Genetically Engineered Salmon
Harold F. Upton
Analyst in Natural Resources Policy
Tadlock Cowan
Analyst in Natural Resources and Rural Development
April 30, 2014
Congressional Research Service
7-5700
www.crs.gov
R43518

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Genetically Engineered Salmon

Summary
If approved by the Food and Drug Administration (FDA), Atlantic salmon would be the first
genetically engineered (GE) animal to be marketed in the United States for human consumption.
Genetic engineering techniques are used by scientists to insert genetic material from one
organism into the genome of another organism. Genetically engineered salmon have been
modified to grow more quickly and use feed more efficiently. However, some are concerned that,
in this rapidly evolving field, current technological and regulatory safeguards are inadequate to
protect the environment and ensure that these products are safe to be used as food.
Over seventeen years ago, AquaBounty Technologies Inc. first applied to the FDA for approval of
a genetically engineered Atlantic salmon. In 2009, AquaBounty submitted to the FDA the last
required study for their new animal drug (NAD) application. The FDA is regulating GE Atlantic
salmon as an NAD under the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §321).
An NAD is approved by the agency only after the drug is shown to be safe and effective. On
September 19-21, 2010, the FDA’s Veterinary Medicine Advisory Committee (VMAC) met to
consider the AquaBounty application for approval of GE salmon, trademarked as AquAdvantage
salmon, for human consumption, and held a public hearing. 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. In the FONSI, FDA reiterated that food from
AquAdvantage salmon is as safe as food from non-GE salmon and determined that there are no
significant food safety hazards or risks associated with AquAdvantage salmon. FDA may still
require a full environmental impact statement (EIS) prior to approval of AquaBounty’s
application. No further action has been taken by FDA, and the Aquabounty NAD application is
still under consideration.
Environmental concerns related to the development of GE salmon include the potential for
competition and interbreeding with wild fish. According to some, escaped GE salmon could
spawn with wild Atlantic salmon and introduce the modified genetic material to the wild
population. Sterilization and bioconfinement have been proposed as a means of isolating GE
salmon to minimize the likelihood of harm to wild fish populations. To address these concerns,
AquaBounty proposes to produce salmon eggs (all sterile females) in Canada, ship these eggs to
Panama, grow and process fish in Panama, and ship table-ready, processed fish to the United
States for retail sale. Additional concerns have been voiced concerning food safety, labeling of
GE salmon, and economic effects on existing wild salmon fisheries.
Some have asserted that FDA approval of AquAdvantage salmon is overdue and that delays have
hindered investment and development of the U.S. biotechnology sector. Others have questioned
the adequacy of the FDA’s review of GE salmon and whether the existing approval process is
equipped to fully evaluate the risks of this technology, especially potential environmental harm.
In response to food safety and environmental concerns, legislation has been introduced during the
113th Congress, including S. 246 and H.R. 1667, which would prohibit the transport, sale,
possession, release, or use of GE fish. H.R. 584 and S. 248 would amend Section 403 of the
FFDCA by adding a requirement to label genetically engineered fish, while H.R. 1699 and S. 809
would require labeling of foods produced using genetic engineering, including fish. No further
action has been taken on these or other bills which would require additional regulation of
genetically engineered organisms.
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Contents
Introduction ...................................................................................................................................... 1
U.S. Biotechnology Regulation and Oversight ................................................................................ 2
Coordinated Framework for Regulation of Biotechnology ....................................................... 2
FDA Regulatory Framework ..................................................................................................... 3
U.S. Department of Agriculture (USDA) .................................................................................. 5
Labeling of Food Containing GE Material ................................................................................ 6
General Mandatory Labeling Issues .......................................................................................... 7
GE Salmon Background .................................................................................................................. 8
Wild Salmon Production............................................................................................................ 8
Salmon Aquaculture .................................................................................................................. 9
Production and Trade ................................................................................................................. 9
AquaBounty Case: The First Genetically Engineered Food Fish ............................................ 10
AquAdvantage Salmon ..................................................................................................... 10
AquaBounty Application ................................................................................................... 12
Food Safety Issues ......................................................................................................................... 16
Environmental Issues ..................................................................................................................... 17
Interbreeding with Wild Atlantic Salmon ................................................................................ 17
Competition and Other Interactions ........................................................................................ 19
Future Concerns....................................................................................................................... 20
Labeling Issues .............................................................................................................................. 20
Fishing Industry Interactions ......................................................................................................... 21
Consumer Acceptance.................................................................................................................... 23
Congressional Actions ................................................................................................................... 23
Future Considerations .................................................................................................................... 25

Figures
Figure 1. Driving Forces of Salmon Production ............................................................................ 22

Tables
Table 1. Atlantic Salmon Farm Production and U.S. Imports of Atlantic Salmon ........................ 10

Contacts
Author Contact Information........................................................................................................... 26

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Introduction
By a broad definition, “genetic modification” refers to changes in an organism’s genetic makeup
that do not occur in nature. For millennia, farmers and scientists have modified the genetics of
animals by selecting those individuals with desirable traits for further breeding. With the advent
of modern biotechnology (e.g., genetic engineering or bioengineering), it is now possible to take a
gene (or genes) for a specific trait from an organism and transfer it to another organism of a
different species. For the purpose of FDA’s guidance to industry, FDA defines genetically
engineered (GE) animals as those animals modified by recombinant DNA (rDNA)1 techniques,
including the entire lineage of animals that contain the modification.2
Recombinant DNA techniques expand the range of traits that may be transferred to another
organism and increase the speed and efficiency by which desirable traits may be incorporated into
organisms. Desirable traits may reduce production costs and sometimes make the organism or
products made from it more desirable to consumers. Genetically engineered plant varieties, such
as herbicide-resistant corn and soybeans, have already been widely adopted by U.S. farmers.
These techniques are now being used to develop genetically engineered organisms for the
aquaculture industry.
Approximately 50 species of fish have been subject to genetic modification and more than 400
fish/trait combinations have been developed.3 Fish and other marine organisms are being
modified to reduce production costs of human food, to produce pharmaceuticals, to test water
contamination, and for other uses.4 Fish are particularly attractive candidates for genetic
engineering because they produce eggs in large quantities and their eggs are more easily
manipulated because they are fertilized and develop externally. Aquaculture also supplies a
rapidly expanding market of different seafood products. Countries with active research programs
for genetically engineered fish include China, Cuba, India, Korea, the Philippines, and Thailand.
Development of GE fish has prompted some advocacy groups to raise a number of environmental
concerns.5 If fish are accidently released into the environment they may spread quickly and be
difficult to contain. GE fish that escape to the wild could compete with wild fish and harm wild
populations. Another concern is that GE fish may interbreed with wild fish and allow the
modified genetic material to become assimilated into the wild fish population.6 Sterilization and

1 Recombinant DNA (deoxyribonucleic acid) is formed by using laboratory methods to combine DNA from different
sources to create DNA sequences that do not occur in nature.
2 U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry Regulation of
Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, Rockville, MD, January 15,
2009. Hereinafter cited as FDA Guidance 2009.
3 I.G. Cowx et al., Environmental Risk Assessment Criteria for Genetically Modified Fishes to be Placed in the EU
Market, European Food Safety Authority, May 27, 2010, http://www.efsa.europa.eu/en/supporting/doc/69e.pdf.
4 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.
5 Timothy Schwab, “Is FDA Ready to Regulate the World’s First Biotech Food Animal?,” FDLI’s Food and Policy
Forum, vol. 3, no. 12 (July 24, 2013). Hereinafter cited as Schwab 2013.
6 Letter from Rebecca Wodder, President, American Rivers, Margie Alt, Executive Director, Environment America,
and Vikki Spruill, President and CEO, Ocean Conservancy, et al. to Margaret Hamburg, M.D., Commissioner, FDA,
November 8, 2010.
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bioconfinement have been proposed as a means of isolating GE fish to minimize the potential for
interactions with wild fish populations and changes to related ecosystems.
Food safety concerns also have been expressed by consumer groups who question whether
genetically modified organisms could pose unique hazards to public health.7 Furthermore, some
in the fishing industry are concerned that greater efficiency in the aquaculture industry could
harm salmon fisheries.8 Salmon farm production in the 1990s depressed salmon prices and
affected fishing businesses and coastal communities that depend on wild fisheries.
Some have asserted that FDA approval of GE salmon is overdue and has been delayed due to
political interference.9 They conclude that delays have hindered investment and development of
the U.S. biotechnology sector. They also question whether biotechnology industries in the United
States will be able to compete with companies in other parts of the world. Moreover, they also
infer that the availability of GE salmon could benefit consumers who are seeking low-fat and
affordable options.10
During the 112th and 113th Congresses, the adequacy of the FDA’s review of GE animals has been
questioned. Several bills introduced in the 112th Congress would have amended the Federal Food,
Drug, and Cosmetic Act (FFDCA) to prevent approval of GE salmon or to require labeling of
genetically engineered fish. None of these bills was enacted. Several bills have been introduced
during the 113th Congress, including S. 246 and H.R. 1667, which would prohibit the possession
or use of GE fish in the United States. H.R. 584, H.R. 1699, S. 248, and S. 809 would add a
requirement under the FFDCA to label genetically engineered fish. No further action has been
taken on these or other bills that would mandate additional regulation of genetically engineered
organisms.
U.S. Biotechnology Regulation and Oversight
Coordinated Framework for Regulation of Biotechnology
Federal guidance for regulating biotechnology products is provided in the Coordinated
Framework for Regulation of Biotechnology (51 Fed. Reg. 23302), published in 1986 by the
White House Office of Science and Technology Policy (OSTP). A key regulatory principle of the
U.S. biotechnology regulatory structure is that genetically engineered products should continue to
be regulated according to their characteristics and unique features, not their production method—
that is, whether or not they were created through biotechnology. The framework provides a
regulatory approach intended to ensure the safety of biotechnology research and products, using

