What We Heard: Draft strategy to replace, reduce, or refine vertebrate animal testing under the Canadian Environmental Protection Act, 1999 (CEPA)
Overview of consultation
On September 14, 2024, Health Canada (HC) and Environment and Climate Change Canada (ECCC) published a draft strategy to guide continued efforts to replace, reduce or refine vertebrate animal testing under the modernized Canadian Environmental Protection Act, 1999 (CEPA).
Comments on the draft strategy were invited by e-mail during a 60-day public comment period, from September 14, 2024, to November 13, 2024.
Comments were also received verbally during stakeholder engagement opportunities that took place during the consultation period.
Feedback received through this consultation process was taken into consideration and helped inform revisions of the draft strategy.
Engagement on the draft strategy
HC and ECCC hosted information sessions on October 16 and 17, 2024, to provide an overview and help guide the review of the draft strategy to replace, reduce or refine vertebrate animal testing and the proposed Plan of Priorities under CEPA.
Other engagement opportunities through which input on the draft strategy was shared with HC and ECCC included the Chemicals Management Plan Multi-Stakeholder and Partner Workshop, which took place virtually on October 28 and 29, 2024. The draft strategy was included as a point of discussion during this workshop, and participants included representatives from industry, civil society, academia, Indigenous organizations and youth.
Who responded
Written comments on the draft strategy
The consultation generated just over 6,000 e-mail submissions. The comments represented the views of members of industry, non-governmental organizations (NGOs), and other groups, such as academia. The majority of comments received were from members of the public (over 99%). The breakdown of the respondents within stakeholder groups other than members of the public is shown in Figure 1.
Figure 1 - Text equivalent
Numbers reflect e-mail submissions from each stakeholder group; some submissions were submitted on behalf of organizations.
| Stakeholder group | Number of respondents |
|---|---|
| Non-Governmental Organizations | 13 |
| Industry | 20 |
| Others | 7 |
What we heard about the development of a strategy to guide the replacement, reduction, or refinement of vertebrate animal testing under CEPA
Almost all respondents shared their support for the draft strategy or their appreciation for Government of Canada efforts to reduce reliance on vertebrate animal testing under CEPA.
All comments received have been grouped based on the 2 questions included in the consultation on the draft strategy.
1. What are your views on the proposed key elements?
The draft strategy proposed five key elements:
- Identify and Prioritize New Approach Methods (NAMs) for Regulatory Needs;
- Advance NAMs Research and Data Generation;
- Promote Harmonization and Collaboration;
- Communicate and Consult with Stakeholders; and
- Implement NAMs in CEPA Regulatory Programs
Overall, respondents were supportive of the draft strategy.
Regarding the first element, some respondents suggested other factors or types of tests that could be considered when prioritizing NAMs. Comments were also shared on the proposed longer-term priorities described in the draft strategy, particularly regarding the importance of advancing efforts in these key areas in the near term. The benefits of sharing prioritized NAMs with industry and other stakeholders was also raised.
For the second element, some respondents described specific examples of NAMs or emphasized certain research topics, such as in silico approaches, biomarkers and data sharing. The importance of ecosystem-level research and the challenge of characterizing highly complex interactions within ecosystems using only NAMs were highlighted. Other respondents raised the benefits of a One Health Approach, which recognizes the interconnectedness between human, animal and environmental health.
Related to the third element, respondents recognized the benefits of coordinating efforts across scientific communities. Industry respondents also noted the importance of international alignment and shared their appreciation for how the draft strategy aligns with ongoing international efforts.
In regard to the fourth element, industry respondents highlighted the key roles of ongoing collaboration and engagement, and that these will be critical moving forward.
Related to the fifth element, respondents from industry shared their appreciation for current flexibilities in terms of acceptance of alternative data, and noted that this is necessary to encourage the development of novel approaches. Many respondents raised the importance of capacity building, including through training and education for regulatory staff, as well as for the next generation of scientists.
2. What other elements or considerations, if any, should be included in the strategy to replace, reduce or refine vertebrate animal testing?
Almost all respondents shared additional elements that they felt would be important to consider in the strategy, or that should be considered as the strategy is implemented. These have been summarized in the following paragraphs.
Comments from members of the public
Two main points were raised in almost all of the comments from members of the public. The first was the critical role of federal funding and investments to move these efforts forward, including to support the development and implementation of NAMs and to build capacity. The second was the importance of tracking and transparently sharing, on a regular basis, progress on reducing reliance on vertebrate animal testing, including through measurable impact metrics. The benefits of establishing clear goals with timelines were noted as well.
Other comments from members of the public raised the limitations of current animal tests, the importance of adapting and implementing this strategy across the Government of Canada and that while the focus of the strategy should be on the replacement of vertebrate animal testing, further emphasis should be placed on reduction and refinement for animals that continue to be used. Public comments also indicated the view that a national hub would be important to help achieve key objectives in this space.
Comments from industry, NGOs and other stakeholders
Many stakeholder respondents highlighted similar points as those raised by members of the public, including the importance of federal funding and investments to advance efforts under the strategy, and of setting clear goals and regularly reporting on progress. Some respondents shared various factors that should be considered and balanced in the implementation of NAMs, including the time and resources that are needed for industry to adapt.
Suggestions were received to establish multi-stakeholder working groups or advisory committees to help guide and support efforts to reduce reliance on vertebrate animal testing. Some industry respondents pointed out the importance of collaboration across the Government of Canada, as well as with provincial and territorial partners, to align requirements and move forward together.
Certain industry and NGO respondents highlighted frameworks, data and other information that they would find helpful to support the transition towards NAMs. Other respondents raised the importance of transparently sharing the limitations and uncertainties of new methods. The lack of reproducibility of some vertebrate animal tests was also pointed out. Other respondents shared that further details on refinement approaches would be helpful to include in the strategy. The opportunity for Canada to be a leader internationally in reducing reliance on vertebrate animal testing was emphasized, as well as the benefits of defining key areas where we may be able to have the most impact.
Conclusion
The Government of Canada would like to thank everyone who provided comments on the draft strategy to replace, reduce or refine vertebrate animal testing under CEPA. The comments received provide diverse perspectives and valuable feedback. The Government considered all comments within the scope of the strategy and used them to support revisions to the strategy. The strategy was published alongside the Plan of Priorities under CEPA.
Contact Information
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada