What We Heard: Stakeholder pre-consultation on the review of Part 6 of the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Organisms)

The What We Heard report summarizes the feedback received over the course of the pre-consultation that was held in Fall 2022 on the review and modernization of the New Substances Notification Regulations (Organisms) (the Regulations) of the Canadian Environmental Protection Act, 1999 (CEPA). The review and modernization of the Regulations have been an important part of the Government of Canada’s commitment to strengthen CEPA since the announcement made in April 2021. With the adoption of the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5) in June 2023, the ongoing review and modernization process represents an opportunity to implement amendments made to CEPA, improve openness and transparency, keep pace with advances in science, and address identified elements requiring improvement under the Regulations.

1. Introduction

Biotechnology is a powerful enabling technology that has been applied across a number of sectors, including health, agriculture, aquaculture, and environmental. Modern biotechnology has allowed researchers and developers to use living organisms for several new applications, such as the development of vaccines, personalized medicines that can treat genetic diseases and cancer, production of alternate fuels, bioplastics, and as an alternative to harmful chemicals in cleaning products.

The Government of Canada regulates the import and manufacture of new living organisms that are animate products of biotechnology, or living organisms, under Part 6 of the Canadian Environmental Protection Act (CEPA), and the New Substances Notification Regulations (Organisms) (NSNR (Organisms)). The purpose of these legal instruments is to help protect the health of Canadians and the environment as they allow for the assessment of new living organisms before they enter the Canadian marketplace. The NSNR (Organisms), hereinafter referred to as the Regulations, is administered jointly by Health Canada (HC) and Environment and Climate Change Canada (ECCC) through the New Substances (NS) Program.

Since April 2021, the NS Program has been undertaking a process to review and modernize the Regulations, to help ensure that these regulations remain pragmatic, effective, and appropriate as science and technology in the biotechnology sector continues to evolve. This will allow Canadians to continue to benefit from innovative products of biotechnology. As part of this review and modernization process, the NS Program developed a Discussion Paper to facilitate discussions with stakeholders on areas of Part 6 of CEPA and the Regulations that may benefit from modernization.

On October 13, 2022, the NS Program published a Discussion Paper, on the PlaceSpeak online consultation platform, to gather feedback from interested parties, and to provide an opportunity for Canadians to bring forward any additional considerations. The Discussion Paper provided information on three major themes/drivers for this regulatory review:

• Improving openness and transparency
• responding to advances in science and technology; and
• reducing regulatory inefficiencies

2. Openness and transparency

In 2017, the Standing Committee on Environment and Sustainable Development (ENVI) recommended:

• more meaningful public engagement
• increased transparency
• better communication of the risk assessment process and regulatory decisions for new living organisms.

Enhancing openness and transparency in the regulation of new living organisms will help Canadians make informed decisions about the substances they use, and will increase confidence in the regulatory and decision-making process.

3.  Advances in science and technology

Despite substantial scientific and technological advances in the field of biotechnology, and the increased prevalence of both genetically modified and unmodified living organisms being imported and manufactured in Canada since CEPA and the Regulations first came into force, the Regulations have not been significantly updated since 2005.

Updating the Regulations and Program policies to address advances in science and technology is necessary to ensure that the Regulations continue to protect human health and the environment from potential risks posed by new living organisms. It is also an opportunity to help ensure the Regulations keep pace with new, innovative products and applications so that Canadians can benefit from advances in biotechnology.

4. Regulatory inefficiencies

The modernization of the Regulations presents an opportunity to address some inefficiencies, redundancies, and gaps identified in the regulation of animate products of biotechnology. In turn, this will create a process that is both more efficient and less onerous for both regulators and regulated parties.

5. Pre-consultation

In order to gather stakeholder feedback on the themes identified above, a pre-consultation with stakeholders and public on the review of Part 6 of CEPA, and modernization of the Regulations, was launched on the PlaceSpeak online consultation platform. More than 2300 stakeholders were notified of the consultation by the NS Program via email, and an additional notification was sent to PlaceSpeak users across Canada. The NS Program also promoted the consultation through social media (Figure 1). Interested parties were invited to submit comments and feedback between October 13 and December 5, 2022.

Online consultation activities included:

Written comment period: The NS Program solicited written input through PlaceSpeak or by email from all interested parties between October 13 and December 5, 2022. Extensions were provided upon request until January 20, 2023.

Stakeholder discussions: The NS Program held bilateral and small group discussions with stakeholders upon request, including with industry, Indigenous organizations, and representatives from academic institutions.

For further information, please visit the consultation page on PlaceSpeak.

Figure 1. Twitter post from October 13, 2022

6. Participants

Most interested parties participated by providing written comments through PlaceSpeak or through email. A small number of stakeholders provided input via requests for discussions with officials from the NS Program. We heard from:

• Biotechnology industry
• non-governmental organizations
• general public
• Indigenous organizations
• academia

The Government of Canada and the NS Program wishes to thank everyone who provided input.

