(Nanowerk Spotlight) The first part of this survey, which we posted yesterday in our Nanowerk Spotlight, introduces nanotechnology policy making and the reasons for its complexity, and offers a panorama of the set of mandatory tools that are currently available to regulate nanotechnologies. The second part, today, provides an outlook of the set of voluntary tools that coexist with the mandatory ones.
Not being able to create any breathing room for lengthy political and legal considerations, the last 15-20 years have seen several governments adopting voluntary environmental programs (VEPs), arguing that this is the only viable proportional option for the time being. It is estimated that there are some 300 VEPs in the European Union and over 200 in the United States, dealing with matters such as climate change, energy, waste, water, toxic materials, agriculture, manufacturing, mining, forestry, hotels, hospitals, and financial institutions. If these voluntary programs work is subject to debate - some apparently do, some less so.
For the VEPs that are in place for nanomaterials, governments are urging companies to submit health and safety information on the nanomaterials they produce or commercialize. The number of VEPs has increased dramatically over the last twenty years as a supplement or even as a replacement for traditional command-and-control regulation. These VEPs are now viewed by several governments as a favored approach to fill in the current gaps of knowledge about the health and environmental impacts of nanomaterials (read more in our prevous Nanowerk Spotlight"Implementing successful voluntary nanotechnology environmental programs appears to be a challenge").
Voluntary reporting schemes
The "Voluntary Reporting Scheme for Manufactured Nanomaterials" was set up in the UK in September 2006 as a 2-year trial initiative for industry and research organisations to provide Government with information relevant to understanding the potential risks posed by free engineered nanoscale materials. During the 2-year trial thirteen data submissions were received, eleven from industry and 2 from academia. The scheme aimed to provide an indication of the kinds of nanomaterials currently in development and production to help inform policy making decisions and to focus efforts and funding on areas which were relevant to the UK’s current nano manufacturing and research base. After the trial period ended, the scheme was not continued.
In January 2008, the United States Environmental Protection Agency (EPA) launched the Nanoscale Materials Stewardship Program (NMSP), a similar voluntary reporting scheme covering engineered nanoscale materials manufactured or imported for commercial purposes. The NMSP ended in December 2009. This scheme met the same fate as the UK Voluntary Reporting Scheme. When it launched the NMSP program, the EPA said it expected to receive 240 submissions from 180 companies under the basic program, and to attract 15 participants in the in depth This projection was based on an estimate that
in 2005 more than 600 companies were manufacturing and applying nanotechnology. However, in 2008, the EPA provided on its website a list of only nine companies that had made submissions and 11 companies that intended to, and two more volunteering for the ‘in depth’ program component.
Codes of conduct (CoC)
Roughly at the same time, a few initiatives were launched to design codes of conduct founded on voluntary implementation.
The European Commission adapted a "Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research". It is based on seven general principles and gives guidance to the member for their research actions in the field of nanotechnology. The EU launched a period of public consultation from October 2009 to January 2010 to evaluate the impact of this voluntary initiative and the revisions that might be introduced. The public consultation had been opened to all stakeholders directly or indirectly involved or interested in Nanosciences and Nanotechnologies Research, but it received very little feedback. Only 49 valid answers were received from 17 countries including four which were outside the EU. In mid-2011 there had not been an updated version of the code.
In 2008, the UK´s Royal Society developed a CoC (Responsible NanoCode) for businesses involved in nanotechnologies. The Responsible NanoCode had seven principles. It aimed to establish a consensus of what constituted good practice across the nanotechnology value chain (i.e. from research and development to manufacturing, distribution and retailing) so that businesses could align their processes with emerging good practice and form the foundation for the development of indicators of compliance. It illustrated expected behaviours and processes, not standards of performance, and it did not aim to be an auditable standard. The scope of its application was limited and its 2008 update was not followed by any recent documentation (the website www.responsiblenanocode.org has been taken down).
Another type of voluntary governance was the 2005 Nano Risk Framework, a coproduction of the chemical company DuPont and the environmental group Environmental Defense. It was based on a six-step process for the identification, assessment and management of potential risks with a focus on toxicity considerations. DuPont made the framework mandatory for all its nanotechnology work. However, after two interactive workshops on nano risk management in 2008, the initiative did not seem to be taken further.
Finally, there was a purely corporate initiative. The chemical company BASF, which had developed in 2004 the first corporate code of conduct outlining the company’s duties to workers, investors and clients, introduced in 2007 a specific nanotechnology code of conduct.
Auplat writes that the analysis of these voluntary codes showed that they had a limited impact. "They were designed as voluntary, principles based guidelines establishing a consensus of what constituted good practice in businesses across the nanotechnology value chain, so that these businesses could align their processes with emerging good practice. However, they dealt more with management principles than with the technology risks themselves. They illustrated expected behaviours and processes, not standards of performance, and they did not aim to be auditable standards. They did not include tools to evaluate their successful (or not) implementation. It was therefore impossible to measure their effectiveness in terms of regulation of the emergence of the nano industry."
Certifications and standards
There has been a lot of activity from standardization organizations working on nanotechnology standards – the American National Standards Institute (ANSI), the Chinese National Nanotechnology Standardization Committee, the French Standards Agency (AFNOR), the UK British Standards Institute (BSI), and the Japanese Standards Association (JSA) all have issued nanotechnology related standards.
Auplat concludes that the diversity of voluntary frameworks that appear alongside mandatory ones indicates that nanotechnology policy making may shape around the integration of several forms of collective actions which traditionally tended to remain disconnected.
"Governments use three different approaches to shape nanogovernance. One approach is to adapt existing regulations to gradually take nanotechnology on board (REACH, TSCA), the other one is to design entirely new forms of regulation (regulation on cosmetics, French Code de l’environnement) and finally one is to foster voluntary initiatives (EU code for responsible nanotechnology)."
"One may conclude that the development of nanotechnologies is symptomatic of a new form of policy making, where national decisions or roadmaps about regulatory frameworks may well be superseded by new forms of international regulation which are being put into place more or less independently of individual nation states. This new system of governance has the following characteristics:
It is global and trans-sectorial.
It pushes back the notion of regulatory ownership. Traditionally, policy making could have a national identification. With all the collective interactions mentioned above, the national identity of policy making is becoming blurred and subsumed into global policy with a transnational and multi level character.
It has a form of autonomy which evokes autocatalysis. In other words, it develops a life of its own which transcends boundaries and expectations and separates from its creators and contributors to evolve from its own input. The case of ISO TC229, with the history of the involvement of China in its development, and its influence on nano policy making is a good illustration of this phenomenon."