Voluntary public engagement initiative
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 plants and 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 (the Act). The Committee's report made recommendations on Part 6 of the Act 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.
The NS program publishes summaries of New Substances Notifications (NSNs) submitted for higher organisms and invites stakeholders to share 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 or
- exposure information (including sources and routes of exposure)
Active engagement initiatives
Title: Notification for a fruit fly for use in recombinant protein production
Notifier: Future Fields
NSN number: 21233
Substance designation: EntoEngine (Drosophila melanogaster, genetically modified)
Start date of the assessment: November 18, 2022
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: The 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
How to participate
All interested parties are invited to share scientific information and test data related to potential risks to the environment or human health from EntoEngine.
By email
Submit your comments by email: substances@ec.gc.ca
By mail
Send your comments to the address below:
Substances Management Information Line
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)
Review our privacy statement for this consultation.
Please provide information in English or French. Your information may be summarized and published in part or in full, along with your name and affiliation. Please be sure to identify any confidential business information so that it may be protected.
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].
Past engagement initiatives
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 the Act.
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 the Act.
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 the Act.
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 the Act.
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 the Act.
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 the Act. 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 the Act 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 the Act.
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