Tag Archives: OECD Working Party on Manufactured Nanomaterials

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at Substances@ec.gc.ca.

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

Ecotoxicology and environmental fate of manufactured nanomaterials—testing guidelines from Organization for Economic Cooperation and Development (OECD)

The Organization for Economic Cooperation and Development (OECD) has released guidelines for testing manufactured nanomaterials according to a March 11, 2014 news item on Nanowerk,

As part of its Programme on the Safety of Manufactured Nanomaterials, and in particular work on the testing and assessment of manufactured nanomaterials, OECD initiated a series of expert meetings to improve the applicability of the OECD Test Guidelines to nanomaterials. With this in mind, the Working Party on Manufactured Nanomaterials agreed to address the ecotoxicology and environmental fate of manufactured nanomaterials.

The OECD Expert Meeting on Ecotoxicology and Environmental Fate took place on 29th-31st January 2013 in Berlin, Federal Press Office. The event was hosted by the German delegation and funded by the German Federal Ministry of the Environment, Nature Conservation and Nuclear Safety (BMU) as well as the United States Environment Protection Agency (US EPA).

Three documents were published one of which being a preview,

The OECD expert meeting on ecotoxicology and environmental fate — Towards the development of improved OECD guidelines for the testing of nanomaterials by Dana Kühnel and Carmen Nickel. Science of The Total Environment Volume 472, 15 February 2014, Pages 347–353 http://dx.doi.org/10.1016/j.scitotenv.2013.11.055

This document is open access.

The report itself,

Series on the Safety of Manufactured Nanomaterials. ENV/JM/MONO(2014)1

TEST GUIDELINES Expert Meeting Report
Series on the Safety of Manufactured Nanomaterials No. 40

Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines

There’s an addendum which includes the presentations made at the meeting (you can find both the report, proper, and the addendum on this page scroll to report no. 40),



Series on the Safety of Manufactured Nanomaterials No. 40
Ecotoxicology and Environmental Fate of Manufactured Nanomaterials:
Test Guidelines.

As it can get a little tricky accessing OECD documents, I’ve tried to give a couple different links and as much identifying information as possible. Good luck!

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft


  • Intelligent Transportation Systems


  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards


  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals


  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,


(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada (karen.dodds@ec.gc.ca; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch (hilary.geller@hc-sc.gc.ca; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget (Margaret_A._Malanoski@omb.eop.gov)

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

OECD (Organization for Economic Cooperation and Development) and six years of nanomaterials safety work

Thank to Carla Caprioli (@carlacap)for pointing out this OCED (Organization for Economic Cooperation and Development overview document of their health and safety activities regarding nanomaterials, which was announced on Sept. 13, 2012 according SafeNano,

The Organisation for Economic Co-operation and Development Working Party on Manufactured Nanomaterials (OECD WPMN) has released an announcement regarding “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities“.

As nanomaterials started to be used in commercial applications, OECD launched a programme of work in 2006 to ensure that the approaches for hazard, exposure and risk assessment for manufactured nanomaterials are of a high quality, science-based and internationally harmonised.

Based on this, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials. As with other chemicals, it is clear that each nanomaterial may pose specific challenges, but in most instances, they can be addressed with existing test methods and assessment approaches. In some cases, it might be necessary to adapt methods of sample preparation and dosimetry for safety testing. Similarly, adaptations may be needed for certain Test Guidelines but it will not be necessary to develop completely new approaches for nanomaterials. OECD continues to review all existing methodologies to identify and implement the necessary changes needed for their application to nanomaterials.

