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Posted: Dec 21st, 2010
Science policy considerations for responsible nanotechnology decisions
(Nanowerk Spotlight) Governments are charged with determining whether chemical substances, and products that include those substances, can be used without adversely affecting humans and other living beings. Science helps inform policy decisions by providing information on the benefits and drawbacks of a technology or a product of that technology. So much for the theory. Currently, there
are significant limitations in the environmental, health and safety (EHS) data available for nanomaterials. Furthermore, although a wide variety of test methods and guidance for regulatory testing of bulk chemicals is available, a number of them will need significant modification before being applicable to nanomaterials.
Complicating things, science is quite divided on how to assess nanotechnology materials and applications. Consequently, as the public discussion about the regulation of nanotechnology in general, and nanomaterials in particular, heats up, emerging opinions on the applicability of existing regulation differ substantially (read more: "Regulating nanotechnology - how adequate is current regulation?") and so do views on which regulatory options best address the current lack of information about environment, health and safety risks of nanomaterials, as well as the regulatory uncertainty and concerns expressed by the politicians, members of the public and industry, and investors.
Although the literature grows on the use of science to inform decisions on the environmental, health and safety implications of nanotechnology, little has been published by those who make such decisions. In a recent commentary in Nature Nanotechnology, officials of the US Environmental Protection Agency (EPA), the European Commission and the Organisation for Economic Co-operation and Development (OECD), discuss the types of decision facing government regulators, the new considerations nanotechnology brings to decision-making, the role of science in informing decisions, how regulators cooperate internationally on policy issues, and the challenges that lie ahead.
The eight authors from the EPA (Jeff Morris, Jim Willis), the European Commission, Environment DG (Domenico De Martinis, Bjorn Hansen, Henrik Laursen) the European Commission, Joint Research Centre, Institute for Health and Consumer Protection (Juan Riego Sintes), and OECD (Peter Kearns and Mar Gonzalez) provide an overview of key reports and regulations and then discuss the complexity of issues with regard to addressing nanomaterials within the context of existing regulations and the need to weigh nanomaterial risk and benefits. Complicating the matter further is the need for international cooperation and harmonization of regulatory approaches.
Rather than discussing the different approaches of the EU and the US in managing chemicals under REACH
and TSCA, the authors note that there are more similarities than differences between the two geographies because the governments in both jurisdictions share the goal of providing for the health and safety of their citizens and environments:
"The state of nanomaterials science has resulted in an increased number of points of convergence among the relevant bodies in Europe, the USA and other countries, particularly in grappling with how best to protect human health and the environment in the complete or partial absence of information, and with the substantive challenges in developing the information needed to make decisions."
The commentary points out that, although questions exist about the EHS implications of nanomaterials, governments around the world understand that nanomaterials may have considerable environmentally beneficial applications: these include technologies with increased energy efficiency, improved solar technologies, self-cleaning surfaces, alternatives to highly toxic chemicals, opportunities to use less of a given chemical, and the remediation of contaminated sites.
"This creates a conundrum for regulators who on the one hand may wish to see an environmentally beneficial material enter the marketplace, yet on the other hand may have unanswered concerns about its possible risks."
Another problem is that, because many results are not expected to be available for a number of years, regulatory agencies must act in the absence of complete or even substantial toxicology and effects data sets.
"To allow better-informed decision-making in the absence of such data, we need more-robust exposure measurements and information on the effectiveness of exposure mitigation approaches. So far, much of the effort has focused on occupational settings. However, the data on the levels and identity of nanomaterials that consumers, the environment and general populations are exposed to are either limited or non-existent, which makes it difficult to quantify exposures."
The authors point out that responsibility for addressing this information gap resides as much, if not more, with those who produce nanomaterials as it does with those who regulate them.
"Although there are legitimate confidentiality concerns, information on actual and estimated production volumes, material use and usage in products, and processes used to manufacture nanomaterials will be critical to understanding, from a life cycle perspective, the environmental impacts of specific nanomaterials. To obtain such information, enhanced collaboration between industry and regulators will be a necessary part of successful governance strategies."
Consequently, they advocate that industry should contribute significantly to the risk assessment of nanomaterials because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.
For some nanomaterials, it will take considerable time to address the many environmental science questions in a manner that is adequate to develop quantitative risk assessments. it therefore makes sense for researchers and risk managers to work together to develop approaches to limit exposure, and to identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. In some cases, it may even be necessary to take action to mitigate exposure even while environmental and health risks are being assessed.
"It is important to note that there is a discrepancy between what information we as regulators would like to have when making solid, scientifically informed regulatory decisions and what information is available to us" the authors write. "The discrepancy exists because it takes time to develop a body of scientific information, whereas regulations must be promulgated and decisions made on the basis of existing information. However, this is not new. History has taught us that it is important for all interested parties, in particular those who manufacture and market nanomaterials, to play leadership roles in taking action to anticipate and minimize any potential negative impacts on humans and the environment, for instance by controlling releases or identifying and eliminating those material properties that may produce adverse environmental impacts."
"This will advance our understanding of how nanomaterial properties may be modified or contained to minimize and manage potential risks from products with nanomaterials; it will also point to ways of minimizing inputs, including energy usage, during the production of nanomaterials. Doing so will put us on a path towards responsible and sustainable nanotechnology."