Consultations on certain living organisms new to Canada
Background
Environment and Climate Change Canada and Health Canada are promoting more public engagement in the risk assessment of higher organisms (such as genetically modified fish, insects and livestock animals) conducted by the New Substances (NS) program.
In June 2017, the Standing Committee on Environment and Sustainable Development made a number of recommendations to the House of Commons on the statutory review of the Canadian Environmental Protection Act, 1999 (CEPA). The Committee's report made recommendations on Part 6 of CEPA regarding the need for meaningful public consultation, increased transparency and better communication on the risk assessment process and regulatory decisions for living organisms. The voluntary public engagement initiative was launched in 2018 as part of the Government of Canada’s commitment to address these recommendations.
In June 2023, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent, amending CEPA by introducing, among other things, new obligations concerning living organisms new to Canada. For instance, consultation is now mandatory when the NS program assesses a vertebrate animal or a prescribed living organism or group of living organisms before the end of the assessment period. When these consultation requirements do not apply, the New Substances program encourages the notifiers of higher organisms to participate voluntarily in the public consultation. For ease of reference, consultations on organisms new to Canada whether open, closed (including those under the voluntary public engagement initiative), mandatory or voluntary, can be found on this webpage. For greater certainty, the consultation requirements under CEPA do not apply to notifications received prior to June 2023.
The NS program publishes summaries of certain New Substances Notifications (NSNs) submitted and invites stakeholders to provide comments, including scientific information and test data related to potential risks to the environment or human health from the new living organisms. Information that could be shared to inform the risk assessment process includes:
- environmental fate information
- ecological effects information
- human health effects information
- exposure information (including sources and routes of exposure)
Open consultations
There are currently no open consultations.
Closed consultations
Share your thoughts: Participate in the risk assessment process for four lines of Gene Edited Pigs
NSN Numbers: 22051, 22196-22198
Substance designation of the organisms:
- A gene edited Sus scrofa domesticus, Landrace descended from the L02 line, lacking a binding site for Porcine Reproductive and Respiratory Syndrome Virus (PRRSV)
- A gene edited Sus scrofa domesticus, Large White descended from the L03 line, lacking a binding site for Porcine Reproductive and Respiratory Syndrome Virus (PRRSV)
- A gene edited Sus scrofa domesticus, mix breed of Pietrain, Large White, Hampshire and Durocs descended from the L65 line, lacking a binding site for Porcine Reproductive and Respiratory Syndrome Virus (PRRSV)
- A gene edited Sus scrofa domesticus, Duroc descended from the L800 line, lacking a binding site for Porcine Reproductive and Respiratory Syndrome Virus (PRRSV)
Subject to consultation requirements under section 108.1 of CEPA: Yes, the organism is a vertebrate.
Activity: The notified organisms are four genetically edited domestic breeds of pigs (scientific name, Sus scrofa domesticus) which include:
- Landrace
- Large White
- Mix of Pietrain, Large White, Hampshire and Duroc
- Duroc
They are notified for use in breeding with commercially raised pigs used for pork production.
Genetic modifications: All four lines of pigs have had their genomes edited to remove a binding site for the virus that causes porcine reproductive and respiratory syndrome PRRS. No new genetic material has been introduced to the notified organisms.
The gene editing is intended to remove the binding site for PRRS. Without this binding site, the virus is unable to bind and infect the host organism. PRRS is a highly contagious viral infection that is considered to be one of the most significant diseases in commercially raised pigs around the world. Currently, there is no effective treatment program for acute PRRS. The removal of the binding site for the PRRS virus from the notified organisms makes these pigs resistant to infection by the virus.
Exposure: According to the notifier, the pigs will be used for conventional breeding in commercial pig production systems in the same manner as non-edited pigs, to generate PRRS virus-resistant pig offspring for food and feed product use. The usage includes the import of animals derived from the edited pigs into production facilities in Canada. The notifier plans to maintain the animals under confinement and have described the biosafety and biosecurity procedures to be used at these facilities. There are no plans for any introduction into the environment outside production facilities
Waiver of information requirement: No waiver was requested.
Privacy Act Notice Statement
The personal information is collected under the authority of section 5 of the Department of the Environment Act and subsection 7(1) of the Financial Administration Act.
The New Substances Program, jointly administered by ECCC and Health Canada, is undertaking public consultation that could inform the risk assessment process for the four lines gene edited pigs. The information is collected, used and disclosed for the purpose of evaluating the potential risks posed by the gene edited organisms to the environment and human health. Information collected by ECCC will be retained by the department and shared with Health Canada for the purposes of the evaluation. Your participation and decision to provide any information is voluntary.
The personal information created, held or collected by Environment and Climate Change Canada is protected under the Privacy Act. Information from this consultation will be used, disclosed and retained in accordance with the conditions listed in the Personal Information Bank Outreach Activities PSU 938.
