Tag Archives: JRC

Nanosafety research: a quality control issue

Toxicologist Dr. Harald Krug has published a review of several thousand studies on nanomaterials safety exposing problematic research methodologies and conclusions. From an Oct. 29, 2014 news item on Nanowerk (Note: A link has been removed),

Empa [Swiss Federal Laboratories for Materials Science and Technology] toxicologist Harald Krug has lambasted his colleagues in the journal Angewandte Chemie (“Nanosafety Research—Are We on the Right Track?”). He evaluated several thousand studies on the risks associated with nanoparticles and discovered no end of shortcomings: poorly prepared experiments and results that don’t carry any clout. Instead of merely leveling criticism, however, Empa is also developing new standards for such experiments within an international network.

An Oct. 29, 2014 Empa press release (also on EurekAlert), which originated the news item, describes the new enthusiasm for research into nanomaterials and safety,

Researching the safety of nanoparticles is all the rage. Thousands of scientists worldwide are conducting research on the topic, examining the question of whether titanium dioxide nanoparticles from sun creams can get through the skin and into the body, whether carbon nanotubes from electronic products are as hazardous for the lungs as asbestos used to be or whether nanoparticles in food can get into the blood via the intestinal flora, for instance. Public interest is great, research funds are flowing – and the number of scientific projects is skyrocketing: between 1980 and 2010, a total of 5,000 projects were published, followed by another 5,000 in just the last three years. However, the amount of new knowledge has only increased marginally. After all, according to Krug the majority of the projects are poorly executed and all but useless for risk assessments.

The press release goes on to describe various pathways into the body and problems with research methodologies,

How do nanoparticles get into the body?

Artificial nanoparticles measuring between one and 100 nanometers in size can theoretically enter the body in three ways: through the skin, via the lungs and via the digestive tract. Almost every study concludes that healthy, undamaged skin is an effective protective barrier against nanoparticles. When it comes to the route through the stomach and gut, however, the research community is at odds. But upon closer inspection the value of many alarmist reports is dubious – such as when nanoparticles made of soluble substances like zinc oxide or silver are being studied. Although the particles disintegrate and the ions drifting into the body are cytotoxic, this effect has nothing to do with the topic of nanoparticles but is merely linked to the toxicity of the (dissolved) substance and the ingested dose.

Laboratory animals die in vain – drastic overdoses and other errors

Krug also discovered that some researchers maltreat their laboratory animals with absurdly high amounts of nanoparticles. Chinese scientists, for instance, fed mice five grams of titanium oxide per kilogram of body weight, without detecting any effects. By way of comparison: half the amount of kitchen salt would already have killed the animals. A sloppy job is also being made of things in the study of lung exposure to nanoparticles: inhalation experiments are expensive and complex because a defined number of particles has to be swirled around in the air. Although it is easier to place the particles directly in the animal’s windpipe (“instillation”), some researchers overdo it to such an extent that the animals suffocate on the sheer mass of nanoparticles.

While others might well make do without animal testing and conduct in vitro experiments on cells, here, too, cell cultures are covered by layers of nanoparticles that are 500 nanometers thick, causing them to die from a lack of nutrients and oxygen alone – not from a real nano-effect. And even the most meticulous experiment is worthless if the particles used have not been characterized rigorously beforehand. Some researchers simply skip this preparatory work and use the particles “straight out of the box”. Such experiments are irreproducible, warns Krug.

As noted in the news item, the scientists at Empa have devised a solution to some to of the problems (from the press release),

The solution: inter-laboratory tests with standard materials
Empa is thus collaborating with research groups like EPFL’s Powder Technology Laboratory, with industrial partners and with Switzerland’s Federal Office of Public Health (FOPH) to find a solution to the problem: on 9 October the “NanoScreen” programme, one of the “CCMX Materials Challenges”, got underway, which is expected to yield a set of pre-validated methods for lab experiments over the next few years. It involves using test materials that have a closely defined particle size distribution, possess well-documented biological and chemical properties and can be altered in certain parameters – such as surface charge. “Thanks to these methods and test substances, international labs will be able to compare, verify and, if need be, improve their experiments,” explains Peter Wick, Head of Empa’s laboratory for Materials-Biology Interactions.

