Nanotechnology, defined by the manipulation of matter at the 1-100 nanometer scale, continues to unlock significant innovation across industries, driving the growing presence of manufactured nanomaterials (NMs) in the Canadian market.
In response, Canada regulates these substances under the Canadian Environmental Protection Act, 1999 (CEPA), which provides the authority to collect information and to assess and manage risks of substances to the environment and human health.
Guidance on adapting the existing practices for risk assessment
In 2013, the Organization for Economic Co-operation and Development (OECD) recommended its Member Countries apply existing international and national chemical regulatory frameworks to manage the risks associated with manufactured NMs:
“to manage the risks of manufactured nanomaterials, [country members should] apply the existing international and national regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials” (OECD 2013).
As such, the principles used for the assessment of substances in Canada are appropriate for the assessment of NMs with necessary modifications to address the specificities of NMs. This framework provides guidance on adapting the existing practices for risk assessment to account for the novel properties exhibited by substances at the nanoscale in accordance with the OECD recommendation.
Structure of the risk assessment framework
The framework is divided into three sections. Section 1 introduces the context, the scope, and the purpose of the document. It also contains a summary of the policies that support the risk assessment of NMs under CEPA. Section 2 provides an overview of substance risk assessment under CEPA. Although section 2 is not specific to NMs, it provides context on practices and processes generally used under CEPA to assess substances, considering that many of the principles used for the assessment of substances are appropriate for the assessment of NMs. Section 3 presents modifications to those general practices and processes for risk assessment to address the specificities of NMs.
Notably, the nanomaterial-specific considerations for risk assessment include discussions on the physical and chemical properties specific for NM identification and characterization, their behavior, and their potential effects on human health and the environment. Furthermore, section 3 explains how the overall risk characterization of NMs is conducted under CEPA and how uncertainties are weighted into risk characterization.
This document was prepared by staff in the Chemicals Management Program at Health Canada and Environment and Climate Change Canada and incorporates input from other programs within these departments. The draft of this document (published June 17, 2022) was subject to a 60-day public comment period. While external comments were taken into consideration, the final content of the document remains the responsibility of Health Canada and Environment and Climate Change Canada.