Fast-growing GM salmon for a “sustainable aquaculture industry”

Claims 

“Our mission is to play a significant part in ‘The Blue Revolution’ – bringing together biological sciences and molecular technology to enable an aquaculture industry capable of large-scale, efficient, and environmentally sustainable production of high quality seafood. Increased growth rates, enhanced resistance to disease, better food-conversion rates, manageable breeding cycles, and more efficient use of aquatic production systems are all important components of the sustainable aquaculture industry of the future.” ((PR Newswire (2010). AquaBounty’s response to the press release titled ‘Coalition demands FDA deny approval of first genetically engineered food animal’. https://www.prnewswire.com/news-releases/aquabountys-response-to-the-press-release-titled-coalition-demands-fda-deny-approval-of-first-genetically-engineered-food-animal-101927263.html  Accessed 10 Mar 2024.))

In 2010, Ronald L. Stotish, executive director, CEO, and president of AquaBounty made this statement in response to a coalition of 31 US consumer, animal welfare and environmental groups calling on the US Food and Drug Administration (FDA) to deny regulatory approval to its transgenic salmon.((Center for Food Safety (2010). Coalition demands FDA deny approval of controversial genetically engineered fish. 27 Aug. https://www.centerforfoodsafety.org/press-releases/797/coalition-demands-fda-deny-approval-of-controversial-genetically-engineered-fish))

AquaBounty said its “land-based farms, combined with its expertise in genetic engineering, are the answers to a rapidly increasing global demand for high-quality seafood”.((AquaBounty website. https://aquabounty.com/company/company-history-292.aspx Accessed 10 Mar 2024.)) It promoted its fast-growing GM salmon on the basis that it provided gains to productivity, sustainability, and animal welfare.((AquaBounty (2024). Why AquaBounty salmon. https://aquabounty.com/our-salmon/why-aquabounty-salmon ; Time Magazine (2010). The fifty best inventions of 2010 – faster-growing salmon. 11 Nov.))

Time Magazine declared the GM salmon one of “the 50 best inventions of 2010”.((Time Magazine (2010). The fifty best inventions of 2010 – faster-growing salmon. 11 Nov. https://content.time.com/time/specials/packages/article/0,28804,2029497_2030617_2029720,00.html))

The genetic modification

The AquAdvantage salmon was genetically engineered by adding a growth hormone gene from Pacific Chinook salmon, which is placed under the control of a promoter (DNA sequence that turns on the expression of a gene) and termination element from the antifreeze gene of the ocean pout, another type of fish.((Yaskowiak ES et al (2006). Characterization and multi-generational stability of the growth hormone transgene (EO-1α) responsible for enhanced growth rates in Atlantic salmon. Transgenic Research 15: 465–480. https://link.springer.com/article/10.1007/s11248-006-0020-5 )) This gene enables the GM salmon to grow all year round, instead of only during spring and summer,((Pollack A (2015). Genetically engineered salmon approved for consumption. New York Times, 19 Nov. http://www.nytimes.com/2015/11/20/business/genetically-engineered-salmon-approved-for-consumption.html?_r=0 )) as non-GM Atlantic salmon do.

The modification, according to AquaBounty, meant the fish would “Reach market size twice as fast as traditional salmon. This advancement provides a compelling economic benefit to farmers (reduced growing cycle) as well as enhancing the economic viability of inland operations, thereby diminishing the need for ocean pens. AAS [AquAdvantage salmon] are also reproductively sterile, which eliminates the threat of interbreeding amongst themselves or with native populations, a major recent concern in dealing with fish escaping from salmon farms.” ((Fish Information Services (2011). AquaBounty Technologies Inc., detailed selling lead description. 5 Feb. https://seafood.media/fis/tradingmarket/Read.asp?sector=aquaculture&id=18397&id_reply=18397&image))

The broodstock for AquAdvantage salmon consists of conventionally bred females and GM male salmon, from which eggs and milt (fish semen) are extruded.((AquaBounty (2013). How we produce AquAdvantage® salmon eggs. https://aquabounty.com/wp-content/uploads/2014/02/How-AquAdvantage-Salmon-Eggs-are-Produced.pdf )) The milt is added to the eggs and the resulting fertilised eggs are “pressure shocked” to create fish eggs with three copies of each chromosome (triploid) rather than two copies (diploid) and to make the fish genetically sterile. Only around 1% of AquAdvantage eggs remain diploid.((Bodnar A (2010). Risk assessment and mitigation of AquAdvantage salmon. ISB News Report. Archived in the Wayback Machine, 25 May 2017. Bodnar A (2010). Risk assessment and mitigation of AquAdvantage salmon. ISB News Report. Archived in the Wayback Machine, 25 May 2017.))

Results

Since the AquAdvantage salmon was approved for sale in North America in 2015((US FDA (2015). Final rule: New animal drugs in genetically engineered animals; opAFP-GHc2 recombinant deoxyribonucleic acid construct. 80 FR 73104. )) there has been no independent scientific analysis of AquaBounty’s claims for growth, feed efficiency, yield, nutritional content, better animal welfare, or environmental impact. Therefore this account of the GM fish can only be told through its regulatory process, legal and civil society analysis, and media reports.

Regulatory approvals

In September 2010 the FDA held a meeting to consider the safety and effectiveness of a New Animal Drug Application (NADA) concerning AquaBounty’s AquAdvantage salmon.

