Waivers for New Substances and Organisms

Summary#

The notice says the Minister of the Environment granted exemptions from some information requirements under the Canadian Environmental Protection Act, 1999 for a number of companies. The exemptions cover tests normally required when someone wants to import or make a living organism or a new chemical substance that is not on Canada’s Domestic Substances List.

What it does#

• Lists companies that received waivers of specific test or data requirements for new living organisms. Companies named include Adaptimmune LLC, Allogene Therapeutics Inc., AstraZeneca Canada Inc., AVROBIO Inc., CanSino Biologics Inc., Cross Cancer Institute, CSL Behring Canada Inc., Future Fields, iECURE Inc., Janssen Inc., and PCI Pharma Services.
  • The kinds of information waived include tests on effects to aquatic and terrestrial plants, invertebrates and vertebrates, and tests of antibiotic susceptibility.
  • One waiver listed for Future Fields was for a test of ecological effects such as pathogenicity, toxicity or invasiveness.
  • Some entries show a number in brackets; that number is how many times that specific information requirement was waived for the company.
• Lists companies that received waivers for information about new chemical substances. Companies named include Arkema Canada Inc., BASF Canada Inc., and Evonik Canada Inc.
  • Waived information includes certain toxicity tests (for example, an in vivo mammalian mutagenicity test), and various physical-chemical data such as adsorption-desorption, hydrolysis rate by pH, water solubility and octanol/water partition coefficient.
• The notice explains these waiver decisions are made case-by-case by the Minister of the Environment in consultation with the Minister of Health.
• The notice also says about 400 regulatory declarations are submitted each year for new chemicals, polymers and living organisms, and about 100 waivers are granted annually for these categories.

Who's affected#

• The most directly affected are the named companies and other firms that import or manufacture new living organisms or chemical substances in Canada.
• Researchers, biotech and pharmaceutical companies, and contract manufacturers that work with new biological products or chemicals will notice similar rules when they submit new-substance notifications.
• The general public and environmental groups may be indirectly affected because waivers mean less public data may be produced about potential environmental or health effects.
• If it is unclear whether a particular company or product will be affected, the notice does not give more detail on specific products or risk assessments.

Why it matters#

• For companies: waivers can reduce the time and cost of bringing new organisms or substances into Canada, by allowing them to skip some tests.
• For regulators and health officials: waivers are supposed to be decided case-by-case and in consultation with health authorities, but they mean decisions rely on smaller bodies of information.
• For the public and environment: fewer required tests can mean less publicly available data about how a new organism or chemical might affect plants, animals or antibiotic resistance. That is a trade-off between faster access and lower transparency about environmental or health risks.
• The notice also gives a sense of scale: roughly 400 notifications and about 100 waivers happen each year, so this is a regular part of how Canada handles new substances and organisms.