7 Food and Water Watch, Consumers Union, and Center for Food Safety, Petition to Deem ABT Technologies’
Genetically Engineered AquAdvantage Salmon an Unsafe Food Additive, February 7, 2012.
8 Letter from Dale Kelly, Executive Director, Alaska Trollers Association, Brian Lynch, Executive Director, Petersburg
Vessel Owners Association, and Buck Laukitis, President, North Pacific Fisheries Association, et al. to Aleta Sindelar,
FDA, Center for Veterinary Medicine, April 26, 2013.
9Alison L. Van Eenennaam, William M. Muir, and Eric M. Hallerman, “Is Unaccountable Regulatory Delay and
Political Interference Undermining the FDA and Hurting American Competitiveness?,” Food and Policy Forum, vol. 3,
no. 13 (July 24, 2013).
10 Henry I. Miller, “With a Forked Tongue: How the Obama Administration Stymies Innovation in Food Production,”
Forbes, March 19, 2014.
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existing statutory authority and previous agency experience with traditional breeding techniques.
The three lead agencies are USDA’s Animal and Plant Health Inspection Service (APHIS), the
Food and Drug Administration (FDA) at the Department of Health and Human Services, and the
Environmental Protection Agency (EPA).
In 2002, the National Research Council (NRC) published its report on animal biotechnology.11
Some newer applications of biotechnology did not exist when the current regulatory framework
was enunciated. The NRC animal biotechnology report concluded that this General Framework
“might not be adequate to address unique problems and characteristics associated with animal
biotechnologies” and that federal agency responsibilities are not clear.12
FDA Regulatory Framework
FDA regulates food, animal feed additives, and human and animal drugs, including those from
biotechnology, primarily to ensure that they pose no human health risks, mainly under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.) and the Public Health Service Act (42
U.S.C. §201 et seq.). Under the FFDCA, all food and feed manufacturers must ensure that the
domestic and imported products they market, except for most meats and poultry, are safe and
properly labeled, including those developed through genetic engineering.
FDA has stated that most—although probably not all—gene-based modifications of animals for
production or therapeutic claims fall within the purview of the agency’s Center for Veterinary
Medicine (CVM), which regulates them under the FFDCA as new animal drugs (NAD) (21
U.S.C. §321).13 Under the FFDCA, drugs are defined in Section 201(g) as “articles intended for
the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other
animals; and articles (other than food) intended to affect the structure or any function in the body
of man or other animals.”14
On January 15, 2009, CVM released its industry guidance for producers and developers of GE
animals and their products. The guidance provides an approach to satisfy applicable statutes and
regulations.15 The guidance states (on page 6): “The rDNA construct in a GE animal that is
intended to affect the structure or function of the body of the GE animal, regardless of the
intended use of products that may be produced by the GE animal, meets the FFDCA drug
definition.”

11 National Research Council (NRC), Animal Biotechnology: Science-Based Concerns, (Washington, DC, National
Academy Press, 2002). Hereinafter cited as NRC, Animal Biotechnology 2002.
12 NRC, Animal Biotechnology, 2002. p. 14.
13 FDA Guidance 2009. FDA noted that much of the new guidance also will be relevant to non-heritable rDNA
constructs (such as modifications intended for gene therapy); a separate guidance for non-heritable constructs might
come later.
14 Also, part of the FFDCA definition of “new animal drug” is one intended for use in animals that is not generally
recognized as safe and effective for use under the conditions prescribed or recommended, and that has not been used to
a material extent or for a material time.
15 The agency states at the outset: “This guidance represents the Food and Drug Administration’s (FDA’s) current
thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or
the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and
regulations.”
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A new animal drug (NAD) is assumed to be “unsafe” unless FDA has approved a new animal
drug application (NADA) for that particular use, or the NAD is for investigational use and subject
to an exemption from the drug approval requirement (among a few other specified exemptions).
FFDCA and federal regulations describe information that must be submitted to FDA as part of
NADAs.16 The industry guidance lays out the pre-market approval process, including the
information required of applicants which fulfills the regulatory requirements. Required
information is broken out into six categories, which include product identification, molecular
characterization of the construct, molecular characterization of the GE animal lineage, phenotypic
characterization of GE animal, genotypic and phenotypic durability assessment, and the food/feed
safety and environmental safety assessments.
The food safety assessment includes examination of both the direct toxicity (including
allergenicity) potential of food from a GE animal as well as any indirect toxicity. Food and feed
will be considered safe if the composition of edible materials from the GE animal can be shown
to be “substantially equivalent” to that from a non-GE animal. Therefore, if animals of the same
or comparable type are commonly and safely consumed, there is a presumption that food from the
GE animal is safe17 and the product will not have to be labeled.
An FDA decision regarding an NADA is a federal action subject to the National Environmental
Policy Act (NEPA; 42 U.S.C. 4321).18 NEPA requires federal agencies to consider the
environmental consequences of an action before proceeding with it and to involve the public in its
decision-making process. To demonstrate compliance with NEPA, federal agencies must prepare
an environmental impact statement (EIS) for federal actions anticipated to have “significant”
impacts on the environment. The EIS is a detailed evaluation of the proposed action and provides
opportunity for the public, other federal agencies, and outside parties to provide input into the
process. In this case, the FDA is ultimately responsible for determining whether or not an EIS is
necessary.19
To assist the agency in making the determination of whether an EIS is necessary, an applicant for
an NAD must submit documentation to support a claim for a categorical exclusion or for drafting
a preliminary environmental assessment (EA). Actions that, based on an agency’s past experience
with similar actions, have no significant impacts are categorically excluded from the requirement
to prepare an EA or EIS. If an EA is developed and it is found that the NAD would have no
significant environmental impacts, the agency would issue a finding of no significant impact
(FONSI). If the EA determines that the environmental consequences of an NAD are anticipated to
be significant, an EIS is prepared. In cases where significant impacts are anticipated, the federal
agency may decide to prepare an EIS without first preparing an EA.
Under the NAD regulatory protocols, FDA must keep all information about a pending drug
application confidential, with the exception of information publicly disclosed by the
manufacturer, to protect proprietary information. This approach can limit the opportunity for
public comment before approval. Given that the AquaBounty salmon could be the first GE animal

16 Sections 512 and 571 of the FFDCA and Title 21 CFR 514 of associated federal regulations.
17 Michael P. McEvilly, “Lack of Transparency in the Premarket Approval Process for AquAdvantage Salmon,” Duke
Law and Technology Review, vol. 17, no. 2 (2013), p. 421.
18 The FDA guidance discusses how NEPA requirements will apply to the GE animal approval process.
19 Section 514.1(b)(14).
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approved for human consumption, some critics have called for more transparency during the pre-
market approval process.20
The FDA guidance does not require evaluation of genetically engineered organisms such as GE
salmon as a food additive. A food additive is “any substance, the intended use of which results
directly or indirectly, in it becoming a component or otherwise affecting the characteristics of
food.”21 Food additives require pre-market approval from FDA, unless the additive has been
evaluated by scientific experts and determined to be “generally regarded as safe” (GRAS). If
made subject to a food additive review, products such as GE salmon would have to undergo
comprehensive toxicological studies. Critics have questioned whether the NAD regulatory review
is sufficient and have petitioned for evaluation of GE salmon under FDA’s food additive
requirements.
U.S. Department of Agriculture (USDA)
Several USDA agencies, operating under a number of statutory authorities, also have at least
potential roles in the regulation of transgenic and cloned animals and their products. As several
critical reviews have indicated, USDA has not had a clearly spelled out policy in this area,
including whether it intends to exercise these authorities to regulate GE animals.22 USDA’s
Animal and Plant Health Inspection Service earlier had expressed its intention to publish an
advance notice of proposed rulemaking (ANPR) on GE animals, possibly in 2008.23 Instead, in
concert with FDA’s notice on its draft guidance, APHIS published, in the September 19, 2008,
Federal Register, a request for information from the public and scientists on how GE animals
might affect U.S. animal health.24 Over 670 comments were received by November 18, 2008, as
they had been for the FDA draft guidance. Most of the comments were outside APHIS’s authority
under the Animal Health Protection Act. FDA issued its final guidance for developers of GE
animals on January 15, 2009. The guidance states that FDA intends to develop a memorandum of
understanding with APHIS to determine its role in the comprehensive oversight of GE animals.
APHIS has broad authority, under the Animal Health Protection Act (AHPA; 7 U.S.C. §8301 et
seq.), to regulate animals and their movement to control the spread of diseases and pests to farm-
raised animals. APHIS also administers the Viruses, Serums, Toxins, Antitoxins, and Analogous
Products Act (21 U.S.C. §151-159), aimed at assuring the safety and effectiveness of animal
vaccines and other biological products, including those of GM origin, and the Animal Welfare Act
(7 U.S.C. §2131 et seq.), portions of which govern the humane treatment of several kinds of
warm-blooded animals used in research (but generally not agricultural animals or cold-blooded
animals such as fish). Elsewhere at USDA, the Food Safety and Inspection Service (FSIS) is
responsible for ensuring the safety and proper labeling of most food animals and meat and related