6.1 Written comments on the Discussion Paper

The NS Program received over 300 written comments from 34 respondents (see Figures 2 & 3). This included:

• 182 comments from 20 representatives from the biotechnology industry. The majority of comments were from companies, industry organizations, and from regulatory consulting firms
• 57 comments from 4 non-governmental organizations (NGOs). NGOs provided the second highest number of comments after industry stakeholders. NGOs who provided written comments included environmental NGOs, NGOs focused on animal welfare, and NGOs focused on raising awareness about issues related to products of biotechnology
• 15 comments from 4 representatives from academic institutions. Written comments were received from biosafety officers and other representatives from academic institutions across Canada. Participation amongst academic stakeholders was greater in discussions with the NS Program than through written comments submitted via PlaceSpeak or email
• 31 comments from 2 Indigenous organizations. The third highest number of written comments were received from Indigenous national advocacy organizations and officially recognized Indigenous Governments
• 16 comments from 4 members of the general public

Figure 2. Sectoral breakdown of number of respondents

Figure 3. Sectoral breakdown of number of comments received

6.2 Stakeholder discussions

The NS Program hosted discussions with 7 interested stakeholder groups, at their request, including representatives from:

• Canadian academic institutions
• Indigenous Organizations
• industry and industry associations

7. Feedback

This section presents a summary of comments received on the areas that were identified as potentially benefitting from modernization as outlined in the Discussion Paper. It summarizes a large number of the comments received. It is not intended to be attributed to specific organizations or individuals.

For more information on the specific discussion questions that were included in the Discussion Paper, please consult the Appendix.

7.1 Improving openness and transparency

Openness in risk assessments and decision-making

• All stakeholder sectors were interested in strengthening engagement with the NS Program
• Some stakeholders expressed:
  • Interest to expand public engagement initiatives to include mandatory consultations. They identified increased trust and confidence in the regulatory process and consumer products as important benefits to mandatory public engagement.
  • Early, direct, and mandatory consultations would be important to establish free, prior, and informed consent for the import and manufacture of new living organisms that may have impacts on First Nations’ Inherent or treaty rights.
  • The existing voluntary public engagement initiative is sufficient. These stakeholders expressed concerns about the possibility of extending regulatory timelines to facilitate mandatory public engagement, about misalignment with other domestic and international regulations which provide oversight for products of biotechnology, and about the implications that mandatory public engagement would have for confidential business information (CBI).
  • “First-in-class” organisms^{Footnote 1} and organisms without comparators would benefit the most from greater levels of openness and transparency. However, some of these stakeholders also made it clear that openness and transparency for other, non-first-in-class products should not be compromised.
  • Concerns about mandatory public engagement for first-in-class products because the term “first-in-class” is too subjective and could hinder innovation.
  • A scientific advisory council could be established as a means of expanding engagement with academia.
  • Interest in establishing regulator-industry working groups.

Labelling of animate products of biotechnology

• Some stakeholders expressed:
  • Mandatory labelling for animate products of biotechnology would increase transparency and help consumers make informed decisions about the products that they buy, and that labelling requirements could improve regulators’ ability to monitor and track genetically modified organisms (GMOs).
  • Concerns that mandatory labelling, for reasons other than identified risks to human health and the environment, could contribute to negative perceptions surrounding animate products of biotechnology, and could result in regulatory misalignment both domestically and internationally.

7.2 Responding to advances in science and technology

Facilitating access to products of biotechnology, including biologic drugs subject to the Food and Drugs Act (F&DA)

• Some stakeholders recommended:
  • Certain F&DA products should be exempted from environmental assessment under the Regulations, such as animate products that are of low risk to the environment due to the nature of how they are used (for example, cell and gene therapies). They indicated that regulatory oversight provided by other instruments (for example the Human Pathogens and Toxins Act and Regulations [HPTA/HPTR]) is sufficient to identify and mitigate risks posed by F&DA products manufactured and used in contained facilities.
  • Streamlining the regulation of organisms used in F&DA products while still retaining oversight under the Regulations would be the preferred approach. They indicated that a pre-market assessment regime was necessary to identify and mitigate any potential risks to the environment; however, they also suggested that duplicate regulatory requirements should be reduced and certain information requirements could be waived.
  • A focus on international alignment, especially for newer animate products of biotechnology and products that are exempt from pre-market assessment in other jurisdictions.

