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The Regulatory Cooperation Council (RCC) Nanotechnology Initiative was established to increase alignment in regulatory approaches for nanomaterials between Canada and the United States (US) in order to reduce risks to human health and the environment while also fostering innovation. The Work Plan that was developed to achieve greater regulatory alignment consists of five Work Elements, each designed to realize specific final deliverables: Principles, Priority-Setting, Risk Assessment/Management, Commercial Information, and Regulatory Cooperation in Areas of Emerging Technologies.
The RCC Nanotechnology Initiative primarily focuses on those industrial nanomaterials that would be considered new substances (referred to herein as nanomaterials), regulated in Canada under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and in the US under the Toxic Substances Control Act (TSCA).
The overarching action item identified for Work Element 4, Commercial Information, in the Regulatory Cooperation Council (RCC) Nanotechnology Work Plan is to characterize existing commercial activities and to identify gaps and priorities for future knowledge gathering for nanomaterials. The Work Plan action items are:
- By November, 2012: Share information and lessons learned from previous commercial data gathering activities.
- By May, 2013: Share non-Confidential Business Information (CBI) concerning industrial nanomaterials in the marketplace; identify areas where information is limited and invite stakeholder comment and input to help address these gaps.
- By November, 2013: Initiate an analysis of industrial nanomaterials uses in Canada and the US.
- Beyond November, 2013: Complete an assessment of industrial nanomaterial uses in Canada and the US; identify opportunities for and barriers to ongoing collaborations and regulatory alignment.
From the outset of the RCC Nanotechnology Initiative, the Canadian New Substances Program and US New Chemicals Program (the Canada/US Programs) recognized that more complete and accurate information on the use of nanomaterials would improve their understanding of the potential environmental release of nanomaterials as well as the potential for exposure to nanomaterials, which would result in more targeted and consistent information requests by the Canada/US Programs for regulatory purposes. More complete information on the uses of nanomaterials would also inform the targeting and prioritization of further research. Over the long-term, an improved understanding of the potential environmental release of nanomaterials and the potential for exposure to them could help the Canada/US Programs make risk assessment and regulatory decisions that are more consistent and predictable by, for example, prioritizing development of harmonized generic exposure models and relevant exposure testing guidelines.
This report is the final deliverable for Work Element 4. It addresses the action items completed up to 18 months (November, 2013); items beyond 18 months have already been initiated. This report represents the current state of knowledge on the uses of nanomaterials from data gathered by both Canada and the US prior to and during the RCC Nanotechnology Initiative. All of the data gathered to date has been used to create a Nanomaterials Use Matrix, which represents the most up-to-date information the Canada/US Programs have on a wide range of known commercially available nanomaterials. The report also explores next steps for Canada and the US as the two countries continue to build on and apply this knowledge in support of regulatory alignment, and to better inform risk assessment and risk management.
 While this document focuses on industrial nanomaterials, some of the uses of these materials may fall under the jurisdictions of other regulatory agencies in the U.S. and Canada. This document is not intended to address the materials/products or their intended uses that are appropriately regulated by the other agencies.
 In the US these exposure models are termed generic engineering scenarios (http://www.epa.gov/oppt/exposure/pubs/guidance.htm), while the OECD uses the term emission scenario document (http://www.oecd.org/chemicalsafety/risk-assessment/introductiontoemissionscenariodocuments.htm).
Nanomaterials Notified in Canada and the US
The dataset used as a basis for the analysis of nanomaterial use information came from new nanomaterials notifications to the Canada/US Programs. In the US, Pre-Manufacture Notices (PMNs) regarding new substances are made to the New Chemicals Program under the Toxic Substances Control Act (TSCA); in Canada New Substances Notifications (NSNs) are submitted to the New Substances Program according the New Substances Notification Regulations (Chemicals and Polymers) of the Canadian Environmental Protection Act 1999 (CEPA 1999). As part of the RCC Work Plan, the two countries shared non-Confidential Business Information (CBI) and analyzed trends in new nanomaterial notifications within the two countries.
