Genetically Engineered Fish and Seafood:
Environmental Concerns
Eugene H. Buck
Specialist in Natural Resources Policy
January 29, 2013
Congressional Research Service
7-5700
www.crs.gov
R41486
CRS Report for Congress
Pr
epared for Members and Committees of Congress

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Genetically Engineered Fish and Seafood: Environmental Concerns

Summary
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. The 60-day
public comment period runs through February 25, 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.

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Genetically Engineered Fish and Seafood: Environmental Concerns

Contents
Background ...................................................................................................................................... 1
Environmental Concerns and Control Options ................................................................................ 2
Concerns .................................................................................................................................... 2
Interbreeding with Wild Fish ............................................................................................... 3
Competition with Wild Fish ................................................................................................ 3
Potential Control Options .......................................................................................................... 4
Sterilization ......................................................................................................................... 4
Confinement ........................................................................................................................ 5
Other Possible Benefits and Disadvantages of Genetically Engineered Fish and Seafood ............. 5
Potential Benefits ....................................................................................................................... 5
Disadvantages ............................................................................................................................ 6
Regulation and Recent Action ......................................................................................................... 6
Congressional Interest...................................................................................................................... 8

Contacts
Author Contact Information............................................................................................................. 9
Acknowledgments ........................................................................................................................... 9

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armers and scientists have a history of modifying animals to maximize desirable traits.
Genetic modification is one of the current approaches for modifying animals to increase
F their beneficial traits. In the broadest sense, genetic modification refers to changes in an
organism’s genetic makeup not occurring in nature, including the production of conventional
hybrids. With the advent of modern biotechnology (e.g., genetic engineering or bioengineering),
it is now possible to take the gene (or genes) for a specific trait either from an organism of the
same species or from an entirely different one and transfer it to create an organism having a
unique genetic code. This technique can add both speed and efficiency to the development of new
foods and products. Genetically engineered plant varieties, such as herbicide-resistant corn and
soybeans, have already been widely adopted by U.S. farmers, and some advocate using similar
techniques to produce genetically engineered fish or seafood for the aquaculture industry.
A number of environmental concerns have been raised related to the development of genetically
modified (GM) fish, including 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 the potential for harming wild fish populations.
In the process of congressional oversight of executive agency regulatory action, concerns have
been raised about the adequacy of the U.S. Food and Drug Administration’s review of
applications for approval of GM animals, with respect to the potential for environmental harm.1
In response to these concerns, several bills were introduced in the 112th Congress seeking to
declare GM fish unsafe or require that GM fish be specifically labeled as such. No final action
was taken on these bills in the 112th Congress.
Background
Scientists are seeking ways to genetically engineer fish and other seafood species to introduce or
amplify economically valuable traits. Fish are of particular interest to food researchers since
many fish produce large quantities of eggs; those eggs, being external to the animal (as opposed
to mammals that produce a few eggs internally), make it relatively simple to insert novel DNA.
Research on transgenic strains is currently under development for at least 35 species of fish
worldwide, as well as for a variety of mollusks, crustaceans, plants, and marine microorganisms.2
Fish are being modified to improve the production of human food, to produce pharmaceuticals, to
test water contamination, and for other uses.3
The U.S. Food and Drug Administration (FDA) regulates GM fish under the Federal Food, Drug,
and Cosmetics Act (FFDCA)4 provisions on new animal drugs (21 U.S.C. §321).5 Under these

