Women in Europe for a Common Future Issues Position Paper: Nano the Great Unknown

Women in Europe for a Common Future, (WECF) founded in the Netherlands in 1994, " is a network of 100 member organizations and individual members who share a common concern to promote a healthy environment for all, strengthen the role of women and promote a gender and rights based approach in environment and sustainable development policy and implementation." Recently, WECF issued a position paper, "Nano: The Great Unknown". WECF takes the position that "Neither the industry nor public authorities have shown adequate leadership and willingness in addressing" the possible toxic effects of manufactured nanomaterials (MNMs) on humans and the environment.

After briefly surveying European Union (EU) and non-EU regulatory efforts and finding them all lacking, the WECF calls for applying the precautionary principle and the principle of "no data, no market" for all nanomaterials and products containing nanomaterials.

WECF demands that full information about possible risks of nanoparticles as well as access to information on which products contain nanomaterials should be provided to the public, including developing countries) without delay.

The position paper then presents seven additional demands or "actions" by WECF:

1- "WECF demands that manufactured nanomaterials are treated as totally new substances."

2- " WECF demands the application of "no data, no market" - and in the case of REACH, this is to be independent of tonnage. Registration of nanomaterials under the corresponding bulk chemical should by default be prohibited."

3- "Nanosubstances should be subject to a far reaching health assessment (health, environment)."

4- "WECF asks decision-makers specifically to implement the precautionary principle and introduce producers liability immediately; this will render companies already producing or using nanomaterials accountable for possible damage caused by their products."

5- "Immediate compulsory labelling of all products containing nanomaterials."

6- "Citizens must be informed and involved in decision making . . . .WECF demands a wide-ranging citizens dialogue on the risks and benefits of the new technology. The decision making procedures have to become more democratic and need to be adapted to cover dynamic technological revolutions such as nanotechnology."

7- "All products for children and pregnant women must be MNM-free until it is proven that they present no health risks to those specific groups of consumers. WECf considers the sale of products without adequate risk research as absolutely irresponsible."

While the position paper does raise legitimate issues that have been raised by other groups, legislatures and interested parties, such as providing information on product labels indicating if the product does contain nanomaterials, other issues, such as the demand for public debates, are more problematic. It should be recalled that such debates were tried in France in 2010 (and discussed here), debates which ended in chaos.  The potential exists for such public forums to become the territory of demagogues. Other demands, such as "Immediate, compulsory labelling", show that WECF has no understanding of the regulatory process.

While the position paper may hold the spotlight for a short time, it probably won't have much of an impact on the EU's regulatory bodies.

Guide to Responsible Nano-Business

ObservatoryNANO recently published a "Guide to Responsible Nano-Business", a brief report written for an audience of "Medium sized companies involved in the development, processing, production, or trade of nanotechnology-enabled materials, components, or applications".

ObservatoryNANO was created and funded by the then extant European Community (EC), the predecessor of today'sEuropean Union (EU),  “to create a European Observatory on Nanotechnologies to present reliable, complete and responsible science-based and economic expert analysis, across different technology sectors, establish dialogue with decision makers and others regarding the benefits and opportunities, balanced against barriers and risks, and allow them to take action to ensure that scientific and technological developments are realized as socio-economic benefits.”

The Guide sets out and briefly discusses four "tools to identify and manage nanotechnology-related priorities":

Tool 1: Set priorities, focusing on the process of framing responsibility measures

Tool 2: Check and complement established internal guidelines and code of conduct

Tool 3: Focus actions, described in the guide as the "strategies and programmes [needed] to be put in place to assure that a guideline is of any practicle use".

Tool 4: Inform transparently, focusing on what to communicate (content), how to communicate to employees of the company, customers and/or the general public, and the choice of communication media, ranging from company websites to product labels.

The Guide has links to "Good Practice Examples", such as BASF's Code of Conduct and to sites where more information can be found.

While the Guide to Responsible Nano-Business is not on the same level as "Guide for the Perplexed" by Moses Maimonides, it is a good short and clearly written work that the owners and managers of nano-businesses would find useful in formulating policies for the workplace and for communicating with the general public.

Joint US-EU Workshop: Bridging NanoEHS Research Efforts

In the Federal Register for February 15, 2011, the National Nanotechnology Coordination Office announced it would hold a workshop on March 10 & 11 2011

to provide an open forum and engage in an active scientific discussion
about environmental health and safety questions for nanomaterials and
nanotechnology-enabled products, to encourage joint US-EU programs of
work that would leverage resources, and to establish communities of
research practice, including identification of key points of contact/
interest groups/themes between key US and EU researchers for near-term
and future collaborations.