Over the following months, the FDA received 322,031 written comments from stakeholders, voicing concerns ranging from food safety, allergenicity, and nutrition to animal welfare, Native American rights, science, and the data submitted by the company. The FDA dismissed the concerns.((FDA website. AquAdvantage Salmon – FDA response to public comments to the Veterinary Medicine Advisory Committee.https://www.fda.gov/animal-veterinary/intentional-genomic-alterations-igas-animals/aquadvantage-salmon-fda-response-public-comments-veterinary-medicine-advisory-committee#1 ))

In 2012 the FDA released a Draft Environmental Assessment and a preliminary Finding of No Significant Impact (FONSI) for public comment. Around 1.8 million people submitted comments opposing approval of the GM salmon.((Andrews J (2013). Target and other retailers reject GE salmon as FDA nears decision on approval. Food Safety News, 30 May. https://www.foodsafetynews.com/2013/05/target-and-other-retailers-reject-ge-salmon/ ; Center for Food Safety (2013). Nearly 2 million people tell FDA not to approve GE salmon. 30 Apr. https://www.centerforfoodsafety.org/press-releases/2151/nearly-2-million-people-tell-fda-not-to-approve-ge-salmon)) Again, their concerns were dismissed.((FDA website. AquAdvantage salmon – response to public comments on the Environmental Assessment. https://www.fda.gov/animal-veterinary/intentional-genomic-alterations-igas-animals/aquadvantage-salmon-response-public-comments-environmental-assessment ))

Around the same time, Canada was also considering approval of the salmon. AquaBounty filed a novel food application for AquAdvantage salmon with Health Canada in 2012((Canadian Government webpage. AquAdvantage salmon. https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products/aquadvantage-salmon.html)) and a novel feed application with the Canadian Food Inspection Agency.((US Securities and Exchange Commission (2014). AquaBounty Technologies, Inc. https://investors.aquabounty.com/node/7966/html)) In 2013, Environment Canada approved the commercial production of GM salmon eggs.((Canada Gazette, Part 1 (2013). Significant New Activity Notice No. 16528. 23 Nov. http://www.gazette.gc.ca/rp-pr/p1/2013/2013-11-23/pdf/g1-14747.pdf)) The ruling gave the company permission to produce and export the eggs from its hatchery in Prince Edward Island to a grow-out site in Panama.((Goldenberg S (2013) Canada approves production of GM salmon eggs on commercial scale. Guardian, 25 Nov. https://www.theguardian.com/environment/2013/nov/25/canada-genetically-modified-salmon-commercial ))

FDA approval for consumption in the US followed in 2015.((FDA (2015). Final rule: New animal drugs in genetically engineered animals; opAFP-GHc2 recombinant deoxyribonucleic acid construct. 80 FR 73104. https://www.federalregister.gov/documents/2015/11/24/2015-29902/new-animal-drugs-in-genetically-engineered-animals-opafp-ghc2-recombinant-deoxyribonucleic-acid))

In 2016 Health Canada approved the production, sale, and consumption of AquAdvantage salmon as a novel food and feed in Canada.((Government of Canada (2016). Decision document DD2016-117 – Determination of the safety of AquaBounty Technologies Inc.’s salmon (Salmo salar L.) event. 19 May.https://inspection.canada.ca/plant-varieties/plants-with-novel-traits/approved-under-review/decision-documents/dd2016-117/eng/1463076782568/1463076783145 )) In 2018 the FDA announced approval of a contained grow-out facility in Indiana for rearing the salmon.((FDA approves application for AquaBounty salmon facility in Indiana (2018). Press release. Archived at Archive-It, 22 Dec 2020. https://wayback.archive-it.org/7993/20201222195002/https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-application-aquabounty-salmon-facility-indiana. See also: Hjul J (2018). US go ahead for GM salmon facility, 27 Apr. Fish Farmer Magazine. https://www.fishfarmermagazine.com/2018/04/27/us-go-ahead-gm-salmon-facility))

Approval by these two major authorities should have signalled an open road ahead, but AquaBounty was to be plagued with challenges and delays on multiple fronts.

Legal challenges

In 2013 environmental groups in Canada applied for a judicial review of Environment Canada’s decision to approve the production of AquAdvantage salmon eggs in Prince Edward Island, on the grounds that it failed to assess whether the GM salmon could become invasive, potentially putting ecosystems and wild salmon at risk.((Living Oceans (2017). CEPA Review shines light on GMOs. 15 Jun. https://livingoceans.org/media/releases/cepa-review-shines-light-gmos?language=fr)) The Federal Court in Canada dismissed the application and ruled that the approval in Canada was lawful. The environmental groups appealed, but were unsuccessful.((Mitchell A (2016), Court upholds approval of GM AquaBounty salmon. The Fish Site, 26 Oct. https://thefishsite.com/articles/court-upholds-approval-of-gm-aquabounty-salmon))

