Cross-posted from The Risk Science Blog:

In a recent letter to the journal Nature (Nature 476; 399), Hermann Stamm of the European Commission Joint Research Centre Institute for Health and Consumer Protection (JRC-IHCP) defended the need to define engineered nanomaterials for regulatory purposes. The letter, titled “Nanomaterials should be defined”, was a direct response to my earlier commentary in Nature “Don’t define nanomaterials”.

Stamm’s letter is behind a paywall and so not easily accessible to many readers. But these are the main points he makes:

• A definition for engineered nanomaterials is required for labeling purposes, and would assist industry and regulators in identifying where specific safety assessments might be necessary.
• This should identify a general class of materials for attention, whether they are benign or hazardous.
• Nanomaterials have many properties not shared by their larger-scale counterparts, some of which have safety implications. And an increasing number of products containing novel nanomaterials are entering the market.
• Engineered nanomaterials are heterogeneous. But, they all have structures on the nanoscale which modify their other properties. Because of this, size is therefore most appropriate parameter to base a regulatory definition on.

Stamm also references a Joint Research Center Reference Report on “Considerations on a Definition of Nanomaterial for Regulatory Purposes”, co-authored by him and published in 2010.

As is probably clear from my Nature commentary (an early draft is freely available here), I have some sympathies with the challenges the JRC and regulators across the world are facing. Without a doubt, sophisticated materials arising from nanoscale science and engineering are presenting safety challenges that are not readily captured by current regulatory regimes. Yet I am increasingly concerned that, with the momentum that has built up behind the field of nanotechnology, it is becoming increasingly difficult to formulate evidence-based questions that will lead to science-justified regulation. And despite policy makers repeatedly stating that any form of nanomaterial regulation should be science-based, I have the sense that they are scrambling to use science to justify a predetermined conclusion – that engineered nanomaterials should be regulated on the basis of a hard and fast definition – rather than using science to guide their actions.

Instead, I would suggest that we need to put aside preconceptions of what is important and what is not here, and start by asking how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible – no matter what label or “brand” is applied to them.

The materials that most current regulations were designed to handle are pretty simple by today’s standards. Sure they can do some nasty things to the environment or your body if handled inappropriately. And without a doubt some of the risks associated with these “simple” materials are not yet well understood – especially when it comes to long term and trans-generational impacts.

Yet it’s hard to escape that reality that researchers are now designing new materials from the ground up that behave in novel ways, that have few analogs in the world of conventional materials, and that exhibit different properties according to the environment they are in. And as they do, it is becoming increasingly apparent that many of the regulations we rely on are ill-equip them to deal with the pending flood of sophisticated materials that is coming our way.

The development of relatively simple engineered nanomaterials in recent years has highlighted this disconnect between established regulations and the new demands being placed on them. Fortunately, many of the first nanomaterials to emerge have not presented insurmountable challenges, and regulators have been able to stretch existing regulatory frameworks to cover them (although even this in itself has not been an easy task). But these are just the beginning of a trend in novel materials designed and engineered at the nanoscale that will transcend current regulatory mindsets.

So what what are the options here? Before this question can be answered, a clearer understanding of the issues being faced needs to be developed.

Some of these are explored by Graeme Hodge, Di Bowman and myself in a commentary in the August 2011 edition of the journal Nature Materials.

“The problem of regulating sophisticated materials” [DOI: dx.doi.org/10.1038/nmat3085 - paywall] explores issues surrounding the safe introduction and use of complex new materials such as engineered nanomaterials, and suggests that there are seven key regulatory challenges that need to be addressed for progress to be made.

Unfortunately, I can’t reproduce the commentary in full here because of copyright restrictions. However, much of it draws on and builds upon an analysis presented in the recent International Handbook on Regulating Nanotechnologies.

What I thought it would be useful to do here is to summarize the seven challenges discussed in both the Handbook and the Nature Materials commentary. These are summarized from the final chapter of the Handbook (the full chapter can be downloaded here) – further information can be found both in the Handbook chapter and in the Nature Materials Commentary.

One of the problems with publishing in journals like Nature is that it can get a little pricey for people to read your work if they (or their organization) don’t subscribe.  For instance, if you want to read the commentary I’ve just had published on defining engineered nanomaterials for regulatory purposes, you are facing a hefty $32 fee to push through the paywall.  Now I know that I write interesting stuff.  But I’m not sure it’s that interesting!

Which is why I have just posted an earlier draft of the piece over on the Risk Science Blog.

This isn’t as focused or specific as the published commentary.  But it gives a rough idea of where I’m coming from.

And just because I can, I have also posted link to a later draft, and some notes on the editing process – so that those of you with more time than  sense can study in depth the evolution of the piece from initial scribblings to final product!

The early draft can be read here, and the published commentary “Don’t define nanomaterials” (Nature 475, 31 2011) can be accessed here.

It must be Nanotechnology Regulation week in Washington DC.  Yesterday, two federal agencies and the White House released documents that grapple with the effective regulation of products that depend on engineered nanomaterials.

In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials.

On the same day, the US Environmental Protection Agency posted a prepublication notice on Policies Concerning Products Containing Nanoscale Materials.

And to cap it all, the US Food and Drug Administration released Draft Guidance for Industry on Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.

A busy week for nanotechnology regulation!

White House Memo on Nanotechnology Regulation Policy Principles

The White House memorandum is the latest document to come out of the Emerging Technologies Interagency Policy Coordination Committee – ETIPC for short.  In part, it is a response to the 2010 review of the National Nanotechnology Initiative by the President’s Council of Advisors on Science and Technology, and in particular the concern expressed by PCAST that

“In the absence of sound science on the safe use of nanomaterials and of technologies and products containing them, the chance of unintentionally harming people and the environment increases.  At the same time, uncertainty and speculation about potential risks threaten to undermine consumer and business confidence.”

Correspondingly, this is a memorandum that is heavily focused on science-driven regulation, and the avoidance of knee-jerk responses to speculative concerns.

Reading through it, a number of themes emerge, including:

• Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider administrative and legal modifications to the regulatory landscape should the need arise.
• Regulatory action on nanomaterials should be based on scientific evidence of risk, and not on definitions of materials that do not necessarily reflect the evidence-based likelihood of a material causing harm.
• There should be no prior judgement on whether nanomaterials are intrinsically benign or harmful, in the absence of supporting scientific evidence.
• Transparency and communication are important to ensuring effective evidence-based regulation.

Overall, this is a strong set of policy principles that lays the groundwork for developing regulation that is grounded in science and not swayed by speculative whims, and yet is responsive and adaptive to emerging challenges.  Gratifyingly, the memorandum begins to touch on some of the concerns I have expressed previously about approaches to nanomaterial regulation that seem not to be evidence-based.  There is a reasonable chance that they will help move away from the dogma that engineered nanomaterials should be regulated separately because they are new, to a more nuanced and evidence-based approach to ensuring the safe use of increasingly sophisticated materials.  Where it perhaps lacks is in recognizing the importance of other factors in addition to science in crafting effective regulation, and in handling uncertainty in decision making.  But it is undoubtedly a move in the right direction.  The principles are listed at the end of this post.

EPA Draft Pesticides and Nanomaterials Policies

The second piece in this triumvirate is a prepublication version of a document from EPA that should appear in the Federal Register next week, titled “Pesticides; Policies Concerning Products Containing nanoscale Materials; Opportunities for Public Comment.”

As the title makes very clear, this is a statement from the EPA that is setting out draft policies for dealing with nanomaterials in pesticide products – materials such as nanoscale silver particles – and asking for public comment.  This is the latest iteration in a process that has been going on for some time to address the use of nanoscale silver as an antimicrobial agent, together with other antimicrobial, fungicidal and pesticide uses of nanomaterials.

The crux of the proposed policy is a requirement for manufacturers to let EPA know when a pesticide product contains an engineered nanomaterial – irrespective of whether it is an active or passive ingredient in the product. EPA acknowledges that the presence of a nanoscale material in a product does not necessarily indicate the possibility that it will exhibit new or unusual risks – but the agency intends to use this information as a trigger for a more thorough evaluation of products that might raise concerns.

This is a long and somewhat convoluted document, that spends some time outlining what the agency considers is an engineered nanomaterial, and reviewing nanomaterial hazard data.

Reading the document, EPA still seems somewhat tangled up with definitions of engineered nanomaterials. After outlining conventional attributes associated with engineered nanomaterials, including structures between ~1 – 100 nm and unique or novel properties, the document states

“These elements do not readily work in a regulatory context because of the high degree of subjectivity involved with interpreting such phrases as “unique or novel properties” or “manufactured or engineered to take advantage of these properties” Moreover the contribution of these subjective elements to risk has not been established.”

This aligns with where my own thinking has been moving in recent years.  Yet following this statement, the document reverts back to considering nanoparticles between 1 – 100 nm as the archetypal nanomaterial, and intimates “novel” properties such as “larger surface area per unit volume and/or quantum effects” as raising new risk concerns.

I also found the background information on potential hazards somewhat lopsided, as a litany of studies were cited that indicate a number of potential hazards associated with a range of materials, but without clear information on how this might translate to plausible and quantifiable risk.

At the end of the day, I found this to be a mixed bag of a document – some useful information and some evidence of new thinking, but all surrounded by a rather unfocused assessment.   However, it is a draft that has been put out for public comment, which means that there is an opportunity here to tighten it up considerably in the final version.

