[Senate Hearing 112-463]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 112-463

                        ENVIRONMENTAL RISKS OF 
                      GENETICALLY ENGINEERED FISH

=======================================================================

                                HEARING

                               before the

     SUBCOMMITTEE ON OCEANS, ATMOSPHERE, FISHERIES, AND COAST GUARD

                                 of the

                         COMMITTEE ON COMMERCE,
                      SCIENCE, AND TRANSPORTATION
                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                           DECEMBER 15, 2011

                               __________

    Printed for the use of the Committee on Commerce, Science, and 
                             Transportation




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       SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

            JOHN D. ROCKEFELLER IV, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii             KAY BAILEY HUTCHISON, Texas, 
JOHN F. KERRY, Massachusetts             Ranking
BARBARA BOXER, California            OLYMPIA J. SNOWE, Maine
BILL NELSON, Florida                 JIM DeMINT, South Carolina
MARIA CANTWELL, Washington           JOHN THUNE, South Dakota
FRANK R. LAUTENBERG, New Jersey      ROGER F. WICKER, Mississippi
MARK L. PRYOR, Arkansas              JOHNNY ISAKSON, Georgia
CLAIRE McCASKILL, Missouri           ROY BLUNT, Missouri
AMY KLOBUCHAR, Minnesota             JOHN BOOZMAN, Arkansas
TOM UDALL, New Mexico                PATRICK J. TOOMEY, Pennsylvania
MARK WARNER, Virginia                MARCO RUBIO, Florida
MARK BEGICH, Alaska                  KELLY AYOTTE, New Hampshire
                                     DEAN HELLER, Nevada
                    Ellen L. Doneski, Chief of Staff
                   James Reid, Deputy Chief of Staff
                Todd Bertoson, Republican Staff Director
           Jarrod Thompson, Republican Deputy Staff Director
   Rebecca Seidel, Republican General Counsel and Chief Investigator
                                 ------                                

     SUBCOMMITTEE ON OCEANS, ATMOSPHERE, FISHERIES, AND COAST GUARD

                     MARK BEGICH, Alaska, Chairman
DANIEL K. INOUYE, Hawaii             OLYMPIA J. SNOWE, Maine, Ranking
JOHN F. KERRY, Massachusetts         ROGER F. WICKER, Mississippi
BILL NELSON, Florida                 JOHNNY ISAKSON, Georgia
MARIA CANTWELL, Washington           JOHN BOOZMAN, Arkansas
FRANK R. LAUTENBERG, New Jersey      MARCO RUBIO, Florida
AMY KLOBUCHAR, Minnesota             KELLY AYOTTE, New Hampshire
MARK WARNER, Virginia                DEAN HELLER, Nevada
















                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on December 15, 2012................................     1
Statement of Senator Begich......................................     1
Statement of Senator Snowe.......................................     3

                               Witnesses

Dr. Ron L. Stotish, President and Ceo, Aquabounty Technologies, 
  Inc............................................................     5
    Prepared statement...........................................     7
John Epifanio, Ph.D., Fish Conservation Geneticist, Illinois 
  Natural History Survey and University of Illinois..............    28
    Prepared statement...........................................    30
George H. Leonard, Ph.D., Aquaculture Program Director, Ocean 
  Conservancy....................................................    32
    Prepared statement...........................................    34
Paul Greenberg, Author of ``Four Fish: The Future of the Last 
  Wild Food''....................................................    46
    Prepared statement...........................................    48

                                Appendix

Hon. John D. Rockefeller IV, U.S. Senator from West Virginia, 
  prepared statement.............................................    69
Response to written questions submitted to Dr. Ron Stotish by:
    Hon. John D. Rockefeller IV..................................    70
    Hon. Maria Cantwell..........................................    71
    Hon. Mark Begich.............................................    73
    Hon. Roger F. Wicker.........................................    74
Response to written questions submitted to John Epifanio, Ph.D. 
  by:
    Hon. Maria Cantwell..........................................    77
    Hon. Mark Begich.............................................    78
    Hon. Roger F. Wicker.........................................    79
Response to written questions submitted by Hon. Roger F. Wicker 
  to George H. Leonard, Ph.D.....................................    80
Response to written questions submitted by Hon. John D. 
  Rockefeller IV to Tom Iseman...................................    84
Response to written questions submitted to Paul Greenberg by:
    Hon. Maria Cantwell..........................................    85
    Hon. Roger F. Wicker.........................................    85
Letter dated December 14, 2011 to Hon. Mark Begich and Hon. 
  Olympia Snowe from Sean Parnell, Governor, State of Alaska.....    87
Executive Summary of Report entitled ``American Consumers' 
  Finfish-Purchasing Behaviors at the Retail Level'' submitted by 
  SeafoodSource.com..............................................    88
Letter dated December 13, 2011 to Hon. Jay Rockefeller, Hon. Mark 
  Begich, Hon. Kay Bailey Hutchison, and Hon. Olympia Snowe from 
  James C. Greenwood, President and CEO, Biotechnology Industry 
  Organization...................................................    89

 
                        ENVIRONMENTAL RISKS OF 
                      GENETICALLY ENGINEERED FISH

                              ----------                              


                      THURSDAY, DECEMBER 15, 2011

                               U.S. Senate,
Subcommittee on Oceans, Atmosphere, Fisheries, and 
                                       Coast Guard,
        Committee on Commerce, Science, and Transportation,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:57 a.m. in 
room SR-253, Russell Senate Office Building, Hon. Mark Begich, 
Chairman of the Subcommittee, presiding.

            OPENING STATEMENT OF HON. MARK BEGICH, 
                    U.S. SENATOR FROM ALASKA

    Senator Begich. Thank you very much. Thanks for being 
patient. I apologize.
    We were notified last night that we would have our Ninth 
Circuit judge up this morning, so we had to go down and put 
that on the record, this morning at 10:30, and I apologize for 
the delay.
    Welcome to the Senate. Nothing's on time, and nothing's 
scheduled, but yet we have a schedule.
    So, thank you all very much. Thank you very much and 
welcome to the hearing. And, again, thank you for being patient 
while I got here. And I know other members may attend as we 
move through the hearing this morning.
    Usually when we have a hearing about fish, we're 
considering the economic and environmental aspects of taking 
fish out of the ocean.
    Today we are here to talk about the economic and 
environmental impacts of adding a completely new type of fish 
that was created in a laboratory into our oceans.
    As I speak, the Food and Drug Administration is considering 
a landmark decision: whether to allow the first genetically 
engineered animal to be produced and sold for human 
consumption.
    This animal has been created in a lab by mixing the genes 
from three separate fish species. The result is a genetically 
engineered Atlantic Salmon that is said to grow much faster 
than the regular Atlantic Salmon.
    The company calls the lab created fish AquAdvantage salmon. 
Others have given the nickname ``Frankenfish.'' Whatever you 
call it, when we are talking about this genetically engineered 
fish, we are talking about the entire future of wild fish and 
fisheries.
    The stakes are high. If these fish were to get out into the 
wild, they could wreak untold havoc on our marine and 
freshwater ecosystems.
    Although the company that has created the fish says that 
they have taken precautions to make sure the fish don't escape, 
the prudent and responsible approach for us to take here is to 
assume that fish will escape. We have plenty of examples where 
non-native fish have escaped into the wild and wreaked 
environmental havoc. Look at the huge economic and 
environmental impacts from the uncontrolled spread of the Asian 
carp in the Great Lakes region. We have been trying to contain 
the spread of these fish for over a decade with little success.
    The lesson that we should take from this and other examples 
is that non-native fish can, and will, get out in the wild. And 
once they are out, they are impossible to contain.
    Now think about genetically engineered fish that have only 
existed in labs, and have never existed in the wild. As you can 
imagine, it's very difficult to assess the environmental 
impacts from fish that have never existed before now. And the 
FDA is now asked to carry out an impossible task of trying to 
assess the food safety and environmental impact of genetically 
engineered fish.
    We'll leave it to the Food and Drug Administration to 
assess the food safety aspects, but I'm not convinced that this 
agency has the scientific expertise to adequately assess the 
environmental aspects.
    Looking at the available science, scientific information, 
it is clear that there is no guarantee that these GE fish--
genetically engineered fish--won't ever escape into the wild. 
And there is an alarming degree of scientific uncertainty about 
the environmental risk of these fish if they do escape.
    I feel that America's wild salmon stock and aquatic 
ecosystems are too important to allow them to be guinea pigs in 
what will amount to basically a huge experiment with GE fish in 
our waters.
    That is why I've introduced Senate bill 1717--the 
Prevention of the Escapement of Genetically Altered Salmon in 
the United States Act, which will prohibit the sale of 
Frankenfish within the United States.
    This prohibition will still allow research and development 
of genetically engineered fish for purposes such as medical 
research.
    My bill seeks to prevent the release of GE salmon and other 
marine fish into the wild until we have enough scientific 
evidence to show that the GE fish can be produced without risk 
to our Nation's wildfish stocks and aquatic environments.
    By introducing this bill, I'm simply asking for more time--
more science to be done before we make a decision that could 
have such enormous impacts to the environment.
    We have convened a panel of experts here today, so that we 
can have a clear-eyed discussion of the environmental risk of 
escapement of genetically engineered fish.
    I would also like to hear some ideas on how we can 
strengthen the Federal approval process so that all of the 
necessary scientific information is considered when assessing 
the environmental risk of producing GE fish for food.
    We have four individuals today who will be testifying at 
this hearing, but before I introduce them I would like to ask 
if the Ranking Member, Senator Snowe, would like to say a few 
words.

              STATEMENT OF HON. OLYMPIA J. SNOWE, 
                    U.S. SENATOR FROM MAINE

    Senator Snowe. Thank you, Mr. Chairman, for calling this 
hearing today to explore the environmental risk posed by 
commercial aquaculture of genetically engineered salmon.
    The case study we will examine today, the AquaBounty 
AquAdvantage salmon would be the first genetically engineered 
animal approved for human consumption, if approved by the Food 
and Drug Administration.
    We will not be examining the food safety implications here, 
and rather will focus on the potential impact should these fish 
escape from their confined grow-out facilities and interact 
with wild salmon stocks or with traditional aquaculture 
operations.
    For Maine, these risks cannot be understated. Wild-caught 
fisheries are a fundamental part of our heritage. Our Atlantic 
salmon runs have a storied history even here in Washington.
    For over 100 years, the first Maine salmon caught each year 
would be presented to the president by the Maine congressional 
delegation. I was honored to participate in that rite of 
spring.
    Sadly, this proud tradition came to an end in 1992 as 
populations declined to the point they were unable to sustain 
even a catch-and-release recreational fishery.
    Atlantic salmon in eight rivers, many of them in 
easternmost Washington County, have been listed as endangered 
under the Endangered Species Act since 2000. In 2009, the 
designation was expanded to include all salmon populations in 
the watersheds of our three major river systems: the Penobscot, 
the Kennebec, and the Androscoggin.
    Despite yeoman efforts at Maine's Atlantic salmon 
hatcheries, in a landmark restoration plan for the Penobscot, 
only 1,316 spawning fish returned to that river last year--far 
fewer than would be necessary to support a healthy wild 
population.
    With so much uncertainty about the impact an escaped 
genetically engineered fish could have on the wild population 
we've gone to such lengths to protect, clearly we must proceed 
cautiously.
    Aquaculture has long been an integral part of sustaining a 
coastal economy as well. Gross revenues from Maine salmon 
aquaculture totaled $76.8 million in 2010, second only to, and 
approximately a quarter of the value of, Maine's iconic lobster 
fishery revenues last year.
    What is truly striking is the fact that salmon production 
in Maine has tripled over the last 4 years with over 24 million 
pounds harvested, and it is expected to continue growing.
    Downeast Maine, where this industry thrives, is the hub of 
a growing biotechnology sector in the state. For communities 
that have worked on the water for generations, aquaculture is 
an innovative job creator that has huge potential to create 
economic growth in a rural region.
    The application currently pending for AquAdvantage salmon 
is precedent setting, and should be treated accordingly. We 
have a unique opportunity at this moment to ensure that the 
regulatory framework used to assess this new technology is 
vigorous enough to provide a complete picture of all the 
possible benefits and detriments of creating a new living 
creature.
    It is imperative that we require a thorough application and 
review process so that the American people have confidence that 
their interests, and those of the living marine resources held 
in the public trust, are being protected.
    The fact is, Congress has never legislated on the 
regulatory framework for approval of a GE animal, nor has the 
Food and Drug Administration created a process specifically 
designed to assess the risks to the environment, to marine 
fish, or to human health that may be posed by these new 
products.
    To the contrary, the FDA is using an approval process 
originally created to review new animal drugs that the agency 
has interpreted to include genetically engineered or modified 
fish.
    This is an outdated and inadequate approach to evaluating a 
technology of this magnitude.
    I have supported efforts to establish a rigorous approval 
process before the introduction of these animals into commerce, 
and am strongly committed to continuing that work.
    Specifically, I have called upon the FDA to halt their 
approval process until the agency of Congress establishes a 
transparent and comprehensive review process for genetically 
engineered animals.
    Opportunities for public comment should be built in so that 
the industries and stakeholders who may be affected by the 
development of GE salmon have an opportunity to be heard. 
Undoubtedly, this process should also include meaningful 
consultation with the National Oceanic and Atmospheric 
Administration, otherwise known as NOAA.
    FDA should be capitalizing on NOAA's expertise in marine 
ecology, aquaculture, and the protection of threatened and 
endangered living resources by engaging NOAA in a formal, 
consultative process.
    So I look forward to working with you, Mr. Chairman, our 
colleagues, and also as well listening to our witnesses here 
today to further advance our knowledge on what is the best 
approach to take. Thank you.
    Senator Begich. Thank you very much, Senator Snowe.
    Let me introduce our panel. We first have Dr. Ron Stotish, 
President and CEO of AquaBounty Technologies.
    Next we'll have John Epifanio, a molecular ecologist, 
Illinois Natural History Survey; Dr. George Leonard, 
Aquaculture Program Director, Ocean Conservancy; and Mr. Paul 
Greenberg, journalist and author--most recently of the 
bestselling book Four Fish: The Future of the Last Wild Food.
    Let me--we're going to go from this side over, so let me 
first start with Dr. Ron Stotish, if you could go ahead.
    And we have 5 minutes for each of you and then we'll engage 
in questions. The way we kind of do this is we are formal but 
informal in our Q&A. Sometimes you'll see us just kind of going 
back and forth--that's how we kind of operate at the 
Subcommittee here.
    Dr. Stotish.

STATEMENT OF DR. RON L. STOTISH, PRESIDENT AND CEO, AQUABOUNTY 
                       TECHNOLOGIES, INC.

    Dr. Stotish. Thank you very much, Mr. Chairman, and Senator 
Snowe.
    I appreciate the opportunity to appear before you this 
morning to discuss, in the context of Senate 1717, whether the 
AquAdvantage salmon that is the subject of a pending 
application before the Food and Drug Administration would 
present a risk to the environment if marketed.
    I am the Chief Executive Officer and President of 
AquaBounty Technologies, the sponsor of the application. I can 
assure you I would not be here before you today if we had not 
been able to provide the FDA with dispositive science-based 
evidence addressing environmental concerns.
    In my brief remarks this morning, I will summarize that 
evidence.
    But first let me tell you a little about our company. 
AquaBounty Technologies is a biotechnology company 
headquartered in Waltham, Massachusetts. We have 27 current 
employees and have facilities in San Diego, California, 
Waltham, Prince Edward Island, Canada, and St. John's, 
Newfoundland.
    Among our employees are many respected scientists. We also 
have a leased facility in Panama which is part of our 
development program for AquAdvantage.
    The AquAdvantage salmon is an Atlantic salmon, which has 
been modified by the insertion of a gene construct containing 
the growth hormone gene from the Chinook salmon.
    The original construct was made over 20 years ago, and a 
line of rapidly growing salmon has been maintained over 10 
generations in our hatchery.
    We've conducted a detailed series of specific regulatory 
studies defining the detailed biological characteristics of 
AquAdvantage salmon, and submitted those--the results of those 
studies to the FDA.
    We've made the results of those studies public and 
available for scrutiny nearly 16 months ago.
    You may be aware that over 170 pages of data, the results 
of the center's review, and an 84-page draft environmental 
assessment prepared by the firm was released in August of 2010.
    The FDA''s center for veterinary medicine has concluded 
that the AquAdvantage salmon, in addition to being 
indistinguishable from Atlantic salmon, is an Atlantic salmon, 
and that the food from AquAdvantage salmon is the same as food 
from any other Atlantic salmon.
    CVM has determined that the genetic change does not harm 
the fish, and is safe for the consuming public. It's also 
determined that the data and the information we have provided, 
as well as the conditions and controls we propose to implement, 
that would be required upon approval of any application, 
provide meaningful assurance that the AquAdvantage salmon are 
not expected to have a significant impact on the quality of the 
human environment in the United States or in foreign countries.
    Atlantic salmon are perhaps the most intensively farmed 
fish in the world, and with the exception of a small wild-
caught industry off the coast of Iceland, there are no wild-
caught Atlantic salmon fisheries. There are sport fisheries and 
recreational fisheries, as you've pointed out.
    The United States currently imports more than 97 percent of 
the Atlantic salmon consumed from countries like Chile, Norway, 
Canada, Scotland, and the Faroe Islands.
    Conventional aquaculture produces Atlantic salmon in sea 
cages, a practice that has a variety of environmental, 
ecological, and economic consequences.
    The availability of a more rapidly growing Atlantic salmon, 
for example, the AquAdvantage salmon, could facilitate land-
based cultivation of this species, much like trout, catfish, 
and tilapia, reducing the cost and environmental impact of 
transportation, as well as reducing the environmental 
consequences of sea cage cultivation.
    In sum, the AquAdvantage salmon, when approved, would in 
all likelihood, approve the sustainability of salmon 
aquaculture, reduce imports, and create an opportunity for 
economic development in the United States.
    Some additional facts may be helpful in your inquiry.
    In anticipation of concerns of potential impacts of our 
products on biological diversity and the environment, we 
attempted to mitigate any possible risk in advance.
    Our hatchery is designed with multiple redundant physical 
barriers that prevent escape of any life stage. We've operated 
this hatchery for more than 15 years, been inspected on 
multiple occasions by a variety of Federal agencies from two 
countries, and have never lost a single fish.
    Our product is designed so that it is all female, and 
triploid, meaning the fish cannot successfully reproduce.
    Last, because of their rapid growth phenotype, they can be 
economically reared in land-based, physically contained 
facilities that prevent release and interaction with the 
environment.
    In the proposed site in Panama for the growth of the fish--
there are additional geographical and geophysical barriers that 
make survival in the environment essentially impossible.
    It is also of interest to note that the Atlantic salmon 
cannot breed with Pacific salmon or Alaskan salmon. They are 
distinct species.
    Time constraints limit my ability to provide more details, 
but in my written testimony, which I hereby submit, contain the 
technical explanation and analysis, including the summary of 
the environmental assessment, an analysis of the production and 
deployment of our product candidate.
    Let me, though, add that recent publications have appeared 
in ecology and environmental research. These publications 
conclude that the traits of our rapidly growing salmon reduce 
the reproductive fitness of the fish. Said another way, even if 
fertile adults were introduced into the wild population, the 
rapid growth phenotype would be a selective disadvantage and 
would not spread into the wild population.
    I would point out that this would be a lower risk to 
biodiversity than the current practice. The references are 
contained in my written testimony.
    CVM has publicly stated that any additional productionsites 
would be separately approved by FDA, and must be the subject of 
individual environmental assessments and CVM preapproval 
inspection.
    Simply put, although the regulatory procedures for 
approving AquAdvantage and for approving any new site for the 
production of this fish are complex, they unquestionably 
provide rigorous public health and environmental precautions 
and protections.
    We believe our technology and our product are timely 
examples of American and Canadian innovation. We believe it 
will create additional opportunities and further the interest 
of global food security.
    Our application also represents an opportunity to validate 
the important American principle of science-based regulation.
    I would be pleased to take your questions later.
    [The prepared statement of Dr. Stotish follows:]

