The journal Nature has just published a commentary of mine on the dangers of defining engineered nanomaterials for regulatory purposes (doi:10.1038/475031a). As the piece is behind a paywall, I thought it worth posting an early draft here. It’s not as well developed as the final commentary, but I don’t think it reads too badly.
For those of you interested in how a piece like this evolves, I’ve also added some notes and an intermediate draft at the end of the blog.
Why we don’t need a regulatory definition for nanomaterials
[Draft commentary submitted to Nature after discussions with a commissioning editor – final piece published 7/7/11]
Five years ago, I was a strong proponent of developing a regulatory definition of engineered nanomaterials. Today I am not. Even as policy makers are looking for clear definitions on which to build and implement nano-regulations, the science is showing there is no bright line separating the risks presented by nanometer and non-nanometer scale materials. As a result, there is a growing danger of science being pushed to one side as government agencies strive to regulate nanomaterials and the products they are used in.
Engineered nanomaterials are typically designed to exploit scale-specific physical and chemical properties associated with nanoscale structures. And it makes sense to assume therefore that these “unique” properties could lead to unique risks, triggering the need for nano-specific regulation. Indeed a rapidly growing body of research indicates that many nanoscale materials do behave differently to their non-nanoscale counterparts in humans and the environment.
This has led regulatory and oversight organizations around the world to consider how existing regulations stack up against the new challenges presented by engineered nanomaterials. In Europe, the introduction of the REACH regulations has been accompanied by extensive and highly contentious (although still unresolved) discussions on how they apply to engineered nanomaterials. More recently, proposed (but not adopted) changes to EU Novel Foods regulations would have placed specific restrictions on the use of engineered nanomaterials in food products. And new European cosmetics regulations will require engineered nanomaterials used as ingredients to be listed on product labels by 2013. In the United States, the Food and Drug Administration has issued a number of guidelines on how existing regulations apply to these new materials. And the Environmental Protection Agency has just issued draft policies concerning regulation of pesticide products containing engineered nanomaterials.
Underlying each of these initiatives is the need to define or otherwise identify engineered nanomaterials as a discrete class of material to be regulated. Yet the more we learn about how materials of all sizes interact with biological systems, the less obvious it becomes where the boundaries that differentiates nanoscale from non-nanoscale material behavior lie, or even whether “nanomaterial” is a legitimate class of material at all from a regulatory perspective.
In spite of this, regulators continue to search for a definition that will underpin nanomaterial regulation. And faced with conflicting evidence, it seems that some are beginning to turn away from science. Last year the European Commission released a draft definition the term “nanomaterial” for public comment. Yet despite a stated intent to base the definition on “available scientific knowledge,” there is a notable absence of science behind the resulting criteria distinguishing nano- from non nano-materials. Unsurprisingly, there has so far not been consensus on a European definition, which recently prompted the coordinator of the European Commission’s environment department’s nano team to suggest that ultimately, the decision on a regulatory definition of nanomaterials would be a policy one.
This should ring alarm bells throughout the scientific community. It implies that the basis for determining whether a material or product is regulated as a nanomaterial will be a term of art, not of science – pulling the scientific rug from under the very foundations of the regulatory system.
The dangers of substituting policy for science in the definitions arena are now being recognized in U.S. Regulatory policy principles just released by the Executive Office of the President emphasize heavily the need for science-based regulation with respect to engineered nanomaterials. This is an important move in the right direction, and one that has already been taken up by the US FDA in draft guidance on how the agency is thinking about nanomaterials. But the belief that engineered nanomaterials are a unique class of material continues to present a stumbling block to effective regulation in the U.S. and elsewhere; forcing policy makers to respond to the political and economic conceptualization of a technology, rather than the reality that it represents.
Rather, it is time to move away from dogma-driven definitions and toward science-informed guidelines that identify materials and products that raise plausible and specific concerns – irrespective of what they are called. In this way, frameworks can be developed that support responsive and adaptive regulations that are truly based on science.