I must also add that I was impressed by the final section on Questions for Comment – here you will find a list of highly relevant questions that are the clearest indication in the document that EPA understands many of the critical issues here, and is genuinely looking for expert input to address them.

Interestingly though, the EPA document does not reference the White House memorandum on Policy Principles published at the same time – unlike my third and final document in this set from FDA.

FDA Draft Guidance for Industry on Products and Nanotechnology

The FDA Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology is a very different kettle of fish to the EPA document.  It is overtly responsive to the White House memo; it demonstrates a deep understanding of the issues surrounding nanotechnology and regulation; and it is mercifully concise.

To be fair, the scope of the draft guidance is limited to helping manufacturers understand how the agency is approaching nanotechnology-enabled products under their purview.  But this is something it does well.

One of the more significant aspects of the guidance is the discussion on regulatory definitions of nanomaterials.  Following a line of reasoning established some years ago, the agency focuses on material properties rather than rigid definitions:

“FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms… Based on FDA’s current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit”

Of course, this still begs the question “what is a nanomaterial in FDA’s eyes?”  The agency answer by stating:

At this time, when considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, FDA will ask:

1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

The guidance goes on to state

“These considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, they are subject to change in the future as new information becomes available, and to refinement in future product-specific guidance documents.”

FDA is clearly aiming for responsive and adaptive regulation here.

Reading the first of the two criteria above and the associated justification in the guidance, I can’t help feeling that FDA is still trying to justify responding to sub-100 nm scale materials based on assumptions of risk rather than evidence.  But the second criteria is important, because it opens the door to considering physical form and structure as a factor in determining potential risk irrespective of scale – as long as a material can come into intimate biological contact with a person.  This is a significant move, as it supports evidence-based decision-making on materials and products under FDA’s jurisdiction, irrespective of what technological label is applied to them.

That said, there remains some confusion as to how this criteria will be applied, and the reasoning behind it. Clearly, there is an aim here to capture supra-100 nm materials that nevertheless exhibit biological behavior associated with a nanometer-scale structure – including agglomerates, coated materials and hierarchical structures.  Yet the criteria is also said to have been selected to “exclude macro-scaled materials that may have properties attributable to their dimension(s) but are not likely relevant to nanotechnology”.  This statement seems to hark back to an assumption that “nanotechnology” is something that needs to be regulated, rather than focusing on materials and products that run the risk of slipping through the regulatory net – no matter what they are called.

But like the EPA document, the FDA guidance is still in draft form, and open to public comment.  And so is still very much a work in progress.

Overall, all three of these documents seem to be heading in the right direction if evidence-based, responsive and responsible regulations are the end goal.  There is still a way to go for both FDA and EPA before regulatory policy escapes being mesmerized by “nanotechnology”. But with strong science-driven policy principles emerging from the White House, the odds of this occurring are looking decidedly more healthy.

_____________

While House Policy Principles for the U.S. decision-Making Concerning Regulation and Oversight of Applications of nanotechnology and Nanomaterials:

In addressing issues raised by nanomaterials, agencies will adhere to the Principles for Regulation and Oversight of Emerging Technologies. Specifically, to the extent permitted by law, Federal agencies will:

• To ensure scientific integrity, base their decisions on the best available scientific evidence, separating purely scientific judgments from judgments of policy to the extent feasible;
• Seek and develop adequate information with respect to the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available;
• To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), develop relevant information in an open and transparent manner, with ample opportunities for stakeholder involvement and public participation;
• Actively communicate information to the public regarding the potential benefits and risks associated with specific uses ofnanomate rials;
• Base their decisions on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making;
• To the extent practicable, provide sufficient flexibility in their oversight and regulation to accommodate new evidence and learning on nanomaterials;
• Consistent with current statutes and regulations, strive to reach an appropriate level of consistency in risk assessment and risk management across the Federal Government, using standard oversight approaches to assess risks and benefits and manage risks, considering safety, health and environmental impacts, and exposure mitigation;
• Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment.
• Seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with nanomaterials; and
• Encourage coordinated and collaborative research across the international community and clearly communicate the regulatory approaches and understanding of the United States to other nations.

Cross-posted from The Risk Science Blog:

Back in 2007 the White House Office of Science and Technology Policy (OSTP) issued a set of “Principles for Nanotechnology Environmental, Health and Safety Oversight” (no longer available on the OSTP website it seems, but you can read them in this Nanowerk article). At the time, I was less than enamored with the “don’t mess with business” tone of the principles. So I was particularly interested to read what the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) had to say on a very similar issue last month.

ETIPC was formed last year, and consists of assistant secretary-level representation from about twenty federal agencies. From the White House blog, the group is

…part of an effort to give special attention to technologies so new—such as nanotechnology and synthetic biology—that their policy implications are still being gauged. Created jointly by OSTP, the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA), and the Office of the United States Trade Representative (USTR), the ETIPC consists of assistant secretary-level representatives from about 20 Federal agencies.

The same post goes on to explain that

Emerging technologies promise to have significant scientific, economic, and perhaps societal impacts because of their potential to revolutionize fields as varied as materials science, electronics, medicine, communications, agriculture, and energy. Rapid scientific and technological advances in these fields are resulting in a variety of new products and processes with unique and transformational characteristics. But full realization of the economic and public benefits of these applications will require open consideration of policy questions with the full range of stakeholders, including governments, industry, non-governmental organizations, academia, and the public.

The first publicly released outcomes of ETIPC were released last month. On March 11 2011, John Holdren (Director of OSTP and Assistant to the President for Science and Technology), Cass Sunstein (Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget) and Islam Siddiqui (Chief Agricultural Negotiator, United States Trade Representative) issued a joint memorandum on Principles for Regulation and Oversight of Emerging Technologies, developed by ETIPC.

These are consistent with the President’s Executive Order 13563 (issued on January 18 2011) on Improving Regulation and Regulatory Review. They also include much of the same language of the 2007 principles. But the tone and emphasis are markedly different.

The memorandum starts by noting that

Innovation with respect to emerging technologies — such as nanotechnology, synthetic biology, and genetic engineering, among others — requires not only coordinated research and development but also appropriate and balanced oversight.

It then frames the issues at stake by stating:

We share a fundamental desire for regulation and oversight that ensure the fulfillment of legitimate objectives such as the protection of safety, health, and the environment. Regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.

This is in stark contrast to the 2007 principles, which have a much stronger primary focus on not intrfereing with business and innovation.

The principles follow up this focus on safety, health and the environment with an emphasis on science-based decision-making, public participation, and flexibility. These reflect emerging thinking on the challenges and opportunities presented by emerging technologies, and appear to offer a firm foundation for moving forward.

However, reading the principles (which are included below) I do have a couple of concerns.

The first is that these principles are extremely general. While establishing laudable objectives such as basing regulation on scientific evidence, engaging stakeholders in the process of developing regulation, balancing the costs and benefits of regulations and ensuring regulatory flexibility, they lack the details which would transform them from a set of nice ideas to something that has impact. This is understandable in a document of this type, but it would be good to see a move toward actionable recommendations coming out of this group.

I’m also concerned that some of the principles hint at less than innovative thinking to address the safe and sustainable development of technology innovation. For instance, while the emphasis on public participation is welcome, the principles are written in terms of modes of public consultation that rarely allow engagement with and input from citizens as opposed to mobilized interest groups. Rather than supporting the idea that posting details of public meetings and consultation periods in the Federal Register constitutes public participation, (it doesn’t), it would be good to see some innovative thinking on what true engagement means in terms of developing effective regulations for emerging technologies.

I am also unsure what “Risk assessment should be distinguished from risk management” means – especially when risk experts are beginning to explore more integrative approaches to risk assessment and management as a way of addressing complex and emerging issues.

But these concerns aside, there is a lot to applaud here. In particular, the combination of science-driven, participatory and flexible approaches to emerging technologies regulation should lay the groundwork for approaches to oversight that both protect people and the environment, and support technology innovation.

It is also worth noting that the principles align closely with the University of Michigan Risk Science Center’s vision of evidence-informed and socially-responsive action on human health risks. And they set the scene rather well for this September’s Risk Science Symposium on Risk, Uncertainty and Sustainable Innovation.

So although there is still a long way to go before technology innovation is accompanied by innovations in governance that will support rather than hinder its safe and sustainable development, these principles are an important step toward the federal government coordinating approaches to ensuring emerging technologies and emergent risks are regulated effectively.

