The United States (US) Food and Drug Administration (FDA) finally allows sale of fast-growing genetically engineered AquAdvantage salmon. Many people are asking about the impacts of the fish on human health and the environment. We have answers to these questions thanks to two independent sets of regulatory processes, one in Canada and one in the United States. This AquAdvantage Regulatory Timeline Infographic displays some of the key steps in the regulatory process.
Find information about safety of the fish for human health and for the environment in Fast-growing genetically engineered salmon approved.
Detailed AquAdvantage Regulatory Timeline
Detailed information for the AquAdvantage Regulatory Timeline Infographic can be found below. Parts of the timeline are adapted from Chronology of AquAdvantage® Salmon and AquaBounty Technologies.
- 1989 – Initial development of fast-growing genetically engineered salmon begins.
- 1992 – AquaBounty establishes the AquAdvantage salmon (AAS) line.
- 1995 – AquaBounty starts an Investigational New Animal Drug file with FDA’s Center for Veterinary Medicine to pursue development of AquAdvantage salmon.
- 2003 – AquaBounty submits its first regulatory study for a New Animal Drug Application to the FDA.
- 2008 – The FDA inspects AquaBounty’s hatchery in Prince Edwards Island as an authorized production site for AAS eggs, and has no adverse findings. AquaBounty begins construction of a land-based aquaculture facility in Panama.
- 2009 – AquaBounty Technologies submits its final regulatory study to the FDA. The FDA releases Guidance 187 for evaluation of genetically engineered animals. The FDA inspects the Panama facility for production of AAS for import into the US, and has no adverse findings.
- 2010 – AquaBounty receives section complete letters from the FDA on all seven parts of the New Animal Drug Application. The FDA convenes a public meeting of the Veterinary Medicine Advisory Committee to review its findings. They conclude the genetically engineered salmon is indistinguishable from Atlantic salmon, is safe to eat, and that it poses no threat to the environment under its conditions of use. FDA also holds a public hearing about GMO salmon, accepts comments, then responds to public comments.
- 2011 – The FDA consults with the National Marine Fisheries Service and the US Fish and Wildlife Service. Both agencies concur that AAS does not pose a threat to the environment. Environmental groups submit a petition to the FDA asking them to slow or stop approval of GMO salmon (which FDA subsequently rejects).
- 2012 – The FDA releases a draft Environmental Assessment with a preliminary Finding of No Significant Impact. A 60-day public commentary period, later extended to 120 days, begins. The FDA inspects AquaBounty’s hatchery in Prince Edwards Island, and has no adverse findings. AquaBounty submits a request to Canadian regulatory agencies to sell AAS.
- 2013 – The public comment period on the draft Environmental Assessment concludes in April, and FDA responds to public comments. The Canadian Science Advisory Secretariat (CSAS) releases their Environmental and Indirect Human Health Risk Assessment, which determines that AAS does not pose a risk to the environment. Environment Canada authorizes AquaBounty to produce AAS eggs for commercial sale.
- 2014 – AquBounty submits labels to the FDA for review.
- 2015 – FDA determines that Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” does not apply to fast-growing genetically engineered salmon. Environmental groups submit a petition to the FDA asking them to deem genetically engineered salmon an unsafe food additive (which FDA subsequently rejects). FDA approves AquBounty’s New Animal Drug Application and labels, with conditions on where and how the salmon may be raised. FDA also issued guidance on labeling genetically engineered salmon.
- 2016 – Health Canada approves AAS for use as a human food. The Canadian Food Inspection Agency determines that AAS may be used in livestock feed. The FDA issued an import alert that “prevented the introduction or delivery for introduction into interstate commerce of food containing GE salmon, including their eggs.” This blocks AquaBounty from commercializing AAS in the US.
- 2017 – AquaBounty submits a Supplemental New Animal Drug Application for a new rearing facility in Indiana. AquaBounty announces they sold 5 tons of AAS filets in Canada. The Organisation for Economic Co-operation and Development (OECD) publishes a Consensus Document on the Biology of Atlantic Salmon, which provides background information about Atlantic salmon that might be useful in regulatory assessments.
- 2018 – FDA approves AquaBounty’s supplemental application, releasing an updated approval letter, appendix with conditions, a Supplemental Environmental Assessment, and a Supplemental Finding of No Significant Impact. AquaBounty announces they sold 5 tons of AAS filets in Canada.
- 2019 – In response to new regulations about Bioengineered Labels, FDA revises its draft guidance on labeling genetically genetically engineered salmon to state that labeling will not be required, but that they support voluntary labeling (GM food labeling is also not required in Canada, unless the food has a significant nutritional change or a health risk). FDA deactivates the import alert they issued in 2016. Finally, AquaBounty may sell the previously-approved genetically engineered salmon in the US, import eggs from their Canadian facility, and raise AAS in their FDA-approved, land-based facility in Indiana.
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- Citation: Anastasia Bodnar. AquAdvantage Salmon Regulatory Timeline. Version 1.0. Biology Fortified, Inc. Mar 12, 2019.
- Permissions: Biology Fortified is making this infographic available under a Creative Commons Attribution-NonCommercial-NoDerivatives License. Everyone may download, republish, and use this infographic in its original form for non-profit educational use. Please attribute us when you use this infographic, link back to this page whenever possible, and do not modify the infographic without permission from Biology Fortified.
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