Summary of information submitted by the public to the New Substances program on the environmental and human health risks of the EntoEngine fruit fly
Through the voluntary public engagement initiative, the New Substances program provides an opportunity for notifiers of higher organisms under Schedule 5 of the New Substances Notification Regulations (Organisms) to engage the public by inviting the submission of 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 bovine FGF2 and a marker gene balanced over a chromosome balancer, also known as the EntoEngine fruit fly. This is a fruit fly modified to express a growth factor isolated from cows. Public participation regarding the EntoEngine fruit fly was sought during a 30-day period, which ended on January 28, 2023.
Comments were provided by 2 Non-Governmental Organizations and 15 citizens.
A summary of comments and responses is included below, organized by topic:
Containment
Comment summary 1: There has historically been failure in containing genetically engineered organisms, and the possibility of escape increases the environmental risk.
Response 1: The notified organism has been genetically modified with curly wings to ensure a minimal likelihood of dispersal in the environment. Curly wings in adults reduce the ability to fly, which will decrease their ability to find food or mates, or escape predators. Moreover, the modifications present in the organism lose expression over time and will reduce in frequency across the population as a whole if reproduction with wild-type does occur. Taken together with the non-hazardous nature of this organism, risk to the environment remains low.
Comment summary 2: The risk assessment should take into consideration the human health and environmental effects of the organism given that containment can’t be fully guaranteed.
Response 2: The Canadian Environmental Protection Act, 1999 requires the Minister of the Environment and Climate Change and the Minister of Health to assess information (provided under the New Substances Notification Regulations (Organisms) and other information available to the Departments) in respect of a notified living organism to determine whether it is toxic or capable of becoming toxic. The Government of Canada conducted a robust, scientific and risk-based assessment. The assessment considered the potential for adverse human health and environmental effects due to exposure to the living organism in the event of release from the facility. The outcome of the government’s scientific assessment indicated that even if releases of the organism from the facility occur, the low likelihood of dispersal of the organism in the environment due to its curly wings would not result in any risks to the environment or human health.
Comment summary 3: These flies may cause effects up the food chain (including in the animals who eat them directly and in humans).
Response 3: Neither the wild-type flies nor the source organisms from which the inserted genetic material was derived are known to produce toxins. The genetic material and expressed protein are not associated with any toxicity or pathogenicity in humans or animal or plant species in the environment and are not known to be allergenic.
Comment summary 4: The rate of reproduction of Drosophila melanogaster could allow the genetically modified version to render the native fruit fly a secondary species in a matter of months.
Response 4: The notified organism has been genetically modified with curly wings to ensure a minimal likelihood of dispersal and interaction with native fruit flies in the environment, thus producing a low probability of mating with native D. melanogaster. Curly wings in adults reduce the ability to fly, which will decrease their ability to find food or mates, or escape predators. Moreover, the expression of proteins from the inserted genetic modification is not stable and has been shown to be lost over a few generations.
Comment summary 5: The fruit fly’s ability to withstand a tropical climate creates excess hazard.
Response 5: Canada does not have a tropical climate, and therefore these flies are unlikely to withstand the Canadian climate long-term. Adult fruit flies need prolonged temperatures above 6°C to mate and lay eggs. Chill injury to fruit flies occurs below 6°C, and all life stages cannot survive more than a few hours if temperatures are below -5°C. Therefore, although there may be a chance for a short-term survival, winter temperatures in Canada frequently fall below -5°C.
Although Canada does not have a tropical climate, the Departments 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.
Transparency in the assessment of genetically modified organisms
Comment summary 6: The Voluntary Public Engagement Initiative doesn’t provide the public with enough information to provide valuable comments and information.
Response 6: Any person (individual or corporation) completing the notification process under the New Substances Notification Regulations (Organisms) provides information to Environment and Climate Change Canada and Health Canada that is needed to conduct a risk assessment of their proposed activity with a new organism. Given the information submitted is often confidential, a non-confidential summary is generally provided.
The Voluntary Public Engagement Initiative provides an opportunity for any member of the public to provide additional scientific information or test data to the government to take into consideration during its scientific risk assessment. As described in the Follow-up report to the House of Commons Standing Committee on Environment and Sustainable Development on the Canadian Environmental Protection Act, 1999, Environment and Climate Change Canada is committed to enhancing the Voluntary Public Engagement Initiative to align with the spirit of the recommendations made by the Committee.
Comment summary 7: Halt any further approvals of genetically engineered animals in Canada until the review of the Canadian Environmental Protection Act, 1999 is complete and regulations are strengthened, including to increase transparency and public participation.
Response 7: The Canadian Environmental Protection Act, 1999 mandates the Minister of the Environment and Climate Change and the Minister of Health to assess information provided under the New Substances Notification Regulations (Organisms) within the assessment period prescribed by those Regulations.
Environment and Climate Change Canada remains committed to improving on the Voluntary Public Engagement Initiative to enhance transparency and public participation.
Comment summary 8: Public notification and consultation should be mandatory for all notifications of genetically modified organisms, including those used in food and farming.
Response 8: Notification under the New Substances Notification Regulations (Organisms) is required if the living organism proposed for import or manufacture is subject to the Animate Products of Biotechnology provisions of the Canadian Environmental Protection Act, 1999 and is new to Canada (i.e. not on the Domestic Substances List). As of June 13, 2023, consultation must be done for all notifications concerning a vertebrate animal or a prescribed living organism or group of living organisms before the end of the assessment period. These consultation requirements do not apply to the EntoEngine fruit fly as it is not a vertebrate animal or a prescribed living organism. When the consultation requirements do not apply, the New Substances program encourages the notifiers of higher organisms to participate in the Voluntary Public Engagement Initiative.
Comments outside the scope
Comment summary 9: The fly is of questionable utility.
Response 9: Under the Voluntary Public Engagement Initiative, the New Substances program invites stakeholders to share scientific information and test data related to the potential risks to the environment or human health from the living organism. As such, this comment is outside the scope of the Voluntary Public Engagement Initiative and the program’s risk assessment process under the Canadian Environmental Protection Act, 1999.
Comment summary 10: Treatment of the flies is unethical.
Response 10: Under the Voluntary Public Engagement Initiative, the New Substances program invites stakeholders to share scientific information and test data related to the potential risks to the environment or human health from the living organism. As such, this comment is outside the scope of the Voluntary Public Engagement Initiative and the program’s risk assessment process under the Canadian Environmental Protection Act, 1999.
Comment summary 11: Members of the public express concern over lab-grown meat.
Response 11: Under the Voluntary Public Engagement Initiative, the New Substances program invites stakeholders to share scientific information and test data related to the potential risks to the environment or human health from the living organism. As such, this comment is outside the scope of the Voluntary Public Engagement Initiative and the program’s risk assessment process under the Canadian Environmental Protection Act, 1999. In addition, the consumption of genetically engineered foods falls under the scope of the Food and Drugs Act, and risk assessments conducted under the Canadian Environmental Protection Act, 1999 therefore do not include an assessment of the fly or its by-products as food.