Tag Archives: Craig Cormick

Risk assessments not the only path to nanotechnology regulation

Nanowerk has republished an essay about nanotechnology regulation from Australia’s The Conversation in an Aug. 25, 2015 news item (Note: A link has been removed),

When it comes to nanotechnology, Australians have shown strong support for regulation and safety testing.

One common way of deciding whether and how nanomaterials should be regulated is to conduct a risk assessment. This involves calculating the risk a substance or activity poses based on the associated hazards or dangers and the level of exposure to people or the environment.

However, our recent review (“Risk Analysis of Nanomaterials: Exposing Nanotechnology’s Naked Emperor”) found some serious shortcomings of the risk assessment process for determining the safety of nanomaterials.

We have argued that these shortcomings are so significant that risk assessment is effectively a naked emperor [reference to a children’s story “The Emperor’s New Clothes“].

The original Aug. 24, 2015 article written by Fern Wickson (Scientist/Program Coordinator at GenØk – Centre for Biosafety in Norway) and Georgia Miller (PhD candidate at UNSW [University of New South Wales], Australia) points out an oft ignored issue with regard to nanotechnology regulation,

Risk assessment has been the dominant decision-aiding tool used by regulators of new technologies for decades, despite it excluding key questions that the community cares about. [emphasis mine] For example: do we need this technology; what are the alternatives; how will it affect social relations, and; who should be involved in decision making?

Wickson and Miller also note more frequently discussed issues,

A fundamental problem is a lack of nano-specific regulation. Most sector-based regulation does not include a “trigger” for nanomaterials to face specific risk assessment. Where a substance has been approved for use in its macro form, it requires no new assessment.

Even if such a trigger were present, there is also currently no cross-sectoral or international agreement on the definition of what constitutes a nanomaterial.

Another barrier is the lack of measurement capability and validated methods for safety testing. We still do not have the means to conduct routine identification of nanomaterials in the complex “matrix” of finished products or the environment.

This makes supply chain tracking and safety testing under real-world conditions very difficult. Despite ongoing investment in safety research, the lack of validated test methods and different methods yielding diverse results allows scientific uncertainty to persist.

With regard to the first problem, the assumption that if a material at the macroscale is safe, then the same is true at the nanoscale informs regulation in Canada and, as far as I’m aware, every other constituency that has any type of nanomaterial regulation. I’ve had mixed feelings about this. On the one hand, we haven’t seen any serious problems associated with the use of nanomaterials but on the other hand, these problems can be slow to emerge.

The second issue mentioned, the lack of a consistent definition internationally, seems to be a relatively common problem in a lot of areas. As far as I’m aware, there aren’t that many international agreements for safety measures. Nuclear weapons and endangered animals and plants (CITES) being two of the few that come to mind.

The lack of protocols for safety testing of nanomaterials mentioned in the last paragraph of the excerpt is of rising concern. For example, there’s my July 7, 2015 posting featuring two efforts: Nanotechnology research protocols for Environment, Health and Safety Studies in US and a nanomedicine characterization laboratory in the European Union. Despite this and other efforts, I do think more can and should be done to standardize tests and protocols (without killing new types of research and results which don’t fit the models).

The authors do seem to be presenting a circular argument with this (from their Aug. 24, 2015 article; Note: A link has been removed),

Indeed, scientific uncertainty about nanomaterials’ risk profiles is a key barrier to their reliable assessment. A review funded by the European Commission concluded that:

[…] there is still insufficient data available to conduct the in depth risk assessments required to inform the regulatory decision making process on the safety of NMs [nanomaterials].

Reliable assessment of any chemical or drug is a major problem. We do have some good risk profiles but how many times have pharmaceutical companies developed a drug that passed successfully through human clinical trials only to present a serious risk when released to the general population? Assessing risk is a very complex problem. even with risk profiles and extensive testing.

Unmentioned throughout the article are naturally occurring nanoparticles (nanomaterials) and those created inadvertently through some manufacturing or other process. In fact, we have been ingesting nanomaterials throughout time. That said, I do agree we need to carefully consider the impact that engineered nanomaterials could have on us and the environment as ever more are being added.

To that end, the authors make some suggestions (Note: Links have been removed),

There are well-developed alternate decision-aiding tools available. One is multicriteria mapping, which seeks to evaluate various perspectives on an issue. Another is problem formulation and options assessment, which expands science-based risk assessment to engage a broader range of individuals and perspectives.

There is also pedigree assessment, which explores the framing and choices taking place at each step of an assessment process so as to better understand the ambiguity of scientific inputs into political processes.

