AquAdvantage salmon

AquAdvantage salmon is a genetically engineered (GE) Atlantic salmon developed by AquaBounty Technologies in 1989. The typical growth hormone-regulating gene in the Atlantic salmon was replaced with the growth hormone-regulating gene from Pacific Chinook salmon, with a promoter sequence from ocean pout. This gene enables the GM salmon to grow year-round instead of only during spring and summer.[1]

Wild-type Atlantic salmon (Salmo salar)

These GE salmon are a commercially competitive alternative to wild-caught salmon and to fish farming of unmodified salmon. The purpose of the modifications is to increase the speed at which the fish grows without affecting its ultimate size or other qualities. Fish-farmed Atlantic salmon growth rates have already been improved over wild fish as a result of traditional selective breeding practices. However, GM fish are able to grow even faster and grow to market size in just 16 to 18 months rather than three years.[2]

Significance

AquAdvantage salmon are the first genetically engineered animals approved for human consumption in the United States and Canada.[3] [4] This approval has been subject to much controversy. [5]

Genetic modification

AquAdvantage salmon were developed in 1989 by the addition of a single copy of the opAFP-GHc2 construct, which consists of a promoter sequence from ocean pout directing production of a growth hormone protein using the coding sequence from Chinook salmon.[6]:vii, 8 The continuous expression of this transgene allows the fish to grow all year-round instead of only during spring and summer.[7] The stability of the new DNA construct was tested, revealing no additional mutational effects during insertion other than the two desired genes.[1] These GM fish were back-crossed (a two generation breeding protocol that starts by generating a hybrid offspring between two inbred strains, one of them carrying the mutation of interest) to wild-type Atlantic salmon, and the genetically modified EO-1ɑ gene sequence was identical in the second through fourth generations, indicating that the insertion is stable.[1]

While wild Atlantic salmon (Salmo salar) have two sets of chromosomes, raised AquaAdvantage salmon have three sets (i.e. are triploid). Induction of triploidy by treatment of eggs renders the fish sterile, reducing the risk of interbreeding with wild-type fish if any of the genetically modified fish were introduced into the wild.[8]

Concerns
See also: Genetically modified fish (AquAdvantage salmon) and Genetically modified food controversies

There are three main concerns regarding the approval of GE salmon: consumption of these fish could be harmful, there could be unintended consequences of the gene alteration, and non-sterile fish could escape and intermingle with the wild population. Risks assessments have been conducted to determine the health and safety of this technology and a number of preventatives have been implemented to prevent the release of these fish into the wild.

Ethical

Proponents of natural ethics consider genetically engineered salmon to be "unnatural" and thus unethical. However, as the global human population continues to grow, new and innovative methods will be required to ensure adequate food supply. The fast-growing genetically engineered AquAdvantage salmon could be considered ethical under utilitarian ethics as a means to feed a large number of people.

Human health risk assessment

Fish are one of the eight food types that the Food and Drug Administration (FDA) is required, by law, to treat with special care, with regard to allergies.[6]:97 As part of the regulatory process, the FDA required data on whether changes occur in the kinds or levels of fish allergens (such as parvalbumin) in AquAdvantage. The FDA has upheld that people with allergies to Atlantic Salmon will likely be allergic to AquAdvantage Salmon due to the similar species properties, but not because it is genetically engineered[9] and that AquAdvantage Salmon is as safe to eat as non-GE salmon because there are no significant food safety hazards associated with AquAdvantage.[10] Other human health concerns arise due to the increased hormone content in the edible tissue of transgenic fish.[11] The AquAdvantage salmon showed a statistical difference in the concentration of an insulin-like growth factor, yet the amount of (IGF-1) found in AquAdvantage salmon is similar to, or lower than, other amounts found in other common animal products such as organic cow milk.[8]

Off-target effects of gene editing

A concern with genetic engineering is that another gene other than the one intended may also be accidentally edited. [5] The genome sequence of the AquAdvantage salmon has been analyzed and no off-target effects or changes in other genes have been detected. [8]

