Mitotane subject to SNAc rules

Summary#

This Order — Order 2021-87-21-01 Amending the Domestic Substances List — makes the chemical known as mitotane subject to Canada’s “significant new activity” rules. From its registration day (July 5, 2021), anyone planning new or expanded uses of mitotane must notify the federal government in advance and provide specific information about the planned activity.

What it does#

• Adds the substance identified by CAS number 53-19-0 (mitotane) to Part 2 of the Domestic Substances List so the Canadian Environmental Protection Act, 1999 significant new activity (SNAc) rules apply.
• Requires a formal notification to the Minister at least 180 days before starting any significant new activity that would import, manufacture, or use mitotane in ways not already exempted.
• Exempts certain existing or small-scale uses from notification, including:
  • use in therapeutic products that are authorized in Canada or under review (including clinical trials);
  • use as a laboratory analytical standard at ≤ 10 g per year;
  • research and development use at ≤ 10 g per year.
• Sets out what information must be included in a notification (for example: description of the activity, anticipated annual quantity, product uses, site locations, and technical and safety data). More detailed data are required for activities likely to lead to environmental release or wider use.
• The Order is part of the government’s follow-up after a screening assessment found environmental concerns for the substance.

Who's affected#

• Companies or people who would import, manufacture, or use mitotane for new or expanded purposes not already covered by the exemptions. That can include:
  • chemical manufacturers and importers;
  • pharmaceutical companies proposing new uses of mitotane outside existing authorized medical uses;
  • laboratories or contract testing facilities that would use more than 10 g per year as a standard;
  • firms planning to use mitotane in consumer products, cosmetics, natural health products, or as a site-limited intermediate.
• Hospitals and clinics are not affected for current, authorized medical uses of mitotane.
• The general public is unlikely to see direct effects unless new uses lead to changes in availability or environmental releases.

Why it matters#

• The government’s assessment found mitotane persists in the environment, can build up in organisms, and is highly toxic to aquatic life at low concentrations. That is why new or expanded uses are being tracked.
• The notification rule gives regulators time (at least 180 days) to review proposed new activities and require additional risk controls before those activities start.
• The Order keeps current medical uses available while aiming to prevent increases in environmental release that could harm wildlife or water quality.
• The screening assessment estimated possible local environmental concerns near wastewater discharges: modelling used 1,000 wastewater treatment discharge points and suggested exceedances could occur at around 25 to 250 sites (about 2.5% to 25% of sites) under certain assumptions. This is why new, larger-scale uses are being restricted by notification.