Tag Archives: precautionary principle

Council of Europe makes some suggestions about regulating nanotechnology

There was a rather confusing Apr. 27, 2013 news item on Nanotechnology Now about nanotechnology regulation,

As an established vanguard for law governing the right to health, public health and consumer protection throughout Europe, the Council of Europe [CoE] and its human rights court has remained a leading model for jurisprudence throughout the world. Its 47 (forty seven) Member nations embrace 800 million people, including Switzerland. CoE efforts in consumer protection and environmental health exemplify the concept that protection and promotion of the health and welfare of its citizens is considered to be one of the most important functions of the modern state”. CoE legal instruments frequently are the basis of juridical determinations in the Court of Human rights and serve as influential models for the entire world.

The report outlines essential European legal concepts for public discourse concerning nanotechnology safety and the regulation of nanotechnology in commerce: First, the report offers an overview of the legal landscape in nanotechnology regulation confronting everyone: bioethics issues, impact on human and non-human health, environmental impact and the promise of nanomedicine for improving everyone’s quality of life. [emphasis mine] Second, the report helps to chart a path regarding possible treaties or international agreements governing the use and monitoring of nanotechnology.

What has me confused is that the Council of Europe has no real regulatory powers according to its Wikipedia essay (Note: Links have been removed),

The Council of Europe is an international organization promoting co-operation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation. It was founded in 1949, has 47 member states with some 800 million citizens, and is an entirely separate body[1] from the European Union (EU), which has only 27 member states. Unlike the EU, the Council of Europe cannot make binding laws. [emphasis mine] The two do however share certain symbols such as the flag and the anthem.

Additionally, since there have been a number of reports and dialogue/public engagement exercises produced by the European Union, the newest report and a debate which took place on Apr. 26, 2013 in Strasbourg, France at the Council of Europe Parliamentary Assembly seem unnecessary.

Ilise L Feitshans who authored the 16 pp. report (Nanotechnology: balancing benefits and risks to public health and the environment) had this to say in her Apr. 24, 2013 posting on Yahoo about her report,

PRESS ADVISORY: COUNCIL OF EUROPE  PARLIAMENTARY ASSEMBLY SEEKS PRECAUTIONARY
PRINCIPLES FOR NANOTECHNOLOGY  LAWS April 26 2013
Contact:  forecastingnanolaw@…  …

In 2012, the Council of Europe  (CoE) Parliamentary Assembly began the first steps towards nanotechnology regulation with a view to respecting the scientific precautionary principles.  It commissioned an expert report, “Nanotechnology: balancing benefits and risks to public health and the environment”, enthusiastically accepted at the CoE meeting of the Committee on Social Affairs, Health and Sustainable Development in November 2012. That same report is slated for public debate before the entire Council of Europe Parliamentary Assembly in Strasbourg France, April 26, 2013.

This is a draft/provisional version of the recommendation accepted by the Council of Europe Parliamentary Assembly (you can find a summary here),

Recommendation 2017 (2013)1

Provisional version

Nanotechnology: balancing benefits and risks to public health and the environment
Parliamentary Assembly

1. Nanotechnology is the manipulation of matter on an atomic and molecular scale. Nanomaterials involve structures having dimensions of nanometres (nm), th at is one billionth (or 10-9) of a metre, typically between 1 and 100 nanometres in size. At such dimensions, materials can show significantly different physical, biological and/or chemical properties from materials at bigger dimensions, which opens up a range of new possibilities for technology.
2. Nanotechnology and its myriad applications have the potential for enormous benefits (in particular in the field of “nanomedicine”), but also for serious harm. As with most emerging technologies, many risks, both to public health and to the environment, are as yet poorly understood. However, commercial applications of nanotechnology are already in widespread use. Regulations have struggled to keep up with the pace of
scientific innovation.
3. For years, the Parliamentary Assembly and the Committee of Ministers of
the Council of Europe have been advocating the need for a culture of precaution inco rporating the precautionary principle into scientific and technological processes, with due regard for freedom of research and innovation. In 2005, the Heads of State and Government of the Council of Europe gave undertakings in the Final Declaration of the 3rd Summit of the Council of Europe “to ensure security for our citizens in the full respect of human rights and fundamental freedoms” and to meet, in this context, “the challenges attendant on scientific and technical progress”.
4. The Assembly believes that, in keeping with these undertakings, the Council of Europe, as the only pan-European body with a human rights protection mandate, should set legal
standards on nanotechnology based on scientific knowledge and the precautionary principle, which will protect 800 million Europeans from risk of serious harm, while encouraging nanotechnology’s potential beneficial use.
5. The Assembly thus recommends that the Committee of Ministers work out guidelines on balancing benefits and risks to public health and the environment in the field of nanotechnology which:

