Questions and answers from 2024 stakeholder engagement: Proposed approach to modernize the New Substances Notification Regulations (Organisms)

Background

On April 13, 2021, the Government of Canada announced its commitment to strengthen the Canadian Environmental Protection Act, 1999 (CEPA). It introduced Bill C-28 and later Bill S-5 (Strengthening Environmental Protection for a Healthier Canada Act), which came into force on June 13, 2023. This initiated a full review of the New Substances Notification Regulations (Organisms) [NSNR (Organisms)]. Its objective is to modernize and update the regulatory framework for animate products of biotechnology in Canada. The modernization of the NSNR (Organisms) proposes both regulatory amendments and non-regulatory tools, such as policy or guidance. It aims to address issues under the following three themes:

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

On October 17, 2023, the New Substances (NS) program published a "What We Heard" report on its review of Part 6 of CEPA and the NSNR (Organisms). As part of its ongoing public engagement efforts, the program held virtual information sessions on June 3 and June 5, 2024. These sessions, held in French and English respectively, focused on proposed approaches to modernize the NSNR (Organisms). Stakeholders and partners in attendance included representatives from industries, non-governmental organizations (NGOs), Indigenous partners and academia. Upon request, additional sessions were held with industry and NGO stakeholders on June 17 and June 19, 2024. The NS program encouraged stakeholders and partners to submit written comments on the proposed approaches presented during these engagement sessions. The NS program also held bilateral meetings upon request. The following summarizes the comments and questions that the NS program received during this engagement period. The NS program has provided responses to them. It is considering incorporating feedback from these engagements into the modernization of the NSNR (Organisms). Broad, public consultation on any proposed amendments to the NSNR (Organisms) will follow the usual Canada Gazette process.

The NS program recommends that this publication be read alongside the following documents:

• the Stakeholder Engagement Document used during the June 2024 information sessions
• the “What We Heard” report and the Discussion Paper from the 2022 pre-consultation on the modernization of the NSNR (Organisms)

Please contact the Substances Management Information Line (substances@ec.gc.ca) if you have questions. You may also request to be added to the NS program’s stakeholder list to stay informed of the NSNR (Organisms) modernization.

Abbreviations, acronyms and glossary

Mandatory consultations for vertebrate or prescribed living organisms

Comment 1: What falls under the definition of a “higher organism”?

Response 1: Any living organism that is not defined as a micro-organism according to subsection 1(1) of the NSNR (Organisms) is an “organism other than a micro-organism”. In other words, this is a higher organism.

Comment 2: Why is the NS program considering extending the risk assessment period by 60 days for organisms subject to mandatory consultation? Existing assessment timelines and the simultaneous risk assessment and consultation process have been effective thus far.

Response 2: The NS program intends to continue conducting mandatory or voluntary public consultations simultaneously with the risk assessment of new living organisms. However, there are challenges with completing assessments and consultations at the same time. This challenge is greater for organisms with a mandatory consultation period (60 days) compared to a consultation period under the Voluntary Public Engagement Initiative (VPEI) (30 days). Extending the assessment timeline by 60 days for mandatory consultation would allow sufficient time to review and consider people’s feedback effectively. If no comments are received, the NS program can finish the risk assessment before the assessment period expires. This is allowed under subsection 108(6) of CEPA.

Comment 3: Please clarify the CEPA subsection 108.1(1) requirement for mandatory consultation on certain living organisms, including:

• when it comes into force
• the organisms which are currently subject to the requirement
• the designation process for “prescribed living organisms”
• the conditions distinguishing mandatory consultation from the VPEI

Response 3: The Strengthening Environmental Protection for a Healthier Canada Act (introduced to Parliament as Bill S-5) requires mandatory consultation for:

• vertebrate animals
• prescribed living organisms
• groups of prescribed living organisms

However, prescribed living organisms or groups of living organisms are not yet defined. Currently, only vertebrate animals have been subject to mandatory consultation. The NS program will continue to encourage notifiers of other higher organisms to participate in voluntary consultation under the VPEI.

Please note that risk assessments of vertebrate animals have previously undergone consultation through VPEI, prior to Bill S-5’s Royal Assent. The mandatory consultation provision applies to notifications received after Bill S-5 came into force on June 13, 2023. The NS program will be seeking stakeholder and partner input on criteria and rationale to designate prescribed living organism(s).

Comment 4: How do new requirements for mandatory consultation impact the proposed Schedules for higher organisms? Will vertebrate organisms for use only within a contained facility be exempt from the mandatory consultation?

Response 4: The program has considered 2 amendments to the NSNR (Organisms) to support mandatory consultation under CEPA subsection 108.1(1).

First, a 60-day extension to the assessment period for risk assessments of any notified organism that:

• is a vertebrate animal
• is a prescribed living organism
• belongs to a group of prescribed living organisms

This is to allow a 60-day mandatory consultation.