In 2016 the Institute for Fisheries Resources and environmental groups filed a lawsuit against the FDA, ((Case 3:16-cv-01574. Filed: 30 March 2016. https://www.centerforfoodsafety.org/files/2016-3-30-dkt-1–pls–complaint_94703.pdf )) arguing that the FDA failed to properly consider the potential environmental impacts of the AquAdvantage salmon. It also demanded that the FDA publish the information on which it based its decision.((Marie C (2020). Overview of the regulatory and legal developments surrounding the FDA approved genetically-modified Atlantic salmon. Center for Agricultural and Shale Law. https://aglaw.psu.edu/ag-law-in-the-spotlight/overview-of-the-regulatory-and-legal-developments-surrounding-the-fda-approved-genetically-modified-atlantic-salmon)) In 2017 a court ruled that the FDA must release the information, but the FDA appealed. The plaintiffs opposed FDA’s appeal((Case: 17-71121. Filed: 15 August 2017. https://www.centerforfoodsafety.org/files/mandamus-opp_final_8_15_2017_43371.pdf )) and were joined by two dozen law professors.((Case: 17-71121, Amicus Brief. Filed: 15 August 2017. https://www.centerforfoodsafety.org/files/deliberative-process-amicus-motion-and-brief–as-filed_43581.pdf )) In 2018 the FDA’s appeal was denied and it was ordered to make public thousands of pages of documents relating to its approval of the transgenic salmon for human food.((Center for Food Safety (2018). Court rejects Trump Administration secrecy in genetically engineered salmon case. Press release. https://www.centerforfoodsafety.org/press-releases/5222/court-rejects-trump-administration-secrecy-in-genetically-engineered-salmon-case))

In 2020 a court ruled that in approving the salmon, the FDA had ignored data on possible environmental consequences and violated the National Environmental Policy Act and the Endangered Species Act.((Case 3:16-cv-01574-VC. Filed: 5 November 2020. https://www.centerforfoodsafety.org/files/2020-10-05-ecf-285–order-granting-in-part-and-denying-msj_03835.pdf )) The judge also told the FDA to complete its analysis of what might happen to non-GM salmon if the transgenic salmon escaped from landlocked farms into the wild. But the court did not rescind the approval of the fish – meaning it remained legal to produce and sell the salmon.

By 2022 the FDA had still failed to release the documents it had been ordered to release in 2018, prompting another lawsuit.((Center for Food Safety (2022). FDA sued over failure to release documents regarding approval of genetically engineered salmon, planned Ohio production facility. Press release. http://web.archive.org/web/20240715091319/https://www.centerforfoodsafety.org/press-releases/6589/fda-sued-over-failure-to-release-documents-regarding-approval-of-genetically-engineered-salmon-planned-ohio-production-facility )) In the midst of the legal activity, AquaBounty closed its Panama facility.((Blank C (2019). AquaBounty to close Panama farm. Seafood Source, 3 May. https://www.seafoodsource.com/news/supply-trade/aquabounty-to-close-panama-farm))

Expansion – and contraction

Over the years, AquaBounty received $3m from the US government and $6m from the Canadian government.((Goldenberg S (2011). Obama administration ‘bailed out’ GM salmon firm. The Guardian, 18 Oct. https://www.theguardian.com/environment/2011/oct/18/gm-salmon-aquabounty  See also USDA National Institute of Food and Agriculture. 2011 Biotechnology Risk Assessment Grants. https://www.nifa.usda.gov/2011-biotechnology-risk-assessment-grants )) However, one US grant was rescinded after a public outcry.((Pollack A (2012), An entrepreneur bankrolls a genetically engineered salmon. New York Times, 21 May. https://www.nytimes.com/2012/05/22/business/kakha-bendukidze-holds-fate-of-gene-engineered-salmon.html))

In 2012, a New York Times article reported that AquaBounty’s finances were not in good shape and that the company had reduced staff numbers. In March 2012, AquaBounty raised US$2m in new capital, partly from a businessman investor.((Pollack A (2012). An entrepreneur bankrolls a genetically engineered salmon. New York Times, 21 May. https://www.nytimes.com/2012/05/22/business/kakha-bendukidze-holds-fate-of-gene-engineered-salmon.html)) But by October 2012 he was selling his stock to synthetic biology company Intrexon,((The Fish Site (2012). Intrexon to acquire 48 per cent stake in AquaBounty Technologies. 6 Nov. https://thefishsite.com/articles/intrexon-to-acquire-48-per-cent-stake-in-aquabounty-technologies-1 ; Pollack A (2012). Engineered fish moves a step closer to approval. New York Times, 21 Dec. https://www.nytimes.com/2012/12/22/business/gene-altered-fish-moves-closer-to-federal-approval.html ; Fish Update (2012). Delays put question mark over GM salmon as development company receives bid. 10 Dec. Archived at the Wayback Machine 21 Jan 2023. https://web.archive.org/web/20130121121155/http://fishupdate.com/news/fullstory.php/aid/18699/Delays_put_question_mark_over_GM_salmon_as_development_company_receives_bid.html)) which acquired majority ownership of AquaBounty in 2013.((Bunge J (2015). Firm bets on biotech that changes how food is produced. Wall Street Journal, 15 Dec. https://www.wsj.com/articles/firm-bets-on-biotech-that-changes-how-food-is-produced-1450220986))

In a filing with the US Securities and Exchange Committee (SEC) AquaBounty noted: “We have incurred significant losses since our inception…For the fiscal years ended December 31, 2017, 2016, and 2015, we experienced net losses of $9.3 million, $8.5 million, and $7.0 million, respectively.”((AquaBounty Technologies, Inc (2019). Annual report filed with the US Securities and Exchange Commission for the fiscal year ended 31 Dec 2017. https://www.annualreports.com/HostedData/AnnualReportArchive/a/NASDAQ_AQB_2017.pdf))