From the memorandum:

…the following principles, consistent with Executive Order 13563 and discussed and approved by the ETIPC, should be respected to the extent permitted by law:

• Scientific Integrity: Federal regulation and oversight of emerging technologies should be based on the best available scientific evidence. Adequate information should be sought and developed, and new knowledge should be taken into account when it becomes available. To the extent feasible, purely scientific judgments should be separated from judgments of policy.
• Public Participation: To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), relevant information should be developed with ample opportunities for stakeholder involvement and public participation. Public participation is important for promoting accountability, for improving decisions, for increasing trust, and for ensuring that officials have access to widely dispersed information.
• Communication: The Federal Government should actively communicate information to the public regarding the potential benefits and risks associated with new technologies.
• Benefits and costs: Federal regulation and oversight of emerging technologies should be based on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making.
• Flexibility: To the extent practicable, Federal regulation and oversight should provide sufficient flexibility to accommodate new evidence and learning and to take into account the evolving nature of information related to emerging technologies and their applications.
• Risk Assessment and Risk Management: Risk assessment should be distinguished from risk management. The Federal Government should strive to reach an appropriate level of consistency in risk assessment and risk management across various agencies and offices and across various technologies. Federally mandated risk management actions should be appropriate to, and commensurate with, the degree of risk identified in an assessment.
• Coordination: Federal agencies should seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with the commercialization of an emerging technology, in an effort to craft a coherent approach. There should be a clear recognition of the statutory limitations of each Federal and state agency and an effort to defer to appropriate entities when attempting to address the breadth of issues.
• International Cooperation: The Federal Government should encourage coordinated and collaborative research across the international community. It should clearly communicate the regulatory approaches and understanding of the United States to other nations. It should promote informed choices and both sharing and development of relevant data, particularly with respect to the benefits and costs of regulation and oversight. The Federal Government should participate in the development of international standards, consistent with U.S. law and guidance (e.g., the National Technology Transfer and Advancement Act and OMB Circular A-119). When appropriate, international approaches should be coordinated as far in advance as possible, to help ensure that such approaches are consistent with these principles.
• Regulation: The Federal Government should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principles, to the extent permitted by law, when regulating emerging technologies:
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency;
  • Regulations should be developed with a firm commitment to fair notice and to public participation;
  • The benefits of regulation should justify the costs (to the extent permitted by law and recognizing the relevance of uncertainty and the limits of quantification and monetary equivalents);
  • Where possible, regulatory approaches should promote innovation while also advancing regulatory objectives, such as protection of health, the environment, and safety;
  • When no significant oversight issue based on a sufficiently distinguishing attribute of the technology or the relevant application can be identified, agencies should consider the option not to regulate;
  • Where possible, regulatory approaches should be performance-based and provide predictability and flexibility in the face of fresh evidence and evolving information; and
  • Regulatory approaches shall comply with established requirements and guidance such as the following:
    • Executive Order 13563 – Improving Regulation and Regulatory Review. Federal Register, Vol. 76, No. 14, Friday, January 21, 2011, 3821-3823, available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf;
    • Executive Order 12866 – Regulatory Planning and Review. Federal Register Vol. 58, No. 190, Monday, October 4, 1993, 51735-51744, available at http://www.whitehouse.gov/omb/inforeg/eo12866.pdf;
    • Information Quality Act (Sec. 515 of the Treasury and General Government Appropriations Act for FY 2001, Pub. L. No. 106-554); Information Quality Guidelines: OMB (2002) Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf;
    • National Technology Transfer and Advancement Act of 1995 (“NTTAA”). Public Law 104-113, available at http://standards.gov/standards_gov/nttaa.cfm;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (02/10/1998), available at http://www.whitehouse.gov/omb/circulars/a119/a119.html;
    • OMB Final Information Quality Bulletin for Peer Review (December 16, 2004), available at http://www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf;
    • OMB Bulletin No. 07-02 (M-07-07), Issuance of OMB’s “Final Bulletin for Agency Good Guidance Practices” (January 18,2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-07.pdf;
    • OMB/OSTP Memorandum: M-07-24, Updated Principles for Risk Analysis (September 19, 2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf;
    • The Trade Agreements Act of 1979, as amended (Pub.L. 96-39, 93 Stat.
      144, enacted July 26, 1979, codified at 19 U.S.C. ch.13 (19 U.S.C. §
      2501-2581);
    • A Strategy for American Innovation: Driving Towards Sustainable
      Growth and Quality Jobs” (September 2009), available at: http://www.whitehouse.gov/assets/documents/SEPT_20_Innovation_Whitepaper_FINAL.pdf; and
    • Office of Information and Regulatory Affairs, Disclosure and Information As Regulatory Tools (June 18, 2010), available at http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/disclosure_principles.pdf

I‘ve just posted a piece over on the Risk Science Blog on regulatory definitions of engineered nanomaterials.  What may come as a surprise to many readers given my comments over the years is the title – “Why we don’t need a regulatory definition for nanomaterials”!  Have I flipped, lost my senses, or what?

As you might guess, I still think that engineered nanomaterials present a huge regulatory challenge – both from the perspective of avoiding unnecessary health impacts, and providing manufacturers with clear, rational rules for their safe use.  But I also have this odd idea that regulations should at the minimum be built on evidence if the resulting rules and guidelines are to have any relevance and traction.

Sadly, it now looks like we are heading toward a situation where the definitions of nanomaterials underpinning regulations will themselves be based on policy, not science.

This scares the life out of me, because it ends up taking evidence off the table when it comes to oversight, and replacing it with assumptions and speculation on what people think is relevant, rather than what actually is – not good for safety, and certainly not good for business.

But you can read more about why I’m getting worried about a regulatory definition for nanomaterials over at the Risk Science Blog.

The recently published International Handbook on Regulating Nanotechnologies has a rather unconventional cover image. But it’s one that I must confess I am rather pleased with.

The image is a photo of a piece of Murano glass that I picked up several years ago while visiting Venice. At the time I was participating in a nanotoxicology conference, and so was sensitized to all things nano. Taking some time out to wander round the glass showrooms of Murano, I was struck by the deep red glass that a number of the pieces were showcasing. The coloring comes from the glass being infused with gold nanoparticles – a technique that dates back to medieval times, but is especially associated with the artisans of Murano. Given the nanoparticle connection, I picked up this particularly eye-catching piece, thinking that it might come in useful some day.

The original inspiration for the book cover

Fast forward a few years to the final stages of pulling the International Handbook on Regulating Nanotechnologies together. As we neared completing the book, my co-editors Graeme Hodge and Di Bowman and I were looking for an arresting image for the book’s cover. At the time, my daughter was taking a photography class at school, and had just taken an abstract image of my Murano glass piece. As a photo, it worked rather well, and got me thinking about whether I could finally use the piece for something nanotech-related.

Examining the piece more closely, it struck me that there was scope here for a rather sophisticated image that illustrated the challenges of regulating nanotechnologies on multiple levels. On one level, the piece used gold nanoparticles to achieve a specific effect. On a more abstract level, the nanoparticles were used to illustrate an ordered array of circular objects – a little reminiscent of an ordered array of nanoparticles. Then, these objects were multi-layered – hinting at the sophistication that can now be achieved in engineering nanometer scale structures with multiple components.

So the piece took on the role of an elegant and sophisticated metaphor for nanotechnology, that incorporated the technology within the metaphor itself.

But what persuaded me that this might be an image that would work on the front of a book about regulation was an intriguing question that the piece raised. Even though the technology used to color the glass uses nanoparticles, the technology could hardly be termed nanotechnology when it was initially developed – simply because the artisans had no idea that the effect they were achieving was due to these small, uniform particles in the glass. But now we know that this is the cause of the effect. And artisans continue to utilize the technology with the full knowledge that it is associated with uniformly sized nanometer diameter particles of gold infused through the glass. Does this conscious understanding and use make it nanotechnology? And does that mean that we need to ask new questions about how the technology is regulated – even though it’s been around for thousands of years?

These are some of the overarching questions that we and our co-authors were grappling with in the book. So it made perfect sense to use the image as a metaphor for the the challenges we face in regulating nanotechnologies – or even formulating the questions we need to address.

And, as it turns out, it doesn’t look half bad!

From the book cover:

An abstract image realized in contemporary glass, from the Venetian island of Murano. The deep red coloring results from the glass being infused with gold nanoparticles, a technique used by artisans lung long before it was realized that the effect was due to the size of the gold particles suspended within the glass. The regular array of concentric geometric shapes is an apt metaphor for the complexity of engineered nanomaterials, where useful attributes arise from controlling how matter is structured from the nanoscale up to the scale of everyday objects. But it also poses an intriguing question in the context of regulation: now that the artisans know the glass gets its unique properties from nanometer-scale gold particles – and can presumably better control it as a result – is it nanotechnology?

Cross-posted from the Risk Science Blog

]]> http://2020science.org/2011/02/26/the-art-of-regulating-nanotechnologies/feed/ 3 http://2020science.org/2010/11/04/international-handbook-on-regulating-nanotechnologies-sneak-peak-of-contents/ http://2020science.org/2010/11/04/international-handbook-on-regulating-nanotechnologies-sneak-peak-of-contents/#comments Thu, 04 Nov 2010 19:49:38 +0000 Andrew Maynard http://2020science.org/?p=3778

Back in the mists of time, I was approached with a crazy proposition – would I help co-edit a book on nanotechnologies regulation!  In a moment of weakness I said yes, and a little more than two and a half years later, the book is finally about to hit the shelves.

I actually think the resulting International Handbook on Regulating Nanotechnologies rather a useful, coherent and engaging collection of chapters – my co-editors Di Bowman and Graeme Hodge did a wonderful job encouraging a bunch of top thinkers in the field to write under occasionally whimsical but always relevant titles.

