Summary of information submitted by the public to the New Substances program on the environmental and human health risks of 4 GloFish® Sharks

The New Substances program invites public participation in the risk assessment process of vertebrate organisms notified under Schedule 5 of the New Substances Notification Regulations (Organisms) in order to address the consultation requirements set out in section 108.1 of the Canadian Environmental Protection Act, 1999. This public consultation requests comments, including scientific information and test data to help the departments determine the organism’s potential risks to the environment or human health.

Schedule 5 New Substances Notifications (NSNs) were assessed for 4 notified lines of GloFish® Shark:

• 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)

Public participation regarding the GloFish® Sharks was sought during a 30-day period, which ended on December 13, 2023. Comments were provided by a non-governmental organization and 2 citizens.

A summary of comments and responses is included below:

Comment summary 1: If these fish escape or are released in their native range, or outside of their native range but still in a favourable climatic zone, they could establish a viable population, and potentially breed with wild counterparts of the same or closely adjacent species. Providing a market for GloFish® in Canada directly or indirectly encourages the production of these fish in tropical regions.

Response 1: Although some lakes in Canada may reach 25°C for short periods during the summer, which could be considered a favourable climactic zone for these fish, Epalzeorhynchos are seasonal breeders with specific water temperature, turbidity, pH and light exposure spawning conditions, therefore it is highly unlikely that all other environmental conditions required for GloFish® Sharks to spawn will occur. Additionally, there are no native Epalzeorhynchos in Canada and highly unlikely hybridization to native Cyprinidae due to phylogenetic and adaptive differentiation.

Health Canada and Environment and Climate Change Canada are involved in various international biotechnology initiatives to ensure that regulations and risk assessments for biotechnology products are protecting the environment, including within jurisdictions with a tropical climate. For example, Canada is a Party to the Convention on Biological Diversity, which establishes standards and approaches for biodiversity protection activities, and the Organisation for Economic Co-operation and Development’s Working Party on the Harmonisation of Regulatory Oversight in Biotechnology. Canada’s rigorous, evidence- and risk-based assessments conducted under the Canadian Environmental Protection Act, 1999 aligns with approaches recommended by the international community.

Comment summary 2: Genetic modification of animals for cosmetic reasons is unethical, particularly considering the temperature tolerance testing conducted to determine invasiveness.

Response 2: The Canadian Environmental Protection Act, 1999 provides the authority to conduct science-based risk assessments on living organisms to determine whether they constitute a danger to human life or health or the environment prior to their manufacture, import or use in Canada.

Temperature tolerance testing is necessary to the risk assessment process in this case. The temperature tolerance experiment was reviewed by the Pacific Region Animal Care Committee and conducted under an institutional animal care permit (AUP18-007), which meets the guidelines established by the Canadian Council on Animal Care. Though the stated purpose of the organisms is for sale in the ornamental market, and hobbyists who purchase the product do, for the most part, follow the instructions for disposal that are recommended by the retailer or the notifier company itself, there is possibility that GloFish® Sharks will be introduced into the Canadian environment. Therefore, the extent to which the organisms are further exposed to the environment will depend heavily on their ability to survive and reproduce in Canadian lakes and rivers. Temperature tolerance testing is necessary to determine whether GloFish® Sharks can survive the Canadian winter. Test results confirmed that there is a very low likelihood that they would survive the Canadian winter and the occurrence of GloFish® Sharks in the Canadian freshwater environment would at best be seasonal or ephemeral.

Additionally, while the assessment under the Canadian Environmental Protection Act, 1999 was conducted to determine whether these aquaria fish constitute a danger to human life or health or the environment prior to their manufacture, import or use in Canada, the information provided also demonstrated that introducing colour to aquarium fish through these types of genetic modification has minimal impact on the quality of life for the fish.

Comment summary 3: While there is no indication that these fish are toxic to other animals, there is a possibility that the genetic modifications are harmful to the GloFish® themselves.

Response 3: The Canadian Environmental Protection Act, 1999 provides the authority to conduct science-based risk assessments on living organisms to determine whether they constitute a danger to human life or health or the environment prior to their manufacture, import or use in Canada.

Selective breeding is performed to ensure that healthy new lines of GloFish® are generated. A comprehensive health assessment was conducted by the notifier, which found no significant microbiological, histological, or pathological findings for all four lines of GloFish® Sharks compared to the wild type. Moreover, fluorescent transgenic fish of another species (Danio rerio) have been used extensively for genetic research in laboratory conditions for years with no known reported effects of fluorescence on health or disease susceptibility.

Comment summary 4: These fish may be prone to Swim Bladder Syndrome.

Response 4: The Canadian Environmental Protection Act, 1999 provides the authority to conduct science-based risk assessments on living organisms to determine whether they constitute a danger to human life or health or the environment prior to their manufacture, import or use in Canada.

The risk assessment did not find an increased chance of Swim Bladder Syndrome in the genetically modified Rainbow Sharks compared to the wild type. Additionally, a comprehensive health assessment was conducted by the notifier, which found no significant microbiological, histological, or pathological findings for all four lines of GloFish® Sharks, and no evidence of greater susceptibility to swim bladder syndrome, compared to the wild type.

Comment summary 5: Concerned citizens call for a ban on genetically modified organisms in Canada.

Response 5: 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 effective and transparent, while allowing for innovation in the field of biotechnology. The risk assessment concluded that GloFish® Sharks used in the ornamental aquarium trade in Canada pose a low risk to Canadians and their environment.