"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]. 

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.