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

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.

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.

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.

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: substances@ec.gc.ca

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.