20 Michael P. McEvilly, “Lack of Transparency in the Premarket Approval Process for AquAdvantage Salmon,” Duke
Law and Technology Review, vol. 11 (2013), pp. 413-433.
21 FFDCA, Section 201(s).
22 See, for example, Pew Foundation, Issues in Regulation. Beginning on p. 139, the report contains an extensive
discussion on how these and several other USDA authorities might be used for oversight of animal biotechnology.
23 APHIS in 2007 established an Animals Branch within its Biotechnology Regulatory Services “to develop a
regulatory framework for the possible regulation of genetically engineered animals.” Source: APHIS website,
“Regulation of Genetically Engineered Animals,” at http://www.aphis.usda.gov/biotechnology/
news_transgenic_animals.shtml.
24 Federal Register, vol. 73, no. 183, September 19, 2008, at http://edocket.access.gpo.gov/2008/pdf/E8-21917.pdf.
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products derived from them under the Federal Meat Inspection Act (21 U.S.C. §601 et seq.) and
Poultry Products Inspection Act (21 U.S.C. §451 et seq.).
Labeling of Food Containing GE Material
Federal food labeling policy, including the labeling of foods containing bioengineered material, is
regulated under the Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C. §§301 et seq.) and
the Fair Packaging and Labeling Act of 1966 (P.L. 89-755;15 U.S.C. §§1451 et seq.).25 Section
403 of the FFDCA governs food labeling. Under Section 403(a)(1), a food is considered
misbranded if its labeling is false or misleading. Section 201(n) of the FFDCA provides
additional guidance on how food labeling may be misleading. It states that a label is misleading if
it fails to reveal facts that are material in light of representations made or suggested in the
labeling, or material with respect to consequences that may result from the use of the food
prescribed in the labeling, or under such conditions of use that are customary or usual.
The United States does not require mandatory labeling that identifies foods containing genetically
modified material.26 The notion of “substantial equivalence” guides food labeling requirements; if
a food containing GE material is “substantially equivalent” to a food not containing GE material,
federal regulations do not require that it be labeled as containing GE material. When there is no
material difference between products, FDA does not have the authority to require labeling on the
basis of consumer interest alone. If there is a material difference between GE and non-GE foods,
FDA could require such differences to be identified in food labeling.27 Companies that might wish
to label their foods as not containing bioengineered products may do so, if they can definitively
show that the foods do not contain GE products.
Genetically engineered crops became commercially available in the mid-1990s.28 Generally, FDA
has not found that food from GE organisms warrants different or greater safety concerns than
non-GE organisms or exhibits different characteristics such as nutritional value or functional
characteristics than from non-GE organisms. Today, oil from bioengineered soy and canola, soy
protein, and high fructose corn syrup can be found in many manufactured foods, perhaps as high
as 60%-70% of processed foods. The FDA has found most GE crops to be “substantially
equivalent” to non-GE crops and approved their safety for human consumption in processed
foods.
In 1992, FDA published a policy statement on foods derived from new plant varieties, including
those developed through genetic engineering.29 This policy statement did not establish any special
labeling requirements for bioengineered foods as a particular class of foods. FDA stated that the
agency had no basis for concluding that bioengineered foods differed in any meaningful way

25 The Nutrition Labeling and Education Act of 1990 (P.L. 101-535; 21 U.S.C. §343), which amended the Federal
Food, Drug, and Cosmetic Act, requires most foods to carry nutrition labeling and requires food labels with claims
about nutrient content or certain health messages to comply with specific requirements.
26 The labeling of GE foods is required by 68 other countries.
27 Food and Drug Administration, Background Document: Public Hearing on the Labeling of Food Made from the
AquAdvantage Salmon, August 2010, http://www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm222608.htm.
28 For more information see CRS Report RL32809, Agricultural Biotechnology: Background, Regulation, and Policy
Issues.
29 “Statement of Policy: Foods Derived from New Plant Varieties.” Federal Register (57 FR 22984), May 29, 1992.
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from non-bioengineered foods, and therefore had no basis for requiring that such foods be
labeled.30
Although the 1992 policy statement did not require special labeling for bioengineered foods, FDA
did advise that any labeling requirements that apply to foods in general also apply to
bioengineered foods. Under Section 201(n), the label of the food must reveal all “material facts”
about the food. FDA currently requires special labeling of bioengineered foods if the food has a
significantly different nutritional property. For example, if a new food contained an allergen that
consumers would not expect to be present, or if a food contained a toxic ingredient above
acceptable limits, FDA would require that the food be labeled as such.
FDA subsequently issued a 2001 draft guidance document for the voluntary labeling of foods that
have or have not been developed by bioengineering. These guidelines address how the agency
interprets revealing “material facts” about a food on a label. In their guidelines, FDA suggests
that terms such as “GMO free” or “not genetically modified” could be technically inaccurate and
misleading. On the other hand, labeling statements that the food or its ingredients were not
created by bioengineering processes would likely be appropriate.31 For example, currently, no
bioengineered watermelons are on the market. A statement that a watermelon was not genetically
engineered might be deemed misleading by FDA because it implies that other watermelons might
be bioengineered.
General Mandatory Labeling Issues
Mandatory labeling of bioengineered products in the United States has been proposed at the
national, state, and local levels. No labeling requirement has been enacted. Proponents of
mandatory labeling for bioengineered foods argue that consumers should have the right to know
what they are purchasing. Even if the FDA states that a bioengineered product is, from a food
safety perspective, “substantially equivalent” to its traditional counterpart, labeling proponents
assert that the consumer should be able to choose between those foods that may contain
bioengineered products and those that do not. Some proponents of labeling also argue that for
religious or ethnic reasons, many consumers may want to avoid eating animal products, including
processed food products that contain animal genetic material.
With the widespread adoption of bioengineered plants and their now ubiquitous use in food
processing, labeling opponents point to the logistical difficulties and costs of ensuring a food
product does not contain bioengineered ingredients. As the global food system is currently
constructed, segregating bioengineered products from non-bioengineered products would be
technically complex and costly.32 Labeling opponents also argue that the increased food prices as

30 The basic federal guidance for regulating biotechnology products is the Coordinated Framework for Regulation of
Biotechnology (51 Fed. Reg. 23302), published in 1986 by the White House Office of Science and Technology Policy.
A key regulatory principle is that bioengineered products should continue to be regulated according to their
characteristics and unique features, not their production method—that is, whether or not they were created through
bioengineering. Under the Coordinated Framework, if a bioengineered product is “substantially equivalent” to a non-
bioengineered product, no special regulations or labeling are required.
31 U.S. Food and Drug Administration. 2001. Guidance for Industry: Voluntary Labeling Indicating Whether Foods
Have or Have Not Been Developed Using Bioengineering. http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059098.htm.
32 Some assert that accurate labeling would require a commodity identity preservation system extending from the
farmer to the consumer. From their perspective, such a system could require extensive testing and detailed record-
(continued...)
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a result of labeling would be borne by all consumers, not just those who wish to avoid
bioengineered products. Opponents also point out that, under the regulatory basis of “substantial
equivalence,” to label a bioengineered food product as such would suggest to a consumer that
something is unhealthy about the bioengineered food product, and would be prejudicial.
GE Salmon Background
Wild Salmon Production
Salmon is a general name for anadromous species which belong to the taxonomic family known
as salmonidae. Anadromous species live in fresh water during early stages of their life (egg, fry,
and juvenile), migrate to the ocean to grow to adult size, and when sexually mature, return to
freshwater to spawn. Most salmon production in the United States is from the wild and consists of
five main species of Pacific salmon which include Chinook salmon Onchorhynchus tshawytscha;
sockeye salmon Onchorhynchus nerka; coho salmon Onchorhynchus kisutch; pink salmon
Onchorhynchus gorbuscha; and chum salmon Onchorhynchus keta.
Over 95% of wild commercial salmon production is from Alaskan stocks. These stocks are
abundant and productive, largely because there have been relatively few human disturbances on
major salmon rivers in Alaska such as dams. Stocks in the Pacific Northwest vary widely in
health, but most are in relatively poor condition because of historic overfishing and degradation
of riverine habitat. These stocks are of limited commercial importance although they still support
recreational fisheries and contribute to local economies.33 Production in both Alaska and the
Pacific Northwest is enhanced by releases of salmon from hatcheries which are subsequently
harvested after growing to adult size in the ocean. In 2012, total commercial landings of Pacific
salmon were 288,400 metric tons with a value of $489.1 million.34
There are no commercial wild fisheries for Atlantic salmon in North America, and only limited
numbers of Atlantic salmon Salmo salar spawn in New England rivers. Many Atlantic salmon
runs are at historically low levels, especially in the southern parts of their range, such as New
England. Population declines have been caused by overfishing, dams, and degraded
environmental quality of rivers. The remaining Atlantic salmon runs in Maine are listed as
endangered under the Endangered Species Act (16 U.S.C. §§1531-1543). A limited recreational
fishery exists in Canada and small commercial fisheries remain in the North Atlantic.

(...continued)
keeping at each step along the food supply chain. Estimates of the costs of mandatory labeling vary from a few dollars
per person per year to as much as 10% of a household food bill. See G. P. Gruere and S. R. Rao, “A review of
international labeling policies of genetically modified food to evaluate India’s proposed rule.” AgBioForum, vol. 10,
no. 1, 2007, http://www.agbioforum.org.
33 Significant recreational fisheries exist for these stocks as well as aboriginal rights to harvest stocks in the Pacific
Northwest.
34 Fisheries Statistics Division, Fisheries of the United States 2012, National Marine Fisheries Service, Office of
Science and Technology, Current Fisheries Statistics No. 2012, Silver Spring, MD, September 2013,
http://www.st.nmfs.noaa.gov/Assets/commercial/fus/fus12/01_front2012.pdf.
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Salmon Aquaculture
For the aquaculture industry, salmon is a desirable candidate for genetic engineering because of
high consumer demand for salmon products. Salmon aquaculture technology is well developed
and commercial salmon farming has been established in many temperate countries. Of the salmon
species used for aquaculture, Atlantic salmon account for most production. Atlantic salmon grow
well under culture conditions and adapt well to culture conditions outside its range.35 Most
production is from net pens that are suspended in coastal waters, but salmon can be grown in
freshwater raceways, tanks, or recirculating systems where adequate water supplies are available.
Salmon farming has an advantage over the wild seasonal fishery because it can provide a
consistent fresh product throughout the year.
During the 1970s intensive commercial salmon farming in net pens was adopted in Norway and
production expanded rapidly. Salmon production in other countries with suitable coastal areas
such as Great Britain, Chile, and Canada followed and also increased rapidly. Production costs
decreased with improvements in broodstock quality, feed, disease management, and other
production factors. During the period of rapid expansion of salmon farming, prices for both
cultured and wild salmon have generally trended downward. Environmental concerns also
emerged because of potential harm to wild fish stocks used for salmon feed, possible transfer of
disease from farmed to wild salmon stocks, environmental effects of fish wastes and lost feed
from open water cages, transfer of therapeutic agents used for cultured fish to the environment,
and escapes of cultured fish.36 The aquaculture salmon industry has reportedly made progress in
addressing some of these concerns and has begun adopting best management practices to
decrease external effects on the environment.37
Production and Trade
In 1996, world-wide salmon farm production exceeded commercial harvest of wild salmon,38 and
in 2011, aquaculture production of salmon, trouts, and smelts was 2.773 million metric tons
(mmt) with a value of $15.174 billion.39 Production of Atlantic salmon, the main species of this
group, was 1.721 mmt with a value of $9.710 billion.40 Norway led production followed by Chile
and the United Kingdom (Table 1). In 2011, farmed production of Atlantic salmon in the United
States was 18,595 metric tons with a value of $104 million.

