Tag Archives: 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 [email protected]

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

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.

OECD (Organization for Economic Cooperation and Development) makes recommendation regarding regulatory frameworks for nanomaterials.

A Sept. 26, 2013 news item on Nanowerk announces the latest OECD (Organization for Economic Cooperation and Development) recommendations on nanomaterial safety,

The OECD has recommended its Member Countries apply existing international and national chemical regulatory frameworks to manage the risks associated with manufactured nanomaterials.

The Sept. 20, 2013 OECD news release, which originated the news item, provides more details,

The Recommendation, approved by the Organisation’s governing Council, noted that these frameworks and other management systems may need to be adapted to take into account the specific properties of manufactured nanomaterials.

Manufactured nanomaterials are chemical particles that exhibit new characteristics in contrast to the same material without nanoscale features. These novel features offer possibilities for new commercial applications, such as solar cells using silicon nanocrystals to achieve higher efficiency. They also raise questions regarding potential unintended risks to humans and the environment. For example, new manufactured nanomaterials have applications in sunscreens and cosmetics, and so the potential risk from their exposure to consumers needs to be carefully assessed and managed.

The OECD has been working since 2006 to develop approaches for risk assessment for manufactured materials that are of high quality, science-based and internationally harmonised.

The Recommendation notes the importance of the OECD Test Guidelines for the Safety Testing of Chemicals, concluding that many of the existing guidelines are also suitable for the safety assessment of nanomaterials. At the same time, it recognises that some guidelines may need to be adapted to take into account the specific properties of nanomaterials. Work continues at OECD to achieve that.

An important consequence of this Recommendation is that much of the data collected as part of the safety assessment of nanomaterials will fall within the scope of the OECD system for the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals. The OECD Mutual Acceptance of Data system is a multilateral agreement which saves governments and chemical producers around €150 million every year by allowing the results of a variety of non-clinical safety tests done on chemicals and chemical products, such as industrial chemicals and pesticides – and now nanomaterials – to be shared across OECD and other countries that adhere to the system.  Argentina, Brazil, India, Malaysia, Singapore, South Africa as well as all OECD countries are full adherents to the MAD system, and Thailand is a provisional adherent.

The extension of the scope of MAD to nanomaterials will considerably reduce the potential for non-tariff trade barriers between countries when marketing manufactured nanomaterials or products which include nanomaterials as well as allow for sharing the workload between countries in testing and assessing all the nanomaterials which are on the market. There will be a review of the Recommendation in three years to assess how it has been implemented in OECD countries and those partner countries which have adhered to it.

I find it odd the Working Party on Nanomaterialsis (or the Working Party on Manufacture Nanomaterials as it sometimes called) is not mentioned. This recommendation seems to have  arisen from the  Council on the Safety Testing and Assessment of Manufactured Nanomaterials. Canada is a member of the OECD and of its Working Party on Nanomaterials. I don’t know where we stand if anywhere on the Council on the Safety Testing and Assessment of Manufactured Nanomaterials. Perhaps I can check later when I have time.

NanoValid invites you to a Sept. 2013 workshop on the Advanced Characterization of Nanomaterial

I received (Aug. 5, 2013) an announcement, which I’m passing on here, about a workshop taking place in Spain this coming September (2013),

The EC-funded NanoValid Project (www.nanovalid.eu) invites you to register for the last remaining places at the “Advanced Characterization of Nanomaterials” workshop organised by the University of Zaragoza and the Institute of Nanoscience of Aragon (INA).

When: September 16th – 20th 2013

Where: University of Zaragoza, Institute of Nanoscience of Aragon

BACKGROUND:

The characterization of nanomaterials is a challenging topic that requires in-depth knowledge of physicochemical techniques and state-of-the-art devices. This workshop contributes to continuous training of analytical procedures at the nanoscale for enhancing current knowledge and developing novel materials and procedures in nanotechnology.

FEATURES AND BENEFITS:

•             Addresses both PhD students and Post-Doc researchers

•             Access to advanced techniques of nanotechnology

•             Fully qualified scientific and technical personnel

•             Open poster and oral communication sessions

FEE:

€ 525:    This includes workshop fees, a welcome reception, lunches, coffee-breaks & booklet.

Optional banquet in a traditional Aragonese cuisine venue (€50)

PROGRAMME:

The full programme includes theory sessions, practical demonstrations and training sessions, as well as oral and poster presentations (…).