As of September 2013, the Canadian New Substances Program had assessed approximately 18 nanomaterials; the US New Chemicals Program had assessed approximately 130. In terms of notified uses, there was considerable consistency between the Canada/US Programs. The most prevalent uses were coatings, mechanical strength additives (e.g., composites), chemical intermediates, conductive additives, and dyes/inks. Production volumes in notifications to both the Canadian and US Programs ranged widely, from less than 100 kg to greater than 10,000 kg per notified nanomaterial.
Comparison with Findings from other Commercial Data Gathering Activities
As per the RCC Nanotechnology Work Plan, the two countries also shared information and lessons learned from other commercial data gathering activities. This information is summarized below, and, where possible, compared with the information on nanomaterials notified under the Canada/US Programs.
To supplement the data gathered through PMNs, the US also looked at data gathered through the United States Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program (NMSP). In 2008, the NMSP requested voluntary submissions of information from manufacturers, importers, processors and users of nanomaterials. From 2008 - 2009, 29 companies and trade associations submitted information to the US EPA on a total of 123 nanoscale materials based on 58 different chemicals. (Although there was some overlap, these 123 materials are not the same as the approximately 130 notices reviewed by the US New Chemicals Program noted previously.) Approximately 75 – 80% of these submissions included some type of use information although the information was very limited (e.g., no submission contained sufficient information for EPA to conduct an exposure assessment without the use of generic industry exposure scenarios).
When the US EPA compared the information obtained through the NMSP with other available information, including the Woodrow Wilson Project on Emerging Nanotechnology Consumer Products Inventory and the Nanowerk Nanomaterials Database, it was estimated that there were over 200 existing nanomaterials being produced for commercial and R&D purposes in the US. The US EPA acknowledged that this type of comparison has significant limitations because none of the databases was designed to answer questions regarding any specific company’s production or use of a particular nanoscale material, many of the nanomaterials in the databases could be excluded from or exempt from TSCA regulation (e.g., for research and development or pesticide or food/drug-related uses), and none of the databases provided the specific molecular identity and form of a particular nanoscale material for verification.
Post-analysis, 28 of the 200+ existing chemicals being produced at the nanoscale were included in the NMSP nanomaterials submissions; these 28 are included in the 130 nanomaterials assessed by the US New Chemicals Program. The chemicals were generically identified as metals, metal oxides, carbon nanotubes, amorphous silica, organic polymers, and nanoclays. Reported uses were similar to what had been notified as PMNs, including imaging agents, plastic additives, catalysts, coatings, ingredients in sunscreens, cells for batteries, and composite parts for marine, aircraft, and automobile applications. No particular uses predominated.
The NMSP is considered a limited success primarily due to under-participation, and because a number of environmental health and safety data gaps still exist. Many submissions were for research and development only, and a significant number were also submitted as PMNs, although some were submitted after NMSP. The NMSP did, to a limited degree, improve the US EPA’s understanding of nanomaterials and the nanomaterials industry, contribute to EPA’s engagement with other agencies and international bodies, and inform next steps on regulatory and research issues.
In Canada, the federal Department of Industry maintains Company Directories for Nanotechnologies, organized under broad categories such as Nanotechnology Appliers or Users, and Nanotechnology Producers; as well as by Advanced Materials, including Advanced Metals, Ceramics and Composite Materials. There are approximately 120 companies listed in the directories: inclusion is voluntary, and all listed information is provided by the companies. The information provided varies widely by company, and may include: company information; product, service or licensing information; technology and market profiles; and, sector information. The database is not comprehensive as companies involved in nanotechnology may or may not have self-identified. As well, the database is limited as the type of nanomaterial being used is not generally identified.
