Waivers Granted for New Substances and Organisms

Summary#

On July 27, 2024, the Canada Gazette published notices that the Minister of the Environment waived some information requirements under the Canadian Environmental Protection Act, 1999 for a small list of proposed new living organisms and chemical substances. The notices name the companies and the specific kinds of test data they were allowed not to submit.

What it does#

• It records waivers the Minister granted that remove the requirement to provide certain test data when a company proposes to import or manufacture a living organism or substance not already on the Domestic Substances List.
• For living organisms, the following companies had some test-data requirements waived:
  • Canadienzyme Inc. — data from tests of antibiotic susceptibility ((4)).
  • Cordex Biologics Inc. — data on effects on aquatic plants, invertebrates and vertebrates; effects on terrestrial plants and invertebrates; and tests of antibiotic susceptibility.
  • Janssen Inc. — data on effects on aquatic plants, invertebrates and vertebrates; effects on terrestrial plants and invertebrates; and tests of antibiotic susceptibility.
  • Qeen Biotechnologies — data on effects on aquatic plants, invertebrates and vertebrates ((2)); effects on terrestrial plants and invertebrates ((2)); and tests of antibiotic susceptibility ((2)).
  • Solid Biosciences — data on effects on aquatic plants, invertebrates and vertebrates; effects on terrestrial plants and invertebrates; and tests of antibiotic susceptibility.
• For chemical substances, the following companies had specific data points waived:
  • 3313045 Nova Scotia Company — data on octanol/water partition coefficient.
  • Milliken & Company — data on density.
  • NextStar Energy Inc. — data on density.
  • Sika Canada Inc. — data on water solubility.
  • Wego Chemical Group — data on hydrolysis rate as a function of pH.
• The notices include an explanatory note saying waiver decisions are made case-by-case by the Minister of the Environment in consultation with the Minister of Health. They also point readers to the New Substances website for more information.

Who's affected#

• Companies that want to import or manufacture living organisms or chemical substances that are not on the Domestic Substances List. The companies named above are directly affected because they received waivers.
• The Minister of the Environment and Minister of Health, who review and approve waiver requests.
• People and groups who follow environmental testing and safety data (researchers, environmental organizations, and potentially local communities) because fewer required tests mean less new data is submitted to the government.

Why it matters#

• A waiver means a company did not have to submit specified test results that would normally be provided before new organisms or substances are reviewed. The notice itself does not say the organism or substance is approved or in use.
• These waivers affect what information is available to regulators and the public about potential environmental or antibiotic-resistance risks from new organisms or chemicals.
• Waivers are fairly common: the notice says about 400 regulatory declarations are submitted each year and around 100 waivers are granted annually.