In 2019 AquaBounty reported to the SEC that it had only sold small quantities of salmon and that for fiscal years 2019 and 2018, operating losses were $13.2 million and $10.4 million, respectively.((AquaBounty Technologies, Inc (2017). Annual report filed with the US Securities and Exchange Commission for the fiscal year ended 31 Dec 2019. https://seekingalpha.com/filing/4875141))

In October 2020 AquaBounty announced it had chosen a site in Kentucky for its third planned large-scale facility,((Fish Farming Expert (2020). AquaBounty chooses Kentucky for 10,000-tonne salmon farm. 29 Oct. https://www.fishfarmingexpert.com/aquabounty-kentucky-mayfield/aquabounty-chooses-kentucky-for-10000-tonne-salmon-farm/1151035 )) known as “Farm 3”. But by December it had abandoned this plan.((Moore G (2020). AquaBounty chooses Innovasea RAS for new farm and may change site. Fish Farming Expert, 10 Dec. https://www.fishfarmingexpert.com/aquabounty-aquadvantage-salmon-farm-3/aquabounty-chooses-innovasea-ras-for-new-farm-and-may-change-site/1151032))

In 2021 the company announced plans for $200 million expansion with a new “Farm 3” – a 479,000 square foot facility in Ohio which would produce 10,000 tonnes of GM salmon per year. Stocking, it said, would begin by 2023.((Food Safety News (2021). Ohio gets $200 million investment in genetically engineered salmon. 4 Aug. https://www.foodsafetynews.com/2021/08/ohio-gets-200-million-investment-in-genetically-engineered-salmon ))

In September 2022 it announced a new roadmap for the business – which included significant expansion. New land-based recirculating aquaculture system (RAS) facilities for its salmon, it said, would be built every two years. In addition to a new site in Brazil, the company said it was in “final negotiations’” for a joint venture with a partner in Israel. Other target sites were near New York City and in California, Mississippi, and Canada.((Chase C (2022). AquaBounty’s roadmap features new farms every two years, international expansion. Seafood Source, 28 Sept. https://www.seafoodsource.com/news/aquaculture/aquabounty-s-roadmap-features-new-farms-every-two-years-international-expansion))

In November 2022 the Nasdaq threatened to delist AquaBounty due to its low share price.((Undercurrent News (2022). Nasdaq warns AquaBounty over low share price, threatens delisting. 7 Nov. https://www.undercurrentnews.com/2022/11/07/nasdaq-warns-aquabounty-over-low-share-price-threatens-delisting/ )) By October 2023 the company had regained compliance with the minimum share price requirement.((Fish Farming Expert (2023). AquaBounty no longer facing de-listing from Nasdaq. 1 Nov. https://www.fishfarmingexpert.com/aquabounty-gm-salmon-nasdaq/aquabounty-no-longer-facing-de-listing-from-nasdaq/1586957 ))

However, in its 2022 end of year filing with the SEC AquaBounty noted it had an accumulated deficit of $193 million, adding, “We expect to continue to experience losses from operations for the foreseeable future.” ((AquaBounty Technologies, Inc (2022). Annual report filed with the US Securities and Exchange Commission for the fiscal year ended 31 Dec 2022. https://www.sec.gov/Archives/edgar/data/1603978/000160397823000007/aqb-20221231x10k.htm))

The following year saw a reversal of the expansion plans. In February 2023 AquaBounty announced it would transition its facilities in Prince Edward Island, Canada, from producing GM salmon to primarily producing non-GM salmon broodstock and eggs to meet a growing US market demand for the conventional product.((Sapin R (2023). AquaBounty shifts GM salmon egg supply strategy in hunt for new revenue streams. IntraFish, 7 Feb. https://www.intrafish.com/salmon/aquabounty-shifts-gm-salmon-egg-supply-strategy-in-hunt-for-new-revenue-streams/2-1-1400569))

By November 2023 the proposed Ohio-based farm had still not been completed.((Fish Farming Expert (2023). AquaBounty farm cost estimate rises to nearly $½ billion. 7 Nov. https://www.fishfarmingexpert.com/aquabounty-q3-2023-pioneer-ohio-ras/aquabounty-farm-cost-estimate-rises-to-nearly-billion/1589267 )) In its 31 December 2022 filing with the SEC, AquaBounty stated that it did not have the financial resources to fully finance its construction.((AquaBounty Technologies, Inc (2022). Annual report filed with the US Securities and Exchange Commission for the fiscal year ended 31 Dec 2022. https://annualreport.stocklight.com/nasdaq/aqb/23711101.pdf))

In February 2024 AquaBounty announced it was selling its Indiana salmon farm “to secure the necessary financing… to pursue its growth strategy.” ((Negrete M (2024). AquaBounty puts its Indiana salmon farm for sale. 14 Feb. https://weareaquaculture.com/news/aquaculture/aquabounty-puts-its-indiana-salmon-farm-for-sale )) In July 2024 Superior Fresh – which produces non-GM salmon that are fed a non-GMO diet – agreed to buy the farm for $9.5 million.((Moore G (2024). AquaBounty agrees to sell Indiana salmon RAS for $9.5m. Fishfarming Expert, 2 Jul. https://www.fishfarmingexpert.com/aquabounty-superior-fresh/aquabounty-agrees-to-sell-indiana-salmon-ras-for-95m/1790656#))

