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New substances: risk assessment, New Substances Notification 21657

Name of company: GloFish LLC

First day of assessment period: October 4, 2023

Last day of assessment period: January 31, 2024

Identity: 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

Organism type: Fish

Activity: Import of ornamental fish from United States for home aquaria

Assessment level of concern:

Assessment conclusion under section 64 of the Canadian Environmental Protection Act, 1999: Not suspected to be toxic.

Recommended action: None

Waiver: None

Synopsis

Epalzeorhynchos frenatum OS2016, also known as the GloFish® Sunburst Orange® Shark, was notified for use as an ornamental fish in home aquaria. Other potential uses could include release or culturing in outdoor ponds, as an environmental sentinel, as bait fish, as well as in scientific research and for future manufacture in Canada. There is no evidence to suggest a potential risk of adverse environmental effects at the exposure levels predicted for the Canadian environment, from the notified use as an ornamental fish in home aquaria. The potential risk of adverse environmental effects remains low despite the identified potential uses. Owing to the low potential for hazard and the low potential for exposure, the risk to the environment associated with E. frenatum OS2016 is not suspected to meet the criteria in paragraphs 64(a) or (b) of the Canadian Environmental Protection Act, 1999 (CEPA). Similarly, there is no evidence to suggest a risk of adverse human health effects at the exposure levels predicted for the general Canadian population from use as an ornamental aquarium fish as well as other identified potential uses. Owing to the low potential for hazard and the low to medium potential for exposure, E. frenatum OS2016 is not suspected to meet the criteria in paragraph 64(c) of CEPA.

Epalzeorhynchos frenatum OS2016: background information

Rainbow sharks (Epalzeorhynchos frenatum) are a small tropical cyprinid freshwater fish native to Southeast Asia and can be found in rivers in Cambodia, Laos, Malaysia, Myanmar, and Thailand. While preferring rivers with sandy bottoms, rainbow sharks are known to migrate into floodplains during periods of heavy rain or flooding. They are known as bottom-feeders and have an omnivorous diet in the wild primarily consisting of algae, periphyton, and small invertebrates (Brand, 2020; Yang, 2022; Ocean Info, 2023). E. frenatum OS2016 is a genetically modified line of diploid, hemizygous or homozygous, fluorescent rainbow shark, containing an expression cassette, which make the fish appear orange under ambient light, including sunlight. OS2016 was derived from a domesticated strain of albino rainbow shark. The orange fluorescent protein was not used in any of the previously assessed GloFish® Sunburst Orange® lines.

E. frenatum OS2016 will be imported from the United States, for use as an ornamental fish in home aquaria and will be marketed throughout Canada. OS2016 received its Enforcement Discretion decision by the U.S. Food and Drug Administration in 2017 and has since been commercially available in the United States. The parental non-transgenic E. frenatum has been available worldwide as a home aquarium fish since the 1970s (Brand, 2020).

Context of this risk assessment: joint effort between departments

On October 3, 2023, a notification under the New Substances Notification Regulations (Organisms) was submitted by GloFish LLC to Environment and Climate Change Canada (ECCC) for the GloFish® Sunburst Orange® Shark (OS2016), a genetically engineered rainbow shark (Epalzeorhynchos frenatum), for use as an ornamental fish in home aquaria. Under a Memorandum of Understanding between the Department of Fisheries and Oceans (DFO), Environment and Climate Change Canada (ECCC) and Health Canada (HC), DFO conducted an environmental risk assessment, and collaborated with HC to conduct an indirect human health risk assessment of the submitted information. As part of this collaboration, the services of the Canadian Science Advisory Secretariat (CSAS) were used to apply a peer review process to strengthen the scientific basis of these assessments, the result of which was a Science Advisory Report (SAR) (DFO, 2024). The SAR provided the peer-reviewed science advice to ECCC and HC, which was used to inform the risk assessment decision under CEPA. This facilitated ECCC’s and HC’s legislative, regulatory and policy obligations under CEPA. The SAR will be publicly available on the CSAS website.