1 This CRS report does not consider the food safety of GM fish; for background on food safety regulation, see CRS
Report RS22600, The Federal Food Safety System: A Primer, by Renée Johnson.
2 For additional background on genetic engineering in animals, see http://www.cast-science.org/publications/?
the_science_and_regulation_of_food_from_genetically_engineered_animals&show=product&productID=21628.
3 For a list of some of the genetically engineered organisms under research, see Table 2-2 in National Research
Council, Animal Biotechnology: Science-Based Concerns (Washington, DC: National Academies Press, 2002),
http://books.nap.edu/books/0309084393/html/73.html#pagetop.
4 21 U.S.C. §§301 et seq.
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provisions, FDA must keep all information about a pending drug application confidential, with
the exception of information publicly disclosed by the manufacturer. This approach limits the
opportunity for public comment before approval. Some critics are calling for more transparency
in this process and for more authority to be given to environmental and wildlife agencies.6
One GM fish has been marketed to date. Glofish™, a genetically altered version of the popular
aquaria zebrafish (Danio rerio), fluoresce after the insertion of a sea anemone gene into the
zebrafish egg.7 This fish is currently legal to be sold in all states except California. Since
Glofish™ are not meant for human consumption, FDA determined that the Glofish™ was not
under its jurisdiction.8
Another private research company has taken genetic information from Chinook salmon and ocean
pout (an eel-like, edible fish) and inserted this material into Atlantic salmon to create a fish that
grows to market size twice as fast as its non-GM counterparts. This company, AquaBounty
Technologies, Inc., is currently seeking regulatory approval from the FDA to sell its
AquAdvantage salmon for human consumption in the United States9 and received a grant from
the U.S. Department of Agriculture’s National Institute of Food and Agriculture for work on
transgenic tilapia.10 Other examples of GM fish that have been developed, but for which
regulatory approval has not yet been sought, include fish that would produce a blood-clotting
factor to treat individuals with hemophilia11 and disease-resistant channel catfish.12
Environmental Concerns and Control Options
Concerns
In addition to its responsibility for assuring food safety, FDA is charged with assessing the
potential environmental impacts of newly engineered plants and animals. To fully assess these
potential impacts, FDA consults with the Fish and Wildlife Service and the National Marine
Fisheries Service (NOAA Fisheries).13 Despite this consultation, critics question whether FDA

(...continued)
5 For additional background on FDA regulation of genetically engineered animals, see http://www.fda.gov/
ForConsumers/ConsumerUpdates/ucm048106.htm.
6 Union of Concerned Scientists, “Risks of Genetic Engineering,” http://www.ucsusa.org/food_and_agriculture/
science_and_impacts/impacts_genetic_engineering/risks-of-genetic-engineering.html.
7 Yorktown Technologies, L.P., http://www.glofish.com/.
8 For the FDA statement regarding Glofish, see http://www.fda.gov/AnimalVeterinary/NewsEvents/
FDAVeterinarianNewsletter/ucm106233.htm.
9 AquaBounty Technologies, Inc., http://www.aquabounty.com/.
10 See http://www.nifa.usda.gov/newsroom/news/2011news/brag_awards.html.
11 Amitabh Avasthi, “Can Fish Factories Make Cheap Drugs?” New Scientist, vol. 183, no. 2464 (Sept. 11-17, 2004): 8.
12 See Pew Initiative on Food and Biotechnology, “Harvest on the Horizon, Future Uses of Agricultural
Biotechnology,” http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/
hhs_biotech_harvest_report.pdf.
13 21 U.S.C. §2106 requires FDA to consult with NOAA to produce a report on any environmental risks associated with
genetically engineered seafood products, including the impact on wild fish stocks. According to FDA, as of October 6,
2010, this report has not been completed and no target date for completion is specified (http://www.fda.gov/
RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/
(continued...)
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has the mandate and sufficient expertise to identify and protect against all potential ecological
damage that might result from the widespread use of transgenic fish.14
The possible impacts from the escape of GM organisms from aquaculture facilities are of great
concern to some scientists and environmental groups.15 A National Research Council report stated
that transgenic fish pose the “greatest science-based concerns associated with animal
biotechnology, in large part due to the uncertainty inherent in identifying environmental problems
early on and the difficulty of remediation once a problem has been identified.”16
Interbreeding with Wild Fish
Critics and scientists argue that GM fish could breed with wild populations of the same species
and potentially spread undesirable genes. One study postulated a “Trojan gene hypothesis” after
observing that GM Japanese medaka, a fish commonly used as an experimental model, were able
to out-compete nonaltered fish for mates in a laboratory environment. However, the resulting
offspring of this mating between GM fish and wild fish were less fit, lacking certain physical or
behavioral attributes that resulted in the eventual demise of the modified population.17
The ecological risks of stocking GM shellfish in the wild have not yet been thoroughly examined,
since confining and isolating these organisms is more difficult than confinement of many fish
species, due to their methods of reproduction and dispersal.18
Competition with Wild Fish
Even if fast-growing GM fish do not spread their genes among their wild counterparts, critics fear
GM fish could disrupt the ecology of streams by competing with native fish for scarce resources.
Escaped transgenic fish could harm wild fish through increased competition or predation. In
addition, some argue that transgenic fish, especially if modified to improve their ability to
withstand wider ranges of salinity or temperature, could be difficult or impossible to eradicate,
similar to an invasive species. The consequences of such competition would depend on many
factors, including the health of the wild population, the number and specific genetic strain of the
escaped fish, and local environmental conditions. Critics maintain that an indication of the
magnitude of this potential problem may be noted where non-GM Atlantic salmon from nearshore

