Tag Archives: Ian Illuminato

New digital technologies could unlock greater potential for microbes and fungi and some thoughts on civil society groups

Not sure how this escaped my notice for so long: an August 7, 2024 news item on phys.org presents an intriguing proposition,

Microbes and fungi have long been nature’s helpers in producing fine food, drinks and medicine, but new digital technologies could unlock far greater potential for the European biotech sector.

An August 6, 2024 article by Anthony King for Horizon; The EU Research & *Innovation magazine, which originated the news item, explores the matter further, Note: A link has been removed,

Beer may not be the answer to all of life’s problems, but the science behind it could help decarbonise industrial processes and clean up the environment.

Biotechnology, which uses living organisms to create different products or processes, remains important in today’s production of food and drink. But it is also increasingly used for a wide range of industrial products, including medicines, where it combines ancient principles with cutting-edge technology.

Ancient wisdom, modern processes

‘We’ve used biotechnology for thousands of years to make cheese, to make beer, to make wine,’ said Michael O’Donohue, an expert in microbial enzymes and industrial biotechnology at France’s National Research Institute for Agriculture, Food and Environment (INRAE).

Little workhorses

Biotech has already transformed our lives, far beyond improving the taste of beer. Modern advances started with the use of fungi in the early 20th century to make life-saving antibiotics. Today, biotech remains crucial for making medicines.

As O’Donohue explained, ‘the workhorses of biotechnology at an industrial level are mainly yeast and filamentous fungi.’ 

But because yeasts can be unpredictable in what compound, and how much, they produce, Bioindustry 4.0 [EU-funded project], which runs until December 2026, will use digital technology to improve the consistency of biotech outcomes.

An upside of biotechnology is that it can offer a cleaner alternative to traditional chemical manufacture.

Playing catch-up

Biotech is a major global industry worth €720 billion in 2021, but Europe currently lags behind the US. The European Commission describes biotechnology as “one of the most promising technological areas of this century” and has taken steps to boost it in Europe.

‘The US is the big player. They take 60% of the cake,’ said O’Donohue. ‘We’ve identified several weaknesses in Europe for biotech. We’ve got a fragmented landscape, which makes it quite tricky, if you are developing biotechnology, to know what is available and where.’

Nevertheless, O’Donohue said, the potential is there. ‘Europe was the birthplace of modern biotechnology. We have a lot of infrastructure. We have a lot of expertise.’

Building the market

The concept has already been put to work, assisting young European companies such as Calidris Bio, a Belgian start-up that aims to manufacture high-quality protein using fewer resources. 

‘We want to bring it to the market as an ingredient to replace fishmeal and soy that at the moment is not grown sustainably,’ said Lieve Hoflack, a co-founder of Calidris Bio. 

But producing the protein is just half the battle. A new product must be tested for safety, taste and nutritional value. 

‘With IBISBA, we found a place with the right equipment, the right expertise and also the right mindset to bring our process to the next step,’ said Hoflack.

The European Commission has said it aims to boost biotechnology to combat climate change and resource scarcity. It is working towards an EU Biotech Act and aims to promote regulatory sandboxes to test novel approaches in a controlled environment for a limited amount of time, under regulatory supervision.

IBISBA describes itself as “a pan-European distributed research infrastructure dedicated to industrial biotechnology” on its About webpage.

Civil society groups and their protests

As interesting as King’s August 6, 2024 article is, it doesn’t mention the campaigns against biotechnology, which had a dampening effect on research in many countries. Here’s more about the history of these efforts in an October 9, 2023 article on the Genetic Literacy Project website, Note: Links have been removed,

ETC Group: ‘Extreme’ biotechnology critic campaigns against synthetic biology and other forms of ‘extreme genetic engineering’

screen shot at pm

The ETC group, an international NGO based in Canada, claims it monitors the “impact of emerging technologies” that impact biodiversity, agriculture and human rights. It promotes imposing an extreme version of the ‘precautionary principle’ to all technologies, claiming that many modern innovations, including genetic engineering of crops and medicines, are too risky to implement, and even basic research should be suspended indefinitely.