The four-page document won’t provide any new information or insights for long time observers but for new observers it does offer a listing of the OECD-published documents on safety and engineered nanomaterials. This excerpt from p. 4 of the document describes the OECD’s future plans,

There is still much to learn before our understanding of the safely [sic] use of manufactured nanomaterials is sufficient. However, the work achieved so far allows a better understanding of remaining “unknowns”. Knowing that the general approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, OECD will now focus on those specific aspects of manufactured nanomaterials, which require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety as well as on developing guidance documents for assessing manufactured nanomaterials adapted to their specifities. This will  include guidance on estimating exposure (including fate and transport) on how to use results on physicochemicals [sic] endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels (defining appropriate exposure metrics). At the same time, as R&D on manufactured nanomaterials/nanotechnologies is increasing, OECD remains vigilant in order to address emerging issues in a timely and resource efficient way.

It’s a good to find compilations either to point you in the right direction for your document or to confirm that you’ve found everything on the subject and on very rare occasions you may realize you found something everyone else missed.

Latest Canadian nano news courtesy of the OECD

The OECD (Organization for Economic Cooperation and Development) has issued another of its reports (CURRENT DEVELOPMENTS/ACTIVITIES ON THE SAFETY OF
MANUFACTURED NANOMATERIALS) in its Series on the Safety of Manufactured Nanomaterials. Published after the Dec. 7 – 9, 2011 Meeting of the Working Party on Manufactured Nanomaterials, the report (aka, Tour de Table) is no. 34 in the series. The delegations were:

  • Australia
  • Austria
  • Canada
  • Czech Republic
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Korea
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • Switzerland
  • Thailand
  • United Kingdom
  • United States
  • European Commission
  • Business and Industry Advisory Committee

As one might expect, I’m focussing on the Canadian response, which starts on p. 24 of the report,

Work completed, underway or planned

1. Any national regulatory developments on human health and environmental safety including recommendations or discussions related to adapting existing regulatory systems or the drafting of laws/ regulations/ guidance materials.

A. In October, 2011, Health Canada published a revised Policy Statement based on stakeholder

feedback, as well as developments in international norms, evolving scientific evidence and regulatory program needs. The Policy Statement on Health Canada’s Working Definition for Nanomaterial (Working Definition) which is available on Health Canada’s website, will continue to be updated as the body of scientific evidence and international norms progress. Health Canada’s responses to stakeholders’ comments and a set of frequently asked questions are also posted on Health Canada’s website.

B. Discussions at the 4th annual meeting of International Cooperation on Cosmetic Regulation (ICCR-4) in Canada on cosmetics and cosmetic-like drug/quasi-drug products led to the formation of a new Joint Industry/Regulator Working Group. Canada is participating in the Joint WG which is a follow up from the previous ICCR Ad Hoc Nano Working Group that developed criteria for identification of nanomaterials within the context of cosmetic regulation. The criteria statement was as follows:

For purposes of the International Cooperation on Cosmetic Regulation, a substance used in a cosmetic is considered a nanomaterial if it is an insoluble ingredient, intentionally manufactured, with one or more dimensions in the realm of 1 to 100 nanometers in the final formulation and is sufficiently stable and persistent in biological media to allow for the potential of interaction with biological systems.

The purpose of the Joint WG is to examine the existing safety approaches for applicability to nanomaterials in use by (or relevant to) activities within the cosmetic industry. The main task of the Joint WG is to carry out a review of the existing safety approaches, and to identify any specific aspects relevant to consumer safety that should be taken into consideration in relation to the use of nanomaterials in cosmetics.

The Joint WG will aim to produce a document that will be aimed at providing guidance and help to those intending to use or assess nanomaterials in a cosmetic product in the form of an expert view on important safety aspects for consideration in an industry or regulatory setting. It is, however, not the intention of the Joint WG to focus exclusively on regulatory (mandatory) safety testing, or to develop any strict pathway or protocol, although it will take a brief account of the current requirements for safety assessment under the existing regulatory frameworks within the ICCR jurisdictions.

2. Developments related to voluntary or stewardship schemes.


3. Information on any Risk Assessment Decisions.

A number of notifications have been received by some regulatory programmes.