5.1. respect the precautionary principle while taking into account freedom of research and
encouraging innovation;
5.2. allow for consistent application across borders, across the origins of nanomaterials (synthetic, natural, accidental, manufactured, engineered) and across the functional uses and biological fate of the nanomaterials under regulation;
5.3. seek to harmonise regulatory frameworks, including of risk assessment and risk management methods, protection of researchers and workers in the nanotech industry, consumer and patient protection and education (including labelling requirements taking into account informed consent imperatives), as well as of reporting and registration requirements, in order to lay down a common standard;
5.4. are negotiated in an open and transparent process, involving multiple stakeholders (national governments, international organisations, the Parliamentary Assembly, civil society, experts and scientists) in the framework of a dialogue which transcends the Council of Europe area;
5.5. can be used as a model for regulatory standards worldwide;
5.6. could first take the form of a Committee of Ministers recommendation, but could also be transformed into a binding legal instrument if the majority of member States so wish, for example in the form of an additional protocol to the 1997 Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164, “Oviedo Convention”); [emphasis mine]
5.7. aspire to create an international interdisciplinary centre to be the world’s knowledge base in the field of nanosafety in the near future, without prejudice to the continued support, even in financial terms, to ongoing research projects aimed at determining potential risks of nanomaterials;
5.8. will be able to promote the development of an assessment system
of ethical rules, advertising materials and consumer expectations, regarding research projects and consumer products in thenanotechnology field impacting on human beings and the environment.

6. The Assembly recommends that the Council of Europe’s Committee on Bioethics (DH-BIO) be entrusted with a feasibility study on the elaboration of possible standards in this area, based on paragraph 5 of the present recommendation, as a first step in the start of negotiations on the topic with a multiple stakeholder approach. This study should include, in any case, ongoing scientific research at international level to learn about the risks of nanotechnological material. Thus, the scientific community will be actively involved in the drafting of any proposal of standardisation and/or legislation.

1Assembly debate on 26 April 2013 (18th Sitting) (see Doc. 13117, report of the Committee on Social Affairs, Health and Sustainable Development, rapporteur: Mr Sudarenkov). Text adopted by the Assembly on 26 April 2013 (18th Sitting). [emphasis mine]

The whole thing has me somewhat puzzled since the Council of  Europe cannot enact ‘binding laws’ and they are somewhat late to the ‘nanotechnology regulation’ party, which has been taking place for years by various constituencies such as the US, Britain, France, Germany, Australia, Canada, the OECD (Organization for Economic Cooperation and Development), ISO (International Standards Organization) and the European Union among others. (Please accept my apologies for not mentioning more regions and linguistic groups but my language skills don’t allow me to scan for as much information as I’d like.)

This particular move by the Council of Europe seems to be of a redundant redundancy (I have borrowed this term from one of my favourite science fiction authors, Lois McMaster Bujold). But perhaps there’s someone out there who can explain why more regulatory standards from the Council of Europe are needed.

Women in Europe for a Common Future advises precautionary principle for manufacture nanomaterials

Another organization advises the precautionary principle when dealing with nanomaterials. This time it’s the Women in Europe for a Common Future (WECF) organization and they’ve just released a position paper. From the March 30, 2012 news item on Nanowerk,

Women in Europe for a Common Future, an international network of over 100 women’s, environmental and health organisations implementing projects in 40 countries and advocating globally for a healthy environment, has released a position paper on nanoparticles and nanotechnology: Nano – The great unknown (pdf).