In October 2024 AquaBounty announced it was selling its Rollo Bay facility to resolve its “immediate cash requirements”.((AquaBounty (2024). AquaBounty Technologies provides update. 3 Sept. https://investors.aquabounty.com/news-releases/news-release-details/aquabounty-technologies-provides-update )) Nevertheless, in November 2024 the Government of Canada and the Government of Prince Edward Island announced $231,095 in new funding for the company.((Government of Canada (2024). Government of Canada and Province of Prince Edward Island fund projects under the Atlantic Fisheries Fund. 13 Nov. https://www.canada.ca/en/fisheries-oceans/news/2024/11/government-of-canada-and-province-of-prince-edward-island-fund-projects-under-the-atlantic-fisheries-fund.html))

In December 2024 AquaBounty announced it would stop production of all GM salmon and was closing its last working facility, at Bay Fortune in Prince Edward Island.((AquaBounty (2024). AquaBounty Announces Plans to Cease Fish Farming Operations. 11 Dec. https://investors.aquabounty.com/news-releases/news-release-details/aquabounty-announces-plans-cease-fish-farming-operations )) In March 2025 Canadian fish farm company Cooke Aquaculture agreed to buy the Canadian subsidiary of AquaBounty. Cooke said it does not farm GM fish and has no plans to do so; it bought the company for its hatcheries.((Fish Farming Expert (2025). Cooke buys AquaBounty Canada for hatchery facilities. 4 Mar. https://www.fishfarmingexpert.com/aquabounty-canada-cooke-aquaculture/cooke-buys-aquabounty-canada-for-hatchery-facilities/1903676))

Environmental, food safety, and regulatory issues 

Concerns about the food safety and environmental effects of AquaBounty’s transgenic salmon arose from diverse sources.

In 2010 Dr Michael Hansen, senior scientist at Consumers Union, sent comments to the FDA on AquaBounty’s application to market the GM salmon. Hansen criticised the poor quality of AquaBounty’s data and the FDA’s analysis. He was concerned about the potential for increased allergenicity of the GM salmon and the possible presence of IGF-1, a hormone linked to cancer,((Hansen M (2010). Comments of Consumers Union on Genetically Engineered Salmon, Food and Drug Administration Docket No. FDA-201034-N-0001, Veterinary Medicine Advisory Committee Meeting. Consumers Union, 16 Sept. Archived 9 May 2012 in Wayback Machine. https://web.archive.org/web/20120509020206/http://www.consumersunion.org/pdf/CU-comments-GE-salmon-0910.pdf)) which had been found at abnormally high levels in a 1992 study on the GM salmon.((Du SJ et al (1992). Growth enhancement in transgenic Atlantic salmon by the use of an “all fish” chimeric growth hormone gene construct. Nature Biotechnology 10(2):176-81. doi: 10.1038/nbt0292-176. https://pubmed.ncbi.nlm.nih.gov/1368229/ )) He accused the company and FDA of “sloppy science” and warned: “This salmon may pose an increased risk of severe, even life-threatening allergic reactions to sensitive individuals.”((Hansen M (2010). Comments of Consumers Union on Genetically Engineered Salmon, Food and Drug Administration Docket No. FDA-201034-N-0001, Veterinary Medicine Advisory Committee Meeting. Consumers Union, 16 Sept. Archived 9 May 2012 in Wayback Machine. https://web.archive.org/web/20120509020206/http://www.consumersunion.org/pdf/CU-comments-GE-salmon-0910.pdf))

In a 2010 issue of the journal Science, a Duke University-led team published an article analysing the FDA’s approval procedures. The researchers concluded that the FDA failed to weigh the full impacts that production of GM salmon could have on health and ecology.((Smith MD et al (2010). Genetically modified salmon and full impact assessment. Science Magazine 330, 19 Nov. Archived at Salmone.org. http://www.salmone.org/wp-content/uploads/2010/11/gm-salmon-impact-assessment.pdf )) The first author recommended a stronger approval process “to ensure that such decisions serve society’s best interests”.((Duke Law (2010). Wiener co-authors Science article on genetically modified salmon. 18 Nov. https://law.duke.edu/news/5841))

In 2011 eight senators asked the FDA to cease considering approval of the GM salmon. The senators, who represented coastal states with fisheries, pledged to strip the FDA’s funding for the approval process. They argued that GM salmon could kill jobs in the fish farming industry, cause environmental damage, and harm consumers.((Seidman A (2011). FDA faces opposition over genetically engineered salmon. Los Angeles Times, 31 Jul.))

Their fears were not entirely unfounded. In a 2013 study for which AquaBounty provided the GM salmon, the transgenic fish crossbred with wild brown trout and the resulting hybrids grew more rapidly than the GM salmon and non-GM crosses, outcompeting them. The authors concluded that inter-species hybridisation should be considered when assessing the risk of escape of GM salmon.((Oke KB et al (2013). Hybridization between genetically modified Atlantic salmon and wild brown trout reveals novel ecological interactions. Proceedings of the Royal Society B. https://royalsocietypublishing.org/doi/10.1098/rspb.2013.1047#d1e473 ))

Animal welfare issues

AquaBounty claimed that its land-based pens help keep its salmon disease-free: “AquaBounty’s salmon are free of antibiotics and ocean contaminants. Controlling the growing environment prevents exposure to parasites and pathogens that can lead to disease.”((AquaBounty (2021). Press release: AquaBounty sells out the first commercial-scale harvest of genetically engineered Atlantic salmon from its Indiana farm. 10 May. https://investors.aquabounty.com/news-releases/news-release-details/aquabounty-sells-out-first-commercial-scale-harvest-genetically))

However, some assessments provide a different picture of the welfare of the GM salmon. 

