Category: Regulation

A few weeks ago I spent some time chatting with Howard Lovy for an article for the Nanobusiness Commercialization Association.  That interview was posted by Vincent Caprio on his blog a few days ago, and raised a few eyebrows – was I showing signs of becoming a nano-risk skeptic? I hope not, as as I still feel emerging evidence and trends indicate major perceived and real risk-related barriers lie in the path of developing nanoscale science and engineering successfully, if we aren’t smart.  But I have always adhered to the idea that successful and responsible technology development depends on taking an evidence-based approach – even if that evidence is sometimes uncomfortable.  And so these days I sometimes worry that too much is made of artificial constructs surrounding “nanotechnology”, and not enough is made of the underlying science. Reading through Howard’s piece, I felt it was a pretty accurate reflection of our conversation.  There are a couple of places where it possibly indicates less concern on my part than is warranted.  Toward the end of the piece for instance I am quoted as saying “there is no need [for the nanobusiness community] to respond to individual challenges such as this lawsuit against the FDA”, referring to a recent lawsuit by consumer advocates against the U.S. Food and Drug Administration, which claims the FDA is failing to regulate nanomaterials in products. I’m pretty sure I did say something along these lines.  But the context was that lawsuits like these are a relatively widely used mechanism for holding federal agencies to account and prodding them into action.  And while they are often important, the nanobusiness community need to understand this context and be aware of the bigger picture when it comes to responsible and sustainable development. Overall though, the piece captures my increasing

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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:

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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.

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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.

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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

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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

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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.

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Here’s an offer I’m sure you won’t be able to resist: The opportunity to read the first and last chapters of the just-published International Handbook on Regulating Nanotechnologies – for free! Due to the farsightedness of my co-editors, the publishers have agreed to let authors post their chapters on their institutional web pages. So if you head over to the Risk Science Blog, you can download the chapter that frames the book, and the one that pulls everything together at the end. Don’t all rush at once! I have to add, this was a master-stroke by Di Bowman in her negotiations with Edward Elgar Publishing- kudos to her!

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Cross posted from the Risk Science Center Blog: There’s a lot to like in President Obama’s perspective on 21st century regulation. Writing in today’s Wall Street Journal, Obama outlines his thinking behind his new executive order to review and revise a convoluted and potentially disruptive federal regulatory system. But if regulation in the 21st century is to be effective in protecting people and enabling economic growth, it needs to become more sophisticated and innovative, while avoiding the traps of over-simplistic thinking. I’m glad Obama puts a strong emphasis on public health in his op ed. It’s all too easy easy for these conversations to degenerate into regulatory bashing in favor of business freedom – a trap Obama deftly avoids. Yet he is spot on when he calls out the dangers of out-dated and ill-conceived regulations potentially stifling innovation and economic growth – an outcome which ultimately also impacts on public health, albeit in less directly measurable ways. The trick is to find that sweet spot between preventing harm while supporting the economy. As society and the technologies it relies on become ever-more complex, finding this sweet spot is becoming increasingly difficult. New technologies are spawning new products that cause harm in new and sometimes unanticipated ways. An ever more interconnected global society is eroding traditional command-and-control oversight frameworks. And a growing flood of tantalizing yet often incomplete data is creating confusion over what is safe, and what is not. Yet the same changes that are making old-style regulation increasingly difficult are also opening up opportunities for innovation in how we protect people.

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Last week, I posed Friends of the Earth a challenge – “What is your worst case estimate of the human health risk from titanium dioxide and/or zinc oxide nanoparticles in sunscreens?”  Georgia Miller of FoE Australia and Ian Illuminato of FoE in the US have kindly provided a detailed response.  Rather than just keep this as a comment on the original blog, I thought it deserved a wider airing – and so am posting it here. I will respond to the response in a few days time.  In the meantime, I would be extremely interested in what others think of the use of nanoparticles in sunscreens, based on my original piece and Georgia and Ian’s piece below.  Please do comment – this seems to be an area that desperately needs some good and open discussion.

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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.

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