WECF recognizes that nanotechnologies could bring long-term profits and overall societal benefits. However, in order to make an overall judgment, data is needed regarding the hazards, exposure, risks and ethical consequences for humans, the environment and our society as a whole.

Maybe I’m getting grumpy these days but It seems to me that the time for describing ‘nanotechnology as the latest buzzword’ has passed. Here’s the opening sentence from the position paper,

Nanotechnology, the latest buzzword in the global technology revolution, is the science of ‘small things’: the de­signing, manipulating and engineer­ing of materials at nanoscale. (p. 1)

Also on page 1 is a claim as to the number of nanotechnology-enabled products on the market,

The number of consumer products on the world market claiming to contain nanomaterials exceeded 1300 already by 2010, and there are probably more, as the actual presence of nanomaterials is dif­ficult to identify.

The source for the number of nano products is not cited although WECF does list the Project for Emerging Nanotechnologies (PEN) and its product inventory in the bibliography. PEN’s inventory has no oversight (PEN has always been quite frank about this); anyone can register a product and claim there are nanomaterials in it.

Further in the position paper, Canada and California are mentioned,

Other regulatory entities too are work­ing on developing the first laws that can address the concerns on nanomaterials. Canada and the state of California, for example, took the step of imposing mandated disclosure requirements on nanomaterial use and toxicity assess­ment. Canada’s law of January 2009 targets domestic companies and institu­tions that manufacture or buy more than 1 kilogram of nanomaterial per year. According to these new regulations, these entities must now reveal how much nanomaterial they use, how they use it, and what they know about its toxicity. (p. 3)

I’m not familiar enough with the situation in California to comment on it but I am somewhat puzzled by the description of a Canadian law targeting domestic companies and institutions that manufacture or buy more than 1 kilogram of nanomaterials per year. There was a one time only requirement to report on how much nanomaterial was being imported into Canada but, as far as I’m aware, there is no law or regulation which states that this must be done on an ongoing basis. (You can read more about the reporting scheme in my April 12, 2010 posting.) This statement was not cited and I can’t find anything in the bibliography that might be the source for this information.

My problem with this position paper is that I can’t trust any of the information because the little I am familiar with contradicts their statements and they don’t support those statements with sources that I can research.

Precautionary principle and the new Swiss synthetic nanomaterial matrix

The precautionary principle appears to be much loved by civil society groups such the ETC Group and Friends of the Earth. They tend to cite it with some frequency as a means of managing scientific research or, as some might suggest, as a means of stopping research. I have to admit I’ve tended to view the precautionary principle as a way of saying ‘don’t do anything unless you can prove it’s safe’, and that is a gross misunderstanding of the principle. The recent announcement from Switzerland about developing a precautionary matrix for synthetic nanomaterials had me revisiting my ideas.

I found this description of the principle in a July 18, 2010 posting about nanosunscreens by Andrew Mayanard on his 2020 Science blog,

The Precautionary Principle is one approach – and a very misunderstood and misused one – to addressing this [risk and uncertainty], and one brought up by FoE and others in the context of sunscreens.  It has many formulations – it’s not a hard and fast principle.  But it is currently described in the European Union in this way:

The precautionary principle should be informed by three specific principles:

  • implementation of the principle should be based on the fullest possible scientific evaluation. As far as possible this evaluation should determine the degree of scientific uncertainty at each stage;
  • any decision to act or not to act pursuant to the precautionary principle must be preceded by a risk evaluation and an evaluation of the potential consequences of inaction;
  • once the results of the scientific evaluation and/or the risk evaluation are available, all the interested parties must be given the opportunity to study of the various options available, while ensuring the greatest possible transparency.

This is a pragmatic principle that looks to using evidence and an evaluation of consequences in making informed decisions in the face of uncertainty.  It certainly does not preclude the development or implementation of a new technology until there is certainty on safety.

The emphasis on the potential consequences of inaction are particularly relevant to today’s world, where we are stuck on a technological tight-rope, and where the consequences of not doing something may be more harmful than taking action. [emphasis mine]  Richard Jones [author Soft Machines and a Professor of Physics and the Pro-Vice Chancellor for Research and Innovation at the University of Sheffield] picked up on this in his suggestion for a more relevant application of the Precautionary Principle to emerging technologies:

  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?

