Canada Publishes New Nanomaterial Risk Assessment Framework Under the Canadian Environmental Protection Act
After much anticipation, Environment and Climate Change Canada (ECCC) and Health Canada (HC) have released the final version of their Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act (CEPA), 1999. The Framework establishes how nanomaterials (NMs) will be assessed for their risks to human health and the environment under CEPA.
The Framework applies to new and existing NMs in Canadian commerce, and is organized into three sections:
Context, scope, purpose, and supporting policies;
Overview of the existing chemical risk assessment framework; and
NM-specific considerations and modifications.
One key feature is expanded guidance on how NMs are defined under CEPA. The Framework adopts HC’s Working Definition of Nanomaterials (2011) and specifies it includes any manufactured substance or product and any component material, ingredient, device or structure that:
it is at or within the nanoscale (1-100nm) in at least one external dimension, or has internal or surface structure at the nanoscale; or
it is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena.
The framework further clarifies that a substance is evaluated as a NM if 10% or more by number OR 1% by weight of primary particles have at least on internal or external dimension in the nanoscale. Agglomerates and aggregates are considered NMs regardless of their external dimensions if the constituent particles meet the definition of a NM.
Other notable elements include:
1. Physical and chemical data recommendations for NMs, including particle characterization;
2. Considerations for grouping, read-across, weight-of-evidence (WoE), and alternative test methods; and
3. The risk assessment framework for NMs under CEPA.