Instead of the all-too-familiar “fumbling around in the dark”, this would provide an opportunity for internationally coordinated research strategies to not only clarify the potential risks of new nanoparticles in retrospect but even be able to predict them. The Swiss scientists therefore coordinate their research activities with the National Institute of Standards and Technology (NIST) in the US, the European Commission’s Joint Research Center (JRC) and the Korean Institute of Standards and Science (KRISS).

Bravo! and thank you Dr. Krug and Empa for confirming something I’ve suspected due to hints from more informed commentators. Unfortunately my ignorance. about research protocols has not permitted me to undertake a better analysis of the research. ,

Here’s a link to and a citation for the paper,

Nanosafety Research—Are We on the Right Track? by Prof. Dr. Harald F. Krug. Angewandte Chemie International Edition DOI: 10.1002/anie.201403367 Article first published online: 10 OCT 2014

This is an open access paper.

FOE, nano, and food: part three of three (final guidance)

The first part of this food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

The second part of this series focused largely on a couple of  research efforts (a June 11, 2014 news item on Nanowerk highlights a Franco-German research project, SolNanoTox) and in the US (a  June 19, 2014 news item on Azonano about research from the University of Arizona focusing on nanoscale additives for dietary supplement drinks) and noted another activist group’s (As You Sow) initiative with Dunkin’ Donuts (a July 11, 2014 article by Sarah Shemkus in a sponsored section in the UK’s Guardian newspaper0).

This final part in the series highlights the US Food and Drug Administration’s (FDA) final guidance document on nanomaterials and food issued some five weeks after the FOE’s report and an essay by a Canadian academic on the topic of nano and food.

A July 9, 2014 news item on Bloomberg BNA sums up the FDA situation,

The Food and Drug Administration June 24 [2014] announced new guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products, including drugs, devices, cosmetics and food.

In this final guidance, the agency said that nanotechnology “can be used in a broad array of FDA-regulated products, including medical products (e.g., to increase bioavailability of a drug), foods (e.g., to improve food packaging) and cosmetics (e.g., to affect the look and feel of cosmetics).”

Also on the agency website, the FDA said it “does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.”

This July 18, 2014 posting by Jeannie Perron, Miriam Guggenheimm and Allan J. Topol of Covington & Burling LLP on the National Law Review blog provides a better summary and additional insight,

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.

These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.

The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. …

The notion of an “evolving regulatory structure” is very appealing in situations with emerging technologies with high levels of uncertainty. It’s surprising that more of the activist groups don’t see an opportunity with this approach. An organization that hasn’t devised a rigid regulatory structure has no investment in defending it. Activist groups can make the same arguments, albeit from a different perspective, about an emerging technology as the companies do and, theoretically, the FDA has become a neutral party with the power to require a company to prove its products’ safety.

You can find the FDA final guidance and other relevant documents here.

Finally, Sylvain Charlebois, associate dean at the College of Business and Economics at the University of Guelph, offers a rather provocative (and not from the perspective you might expect given his credentials) opinion on the topic of ‘nano and food’  in a July 18, 2014 article for TheRecord.com,

Nanotechnology and nanoparticles have been around for quite some time. In fact, consumers have been eating nanoparticles for years without being aware they are in their food.

Some varieties of Dentyne gum and Jell-O, M&M’s, Betty Crocker whipped cream frosting, Kool-Aid, Pop-Tarts, you name it, contain them. Even food packaging, such as plastic containers and beer bottles, have nanoparticles.

While consumers and interest groups alike are registering their concerns about genetically modified organisms, the growing role of nanotechnology in food and agriculture is impressive. When considering the socio-economic and ethical implications of nanotechnology, comparisons to the genetic modification debate are unavoidable.

The big picture is this. For years, capitalism has demonstrated its ability to create wealth while relying on consumers’ willingness to intrinsically trust what is being offered to them. With trans fats, genetically modified organisms and now nanoparticles, our food industry is literally playing with fire. [emphasis mine]

Most consumers may not have the knowledge to fully comprehend the essence of what nanotechnology is or what it can do. However, in an era where data access in almost constant real-time is king, the industry should at least give public education a shot.

In the end and despite their tactics, the activist groups do have a point. The food and agricultural industries need to be more frank about what they’re doing with our food. As Charlebois notes, they might want to invest in some public education, perhaps taking a leaf out of the Irish Food Board’s book and presenting the public with information both flattering and nonflattering about their efforts with our food.