35 Chile is a major aquaculture producer of Atlantic salmon, but there are no native anadromous salmon stocks in Chile.
36 For example Atlantic salmon have escaped from culture sites in British Columbia and survived in the wild.
37 Ken Coons, “Global Salmon Initiative does outreach at Seafood Expo,” Seafood.com, March 18, 2014.
38 Gunnar Knapp, Cathy A. Roheim, and James L. Anderson, The Great Salmon Run: Competition Between Wild and
Farmed Salmon, TRAFFIC North America, Washington DC, 2007.
39 United Nations Food and Agriculture Organization, Fishery Statistical Collections, Global Aquaculture Production,
Accessed October 15, 2013, http://www.fao.org/fishery/statistics/global-aquaculture-production/en. Hereinafter cited as
FAO Global Aquaculture Production 2013. In this case, value is the revenue obtained by the aquaculturalist from the
first buyer of the product.
40 FAO Global Aquaculture Production 2013.
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Table 1. Atlantic Salmon Farm Production and U.S. Imports of Atlantic Salmon
2011 Atlantic
2011 Atlantic
2011 Exports to
2011 Exports to
Salmon Production
Salmon Value
the United States
the United States
Country
(metric tons)
(US Dollars 000s)
(metric tons)
(US Dollars 000s)
Norway 1,059,958
4,855,561
18,850
222,054
Chilea 264,319
2,223,175
54,607
563,398
United Kingdom
158,018
942,642
15,863
113,566
Canada 102,064
613,523
70,995
478,342
Faroe Islands
60,473
413,999
14,935
97,208
Australia 35,198
419,850
1
-
United States
18,595
104,132
-
-
Ireland 12,196
101,987
322
3,796
Others 10,433
35,913
5,652
41,853
Total
1,721,254 9,710,782 181,225 1,520,228
Source: FAO, Fisheries and Aquaculture Department, Fisheries Statistics and Information, Global Aquaculture
Production 1950-2011 Online Query, http://www.fao.org/fishery/statistics/global-aquaculture-production/query/
en.
National Marine Fisheries Service, U.S. Foreign Trade, Imports of Fishery Products, Online Query,
http://www.st.nmfs.noaa.gov/commercial-fisheries/foreign-trade/raw-data/imports-exports-annual#1.
Notes:
a. U.S. imports from Chile rebounded in 2012 with an increase to 93,552 thousand metric tons. For 2009 to
2011, disease problems on Chilean fish farms decreased salmon production and imports to the United
States.
Global trade of salmon products has continued to increase with gains in farmed production.
Although the United States is a major producer and consumer of wild Pacific salmon, in 2011,
U.S. imports of fresh and frozen farmed Atlantic salmon totaled 181.2 thousand metric tons with
a value $1.520 billion. During the last decade, Atlantic salmon imports have accounted for
approximately 50% to 60% of the total U.S. fresh and frozen salmon supply.41
AquaBounty Case: The First Genetically Engineered Food Fish
AquAdvantage Salmon
The Atlantic salmon is the first genetically engineered fish to be considered for commercial
production and human consumption.42 AquaBounty Technologies, Inc. is currently seeking
regulatory approval from the FDA to sell its AquAdvantage salmon for human consumption in the

41 U,S. Department of Commerce, National Oceanic and Atmospheric Administration and National Marine Fisheries
Service, Fisheries of the United States 2012, Silver Spring, MD, September 2012, http://www.st.nmfs.noaa.gov/
commercial-fisheries/fus/fus12/index.
42 Glofishâ„¢ is a genetically altered version of the popular aquaria zebrafish (Danio rerio). The zebrafish was made
fluorescent after the insertion of a sea anemone gene into the zebrafish egg.42 This fish is currently legal to be sold in
all states except California. Since Glofishâ„¢ are not meant for human consumption, FDA determined that the Glofishâ„¢
was not under its jurisdiction.42
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United States.43 In 2011, the company also received a grant from the U.S. Department of
Agriculture’s National Institute of Food and Agriculture for work on technologies to render
transgenic fish sterile to reduce the risk of gene flow to wild populations.44
Genetic engineering technology can be used to introduce a desirable trait(s) into an organism by
transferring genetic material (DNA) from another organism. The process creates recombinant
DNA (rDNA)—the result of combining two or more DNA sequences that would not normally
occur together in nature. Unlike the natural process of genetic recombination, rDNA is engineered
by isolating and combining DNA in a laboratory. The DNA that carries the code for a desirable
protein such as a hormone is then introduced to an existing organism such as an Atlantic salmon.
The introduced DNA becomes part of the organism’s genetic makeup and may be passed on to the
organism’s offspring. Some sequences of DNA are promoters which tell the organism’s cells
when to make certain substances. Promoters can be spliced to the desired gene that has specific
instructions to make a protein such as a growth hormone. When genes are moved from one
organism to another a transgenic organism is created.
GE salmon were developed by injecting rDNA composed of a promoter from another fish, an
ocean pout, and a growth hormone gene from a Pacific Chinook salmon into fertilized eggs of
Atlantic salmon. Subsequent selection and breeding led to the development of the AquAdvantage
salmon line, which produces growth hormone throughout the year. The year-round production of
growth hormone allows for continuous feeding and growth of AquaAdvantage salmon. Growth
hormone production of non-GE Atlantic salmon decreases during the winter months, and Atlantic
salmon stop feeding and growing during this period.
The AquAdvantage salmon also increases the efficiency of salmon production because of faster
growth and better feeding efficiency than non-GE Atlantic salmon. GE Atlantic salmon reach
smolt size45 more quickly than non-GE Atlantic salmon and grow to a market size of 1 to 3
kilograms in 16 to 18 months instead of the typical three years.46 Although AquAdvantage salmon
grow more quickly, they do not reach an overall larger size than non-GE Atlantic salmon.
According to AquaBounty, analysis of AquAdvantage salmon has shown that they consume 25%
less feed to achieve the same size as non-GE Atlantic salmon.47 Feed is the most significant cost
for commercial salmon aquaculture operations. Characteristics exhibited by GE salmon include
accelerated growth, elevated metabolism, greater feeding motivation and efficiency, increased
aggression and foraging activity, and reduced anti-predator response.48 Similar traits have been
observed for domesticated Atlantic salmon developed through selective breeding.

43 AquaBounty Technologies, Inc., http://www.AquaBounty.com/.
44 See http://www.nifa.usda.gov/newsroom/news/2011news/brag_awards.html.
45 Atlantic salmon go through several stages including egg, alevin, fry, parr and smolt. Salmon make the transition from
fresh to salt water environments during the smolt stage. The age of this transition may vary widely depending on
Atlantic salmon stock.
46 According to the Development Fund, the Norwegian aquaculture industry has developed strains of salmon through
selective breeding that grow as fast or faster than AquAdvantage salmon. See http://www.utviklingsfondet.no/files/uf/
documents/GMO-Salmon_Fast_Growing_Hype_web.pdf.
47 “As Final U.S. decision Nears, A Lively Debate on GM Salmon,” Environment 360, April 18, 2013, p.
http://e360.yale.edu/feature/as_final_us_decision_nears_a_lively_debate_on_gm_salmon/2641/. Hereinafter cited as
Environment 360, 2013.
48 U.S. Food and Drug Administration, AquaAdvantage Salmon, Draft Environmental Assessment, May 4, 2012,
http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333102.pdf. Hereinafter cited as FDA Draft Environmental Assessment 2012.
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Faster growth confers an advantage to using GE salmon relative to non-GE salmon and,
according to some, could make land-based closed aquaculture systems competitive with cage
culture currently used in coastal areas. Proponents of GE salmon maintain that this is a significant
development because of environmental harm caused by salmon cage culture.
AquaBounty Application
Proposed Operations
The AquAdvantage salmon would be produced and imported into the United States under
specified conditions proposed by AquaBounty. AquaBounty would produce eyed eggs at a
specific facility on Prince Edward Island (PEI), Canada.49 Eggs would be shipped to Panama and
reared to market size in land-based facilities. The grow-out facility would be based in the
Panamanian highlands to reduce the risk of salmon escapes and interactions with wild salmon
populations.50 Salmon would be processed in Panama before being shipped to the United States
for retail sale and no live fish would be imported into the United States.
AquaBouuty has stipulated that they would only produce sterile female GE Atlantic salmon by a
process which manipulates salmonid reproductive biology. The production of monosex salmon is
considered to be 100% effective. In addition, pressure treatment of the eggs induces triploidy (an
extra set of chromosomes) which results in sterility. When done on a commercial scale, batches of
eggs are on average 99.8% triploid and rates greater than 98% are expected for most inductions.51
All-female lines of triploid fish are considered to be one of the best current methods to insure
nonbreeding populations of GE fish. Therefore, the risk of an independent breeding population of
GE salmon is considered to be extremely low.
Growing GE marine fish in isolated onshore tanks rather than in offshore or nearshore pens may
substantially lower the risk of escape into the wild. Both facilities currently used by AquaBounty
confine production to land-based freshwater areas and proposed production would be continued
in this manner. The egg production facility on Prince Edward Island is currently licensed to
conduct research on GE fish under Canadian regulations. The facility has incorporated redundant
measures to provide for physical containment and ensure that neither brood stock nor eggs can
escape. Security is also provided at the PEI facility to stop unauthorized or unintentional access.
The grow-out facility in the highlands of Panama is located at the upper portion of a watershed at
5,000 feet above sea level. The river which supplies the facility runs into several other tributaries
and discharges into the Pacific Ocean. Water is diverted from the river into a basin which supplies
the facility’s grow-out tanks. Screens are used wherever water flows out of the facility to prevent
the escape of fish while security is provided to deter human or animal intrusion. The Panama site
is geographically isolated from the range of salmon species, and environmental conditions in the
river’s estuary and the Pacific Ocean are unfavorable for salmon survival. According to FDA’s
Draft Environmental Assessment, in the event that AquAdvantage Salmon escape, geographical