In 2005, according to a 2010 US FDA briefing based on AquaBounty data, the GM fish had a high frequency of physical deformities. Only 7.9% of triploid GM salmon and 17.2 percent of diploid GM salmon were free from malformations, compared with 89% of triploid and 98.7% of diploid non-GM salmon.((US FDA Center for Veterinary Medicine: Veterinary Medicine Advisory Committee (2010). Briefing packet: AquAdvantage salmon. 20 Sept. Table 4. https://wayback.archive-it.org/7993/20170404230823/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf))

AquaBounty tested its GM salmon and non-GM controls for physical and behavioural problems, blood measurements and hormone levels, and allergenicity.((US FDA Center for Veterinary Medicine: Veterinary Medicine Advisory Committee (2010). Briefing packet: AquAdvantage salmon. 20 Sept. Table 4. https://wayback.archive-it.org/7993/20170404230823/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf))  However, in many tests, AquaBounty used sample sizes as low as six fish, too few to produce statistically significant results. Hansen said AquaBounty should have tested more fish. Moreover, in one test, the six fish in each study group were selected from larger groups of 100–200, and the report did not specify that they were chosen randomly. Additionally, AquaBounty admitted to culling deformed fish prior to selecting fish for inclusion in its studies, reducing the reliability of the results.((Richardson J (2010). The ‘creepy’ science behind GM salmon. Food Safety News, 17 Sept. https://www.foodsafetynews.com/2010/09/frankenfish-created-with-creepy-science/))

A report published by Norway’s Development Fund condemned this practice: “A more complete understanding of animal welfare issues is not possible… because of major scientific errors and bias in AquaBounty’s data collection. Before AquaBounty researchers physically examined salmon for health problems, they selectively killed off irregular fish, biasing the data set and severely compromising the integrity of the data. The FDA acknowledged this major scientific error, but never indicated that it would require AquaBounty to submit additional studies.” ((The Development Fund, Norway (2013). Genetically engineered salmon – fast growing hype. Briefing paper. https://web.archive.org/web/20171207074227/http://www.utviklingsfondet.no/files/uf/documents/GMO-Salmon_Fast_Growing_Hype_web.pdf ))

Additional welfare concerns were raised in an assessment by the Office of Aquatic Biotechnology, Dept of Fisheries and Oceans Canada, compiled in 2013 and made public in 2015 by legal disclosure.((Friends of the Earth (2015). Canadian Risk Assessment Finds GMO salmon Susceptible to Disease. Press release.  https://foe.org/news/2015-05-canadian-risk-assessment-finds-gmo-salmon-susceptible-to-disease)) The partially redacted assessment concluded that AquAdvantage salmon was “more susceptible to A. salmonicida”, a disease-causing bacterium, than non-GM farmed comparators. The assessment added that it is “highly certain that AAS [AquAdvantage salmon] is highly susceptible to ISAV [infectious salmon anemia virus]”.((Office of Aquatic Biotechnology of the Department of Fisheries and Oceans Canada (2013). Environmental and indirect human health risk assessment of Aquadvantage® salmon (draft in revision). (Protected B). 2 Jul. https://downloads.regulations.gov/FDA-2015-P-1094-0043/attachment_2.pdf))

A 2021 assessment by Fisheries and Oceans Canada noted increased presence of inflammation and jaw erosions in the diploid AquAdvantage salmon, as well as gill, fin, and heart abnormalities and signs of liver damage in the triploid salmon. The assessment also expressed concern about the lack of measures “to ensure that all relevant mechanical barriers are in place and functioning properly”.((Fisheries and Oceans Canada (2021). Environmental and indirect human health risk assessment of the AquAdvantage® salmon. Nov. https://waves-vagues.dfo-mpo.gc.ca/library-bibliotheque/41026998.pdf))

Performance

The 2013 report by the Office of Aquatic Biotechnology, Dept of Fisheries and Oceans Canada said “there appears to be noteworthy variation in growth rate” of AquAdvantage salmon between different generations and environmental conditions.((Office of Aquatic Biotechnology of the Department of Fisheries and Oceans Canada (2013). Environmental and indirect human health risk assessment of Aquadvantage® salmon (draft in revision). (Protected B). 2 Jul. https://downloads.regulations.gov/FDA-2015-P-1094-0043/attachment_2.pdf))

Fish production

It was always unclear how much transgenic salmon AquaBounty produced.