    Prepared Statement of Dr. Ronald L. Stotish, President and CEO, 
                     AquaBounty Technologies, Inc.
1.0 Introduction
    AquaBounty is seeking FDA approval for a genetically modified 
Atlantic salmon with enhanced growth characteristics. The enhanced 
growth phenotype enhances the economics of land-based production of 
Atlantic salmon, overcoming many of the practical and environmental 
issues associated with conventional sea cage aquaculture of this 
species. The United States currently imports approximately 300,000 
metric tons of Atlantic salmon each year from a variety of foreign 
producing countries, but produces less than 17,000 metric tons from 
aquaculture. The ability to produce Atlantic salmon in land based 
aquaculture systems in the U.S. could reduce our dependence upon 
foreign sources, and create a U.S. based industry with the accompanying 
jobs and economic development opportunities. The availability of a 
fresh and desirable Atlantic salmon product closer to U.S. consumers 
would also reduce the sizeable ``carbon footprint'' associated with 
transport of large volumes of this food over great distances as is the 
current practice. Lastly, the cultivation of Atlantic salmon would not 
likely impact the wild caught Alaskan salmon fishery market as this 
product is well positioned both with respect to brand and price. The 
current wild Alaskan salmon catch has been stable at approximately 
300,000 tons per year, with approximately 60 percent of this product 
exported to Japan, China and other overseas markets; the remaining 
Alaskan wild caught salmon satisfies approximately 26 percent of the 
total market demand for salmon in the US, and is a well differentiated 
marketed product. Interestingly, in the management of the Alaskan wild 
caught fisheries, five billion smolts are released into the Pacific 
Ocean each year from Alaskan hatcheries (Alaska Fish & Wildlife).
    AquAdvantage Salmon is a genetically engineered (GE) Atlantic 
salmon with a rapid-growth phenotype that has been developed over the 
past 15 years. The genetic modification comprises one copy of a salmon 
growth hormone transgene that is stably integrated at a specific site 
in the genome in a line of Atlantic salmon. Triploid AquAdvantage 
Salmon eggs for are produced in a manner that results in the culture of 
an all-female population of reproductively sterile fish that are 
otherwise substantially equivalent to farmed Atlantic salmon. The 
monosex nature of the population derives from the use of a breeding 
strategy that is 100 percent effective; and the induction of triploidy, 
which renders the animal reproductively incapable, is achieved using a 
validated method that is more than 99 percent effective at commercial 
scale. The product is intended for the contained, land-based culture of 
Atlantic salmon for commercial sale and human consumption under the 
following specific conditions: production of eyed-eggs in Canada; 
shipment of eyed-eggs to Panama; grow-out and processing of fish in 
Panama; and, shipment of table-ready, processed fish to the United 
States for retail sale.
    Assessment of the potential risks to the environment from 
AquAdvantage Salmon involves consideration of the likelihood and 
consequences of the fish escaping, becoming established in the 
environment, and spreading to other areas. If the likelihood of these 
events, which are analogous to ``exposure'' in the traditional risk 
assessment paradigm, is zero or close to zero, it is reasonable to 
conclude that the consequences of these events, which are analogous to 
the ``effects,'' are not of concern. In other words, if there is no 
exposure, there is no risk. The likelihood of escape, establishment, 
and spread of AquAdvantage Salmon is effectively zero due to redundant 
containment measures, including physical, physicochemical, geographic/
geophysical, and biological measures that are being implemented at the 
sites of egg production and grow-out. The combination of these various 
methods results in a very high degree of control. Physical containment 
measures include multiple mechanical barriers to prevent escape (e.g., 
screens, filters, etc.). A strong management operations plan ensures 
that these containment measures are reliably implemented. Geographical 
and geophysical containment is provided by the location of the egg 
production and grow-out sites: the environment surrounding the egg-
production site in Canada is inhospitable to early-life stages of 
Atlantic salmon due to high salinity; and, the environment downstream 
of the grow-out site in Panama is inhospitable to all life stages of 
Atlantic salmon due to high water temperatures, poor habitat, and 
physical barriers (e.g., several hydro-electric facilities). Biological 
containment is accomplished through the grow-out of all-female triploid 
(sterile) fish, which significantly reduces the risk of transgene 
propagation in the environment. The domesticated nature and lack of 
competitive fitness in the wild relative to native fish also 
constitutes a formidable barrier to survival and spread in the wild.
    In summary, production and rearing of AquAdvantage Salmon will 
involve simultaneous, multiple, and redundant containment strategies of 
various types that serve to adequately mitigate the environmental risk. 
These measures consist of producing triploid, all-female salmon that 
will be reared in a land-based aquaculture system itself possessed of 
redundant physical containment measures engineered and managed to 
confine the fish to the culture systems. Furthermore, the facilities 
are located in geographical areas that are highly unfavorable to the 
survival, establishment and spread of AquAdvantage Salmon, should there 
be an escape. Consequently, the environmental risk associated with the 
production and grow-out of AquAdvantage Salmon under the conditions 
described is as low as can be reasonably expected.
2.0 Product and Production
2.1 Product Definition
    The AquAdvantage Salmon to be sold into commerce is a triploid 
Atlantic salmon bearing a single copy of a stably integrated transgene 
(termed opAFP-GHc2) at a specific location in the genome (the a-locus) 
in a specific line of salmon (the EO-1a line). The product subject to 
regulatory approval is an eyed-egg produced in Canada and delivered to 
Panama for grow-out to market size and processing, pursuant to retail 
sale in the United States. The opAFP-GHc2 transgene is a recombinant 
DNA construct comprising the coding sequence from a Chinook salmon 
growth hormone gene and regulatory sequences (the switches that turn on 
the growth hormone gene) from the gene encoding the ocean pout anti-
freeze protein. The founder animal from which the AquAdvantage line 
derives was a transgenic female (EO-1) generated by injecting the 
transgene into the fertilized eggs of wild Atlantic salmon. Two rapidly 
growing transgenic progeny were selected for further development. The 
breeding of eight subsequent generations has led to the establishment 
of an AquAdvantage Salmon line (EO-1a) which bears a single copy of the 
integrated transgene. The broodstock used in spawning of AquAdvantage 
Salmon are homozygous females (i.e., having two copies of the 
transgene) that have been phenotypically sex-reversed for breeding 
purposes. These so-called neomales are bred with non-transgenic female 
Atlantic salmon to produce eggs containing a single-copy of the 
transgene. The fertilized eggs resulting from the cross are pressure-
shocked to induce triploidy, a process which renders the fish sterile. 
Therefore, the salmon deriving from these eggs are females incapable of 
reproduction. The fish that develop from these eggs have an enhanced 
growth rate compared to non-transgenic Atlantic salmon.
    In evaluating potential environmental risk associated with the 
construct itself, three specific elements of genetic engineering were 
taken into consideration: the selection of genes and promoters from 
fish; the removal of antibiotic resistance genes; and, the avoidance of 
viral vectors and transposons. The AquAdvantage construct employs a 
salmon growth hormone gene and a fish-derived promoter from the ocean 
pout. The use of an all-fish gene transfer cassette suitable for gene 
transfer in other fish avoids issues with genes and genetic materials 
from other groups of organism (Du et al., 1992a). The vector used to 
prepare the AquAdvantage construct was a bacterial plasmid called 
pUC18. Because the plasmid was purified from the transgene prior to 
injection into the salmon eggs, no bacterial genes were introduced into 
the genome of AquAdvantage salmon. Viral vectors and transposons were 
not used in the AquAdvantage construct to improve transgene integration 
efficiency. The absence of viral vectors and transposons eliminates a 
major mechanism for unexpected movement of genetic material within the 
genome of the GE fish or transfer to other unrelated species.
2.2 Technical Details and Logistics of Commercial Production
2.2.1 Development of AquAdvantage broodstock
    In order to produce AquAdvantage broodstock, eggs from AquAdvantage 
females with two copies of the transgene are subjected to gynogenesis, 
an established reproductive method that generates an all-female 
population. These female fish are then sex-reversed to produce 
neomales. Neomales are genetic females (thus possessing no Y 
chromosome) that produce sperm, and produce only female progeny when 
crossed with a female. These AquAdvantage (neomale) broodstock are 
reared to sexual maturity and bred with nontransgenic females to 
produce 100 percent female offspring. All broodstock and egg production 
takes place at the production facility in Prince Edward Island (PEI).
2.2.2 Maintenance of AquAdvantage Broodstock for Commercial 
        Manufacture
    Subsequent generations of AquAdvantage broodstock can be derived 
from existing neomales with two copies of the transgene by using the 
milt from those animals to fertilize eggs from females with two copies 
of the transgene. The offspring are sex-reversed, graded, tagged, and 
genotype confirmed prior to their use as AquAdvantage broodstock.
2.2.3 Production of AquAdvantage Eyed-Eggs for Commercial Sale
    The AquAdvantage neomales are bred with non-transgenic females to 
produce fertilized egg populations that are 100 percent AquAdvantage 
females with a single copy of the transgene. Triploidy in the eggs is 
then induced by pressure shock to render the animal sterile. The eyed-
eggs will be incubated for at least 325 deg-days, at which time batch-
wise sampling will be done to confirm the successful induction of 
triploidy via flow cytometry (FACS) prior to quality control (QC) 
approval for commercial sale. The eggs will then be transferred to the 
approved grow out site in Panama. The production plan is defined in 
Figure 1.
    For production details, see the briefing packet prepared by U.S. 
FDA (Food and Drug Administration Center for Veterinary Medicine, 2010, 
p 51-60).


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



    Figure 1. Production plan for AquAdvantage Salmon.
3.0 Environmental Risk
    The environmental assessment of AquAdvantage Salmon has 
incorporated an ecological risk assessment approach, modified for the 
consideration of GE organisms as described by the National Research 
Council (NRC, 2002). Ecological risk assessment ``evaluates the 
likelihood that adverse ecological effects may occur or are occurring 
as a result of exposure to one or more stressors'' (U.S. Environmental 
Protection Agency, 1992). Inherent in this definition is that both 
exposure and effects are required components of risk, i.e., Risk = 
Exposure x Effects. Muir (2004) has presented a modification of this 
concept for the risk assessment of GE organisms, wherein exposure 
comprises two parts: 1) the probability of the organism escaping into 
the wild, dispersing and becoming feral; and, 2) the ability of the 
transgene to spread into the wild population once it has been 
introduced by an escaped animal. These two parts condense the five 
steps identified by the NRC (2002) and concisely express the two 
requirements for the existence of ecological risk: both exposure and 
effects. Without either, there can be no risk. Redundant measures can 
be taken to ensure that the probability of escape and establishment of 
AquAdvantage Salmon, and of the AquAdvantage transgene spreading, is so 
remote that it is essentially zero. With essentially zero exposure, the 
risk is essentially zero.
    No single containment measure can be assured of 100 percent 
effectiveness. Therefore, optimum containment can be achieved by the 
simultaneous deployment in series of a number of independent 
containment measures. Three to five separate measures have been 
recommended (ABRAC, 1995). The NRC (2002) recommended the simultaneous 
use of multiple, redundant containment strategies for GE fish. By 
combining containment measures with different strengths, attributes and 
modes-of-action, the compromise of aggregate containment by the failure 
of a single measure becomes increasingly unlikely. GE fish are 
considered to pose little risk to native populations if they are 
adequately contained (Mair et al., 2007).
    The major difference between AquAdvantage Salmon and their non-GE 
counterparts is an increased rate-of-growth that is most evident during 
their first year of life. Muir (2004) has observed that the 
environmental risk of GE fish results from a chain of events: escape, 
followed by spread, followed by harm, such that the weakest link 
defines the upper-limit of risk. If the probabilities of any of the 
links can be shown to be close to zero, it is not necessary to quantify 
all of the risks.
    A number of questions are pertinent when considering the 
environmental hazards of GE salmon (Muir, 2004; Kapuscinski et al., 
2007):

   Are GE salmon able to escape into the environment?

   If an accidental escape occurred, could GE salmon survive in 
        the surrounding environment and compete with wild salmon (and 
        escaped domestic nontransgenic salmon), or otherwise impact 
        natural or ecological resources of global importance?

   Could the rDNA construct be transmitted to wild salmon, 
        escaped non-GE domesticated salmon, or other species?

   Could GE salmon breed successfully with populations of wild 
        salmon (and escaped domesticated non-GE salmon)?

   Could the offspring resulting from these hypothetical 
        matings adversely affect the population of Atlantic salmon or 
        other ecological resources of global importance?

    These questions are important because populations of wild Atlantic 
salmon are in decline. The potential hazards addressed in this document 
center on the likelihood and consequences of AquAdvantage Salmon 
escaping, becoming established in the environment, and spreading to 
other areas.
3.1 Likelihood of Escape
    For AquAdvantage Salmon, both the production of eyed-eggs and the 
grow-out of the fish are conducted in land-based facilities with 
redundant physical barriers designed to prevent escape. In general, 
fish are among the groups of organisms with a high degree of mobility 
and significant capacity to escape captivity and become feral (NRC, 
2002). They can be highly mobile if the aquatic environment is 
sufficiently hospitable. The use of land based facilities and 
concurrent containment measures can reduce the potential of escape to a 
small fraction of 1 percent.
3.2 Likelihood of Establishment
    The risk assessment paradigm involves the integration of the 
probability of exposure with the probability of harm resulting from 
exposure. In evaluating the environmental concerns associated with GE 
organisms, the National Research Council stated that exposure must be 
more than just release or escape for a GE organism to constitute a 
hazard; rather the GE organism must spread into the community (NRC, 
2002). The NRC (2002) thus defined exposure as the establishment of a 
GE organism in the community, and identified the following three 
variables as important in determining the likelihood of establishment: 
(1) the effect of the transgene on the fitness of the animal within the 
ecosystem into which it is released; (2) the ability of the GE animal 
to escape and disperse into diverse communities; and, (3) the stability 
and resiliency of the receiving community. The components of fitness 
include all attributes of the organism's phenotype that affect survival 
and reproduction. For example, a transgene could increase the 
organisms' adaptation to a wider range of environmental conditions or 
allow it to obtain nutrition from previously indigestible sources. A 
stable receiving community has an ecological structure and function 
that is able to return to the initial equilibrium following a 
perturbation; resiliency is a measure of how fast that equilibrium is 
re-attained (Pimm, 1984). The overall concern is a product of these 
three variables, not the sum; thus if the risk of any one of the 
variables is negligible, the overall concerns would be very low (NRC, 
2002). In order for escapees to survive and proliferate, the accessible 
ecosystem must meet their needs for food, habitat, and environmental 
cues for reproduction. In addition to grow-out sites with all-female 
and >99 percent sterile salmon, escapee AquAdvantage Salmon would 
demonstrate life history characteristics associated with enhanced 
growth that would reduce survival in natural environments, and have 
demonstrated deficiencies in spawning behavior and securing mates.
    As Kapuscinski and Brister (2001) have noted, even if the escaped 
fish were sterile, a type of pseudo-establishment could occur if 
successive waves of large numbers entered the environment, with each 
wave replacing the former as it dies off. This scenario implies 
frequent release of large numbers, which will not be pertinent to 
either the egg production or grow-out sites for AquAdvantage Salmon due 
to the multiple redundant containment measures employed.
    It should be noted that intentional efforts to re-establish 
Atlantic salmon in their native habitats have been largely 
unsuccessful, inclusive of programs targeting Prince Edward Island and 
Lake Ontario, efforts in the latter case have been unsuccessful despite 
more than 100 years of attempting to do so. Moreover, farmed Atlantic 
salmon have not established themselves successfully in the wilds of 
North America (Council on Environmental Quality, 2001), despite the 
fact that they are reared in ocean pens on both coasts. AquAdvantage 
Salmon have no obvious life history advantages to suggest they would be 
any more invasive than conventional farmed Atlantic salmon.
3.3 Likelihood of Spread
    The spread of GE fish would depend upon how many escaped and 
survived, their characteristics, and their reproductive potential. For 
example, highly domesticated fish may be ill-equipped to persist in the 
wild due to the effects of captivity, such as poor adaptation, reliance 
on artificial diets, and rearing at a high stocking density 
(Kapuscinski et al., 2007). The reproductive potential of escapees is 
based upon their survival rate and fertility, and environmental 
conditions affecting reproduction in the affected ecosystem.
3.4 Consequences of Potential Escape, Establishment, and Spread
    There are numerous factors, both genetic and environmental, that 
can influence the ability of AquAdvantage Salmon to affect the 
environment should they escape, survive and spread; these factors may 
have positive or negative impacts, which are further complicated by 
their mutual interaction. However, per the analogy of Muir (2004), it 
is not necessary to quantify the consequences (or harm, or effects) if 
the probability leading to the harm (the exposure) is zero or close to 
zero. The environmental risk posed by GE organisms is similar to that 
of introduced species. As discussed by Kapuscinski and Hallerman 
(1991), ecological impacts of GE individuals would be related to their 
fitness, interactions with other organisms, role in ecosystem 
processes, or potential for dispersal and persistence. With respect to 
their interactions with other organisms, AquAdvantage Salmon would be 
expected to occupy the same ecological niche as wild and domesticated 
Atlantic salmon, and compete for food, shelter, and other resources. As 
will be described later, because AquAdvantage Salmon are cultured as 
sterile females, they will be unable to reproduce. Finally, the 
potential for dispersal and persistence of AquAdvantage Salmon is very 
low due to the multiple redundant biological, physical, geographical 
and geophysical containment measures, as well as likely reduced ability 
to survive in natural ecosystems and reduced reproductive capacity. The 
scale and frequency of introductions of GE fish into a particular 
environment would have a large influence on the potential ecological 
risk. Any introductions would have to include a critical mass to allow 
survival of natural mortality, and would have to be of sufficient 
frequency and occur in the proper season to allow for establishment. 
Kapuscinski and Hallerman (1991) have stated:

        ``Although surprising outcomes cannot be ruled out a priori, 
        low ecological risk may be a reasonable conclusion in 
        situations where phenotypic and ecological attributes of 
        transgenic individuals raise concerns, but the scale and 
        frequency of their introductions are so small that their 
        chances of becoming established in the natural setting are 
        extremely low.''