49 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.
50 There are no native populations of salmon in rivers or adjacent marine areas of Panama because these areas are not
suitable for wild Atlantic salmon.
51 Food and Drug Administration Center for Veterinary Medicine, Briefing Packet AquaAdvantage Salmon, September
20, 2010, p. 57.
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and geophysical containment would preclude or significantly reduce the probability of survival,
dispersal, and long-term establishment.
Application History
In 1993, AquaBounty first approached the FDA concerning the commercial use of GE salmon,
and in 1995 they formally applied for approval. In 2009, AquaBounty provided FDA with the last
required study of AquAdvantage Atlantic salmon for their New Animal Drug Application
(NADA). On September 19-20, 2010, FDA’s Veterinary Medicine Advisory Committee (VMAC)
met to consider issues regarding the safety and effectiveness of the NADA. The public was also
given the opportunity to provide written submissions and oral testimony to the committee. On
December 20, 2012, FDA announced the availability for public comment of (1) the draft
environmental assessment of impacts associated with NADA submitted by AquaBounty52 and (2)
FDA’s preliminary finding of no significant impact (FONSI).53 A 60-day public comment period
initially ran through February 25, 2013, but was extended through April 26, 2013.54 On
November 23, 2013, Environment Canada granted AquaBounty permission to export up to
100,000 eggs a year from a hatchery in Prince Edward Island to Panama. A land-based research
facility is currently operating and raising GE salmon in Panama.55 On March 13, 2014, the FDA
Commissioner, Dr. Margaret Hamburg, stated that the Aquabounty NAD application is still under
consideration and that FDA will be moving forward in a deliberate science-driven way.56
Food Safety
The VMAC briefing pack included a section on food safety which concluded that there are no
direct or indirect food consumption hazards related to AquAdvantage salmon.57 Although the
VMAC concluded that test results established similarities and equivalence between
AquAdvantage salmon and non-GE Atlantic salmon, the chairman’s report added that it cannot be
concluded from the data submitted that AquAdvantage Salmon would be more or less allergenic
than Atlantic salmon.58 FDA has maintained that people who are allergic to Atlantic salmon will
likely be allergic to AquAdvantage Salmon because it is a finfish, but not because it has been
genetically engineered.59 In the preliminary finding of no significant impact released on
December 20, 2012, FDA reiterated that food from AquAdvantage salmon is as safe as food from

52 FDA Draft Environmental Assessment 2012.
53 U.S. Food and Drug Administration, Preliminary Finding of No Significant Impact AquAdvantage Salmon, May 4,
2012, http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333105.pdf.
54 78 Federal Register 10620-10621 (February 14, 2013).
55 It has been reported that if the FDA approves imports of GE salmon, AquaBounty will request Panama’s permission
to convert the research facility into a production facility.
56 U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Protecting the Public Health:
Examining FDA’s Initiatives and Priorities, 113th Cong., 2nd sess., March 13, 2014.
57 Food and Drug Administration, Briefing Packet AquaAdvantage Salmon, FDA Center for Veterinary Medicine,
September 20, 2010, p. 61, http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf.
58 Chairmen’s Report, 2010.
59 Food and Drug Administration, Key Facts Commonly Misunderstood, http://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm226223.htm.
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non-GE salmon and determined that there are no significant food safety hazards or risks
associated with AquAdvantage salmon.60

The Veterinary Medicine Advisory Committee and GE Salmon
The Center for Veterinary Medicine regulates transgenic animals intended for human consumption under the same
authority it uses to regulate NADs.61 As a first step in the review process, on September 19-21, 2010, FDA’s
Veterinary Medicine Advisory Committee met to consider the application and held a public hearing.62 The FDA uses
advisory committees and panels to obtain expert advice on science, technology, and policy. The VMAC is composed
of members with technical expertise such as veterinary medicine, animal science, microbiology, biostatistics, and food
sciences. Opponents of the AquaBounty application have been critical of the committee’s composition and have
argued for more experts in fisheries and ecology. The FDA charged the VMAC with reviewing issues regarding the
safety and effectiveness of the new animal drug application. The VMAC Chairmen’s report provided the following four
basic questions and responses to issues related to AquAdvantage Salmon.63
1. Do the data and information demonstrate that the rDNA construct is safe to AquAdvantage salmon?
The committee found no evidence in the data to conclude that the introduction of the construct was unsafe to the animal.
2. Do the data and information demonstrate that there is a reasonable certainty of no harm from consumption of
foods derived from AquAdvantage salmon? (safety of food from AquAdvantage Salmon was considered in the context
of non-GE Atlantic salmon)
The committee deemed the studies selected to evaluate this question to be overall appropriate and a large number of test
results established similarities and equivalence between AquAdvantage Salmon and Atlantic salmon.
3. Do the data indicate that AquAdvantage Salmon grow faster than their conventional counterparts?
The committee found evidence in support of this claim.
4. Are any potential environmental impacts from AquAdvantage Salmon production adequately mitigated by
AquaBounty Technologies’ proposed conditions of use?
Although the committee recognized that the risk of escape from either facility could never be zero, the multiple barriers to
escape at both the Prince Edward Island and Panama facilities were extensive. Because part of the containment strategy is
dependent on management standard operating procedures, the committee felt that rigorous adherence to policy would need to
be maintained at both sites to sustain the barriers.
Evaluation of Potential Environmental Impacts
To assess potential environmental impacts, FDA has released a draft EA and consulted with the
Fish and Wildlife Service and the National Marine Fisheries Service (NOAA Fisheries). In 2007,
legislation was passed to require the FDA to consult with the National Marine Fisheries Service
and to produce a report on any environmental risks associated with genetically engineered
seafood products, including the impact on wild fish stocks.64 According to FDA, the two agencies

60 Food and Drug Administration, Preliminary Finding of No Significant Impact, AquAdvantage Salmon, May 4, 2012,
http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333105.pdf.
61 The FDA Center for Veterinary Medicine’s “Questions and Answers about Transgenic Fish,” http://www.fda.gov/
AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm133255.htm.
62 Background documents for this public hearing are available at http://www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm201810.htm. Also see 75 Federal Register
52602-52605, August 26, 2010.
63 David Senior, Interim Chair, VMAC, Chairman’s Report, Food and Drug Administration, VMAC Meeting,
September 20, 2010, http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/UCM230467.pdf.
64 21 U.S.C. §2106.
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have consulted on this matter, but this report has not been developed and no target date for its
completion has been specified.
FDA has made a “no effect” determination under the Endangered Species Act (ESA; 16 U.S.C.
1531 et seq.) and concluded that approval of the AquAdvantage Salmon NADA will not
jeopardize the continued existence of Atlantic salmon listed as threatened or endangered or result
in the destruction or adverse modification of their critical habitat. FDA and NMFS engaged in
technical discussions during 2010 and 2011 and based on those discussions NMFS did not object
to the proposed action. However, critics have questioned whether FDA has sufficient expertise to
identify and protect against all potential ecological damage that might result from the widespread
use of transgenic fish.65

Summary of FDA Conclusions Concerning the Environmental Impacts of
AquaAdvantage Salmon
The Draft EA attempted to address potential hazards and harms to the U.S. environment if AquAdvantage Salmon
were to escape. The EA posed the fol owing risk related questions and provided the corresponding answers.66
1. What is the likelihood that AquAdvantage Salmon will escape the conditions of confinement?
Due to multiple, redundant containment measures at the sites of egg production and grow-out, the possibility of AquAdvantage
Salmon (or the broodstock used to produce these fish) escaping to the environment is extremely remote.
2. What is the likelihood that AquAdvantage Salmon will survive and disperse if they escape the conditions of
confinement?
In the unlikely event of an escape or release, environmental conditions at both the egg production and grow-out sites are
sufficiently inhospitable to limit long-term survival and spread of AquAdvantage Salmon to other locations.
3. What is the likelihood that AquAdvantage Salmon will reproduce and establish if they escape the conditions of
confinement?
AquAdvantage Salmon would be produced as all-female, triploid fish. As such they would be effectively sterile. The combination
of triploidy and an all-female population is expect to render AquAdvantage Salmon effectively and functionally sterile resulting in
complete reproductive containment.
4. What are the likely consequences to, or effects on, the environment of the United States should AquAdvantage
Salmon escape the conditions of confinement?
The collective information on the potential for survival, dispersal, reproduction and establishment indicates that exposure
pathways for AquAdvantage Salmon to reach the United States are incomplete; therefore, no effects are expected on the
environment of the United States.

