Eugene H. Buck Specialist in Natural Resources Policy
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
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
Date of Report: February 20, 2013
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