Governments are Gearing Up for Nanoregulation

Steffi Friedrichs, Nanotechnology Consultant
Technology Partnership plc., Cambridge (UK)

The summer of 2006 was a hot one, not only with regard to record temperatures in the United States and across Europe, but also with regard to the ongoing debate about the regulation of nanotechnology. Unlike many of the devastating forest fires that followed this year's dry months in a much greater number than usual, the nanotechnology debate was initiated by the spark of an entirely unnecessary and easily-preventable incident: the safety recall of an aerosol bathroom sealant called Magic Nano, which, within three days of its retail launch in late March 2006, had caused nearly 100 reported cases of respiratory problems, some of which were severe.

The incident has since been investigated by governmental agencies and test labs, which confirmed that Magic Nano contained no nanometer-sized material. Rather than delivering a general "all-clear" signal for nanotechnology, however, the findings forced the discussion about the regulation of nanotechnology R&D out of its quiet background existence, where it had infrequently appeared on the agendas of national and regional regulatory bodies, into the limelight of public scrutiny. As the heated summer debates come to an end, the resulting regulation reviews, strategy reports, and initiative proposals document the efforts that have gone into conducting largely-unprecedented multi-stakeholder dialogues.

The UK government's Department of Food and Rural Affairs (DEFRA) has just launched a Voluntary Reporting Scheme for Engineered Nanoscale Materials, which aims to collect data from any company or organization dealing with engineered nanoscale materials (i.e., as part of the processes concerned with the manufacture, use, import, research, or waste management of engineered nanoscale materials); the launch of the scheme follows a five-month consultation period, during which the above-mentioned stakeholders were encouraged to submit their opinions and suggestions regarding the scheme to DEFRA. The latter subsequently changed some details of the scheme prior to the release of the final data reporting form (i.e., DEFRA abolished a criterion based on production volume that was widely regarded as an unduly limiting factor). The reporting scheme will operate for two years, with a review scheduled to take place every six months; it has been welcomed by the U.S. Environmental Protection Agency, which has been considering the creation of a similar program, for some time. The precedent of a nanomaterials reporting program, however, was established by the Australian government's Department of Health and Aging in February 2006, when the National Industrial Chemical Notification and Assessment Scheme issued a voluntary call to companies to provide information on uses and quantities of nanomaterials imported or manufactured for industrial use.

The nanotechnology industry generally supports the idea of reporting programs to prioritize areas for future governmental initiatives, and to indirectly support the ongoing standardization efforts at the national and international levels. It is, however, yet to be seen how many companies voluntarily submit the full set of data, including highly-confidential physical property characterizations, tonnages, and commercial applications, to databases that fall under the Freedom of Information Act. This aspect of the scheme has met with severe criticism during the comment period, and, although DEFRA has consequentially agreed to "treat all submitted data as confidential, unless stated otherwise," it admits that "DEFRA may be obliged to provide information, upon such a request, to third parties." Such requests are expected to be made by NGOs and consumer interest groups that have already articulated their vested interest in the regulation of nanoparticulate materials by filing a petition that demands that the U.S. Food and Drug Administration formulate specific regulations for products containing engineered nanoparticles.

Nevertheless, the millstones of bureaucracy turn slowly, and there is little doubt that the Magic Nano incident in March achieved little more than merely catalyzing the summer's heated governmental debates about nanotechnology. It does, however, serve as a reminder to industry that they will not be able avoid nanoreporting and nanoregulation, and that, perhaps, they should even welcome it to weed out free riders and nanoposers. It is now up to all stakeholders to support an international dialogue on nanoregulation and nanogovernance, and to shape the ongoing efforts in these areas in a manner that provides maximum safety for nanoworkers, consumers, and the environment, as well as a sustainable economic environment for nanotechnology R&D and commercialization.

Steffi Friedrichs, D.Phil., is a nanotechnology consultant at The Technology Partnership plc., in Cambridge (UK), where she contributes to the tendering and due diligence processes for the MNT Network (Department of Trade and Industry, UK Government). She is a member of the Board of Directors of the Chicago Microtechnology & Nanotechnology Community, and the Advisory Board of the Institute of Nanotechnology, and she heads up the Advisory Board to the EHS Council of the NanoBusiness Alliance.