Eugene H. Buck
Specialist in Natural Resources Policy
In the process of congressional oversight of executive agency regulatory action, concerns have been raised about the adequacy of the FDA’s review of a genetically modified (GM) salmon. More specifically, concern has focused on whether and how potential environmental issues related to this GM salmon might be addressed. In response to these concerns, several bills were introduced in the 112th Congress seeking to declare GM fish unsafe and thus prevent FDA approval of this salmon for human consumption or to require that GM fish be specifically labeled. No final action was taken on these bills by the 112th Congress.
Genetic engineering techniques allow the manipulation of inherited traits to modify and improve organisms. Several GM fish and seafood products are currently under development and offer potential benefits such as increasing aquaculture productivity and improving human health. However, some are concerned that, in this rapidly evolving field, current technological and regulatory safeguards are inadequate to protect the environment and ensure public acceptance that these products are safe for consumption. (The safety of GM foods for human consumption is not addressed in this report.)
In the early 2000s, several efforts began to develop GM fish and seafood products, with a GM AquAdvantage salmon developed by AquaBounty, Inc., in the forefront of efforts to produce a new product for human consumption. By September 2010, requested data had been provided to the U.S. Food and Drug Administration (FDA) by AquaBounty, and FDA’s Veterinary Medicine Advisory Committee held public hearings on the approval of AquAdvantage salmon for human consumption. The public comment period on FDA approval closed on November 22, 2010.
Environmental concerns related to the development of GM fish include the potential for detrimental competition with wild fish, and possible interbreeding with wild fish so as to allow the modified genetic material to escape into the wild fish population. Sterilization and bioconfinement have been proposed as means of isolating GM fish to minimize harm to wild fish populations. To address these concerns, AquaBounty proposed producing salmon eggs (all sterile females) in Canada, shipping these eggs to Panama, growing and processing fish in Panama, and shipping table-ready, processed fish to the United States for retail sale.
On December 20, 2012, FDA announced the availability for public comment of (1) a draft environmental assessment of the proposed conditions specified by AquaBounty and (2) FDA’s preliminary finding of no significant impact (FONSI) for AquaBounty’s conditions. A 60-day public comment period initially ran through February 25, 2013, but was extended through April 26, 2013. If significant new information or challenges arise in the public comments, FDA must decide whether or not a full environmental impact statement is required prior to approval of AquaBounty’s application. If approved, AquAdvantage salmon would be the first GM animal approved for human consumption.
Date of Report: February 20, 2013
Number of Pages: 12
Order Number: R41486
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