Any questions or comments regarding this privacy notice may be directed to ECCC’s Access to Information and Privacy Division at ECATIP-ECAIPRP@ec.gc.ca. If you are not satisfied that your privacy has been adequately respected, you have the right to file a complaint. You may contact the Office of the Privacy Commissioner of Canada by calling their information center at 1-800-282-1376 or by visiting their contact page.
Request for Confidentiality under CEPA
Please provide information in English or French. Your information may be summarized and published in part or in full. Pursuant to section 313 of CEPA, any person who provides information in response to New Substance Notification 22051, 22196, 22197, and 22198 may submit, with the information, a request that it be treated as confidential. A request for confidentiality must indicate which specific information or data should be treated as confidential, and it must be submitted with reasons taking into account the criteria referred to in subsection 313(2) of CEPA.
Include your name, affiliation, telephone number, e-mail and mailing address and use the following format in the title of your submission: Public Participation: [NSN number(s)] – [Substance Designation].
Join in: how to participate
All interested parties are invited to provide comments, including scientific information and test data related to potential risks to the environment or human health from the four lines of gene edited pigs. This information will be considered as part of the department’s assessment of the organism’s potential risks to the environment or human health, which is ongoing. A summary of the public comments received as well as the New Substances Program’s responses will be published once the evaluation has been completed.
By mail
Send us a letter with your comments and input to the address in the contact information below.
By email
Send an email to substances@ec.gc.ca with your comments and input.
Who is the focus of this consultation
We would like to hear from:
- Indigenous peoples
- provincial, territorial and local governments
- industry stakeholders and association members
- non-governmental organizations
- general public
Key questions for discussion
All people in Canada are invited to provide comments, including scientific information and test data that could inform the risk assessment process. Information that may inform the risk assessment process could include:
- environmental fate information
- ecological effects information
- human health effects information or
- exposure information (including sources and routes of exposure)
Related information
Contact us
Science and Technology Branch
Environment and Climate Change Canada
Place Vincent Massey, 351 St. Joseph Blvd
Gatineau QC K1A 0H3
Telephone: 1-800-567-1999 (Toll Free in Canada) or 1-819-938-3232 (Outside of Canada)
E-mail: substances@ec.gc.ca
Three lines of fluorescent Corydoras fish
Title: Notification for three lines of fluorescent Corydoras fish for use in aquaria as ornamental fish
Public comment period: March 8th, 2025, to April 6th, 2025
Notifier: GloFish LLC
NSN numbers: 22084, 22085, 22086
Substance Designation:
- A genetically modified Corydoras aeneus descended from Green Corydora 0, founder of the GCA2021- 0 line, with multiple copies inserted of a construct containing genes expressing a green fluorescent protein derived from a foreign organism (GloFish® Electric Green® Corydoras, NSN 22084)
- A genetically modified Corydoras aeneus, descended from Pink Corydora 0, founder of the PiCA2020-0 line, with multiple copies inserted of a construct containing genes expressing a pink fluorescent protein derived from a foreign organism (GloFish® Moonrise Pink® Corydoras, NSN 22085)
- A genetically modified Corydoras aeneus, descended from Orange Corydora 0, founder of the OCA2020-0 line, with multiple copies inserted of a construct containing genes expressing an orange fluorescent protein derived from a foreign organism (GloFish® Sunburst Orange® Corydoras, NSN 22086)
Subject to consultation requirements under section 108.1 of CEPA: Yes, organism is a vertebrate.
Activity: These ornamental fish are domesticated Corydoras aeneus, commonly referred to as “Cory catfish”, that have been genetically engineered to produce unique colours and fluorescence for use in home aquaria. The unmodified Cory catfish has been commercially cultured in the United States since at least 1933. GloFish LLC requested a review by the United States Food and Drug Administration of Orange and Pink Corys in 2021 and Green Corys in 2022. They received decision letters for commercialization in the US market. To develop the lines of fluorescent green, pink and orange colours using fluorescent proteins, a domesticated albino was used as founder.
Genetic modifications: All three lines of GloFish® Corydoras have been modified to express different fluorescent proteins that were derived from natural marine organisms such as jellyfish, corals and anemones, giving each GloFish® Corydora their corresponding colour. The Electric Green® Cory contains multiple copies of a genetic construct expressing a green fluorescent protein. The Sunburst Orange® Cory contains multiple copies of a genetic construct expressing an orange fluorescent protein. The Moonrise Pink® Cory contains multiple copies of a genetic construct expressing a red fluorescent protein.
According to the notifier, the safety of these fluorescent proteins has been discussed broadly in the notification, and no cytotoxic or adverse effects have been identified by the notifier.The majority of these fluorescent proteins have been used in GloFish® species for decades, some proteins were in lines which were commercialized as early as 2005, without any reports of adverse effects.
Exposure: These fish are developed only for ornamental use and are not for human or animal consumption. According to the notifier, their potential to survive in the Canadian environment, including cold winter temperatures is highly unlikely. The genetic modifications are not expected to confer any advantage for surviving in Canadian water bodies.
