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 : 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 : 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.