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:
- Czech Republic
- South Africa
- United Kingdom
- United States
- European Commission
- Business and Industry Advisory Committee
As one might expect, I’m focussing on the Canadian response, which starts on p. 24 of the report,
Work completed, underway or planned
1. Any national regulatory developments on human health and environmental safety including recommendations or discussions related to adapting existing regulatory systems or the drafting of laws/ regulations/ guidance materials.
A. In October, 2011, Health Canada published a revised Policy Statement based on stakeholder
feedback, as well as developments in international norms, evolving scientific evidence and regulatory program needs. The Policy Statement on Health Canada’s Working Definition for Nanomaterial (Working Definition) which is available on Health Canada’s website, will continue to be updated as the body of scientific evidence and international norms progress. Health Canada’s responses to stakeholders’ comments and a set of frequently asked questions are also posted on Health Canada’s website.
B. Discussions at the 4th annual meeting of International Cooperation on Cosmetic Regulation (ICCR-4) in Canada on cosmetics and cosmetic-like drug/quasi-drug products led to the formation of a new Joint Industry/Regulator Working Group. Canada is participating in the Joint WG which is a follow up from the previous ICCR Ad Hoc Nano Working Group that developed criteria for identification of nanomaterials within the context of cosmetic regulation. The criteria statement was as follows:
For purposes of the International Cooperation on Cosmetic Regulation, a substance used in a cosmetic is considered a nanomaterial if it is an insoluble ingredient, intentionally manufactured, with one or more dimensions in the realm of 1 to 100 nanometers in the final formulation and is sufficiently stable and persistent in biological media to allow for the potential of interaction with biological systems.
The purpose of the Joint WG is to examine the existing safety approaches for applicability to nanomaterials in use by (or relevant to) activities within the cosmetic industry. The main task of the Joint WG is to carry out a review of the existing safety approaches, and to identify any specific aspects relevant to consumer safety that should be taken into consideration in relation to the use of nanomaterials in cosmetics.
The Joint WG will aim to produce a document that will be aimed at providing guidance and help to those intending to use or assess nanomaterials in a cosmetic product in the form of an expert view on important safety aspects for consideration in an industry or regulatory setting. It is, however, not the intention of the Joint WG to focus exclusively on regulatory (mandatory) safety testing, or to develop any strict pathway or protocol, although it will take a brief account of the current requirements for safety assessment under the existing regulatory frameworks within the ICCR jurisdictions.
2. Developments related to voluntary or stewardship schemes.
3. Information on any Risk Assessment Decisions.
A number of notifications have been received by some regulatory programmes.
Industrial or commercial chemicals: Since March 2011, an additional five notifications have been received for nano-related assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The Significant New Activity (SNAc) provisions of CEPA 1999 have been applied to these notifications, requiring the submission of additional information and assessment prior to use of the substances at the nanoscale or in other nanoscale applications.
Pharmaceuticals: A number of nanotechnology based products in the areas of medical devices and drugs are currently under review by Canada, under the current regulations and policies.
Pesticide applications: Some inquiries have been made, but no notifications have been submitted to date.
Food related application: Six notifications have been received. Two letters of no objection have been issued; the other four are still under review.
Others: No notifications with respect to fertilizers, veterinary biologics, or animal feed have been received to date.
4. Information on any Developments Related to Good Practice Documents.
A. The Canadian Standards Association (CSA) Technical Committee on Nanotechnologies –
Occupational Health and Safety has completed a draft national standard (CSA Z12885) to provide guidance for workers, entitled “Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings” This document is largely based on the published international ISO Technical Report, ISO/TR 12885:2008 entitled “Health & Safety Practices in Occupational Settings relevant to Nanotechnologies”. The CSA Z12885 standard has completed the public review process and is proceeding to ballot, with completion anticipated in mid-2012.
B. Government, industry, research, user, and consumer interests are participating as designated experts from Canada on international standards development through the Canadian Advisory Committee to International Organization for Standardization/Technical Committee 229 (ISO/TC229) Nanotechnologies, facilitated by CSA Standards. This includes active participation on terminology, nomenclature, measurement, characterization, material specification and health, safety, environmental aspects of nanotechnologies standards under development.
C. Canada is the lead for the ISO TC 229 Working Group 1 Task Group on Nomenclature. This Task Group includes active representation from the United States, Japan, Germany, France, Australia, and includes regulators, industry, and academia, as well as observers from the Chemical Abstracts Service and the International Union of Pure and Applied Chemistry (IUPAC). The Group is tasked with developing a nomenclature system which meets the needs of regulators, industry, and academia. A liaison between ISO TC 229 and IUPAC has been secured and a subcommittee has been formed to pursue work on developing nomenclature.
5. Research programmes or strategies designed to address human health and/ or environmental safety aspects of nanomaterials.
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]
Canada participates in the project on Regulatory Framework for Nanotechnology in Food and Medical Products. The project is composed of two independent surveys addressing the same set of questions related to: (1) the regulatory frameworks being used to provide oversight for the use of nanotechnology in food and medical products, (2) the legislative frameworks relevant to these regulatory frameworks, and (3) relevant government-supported research programmes and institutions.
The surveys have been circulated to member countries and responses have been collected.
The information generated by the surveys will be used to populate inventories, and draft a report on areas of shared interest and highlight opportunities for enhancing communication related to regulation and applications of nanotechnology in food and medical products. The report is expected to be completed in 2011/2012.
6. Information on any public/ stakeholder consultations.
7. Information on any developments related to Integrated Testing Strategies and/or Alternative test methods.
8. Information on research programmes or strategies which focus on life cycle aspects of nanomaterials, as well as positive and negative impacts on environment and health of certain nano-enabled applications. (You may wish to contact your colleagues participating in SG9.)
Canada is engaged in a project lead by the International Life Sciences Institute (ILSI) to look at releases of nanomaterials from industrial matrices (e.g., coatings). The purposes of this project are to develop information on different test methodologies and nanomaterials used to study releases from matrices, and to develop standard methodologies (validated through round-robin testing) to quantify releases of nanomaterials from a matrix. At present, the Steering Committee for the project has selected the nanomaterial to be studied (MWCNT) and is requesting input from manufacturers and processors to select the polymeric matrix to be used. Government agencies in the United States, Non-Governmental Organizations and Industry are also engaged in the project. Additional information can be found at http://www.ilsi.org/ResearchFoundation/Pages/NanoRelease1.aspx.
9. Information on any development related to exposure measurement and exposure mitigation
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,
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.