Waiver of information requirement: No waiver requested.
Start date of the assessment: January 23, 2025
Privacy Act Notice Statement
The personal information is collected under the authority of section 5 of the Department of the Environment Act and subsection 7(1) of the Financial Administration Act.
The New Substances Program, jointly administered by ECCC and Health Canada, is undertaking public consultation that could inform the risk assessment process for GloFish® Corydoras organisms. The information is collected, used and disclosed for the purpose of evaluating the potential risks posed by GloFish® Corydoras to the environment and human health. Information collected by ECCC will be retained by the department and shared with Health Canada for the purposes of the evaluation. Your participation and decision to provide any information is voluntary.
The personal information created, held or collected by Environment and Climate Change Canada is protected under the Privacy Act. Information from this consultation will be used, disclosed and retained in accordance with the conditions listed in the Personal Information Bank Outreach Activities PSU 938.
Any questions or comments regarding this privacy notice may be directed to ECCC’s Access to Information and Privacy Division at ECATIP-ECAIPRP@ec.gc.ca. If you are not satisfied that your privacy has been adequately respected, you have the right to file a complaint. You may contact the Office of the Privacy Commissioner of Canada by calling their information center at 1-800-282-1376 or by visiting their contact page.
Request for Confidentiality under CEPA
Please provide information in English or French. Your information may be summarized and published in part or in full. Pursuant to section 313 of CEPA, any person who provides information in response to NSNs 22084, 22085 and 22086 may submit, with the information, a request that it be treated as confidential. A request for confidentiality must indicate which specific information or data should be treated as confidential, and it must be submitted with reasons taking into account the criteria referred to in subsection 313(2) of CEPA.
Include your name, affiliation, telephone number, e-mail and mailing address and use the following format in the title of your submission: Public Participation: [NSN number(s)] – [Substance Designation].
How to participate
All interested parties are invited to provide comments, including scientific information and test data related to potential risks to the environment or human health from the GloFish® sharks. This information will be considered as part of the departments’ assessment of the organism’s potential risks to the environment or human health, which is ongoing.
By email
Submit your comments by email: substances@ec.gc.ca
By mail
Send your comments to the address below:
Science and Technology Branch
Environment and Climate Change Canada
Place Vincent Massey, 351 St. Joseph Blvd
Gatineau QC K1A 0H3
Substances Management Information Line
Telephone: 1-800-567-1999 (Toll Free in Canada) or 1-819-938-3232 (Outside of Canada)
Four lines of GloFish® Shark
Title: Notification for four lines of fluorescent Rainbow Shark for use in aquaria as ornamental fish
Notifier: GloFish LLC
NSN numbers: 21655, 21656, 21657 and 21658
Substance designation:
- A genetically modified Epalzeorhynchos frenatum, descended from Blue Shark 0, founder of the BS2017-0 line, with multiple inserted copies of constructs containing genes expressing a chromoprotein derived from a foreign organism and a blue fluorescent protein (GloFish® Cosmic Blue® Shark, NSN 21655)
- A genetically modified Epalzeorhynchos frenatum, descended from Green Shark 0, founder of the GS2017-0 line, with multiple inserted copies of a construct containing genes expressing a green fluorescent protein derived from a foreign organism (GloFish® Electric Green® Shark, NSN 21656)
- A genetically modified Epalzeorhynchos frenatum, descended from Orange Shark 0, founder of the OS2016-0 line, with multiple inserted copies of a construct containing genes expressing an orange fluorescent protein derived from a foreign organism (GloFish® Sunburst Orange® Shark, NSN 21657)
- A genetically modified Epalzeorhynchos frenatum, descended from Purple Shark 0, founder of the PS2016-0 line, with multiple inserted copies of a construct containing genes expressing a far-red fluorescent protein derived from a foreign organism (GloFish® Galactic Purple® Shark, NSN 21658)
Assessment period: October 4, 2023 to January 31, 2024
Activity: These ornamental fish are domesticated Epalzeorhynchos frenatum, commonly referred to as “Rainbow Shark”, that have been genetically engineered to produce unique colours and fluorescence for use in home aquaria. The unmodified Rainbow Shark has been commercially cultured in the United States since the mid-1970s. All four GloFish® lines have been available in the USA since 2018. To develop the lines of fluorescent blue, green, purple and orange colours using fluorescent proteins, a domesticated albino Rainbow Shark was used as founder.
Genetic modifications: All four lines of GloFish® Shark have been modified to express different fluorescent proteins that were derived from natural marine organisms such as jellyfish, corals and anemones, giving each GloFish® Rainbow Shark their corresponding colour. The Cosmic Blue® Shark contains multiple copies of genetic constructs expressing a blue fluorescent protein and a chromoprotein. The Electric Green® Shark contains multiple copies of a genetic construct expressing a green fluorescent protein. The Sunburst Orange® Shark contains multiple copies of a genetic construct expressing an orange fluorescent protein. The Galactic Purple® Shark contains multiple copies of a genetic construct expressing a purple fluorescent protein.