ETC Group works with other radical environmental groups such as Friends of he Earth, campaigning against nearly every application of genetic engineering, including biotechnology-based disease research, synthetic biology, and most aggressively gene drives, which it refers to as “extreme genetic engineering” an claims it will result in the “end of Nature.” ETC Group calls has criticized increased corporate involvement in food and agriculture, what it calls threats to biodiversity and farmers’ rights, and what it sees as insufficient government regulation.

“The speed with which those developments are scaling up is often presented in terms of carefully crafted speculative conservation and health benefits while the overwhelming military interest driving these developments, while not hidden, has been very much downplayed,” ETC Group co-executive director Jim Thomas has said, citing the military’s interest in synthetic biology.

ETC Group staff members are often quoted by major media outlets criticizing various applications of genetic engineering. The organization has used Freedom of Information Acts (FOIA) to obtain emails and background information on university and government research, which they provide to journalists.

Obviously, the article was not written as a love letter. While I find the tone a bit harsh, I have seen how at least one civil society group has distorted research results to prove its point. More about that later.

ETC history

From the October 9, 2023 article for the Genetic Literacy Project, Note: A link has been removed,

Originally formed in the late 1970s as Rural Advancement Foundation International (RAFI), the group changed its name to the ETC Group in 2001. Its official name is the Action Group on Erosion, Technology and Concentration.

ETC Group is a registered CSO in Canada and The Netherlands. Friends of ETC Group is a private non-profit organization under section 501(c)3 in the United States.

The group claims to be the “first civil society organization (nationally or internationally) to draw attention to the socioeconomic and scientific issues related to the conservation and use of plant genetic resources, intellectual property and biotechnology.”

According to the group’s website, “In the late 1970s, we were the first CSO to recognize the trend toward life patenting and the first to organize against national plant patenting laws (plant breeders’ rights).” In the 1990s, the ETC Group says its work “expanded to encompass social and environmental concerns related to biotechnology, biopiracy, human genomics and, in the late 1990s, to nanotechnology.” [emphases mine]

Distortions

By the time I started this blog in May/June 2008, the biotechnology protests were winding down. One of the new focal points for civil society groups was nanotechnology and that’s where I observed the distortions.

A Friends of the Earth (FOE) report

My first observation dates as far back as this August 20, 2009 posting, Note: Links have been removed,

In a bit of interesting timing given that it’s on the heels of the publication of a study about two tragic deaths which are being attributed to exposure to nanoparticles, the Friends of the Earth (FOE) organization has released a report titled Nano-Sunscreens: Not Worth the Risk.The media release can be found on Azonano or Nanowerk News.

I have read the report (very quickly) and noted that they do not cite or mention the recently released report on the same topic by the Environmental Working Group (EWG) which stated that after an extensive review of the literature, there was no evidence that the titanium dioxide or zinc oxide nanoparticles used in sunscreens were dangerous. (posting here).

Shortly after the EWG report’s release, a new study (which I mentioned here … if you are inclined, do read the comments as some additional points about reading research critically are brought out)  suggested concerns based on the work of researchers in Japan.  The new study from Japan is cited in the Friends of the Earth report.

While the overall tone of the FOE report is fairly mild (they suggest precaution) they cite only a few studies supporting their concern [emphasis mine] and they damage their credibility (in my book) by ignoring a report from a well respected group that reluctantly admitted that there is no real cause for concern about nanoparticles in sunscreens based on the current evidence.

Zinc dioxide nanoparticles in sunscreens

About a year later in a July 20, 2010 posting I featured some issues with how Friends of the Earth (Georgia Miller, Australian representative, and Ian Illuminato, North American representative) guest blogging on another blog known as “2020 Science” distorted research findings from a study on zinc oxide nanoparticles in sunscreens. Dr. Andrew Maynard, the blog owner, made some critical observations about their posting. In addition, the researcher for the study, along with two other scientists, noted distortions in the Miller and Illumanito critique.