Precautionary containment procedures
Further information: Aquaculture

Critics raised concerns about potential environmental impacts if these fish reached the rivers or oceans. Modeled invasion scenarios in semi-natural environments suggest that GM salmon would out compete wild-type salmon.[12][13] To address concerns about biological containment, the FDA requires AquaBounty to take precautionary measures to ensure that transgenic fish do not mix with the wild population. Aquaculture that uses conventionally bred salmon, mostly Atlantic salmon, cultivates the fish in net pens. In North America, this occurs mostly in coastal waters off Washington, British Columbia, and Maine. However, the application for FDA approval of AquAdvantage salmon specified land-based tank cultivation with no ocean involvement.[11] AquaBounty also altered the fish to be only female and sterile. Male fish are created only for egg-producing service, and are kept in secure, land-based facilities in Canada. These eggs are then shipped to a land-based aquaculture facility at high altitude in Panama near a river that drains into the Pacific Ocean.[14] If eggs were to escape this facility, they would be unable to survive in the high salinity water nearby.[9]

In order to make the fish sterile AquAdvantage salmon eggs are treated with pressure, to create batches of fish eggs with three copies of each chromosome (triploid) rather than to two copies (diploid). Any batch that contains 5 percent or more diploid fish, is destroyed because these diploid fish are capable of reproducing.[8]

Government regulation

United States

In September 2010, an FDA advisory panel indicated that the fish is "highly unlikely to cause any significant effects on the environment" and that it is "as safe as food from conventional Atlantic salmon"[6][15] In October 2010, 39 lawmakers asked the FDA to reject the application. Other groups requested that the fish carry a label identifying its transgenic origin.[15] Concerns included alleged flaws in sterilization and isolation, and excessive antibiotic use.[16]

On 25 December 2012, the FDA published a draft environmental assessment for AquAdvantage salmon.[7] The FDA also published a preliminary Finding of No Significant Impact.[17] A 60-day period for the public to comment was to elapse before the FDA reviewed Aquadvantage salmon again, which was arbitrarily extended until May 2013.[18][19]

The Food and Drug Administration (FDA) approved AquaBounty Technologies' application to sell the AquAdvantage salmon to U.S. consumers on November 19, 2015.[20] However, a rider to a spending bill signed into law on December 18, 2015 by President Obama bans its import until the FDA mandates labels for the genetically modified product.[21][22] The decision marks the first time a genetically modified animal has been approved to enter the United States food supply. The decision came nearly twenty years after the company first submitted data to the FDA, and after they had raised ten generations of the animals.[16] The announcement released by the FDA states: "AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious."[23][24] One month later, language was introduced into a proposed federal spending bill requiring consumer notification that the fish is genetically modified.[25] In October, 2018, AquaAdvantage salmon was not being sold in the US and the import of the salmon eggs from Canada to be raised at an AquaAdvantage fish farm in Indiana was prohibited by FDA.[26] However, on March 8, 2019, the import alert issued previously by the FDA was deactivated, and AquAdvantage salmon may now be sold in the U.S. and the salmon eggs may now be imported to the Indiana facility.[27]

On November 5 2020 the United States District Court for the Northern District of California granted a motion to force the FDA to reconsider its approval of AquAdvantage, holding that the FDA had failed to follow its own procedures by ignoring some environmental consequences of these fish.[28][29][30]

Canada

On 25 November 2013, Environment Canada approved the product for salmon egg production for commercial purposes in Canada.[31] In May 2016, the Canadian Food Inspection Agency approved the sale of the GM fish.[32] In July 2017, AquaBounty Technologies said they had sold 4.5 tons of AquaAdvantage salmon fillets to customers in Canada.