(...continued)
FoodandDrugAdministrationAmendmentsActof2007/FDAAAImplementationChart/default.htm).
14 See the Center for Food Safety’s “Genetically Engineered Fish,” http://www.centerforfoodsafety.org/geneticall3.cfm.
15 See also Matthew Morgan, “The AquAdvantage Salmon: Who Owns Escaped Genetically Modified Animals?”
Ocean and Coastal Law Journal, v. 17, no. 1 (2011): 127-161.
16 National Research Council, Animal Biotechnology: Science-Based Concerns (Washington, DC: National Academies
Press, 2004), http://books.nap.edu/openbook.php?record_id=10418&page=R1.
17 Richard D. Howard et al., “Transgenic Male Mating Advantage Provides Opportunity for Trojan Gene Effect in a
Fish,” Proceedings of the National Academy of Sciences, vol. 101, no. 9 (March 2, 2004): 2934-2938,
http://www.pnas.org/cgi/reprint/101/9/2934.pdf.
18 Many shellfish, such as oysters, broadcast their eggs and sperm into the water column and have larvae that have a
planktonic or swimming form, making them very difficult to contain in an open water pen.
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net pens in the northwest United States19 and British Columbia20 have escaped and entered
streams, in some cases outnumbering their wild Pacific salmon counterparts.
However, it is not known whether GM fish could survive in the wild in sufficient numbers to
inflict permanent population damage. One study indicated that, when food supplies were low, GM
fish might have the ability to harm a wild population, although the authors caution that laboratory
experiments may not reflect what would happen in the wild.21 Biotechnology proponents argue
that GM fish, if they escape, would be less likely to survive in the wild, especially when they are
reared in protected artificial habitats and have not learned to avoid predators.
Potential Control Options
A number of potential safeguards to address these environmental concerns exist and could be
required.
Sterilization
FDA could require that only sterile GM fish be approved for culture. Fertilized fish eggs that are
subjected to a heat or pressure shock retain an extra set of chromosomes. The resulting triploid
fish do not develop normal sexual characteristics and, in general, the degree of sterility in triploid
females is greater than males.22 Thus, all-female lines of triploid fish are considered to be one of
the best current methods to insure nonbreeding populations of GM fish. Nonetheless, there are
batch-to-batch variations, and it is uncertain whether this method could be effective for all
species; it has not been successful for shrimp, for example.23 Also, critics question whether
escaped triploid fish, which in some species have sufficient sex hormone levels to enable normal
courtship behavior, could mate with wild individuals, lowering reproductive success of the wild
population.24
Other sterilization methods are currently under study, and it is likely that research in this area will
increase options. Critics of GM fish counter that the risks to native fish populations, however
small, may outweigh the potential benefits of this technology, especially where native fish
populations are already threatened or endangered.