Two Chinese workers, nanoparticles and death

This excerpt from a July 26, 2011 posting is my critique of an article by Alex Roslin in a local newspaper, which relied almost exclusively on a report from the Friends of the Earth,

It’s good to see articles about nanotechnology. The recent, Tiny nanoparticles could be a big problem, article written by Alex Roslin for the Georgia Straight (July 21, 2011 online or July 21-28, 2011 paper edition) is the first I’ve seen on that topic in that particular newspaper. Unfortunately, there are  some curious bits of information included in the article, which render it, in my opinion, difficult to trust.

I do agree with Roslin that nanoparticles/nanomaterials could constitute a danger and there are a number of studies which indicate that, at the least, extreme caution in a number of cases should be taken if we choose to proceed with developing nanotechnology-enabled products.

One of my difficulties with the article is the information that has been left out. (Perhaps Roslin didn’t have time to properly research?) At the time (2009) I did read with much concern the reports Roslin mentions about the Chinese workers who were injured and/or died after working with nanomaterials. As Roslin points out,

“Nanotech already appears to be affecting people’s health. In 2009, two Chinese factory workers died and another five were seriously injured in a plant that made paint containing nanoparticles.

The seven young female workers developed lung disease and rashes on their face and arms. Nanoparticles were found deep in the workers’ lungs.

“These cases arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs,” wrote Chinese medical researchers in a 2009 study on the incident in the European Respiratory Journal.”

Left undescribed by Roslin are the working conditions; the affected people were working in an unventilated room. From the European Respiratory Journal article (ERJ
September 1, 2009 vol. 34 no. 3 559-567, free access), Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma,

“A survey of the patients’ workplace was conducted. It measures ∼70 m2, has one door, no windows and one machine which is used to air spray materials, heat and dry boards. This machine has three atomising spray nozzles and one gas exhauster (a ventilation unit), which broke 5 months before the occurrence of the disease. The paste material used is an ivory white soft coating mixture of polyacrylic ester.

Eight workers (seven female and one male) were divided into two equal groups each working 8–12 h shifts. Using a spoon, the workers took the above coating material (room temperature) to the open-bottom pan of the machine, which automatically air-sprayed the coating material at the pressure of 100–120 Kpa onto polystyrene (PS) boards (organic glass), which can then be used in the printing and decorating industry. The PS board was heated and dried at 75–100°C, and the smoke produced in the process was cleared by the gas exhauster. In total, 6 kg of coating material was typically used each day. The PS board sizes varied from 0.5–1 m2 and ∼5,000 m2 were handled each workday. The workers had several tasks in the process including loading the soft coating material in the machine, as well as clipping, heating and handling the PS board. Each worker participated in all parts of this process.

Accumulated dust particles were found at the intake of the gas exhauster. During the 5 months preceding illness the door of the workspace was kept closed due to cold outdoor temperatures. The workers were all peasants near the factory, and had no knowledge of industrial hygiene and possible toxicity from the materials they worked with. The only personal protective equipment used on an occasional basis was cotton gauze masks. According to the patients, there were often some flocculi produced during air spraying, which caused itching on their faces and arms. It is estimated that the airflow or turnover rates of indoor air would be very slow, or quiescent due to the lack of windows and the closed door.” [emphases mine]

Here’s the full text from the researchers’ conclusion,

“In conclusion, these cases arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs. It is impossible to remove nanoparticles that have penetrated the cell and lodged in the cytoplasm and caryoplasm of pulmonary epithelial cells, or that have aggregated around the red blood cell membrane. Effective protective methods appear to be extremely important in terms of protecting exposed workers from illness caused by nanoparticles.”

There is no question that serious issues about occupational health and safety with regards to nanomaterials were raised. But, we work with dangerous and hazardous materials all the time; precautions are necessary whether you’re working with hydrochloric acid or engineered nanoparticles. (There are naturally occurring nanoparticles too.)

In general, I found the tenor of the article more alarmist than informational and I’m sorry about that as I would like to see more information being shared and, ultimately, public discussion in Canada about nanotechnology and other emerging technologies.