• Industrial or commercial chemicals: Since March 2011, an additional five notifications have been received for nano-related assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The Significant New Activity (SNAc) provisions of CEPA 1999 have been applied to these notifications, requiring the submission of additional information and assessment prior to use of the substances at the nanoscale or in other nanoscale applications.

• Pharmaceuticals: A number of nanotechnology based products in the areas of medical devices and drugs are currently under review by Canada, under the current regulations and policies.

• Pesticide applications: Some inquiries have been made, but no notifications have been submitted to date.

• Food related application: Six notifications have been received. Two letters of no objection have been issued; the other four are still under review.

• Others: No notifications with respect to fertilizers, veterinary biologics, or animal feed have been received to date.

4. Information on any Developments Related to Good Practice Documents.

A. The Canadian Standards Association (CSA) Technical Committee on Nanotechnologies –

Occupational Health and Safety has completed a draft national standard (CSA Z12885) to provide guidance for workers, entitled “Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings” This document is largely based on the published international ISO Technical Report, ISO/TR 12885:2008 entitled “Health & Safety Practices in Occupational Settings relevant to Nanotechnologies”. The CSA Z12885 standard has completed the public review process and is proceeding to ballot, with completion anticipated in mid-2012.

B. Government, industry, research, user, and consumer interests are participating as designated experts from Canada on international standards development through the Canadian Advisory Committee to International Organization for Standardization/Technical Committee 229 (ISO/TC229) Nanotechnologies, facilitated by CSA Standards. This includes active participation on terminology, nomenclature, measurement, characterization, material specification and health, safety, environmental aspects of nanotechnologies standards under development.

C. Canada is the lead for the ISO TC 229 Working Group 1 Task Group on Nomenclature. This Task Group includes active representation from the United States, Japan, Germany, France, Australia, and includes regulators, industry, and academia, as well as observers from the Chemical Abstracts Service and the International Union of Pure and Applied Chemistry (IUPAC). The Group is tasked with developing a nomenclature system which meets the needs of regulators, industry, and academia. A liaison between ISO TC 229 and IUPAC has been secured and a subcommittee has been formed to pursue work on developing nomenclature.

5. Research programmes or strategies designed to address human health and/ or environmental safety aspects of nanomaterials.

Scientific research

Health Canada has begun a research project to investigate the toxicity of surface-modified silica nanoparticles. The aim of the project is to investigate the importance of size and surface modification to the toxicity of silica nanoparticles. Silica nanoparticles are being modified to most closely resemble those for which notifications for assessment have been received by the New Substances Program.

Canada has supported multiple research projects under the Strategic Grants Program of the Natural Sciences and Engineering Research Council (NSERC). The nanomaterials used in these projects have included OECD priority nanomaterials such as TiO2, ZnO and Ag. The projects examined fate both in the aqueous and the subsurface compartments and include establishing methodologies for suspension and physical-chemical characterization of the nanomaterials prior to any exposure testing.

A larger Canadian initiative is a multidisciplinary, 3-year collaborative project that brings together: 1) industry and academic/government researchers involved in the engineering and production of new and existing commercial nanomaterials, 2) representatives involved in the current regulatory testing industry that require new, cost-effective, time-sensitive, and efficient testing methods, 3) academic/government researchers who can develop and apply new technologies to the area of safe nanomaterials production and effective ecotoxicology testing, and 4) Canadian regulatory community. The goal of the project is to understand the fate and effects of nanomaterials (including OECD priority materials) in the aquatic environment, with specific themes targeting (1) synthesis; (2) characterization in complex media; (3) methods for biological effects testing; and (4) establishing collaborative dialogue between key stakeholders.