Hazard assessment

The environmental hazard potential of E. frenatum OS2016 is assessed to be low because:

  1. OS2016 is not likely to produce toxins that could affect other species if released in the environment. While some of the source organisms from which the inserted genetic material was derived appear to produce toxins, there is no indication that any of the inserted genetic material or expressed proteins in these lines are associated with any toxicity or pathogenicity in aquatic and terrestrial species
  2. The introduction of the fluorescence transgene through horizontal gene transfer (HGT) to a novel host is not likely to result in harmful effects as genes that encode fluorescent proteins have been introduced to a wide range of organisms with few reports of harmful effects
  3. There is no direct evidence that the expressed fluorescent protein from OS2016 would increase the hazard to the Canadian environment relative to domesticated E. frenatum
  4. Based on the information available, the potential for GloFish® Sharks to have an altered capacity as a vector for disease relative to non-transgenic E. frenatum is negligible
  5. Temperature sensitivity test data indicate that OS2016 and the non-transgenic E. frenatum have similar median lethal dose temperatures, demonstrating similar sensitivity to cold water temperatures. There are no lakes in Canada that consistently remain above 7°C throughout the entire course of a year, or above 6°C across multiple years and almost all do not remain above 4°C throughout the year. Therefore, the likelihood of the notified strain surviving in Canadian waters is low. Freshwater surface temperatures in Canada are rising as a result of global climate change and are projected to increase by 1.5 to 4.0°C by 2063 (DFO, 2013) and therefore, could increase the number of possible lakes in which organisms with moderate cold tolerance could survive. The sale of this line can be halted at any time if it is determined necessary to terminate the introduction
  6. OS2016 is a freshwater fish of the family Cyprinidae that are native to Southeast Asia; therefore, due to their temperature tolerances they are restricted to tropical climates. Canada does not have native species of E. frenatum, but it does have several genera within the Cyprinidae family. The likelihood of successful breeding between E. frenatum and Canadian Cyprinids is considered highly improbable due to significant phylogenetic differences and adaptive variations. E. frenatum are scatter breeders, increasing the chance of hybridization with related species spawning concurrently. However, their seasonal breeding habits make natural reproduction challenging in unfamiliar environments. Therefore, there is low potential for OS2016 to cause hazard through natural hybridization with native fish in Canada
  7. E. frenatum are not known to build structures that are expected to impact habitats of other species and there are no reports of GloFish® Sharks having altered behaviour, relative to their domesticated non-transgenic counterparts
  8. OS2016 would be expected to contribute to nutrient cycles within habitats if released, through the ingestion of prey and other food items and the release of waste (ammonia and feces). In addition, the potential effects of the fluorescent protein in OS2016 on metabolism, and hence nutrient cycling, have not been examined. However, its size and the low potential numbers of individuals that would be released into an ecosystem, results in a negligible potential for OS2016 to impact biogeochemical cycling in natural environments, even with altered metabolic pathways
  9. When environmental hazard points are taken together, the capability of GloFish® Sharks affecting biodiversity of Canadian ecosystems is negligible

The human hazard potential of E. frenatum OS2016 is assessed to be low because:

  1. OS2016 is a genetically modified tropical fish containing copies of an expression cassette at a single site of insertion (although alternate insert patterns may exist in the population) that appears phenotypically stable based on line maintenance protocols
  2. The methods used to produce OS2016 do not raise any indirect human health concerns. While some of the source organisms from which the inserted genetic material was derived appear to produce toxins, there is no indication that any of the inserted genetic material or expressed protein in the notified line are associated with any toxicity, allergenicity, or pathogenicity in humans
  3. While there are reported cases of zoonotic infections associated with tropical aquarium fish, particularly for immunocompromised individuals and children, there are no reported cases attributed to any of the commercially available lines of GloFish® or to wild-type E. frenatum. The zoonotic potential of OS2016 is not expected to be any different than for wild-type E. frenatum currently commercially available
  4. Sequence analysis of the inserted transgene did not match any known allergens
  5. There is a history of safe use for OS2016 in the United States since the organism has been commercially available since 2017 and the wild-type species has been safely used globally as an ornamental aquarium fish since the 1970s. In addition, no adverse human health effects have been reported for the other commercially available lines of GloFish®

Hazards related to organisms used in the workplace should be classified accordingly under the Workplace Hazardous Materials Information System (WHMIS)Footnote 1.