4.0 Mitigation of Environmental Risk
    It is not necessary to quantify the consequences of the escape, 
establishment and spread of GE salmon if the probability of escape 
leading to the exposure (i.e., establishment and spread) is zero or 
close to zero. Therefore, the use of measures to ensure that the 
exposure is effectively zero is considered the best means of reducing 
the risk. Measures for containment of AquAdvantage Salmon preventing 
exposure are discussed in this section. It is difficult to guarantee 
that 100 percent containment can be achieved by any single method. 
Thus, several different methods are used simultaneously to provide 
redundancy and ensure that the likelihood for escape for GE salmon is 
as close to zero as can be reasonably expected. These measures are: 
biological containment, physical containment, geographical/geophysical 
containment, and life history associated barriers of AquAdvantage 
Salmon to invasiveness.
4.1 Biological Containment
    Biological containment can serve as a barrier by either a) 
preventing any possibility of reproduction at the site, thus avoiding 
risk of escape of gametes, embryos, or larval stages, or b) 
significantly reducing the possibility of reproduction or survival of 
the GE organisms in the unlikely event of an escape.
4.1.1 Induction of Triploidy
    Triploidy as a process is commonly applied to make fish sterile, 
and is used commercially in aquaculture. For example, triploidy is used 
to produce sterile rainbow trout for aquaculture purposes by the 
leading supplier of trout eggs in the world, TroutLodge (an Idaho based 
salmonid genetics company; http://www.trout
lodge.com/index.cfm?pageID=9C4DCE84-3048-7B4D-A93C4B67EECD271F). 
Additionally, all grass carp sold commercially in the United States are 
rendered triploid and sterile, a program monitored by the Fish and 
Wildlife Service (http://www
.fws.gov/warmsprings/FishHealth/frgrscrp.html). Triploidy has two 
fundamental effects on fish physiology (Benfey 2001): (1) the size of 
the cells increases to accommodate the extra genetic material, but the 
number of cells decreases so that triploids are no larger overall than 
diploids; and, (2) gametogenesis and gonadal development is so severely 
impaired that triploids are sterile. Other than their sterility, a 
comprehensive review of the literature conducted by Benfey (1999) 
reveals little difference between triploids and diploids on a whole-
animal level.
    AquaBounty uses triploidy to produce sterile AquAdvantage Salmon. 
One of the most important means of biological containment is the 
sterility of the fish. Thus, even if some AquAdvantage Salmon were to 
escape the grow-out facility and survive in the environment, and find a 
compatible male even though the cultured populations is all-female, 
they would not be able to reproduce if triploid. The induction of 
triploidy is the only accepted method currently available for 
sterilizing fish on a commercial scale. AquaBounty uses this method on 
all eyed-eggs destined for commercial production, achieving an 
induction of triploidy on a commercial scale of 99.8 percent (Food and 
Drug Administration Center for Veterinary Medicine 2010, p 56-57). This 
is significantly greater than the 95 percent minimum level of induction 
of triploidy recommended by FDA (Food and Drug Administration Center 
for Veterinary Medicine 2010, p 50).
    Although the reproductive potential of triploid escaped 
AquAdvantage Salmon would be essentially nil, the method used to induce 
triploidy to eliminate reproductive risk is not perfect. A small 
proportion of AquAdvantage Salmon may remain reproductively capable, 
since the induction process, albeit greater than 99 percent effective 
on average, is not 100 percent in all cases. Of countervailing benefit 
is the fact that the production of all-female populations of 
AquAdvantage Salmon can be accomplished with 100 percent efficiency, 
since the process of gynogenesis offers that guarantee based upon 
reproductive biology.
4.1.2 All-Female Populations
    The commercial deployment of all-female populations has obvious 
advantages in reducing risk of environmental impact and establishment 
of feral populations (Beardmore et al 2001, Devlin et al 2006). If all-
female fish are cultivated in areas where species with which they can 
interbreed are absent, then establishment of feral populations is 
impossible. AquAdvantage Salmon will be cultivated as 100 percent 
female populations in the highlands of Panama, which support no native 
salmonids. This prevents the establishment of feral populations in all 
escape scenarios. Production of 100 percent female populations of 
Atlantic salmon is a well described process that has been practiced for 
almost 30 years (Johnstone and Youngson 1984; Johnstone and MacLachlan 
1994).
    In summary, the combination of triploidy with the production of all 
females, is considered the most reliable for biological containment 
(Donaldson and Devlin, 1996). As stated by Mair et al. (2007)

        ``The production of all-female triploids combines the benefit 
        of almost-guaranteed sterility of any escapees with the reduced 
        risk of disruption of spawning in natural populations that 
        might arise with triploid males.'' Arai (2001) has stated ``All 
        female triploids can be used for effective biological 
        containment of transgenic fish, so as to protect wild 
        populations from contamination with genetically modified 
        fish.''

    Taken together, for commercial production systems like the one in 
Panama, the combination of 100 percent of the AquAdvantage salmon being 
female and at least 99.8 percent of the fish being sterile, plus 
locating grow-out in areas where no native reproductively compatible 
salmonids exist, makes the chance of escapee salmon establishing a 
feral population effectively zero. Nevertheless, physical containment 
in the grow-out facilities has been taken very seriously to mitigate 
the risk of escape.
4.2 Physical Containment
    Physical containment refers to measures implemented on-site, such 
as the use of mechanical devices, either stationary or moving (e.g., 
tanks, screens, filters, covers, nets, etc.), or the use of lethal 
temperatures or chemicals to prevent uncontrolled escape. An important 
component of physical containment is the implementation of Standard 
Operating Procedures (SOPs) to ensure that proper procedures and use of 
devices are followed (Mair et al., 2007). Security measures are also 
needed to prevent unauthorized access, control movement of authorized 
personnel, and prevent access by predators.
    The potential for accidental escape could derive from any of the 
following components of the water system: influent water and makeup 
water; effluent and draw-down water; and, waste slurries collected when 
filters are backwashed, screens scrubbed, or rearing units cleaned by 
siphoning (ABRAC, 1995). In addition, it is important that all 
equipment that comes in contact with live GE animals is properly 
cleaned and drained after each use. The physical containment measures 
are described below for both the sites of egg production (Prince Edward 
Island) and grow-out (Panama).
4.2.1 Panama Grow Out
    There is only one proposed FDA approved site for commercial growout 
of AquAdvantage Salmon anywhere in the world, a site in the highlands 
of Panama. The site is located more than 100 km from the Pacific Ocean, 
at an elevation of approximately 1800 meters. The site is equipped with 
a total of 21 individual containment measures, which maintain the 
salmon in confinement (Table 1; Draft EA for AquAdvantage Salmon, CVM, 
2010). Physical containment to prevent the escape of fish at the grow-
out facility is provided by the use of screens wherever water flows out 
of the system. There are a minimum of 11 sequential physical barriers 
in place between the fish tanks and the nearest natural body of water 
(a river), confining AAS to the site; seven of these barriers are 
positioned posterior to the outflow from the grow-out tanks. In 
addition, netting prevents the fish from being actively removed from 
containment by predators or passively removed in the event of any 
overflow of the water level. The multiple, redundant containment 
measures consist of tanks, screens, filters, stand-pipes, containment 
boxes, netting, and sedimentation ponds (Figure 2; Draft EA for 
AquAdvantage Salmon, CVM, 2010), making it virtually impossible for the 
salmon to leave the confines of the culture system and enter the 
environment.
    Drainage from the fish tanks must pass through rigid metal 
screening sized to block migration of even the smallest fish in the 
population. The effluent from the tanks enters the drainage canal where 
it flows through a second concrete containment sump equipped with a 12 
mm steel screen-plate, anchored in such a way that all water passing 
through the sump is screened. Distal to the sump, the water flows into 
a sequential series of four settling ponds, each of which is equipped 
with a 12 mm rigid-metallic outlet screen on which a secondary, 
variable-gauge screen is placed to facilitate flow, while maintaining 
exclusion of fish as they increase in size from fry to market size.

               Table 1.--Key Components of Physical Containment Measures at the Grow-Out Facility
----------------------------------------------------------------------------------------------------------------
                 Purpose                                            Feature or Component
----------------------------------------------------------------------------------------------------------------
                                               Primary containment
----------------------------------------------------------------------------------------------------------------
                                           Center standpipe cut below tank rim to ensure water level is always
                                            below rim
                                           Netting stretched taut over top of tank to prevent fish from escaping
                                            even if tank was overflowing
                                          ----------------------------------------------------------------------
    To prevent escape from fry tanks via   Collar-sleeve screens inserted into top of standpipes to prevent fish
                                    water   from entering standpipe by swimming
                                          ----------------------------------------------------------------------
                                           Metal screen inside standpipe at base of basket screen impedes fish
                                            that entered standpipe (by jumping) from leaving the tank
                                          ----------------------------------------------------------------------
                                           Rigid circular plastic screens surrounding the center standpipes
                                          ----------------------------------------------------------------------
                                           Porous gravel floor around each tank allows downward percolation of
                                            overflow water but traps any fish in the overflow
----------------------------------------------------------------------------------------------------------------
                  To prevent escape from   The building is covered and sealed by netting
                        the fry tanks by
                                          ----------------------------------------------------------------------
                         avian predators   Netting stretched taut over the top of each tank
----------------------------------------------------------------------------------------------------------------
                                           A single external (so no fish can jump into it) standpipe cut below
                                            tank rim to ensure water level is always below rim
                                          ----------------------------------------------------------------------
              To prevent escape from the   A 1 cm thick, rigid PVC slotted drain plate affixed by screws to the
                grow-out tanks via water    only drain in the tank
                                          ----------------------------------------------------------------------
                                           Porous gravel floor around each tank allows downward percolation of
                                            overflow water but traps any fish in the overflow
----------------------------------------------------------------------------------------------------------------
              To prevent escape from the   Each tank is entirely covered by netting stretched over and around
       grow-out tanks by avian predators    the tank on a rigid support structure
                                          ----------------------------------------------------------------------
                                           Netting stretched taut over the top of each tank
----------------------------------------------------------------------------------------------------------------
                                              Secondary containment
----------------------------------------------------------------------------------------------------------------
                  To prevent escape from   Sock filter (500 mm) on the terminal end of the only drain pipe
                   fry tanks into drains    receiving effluent from the fry tanks
----------------------------------------------------------------------------------------------------------------
                  To prevent escape from   Sealed metal cage (affixed to ground) through which all effluent from
              grow-out tanks into drains    grow-out tanks must pass before entering drain canal
----------------------------------------------------------------------------------------------------------------
    To prevent escaped fish from passing   Concrete structure and containment sump through which all water must
          through the drain canal to the    pass
                     sedimentation ponds
                                          ----------------------------------------------------------------------
                                           Rigid metal screen affixed to bottom of containment sump through
                                            which all water must pass
----------------------------------------------------------------------------------------------------------------
    To prevent escaped fish from passing
  from one sedimentation pond to another   Rigid metal screens on the outlet of each pond
----------------------------------------------------------------------------------------------------------------
   To prevent escaped fish from entering   Four sedimentation ponds in series, each with its own outlet screen
          the river from the drain canal
----------------------------------------------------------------------------------------------------------------
                                       Tertiary and Quaternary containment
----------------------------------------------------------------------------------------------------------------
                                           The project is in a very remote location
                                          ----------------------------------------------------------------------
                                           The project is built on the opposite side of the river from the road
                                          ----------------------------------------------------------------------
  To prevent unauthorized personnel from   A narrow pedestrian bridge crosses the river, with access controlled
          entering the fish rearing area    by a locked metal fence
                                          ----------------------------------------------------------------------
                                           Tall barbed wire security fence completely surrounding the perimeter
                                            of the fish rearing tanks, with locked entry gates
                                          ----------------------------------------------------------------------
                                           Permanent presence of aggressive dogs
----------------------------------------------------------------------------------------------------------------

Figure 2. Schematic Summary of Containment Measures at the Grow-Out 
        Facility


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


        
    The fry tanks and building containing them, as well as the outdoor 
grow-out tanks, are covered with netting to prevent avian predation and 
``jumpers'' (i.e., fish that escape confinement by jumping out of the 
tank). In particular, the grow-out tanks are sealed horizontally and 
vertically inside a cage comprised of netting supported by a rigid 
structure. Escape from the tanks by jumping, or removal of fish by 
avian predators, is impossible. Security is provided by surrounding the 
fish tanks with netting and fencing topped with barbed wire to deter 
human or animal intrusion.
    The facilities at this site are secured as follows:

   The site is located in a remote, highland area with very 
        limited access.

   Entry onto the site requires passage via a securely gated 
        footbridge that crosses a river, and is the only pedestrian 
        access to the site.

   Culture facilities are enclosed by an 8-foot security fence 
        topped with barbed wire.

   Entrance gates are securely locked and the area is protected 
        by dogs.

   A private residence adjacent to the property provides for 
        additional surveillance by management living on-site.

    In summary, a minimum of 11 sequential physical barriers (total of 
21) are in place between the fish tanks and the nearest body of water, 
confining the salmon to the site; seven of these barriers are installed 
following outflow from the grow-out tanks. In addition, netting 
prevents the fish from being actively removed from containment by 
predators or passively removed in the event of any overflow of the 
water level.
    An additional level of physical containment is provided by several 
downstream hydro-electric plants, which also serve to prevent passage 
of any escaped fish to downstream riverine areas or the Pacific Ocean.
4.2.1.1 Thermal Containment Barriers--Panama
    In addition to the numerous physical containment barriers in place 
at the Panama growout site, there also exists a powerful natural, 
geographic, thermal barrier that would effectively prevent AquAdvantage 
Salmon from migrating from the growout site to the Pacific Ocean. Stead 
and Laird (2002) have cited the upper lethal temperature for salmon as 
being 23ºC. Water temperature measurements recorded for the rivers 
leading from the aquaculture project to the Pacific Ocean (Table 2; 
Draft EA for AquAdvantage Salmon, CVM, 2010) amply demonstrate that any 
escaped salmon attempting to migrate downstream towards the Pacific 
Ocean would inevitably encounter lethal water temperatures, preventing 
the fish from reaching the ocean.

------------------------------------------------------------------------
                                                            Temp (C)
                    Point                        Elev  -----------------
                                                 (m)      Air     Water
------------------------------------------------------------------------
1                                                   13     28.9     26.4
------------------------------------------------------------------------
2                                                   91     31.9     28.1
------------------------------------------------------------------------
3                                                  250     29.4     26.0
------------------------------------------------------------------------
4                                                  347     28.6     25.8
------------------------------------------------------------------------
5                                                  649     24.3     22.6
------------------------------------------------------------------------
6                                                  995     21.6     19.3
------------------------------------------------------------------------
7                                                 1024     21.6     19.0
------------------------------------------------------------------------
8                                                 1086     21.7     20.7
------------------------------------------------------------------------
9                                                 1278     20.7     18.8
------------------------------------------------------------------------
10                                                1792     17.2     15.1
------------------------------------------------------------------------
11                                                1850     18.1     15.8
------------------------------------------------------------------------
* Abbreviations: Elev, elevation; Temp, temperature.

