Tag Archives: Current Developments/Activities on the Safety of Manufactured Nanomaterials

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.

Latest report on Canada’s work on nanomaterial safety via an OECD report

As usual I’m getting the best and most comprehensive overview of Canada’s current safety efforts with regard to nanomaterials from an external source, an OECD (Organization for Economic Cooperation and Development) report. From the news item on Nanowerk,

A new document from the OECD (“Current Developments/Activities on the Safety of Manufactured Nanomaterials”; pdf) provides information on current/planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended at the 7th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 7-9 July 2010).

This new document compiles information provided by member countries and other delegations on current developments on the safety of manufactured nanomaterials (section I) in their countries or organisations. …

This is intended to provide delegations and other stakeholders with a “snapshot” of information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies, at the national and international level. This “snapshot” was current at the time of the 7th meeting of the WPMN (July 2010).

For anyone who is interested, the report can be found here. I did take a look at the section on Canada. From the report,

A. Canada has announced the adoption of the Interim Policy Statement on Canada’s Working Definition for Nanomaterials and it’s public posting (http://www.hc-sc.gc.ca/srsr/ consult/_2010/nanomater/draft-ebauche-eng.php).The Interim Policy is now in effect and comments on this policy statement are being accepted until August 31st, 2010. [now closed]

Currently, the Acts and Regulations administered by Canada have no explicit reference to nanomaterial. Among four key objectives, this policy statement establishes a transparent working means of identifying nanomaterials. It will also provide Canada with a consistent set of approaches and a trigger to request information. Given the range of nanomaterial-related regulatory responsibilities in Canada, the working definition is intentionally broad and will be applied more specifically in each regulatory programme area.

In preparing the Interim Policy Statement on Canada’s Working Definition for Nanomaterials, Canada sought the informal feedback of some international stakeholders, industry trade groups and standards associations.

B. A Workshop on the Human and Environmental Risk Assessment of Nanomaterials was convened by Canada from March 24-26, 2010. This workshop provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by experts from Australia, Canada, Europe, Korea and the United States of America.

The Workshop was designed to be complementary to the work of the OECD Working Party on Manufactured Nanomaterials (WPMN) and followed on from the recent Workshop on Risk Assessment in a Regulatory Context that took place September 16-18, 2009 in Washington DC. Workshop participants agreed that scientific knowledge on the properties, environmental fate, behaviour and toxicity of nanomaterials is advancing, however, currently is still inadequate to allow general trends/structure-activity relationships to be made. Nanomaterials should continue to be assessed on a case-by-case basis, efforts should be made to minimize exposures and releases to the extent possible, and jurisdictions should continue to cooperate on research projects aimed at the development of scientific data on nanomaterials. Workshop participants emphasised that exchanges of information and views on nanomaterials at this time are especially helpful for promoting best practices in risk assessment and risk management.

C. Canadian Standards Association (CSA) Standards has formed a Technical Committee on Nanotechnologies – Occupational Health and Safety. Initial activities include working to adopt the published international ISO Technical Report, ISO/TR 12885:2008 on Health & Safety Practices in Occupational Settings relevant to Nanotechnologies, as well as to produce a national standard to provide guidance for workers using nanomaterials in the workplace. The Committee’s inaugural meeting was held on May 7th, 2009 and work is continuing in subsequent meetings through 2010.

D. Canada is the lead for the ISO TC/229 WG1 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. In July 2009 the Task Group completed the report: “Considerations for Developing a Nomenclature Model for Nano-Objects”. Canada has now welcomed United States in co-chairing this activity, and is continuing development of a framework for nomenclature models for nano-objects. Canada has pursued and secured a liaison between ISO/TC 229 and IUPAC to further this nomenclature work.

E. Canada has completed a report titled, Nanotechnologies — Terminology – Initial framework model for core concepts, under ISO TC/229 JWG1. Also, Canada has led a project (JWG1-PG5) to develop definitions for core terms resulting from the taxonomy system. ISO 80004-1 Nanotechnologies — Vocabulary — Part 1: Core terms has now been approved after ISO Draft Technical Specification balloting.

F. Under the International Cooperation on Cosmetic Regulation (ICCR), Canada is participating in the international ad hoc working group on nanomaterials in cosmetics (ICCR Nano WG) that was initiated in December 2009. This working group is composed of regulators and industry representatives to identify specific criteria for nanomaterials in cosmetics. Completion of recommended criteria for ICCR acceptance is expected in July 2010. The ICCR Nano WG will then commence work on endpoints for risk assessment relevant to cosmetics safety (starting late 2010). (pp.22/3)

I have mixed feelings about this, appreciation that we’re doing work on nanomaterials and safety and frustration that the best source of information is in a report produced by an international organization.

There’s more information about various Canadian nanosafety projects  in the report including a reference to Québec’s recent IRSST (Institut de recherche Robert-Sauvé en santé et en sécurité du travail) on safety and engineered nanoparticles. Here’s a bit more,

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. The projects examined fate both in the aqueous and the subsurface compartments and include establishing methodologies for suspension and phys-chem characterisation 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) characterisation in complex media; (3) methods for biological effects testing; and (4) establishing collaborative dialogue between key stakeholders. Funding and partnering opportunities are currently being considered by Canada to a) develop in-house analytical chemistry infrastructure for the measurement of nanoparticles in food; b) to assess the health effects of orally ingested nanomaterials for addressing exposure through food contamination from packaging materials, or through nanostructures in food additives; c) to evaluate the effects of nanomaterials in food on nutrient bioavailability, functionality and efficacy for addressing the regulation of nanotech products designed. 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, also carbon black, 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. Canada has hosted various workshops pertaining to challenges in nanotechnology, such as the 4th Tri- National Workshop on Standards for Nanotechnology (Feb, 2010), which addressed measurement and characterisation in support of toxicology R&D for Human Health and Environment., focusing on identification of measurands for toxicological research on nano-objects, and the measurement science supporting accurate measurement and characterisation. This workshop supported the Canadian contribution to the North American Platform Program (NAPP) in Metrology in Support of Nanotechnology, strengthening partnerships between Canada, the United States and Mexico. Information on the 4th Tri- National Workshop on Standards for Nanotechnology is available at: https://www.nrccnrc. gc.ca/eng/events/inms/2010/02/03/tri-national workshop.html. (p. 25)

I’d never heard of the Tri-National Workshop on Standards before or the work on measuring and assessing the safety of nanoparticles in foods or some of the other initiatives for that matter. I’ve noted before that it seems odd that laudable work such as this is being kept, to all intents and purposes, secret.

There’s a section for public consultation which boasts the one (closed as of Aug. 31, 2010) for the Interim Policy Statement on Canada’s Working Definition for Nanomaterials. I commented on this consultation, which was hosted by Health Canada, in my April 2, 2010, April 12, 2010, and April 26, 2010 postings. I also made a submission and wonder if I’ll ever hear back from anyone about it. I don’t imagine so.

I notice that this OECD report does not include any reference to Canada’s nano portal (as I recall, the last OECD report did mention it). The nanoportal has been opened (I’m not sure when).