There are several provincial nanotechnology associations in Canada who have undertaken efforts to identify companies involved in nanotechnology, and nanomaterials and nanomaterial uses within their jurisdictions. In 2009 Alberta Innovates Technology Futures (formerly Alberta Ingenuity, Alberta Research Council, iCORE, and nanoAlberta) produced an asset map, designed to “to present a snapshot of nanotech activity in the province”. The report identified 22 nanotechnology companies operating in Alberta and placed them into five categories based on industrial uses: nano-intermediates (38%); nano-enabled products (33%); nano-services (13%); nanomaterials (12%); and nano-tools (4%).
Another provincial association, NanoQuébec, also looked at nanotechnology research and industrial activities within its provincial boundaries. It identified that at least 64 companies in Québec are using and/or testing nanomaterials for commercial purposes. The main nanomaterials being used in Québec were found to be nanocrystalline cellulose (NCC), carbon nanotubes, and quantum dots. Intended uses included: industrial and medical membranes, protective coatings, imaging devices and agents, drugs, lab-on-a-chip applications, paper, printed electronics applications, fuel cells, solar cells, textiles, security clothing, and food packaging.
Information on nanotechnologies in Canada was also gathered from the online database Nanowerk also used by the US EPA for its 2008 research. Although this database is not rigourously collated or validated, and may therefore contain out-of-date or inaccurate information, the New Substances Program was able to use some of the Nanowerk data by doing additional verification (e.g., web searches).
Based on information gathered from these sources, approximately 100 companies have been identified which appear to be manufacturing, importing or using nanomaterials in Canada. Analysis indicates there are a similar number of nanomaterial producers and of nanomaterial integrators (companies who integrate nanomaterials in other materials or products along the value chain) in Canada. Geographic clusters of nanotechnology companies can be found in Toronto, Vancouver, Montréal and Ottawa. The primary nanomaterials being produced or being used for commercial purposes in Canada are: nanoparticle metals (e.g. iron, copper), metal oxides, metalloids (e.g., silica), carbon nanotubes, and organic (e.g., NCC). The main use categories for these nanomaterials are: coatings, composites, and dyes/pigments/inks. These overall findings are consistent with information received through notifications to the Canadian New Substances Program.
A report on the global nanotechnology industry released in January 2013 by Future Markets, a London, UK-based technology consulting firm with an expertise in nanotechnology, provided a review of the main nanomaterials suppliers and user markets for 30 nanomaterials. The report also forecasted nanomaterial production and demand for nanomaterials by end-user market from 2010 through to 2020. (It should be noted that the nanomaterials identified in the Future Markets report may not be consistent with nanomaterials that the Canada/US Programs consider to be nanomaterials.) The report predicts that the global nanotechnology market will continue to grow over the coming decade, but also highlights the difficulty of obtaining accurate information on nanomaterial use, both current and projected. Its estimates for annual global nanomaterial production in 2010 varied from a conservative 400,000 tons to an “optimistic” 1 million tons; 2020 production estimates ranged from 1 million to 6 million tons.
In 2012, the largest global marketplace applications identified for nanomaterials by the Future Markets report were paints and coatings (19%), medical applications (14%), and electronics/optics (14%); the report predicts that most innovation and growth will occur in medical applications and electronics/optics. Cosmetics/personal care (10%) and composites (8%) were also identified as major areas of marketplace application. (The percentages cited above represent the estimated percentage of total global demand in 2012 for nanomaterials in those areas.) These findings suggest that coatings are currently the major commercially-relevant use of nanomaterials, which is consistent with notifications to the Canada/US Programs.
 United States Environmental Protection Agency (US EPA). January 2009. Nanoscale Materials Stewardship Program Interim Report.
 Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) 2008. Nanotechnology Consumer Products Inventory. Available online at: http://www.nanotechproject.org/inventories/consumer/. Accessed December 15, 2008.
 Nanowerk is a for-profit nanotechnology portal with offices in the US and Europe; the US used the data available when they did their research, in 2008.
 United States Environmental Protection Agency (US EPA). January 2009. Nanoscale Materials Stewardship Program Interim Report.
 Researchers validated those companies listed in the Industry Canada database to ensure they were still producing and/or using nanomaterials.
