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Risk Assessment/Management

Future Harmonization Considerations

Areas of further collaboration and harmonization for risk assessment and risk management of nanomaterials between Canada and the US were discussed as part of the work undertaken by this task group[1].  Areas of future collaboration include:

  • Development of common approaches/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 nanomaterials for toxicity and prioritising toxicological testing (e.g., use of in vitro/high throughput methodologies), data generating and risk assessment as nanotechnology and nanoscience evolves.

Harmonization Timelines

The following could be harmonized in the short- to mid-term:

  • Sharing/development of standard operational procedures and guidelines to be used by both jurisdictions, including:
  1. use of similar criteria to choose analogues/surrogates;
  2. use of similar criteria to identify structures/characteristics of concern;
  3. creation of a list of structures/characteristics of concern to be used by both jurisdictions (possible); and,
  4. use of similar exposure control measures by controlling the allowed uses of the new substance.
  • Importance/weight given to a particular type of study for the assessment of toxicity (related to the notified use(s) and relevant route of exposure).
  • Criteria for evaluating the quality and relative weight of data from published scientific articles

The following could also be harmonized, although a longer timeline is likely:

  • Requirement of the same data/studies for the same uncertainties/concerns.
  • Coordinating the development of new approaches to developing data and assessing risk.

Areas That Cannot be Harmonized

  • Harmonization of assessment triggers, assessment timelines and data requirements, which are all prescribed in the regulations of each jurisdiction, would not be possible without amendments to regulatory statutes or regulations.

[1] It was recognised, however, that detailed discussions would be constrained by the inability to readily exchange information subject to CBI claims.