Part one (an FOE report is published)

Part two (the problem with research)

ETA Aug. 22, 2014: Coincidentally, Michael Berger has written an Aug. 22, 2014 Nanowerk Spotlight article titled: How to identify nanomaterials in food.

ETA Sept. 1, 2014: Even more coincidentally, Michael Berger has written a 2nd Nanowerk Spotlight (dated Aug. 25, 2014) on the food and nano topic titled, ‘Nanotechnology in Agriculture’ based on the European Union’s Joint Research Centre’s ‘Workshop on Nanotechnology for the agricultural sector: from research to the field”, held on November 21-22 2013′.

Webinar featuring REACH and JRC perspectives on the European Union’s definition of nanomaterials

NanoSight is once more hosting a webinar on the European Union’s definition of nanomaterials (the first nanomaterials definitiion webinar was mentioned in my March 6, 2012 posting).  Here’s more about their latest nanomaterials definition webinar,  from NanoSight’s webinar registration page,

Update on the EU Nanomaterials Definition: Impact of Recent EU and JRC [European Commission's Joint Research Centre] Publications

Wednesday, 14th November 2012
Live at 15:00 GMT (16:00 CET, 07:00 PST, 10:00 EST)
Repeated Live at 17:00 GMT (18:00 CET, 09:00 PST, 12:00 EST)

Dr Denis Koltsov is an international nanotechnology legislation and control expert. He is Director and Principal Consultant at BREC Solutions offering technology consulting services. He also holds a lectureship in the Department of Engineering at Lancaster University.
Dr Matteo Della Valle is from the REACH Centre, an organization that provides the highest quality advice on the many regulatory, technical and commercial aspects of REACh and other chemical regulations.

During the 30 minute interactive presentations, the speakers will

  • Review the JRC methods document and dicuss the key conclusions and the challenges presented
  • Outline the EU’s Second Regulatory Review and forthcoming legislation where it will have most impact with particular emphasis on the REACh [European Community's (Registration, Evaluation, Authorisation and restriction of CHemicals] registration process
  • Report on the USA perspective concerning regulation of nanomaterials. This reporting will include matters tabled as SENN2012 – International Congress on Safety of Engineered Nanoparticles and Nanotechnologies, at the end of this month in Helsinki

As part of this fully interactive presentation you will be able to put your question to both myself and Denis, so please take advantage of this opportunity to clarify any queries you may have.

H/T to Azonano’s Nov. 2, 2012 news item.

How much more nanomaterial safety discussion do we need?

The report (Impact of Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment) from Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) was issued in Sept. 2011 and the authors are still trying to get people to read it. The Aug. 16, 2012 online issue of Nature features correspondence from the authors citing the report,

Our analysis indicates that formulation of a coherent public policy will depend on scientists closing knowledge gaps in safety research, on gathering more data to connect science and regulation, and on training graduate students in nanotechnology research. Policies will need to be flexible to accommodate fresh discoveries in this rapidly advancing technology.

Getting notice for your work can be hugely difficult in an information-rich environment, so it’s not unusual to see efforts continuing over a year or more after publication.  Meanwhile a question persists, how many reports of this type do we need?

Nanomaterials definition for Europe

After all the ‘sturm und drang’ in the last few months (my Sept. 8, 2011 posting summarizing some of the lively discussion), a nanomaterials definition for Europe has been adopted. It is the first ‘cross-cutting’ nanomaterials definition to date according to the Oct. 18, 2011 news item on Nanowerk,

“Nanomaterials” are materials whose main constituents have a dimension of between 1 and 100 billionth of a metre, according to a Recommendation on the definition of nanomaterial (pdf) adopted by the European Commission today. The announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation.

European Environment Commissioner Janez Potocnik said: “I am happy to say that the EU is the first to come forward with a cross-cutting designation of nanomaterials to be used for all regulatory purposes. We have come up with a solid definition based on scientific input and a broad consultation. Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances. It is an important step towards addressing any possible risks for the environment and human health, while ensuring that this new technology can live up to its potential.”

As I understand it , ‘cross-cutting’ doesn’t refer to national boundaries so much as it refers to agency boundaries. Take for example the recent nanomaterial definition (my initial comments in an Oct. 11, 2011 posting) adopted by Health Canada. It is applicable only to Health Canada’s jurisdictional responsibilities. Environment Canada uses a different definition.

