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Risk Assessment/Management

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The Regulatory Cooperation Council (RCC) Nanotechnology Initiative was established to increase alignment of regulatory approaches for industrial nanomaterials (herein referred to as “nanomaterials”) between Health Canada/Environment Canada and the United States (US) Environmental Protection Agency. This report presents findings from Work Element 3: Risk Assessment/Risk Management; the overarching action item for this work element was the sharing of best practices for assessing and managing the risks of nanomaterials.   

In order to provide regulatory context to the analysis of risk assessment and risk management methods used by the New Substances Program in Canada and the New Chemicals Program in the US (Canada/US Programs), and to develop an understanding of the regulatory requirements, policies and options in Canada and the US, a comparative analysis of regulatory frameworks under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the Toxic Substances Control Act (TSCA 1976) was undertaken through a review and analysis of the respective legislations, regulations, policies and material definitions.  Though no specific regulations for nanomaterials have been developed, both jurisdictions believe that existing regulatory tools for industrial chemicals are applicable to nanomaterials. Nanomaterials are not specifically named in any of the regulations, although the definitions of a ‘chemical’ or a ‘substance’ under these legislative tools are considered broad enough to include nanomaterials.  This finding is consistent with the international consensus that current regulatory frameworks are appropriate for nanomaterials, albeit with some modifications (i.e., Draft OECD Council Recommendation on the Safety Testing and Assessment of Manufactured Nanomaterials).

Though some regulatory differences were identified between the Canada/US Programs within their respective pre-market notification requirements, information packages, assessment timelines, and target populations of interest, the overarching principles for the assessment and management of the risks of nanomaterials are consistent between the two.  

In order to develop an understanding of the methodologies and tools used by the Canada/US Programs to support regulatory decisions, a comparative analysis of current risk assessment and risk management approaches to nanomaterials in Canada and in the US was conducted using a case study approach.  This analysis demonstrated that the Canada/US Programs share many more commonalities in their approaches to the risk assessment and risk management of nanomaterials than they do differences: risk assessments of nanomaterials in the Canada/US Programs employ a conservative approach and are assessed on a case-by-case basis. Furthermore, management efforts are designed to reduce exposures and allow further assessment of potential scenarios of increased environmental release and/or direct human exposure when appropriate. 

After the comparative analysis of regulatory frameworks and approaches was complete, a common framework for systematically focusing human health concerns and additional testing requirementsfor nanomaterials based on physical-chemical characteristics, and a common outlook on the environmental fate and ecological effects of nanomaterials were developed. The development of these common approaches reflects an effort to increase consistency, transparency, and predictability between the jurisdictions.

Further areas of possible collaboration and harmonization were also discussed.  It was recognised that ongoing collaboration would be constrained by the current inability to readily exchange notification information because of Confidential Business Information (CBI) requirements. 

Future areas that were identified for collaborative activities include:

  • Further development of common approaches/standard operating procedures (SOPs) for the assessment of human health hazard, exposure, environmental fate and ecotoxicity of nanomaterials to be used by both jurisdictions.
  • Development/adoption of new approaches to screening and prioritizing toxicological testing (e.g., the use of in vitro/high throughput methodologies), data generation, and risk assessment of nanomaterials as nanotechnology and nanoscience evolves.

Context

The Regulatory Cooperation Council (RCC) Nanotechnology Initiative was established to increase alignment in regulatory approaches for nanomaterials between Canada and the United States (US)[1] 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 1976).

The overarching action item identified for Work Element 3, Risk Assessment/Risk Management, in the RCC Nanotechnology Work Plan is to share best practices for assessing and managing the risks of nanomaterials.  In order to share best practices and develop mechanisms of cooperation on risk assessment and risk management between Canada and the US, the work plan included the following objectives:

  • development of an understanding of the regulatory requirements, policies, and regulatory options available to each jurisdiction;
  • development of an understanding of the methodologies and tools used by the Canadian New Substances Program and US New Chemicals Program (Canada/US Programs); 
  • identification of mechanisms for sharing information and tools (including Confidential Business Information [CBI], subject to appropriate protections); and,
  • development of mechanisms for stakeholder outreach and engagement.

(Because CBI sharing and stakeholder outreach are issues that affect each of the RCC Joint Action Plan Work Elements, these are not specifically addressed within this report.) 

In order to meet the proposed objectives, the following tasks were undertaken:

  • A comparative analysis of regulatory frameworks was conducted in order to identify commonalities, differences and gaps.
  • A comparative analysis of current assessment approaches for nanomaterials in the Canada/US Programs was conducted through case studies/peer reviews of each other’s assessments.
  • A best practices document for the assessment and management of nanomaterials was prepared, taking into consideration current data/knowledge gaps.
  • Barriers to and opportunities for ongoing collaborations and regulatory alignment were identified.

After the comparative analysis of regulatory frameworks was complete, a common framework for systematically focusing on human health concerns and additional testing requirements for nanomaterials based on physical-chemical characteristics, and a common outlook on the environmental fate and ecological effects of nanomaterials were developed. The development of these common approaches reflects an effort to increase consistency, transparency, and predictability between the jurisdictions.

Further areas of possible collaboration and harmonization were also discussed.  Future areas that were identified for collaborative activities include:

  • further development of common approaches/standard operating procedures (SOPs) for the assessment of human health hazard, exposure, environmental fate and ecotoxicity of nanomaterials to be used by both jurisdictions; and,
  • development/adoption of new approaches to screening and prioritizing toxicological testing (e.g., the use of in vitro/high throughput methodologies), data generating, and risk assessment of nanomaterials as nanotechnology and nanoscience evolves.

This report is a summary of the work conducted under Work Element 3 over from November 2012 to April 2014  . Supporting information and a more detailed description of the tasks described above can be found in the Appendices.



[1] 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.

Introduction