 Industry Canada. 2011. Company Directories for Nanotechnologies. Available online at: http://www.ic.gc.ca/eic/site/aimb-dgami.nsf/eng/03503.html.
Alberta Innovates – Technology Futures/NanoAlberta. 2009. Creating Opportunity: Alberta’s Nanotechnology Asset Map 2009.
 NanoQuebec. 2013. Mapping of Quebec Companies Using Nanomaterials in their Product Development and Highlight of Main Market/Application Trends.
 Nanowerk. 2013. Nanotechnology companies in Canada. Available online at: http://www.nanowerk.com/nanotechnology/Nanotechnology_Companies_Research_and_Degree_Programs_in_Canada.php.
 Future Markets Inc. 2013. The Global Nanotechnologies and Nanomaterials Industry.
Nanomaterials Use Matrix: Purpose, Inclusions and Findings
Purpose and Inclusions
The information on nanomaterial uses gathered through the RCC Nanotechnology Initiative has been used to create a Nanomaterials Use Matrix. This represents the most up-to-date information the Canada/US Programs have on a wide range of known commercially available nanomaterials. The data was collected from a variety of sources, as outlined in Sections 2.0 and 3.0, including information from the Canadian and US regulatory programs, publicly available and third-party information (such as the Future Markets report and the Nanowerk database). As well, the Canada/US Programs undertook extensive consultation with industry stakeholders to inform the Nanomaterials Use Matrix. This matrix lists nanomaterial uses that are (likely) currently or soon to be commercially available in Canada and the US.
The purpose for developing the Nanomaterial Use Matrix was to assemble a common foundation of information on commercially-relevant potential uses of nanomaterials in Canada and the US beyond those that are solely covered by new substances requirements under CEPA 1999 and TSCA. This information will provide the Canada/US Programs with a better understanding of potential exposures associated with various use scenarios. This should, in turn, help focus the Canada/US Programs information collection efforts on those uses with greatest potential for exposure, and may be used for the refinement of generic exposure models. However, the Nanomaterials Use Matrix in this document is not, by itself, a prioritization list or a categorization of nanomaterials of concern/no-concern, nor is it intended to be a verified/confirmed source of information on nanomaterial applications or products involving nanotechnology currently in the marketplace.
The Canada/US Programs recognize that the use categories in the Nanomaterials Use Matrix inevitably lead to areas of overlap as some categories represent more specific application areas than others. For example, silver is used in inks and also in electronics. The use matrix will continue to evolve as information becomes available.
Furthermore, the use matrix includes information about end products that are not within the scope of uses managed under the Canada/US Programs as they are regulated under other statutes (e.g. medical devices, drugs, cosmetics, food contact materials, and pesticides). All available information was incorporated for all known or reported uses of nanomaterials in order to estimate the potential cumulative exposure to workers, general population and the environment from industrial uses in risk assessments of substances under TSCA or CEPA 1999. Whether a particular use does or does not fall under TSCA jurisdiction, awareness of the various applications of a given nanomaterial will help the Canada/US Programs understand how its properties are intended to be applied in materials or products (e.g., antimicrobial properties of silver nanoparticles being used in textiles).
Finally, some of the third party sources of use information did not clearly distinguish between known and potential commercial uses; identification of a particular nanomaterial for a particular use does not imply that such materials have undergone relevant regulatory reviews. It is important to note that inclusion of a material/end product in the matrix does not confirm that the material/end product is currently in commercial use, has undergone relevant regulatory reviews, and/or has been approved/registered by relevant regulatory authorities. The inclusion of the material/end product in the use matrix is based on information available to or gathered by the Canada/US Programs, and includes unverified information gathered from publicly available databases. In addition, some of the reported uses covered in the matrix may relate to uses for investigational purposes only (rather than for commercial use). The Canada/US Programs used information about the stage of commercial development, as well as their best professional judgment, when deciding whether to include a particular use for a given nanomaterial.