Unintended consequences

After years of concerted effort the Friends of the Earth saw this result in Australia,

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]

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

Unexpected outcomes

Here’s what happened, eventually, to the EWG and its work on sunscreens, from a June 23, 2020 posting “Sunscreens 2020 and the Environmental Working Group (EWG),”

There must be some sweet satisfaction or perhaps it’s better described as relief for the Environmental Working Group (EWG) now that sunscreens with metallic (zinc oxide and/or titanium dioxide) nanoparticles are gaining wide acceptance. (More about the history and politics EWG and metallic nanoparticles at the end of this posting.)

This acceptance has happened alongside growing concerns about oxybenzone, a sunscreen ingredient that EWG has long warned against. Oxybenzone has been banned from use in Hawaii due to environmental concerns (see my July 6, 2018 posting; scroll down about 40% of the way for specifics about Hawaii). Also, it is one of the common sunscreen ingredients for which the US Food and Drug Administration (FDA) is completing a safety review.

Today, zinc oxide and titanium dioxide metallic nanoparticles are being called minerals, as in, “mineral-based” sunscreens. They are categorized as physical sunscreens as opposed to chemical sunscreens.

A few thoughts on civil societies, business, and technological progress

The description of how sunscreens and other products with engineered nanoparticles were presented in misleading reports and articles is unfortunately not unusual where many civil society groups are concerned. (i found that very disillusioning.)

As for business and industry group, they use the same tactics.

Whether the topic is cigarette smoking, genetically modified organisms, engineered nanoparticles in sunscreens, etc. I keep reminding myself it’s best to consult more than one source and to remember that things change. All we’ve got to work with is the information at hand.

In the end, civil society groups provide an important function as do business and industrial groups. Trusting everything they say, is not a good idea. Something to remember when looking up organizations such as the Genetic Literacy Project and reading people like me.

Public comment invited on *2016* US draft National Nanotechnology Initiative strategic plan

A Sept. 23, 2016 news item on Nanowerk announces a public consultation on the latest draft US National Nanotechnology Initiative strategic plan (Note: Links have been removed),

The draft 2016 National Nanotechnology Initiative (NNI) Strategic Plan is now available online for public comment prior to publication. The public is encouraged to submit comments electronically through www.nano.gov/2016strategy, or via email to 2016NNIStrategy@nnco.nano.gov. Public comments should be one page or less and include reference page and line numbers. Comments are due by September 23, 2016. Additional guidance is available in the Federal Register.

The NNI Strategic Plan describes the initiative’s vision and goals and the strategies by which these goals are to be achieved. The plan includes a description of the NNI investment strategy and the program component areas called for by the 21st Century Research and Development Act of 2003, and it also identifies specific objectives toward collectively achieving the NNI vision. This plan updates and replaces the NNI Strategic Plan of February 2014.

A Sept. 12, 2016 US National Nanotechnology Initiative notice provides a link to the 67pp. draft document and further information. You can also check the US Federal Register for the official document. The deadline for submitting comments is Sept. 23, 2016, in short, you have ten days.

*ETA Sept. 15, 2016: Sam Pearson in a Sept. 14, 2016 article (open access during a free trial) for Bloomberg BNA offers some analysis of the 2016 draft plan,

The draft document, which sets out goals for developing and commercializing the technology and was released Sept. 12 [2016], is largely unchanged from previous versions. The plan, which is required under the 21st Century Nanotechnology Research and Development Act, sets policy for the White House-led National Nanotechnology Initiative for the next three years across 20 departments and independent agencies.

The environment and health spending is about 7 percent of the initiative’s total budget, an increase from 4.8 percent in fiscal year 2011 and just 2.8 percent in fiscal year 2006. When combined with related spending in other sectors, the total is about 10 percent of the budget, the document states.

“There’s significant potential positive aspects of this, but we need those to be managed in a mature way to ensure that we’re not bringing about something that’s so profound without any laws in place,” Ian Illuminato, a health and environment consultant at Friends of the Earth, told Bloomberg BNA Sept. 12 [2016], “which has so far been what’s happening.”

Friends of the Earth and other environmental groups have pushed for tougher evaluations of the potential health risks of nanotech products.

In a statement to Bloomberg BNA Sept. 12 [2016], Jay West, head of the Nanotechnology Panel of the American Chemistry Council, said the group planned to examine the proposal.