The inserted genetic constructs and expressed fluorescent proteins are not known to be toxic to either humans or animals. The safety of these fluorescent proteins has been discussed broadly and no cytotoxic or adverse effects have been identified. The majority of these fluorescent proteins have been used in GloFish® species since their introduction to commercial markets in 2005 without any reports of adverse effects.
Exposure: These fish are developed only for aquarium display and are not for human or animal consumption or to be released to the environment. Rainbow Sharks are native to tropical countries and their ability to survive in the Canadian environment, including cold winter temperatures, were considered as part of the formal risk assessment. The genetic modifications are not expected to confer any advantage of surviving in Canadian water bodies.
Waiver of information requirement: No waiver requested.
Subject to consultation requirements under section 108.1 of CEPA: Yes, organism is a vertebrate.
Public comment period: November 13, 2023 to December 13, 2023
Public comments received: Summary of public comments received
NS program risk assessments:
- Risk assessment conducted under CEPA for GloFish® Cosmic Blue® Shark, NSN 21655
- Risk assessment conducted under CEPA for GloFish® Electric Green® Shark, NSN 21656
- Risk assessment conducted under CEPA for GloFish® Sunburst Orange® Shark, NSN 21657
- Risk assessment conducted under CEPA for GloFish® Galactic Purple® Shark, NSN 21658
Risk assessment conclusions: It is determined that the four lines of GloFish® Shark (Epalzeorhynchos frenatum genetically modified) are not toxic or capable of becoming toxic according to the criteria under section 64 of CEPA.
EntoEngine fruit fly producing human FGF2
Title: Notification for a fruit fly for use in recombinant protein production, human FGF2
Notifier: Future Fields
NSN number: 21561
Substance designation: A genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing human FGF2 and a marker gene balanced over a chromosome balancer (EntoEngine producing human FGF2)
Assessment period: July 5, 2023 to January 11, 2024
Activity: The genetically modified Drosophila melanogaster, commonly referred to as the “fruit fly”, acts as a living insect bioreactor, capable of expressing recombinant proteins on demand. The line subject to this notification expresses a growth factor protein (human FGF2). Growth factors are the unique cell signaling molecules that play important roles in cell proliferation and development. The present growth factor (human FGF2) is intended for use as a highly purified component of cell culture medium for research use only.
Genetic modifications: Drosophila melanogaster have been used in research settings globally since 1909 with no evidence to date of adverse environmental impact. Drosophila are not the intermediate host for any parasite, and are not naturally infected by any pathogen of human or agricultural concern.
This EntoEngine fly line has been genetically engineered to express the growth factor protein - human FGF2. The gene sequence of interest is not known to be toxic to either humans or animals.
Expression of the gene encoding the growth factor is under the control of a promoter activated by a specific stimuli. This means the growth factor protein is not constitutively expressed in the host organism and does not produce the recombinant protein under typical rearing or environmental conditions.
Exposure: Future Fields applies preventative controls, including containment measures for all genetically engineered organisms. They are kept triple contained in shatter-proof containers within a designated production area (interior room) that has physical barriers and controlled personnel entry and exit.
The curly wing phenotype causes flightlessness, resulting in minimal likelihood of escape or dispersal. The probability of transmission of the curly wing trait for this strain of Drosophila melanogaster is 66.67%, meaning approximately ⅓ of the adult fly population would be expected to develop straight wings. Any adult fly with straight wings will be discarded before breeding.
Measures are taken to ensure safe and regulated disposal of all surplus organisms and associated waste via a contracted hazardous waste management company. Live organisms do not leave the Future Fields facility and are fully processed on site. The commercial end product is a highly purified recombinant human FGF2 protein. Downstream processes ensure the removal of host components including but not limited to DNA, RNA, proteins and lipids.
Subject to consultation requirements under section 108.1 of CEPA: No, the organism is not a vertebrate nor a prescribed organism.
Public comment period: August 2 to October 1, 2023
Public comments received: Summary of the public comments received
Waiver of information requirement: Waiver of information requirement for Future Fields, NSN 21561
NS program risk assessment: Risk assessment conducted under the Canadian Environmental Protection Act, 1999.
Risk assessment conclusion: It is determined that the genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing human FGF2 and a marker gene balanced over a chromosome balancer is not toxic or capable of becoming toxic according to the criteria under section 64 of CEPA.
Additional information: Questions and answers
EntoEngine fruit fly producing bovine FGF2
Title: Notification for a fruit fly for use in recombinant protein production, bovine FGF2
Notifier: Future Fields
NSN number: 21233
Substance designation: A genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing bovine FGF2 and a marker gene balanced over a chromosome balancer (EntoEngine producing bovine FGF2)
Assessment period: November 18, 2022 to July 15, 2023
Activity: The genetically modified Drosophila melanogaster, commonly referred to as the “fruit fly”, acts as a living insect bioreactor, capable of expressing recombinant proteins on demand. The line subject to this notification expresses a growth factor protein that is intended for use as a component of cell culture medium for research use.
Genetic modifications: This EntoEngine fly line has been genetically engineered to express a growth factor isolated from cows. Growth factors are the unique cell signaling molecules that play important roles in cell proliferation and development. The gene sequence poses no known risks to either humans or animals. Expression of the gene encoding the growth factor is under the control of a gene expression regulator isolated from yeast. A chromosome stabilizer increases the stability of the line.
Public comment period: December 30, 2022 to January 28, 2023
Public comments received: Summary of public comments received
Waiver of information requirement: Waiver of information requirement for Future Fields, NSN 21233
NS program risk assessment: Risk assessment conducted under the Canadian Environmental Protection Act
Risk assessment conclusion: It is determined that the genetically modified Drosophila melanogaster strain with a single insert of a construct containing a gene expressing bovine FGF2 and a marker gene balanced over a chromosome balancer is not toxic or capable of becoming toxic according to the criteria under section 64 of CEPA.
Four lines of GloFish® pristella
Title: Notification for four ornamental aquarium fish that fluoresce
Notifier: GloFish LLC
NSN numbers: 21316-21317-21318-21319
Substance designation:
- GloFish® Sunburst Orange® Pristella (Pristella maxillaris genetically modified – 21316)
- GloFish® Starfire Red® Pristella (Pristella maxillaris genetically modified – 21317)
- GloFish® Electric Green® Pristella (Pristella maxillaris genetically modified – 21318)
- GloFish® Galactic Purple® Pristella (Pristella maxillaris genetically modified – 21319)
Assessment period: August 26, 2022 to December 23, 2022
Activity: Pristella maxillaris (Ulrey, 1894), commonly referred to as “X-ray tetra” or “X-ray fish”, are tropical aquarium fish that have been in the aquarium trade for at least three decades. The genetically modified lines that are the subject of the notification are also intended for use in home aquaria (ornamental trade).
Genetic modifications: All GloFish® lines of fluorescent aquarium fish have been genetically engineered to express fluorescent proteins isolated from common marine invertebrates including corals and sea anemones. The fluorescent proteins are well characterized and not toxic to fish, humans, and most other organisms. Expression of the genes encoding the fluorescent proteins are under the control of promoters isolated from fish.
Public comment period: October 11 to 25, 2022
Public comments received: no comments received
Risk assessment conclusion: The four lines of GloFish® Pristella (Pristella max, genetically modified) are not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
Four lines of GloFish® barb
Notifier: GloFish LLC
NSN numbers: 21071, 21072, 21073 and 21074
Substance designation:
- GloFish® Electric Green® Barb (Puntigrus tetrazona genetically modified – 21071)
- GloFish® Starfire Red ® Barb (Puntigrus tetrazona genetically modified – 21072)
- GloFish® Galactic Purple® Barb (Puntigrus tetrazona genetically modified – 21073)
- GloFish® Sunburst Orange® Barb (Puntigrus tetrazona genetically modified – 21074)
Assessment period: January 22, 2022 to May 21, 2022
Activity: Puntigrus tetrazona (Bleeker 1855), commonly referred to as “Tiger Barb” or “Sumatra Barb”, are tropical aquarium fish that have been in the aquarium trade since the 1950s. The genetically modified lines that are the subject of the notification are also intended for use in home aquaria (ornamental trade). The green line was the first GloFish® Barb to be introduced to the US market in 2012 and has been sold since then.
Genetic modifications: All GloFish® lines of fluorescent aquarium fish have been genetically engineered to express fluorescent proteins isolated from common marine invertebrates including corals and sea anemones. The fluorescent proteins are well characterized and not toxic to fish, humans, and most other organisms. Expression of the genes encoding the fluorescent proteins are under the control of promoters isolated from fish.
Public comment period: February 14, 2022 to March 1, 2022
Public comments received: Comments and information were provided by 15 citizens and one non-government organization. A summary of the comments and responses is included below.