Second, a requirement for the notifier to provide a summary of the information and data provided in the New Substances Notification package. This summary will be published during mandatory consultation.

The assessment of vertebrate animals, prescribed living organisms, or groups of living organisms under the NSNR (Organisms) must undergo consultation. This is required under CEPA subsection 108.1(1). This applies irrespective of the intended use or the Schedule under which these organisms are notified. Therefore, these proposed amendments would apply to the assessment of these organisms whether they are notified under the NSNR (Organisms) for:

• introduction into the environment (for example Schedule 5)
• under the proposed Schedules for use of higher organisms in a contained facility or in an experimental field study

Comment 5: Some suggested organisms that should be considered as “prescribed living organisms” for mandatory consultation. Recommendations included:

• organisms with wild counterparts in Canada
• invertebrates with complex nervous systems, like cephalopods and some decapods
• micro-organisms intended for environmental release

Response 5: The NS program will consider these recommendations. It will assess potential impacts on human health, the environment and biodiversity when developing an approach to prescribing living organisms under the NSNR (Organisms). The NS program will engage with stakeholders and partners to determine the criteria for prescribing living organisms that require mandatory consultation. The NS program will continue to encourage public consultations for organisms that are not subject to mandatory consultation, including invertebrates, through the VPEI.

Comment 6: Some raised concerns that the VPEI is insufficient for public consultation. They noted that the VPEI is the only consultation tool available for new invertebrate animals, despite their importance for biodiversity.

Response 6: CEPA subsection 108.1(1) requires the NS program consult with any interested persons when it receives notification of vertebrate animals, prescribed living organisms, or group of living organisms. This must be done before the assessment period of the notification expires. However, please note that all new living organisms must undergo a science-based risk assessment. This must be done whether they are subject to public consultation or not. This assessment is to evaluate their potential impact on human health and the environment. New invertebrate organisms are not subject to mandatory consultation under CEPA. However, the NS program will continue to encourage notifiers of these organisms to participate in public consultation through the VPEI.

Comment 7: Has the NS program involved Indigenous partners in the pre-consultations and engagement sessions? How does biotechnology intersect with Indigenous rights? Some recommended to establish an advisory committee with Indigenous representation for active engagement. They also recommended mandatory public comment periods and requirements to respond to Indigenous feedback.

Response 7: As part of the engagement sessions organized in June 2024, the NS program invited 67 indigenous partners from every province and territory of Canada. These partners were invited to participate and provide their input on the proposed approaches to modernizing the NSNR (Organisms). These included First Nations, Métis and Inuit partners. Partners that were invited include:

• national and regional indigenous organizations
• organizations representing indigenous women
• treaty rights holders
• political advocacy groups
• economic development organizations
• environmental impact advisory committees

The NS program also reached out directly to communities, organizations, and people who expressed interest in participating in the engagement sessions. This was to offer additional bilateral meetings with these Indigenous partners. The NS program will continue to seek out and incorporate the perspectives and feedback of Indigenous partners into the modernization of the NSNR (Organisms). The goal is to align with the 2023-2028 UN Declaration Act Action Plan, concerning the implementation of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). The program will further engage with Indigenous partners during the CGI public consultation process.

Post-assessment review of living organisms under NSNR (Organisms)

Comment: Some expressed support for the proposed post-assessment review of previously assessed organisms. Suggestions from stakeholders and partners for this proposal include:

• public notification
• public engagement
• regulatory obligation for the NS program to conduct the proposed periodic review of completed assessments

Some inquired if the NS program would require additional information if a Significant New Activity (SNAc) provision is already in place. Some asked whether the review would focus only on new information, or revisit information submitted for the original notification.

Response: The post-assessment review policy would prioritize organisms when new and relevant scientific information would lead to suspicion that the organisms are toxic or capable of becoming toxic. The following examples could all contribute to the prioritization of organisms for post-assessment review:

• information from scientific literature
• information from assessments that other jurisdictions have conducted
• information from other reliable sources

This would occur regardless of whether an organism has been subject to risk management tools or SNAc provisions. If the NS program identifies this information, it may request information from the notifier. This would be to determine if the program should apply risk management measures or if it should amend existing risk management measures. Program officials would review the original application along with new and relevant information before additional information is requested from the notifier(s).

Revising regulatory requirements for higher organisms according to the level of intended release

Comment 1: Are the proposed new Schedules for higher organisms intended to be simpler and to increase regulatory efficiency? Are there objectives other than regulatory efficiency?

Response 1: Currently, notifiers can only submit higher organisms under Schedule 5 of the NSNR (Organisms), for the import or manufacture anywhere in Canada. This is necessary regardless of the intended use of the organism. The NS program is considering proposing 2 new Schedules for higher organisms. One would be for higher organisms used in contained facilities. The other one would be for higher organisms used in experimental field studies. These will have reduced information requirements and shorter assessment periods relative to the proposed 180 days for Schedule 5. Information requirements under these new Schedules will focus on identifying risks specific to their intended uses. For example, the proposed Schedule for higher organisms used in contained facilities would require information on containment procedures. The proposed Schedule for higher organisms used in an experimental field study would require information on confinement procedures.