Exposure assessment

The environmental exposure potential of E. frenatum OS2016 is assessed to be low because:

  1. The intended use of OS2016 is in the ornamental aquarium trade. Therefore, these modified E. frenatum are intended to be contained and maintained in indoor aquaria
  2. Should OS2016 be released accidentally or intentionally into the Canadian environment the low winter-temperatures in Canadian lakes and rivers will limit the ability and the capacity for the fish to establish themselves in the Canadian environment. Therefore, any exposure to Canadian freshwater ecosystems to OS2016 is expected to be isolated. In addition, OS2016 is not expected to persist where water temperatures are below optimal for its survival and reproduction
  3. Isolated opportunities for reproduction may occur in a few Canadian lakes that have temperatures in the mid 20°C for a short period during the summer months as the reported rearing temperatures for E. frenatum range from 24°C to 27°C and they have an optimal temperature of 25°C for hatching. This short window would lead to a seasonal occurrence, potentially with localized overwintering pockets in specific environments like industrial effluent, hot springs, or isolated lakes. While this may provide a tolerable temperature range for reproduction, other environmental conditions required for spawning would need to be met which is unlikely due to the seasonal differences between Canada and Southeast Asia

The human exposure potential of E. frenatum OS2016 is assessed to be low to medium because:

  1. The primary sources of human exposures would stem from the proposed import of adult fish of OS2016 through unidentified points of entry in Canada and distribution through about 500 retail outlets
  2. The sole intended use of OS2016 is as ornamental aquarium fish, thus limiting potential exposure primarily to those that possess a home aquarium
  3. Like other aquarium fish, human exposure may include immunosuppressed individuals, children, those with underlying medical conditions, or other individuals who may be more susceptible
  4. Typical human exposure to live or dead fish in the home is most often related to maintenance activities such as tank cleanings and water changes. Low winter water temperatures in Canadian waters and low cold tolerance of the notified line limits human exposure through the environment
  5. Any release of live or dead OS2016 on garden lawns, fields or into landfills or into water bodies is not expected to result in survival and establishment in the environment. Should there be such releases, both fish and the fluorescent protein are expected degrade normally and not accumulate or result in human exposure
  6. No significant increase in human exposure is expected from other potential uses of OS2016 such as for research, as bait, or as environmental sentinels

Risk characterization

Owing to the low potential hazard and the low potential exposure, the environmental risk associated with the use of E. frenatum OS2016 as an ornamental aquarium fish is assessed to be low. Owing to the low potential hazard and the low potential exposure from other potential uses (the organism could be manufactured in Canada or used for other purposes once included on the Domestic Substances List), the environmental risk associated with the use of OS2016 for those uses is not expected to increase significantly and would not be of concern. Owing to the low potential hazard and the low to medium potential exposure, the human health risk associated with the use of E. frenatum OS2016 as an ornamental aquarium fish is assessed to be low. Should other potential uses occur, such as uses as bait fish, as environmental sentinels, and for scientific research, risks from indirect human exposure are not expected to be different from those of any other typical aquarium fish.

Risk assessment conclusion

There is no evidence to suggest a potential risk of adverse environmental effects at the exposure levels predicted for the Canadian environment from use of E. frenatum OS2016 as an ornamental aquarium fish, nor from any uses that may result in introduction of the fish into the Canadian environment. The risk to the environment associated with E. frenatum OS2016 is not suspected to meet the criteria in paragraphs 64(a) or (b) of CEPA. No further action is recommended.

Similarly, there is no evidence to suggest a potential risk of adverse human health effects at the exposure levels predicted for the general Canadian population from use of OS2016 as an ornamental aquarium fish. This risk to human health associated with E. frenatum OS2016 is not suspected to meet the criteria in paragraph 64(c) of CEPA. No further action is recommended.

References

Brand, R. 2020. The complete rainbow shark care guide (Epalzeorhynchos frenatum). Accessed October 3, 2023.

DFO. 2013. Risk-based assessment of climate change impacts and risks on the biological systems and infrastructure within Fisheries and Oceans Canada's mandate - Freshwater Large Aquatic Basin. DFO Can. Sci. Advis. Sec. Sci. Resp. 2013/011.

DFO. 2024. Environmental and indirect human health risk assessment of the GloFish® Cosmic Blue®, Electric Green®, Sunburst Orange®, and Galactic Purple® sharks (Epalzeorhynchos frenatum): transgenic ornamental fishes. DFO Can. Sci. Advis. Sec. Sci. Advis. Rep. 2024/nnn.

Ocean Info. 2023. Rainbow shark. Accessed October 10, 2023.

Yang, A. 2022. Rainbow shark 101: care guide, tank size, food & tank mates. Accessed October 27, 2023.

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