Summary of information submitted by the public to the New Substances program on the environmental and human health risks of the AquAdvantage® salmon

Substance designation

The notified organism is an Atlantic Salmon (Salmo salar) containing a single insert of the opAFP-GHc2 transgene at the EO-1α locus. The opAFP-GHc2 gene construct consists of a Chinook Salmon (Oncorhynchus tshawytscha) growth hormone (GH) gene under the control of an Ocean Pout (Macrozoarces americanus) anti-freeze protein (AFP) promoter. The notified organism is referred to as EO-1α salmon in scientific documents. On this webpage, AquAdvantage® salmon (AAS) refers to all forms of EO-1α salmon including the sterilized all-female fish produced for fish farming.

For more information on EO-1α salmon please see:

DFO. 2019. Environmental and Indirect Human Health Risk Assessments for the Manufacture and Grow-out of EO-1α Salmon, including the AquAdvantage® Salmon, at a Land-Based and Contained Facility near Rollo Bay, PEI. DFO Can. Sci. Advis. Sec. Sci. Advis. Rep. 2019/014.

 

Public comments for AquAdvantage® salmon – NSN-19702

The New Substances (NS) program provides an opportunity for notifiers of higher organisms under the Schedule 5 of the New Substances Notifications Regulation (Organisms) to engage the public by inviting the submission of scientific information and test data to help the departments determine potential risks to the environment or human health from the manufacture or import of AquAdvantage® salmon into Canada. Public participation was sought during a 30-day period, which ended on October 12, 2018.

Comments and information were provided by: 1 University Science Department; 6 Non-Governmental Organizations or Coalitions; and 2 citizens.

A summary of comments and responses is included below, organized by topic:

1. Ecological effects

Comment summary Response
Moreau DT, Conway C, Fleming IA. Reproductive performance of alternative male phenotypes of growth hormone transgenic Atlantic salmon (Salmo salar). Evol Appl. 2011;4(6):736-48. This paper was taken into consideration in the AquAdvantage® salmon risk assessment to inform the characterization of the notified organism, and contribute to the environmental exposure and hazard assessment.
Muir WM, Howard RD. Possible ecological risks of transgenic organism release when transgenes affect mating success: sexual selection and the Trojan gene hypothesis. Proc Natl Acad Sci U S A. 1999;96(24):13853-6. This paper was taken into consideration in the AquAdvantage® salmon risk assessment to inform the environmental hazard assessment.
Dr. Robert Devlin's work on genetically modified (GM) salmon outcompeting non-GM salmon.

This work was taken into consideration in the AquAdvantage® salmon risk assessment to inform the environmental exposure and hazard assessment.

Dr. Devlin was also a contributor at the Canadian Science Advisory Secretariat review meeting.

Le Curieux-Belfond O, Vandelac L, Caron J, Séralini GÉ. Factors to consider before production and commercialization of aquatic genetically modified organisms: the case of transgenic salmon. Environ Sci Policy. 2009:12(2):170-89. Elements of this review paper relating to indirect human health or environmental risk factors were taken into consideration in the risk assessment.

2. Scope of risk assessment

Comment summary Response

A comprehensive toxicity assessment, based on all legally mandated information should be done. This assessment should include environmental and human health risks and the degree of toxicity associated with production at the facility.

The biotechnology provisions of the Canadian Environmental Protection Act, 1999 (CEPA), administered by Environment and Climate Change Canada (ECCC) and Health Canada, take a preventative approach to environmental protection by requiring all new living organism products of biotechnology to be assessed for their potential harm to the environment and human health. The New Substances Notification Regulations (Organisms) prescribe the information that must be provided to ECCC prior to the import to or manufacture in Canada of new organisms that are animate products of biotechnology, including genetically engineered fish.

To begin the assessment all mandated information must be provided to ECCC so that it can be considered in the regulatory risk assessment period.

CEPA has provisions that allow the Minister of the Environment to waive information requirements when the Ministers (the Minister of the Environment and the Minister of the Health) are satisfied that:

a) the information is not needed in order to determine whether the living organism is toxic or capable of becoming toxic;

b) a living organism is to be used for a prescribed purpose or manufacture at a location where the person requesting the waiver is able to contain the living organism so as to satisfactorily protect the environment or human health; or

c) it is not practicable or feasible to obtain the test data necessary to generate the information.

The previous assessment of AquAdvantage® salmon, as described in Department of Fisheries and Ocean’s 2013 Science Response: “Summary of the Environmental and Indirect Human Health Risk Assessment of AquAdvantage® Salmon” covers only the manufacture of genetically modified salmon eggs, how can AquaBounty proceed with operations at the Rollo Bay facilities without a risk assessment including environmental and human health risks?

The result of the risk assessment decision on AquAdvantage® salmon manufacture at the Bay Fortune facility was implemented in Significant New Activity Notice 16528. This Notice is applied to the egg manufacture process and for the land-based fish farming (grow-out) activities in stringent containment conditions. Any person growing AquAdvantage® salmon are required to comply with this Notice. This includes the provision that only euthanized fish can leave the facility.

During the assessment of AquAdvantage® salmon in 2013, the Minister of the Environment granted a waiver on the basis that the living organism was to be used at a location where AquaBounty was able to contain the living organism so as to satisfactorily protect the environment and human health. A change of location of production of AquAdvantage® salmon would trigger an assessment under the New Substances Notification Regulations (Organisms).