The intent is to adopt an approach that is similar to the one used for micro-organisms. Information requirements and assessment periods for micro-organisms also correspond with the intended level of release. The objective of these new Schedules is to improve regulatory efficiency while maintaining high environmental and human health protection standards.

Comment 2: Some raised the following questions concerning the containment of higher organisms:

• will the definition of a “contained environment” adapt to the type of contained organism
• will that definition adapt to the existing industry containment standards that apply to the organism
• what are the differences in containment requirements between use in a contained facility and in an experimental field trial
• what does the NS program mean by “fit to use” standards and guidelines for the containment of higher organisms, and what obstacles in developing these standards and guidelines exist

Response 2: See subsection 1(1) of the NSNR (Organisms) for the definitions of “confinement procedures”, “experimental field study”, and “contained facility”. Note that the current definitions apply to micro-organisms, not to higher organisms.

The NS program is considering the following definition of a “contained facility” regarding higher organisms that are products of biotechnology:

“An enclosed building with walls, floor and ceiling, or an area within such a building, from which there is no release into the environment of (a) the organism (b) the genetic material of the organism or (c) material from the organism involved in toxicity.”

Note that there are situations where the use of an organism may not fulfill the conditions of a contained facility. For example, imported higher organisms that are subject to containment measures, where the notifier plans to distribute them in the Canadian environment later. In this case, they would not be eligible for notification under the proposed Schedule for use in a contained facility. This proposed Schedule would allow the manufacture in or import of new higher organisms to a contained facility. This means that they must not be introduced outside of the contained facility or can only be exported. This is the same intent as Schedule 2 for micro-organisms.

Currently, there are no specific containment standards or guidelines for higher organisms under the NSNR (Organisms). To address this, the NS program is considering updating the Notification Guidelines to include biosafety best practices. The NS program will base these best practices on international and Canadian standards and guidelines. The intent is to support the safe use of higher organisms in contained facilities. They will serve as guidance for regulated parties to help to ensure that their facility meets the requirements for higher organisms. The NS program is currently assessing standards to ensure that they are suitable for the Canadian regulatory context.

“Fit to use” refers to the need for biosafety guidelines that adapt to specific groups of organisms. Examples include aquatic vertebrates and terrestrial vertebrates. This serves to reflect the different measures needed to contain them. However, the onus would be on notifiers to demonstrate to the NS program that adequate physical and operational measures are in place. These measures must meet the proposed definition of a “contained facility” that would include higher organisms.

The NS program has engaged with academia and regulated parties regarding their biosafety practices and will continue to do so. The program will hold future consultations to consider the development of any standards that would be specific to CEPA and the Canadian context.

When a new higher living organism is notified for use in experimental field study, it may be released at one or more sites. However, the notifier must use the minimum area and quantity of the organism required to meet the objectives of the study. A notification for a higher organism that will be used in an experimental field study would require:

• a description of any confinement procedures (that is, physical, chemical, biological, and/or operational controls)
• biosafety conditions for the organism that would limit the dispersal of the organism beyond the confines of the study site

The NS program will use this information to assess any risk to the environment and human health.

Comment 3: How will risk assessment periods for higher organisms change compared to those currently in place? Some stakeholders expressed support for the extension of risk assessment periods. Others suggested that the NS program should remove regulated assessment periods altogether. This would be to reduce pressure on regulators during complex assessments.

Response 3: Section 108 of CEPA requires that the risk assessment of new living organisms be completed within timelines prescribed by the regulations. The NS program is proposing the following changes to the assessment period of higher organisms:

• 180 days for higher organisms manufactured or imported anywhere in Canada (which is currently 120 days under Schedule 5)
• 150 days for higher organisms used as part of an experimental field study
• 120 days for higher organisms used in containment

Any assessment period would become 60 days longer if the notified organism is subject to mandatory consultation under CEPA section 108.1(1). The Minister of Environment and the Minister of Health also have the authority to extend the assessment period if necessary. The assessment period can be extended to assess any information as needed. The assessment can be extended by a number of days not exceeding the initial assessment period, per CEPA section 108(4). They can also end an assessment before the assessment period expires, as per CEPA section 108(6). The NS program will continue to conduct risk assessments within prescribed timelines. It will also maintain the same high standards of environmental and human health protection under the NSNR (Organisms). 

Comment 4: Some raised concerns about the development of Schedules with fewer information requirements for higher organisms. They mentioned possible containment failures, reduced accountability towards animal welfare, and insufficient enforcement of containment plans.