As for the new European definition of nanomaterials, Dr. Andrew Maynard offers some interesting observations on his 2020 Science blog in an Oct. 18, 2011 posting (Note: Andrew favours an approach other than the one adopted by the European Commission and was an active participant in the lively discussion that took place),

1.  The inclusion of incidental and natural materials in the definition. The inference is that any product containing or associated with nanomaterials from any of these sources will potentially be regulated under this definition.  Strict enforcement of this definition would encompass many polymeric materials and most heterogeneous materials currently in use.  And the lack of distinction between “hard” and “soft” nanoparticles means that the definition applies to any substance containing small micelles or liposomes – someone needs to check the micelle size distribution in homogenized milk.

2.  The focus on unbound nanoparticles and their agglomerates and aggregates. This makes sense in terms of targeting materials with the greatest exposure potential.  But it may be hard to apply to complex nanostructured materials which nevertheless present unusual health and environmental risks – such as materials with biologically active structures that are not based on unbound nanoparticles (patterned surfaces, porous materials and nano-engineered micrometer-sized structures come to mind).

3.  The threshold of 50% of a material’s number distribution comprising of particles with one or more external dimension between 1 nm – 100 nm. This is a laudable attempt to handle materials comprised of particles of different sizes.  But it is unclear where the scientific basis for the 50% threshold lies, how this applies to aggregates and agglomerates, and how diameter is defined (there is no absolute measure of particle diameter – it depends on how it is defined and measured).

The desire to identify materials that require further action makes sense.  But I do worry that this definition is a significant move toward requiring industry action and providing consumer information in a way that creates concern and raises economic barriers, without protecting health (and possibly taking the focus off materials that could present unusual risks) – in the “do no harm” and “do good” stakes, it seems somewhat lacking.

Andrew does include the full text of the definition and more points of interest in his full posting. I’m very happy to see his comments as they give me some guidance as I get ready to review the Health Canada definition more closely.

ETA Oct. 18, 2011 1500 hours: The European Commission released the Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) presented the findings of a joint report entitled “Impact of engineered nanomaterials on health: considerations for benefit-risk assessment” (pdf). This was an  event designed to coincide with the adoption of a definition for nanomaterials. The Oct. 18, 2011 news item on Nanowerk notes,

This fulfils one of the recommendations of the report, which was a call for a precise definition of nanomaterials.

ETA Oct. 18, 2011 1525 hours: I particularly appreciate Andrew’s dry comment about micelle and liposome distribution in milk at the end of his first point.

ETA: NanoWiki offers a roundup of responses in an Oct. 21, 2011 posting.

To define or not to define nanomaterials

There’s been a debate of sorts over whether or not nanomaterials should be defined prior to setting a regulatory framework. It’s a topic I covered most recently in my July 8, 2011 posting,

I have mentioned Andrew’s (Dr. Andrew Maynard [Director of University of Michigan Risk Science Center]) perspective vis à vis bypassing a definition of nanomaterials and getting on with the task of setting a regulatory framework in my June 9, 2011 and my April 15, 2011 postings. I expressed some generalized doubts about this approach in the earlier posting while noting that both Andrew and Dexter Johnson (Nanoclast blog on the IEEE [Institute of Electrical and Electronics Engineers]  Spectrumwebsite) have a point when they express concern that the definition may be based on public relations concerns rather than science.

Andrew’s  ‘comment’, Don’t define nanomaterials, had been published the day before in the journal Nature. An Aug. 30, 2011 news item on Nanowerk alerted me to the latest development. A few days ago, Hermann Stamm of the European Commission Joint Research Centre, Institute for Health and Consumer Protection had a rejoinder published, Risk factors: Nanomaterials should be defined.

So here’s how this part of the debate started in July, Andrew notes his concern that policymakers will give in to expediency and define nanomaterials primarily in relation to size, i. e., 1 to 100 nanometres. From Andrew’s July 7, 2011 Nature comment (Note: This is behind a paywall, you can read a draft version here),

It makes sense to assume that nanomaterials could come with unanticipated risks. A rapidly growing body of research indicates that some nanoscale materials behave differently from their bigger and smaller counterparts1. For instance, normally benign titanium dioxide — widely used as a whitener — becomes increasingly toxic as its particle size shrinks. Nanoscale titanium dioxide has been classified as a potential human carcinogen by the US National Institute for Occupational Safety and Health.