    An additional temperature related barrier to migration and survival 
that is present at the Panama growout location is the lack of suitable 
temperatures required by Atlantic salmon for spawning and egg 
incubation. The ideal water temperature for incubating Atlantic salmon 
eggs is 8+ C, and temperatures in excess of 12+ C result in low 
hatchability and viability (Stead & Laird, 2002). Based on water 
temperature data from the nearby river (Table 2), it is evident that 
ambient water temperatures in the river would not allow for spawning or 
hatching of eggs produced from escaped AquAdvantage salmon (ignoring 
for purposed of discussion, that the AquAdvantage salmon are sterile 
and all-female).
4.2.2 PEI Production
    There is only one proposed approved site for the production of 
AquAdvantage Salmon eyed-eggs, the land-based, freshwater aquaculture 
facility on Prince Edward Island (PEI) owned and operated by 
AquaBounty, which comprises a main building, storage facility, and 
ancillary enclosures for operational structures that are secured as 
follows:

   Perimeter security: Approximately 1590 linear feet of 
        galvanized chain-link fence of commercial quality surrounds the 
        property, inclusive of freshwater well-heads, back-up 
        generators, liquid oxygen containment, and the storage 
        facility. A service entry adjacent to the storage building 
        remains secured by a double-swing, chain-link gate except when 
        service access to the property is required. A roll-away, chain-
        link gate spanning the main entry to the property, which is 
        adjacent to the main building, is secured during non-business 
        hours. At night, the entire perimeter remains well-lit.
   Outside entries: Windows on the lower-level of the main 
        building are barred, and all exterior steel-doors on the main 
        and storage buildings are dead-bolted. Entry into the main 
        building requires a key or intercom-interrogation and remote 
        unlocking by facility staff. Within the main building, access 
        to the first-floor aquaculture facility is further protected by 
        a cipher-locked, interior entry.
   Security monitoring: Eight motion-activated security cameras 
        are positioned for maximum surveillance of the property 
        immediately surrounding the main building. These cameras are in 
        continuous operation and automatically capture digital images 
        that are stored for later retrieval. Magnetic door-contacts and 
        interior motion-detectors deployed throughout the main 
        building, storage facility, and out-buildings comprise a 
        network of zones that are monitored by a commercial security 
        service.
   Water supply & pump-house: The primary well and pumping 
        facilities (one primary, two back-ups) that supply the 
        aquaculture facility are securely enclosed in a steel 
        containment structure.
   Remote notification of status: Environmental alarms 
        indicating emergent change in operational conditions (e.g., 
        water level, dissolved oxygen (DO) content), and security 
        alarms indicating suspected intrusion during non-working hours, 
        are conveyed by the security service to senior facility staff 
        via numeric page; in addition, direct telephone contact with 
        the facility manager or other on-call staff is pursued until 
        successfully made, so that clear communication of the event 
        occurs and proper and immediate response is managed.
   Additional security: AquaBounty may employ professional 
        security personnel to remain on-site during non-business hours 
        as conditions warrant. In addition to their direct surveillance 
        of the property, these personnel would have access to the 
        central, security-monitoring system in the main building, but 
        would not have access to the facility at-large, which would 
        remain locked-down and subject to the network of electronic 
        sensors and motion-activated cameras comprising that system. An 
        apartment in the main building provides for additional 
        surveillance by staff living on-site.

    A number of measures have been implemented to provide physical 
containment of the GE salmon at the Prince Edward Island facility. In 
general, means of physical containment comprise entrapment of animals 
at the immediate source of housing for cultivation (i.e., via tank 
covers or nets), and redundancy in screening and filtration of water 
flows into which fish could gain access. These containment measures 
function at different as well as multiple levels of the containment 
strategy. Key components of the system are described in great detail in 
Aqua Bounty Protocols. The measures are summarized in Table 3 and a 
schematic is provided in Figure 3. Inspections for various purposes 
over the past 10 years have resulted in the facility having been: (1) 
deemed compliant with containment practice and licensed to conduct 
research on GE fish under applicable Canadian regulations; and (2) 
classified as an acceptable manufacturing establishment and judged as 
having no significant environmental impact by FDA.

                   Table 3.--Key Components of Physical Containment at the Production Facility
----------------------------------------------------------------------------------------------------------------
                 Purpose                                            Feature or Component
----------------------------------------------------------------------------------------------------------------
                                                         Primary containment
----------------------------------------------------------------------------------------------------------------
                                           Perforated metal screens on tank bottoms
                                          ----------------------------------------------------------------------
       To prevent escape through rearing   Screens on stand pipes, top and bottom (where
        unit or incubator water overflow   appropriate for size of fish to be contained)
                                          ----------------------------------------------------------------------
                                           Incubator tray screens
----------------------------------------------------------------------------------------------------------------
                                           Screened tank overflows
                                           Cover nets
      To prevent escape over the side of   Jump fences
                     a tank or incubator   Tank covers
                                           Incubator tray screens
----------------------------------------------------------------------------------------------------------------
                                           Chemically lethal environment (chlorine puck) in
           To prevent downstream passage   spawning area drain
                                          ----------------------------------------------------------------------
                of newly fertilized eggs   Perforated metal drain cover in spawning area
                          and/or gametes
                                          ----------------------------------------------------------------------
                                           Closed septic system
----------------------------------------------------------------------------------------------------------------
                                                       Secondary containment
----------------------------------------------------------------------------------------------------------------
                                           Floor drain covers, solid or mesh
                                          ----------------------------------------------------------------------
    To prevent entry of fish into drains   Incubator-stack catchment box
                                          ----------------------------------------------------------------------
                                           Waste de-watering sieve box
----------------------------------------------------------------------------------------------------------------
           To prevent downstream passage   Barrier screens within drains
                                          ----------------------------------------------------------------------
               of fish within the drains   Drum filter
----------------------------------------------------------------------------------------------------------------
                                         Tertiary and Quaternary containment
----------------------------------------------------------------------------------------------------------------
                                           Barrier screens within drains of various sizes &
                                           locations
                                          ----------------------------------------------------------------------
           To prevent downstream passage   Double screens within the sump
               of fish within the drains
                                          ----------------------------------------------------------------------
                                           Mesh filter on drum-filter gray water
                                          ----------------------------------------------------------------------
                                           Heat exchanger
----------------------------------------------------------------------------------------------------------------
                                                             Waste treatment
----------------------------------------------------------------------------------------------------------------
Sock filters, containment screens, basket-sieve for straining waste material from the ERA tanks
----------------------------------------------------------------------------------------------------------------
                                                                            Chlorine kill solution (5 mL Javex containing 0.52 grams sodium hypochlorite per liter of water)
----------------------------------------------------------------------------------------------------------------
                                                                            Chlorine pucks
----------------------------------------------------------------------------------------------------------------

Figure 3. Schematic Summary of Containment Measures at the Production 
        Facility


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


        
    Hatchery-reared Atlantic salmon do inhabit the ocean waters 
surrounding PEI, although they are not known to frequent the area near 
the egg production site. Thus, the local environment does provide 
suitable habitat for at least some life stages during part of the year. 
The climate is temperate, with warm summers and cold winters. Open 
waters in proximity to the production facility are saline. Salmon eggs 
and fry are adapted to freshwater conditions and would be adversely 
affected by escape into the local estuarine environment. The extreme 
temperature conditions during the winter months at this location would 
be lethal to salmonids of all developmental stages. During the 
remainder of the year, the local environment would not be inhospitable 
to escaped smolt, juvenile or adult GE salmon, which have adapted to 
salt water and could survive. Escapees would face considerable 
environmental impediments to survival, one clear indication being the 
substantial failure of intentional efforts to re-establish Atlantic 
salmon in their native habitat. In fact, as noted by the Council on 
Environmental Quality and Office of Science and Technology Policy (CEQ-
OSTP), farmed Atlantic salmon have not established themselves 
successfully in the wilds of North America (CEQ-OSTP, 2001), despite 
the fact that they are reared commercially on both coasts.
    In 15 years of operation, there has never been a documented escape 
from the PEI facility.
4.2.3 Containment Infrastructure Management
    The containment measures described above for the sites of egg 
production and grow-out include physical measures (e.g., screens, 
covers, filters), as well as physico-chemical measures (e.g., chlorine) 
and environmental tolerances (e.g., temperature). In addition, a strong 
operations management plan is in place at both sites, comprising 
policies and procedures that meet the recommendations for an integrated 
confinement system for GE organisms (Kapuscinski, 2005), as summarized 
in Table 4. All of these factors mean that the likelihood of even a 
single AquAdvantage Salmon escaping into the wild is extremely low.
    AquaBounty will comply with these same standards of effectively 
zero risk of establishment of feral escapee salmon populations for 
every facility that produces AquAdvantage Salmon. To further mitigate 
risk, AquaBounty has no plans to sell eyed-eggs to any grow-out 
facility with drainage to native Atlantic salmon habitat.
    For additional prospective grow out facilities for AquaAdvantage 
Salmon, the same rigorous management and containment strategies will be 
employed, consistent with the terms of the NADA provisions for 
conditions of use. Candidate sites will be the subject of an 
Environmental Assessment and preapproval inspection by CVM, and 
additional inspections to assure compliance with the terms of the NADA. 
The administrative device CVM has indicated it will use for this 
process is the Supplemental New Animal Drug Application, or S-NADA. 
This is analogous to the long standing FDA process used to approve 
alternate drug manufacturing facilities or changes in facilities. The 
regulation of the grow-out sites for AquAdvantage Salmon will therefore 
be more rigorous than the regulation of any production site for any 
food animal.

              Table 4.--Implementation of an Integrated Confinement System for AquAdvantage Salmon
                                            (From: Kapuscinski, 2005)
----------------------------------------------------------------------------------------------------------------
                                                                Use at Production & Grow-Out Sites
               Recommended element               ---------------------------------------------------------------
                                                        PEI Egg Production                Panama Grow-Out
----------------------------------------------------------------------------------------------------------------
                                         Commitment by top management   3                               3
----------------------------------------------------------------------------------------------------------------
Written plan for implementing backup measures in                        3                               3
 case of failure, including documentation,
               monitoring, and remediation
----------------------------------------------------------------------------------------------------------------
                    Training of employees                               3                               3
----------------------------------------------------------------------------------------------------------------
Dedication of permanent staff to maintain                               3                               3
                                continuity
----------------------------------------------------------------------------------------------------------------
 Use of standard operating procedures for                               3                               3
 implementing redundant confinement measures
----------------------------------------------------------------------------------------------------------------
 Periodic audits by an independent agency                               3                               3
----------------------------------------------------------------------------------------------------------------
Periodic internal review and adjustment to allow                        3                               3
                    adaptive modifications
----------------------------------------------------------------------------------------------------------------
Reporting to an appropriate regulatory body                             3                               3
----------------------------------------------------------------------------------------------------------------

5.0 Invasiveness
    A final barrier to establishment and spread of feral AquAdvantage 
Salmon populations is the potential invasiveness of GH transgenic 
salmon. The extent to which the genetic construct can spread into wild 
populations would depend on the fitness of transgenic individuals in 
the receiving environment, which may vary along a continuum featuring 
high fitness at one end--leading to the fixation of the transgene, and 
low fitness at the other end--leading to its elimination within a few 
generations (Muir and Howard 1999). If the salmon are highly effective 
at adapting to and competing in natural ecosystems, they may persist 
for long periods of time in the environment. This increases the chance 
for encounter with suitable mates for reproduction and establishing a 
reproductive population. If the transgenic fish do not adapt well to 
the natural environment, the risk of invasiveness is low and the 
transgene will likely be lost from the wild population. Additionally, 
in modeling the invasiveness of a hypothetical escape of transgenic 
fish populations, a hypothesis known as the Trojan Gene Hypothesis has 
been advanced (Muir and Howard, 1999). Under this hypothesis, it was 
calculated that escaped transgenic fish could theoretically drive a 
native population to extinction within as little as 40 generations. 
This hypothesis could be true only if the transgenic fish enjoyed an 
advantage in competing for mates (based on color for example), but 
experienced a disadvantage in overall fitness (so were unable to 
survive in the wild well) (Muir and Howard, 1999). As will be explained 
below, all indications are that AquAdvantage Salmon are poorly adapted 
for life in the wild, are remarkably ineffective in securing mates, and 
that the transgenic fish would not be invasive, but would rather more 
likely be selected against and eliminated from wild populations.
5.1 Life History Constraints that Reduce Invasiveness
    The main distinguishing feature of AquAdvantage Salmon is rapid 
growth, where growth rate is a composite of many physiological factors. 
AquAdvantage Salmon have metabolic traits that also appear in other 
fast-growing Atlantic salmon or in fish that have been treated with 
time-release GH implants (Johnsson and Bjornson, 2001). Metabolic rates 
influence the components of the overall energy budget for an 
individual; the components of the energy budget in turn influence an 
individual's impact on nutrient and energy flows and on other 
organisms. The unique attributes of the GE fish appear to be an 
increase in the scale of trait expression commensurate with the 
increase in growth rate when food is available, and the allocation of 
energy to current growth at the expense of stored reserves (Cook et 
al., 2000b).
    GH increases metabolic activity through several channels: lipid 
breakdown and mobilization are improved and energy more immediately 
deployed for maintenance or growth; protein synthesis is enhanced, 
providing the essential material for faster additions to body mass; 
mineral uptake is enhanced promoting skeletal development and longer, 
leaner fish; and, feeding efficiency (feed conversion ratio, or FCR) is 
improved (Bjornsson, 1997). The cost to the animal is higher oxygen 
need due to increased digestive demand and anabolic protein synthesis, 
and the need for increased feed availability. In early-generation 
relatives of AquAdvantage Salmon (hereinafter ``AquAdvantage 
relatives''), feed consumption was 2.1-2.6 times higher than in non-
transgenic controls; during starvation, transgenics depleted body 
protein, dry matter, lipids, and energy more quickly that controls, and 
had lower initial energy reserves (Cook et al., 2000a,b). Routine 
oxygen uptake in these fish was 1.7 times that of controls, including 
the higher `heat increment' associated with digestion (Stevens et al., 
1998); and, oxygen consumption under activity was 1.6 times the non-
transgenic rate, further increasing with effort (Stevens and Sutterlin, 
1999). Although these AquAdvantage relatives demonstrated an ability to 
reduce their metabolic rate in response to starvation, their higher 
metabolic effect and lower initial energy reserves suggest that they 
would be unlikely to grow rapidly or survive outside of culture 
conditions (Hallerman et al., 2007). The increased requirement for 
oxygen exhibited by AquAdvantage relatives (Abrahams and Sutterlin, 
1999; Cook et al., 2000a; Cook et al., 2000b; Deitch et al., 2006) 
would engender a reduced tolerance for diminished oxygen content in 
general, and a reduced capacity for survival when DO content is 
critically low, compared to their non-transgenic counterparts in the 
wild. In experiments with AquAdvantage relatives, oxygen uptake was 
independent of oxygen concentration above 10 mg/L, but started to 
decrease at about 6 mg/L DO in transgenic fish versus 4 mg/L in control 
fish (Stevens et al., 1998). Under conditions of oxygen saturation, 
transgenics are not at a disadvantage compared to controls, since 
oxygen demand is readily satisfied. Oxygen saturation is rarely 
encountered in natural environments.
    The need for food tends to increase the predation risk for GE fish. 
Abrahams and Sutterlin (1999) also demonstrated that AquAdvantage 
relatives would spend significantly more time feeding in the presence 
of a predator than non-transgenic salmon, indicating that they possess 
a higher tolerance for predation risk. The transgene confers a powerful 
stimulation of appetite in the presence of food and a larger capacity 
for food consumption in the presence of opportunity, even when 
predators are present. AquAdvantage relatives consumed approximately 
five times more food than same-age controls that were also size-matched 
by delaying the hatch time of the transgenics. In part, the consumption 
differential reflected the greater willingness of the transgenics to 
feed in the presence of a predator and, in part, a higher feeding 
motivation in transgenics, which were 60 percent more likely to be 
observed feeding at both the safe and the risky sites than were the 
controls (Abrahams and Sutterlin 1999). GH also increased appetite in 
various species of salmonids (Raven et al., 2006; Abrahams & Sutterlin, 
1999; Devlin et al., 1999), which influences behavioral traits 
associated with feeding, foraging, and social competition. The 
availability of food also influences behavior. The difference in scale 
between GE and other fast-growing Atlantic salmon is less quantifiable 
for behavioral traits and further confounded by the effects of hatchery 
culture, particularly in acclimation to high rates of social 
interaction. Salmon form dominance hierarchies around foraging 
opportunities, and hatchery fish have more opportunities to reinforce 
their social status in confinement. In nature, social dominance is 
dampened by a resident advantage that generally deters other fish from 
evicting territory holders from home ground. It is estimated that at 
least a 25 percent difference in size is necessary to overcome the 
resident advantage (Metcalfe et al., 2003).
    Changes in the morphology of the organism (e.g., size, shape & 
color) could alter species interactions (ABRAC, 1995); however, it 
should be noted that accelerated growth is not an assured outcome for 
GE salmon in nature. The rapid-growth phenotype is expressed only if 
supported by sufficient food, as has been shown in both transgenic Coho 
salmon (Devlin et al., 2004b; Sundstrom et al., 2007) and AquAdvantage 
relatives (Cook et al., 2000b). This is a function of both the 
productivity of the habitat and the density and behavior of competitors 
for the resource.
    AquAdvantage Salmon are triploid fish, and triploidy may be another 
factor apart from transgenesis affecting environmental tolerance 
limits. Atkins and Benfey (2008) reported that triploids of Atlantic 
salmon had lower thermal optima than diploids, which could explain 
prior observations of mortality of other triploid salmonids (brown 
trout, brook trout, and rainbow trout) at chronically elevated, but 
sub-lethal, rearing temperatures. Data exist for a variety of species 
of fish to indicate that triploidy could be responsible for reduced 
survival of early-life stages and reduced survival and growth of later-
life stages, particularly when environmental conditions are not optimal 
(Piferrer et al., 2009). Ocean migration studies in Ireland revealed 
that male triploids returned to their natal area in nearly the same 
proportions as diploids, whereas female triploids mostly did not 
(Wilkins et al., 2001). Similar results were found in another trial in 
which the return rate of triploid Atlantic salmon was substantially 
reduced (Cotter et al., 2000a).
5.2 Spawning and Reproduction
    Changes in the age at maturation, fecundity, and sterility could 
alter population and community dynamics and interfere with the 
reproduction of related organisms (ABRAC, 1995). However, domesticated 
Atlantic salmon in general have markedly reduced spawning performance 
relative to wild fish (), and triploid females do not engage in 
spawning behavior.
    Varying degrees of exposure to captive environments and 
domestication selection have been shown to affect the breeding behavior 
and success of adult salmonids negatively (Fleming and Gross 1993; 
Fleming et al. 1997; Berejikian et al. 2001a; Weir et al. 2004). Thus, 
the captive rearing environment appears to diminish the competitive and 
reproductive performance of salmonids, irrespective of genetic 
background (Berejikian et al. 1997, 2001a,b). As AquAdvantage salmon 
will be reared in intensive cultivation systems, a similar reduction in 
ability to compete for mates and survive outside of the culture 
environment is expected.
    Age at maturation is a factor in estimating the risk of 
invasiveness of transgenic strains, with early maturation associated 
with increased invasiveness. If the transgenic fish mature before non-
transgenic contemporaries, they have an increased opportunity for 
mating success. Atlantic salmon can mature as very young parr and sneak 
matings from larger fish, and if transgenic salmon matured more readily 
as parr, an increased risk of invasiveness could be prescribed. 
However, recent work (Moreau et al 2011c) clearly indicated that 
AquAdvantage salmon mature later than nontransgenics, with very little 
maturation as parr. The authors conclude that this characteristic 
reduces the risk of transgene invasion into a wild population.
    Considering AquAdvantage Salmon specifically, recent research 
(Moreau et al 2011 b) indicates that transgenic AquAdvantage Salmon 
(whether adults or parr) are at a significant disadvantage competing 
for mates and contributing genetics to subsequent generations. When in 
competition, nontransgenic males dominated transgenic males in securing 
mates, participating in over 90 percent of spawning events. Transgenic 
parr were also at a disadvantage compared with nontransgenic parr. 
Taken together, this indicates that escapee transgenic salmon males 
would be at a significant disadvantage in securing mates in a wild 
environment, reducing invasive potential. Further, in simulated 
streambeds, there was no advantage to transgenesis in early life just 
after hatch in terms of feeding or aggression that might facilitate 
invasion of natural systems by transgenic salmon; the transgenic fry 
did not displace or out-compete nontransgenic fry (Moreau et al 2011a). 
The work with GH transgenic Atlantic salmon echoes similar work with GH 
transgenic Coho salmon (Fitzpatrick et al 2011), where researchers 
found that in competitive mating, transgenic salmon sired less than 6 
percent of offspring. Milt harvested from transgenic males also 
contained fewer sperm that swam slower and for shorter durations than 
sperm from wild males (Fitzpatrick et al 2011). Together, these 
findings suggest very limited potential for the transmission of 
transgenes from cultured GH transgenic salmon through natural mating 
should they escape from a contained culture facility into nature and 
reproductively interact with a local wild salmon strain. The additional 
redundant biological and physical containment provisions built into the 
production and grow-out of AquAdvantage Salmon product effectively 
eliminate any potential impact on the biological diversity or ecology 
of wild populations.
5.3 Summary Comparison of Atlantic Salmon and AquAdvantage Salmon
    Atlantic salmon display a wide range of characteristics and can 
adapt to a variety of conditions. AquAdvantage Salmon share many of 
these traits, the notable exception being their increased growth rate 
and the physiologic sequelae thereof (e.g., increased oxygen 
consumption).
    Table 5 summarizes the observed differences between GH-transgenic 
salmonids and non-transgenic Atlantic salmon. In many cases, these 
differences were of greater magnitude under laboratory conditions than 
in a simulated natural environment. Consequently, not all of these 
differences may be expressed, or may be expressed to a lesser extent, 
in the wild.
    None of these differences will lead to environmental impact unless 
AquAdvantage Salmon actually enter the environment. The likelihood of 
that happening is extremely remote.