Response 4: The new proposed Schedules for higher organisms would include fewer information requirements compared to the current Schedule 5. However, the new Schedules’ requirements would serve to identify potential risks specifically associated with use in containment or as part of an experimental field study.

Part 6 of CEPA and the NSNR (Organisms) are responsible for protecting human health and the environment. Animal welfare falls outside the purview of CEPA and the NSNR (Organisms). However, the proposed amendments for higher organisms include mechanisms that can address animal welfare concerns. Namely, the proposal would include an information exception under Schedule 5 for higher organisms released with confinement procedures. This is similar to the approach taken for micro-organisms under Schedule 1. The intent is to encourage notifiers to provide a degree of free-range activities for higher organisms that may otherwise be restricted to a contained facility. For organisms restricted to contained facilities, the NS program expects that they will be handled and transported according to federal and provincial animal welfare regulations. For information on CEPA’s compliance and enforcement for substances, including new living organisms, please see the Compliance and enforcement policy for the Canadian Environmental Protection Act.

Comment 5: How can people stay updated on policy changes regarding Somatic Cell Nuclear Transfer (SCNT) clones? Some opposed the proposed exemption of SCNT cloned animals from notification under the NSNR (Organisms). This was particularly from the perspective of animal welfare.

Response 5: For information concerning the federal government’s positions on SCNT clones of livestock cattle and swine, please see the Policy update on foods derived from somatic cell nuclear transfer (SCNT) clones and their offspring. This policy builds on the scientific opinion published in 2023. It addresses various animal health considerations, including animal welfare. However, the regulation of animal welfare is not in the scope of CEPA and the NSNR (Organisms).

The existing NSNR (Organisms) requirements are in place until any proposed regulatory amendments are consulted on (CGI) and come into effect after publication in CGII. Until then, SCNT cloned cattle and swine that are not on the DSL continue to be subject to the NSNR (Organisms).

Comment 6: Will genetically modified animals that someone then clones through SCNT be subject to the NSNR (Organisms)?

Response 6: When a genetically modified animal is cloned, it remains subject to CEPA and to the NSNR (Organisms) if it is not on the DSL. The NS program conducts risk assessments for new organisms that are not on theDSL and that are animate products of biotechnology. This includes genetically modified animals, cloned animals, and their progeny. Anyone intending to manufacture or import a new living organism (not on the DSL) in Canada must submit a notification to the NS program. This notification must be according to the appropriate Schedule of the NSNR (Organisms).

However, only SCNT cloned cattle and swine, their derived products and their progeny, would be exempt from notification under the NSNR (Organisms). This is based on scientific evidence and the Scientific Opinion on the Impact of Somatic Cell Nuclear Transfer (SCNT) Cloning of Cattle and Swine on Food and Feed Safety, Animal Health and the Environment (2023).

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

Comment 1: The NS program is proposing to exempt human cell culture therapies used for clinical trials and commercialization from notification under the NSNR (Organisms). What is the best course of action for upcoming human cell-based projects that may occur before the regulations are amended?

Response 1: Until the NSNR (Organisms) are amended, cultured human cells not on the DSL must be notified before its import into or manufacture in Canada. However, this does not apply if it meets one of the exemptions of section 2.5 of the Guidelines. For example,the NSNR (Organisms) provide a Research and Development (R&D) exemption, which Section 2.5.2.3 of the Guidelines explains. However, if a living organism is administered to patients that can leave a contained facility, then the living organism is no longer contained. Therefore, this living organism would require notification under Schedule 1 of the NSNR (Organisms).

The NS program plans to publish the NSNR (Organisms) amendments in Canada Gazette, Part I in 2026 for broad public consultation. The amended regulations come into effect after the consultation and publication in the Canada Gazette, Part II. Only after the new regulations come into effect might clinical trials involving human cell-based therapies qualify for exemption from notification. In the meantime, the NS program currently has interim measures in place to promote efficient regulation of biologic drugs subject to NSNR (Organisms).

Firstly, it has published the Supplementary Guidance Document for the Notification and Testing of New Substances: Organisms Used in Cell and Gene Therapy under Schedule 1 of the New Substances Notification Regulations (Organisms)

Secondly, it has committed to complete environmental assessments for living organisms used in human clinical trials within 30 days of receiving a complete notification. This is instead of the 120 days that CEPA mandates. The intent is to align with the current clinical trial applications (CTA) timelines of Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD).

Thirdly, it has established an information-sharing agreement to reduce submission burden for notifiers. Through this agreement, the NS Program directly accesses human health information submitted to BRDD (for both CTA and New Drug Submissions).

Comment 2: How will modernizing the NSNR (Organisms) affect phage therapies for clinical uses?

Response 2: The NS program assesses phages as viruses under the NSNR (Organisms) of Part 6 of CEPA. It proposes to streamline phage therapy notifications by aligning information requirements and assessment timelines with those of the Food and Drugs Act (F&DA). However, it will continue to ensure the protection of human health and the environment under the NSNR (Organisms).