19 Washington Dept. of Fish and Wildlife, “Atlantic Salmon in Washington State,” http://wdfw.wa.gov/publications/
pub.php?id=00922.
20 The Alaska Fish and Game Dept. reports statistics on escaped and recovered Atlantic Salmon in Washington State,
British Columbia, and Alaska, http://www.adfg.state.ak.us/special/as/docs/esc_rec87-04.pdf.
21 Robert H. Devlin et al., “Population Effects of Growth Hormone Transgenic Coho Salmon Depend on Food
Availability and Genotype by Environment Interactions,” Proceedings of the National Academy of Sciences, vol. 101,
no. 25, pp. 9303-9308, (June 22,2004), http://www.pnas.org/cgi/content/abstract/101/25/9303.
22 Gary H. Thorgaad and Standish K. Allen, “Environmental Impacts of Inbred, Hybrid and Polyploid Aquatic
Species,” in Dispersal of Living Organisms into Aquatic Ecosystems (Univ. of Maryland Sea Grant, 1992), pp. 281-
288.
23 National Research Council, Bioconfinement of Genetically Engineered Organisms (Washington DC: National
Academies Press 2004), http://books.nap.edu/openbook.php?record_id=10880&page=R1.
24 See Darek T. R. Moreau, Corinne Conway, and Ian A. Fleming, “Reproductive Performance of Alternative Male
Phenotypes of Growth Hormone Transgenic Atlantic Salmon (Salmo salar),” Evolutionary Applications, vol. 4 (2011):
736-748.
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Confinement
To be most effective in reducing ecological risk, the National Research Council report on
Bioconfinement of Genetically Engineered Organisms recommends that each individual species
have its own bioconfinement25 plan. Also, since no single method is likely to be 100% effective,
bioconfinement redundancy significantly increases the likelihood of control, especially if it will
not be combined with physical confinement. Growing GM marine fish in isolated onshore tanks
rather than in offshore or nearshore pens may substantially lower the risk of escape into the
wild.26
Other Possible Benefits and Disadvantages of
Genetically Engineered Fish and Seafood
Potential Benefits
Biotechnology proponents maintain that genetic modification techniques have many advantages
over traditional breeding methods, including faster and more specific selection of beneficial traits.
Because scientists are able to directly select traits they wish to create or amplify, the desired
change can be achieved in very few generations, making it faster and lower in cost than
traditional methods, which may require many generations of selective breeding. Genetic
modification techniques allow scientists to precisely select traits for improvement, enabling them
to create an organism that is not just larger and faster-growing, but potentially improved, for
example, by increasing nutritional content.27 Proponents claim that faster-growing fish could
make fish farming more productive, increasing yields while reducing the amount of feed needed,
which in turn could reduce waste. With intense exploitation of wild fish stocks, GM fish and
seafood could be important means to meet increasing human nutrition needs and address food
security concerns.
Shellfish and finfish, genetically modified to improve disease resistance, could reduce the use of
antibiotics. Increased cold resistance in fish could lead to the ability to grow seafood in
previously inhospitable environments, allowing aquaculture to expand into previously unsuitable
areas. Research efforts are also under way to improve human health by genetically modifying fish
to produce human drugs like a blood clotting factor and to create shellfish that will not provoke
allergic reactions. Biotechnology proponents claim that these advantages could translate into a
number of potential benefits, such as reduced costs to producers, lower prices for consumers for
edible fish and pharmaceuticals, and environmental benefits, such as reduced water pollution
from wastes. Food scientists and the aquaculture industry may support the introduction of genetic

25 Bioconfinement refers to biological methods, such as induced sterilization, used to confine GM organisms and their
transgenes to their designated release setting.
26 A federal biological opinion issued in November 2003 by the Fish and Wildlife Service and National Oceanic and
Atmospheric Administration prohibited the use of GM salmon in open-water net pens pursuant to the Endangered
Species Act; see http://stopgefish.files.wordpress.com/2010/10/corp-bo-full-file.pdf.
27 This point is contested by some who cite research indicating nutritional deficiencies, including decreased omega-3
fatty acid content in cultured salmon fed an artificial diet high in vegetable protein. For example, see
http://www.whfoods.com/genpage.php?tname=george&dbid=96.
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engineering, provided that issues of product safety, environmental concerns, ethics, and
information are satisfactorily addressed.
Disadvantages
On the other hand, while the majority of consumers in the United States appear to have generally
accepted GM food and feed crops,28 it is uncertain whether consumers will be as accepting of GM
fish. Although such fish may taste the same and are expected, like their traditionally bred
counterparts, to be less expensive than wild-caught fish, ethical concerns over the appropriate use
of animals, in addition to environmental concerns, may affect public acceptance of GM fish as
food. Ongoing campaigns by environmental and consumer groups have asked grocers,
restaurants, and distributors to sign a pledge to not sell GM fish products, even if they are
approved by FDA.29
In addition, the commercial fishing industry says that it has successfully educated the public to
discriminate among fish from different sources, such wild and farmed salmon. It is possible that a
publicized escape of GM fish could lead to reduced public acceptance of their wild product.
Environmental and consumer groups are asking that genetically engineered products be specially
labeled. However, industry groups are concerned that such labeling might lead consumers to
believe that their products are unsafe for consumption.30
Regulation and Recent Action
A National Research Council study maintains that there is a low to moderate food safety risk from
GM seafood.31 Since genetic engineering can introduce new protein into a food product, there are
concerns that this technique could introduce a previously unknown allergen into the food supply
or could introduce a known allergen into a “new” food. Within FDA, the Center for Veterinary
Medicine regulates transgenic animals intended for human consumption under the same authority
it uses to regulate new animal drugs.32 In addition, GM fish must adhere to the same standards of
safety under the FFDCA and the FDA’s Center for Food Safety and Applied Nutrition33 that apply
to conventionally bred fish. Under the adulteration provisions in Section 402(a)(1) of the FFDCA,
FDA has the power to remove a food from the market or sanction those marketing the food if that
food poses a risk to public health. This CRS report does not consider the food safety regulation of
GM fish; for background on food safety regulation, see CRS Report RS22600, The Federal Food
Safety System: A Primer, by Renée Johnson.