Canada is also currently engaged in both in-house and collaborative research projects involving a range of different nanomaterials (e.g., nanoparticulates of zero-valent iron, gold, silver, TiO2, single walled carbon nanotubes, and C60 fullerenes). Testing includes pulmonary and cardiovascular injury; reproductive, developmental and transgenerational effects; exposure and tissue penetration, interactive effects with microorganisms, immune defenses, and genotoxicity. Alternative tests such as molecular (genomic/proteomic) and cellular in vitro techniques play an important part of the repertoire for such investigations. Other on-going projects include developing bioassays and biomarkers for nanomaterials, harmonizing and standardizing chemical and toxicological assays, toxicogenomics, evaluating fate in aquatic environments understanding the interaction of nanoparticles with microbial cells, soil effects research, and bioaccumulation and toxicity in benthic invertebrates, and ecosystem level effects studies of silver nanoparticles. [emphases mine]

Policy research

Canada participates in the project on Regulatory Framework for Nanotechnology in Food and Medical Products. The project is composed of two independent surveys addressing the same set of questions related to: (1) the regulatory frameworks being used to provide oversight for the use of nanotechnology in food and medical products, (2) the legislative frameworks relevant to these regulatory frameworks, and (3) relevant government-supported research programmes and institutions.

The surveys have been circulated to member countries and responses have been collected.

The information generated by the surveys will be used to populate inventories, and draft a report on areas of shared interest and highlight opportunities for enhancing communication related to regulation and applications of nanotechnology in food and medical products. The report is expected to be completed in 2011/2012.

6. Information on any public/ stakeholder consultations.


7. Information on any developments related to Integrated Testing Strategies and/or Alternative test methods.


8. Information on research programmes or strategies which focus on life cycle aspects of nanomaterials, as well as positive and negative impacts on environment and health of certain nano-enabled applications. (You may wish to contact your colleagues participating in SG9.)

Canada is engaged in a project lead by the International Life Sciences Institute (ILSI) to look at releases of nanomaterials from industrial matrices (e.g., coatings). The purposes of this project are to develop information on different test methodologies and nanomaterials used to study releases from matrices, and to develop standard methodologies (validated through round-robin testing) to quantify releases of nanomaterials from a matrix. At present, the Steering Committee for the project has selected the nanomaterial to be studied (MWCNT) and is requesting input from manufacturers and processors to select the polymeric matrix to be used. Government agencies in the United States, Non-Governmental Organizations and Industry are also engaged in the project. Additional information can be found at http://www.ilsi.org/ResearchFoundation/Pages/NanoRelease1.aspx.

9. Information on any development related to exposure measurement and exposure mitigation


Additional Information


Unless I miss my guess, the three-year multidisciplinary project in Item no. 5, Scientific Research where I’ve highlighted some phrases, is the same or closely related to the project at Trent University which was scheduled to start this year in the Environmental Lakes Area (ELA). The ELA was  mentioned in an earlier post today (June 12, 2012) in the context of Andy Park’s commentary about the Canadian federal budget cuts, the ELA, and ensuing international protest in his June 7, 2012 posting on It’s the Ecology, Stupid! blog.

I don’t see any mention of the project on nanosunscreens described in my June 3, 2011 posting about an international  meeting in Brussels where I highlighted a presentation from a Canadian delegate,

The slides indicate that there will be a case study developed around nanosunscreens. From slides 13 & 14,

Sunscreens are regulated as drugs in Canada, subject to either the Food and Drug Regulations or the Natural Health Product Regulations depending on the active ingredient and claim.

The Sunburn Protectants Monograph outlines active ingredients and their concentrations, as well as appropriate warnings, directions for use, and claims which are generally considered to be safe and effective.

The nanomaterial based sunscreens are excluded from the Sunburn Protectants monograph.

In order to satisfy the Safety & Effectiveness requirements of the Regulations, safety data are being requested.

Also noted in that June 3, 2011 posting about the Canadian presentation,

Awareness Perspective
Develop public engagement and risk communication strategies
Engage industry stakeholders

I gather plans have changed. There won’t be any research into nanosunscreens and there will be no consultations? Or, did the information not make its way across from the team at the spring 2011 international meeting in Brussels to the team at the Dec. 2011 OECD meeting in Paris? In any event, it’s nice to find a little information on what’s happening in the Canadian nanotechnology scene and to see that we are active participants internationally.

