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Genetically Modified Salmon ('Frankenfish') for direct human consumption, Canada


Description

"AquAdvantage salmon" is a genetically modified (GM) Atlantic salmon developed by AquaBounty Technologies. It grows much faster than its farmed non-GE or wild counterparts by containing a gene encoding Chinook salmon growth hormone under the control of an antifreeze protein promoter and terminator from ocean pout [11, 12]. The debates regarding its approval as a species that can be commercialized — it has been dubbed Frankenfish by its opponents — began in September 2011 with a meeting of the Veterinary Medicine Advisory Committee (VMAC) as well as a public hearing, together with the release of a health and safety briefing and an environmental assessment package on the transgenic animal developed by AquaBounty Technologies of Waltham, Massachusetts. Despite VMAC’s determination that AquAdvantage salmon is “as safe as food from conventional Atlantic salmon,” critics continue to raise concerns relating to its allergenicity, levels of insulin-like growth factor 1 (IGF-1) and composition of polyunsaturated fatty acids as well as the potential impacts of the farmed GMO fish on the environment. This development has resulted in various concerns and debates about its safety, health and environmental impacts both in US and Canada, including the regulatory regimes in both countries and their markets [11]. 

"Unlike transgenic plants, GE food animals are regulated as drugs in the United States, and as such they must go through the US Food and Drug Administration (FDA) new animal drug approval process. This means that developers must show their product to be safe and effective as well as provide an assessment of its environmental impacts, under the requirements of the National Environmental Policy Act (NEPA). When AquaBounty Technologies (then A/F Protein) initiated discussions with the FDA seeking regulatory guidance for development and approval of AquAdvantage salmon in 1993, no defined regulatory pathway existed for GE animals. Under the Coordinated Framework for Regulation of Biotechnology, a 1986 policy that called for the US Environmental Protection Agency (EPA), US Department of Agriculture (USDA) and FDA to regulate GE products using existing laws, USDA was the lead agency to regulate GE plants, but no regulatory path had been clearly set out for GE animals. Thus, the company petitioned for regulation under FDA" [11].

Nevertheless, “during the winter of 2012–2013, anticipation of the Food and Drug Administration’s approval of the AquAdvantage Salmon as the first genetically modified animal for human consumption generated much discussion. Proponents were excited about this invention, suggesting that genetically modified salmon provides economic and ecological benefits through the application of new technologies and market mechanisms” [12]; while opponents were not convinced by these ideas and strongly argued against its approval. After receiving the news of the Canadian Government's approval of GM salmon in November 2013, Nova Scotia’s Ecology Action Centre and British Columbia’s Living Oceans Society have taken the Canadian government to court to challenge its decision to allow AquaBounty Technologies Inc. to manufacture genetically modified (GM) salmon eggs at Bay Fortune, Prince Edward Islands. They argued that the federal government violated its own laws in issuing that approval and managed to halt the project due to the legal action. Both organisations promote healthy local food, protecting wild salmon, demanding openness and transparency in government decision-making, ensuring thorough risk assessments [1].

In 2016, the Canadian Food Inspection Agency and Health Canada approved the rearing of genetically modified salmon [4]. Ecojustice lawyers representing environmental groups such as Ecology Action Centre and Living Oceans Society claimed that the approval for this genetically modified species is unlawful because it failed to assess whether genetically modified salmon could become invasive, potentially putting ecosystems and species such as wild salmon at risk. Both groups were asking the court to set aside the government’s assessment and require the government to comply with the law before permitting the manufacture of these genetically modified organisms [5].

AquaBounty's plan was to grow the genetically modified salmon eggs in Prince Edward Islands, Canada; then to transport them to Panama, where they would grow to market size in salmon farms before sending them to US and Canada markets. However, the approval would also allow the manufacture and growth of the genetically modified salmon elsewhere in Canada under certain conditions [5].

According to Living Oceans Society, another worrying aspect of this case is the lack of transparency and public consultation in the decision-making process even though this is the world’s first genetically modified food animal for direct human consumption. They asserted that this was done without any public debate at all and under circumstances that look like a deliberate attempt to prevent public comment [5]. 

Basic Data

NameGenetically Modified Salmon ('Frankenfish') for direct human consumption, Canada
CountryCanada

Source of Conflict

Type of Conflict (1st level)Biomass and Land Conflicts (Forests, Agriculture, Fisheries and Livestock Management)
Type of Conflict (2nd level)Intensive food production (monoculture and livestock)
Aquaculture and fisheries
GMOs
Other
Specific CommoditiesLive Animals
Fish

Project Details and Actors

Project DetailsIn 1989, AquaBounty firm's initial research and development attempts with transgenic salmon began in cooperation with the Memorial University of Newfoundland. Canadian researchers created the AquAdvantage® transgene (genetic construct), which expressed Chinook salmon growth hormone under the control of an Ocean Pout promoter. The founder animal from which the AquAdvantage® line was derived was created by microinjection of the transgene into fertilized eggs of wild Atlantic salmon. In 1992, AquAdvantage® Salmon was established from the F1 generation of the EO-1α line.

In 1995, A/F Protein (the corporate precursor to AquaBounty Canada) established an Investigational New Animal Drug (INAD) file with the Center for Veterinary Medicine (CVM) of the U.S. FDA to pursue the development of AquAdvantage® Salmon. In 2000, A/F Protein got restructured: it changed its name to AquaBounty Farms (and changed the name of A/F Protein Canada to AquaBounty Canada), and created a subsidiary called A/F Protein (and A/F Protein Canada). AquaBounty Farms, the surviving company, retained the AquAdvantage® technology.

In 2003, AquaBounty Farms submitted to the FDA its first regulatory study for a New Animal Drug Application (NADA); and in 2004, AquaBounty Farms headquartered in Waltham, Massachusetts, changed its name to AquaBounty Technologies. In 2006, AquaBounty Technologies (ABTX) was listed on the London Stock Exchange’s Alternative Investment Market (AIM) raising $30 million in an initial public offering of stock. In 2008, the FDA inspected AquaBounty Canada’s hatchery in PEI as an authorized production site for eggs. Following that, AquaBounty Technologies began to construct a land-based aquaculture grow out facility (AquaBounty Panama) in the highlands of Panama for the purpose of conducting trials of the Company’s AquAdvantage® Salmon. In 2009, AquaBounty Technologies submitted its final regulatory study to the FDA. CVM released Guidance 187 for the evaluation of genetically engineered animals.

The FDA inspected AquaBounty Panama’s site for the production of AquAdvantage® Salmon for import into the US and did not declare any adverse findings. In 2010, AquaBounty Technologies received section complete letters from the FDA on all seven parts of the New Animal Drug Application for AquAdvantage® Salmon. The FDA convened a Veterinary Medicine Advisory Committee (VMAC), a public meeting to review its findings of AquAdvantage® Salmon and concluded that it was safe to eat. In 2011, the FDA consulted with the National Marine Fisheries Service of NOAA and the U.S. Fish and Wildlife Service, which concurred with the FDA’s “no effect” findings revealing that the AquAdvantage® Salmon does not pose a threat to the environment [9].

Additional to the integration of the growth hormone gene from the Chinook into Atlantic salmon, AquaBounty integrated the recirculating aquaculture system (RAS) of production. This production system was first employed to raise juvenile salmon, which would then be raised for another year in sea cages due to cost. However, the accelerated growth rate of AquaBounty’s genetically modified AquAdvantage Salmon allows for the entire process to be completed in 16-18 months in a closed, land-based production system [21].

Recently, in 2018, the company AquaBounty Technologies announced that it has issued an underwritten public offering with the goal of raising $12 million. The company plans to use the funds raised through this public offering to support its goal of continuing construction and renovations on its existing facilities in Rollo Bay, Prince Edward Island, Canada, and in the state of Indiana in the United States. The company declared that capital also would be used to fund the growing of the company’s initial batches of fish at both sites, and for other general corporate purposes. The terms of the offering include an aggregate of 3,692,307 shares of common stock, and warrants to purchase up to 3,692,307 shares of common stock in the company at an offering price of US$3.25 per share [21].