The draft environmental assessment evaluated the potential environmental impacts associated
with approving the NADA for AquAdvantage Salmon. According to FDA, it has verified that
AquAdvantage Salmon would be produced and grown in secure facilities. The escape and
survival of GE salmon from containment into the local environments of PEI and Panama is
considered by FDA to be extremely remote. The environment around the egg producing facility
and the grow-out facility are described by FDA as inhospitable. In the event that fish escape and
survive, reproduction in the wild would be unlikely because the AquAdvantage salmon will be all

65 See the Center for Food Safety’s “Genetically Engineered Fish,” http://www.centerforfoodsafety.org/geneticall3.cfm.
66 Food and Drug Administration, AquAdvantage Salmon, Draft Environmental Assessment, May 4, 2012,
http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/
GeneticallyEngineeredAnimals/UCM333102.pdf. Hereinafter cited as Draft Environmental Assessment, 2012.
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female triploid fish which are nearly all sterile.67 In the draft EA, FDA concluded that it “found
no evidence that approval of an NADA for AquaAdvantage Salmon would result in significant
impacts on the environment in the United States.”68 If significant new information or challenges
arise in the public comments, FDA may determine that a full environmental impact statement is
required prior to approval of AquaBounty’s application.
NEPA does not require an analysis of environmental effects in other countries and therefore,
potential effects on the environment in Canada and Panama were not considered. These effects
would be evaluated only if potential exposure pathways exist which could cause significant
effects on the environment in the United States. Social and economic effects were not analyzed in
the EA because the proposed action, if implemented as required, is not anticipated to significantly
affect the physical environment of the United States.
In an effort to broaden the evaluation of the AquaBounty application, a coalition of environmental
groups called on FDA to prepare an EIS on this action and to consult more closely with federal
agencies about possible threats to endangered wild Atlantic salmon.69 On May 25, 2011, these
groups filed a formal citizen petition urging FDA to withhold approval until an EIS has been
completed.70 Some VMAC members also stated that an EIS would be needed if the company
proposes additional facilities for growing salmon.
Food Safety Issues
A National Research Council study maintains that there is a low to moderate food safety risk from
GE seafood.71 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.
On February 7, 2012, three non-governmental organizations petitioned the FDA’s Office of Food
Additive Safety (OFAS) to review the AquaBounty application under the FFDCA food additive
provisions.72 The petitioners argued that the gene expression product (GEP) of the genetic
construct creating the AquAdvantage salmon, is a food additive under FFDCA (§201(s), 21
U.S.C. §321). AquAdvantage salmon exhibit an elevated level of Insulin Growth Factor-1
(IGF-1), which they asserted is a novel food additive and constitutes a “material fact” about the
GE-salmon compared to its non-GE counterpart.73 They have requested that FDA make a finding

67 Triploid salmon have an extra set of chromosomes and triploidy renders them sterile. On average, treatment is
expected to result in 99.8% triploid fish, and according to FDA with rates of over 98% for most inductions.
68 Draft Environmental Assessment, 2012.
69 Letter from Rebecca Wodder, President, American Rivers, et al. to Margaret Hamburg, Commissioner, U.S. Food
and Drug Administration, November 8, 2010, http://www.eenews.net/assets/2010/11/08/document_pm_01.pdf.
70 Ocean Conservancy et al., Citizen Petition Regarding AquaBounty Technologies’ Application for Approval of
Genetically Engineered Salmon, Citizen Petition Before the U.S. Food and Drug Administration, May 25, 2011,
http://earthjustice.org/sites/default/files/FinalGESalmonCitizenPetition.pdf.
71 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.
72 Food and Water Watch, Consumers Union, and The Center for Food Safety, Petition to Deem ABT Technologies’
Genetically Engineered AquaAdvantage Salmon An Unsafe Food Additive, February 7, 2012.
73 IGF-1 is a hormone that helps accelerate the growth of the bioengineered salmon. According to the petition, IGF-1
(continued...)
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that neither the AquAdvantage salmon nor the GEP used to create it is “generally regarded as
safe” (GRAS).74 In particular, the petition requested extensive pre-market testing, arguing that
“[t]he Agency’s general classification of rDNA constructs as new animal drugs does not displace
or override the Agency’s regulations and guidelines, and nothing precludes the Agency from also
regulating GE salmon and its components as food additives.”
Opponents of approval also question the validity of data supplied by AquaBounty for risk
assessment.75 They contend that FDA should have AquaBounty re-conduct its studies, or FDA
should either conduct the studies themselves or ask an independent laboratory to undertake the
studies. If the AquAdvantage Salmon were shown to have materially different nutritional or
health characteristics from a non-GE salmon, while still being deemed safe, FDA could require
that the fish be labeled.
FDA has continued to review the AquaBounty proposal solely under the NAD protocol. Because
the review process of the AquAdvantage Salmon could become precedent-setting for review of
other GE animals, the issue of the appropriate agency regulatory protocol—NAD or that of a food
additive—is likely to remain a significant point of contention in the regulatory process.
Environmental Issues
The potential harm that might be caused by GE organisms which escape from aquaculture
facilities is of great concern to some scientists and environmental groups.76 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.”77 For AquAdvantage Salmon, concerns include interbreeding and competing with
wild Atlantic salmon and competition with fish both within and outside the range of Atlantic
salmon.
Interbreeding with Wild Atlantic Salmon
Experiences with farmed Atlantic salmon may provide some insights regarding potential
interactions of GE Atlantic salmon and wild Atlantic salmon. Farmed Atlantic salmon frequently
escape from fish farms in areas both within and outside their native ranges.78 Escaped farmed

(...continued)
has been shown in some studies to be linked to breast, colon, prostate, and lung cancers.
74 The petition also argues that the AquaBounty salmon raises safety concerns because the salmon exhibits higher
levels of the growth hormone IGF-1 that could have increased allergen potential.
75 Tim Schwab, “Is FDA Ready to Regulate the World’s First Biotech Food Animal?” Food and Drug Policy Forum,
vol. 3 (July 24, 2013).
76 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.
77 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.
78 Eva B. Thorstad, Ian A. Fleming, and Philip McGinnity, Incidence and impacts of escaped farmed Atlantic salmon
Salmo salar in nature, Norwegian Institute for Nature Research, Norway, 2008. Hereinafter cited as Thorstad et al.
2008. For example, Atlantic salmon have escaped from areas within their ranges such as coastal farms in the North
(continued...)
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salmon have been found on spawning grounds during the period when wild Atlantic salmon
spawning occurs.79 Farmed salmon also spawn in these areas, but with lower success than wild
Atlantic salmon. Successful spawning appears to have most frequently occurred between farmed
females and wild males. The offspring of farmed and farmed and wild salmon (hybrids) occupy
areas also inhabited by wild salmon. It is not known whether the presence of farmed and hybrid
juveniles limit food and resources for wild fish and competitively displace native juveniles. The
outcomes of interactions between farmed and wild juveniles are likely to vary depending on
specific circumstances such as the quality and availability of habitat and associated resources.
Domestication of farmed salmon has changed their genetic composition and reduced genetic
variation. These changes have occurred because limited numbers of brood fish are used for
spawning farmed fish and farmers select for specific traits.80 Much of present-day farm
production of Atlantic salmon is now based on five Norwegian strains. Farmed and wild hybrids
and backcrossing of hybrids in subsequent generations may change genetic variability and the
frequency and type of alleles present in wild populations.81 The extent and nature of these
changes to genetic variability may affect survival (fitness) of these populations. Changes in the
genetic profiles of wild populations have been shown to have occurred in several rivers in
Norway and Ireland where inter-breeding of wild and farmed fish is common.82 Large-scale
experiments in Norway and Ireland show highly reduced survival and lifetime success of farmed
and hybrid salmon compared to wild salmon.83
Given previous experiences with farmed salmon, opponents hypothesize that farmed GE salmon
will eventually escape from aquaculture systems and interbreed with wild Atlantic salmon. GE
salmon may exhibit different fitness-related traits such as higher feeding and growth rates.
Researchers have questioned whether the flow of a gene or genes from transgenic fish such as GE
salmon may confer specific advantages to hybrids relative to wild fish resulting in population-
wide consequences.84 The “Trojan gene hypothesis” speculates that populations could become
extinct when a gene that confers a reproductive advantage also renders offspring less able to
survive in the natural environment. However, comments to the VMAC from one of the
researchers who framed the hypothesis stated that the Trojan gene effect only occurs when there
is a conflict between mating success (if GE salmon were to mate more successfully) and viability
fitness (offspring were less likely to survive in the wild). He concluded that the risk of harm is
low because data conclusively show that in this case there is no Trojan gene effect and the
transgene will be purged by natural selection.85 However, the potential consequences of the

