Summary of information submitted by the public to the New Substances program on the environmental and human health risks of the EntoEngine 2 fruit fly
The New Substances program provides an opportunity for notifiers of higher organisms under Schedule 5 of the New Substances Notification Regulations (Organisms) to invite public participation in the risk assessment process. 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.
A Schedule 5 notification was assessed for the notified organism, 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, also known as the EntoEngine 2 fruit fly. This is a fruit fly modified to express a growth factor isolated from humans. Public participation regarding the EntoEngine 2 fruit fly was sought during a 60-day period, which ended on October 1, 2023.
Comments were provided by 3 non-governmental organizations.
A summary of comments and responses is included below:
Comment summary 1: The correction published on September 1, 2023, which indicated that only 2/3 of the organisms would develop curly wings, was not applied to the previous risk assessment for New Substances Notification (NSN) 21233.
Response 1: The first EntoEngine fruit fly producing bovine FGF2 was notified in November 2022 and assessed for risk(s) by Health Canada and Environment and Climate Change Canada as NSN-21233. The risk assessment conclusion was that it is not toxic or capable of becoming toxic according to the criteria under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). The first EntoEngine fruit fly producing bovine FGF2 is genetically modified in such a way that only flies with curly wings can develop.
For the purposes of CEPA, the second EntoEngine fruit fly producing human FGF2 is considered to be a different living organism (NSN-21561), also new to Canada. It is the product of different genetic modifications resulting in a pattern of wing development in progeny that is distinct from that of the first EntoEngine producing bovine FGF2. The correction published on September 1st, 2023 applies only to the second EntoEngine fruit fly producing human FGF2 and therefore only applies to the risk assessment of this second fruit fly.
Comment summary 2: A waiver of information requirements was granted to FutureFields for paragraph 5(a) of the New Substances Notification Regulations (Organisms), the data from a test to determine the ecological effects of the living organism (pathogenicity, toxicity or invasiveness). All genetically modified organisms need to be assessed for these ecological effects because containment cannot be 100% guaranteed.
Response 2: The Drosophila melanogaster species is a well-characterized model organism that has been used widely in many areas of research, including genetics, cancer and more recently in protein expression. D. melanogaster is a well-researched and lab-established organism with a long history of safe use. It is not a known vector for disease, nor does it produce any toxins. Neither wild type nor the parental D. melanogaster from which this strain was derived have any history of negative effects to the environment. Literature searches did not return any results indicating the organism has adverse effects on any environmental compartments. Moreover, the parental strain is not robust as the flies demonstrate neurodegeneration, a reduced ability to climb and move, a shortened life span, and impaired resistance to various forms of stress. Should accidental release of adult flies occur, it is unlikely that they will survive and disseminate in the environment as they would be at a disadvantage to compete with wildtype flies, thus significantly limiting opportunities for interbreeding.
The gene insert (human FGF2) is a mammalian growth factor that is used in fundamental cellular processes such as cell growth and proliferation. The expressed protein is not anticipated to be harmful to organisms because it is a benign human growth factor that will have no benefit to the modified flies nor any expected effects on other organisms with which the fly could come into contact with.
Given the long history of safe use for wildtype and otherwise modified D. melanogaster, the lack of any identified toxin or virulence genes in the notified organism and its specific genetic modifications, the EntoEngine fruit fly producing human FGF2 is not expected to have any adverse effects on aquatic or terrestrial organisms (plants, invertebrates or vertebrates) in the environment.
Comment summary 3: Environment Climate Change Canada should publicly release all the science that will be reviewed in the risk assessments of EntoEngine products, for transparency and to enable public comment, and all subsequent risk assessment documents.
Response 3: Pursuant to section 313 of CEPA, any person who provides information under the New Substances Notification Regulations (Organisms) may submit, with the information, a request that it be treated as confidential. Access to confidential information submitted under CEPA, including information related to these organisms, is limited to specific circumstances set out in CEPA and the Access to Information Act. A summary of the risk assessment report was published following the assessment period, along with this summary of public comments received and the Government of Canada’s responses.
It is important to note that not all higher organisms are currently subject to mandatory consultation. The New Substances program continues to encourage the notifiers of those higher organisms to participate in the consultation process voluntarily (for example, for insects that are new living organisms) and find opportunities to enhance the consultation process (for example, continue to work with notifiers to develop a more detailed notification summary for consultation).