The NS program proposes to align the regulatory timelines of the NSNR (Organisms) with the those of the Food and Drug Regulations for biologic drugs such as phage therapies. This would reduce the assessment period under the NSNR (Organisms) for biologic drugs. For biologic drugs intended for clinical trials, the assessment period would be reduced from 120 calendar days to 30 calendar days. However, the 120-calendar day assessment period will be maintained for biologic drugs intended to be commercialized.

Comment 3: How will the NSNR (Organisms) modernization impact micro-organisms that are used by the biomanufacturing sector? How will it affect the manufacture of biological drugs that are used in clinical trials and drug administration?

Response 3: Various naturally occurring and genetically modified micro-organisms are used as production organisms. These produce active ingredients for biological drugs. The safety, efficacy and quality reviews of these ingredients and drug products are conducted under authority of the Food and Drug Act (F&DA). However, the assessments of the indirect human health and environmental risks of these living organisms are needed before someone can manufacture them or import them into Canada. This is because these living organisms, or products of biotechnology, are subject to CEPA and the NSNR (Organisms). If a living organism is an active ingredient in drug dosage form, the Public Health Agency of Canada (PHAC) does not currently regulate it.

By modernizing the NSNR (Organisms), the NS program aims to use a risk-based approach to streamline the environmental assessment of biologic drugs subject to the Canadian F&DA. The proposed approach includes the exemption of cultured human cells and non-replicative viral vectors used in cell and gene therapies. These would not need to be notified if they qualify for certain defined criteria.

Furthermore, the NS program may streamline the regulation of certain new micro-organisms. This applies to notifiers that intend to import or manufacture these micro-organisms in contained facilities licensed under the Human Pathogens and Toxins Act (HPTA). Streamlined regulation could apply to the situations below.

The NS program proposes a directive where notifiers can request waivers from certain information requirements under the NSNR (Organisms) for naturally occurring, unmodified micro-organisms that:

• have been isolated from the Canadian environment
• are intended to be manufactured solely within a contained facility
• PHAC has identified as low-risk to individual and public health (ithat is Risk Group 1)

The NS program is also proposing a policy for micro-organisms classified by PHAC as human and animal pathogens. Notifiers could not submit these organisms under Schedules of the NSNR (Organisms) inherently involving environmental release. Therefore, they could not be notified under Schedules 1, 3, and 4. Instead, they should be notified under Schedule 2 (not for introduction outside a contained facility), unless PHAC has authorized prescriptive environmental release for the micro-organism. This would avoid delays in assessing the organism.

However, regardless of oversight provided by PHAC, notification under the NSNR (Organisms) is required. This is so the NS program can ensure that environmental risks are assessed. If these organisms are used in contained facilities with a HPTA license, notifiers may request waivers under the NSNR (Organisms) for certain information requirements. Notifiers could do so if a copy of the license is provided as part of their justification for the request of these waivers.

Comment 4: What is the timeframe for the transition of environmental reviews of biologic drugs to Health Canada under the amended Food and Drugs Act?

Response 4: Amendments made to Canada’s Food and Drugs Act (F&DA) in 2023 included the expansion of the Minister of Health’s regulation-making authority. This is to support the development of an enhanced environmental risk assessment and risk management regulatory regime for drugs (F&DA ERA Regime). The exact timing for the implementation of the regulations is currently unknown. Health Canada’s Health Products and Food Branch will continue to consult with affected parties as part of the regulatory development process. People can contact Health Canada’s Environmental Policy and Chemicals Management Plan Coordination Team at eri-ire@hc-sc.gc.ca. They can request the Team to add them to their email distribution list. Until the F&DA ERA Regime has been brought into force and implemented, new substances regulated under the F&DA, including biological drugs, will continue to undergo environmental risk assessment under the New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] and/or the NSNR (Organisms) of CEPA.

Comment 5: Canada should align the NSNR (Organisms) environmental risk assessment and management regime for biologic drugs with the United States.

Response 5: Unlike the United States, it is a regulatory requirement in Canada that all new living organisms not on the DSL must be notified under the NSNR (Organisms). Notifiers must do this before they import or manufacture the organisms in Canada in any quantity. This includes those used in biologic drugs, whether they are genetically modified or not. Notification is not needed if the organism meets one of the exemptions described in section 2.5 of the Guidelines. However, the NS program recognizes the need to streamline the environmental risk assessment of biologic drugs. It includes coordinating with timelines and requirements under the Canadian Food and Drugs Act. It also recognizes the importance of aligning with international regulatory frameworks as appropriate. This is especially important during the clinical trial stage. The goal is to address regulatory barriers to emerging products while maintaining a rigorous, risk-based pre-market approach for the environmental assessment of biologic drugs. Considering these factors, the NS program is proposing to exempt the following organisms:

• cultured human cells used in cellular therapies
• non-replicative viral vectors used in gene therapies

 These organisms would be exempted from notification under NSNR (Organisms) during the clinical trials and for commercialization stages, if they qualify for defined criteria.