Its first facility to produce GM-eggs was established in Prince Edward Island (PEI), Canada, which was then followed with attempts of expansion in Rollo Bay. These eggs were then transported to Panama for fattening them in salmon farms, and then when they reach the market size, selling them in (US and) Canadian markets. In August 2017, the firm AquaBounty reported that about 4.5 tonnes of genetically modified salmon filets have been sold so far in Canada [22]. Despite several environmental and health concerns and fair trade and consumer information, in 2018, the firm continues to produce and sell in Canadian markets.
Level of Investment (in USD)12,000,000
Type of PopulationUnknown
Start Date01/01/2010
Company Names or State EnterprisesAquaBounty Technologies from United States of America
Relevant government actorsU.S. Food and Drug Administration (FDA);

Canada’s Federal Court of Appeal;

Canada's Ministry of Environment;
Environmental justice organisations and other supportersEcology Action Centre: https://ecologyaction.ca;

Canadian Biotechnology Action Network (CBAN): https://cban.ca;

Ecojustice: https://www.ecojustice.ca/approach/;

The Council of Canadians: https://canadians.org;

Sitka Local Foods Network: https://sitkalocalfoodsnetwork.org/tag/aquabounty-technologies/;

Living Oceans Society: https://livingoceans.org;

Sitka Conservation Society: http://www.sitkawild.org

The Conflict and the Mobilization

Intensity of Conflict (at highest level)LOW (some local organising)
When did the mobilization beginPREVENTIVE resistance (precautionary phase)
Groups MobilizingInternational ejos
Local ejos
Neighbours/citizens/communities
Social movements
Women
Recreational users
Local scientists/professionals
Environmental lawyers, food organisations
Fisher people
Forms of MobilizationCreation of alternative reports/knowledge
Development of a network/collective action
Development of alternative proposals
Involvement of national and international NGOs
Lawsuits, court cases, judicial activism
Media based activism/alternative media
Objections to the EIA
Official complaint letters and petitions
Public campaigns
Street protest/marches

Impacts

Environmental ImpactsPotential: Biodiversity loss (wildlife, agro-diversity), Genetic contamination, Other Environmental impacts
OtherAquAdvantage fish might escape and cause the collapse of wild salmon populations. Environmental concerns are the most significant ones associated with the development of GE animals (see the report of the National Research Council), which was prepared at the request of the FDA after the AquAdvantage salmon submission. The risk of harm from GE animals is the product of (i) harm, given exposure to the hazard (that is, the GE animal), and (ii) the probability of exposure17,18. And in this case, the probability of exposure given the ‘Limitations for Use’ associated with the AquAdvantage salmon product definition was seen to be extremely small due to the triple redundancy of simultaneous containment measures—that is, (i) land-based production with physical confinement barriers (screens), (ii) reproductive confinement measures resulting in 99% sterility and 100% female production stocks and (iii) thermally lethal lake and stream temperatures downstream from the proposed production facility in Panama— and high salinity of waters surrounding the Canadian location" [11].
Health ImpactsPotential: Exposure to unknown or uncertain complex risks (radiation, etc…), Malnutrition
Socio-economic ImpactsPotential: Loss of livelihood, Loss of traditional knowledge/practices/cultures, Loss of landscape/sense of place

Outcome

Project StatusUnder construction
Pathways for conflict outcome / responseCourt decision (failure for environmental justice)
New legislation
New Environmental Impact Assessment/Study
Project temporarily suspended
Development of AlternativesThe opponents demand the protection of wild salmon and the application of precautionary principle regarding the production, marketing and consumption of GM-salmon.
Do you consider this as a success?No
Why? Explain briefly.The raising and marketing of GM salmon has been stopped several times through street protests and judicial activism, but the project is ongoing.

Sources and Materials

Legislations

Food and Drugs' Administration on AquAdvantage Salmon [17]
https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm280853.htm

Food and Drugs' Administration (FDA), AquAdvantage Salmon Fact Sheet [7]
https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm473238.htm

References

The Tragedy of the Commodity (Longo, Clausen and Clark; 2015) [12]
https://www.jstor.org/stable/j.ctt16xwb3r

Transgenic salmon: a final leap to the grocery shelf? (Van Eenennaam and Muir, Nature Biotechnology; 2016) [11]
http://aquabounty.com/wp-content/uploads/2016/11/Transgenic-salmon-a-final-leap-to-the-grocery-shelf-VanEenennaam-Muir.pdf