| Comment summary | Response |
|---|---|
|
Publication of a research paper on the escape of fluorescent zebrafish in Brazil has raised concerns with the release of other genetically modified aquarium fish. The Government of Canada must consider how the assessment conclusion of these notifications in Canada may impact biodiversity in Canada and other parts of the world, and its role in mitigating this risk. André Lincoln Barroso Magalhães, Marcelo Fulgêncio Guedes Brito & Luiz Gustavo Martins Silva (2022) The fluorescent introduction has begun in the southern hemisphere: presence and life-history strategies of the transgenic zebrafish Danio rerio (Cypriniformes: Danionidae) in Brazil, Studies on Neotropical Fauna and Environment, DOI: 10.1080/01650521.2021.2024054 |
This paper was taken into consideration in the risk assessment of the GloFish® Barbs to inform the environmental exposure assessment. Water temperatures in the native region of Zebrafish and other tropical fish are comparable to those of Brazil. Given the significant temperature differences between waters in Canada and Brazil, the notified species, which is a tropical fish, is not expected to survive the Canadian winter. Canada is involved in various international biotechnology initiatives to ensure that regulations and risk assessments for biotechnology products are protecting the environment. For example, Canada demonstrates engagement to protect biological diversity through various international biotechnology initiatives such as participation in the Convention on Biological Diversity, an international body that establishes standards and approaches for biodiversity protection activities. Canada also participates in the Organisation for Economic Co-operation and Development’s Working Party on the Harmonisation of Regulatory Oversight in Biotechnology, which promotes international harmonization in environmental risk and safety assessments and provides a forum to discuss the regulation of organisms produced through modern biotechnology. Canada’s rigorous, evidence-based assessments conducted under the Canadian Environmental Protection Act, 1999 aligns with these approaches recommended by the international community. |
| Human error has historically resulted in the release of genetically engineered organisms. | The risk assessment took into consideration the possibility of these fish being released into the Canadian environment. Puntigrus tetrazonas is a tropical species and the notified organisms is not expected to survive Canadian winter. The occurrence of GloFish® Barbs in the Canadian freshwater environment would be seasonal or ephemeral at most. |
| Halt any further approvals of genetically engineered animals in Canada until the regulations are strengthened, including to increase transparency and public participation. | The Government of Canada is committed to the protection of our environment and to the health and safety of Canadians. We use a robust science-based process to evaluate the effect of genetically modified animals on our environment and the health of Canadians. Environment and Climate Change Canada is continuously working with other federal departments and agencies to improve Canada’s regulatory regime for genetically modified organisms by ensuring that it is both effective and transparent. The Government of Canada acknowledges the need for meaningful public consultation during the risk assessments for genetically modified organisms, and steps taken to promote transparency include the voluntary public engagement initiative, which has been implemented through administrative changes. |
| Genetically engineered aquarium fish are unnecessary and the threat to native species outweighs their commercial benefit. | The risk assessment took into consideration the intended use as an aquarium fish and concluded that GloFish® Barbs used in the ornamental aquarium trade in Canada pose a low risk to Canadian environments. |
| Genetically engineered fish should be labelled as such so the public can decide whether they want to support the producers of these fish by purchasing them. | Labelling may be required in Canada for some genetically engineered organisms; for example, the Food and Drugs Act requires special labelling of all food products, including genetically engineered foods, where there are clear, scientifically established, health risks or significant nutritional changes, which might be mitigated through labelling. However, there is currently no requirement for the labelling of genetically engineered ornamental fish under the Canadian Environmental Protection Act, 1999. |
| Concerned citizens call for a ban on all genetically modified foods. | GloFish® Barbs and all other lines of GloFish® are not intended for human consumption as per the manufacturer. As the consumption of genetically engineered foods fall under the scope of the Food and Drugs Act, risk assessments conducted under the Canadian Environmental Protection Act, 1999 do not include an assessment of the fish as food. |
Risk assessment conclusion: The four lines of GloFish® Barbs (Puntigrus tetrazonas, genetically modified) are not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
Three lines of GloFish® betta
Notifier: GloFish LLC
NSN numbers: 20658, 20659 and 20660
Substance designation:
- GloFish® Moonrise Pink® Betta (Betta splendens, genetically modified) – 20658
- GloFish® Sunburst Orange® Betta (Betta splendens, genetically modified) – 20659
- GloFish® Electric Green® Betta (Betta splendens, genetically modified) – 20660
Assessment period: February 4, 2021 to June 3, 2021
Activity: Betta splendens (Regan 1910), commonly referred to as “Siamese fighting fish” or “betta”, are tropical aquarium fish that have been in the aquarium trade since the 1930s. The genetically modified lines that are the subject of the notification are also intended for use in home aquaria (ornamental trade). The green line has been sold in the United States since 2020. The pink and orange lines have recently been developed and are not yet available on the market.
Genetic modifications: All GloFish® lines of fluorescent aquarium fish have been genetically engineered to express fluorescent proteins isolated from common marine invertebrates including corals and sea anemones. The fluorescent proteins are well characterized and not toxic to fish, humans, and most other organisms. Expression of the genes encoding the fluorescent proteins are under the control of promoters isolated from fish.