Ease of accessibility and affordability of living organisms resulting from advanced tools

• Stakeholders who responded to this issue were supportive of improving engagement with the do-it-yourself (DIY) and amateur science community, such as by engaging with the iGEM foundation and participants could be helpful in promoting awareness amongst the DIY/amateur community
• Some stakeholders expressed:
  • a need for increased engagement with the DIY and amateur science community. They mentioned that low awareness was responsible for most instances of non-compliance with Regulations with this community.
  • a regulatory amendment was unnecessary to improve compliance amongst the DIY and amateur science community. They indicated that treating amateur scientists as “manufacturers” may not be feasible, and may not effectively resolve the fundamental issue of low awareness.
  • DIY community could have issues in complying with the Regulations due to the technical nature of the regulations and the resources required to draft a new substance notification. They suggested that the regulations could be amended to reduce regulatory burden for the DIY sector.
  • they were generally not familiar with the NS Program and the Regulations and indicated that they would support efforts to improve awareness through engagement and education activities.

Strengthening post-assessment monitoring information requirements for achieving sustainability goals

• Some stakeholders expressed:
  • the strengthening of post-assessment authorities is necessary to build confidence in the regulatory process and address the possibility of irreversible, long-term environmental impacts that could arise from the accidental or intentional release of GMOs. There was also suggestion for more emphasis on prohibiting production and release of new living organisms that have the potential to cause long-term environmental harm before they are imported or manufactured in Canada.
    • These particular stakeholders also suggested that post-assessment monitoring would capture and manage risks associated with uncertainty, and could help in demonstrating the safe use of a new living organism, especially where no history of safe use exists internationally (that is for “first-in-class” products).
  • a concern regarding post-assessment authorities and long-term environmental monitoring, and indicated that it would increase administrative burden, create barriers to innovation and adoption of animate products of biotechnology, and introduce obstacles to international trade.
  • post-assessment information requirements, including monitoring, should be implemented proportionally to the risk posed by a new living organism, to minimize impacts on products that are less likely to pose a risk to human health and/or the environment.
  • the concept of sustainability should be kept separate from risk assessments conducted under the Regulations, viewing this as a departure from the current risk-based approach.

Demonstration of need for living organisms, including GMOs, and its impact on biodiversity and ecosystem sustainability

• Some stakeholders expressed:
  • new living organisms, particularly GMOs, should have to show demonstrable benefits (for example, societal, environmental) before they can be imported into or manufactured in Canada because of their potential to have long-term and irreversible impacts on biological diversity and the environment.
    • These particular stakeholders also expressed concerns that non-scientific considerations (for example ethics, animal welfare, economic and cultural significance of wild-counterparts) are not addressed in the current risk assessment process.
  • concerns that the “demonstration of need” requirement under the Regulations would introduce additional cost and burden that would disproportionally affect new and innovative products, such as innovative medicines, that could hinder the Canadian biotechnology sector’s competitiveness on the global market. They also indicated that it was up to consumers to determine whether a given product is “necessary”.
  • Norway as an example of a country that has incorporated the concepts of demonstrable benefits in their regulation of genetically modified organisms.
  • including a demonstration of need for new living organisms under the Regulations could be used to place the onus on proponents of new living organisms to demonstrate that their product can be used safely with relative benefits compared to alternative products.

7.3 Reducing identified inefficiencies

Streamlining the regulatory scope for unmodified organisms

• Some stakeholders expressed:
  • exempting unmodified micro-organisms would be justifiable if the micro-organism is used in contained facilities and if the micro-organism is also regulated under other Acts.
  • unmodified organisms should not be exempted from notifications, that is, that a pre-market assessment is still necessary to identify potential risks to human health and the environment. They suggested that the regulation of unmodified organisms could be streamlined by reducing information and data requirements for certain low-risk activities (for example, for use in contained facilities).
  • concerns with any streamlining of the regulation of unmodified organisms due to the possibility of invasive species entering the environment and disrupting biological diversity.

Refining the Regulations definitions for micro-organisms and research and development (R&D) organisms

• Some stakeholders expressed:
  • the definition of micro-organisms should be amended to exclude cultured cells, virus-like particles (VLPs), and sub-viral particles (SVPs). They mentioned that these substances should be exempt from the Regulations because they are non-replicative and therefore are of low environmental concern
  • VLPs and SVPs should not be removed from the definition of micro-organisms, as it would be more practical to regulate VLPs and SVPs under the Regulations rather than the NSNR (Chemicals & Polymers). These stakeholders noted that the NSNR (Chemicals & Polymers) may allow small quantities to be imported and/or manufactured without undergoing an assessment.
  • cultured cells should continue to be regulated under the Regulations, as they may harbor zoonotic pathogens and other potential risks to human health and the environment.
  • a policy approach could be implemented to waive certain information requirements for cultured cells, so that regulatory oversight would be retained under the Regulations while still streamlining the regulations for low-risk applications
  • the definition of R&D organisms be amended to exclude QA/QC organisms, organisms used as experimental controls, and organisms used as models, since they are already sufficiently regulated by other instruments (e.g., HPTA/HPTR)
  • including Quality Assurance and Quality Control (QA/QC) organisms under the definition for R&D organisms would increase the regulatory burden for these organisms, and that QA/QC organisms should be exempted separately from R&D organisms
  • A lack of clear reasoning or justification for amending the mass and volume thresholds for R&D organisms in the Regulations.
• One stakeholder indicated that because QA/QC organisms are sold commercially and are in widespread use beyond R&D applications, they should not be included under the definition of R&D organisms.