To whet your appetite prior to the book’s release sometime in November, here’s a sneak peak at the contents:

PART I:    Concepts and Foundations

1.    Introduction: the regulatory challenges for nanotechnologies

Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard

2.    Philosophy of technoscience in the regime of vigilance

Alfred Nordmann

3.    Tracing and disputing the story of nanotechnology

Chris Toumey

4.    The age of regulatory governance and nanotechnologies

Roger Brownsword

PART II:    Frameworks for Regulating Nanotechnologies

5.    Nanotechnology captured

John Miles

6.    The scientific basis for regulating nanotechnologies

David Williams

7.    The current risk assessment paradigm in relation to the regulation of nanotechnologies

Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel

8.    Regulating risk: the bigger picture

Karinne Ludlow and Peter Binks

9.    Producing safety or managing risks? How regulatory paradigms affect insurability

Thomas K. Epprecht

PART III:    Case Studies in Regulating Nanotechnologies and Nano-Products

10.    The evolving nanotechnology environmental, health, and safety landscape: A business perspective

Oliver Tassinari, Jurron Bradley and Michael Holman

11.    Regulation of carbon nanotubes and other high aspect ratio nanoparticles: approaching this challenge from the perspective of asbestos

Robert J. Aitken, Sheona Peters, Alan D Jones and Vicki Stone

12.    Approaching the nanoregulation problem in chemicals legislation in the EU and US

Markus Widmer and Christoph Meili

13.    A good foundation? Regulatory oversight of nanotechnologies using cosmetics as a case study

Geert van Calster and Diana M. Bowman

14.    Therapeutic products: regulating drugs and medical devices

Rogério Sá Gaspar

15.    Regulatory perspectives on nanotechnologies in foods and food contact materials

Anna Gergely, Qasim Chaudhry and Diana M. Bowman

16.    Regulation of nanoscale materials under media-specific environmental laws

Linda Breggin and John Pendergrass

17.    Military applications: special conditions for regulation

Jürgen Altmann

18.    Regulating nanotechnology through intellectual property rights

Gregory N. Mandel

PART IV:    The Future Regulatory Landscape

19.    The role of NGOs in governing nanotechnologies: challenging the ‘benefits versus risks’ framing of nanotech innovation

Georgia Miller and Gyorgy Scrinis

20.    Voluntary measures in nanotechnology risk governance: the difficulty of holding the wolf by the ears

Christoph Meili and Markus Widmer

21.    The role of risk management frameworks and certification bodies

Thorsten Weidl, Gerhard Klein and Rolf Zöllner

22.    Risk governance in the field of nanotechnologies: core challenges of an integrative approach

Ortwin Renn and Antje Grobe

23.    International coordination and cooperation: the next agenda in nanomaterials regulation

Robert Falkner, Linda Breggin, Nico Jaspers, John Pendergrass and Read Porter

24.    Transnational regulation of nanotechnology: reality or romanticism?

Kenneth W. Abbott, Douglas J. Sylvester and Gary E. Marchant

25.    From novel materials to next generation nanotechnology: a new approach to regulating the products of nanotechnology

J. Clarence Davies

PART V:    Conclusion

26.    Conclusions: triggers, gaps, risks and trust

Andrew D. Maynard, Diana M. Bowman and Graeme A. Hodge

More information on the International Handbook on Regulating Technologies can be found here.  The anticipated publication date is late November.

Marc Saner at Carleton University in Canada sent this timeline of key nanotech policy events to me the other day.  It’s probably the most comprehensive compilation of events influencing the development of nanotech policy in America, Europe and Australia I’ve seen to date – well worth taking a look at if you have any interest whatsoever in what happened when related to the oversight of nanotechnology and engineered nanomaterials.

It also includes hotlinks to web-based documents where they are available, making the timeline a great resource for tracking down elusive reports.

The timeline isn’t inclusive – I’m not sure capturing everything is humanly possible – but it’s pretty good.  It’s also a living document – if you have something you think should be there that isn’t, you can email in your updates.

A bit of a wonky blog I’m afraid, but having seen relatively little on the recently introduced Safe Chemicals Act of 2010 and its relevance to engineered nanomaterials on the web, I thought I would post something short and sweet here.

Just over a week ago, Senator Lautenberg introduced a bill in the US Senate aimed at a long-overdue reform of toxic substances regulation in the United States – the Safe Chemicals Act of 2010.  At the same time, Congressmen Rush and Waxman released a discussion draft in the House – The Toxic Chemicals Safety Act of 2010 – covering much of the same ground.  Both documents aim to update substantially the Toxic Substances Control Act, or TSCA – which has been the mainstay of US chemicals regulation since 1976.

Both the 169-page Safe Chemicals Act of 2010 and the slightly shorter 119 page long Toxic Chemicals Safety Act of 2010 aim to bring US chemicals safety regulation into the 21st century.  Richard Denison at EDF has already posted a comprehensive overview of proposed changes to the regulation that I would recommend reading if you are into this stuff.  But here, I thought I would highlight what the proposed changes mean for the engineered nanomaterials – a class of substances that have been a bit of a thorn in TSCA’s side for the past few years.

The problem with TSCA (the old version) is that it is built on a chemicals world-view – substances are regulated based on their unique “molecular identity” – how they are described as chemicals. This works well for substances that do what they do because of their chemistry.  But it runs into problems where something behaves in a certain way because of its physical form, as well as its chemical makeup.  In other words, where you have stuff that is more harmful that molecular identity would suggest because of how the constituent atoms and molecules are put together, you have a problem.

There are workarounds to this within TSCA – a new substance that is chemically identical to an existing one can be regulated under the “Significant New Use Rule” for instance – but it’s a bit of a bootstrap.  And with the emergence of an increasing number of engineered nanomaterials where functionality – and possibly toxicity – depend on physical form as well as molecular identity, this bootstrap has been stretched to breaking point.

So there’s been considerable interest in how the new-look TSCA will handle this.

Fortunately, things are looking good at this stage.  The Senate bill has language that is in effect a substance “get out of jail free” card for EPA.  Section 4 of the bill proposes amending section 3(2) of the original Toxic Substances Control Act with

“Notwithstanding molecular identity, the Administrator may determine, under section 5(a)(6), that a variant of a chemical substance is a new chemical substance.” (page 6)

In other words, EPA can decide when something with the same molecular identity as an existing substance should be treated as a new substance.

And the determiners of when this is justified? The bill proposes that section 3(13) of the 1976 TSCA act is amended with

“(C) SPECIAL SUBSTANCE CHARACTERISTICS.—The term ‘special substance characteristics’ means, such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider—

(A) size or size distribution;

(B) shape and surface structure;

(C) reactivity; and

(D) any other properties that may significantly affect the risks posed.” (page 13)

In other words, the new bill allows many of the characteristics that potentially lead to engineered nanomaterials presenting novel risks to trigger them being treated as new substances.

The House draft document is a little more explicit.  It recommend amending section 3(2) of the original act with:

“(C) For purposes of this Act, such term may include more than 1 form of a substance with a particular molecular identity as described in sub-paragraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.” (page 6)

with the clarification that

“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—

(A) chemical structure and composition

(B) size or size distribution

(C) shape

(D) surface structure

(E) reactivity; and

(F) other characteristics and properties that may bear on toxicological properties” (page 11)

Both the Senate bill and the House discussion document provide EPA with the authority to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance.  This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance.  But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented.  In other words, these provisions effectively future-proof the new regulation.

Of course there’s a long way to go yet.  The final details of the new legislation have to be hashed out between the Senate and the House before they are finally signed off on.  Then the process of interpreting and enacting the new regs starts – including working out how exactly to determine when something should be considered new for regulatory purposes.

But at least things seem on the right track as far as enabling the safe development and use of engineered nanomaterials goes.

_____________________________

The two documents can been downloaded here:

The Safe Chemicals Act of 2010 (US Senate)

The Toxic Chemicals Safety Act of 2010 (US House of Representatives)

A new report released today from the UK Department for Business, Innovation and Skills (BIS) Expert Group on Science and Trust emphasizes the need to address risk and uncertainty in developing and using science and technology within society.  “Acknowledging risk and uncertainty” is the second of eight broad aspirations from the independent group, established to develop a UK action plan to “enhance society’s capabilities to make better-informed judgements about the sciences and their uses in order to ensure that the “license to operate” is socially robust.”

The report “Starting a National Conversation about Good Science” [PDF, 478 KB] is a rich, informative and insightful document, that demands careful consideration.  It comes out of a group assembled to consider new mechanisms to increase public trust in science and engineering; review the impact of the existing science-related ethical code of practice; examine how movement of knowledge and people across the different sectors can be facilitated in order to maximize the benefits and impacts of science and society activities; and think about better ways to evaluate the impacts of science and society initiatives.  Despite this being a purely British affair, many of the recommendations are relevant far beyond the confines of a UK-centered “national conversation,”  and will hopefully stimulate a global dialogue on what is a global challenge.

Amidst the eight “broad aspirations” of the group, which span public judgment about science and awareness of the scientific process, to underpinning science-informed decision-making and good science governance, I was particularly struck by an emphasis on risk and uncertainty.  This may be because in a few weeks I will becoming increasingly involved in risk, uncertainty and science-informed decision-making, as I take over as Director of the Risk Science Center at the University of Michigan.  But beyond this, I was struck by the group’s recognition that, from the publics’ various perspectives, uncertainties surrounding science and technology – their implications in particular – are often more important than the science and technology themselves.

The overarching aim of the Science and Trust Expert Group -  and of this report – was

“To enhance society’s capabilities to make better-informed judgements about the sciences and their uses in order to ensure that the “licence to operate” is socially robust.”

In this context,the group recommended that

“Expert advice to Government should identify and characterize uncertainties; policy makers should communicate clearly actions that take account of inevitable uncertainties; efforts should be made to support public judgements about risks and uncertainties.”

In particular, the report emphasizes the need to address uncertainties surrounding the potential impacts and benefits of emerging technologies “in the wider context of science and society relations.”

