Waivers for New Substances Information Requirements

Summary#

On April 30, 2022, the Department of the Environment published notices that it granted waivers of some information requirements under the Canadian Environmental Protection Act, 1999. The waivers let several universities and companies provide fewer test results when applying to import or manufacture certain new living organisms or chemical substances.

What it does#

• For living organisms, the department waived requirements for some test data that would normally show effects on aquatic and terrestrial plants and animals, and for tests of antibiotic susceptibility. Waivers were granted to institutions including McMaster University, Queen’s University, University Health Network, and Vertex Pharmaceuticals Incorporated.
• For chemical substances, the department waived specific testing requirements such as hydrolysis rate as a function of pH, vapour pressure, and certain in vivo mammalian mutagenicity tests. Waivers were granted to companies including 3M Canada Company, Chemical Compliance CA Inc., and Piramal Healthcare (Canada) Limited.
• The notices say these waivers are granted case-by-case and in consultation with the Minister of Health.

Who's affected#

• The named research institutions and companies listed above are directly affected because they received the waivers.
• More broadly, anyone who proposes to import or manufacture a living organism or a chemical substance that is not on the Domestic Substances List and who seeks a similar waiver could be affected, since waiver decisions change what information applicants must provide.
• The notices do not make clear how often similar waivers will be granted to other parties in future cases.

Why it matters#

• Waivers reduce the amount of testing data applicants must provide. That can speed research or product development and lower testing costs for the organizations involved.
• It also means regulators will be making assessments with less information in some cases. That could affect how much safety or environmental data is publicly available about a new organism or substance.
• The notices note that about 450 regulatory declarations are submitted each year and around 100 waivers are granted annually for chemicals, polymers and living organisms. For more information, the notices point readers to the waivers page on the New Substances website.