The intent of AquaBounty to manufacture of AquAdvantage® salmon in new facilities at Rollo Bay triggered a new assessment including environmental and indirect human health risk assessments.

3. Environmental risk and impact

Comment summary Response
There are concerns about the long-term and wider impacts of permitting genetically modified salmon production, and expansion to other locations, increasing the risk of escape.

The result of the risk assessment decision on AquAdvantage® salmon manufacture at the Bay Fortune facility was implemented in Significant New Activity Notice 16528. Any person growing the AquAdvantage® salmon are required to comply with this Notice. This includes the provisions that manufacture of AquAdvantage® salmon must take place under stringent containment conditions and that only euthanized fish can leave the facility.

The stringent containment processes at the Bay Fortune and Rollo Bay facilities have been assessed and were found to be satisfactory to protect the environment and prevent release.

Was the latest modeling of climate change impacts, including catastrophic events, taken into consideration in the risk assessment? The potential for unintentional release resulting from catastrophic natural events (such as earthquakes, tsunamis, tornados, hurricanes, tidal surges, flooding or fires) is taken into consideration in the risk assessment’s exposure section. This section examines the potential of the AquAdvantage® salmon to enter the environment (release) and their fate once in the environment. The likelihood and magnitude of environmental exposure is determined through an extensive cradle-to-grave assessment that details the potential for the release of AquAdvantage® salmon, as well as its survival, reproduction, and proliferation in the Canadian environment. All relevant information on physical, chemical and biological containment strategies used at all life stages is considered.

4. Voluntary public engagement initiative

Comment summary Response
The notice posted is insufficient to enable the public to provide informed comments. As such, it is difficult to comment on the potential ecological risks. We recommend a full disclosure of the scientific literature on which government bases its assessments.

Companies or persons completing the notification process under the New Substances Notification Regulations (Organisms) provide confidential business information to Environment and Climate Change Canada and Health Canada. That information is needed in order to conduct a risk assessment of their proposed activity with a new organism. As such, a limited amount of information is available to the public. The Voluntary Public Engagement Initiative provides an opportunity for the public to provide additional information to the government to take into consideration during the 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 improving the Voluntary Public Engagement Initiative to align with the spirit of the recommendations made by the Committee.

The Government of Canada risk assessment process is robust, and involves impartial, science-based reviews that adhere to the laws and regulations that govern those products. In the case of the AquAdvantage® salmon, this practice was followed, and through the involvement of the Department of Fisheries and Oceans, included the additional step of peer-review by a panel of scientific experts and publication of a risk assessment summary on the website of the Canadian Science Advisory Secretariat.

The notice of public consultation was not widely advertised, the short timeline given does not allow Canadians to research effectively in order to comment on this very important subject.

A public notice was posted on the Voluntary Public Engagement Initiative web page on September 14, 2018. This notice included a summary of the new substance notification and information on the proposed activity. For a period of 30 days, ending on October 12, 2018, the public was invited to submit scientific information and test data related to potential risks to the environment or human health from the AquAdvantage® salmon that could inform the risk assessment. To inform about this opportunity to provide scientific information, an email was sent on September 17, 2018 to those who had previously expressed an interest in the New Substances program. These included: industry, academia, non-governmental organizations, individuals and groups that commented on the Prince Edward Island provincial review of the new fish farming site at Rollo Bay West, Indigenous groups located in the region, as well as witnesses to the Standing Committee on Environment and Sustainable Development.

The New Substances Notification Regulations (Organisms) provide regulatory timelines to complete the risk assessment. All scientific information and test data must be considered within these timelines.

Members of the public can request to be added to the mailing list for future Voluntary Public Engagement Initiatives by contacting the Substances Management Information Line:

Substances Management Information Line
Information Management and Data Collection
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)
Telephone:  1-819-938-3232 (Outside of Canada)
Facsimile: 1-819-938-5212
E-mail: eccc.substances.eccc@canada.ca

5. Animal welfare and food safety

Comment summary Response
Concerned citizens ask for the closure of open pen fish farms and mandatory labelling of all genetically modified foods in the grocery store.

AquAdvantage® salmon intended to be produced under strictly controlled conditions at a location where AquaBounty is able to contain the living organism to prevent release into the environment. AquAdvantage® salmon is not intended for production outside of this contained, land-based facility.

The result of the risk assessment decision on AquAdvantage® salmon manufacture at the Bay Fortune facility was implemented in Significant New Activity Notice 16528. Any person growing the AquAdvantage® salmon are required to comply with this Notice. This includes the provisions that production of AquAdvantage® salmon must take place under stringent containment conditions and that only euthanized fish can leave the facility.

The risk assessments conducted under the Canadian Environmental Protection Act, 1999 do not include an assessment of the fish for food or feed use. These specific uses are assessed independently by Health Canada (HC), under the Food and Drugs Act, and by the Canadian Food Inspection Agency (CFIA) under the Feeds Act, respectively.

HC and CFIA 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, for instance, the presence of an allergen in a food. In these situations, labelling is required to alert consumers or susceptible groups in the population at large. For more information please see the Novel Food Decision on AquAdvantage® salmon and the Labelling of Genetically Engineered Foods in Canada Factsheet.

6. Support for science-based decisions

Comment summary Response
It is important for the Government of Canada (GC) to conduct science-based risk assessments. The GC should support scientific innovation by limiting regulatory uncertainty. The Government of Canada is committed to the health and safety of Canadians and to the protection of our environment. We use a robust science-based process to evaluate the effect of genetically modified animals on our environment and their safety for human consumption.
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