"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]. 

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