This seems a useful place to start from when faced with the reality of having to make the best possible decisions in the face of uncertainty, and where inaction isn’t an option.

But to make decisions – even when there are gaping holes in the data – you need something to go on.

The new Swiss matrix helps to further flesh out the precautionary principle (from the July 29,2011 news item on Nanowerk),

The precautionary matrix provides a structured method to assess the “nanospecific precautionary need” of workers, consumers and the environment arising from the production and use of synthetic nanomaterials.

The matrix is a tool to help trade and industry meet their obligations of care and self-monitoring. It helps them to recognise applications which may entail risk and to take precautionary measures to protect human health and the environment. In the case of new developments, the matrix can contribute to the development of safer products. It enables users to conduct an initial analysis on the basis of currently available knowledge and indicates when further investigations are necessary.

The matrix can be found on this page of the Swiss Federal Office of Public Health (scroll to the right of the page for the guidelines, matrix, FAQs, etc.).

One question keeps popping up. The phrase ‘consequences of inaction’ has me asking how do we define inaction? My suspicion is that a research nanoscientist and a representative from a civil society organization may have two very different answers to that question, i.e., ‘we must continue with the research to solve the problem’ as opposed to ‘we must stop the actions that caused the problem in the first place’.

Peter Julian’s interview about proposing Canada’s first nanotechnology legislation (part 2 of 3); more on the UK Nanotechnologies Strategy; Dylan Thomas, neuroscience and an open reading

This is part 2 of an interview with Member of Parliament, Peter Julian, NDP (New Democrat Party) who tabled the first Canadian bill to regulate nanotechnology. Yesterday’s part of the interview featured some biographical notes about Mr. Julian and his answers to questions about why he, in particular, tabled the bill; the NDP’s shadow science minister’s (Jim Malloway) involvement; and the NDP’s commitment to science policy. Today, Julian explains why he favours the application of the precautionary principle to nanotechnology, notes the research he used before writing his bill, and comments on a national inventory scheme. NOTE: As some folks may prefer other media or summaries/commentaries on these reports, in situations where I have additional material, I’ve taken the liberty of giving links, clearly marking my additions.

Why do you favour applying the precautionary principle which has received some criticism as it favours the status quo?

I believe that the precautionary principle does not favour the status quo. The status quo hinders appropriate applications of precaution. Environmental, health, and safety gaps in the application of Nanotechnology are a shared concern between countries, as reflected in recent reports to Congress and the EU and at the OECD. Precaution towards discovery, product, production, use and eventual disposal is simple common sense.

The precautionary principle deters action without reflection. When a product is massively put on the market we have to be sure that it will not have adverse effects on health and the environment, and not just a short lived positive effect on the bottom line.

What research materials support your (BILL) and are these materials that you would recommend interested citizens read?

I have a list of links concerning these materials:

ED. NOTE:  I offered some commentary here and links to other commentaries here about this report.

  • The Chatham House briefing paper, Regulating Nanomaterials: A Transatlantic Agenda (September 2009) an excellent eight page read:

http://www.chathamhouse.org.uk/publications/papers/view/-/id/774/

ED. NOTE: There is a Project on Emerging Nanotechnologies (PEN)webcast of a presentation by the folks who authored the report. The webcast and speaker presentations can be found here and my commentary on the webcast here.

ED. NOTE: PEN webcast a presentation by J. Clarence Davies on Oversight of Next Generation Nanotechnology available here along with a speaker’s presentation and additional materials.

  • The National Nanotechnology Initiative document lays out a substantive, and sound, research program. Canada’s strategy remains limited in scope and vision.

http://www.nano.gov/NNI_EHS_Research_Strategy.pdf

I noticed mention of a public inventory for nanomaterials and it reminded me of a proposed Environment Canada nanomaterials inventory or reporting plan that was announced in January 2008. Do you know if this inventory ever took place or what its current status is?

The inventory is not completed yet. The bill develops a mandatory requirement for an inventory and there have been no prior operational inventories regarding nanotechnology products, which is why this bill is so important.

I would like to stress that in addition to the precautionary principle, Bill C-494 is built on a definition of Nanotechnology that adopts a broader and more inclusive definition of nanomaterials. This is consistent with the findings of the UK House of Lords Science and Technology Committee:

  • We recommend that the Government should work towards ensuring that any regulatory definition of nanomaterials proposed at a European level, in particular in the Novel Foods Regulation, should not include a size limit of 100nm but instead refer to ‘the nanoscale’ to ensure that all materials with a dimension under 1000nm are considered.A change in functionality, meaning how a substance interacts with the body, should be the factor that distinguishes a nanomaterial from its larger form within the nanoscale.

UK House of Lords Science and Technology Committee
Nanotechnologies and Food (8 January 2010)
Recommendation 12, p.76

http://www.publications.parliament.uk/pa/ld/ldsctech.htm

This is in contrast with Health Canada policy which looks at narrow definition of nanomaterials:

  • Health Canada’s Science Policy Directorate announced the adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials and its posting on the Health Canada website 2 March 2010. This Government of Canada policy adopts a 1-100nm “inclusive” regulatory benchmark, effective immediately, with a public comment period underway.

http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/index-eng.php

ED. NOTE: I made an error in my question, the proposed nano inventory by Environment Canada was announced in Jan. 2009. My postings on the announcement are here and here. The odd thing about the announcement was that it was made initially by PEN which is located in Washington, DC and subsequently picked up by Canadian news media. As far as I know, Environment Canada has never offered comment about its 2009 plan for a nanotechnology inventory.

Tomorrow Julian wraps up with answers to questions about why someone who’s shadow portfolio includes international trade is interested in nanotechnology and the potential costs for his proposed legislation.

Peter Julian interview Part 1, Part 3, Comments: Nano Ontario, Comments: nanoAlberta

More on the UK 2010 Nanotechnologies Strategy Report

Dexter Johnson over on Nanoclast has done some detective work in a bid to understand why the market numbers used in the report differ wildly from anyone else’s. From Dexter’s posting,

It [the report] quotes market numbers for nano-enabled products that are such a drastic departure from most estimates that it leaves one questioning why tens of billions of dollars are being poured in by governments around the world to fund research.

If you have it, do take the time to follow along as Dexter  trails the company that the UK government used as its source for their market numbers. Amongst other names, I recognized one, ObservatoryNANO. (It was an organization I followed briefly and dismissed as being frivolous.)

One other commenter has emerged, Tim Harper. Now as the  principle of a nanotechnology business consulting company (Cientifica) some might be inclined to dismiss his comments but they have the ring of honest frustration and a sincere desire to contribute. From Harper’s posting,

Every UK nanotech report to date has excluded any data provided by UK companies. Even offers of free copies of our market research to government committees looking into various bits of nanotechnology provoke the same response as if we’d offered them a fresh dog turd wrapped in newspaper.

And now for a complete change of pace,

Dylan Thomas and neuroscience

There‘s an event tonight  (Thursday, March 25, 2010) in Vancouver being put on by the Dylan Thomas Circle (he lived in North Vancouver for a time as he worked on Under the volcano). It’s being held at the Red Dragon Pub at the Cambrian Hall on 17th & Main St.  Doors open at 6:45 pm and the presentation starts at 7:30 pm followed by an open reading. From the news release,

THE DYLAN THOMAS CIRCLE OF VANCOUVER presents

“Dylan Thomas, Creativity and Neuroscience”

Ariadne Sawyer will lead an exploration into creativity and the creative process as manifest through the works and the life of Dylan Thomas. She will investigate why we are creative, what happens during the creative process and what effect it has upon us.

This will be followed by an intermission and an: ‘OPEN READING’: an invitation to everyone who is interested to read aloud a poem or literary excerpt of their choice. This can be your own work, Dylan’s work or any other writer’s material. Most importantly, it is our chance to indulge in a little of our own creativity and to do it in a relaxed and in a friendly atmosphere.