But it is becoming clear that many parameters other than size modulate risk, including particle shape, porosity, surface area and chemistry. Some of these parameters become more relevant at smaller scales — but not always. The transition from ‘conventional’ to ‘unconventional’ behaviour, when it does occur, depends critically on the particular material and the context.

A ‘one size fits all’ definition of nanomaterials will fail to capture what is important for addressing risk.

He then provides a series of arguments supporting his notion that a list of attributes along with values that would precipitate action is preferable to what he described as a ‘one size fits all’ approach.

Herman Stamm’s rejoinder (August 25, 2011 Nature comment [Note: this is behind a paywall]) simplifies Andrew’s arguments for a simple reiteration of his position,

Maynard’s point that such materials are heterogeneous is justified. However, they all have structures on the nanoscale, which modify their other properties. Size is therefore the most appropriate parameter on which to base a broad definition …

My concern with these things has to do with implementation and which approach is going to ensure better safety? Andrew’s approach reminds me of fuzzy logic and computers. I think they’re called ‘if then’ programming scripts: if [xxx happens] then do [yyy]; if [ssss happens] then do [ttt] and so on. Stamm’s approach is a standard one for regulation, i. e., create a hard and fast rule.

Both approaches have their strengths and weaknesses. Andrew’s proposed method allows for great flexibility and agility but as the system becomes more complex (and they always do) then there’s a strong probability of incompatible ‘scripts’ and if there isn’t an overarching principle or rule, then disputes become very difficult if not impossible to resolve.

Stamm’s method, i. e., using size as the key determinant for a rule is likely to lead to an inflexibile attitude and a lack of agility when dealing with situations that are ambiguous or don’t fit the definition. Who hasn’t experienced or heard of a bureaucrat who abides strictly by the rules as written even if they’re not appropriate for the specific situation?

As I’ve noted before I’m slowly coming round to Andrew’s suggestion although I continue to have doubts.

Nano regulatory frameworks are everywhere!

The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks (my June 9, 2011 posting).

I’ll start off slow and easy with this roundup of sorts with a brief look at the international scene, move on to US initiatives, offer a brief comment on the Canadian situation, and wrap up with Europe.

International

Dr. Andrew Maynard at the University of Michigan Risk Science Center (UMRSC) blog has written a commentary about the ISO’s (*International Organization for Standardization) latest set of nanotechnology guidelines in his May 27, 2011 posting.  From the posting,

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. …The ISO report is written in a much tighter style than that of the original document, and loses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.

It’s build around a framework of six steps:

  1. describe materials and applications
  2. material profiles
  3. evaluate risks
  4. assess risk management options
  5. decide, document, and act
  6. review and adapt

From the posting,

Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions. This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available. It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.

Andrew’s view of these guidelines is largely positive and you can get more details and history by viewing his original commentary. (I first mentioned these new ISO guidelines in my May 18, 2011 posting.)

Sticking with the international scene (in this case, ISO), there was a June 13, 2011 news item on Nanowerk about a new ISO general liability classification for nanotechnology and alternative energy (from the news item),

The new classifications to address the growing use of nanotechnology are Nanomaterial Distributors and Nanomaterial Manufacturing. The once-limited use of nanotechnology in electronics and information technology industries is now swiftly permeating the consumer marketplace, from cosmetics to clothing and more. The Nanomaterial Distributors classification applies to risks that sell nanomaterials to others, and the Nanomaterial Manufacturing classification applies to risks that manufacture or engineer nanomaterials for others.

“With heightened interest to reduce the carbon footprint, establish energy independence, and increase the use of renewable resources, alternative power is a priority for many,” said Beth Fitzgerald, vice president of commercial lines and modeling at ISO. “In response to the growing demand for alternative energy, ISO introduced classifications for risks in three main areas: biofuels, solar energy, and wind energy. The new classifications will allow for future evaluation of the loss experience of those emerging markets.”

The biofuels classifications consist of Biofuels Manufacturing and Biofuels Distributors. Since ethanol already has a widespread and accepted use, a further distinction is made between “ethanol” and “biofuels other than ethanol.”

The solar energy classifications include Solar Energy Farms, Solar Energy Equipment Dealers or Distributors, and Solar Energy Equipment Manufacturing. The wind energy classifications include Wind Turbine Contractors – Installation, Service, or Repair and onshore and offshore Wind Farms.