28 Thomas Hoban, “Trends in Consumer Attitude About Agricultural Biotechnology,” AgBioForum, vol. 1, no. 1
(1998): 3-7, http://www.agbioforum.org/v1n1/v1n1a02-hoban.htm.
29 See the Center for Food Safety’s “Genetically Engineered Fish,” http://www.centerforfoodsafety.org/geneticall3.cfm.
30 See CRS Report RL32809, Agricultural Biotechnology: Background and Recent Issues, by Tadlock Cowan.
31 National Research Council, Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health
Effects, (Washington, DC: National Academies Press, 2004), http://books.nap.edu/openbook.php?record_id=10977&
page=R1.
32 The FDA Center for Veterinary Medicine’s “Questions and Answers about Transgenic Fish,” http://www.fda.gov/
AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm133255.htm.
33 FDA’s Center for Food Safety and Applied Nutrition administers the agency’s seafood inspection program; see
http://www.cfsan.fda.gov/seafood1.html.
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By early 2010, AquaBounty Technologies, Inc., had provided FDA with almost all of the data
required by the agency to consider approving the company’s GM AquAdvantage salmon. The
approval debate has focused on whether GM animals should be allowed, and if so, whether they
should be labeled as such. The question of how to label the food derived from the AquAdvantage
salmon is separate from the decision about whether to approve the new animal drug application.
If the Commissioner determines that the new animal drug meets the approval standard, she “shall
issue an order approving the application.”34 Issues related to the question of whether a food from
the AquAdvantage salmon is misbranded, based on its labeling, are separate. Although FDA is not
required to address these issues prior to the food being marketed, FDA is considering these two
issues simultaneously.35
The AquAdvantage salmon, all sterile females, are proposed to be grown only in isolated
contained facilities, not in ocean pens that have a higher risk of escape into the wild. More
specifically, AquaBounty has proposed producing eggs on Prince Edward Island, Canada,36
shipping these eggs to Panama, growing and processing the fish in Panama, and shipping table-
ready, processed fish to the United States for retail sale. If approved, it could take two to three
years for the AquAdvantage salmon to reach supermarkets.37 As a first step in the approval
process, FDA held public hearings on AquAdvantage salmon by its Veterinary Medicine Advisory
Committee on September 19-21, 2010.38 Although the public comment period on FDA approval
was open through November 22, 2010, there was no deadline for FDA’s decision on
AquaBounty’s application. Meanwhile, critics claimed the convoluted 16-year FDA review
process was scientifically unjustified, and threatened to rob society of both environmental and
economic benefits.39
In an effort to broaden the evaluation of the AquaBounty application, a coalition of environmental
groups called on FDA to prepare an environmental impact statement (EIS) on this action and to
consult with federal agencies about possible threats to endangered wild Atlantic salmon.40
Subsequently, on May 25, 2011, these groups filed a formal citizen petition urging FDA to
withhold approval until an EIS has been completed.41 Some scientists also expressed concern for
a broader evaluation, including pointing out that potential price decreases from technological