This emphasis on uncertainty is particularly welcome, and closely aligns with where I hope to be taking the University of Michigan Risk Science Center over the next few years.  New technologies – or innovative ways of using existing technologies for that matter – lead to inherently uncertain futures.  There is a great danger of mistaking this uncertainty for risk (risk is a reasonably well-understood chance of something bad happening; uncertainty is a poor understanding of whether good or bad will come out of a course of action) – with the result that there is a tendency to shy away from potentially beneficial technologies, simply because we don’t know how they are going to unfold.  On the other hand, uncertainty means that we do need to move forward carefully, in case there are very real and relevant risks lurking in the shadows.  The trick is to develop better ways of handling uncertainty so that the best possible choices are made.

Being up-front about uncertainty and potential risks associated with science and technology is a critical step toward developing conversations and actions that underpin a science-informed approach to minimizing and otherwise handling uncertainty and risk.  One particularly good resource that the report recommends is A Worriers’s Guide to Risk [PDF, 222 KB] – a one-pager intended to help everyone make more sense of the seemingly unending series of stories on risk.

In its specific recommendations and actions, the Science and Trust Expert Group includes:

• Support Government to take better account of risks and uncertainties in policy making;
• Support public judgements about risks and uncertainties inherent in the scientific advisory process;
• Support policy makers to take better account of public attitudes and values to the risks, benefits and uncertainties in the governance of emerging technologies;
• Enable wider discussions in the media and elsewhere on uncertainty inherent in the scientific process; and
• Enable greater discussion of risk.

Although these are aimed fair and square at the UK, they provide a valuable template for a global conversation about good science, and its role within society.  Hopefully, now that the UK has set the pace, we will see this develop as an International conversation about good science.

Regulators around the world are currently grappling with how to manage the possible risks associated with first generation nanotechnologies.  But increasingly sophisticated nanotechnology-based products are coming – will the old regulations still cover these emerging nanotechnologies, or is a re-think in how substances are regulated in order?  These are some rough notes I prepared for a short talk given at Chatham House in the UK, on some of the possible challenges to regulating next generation nanotechnologies.

Nanotechnology is oft-heralded as the next industrial revolution—something that will transform our lives.  But despite this lofty vision, many of the nano-driven products that consumers and regulators are grappling with at the moment seem rather mundane.  Nanotechnology promoters talk about smart drugs, super-strong materials and science fiction-like invisibility cloaks. Yet for most people, the nanotechnology of the hear-and-now doesn’t extend much beyond sunscreens and stain-resistant pants.

Okay, so this is something of an oversimplification.  But it’s fair to say that regulatory agencies charged with protecting people and the environment  have so far been faced with rather simple and crude nanotech-enabled products.  These early products of engineering matter at the nanoscale have raised plenty of challenges of their own when it comes to ensuring safe use—like how a material that can cause harm because of its size as well as its chemistry should be regulated, or which of the current battery of toxicity tests applied to new substances work for nanomaterials, and which do not.  However, with some creative thinking, a dash of new research and a bit of hand waving, there’s a general (although by no means universal) feeling that existing regulatory frameworks can just about stretch to cover many of the current products of nanotechnology.

But will this always be the case?

What are the chances of future developments in nanotechnology throwing up products that are so unusual, that existing regulatory frameworks are stressed to the point of breaking?

Looking into the emerging technologies crystal ball is always a dangerous business—there’s often a gaping chasm between the seeds of new technologies and those that eventually make it to market.  Development timescales are inevitably longer than predicted.  And more often than not, the most successful new technologies are the ones that sneak under the radar – taking everyone unawares.

Yet even with these limitations, we probably know enough about where nanotechnology is heading to gain some insight into whether existing regulatory frameworks are likely to suffice, or whether, at some point, new approaches need to be considered.

In tackling the question of future regulatory challenges from emerging nanotechnologies, it seems important to ask “what is different about nanotech?”  It’s where new materials and products deviate from established norms that regulatory frameworks will be most likely be stressed. Some emerging products of nanotechnology will quite conceivably look very conventional from a regulatory perspective – these shouldn’t cause too many problems.  But where a new product’s ability to cause harm doesn’t fit with current understanding, alarm bells should start to ring.

In working out what (if anything) is different about nanotech, there is a tendency to fall back on generally accepted definitions of nanotechnology, such as the one crafted by the US National Nanotechnology Initiative (NNI).  But this is a temptation that needs to be resisted.  The NNI definition of nanotechnology is one of expedience, not science. It serves the purpose of stimulating new research and technology innovation in an exciting new area—and does this brilliantly.  But it doesn’t clearly define a set of products and processes that have common and specific safety issues; and it was never intended to.

Instead, it is more helpful to ask how materials engineered at a nanometer scale might behave differently to more conventional materials, and how this might affect their safe use.

In asking “what is different?” it is useful to distinguish between the intrinsic and extrinsic properties of material that has been engineered at the nanoscale.  In essence, to differentiate between what it is, and what it does. Again, this is something of a simplification, but is useful for getting a handle on what might be important here.

Intrinsic properties can be seen as those that associated with the material itself, rather than how it is being used.  For instance, chemical composition leads to intrinsic properties. Size and shape can also underpin some intrinsic properties.

Some materials begin to show novel intrinsic chemical and biological properties when formed as nanometer-sized particles, or are engineered with nanometer-scale structures.  Some materials that are engineered at the nanometer scale can be used in different ways—and get to different places—simply by nature of their small size – this can also be seen as an intrinsic property of the nano-engineered material.

Much of nanotechnology is about tapping into and exploiting these novel, scale-specific intrinsic properties.

From a regulatory perspective, it becomes important to know when these novel intrinsic properties lead to enhanced or new risks to people and the environment—in other words, when does engineering a substance at the nanoscale leads to a deviation in its conventionally established risk profile?  This is very much the challenge presented by the first wave of engineered nanomaterials that regulators are currently facing.

These challenges are not insignificant.  It is clear that the potential impact from nanomaterials can no longer be predicted by chemistry alone, and regulators are having to adjust to a world where physical form and chemical composition potentially determine risk.  But there are a number of organizations that believe that with the right research, and appropriate interpretation of existing regulations, these challenges are not insurmountable—at least for many types of nanomaterials currently being used.

The situation is not so simple though when it comes to addressing the extrinsic properties of engineered nanomaterials.

But what is the nature of these extrinsic properties?

An important characteristic of nanotechnology is the sophistication it brings to working with matter at the level of atoms and molecules.  Advances in tools and understanding are making it possible to precisely engineer the structure of matter at the finest possible level.  As a result, we are beginning to create materials that are unique—not only do they have properties never before available to scientists, engineers and technologists; they also potentially present human health and environmental risks never before encountered.

This sophistication brings within our grasp the ability to build complex “devices” that are mere nanometers in size.  Using atoms and molecules (or small clusters of them) as our building blocks, we can start to engineer matter at a nanometer scale, and in the words of the late Richard Smalley, “build stuff that does stuff.”

At this point, the extrinsic properties of the “stuff” that we build become critical—the functionality associated with a carefully engineered collection of chemicals and components (what it does) becomes more than just the sum of its parts.

It is these extrinsic properties that may end up stressing established regulatory frameworks to breaking point.

At this point, it is worth clarifying what I mean by “device.”  I’m thinking here of something engineered to do something. From this perspective, a lever or a fork is a simple device.  So is a chair.  Or a car.  At the nanoscale, a device is anything that has been engineered to do something that goes beyond the intrinsic properties of its individual components. So a nanoparticle engineered with just the right size and shape to target and penetrate a tumor is a simple device.  So is a material engineered to bend light or transmit electrons in a specific way.

This is intuitive when working with objects at the human scale.  The difference in functionality between a lump of iron, a knife, and a car, is blindingly obvious.  So are the relative risks.  Once engineered, the extrinsic properties of the resulting device become critical in determining how it is used, and how it might cause harm.

This holds true at the nanoscale as much as it does at the human scale.  But here we face a conceptual hurdle that regulators will need to overcome if the products of emerging nanotechnologies are to be handled safely.  There is a natural tendency to assume that, if we can’t see the physical form and complexity of something, its form and complexity don’t matter.  As a consequence, most substance-related regulations—irrespective of the country or region they apply to—focus on the intrinsic properties of materials—which usually means focusing on their chemical composition.

To be fair, this chemistry world-view has been reasonably effective in reducing the impact of materials on people and the environment over the past fifty years or so.  But nanotechnology is increasingly pushing us into a post-chemistry world, where knowing what something is made of is no guarantee that we know how to handle it safely.

So assuming that nanotechnology is going to lead to increasingly sophisticated materials and “devices” that may present significant challenges to existing regulatory frameworks in the future, do we have an idea of what these emerging technologies will look like?

I’m not sure how far we can predict specific products that are likely to hit the market over the next decade or so.  But it should be possible to get a handle on emerging nanotechnology trends that could help inform future regulatory decisions. Here, the key is sophistication – how will our increasing dexterity at the nanoscale change things?

Mike Roco – one of the instigators of the modern nanotechnology movement –famously mapped out a series of nanotechnology “generations” that try to capture this idea of increasing sophistication.  These progress from passive nanostructures through active nanostructures to systems of nanosystems and molecular nanosystems.  However, as J. Clarence Davies notes in his 2009 report Oversight of Next Generation Nanotechnology,

“Even knowledgeable experts have expressed difficulty distinguishing among Roco’s last three generations and understanding some of the applications he describes.”