Streamlining the regulatory scope for unmodified organisms

Comment 1: What is the definition of “modified” and “unmodified” organisms under the NSNR (Organisms)? This is regarding organisms with modifications introduced through biotechnology that are identical to unmodified organisms. Some raised concerns about defining gene-edited organisms as substantially the same as traditionally bred organisms. That is a similar approach to how the Canadian Food Inspection Agency regulates certain Plants with Novel Traits.

Response 1: The NS program is proposing to clarify in the Guidelines what it means by “naturally-occurring organism”, “unmodified organism”. It would also clarify what is an application of biotechnology under the NSNR (Organisms). The NS program will not provide regulatory definitions for terms such as “modified organism” and “unmodified organism”. This allows the NS program to maintain flexibility as science evolves. Under the proposed approach, modified and unmodified organisms will continue to need notification under the NSNR (Organisms). This requirement applies if they are new living organisms in Canada (not listed on the DSL), and not subject to other exemptions. The NS program intends to clarify in the Guidelines which information requirements are eligible for these waivers. These waivers would apply to low-risk, unmodified organisms that notifiers use in a contained facility. However, the NSNR (Organisms) has an approach that is substance-based and risk-based. Therefore, these organisms will continue to undergo assessments to determine their risks to human health or the environment. The NS program is not considering including gene-edited organisms for the proposed waivers at this time. Gene-edited organisms that are new to Canada will continue to be subject to the NSNR (Organisms).

Comment 2: Some opposed the exemption of unmodified organisms other than micro-organisms that are described as "implicitly listed on the DSL” in the Guidelines. They requested the NS program to clarify this proposal.

Response 2: The NS program proposes to exempt certain unmodified higher organisms. The following organisms would not need notification:

• livestock and domesticated animals
• animals in zoos, aquariums, circuses
• wild animals that are naturally found in Canada

These higher organisms are currently described in section 2.2 of the Guidelines. Other federal and provincial legislation are better positioned for addressing animal welfare concerns and potential risks to human health and the environment posed by these organisms. For example, these include:

• the Wild Animal and Plant Protection and Regulation of International and Interprovincial Trade Act
• the Plant Protection Act
• the Ontario Invasive Species Act

Other concerns and issues

Comment 1: How does the NS program process notifications with missing information? How does this affect risk assessment timelines? When are notifications declined? Is the public informed about any of these instances?

Response 1: When a notifier submits a New Substances Notification (NSN) to the NS program under the NSNR (Organisms), the NSN undergoes a screening process. During this process, the NS program reviews the NSN package to ensure that sufficient information has been provided. This means that the package fulfills each information requirement of the Schedule under which it was notified. If the notifier provides all information required by the NSNR (Organisms), the NS program informs them that it has started the assessment period. If the notifier does not provide enough information, the NS program informs them that the notification is missing information. In which case, the screening process stops until the notifier provides that information. Once the NS program receives all information required by the NSNR (Organisms), it will acknowledge the NSN. Once that is done, the risk assessment period begins. If the NS program finds that required information is missing during this time, it may stop the assessment period. It can then restart it from Day 1 when the required information is provided by the notifier and accepted.

The processing of missing information is not subject to public notification. It is part of the NS program’s routine control of the quality of submitted notifications.

Comment 2: What is the process of adding organisms on the DSL? What is the purpose of the information requirements under the NSNR (Organisms)?

Response 2: Any substance that is not on the DSL is considered new to Canada. If the substance is a living organism, anyone intending to import into or manufacture the organism in Canada must submit a NSN to the NS program under the NSNR (Organisms). They must do so before the importation or manufacturing activities begin. ECCC and HC use the information submitted to conduct a joint risk assessment. This serves to determine whether a new substance is toxic or capable of becoming toxic. A toxic substance is defined as per any of the criteria of section 64 of CEPA. When an assessment has led to a “suspicion of toxicity”, this indicates a potential risk to human health or the environment. The Minister of the Environment may then undertake one of several risk management measures under subsection 109(1) of CEPA. The Minister takes these measures prior to the substance’s introduction into Canada to mitigate identified risks. A substance may become eligible for addition to the DSL once the requirements under subsection 112(1) of CEPA are met.

For more information, please refer to: 

• the New Substances program website 
• the Guidelines for the Notification and Testing of New Substances: Organisms
• The NSN form (which specifies what information is required for a specific Schedule). 
• the Fact Sheet: New Substances Notification Regulations (Organisms) 
• the Substances Search tool, which is used to determine whether or not a substance is considered new to Canada

Please note that this tool does not search the Revised-In Commerce List.