Another, though less well developed, approach popular in Europe involves a shift from risk to innovation governance, with emphasis on developing “responsible research and innovation”.

I have some hesitation about recommending this read due to Georgia Miller’s involvement and the fact that I don’t have the time to check all the references. Miller was a spokesperson for Friends of the Earth (FoE) Australia, a group which led a substantive campaign against ‘nanosunscreens’. Here’s a July 20, 2010 posting where I featured some cherrypicking/misrepresentation of data by FoE in the persons of Georgia Miller and Ian Illuminato.

My Feb. 9, 2012 posting highlights the unintended consequences (avoidance of all sunscreens by some participants in a survey) of the FoE’s campaign in Australia (Note [1]: The percentage of people likely to avoid all sunscreens due to their concerns with nanoparticles in their sunscreens was originally reported to be 17%; Note [2]: Australia has the highest incidence of skin cancer in the world),

Feb.21.12 correction: According to the information in the Feb. 20, 2012 posting on 2020 Science, the percentage of Australians likely to avoid using sunscreens is 13%,

This has just landed in my email in box from Craig Cormick at the Department of Industry, Innovation, Science, Research and Tertiary Education in Australia, and I thought I would pass it on given the string of posts on nanoparticles in sunscreens on 2020 Science over the past few years:
…

“An online poll of 1,000 people, conducted in January this year, shows that one in three Australians had heard or read stories about the risks of using sunscreens with nanoparticles in them,” Dr Cormick said.

“Thirteen percent of this group were concerned or confused enough that they would be less likely to use any sunscreen, whether or not it contained nanoparticles, putting them selves at increased risk of developing potentially deadly skin cancers.

“The study also found that while one in five respondents stated they would go out of their way to avoid using sunscreens with nanoparticles in them, over three in five would need to know more information before deciding.”

This article with Fern Wickson (with whom I don’t always agree perfectly but hasn’t played any games with research that I’m know of) helps somewhat but it’s going to take more than this before I feel comfortable recommending Ms. Miller’s work for further reading.

FrogHeart at the 2012 S.NET conference, part 1: the Nanopants attack (protest); more on the Australian nanosunscreen shocker; Hegel; and thanks

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I very much enjoyed and appreciated the 2012 S.NET (Society for the Study of Nanoscience and Emerging Technologies) conference in Enschede, Netherlands from Oct. 22-25, 2012. It was my first nano-themed conference and I suffered from an embarrassment of riches so what follows is just a sliver of the available presentation offerings and my opinions.

I’m sad to say that I have no sensible notes from the opening plenary (‘Emerging technologies — From Technology Push to Societal Pull’ with Dave Blank, Christos Tokamanis, and Pat Mooney on a panel moderated by Arie Rip) largely due to the fact that I’d been travelling continuously for about 15 or 16 hours by then and had trouble absorbing information. The next day was much better.

Public risk perceptions: Mary Collins talking about the Nanopants attack (protest) and about scientists’ approaches to public communication about nanotechnology risks ; Frederico Neresini discussing perceptions in Italy; and Craig Cormick providing more details about the nanosunscreen debacle in Australia.

Mary Collins (University of California at Santa Barbara) presented her work analyzing the various points of view from the science and non-science communities regarding discussions of public risk. She noted there is still concern that the GMO (genetically modified organisms) movement could happen again with nanotechnology and scientists are devoutly interested in avoiding this circumstance. By and large, most scientists want to promote some discussion about risks as a means of avoiding a ‘GMO disaster’ although there is no universal agreement as to which groups/social communities should be apprised. Some scientists favour elite groups only while others prefer a more universal dissemination of information. Collins noted that it is very difficult to find any documentation of scientists espousing the belief that communication of risk should be nonexistent. One audience member noted that a policy of suppressing discussion could be inferred by the lack of media coverage for an activist protest known as the ‘Nanopants attack’. Wired Magazine appears to have been the only media outlet to have covered the event by featuring a June 10, 2005 article by Howard Lovy,

On a chilly Chicago afternoon in early May, environmental activists sauntered into the Eddie Bauer store on Michigan Avenue, headed to the broad storefront windows opening out on the Magnificent Mile and proceeded to take off their clothes.

The strip show aimed to expose more than skin: Activists hoped to lay bare growing allegations of the toxic dangers of nanotechnology. The demonstrators bore the message in slogans painted on their bodies, proclaiming “Eddie Bauer hazard” and “Expose the truth about nanotech,” among other things, in light of the clothing company’s embrace of nanotech in its recent line of stain-resistant “nanopants.”