In 2016, media reports said that barring regulatory or legislative setbacks, the GM salmon would be available at restaurants and grocers in about two years.((Meyer J (2016). GM salmon is just the beginning. Forbes, 6 Jan. https://www.forbes.com/sites/jaredmeyer/2016/01/06/gm-salmon-aquadvantage-aquabounty-benefits-safe )) By 2017 small quantities had reportedly been sold in Canada.((Waltz E (2017). First genetically engineered salmon sold in Canada. Scientific American, 7 Aug. https://www.scientificamerican.com/article/first-genetically-engineered-salmon-sold-in-canada/ )) However, assessing quantities sold has been hindered by a lack of labelling. Based on AquaBounty reports, sales of the unlabelled transgenic salmon into the marketplace were estimated at around 4.5 tonnes.((Canadian Biotechnology Action Network (2017). Tracking GM salmon: Salmon imports from Panama.https://cban.ca/wp-content/uploads/GM-Fish-Imports-from-Panama_media-background-and-summary_Oct-2017.pdf))

In the US, genetically engineered (“bioengineered”) human food – including AquAdvantage salmon – must be labelled.((FDA website. Q&A on FDA’s Approval of AquAdvantage salmon. https://www.fda.gov/animal-veterinary/aquadvantage-salmon/qa-fdas-approval-aquadvantage-salmon )) This should, in theory, help regulators and consumers trace the fish through the human food supply and animal feed chains, though there was never a clear picture of where the relatively small amount of AquAdvantage salmon that was produced was sold.

In 2020 reports said the fish would be ready for sale throughout the US Midwest in October.((Manning L (2020). AquaBounty’s GE salmon is coming to menus in the US Midwest – for real this time. AgFunderNews, 20 Jul. https://agfundernews.com/aquabountys-ge-salmon-is-coming-to-menus-in-the-us-midwest-for-real-this-time))

That year, in a bid to raise $9.2 million from investors, the company announced that its new goal was to produce 50,000 tonnes of transgenic salmon per year by 2027. However, the Fish Site noted, “The company has a long way to go – its current locations in Prince Edward Island and Indiana have the capacity to produce 250 tonnes and 1,200 tonnes respectively” per year. 

By May 2021 the company said it had received purchase orders for five tonnes of GM salmon.((Sapin R (2021). First batch of US-grown GM farmed salmon already sold out. IntraFish, 10 May. https://www.intrafish.com/aquaculture/first-batch-of-us-grown-gm-farmed-salmon-already-sold-out/2-1-1008514 ))

In 2022 AquaBounty reported making $783,000 on harvested salmon, but only $340,900 of this was from transgenic salmon.((Fish Farming Expert (2022). AquaBounty sold salmon worth $783,000 last year. 10 Mar. https://www.fishfarmingexpert.com/aquabounty-ge-salmon-q4-and-full-year-results/aquabounty-sold-salmon-worth-783000-last-year/1151439)) As a comparison, the North American salmon market in 2022 was worth USD 6.3 billion.((Global Market Insights (2023). Salmon fish market size. Oct. https://www.gminsights.com/industry-analysis/salmon-fish-market))

A 2023 press report suggested AquaBounty’s GM salmon production was about 1,200 tonnes a year.((Hein T (2023). AquaBounty GE Atlantic salmon: the update. Aquaculture North America, 5 Jul. https://www.aquaculturenorthamerica.com/aquabounty-ge-atlantic-salmon-the-update )) This represents a tiny proportion of the salmon the US consumes annually – 420,000 tonnes of the processed product((Globe Newswire (2023). Global salmon market to reach valuation of US$ 32,118.7 million by 2031: Astute Analytica. 20 Mar. https://www.globenewswire.com/news-release/2023/03/20/2630275/0/en/Global-Salmon-Market-to-Reach-Valuation-of-US-32-118-7-Million-by-2031-Astute-Analytica.html)) or 600,000 tonnes of “whole fish equivalent” (weight of the fish as caught, before processing).((MOWI (2022). Salmon Farming Industry Handbook 2022. https://mowi.com/wp-content/uploads/2022/07/2022-Salmon-Industry-Handbook-1.pdf ; see also: Salmon Business (2022). Salmon sales jump 120 percent over nine-year period. 1 Jul. https://www.salmonbusiness.com/salmon-sales-jump-120-percent-over-nine-year-period/ )) In 2022 top North American producers Cooke Aquaculture and Mowi respectively produced 58,000 and 41,000 tonnes of farmed conventional salmon.((MOWI (2023). Salmon Farming Industry Handbook 2023. https://mowi.com/wp-content/uploads/2023/06/2023-Salmon-Farming-Industry-Handbook-2023.pdf ))

AquaBounty’s ambition to produce 50,000 tonnes of transgenic salmon annually by 2027 must be set against the 91 tonnes it produced in 2022 and its reported 1,200 tonnes in 2023.

No consumers = no market

From the first hint that the salmon would be approved, surveys of US consumers showed rejection of the product. A 2010 poll showed 78% of consumers felt the FDA should not approve it.((Lake Research Partners (2010). Americans in near unanimity in their disapproval of genetically engineered fish and meat in the marketplace. Press release. 20 Sept. https://www.centerforfoodsafety.org/files/lrp_fish_survey_02364.pdf )) In a 2013 poll, 77% of respondents said they would refuse to eat the GM salmon if given a choice and 73% said the FDA should require independent safety testing of the salmon.((O’Halloran H (2013). Consumers not interested in genetically modified salmon. Food Engineering, 23 Apr. https://www.foodengineeringmag.com/articles/90611-consumers-not-interested-in-genetically-modified-salmon )) The same year, a poll for the New York Times found 93% wanted GM foods labelled and 75% said they would not eat GM fish.((Kopicki A (2013) Strong support for labeling modified foods. New York Times, 27 Jul. https://www.nytimes.com/2013/07/28/science/strong-support-for-labeling-modified-foods.html ))

