Tag Archives: Working Party on Nanotechnology

OECD’s (Organization for Economic Cooperation and Development) latest report on its regulating manufactured nanomaterials questionnaire

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As I have commented on several occasions, most of my information about Canada’s activities with regard to risk and nanomaterials comes from outside the country, notably the OECD (Organization for Economic Cooperation and Development).

Thanks* to Lynn Bergeson and her Sept. 17, 2014 posting on Nanotechnology Now for information about the latest publication from the OECD’s Working Party on Manufactured Nanomaterials (Note: a link has been removed),

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. … The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration.

You can find all of the reports from the OECD’s WPMN here, including this latest report, which is no. 42, Report of the questionnaire on regulatory regimes for manufactured nanomaterials 2010-201, ENV/JM/MONO(2014)28. This is the third time there’s been a questionnaire and subsequent report.

I have quickly skimmed through the report and found a few interesting items about Canada’s current activities and collaborations vis à vis manufactured nanomaterials and risk. From the REPORT OF THE QUESTIONNAIRE ON REGULATORY REGIMES FOR MANUFACTURED NANOMATERIALS 2010-2011 which appears to have been published Sept. 4, 2014. I have had an unusually difficult time including excerpts from the report along with page numbers, etc. On the first try, after almost an hour of cutting and pasting, I was unable to get an intelligible version into a preview. To all intents and purposes the text was in place but the preview attempt resulted in a bizarre column of text overwriting the sidebar to the right of the posts.

I tried again and found that extensive reformatting was necessary and that the original table format has been lost. Nonetheless. you will find there are two pieces of legislation being reported on, CEPA (1999), which I believe has something to do with Environment Canada, and F&DA, which seems to be associated with Health Canada. One or both pieces of legislation may be referenced as per the OECD report. Page numbers from the document are included after the excerpted table entries.

Table 12: Hazard identification …

CEPA (1999)

Extrapolation between nanomaterials (i.e., choosing the appropriate surrogate)

Validity of testing methods and analytical tools to detect, characterize and measure nanomaterials

Participating in international forums such as the WPMN [OECD Working Party on Manufactured Nanomaterials], Expert Meetings, and ISO [International Standards Organization] TC/229 to support the generation and synthesis of appropriate science.

Support domestic research to help minimize challenges in hazard identification.

F&DA

Nanomaterial-based products under the F&DA (i.e. nanomedicines) can be associated with a broad spectrum of toxicities that are dependent on the nanoparticle properties (e.g. size, surface charge and solubility). However, there is currently no specific guidance document available for nanomedicines. Nanoparticle properties can significantly impact the PK profile/biodistribution of nanomedicines resulting in safety concerns. The components of the nanomedicines can also interact with the immune system and may trigger unique immunogenicity/immunotoxicity profile. Animals are generally not predictive of immunological responses for biologics (however, it may not be the case if the nanomedicine is a chemical drug), it is likely that immunological studies for nanomedicines should be carried out in human clinical trials. Long term studies may be required for a nanomaterial that persist and accumulated in particular tissues for an extended period of time.  p. 45

Table 13: Health and safety …

F&DA Veterinary Drugs

Due to the lack of a comprehensive understanding of the effects of nanomaterials on human, animal and environmental health, the Veterinary Drugs Directorate has not yet established a comprehensive occupational health and safety policy. Moreover, occupational health and safety is a shared responsibility between the federal and provincial governments in Canada.

At this time, there is no conclusive evidence linking exposure of nanomaterials from veterinary drugs or food sources to negative impact on human health. Additional research is necessary before a definitive policy approach can be taken.

F&DA Veterinary Drugs
Veterinary drugs including those that contain nanomaterials are regulated by the Food and Drugs Act and the Food and Drug Regulations. These provide the Veterinary Drugs Directorate with the authority to regulate the human health and safety aspects of veterinary drug products. The Regulations cover the aspects of the manufacturing, human and animal safety and efficacy assessment, and post-market surveillance of veterinary drug products including those containing nanomaterials. The latter products are subject to the same rigorous assessments as non-nanomaterial-containing veterinary drug products. p. 47

Table 14: Risk Assessment Methodologies

CEPA (1999)

Our understanding of risk assessments of nanomaterials is still evolving. Nanomaterials regulated under the industrial chemicals program employ a precautionary approach (i.e., exposure is typically mitigated), and nano-relevant information is requested whenever appropriate to conduct more informed risk assessments.