An alternative perspective is given by Jim Tour of Rice University, who divides the nano-universe up into passive nanotechnologies, active nanotechnologies and hybrid nanotechnologies.  This is slightly easier to work with than Roco’s “generations,” and makes sense in terms of what increasing sophistication will lead to.

From both of these perspectives, regulators are currently grappling with passive nanotechnologies—simple engineered nanomaterials that may have novel properties which typically do not change according to what is going on around them .  It is the products of these first generation nanotechnologies that are stretching regulations, but apparently not breaking them. However, active nanotechnologies (and beyond) – the nanotechnologies that are just around the corner – are the ones that I suspect are going to require far more thought as to how nano-stuff is regulated in terms of what it does, rather than what it is.

But what exactly is an “active” nanotechnology?

Recently, Vrishali Subramanian at the Georgia Institute of Technology and colleagues took a stab at describing more fully what “active” nanotechnologies are, and came up a scheme that not only makes a lot of sense, but also helps give a feel for what some of the coming next generation nanotechnologies might look like.

Starting from an analysis of the scientific literature between 1995 and 2008, Subramanian came up with five different types of active nanotechnology.  From a regulatory perspective, these are particular useful because they provide a framework for classifying emerging technologies by what they do, rather than what they are.

The five categories she ended up with are:

Remote actuated active nanostructures: Nanotechnologies whose active principle is remotely activated or sensed. In other words, materials or “devices” that are either nano-scale or nano-structured, that change what they do in response to an external signal—a laser pulse say, or a high frequency radio signal.

Environmentally responsive active nanostructures: Nanotechnologies that are sensitive to stimuli like pH, temperature, light, oxidation–reduction, certain chemicals etc.  These are nanomaterials and devices that change what they do according to the environment they find themselves in.  Subramarian gives examples of smart drugs, molecular motors and other devices that respond to changes in their local environment with physical actions.

Miniaturized active nanostructures: Nanotechnologies which are a conceptual scaling down of larger devices and technologies to the nanoscale. This category captures the relatively conventional technologies (including semiconductor electronics and Micro Electrical Mechanical Systems or MEMS – lab-on-a-chip technologies) and how nanotechnology is enabling their construction on an ever-smaller scale.  It also includes the synthesis of new molecules that are designed for a specific purpose—essentially engineering chemistry at the nanoscale.

Hybrid active nanostructures: Nanotechnologies that involve uncommon combinations (biotic–abiotic, organic–inorganic) of materials. These include the fusion of living and non-living systems (biotic-abiotic hybrids) and the interfacing of semiconductors with organic materials.  The resulting technologies not only lead to functional nanoscale devices; they also blur the boundary between biological and non-biological systems.

Transforming active nanostructures: Products of nanotechnology that change irreversibly during some stage of their use or life. These are nanomaterials that undergo a significant change in what they do, and thus might appear as different materials or products, depending on when they are assessed.  Subramanian gives the example of self-healing materials that may undergo a one-off transformation when damaged.

This framework for thinking about emerging nanotechnologies still doesn’t shed too much light on the precise nature of the products regulators are going to be faced with over the coming 5, 10 or 20 years.  But it does underline the shift from nanotechnology products that can be squeezed into an intrinsic properties-based regulatory framework, to those that will almost definitely demand a new way of thinking about potential risks, and how to manage them.

And this brings me back to the question that is central to regulating emerging nanotechnologies effectively – “what is different about nanotech?”  From a risk perspective, there will undoubtedly be new and novel nanotechnologies that do not present unusual regulatory challenges, and it will be important not to fall into the trap of assuming new means different by default.  On the other hand, it does seem that increasingly sophisticated nanotechnologies are going to present a major challenge to regulations that are built on assessing and managing risk associated with what they are made of, rather than what they do.

In the post-chemistry world of nanotechnology, this is a challenge that isn’t going to go away.

End Notes

These notes were prepared for a short talk at the launch of a new report on transatlantic regulation cooperation and nanotechnology, prepared by the London School of Economics, Chatham House, the Environmental Law Institute and the project on Emerging Nanotechnologies.  They are something of a work in progress!

The distinction between intrinsic and extrinsic properties is a useful one I feel for tackling emerging nanotechnologies and potential risks.  But the distinctions probably aren’t as black and white as I infer above – either in terms of the materials and products themselves, or the regulations that are and will be used to ensure their safe use.  Likewise, I suspect that there will be some overlap between the five categories of active nanotechnologies (or more accurately, nanostructures) identified by Subramanian.

Some existing regulations do focus on what a product does, rather than what it is—regulations applying to pharmaceuticals in particular would apply here.  But many of these regulations still come down to characterizing and assessing the product in question in terms of its chemical identity.

Many regulators think that existing regulations are sufficiently robust to cover first generation nanotechnologies.  Not everyone agrees with this perspective though.

And finally, there are moves to work out how to interpret regulations so they are responsive to physical form as well as chemistry – in the US, Europe and elsewhere.  Whether these will simply enable regulations to address first generation nanotechnologies effectively, or whether they will extend to emerging technologies, remains to be seen.

There’s an absolute killer of a nanotechnology blog post over on placescope, if you are looking for something to brighten your day.  It appears to be based on some old Project on Emerging Nanotechnologies (PEN) press releases.  But the process of translation and re-translation has rendered them so wonderfully bizarre as to make any connection with the original piece entirely coincidental.

Some of the resulting turns of phrase are surely destined to become classics in nanotechnology circles.  But there’s plenty for non-nano affectionados to enjoy here as well, such is the genius of the writer.

The original article can be found here.  But rather than leaving you to plough through it on your own, here’s a guided tour of the juicy bits…

First though, a bit of context.  The piece addresses the regulation of engineered nanomaterials by the US Environmental Protection Agency (EPA), under the Toxic Substances Control Act (TSCA).  It harks back to a program the EPA started a couple of years back to encourage industry to provide information on the nanomaterials they are working on. Key characters in the piece (apart from EPA and TSCA) are J. Clarence (Terry) Davies, one of the original authors of TSCA and an expert on nanotechnology regulation, and David Rejeski, Director of the Project on Emerging Nanotechnologies.  And then there’s nanotechnology itself – but more of that later.  (I also make a cameo appearance, but much to my disappointment, I come across as reasonably sane).

All emphases in the quotes below are mine by the way.

The piece starts off on an positive note, referring to the EPA regulation formerly known as the Toxic Substances Control Act:

The U.S. Environmental Protection Medium (EPA) has published in the Federal Manifest its method for the Nanoscale Materials Stewardship Program under the Toxic Substances Hold back Act (TSCA).

This is followed by a decisive quote from the “Captain” of PEN, David Rejeski:

According to Project on Emerging Nanotechnologies (PEN) Captain David Rejeski, “The information obtained under the stewardship program could help government officials develop a cured understanding of the risks and benefits posed by the story materials.

Pondering how to help regulators cure their understanding (hopefully as in developing a better understanding, rather than treating a diseased one), Terry Davies adds:

Starting the stewardship program is a positive step toward padding in some of the news gaps facing the mechanism.

But then he throws caution to the wind, stating:

A sequential chat up advances will bugger off nanomaterials unregulated fitted afar too long, and choose also be less fruitful than if the two efforts proceed in tandem.

Strong stuff Terry!

The piece then moves back to EPA, and tackles the tricky issue of chemical ripeness:

In its announcement of the voluntary program, EPA also notes that it will not change its policy on what constitutes a unripe chemical under TSCA.

Reading this, I realize I have been under a misapprehension for years.  I thought that nanotechnology brought into question what constitutes a new chemical.  No wonder progress has been slow – I should have been talking to the agency about unripe chemicals all this time.  Doh!

The main article ends by summarizing the conclusions of a report published by PEN back in 2007:

The record recommends more than 25 actions that need to be entranced – by EPA, Congress, the President, the Public Nanotechnology Hustle, and the nanotech industry – to improve the blunder of nanotechnologies.

I’m still trying to work out what the Public Nanotechnology Hustle is – whatever it is, it better get on with improving those nanotechnology blunders!

To round things off, the piece includes some background information under the heading “Helter-skelter Nanotechnology,”  including a definition of nanotech that is worthy of the most exalted international standards committees:

Nanotechnology is the ability to measure, walk, manipulate and manufacture things usually between limerick and 100 nanometers. A nanometer is one billionth of a meter; a soul hair is roughly 100,000 nanometers wide.

It then has this to say about David Rejeski, who you will remember is the “Captain” of PEN, as well as director of the Foresight and Governance Project:

David Rejeski directs PEN and for the past four years he has been the Director of the Perspicacity and Governance Project at the Woodrow Wilson Center. He was a Visiting Fellow at Yale University’s School of Forestry and Environmental Studies and an agency representative (from EPA) to the White Dynasty Council on Environmental Quality (CEQ) … Earlier emotional to OSTP, he was head of the Future Studies Entity at EPA.

I must confess, I’m a little worried about the sound of this White Dynasty!

And what about the two organizations principally involved in the report I think is being reported on here – the Pew Charitable Trusts, and the Woodrow Wilson International Center for Scholars?

The Pew Well-wishing Trusts … is driven by the power of discernment to solve today’s most challenging problems.

What a delightfully quaint re-interpretation of Pew’s name, although I’m not sure they would see it that way!  And finally:

The Woodrow Wilson Cosmopolitan Center over the extent of Scholars … is the living, national memorial to President Wilson established by Congress in 1968 and headquartered in Washington, D.C. The Center establishes and maintains a noncommittal forum for free, undefended, and informed dialogue. It is a nonpartisan sanatorium, supported by public and private funds and engaged in the reflect on of national and global affairs.