                         Table 5.--Differences between GE- and Non-transgenic Salmonids
----------------------------------------------------------------------------------------------------------------
               Trait                                    Transgenic Relative to Non-transgenic
----------------------------------------------------------------------------------------------------------------
                   Metabolic rates   Increased metabolic rates
                                     Increased growth when food is available
                                     Reduced initial energy reserves
                                     Increased oxygen consumption
----------------------------------------------------------------------------------------------------------------
     Tolerance of physical factors   Reduced tolerance to low oxygen availability
                                     Reduced thermal optimum range (effect of triploidy not GH)
----------------------------------------------------------------------------------------------------------------
         Behavior (lab conditions)   Increased feeding motivation and reduced prey
                                     discrimination
                                     Reduced schooling tendency
                                     Reduced anti-predator response
----------------------------------------------------------------------------------------------------------------
         Resource or substrate use   Increased utilization of lower quality food (lab conditions)
                                     Increased utilization of larger prey (potential)
----------------------------------------------------------------------------------------------------------------
            Resistance to disease,   Reduced disease resistance
            parasites or predation   Reduced anti-predator response, increased predation mortality
----------------------------------------------------------------------------------------------------------------
                      Reproduction   Accelerated growth to sexually-mature size
                                     Larger males can have a mating advantage
----------------------------------------------------------------------------------------------------------------
                      Life history   Accelerated growth to smolt-size
                                     Smoltification at higher temperatures and constant light
----------------------------------------------------------------------------------------------------------------

5.4 Comment on the Trojan Gene Hypothesis
    Given the poor reproductive fitness of AquAdvantage Salmon, the 
Trojan Gene Hypothesis almost certainly does not apply to any escapees. 
The author of the Trojan gene hypothesis (Dr. Bill Muir) has weighed in 
on the applicability of this doomsday scenario, concluding emphatically 
that the Trojan Gene Hypothesis indeed does not apply to AquAdvantage 
Salmon, both in press releases (press release from Bill Muir; http://
www.purdue.edu/newsroom/research/2011/story-print-deploy-
layout_1_14241_14241.html) and the peer-reviewed scientific literature 
(Van Eenennaamm and Muir 2011). Quoting from Van Eenennaamm and Muir 
2011, pg 708:

        As a result, the Trojan gene effect would not be predicted to 
        occur in the unlikely event AquAdvantage salmon did escape from 
        confinement. Rather, selection over time would be expected to 
        simply purge the transgene from any established population, 
        suggesting a low probability of harm resulting from exposure to 
        AquAdvantage Salmon.
5.5 Ability to Breed with Pacific Salmon
    It is a well established and documented fact that Atlantic salmon 
cannot reproduce or breed with any of the five species of Pacific 
salmon (Fisheries & Oceans Canada, 2005; Waknitz et al., 2002). Under 
controlled and protected laboratory conditions, where survival of 
hybrid offspring should be optimized, genetically viable hybrids 
between Atlantic and Pacific salmonid species have been impossible to 
produce (Waknitz et al., 2002). Therefore, in the unlikely event that 
AquAdvantage Salmon should breach the numerous redundant physical 
containment barriers that confine it to the culture system, and by some 
means find their way to the northern Pacific Ocean, they would be 
unable to mate or reproduce with native Pacific salmon.
5.6 Resistance to Establishment in the Wild
    In the past century, there have been numerous unsuccessful attempts 
in the United States and elsewhere to establish Atlantic salmon outside 
their native range via intentional introductions (Fisheries & Oceans 
Canada, 2005). At least 170 attempts to artificially introduce and 
establish populations of Atlantic salmon have been documented in 34 
different states where Atlantic salmon were not native, including 
Washington, Oregon, and California. None of these efforts was 
successful (Waknitz et al., 2002). No reproduction by Atlantic salmon 
was verified after introductions of fertile, mixed sex populations of 
Atlantic salmon in the waters of these states.
    The risk of anadromous Atlantic salmon establishing self-
perpetuating populations anywhere outside their home range has been 
shown to be extremely remote, given that substantial and repeated 
efforts over the last 100 years have not produced a successful self-
reproducing anadromous population anywhere in the world (Lever, 1996). 
In the Pacific Northwest, there have been no reports of self-sustaining 
populations resulting from deliberate or accidental Atlantic salmon 
introductions (Waknitz et al., 2002).
    Given that escapee transgenic Atlantic salmon are likely to have 
diminished capacity to spawn successfully compared to wild type salmon, 
the risk of escapee AquAdvantage salmon establishing a feral population 
anywhere is very remote.
6.0 Conclusions
6.1 Escape, Establishment and Spread
    The potential hazards addressed in this document center on the 
likelihood and consequences of AquAdvantage Salmon escaping, becoming 
established in the environment, and spreading to other areas. These 
hazards are addressed for the production of eyed-eggs and grow-out to 
market size fish. Because AquAdvantage Salmon is produced and grown out 
in secure facilities equipped with numerous redundant containment 
measures designed to prevent escape, the possibility that even one 
transgenic animal will enter the environment and survive is extremely 
remote. In addition, because AquAdvantage Salmon are produced to be 
triploid, all-female animals, the possibility of them reproducing in 
the wild is likewise extremely remote. The relatively poor reproductive 
fitness of AquAdvantage Salmon, as demonstrated in evaluations of 
breeding efficiency, clearly show that AquAdvantage Salmon fare poorly 
interacting with wild stocks. AquAdvantage Salmon are reproductively 
incompatible with almost all fish, in particular Pacific salmon. 
Finally, the inhospitable environmental conditions around the egg 
production and grow-out facilities further reduce the possibility of 
establishment and spread. In short, it is not reasonable to believe 
that AquAdvantage Salmon will have any impact on the environment by 
escaping, surviving and thriving in regional. This argument is 
reinforced by the historical fact that hundreds of worldwide attempts 
to intentionally introduce fertile mixed sex populations of Atlantic 
salmon in the wild have failed to establish self-sustaining 
populations.
6.2 Using Confinement Measures to Mitigate Risks
    A key way to manage risks associated with the use of GE fish in 
aquaculture is through the application of confinement measures designed 
to minimize the likelihood of their causing harm to the environment 
(Kapuscinski, 2005). It is difficult to guarantee that 100 percent 
containment can be achieved by any single method. Thus, several 
different methods are used simultaneously to provide redundancy and 
ensure that it is highly unlikely that GE salmon can escape. These 
measures are: biological containment, physical containment (including 
physico-chemical containment and operations management), and 
geographical/geophysical containment.
    The three primary aims of confinement cited by Mair et al., (2007) 
are listed below along with the measures used for production, grow-out, 
and disposal of AquAdvantage Salmon:

   Limit the organism: prevent the fish from entering and 
        surviving in the receiving environment. AquAdvantage Salmon are 
        prevented from entering the environment by the use of redundant 
        physical and physico-chemical barriers at the sites of egg 
        production and grow-out. They are further prevented from 
        surviving in the receiving environment because of geographic 
        and geophysical issues. The immediate environs of the Prince 
        Edward Island facility are inhospitable to early-life stage 
        salmon due to the salinity of the local waters. The environment 
        downstream of the Panama site is inhospitable to all life-
        stages due to the high water temperatures, poor habitat, 
        predation risk, and abundant physical barriers that diminish 
        the likelihood of survival and establishment in the receiving 
        stream. Atlantic salmon are not found in the tropical areas of 
        Panama.

   Limit (trans)gene flow: prevent gene flow from the GE fish. 
        Gene flow from AquAdvantage Salmon is prevented because the 
        fish are triploid females incapable of reproduction, among 
        themselves or with wild fish, should they escape and survive. 
        For grow-out, species with which they could breed are not 
        present in the surrounding environment.

   Limit transgenic trait expression. It is likely that the 
        expression of the trait, not the transgene itself, poses the 
        hazard. The enhanced growth rate of AquAdvantage Salmon is 
        readily expressed under the optimum conditions provided in a 
        commercial environment; however, in the wild, the absence of 
        readily available food (to which they are accustomed) and 
        consequent depletion of energy reserves decrease the likelihood 
        of effective exploitation of their inherent growth capacity.
6.3 Redundant Mitigation Measures
    Optimum containment is dependent upon the deployment of a number of 
independent measures in series. Biological, physical and geographical/
geophysical means of containment will be used to mitigate the potential 
environmental risk of AquAdvantage Salmon. Each method has different 
strengths and weaknesses, but the combination results in a very high 
level of effectiveness. Biological containment includes the production 
of entirely female, triploid fish with essentially no capacity to breed 
with wild fish; in and of itself, this technique is considered very 
effective (Mair et al., 2007; Arai, 2001). Physical and physico-
chemical means of containment comprise additional, multiple, and 
redundant measures in effect at the production and grow-out sites that 
will effectively prevent escape. The reliability of these measures is 
further ensured by adherence to a strong management operations plan 
that includes staff training, SOPs, and routine audits and inspections. 
In addition, geographical/geophysical containment is provided by the 
specific location of the aforementioned sites.
6.4 Summary of Ecological Risk Assessment
    A report by the Ecological Society of America (ESA; Snow et al., 
2005) has proposed six major environmental processes that may be 
associated with GE organisms. In Table 6, each of these processes and 
their theoretical ecological consequences, which remain largely 
undocumented to date, are presented vis-a-vis their prospective 
applicability to AquAdvantage Salmon.

                             Table 6.--Risk of Environmental Impact of GE Organisms*
----------------------------------------------------------------------------------------------------------------
       Process               Potential Ecological Consequence                  Risk Associated with AAS
----------------------------------------------------------------------------------------------------------------
Persistence without       Transgenic organisms able to spread and        AAS are all sterile females unable to
         cultivation   maintain self-sustaining populations could      reproduce; a self-sustaining population
                         disrupt biotic communities & ecosystems,                       cannot be established.
                       leading to a loss of biological diversity.                                   NO SIGNIFICANT RISK.
----------------------------------------------------------------------------------------------------------------
 Interbreeding with    Incorporation of transgenes could result in   AAS are all sterile females unable to breed
        related taxa              greater invasiveness or loss of    with wild Atlantic salmon or related taxa.
                            biodiversity, depending on particular                                   NO SIGNIFICANT RISK.
                              transgenic trait and gene flow from
                                        generation to generation.
----------------------------------------------------------------------------------------------------------------
Horizontal gene flow   Non-sexual gene transfer is common in some    Integrated transgene in AAS is incapable of
                           microbes but rare in plants & animals;          being passed thru non-sexual means.
                           ecological consequence would depend on                                   NO SIGNIFICANT RISK.
                       particular transgenic trait and gene flow.
----------------------------------------------------------------------------------------------------------------
                   ChangeIn virus-resistant transgenic organisms,     rDNA construct used for AAS had no viral
             disease          genetic recombination could lead to     component; this type of recombination is
                         increased virulence of viral disease and                                not possible.
                            undesirable effects on natural hosts.                                   NO SIGNIFICANT RISK.
----------------------------------------------------------------------------------------------------------------
Non-target & indirect  Loss of biodiversity, altered community or            AAS escape minimized by redundant
             effects   ecosystem function, reduced biological pest             containment; low probability of
                        control, reduced pollination, and altered        establishment due to poor fitness and
                                soil carbon and nitrogen cycling.       reproductive incapacity; likelihood of
                                                                                        further spread is nil.
                                                                                                    NO SIGNIFICANT RISK.
----------------------------------------------------------------------------------------------------------------
       Evolution of       Pesticide resistance leading to greater                     Not applicable for fish.
          resistance      reliance on damaging chemicals or other                                   NO SIGNIFICANT RISK.
                           controls for insects, weeds, and other
                                                           pests.
----------------------------------------------------------------------------------------------------------------
* Process and General Consequence information derives from Snow et al., 2005.

    Conclusion: The production and grow-out of AquAdvantage Salmon 
under the conditions described in the USFDA NADA does not present a 
significant risk of adverse ecological effects.
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(1995). Performance Standards for Safely Conducting Research with 
Genetically Modified Fish and Shellfish. Document No. 95-04. U.S. 
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antipredator behaviour of growth-enhanced transgenic Atlantic salmon. 
Anim. Behav. 58: 933-942.
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of the opAFP-GHc2 gene construct at the a-locus in the EO-1a line. 
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228.
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    Benfey, T. J. (2001). Use of sterile triploid Atlantic salmon 
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J. J. Hard. 1997. Reproductive behavioral interactions between wild and 
captively reared coho salmon (Oncorhynchus kisutch). Ices Journal of 
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    Senator Begich. Thank you very much.
    And just for all the folks that are testifying, your 
testimony--your full testimony--is part of the record, and any 
information that you attach to it was part of the record, so we 
want to make sure.
    Dr. Epifanio? I know I'm still messing it up, but I 
apologize. You're next please.

     STATEMENT OF JOHN EPIFANIO, Ph.D., FISH CONSERVATION 
        GENETICIST, ILLINOIS NATURAL HISTORY SURVEY AND 
                     UNIVERSITY OF ILLINOIS

    Dr. Epifanio. Thank you, Chairman Begich, Ranking Member 
Snowe, and the other members of the Subcommittee for convening 
this hearing.
    I come to you today with some twenty-plus years of 
experience as a fishery geneticist focusing on the ecological 
genetic consequences from the releases of propagated or farmed 
fishes on their wild counterparts.
    I'll focus my comments today rather narrowly on the 
potential hazards from potential escape of genetically 
engineered salmon on the biological diversity and the ecosystem 
services in recipient ecosystems.
    The heart of the matter here today before us is whether a 
proposed New Animal Drug Application for commercial production 
of genetically engineered, growth-enhanced salmon--in light of 
this narrow focus, I think it's worth explicitly stating up 
front that although this is a specific case, it does bring 
critical precedent for other future applications as well.
    To begin, in my career, I've studied and reviewed the 
ecological consequences associated with the release of fish 
with altered genomes, either from conventional or engineered--
and engineered pathways.
    Up front, to my knowledge, there are no documented or 
studied cases of genetically engineered salmon escaping into 
the wild, even though we have laboratory controlled studies--
from Canada in particular--on the growth and reproductive 
performance of these fishes.
    Therefore, to fully understand the impacts, we must rely on 
information from in analogous source, analogous releases of 
altered fishes.
    Generally speaking, we can distill the concerns from any 
escape of genetically engineered salmon into two broad 
categories. One: impacts due to ecological interactions, 
specifically predation, competition, and second: genetic 
impacts from interbreeding or through animal husbandry 
practices. Ecologically, escape of engineered fish may 
represent the release of a novel top predator or a more 
efficient competitor, which are expected to have cascading 
effects throughout the entire and local food web.
    The scope and scale of these effects ultimately can depend 
on how well we know about--how well we know about the numbers 
escaped, their behavioral dominance, reproductive capacity, 
persistence through time, and as well as other variables.
    One need only consider the recent emergence of a non- 
native species--such as sea lamprey in the Great Lakes, 
snakeheads in the mid-Atlantic region, lionfish in the 
Caribbean, Asian carp species in the Mississippi basin--to 
fully comprehend the enormity of ecological effects from 
releases of new predators or competitors.
    By extension, in the case of genetically modified salmon 
escaping into the wild, the full extent of its ecological 
impact will be determined not only by the altered 
characteristics of the salmon itself, but also on the ecosystem 
into which it escapes.
    For example, an already stressed habitat and biotic 
community is more likely to be impacted than one that is 
diverse and resilient.
    Another level of potential disturbance emerges where 
modified fishes escape wherever their wild relatives would 
occur. Here we face additional risks stemming from 
interbreeding. Based on many decades of study on salmon in 
particular, the fish genetics community has discovered that 
even very subtle genetic differences between previously 
isolated groups can seriously disrupt survival and reproduction 
in future generations.
    Now, proponents may claim that genetic engineering does not 
differ from other forms of gene pool manipulation, which we've 
practiced for centuries--such as domestication and 
crossbreeding.
    While this claim has yet to be fully substantiated, I 
assert that the release of modified fish through more classical 
modes has also proven to be problematic.
    In my written testimony, I provide a couple of examples to 
highlight that point, but to keep things short I'll pass on 
those here.
    In short, by failing to consider the consequences of genome 
manipulations, whether classical or by engineering, we risk 
unpredictable environmental effects unless adequate safeguards 
are rigorously carried out.
    While the new animal drug application for genetically 
engineered salmon includes precautions for physical containment 
to prevent escapement and for reproductive sterility should 
that escapement occur, it is critical to consider that no 
established safeguard has ever proven, full proof, nor 
eliminates all classes of risk simultaneously or completely. I 
offer several observations and recommendations to the 
Subcommittee in conclusion.
    One: salmon exhibit very complex life histories. Specific 
expertise in the biology of the species in question are 
crucial. Certainly FDA has experience with food and drug 
science, where as other Federal agencies and state agencies are 
more versed in salmon biology and the unique qualities on the 
environment that they generally occupy--specifically NOAA, Fish 
and Wildlife Service, and the states.
    Second, whereas containment and engineered sterility may in 
fact reduce the probability of escape or reproduction, these do 
not completely remove the risk of escape, reproduction, or 
ecological interference. A robust and formal risk assessment is 
generally warranted under such circumstances.
    Moreover, if approved it would be prudent to treat this as 
a controlled experiment that is, A--actively monitored for 
impacts after approval, and B--can be terminated, should the 
need arise, without lingering environmental effects.
    Last, while I recognize the confidentiality requirements of 
the trade secrets laws that are intended to safeguard 
proprietary information from potential competitors about food 
and drug products, a fuller transparency of the science behind 
environmental risk-reviews differs in a couple of material 
ways.
    First, it promotes bringing the brightest minds and the 
best ideas to bear on an issue. Second, it more adequately 
protects the fisheries and biodiversity that are managed in 
public trust by our public resource agencies.
    So Mr. Chairman, Ranking Member Snowe, thank you again for 
the opportunity to share these views, and I look forward to 
answering any questions you might have.
    [The prepared statement of Dr. Epifanio follows:]