Nanomaterials Use Matrix Findings
The Nanomaterials Use Matrix is attached in Annex 1. Figure 1 shows the number of nanomaterials that were found per use category. The categories in which the greatest numbers of nanomaterials are currently being used are: coatings, electronics, catalysts, inks and pigments, plastics, batteries, rubbers, ceramics and paints. This trend is similar to the uses identified by the Canada/US Programs from their NSNs and PMNs.
It should be noted that the uses information does not take production/import volumes into consideration since this information was not readily available. Volume information could be used to enhance understanding of the uses, which would better inform exposure scenarios. For example, electronics have a large number of nanomaterial uses listed in the matrix, but the total volume of nanomaterials used may be very low. Conversely, carbon nanotubes are the only nanomaterial used in the sporting goods category; however, they may be used in high volumes. The Nanomaterials Use Matrix also does not include specific information on the exact molecular identity of a particular nanomaterial, which may significantly alter the potential for exposure.
Another way to examine the information in the Nanomaterial Use Matrix is to see which nanomaterial classes are represented in the various uses. Figure 2 provides a breakdown of the number of uses within each class of nanomaterials. Metal oxides/metalloid oxides are the most frequently used nanomaterials, followed by organics, carbon nanotubes, metals/metalloids, inorganic carbon, and quantum dots. Enhancing Figure 2 with volume data (once available) would provide further insight into the relative importance of different classes of nanomaterials in Canada and the US.
Note that in both Figures 1 and 2, there may be overlap in some areas. For example, some uses are referred to by their functions - emulsion stabilizers, flame retardants - and others are based on end products.
Figure 1: Number of Nanomaterials by Use Category in the US and Canada
Figure 2: Number of Uses by Nanomaterial Class in the US and Canada
Considerations for Gathering/Sharing Additional Nanomaterial Use Information
As noted, the lack of volume information and specific molecular identity limits the usefulness of the information in the Nanomaterials Use Matrix for nanomaterial risk assessments. Relative volume-share information for each nanomaterial is lacking, and therefore the relative importance of each use in risk assessments could either be under- or over-estimated. Volume information would provide an additional level of confidence on the relative use of a nanomaterial in the two countries. The ability to share use information between the two countries could help. This can be done directly by notifiers through Canada’s New Substance Program and the New Chemicals Program in the US.
Since the completion of the RCC Nanotechnology Work Plan, Canada has continued to engage provincial nanotechnology associations and industry experts in Ontario, Alberta and Saskatchewan in order to further broaden our understanding of the Canadian nanomaterials marketplace.
Lastly, another way to analyze the use information would be to further organize it by the technical function a nanomaterial has within a product (e.g., uses organized by function such as magnetism or tensile strength). Such information would help the Canada/US Programs better identify potential uses to inform risk assessment and risk management, and to help in the derivation of environmental concentrations. This type of analysis will be conducted once the Canada/US Programs have a better understanding of nanomaterial functions.
Ongoing Collaborations and Regulatory Alignment: Barriers and Opportunities
A barrier to ongoing collaboration and regulatory alignment identified through this exercise was the ability to share Confidential Business Information (CBI) obtained through Canada’s New Substances Program and the New Chemicals Program in the US. A mechanism could be developed to allow for industry to voluntarily agree to the sharing of CBI from notified nanomaterials between the Canada/US Programs; this could involve a simple “check-box” on notification forms authorizing the sharing of information. This approach will be pursued post-RCC and stakeholders will be kept apprised of progress.
There are many opportunities for ongoing collaboration between Canada and the US to increase our knowledge and our regulatory alignment for nanomaterials. The information gathered through this exercise has resulted in a better understanding of the commercial uses of nanomaterials within the two countries, and will likely be used to inform both the risk assessment and risk management of nanomaterials.
Annex 1 – Nanomaterials Use Matrix 1
1. Inclusion of these use categories in this RCC document is not intended to imply confirmation of such uses or product categories by relevant regulatory agencies with jurisdictions over these product areas.↩
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