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)

Purpose

This notice is to inform people living in Canada that the Government of Canada intends to commence work on the development of a strategy to guide continued efforts to replace, reduce or refine the use of vertebrate animals when addressing chemical^{Footnote 1} assessment data needs under the Canadian Environmental Protection Act, 1999 (CEPA).

Planned actions

While vertebrate animal testing provides essential information for regulatory programs that aim to protect people living in Canada and their environment, the Government of Canada is committed to advancing efforts to replace, reduce, or refine the use of vertebrate animals in toxicity testing where possible.

In line with this, the Government of Canada introduced amendments to CEPA under Bill S-5 (Strengthening Environmental Protection for a Healthier Canada Act) that recognize the need to replace, reduce or refine the use of vertebrate animal testing when assessing the risks that substances may pose to human health and the environment. These amendments, which received Royal Assent in June 2023, support Health Canada (HC) and Environment and Climate Change Canada (ECCC) in their efforts to promote the development and timely incorporation of alternative methods and strategies, as science permits.

Toward this effort and in line with new requirements introduced through these amendments, HC and ECCC will be developing a strategy as part of the Plan of Chemicals Management Priorities to guide their path to replace, reduce or refine the use of vertebrate animals for toxicity testing and assessment under CEPA.

Background

HC and ECCC are responsible for assessing and managing a wide range of health and environmental risks, including risks from chemicals, under CEPA. This Act is the primary legislative framework for pollution prevention in Canada and provides the legislative basis for a range of federal environmental and health protection programs.

Prioritization and chemical risk assessments rely in large part on data from toxicity testing in vertebrate animals to evaluate a range of possible adverse effects. However, studies in experimental vertebrate animals are expensive, time consuming, and, in some cases, may be of limited biological relevance, in addition to presenting potential animal ethical concerns. New approach methods (NAMs) present a desired alternative to vertebrate animal-based methods for chemical toxicity testing and risk assessment.

NAMs are broadly defined as any technology, methodology, approach or combination thereof that can be used to replace, reduce, or refine animal toxicity testing and may allow for more rapid or effective prioritization and/or assessment of chemicals. These methods may include the use of computer-based (computational) models, modernized whole-organism assays or assays with biological molecules, cells, tissues, or organs, as well as exposure prediction approaches.

As part of the ongoing process to incorporate NAMs into regulatory programs under CEPA, HC and ECCC continue to work towards the development and standardization of NAMs. They are also working on the establishment of frameworks and tools to guide continued evaluation and incorporation of non-animal data and alternative approaches into prioritization and risk assessments. These scientific advances align with the work of a growing number of regulatory authorities, including those in the United States, Australia, and the European Union, where an emphasis is being placed on modern approaches to replace, reduce, or refine the use of vertebrate animals in toxicity testing wherever possible. This includes the development of strategies and research programs to accelerate development and implementation of NAMs for regulatory decision-making.

A strategy is being developed to guide future efforts of HC and ECCC aimed at achieving the goal of replacing, reducing or refining the use of vertebrate animal testing where possible under CEPA for the prioritization and assessment of the potential risks that chemicals may pose to human health and the environment.

This strategy is initially being developed within the context of CEPA; however, it could be applicable, where relevant and possible, to other Government of Canada regulatory programs. Canada will work closely with national and international partners on the development, standardization and implementation of fit-for-purpose NAMs. Further, building scientific confidence and acceptance of NAMs both internally to the Government of Canada and externally with stakeholders is also critical for successful progression and timely incorporation of alternative methods and strategies for regulatory testing and assessment.

The following are proposed key elements to be addressed under the strategy:

1. Identification and prioritization of needs for NAMs for use in chemical regulatory programs under CEPA

   Vertebrate animal toxicity testing serves 3 main functions within regulatory programs:

   1. provides a means for hazard identification as an indication of the types of health effects humans, fish and wildlife may experience from exposure to a chemical;
   2. provides information on the level of exposure required to elicit the toxic effect; and
   3. provides information on how the chemical may be absorbed, distributed, metabolized, and excreted.

   Research and regulatory communities have been developing NAMs to serve these functions as alternatives to vertebrate animal testing. One aspect of the strategy will be to identify the most promising NAMs available to address data needs and requirements currently fulfilled by vertebrate animal testing under CEPA. These NAMs will be evaluated to determine their respective state of readiness for use in regulatory decision-making in the near and longer term. Where a regulatory data need currently met by vertebrate animal testing is identified as having no suitable NAM, this may serve as a priority area for further research on NAM development. Another aspect of the strategy will be to continue to examine opportunities to leverage and integrate various types of information to meet regulatory needs currently met by vertebrate animal methods and increase regulatory acceptance of non-animal methods.