Canada also continues to work in international projects, such as the international life sciences institute NanoRelease project aimed at developing methods to quantify releases of nanomaterials from solid matrices.

Canada is also part of the Regulatory Cooperation Council (RCC) Nanotechnology Initiative with the United States. Under this project, Canada and the US are developing a classification scheme for nanomaterials to inform on the utilization of analogue/read- across, developing frameworks and common assumptions to better
inform risk assessments, and mining public and confidential use information to increase marketplace knowledge of nanomaterials. p. 49

Table 15: Risk Management and Nanomaterials in Commerce …

CEPA (1999)

Knowledge of use profiles of industrial nanomaterials; lack of specificity in risk
management measures given the overall lack of information and nomenclature systems for nanomaterials

Under the RCC, Canada and the US are gathering information on the uses of industrial nanomaterials in the two countries.  p. 52

Table 16: Research … (to support regulatory decisions)

CEPA (1999)

– foster domestic and international capacity to generate research on risk assessment priorities and needs
– applying research findings to nanomaterial risk assessments
– using research on nanomaterials to extrapolate to other nanomaterials

– Canada is actively supporting domestic and international research projects to help inform risk assessments.

F&DA

Filling knowledge gaps

HC [Health Canada] is conducting laboratory research to study the effects of lipid nanoparticles on the thermal stability of various recombinant proteins with the aim of identifying determinants of susceptibility to unintended deleterious interactions.  p. 55

Table 17: Impact of Regulatory Actions and Innovations and Economic Growth

CEPA (1999)

How to obtain the necessary information on nanomaterials, and how to regulate them in a manner that does not prevent them from offering their many benefits to society.

Consult with industry on proposed approaches. Focus information requests and requirements.  pp. 56/7

Table 18: Labelling Communication of Nanomaterials …

CEPA (1999)

Labelling of nanomaterials has not been considered under CEPA 1999 to date. p. 58

Table 19: Collaboration with other countries …

CEPA (1999) & F&DA

New Substances Program is involved in various international activities, including:
1) International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies
2) Organisation for Economic Co-operation and Development (OECD) Working Party on
Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN)
3) Canada-US Regulatory Cooperation Council (RCC)
4) International Cooperation on Cosmetic Regulation (ICCR) – 2 Reports have been published
a) Criteria and Methods of Detection for Nanomaterials in Cosmetics:
http://www.fda.gov/downloads/InternationalPrograms/HarmonizationInitiatives/UCM235485.pdf
b) Methods for Characterization of Nanomaterials in Cosmetics
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/iccr5_char_nano_en.pdf
5) International Regulators Nanotechnology Working Group
6) International Life Sciences Institutes (ILSI) – NanoRelease Food Additive Project
7) NanoLyse

In addition, for veterinary drugs, Health Canada collaborates with other regulatory agencies in USA, Europe, Australia, etc in the regulation of non-nanomaterial products and substances and would do the same for substances that are, or products containing nanomaterials pp. 59/60

Table 19: Expert Workshop Sponsorship [table number repetition noted]

CEPA (1999)

The Workshop on the Human and Environmental Risk Assessment of Nanomaterials convened by Health Canada and Environment Canada (March 24-26, 2010) provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by 25 experts from Australia, Canada, Europe, Korea and the United States of America. In addition, seven observers attended the Workshop.

Regulatory Cooperation Council with the United States

F&DA Foods

Health Canada will be hosting a Joint NanoLyse/NanoRelease Workshop to discuss methods and safety of nanomaterials and share information from the respective projects. NanoLyse is an EU research consortium to develop methods of analysis for engineered nano-materials in foods and NanoRelease is an International Life Sciences Institute lead initiative to develop of analytical methods, alimentary canal models for uptake of engineered nano-materials and review of regulatory issues. p. 61

In any event, good luck with the reading and you can find out more about NanoLyse here and more about Canadian participation in the NanoRelease Food Additive Steering Committee project here.