The March 10, 2011 sessions, to be held at George Washington University Elliott School of International Affairs, is divided into two parts. Part 1, "Understanding Perspectives and Programs", will focus on an overview of EU and US EHS research plans and the different perspectives both bring to their research efforts. Part 2, "Data Needs for Regulatory Decision Making", focuses on

1 - Human health data

2- Environment data needed to make informed regarding regulations, particularly the regulation of nanoindustries.

The March 11, 2011 sessions will be held at the American Association for the Advancement of Science (AAAS). The first part of this days sessions focuses on "Tackling the Challenges of Producing Reliable and Reproducible data for nanoparticles assessment and risk management", while the final session, "Getting it done together", will look at establishing mechanisms for EU and US regulatory agencies to work together in the future.

Pre-registration is required and can be done at www.nano.gov . Registration closes at 4PM on March 9, 2011. Anyone interested in presenting short comments (3-5 minutes) also needs to register at www.nano.gov.

European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes

The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.

European "Framing Nano" Report

Things have been mostly quiet in the United States on nanotechnology regulatory developments lately.  There have been some items, but not much.  So, we look across to Europe to see what they are up to.  A new report adds more perspective to the nano-regulatory question.  The Swiss based Innovation Society recently released its report: "FramingNano Mapping Study on Regulation and Governance of Nanotechnology."  The Innovation Society is part of the European project on nano-regulation: Framing Nano.

The 138-page report takes a look at nanotechnology regulatory actions worldwide, including European, North American, and Asian efforts.  The report looks to the voluntary and regulatory efforts in individual countries (or the EU as appropriate), and particularly focuses on Environmental Health and Safety (EHS) and Ethical, Legal and Societal Issues (ELSI).  It notes, "There is a general agreement among these stakeholders on the principal problems facing nanoregulation and their priorities.  In particular:

  • The major source of concern regarding potential risks of nanotechnology are, at the moment, “free” manufactured nanomaterials
  • There is an urgent need to develop, at least for some specific nanomaterials, new approaches and methods for their risk assessment and to improve the knowledge base on their characteristics and behaviour
  • There is a need for an international approach to the management of nanomaterials risks, with a particular emphasis on the development of harmonised standards and guidance, and on an effective engagement of all stakeholders."

The report ultimately states that it "nanoregulation must be regarded as a dynamic affair which must adapt to the evolution of the scientific knowledge and applications and public attitude. A continuous updating must be part of the governance of nanotechnology." 

The Framing Nano project is ultimately workings towards proposing a governance plan for regulating nanotechnology at the EU level.

The report's stated goal is to "provide a picture of recent developments regarding regulation and governance of [nanoscience and technology] in Europe and worldwide, to identify relevant NS&T stakeholder organisations and to make an assessment of this information to prepare the ground for the following phases of the FramingNano project, i.e. the consultative process among stakeholders and the definition of a Governance Plan for the responsible development of NS&T."  Clearly, in order to know where nanoregulation is heading, we need to know what different governments are doing in this arena.  This is just one step towards the overall "Governance Plan" that, while aimed at the EU may very well be applicable in the United States and other countries working with nanotechnology as well.

More from Europe and REACH

Last week we told you about the just-opened REACH pre-registrations here.  Now, the news from across the pond tells us that carbon and graphite are to be specifically included in the REACH submissions.

While the EU's instruction impacts all forms of carbon and graphite, it is particularly pointed at carbon nanotubes which have recently been linked to asbestos-like impacts.  We previously discussed this concern here.

Consequently, manufacturers and importers of carbon products, including carbon nanotubes will have to submit full health and safety data in order to comply with REACH.  Remember, though, that the data does not have to submitted for a year or so.

Once REACH gets rolling, however, we can expect to see more data, and possibly more detailed data concerning the health impacts and concerns associated with nanotubes.

No Nano Regs in the EU?

Rumors from "across the pond" indicate that a forthcoming official recommendation to the European Union will be that nano-specific regulations are not needed in the EU.

The information is coming from EurActive (via Nanowerk because the EurActive website is down as of this posting), and it is citing a European Commission official who stated a document to be published this Spring will argue that current EU laws and regulation sufficiently cover nanotechnology and nanomaterials.

The European Food Safety Authority is expected to release a study  on risk assessment and nanotechnology issues, but there are no indications as to what that report may reveal at this stage.  It is also unclear if this is the report that EurActive is referring to.

I think its too early in the process to try and predict what the official recommendations to the Commission will be.  And, even then, the Commission will be free to take or leave the recommendation as it sees fit.  Just because the recommendation is to not enact new legislation or regulation, doesn't mean new legislation won't be forthcoming.  But, it looks like a report is imminent, which will shed some light on this rumor.  Stay tuned.