Minister waives data requirements for new substances

Summary#

On October 22, 2022, the federal government published notices saying the Minister of the Environment waived some testing and information requirements under the Canadian Environmental Protection Act, 1999. The waivers apply to specific tests for named companies that want to import or make new living organisms or chemical substances not already on Canada’s lists.

What it does#

• Allows the Minister of the Environment to accept fewer data for certain new-living-organism and new-substance submissions. The legal basis cited is subsection 106(9) (living organisms) and subsection 81(9) (substances) of the Canadian Environmental Protection Act, 1999.
• For living organisms, common types of data waived include:
  • Tests on effects to aquatic plants, invertebrates and vertebrates.
  • Tests on effects to terrestrial plants, invertebrates and vertebrates.
  • Tests of antibiotic susceptibility.
• For chemical substances, common types of data waived include:
  • Vapour pressure, water solubility, density, and octanol/water partition coefficient.
  • Hydrolysis rate as a function of pH.
  • Molecular weight and residual-constituent concentration information.
  • Tests such as skin irritation, skin sensitization, acute mammalian toxicity, in vivo mutagenicity, and adsorption–desorption screening.
• The notices list specific companies that received waivers. Examples named include AlloVir, Inc., CRISPR Therapeutics AG, Merck Canada Inc., BASF Canada Inc., and Stratasys Ltd. (the full notices contain the complete lists).
• The Gazette item says these waiver decisions are made case-by-case and in consultation with the Minister of Health. It also notes about 400 regulatory declarations are submitted each year and about 100 waivers are granted annually.

Who's affected#

• Companies or labs that propose to import or manufacture living organisms or chemical substances that are not on Canada’s Domestic Substances List. Some named recipients were biotech and pharmaceutical firms and chemical suppliers.
• Regulators at Environment and Health departments (they review and approve waivers).
• Other interested parties — for example, researchers, suppliers, environmental groups, and nearby communities — because some types of environmental or toxicity test data will not be required in these cases.
• If it is unclear whether a particular product or company would qualify for a waiver, the notice does not provide a simple threshold — decisions are made case-by-case.

Why it matters#

• For companies: getting a waiver can save time and money and may speed up the ability to import or produce a new organism or substance in Canada.
• For the public and environment: fewer required tests can mean less publicly available information about possible environmental or health effects, which increases uncertainty about risks.
• The notices show the government balances regulatory burden and available evidence on a case-by-case basis, and that these waivers are a recurring part of Canada’s review process (about 100 waivers a year).