REGISTER HERE:

http://www.nanovalid.eu/events/ws/registration.htm

FURTHER INFORMATION:

[email protected]

M. Pilar Lobera, PhD ([email protected]); Francisco Balas, PhD ([email protected])

http://ina.unizar.es

Not having previously investigated the NanoValid project, I checked out the homepage,

The EU FP7 large-scale integrating project NanoValid (contract: 263147) has been launched on the 1st of November 2011, as one of the “flagship” nanosafety projects. The project consists of 24 European partners from 14 different countries and 6 partners from Brazil, Canada, India and the US and will run from 2011 to 2015, with a total budget of more than 13 mio EUR (EC contribution 9.6 mio EUR). [emphasis mine] Main objective of NanoValid is to develop a set of reliable reference methods and materials for the fabrication, physicochemical (pc) characterization, hazard identification and exposure assessment of engineered nanomaterials (EN), including methods for dispersion control and labelling of ENs. Based on newly established reference methods, current approaches and strategies for risk and life cycle assessment will be improved, modified and further developed, and their feasibility assessed by means of practical case studies.

In cooperation with other relevant projects, such as MARINA and QNano, and relevant standardization bodies, such as the OECD [Organization for Economic Cooperation and Development] WPMN [Working Party on Manufactured Nanomaterials], existing industrial or newly designed ENs will be subjected to a rigid and comprehensive inter-laboratory validation campaign that includes the currently most advanced methods and instruments for measuring and characterizing of ENs, to generate accurate and reproducible material data and standardized method protocols, also for tracing and quantifying nanoparticles (NP) in complex matrices. The stability and behaviour of selected NP will be monitored and tested in a variety of relevant environmental samples and test media to derive optimum and reproducible fabrication, measurement and test conditions.

The validated characterization methods will be used to design well-defined certified reference materials, which in turn will help to validate, adapt, modify and further develop current biological approaches (in vitro, in vivo and in silico) for assessing hazard and exposure of ENs, and associated risks to human health and the environment. Effects of chronic and accumulative exposure and of exposure under real-life conditions, where ENPs [engineered nanoparticles] are likely to act as components of complex mixtures, will be duly taken into account.

It was a little surprising to find Canada listed as one of the project partners. I also found this map of the consortium participants which lists McGill University specifically as the Canadian participant.

I briefly mentioned NanoValid in a June 19, 2012 posting which featured a listing of Environmental, Health and Safety projects being funded by the European Union’s 7th Framework Programme.

Nanotechnology for Green Innovation report, Canada, and the OECD’s Working Party on Manufactured Nanomaterials

I will get to the report in a moment but since it led me on a magical mystery tour through the OECD (Organization for Economic Cooperation and Development) and its new website and assorted organizational confusions, I thought I’d share those first.

February 2012 marks the last report from the OECD’s Working Party on Manufactured Nanomaterials that I can find. As well, the OECD appears to have changed its website recently (since Feb. 2012) and I find searching it less rewarding.

There’s more, it seems that the Working Party on Manufactured Nanomaterials either no longer exists or has been subsumed as part of the Working Party on Nanotechnology. I mourn the old nanomaterials working party as I found much valuable information there about the Canadian situation that was available nowhere else. Oddly, Industry Canada still has a webpage devoted to the OECD’s Working Party on Manufactured Nanomaterials but the OECD link on the Industry Canada leads you to a database,

The OECD Working Party on Manufactured Nanomaterials (WPMN ) was established in September, 2006 in order to foster international co-operation in health and environmental safety-related aspects of manufactured nanomaterials. Environment Canada represents the Government of Canada at the WPMN, supported by other interested federal departments and agencies, including Industry Canada, and stakeholders. For more information on the work of the WPMN, please visit the WPMN website or contact Environment Canada.

Nostalgia buffs can find all 37 of the Working Party on Manufactured Nanomaterials reports here on the Nanotechnology Industries Association website (save one) or here on the OECD’s Publications in the Series on the Safety of Manufactured Nanomaterials webpage.

A new ‘green’ nanotechnology and innovation report was announced in a June 18, 2013 news item on Nanowerk (Note: A link has been removed),

A new paper by the OECD Working Party on Nanotechnology (“Nanotechnology for Green Innovation”; pdf) brings together information collected through discussions and projects undertaken relevant to the development and use of nanotechnology for green innovation. It relies in particular on preliminary results from the WPN project on the Responsible Development of Nanotechnology and on conclusions from a symposium, organised by the OECD WPN together with the United States National Nanotechnology Initiative, which took place in March 2012 in Washington DC, United States, on Assessing the Economic Impact of Nanotechnology. [emphases mine]  It also draws on material from the four background papers that were developed for the symposium. The background papers were:

“Challenges for Governments in Evaluating the Return on Investment from Nanotechnology and its Broader Economic Impact” by Eleanor O’Rourke and Mark Morrison of the Institute of Nanotechnology, United Kingdom;

“Finance and Investor Models in Nanotechnology” by Tom Crawley, Pekka Koponen, Lauri Tolvas and Terhi Marttila of Spinverse, Finland;

“The Economic Contributions of Nanotechnology to Green and Sustainable Growth” by Philip Shapira and Jan Youtie, Georgia Institute of Technology, Atlanta, United States; and

“Models, Tool and Metrics Available to Assess the Economic Impact of Nanotechnology” by Katherine Bojczuk and Ben Walsh of Oakdene Hollins, United Kingdom.