For the curious, there’s more analysis in Pearson’s article.

*’2016′ added on Sept. 15, 2016.

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.

First lawsuit on risks of nanotechnology?

I got this Dec. 21, 2011 news release this morning,
 

Consumer Safety Groups File First Lawsuit on Risks of Nanotechnology

San Francisco, CA – Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) today.  The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials.

Nanotechnology is a powerful platform technology for taking apart and reconstructing nature at the atomic and molecular level.  Just as the size and chemical characteristics of manufactured nanomaterials give them unique properties, those same properties – tiny size, vastly increased surface area to volume ratio, and high reactivity – can also create unique and unpredictable health and environmental risks.

The lawsuit demands FDA respond to a petition the public interest organizations filed with the agency in 2006, nearly six years ago.  The coalition is led by the International Center for Technology Assessment (CTA), on behalf of fellow plaintiffs Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.

“Nano means more than tiny; it means materials that have the capacity to be fundamentally different.  Yet more and more novel nanomaterials are being sold infused into new consumer products every day, while FDA sits idly by,” said George Kimbrell, ICTA Attorney.  “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

The eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility.  The 2006 petition [http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf] requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency.

Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action.  The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.

“Year after year goes by but we have yet to see the FDA do the bare minimum and require nanosunscreens to be labeled as such. This is a basic consumer right,” said Ian Illuminato of Friends of the Earth.  “We’re well past the 1800s — nobody likes or should be forced to use mystery chemicals anymore.”

Since 2006, numerous studies and reports, including agency publications by the Environmental Protection Agency, the Office of the Inspector General, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials’ potential effects on human health and the environment.  Most troubling are studies using mice that show that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring.  One study found titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain.

“It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,” said Wenonah Hauter, executive director of Food & Water Watch. “It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.”

“The scientific consensus is that nanomaterials require specific testing to account for their novel capacities and potential risks.  The FDA must do such testing as part of a pre-market safety assessment in a broader regulatory initiative to protect public health,” said Steve Suppan of the Institute for Agriculture and Trade Policy.

For more, see generally (http://www.icta.org/about/).

Despite the headline ICTA gave this news release, I found a 2008 news release for another nanotechnology law suit where they were suing the US Environmental Protection Agency,  GROUPS DEMAND EPA STOP SALE OF 200+ POTENTIALLY DANGEROUS NANO-SILVER PRODUCTS; Nanotech Watchdog Launches First-Ever Legal Challenge To EPA Over Unregulated Nanotech Pesticide Pollution.

If I understand this rightly, the ICTA along with its coalition partners is suing the FDA for not responding to its petition, which would have made for a much less compelling headline. I didn’t have much luck accessing the 2006 petition (clicking on the link brought up an error page) but will try again later.

I notice that sunscreens with with nanoscale titanium dioxide are used as an example of the use of dangerous nanomaterials in consumer products. It seems the general consensus is that nanoscale titanium dioxide and/or zinc oxide used in nanosunscreens are relatively safe. You can read more about this on the Cancer Council of Australia or the Environmental Working Group (EWG) websites. From the EWG,

EWG reviewed the scientific literature on hazards and efficacy (UVB and UVA protection) for all active ingredients approved in the U.S. Though no ingredient is without hazard or perfectly effective, on balance our ratings tend to favor mineral sunscreens because of their low capacity to penetrate the skin and the superior UVA protection they offer.

I really wish they would stop using the nanosunscreens as their ‘go to’ concern as I think it damages these groups’ credibility.

Still, the FDA should respond to a petition and six years seems like a long time to wait.

Sort of secret summit for international nanotechnology activists

Apparently, global activists are meeting for the 4th International Nanotechnology Activist Summit in Berlin, Oct. 6 – 7, 2011. I did a quick search and was unable to find a website for the summit or find any additional information about it on the Friends of the Earth nano website or the ETC Group website, both represented at the summit. The source for the Oct. 7, 2011 news item on Nanowerk is the European Environmental Bureau (one of the activist groups at the Summit). From the news item on Nanowerk,

Some 30 activists representing 14 environmental, technology assessment and consumer organisations from Europe, the United States, Canada and Latin America met for the 4th International Nanotechnology Activist Summit in Berlin on October 6 and 7.

