CANADA | Nanomaterials: update and next steps: outcome of the Chemicals Management Plan Stakeholder Advisory Council Meeting held 2019

Nanomaterials: update and next steps

Representatives from HC gave a presentation on the Government of Canada’s (GoC) regulatory activities to address nanomaterials under CEPA 1999. The presentation included an overview of the CMP assessment process for nanomaterials, including the risk assessment framework, and the ongoing collaborative international efforts to establish harmonized regulations for nanomaterials—an emerging CEPA-toxics category.

The CMP is working to determine what nanomaterials are in commerce, in what format, and the risks or implications of these substances on human health and the environment. Following a two-year data gap analysis, the nanomaterials in commerce have been identified and work to fill remaining gaps is ongoing. The next step in this work is to develop a new risk assessment framework that clearly articulates to stakeholders how these substances will be assessed and managed from a regulatory perspective.

Given the unique properties of nanomaterials, the new risk assessment framework must support a cautious, tiered approach that accounts for both evidence- and risk-based assessment principles. The framework will also leverage the best available knowledge on nanomaterials, leading to a well informed and harmonized international approach to the regulatory management of nanomaterials. In the coming months, the draft nanomaterials risk assessment framework will be circulated for internal consultation, followed by external consultation prior to being published.

With these consultations in mind, the CMP staff noted the importance of continuing to fill data gaps through voluntary outreach, targeted information gathering on priority substances, and ongoing research into what data has been collected internationally and how that can inform the CMPs approach.

Discussion summary

Council members discussed the importance of the risk assessment framework for existing nanomaterials and explored how future or new nanomaterials listed for review will be managed. Options discussed for future management included adding a mechanism to require pre-market assessment of nano forms of DSL substances to prevent a growing list of substances for review under the CMP program or revising the New Substances Notification Regulations post 2020 to include a nano-specific schedule. The CMP staff noted the ideas for consideration and flagged that Significant New Activity (SNAc) procedures and precautionary principles are currently being used for many of these substances. Notably, the discussion around nanomaterials highlighted the need to approach the development of policies and processes with careful consideration of chemicals management ethics.

Action item

• Follow-up discussion on how to capture or identify existing substances in nano form, and how to use SNAc procedures better

While council members supported the risk assessment framework and noted it is a logical approach, it was noted that, in many cases, there is a lack of information and data about how nanomaterials function. Recognizing there are many unknowns, the work being done to better understand nanomaterials is informed by the basic laws of chemistry widely used in science. Staff also highlighted the valuable experience and knowledge on nanomaterials being shared by experts within the community of international regulators and scientists. Council members had a good discussion regarding the various unknowns related to the use and production of nanomaterials as well as the many positive uses—for example, in areas such as medicine.

Council members noted that this work would benefit from broad input from the Science Committee or Council of Canadian Academies, as well as other experts in the field of nanomaterials.

Action item:

• Engage experts from various fields on the risk assessment framework of nanomaterials

As the work to develop a nanomaterials risk assessment framework continues, council members noted the importance of ongoing stakeholder engagement. Council members noted the industry stakeholder support for this work and acknowledged the importance of working collaboratively on an international scale to address this emerging area. Council members briefly discussed the engagement strategy—distinguishing between public engagement, aimed at providing information to the public for use in making informed decisions, and industry engagement, aimed at ensuring regulatory decision-making is carried out in a clear, transparent, and balanced way.