* ‘Thank’s’ changed to ‘Thanks’ on April 7, 2015

Organization for Economic Cooperation and Development’s (OECD) report on responsible development of nanotechnology plus news about upcoming survey on nanotechnology commercialization

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I stumbled onto this OECD (Organization for Economic Cooperation for Development) information in the context of research on another, unrelated, story about the current state of nanotechnology standards and regulations (Dec. 23, 2013 news item on Nanotechnology Now) which is not likely to be written up here.  Getting back to this posting, I found a report from the OECD’s Working Party on Nanotechnology dated Nov. 29, 2013 and titled: RESPONSIBLE DEVELOPMENT OF NANOTECHNOLOGY
Summary Results from a Survey Activity (report no. DSTI/STP/NANO(2013)9/FINAL). This 34 pp. report includes the latest information for 25 countries that agreed to take part in the survey. Here’s the information supplied by Canada,

Canada
While Canada does not have a distinct policy for nanotechnology, the Government of Canada is engaged in a number of activities which specifically address the responsible development of
nanotechnology:
• Policy principles for regulation and oversight: Federal departments are working together under the Canada-United States Regulatory Cooperation Council Nanotechnology Initiative to strengthen current policy principles to guide government decision-making concerning the responsible development of nanotechnology. These principles address the need to protect human health, safety, and the environment, while not unnecessarily hampering innovation and the exploitation of potential benefits from nanotechnology use.
• Research and international collaboration: In collaboration with domestic and international partners, the Government of Canada is actively involved in research and other activities to assess the environmental, health, and safety aspects of nanomaterials and to develop appropriate and internationally compatible approaches for their responsible development and application (e.g. through safety assessment work at the OECD, ISO/IEC nanotechnology standards development, bilateral regulatory co-ordination, and government research and government-funded extramuralresearch).
• Development of new policy tools: In October 2011, Health Canada introduced a Working Definition of Nanomaterials to provide a tool to assist the Government to gather safety information about nanomaterials in support of Health Canada’s mandate. The Working Definition is not an additional source of authority, but applies within existing regulatory frameworks that allow for obtaining information (www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php).
• Federal science and technology (S&T) strategies: Federal strategies for S&T research recognise the interconnection between responsible innovation, regulation, and socioeconomic development. Through its 2007 strategy, Mobilising Science and Technology to Canada’s Advantage, for example, the Government of Canada is committed to ensuring the responsible development of nanotechnology. Federal strategies set out the general priority areas for government S&T research support (www.science.gc.ca/S&T_Reports-WS5F25C99B-1_En.htm). [Ed. Note: I would describe the information as statistical data rather than strategy and,in fact, the webpage you’re being directed to is titled: Science and Technology Data.)
• Interdepartmental collaboration and coordination: Federal science-based departments and agencies (SBDAs) are engaged in an initiative to foster interdepartmental collaboration and coordination of activities for the responsible governance of nanotechnology. The results of this initiative will inform SBDA work and activities concerning innovation, regulation, public engagement and research.
• External collaboration and coordination: Federal departments and agencies collaborate with external partners, such as provincial nanotechnology associations, on issues related to the responsible development of nanotechnology. (p. 9)

I mentioned the Canada-United States Regulatory Cooperation Council Nanotechnology Initiative in a June 26, 2013 posting.

As for this OECD report, there’s always the question, What constitutes ‘responsible’ development? The OECD report provides an answer,

For the purpose of this activity the responsible development of nanotechnology was described as actions to stimulate the growth of nanotechnology applications in diverse sectors of the economy, while addressing the potential risks and the ethical and societal challenges the technology might raise. Policy and initiatives for the responsible development of nanotechnology aim both at supporting research (and/or business activities) and implementing effective legal and regulatory frameworks in order to assure that risk and safety standards are met. They also aim at supporting and stimulating the debate on the place of science and technology in society by engaging with the public on social and ethical issues. As nanotechnology develops, countries and regions have begun to develop, refine and/or articulate regulatory approaches to support the responsible development of nanotechnology. (p. 7)

The question as to which countries have a specific policy for the responsible development of nanotechnology is answered at length (from the OECD report),

All participating delegations responded to the questions on whether a dedicated policy for the responsible development of nanotechnology was in place or if nanotechnology was addressed as part of other policies; and whether a dedicated research programme for nanotechnology was in place or if nanotechnology formed a part of other research programmes.

Many delegations reported a specific policy for the responsible development of nanotechnology, with 11 delegations, out of the 25 participating, indicating the development of a policy brief, a regulatory framework, a legislative framework and/or an overall strategy for the responsible development of nanotechnology. All of these delegations reported that the policy had already been implemented. Some of the delegations that indicated a dedicated policy for the responsible development of nanotechnology also indicated that nanotechnology was included within other policies.

Where there was a dedicated policy for nanotechnology, the policy operated at the national level in all cases with the exception of Spain, which indicated that there was a nanotechnology policy in some of its regions, in parallel with the national dedicated nanotechnology policy for R&D and innovation.

Nine delegations [Canada was one of the nine delegations] indicated there was no dedicated policy for the responsible development of nanotechnology, but those delegations indicated that nanotechnology was included as part of other policies.

Two delegations indicated there was neither a dedicated policy for the responsible development of nanotechnology nor a policy of which nanotechnology was a part. However, these delegations either reported a dedicated research programme on nanotechnology, or that nanotechnology had been recognised as a strategic research area.

Finally, three delegations, out of the 25 participating, indicated that a policy for the responsible development of nanotechnology was under development (Sweden, Turkey, and the United Kingdom) with publication planned for 2013-2014. For those countries, nanotechnology is currently included under the general umbrella of science and technology policy.

The majority of delegations highlighted the importance of collaboration and co-operation across- ministries, departments and agencies to ensure responsible and efficient development of the technology. Indeed, nanotechnology was expected to impact on a variety of industrial and economic sectors; this cross- sectoral nature appears to be a challenge for policy makers who require the involvement of all governmental stakeholders likely to be impacted by nanotechnology development. The majority of delegations involved a number of relevant ministries and departments in the development of their strategies for the responsible development of nanotechnology. This broad involvement was noted as a clear requirement in order to succeed in the development of nanotechnology.

… (pp. 7-8)

Finally, there is an OECD survey currently underway regarding nanotechnology commercialization according to a Dec. 20, 2013 notice on the Nanotechnology Industries Association (NIA) website (Note: A link has been removed),

NIA Members Consultation: OECD WPN Survey on Nanotechnology Commercialisation Policy – Deadline: 3 January 2014
Posted on 20 Dec 2013

The Working Party on Nanotechnology (WPN) of the Organisation for Economic Cooperation and Development (OECD) is undertaking a project examining policies that support the commercialisation of nanotechnology research. It aims to identify:

Which existing government policies help companies efforts in commercialisation;
How significant this support is; and
What else governments could do/do more of, that would most significantly increase the commercialisation of nanotechnology research.

As part of its role within the Business and Industry Advisory Committee (BIAC), NIA is asking its members to provide their views to the project via a short questionnaire.

Participating members have the option to remain anonymous, with their identity and other information kept confidential by the project.

The findings from the questionnaire responses will be presented in a final OECD WPN Report and will be made available to all participants in the new year.

Only NIA members have access to the questionnaire and I cannot find any mention of it on the OECD website although I did stumble on this delightful page titled: OECD Working Party on Nanotechnology: Second meeting of the Working Party on Nanotechnology, which contains a number of documents including one which outlines a 2007 Canadian project: Nanotechnology Pilot Survey by Statistics Canada.

I hope to hear about this commercialization survey in a more timely fashion than I’ve been managing lately. In any event, it’s nice to get caught up on the Canadian nanotechnology scene.

On a related front: In March 2013 the OECD and the US National Nanotechnology Initiative (NNI) held a joint symposium about assessing nanotechnology’s economic impacts. My Sept. 19, 2013 posting features the final report on the symposium. There’s also my July 23, 2012 interview with Vanessa Clive, Industry Canada’s Nanotechnology Policy Advisor and one of the symposium organizers. Finally, there’s the OECD’s 2010 report, The Impacts of Nanotechnology on Companies: Policy Insights from Case Studies. This report was co-designed and co-led by Vanessa, one of her Canadian colleagues and a Swiss colleague. The report itself was written by OECD staff as per Vanessa’s comments in my March 29, 2012 posting.

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

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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