Jaydee Hanson from the International Center for Technology Assessment, which has filed legal challenges to the US Environmental Policy Agency and the Food and Drug Administration, called “for the protection of workers and the public from exposure to nanomaterials that have not been proven safe.”

Paolo Martins, Coordinator of the Brazilian Research Network in Nanotechnology, Society and the Environment called for review of nanotechnologies that will have wide-ranging effects on workers and consumers in the developing world. He noted that there must be, “full consideration of the ethical and social impacts of these technologies.”

Ian Illuminato of Friends of the Earth [FoE]-US demanded that “a full lifecycle analysis must be completed prior to any commercialization of nano-products.” [emphasis mine]

Dorothée Browaeys, Director General of VivAgora (France) noted that “nanomaterials must be classified as new substances and subject to nano-specific regulation. France has initiated mandatory declaration for producers and importers, this should be expanded to include all formulators and retailers of products containing nanomaterials. Other countries should do likewise.”

Pat Mooney, Executive Director of the ETC Group, with offices in Canada, the Philippines, Mexico, and the US called for a moratorium on the commercialization of nano-products, but noted that all “Nano-industries must be fully accountable for liabilities caused by their products if they come on the market.”

Given the carbon footprint from the travel for these 14 individuals, these quotes seem like fairly standard rhetoric. I hope there’s more news forthcoming from this meeting otherwise it would seem to be a waste of time and resources.

As for Ian Illuminato (what a marvelous name!), I’m surprised he heads up the FoE-US arm of the organization since, according to a July 21, 2011 news article by Alex Roslin for Vancouver’s (Canada) Georgia Straight, Illuminato has a “home office in Victoria (Canada).” Is this a new trend? Live in Canada and head up a US organization? Note: I wrote a commentary about Roslin’s article on nanoparticles in my July 26, 2011 posting.

Could science funding in the European Union have an impact on Canadian nanotechnology?

Unexpectedly they’re upping the research budget in the European Union. According to the item online at  BBC News,

The EU has announced 6.4bn euros (£5.4bn) of funding for scientific research and innovation next year – a 12% increase on this year’s allocation.

The programme is aimed at creating more than 165,000 jobs and developing “a more competitive and greener Europe”, the European Commission says.

The focus is on tackling climate change, energy projects, food security, health and Europe’s ageing population.

Grants will be awarded to about 16,000 research bodies and businesses.

“Research and innovation are the only smart and lasting route out of crisis and towards sustainable and socially equitable growth,” said the EU Commissioner for Research and Innovation, Maire Geoghegan-Quinn.

“There is no other way of creating good and well-paid jobs that will withstand the pressures of globalisation.”

EU-funded research currently accounts for about 5% of the total public funding for research in the EU, she said.

The investment includes more than 600m euros for health research, about 206m euros of which will go into clinical trials for new drugs.

Nanotechnologies will get 270m euros, while about 600m euros is earmarked for advanced computer technologies. [emphasis mine]

Another 400m euros is to be spent on computer applications that address the challenges of building a low-carbon economy and managing ageing populations.

I was inclined to view it as a piece of delightful news without really analyzing it, then David Bruggeman (Pasco Phronesis) made a salient comment,

I suspect that the European spending will be insufficient even if individual nations hold the line on their own science funding. Because even those nations are looking at significant cuts to their universities, which affect both the training of the next generation of researchers and a certain amount of research. At best the funding boosts and cuts will be a wash, but the future doesn’t look like the best. What might happen is a greater shift in attention to European Union level research compared to country level research.

David also provides a brief description of the  ‘framework programme’ that the European Union uses to fund science research so that readers (such as me) have a better understanding of the bigger picture. If you’re interested in this kind of thing, do check out his posting.

David’s commentary was particularly timely as, this morning, I came across an article about the French government funding nanotechnology research in Canada (Sherbrooke, Québec to be precise). Since the article is in French, I’m going to be relying on my translation skills (Note: I will reproduce at least some of the French, so do let me know if you spot any errors.)