Europeans wrangle over nanomaterials definitiion

There seems to have been a bit of kerfuffle in Europe about a nanomaterials definition for Europe at the 4th annual Nano Safety for Success Dialogue; Assessing the science & issues at the science/regulation interface workshop which took place March 29 and 30, 2011. From the April 12, 2011 news item on Nanowerk,

The European Commission’s hesitance to define nanotechnology underscores diverging opinions among stakeholders and is causing uncertainty in the sector.

Participants in a Brussels-based international conference, the Safety for Success Dialogue, discussed the Commission’s ongoing search to revise a draft definition of nano that went out to public consultation last year, but made clear that no answer has yet been found.

Henrik Laursen, coordinator of the nano team in the Commission’s environment department, said the EU executive had received around 200 replies to the consultation.

He said: “It is clear that at a certain level many stakeholders are saying different things, and there is no absolute scientific definition.” He said the Commission would not be rushed into making a decision because, once made, it would not be a working model but would immediately have a significant binding effect.

But Chiara Giovanini, a spokeswoman for ANEC, the European Consumer Voice in Standardisation, noted that the “lack of an agreed definition is creating legal uncertainties for regulatory purposes, and hindering the development of adequate safety test and measurement methods”.

She called on the Commission to adopt the draft definition of nanomaterials contained in the consultation at the end of last year “without further delay”.

Unusually for an item of this nature there’s reference to behind the scenes discussions. From the news item,

The Commission is believed to be attempting to frame a definition before the end of the summer. However, the finer detail of how to define nanomaterials is the subject of fervent [emhasis mine] disagreement between stakeholders behind the scenes.

Wim de Jong, vice-chair of the SCENIHR [Scientific Committee on Emerging and Newly Identified Health Risks], told EurActiv that his organisation had recommended to the Commission that the number of particles, rather than the weight of the particles, be used as a guide for determining the definition.

“This is important because the potential hazards of using these particles relates to the number of them within a particular product,” he said.

But other stakeholders are opposed to using numbers as a guide to defining nanomaterials. For example, the European Chemical Industry Council (Cefic) has recommended to the Commission that weight be used instead.

Cefic’s reply to the Commission consultation reads: “Weight is generally used in all chemical legislation and test procedures and should therefore be used instead of particle number concentration.”

Giovanini’s desire to adopt a draft statement for the purposes of getting something done seems similar to the approach Health Canada has taken with its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials.

Laursen’s comment that a draft statement would not be treated as such but instead would have a “significant binding effect,” certainly accords with my experience of how these things work. At the same time, I sympathize with Giovanini’s position as one can’t wait forever to come to an agreement.

I thought the introductory description for the workshop helped to illuminate why details of a dispute which usually remains somewhat behind closed doors have been made public (from the workshop’s introduction page),

Many market modelers identify nanotechnologies as drivers of economic growth. Consequently, most governments in the industrialized and industrializing world adopted ambitious strategic, research and innovation, plans to ensure the commercial success of nanotechnologies and to harvest their fruits.

Nanoscience and the nanotechnologies are progressing at a rapid pace. The number of potential and real applications is increasing rapidly, even when accounting for those claims relating to marketing rather than added-value.

The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the OECD Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission. Moreover, a number of regulatory developments have taken place, while the science was also advancing. The European Commission is therefore convening this international conference
• to take stock of the fast advancing science needed for appropriate and effective policies; and
• to analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design …

It’s hard to tell if this is a new introduction or one that’s been used for all of the workshops regardless, it does convey a sense of urgency.

Note: I’ve added the OECD (Organization for Economic Cooperation and Development) link in particular as this has been an excellent source of material about the Canadian situation.