2. Advancement of NAMs research and data generation to support methods development, standardization, and translational research

   HC and ECCC will focus on the most suitable NAMs for near-term impact and those of greatest anticipated need in the longer term as identified under the first element of the strategy. This will allow for strategic advancement of NAMs research and regulatory priorities and accelerated capacity building including investments in training, increasing technical expertise, as well as expanding infrastructure for information management and technology, data science, and research laboratory equipment. HC and ECCC will also continue to develop case studies to demonstrate the usefulness of NAMs and build scientific confidence in the use of NAM-based data. A key focus will be on overcoming barriers to the regulatory acceptance of NAMs for use in prioritization and risk assessment activities under CEPA. In continuing to work with international partners, HC and ECCC can contribute to the global efforts towards the development and standardization of NAMs while fulfilling domestic testing needs.

3. Promotion of harmonization, collaboration, communication, and engagement

   Animal toxicity tests have a long legacy of use in chemical regulation and, as a result, consistent interpretation and use criteria have emerged globally amongst the Organisation for Economic Co-operation and Development (OECD) member countries.

   HC and ECCC will continue to work with international partners, such as the OECD, to contribute to NAM guidance documents, test guideline development, and Integrated Approaches to Testing and Assessment (IATA). Continued collaboration with international regulatory partners and researchers will facilitate the regulatory acceptance of NAM-based testing strategies by the international community.

   The Government of Canada is committed to clearly communicating new NAM-based testing and assessment strategies with people living in Canada and stakeholders, to promoting open and transparent science, knowledge exchange and opportunities for data sharing with national and international collaborators. The Government of Canada is also committed to carrying out public consultations as progress is made toward the replacement, reduction or refinement of vertebrate animal testing under CEPA.

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

   NAM-based data may be substituted for vertebrate animal data in a chemical risk assessment when the NAM is demonstrated to provide useful and scientifically justified information relevant to the protection of human health or the environment. HC and ECCC will continue to collaborate with international regulatory partners on translational research and implementation studies to demonstrate the use of NAMs to provide as good or improved protection for people living in Canada and the environment.

   As part of the ongoing process to incorporate NAMs into regulatory programs and increase regulatory acceptance, HC and ECCC will continue to work towards the development of frameworks to guide the identification of areas of uncertainty for scientifically justified NAMs, with the intent that the areas of uncertainty can be quantified and reported in a transparent manner.

   As new NAMs gain regulatory acceptance, HC and ECCC will continue to apply flexibility in accepting alternative data to meet regulatory requirements, including through updating frameworks and tools, to guide and promote the use of scientifically justified alternative approaches that replace, reduce, or refine the use of vertebrate animals in toxicity testing whenever possible.

Public comments

Feedback on this notice, including on the proposed key elements to be addressed under the strategy, is invited from people living in Canada, Indigenous partners, as well as scientific and international experts and stakeholders.

To guide feedback, input is sought on the following key questions:

1. What are your views on the proposed key elements?
2. What other elements or considerations, if any, should be included in the strategy to replace, reduce or refine vertebrate animal testing?
3. What else can we do to support the transition towards not relying on vertebrate animals in regulatory decision making?

Comments on this notice can be provided during the next 60 calendar days ending January 29, 2024.

Next steps

Building from this notice and comments received, HC and ECCC will develop a draft strategy to guide efforts to replace, reduce or refine the use of vertebrate animals when addressing data needs under CEPA. A summary of the input received through this consultation will be included with the draft strategy.

Stakeholders, Indigenous partners and other interested parties will have the opportunity to provide input on the draft strategy through a public consultation.

This strategy is intended to respond to the commitment under CEPA’s Plan of Chemicals Management Priorities related to the inclusion of activities or initiatives to promote the development and timely incorporation of scientifically justified alternative methods and strategies in the testing and assessment of chemicals to replace, reduce or refine the use of vertebrate animals.

The strategy is expected to be published alongside the Plan of Chemicals Management Priorities by June 2025.

Contact information

Comments on this notice may be submitted to erhsdgeneral-dssergenerale@hc-sc.gc.ca.