There is an abbreviated version of the article (Nanotechnologies: un petit bout de France à L’UdeS) by Jonathan Custeau for the Sherbrooke Tribune here (fyi, somebody sent me a copy of the full article).

The University of Sherbrooke’s current nanotechnology laboratory (Laboratoire international associé en nanotechnologies et nanosystèmes [LIA-LN2]) is about to receiving funding to the tune of ! million Euros over three years from France’s CNRS (Centre National de la Recherche Scientifique) putting  it in a category occupied by only eight other labs in the world.

I gather the lab’s current LIA-LN2 status is a consequence of previous French funding since the university’s vice-president of research describes the current bonanza as ‘jumping to a new level’, i.e. jumping to Unité mixte international (UMI) status,

“Nous étions tellement en avance que nous sautons à un autre niveau”, fait valoir Jacques Beauvais, vice-recteur à la recherche de l’Université de Sherbrooke.

L’autre niveau, c’est l’Unité mixte internationale, un laboratoire financé par le Centre national de la recherche scientifique (CNRS français. Il n’en existe que huit à travers le monde.

“Une UMI coûte très cher, parce que c’est un vrai laboratoire, avec des chercheurs financés par le CNRS, des fonds de recherches français et européens. C’est comme s’il y avait un bout de France sur le campus de l’Université de Sherbrooke”, fait valoir Vincent Aimez, codirecteur du LIA-LN2.

The nanotechnology researchers at the University of Sherbrooke (L’UdeS) have been liaising and collaborating with researchers in Varennes, Lyon, and Grenoble, France for over two years,  so this new funding is an acknowledgment of the quality of their work.

Bravo—the award is all the more extraordinary given the concerns about science and university funding in Europe.

January 2012 is the launch date for the University of Sherbrooke’s UMI which will have a focus on bringing at least some of the academic research to the market. Miniaturized integrated circuit boards are mentioned specifically and my translation skills failed a bit here,

Les applications des recherches pourraient notamment permettre de relever le défi de la miniaturisation des puces électroniques [integrated circuit boards?]. “Nous cherchons à faire des puces avec plus de fonctions, mais qui consomment moins d’énergie, pour qu’elles restent efficaces pendant un mois par exemple. Nous voulons aussi développer des biocapteurs [?] pour des contrôles environnementaux [?] ou des analyses médicales [medical diagnostics?]”, précise Abdelkader Souifi, également codirecteur du LIA-LN2.

I found the comments regarding products quite interesting in light of the Québec government’s recent moves to improve innovation in that province as per the article (June 30, 2010) by Peter Hadekel in the Montréal Gazette. (Idle thought: This casts a new light on the recent Domtar-FPInnovations collaboration on nanocrystalline cellulose (my July 16, 2010 posting).

Nanotechnology and sunscreens: recalibrating positions and the excruciating business of getting it as right as possible

I’ve been waiting for Andrew Maynard’s comments (on his 2020 Science blog) about the Friends of the Earth (FoE) guest bloggers’ (Georgia Miller and Ian Illuminato) response (ETA June 6, 2016: Just how risky can nanoparticles in sunscreens be? Friends of the Earth respond; a 2020 Science blog June 15, 2010 posting) to his posting (Just how risky could nanoparticles in sunscreens be?) where he challenged them to quantify the nanosunscreen risk to consumers.  His reflections on the FoE response and the subsequent discussion are well worth reading. From Andrew’s posting, The safety of nanotechnology-based sunscreens – some reflections,

Getting nanomaterials’ use in context. First, Georgia and Ian, very appropriately in my opinion, brought up the societal context within which new technologies and products are developed and used:

“why not support a discussion about the role of the precautionary principle in the management of uncertain new risks associated with emerging technologies? Why not explore the importance of public choice in the exposure to these risks? Why not contribute to a critical discussion about whose interests are served by the premature commercialisation of products about whose safety we know so little, when there is preliminary evidence of risk and very limited public benefit.”

Andrew again,

… we need to think carefully about how we use scientific knowledge and data – “evidence” – in making decisions.

As he goes on to point out, cherrypicking data isn’t a substantive means of supporting your position over the long run.

Unfortunately it’s a common practice on all sides ranging from policymakers, politicians, civil society groups, consumers, medical institutions, etc. and these days we don’t have the luxury, ignorance about downsides such as pollution and chemical poisoning on a global scale for example, that previous generations enjoyed.

Three of the scientists whose work was cited by FoE as proof that nanosunscreens are dangerous either posted directly or asked Andrew to post comments which clarified the situation with exquisite care,

Despite FoE’s implications that nanoparticles in sunscreens might cause cancer because they are photoactive, Peter Dobson points out that there are nanomaterials used in sunscreens that are designed not to be photoactive. Brian Gulson, who’s work on zinc skin penetration was cited by FoE, points out that his studies only show conclusively that zinc atoms or ions can pass through the skin, not that nanoparticles can pass through. He also notes that the amount of zinc penetration from zinc-based sunscreens is very much lower than the level of zinc people have in their body in the first place. Tilman Butz, who led one of the largest projects on nanoparticle penetration through skin to date, points out that – based on current understanding – the nanoparticles used in sunscreens are too large to penetrate through the skin.

These three comments alone begin to cast the potential risks associated with nanomaterials in sunscreens in a very different light to that presented by FoE. Certainly there are still uncertainties about the possible consequences of using these materials – no-one is denying that. But the weight of evidence suggests that nanomaterials within sunscreens – if engineered and used appropriately – do not present a clear and present threat to human health.

Go to the comments section of the 2020 Science blog for the full text of Peter Dobson’s response, Brian Gulson’s response posted by Andrew on Gulson’s behalf, and Tilman Butz’s response posted by Andrew on Butz’s behalf. (I found these comments very helpful as I had made the mistake of assuming that there was proof that nanoparticles do penetrate the skin barrier [as per my posting of June 23, 2010].)

I want to point out that the stakes are quite high despite the fact that sunscreens are classified as a cosmetic. I’ve heard at least one commentator (Pat Roy Mooney of The ETC Group, Interview at 2009 Elevate Festival at 4:32) scoff because nanotechnology is being used in cosmetics as if it’s frivolous. Given the important role sunscreens play in our health these days, a safe sunscreen has to be high on the list of most people’s priorities but this leads to a question.

Should we stop developing more effective nanotechnology-enabled sunscreens (and by extension, other nanotechnology-enabled products) due to concern that we may cause more harm than good?

Andrew goes on to provide some interesting insight into the issue citing the Precautionary Principle and supplementing his comments with some of Richard Jones’ (author of Soft Machines book and blog and consultant to UK government on various nanotechnology topics) suggestions to refine the Precautionary Principle guidelines,

1. what are the benefits that the new technology provides – what are the risks and uncertainties associated with not realising these benefits?

2. what are the risks and uncertainties attached to any current ways we have of realising these benefits using existing technologies?

3. what are the risks and uncertainties of the new technology?

I strongly suggest that anyone interested in the issues around risk, the precautionary principle, emerging technologies, and the role of research read this posting (as well as its predecessors) and as much of the discussion as you can manage.

One additional thought which was posited in the comments section by Hilary Sutcliffe (you’ll need to scroll the comments as I haven’t figured out how to create a direct link to her comment) has to do with the role that companies have with regard to their research and making it available in the discussion about health, safety, and the environment (HSE),

… we need to be able to access ‘the best available information’ in order to make informed decisions in the face of uncertainty and enable the rounded assessment that Prof Richard Jones suggests. This is indeed essential, but ‘we’ are usually constrained by the lack of one very large chunk of ‘available information’ which is the HSE testing the companies themselves have done which leads them to judge the material or product they have developed is safe.

Further in the comment she goes on to discuss a project (What’s fair to share?) that her organization (MATTER) is planning where they want to discuss how companies can share their HSE data without giving away intellectual property and/or competitive advantages.

Finally, I want to paraphrase something I said elsewhere. While I am critical of the tactics used by the Friends of the Earth in this instance, there is no doubt in my mind that the organization and other civil society groups serve a very important role in raising much needed discussion about nanotechnology risks.