About Ariadne Sawyer:

Ariadne has done on line Performance Plus Coaching with trainees from England, France, Canada and the United States for the last two years. She has received the Award of Excellence given by McLean-Hunter for the Brain Bulletin Series. Ariadne publishes an electronic newsletter called: Ariadne’s Performance Plus Newsletter along with Performance Plus Tips which are sent to all the participating trainees. She also co-hosts a weekly radio program on CFRO 102.7 FM, which has been on the air for the past two years. The Performance Plus Mini Course has been presented on the show with astounding success. She has two electronic courses available soon on the Internet. Performance Plus Level One and the Performance Plus Diplomacy Course. Ariadne has worked with trainees from Europe, the US and across Canada.

The precautionary principle and a bit about the ‘culture wars’

I was sick for a while there but now I’m back. The article I’ve been talking about is “Risk Management Principles for Nanotechnology” by Gary E. Marchant, Douglas J. Sylvester and Kenneth W. Abbott. The precautionary principle according to the article ‘is often summarized by the phrase ‘better safe than sorry’.” In other words, if there’s a possibility that something bad will happen, don’t do it. As you might expect this seems like a problematic principle to implement. Do you sit around imagining disaster scenarios or do you tell yourself everything will be fine? How do you determine the level of possible risk?

One of the reasons I was so interested in the event that the Project on Emerging Nanotechnologies had organized with L’Oreal (cosmetics firm) was that the company representative would be discussing how they were implementing the precautionary principle when developing and selling their nanotechnology-based cosmetics. Unfortunately, that event has yet to be rescheduled.

The subject of risk is quite topical right now due to an article from the folks at Yale Law School’s Cognition Project (in cooperation with the Project on Emerging Nanotechnologies) that’s just been published in Nature Nanotechnology and which apparently predicts ‘culture wars’. (I read an earlier version of the work online and cited it in a presentation for the 2008 Cascadia Nanotechnology Symposium.) The major thrust of the work at Yale was that people will consider the benefits and risks of an emerging technology (in this case, nanotechnology) according to their cultural values. They used anthropologist Mary Douglas’s two cross-cutting dimensions of culture to explain what they mean by culture. On one axis you have hierarchy/egalitarianism and on the other axis you have individualism/egalitarianism. One of the findings in the paper is that it doesn’t matter how much information you receive (this relates to the notion of science literacy where if you educate people about the technology they will come to accept it and its attendant risks) since your opinion of the technology is more strongly influenced by your cultural values as they are measured on those two axes. I think at least some of this work is a response to the city of Berkeley’s law regulating nanotechnology research. The legislation was passed unusually quickly and, I believe, it was the first such legislation in the US.

Concurrently published in Nature Nanotechnology with the ‘culture wars’ article is an article by Dietram Scheufele where he discusses how ‘religion’ or ‘values’ have an impact on attitudes towards nanotechnology. I think this article is based on some of the material he presented last year at the 2007 American Association for the Advancement of Science annual meeting.

Obama nano and nano risks in cosmetics

Take a look at the image of US president-elect Barack Obama that’s been made out of carbon nanotubes. It’s called Nanobama and it’s here.

Today BBC News had an article about warnings from a consumer safety watchdog group, Which? (formerly known as the Consumers’ Association). They wrote to 67 cosmetics companies asking them about their use of nanotechnology. 17 companies responded and eight of them provided specific information about how they use nanotechnology in their products. The eight companies included: Avon, L’Oreal, The Body Shop, Nivea, Unilever, and others. After examining the information, Which? has advised that nanocosmetic products should have an independent safety assessment.

There has been an attempt at voluntary reporting of engineered nanomaterials. It was instituted by the UK government in the fall of 2006. To date, they’ve had 12 responses and the voluntary programme is under review. I get the feeling that government regulation may be a reality in the not too distant future. Anyway, it’s a good introductory article about cosmetics, the precautionary principle, and nanotechnology and it’s located here.

In fact, the article reminded me of an event with L’Oreal that the Project for Emerging Nanotechnologies (PEN) had to postpone a few months ago. It was called, Small is Beautiful–A European View of Nanotech Cosmetics and Safety and it was to feature a speaker from L’Oreal and PEN’s science advisor, Andrew Maynard. I hope they find a way to reschedule it soon.