The purpose of the paper is to provide background information for future work by the WPN on the application of nanotechnology to green innovation.

I wrote about the March 2012 symposium in a March 29, 2012 posting,

I was hoping for a bit more detail about how one would go about including nanotechnology-enabled products in this type of economic impact assessment but this is all I could find (from the news release),

In their paper, Youtie and Shapira cite several examples of green nanotechnology, discuss the potential impacts of the technology, and review forecasts that have been made.

I checked both Philip Shapira‘s webpage and Jan Youtie‘s at Georgia Tech to find that neither lists this latest work, which hopefully includes additional detail. I’m hopeful there’ll be a document published in the proceedings for this symposium and access will be possible.

So, I’m very happy to see this 2013 report and  I have three different ways to access it,

  1. OECD library page for Nanotechnology for Green Innovation
  2. http://www.oecd-ilibrary.org/docserver/download/5k450q9j8p8q.pdf?expires=1371578116&id=id&accname=guest&checksum=F308B436A883BF6533E66C19182ECF17 which features a title page identifying this is as  an OECD Science, Technology and Industry Policy Papers No. 5 (this one lists 35 pp)
  3. http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=DSTI/STP/NANO%282013%293/FINAL&docLanguage=En which is identified with this Unclassified DSTI/STP/NANO(2013)3/FINAL and a publication date of June 13, 2013 (this one lists 34 pp)

The following comments are based on a very quick read through the report. Pulling together four papers and trying to create a cohesive and coherent single report after the fact is difficult and this report shows some of the stresses. One  of the problems is that 34 or 35 pp., depending on which version you’re reading, isn’t enough to cover the very broad topic indicated by the report’s title. I couldn’t find a clear general statement about government policies. For example, there are various countries with policies and there are trade blocks such as the European Union which also has policies. Additionally, there may be other jurisdictions. All of which contribute an environment which makes ‘green’ innovation nano or otherwise a challenge but no mention is made of this challenge. Further, I don’t recall seeing any mention of patents, which I’d expect would be a major talking point in a paper with innovation in its title. If there was mention of intellectual property, it made no impact on me, odd, especially where nanotechnology is concerned.

The report does have some good specifics and  it is worthwhile reading. For example, I found the section on lithium-ion batteries quite informative.

In any event, I’m not really the audience for this document, the “purpose of the paper is to provide background information for future work by the WPN on the application of nanotechnology to green innovation.”

ETA June 18, 2013 6:00 pm PDT: Here’s a link to the new OECD nanotechnology page, STInano

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.

None

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.

None.

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

None.

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

None

Additional Information

None

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.

European nanosafety and cosmetics

The European Commission has asked the Scientific Commission on Consumer Safety (SCCS) to prepare guidelines (guidance) for assessing the safety of cosmetic products with nanomaterials as ingredients. From the Oct. 11, 2011 news item on Nanowerk,

On the basis of the evolving knowledge based on the health risk assessment of specific manufactured nanomaterials, the Commission considers appropriate to request the SCCS to develop guidance on the essential elements that would be required in a manufactured nanomaterial safety dossier i.e. physicochemical characterisation; toxicological evaluation, exposure assessment etc.

This request is being made in anticipation of some new regulations for cosmetic products containing nanomaterials, which will be implement in January 2013, according to the European Commission’s Request for Guidance document, available here.

This will not only facilitate the submission of safety dossiers at present, but will also assist in the implementation of the provisions of article 16 of the Cosmetics Regulation (EC) No 1223/2009/ which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013.

On the basis of the evolving knowledge based on the health risk assessment of specific manufactured nanomaterials, the Commission considers appropriate to request the SCCS to develop guidance on the essential elements that would be required in a manufactured nanomaterial safety dossier i.e. physicochemical characterisation; toxicological evaluation, exposure assessment etc. (p. 1)

The deadline for developing the guidance (guidelines) is February 2012.  There was this tidbit too,

In elaborating this guidance, and taking into account the growing experience on the matter the SCCS is asked to consider all available documentation on the subject such as the SCCP scientific opinion on safety of nanomaterials in cosmetic products; the documents issued by the OECD Working Party on Manufactured Nanomaterials; the EFSA scientific opinion on guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. [emphasis mine] (p. 2)

Canada has been very involved with the OECD (Organization for Economic Cooperation and Development) Working Party on Manufactured Nanomaterials. In light of this and of Health Canada’s recent policy statement on a working definition for nanomaterials (my Oct. 11, 2011 posting), I wonder if Canadians are going to see any similar attempts at creating guidelines for safety assessments of cosmetics and other products containing engineered nanomaterials as ingredients.

