Tag Archives: The ETC Group

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.

Green-nano zero valent iron (G-nZVI)

I’m quite interested in patents and their possible impact on nanotechnology innovation so this item caught my attention. VeruTEK Technologies, Inc. just received notice of a patent allowance for the Green-nano zero valent iron (G-nZVI) product which was developed in collaboration with the US Environmental Protection Agency (EPA).

From the June 15, 2011 news item on Nanowerk,

The product is ideal for a broad range of remediation applications including treating produced water (wastewater) generated during oil and gas and other chemical production processes.

G-nZVI works more efficiently than conventional iron catalysts, significantly increasing the rate of oxidant activity and can be used under a wide range of conditions.  Unlike other catalysts which are typically sensitive to changes in pH, G-nZVI consistently delivers high performance over a wide pH range. G-nZVI is highly effective as an activator for VeruTEK’s patent-pending Surfactant-enhanced In Situ Chemical Oxidation (S-ISCO®) treatment of hydrocarbon and chlorinated solvent contamination. The product can also be used with conventional in situ chemical oxidation (ISCO) to improve the effectiveness of traditional remediation chemistry.

The EPA works with VeruTEK on a variety of projects, concentrating on new field-proven approaches to address difficult environmental issues. According to John Leazer, Director of the Sustainable Technology Division at EPA’s National Risk Management Research Laboratory in Cincinnati, “Patent awards are superb examples of what can be accomplished through collaborative research and development.” [emphases mine]

I have previously written about nano zero valent iron (nZVI) and site remediation in my March 30, 2011 posting which concerned a benchmarking study for nZVI and briefly in my March 4, 2010 posting (towards the end) where I summarized a Project on Emerging Nanotechnologies webcast (approximately 54 min.) on the topic.

As I understand it, the process (green or environmentally friendly) by which the nano zero valent iron is derived is the reason the VeruTek product has been awarded a patent and not because its remediation capabilities are superior to other nano zero valent iron products. From the VeruTEK’s G-nZVI product page,

GnZVI is a green synthesized nanoscale zero valent iron catalyst invented by VeruTEK and the US EPA. During the green synthesis process iron salts are exposed to naturally reductive plant material, the resultant nanoscale particles are coated in iron oxide and plant polyphenols which confer advantageous properties.  Research conducted by VeruTEK, the EPA and the University of Connecticut, published in peer reviewed journals, demonstrate the efficacy of the product and its unique chemical design.

So, in addition to being used to remove contamination, this product itself is manufactured in a relatively environmentally friendly fashion. Nice!

Of course, there’s a fair amount of discussion about how patenting impedes innovation. From Mike Masnick’s Feb. 17, 2011 article on Techdirt,

As with any “hot” technology area, it doesn’t take long for a massive, innovation hindering patent thicket to spring up. It effectively makes it impossible to bring anything to market unless you’ve got a huge patent portfolio yourself and deep pockets. Yet another example of patents harming the smaller players in the market. A new report is suggesting that the latest “hot” area to get patent crazy is nanotechnology.

However, the really worrying thing about the report is that it notes that the single largest “patent patron” in nanotechnology… is the federal government. [emphasis mine]

The report, The Big Downturn; Nanogeopolitics, that Masnick is referring to is from The ETC Group who released it on Dec. 17, 2010 so the material in it is relatively recent. They provide the only overview of the nanotechnology patent scene (Chapter 12, p. 43 PDF version and p. 36 print version) that I’ve come across so far. I find the reference to the federal government (US in this case) as being the largest patent patron interesting in light of the EPA’s collaborative relationship with VeruTEK.

One comment before you rush off to read The ETC Group’s report, the tone is very much ‘we are on the side of the angels; capitalists and governments and ‘anyone who disagrees with us in any way’ are not.”

Respectful communication cuts both ways

Yesterday in my Masterly science communication—treating your opponent with respect post, I talked about ‘expert/institutionally authoritative’ groups heaping scorn on their opponents, today I’m going to focus on scorn going in the other direction, i. e., scorn being heaped on experts/institutional authorities. I found an example of this in Slate magazine in a piece by Jim Thomas, from his article, The Sins of Syn Bio: How synthetic biology will bring us cheaper plastics by ruining the poorest nations on Earth,

Here’s a grim prediction to chew on. This biotech craze dubbed “synthetic biology”—where hipster geeks design quirky life-forms: That technology is going to wind up costing lives—likely a lot of them. I’m not suggesting a direct kill by rogue viruses. These will be economic deaths. The dead will not be noteworthy: farmers, pastoralists, and forest dwellers who live in poor nations that depend on plant commodities.

Generally, writers have nothing to do with the  headlines for their articles so I won’t lay that ‘sin’ at the writer’s door (I admit it’s not a great pun). Let’s start with the second sentence where we’re introduced to the “biotech craze” which is synthetic biology, followed by “hipster geeks,” presumably scientists, with “quirky life-forms” close behind, and, finally we’re informed “That technology is going to wind up costing lives,” probably lots of them.

That’s a lot of scorn and derision and it’s followed by a dire prediction of death, all in the same sentence. We’re given a respite of sorts in the next few sentences and then the coup de grâce in the final one. The deaths, we’re told, are not “noteworthy” and, by implication, the “hipster geeks” are condemned as casual murderers.

The writer is a member of The ETC Group, a civil society group, that publishes lot of valuable information and research, unfortunately couched in precisely this fashion. The article is publicizing the Future Tense event that I mentioned in my Mon., Jan. 31, 2011 posting, Can governments keep pace with science and technology? Given the two articles I’ve seen (the first one was by Robert J. Sawyer, a science fiction writer), I imagine discussion will be lively.

There is an argument to be made that groups perceived as less powerful, e.g. civil society organizations such as The ETC Group as opposed to a government agency such as Environment Canada, must provoke the institutions they want to change. This leads me to sometimes wonder if The ETC Group is more moderate/respectful in its ‘behind closed doors’ and/or face-to-face discussions than it is in its publications and articles (the ones I’ve read).

In any event, the scorn goes in both directions and I’m inclined to think that it’s used too freely, i.e. constantly, as a weapon. With regard to the astrology/astronomy discourse mentioned yesterday, it is possible to disagree about astrology’s merits without deriding astrologers. As for the strategy used by The ETC Group (a handy example, there are many others doing precisely the same thing), the discussion is couched in a fashion I find relentlessly rude and, ultimately, tiresome. Too many use this approach with the consequence that many are retreating. I point to Canada’s historically low voter turnouts in the last few elections as proof of the Canadian public’s weariness with the current tone of public discourse. (I believe this phenomenon of low voter turnouts has been observed elsewhere as well and attributed to the same cause.)

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.