Public comment period: March 25, 2021 to April 9, 2021
Public comments received: Comments and information were provided by one citizen and one non-government organization. A summary of the comments and responses is included below.
| Comment summary | Response |
|---|---|
| There is a possibility that individuals will use these fish as bait while fishing. Release to a non-native habitat can result in an organism becoming invasive. | The risk assessment took into consideration potential uses, including illegal use of these fish as bait. Although there is a possibility of these fish being exposed to the Canadian environment, Betta splendens is a tropical species and there is a very low likelihood that any of the notified organisms can survive Canadian winter. The occurrence of GloFish® Bettas in the Canadian freshwater environment would be seasonal or ephemeral at most. |
| The risk assessment should take into consideration that these fish are being sold for purely ornamental purposes. | The risk assessment took into consideration the intended use as an ornamental aquarium fish and concluded that GloFish® Bettas used in the ornamental aquarium trade or other uses in Canada pose low risk to Canadian environments. |
| Canadians have a range of concerns around genetically engineered organisms, beyond those intended for consumption. Genetically engineered fish should be labelled to let wholesalers, retailers and customers know about the elevated risk these fish pose to the environment. | Labelling may be required in Canada for some genetically engineered organisms; for example, the Food and Drugs Act requires special labelling of all food products, including genetically engineered foods, where there are clear, scientifically established, health risks or significant nutritional changes, which might be mitigated through labelling. However, there is currently no requirement for the labelling of genetically engineered organisms for environmental concerns in Canada. |
| The risk assessment should consider pathways by which these fish could be released, accidentally or otherwise, in their natural distribution range, or outside their natural distribution range but in environments with climates more favorable to their survival. | No such environments exist within Canada. The effects of genetically engineered organisms on environments outside of Canada are outside the scope of the risk assessment conducted under the Canadian Environmental Protection Act, 1999. |
Risk assessment conclusion: The three lines of GloFish® bettas (Betta splendens, genetically modified) are not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
GloFish® danios (Cosmic Blue® and Galactic Purple®)
Notifier: GloFish LLC
NSN numbers: 20011 and 20012
Substance designation:
- GloFish® Cosmic Blue® Danio (Danio rerio, genetically modified) – 20011
- GloFish® Galactic Purple® Danio (Danio rerio, genetically modified) – 20012
Assessment period: May 9, 2019 to September 5, 2019
Activity: Danio rerio (Hamilton 1822), commonly referred to as “zebra danio” or “zebrafish”, are tropical aquarium fish that have been in the aquarium trade in Europe since 1905 and in the United States since the 1940s. The genetically modified lines that are the subject of these notifications are also intended for use in home aquaria (ornamental trade). The GloFish® Cosmic Blue® and Galactic Purple® Danios have been sold in the United States since 2006 and 2011, respectively.
Genetic modifications: The GloFish® lines of fluorescent danios have been genetically engineered to express fluorescent proteins isolated from common marine invertebrates including corals and sea anemones. Expression of the genes encoding the fluorescent proteins are under the control of promoters isolated from fish.
Public comment period: June 17, 2019 to July 2, 2019
Public comments received: Comments and information were provided by one citizen. A summary of the comment and response is included below.
| Comment summary | Response |
|---|---|
| A concerned citizen asks for the mandatory labelling of all GMO products |
GloFish® danios are only intended for use as ornamental aquarium fish. There are currently no labelling requirements in Canada for non-food genetically modified organisms. Health Canada and Canadian Food Inspection Agency share the federal responsibility for food labelling policies under the Food and Drugs Act. Special labelling of all food products, including genetically modified foods, is required where there are clear, scientifically established, health risks or significant nutritional changes, which might be mitigated through labelling. In these situations, labelling is required to alert consumers or susceptible groups in the population at large. However, GloFish® danios are not intended for consumption as food, and therefore do not require labelling. |
Risk assessment conclusion: The GloFish® Cosmic Blue® and Galactic Purple® danios (Danio rerio, genetically modified) are not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
GloFish® danio (Sunburst Orange®)
Notifier: GloFish LLC
NSN number: 19923
Substance designation: GloFish® Sunburst Orange® Danio (Danio rerio, genetically modified)
Assessment period: March 5, 2019 to July 2, 2019
Activity: Danio rerio (Hamilton 1822), commonly referred to as “zebra danio” or “zebrafish”, are tropical aquarium fish that have been in the aquarium trade in Europe since 1905 and in the United States since the 1940s. The genetically modified line that is the subject of the notification is also intended for use in home aquaria (ornamental trade) and has been sold in the United States since 2006.
Genetic modifications: The GloFish® Sunburst Orange® Danio has been genetically engineered to express a fluorescent protein isolated from common marine invertebrates including corals and sea anemones. Expression of the gene encoding the fluorescent proteins is under the control of promoters isolated from fish.
Public comment period: April 15, 2019 to April 29, 2019
Public comments received: no comments received
Science advisory report: Canadian Science Advisory Secretariat Science Advisory Report 2020/015 on the environmental and indirect human health risk assessment of the Glofish® Sunburst Orange® Danio (Danio rerio): A transgenic ornamental fish
Risk assessment conclusion: The GloFish® Sunburst Orange® Danio (Danio rerio, genetically modified) is not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
AquAdvantage® salmon
Notifier: AquaBounty Technologies Inc.