* I have for many years understood that ISO is the International Standards Organization and I see from a note on the UMRSC blog that these days it is the International Organization for Standardization.

US

On the US front, three different agencies have made announcements that in one way or another will have an impact on the nanotechnology regulatory frameworks in that country.

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) recently released a set of principles for the regulation and oversight of nanotechnology applications and guidance for the development and implementation of policies at the agency level. From the June 9, 2011 news item on Nanowerk,

The realization of nanotechnology’s full potential will require continued research and flexible, science-based approaches to regulation that protect public health and the environment while promoting economic growth, innovation, competitiveness, exports, and job creation.

In furtherance of those goals, the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

These principles reinforce a set of overarching principles (pdf) for the regulation and oversight of emerging technologies released on March 11, 2011. They also reflect recommendations from a report on nanotechnology (pdf) by the President’s Council of Advisors on Science and Technology. The report encourages Federal support for the commercialization of nanotech products and calls for the development of rational, science- and risk-based regulatory approaches that would be based on the full array of a material’s properties and their plausible risks and not simply on the basis of size alone.

You can read more about the guidelines at Nanowerk or on the Environemental Expert website here.

Back over on the UMRSC blog, Dr. Andrew Maynard had these comments in his June 13, 2011 posting,

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.

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.

June 9, 2011 was quite the day as in addition to the White House documents, the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) both announced public consultations on nanotechnology regulation.

From the June 9, 2011 news item on Nanowerk about the US EPA public consultation,

The U.S. Environmental Protection Agency announced today it plans to obtain information on nanoscale materials in pesticide products. Under the requirements of the law, EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197. More information or to read the proposed notice: http://www.epa.gov/pesticides/regulating/nanotechnology.html [Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment]

The US FDA has taken a more complicated approach to its public consultation with two notices being issued about the same consultation. The June 9, 2011 news item on Nanowerk had this to say,

The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Then there was a June 15, 2011 news item on Nanowerk offering more details about the draft guidance announcement of June 9, 2011,

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics. “Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial.”

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it’s already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

  • Drugs
  • Medical imaging
  • Antimicrobial materials
  • Medical devices
  • Sunscreens

Andrew Maynard in his previously noted June 13, 2011 posting on on the UMRSC blog had this to say  about the EPA’s draft document,

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.

Canadian segue

I’ll point out here that Health Canada’s Interim Policy definition also adheres to the 1 to 100 nm definition for a nanomaterial, a concern I expressed in my submission to the public consultation held last year. Interestingly, since 29 submissions does seem particularly daunting to read there has yet to be any public response to these submissions. Not even a list of which agencies and individuals made submissions.

Back to US

Andrew also comments on the FDA document,

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”

I recommend reading the full text of Andrew’s comments.

Europe

Meanwhile, there was a June 10, 2011 news item on Nanowerk about the availability of  28 presentations from a May 10-12, 2011 joint European workshop hosted by the Engineered NanoParticle Risk Assessment (ENPRA) FP (Framework Programme) 7 project and the European Commission’s Joint Research Centre. From the news item about the Challenges of Regulation and Risk Assessment of Nanomaterials workshop,

Twenty-eight presentations delivered at the Joint JRC Nano event and 2nd ENPRA Stakeholders Workshop are now available on-line: ENPRA Workshop 2011 – Programme with Presentations.

The workshop (by invitation only) involved about 90 participants, from industry, government, NGOs, and academia. …

During two days and a half, 34 experts from 26 different organisations informed the participants on the latest scientific progress in the field of nanoparticles risk assessment produced within national and European projects, and first results of ENPRA FP7 project were presented in detail. In addition, recent developments concerning legislation in the EU and beyond were discussed.

Amongst other participants, you can include representatives of EU Associate and Candidate Countries, environment and workers’ protection organisations, CAIQ (Chinese Academy of Inspection and Quarantine), US-EPA, ECHA, and EFSA.

To close this piece (and I want to do that very badly), I’m going to give Tim Harper at his TNT blog (on the Cientifica website) the final word from his June 10, 2011 posting,

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

I’m glad to see that it addresses those two old bugbears, the confusion between risk and hazard and the prejudging of issues without reference to scientific evidence …

It is an approach which appears to diverge slightly from the European adoption of the precautionary principle …

As with any regulation, the problems will arise not from the the original wording, but through its (mis)interpretation and inconsistent application.