(...continued)
Atlantic (Canada, Norway, and Great Britain) and from areas outside their range in the Pacific (Chile and British
Columbia).
79 There are no recorded cases of hybridization in nature between Atlantic and Pacific salmonid species.
80 Oystein Skaala, Vidar Wennevik, and Kevin A. Glover, Evidence of temporal genetic change in wild Atlantic
salmon, Salmo salar, populations affected by farm escapees, “ICES Journal of Marine Sciences,” vol. 63 (2006), pp.
1224-1233. Fitness can be generally described as the ability to survive and reproduce.
81 An allele is one of two or more versions of a gene occupying a specific spot on a chromosome that control a specific
trait.
82 Thorstad et al. 2008.
83 Thorstad et al. 2008.
84 Kelly M. Pennington, Anne R. Kapuscinski, and Michale Morton, et al., “Full Life-cycle assessment of gene flow
consistent with fitness differences in transgenic and wild-type Japanese medaka fish (Oryzias latipes),” Environmental
Biodiversity Research, vol. 9 (2010), pp. 41-57.
85 Draft Environmental Assessment 2012, p. 91.
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interbreeding of farm (including GE salmon) and wild Atlantic salmon remains a long-term
concern of those attempting to conserve wild Atlantic salmon populations.
Competition and Other Interactions
Critics are also concerned that AquAdvantage Salmon could become established in the wild and
compete with native fish, including both Atlantic salmon and other species, for food, habitat,
mates, and other resources.86 This is a concern both within and outside the range of Atlantic
salmon. Previous deliberate attempts to introduce Atlantic salmon have failed and no self-
sustaining populations of anadromous Atlantic salmon have been established outside the natural
range of the species. In British Columbia, Atlantic salmon which escaped from fish farms have
spawned and produced wild-spawned juvenile Atlantic salmon, but it is uncertain whether they
have established self-reproducing breeding populations.87 Experimental crosses between GE
Atlantic salmon and wild brown trout (Salmo trutta) have been shown to be viable and to confer a
growth advantage to the hybrid. Researchers concluded that transgenic hybrids could
detrimentally affect wild salmon populations, but that introgression of the gene into the brown
trout genome through backcrossing is unlikely.88
If GE salmon were to escape and establish self-sustaining populations, competition for resources
is another potential concern. Since GE salmon grow faster, it has been suggested that they may
outcompete wild fish for habitat and food.89 Laboratory experiments on AquAdvantage relatives
indicate that they are more likely to feed in the presence of a predator than non-GE controls.90
Another study which compared GE and non-GE salmon fry under food-limited conditions in
simulated environments showed no difference in territorial dominance, growth, or survival of first
feeding fry at high densities.91 Biotechnology proponents argue that GE 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.
The consequences of potential competition would also depend on many factors, including the size
and health of the wild population, the number and characteristics of the escaped fish, and local
environmental conditions. Some argue that once transgenic fish become established, they could
be difficult or impossible to eradicate such as many invasive species. This scenario would depend
on reproduction of GE salmon in the wild.92 Critics also express concerns that U.S. wild Atlantic
salmon populations are at extremely low levels and especially vulnerable to ecological changes.

86 Atlantic salmon and Pacific salmon are unable to spawn because they are different species.
87 Thorstad et al. 2008, p. 67.
88 Krista B. Oke, Peter A. H. Westley, and Darek T. R. Moreau, et al., “Hybridization between genetically modified
Atlantic salmon and wild brown trout reveals novel ecological interaction,” Proceedings of the Royal Society:
Biological Sciences, vol. 280, no. 1763 (August 7, 2013).
89 Draft Environmental Assessment 2012, p. 91.
90 Draft Environmental Assessment 2012, p. 92.
91 Draft Environmental Assessment 2012 p. 92.
92 Wild reproduction of GE fish is unlikely if only sterile triploid females are produced.
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Future Concerns
According to the FDA, the NADA is for a specific set of conditions and any modification to these
conditions would require notification of the FDA.93 Major or moderate changes to these
conditions would require a supplemental NADA which would trigger environmental analyses
under NEPA. The FDA states that expansion or changes to facilities identified in the proposal
would constitute major or moderate changes which would require a supplemental NADA and
analysis under NEPA. If FDA approves AquaBounty’s application, FDA retains the authority to
withdraw its approval should significant subsequent concerns arise.
If GE salmon are approved for consumption in the United States, it is likely that additional
applications will be made for additional geographic areas and for a variety of different grow-out
or culture techniques. Under the current proposal, AquaBounty would produce GE salmon in a
limited grow-out facility in Panama. Some have speculated that subsequent proposals would be
subject to less scrutiny and question whether future uses will be as apparently benign.94 If
additional applications are approved, it is possible that future grow-out facilities would be located
closer to the range of wild Atlantic salmon thereby decreasing the effectiveness of geographic
containment. The NADA would not include the culture of AquAdvantage Salmon in net pens,95
but if cage culture were used to produce GE salmon it would increase the probability of fish
escaping to the wild. AquaBounty has denied that their company would approve the use of
AquAdvantage Salmon in cage culture.96
Labeling Issues
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. Although FDA is not
required to address labeling issues prior to the food being marketed, FDA is considering these two
issues simultaneously.97 If the AquAdvantage salmon NADA is approved, FDA is to determine
whether additional labeling is appropriate.
FDA has determined that the AquaBounty salmon is as safe for human consumption as non-GE
salmon, in other words, that the AquaBounty salmon is “substantially equivalent” to non-GE
salmon. Opponents of the AquaBounty salmon, however, have argued the need to label it as a GE
product on a presumed basis of consumers’ right-to-know. Proponents of the AquaBounty salmon
argue that labeling a “substantially equivalent” food would imply that the GE fish was different in
ways that could be seen as negative. Given that the labeling issue for GE foods remains unsettled,
labeling the AquaBounty salmon, as potentially the first GE animal approved by FDA for human
consumption, has become an important aspect of FDA’s overall approval process. While

93 FDA Environmental Assessment 2012, p. 2.
94 Northwest Environmental Defense Center, The Newsletter of the Northwest Environmental Defense Center, Critique
of Genetically Engineered Salmon, 2013, http://law.lclark.edu/live/files/14124-articlecritique-of-genetically-
engineered-salmon-.
95 Grow-out in net pens is less costly than culture of salmon in land-based facilities.
96 Environment 360, 2013.
97 FDA, “Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage
Salmon,” http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm222712.htm.
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voluntary labeling would be permissible—as long as the label was not false or misleading—
proponents of the AquaBounty salmon believe such labeling could reduce retail demand for the
fish. Many major grocery retail chains, such as Safeway, Trader Joe’s, Target, Kroger, and Whole
Foods, have already announced that they would not sell the AquaBounty fish when it becomes
commercially available.98
States have also taken steps to regulate the transport and use of GE fish. For example,
Maryland,99 Washington,100 Oregon,101 Minnesota,102 Wisconsin,103 and California104 have passed
laws banning the release of GE fish in some or all state waters. In addition, Alaska requires GE
fish to be labeled.105 No federal law specifically addresses labeling GE fish and seafood.
Fishing Industry Interactions
The success of farm-raised Atlantic salmon has made some who work in the commercial wild
salmon fishing industry, particularly those in Alaska, especially sensitive to potential impacts of
GE salmon. Fishermen have concerns related to further increases in salmon aquaculture
production and environmental harm to wild stocks. The salmon fishing industry in Alaska does
not produce intensively farmed fish salmon in net pens and would not benefit from the use of GE
salmon.106
Over the last three decades, the rapid growth of farmed salmon and trout production has been one
of the primary drivers of world salmon prices.107 In 2002, prices paid to Alaska fishermen were
less than half of the average prices paid from 1980 to 2005.108 Changes to salmon markets were
actually much more complex during this period because the industry was transformed by a variety
of factors in addition to the growth in the total supply of salmon. Salmon markets were also
affected by the availability of different types of salmon products, the timing of production, and
development of market standards.
Some believe that the wide use of GE salmon would depress salmon prices. Potential interactions
between GE salmon aquaculture, ongoing salmon aquaculture, and wild fisheries are difficult to
fully assess. Part of the difficulty is related to the complex nature of interrelated drivers of
aquaculture and wild salmon production. For example, public acceptance can affect prices which

98 “Kroger, Safeway Will Nix GMO Salmon Regardless of FDA Decision,” Food Safety News, March 4, 2014.
99 Maryland Natural Resources Code Ann.§4-11A-02 (2003).
100 Washington Administrative Code 220-76-100 (2003).
101 Oregon Administrative Rules 635-007-0595 (2004).
102 Minn. Stat. §§17.4982, 18B.285, §18B.01, 18F.01-.13 (2003).
103 Wis. Stat. §146.60 (2002).
104 California Fish & Game Code §15007 (2003) and Dept. of Fish and Game §671.1.
105 AK Food & Drug Code §17.20.040 (2005).
106 Alaska salmon fisheries benefit from releases of salmon from hatcheries which grow-out in the ocean and enhance
wild stocks.
107 Gunnar Knapp, Cathy A. Roheim, and James L. Anderson, The Great Salmon Run: Competition Between Wild and
Farmed Salmon, Traffic North America, Washington DC, January 2007. Hereinafter cited as the Great Salmon Run
2007.
108 Great Salmon Run 2007. p. 213.
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in turn may affect salmon production. Major categories of drivers include the regulatory
framework, production, markets, and the public (Figure 1).109
Figure 1. Driving Forces of Salmon Production

Source: Davide Menozzi, Cristina Mora, and Alberto Merigo, “Genetically Modified Salmon for Dinner?
Transgenic Salmon Marketing Scenarios,” AgrBioForum, vol. 15, no. 3 (2012).
Although some assume that approval of GE technology will be followed by a rapid increase in
farmed salmon production, it is unlikely that this will occur. At least initially, annual production at
the AquaBounty Panama facility is limited to a capacity of approximately 100 metric tons
compared to current U.S. salmon consumption of approximately 180 thousand metric tons.
Significant production increases would depend on approval of additional sites in salmon
producing regions of the world. The regulatory framework will determine which production
methods would be used and where they are allowed. If only land-based facilities are allowed, then
greater aquaculture production would depend on whether the advantages of using GE salmon
(higher growth rate and feed conversion efficiency) can outweigh the greater costs of land-based
facilities. Currently, the economic viability of most land-based salmon grow-out facilities is
questionable.110 Significant increases in land-based production also may be constrained by the
number of available sites with sufficient water quality and volume. Therefore, the magnitude and
timing of greater salmon production, if it were to occur, would be very uncertain.
Some in the commercial fishing industry have stated that it has successfully educated the public
to discriminate among fish from different sources, such as wild and farmed salmon. On the other
hand, some believe that a publicized escape of GE fish could lead to less public acceptance of
their wild product. To differentiate wild and GE salmon, commercial Alaskan fishermen also have
requested the labeling of GE salmon.111 Some industry groups are concerned that such labeling
might lead consumers to believe that wild fishery products are also genetically engineered and

