Canada floats reduced animal testing for New Substance Notification Regulations for chemicals and polymers
Chemicals
| By WALKER LIVINGSTON, ESQ
Two Canadian departments have published a notice of intent to amend the country’s New Substance Notification Regulations for chemicals and polymers to promote reduced reliance on animal testing. The notice stems from a broader push in the Canadian government to reduce animal testing.
Regulatory background
- The Canadian Environmental Protection Act, 1999 (CEPA) acts as the overarching force behind chemical and environmental regulation in Canada. CEPA came into force in 2000 and has been amended several times in the interim. The Act covers a diverse array of areas, including pollution prevention, toxic substances management, vehicle emission regulations, as well as the basis for chemical substance registration and management in Canada.
- Under CEPA, new substances entering Canada must undergo ecological and human health assessments before they may be introduced into the marketplace. Canada divides these New Substance Notification Regulations (NSNR) between living organisms and chemicals and polymers. Chemicals and polymers require notification to the Canadian government if the substance is new to Canada (i.e., not already imported or manufactured into the country and present on the country’s Domestic Substances List) or is an already-present substance subject to Significant New Activity (SNAc) restrictions.
- Bill S-5, in its second permutation after failing to be passed before Parliament was dissolved in August 2021, includes clause 2(5), which requires the government to endeavor to “reduce, refine or replace the use of animal testing.” As Bill S-5 makes its way through Parliament, Environment and Climate Change Canada and Health Canada (together, the Departments), announced that both would be exploring regulations to curb animal testing for new chemicals and polymers entering the Canadian marketplace. Notably, the bill specifies that reducing animal testing refers to the effort to “replace, reduce or refine the use of vertebrate animals,” not including invertebrates for testing.
Notice of intent
- The Departments announced that if the regulations are enacted, they may accept data from new approach methods (NAMs) that act as alternatives to animal testing, if those NAMs provide a “scientifically valid measure” of the chemical or polymer undergoing testing. Traditional Canadian testing would require the use of toxicity tests in animals, but NAMs may be used to meet traditional information standards.
- In the guidance for the NSNR (Chemicals and Polymers), the Departments note multiple instances where a human repeated insult patch test (HRIPT) is an acceptable alternative to animal testing. HRIPTs are widely used in testing for personal care or pharmaceutical products, specifically in evaluating the safety of skin sensitizers. The Departments note that both a positive or a negative response to an HRIPT may be used in place of animal testing.
Next steps
- The Departments will accept comments on the proposal until March 29, 2023, via [email protected].
- The proposed regulations come at a point where many governments have proposed to reduce animal testing. The U.S. EPA published an updated work plan for NAMs that reduce the use of vertebrate animals in chemical testing. The EPA has broadly defined NAMs, explaining that the definition encompasses “any non Vertebrate Animals technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment.” In 2019, the EPA announced that it would eliminate animal testing on mammals by 2035, seeking to reduce funding and animal study requests by 30% of 2019 levels by 2025.
- As animal testing continues to fall out of favor, stakeholders will likely see additional regulation of private animal testing in addition to eliminating animal testing funding at the government level. As many research initiatives depend on government funding for survival, eliminating vertebrate animal testing in the future could have an effect far beyond the initially-targeted area.
To contact the author of this analysis, please email Walker Livingston ( [email protected])
To contact the editor of this analysis, please email Patricia Iscaro ( [email protected])