What we heard: Notice of intent on the development of a strategy to guide the replacement, reduction, or refinement of vertebrate animal testing under the Canadian Environmental Protection Act, 1999 (CEPA)

Overview of consultation

On November 30, 2023, Health Canada and Environment and Climate Change Canada published a notice of intent regarding the development of a 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 notice were invited by e-mail during a 60-day public comment period, from November 30, 2023 to January 29, 2024.

Feedback received through this consultation process will help inform the development of the draft strategy.

Who responded

The consultation generated approximately 4,300 e-mail responses. The comments represented the views of members of the general public, industry, non-governmental organizations (NGOs), and other groups, such as academia. The vast majority of responses received were from members of the general public (99%). The breakdown of the responses within stakeholder groups other than members of the general public is shown in Figure 1.

Text equivalent

Stakeholder group	Number of respondents
Non-Governmental Organizations	12
Industry	14
Others	5
The numbers reflect e-mail submissions from each stakeholder group; some submissions were submitted on behalf of organisations.

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 (over 95%) shared their appreciation regarding the development of this strategy and were supportive of the use of non-animal methods. Comments received have been grouped based on the 3 questions included in the notice of intent.

1. What are your views on the proposed key elements?

The notice of intent proposed four key elements to be addressed under the strategy:

1. Identification and prioritization of needs for new approach methods (NAMs), which include non-animal testing methods, for use in chemical regulatory programs under CEPA;
2. Advancement of NAMs research and data generation to support methods development, standardization, and translational research;
3. Promotion of harmonization, collaboration, communication, and engagement; and
4. Implementation of NAMs to reduce reliance on vertebrate animal toxicity testing in chemical regulatory programs under CEPA.

In regard to the first and fourth elements, some respondents noted the value of establishing clear criteria for the prioritization and implementation of NAMs. The importance of considering the degree to which a NAM can support regulatory decision-making, and not on if they would be a suitable direct replacement for a current animal test, was also raised. Related to this, many respondents provided additional examples of the limitations of current animal tests and the advantages that NAMs may present.

In regard to the second element, many respondents highlighted the importance of continued, and in some cases increased, Canadian participation in global efforts to advance the development and implementation of NAMs. Some mentioned that educational opportunities for the general public, scientists and regulators regarding NAMs would help raise awareness, build confidence in NAMs data and enhance capacity to implement NAMs.

Lastly, in regard to the third element, some respondents raised the critical role of Government of Canada collaborations and engagements with a range of sectors and stakeholders. The importance of aligning with international partners was also highlighted in responses from industry and NGOs.

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 they felt would be important to consider in the strategy.

Comments from members of the general public

Most responses received from members of the general public (approximately 97%) raised similar elements. These included that the emphasis of the strategy should be on replacing and reducing vertebrate animal testing. Further, respondents shared that meaningful refinement should be a priority for vertebrate animals that continue to be used.

The importance of the Government of Canada setting clear goals related to the replacement, reduction or refinement of vertebrate animal testing was also highlighted, as well as transparently tracking progress on the implementation of the strategy.

Lastly, responses recognized the support that would be required to enhance Canada's leadership role in this area.

Comments from industry, NGOs and other stakeholders

Many stakeholder respondents, particularly NGOs, highlighted similar elements as those raised by members of the general public. For example, some respondents described the importance of ongoing and open communication between the Government of Canada and stakeholders, and of providing updates on the progress made towards replacing, reducing or refining vertebrate animal testing.

Some industry respondents shared some of the current limitations of NAMs, and how these should be a consideration moving forward with the development and implementation of the strategy. This included consideration of the significant investments, both in time and financially, involved for industry to take a NAM from development to implementation.

Some NGO respondents suggested placing the emphasis of the strategy on replacing vertebrate animal testing. The importance of Canada not only aligning but leading the global movement towards alternative methods was also raised.

3. What else can we do to support the transition towards not relying on vertebrate animals in regulatory decision making?

Comments from members of the general public

Most respondents highlighted how investments could help advance efforts to replace, reduce or refine vertebrate animal testing in Canada. Some respondents also proposed educational opportunities, such as public campaigns to raise awareness about the use of animals in science, to support the transition to NAMs.

Comments from industry, NGOs other stakeholders

Most respondents flagged the importance of engaging a range of stakeholders to support and guide efforts to replace, reduce or refine vertebrate animal testing. Some respondents encouraged the use of out-of-the-box thinking to further reduce testing on vertebrate animals, and collaborative approaches.

Some industry respondents highlighted that they will require time to integrate new methods, and as a result ongoing discussions are key to ensure a strategic and effective path forward.

There was also mention of the use of vertebrate animal testing for regulatory requirements outside of the scope of CEPA. Related to this, the importance of collaborating and working with federal, provincial and territorial partners to move forward strategically, whenever possible and feasible, was mentioned, as well as the value of aligning approaches with other jurisdictions. Similarly, some respondents shared examples of efforts or initiatives underway internationally (e.g. requirements for data sharing) and suggested that these may help orient activities in Canada.

Conclusion

The Government of Canada would like to thank everyone who provided comments on the notice of intent on the development of a strategy to guide the replacement, reduction or refinement of 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 they were used to support the development of the draft strategy. The Government is now inviting any interested party to submit comments on this draft strategy through a 60-day public consultation period.

Contact Information

Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca