AquaAdvantage Salmon Lisa Danielson

Outline Introduction Explanations Significance Research Question Methodology My approach Literature Review Problems and Questions

The AquaAdvantage Salmon What is it? Atlantic salmon modified with a growth hormone adapted from the Chinook Salmon and an anti-freeze gene adapted from Sea Pout. + Why? The salmon grows twice as fast as regular Atlantic salmon and can be raised in colder waters.

Why talk about this now? The FDA is currently deciding if the AquaBounty can sell the eggs to fish farmers The Panel discussion started on Sept 19 th and was supposed to last for 3 days but has been prolonged. They are discussing the proposals science based issues, such as environmental impacts and possible health concerns Upstream research: examining the issue while it is being approved Initial media frenzy

Something Fishy ? Substantial equivalence : The concept a novel food ( such as a GMO food) should be considered to be equivalent and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food  If a novel food is substantially equivalent to its conventional counterpart, then it can be encompassed in existing regulatory frameworks Policy for regulating the Salmon will be the same as used for veterinary drugs “AquAdvantage® Salon are regulated by the Center for Veterinary Medicine under the Food, Drug and Cosmetics Act. As far back as 1986, the U.S. Food and Drug Administration (FDA) asserted jurisdiction over genetically engineered animals and fish on the grounds that the transgene and any expressed proteins, affect the “structure and function” of the receiving animal analogous to the modalities of veterinary drug formulations. FDA jurisdiction has been upheld by the federal courts.” ( Fish eggs are going to manufactured in Canada (in the PEI facility) and then the fish will be grown in Panama before they are shipped to the US

Why Do We Care? This is the first genetically altered animal up for approval for human consumption. This policy decision will set a precedent. For Canadians: Aquqculture is a huge industry in Canada  we produce 110 tons of farmed salmon a year. Questions of Canadian policy - Will health Canada follow the FDA’s decision? Canadian involvement: the technology is manufactured in PEI but we are not benefiting from it. For you: If this approval goes through GM salmon will probably not be labeled, meaning it could very easily end up on your plate. Is that acceptable?

My Question Given the scales of impact of the approval of this product, is current regulatory procedures in the US adequately equipped to make this decision?

My Approach 1.A Normative Analysis of the Technology What are the environmental impacts? What are the health risks? What are the socioeconomic concerns? What are the ethical implications?

Evaluation of the regulatory process Does the FDA’s process meet these concerns? Public involvement and transparency (the labeling dispute) Potential comparison with Canada

Democratic survey Does the regulation process reflect peoples opinions? Potential survey opportunity What is shaping public opinion? Is it well informed?

Literature Review Ethical and Social Concerns: Dawkins, Rollin Policy of Risk and Regulation: Hoberg, Harrison Existing reviews of risk associated with transgenic salmon: Factors to consider before production and commercialization of aquatic genetically modified organisms: the case of transgenic salmon: Le Curieux-Belfond,Olivier; Vandelac,Louise; Caron,Joseph; Séralini,Gilles- ÉricSource: Environ.Sci.& Policy, 2009, 12, 2, Democratic concerns and public perception: newspaper articles, Atwood FDA meeting material : ls/VeterinaryMedicineAdvisoryCommittee/ucm htm

Some Hunches -The potential benefits of this technology outweigh the risks -With that said - Current regulatory process lack transparency -Policy needs to be redone to fit this novel technology. Placing into a category it does not belong does not adequately deal with the issue - A problem of public knowledge and perception

Obstacles A very current topic = a lack of literature? Too broad an approach Is a Canada / US comparison useful? More focus on Canada? Should the EU be involved? I have not addressed the issue that there is no regulatory cohesion No personal science background Questions and Suggestions are greatly appreciated!