Roundup of OECD’s recent nanomaterials publications

Last week the OECD (Organization for Economic Cooperation and Development) made three new publications available on their Safety of Manufactured Nanomaterials website. News items on Nanowerk offer a précis for each document.

From the news item about the results of a questionnaire about regulatory regimes that cover nanomaterials,

The current document presents the information obtained from the WPMN [Working Party on Manufactured Nanomaterials] Questionnaire on Regulatory Regimes for Manufactured Nanomaterials issued July 28, 2008. Responses received are summarized in the Tables (see Annexes). Twenty-four responses were received from nine jurisdictions for Legislations covering a wide variety of chemical substances and/or products including industrial chemicals, pesticides, fertilizers, agricultural compounds, fuels and fuel additives, food and food additives and veterinary medicines. Other Legislations reported included those covering occupational health and safety, consumer products, control of major accidents and labelling and packaging. Although a wide variety of sectors are represented in the data obtained, it is noted that responses from the industrial chemical sector were in the majority for those Legislations reporting pre-market and/or post-market registration/notification and assessment.

None of the respondents reported having legislation specific to nanomaterials, however most respondents indicated that the authority to regulate substances that are nanomaterials, or products containing nanomaterials, exists in current Legislation. [emphasis mine]

This questionnaire was filled out in 2008 and, to the best of my knowledge, the situation in Canada (one of the respondents) remains unchanged from that time. You can access the full report here although I suggest reading the item at Nanowerk first as it offers good preparation for the full report and I have had problems with downloading at least one of these reports from the OECD site and from the link provided at Nanowerk.

There’s a workshop report on risk assessment (from the news item on Nanowerk),

The workshop took place September 16th – 18th, 2009 in Washington D.C., United States, and was cohosted by the Business and Industry Advisory Committee (BIAC) and the Society for Risk Analysis. Seventy (70) participants representing OECD member countries, non-member economies, industries, academia and environmental NGOs attended.

Following general presentations and discussions, case studies on Titanium dioxide nanomaterials, Silver Nanomaterials and Carbon Nanotubes were presented. Workshop attendees then participated in one of five parallel break-out sessions to discuss specific issues of risk assessment methodology including i) Assessment Problem Formulation; ii) Exposure – Public, Occupational and Environment; iii) Hazard – Human Health; iv) Ecological Toxicity and Fate; and v) Determining Risk and Linkage between Assessment and Management.

Workshop participants concluded that the risk assessment paradigm for chemicals will continue to guide approaches to the risk assessment of nanomaterials. However, because of the limited amount of empirical data on nanomaterials, many of the assumptions and estimations employed in chemical risk assessments need to be evaluated for nanomaterials.

If I understand the last two sentences properly, this means that as products continue to enter the marketplace the old rules will apply although nanomaterials may behave in completely unexpected ways so more research is needed. (As per the last report, you can access the full report here although I suggest reading the item at Nanowerk first as it offers good preparation for the full report and I have had problems with downloading at least one of these reports from the OECD site and from the link provided at Nanowerk.)

The third member of this trio of reports is a 2009-2012 operational plan for the OECD’s nanomaterials safety programme. From the news item on Nanowerk,

The OECD programme on the safety of manufactured nanomaterials aims to ensure that the approach to hazard, exposure and risk assessment is of a high, science-based, and internationally harmonised standard.

This programme promotes international co-operation on the human health and environmental safety of manufactured nanomaterials, and involves safety testing and risk assessment of manufactured nanomaterials. This document compiles the operational plans (2009-2012) for the implementation of each project of the Working Party on Manufactured Nanomaterials (WPMN).

There are six projects,

1. OECD Database on Manufactured Nanomaterials to Inform and Analyse EHS Research Activities [led by SG1/2]…

2. Safety Testing of Representative Set of Manufactured Nanomaterials [led by SG3] – …

3. Manufactured Nanomaterials and Test Guidelines [led by SG4] – …

4. Co-operation on Voluntary Schemes and Regulatory Programmes [led by SG5] – …

5. Co-operation on Risk Assessment [led by SG6] – …

6. The Role of Alternative Test Methods in Nanotoxicology [led by SG7] – …

7. Co-operation on Exposure Measurement and Exposure Mitigation [led by SG8] – …

8. Environmentally Sustainable Use of Manufactured Nanomaterials [led by SG9] …

It seems a bit odd to me that a plan which covers 2009 to 2012 is released in 2010 as it seems to be somewhat after the fact. (As per the last report, you can access the full report here although I suggest reading the item at Nanowerk first as it offers good preparation for the full report and I have had problems with downloading at least one of these reports from the OECD  site and from the link provided at Nanowerk.)