Frederico Neresini, University of Padua (Italy), discussed some of his work polling for attitudes toward nanotechnology risk and his tentative hypothesis that the more public debate there is on the topic, the more important trustworthiness becomes. Trust was discussed many times and in many contexts at the conference and seemed to be an emergent theme.

Craig Cormick, Australian Dept. of Innovation, discussed the surprising results of a recent poll in Australia which showed that 13% of the population doesn’t use any sunscreen due to concern about nanoscale ingredients (this finding was mentioned at more length in my Feb. 9, 2012 posting). He also noted that he was on the receiving end of some very personal attacks once this information was released. I hadn’t realized it was coincidental but, almost simultaneously, there was another project (analyzing sunscreens available on the Australian market for nanoscale ingredients) where they announced findings of many more sunscreens with nanoscale ingredients than were labelled as such. There weren’t many new details for public consumption but it was interesting to hear a first hand account. Cormick did offer a provocative idea during the session, ‘apply the precautionary principle to your risk messages’.

Chris Groves of Cardiff University (Wales) offered a lunchtime plenary talk titled, ‘Horizons of care: from future imaginaries to responsible innovation’. We were treated to a discussion of philosophy which featured Hegel and Deleuze amongst others. What I found most intriguing were Groves’ contentions that ‘vision’ is a problematic metaphor; that living in an ‘age of innovation’ means living in an ‘age of surprises’; and that science interprets the world by looking into the past. His quote from Hannah Arendt, “What we make remakes us” brought home the notion that there is a feedback loop and that science and invention are not unidirectional pursuits, i.e., we do not create the world and stand apart from it; the world we create, in turn, recreates us.

I was particularly taken with one of his last comments, ‘mapping as a metaphor for colonizing the future’. I’ve long been interested by the frequency of ‘mapping’ as a metaphor in scientific pursuits (mapping the genome, amongst many others). His comment reminded me that the great mapping bonanzas are associated with ‘colonizing’ various continents.

A big thank you is due to

US National Science Foundation,
the University of California at Santa Barbara (Valerie Kuan and Barbara Herr Harthorn),
the Canadian Academy of Independent Scholars,
Simon Fraser University,
Luinda Bleackley,
Teresa McDowell,
Zoey Ryan,
Susan Baxter,
Helen Dewar,
Debora Gordon, and
Doug Setter

all of whose financial support helped me get to the conference. I am deeply grateful.

I want to thank the organizers for a sumptuous conference not only in content but also in execution. They even managed to cater most of our meals, which made life ever so much easier. In particular, I want to thank Marcia Clifford and Evelien Rietberg of the local organizing committee for their patience and help as I fumbled about on my arrival.

Part 2: Yet again, I discover information about Canadian nanotechnology efforts through European sources.

ETA Nov. 1, 2012: I made a minor grammatical correction in the section about Chris Groves’ talk and I should mention that I never did quite grasp the relationship of ‘care’ to the concepts he presented.

Unintended consequences: Australians not using sunscreens to avoid nanoparticles?

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Friends of the Earth (FoE) Australia has waged a campaign against the use of nanosunscreens. It seems to have been somewhat successful but in a way that I imagine is upsetting. From the Feb. 9, 2012 news item on physorg.com,

The Cancer Council of Australia reports that we have one of the highest rates of skin cancer in the world, with over 440,000 people receiving medical treatment for skin cancers each year, and over 1,700 people dying of all types of skin cancer annually.

The survey of public attitudes towards sunscreens with nanoparticles, commissioned by the Australian Department of Industry, Innovation, Science, Research and Tertiary Education and conducted last month, showed that about 17% of people in Australia were so worried about the issue, they would rather risk skin cancer by going without sunscreen than use a product containing nanoparticles. [emphasis mine] [please see correction at the end of this posting]

The survey along with three research papers were presented at the 2012 International Conference on Nanoscience and Nanotechnology (ICONN) in Perth,Feb. 5-9.

One of the research studies indicates that claims of ‘nano-free’ sunscreen products may be wrong, from the Feb. 9, 2012 news item on Nanowerk,

Scientists from Australia’s National Measurement Institute and overseas collaborators reported on a technique using the scattering of synchrotron light to determine the sizes of particles in sunscreens. They found that some commercial sunscreens that claim to be ‘nano-free’ do in fact contain nanostructured material. The findings highlight the need for clear definitions when describing nanomaterials.