Magical stuff!

Enjoy more from placescope here.

I’m often intrigued by the evolution of an article from its early drafts to the final version.  To complement today’s commentary on nanotechnology regulation in the journal Nature, written jointly with David Rejeski, I thought it would be interesting to post an early draft of the same paper here.  This is what the piece looked like before we started working with the journal’s editors on cleaning it up and squeezing it into an impossibly small number of words (apart from a couple of very small edits to make sure it was up to date and relatively error-free)…

As nanotechnology makes the leap from the lab to the marketplace, regulators are faced with the tough challenge of ensuring safety without stifling innovation.  Get it right and everyone stands to benefit from the economic and technological returns that engineering matter at the nanometer scale promises.  But get it wrong, and people, the environment and business all loose out.  However, developing approaches to effective regulation depends on good science and reliable information—delivered at the right point and at the right time.  In 2006, the UK government initiated a voluntary reporting scheme to collect data from industry on the commercial production, use and handling of engineered nanomaterials as a step towards evidence-based oversight.  Followed shortly after by a similar scheme in the US, both have failed to live up to expectations.  Canada and France are now working on instituting mandatory reporting programs to collect similar information.  This is a welcome move towards the effective oversight of nanotechnology-based products.  But it is only one of many steps that are needed if the promise of this emerging technology is to be realized.

Me handling multi-walled carbon nanotubes some years ago. Data are still needed on how to get the most out of this innovative material while using it safely.

Nearly five years ago, the UK Royal Society and Royal Academy of Engineering stressed the need for evidence-driven oversight of engineered nanomaterials.(RS/RAE 2004)  Since then, the global investment in nanotechnology R&D by the public and private sectors has risen to over $18 billion annually (Lux Research 2009) and nanotechnology has passed from a scientific curiosity to a market reality, with hundreds of substances and products in commerce. Yet discussions continue to revolve around the safety of the technology rather than the many and varied products it leads to… In 2006, five research challenges were proposed that, if addressed, would help underpin evidence-based decisions on using the products of nanotechnology safely (Maynard, Aitken et al. 2006).  Movement has been made towards addressing all five of challenges, which covered exposure monitoring, toxicity testing, predicting and avoiding harmful behavior, evaluating material impact from cradle to grave, and establishing strategic research programs for addressing possible risks.  Yet developers and regulators are still a long way from understanding how to predict and manage the potential risks associated with new nanomaterials (National Academies 2009; SCENIHR 2009).

In addition to new science-based knowledge, regulators need clear information on engineered nanomaterials already in commerce—what is being produced, in what quantities, how is it being handled and used, and what is known about assessing and managing possible risks?  Without this basic information, they are grappling with ensuring the safety of unknown quantities of unknown materials, being used in unknown ways.  It was exactly this information-vacuum that the UK and US voluntary data collection programs aimed to fill.  Yet by the end of its two-year duration, the UK program had received just thirteen submissions (DEFRA 2009). The US program did not fare much better. Even before it was launched, a number of experts warned that the program would be ineffective because it lacked strong incentives for industry participation and the backup of mandatory measures.  The US Environmental Protection Agency moved forward – slowly – and received only 29 submissions by the end of 2008 (USEPA 2009).  The agency’s own assessment concluded “it appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program”—an assessment based in comparing submissions with publicly available information on engineered nanomaterials being produced and used (USEPA 2009).

Against this backdrop, Canadian officials announced in January the country’s intentions to make data reporting on the production and use of engineered nanomaterials mandatory (PEN 2009).  The one-time request will be aimed at gathering information to help develop a regulatory framework and will target companies and institutions that manufacture or import more than 1kg of a given nanomaterial.  France is also in the final stages of establishing mandatory data reporting requirements.  In a move that could put the country at odds with its European neighbors, the “Grenelle de l’environnement”—a large piece of environmental legislation working its way through the French political system—includes language covering mandatory reporting on the identity, quantities and uses of engineered nanomaterials (including materials containing nanoparticles) in industry (Assemblée Nationale 2009). While these moves to make data collection mandatory are not necessarily linked directly to the UK and US experiences, there is little doubt that they were influenced by them.  Representatives from all four countries regularly share information on nanotechnology oversight through the auspices of the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials.

This move towards mandatory data reporting is a welcome one.  Given the reticence of industry to volunteer information, it will enable regulators to make decisions based on reality rather than speculation.  In principle, such data calls and any resulting evidence-based regulations will benefit industry, reducing uncertainty and providing clear operational guidelines. For instance, a recent report on strategic business issues identified regulatory and compliance risk as its number one risk faced by industry worldwide (Ernst & Young 2008).  And a survey of nanotechnology firms in the US highlighted a “lack of sufficient data to quantify risks.” as a major barrier to understanding and managing nanotechnology risks (Lindberg and Quinn 2007). The current dearth of risk data is even raising eyebrows amongst insurance companies—Lloyd’s of London and Zurich Insurance have both placed nanotechnology in their top tier of emerging risks. Canadian Underwriter 2007; Lloyd’s 2007).

Supporting effective nanotechnology risk management and oversight will require action on a number of fronts.  Well-funded and implemented research strategies are still needed that fill current knowledge gaps and inform evidence-based oversight.  Government and industry partnerships are essential to ensuring access to relevant and trusted data on nanomaterial risks.  Small firms and start-up companies need help to address potential risks and meet regulatory requirements.  Innovative data transfer mechanisms are needed between information producers and information users.  And nanotechnology-relevant regulations need to be streamlined and clarified, reducing unnecessary burdens on industry while ensuring safe use.

Progress is being made on all these fronts, but it is patchy.  Agencies including the US EPA have clarified the regulatory status of substances like carbon nanotubes; a major step towards establishing oversight clarity.  Discussions are ongoing on how new European chemicals policy under REACH applies to nanomaterials (Pelley and Saner 2009).  The OECD is coordinating international efforts to generate toxicity data on 14 nanomaterials currently in use (OECD 2008).  And research addressing specific risk-related information gaps is ramping up around the world.  Yet there is still a large and growing chasm between what is needed for effective regulation, and what current plans will provide.  If the economic and social benefits of nanotechnology are to be realized without unnecessary harm being caused, regulators need to get a move on.

Moves towards mandatory data collection are a step in the right direction.  But in the long term, safe and successful nanotechnologies will depend on strategic research, successful government-industry partnerships and responsive, transparent oversight.

_____

Nature subscribers can compare this draft with what was finally published – an interesting exercise.  I’m more comfortable with how the story develops and flows in this draft.  But I have to say, the final version – helped along by three editors – is much sharper in it’s focus and recommendations, as well as being a good bit shorter!  And on balance, I think that our ideas as presented in the final paper reflect a maturity of thought that is lacking in the draft above.

Always pleasantly surprising what a good editor (or three) can bring to a piece!

References

Assemblée Nationale (2009). Projet de loi [modifie par le Senat] de programmation relatif a la mise en oeuvre du Grenelle de l’environnement, Texte Nº 1442 transmis a l’Assemblee nationale le 10 fevrier 2009.  Paris, France. 2009.

Canadian Underwriter (2007). Nanotechnology, climate change, infrastructure among top risks. Canadian Underwriter.

DEFRA (2009). Peronal communication on the UK Voluntary Reporting Scheme for Engineered Nanoscale Materials. London.

Ernst & Young (2008). Strategic Business Risk 2008 – The Top 10 Risks for Business. Enst & Young (in collaboration with Oxford Analytica).

Lindberg, J. E. and M. Quinn (2007). A Survey of Environmental, Health and Safety Risk Management Information Needs an Practices among Nanotechnology Firms in the Massachusetts Region. Washington DC. Project on Emerging Nanotechnologies.

Lloyd’s (2007). Nanotechnology.  Recent developments, risks and opportunities. London, UK. Lloyd’s.

Lux Research (2009). Nanomaterials State of the Market Q1 2009. New York, N.Y. Lux Research Inc.

Maynard, A. D., R. J. Aitken, et al. (2006). “Safe handling of nanotechnology.” Nature 444(16): 267-269.

National Academies (2009). Review of the federal strategy for nanotechnology-related environmental, health, and safety research. Washington DC. The National Academies Press.

OECD (2008). LIST OF MANUFACTURED NANOMATERIALS AND LIST OF ENDPOINTS FOR PHASE ONE OF THE OECD TESTING PROGRAMME. Paris, France. Organization for Economic Co-operation and Development.

Pelley, J. and M. Saner (2009). International Approaches to the Regulatory Governance of Nanotechnology. Regulatory Governance Initiative, Carleton University, Canada.

PEN (2009). World’s First Mandatory National Nanotech Requirement Pending. Washington DC. 2009.
RS/RAE (2004). Nanoscience and nanotechnologies:  Opportunities and uncertainties. London, UK. The Royal Society and The Royal Academy of Engineering: 113 pp.

SCENIHR (2009). Risk Assessment of Products of Nanotechnologies. Brussels. Scientific Committee on Emerging and Newly Identified Health Risks.

USEPA (2009). Nanoscale materials stewardship program.  Interim report. Washington DC. US Enviromental Protection Agency.

A new report looks at the challenges of regulating first generation products of synthetic biology.