     Prepared Statement of John Epifanio, Ph.D., Fish Conservation 
 Geneticist, Illinois Natural History Survey and University of Illinois
    I wish to thank Chairman Begich, Ranking Member Snowe, and members 
of the Oceans, Fisheries, and Coast Guard Subcommittee for convening 
this hearing and for inviting me to share my perspectives and 
experiences on the environmental risks and consequences to marine and 
freshwater ecosystems from the release of manipulated (or GE) fish 
genomes.
    During the past 25+ years, I have had a number of relevant 
experiences both on the scientific side and the administrative side 
that have shaped my perspectives on and overall approach to this 
specific issue and one related to it. First, as a population geneticist 
serving several state agencies and universities, the scope of my 
students' and my own work has focused on the uses and ecological-
genetic consequences from the intentional and inadvertent release of 
propagated fishes on populations in recipient ecosystems. As such we 
have examined species ranging from Pacific salmonids to American shad 
to largemouth bass. Second, I've also served several agencies including 
as Coordinator of the National Fisheries Program with the U.S. 
Geological Survey (in the Reston Headquarters) and Assistant Program 
Leader for Fisheries with the USDA-Forest Service (in the DC 
Headquarters), and Director for Ecology and Conservation Sciences with 
the Illinois state Department of Natural Resources. Third, I served as 
a resource scientist with Trout Unlimited, a non-governmental 
conservation organization, where my focus was on the scientific 
underpinnings of conserving salmonid biodiversity. Finally, I served on 
the Northwest Power and Conservation Council's Independent Scientific 
Review Panel (ISRP) where we review the scientific rigor of the 
Columbia basin's fish and wildlife program--where maintaining the 
integrity of Pacific salmon gene pools is a central focus for projects 
reviewed by the ISRP. In short, each of these and other direct 
experiences has contributed and given shape to the perspectives I offer 
today.
    I intend to focus my comments narrowly on the potential hazards 
from the release or escapement of genetically engineered (GE) salmon on 
the biological diversity and full range of ecosystem services in 
recipient environments.\1\ I ultimately defer to others on issues 
related to product-labeling, food safety, or applications of gene 
transfer in fishes used as models in medical research. The heart of the 
matter before us today is whether a proposed New Animal Drug 
Application (NADA) for commercial production of a genetically 
engineered, growth-enhanced salmon and associated reviews has 
sufficiently weighed the potential consequences if a group of these 
modified individuals were to escape or be released into an adjacent 
ecosystem. In light of this narrow focus, it is worth stating 
explicitly and up front, the importance that the precedence this 
specific case brings to other future applications.
---------------------------------------------------------------------------
    \1\ The foundation for these comments can be made available to the 
Subcommittee staff if desired, and ultimately may be found in the 
Nation's leading professional and technically peer-reviewed journals by 
numerous research groups, including my own, as well as a number of 
reviews by the National Academy of Sciences.
---------------------------------------------------------------------------
    To begin, as a fish conservation geneticist, I am familiar with the 
ecological consequences from the release (or escape) of fish with 
genomes that have been modified either from conventional and transgenic 
pathways. It is important to state upfront that, to my knowledge, there 
are no documented or studied cases of genetically engineered Atlantic 
salmon escaping into the wild, even though we have laboratory studies 
from Canada on growth and reproductive performance. Therefore, we must 
rely on information on analogous releases of altered information. At 
the most general level, there are essentially two broad categories of 
concern that genetically modified salmon represent to marine or inland 
ecosystems (1) impacts due to ecological interactions (such as 
predation, competition, and transmission of diseases); and (2) impacts 
directly from interbreeding or indirectly through husbandry practices.
    In terms of ecological impacts posed by potential escape of 
genetically engineered fish, the release of a novel top-predator or 
more efficient competitor is expected to have cascading effects 
throughout a local food web. While we might be able to make some rather 
wide predictions about the size and shape of potential disruptions, our 
ability to precisely hone in on the scale of these impacts ultimately 
depends on quality of previously-gathered information and the 
appropriate expertise brought to bear on the issue--in short, a formal 
Uncertainty Analysis. Moreover, our understanding several ecological 
attributes of released individuals are key to more accurately 
predicting impacts, such the number escaped, their behavioral 
dominance, reproductive capacity, the overall persistence (through 
time) of the escaped fishes, as well as how these attributes are 
expressed in different local ecosystems. One needs only to consider the 
recent emergence of non-native species such as sea lamprey in the upper 
Great Lakes, northern snakeheads in the mid-Atlantic region, lionfish 
in the Caribbean, or the various Asian carp species in the Mississippi 
River basin to comprehend the enormity of ecological effects on local 
biota from release of new predators or competitors. Ultimately, in the 
case of a genetically modified salmon escaping into the wild, the full 
extent of its ecological impact will be determined not only by the 
characteristics of the salmon itself, but also on the ecosystem into 
which it escapes. For example, an already-stressed habitat and biotic 
community is more likely to be impacted than one that is pristine and 
resilient.
    Another level of complexity and potential disturbance emerges where 
modified fishes can escape into an ecosystem where the species' wild 
relatives occur. Here, we face additional risks stemming from the 
interbreeding. Based on three or more decades of study on salmon and 
other species, the fisheries genetics community has discovered that 
even very subtle genetic differences between previously isolated 
breeding groups can seriously disrupt survival and reproduction in 
future generations. In the case of genetic engineering (or, 
transgenesis), we have a case where a single gene (or a single 
construct of a few genes) is introduced into a genome in a way that is 
essentially a human-directed mutation. Such a mutation is expected and 
designed to have a major effect on the physiology, anatomy, or behavior 
of the host genome--the very reason the genetic engineering is 
undertaken. Whereas in nature the vast majority of random mutations are 
not expected to alter populations because they are generally 
deleterious and quickly removed from a population, human-mediated 
mutations may have lingering effects because they are designed for 
traits that are not subjected to natural selection in the wild.
    To be sure, many of the long-practiced, classical modes of gene 
pool and genome manipulation have proven to be problematic--we should 
expect no exception to this pattern from transgenesis. For example, 
some recent work by scientists in Oregon have observed that release of 
steelhead, a Pacific salmonid domesticated but a few generations, are 
less fit than their wild counterparts. Moreover, the interbreeding 
between these domesticated and wild fish has conveyed an impact by 
lowering the overall reproductive capacity of the supplemented 
population. As another example, a study conducted in my home state of 
Illinois examined the impacts of interbreeding and moving largemouth 
bass from the northern and southern extremes of the state into each 
other's range. Here, even though the populations exhibited very subtle 
genetic-level differences between northern and southern populations, 
their interbred offspring had much reduced survival and reproductive 
rates regardless of the location they were released into.
    One consistent pattern through the documented cases of this kind 
interbreeding penalty in bass, salmon, or other species is a failure to 
adequately predict the full scope of the impacts beforehand. In short, 
by failing to consider the consequences of even these classical modes 
of genome manipulations, we risk unintended environmental effects. 
Ultimately, the newer approaches carry similar and additional risks 
unless adequate safeguards are rigorously carried out. While the New 
Animal Drug Application for Genetically Engineered salmon includes 
precautions for physical containment to prevent escapement and for 
reproductive sterility should escape occur, it is critical to consider 
that no established safeguard has proven foolproof nor eliminates all 
risk classes simultaneously or completely.
    In closing, I offer several observations and recommendations for 
the Subcommittee to consider as it further deliberates the issues 
before it.

        (1) Salmon exhibit a complex suite of life-histories that will 
        benefit from specific experience and expertise in the ecology 
        and genetics of the species in question. Certainly, FDA has 
        experience with food and drug science, whereas other agencies 
        in the Federal and state sphere are more versed in salmon 
        biology and the unique qualities of the environments they 
        generally occupy (especially, NOAA-Fisheries for marine 
        ecosystems, and Fish and Wildlife Service and the states for 
        inland ecosystems).

        (2) Whereas containment and engineered sterility may, in fact, 
        reduce the probability of escape or reproduction (triploidy has 
        proven an imperfect method of mass sterilization), these do not 
        completely remove risks of escape, reproduction, or ecological 
        interference. A robust and formal risk assessment is warranted. 
        Such assessments will benefit from formal uncertainty analyses. 
        Moreover, it would be prudent to treat any transgenic 
        modification of fishes as a controlled experiment that is a) 
        actively monitored for impacts after approval and that can be 
        b) terminated should the need arise without lingering 
        environmental effect. More specific and detailed 
        recommendations may be found in a 2004 National Academy of 
        Sciences report entitled, ``Biological confinement of 
        genetically engineered organisms''.

        (3) While I recognize the confidentiality requirements of trade 
        secrets laws that are intended to safeguard proprietary 
        information from potential competitors about food and drug 
        products, a fuller transparency and debate of the science 
        behind environmental risk-reviews differs in a couple material 
        ways. First, it promotes bringing the brightest minds and best 
        ideas to bear on the issues. Second, it more adequately 
        protects fisheries and fish biodiversity that are managed in 
        trust by public resource agencies.

    As a final thought, I contend we need to consider the scientific 
issues surrounding the risks of Genetically Engineered salmon and other 
fishes based on the appropriate and full-range of scientific fields to 
shape the policy discussions. Based on analogous concerns and risks 
from release of fishes genetically altered in more traditional or 
conventional ways (rather than with more recent molecular and cellular 
biology based approaches), the risks appear to all too real, albeit to 
an insufficiently understood extent. Ultimately, the environmental 
concerns surrounding release or escape have been debated and summarized 
by various experts and groups including no less than three separate 
Panels from the National Academy of Sciences entitled ``Animal 
Biotechnology: Science Based Concerns'' (2002); ``Biological 
Confinement of Genetically Engineered Organisms'' (2004); and, 
``Genetically Engineered Organisms, Wildlife and Habitats'' (2008). I 
trust the Subcommittee will encourage continued examination of these 
concerns by the lead and consulting agencies.
    Mr. Chairman, Thank you, again, for the opportunity to share these 
views. I would be happy to address any questions you or the Members 
might have.

    Senator Begich. Thank you very much.
    Dr. Leonard.

            STATEMENT OF GEORGE H. LEONARD, Ph.D., 
        AQUACULTURE PROGRAM DIRECTOR, OCEAN CONSERVANCY

    Dr. Leonard. Good morning.
    Thank you, Chairman Begich, and Ranking Member Snowe, and 
other members of the Committee for inviting me here today.
    My name is George Leonard, and I direct Ocean Conservancy's 
Aquaculture Program. I have a Ph.D. in Marine Ecology and 
Evolutionary Biology, and for about the last decade I have 
worked to protect the long-term health of our oceans by 
identifying an environmentally responsible seafood supply that 
is critical to America's economic strength.
    It is my assessment that the existing Federal regulatory 
structure under the Food and Drug Administration is incapable 
of asking and answering the suite of questions that's needed to 
appropriately regulate genetically engineered fish.
    More specifically, based on the available science, I 
conclude that we cannot be assured that the expansion of GE 
fish more generally, beginning with the approval of 
AquAdvantage farm salmon, is safe for the environment.
    Approval of the first genetically engineered animal for 
human consumption should only be made with a full understanding 
of the environmental risks and the potential impacts of the 
broad adoption of this type of fish farming.
    This decision will set a precedent that has ramifications 
well beyond the application now before the FDA.
    The standard that we set for ourselves today will determine 
how thoroughly we evaluate other GE fish in the future. For, 
most certainly, others will follow.
    What is at stake here is no less than the future of fish, 
natural ecosystems, and our seafood supply.
    Now, proponents of GE salmon would have us believe that 
there is no risk that the fish will get out, and even if they 
do get out, there is no risk that GE salmon will take hold or 
reproduce with native salmon populations. I would urge the 
Committee to seriously question those assumptions.
    We should, in fact, heed the lessons of history, which is 
replete with examples of other fish that have been introduced 
around the globe with the best of intentions, but which have 
left a trail of destruction in their wake.
    Now, while science can't predict with certainty what the 
outcomes will be if GE fish escape, caution is certainly 
warranted.
    For the purposes of this morning's hearing, I would ask you 
to examine this issue under the assumption that there will be 
fish escapes. And let's imagine the possible consequences if GE 
salmon compete or interbreed with wild salmon.
    If the fish get out, how will this affect commercial and 
recreational salmon fisheries in Alaska, or perhaps along the 
West Coast where I live? How might this impact efforts to 
recover wild Atlantic salmon in New England and Maine? How 
might this impact our international salmon management 
agreements with Canada under the Pacific Salmon Treaty?
    How might this impact other sectors of the economy that are 
already affected by Endangered Species Act restrictions, such 
as the Columbia River hydropower system, the use of pesticides 
by the agriculture industry, or flood control structures along 
salmon-inhabited rivers?
    How might this undermine the billions of taxpayer dollars 
that have been invested in helping protect and restore wild 
salmon?
    And finally, how might this reverberate throughout marine 
food webs? For example, what might be the effects on endangered 
southern resident orcas in Puget Sound, or the endangered Cook 
Inlet beluga whales in Alaska?
    Now, Mr. Chairman, I don't have answers to those questions. 
In fact, nobody does. And, Mr. Chairman, that's exactly the 
point. Not only has the FDA failed to provide answers to those 
questions, they have failed to even ask the questions at all.
    In my view, the question before the Federal Government, and 
before this committee, is whether we're going to allow the 
approval of GE fish under a flawed process that fails to 
adequately analyze these kinds of risks. We need the government 
to stand up and do its job.
    Specifically, we request that Congress do four things. 
First: demand a modern, environmental risk assessment that 
treats uncertainty directly, before decisions are made, on this 
fish or any future fish.
    Demand that the National Marine Fisheries Service and other 
agencies with expertise in fishery biology play a substantive 
role in assessing those risks.
    Demand a far more inclusive and transparent process than 
has happened to date.
    And, finally, demand a moratorium on GE salmon and other GE 
fish, including Senator Begich's bill S. 1717, until we have 
the science to demonstrate that there is little or no risk to 
wild fish in healthy oceans.
    Our nation's seafood's future should not be left to a few 
individual private companies or to the FDA alone. We 
fundamentally need a public debate about the kinds of fish that 
we want to eat, which of those we will farm, and which of those 
we will catch in the wild. And decisions must be based on a 
clear-eyed analysis of the economic, environmental, and 
societal costs and benefits of doing so.
    But right now, that isn't happening. And the American 
people deserve better.
    Thank you for the opportunity to testify. I'm happy to 
answer your questions as well.
    [The prepared statement of Dr. Leonard follows:]