…
The Australian Therapeutic Goods Administration has released a statement on safety of sunscreens containing nanoparticles that concluded: “… the current weight of evidence suggests that TiO2 (titanium dioxide) and ZnO (zinc oxide) nanoparticles do not reach viable skin cells, rather, they remain on the surface of the skin and in the outer layer of the skin…”

You can get more information about the studies in either linked news item. The Australian government’s sunscreen use survey is available on this page; the Australian Therapeutic Goods Administration review of the scientific literature on the safety of nanoscale (nanoparticulate) titanium dioxide and zinc oxide in sunscreens is available on this page; and the Cancer Council of Australia has information about sunscreens and nanoparticles on this page.

One can’t lay the blame for *13%* of the population’s hesitance to use any sunscreens at one door but I hope that civil societies like FoEAustralia will give a little thought to the unintended consequences of their campaigns.

The campaign was against nanosunscreens not all sunscreens but presumably coupled with other influences, it seems to have upset a significant percentage of the population to the point that they refuse to use any sunscreens at all for fear of inadvertently being exposed to nanoparticles.

Feb. 10, 2012 update: It’s a very interesting response from FoEAustralia (from the Feb. 10, 2012 article by Simon Lauder for ABC [Australian Broadcasting Corporation] News),

“We’ve decided to recall the safe sunscreen guides that we have produced this summer until we can revise them based on new information that comes in,” Elena McMaster, the nanotechnology campaigner with Friends of the Earth, said.

“What we see with this research is that in the absence of government regulation, the nanotech industry is able to more or less make up their own rules about what constitutes a nano material,” she said.

“We are obviously probably as shocked as people in the industry about the NMI research results.

“I can’t emphasise enough how urgent we think it is that the Government regulates.”

The best FoEAustralia can offer in the face of the rather shocking information that 17% of the adult population are avoiding sunscreens altogether is a plea for more government regulation of a product that doesn’t seem to be dangerous according to research.

Dexter Johnson in his Feb. 10, 2012 Nanoclast posting noted this about the study which found that sunscreens claiming ‘no nanomaterials/nanoparticles’ did contain some,

“What we see with this research is that in the absence of government regulation, the nanotech industry is able to more or less make up their own rules about what constitutes a nano material,” said Elena McMaster, a FoE spokesperson.

That’s one interpretation, I suppose. But it could also be that traditional sunscreens might contain nanoscale particles even though no attempt had been made to manufacture or add them to the mix. Unintentional nanoparticles, if you will, not unlike those created when the tires of your car drive over the pavement.

I wonder what kind of government regulations the FoE will request. Will each container of sunscreen have to be opened and its contents examined with a scattering of synchrotron light to determine particle size?

In fact, there’s some evidence that nanoparticles are all over the place, some of them created by nature, from the May 11, 2012 article New Evidence for Natural Synthesis of Silver Nanoparticles on Nanowiki,

“this creates the idea that there may be some sort of natural cycle returning some of the ions to nanoparticles.” [said Robert MacCuspie at NIST {US National Institute of Standards and Technology}] It also helps explain the discovery, over the past few years, of silver nanoparticles in locations like old mining regions that are not likely to have been exposed to man-made nanoparticles, but would have significant concentrations of silver ions. [emphasis mine]

My respect for FoEAustralia is seriously damaged by this stance they’ve taken. As far as I’m concerned they should admit they’ve made a mistake by using scare tactics to force some sort of confrontation over nanosunscreens and their strategy to force regulation of nanomaterials has backfired seriously.

Feb.21.12 correction: According to the information in the Feb. 20, 2012 posting on 2020 Science, the percentage of Australians likely to avoid using sunscreens is 13%,

This has just landed in my email in box from Craig Cormick at the Department of Industry, Innovation, Science, Research and Tertiary Education in Australia, and I thought I would pass it on given the string of posts on nanoparticles in sunscreens on 2020 Science over the past few years:
…

“An online poll of 1,000 people, conducted in January this year, shows that one in three Australians had heard or read stories about the risks of using sunscreens with nanoparticles in them,” Dr Cormick said.

“Thirteen percent of this group were concerned or confused enough that they would be less likely to use any sunscreen, whether or not it contained nanoparticles, putting them selves at increased risk of developing potentially deadly skin cancers.

“The study also found that while one in five respondents stated they would go out of their way to avoid using sunscreens with nanoparticles in them, over three in five would need to know more information before deciding.”

*’17%’ corrected to ‘13%’ on Sept. 22, 2016.