Food service suppliers reflected customer preferences in refusing to stock GM salmon. In 2021 US food service supplier Aramark confirmed its boycott of GM salmon,((Salmon Business (2021). Food service giant Aramark says it won’t buy genetically engineered salmon. 5 Feb. https://www.salmonbusiness.com/food-service-giant-aramark-says-it-wont-buy-genetically-engineered-salmon/ )) joining a long list of food service providers, retailers, seafood companies, and restaurants in rejecting the salmon. In all, more than 80 US companies with a combined 18,000 locations said they would not stock the GM fish.((Friends of the Earth website. Company commitments on GMO salmon. https://foe.org/company-commitments-on-gmo-salmon/))

In May 2022 AquaBounty confirmed it was working with only one restaurant distributor.((Tradex (2022). Where is AquaBounty selling their genetically modified salmon? 1 Aug. https://www.tradexfoods.com/3mmi/2022/08-01-where-is-aquabounty-selling-their-genetically-modified-salmon )) But by August 2022 the distributor had “decided to wait until the product was successfully introduced in the marketplace”.((Tradex (2022). Where is AquaBounty selling their genetically modified salmon? 1 Aug. https://www.tradexfoods.com/3mmi/2022/08-01-where-is-aquabounty-selling-their-genetically-modified-salmon ))

Companies

AquaBounty Technologies, incorporated in 1991 as A/F Protein,((AquaBounty (2024). Investor FAQ. https://investors.aquabounty.com/investor-faq  Accessed 3 Apr 2024.)) marketed the GM AquaAdvantage salmon. In 2013 Intrexon acquired majority ownership of AquaBounty.((Bunge J (2015). Firm bets on biotech that changes how food is produced. Wall Street Journal, 15 Dec. https://www.wsj.com/articles/firm-bets-on-biotech-that-changes-how-food-is-produced-1450220986)) In 2019 Intrexon sold AquaBounty to TS Aquaculture, LLC, managed by Third Security, LLC, led by former Intrexon chairman and CEO Randal J. Kirk.((Seeking Alpha (2019). Intrexon sells AquaBounty stake to CEO-affiliated aquaculture business. 31 Oct. https://seekingalpha.com/news/3512527-intrexon-sells-aquabounty-stake-to-ceo-affiliated-aquaculture-business)) In December 2024 AquaBounty closed its last working facility, in Prince Edward Island.((AquaBounty (2024). AquaBounty Announces Plans to Cease Fish Farming Operations. 11 Dec. https://investors.aquabounty.com/news-releases/news-release-details/aquabounty-announces-plans-cease-fish-farming-operations))

Patents 

A patent on a GM gene construct for production of transgenic fish engineered to express a growth hormone gene sequence under control of a promoter from ocean pout (among other fish) was filed at the European Patent Office in 1992, granted in 2001, and has since expired. The applicants were Ontario-based HSC Research and Development Partnership and Seabright Corp Ltd.((Lens.org. https://www.lens.org/lens/patent/126-558-608-750-283/frontpage?l=en)) By this time, Seabright had been renamed Genesis Group, Inc.((Euractiv (2001). First genetically modified fish patented in EU. 11 Sept. https://www.euractiv.com/section/agriculture-food/news/first-genetically-modified-fish-patented-in-eu/ )) The same applicants filed a patent on transgenic salmon expressing a growth hormone gene linked to an antifreeze protein promoter in 1994. It was granted in 1996 and has since expired.((Lens.org. https://www.lens.org/lens/patent/025-061-195-340-079/frontpage?l=en))

In 2014 AquaBounty licensed “the technology covering genetically modified salmonid fish that express endogenous growth hormone under the control of an anti-freeze protein gene promoter from an edible fish” from HSC and Genesis for CAN$150,000 (US$140,235). The agreement replaced a previous one between the same parties.((US Securities and Exchange Commission (2014). Intellectual property licence and full and final release. https://www.sec.gov/Archives/edgar/data/1603978/000119312516760799/d275549dex1019.htm ; US SEC (2014). General form for registration and securities. https://investors.aquabounty.com/static-files/1a53ddf8-ad74-4dbd-9ce3-9f5f10e27095 ))

In 2015 AquaBounty applied for a patent on maternally induced sterility in animals, including fish. The patent was granted in 2019 and is active in the US,((Lens.org. https://www.lens.org/lens/patent/099-463-732-605-332/frontpage?l=en )) Canada,((Lens.org. https://www.lens.org/lens/patent/074-764-319-821-367/frontpage?l=en)) Australia,((Lens.org. https://www.lens.org/lens/patent/169-320-659-740-093/frontpage?l=en)) Brazil,((Lens.org. https://www.lens.org/lens/patent/111-753-303-132-758/frontpage?l=en)) and Korea, ((Lens.org. https://www.lens.org/lens/patent/133-879-028-134-602/frontpage?l=en)) as well as other jurisdictions named in the patent filings. It is discontinued at the European Patent Office.((Lens.org. https://www.lens.org/lens/patent/102-543-153-195-355/frontpage?l=en)) A World Intellectual Property Office filing is pending.((Lens.org. https://www.lens.org/lens/patent/109-633-777-092-550/frontpage?l=en ))

Author: Pat Thomas. Contribution to section, “Animal welfare issues”: Claire Robinson. Editing: Claire Robinson, Franziska Achterberg. Scientific review: Prof Michael Antoniou.

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