NSN number: 19702 (previously notified under NSN 16528)
Substance designation: AquAdvantage® salmon
Assessment period: July 28, 2018 to March 24, 2019
Activity: AquaBounty Technologies reported the construction of new production facilities to meet the growing global demand for AquAdvantage® salmon. One facility will be used to produce eggs for farming of AquAdvantage® salmon in the company’s facilities in Canada, the United States and Panama. The other facilities will be used to produce AquAdvantage® salmon for commercial sale in Canada and/or export to other countries.
Genetic modifications: AquAdvantage® salmon was developed by engineering a St. John River salmon with two genes from the Pacific salmon and from the Ocean Pout for expression of a growth hormone gene in AquAdvantage® salmon. AquAdvantage® salmon reaches a size of 100 g faster than non-engineered counterparts.
Public comment period: September 14, 2018 to October 12, 2018
Public comments received: Summary of public comments received
Waiver of information requirement:
- Waiver of information requirement for AquaBounty Technologies Inc., NSN 19702
- Waiver of information requirement for AquaBounty Technologies Inc., NSN 16528
NS program risk assessment: Risk assessment conducted under the Canadian Environmental Protection Act, 1999 for NSN-19702
Canadian Science Advisory Secretariat publications for NSN 19702:
- Canadian Science Advisory Secretariat Science Advisory Report 2019/014 on the environmental and indirect human health risk assessment for AquAdvantage® salmon at a contained facility near Rollo Bay, PEI
- Proceedings of the National Peer Review on Environmental and Indirect Human Health Risk Assessment for the Manufacture and Production of Sterile AquAdvantage® Salmon at a Land-Based and Contained Facility near Rollo Bay, PEI
- Environmental Risk Assessment for the Manufacture and Grow-out of EO-1α Salmon, Including the Sterile AquAdvantage® Salmon, at a Land-Based and Contained Facility near Rollo Bay, PEI
- Canadian Environmental Protection Act Indirect Human Health Assessment Report on the AquAdvantage® Salmon
Canadian Science Advisory Secretariat publications for NSN 16528:
- Canadian Science Advisory Secretariat Science Response 2013/023 on the environmental and indirect human health risk assessment for AquAdvantage® salmon
- Proceedings of the National Science Response Process for the Environmental and Indirect Human Health Risk Assessment of the AquAdvantage® Salmon
Risk assessment conclusion: When the genetically modified AquAdvantage® salmon is used as notified, it is not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA. However, it is expected that a significant new activity in relation to the organism could result in the organism meeting those criteria. Due to the potential risk to the environment if the substance were to be used outside a contained facility, the significant new activity provisions under CEPA were applied to the organism in order to obtain information to ensure that the organism undergoes further assessment before these potential activities are undertaken.
Significant new activity requirements: Significant New Activity notice no. 16528a (variation to Significant New Activity notice no. 16528)
Related content: Health Canada and Canadian Food Inspection Agency approve AquAdvantage® salmon
Five lines of GloFish® tetra
Notifier: Spectrum Brands
NSN numbers: 19575, 19576, 19577, 19578 and 19579
Substance designation:
- GloFish® Cosmic Blue® Tetra (Gymnocorymbus ternetzi, genetically modified) – 19575
- GloFish® Sunburst Orange® Tetra and Long-Fin Sunburst Orange® Tetra (Gymnocorymbus ternetzi, genetically modified) – 19576
- GloFish® Moonrise Pink® Tetra and Long-Fin Moonrise Pink® Tetra (Gymnocorymbus ternetzi, genetically modified) – 19577
- GloFish® Galactic Purple® Tetra and Long-Fin Galactic Purple® Tetra (Gymnocorymbus ternetzi, genetically modified) – 19578
- GloFish® Starfire Red® Tetra and Long-Fin Starfire Red® Tetra (Gymnocorymbus ternetzi, genetically modified) – 19579
Assessment period: June 16, 2018 to October 13, 2018
Activity: Gymnocorymbus ternetzi, commonly referred to as “black skirt tetra”, are tropical aquarium fish that have been in the aquarium trade in the United States since at least 1950. The genetically modified lines that are the subject of these notifications are also intended for use in the home aquaria (ornamental trade) and have been sold in the United States since 2012.
Genetic modifications: The GloFish® line of fluorescent tetras has been genetically engineered to express fluorescent proteins isolated from common marine invertebrates, including corals and sea anemones. The fluorescent proteins and other inserted genetic material are well characterized. Expression of the genes that encode the fluorescent proteins is under the control of promoters isolated from fish.
Public comment period: July 12, 2018 to July 26, 2018
Public comments received: No comments received
Science advisory report: Canadian Science Advisory Secretariat Science Advisory Report 2019/002 on the environmental and indirect human health risk assessment for the GloFish® tetras: Five lines of transgenic ornamental fish
Risk assessment conclusion: The five lines of genetically modified GloFish® tetra (Gymnocorymbus ternetzi, genetically modified) are not expected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
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