns Associated with Engineered Nanomaterials") but these efforts constitute merely a starting point.
"A critical review and adaptations of the existing legislation are fundamental elements of an incremental approach that still have to be seriously addressed by policy-makers and agencies involved in the administration of, for instance, the Toxic Substances Control Act (TSCA)" says Hansen.
He therefore believes that most stakeholders interviewed welcome the current movement in the U.S. towards reforms to the Toxic Substances Control Act. Recently, legislative reform proposals were proposed in both the U.S. House of Representatives ("Toxic Chemicals Safety Act of 2010") and the U.S. Senate ("Safe Chemicals Act of 2010") and both versions include revisions for nanomaterials.
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