At the J. Craig Venter Institute, scientists are on the verge of creating a living organism from “dead” chemicals, by rebooting a microbe with a new—and completely artificially constructed—genome.

At the University of California Berkeley, researchers are modifying microbes to act as highly efficient chemical plants, by rewriting their DNA.

In Cambridge Massachusetts, amateur biologists are scoring cheap laboratory equipment off eBay and Craigs List, and constructing their own designer bugs.

While all over the world, hundreds of enthusiastic undergraduates are competing to systematically design and build new DNA-based biological systems and get them operating in living cells.

Synthetic biology—the systematic engineering of biological organisms from the DNA up—is a reality now, and is destined to grow into an incredibly powerful transformative technology over the next few years.

But can we handle it?

In amidst the many questions our accelerating ability to manipulate DNA raises is one of oversight:  Are government agencies equipped to ensure the safety of new synthetic biology-related products and processes?

A new report by Mike Rodemeyer—formerly Executive Director of the Pew Initiative on Food and Biotechnology—addresses exactly this question.  Commissioned by the Woodrow Wilson Center in Washington DC, New life, old bottles takes a critical look at regulating the first-generation products of synthetic biology.

Perhaps not surprisingly, Rodemeyer concludes that once you peer under the hood (so to speak), there’s not a lot from a regulatory perspective that differentiates first generation synthetic biology from more traditional recombinant DNA (rDNA)-based technology.  Which means that where things work for rDNA, they look pretty good for synbio.

Of course, this also means that where oversight of traditional biotech is flaky, things aren’t likely to be any easier for synthetic biology.

However, the report also suggests that synthetic biology may have the potential to stretch an already stressed system to breaking point at some point in the future.  As it is, traditional biotechnology was shoehorned into a regulatory system within the US that was developed long before the practical consequences of DNA manipulation were understood.  As a result (for example), genetically engineered organisms are currently regulated as new chemical substances by the Environmental Protection Agency.

Just in case you didn’t catch that: in simple terms, the DNA within a genetically modified organism is legally considered to be a new chemical, and thus is regulated as such.  An elegant solution to fitting new technology into old rules, but one that may find run out of steam rather rapidly as synthetic biology hits its stride.

And the current regulatory framework doesn’t even begin to touch on developments that lie outside its traditional sphere of control—including a growing “biohacking” community.

Rodemeyer’s piece is more about setting out the issues and posing questions than providing solutions.  And it does this extremely well.  If you want aan excellent description of what synthetic biology is all about, the regulatory framework within which it is developing, or the challenges it presents to that framework, this is the report to read. It’s clear, it’s accessible, and it’s highly readable.

But if you insist on an overarching take-home message, it would be this (and these are my words, not his):

We are on the brink of a revolution in biotechnology that will make old biotech look like the fumblings of a toddler.  And while we may have got away with squeezing new tech into old regulatory bottles in the past, this approach isn’t going to work for much longer!  Rather, if synthetic biology is to grow into a mature, safe and accepted technology, some regulatory rethinking will be needed.

The old bottles, it seems, will last us a little longer.  But at some point they are going to burst at the seams.  And what then, if we don’t have bigger, better, more flexible containers handy?

Twelve months ago today I held a bag of multi-walled carbon nanotubes up before a hearing of the U.S. House Science Committee.  I wanted to emphasize the discrepancy between the current state of the science on carbon nanotubes, and a tendency to classify this substance as the relatively benign material graphite from a safety perspective.  So it is perhaps fitting that on the anniversary of that congressional hearing, the US Environmental Protection Agency is making it clear that carbon nanotubes are in fact, a new substance—and should be regulated as such.

Carbon nanotubes are often described as sheets of graphite—the stuff that makes pencil lead black—wrapped into a tube; leading to nanometre-thin “fibres” that are incredibly strong for their weight, and highly conducting—thermally as well as electrically.  But perhaps because of this simple imagery, they are often handled as if they are graphite—especially when it comes to using them safely.

Given the amount of time and money researchers and industry are pouring into producing and using carbon nanotubes, you would think that they are at least marginally different from their flat-sheeted cousins.  In fact the differences are anything but marginal: Wrapping the sheets associated with graphite into tubes radically changes the physical chemical and biological properties of these carbon-based materials—just like re-arranging the carbon atoms that make up soot into diamonds leads to the formation of a fundamentally different material.

Yet many companies continue to persist in claiming “it’s just graphite” when questions arise over the possible health impacts of being exposed to carbon nanotubes.

But all that is about to change.  Hot on the heels of clarification from the European Commission that carbon nanotubes (and other novel forms of carbon) need to be registered under the new REACH chemicals regulations, the US EPA has clarified their position on the material.  According to a just-released notice in the Federal Register, the EPA

“generally considers [carbon nanotubes] to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.”

In effect, this means that any company wanting to manufacture or import carbon nanotubes in the United States needs to submit a Pre Manufacturing Notice (PMN) to the EPA—unless the material can be shown to be on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory. And the chances of that are pretty slim—at present.

EPA actually established their position on carbon nanotubes back in 2007, in a document clarifying how the agency saw TSCA applying to engineered nanomaterials [available here].  But the agency’s stance was so unclear that the Federal Register notice clarifying the situation was felt necessary.  In the words of the notice just published:

“current pre-notice inquiries to the Agency and questions in public forums still indicate a lack of clarity on this issue.”

This is a significant step forward for the US EPA, and a very welcome one.  Research is continuing to show that some forms of carbon nanotubes are potentially dangerous if inhaled in sufficient quantities.  Earlier this year, Craig Poland and colleagues showed that long thin multiwalled carbon nanotubes are potentially able to cause the disease mesothelioma if inhaled.  And more recently Anna Shvedova and co-researchers confirmed that inhaled single walled carbon nanotubes can have a unique impact on the lungs of mice.

Neither of these studies suggests that carbon nanotubes behave anything like graphite if they get into the lungs.  Yet companies persist with treating this material like graphite.

I’ve previously noted that carbon nanotube distribution companies like CheapTubes Inc. consider all forms of the material as being like graphite for health and safety purposes.  In fact, as of October 31, the Materials Safety Data Sheet posted on the CheapTubes website noted of carbon nanotubes:

“This material is listed on the US Toxic Substances Control Act (TSCA) Inventory”

There is little doubt now that this is, in fact, not the case.

The EPA’s clarification will certainly help ensure that this innovative material is used safely, and its full potential is realized without causing undue harm.  There are though, perhaps inevitably, still some unresolved issues.   These include various material use and production quantity exemptions that could be used by some companies to justify not applying TSCA to their nanotubes (see for instance the series of articles by Richard Denison on TSCA and nanomaterials).  But smart companies are realizing that compliance is the best way to ensuring safe and sustainable products—which is why a number of PMN’s for carbon nanotubes have already been submitted to EPA (again, Richard Denison’s blog at the Environmental Defense Fund has useful comments on this point).

There are however two rather large flies in the ointment:

The EPA clarification doesn’t add anything to the question of where many other engineered nanomaterials stand on the regulations front.  Carbon nanotubes are chemically distinct from other forms of carbon, and so are easily defined under TSCA as news substances.  But if you take something like titanium dioxide or silver and form it into nanoparticles, current regulations make no distinction between the nano and non-nano forms of the material—even though research suggests the nano-form may be more harmful.

Just as importantly, submitting a PMN for a specific type of carbon nanotube material opens the way for that material being added to the TSCA Chemical Substances Inventory.  And once there, other companies are free to make, use and sell the material.  As Richard Denison writes,

“Once reviewed and placed on the TSCA Inventory, any company can manufacture and use the nanomaterial without even having to notify EPA it is doing so.” (unless EPA simultaneously issue a Significant New Use Rule)

Yet researchers are only just beginning to discover what might make different carbon nanotubes harmful, and how to avoid that harm.  What are the chances therefore of carbon nanotubes being added to the TSCA inventory before we have a good handle on how to use them safely?

The bottom line here is that resolving the regulatory status of carbon nanotubes is an important step forward.  But there is still some way to go before this material is regulated in a way that will encourage innovation while preventing undue harm—whether to people or the environment.

And while carbon nanotubes can perhaps leave the couch feeling a little more confident about themselves, we shouldn’t forget that there are still plenty of other materials out there that are suffering from a nano-induced identity crisis.

If you’ve ever wondered how to deal with the complexities of regulating a twenty first century technology like nanotechnology, wonder no more.  Last week, President Bush’s top advisors on science and the environment published a set of “principles for nanotechnology environment, health and safety oversight”.

Based on a multi-agency consensus-based process, the document outlines the principles that federal agencies “should follow … as they develop policies for environmental, health and safety oversight related to nanotechnology”.

And the overriding message? Don’t make things hard for industry.

Quoting the first lines of the first principle,

“Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic and environmental benefits…”.[1]

I was under the impression that environmental, health and safety oversight should be first and foremost aimed at preventing harm to people and damage to the environment.

Certainly, the regulatory process needs to account for multiple perspectives, including those of scientists, industry and citizens. Effective oversight will encourage innovation and sustainable advances in the long run—after all, harmful products are bad for business. And a framework for developing nanotechnology oversight can only serve to help coordinate efforts, and prevent regulation being unduly swayed by hype and speculation.

But to start a set of oversight principles with an admonition not to hold up nanotechnology development?  Mmm…
____________________________________
[1] The full first principle in the document is:

“Purpose: Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.”

This post was first published on the SAFENANO blog in November 2007