Waivers for New Substances and Organisms

Summary#

This notice says the Minister of the Environment has allowed several companies to skip some of the usual test data when they submit new-substance or new-living-organism notifications under the Canadian Environmental Protection Act, 1999. The waivers cover specific laboratory and ecological tests and are described in two lists: one for living organisms and one for chemical substances. The government notes there are about 400 new-substance/organism declarations each year and roughly 100 waivers granted annually.

What it does#

• Lets companies request that the government waive certain information they would normally have to provide when proposing to import or make a new organism or substance not already on Canada’s domestic lists under the Canadian Environmental Protection Act, 1999.
• Waivers granted in this notice include requests to omit:
  • Data on effects of living organisms on aquatic plants, invertebrates, and vertebrates.
  • Data on effects of living organisms on terrestrial plants and invertebrates.
  • Tests of antibiotic susceptibility for certain organisms.
  • In vivo mammalian mutagenicity tests for chemicals (chromosomal or gene mutation tests).
  • Physical–chemical data such as adsorption–desorption screening, hydrolysis rate by pH, water solubility, and octanol–water partition coefficient.
• Examples of companies listed as having received waivers (not a complete list): Adaptimmune LLC, Allogene Therapeutics Inc., AstraZeneca Canada Inc., Janssen Inc., BASF Canada Inc., Arkema Canada Inc..
• The notice says these waiver decisions are made case-by-case and are done in consultation with Health Canada.

Who's affected#

• The most directly affected are the biotech, pharmaceutical, research and chemical companies that submit new-substance or new-organism notifications. Several specific firms are named in the notice.
• Regulators at Environment Canada and Health Canada are involved because they review and approve these waiver requests.
• The general public and environmental groups may be indirectly affected because waivers mean less testing information is supplied to the government about some new organisms or chemicals. The notice does not say whether any of these specific waivers raise health or environmental concerns.

Why it matters#

• For companies: waivers can speed up filing and reduce the cost and time needed to bring new organisms or chemicals into Canada.
• For regulators and the public: waivers mean some types of environmental or toxicity data won’t be on file for the substances or organisms listed. That could affect how much information is publicly available about possible ecological effects.
• The notice frames this as a routine part of the new-substances program: decisions are made case-by-case with Health Canada, and the government reports roughly 100 waivers are granted each year.