Comment 3: Some raised concerns that the proposed amendments do not include controls on the import or use of “Do it yourself” (DIY) genetic engineering kits. They cited potential risks to biodiversity, human health, and the environment. They recommended that the NS program establish tools to regulate these kits and materials in Canada.

Response 3: The NSNR (Organisms) and CEPA apply to animate products of biotechnology before they can be imported and manufacture in Canada. This includes those contained in or developed through DIY kits and materials. The NS program intends to increase stakeholder awareness of responsibilities under the NSNR (Organisms) though compliance promotion outreach initiatives. These initiatives could include promotional mailouts to universities, publications on social media, or information sessions. Compliance promotion and outreach could also focus on upstream Canadian manufacturers and distributors of DIY genetic engineering kits. The NS program is not proposing new regulatory tools to address the DIY genetically modified products of biotechnology. Instead, it intends to engage with stakeholders and regulated parties to develop tools. These would help ensure that regulated parties know their responsibilities regarding the import and manufacture of DIY kits and their resulting materials in Canada.

Comment 4: Why is the NS program not addressing labelling of animate products of biotechnology by amending the NSNR (Organisms)?

Response 4: The issue of labelling implicates CEPA as a whole and other Ministries responsible for administering legislation related to products of biotechnology. Therefore, the NS program cannot address labelling during this phase of the NSNR (Organisms) modernization. However, the NS program will monitor and contribute to ongoing government-wide initiatives related to the labelling of consumer products and access to information of toxic substances. It will ensure that it aligns with the broader regulatory framework for animate products of biotechnology as required.

Comment 5: How do these amendments protect nature from genetic contamination? Is genetic contamination considered only for the risk assessment of vertebrate animals?

Response 5: Genetic contamination is a very important consideration in the risk assessment of all organisms under CEPA and the NSNR (Organisms), not just vertebrate animals. During the risk assessment, the NS program examines whether genetic contamination could pose risks to human health or the environment. The NS program uses the independent investigations of its scientific evaluators and the information that notifiers provide. For example, Schedule 5 of the NSNR (Organisms) has requirements that address genetic contamination broadly. Schedule 5 applies to all higher organisms; it is not limited to vertebrates.

The proposed regulatory amendments and non-regulatory changes will maintain and uphold existing high standards of health and environmental protection.

First, the NS program would develop a process for post-assessment review. It would serve to update risk assessment conclusions and any risk management measures based on new scientific information.

Second, it will introduce new data requirements for the NSNR (Organisms) to assess the effectiveness of inactivation procedures. This can help mitigate the risk of accidental release of micro-organisms from contained facilities.

Third, it will consider additional guidance on certain information requirements regarding vulnerable environments and the potential of adverse effects on endangered species and protected areas.

These measures can help the NS program reinforce its ability to assess risks to human health and the environment, including genetic contamination. By aligning with broader federal initiatives to protect nature, such as the Right to a Healthy Environment, these amendments help ensure a robust regulatory framework.

Comment 6: Some raised concerns regarding the NS program’s decisions about notified organisms.

Firstly, some were concerned that the NS program would authorize potentially hazardous organisms if they are notified for use in containment.

Secondly, some were concerned about the potential escape of aquatic species with microscopic life stages. This includes the potential escape of AquAdvantage salmon from contained facilities, or ornamental pet organisms, such as Glofish, without containment.

Thirdly, some asked if the NS program conducts risk assessment of a new organism on the basis of the notified use only, or if it also considers widespread commercial use of the organism.

Lastly, some felt there was a lack of clarity on the level of monitoring and enforcement of SNAc provisions.

Response 6: ECCC and HC assess the information that notifiers submit through NSNs to determine whether a new living organism is toxic or capable of becoming toxic. The risk assessment examines the various life stages of an organism throughout its biological life cycle. The NS program also considers potential uses other than the notified use of the organism. For example, when assessing an organism notified for limited industrial facilities use, the program may also consider the possibility of widespread commercial use.

When there is suspicion that a significant new activity may result in a living organism to become toxic, the NS program issues a SNAc notice in the Canada Gazette. A SNAc notice requires notifiers to submit additional information for assessment. The NS program must assess this information before the notifiers can use the organism for a significant new activity. ECCC enforces SNAc provisions in accordance with CEPA’s publicly available compliance and enforcement policy. In instances of non-compliance, enforcement officers consider factors such as the nature of the alleged violation, potential harm, intent, and compliance history. For more information on SNAc provisions, please visit the Significant new activity provisions: Canadian Environmental Protection Act webpage.

More information is available regarding consultations on certain organisms for which the NS program has received notifications, including organisms subject to mandatory consultation or voluntary engagement. Please consult the Consultations on certain living organisms new to Canada webpage. These consultations have included aquatic vertebrates such as AquAdvantage salmon and Glofish. To promote transparency of the NS program, ECCC and HC publish summaries of environmental and human health risk assessment reports for new substances. Summaries are available through the New substances: Risk assessment summaries webpage and the Substances Search tool. The summaries provide information on new organisms, conclusions on risk assessment, and regulatory decisions.