109 Davide Menozzi, Cristina Mora, and Alberto Merigo, “Genetically Modified Salmon for Dinner? Transgenic
Salmon Marketing Scenarios,” AgrBioForum, vol. 15, no. 3 (2012).
110 Production from salmon land-based systems is insignificant, but the David Suzuki Foundation has advocated for
land-based systems and maintains that they are viable.
111 Erika Bolstad, “Alaskans say GM salmon threatens wild market as public FDA objections top 33,000,” Anchorage
Daily News, March 6, 2013.
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perceived as unsafe for consumption.112 An alternative considered by commercial interests would
involve labeling of wild salmon as a product that was not produced with GE technology.
Consumer Acceptance
It is uncertain whether consumers will accept GE fish, but it appears that a broad segment of the
U.S. population is opposed or at least skeptical of consuming the product.113 GE salmon may taste
the same and are expected, like other Atlantic salmon aquaculture products, to be less expensive
than wild-caught fish. However, food safety issues, ethical concerns over the appropriate use of
animals, and environmental concerns might affect public acceptance of GE fish as food. Ongoing
campaigns by environmental and consumer groups have asked grocers, restaurants, and
distributors to sign a pledge to not sell GE fish products, even if they are approved by FDA.114
Demand for fish products, especially those high in fish oils such as Atlantic salmon, grew quickly
during the past three decades and is expected to continue growing. In the past, aquaculture
productivity gains and reductions in cost have been passed on to the consumer in the form of
lower prices. One study speculated that consumers would require a significant price discount to
purchase the GE salmon product.115 The discount would likely vary by country and depend on
consumer demographic factors such as age.
Production increases could contribute to consumer benefits associated with lower prices and
health benefits from consumption of salmon rather than less healthy protein sources. If GE
salmon can be sold for a relatively low price, it could stimulate salmon consumption in low-
income households.116 Some researchers have questioned whether the potential benefits
associated with the wide use of GE salmon also should be considered as part of the approval
process.117
Congressional Actions
Some Members of Congress have raised concerns about FDA’s approval process for GE salmon.
On April 24, 2013, 20 Members of the House and 12 Members of the Senate sent similar letters
that requested FDA Commissioner Margaret Hamburg halt the approval process.118 In particular,
the letters stated that the FDA process has not been adequate to ensure GE salmon is safe for the

112 See CRS Report RL32809, Agricultural Biotechnology: Background, Regulation, and Policy Issues, by Tadlock
Cowan.
113 Shane O'Halloran, “Consumers not interested in genetically modified salmon,” Food Engineering, April 23, 2013,
pp. http://www.foodengineeringmag.com/articles/90611-consumers-not-interested-in-genetically-modified-salmon.
114 See the Center for Food Safety’s website and featured actions, “Tell Costco to Reject GE Salmon,”
http://www.centerforfoodsafety.org/geneticall3.cfm.
115 Davide Menozzi, Cristina Mora, and Alberto Merigo, “Genetically Modified Salmon for Dinner? Transgenic
Salmon Marketing Scenarios,” AgrBioForum, vol. 15, no. 3 (2012).
116 Martin D. Smith et al., “Genetically Modified Salmon and Full Impact Assessment,” Science, v. 330 (November 19,
2010): 1052-1053. Hereinafter cited as Smith et al. 2010.
117 Smith et al. 2010.
118 Letter from Don Young et al. to Dr. Margaret Hamburg, Commissioner, FDA, April 24, 2013, and Letter from
Senator Mark Begich et al. to Dr. Margaret Hamburg, April 24, 2013.
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environment and consumers. They also expressed concern with the precedent that this ruling
could set for future applications for other genetically engineered fish such as tilapia and trout. If
the agency still proceeds with approval of the product, Members also urged FDA to develop
labeling requirements to distinguish the product as genetically engineered.
Bills focusing on regulating or prohibiting GE salmon have been introduced in the 113th
Congress. S. 246 and H.R. 1667 are similar bills which would make it unlawful to:
(1) ship, transport, offer for sale, sell, or purchase a covered fish (GE fish), or a product
containing a covered fish, in interstate or foreign commerce;
(2) have custody, control, or possession of, with the intent to ship, transport, offer for sale, sell, or
purchase a covered fish, or a product containing covered fish, in interstate commerce;
(3) release a covered fish into a natural environment; or
(4) have custody, control, or possession of a covered fish with the intent to release it into a natural
environment.
The definition of a covered fish under H.R. 1667 would include any finfish while S. 246 would
include salmon, anadromous fish, or marine fish. H.R. 1667 also would explicitly make it illegal
to engage in net-pen culture of covered fish. Both bills would include exceptions for scientific
research, fish collected for the purpose of supporting the act, or if NOAA finds that there would
be no significant impact in accordance with NEPA. The NEPA analysis would have to include an
environmental risk analysis, assessment of best or worst case probabilities of confinement failure,
costs to eradicate escaped covered fish, and assessment of economic damage of escaped covered
fish. Both bills also would require completion of the report on environmental risks associated
with GE seafood products which was required under Section 1007 of the Food and Drug
Administration Amendments Act of 2007 (21 U.S.C. 2106).
H.R. 584 and S. 248 would amend Section 403 of the FFDCA (21 U.S.C. 343) by adding a
requirement to label products which contain genetically engineered fish. H.R. 1699 and S. 809
would require labeling of genetically engineered foods including fish. On May 22, 2013, S.Amdt.
965 to S. 954 was proposed and would have required that any food offered for sale have a label
indicating that the food contains a genetically engineered ingredient. On May 23, 2013, the
amendment was defeated by a vote of 27-71.
In the 112th Congress, several bills also were introduced to address concerns related to GE fish
including House and Senate bills which would have required labeling of GE fish (S. 229, H.R.
520, and H.R. 3553), deemed GE fish as unsafe for human consumption (S. 230 and H.R. 521)
and prohibited the sale of GE fish (S. 1717). On June 16, 2011, Section 744 of H.R. 2112 was
passed by the House which would have prohibited the FDA from spending FY2012 funds to
approve any application for GE salmon. On September 7, 2011, the Senate Committee on
Appropriations reported H.R. 2112 without the prohibition on FDA spending (S.Rept. 112-73),
and the provision was not included in the subsequently enacted P.L. 112-55. On May 24, 2012,
S.Amdt. 2108 to S. 3187 was defeated, which would have prohibited approval of GE fish by FDA
unless NOAA concurred with such approval. No further action was taken on any of these bills
during the 112th Congress.
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Future Considerations
Some have asserted that the FDA’s approach to GE salmon evaluation fails to consider the full
scope of potential impacts or to fully assess the risk of unintended consequences. They claim that
neither the VMAC nor the EA have fully considered the broader potential risks of AquAdvantage
salmon approval. They have argued that FDA is not suited to undertake biological and ecological
studies of this nature and they question whether the regulatory system has kept pace with
advances in GE technology. They support development of a comprehensive EIS to more fully
assess the broader context of social, economic, and environmental implications of GE salmon.
FDA has evaluated GE salmon as a new animal drug which is safe for human consumption.
Regulation of transgenic animals as NADs, however, suggests to some observers (e.g., the Center
for Food Safety, Union of Concerned Scientists) the inherent weakness of existing regulatory
structures to respond adequately to the complexities that arise with animal biotechnology
innovations.119 An immediate issue is whether AquaAdvantage salmon should be subject to a
more rigorous assessment as a food additive by FDA’s Office of Food Additive Safety. Some
might argue that the NAD assessment has already covered issues related to food safety and found
that GE salmon are essentially the same as non-GE salmon. However, in addition to ensuring the
safety of GE salmon further assessment could reassure consumers and retailers who are skeptical
of the new technology, and more rigorous assessment would set a precedent for future products
which may warrant greater scrutiny.
Some have expressed concerns that a continued delay signals that the United States might cede its
leadership position in agricultural biotechnology. Rejection of the AquaBounty application would
send the message that science-based regulatory oversight is subject to political intervention.120
Other countries which are likely to commercialize this technology may be less concerned with
potential environmental effects. GE technology is likely to be adopted for aquaculture in other
parts of the world and according to the FDA, implications of GE salmon disapproval in the
United States and adoption of the technology elsewhere are unknown.121 Aquabounty has reported
that they have spent $50 million developing the technology and in applying for approval. Some
would question whether technology industries in the United States will continue to attract
investors and compete with companies in other parts of the world when there is such a long and
uncertain approval process.
AquAdvantage salmon is likely to be the first of many transgenic candidates for commercial
aquaculture production, and some question whether this case will establish a proper or useful
precedent for future assessment of this technology.122 Some scientists assert that the FDA decision
involves broader social costs and benefits of using genetic engineering and support wide-ranging
interdisciplinary evaluation of GE salmon approval.123 According to one group of researchers,

119 See Center for Food Safety website, at http://www.centerforfoodsafety.org/geneticall7.cfm; and the Union of
Concerned Scientists website, at http://www.ucsusa.org/food_and_agriculture/.
120 Alison L. Van Eenennaam, William M. Muir, and Eric M. Hallerman, “Is Unaccountable Regulatory Delay and
Political Interference Undermining the FDA and Hurting American Competitiveness?,” Food and Policy Forum, vol. 3,
no. 13 (July 24, 2013).
121 Draft Environmental Assessment 2012.
122 Smith et al. 2010.
123 Smith et al. 2010.
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assessment of long-term changes related to GE salmon will require the interrelated study of
production systems, markets, consumer acceptance, and regulatory framework.124 They also
would include assessment of potential long-term changes associated with the wide use of GE
salmon in major salmon-producing countries. Generally, it appears that many would prefer a
comprehensive analysis rather than a piecemeal approach as new culture methods and areas are
proposed by successive applications. Whether the current process affords adequate safeguards for
the public while allowing for the application of new genetic technologies remains an open
question.

Author Contact Information

Harold F. Upton
Tadlock Cowan
Analyst in Natural Resources Policy
Analyst in Natural Resources and Rural
hupton@crs.loc.gov, 7-2264
Development
tcowan@crs.loc.gov, 7-7600



124 David Menozzi, Christena Mora, and Alberto Merigo, “Genetically Modified Salmon for Dinner? Transgenetic
Salmon Marketing Scenarios,” AgBioForum, vol. 15, no. 3 (2012).
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