            Prepared Statement of George H. Leonard, Ph.D., 
            Aquaculture Program Director, Ocean Conservancy
Introduction
    Thank you Chairman Begich, Ranking Member Snowe and other members 
of the Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard 
for convening this hearing at such an important juncture, and for 
inviting me to testify. My name is George Leonard and I direct Ocean 
Conservancy's Aquaculture Program. I have a Ph.D. in marine ecology and 
evolutionary biology. For a decade I have worked to protect the long-
term health of our oceans by identifying a viable, environmentally 
responsible seafood supply that is critical to America's economic 
strength.
    A healthy ocean and a healthy seafood industry are critical to 
America's environmental and economic strength. Based on my assessment 
of the scientific literature and the current policy framework in the 
United States to regulate genetically engineered fish, we cannot yet 
conclude that the introduction of the first genetically engineered 
animal for human consumption--the AquAdvantage farmed salmon--is safe 
for the environment. Furthermore, the existing Federal regulatory 
structure and the current application before the Federal Food and Drug 
Administration (FDA) are incapable of asking and answering the broader 
suite of questions raised by the proliferation of genetically 
engineered fish farming and the range of engineered species that are 
likely to follow this potential first approval for GE salmon.
Genetically Engineered Salmon and the Future of Fish
    The application from AquaBounty Technologies, Inc., for approval of 
its patented, genetically engineered farmed Atlantic salmon continues 
to be extraordinarily controversial. While there are numerous aspects 
of this specific proposal that warrant close scrutiny, much of the 
controversy, I believe, stems from the broader implications of 
approval. While the FDA, Congress, and the American public are right to 
pay close attention to the specific scientific and operational details 
of the proposed hatchery in Canada and the grow out facility in Panama, 
it is the broader ecological and societal consequences of the 
proliferation of genetically engineered salmon and other fish that are 
larger concerns and warrant careful scrutiny.
    Chairman Begich and this Committee are to be commended for 
addressing this issue head-on and ensuring that these larger 
implications of genetically engineered (GE) fish are not ignored. What 
is at stake is no less than the future of fish, natural ecosystems, and 
our seafood supply. The issue is much larger than this single 
application from one private company. The critical question is whether 
society as a whole would be better off or worse from having this 
product on the market.\1\ A more comprehensive analysis of the risks 
and benefits to our seafood supply, our current seafood industry, 
affected stakeholders, and natural ecosystems is desperately needed.
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    \1\ Smith, M.D., Asche, F., Guttormsen, A. G., J. B. Wiener. 2010. 
Genetically Modified Salmon and Full Impact Assessment. Science 
330:1052-1053.
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    The specific controversy around GE salmon is embedded in a larger 
debate about how society hopes to procure fish protein. Unlike only 
three decades ago, our seafood supply is now dominated by farmed fish, 
with 50 percent of global seafood production coming from 
aquaculture.\2\ Indeed, fish farming will play an important role in our 
future seafood choices. But aquaculture's reputation has suffered from 
the poor environmental and societal performance of some forms of 
farming, most notably the global shrimp and salmon 
industries.\3\,\4\ Consumers and seafood businesses are 
increasingly making purchasing decisions based on the environmental 
impacts of their seafood choices, rewarding better environmental 
performance in the marketplace.\5\ Without sufficient understanding of 
the risks, and public confidence in regulatory decision-making, 
adoption of GE technology has the potential to undermine a sustainable 
future for aquaculture, rather than secure it.
---------------------------------------------------------------------------
    \2\ FAO Fisheries and Aquaculture Department. 2011. World 
aquaculture 2010. Technical Paper. No. 500/1. Rome, Food and 
Agriculture Organization.105 pp.
    \3\ Naylor, R. L., Goldburg, R. J., Mooney, H., Beveridge, M., 
Clay, J. Folke, C., Kautsky, N., Lubchenco, J., Primavera, J. and M. 
Williams. 1998. Nature's Subsidies to Shrimp and Salmon Farming. 
Science 282: 883-884.
    \4\ Ford J. S. and R. A. Myers. 2008. A Global Assessment of Salmon 
Aquaculture Impacts on Wild Salmonids. PLoS Biol 6(2): e33. 
doi:10.1371/journal.pbio.0060033.
    \5\ http://www.montereybayaquarium.org/cr/seafoodwatch.aspx.
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    Rather than leaving the future of fish to a series of piecemeal 
decisions, beginning with the approval of AquAdvantage farmed salmon, 
Congress should craft a broader, national vision for our future seafood 
supply that articulates the appropriate role of wild and farmed fish, 
including genetically engineered fish. Our nation's seafood future 
shouldn't be left to individual private companies or the FDA alone. 
Instead, it should be grounded in a public debate about the kinds of 
fish we wish to eat, involve decisions about which fish we will grow on 
farms and which we will catch in the wild, and be based on a clear-eyed 
analysis of the economic, environmental, and societal costs and 
benefits of doing so.
    Chairman Begich and this Committee are to be commended for their 
role in starting the conversation.
Environmental Risks of Genetically Engineered Fish: Knowns and 
        Unknowns
    A decision to approve genetically engineered salmon should only be 
made with a full understanding of environmental risks and potential 
impacts that would accompany the broad adoption of this technology. 
Proponents of GE salmon have postulated that there is no risk of 
escapement, and that even if escapement does occur, there is no risk 
that GE salmon populations could take hold or otherwise reproduce with 
or negatively impact native, wild salmon populations or other 
components of the ecosystem. It would be irresponsible not to seriously 
question these assertions.
    Given the stakes, we should take a more prudent approach. When 
considering approval of GE salmon and other GE fish, decision-makers 
should assume that there will be escapement. As explained in more 
detail below, history is replete with examples of fish and other 
animals that were never intended to get out, and yet they did. Given 
that history, it is only prudent to assume that GE fish will eventually 
escape from production facilities as the technology proliferates.
    To be responsible, we must imagine the possible consequences if GE 
salmon compete and/or interbreed with wild salmon populations. What 
might those impacts be? What and whom will they affect? And what will 
the cost be to us as a nation? These are key questions about 
environmental and biological consequences and risks that must be asked 
and answered before any application for GE fish is approved. We must 
undertake an honest evaluation that includes an objective and clear-
eyed view not only of the probability that an event might happen, but 
also of the magnitude and severity of the consequences of a range of 
potential, unintended outcomes. These are big questions with 
potentially significant consequences, and we must answer them before we 
commit to a course.
    The two general categories of environmental impacts that should 
concern this committee are the effects on wild salmon, and the food web 
impacts on other species. As the members of the Committee are well 
aware, wild salmon are already under considerable threat in many 
regions from a whole range of human activities, including coastal 
development, habitat loss, stream water diversions, net pen salmon 
aquaculture, and climate change.\6\ Any additional impact from GE 
salmon could tip endangered or threatened populations over the edge, 
damaging currently healthy and commercially important salmon stocks and 
inhibiting recovery of those at low abundance. The mechanisms through 
which GE salmon escapement might damage wild salmon populations are 
four-fold: competition for food and habitat; pathogen or disease 
transmission; disruption of wild salmon reproductive behavior; and 
interbreeding with wild salmon. In assessing these issues, we should 
ask not only whether GE fish are more harmful than conventional farmed 
salmon, but more fundamentally, what harm can GE salmon cause and have 
we assessed and addressed these potential risks adequately?
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    \6\ Coates, P. A. 2006. Salmon. Reaktion Books Ltd. London. 216 pp.
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Competition with wild salmon for food and habitat
    Escaped GE salmon would be competitors for food,\7\ habitat, and 
reproduction.\8\ In experiments, growth-enhanced GE salmon dominated 
non-GE salmon for feed acquisition and exhibited strong agonistic and 
cannibalistic behavior when feed resources were inadequate.\9\ A number 
of behavioral effects are reported in growth-enhanced GE fish that 
could affect wild populations, including significantly enhanced feeding 
motivation and reduced discrimination of prey choice. According to 
research from the Canadian Department of Fisheries and Oceans, a Coho 
salmon genetically engineered with a similar growth hormone gene as in 
the AquAdvantage fish expressed aggressive behavior in hunting for 
food that even led to a collapse in wild salmon populations.\10\ 
Studies found that GE Coho salmon are also more likely to take risks 
when feeding.\11\ GE salmon also have greater thermal tolerance than 
wild fish, a trait which could give engineered fish an added advantage. 
GE salmon could thus potentially stress wild counterparts as they lay 
claim to new territory and habitat. Such an introduction could also 
push wild salmon into inferior habitats, which could further increase 
mortality.\12\ \13\
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    \7\ Devlin, R.H., J.I. Johnsson, D.E. Smailus, C.A. Biagi, E. 
Johnsson, and B.T. Bjornsson. 1999. Increased ability to compete for 
food by growth hormone transgenic coho salmon (Oncorhynchus kisutch 
Walbaum). Aquaculture Research 30: 1-4.
    \8\ Johnsson, J. I., and B. Bjornsson. 2001. Growth enhanced fish 
can be competitive in the wild. Functional Ecology 15 (5): 654-659.
    \9\ Devlin, R. H., M. D'Andrade, M. Uh, and C. A. Biagi. 2004. 
Population effects of growth hormone transgenic coho salmon depend on 
food availability and genotype by environment interactions. Proceedings 
of the National Academy of Sciences of the United States of America 101 
(25): 9303.
    \10\ Muir, W. M. and R. D. Howard. 1999. Possible ecological risks 
of transgenic organism release when transgenes affect mating success; 
sexual selection and the Trojan gene hypothesis. Proceedings of the 
National Academy of Sciences.
    \11\ Sundstrom, L. F., Devlin, R. H., Johnsson, J. I. & Biagi, C. 
A. 2003 Vertical position reflects increased feeding motivation in 
growth hormone transgenic coho salmon (Oncorhynchus kisutch). Ethology 
109: 701-712.
    \12\ McGinnity, P., C. Stone, J.B. Taggart, D. Cooke, D. Cotter, R. 
Hynes, C. McCamley, T. Cross, and A. Ferguson. 1997. Genetic impact of 
escaped farmed Atlantic salmon (Salmo salar L.) on native populations: 
use of DNA profiling to assess freshwater performance of wild, farmed, 
and hybrid progeny in a natural river environment. ICES Journal of 
Marine Science 54: 998-1008. McGinnity, P., P. Prodohl, A. Ferguson, R. 
Hynes, N. Maoileidigh, N. Baker, D. Cotter, B. O'Hea, D. Cooke, and G. 
Rogan. 2003. Fitness reduction and potential extinction of wild 
populations of Atlantic salmon, Salmo salar, as a result of 
interactions with escaped farm salmon. Proceedings of the Royal Society 
of London. Series B: Biological Sciences 270: 2443.
    \13\ McGinnity, P., C. Stone, J.B. Taggart, D. Cooke, D. Cotter, R. 
Hynes, C. McCamley, T. Cross, and A. Ferguson. 1997. Genetic impact of 
escaped farmed Atlantic salmon (Salmo salar L.) on native populations: 
use of DNA profiling to assess freshwater performance of wild, farmed, 
and hybrid progeny in a natural river environment. ICES Journal of 
Marine Science 54: 998-1008. McGinnity, P., P. Prodohl, A. Ferguson, R. 
Hynes, N. Maoileidigh, N. Baker, D. Cotter, B. O'Hea, D. Cooke, and G. 
Rogan. 2003. Fitness reduction and potential extinction of wild 
populations of Atlantic salmon, Salmo salar, as a result of 
interactions with escaped farm salmon. Proceedings of the Royal Society 
of London. Series B: Biological Sciences 270: 2443.
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Pathogens and disease transmission
    Unlike fish escapes, where a single large-scale release (or 
sustained, low level ``leakage'') would likely be required to have 
significant impacts, disease transmission from farmed to wild fish can 
cause severe mortality even from a small number of fish. There are few 
data, however, on any additional impact that GE salmon could have on 
disease transmission because no GE salmon have been introduced into 
commercial aquaculture to date. But some GE fish are known to have 
compromised immune systems, and it has been documented that triploid GE 
Coho salmon are more susceptible to disease.\14\ This suggests that the 
introduction of transgenic salmon into commercial aquaculture could 
increase the number of infected fish and the degree of disease transfer 
into the marine environment, especially if GE fish are used in net pen 
grow-out systems. In addition, if escapes and interbreeding were to 
occur, the underlying genetics of GE fish with compromised immune 
systems would be introduced into the gene pool for wild fish.\15\
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    \14\ Jhingan, E., R. H. Devlin, and G. K. Iwama. 2003. Disease 
resistance, stress response and effects of triploidy in growth hormone 
transgenic coho salmon. Journal of Fish Biology 63 (3): 806-823.
    \15\ De Eyto, E., P. McGinnity, S. Consuegra, J. Coughlan, J. 
Tufto, K. Farrell, H. J. Megens, W. Jordan, T. Cross, and R. J. M. 
Stet. 2007. Natural selection acts on Atlantic salmon major 
histocompatibility (MH) variability in the wild. Proceedings of the 
Royal Society B: Biological Sciences 274: 861.
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Disruption of wild salmon reproduction
    Escaped GE salmon could also interfere with wild salmon breeding. 
For example, scientists have observed that spawning of wild females 
with farmed males occasionally results in poor egg fertilization when 
no wild males are involved.\16\ When it comes to competition for 
spawning sites, later arriving fish may destroy a nest from an earlier 
spawn.\17\ There is also some evidence that the hatchery environment 
produces more aggressive and more territorial fish.\18\ While all these 
findings are for interactions between wild salmon and traditional, non-
GE farmed salmon, similar concerns are likely to exist with GE salmon 
should they enter natural ecosystems.
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    \16\ Fleming, I., K. Hindar, I. Mjølnerød, B. 
Jonsson, T. Balstad and A. Lamberg. 2000. Lifetime success and 
interactions of farm salmon invading a native population. Proceedings 
of the Royal Society B: Biological Sciences 267: 1517-1523.
    \17\ Naylor, R., K. Hindar, I. Fleming, R. Goldburg, S. Williams, 
J. Volpe, F. Whoriskey, J. Eagle, D. Kelso and M. Mangel. 2005. 
Fugitive salmon: assessing the risks of escaped fish from net-pen 
aquaculture. Bioscience 55: 427-38.
    \18\ Sundstrom, L. F., M. Lohmus, and J. I. Johnsson. 2003. 
Investment in territorial defense depends on rearing environment in 
brown trout (Salmo trutta). Behavioral Ecology and Sociobiology 54: 
249-255.
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Interbreeding with wild salmon
    Given the complexity of how novel genes function in different 
environments, considerable concern remains over how GE fish may impact 
wild populations. Wild fish have been optimally selected over many 
generations for various life history characteristics such as growth 
rate, age and size at sexual maturity and clutch size. If escaped GE 
salmon and wild salmon interbreed successfully, it could have dire 
consequences for the survival of wild fish. If gene complexes from GE 
salmon take hold in wild populations, wild fish populations could have 
reduced survival and reproduction. In addressing the risk of GE fish 
generally, Muir and Howard (2002) stated: ``If the population is 
struggling for existence prior to an introduction event, the induced 
genetic load may be sufficient to drive the population to extinction.'' 
\19\ One mechanism by which this might occur is the Trojan gene 
hypothesis. First postulated in 1999,\20\ this hypothesis suggests that 
GE fish possess a mating advantage that drives the engineered gene into 
wild populations; but the resulting GE offspring have reduced 
viability, which eventually drives the wild population to extinction. 
There is scientific uncertainty as to whether the Trojan gene effect 
will manifest in AquAdvantage GE salmon. The theory's relevance should 
not be dismissed outright, as other studies note that behavior, 
genetics, and other factors can alter the likelihood of such effects. 
This suggests that an in-depth risk assessment is crucial before GE 
fish are approved.\21\
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    \19\ Muir, W. M. and R. D. Howard. 2002. Methods to assess 
ecological risks of transgenic fish releases. Genetically Engineered 
Organisms: Assessing Environmental and Human Health Effects. D. K. 
Letourneau and B. E. Burrows. Boca Raton, FL, CRC Press: 355-383, p. 
358.
    \20\ Muir, W. M. and R. D. Howard. 1999. Possible ecological risks 
of transgenic organism release when transgenes affect mating success; 
sexual selection and the Trojan gene hypothesis. Proceedings of the 
National Academy of Sciences. 96:13853-13856.
    \21\ Ahrens, R.N.M. and Devlin, R.H. 2010. Standing genetic 
variation and compensatory evolution in transgenic organisms: A growth-
enhanced salmon simulation. Transgenic Research 20(3):583-597.
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    Two very recent studies have shown that escaped GE salmon will not 
die out quickly and, when fertile, can reproduce and pass on genes to 
future generations.\22\ Particularly in situations where the rate of 
non-GE farmed salmon escapement is close to the reproductive rate of 
wild fish, the genetic consequences of such ongoing interbreeding could 
lead to an ``extinction vortex,'' where an increase in presence of GE 
fish would lead to a decrease in genetic variance and adaptive 
potential.\23\
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    \22\ Moreau, D.T. R., I. A Fleming, G. L. Fletcher and J.A. Brown. 
2011a. Growth hormone transgenesis does not influence territorial 
dominance or growth and survival of first-feeding Atlantic salmon Salmo 
salar in food-limited stream microcosms. Journal of Fish Biology 
78:726-740. Moreau, D.T. R., Corrine Conway, and I.A. Fleming. 2011b. 
Reproductive performance of alternative male phenotypes of growth 
hormone transgenic Atlantic salmon (Salmo salar). Evolutionary 
Applications 4(6): 736-748.
    \23\ McGinnity, P., P. Prodohl, A. Ferguson, R. Hynes, N. 
Maoileidigh, N. Baker, D. Cotter, B. O'Hea, D. Cooke, and G. Rogan. 
2003. Fitness reduction and potential extinction of wild populations of 
Atlantic salmon, Salmo salar, as a result of interactions with escaped 
farm salmon. Proceedings of the Royal Society of London. Series B: 
Biological Sciences 270: 2443.
---------------------------------------------------------------------------
    In addition, considerable scientific uncertainty remains regarding 
the evolutionary success of GE offspring in the wild; it is difficult 
to predict how offspring containing the engineered gene would evolve 
over several generations. Natural selection could either increase or 
decrease offspring fitness in the wild, and both could have potential 
impacts on the conservation of wild salmon populations.\24\ A great 
deal more remains to be learned about the effects of GE fish on wild 
fish. Until a larger body of research is available, caution is crucial.
---------------------------------------------------------------------------
    \24\ Kapuscinski, A.R., Hayes, K.R., Li, S., and G. Dana, 2007. 
Environmental Risk Assessment of Genetically Modified Organisms: 
Methodologies for Transgenic Fish. Vol. 3. CABI International, 
Oxfordshire.
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    In sum, GE salmon could potentially damage already-struggling wild 
salmon populations through competition for food and habitat, pathogen 
and disease transmission, disruption of reproduction, and 
interbreeding. If such impacts come to pass, they could have real-world 
and far-reaching impacts on people, industries, and the environment. 
Congress should ensure that key questions are answered before GE salmon 
are approved for commercial production:

   If wild salmon populations are damaged by GE salmon, how 
        will this affect commercial and recreational wild salmon 
        fisheries in Alaska and along the West Coast?

   How might it impact our ongoing efforts to recover wild 
        Atlantic salmon in Maine and throughout New England?

   How would it impact our existing international salmon 
        management agreements with Canada under the Pacific Salmon 
        Treaty?