Links

Website of AquaBounty Technologies [10]
https://aquabounty.com

About 4.5 tonnes of GMO salmon consumed in Canada so far, company says (The Star News/The Washington Post, 4 August 2017) [22]
https://www.thestar.com/news/canada/2017/08/04/about-45-tonnes-of-gmo-salmon-consumed-in-canada-so-far-company-says.html

Living Ocean Resources (2014) [13]
http://www.livingoceans.org/media/releases/environmental-groups-take-federal-government-court-permitting-manufacture-genetically

AquaBounty Technologies announces $12M IPO to fund expansion (January 2018) [21]
http://www.globalaginvesting.com/aquabounty-technologies-announces-12m-ipo-fund-expansion/

AquaBounty salmon was approved for sale in Canada in 2016, paving the way for it to become the first genetically engineered animal to enter the food supply (The Guardian, 9 August 2017) [6]
https://www.theguardian.com/world/2017/aug/09/genetically-modified-salmon-sales-canada-aqua-bounty

The Chronology of AquAdvantage Salmon (AquaBounty, 2014) [9]
https://www.aquabounty.com/wp-content/uploads/2014/01/Chronology-of-AquAdvantage-Salmon-F1.pdf

Environmental groups take the federal government to court (Ecojustice, 2014) [5]
https://www.ecojustice.ca/pressrelease/environmental-groups-take-federal-government-to-court-for-permitting-manufacture-of-genetically-modified-salmon-in-canada/

Reports on GM salmon in Canada (CBAN, 2017, 2018) [2]
https://cban.ca/gmos/products/ge-animals/ge-fish/

Canada sued over approval of genetically modified salmon scheme (The Guardian, 17 November 2015) [3]
https://www.theguardian.com/environment/2015/nov/17/canada-sued-genetically-modified-salmon-scheme-approval-environmental-groups

Food Secure Canada [1]
https://foodsecurecanada.org/resources-news/news-media/gm-salmon-swim-court

Canadian Government Receiving Royalties from Genetically Modified Salmon Sales (CBAN, 22 March 2018) [8]
https://cban.ca/canadian-government-receiving-royalties-from-genetically-modified-salmon-sales/

Groups challenge federal approval of genetically modified salmon in court (CBC News, 18 October 2016) [16]
http://www.cbc.ca/news/canada/british-columbia/gmo-salmon-heads-to-court-1.3809924

Media Links

Discussion on GM salmon [19]
https://www.youtube.com/watch?v=BmwQj6rXc8Y&feature=youtu.be&list=PLfKRRrh2IkUFZ_YxqYBm3vbEUdSbwtWq4

Aquabounty's GM Salmon Facility, PEI Canada (CBAN) [20]
https://www.youtube.com/watch?v=GC4t0_RYIfc&feature=youtu.be&list=PLfKRRrh2IkUFZ_YxqYBm3vbEUdSbwtWq4

Other Documents

Sitka residents say 'NO' to genetically modified fish Protests of Sitka residents against Frankenfish, 2013
https://file.ejatlas.org/docs/Sitka_residents_say_No_to_GM_salmon-protestersoutside1.jpg

No to Frankenfish Protests against 'Frankenfish' at PEI (The Council of Canadians, 2015) [18]
https://file.ejatlas.org/docs/PEI-Canada-protestsGMfish-Council_of_Canadians.jpg

AquAdvantage Salmon [9] The comparison of sizes: GM salmon vs non-GM salmon
https://file.ejatlas.org/docs/AquAdvantage_Salmon__AquaBounty_Technologies_.png

Sitka residents say 'NO' to Frankenfish - 2
https://file.ejatlas.org/docs/Sitka_residents__protest-saynotofrankenfish1.jpg

Meta Information

ContributorIrmak Ertör, ICTA UAB, ENVJUSTICE
Last update27/07/2018

Images

 

Sitka residents say 'NO' to genetically modified fish

Protests of Sitka residents against Frankenfish, 2013

No to Frankenfish

Protests against 'Frankenfish' at PEI (The Council of Canadians, 2015) [18]

AquAdvantage Salmon [9]

The comparison of sizes: GM salmon vs non-GM salmon

Sitka residents say 'NO' to Frankenfish - 2