Streamlining the regulations for higher organisms commensurate to the level of intended release

• Some stakeholders expressed:
• the addition of new schedules for higher organisms for activities other than full environmental release would help make the regulatory requirements commensurate with the level of intended release, and would be justifiable because of the lower risk of exposure inherent to contained use.
• the addition of new schedules for higher organisms for activities other than full environmental release would not be justifiable, because containment measures could be insufficient for mitigating the potential accidental release of organisms. These stakeholders indicated that tailoring information requirements to the level of intended release would ignore the potential hazard posed by the organism and the risk posed to wild counterparts.
• they would be supportive of a continuation of previous work conducted between the NS Program and the U15 group of universities to develop containment best practices specifically for higher organisms used in contained facilities.

Accidental release of living organisms

• Some stakeholders expressed:
  • existing policies and regulations are sufficient to handle the accidental release of most organisms, especially micro-organisms used in contained facilities.
  • containment could not be relied upon to mitigate risks associated with accidental release, and that the Regulations should be amended to place the onus on importers, manufacturers, and users of GMOs to manage and be responsible for containment, accidental release, alerting the public, and funding monitoring efforts.
  • containment cannot be relied upon to prevent accidental release if monitoring, inspection, and enforcement of containment activities are inconsistent, and that new living organisms should always be treated as potentially invasive.
  • regulatory and legislative instruments should be used to prohibit the import, production, and or development of certain GMOs products where an accidental release could result in harm to human health or and/or the environment.
• Stakeholders provided a variety of suggestions for strengthening oversight for instances of accidental release, such as First Nations-led and locally driven environmental monitoring, legal requirements for importers/manufacturers/users of new living organisms to monitor and remediate the environment (if necessary), and the implementation of a more consistent inspection and enforcement program.

Consideration of subpopulations that may be susceptible, or more highly exposed

• Some stakeholders expressed:
  • current protections for these populations are not sufficient under CEPA/Regulations. They suggested that more transparency, openness, and education about the risk assessment process is necessary to promote awareness and understanding among these groups
  • current degree of consideration for these populations under the Regulations is sufficient, especially for medicines and other products that are also regulated under the F&DA
  • the Regulations guidance should be updated to clarify what information and data is necessary to protect these groups
  • mandatory consultations should be carried out with First Nations who have an Inherent or Treaty right to wild counterparts of GMOs, and that mandatory consultations should also be held with Indigenous peoples when a new living organism could potential affect culturally or economically significant species, as part of expanding considerations for subpopulations that may be more susceptible or highly exposed
  • a recommendation that a requirement be added under CEPA and/or the Regulations to consider adverse effects to First Nations,  persons, communities, and the environments on which they depend prior to any approval for creation or use of any new living organism.

Overlap and gaps with the Human Pathogens and Toxins Act and Regulations

• A majority of stakeholders emphasized the need to minimize overlap and redundancy between CEPA/Regulations and HPTA/HPTR, and that doing so would help bolster domestic innovation and improve access for Canadian products to the global marketplace

Inefficiencies in regulatory requirements for contained use (Schedule 2)

• Some stakeholders indicated that this information is already sufficiently captured under the CEPA/Regulations and the HPTA/HPTR, such that further information requirements are not necessary and that the added regulatory burden would outweigh any tangible benefits
• Stakeholders indicated that references to the US National Institutes of Health (NIH) Guidelines from the Regulations could be removed and replaced with the Canadian Biosafety Standards and/or Guidelines, where appropriate; doing so would help to avoid confusion over the differences between the US and Canadian standards

8. Next steps

The NS Program will incorporate stakeholder feedback into the analysis of identified issues in order to develop options and ultimately regulatory and policy proposals. We intend to hold a targeted engagement with stakeholders who provided comments during the pre-consultation on Proposed amendments for modernizing the Regulation of animate products of biotechnology by Fall 2023.

Proposed amendments for the Regulations are targeted for formal consultation and publication, in the Canada Gazette, Part, I by the end of 2024. We will use the information received during the public engagement period and public comment period in the development of the final instruments.

Appendix: Discussion Paper questions

The Discussion Paper questions focused on:

• Openness and transparency
• Responding to advances in science and technology
• Reducing identified inefficiencies