Canada’s new strategy on animal testing

Canada's health and environment ministries, namely Health Canada (HC) and Environment and Climate Change Canada (ECCC), are actively seeking public input as they embark on the development of a comprehensive strategy to reduce the use of vertebrate animal testing in the assessments of chemicals. HC and ECCC are responsible for assessing and managing a wide range of health and environmental risks, including those posed by chemicals, under the Canadian Environmental Protection Act (CEPA). CEPA is the primary legislative framework governing pollution prevention in Canada and provides the legal foundation for a range of federal environmental and health protection initiatives. 

Background 

The process of prioritizing and assessing chemical risks largely relies on data derived from toxicity tests conducted on vertebrate animals to evaluate potential adverse effects. Nonetheless, these studies using experimental vertebrate animals are not only costly and time-consuming but may also have limited biological relevance, in addition to ethical concerns related to animal welfare. In light of these challenges, New Approach Methods (NAMs) have emerged as a promising alternative to traditional vertebrate animal-based approaches for chemical toxicity testing and risk assessment. 

NAMs are broadly defined as any technology, methodology, approach, or combination thereof that can replace, reduce, or refine animal toxicity testing, potentially leading to faster and more effective prioritization and assessment of chemicals. These methods cover a wide range of possibilities, including the use of computer-based models, modernized whole organism assays, assays using biological molecules, cells, tissues, or organs, as well as exposure prediction techniques. 

As part of their ongoing commitment to integrate NAMs into regulatory programs under CEPA, the HC and ECCC are working diligently to develop and standardize of NAMs. Simultaneously, they are actively establishing frameworks and tools to facilitate the ongoing evaluation and incorporation of non-animal data and alternative approaches in prioritization and risk assessment.  

These scientific advances are in line with the efforts by various regulatory authorities around the world, such as those in the United States, Australia, and the European Union, which are increasingly emphasizing modern approaches to minimize the use of vertebrate animals in toxicity testing. These efforts include strategies and research programs designed to accelerate the development and implementation of NAMs for regulatory decision-making. 

The current initiative involves the formulation of a comprehensive strategy to guide the future efforts of the HC and ECCC in their quest to minimize the reliance on vertebrate animal testing under CEPA for the assessment of potential risks to human health and the environment. Although initially developed within the context of CEPA, this strategy has the potential for broader applicability to other Government of Canada regulatory programs, where relevant and feasible. Canada intends to collaborate closely with national and international partners in the development, standardization, and implementation of fit-for-purpose NAMs. Furthermore, building scientific confidence and garnering acceptance of NAMs within the Government of Canada and among external stakeholders is considered critical to the successful advancement and timely adoption of alternative methods and strategies for regulatory testing and assessment.  

This strategy responds to CEPA's commitment outlined in the Plan of Chemicals Management Priorities, which underscores the inclusion of activities and initiatives to promote the development and timely integration of scientifically justified alternative methods and strategies to replace, reduce, or refine the use of vertebrate animals in chemical testing. 

Key elements 

Key elements proposed to be addressed in this strategy include: 

1. Identifying and prioritizing the requirements for NAMs within chemical regulatory programs under CEPA. 

2. Promoting research and data generation for NAMs to support method development, standardization, and translational research. 

3. To promote harmonization, collaboration, communication, and engagement. 

4. Implement NAMs to reduce reliance on vertebrate animal toxicity testing in chemical regulatory programs under CEPA. 

Deadline 

This strategy, which is expected to be published alongside the Plan of Chemicals Management Priorities by June 2025, is an important step towards a more sustainable and ethical approach to chemical assessment. Comments on the animal testing notice are encouraged and should be submitted by January 29, 2024, providing a valuable opportunity for public input into this transformative endeavor.