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.

Unintended consequences: Australians not using sunscreens to avoid nanoparticles?

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 17% 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.”