Notes
  1. Yaskowiak, ES; Shears, MA; Agarwal-Mawal, A; Fletcher, GL (August 2006). "Characterization and multi-generational stability of the growth hormone transgene (EO-1alpha) responsible for enhanced growth rates in Atlantic Salmon". Transgenic Research. Springer. 15 (4): 465–480. doi:10.1007/s11248-006-0020-5. PMID 16906447. S2CID 22247493.
  2. Blumenthal, Les (August 2, 2010). "Company says FDA is nearing decision on genetically engineered Atlantic salmon". The Washington Post. Retrieved 2 August 2010.
  3. "FDA Import Alert 99-40 "GENETICALLY ENGINEERED (GE) SALMON"". FDA. 2016-01-29. Archived from the original on 2016-01-31.
  4. Goldenberg, Suzanne; correspondent, US environment (2013-11-25). "Canada approves production of GM salmon eggs on commercial scale". The Guardian. ISSN 0261-3077. Retrieved 2019-05-03.
  5. Reardon, Sarah (28 December 2012). "Approval for gene-modified salmon spawns controversy". New Scientist. Retrieved 2 January 2013.
  6. FDA 2010.
  7. FDA & December 2012.
  8. Bodnar A (October 2010). "Risk Assessment and Mitigation of AquAdvantage Salmon" (PDF). ISB News Report.
  9. Bodnar A (October 2010). "Risk Assessment and Mitigation of AquAdvantage Salmon" (PDF). ISB News Report.
  10. "FDA Has Determined That the AquAdvantage Salmon is as Safe to Eat as Non-GE Salmon". U.S. Food & Drug Administration. 2015-11-19. Archived from the original on 2015-11-19. Retrieved 2018-02-09.
  11. von Mogel, Karl Haro (24 April 2013). "Interview with Ron Stotish at BIO". biofortified.org.
  12. Sundström & Devlin 2010, pp. 447–460.
  13. Moreau, Conway & Fleming 2011, pp. 736–748.
  14. Bodnar A (October 2010). "Risk Assessment and Mitigation of AquAdvantage Salmon" (PDF). ISB News Report.
  15. Mundy, Alicia; Tomson, Bill (1 October 2010). "Industry Fights Altered Salmon". The Wall Street Journal. Retrieved 5 November 2016.
  16. Naik, Gautam (September 21, 2010). "Gene-Altered Fish Closer to Approval". The Wall Street Journal.
  17. FDA & May 2012.
  18. Federal Register 2012.
  19. Reardon, Sarah (28 December 2012). "Approval for gene-modified salmon spawns controversy". New Scientist. Retrieved 2 January 2013.
  20. "FDA Has Determined That the AquAdvantage Salmon is as Safe to Eat as Non-GE Salmon". U.S. Food & Drug Administration. 2015-11-19. Archived from the original on 2015-11-19. Retrieved 2018-02-09.
  21. Dennis, Brady (2016-01-29). "FDA bans imports of genetically engineered salmon — for now". Washington Post. Archived from the original on 2016-01-29. Retrieved 2016-04-09.
  22. "FDA Import Alert 99-40 "GENETICALLY ENGINEERED (GE) SALMON"". FDA. 2016-01-29. Archived from the original on 2016-01-31.
  23. "FDA Has Determined That the AquAdvantage Salmon is as Safe to Eat as Non-GE Salmon". FDA. 2015-11-19. Archived from the original on 2015-11-19.
  24. Steenhuysen, Julie; Polansek, Tom (2015-11-19). "U.S. clears genetically modified salmon for human consumption". Reuters. Reuters. Archived from the original on 2015-12-08. Retrieved 2016-04-09.
  25. Dennis, Brady (17 December 2015). "FDA must develop plan to label genetically engineered salmon, Congress says". The Washington Post. The Washington Post. Retrieved 6 April 2016.
  26. Blank, C (2018-08-08). "AquaBounty sells GMO salmon as losses mount". Seafood Source. Archived from the original on 2018-12-04.
  27. "Questions and Answers on FDA's Deactivation of an Import Alert for Genetically Engineered Salmon". U.S. Food and Drug Administration. FDA. Retrieved 12 June 2020.
  28. Nosowitz, Dan (5 November 2020). "Court Nixes FDA's Approval of Genetically Engineered Salmon". Modern Farmer.
  29. "Federal Court Declares Genetically Engineered Salmon Unlawful". Center for Food Safety. Retrieved 2020-11-10.
  30. "ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT; GRANTING IN PART AND DENYING IN PART DEFENDANTS' CROSS-MOTION FOR SUMMARY JUDGMENT Re: Dkt. Nos. 244, 254 Case 3:16-cv-01574-VC Document 285 Filed 11/05/20 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA INSTITUTE FOR FISHERIES RESOURCES, et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants" (PDF). Center for Food Safety. Retrieved 2020-11-10.
  31. Goldenberg, Suzanne; correspondent, US environment (2013-11-25). "Canada approves production of GM salmon eggs on commercial scale". The Guardian. ISSN 0261-3077. Retrieved 2019-05-03.
  32. "Canada Approves Sale of Genetically Modified Salmon". Democracy Now. 2016-05-20. Archived from the original on 2016-05-21.

References
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