And what of the science? We now know there are a number of parameters that modulate the human and environmental risk presented by materials, including particle size, shape, physical structure, porosity, chemistry (both on and below the surface), and environment. We know that some these parameters can become increasingly relevant at smaller scales for some materials, although this isn’t always the case. And we know that the transition from “conventional” to “unconventional” behavior – when it does occur – depends critically on a given material and the context within which it is found. What we are struggling with is how to incorporate this knowledge into regulatory frameworks without being straight-jacketed by a “one size fits all” definition.
At the end of the day, there is little doubt that materials arising from nanoscale science and engineering present significant regulatory challenges. But developing a regulatory definition of nanomaterials that is not based on sound science will only exacerbate these challenges – and there is little evidence to suggests that a definition that is based on sound science is possible. Rather, we need to think more critically about how new materials might cause harm, and the science-based guidelines that will help determine how best to regulate them – no matter what label they come with. Only then will we be in a position to use the best available scientific evidence to make informed regulatory decisions on a vast array of sophisticated new materials that are poised to enter the market over the next few years.
1 EC. Public consultation document. Commission recommendation of (…) on the definition of the term “nanomaterial”. (European Commission, 2010).
2 Maynard, A. D., Warheit, D. & Philbert, M. A. The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond. Tox. Sci. 120, S109-S129 (2011).
3 Hodge, G., Bowman, D. & Maynard, A. D. International Handbook on Regulating Nanotechnologies (Edward Elgar, Cheltenham, England, 2010).
4 Morris, J. et al. Science policy considerations for responsible nanotechnology decisions. Nat Nano 6, 73-77 (2011).
5 The Council of the European Union. Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure] (LA) (First reading), <http://register.consilium.europa.eu/pdf/en/09/st10/st10754.en09.pdf> (
6 Bowman, D. M., van Calster, G. & Friedrichs, S. Nanomaterials and regulation of cosmetics. Nat Nano 5, 92-92 (2010).
7 US FDA. Science research: Nanotechnology, <http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm> (2011).
8 US EPA. Regulating Pesticides that Use Nanotechnology, <http://www.epa.gov/pesticides/regulating/nanotechnology.html> (2011).
9 Euractiv.com. Commission’s nano policy lost in definition, <http://www.euractiv.com/en/innovation/commissions-nano-policy-lost-definition-news-503665> (
10 Holdren, J. P., Sunstein, C. R. & Siddiqui, I. A. Policy principles for the U.S. decision-making concerning regulation and oversight of applications of nanotechnology and nanomaterials. (Executive Office of the President Office of Management and Budget; Executive Office of the President United States Trade Representative; Executive Office of the President Office of Science and Technology Policy, Washington DC, 2011).
11 FDA. Considering whether an FDA-regulated product involves the application of nanotechnology. Guidance for industry, <http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm> (2011).
Some of you may recall that I first took up this theme in a blog posted back in April. That formed the basis of a discussion with a commissioning editor at Nature, who thought it might be suitable as a commentary with some work. The piece above is what ended up being submitted to Nature – it draws on the original ideas explored in the blog, while responding to a number of suggestions and comments made by the editor. It also draws on recent developments related to documents released by the White House and federal regulatory agencies. According to my notes, it was my sixth personal draft of the piece.
While the draft was well received, Nature were concerned by the lack of detail and specifics in a number of places. After going back and forth a couple of times, a revised draft was submitted (draft 8). You can read this here if you are interested in seeing how the piece began to shape up.
This draft still missed the mark in places. But working closely with the editor, remaining issues (mainly involving specifics within the commentary) were resolved, the word count was reduced so that the commentary fit on one page, and the piece was finalized.
The published commentary is a far more focused and specific piece of writing than the original I think – largely due to the hands-on involvement of the editor. I’m not sure it has so much of my “voice” in the phrasing and nuances. I think though that it conveys the ideas that were there from the beginning far more effectively.
Not something most people will be interested in I’m sure. But you never know…
- Why we don’t need a regulatory definition for nanomaterials
- Handling the risks of nanomaterials – a personal perspective from Martin Philbert
- A nanotechnology regulation hat trick from the US federal government
- International Handbook on Regulating Nanotechnologies – sneak peak of contents
- Nanotechnology 2.0: The next ten years of nano risk research