Comment 7: Some have raised concerns that the NS program does not consider the welfare of genetically modified animals during risk assessment.

Response 7: The regulation of animal welfare is not under the purview of the NS program. This is based on the authorities granted by CEPA and the NSNR (Organisms). ECCC and HC consider the information submitted by notifiers to conduct a joint risk assessment. This assessment determines whether a new substance is toxic or capable of becoming toxic as defined in section 64 of CEPA. For more information about how the NS program has addressed animal welfare in the proposed amendments, see the response to comment 4 under the Revising regulatory requirements for higher organisms commensurate to the level of intended release responsesection.

Comment 8: Will Canada ratify the Cartagena protocol on Biosafety?

Response 8: Canada supports the environmental objectives of the Biosafety Protocol and signed the agreement in April 2001. However, Canada has not ratified the Protocol because of its lack of clarity and predictability in terms of its implementation and enforcement.

Canada has a strong regulatory framework for biosafety risk assessment. This framework regulates products with novel traits under the appropriate Acts and Regulations depending on the organism and its intended use. These may include the Canadian Environmental Protection Act, the Pest Control Products Act, the Fertilizers Act, the Feeds Act, or the Health of Animals Act.

For more information on the Cartagena Protocol and Canada’s position, please visit the Biosafety: Cartagena Protocol website.

Comment 9: Some stakeholders supported the proposed approach to exempt organisms used R&D. They requested clarity on which R&D activities the NS program considers included or exempted under subsections 2(3) and 2(4) of the NSNR (Organisms). However, others opposed exempting any organisms for R&D purposes.

Response 9: The NS program is proposing to amend the criteria for an R&D organism under the NSNR (Organisms). This includes organisms used in a research context, such as:

• quality assurance or quality control organisms
• organisms used as experimental controls
• organisms used as disease models

The proposed amendment intends to exempt R&D organisms used within contained facilities from notification. Notification requirements still apply for organisms used outside of controlled research contexts, including those intended for commercial or industrial applications.

Comment 10: Some recommended that the government prevent the production and release of GMOs containing gene drives through legislation.

Response 10: The NSNR (Organisms) applies to all new living organisms, including new organisms that contain gene drives. Notifiers must submit them to the NS program unless exemptions under CEPA or the NSNR (Organisms) apply. The NS program assesses their potential impact on human health and the environment before their import or manufacture in Canada. If the NS program finds potential risks, the Minister of the Environment may undertake risk management measures under subsection 109(1) of CEPA to protect human health and the environment. These risk management measures include Ministerial Conditions, Ministerial Prohibitions, and Ministerial Requests for Additional Information. These tools can manage and mitigate risks from new living organisms. In addition, when there is suspicion that a significant new activity may result in a living organism becoming toxic, the NS program can apply SNAc provisions. This is to require additional information before a notifier can use the living organism for a significant new activity. If the NS program identifies risks from a new organism containing a gene drive that it cannot manage, the Minister of the Environment may prohibit its use on a case-by-case basis.

For more information on these risk management measures, please visit the following websites:

• Significant new activity provisions: Canadian Environmental Protection Act - Canada.ca
• New substances: Ministerial conditions - Canada.ca
• New substances: Ministerial prohibitions - Canada.ca
• Publications of Ministerial Conditions under the Canadian Environmental Protection Act, 1999 (CEPA)

Comment 11: Some recommended that the draft regulations should commit to a review of the NSNR (Organisms) within 6 months of the release of the implementation framework to support the Right to a Health Environment.

Response 11: The Government of Canada has a duty, in the administration of CEPA, to protect the right to a healthy environment as provided for under CEPA, subject to reasonable limits. The implementation framework, which sets out considerations to protect this right and uphold the principles described in the framework, was published July 19, 2025. The NS program is working to integrate consideration of the right to a healthy environment and relevant principles in its processes.

Comment 12: Are human proteins subject to the NSNR(Organisms) or the NSNR (Chemicals and Polymers)?

Response 12: Proteins do not meet the definition of a living organism. They fall under the New Substances Notification Regulations (Chemicals and Polymers). These regulations establish information requirements for new chemicals, polymers, biochemicals, and biopolymers. Proteins generally do not meet the regulatory definition of a polymer. They are classified as chemicals or biochemicals on a case-by-case basis. Notifiers must submit a notification under the NSNR (Chemicals and Polymers), unless the activity meets low volume exemption criteria. The exemption applies when the quantity is below regulatory trigger quantities, which are as low as 100 kilograms/year depending on several factors. Section 3.3.1 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) explains substance classification. Section 4 of this document provides guidance on trigger quantities.