THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
FDA’s Approval of GE AquAdvantage Salmon Disregards Precautionary Principle
AquAdvantage is the genetically engineered (GE) salmon produced by AquaBounty Technologies, Inc. The company added a growth hormone into the genetic makeup of Atlantic salmon in order to accelerate the growth period from three years to a swift eighteen months. The AquAdvantage salmon also averages a final weight of 6,000 grams, almost a third heavier than a wild Atlantic salmon. The already endangered salmon population, however, faces the risk of the dominant AquAdvantage salmon compromising the Atlantic salmon’s chance for survival.
The US Food and Drug Administration (FDA) approved the GE salmon by classifying AquAdvantage as a “new animal drug” and granted the use of AquAdvantage salmon for sale in the US in November 2015. Environmental advocates have filed legal action to repeal the ruling. AquAdvantage salmon has entered the production phase and will be ready for sale in grocery stores by the end of 2017.
A legal Note seeks to address the issues concerning the FDA’s approval of GE salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. It highlights that the FDA has not been able to absolutely guarantee that AquAdvantage salmon are safe to eat, and that severe environmental degradation is likely to result from poor review of such a product.
The Note cites the salmon case study as a disturbing example of the key weakness of the FDA’s approach, but also serves as a great example of the strengths of the precautionary approach. It states that public interest and the environment would be better served by a policy shift and the granting of jurisdictional authority to a more qualified agency, with the expertise to determine safety of GE animal products, than the FDA.
The Note concludes that AquaBounty does not present a solution to address the underlying problem of species extinction caused by unsustainable fishing methods and overfishing. Effort ought to instead be spent preserving the natural salmon resource. It recommends that the FDA adhere to the Precautionary Principle to ensure the effects of a new GE product, such as AquAdvantage, are safe for the environment before irreversible damage is caused.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
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SALMON WITH A SIDE OF GENETIC MODIFICATION: THE FDA’S APPROVAL OF AQUADVANTAGE SALMON AND WHY THE PRECAUTIONARY PRINCIPLE IS ESSENTIAL FOR BIOTECHNOLOGY REGULATION
Van Slyck, K. M.
Seattle University Law Review, 41(1), 311
http://digitalcommons.law.seattleu.edu/sulr/vol41/iss1/10/
Abstract
This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison to the European Union’s methods of tackling GE regulation and details why the EU decided to ban AquAdvantage salmon. Part IV offers an analysis of the current issues surrounding the production of AquAdvantage salmon and explores the potential consequences following the FDA ruling. This Note concludes with a suggestion to parallel the U.S. regulatory system to the more succinct and rigorous process the European Union relies on to regulate GE animals, a system that operates under the precautionary principle. This Note will recommend that the FDA adhere to the crucial precautionary principle to ensure the effects of a new GE product, such as AquAdvantage, are safe for the environment before the effects of an unknown product cause irreversible damage.
Conclusion
The salmon case study is a disturbing example of the key weakness of the FDA’s approach but also serves as a great example of the strengths of the precautionary approach. Public interest and the environment would be better served by a policy shift and the granting of jurisdictional authority to a more qualified agency, with the expertise to determine safety of GE animal products, than the FDA. The precautionary principle is not a novel idea to U.S. legislators; by adhering to the millions of people opposing GE salmon and enacting the approach that ensures all foreseeable and reasonable risks have been addressed, we are more likely to have a healthy environment independent of engineered food sources. The purpose of environmental law is to protect natural resources even when uncertainty of the long-term effects exists. The lasting consequences of losing species, damaging habitat, and degrading human health all grossly outweigh the benefits of cheaper production today. AquaBounty does not present a solution to address the underlying problem of species extinction caused by unsustainable fishing methods and overfishing. The efforts being made to skirt around these issues ought to instead be spent preserving the natural salmon resource, while still in existence, and in doing so tackle the root of the problem. What needs to happen now goes beyond bigger and faster-growing fish. The AquAdvantage salmon case becomes another important cause to advocate for, especially in light of a presidential administration dedicated to rollback environmental measures. Failure to act on the approval of AquAdvantage salmon places the United States atop a very slippery slope that descends into a food system completely dependent on lab concoctions and processing plants, all at the risk of a healthy environment. We cannot manufacture an entire ecosystem to compensate for the impending damage caused by allowing genetically engineered salmon now.