Nanotechnology is still an emerging area, primarily used as an enabling technology to improve the performance of existing technologies (e.g., coatings and composites). Nanotechnology is used in a wide variety of applications (See Figure 1) encompassing many different regulatory regimes in Canada and the US.

The RCC Nanotechnology Initiative addressed nanomaterials considered to be new substances regulated in Canada under the Canadian Environmental Protection Act, 1999 (CEPA, 1999) and in the US under the Toxic Substances Control Act (TSCA). In this context, these substances are often referred to as industrial nanomaterials (herein referred to as nanomaterials). 

Figure 1: Examples of Nano-enabled Technologies[1].

applications of nanoparticles

All new substances, including nanomaterials, must be notified to the Canadian New Substances Program and/or the New Chemicals Program in the US (Canada/US Programs) for a pre-market environmental and human health risk assessment. A “new substance” refers to a substance that is not on a public inventory (the Domestic Substances List in Canada or TSCA Inventory in US).  Nanomaterials in Canada and the US are currently evaluated under existing chemical risk assessment frameworks.[2]

Since there is no regulatory definition for nanomaterials, the Canada/US Programs both identify nanomaterials based on: (1) a size range of 1-100nm; and/or (2) particles which exhibit nanomaterial properties outside the 1-100nm size range. These nanomaterial identification criteria, identified by    stakeholders at the November 28, 2012 RCC webinar, will likely evolve with the science of nanomaterials. Both countries actively follow and/or participate in international discussions on definitions and nomenclature at the International Organization for Standardization (ISO); information from these discussions is considered in determining definitions and nomenclature of nanomaterials within their respective domestic programs.

The manipulation of matter at the nano-scale is creating many novel substances with characteristics that are not always predictable based on current knowledge. For example, a substance with a fixed composition can be engineered into many different forms (e.g., spheres, fibres, and sheets) with varying physical characteristics (e.g., size, surface area, crystal structure) at the nano-scale.  Though these different forms possess identical composition, the effects of changing the physical characteristics may alter the substance’s behavior in environmental and biological media. The near-limitless diversity of substances that can be engineered from one particular composition can also have a near-limitless spectrum of toxicity: some particles may confer health benefits, others may be harmless, some become toxic, and some may retain the toxicity profile of the original bulk counterpart.  These characteristics, together with the current lack of scientific information and data on potential exposures to specific nanomaterials and the resultant hazards, make the risk assessment of nanomaterials more challenging than the risk assessment of traditional chemicals. These challenges underscore the need to develop harmonized approaches and methodologies.

Prior to the RCC, Health Canada, Environment Canada, and the EPA worked bilaterally on nanomaterial risk assessments on an ad hoc basis, and internationally within the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN). The RCC Nanotechnology Initiative supported regular engagement between Canada and the US and relevant stakeholders within each country – including industry, NGOs, and academia – in order to facilitate knowledge-sharing and the development of risk assessment approaches for nanomaterials designed to benefit both governments and stakeholders.

[1] Tsuzuki, Takuya; Int. Jo. Nanotech., 2009, 6, 567-578.

[2] This is consistent with the OECD Council recommendation “Members… apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.”