Download Work Element 2 (PDF; 1.01 MB)
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 (CEPA) and in the US under the Toxic Substances Control Act (TSCA).
The overarching action item of Work Element 2, Priority-Setting, is to establish criteria for identifying key characteristics of nanomaterials and subsequently determining which nanomaterials are sufficiently different from their non-nano counterparts to warrant a closer examination for environmental, human health, and safety endpoints (those of concern); and which nanomaterials are sufficiently similar to their non-nano counterparts to be considered as traditional chemicals for regulatory purposes (those of no-concern).
Work Element 2 Deliverables:
- By November, 2013: Develop draft criteria for identifying characteristics of nanomaterials that are of potential concern/no-concern.
- Beyond November, 2013: Draft technical language providing common descriptions and criteria of classes of nanomaterials, and incorporate into summary report.
- Beyond November, 2013: Draft document on a common Canada/US approach to definition, characteristics and test methods for assessing nanomaterials.
The first deliverable for this Work Element is to develop draft criteria for identifying characteristics of nanomaterials of potential concern/no-concern. As part of this Work Element, the Canadian New Substance Program and the US New Chemicals Program (Canada/US Programs) developed a classification scheme which identifies which nanomaterials are likely to typically behave differently on the nanometer scale when compared to their bulk or molecular counterparts, and, those that are unlikely to behave differently than their bulk or molecular counterparts. Currently, this list is used only for sorting those nanomaterials which need additional nano-specific consideration (concern) and those that can be considered as traditional chemicals (no-concern). Exceptions will continue to be considered on a case-by-case basis.
To further develop this approach, scientific information is still needed on what unique properties nanomaterials have and how these properties affect organisms. This information will be incorporated as it becomes available.
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 evolve with science.
In the absence of specific criteria to determine nanomaterials of potential concern/no-concern for hazard assessment (more scientific information must be generated to determine criteria), the Canada/US Programs, in consultation with stakeholders, have developed a classification scheme for nanomaterials based on similarities in chemical composition that will support the use of analogue/read across information. (That is, identification of a chemical analogue to the nanomaterial in question and allocation of known characteristics from that analogue to the new nanomaterial.) The Canada/US Programs believe this is an appropriate first step in fostering discussion on the utilization of read-across information for similar nanomaterials.
The RCC classification scheme provides the Canada/US Programs with a framework to: (1) identify which classes of nanomaterials typically require nano-specific considerations in risk assessments; and, (2) support the selection of appropriate analogue/read-across information to be used in substance-specific risk assessments for nanomaterials. In addition, the classification scheme will also highlight the type of information needed for characterization of the nanomaterials within each class, providing consistency within classes in the information required by the Canada/US Programs for regulatory purposes.
This shared approach is expected to result in increased transparency, consistency, predictability and alignment between the Canadian New Substances Program and the US New Chemicals Program in the assessment and management of nanomaterials. This classification scheme is intended to be continually refined by Canada and the US as more scientific knowledge becomes available. The Canada/US Programs will also look to the global research community to help to validate and refine this approach.
In this document, the term “classification scheme” will refer to the organization of nanomaterials for regulatory purposes. The word ‘classification’ is not intended to be similar to its use in other regulatory/policy documents in Canada, the US or internationally.
 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.
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