Category Archives: Regulation

Is Maynard going over to the nano-dark side?

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 interest in getting to the bottom of what can go wrong as new technologies are developed, and how we need to start exploring better ways of ensuring responsible innovation.

Here’s the piece that Howard wrote – the original can be read on Vincent Caprio’s blog Evolving Innovations.

When Andrew Maynard, director of the Risk Science Center at the University of Michigan, read the text of 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, one phrase jumped out at him. The groups used the words “fundamentally unique properties” when referring to nanoscale ingredients.

The phrase, in fact, comes directly from marketing material of the National Nanotechnology Initiative. So, in one sense, the nanotech industry is a victim of its own public relations, Maynard believes. A phrase used to promote nanotech commercialization is being thrown back at nanotech advocates by those who would use the same logic to demand strict regulations.

“There is an assumption that you can have everything your own way,” Maynard says. “You can say something was unique and important and world-changing, selling the hype, and yet not really understanding what the long-term consequences of that hype are.”

This is what Maynard does for a living. He tries to reach beyond hype and beyond gloom to assess and communicate the real risks associated with emerging technologies, including nanotechnology. But he approaches these assessments from a starting point that seems increasingly difficult to achieve in these polarized political times – one based on scientific principles rather than political agenda.

The problem with that “unique properties” phrase that has been so misused over the years is that the science does not necessarily back it up. Material at the nanoscale is not necessarily any different from its macroscale cousin.

“Now, with the research that’s been generated in the last few years, it’s become increasingly clear that there’s no well-defined set of materials that raise red flags when it comes to size,” Maynard says. “About the best you can do is say that the smaller and more sophisticated you make things the more you have to think about a wide range of questions when you’re evaluating safety.”

So, when Maynard now discusses nanotechnology and potential risk, he’s not likely to even use the “n” word. He’s talking about advanced materials, or “sophisticated materials.”

For example, he says, what questions do you ask when trying to determine whether quantum dots are safe? Well, you talk about the composition of the quantum dot, how its physical and chemical structure determines how it interacts with biological systems, and how its size effects where it goes in the body and how it interacts within it.

“But those are not nano-specific questions,” he says. “They’re the questions associated with a specifically designed material.”

The same thing with titanium dioxide found in sunscreens. Shrink them down to nanosize and you get concerns raised by advocacy groups such as the Friends of the Earth and others involved in the lawsuit against the FDA, but the research says titanium dioxide, even at that size, is still pretty benign.

It has taken Maynard a few years to reach this point in his thinking about nanotech. Many in the nanotech business community might remember Maynard when he was scientific adviser for the Wilson Center’s Project on Emerging Nanotechnologies (PEN) between 2005 and 2008. The PEN raised many questions about the potential risks of nanomaterials. Has he changed since his Wilson Center days?

“I have, which is I think inevitable. If you take a young field, our knowledge is going to change over time,” Maynard says. “And if we don’t change our opinions based on that knowledge there’s something wrong.”

But one thing that has not changed is his belief that if nanotech is going to develop into a sustainable industry that is economically robust, it needs to also be “socially robust” and develop with an eye toward social implications.

“It makes a lot of business sense, if you’re developing any new technology – not just nanotech or whatever – to be aware of the possiblities of what might go wrong with that technology and those products and shore things up as early as possible,” he says.

The problem, though, is that roughly 10 years after these questions were first asked, after the U.S. government has invested millions in looking at the environmental and health implications of nanotechnology, we still are not much wiser.

“We know a lot more now,” Maynard says. “The question is do we know a lot more that’s useful now. That’s what I would debate.” The problem, he says, is that the wrong questions are being asked.

Take, for example, carbon nanotubes. There is an assumption by many researchers, Maynard said, that the material is similar to asbestos. But nanotubes are not straight, long, rigid fibers, yet this assumption is driving the research.

“I am quite often concerned that you talk to toxicology groups doing research on carbon nanotubes, I don’t think many of them could actually accurately describe to you the physical form or nature of a carbon nanotube. And yet they’re doing research under various assumptions of what these things are like.”

So, this is the mission of Maynard’s Risk Science Center – to start discussions about the risks of technology with a grounding in real science and not on speculation, taking and “evidence-based approach.”

He’s come a long way since the early 1990s, Maynard, now 46, worked on his Ph. D. at Cambridge in the UK, using advanced microscopy techniques to analyze airborne particles. At the time, many of his colleagues told him he was wasting his time. There would be no future in tiny materials. They were wrong, of course, and Maynard got involved further and further into studying emerging technologies. Eventually, he made the jump from doing science to studying the proper ways of communicating it to the public.

Next on his agenda is looking at issues involved in advanced manufacturing, which overlaps with nanotech. Again, he said he is asking questions having to do with how businesses using new manufacturing technologies, producing new materials, can predict where economic and social barriers are going to be and have a plan to get over them. That includes codes of conduct, standards and best practices. It is up to the industry, itself, to make sure these are in place. The alternative is unwanted regulation.

The most-important advice Maynard gives to the nanotech business community is to simply be aware of the possible implications of the technology they’re developing and make sure regulatory agencies are properly informed of what is being done. But there is no need to respond to individual challenges such as this lawsuit against the FDA.

“It’s worthwhile playing the long game and not being too reactionary to what happens,” Maynard says. “What’s happened over the last 10 years is that concerns over nanotechnology really haven’t gained that much traction.”

In fact, it’s just the opposite. People, in general, remain excited about the prospects of nanotechnology.

“I think the bottom line is to be as honest as possible, and talk to people,” Maynard says. “One of the biggest problems is if you come across as trying to hide things or trying to obscure things. Generally, people are really excited about this technology. They just want to know what’s going on. They want to know what it’s about.”

For more on where my thinking is going on sophisticated materials, check out:

Maynard, A. D., Philbert, M. A. and Warheit, D. B. (2011) The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond. Toxicol. Sci. 120 (suppl 1): S109-S129. [Free download]

Maynard, A. D. (2011) Don’t Define Nanomaterials. Nature 475, 31 [Accessible here]

Maynard, A. D., Bowman, D., Hodge, G. (2011) The problem of regulating sophisticated materials. Nature Materials 10, 554–557 [Accessible here]

Define nanomaterials for regulatory purposes? EU JRC says yes.

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: Continue reading Define nanomaterials for regulatory purposes? EU JRC says yes.

Seven challenges to regulating “sophisticated materials”

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. Continue reading Seven challenges to regulating “sophisticated materials”

Don’t define nanomaterials – new commentary in Nature and an early draft

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.

A nanotechnology regulation hat trick from the US federal government

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.

Regulating emerging technologies – Science & Public Participation top a new White House set of principles

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. Continue reading Regulating emerging technologies – Science & Public Participation top a new White House set of principles

Why we don’t need a regulatory definition for nanomaterials

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.

International Handbook on Regulating Nanotechnologies – free access to first and last chapters

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!

Obama’s 21st century regulatory system will demand more innovative thinking on risk

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. Continue reading Obama’s 21st century regulatory system will demand more innovative thinking on risk

Just how risky can nanoparticles in sunscreens be? Friends of the Earth respond

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. Continue reading Just how risky can nanoparticles in sunscreens be? Friends of the Earth respond

TSCA reform and engineered nanomaterials

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. Continue reading TSCA reform and engineered nanomaterials