Waivers for New Substances and Organisms

Summary#

The Minister of the Environment published a notice saying some companies were allowed to skip certain information when they notify the government about new living organisms or chemical substances under the Canadian Environmental Protection Act, 1999. The waivers remove the need to submit specific test data (for example, some ecological tests and antibiotic‑susceptibility tests) for the items listed in the Gazette.

What it does#

• Allows specific companies to omit particular test data when they submit notifications for living organisms not on the Domestic Substances List. Examples named in the notice include Adaptimmune LLC, AstraZeneca Canada Inc., Janssen Inc., AVROBIO Inc., and several others.
  • Types of living‑organism data waived include tests on effects to aquatic plants, aquatic invertebrates and vertebrates, terrestrial plants and invertebrates, and tests of antibiotic susceptibility.
  • One company (Future Fields) had a waiver for a test on ecological effects (pathogenicity, toxicity or invasiveness).
• Allows specific companies to omit particular test data when they submit notifications for chemical substances not on the Domestic Substances List. Examples include Arkema Canada Inc., BASF Canada Inc., and Evonik Canada Inc.
  • Types of substance data waived include an in vivo mammalian mutagenicity test for chromosomal aberrations or gene mutations, adsorption‑desorption screening, hydrolysis rate by pH, water solubility, and octanol/water partition coefficient.
• The notice says these waiver decisions are made case‑by‑case by the Minister of the Environment in consultation with the Minister of Health.
• The Gazette lists how many times a particular requirement was waived (shown in brackets in the table).

Who's affected#

• The named companies and other firms that make or import new living organisms or chemical substances. These are mainly biotech, pharmaceutical and chemical companies, and testing or manufacturing service providers.
• The regulator that runs the program (the federal Department of the Environment; the notice is part of the federal new‑substances review process).
• Researchers, environmental groups, and communities near potential releases may be interested because the waived tests relate to environmental effects and antibiotic susceptibility.
• It is unclear from the notice whether any members of the public will see immediate, direct effects from these specific waivers.

Why it matters#

• For companies: waivers can reduce the time, cost and data needed to bring new organisms or chemicals through the federal notification process. That can speed development and imports.
• For the environment and public health: skipping some tests means the government will have less of certain kinds of data when it assesses risk. That creates a trade‑off between faster approvals and less testing information.
• This is part of a routine practice: the notice says roughly 400 regulatory declarations are submitted each year and about 100 waivers are granted yearly, so waivers are a regular feature of the program.