34 21 U.S.C. 360b(d)(1).
35 FDA, “Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage
Salmon,” http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm222712.htm.
36 Questions have been raised concerning AquaBounty’s approval by Environment Canada for producing and
transporting the GE salmon eggs. See http://lists.cban.ca/pipermail/cban-e-news/2011-October/000346.html.
37 Andrew Pollack, “Genetically Altered Salmon Get Closer to the Table,” New York Times, June 26, 2010, p. A1.
38 Background documents for this public hearing are available at http://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm201810.htm. See also 75 Federal Register
52602-52605, August 26, 2010.
39 See Alison L. Van Eenennaam and William M. Muir, “Transgenic Salmon: A Final Leap to the Grocery Shelf?”
Nature Biotechnology, v. 29, no. 8 (August 2011): 706-710.
40 http://www.eenews.net/assets/2010/11/08/document_pm_01.pdf.
41 http://earthjustice.org/news/press/2011/environmental-groups-petition-federal-government-to-complete-full-and-
transparent-review-of-environmental-impact.
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innovation in producing GM fish could promote health benefits from increased consumption.42
Concern has also increased in Canada over the possible effects of producing these GM fish.43
On December 20, 2012, FDA announced the availability for public comment of (1) a draft
environmental assessment of the proposed conditions specified by AquaBounty44 and (2) FDA’s
preliminary finding of no significant impact (FONSI)45 for AquaBounty’s conditions.46 The 60-
day public comment period runs through February 25, 2013. If significant new information or
challenges arise in the public comments, FDA must decide whether or not a full EIS is required
prior to approval of AquaBounty’s application. If FDA approves AquaBounty’s application, FDA
retains the authority to withdraw its approval should significant concerns arise subsequently.
States have also taken steps to regulate the use and transport of GM fish. For example,
Maryland,47 Washington,48 Oregon,49 Minnesota,50 Wisconsin,51 and California52 have passed laws
banning the release of GM fish in some or all state waters. In addition, Alaska requires GM fish to
be labeled.53 No federal law specifically addresses GM fish and seafood.
Congressional Interest
In the 112th Congress, several bills were introduced to address concerns related to GM fish. S.
229, H.R. 520, and H.R. 3553 would have amended the Federal Food, Drug, and Cosmetic Act to
require labeling of genetically engineered fish. S. 230 and H.R. 521 would have amended the
Federal Food, Drug, and Cosmetic Act to prevent the approval of genetically engineered fish for
human consumption. Section 744 of H.R. 2112, as passed by the House on June 16, 2011, would
have prohibited the Food and Drug Administration from spending FY2012 funds to approve any
application for genetically engineered salmon.54 On September 7, 2011, the Senate Committee on
Appropriations reported H.R. 2112, without the prohibition on FDA related to genetically

42 Martin D. Smith et al., “Genetically Modified Salmon and Full Impact Assessment,” Science, v. 330 (November 19,
2010): 1052-1053.
43 http://www.thefishsite.com/fishnews/13771/coalition-demands-govt-openness-on-ge-salmon; see also
http://www.montrealgazette.com/story_print.html?id=4330327&sponsor= and http://www.newswire.ca/en/releases/
archive/March2011/03/c7657.html.
44 Available at http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333102.pdf.
45 Available at http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333105.pdf.
46 77 Federal Register 76050 (December 26, 2012).
47 Maryland Natural Resources Code Ann.§4-11A-02 (2003).
48 Washington Administrative Code 220-76-100 (2003).
49 Oregon Administrative Rules 635-007-0595 (2004).
50 Minn. Stat. §§17.4982, 18B.285, §18B.01, 18F.01-.13 (2003)
51 Wis. Stat. §146.60 (2002)
52 California Fish & Game Code §15007 (2003) and Dept. of Fish and Game §671.1.
53 AK Food & Drug Code §17.20.040 (2005)
54 In response a group of 38 food-related organizations urged Congress not to interfere in the FDA regulatory process;
see http://www.bio.org/sites/default/files/20110802_fda_review.pdf. A contrary opinion was expressed by Andrew
Kimbrell and Colin O’Nell, “Biotechnology: US Congress Right to Halt GM Salmon,” Nature, v. 476, no. 283 (August
18, 2011): 283.
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engineered salmon (S.Rept. 112-73), and this provision was not in the subsequently enacted P.L.
112-55. S. 1717 would have prohibited the sale of genetically altered salmon. On December 15,
2011, the Senate Commerce, Science, and Transportation Subcommittee on Oceans, Atmosphere,
Fisheries, and Coast Guard held an oversight hearing on the environmental risks of genetically
engineered fish. On May 24, 2012, S.Amdt. 2108 to S. 3187 was defeated, proposing to prohibit
approval by FDA of genetically engineered fish unless NOAA concurred with such approval. No
further action was taken on any of these bills by the 112th Congress.

Author Contact Information

Eugene H. Buck

Specialist in Natural Resources Policy
gbuck@crs.loc.gov, 7-7262

Acknowledgments
CRS summer intern Rachel Borgatti prepared the initial draft of this document in 2004. Other CRS
contributors include Tadlock Cowan, analyst in natural resources and rural development, and Harold
Upton, analyst in natural resources policy.

Congressional Research Service
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