   What implications would a further-weakening of Endangered 
        Species Act-listed salmon stocks have on other sectors of our 
        economy that are already impacted by ESA restrictions, such as 
        the Columbia River hydropower system, the use of agricultural 
        pesticides, and flood-control structures along salmon-inhabited 
        rivers?

   Would damage done by GE salmon roll back the positive impact 
        of billions of dollars of Federal taxpayer money that has been 
        invested in helping protect, replenish, and restore wild salmon 
        populations?

    Beyond these direct impacts of GE salmon, we must remember that 
wild salmon are a major component of the marine food web. A major blow 
to wild salmon could reverberate throughout the system in unexpected 
ways. In particular, wild salmon populations damaged by the effects of 
GE salmon could have implications on their predators through a 
reduction in wild salmon availability as prey for higher trophic 
levels.
    For example, if the effects of GE salmon impair wild salmon, how 
would it affect Puget Sound's iconic and endangered Southern Resident 
Orca population? Members of this cetacean population have been observed 
in an emaciated state, and the population struggles with high levels of 
contaminants--especially among young and newborn whales.\25\ If GE 
salmon trigger a further collapse in the availability of wild salmon 
prey in the Puget Sound or somehow add to toxicity loads, it is 
reasonable to expect that this could further imperil Puget Sound's 
endangered orcas. The same question could--and should--be asked of Cook 
Inlet beluga whales in Alaska, another population that relies heavily 
on wild salmon as prey and whose endangered status has caused great 
consternation in surrounding communities.\26\ Given the central role of 
salmon in marine and terrestrial food webs,\27\ \28\ impacts could also 
extend to a long list of other predator species such as bald eagles, 
river otters, and bears.
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    \25\ http://www.nwr.noaa.gov/marine-mammals/whales-dolphins-
porpoise/killer-whales/esa-status/.
    \26\ http://www.defenders.org/wildlife_and_habitat/wildlife/
beluga_whale.php; http://www
.biologicaldiversity.org/species/mammals/Cook_Inlet_beluga_whale/
index.html.
    \27\ Hocking, M. D., and J. D. Reynolds. 2011. Impacts of salmon on 
riparian plant diversity. Science. 331:1609-1612.
    \28\ Gende, S. M., Edwards, R. T., Willson, M. F., and M. S. 
Wipfli. 2002. Pacific salmon in aquatic and terrestrial ecosystems. 
BioScience 52:917-928.
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    We know a great deal about the importance of wild salmon and 
healthy ecosystems. We know a great deal less about the risks and 
potential consequences to wild salmon and healthy ecosystems from 
commercial-scale production of GE salmon. The process of approving GE 
salmon should not proceed without rigorous and objective assessment of 
those risks and consequences. Thus far, the FDA has not only failed to 
provide answers to these questions, the agency has failed to even ask 
the questions at all.
Ecological Consequences of Management Decisions in the Face of 
        Imperfect Information
    As the Committee ponders the range of questions that must be 
answered before GE salmon are allowed in commercial aquaculture, it is 
worth examining a few examples of other fish species that were 
intentionally deployed for what appeared good reasons at the time, but 
that only later became recognized as poor management decisions. While 
these examples are not related to genetic engineering, they do 
highlight the dire consequences that can occur when novel species are 
moved outside their natural habitats. They are ``object lessons'' in 
the need for a precautionary approach when potential impacts could be 
dire.
    The United Nations has acknowledged that the introduction of exotic 
(non-indigenous) species poses the second greatest threat to global 
biodiversity, behind only habitat loss. The peer-reviewed literature is 
replete with examples of plants and animals, both intentionally 
released and accidentally escaped, that have caused extreme ecological 
harm. One study has estimated that 50,000 non-indigenous species are 
now present in the U.S., causing major environmental damage that totals 
nearly $137 U.S. billion annually.\29\
---------------------------------------------------------------------------
    \29\ Pimental, D., L. Lach, R. Zuniga, and D. Morrison. 2000. 
Environmental and economic costs of non-indigenous species in the 
United States. . BioScience 50:53-65.
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    In many cases, species have been introduced with little concern or 
evaluation of potential ecological consequences, under the belief that 
transporting or otherwise using species outside their natural habitat 
provided societal benefits. Plants have been used as erosion or 
predator control, while other species have been intentionally released 
to provide new hunting and fishing opportunities.\30\ In an 
extraordinarily large number of cases, this has resulted in ecological 
harm.
---------------------------------------------------------------------------
    \30\ Davis, M.A. 2009. Invasion Biology. Oxford University Press. 
Oxford, UK. 243 pp.
---------------------------------------------------------------------------
    In studying these examples, scientists have found that the behavior 
of exotic species is often puzzling. Introduced species often defy 
efforts to predict if and when they become established, whether they 
will spread, and what their impacts will be in new habitats. Resource 
managers have learned that it is much easier and less costly to prevent 
an introduction of a species than to remove it once it has been 
established.\31\ In the absence of sufficient information, the 
precautionary approach is to refrain from deploying a species when 
there is an unacceptable risk of escape and harm. In all cases, a hefty 
dose of caution and skepticism is warranted. This is especially true 
for genetically engineered species, which can be thought of as special 
case of non-indigenous species, where the engineered gene could 
interact with the genetic makeup of wild populations in novel and 
difficult to predict ways.\32\
---------------------------------------------------------------------------
    \31\ Volpe, John. 2001. Super un-Natural: Atlantic salmon in BC 
waters. David Suzuki Foundation. 31 pp.
    \32\ Ahrens, R.N.M. and R. H. Devlin. 2010. Background: genotype 
effects on transgenes in populations: a growth-enhanced salmon 
simulation. Transgenic Research. DOI 10.1007/s11248-010-9443-0.
---------------------------------------------------------------------------
    With the growth of aquaculture globally, a number of aquatic 
species have been distributed well beyond their natural borders and 
grown in non-indigenous environments. While never intended to be 
released, many have escaped, validating the now famous quote from 
Jeffrey Goldblum in Jurassic Park that ``life often finds a way.'' 
Furthermore, the ``law of unintended consequences'' often governs the 
fate of species when people utilize them in ways that fail to recognize 
or account for the species' natural history or their potential 
ecological role in new habitats.
    Several examples illustrate the dire consequences for natural 
ecosystems of management decisions made without sufficient 
understanding of ecological risk.
Atlantic salmon
    Salmon farming began in the mid 1970s on the western coast of 
British Columbia, Canada, largely in response to a growing global 
market for farmed salmon and a provincial government focused on the 
economic benefits that a new seafood industry could bring to struggling 
coastal communities. From 1972 to 1985, salmon farms grew from zero to 
185 coastal farm sites.\33\ This expansion was driven by national 
legislation that encouraged foreign investment, combined with a weak 
and poorly coordinated regulatory regime in Canada. Critics have raised 
numerous concerns about farmed salmon, including disruption of natural 
ecosystems, spread of disease like sea lice and infectious salmon 
anemia, harm to wild salmon stocks, and pollution from feed, chemicals 
and waste. My comments, however, address only one main issue: 
regulators were repeatedly proven wrong when they made assumptions 
about whether farmed salmon could escape and be viable in the wild.
---------------------------------------------------------------------------
    \33\ Keller B. C. and R. M. Leslie. 1996. Sea-silver: Inside 
British Columbia's salmon farming industry. Horsdal and Shubart 
Publishers Ltd., Victoria. .
---------------------------------------------------------------------------
    Starting in the mid 1980s, Federal regulators and the salmon 
farming industry made a series of assurances related to farmed Atlantic 
salmon impacts that were based on a combination of invalid assumptions, 
wishful thinking, and willful ignorance.\34\ Long after the industry 
had already become entrenched, a body of research showed each of these 
statements to be patently false.
---------------------------------------------------------------------------
    \34\ Volpe, John. 2001. Super un-Natural: Atlantic salmon in BC 
waters. David Suzuki Foundation. 31 pp.
---------------------------------------------------------------------------
    Particularly germane to genetically-engineered salmon and other GE 
fish, these assurances--in chronological order--were:

   Fish escapes are rare;

   Escapes are inevitable but fish can not survive;

   Escaped fish can survive, but they don't ascend rivers;

   Some escaped fish are found in rivers, but they can't spawn 
        in those habitats;

   Escaped fish in rivers are likely to spawn, but their 
        progeny are not viable; and finally

   Multi-year classes of escaped fish are not a threat to 
        native wild salmon populations.\35\
---------------------------------------------------------------------------
    \35\ Ibid.

    In hindsight, all of these assurances turned out to be false when 
they were empirically tested. Over a period of years, information was 
gleaned through observations made by fishermen, concerned citizens, and 
a large body of empirical research (in the laboratory and in the field) 
by Dr. John Volpe. But by 1997, when Atlantic salmon had already been 
in the natural environment in British Columbia for over a decade, 
government regulators still had not seen fit to conduct a proper 
environmental analysis to evaluate the potential spawning performance 
of aquaculture-reared Atlantic salmon compared to native Pacific 
salmon. From the beginning of the industry's development, government 
officials and Federal scientists had been silent on the need to 
estimate this risk. And throughout the period, the aquaculture industry 
had portrayed the risk as essentially non-existent, a portrayal 
revealed to be false once the correct questions were asked and 
answered.
    In contemplating this issue in 2001, Volpe concluded that the only 
answer to the question of the potential ecological consequences of the 
BC salmon farming industry should have been ``we don't know,'' given 
the high levels of uncertainty regarding the impacts of ocean farming 
of salmon. In evaluating the effectiveness of Canadian regulators, 
Volpe concluded that to safeguard common resources, the government must 
ensure there is a rational evaluation of the industry with a full 
accounting, not only of benefits, but also of risks.\36\ The same is 
equally true in the United States with respect to the proposed 
deployment of genetically engineered salmon and the other genetically 
engineered fish that are sure to follow.
---------------------------------------------------------------------------
    \36\ Ibid.
---------------------------------------------------------------------------
Nile tilapia
    Today, tilapia is likely the world's most widely distributed non-
indigenous ﬁsh species--having invaded every tropical and 
subtropical environment to which they have gained access.\37\ Since the 
1980s, almost all of the worldwide introductions of tilapia have been 
for new aquaculture developments.\38\ Over this time, there has been a 
shift from growing Mozambique tilapia (Oreochromis mossambicus) toward 
growing Nile tilapia (Oreochromis niloticus) in aquaculture.\39\ Nile 
tilapia now dominate global tilapia aquaculture, accounting for 72 
percent or 474,000 metric tons of production in 1995.\40\ Throughout 
the world, cases of tilapia introductions are the result of both 
intentional release and unintentional escape. Regardless of mechanism, 
this has resulted in the decline of native fish and alteration of 
natural benthic communities globally. \41\ \42\
---------------------------------------------------------------------------
    \37\ Costa-Pierce, Barry A. ``Rapid evolution of an established 
feral tilapia (Oreochromis spp.): the need to incorporate invasion 
science into regulatory structure.'' Biological Invasions 5 (2003): 71-
84
    \38\ Ibid.
    \39\ Ibid.
    \40\ FAO (Food and Agriculture Organization of the United Nations) 
(1997) Review of the state of world aquaculture. FAO Fisheries 
Circular. No 886, Rev 1. Inland Water Resources and Aquaculture 
Service, Fishery Resources Division, Rome, 163 p
    \41\ ``Oreochromis spp. (fish).'' Global Invasive Species Database. 
9 Dec. 2011. 
    \42\ Canonico, Gabrielle C., Angela Arthington, Jeffrey K. McCrary, 
and Michele L. Thieme. . ``The effects of introduced tilapias on native 
biodiversity.'' Aquatic Conservation: Marine and Freshwater Ecosystems 
15 (2005): 463-483.
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    The United States is no exception. In the U.S., Nile tilapia has 
been used for aquaculture since 1974, and while it was never intended 
to be released, it has become introduced into open waters through 
escape or release from fish farms.\43\ Reports of Nile tilapia in the 
wild have come from the states of Arizona, Illinois, Massachusetts, 
Georgia, and the Gulf of Mexico, including Texas, Mississippi, Alabama, 
and Florida.\44\ Studies suggest that Nile tilapia can invade coastal 
areas beyond their initial point of introduction by finding areas of 
thermal refuge from cold winter temperatures which would otherwise 
limit their survival. In particular, thermal gradients within a power 
plant cooling pond have provided Nile tilapia with the warm habitat 
needed for successful invasion and establishment.\45\ Studies have also 
shown that the fish's reproduction is not hampered by the salinity of 
typical ocean seawater.\46\
---------------------------------------------------------------------------
    \43\ ``Oreochromis niloticus Factsheet.'' United States Geological 
Survey. 9 Dec. 2011. .
    \44\ Ibid.
    \45\ McDonald, Jennifer L., Mark S. Peterson, and William T. Slack. 
. ``Morphology, density, and spatial patterning of reproductive bowers 
in an established alien population of Nile tilapia, Oreochromis 
niloticus.'' Journal of Freshwater Ecology 22.3 (2007): 461-468.
    \46\ Schofield, Pamela, Mark S. Peterson, Michael R. Lowe, Nancy J. 
Brown-Peterson, and William T. Slack. ``Survival, growth and 
reproduction of non-indigenous Nile tilapia, Oreochromis niloticus 
(Linnaeus 1758). I. Physiological capabilities in various temperatures 
and salinities.'' Marine and Freshwater Research 62.5 (2011): 439-449.
---------------------------------------------------------------------------
    In coastal Mississippi in particular, Nile tilapia was deployed in 
the state through aquaculture and has since established breeding 
populations.\47\ The environmental conditions in coastal southeastern 
Mississippi appear to provide a high quality environment for the 
survival of released Nile tilapia.\48\ This species of tilapia can 
spawn year-round. Fish as small as 80 millimeters in total length carry 
mature eggs, showing that this exotic species can survive and become 
established in our present ocean landscape.
---------------------------------------------------------------------------
    \47\ McDonald, Jennifer L., Mark S. Peterson, and William T. Slack. 
. ``Morphology, density, and spatial patterning of reproductive bowers 
in an established alien population of Nile tilapia, Oreochromis 
niloticus.'' Journal of Freshwater Ecology 22.3 (2007): 461-468.
    \48\ Peterson, Mark S., William T. Slack, and Christa M. Woodley. 
``The occurrence of non-indigenous Nile tilapia, Oreochromis niloticus 
(Linnaeus) in coastal Mississippi, USA: ties to aquaculture and thermal 
effluent.'' Wetlands 25.1 (2005): 112-121.
---------------------------------------------------------------------------
    Tilapia provides a second cautionary tale of the consequences of 
growing a fish known to pose ecological risks beyond its native range. 
Even with the best of intentions, fish can and do escape.
Asian carp
    Asian carp is a third example of a non-indigenous fish species that 
has spiraled out of control. . The carp now infesting the Mississippi 
River Basin and threatening the fisheries of the Great Lakes were 
introduced both intentionally by the government and unintentionally 
through escapes from fish farms. In the late 1970s and early 1980s, the 
Environmental Protection Agency and state Fish and Game programs 
carried out research using bighead and silver carp to clean sewage 
ponds and to consume undesirable aquatic vegetation. At the time, carp 
were touted as an innovative breakthrough to control water pollution 
because the fish were a cheaper, more wholesome form of biological 
control than that provided by traditional chemical treatments.\49\
---------------------------------------------------------------------------
    \49\ See Myths, Dangers, U.S. Failures: The Truth About Asian Carp, 
6 Part Series, Detroit Free Press (July 20, 2011).
---------------------------------------------------------------------------
    Yet today, we know the dire consequences of the decision to 
introduce this highly invasive fish. The once-desirable fish are now 
spreading northward, especially up and throughout the Mississippi River 
Basin. A growing body of evidence shows that Asian carp compete with 
native species for both food and habitat, may spread disease to native 
wild fish, and negatively affect water quality.\50\
---------------------------------------------------------------------------
    \50\ See, e.g., Laird, C. A., and L. M. Page (1996) (The silver 
carp has the potential to cause enormous damage to native species 
because it feeds on plankton required by larval fish and native 
mussels); A.J. Bocek et al., (1992) (Silver carp is an effective 
carrier of Salmonella typhimurium, and it can transport diseases to new 
areas).
---------------------------------------------------------------------------
    It is not just biologists who know the dangers posed by non-
indigenous carp; recreational fishermen have experienced these dangers 
first hand. Not only do the fish that recreational anglers seek compete 
with carp for food, but fishermen can be personally injured in pursuit 
of their catch. Enormous silver carp--weighing up to 100 pounds--can 
jump out of the water and have been known to injure anglers sitting in 
their boats.\51\ Now, millions of Federal and state dollars are being 
spent to try to stop Asian carp from spreading into additional lakes 
and waterways. But this effort may be doomed to failure; just last week 
DNA from the invasive silver carp was found in the Mississippi River 
above the Coon Rapids Dam, further north than it has ever been 
discovered, raising the prospect that the fish may be headed to 
Minnesota's most popular recreational lakes.\52\
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    \51\ Injurious Wildlife Species: Silver Carp and Largescale Silver 
Carp, Federal Register: July 10, 2007 (volume 72, number 131).
    \52\ http://www.startribune.com/local/135259173.html?page=1&c=y.
---------------------------------------------------------------------------
    Like tilapia and salmon, Asian carp provides an example of the law 
of unintended consequences. With all these fish, important questions 
should have been asked before they were introduced and ultimately 
escaped.
Regulation of Genetically Engineered Fish: FDA Approval Process Is 
        Inadequate
    Given these cautionary tales and the environmental perils 
associated with the potential escape of GE salmon and other GE fishes, 
it is critical that the United States has in place a regulatory process 
that can anticipate, evaluate, and guard against these concerns. I have 
little confidence that the process led by the Food and Drug 
Administration is up to the task.
    Under the 1986 Coordinated Framework for the Regulation of 
Biotechnology (``Coordinated Framework''), genetically engineered 
organisms (GEOs) are regulated according to the concept of ``product, 
not process.'' This means that, Federal agencies evaluate GEOs as 
products like any other--``substantially equivalent'' to their non-
engineered analogues--not as a special category distinguished by their 
development using the process of recombinant DNA technology.\53\ The 
Coordinated Framework assumes that the existing agencies, using 
existing authority, have the ability and expertise to review 
commercialization applications.
---------------------------------------------------------------------------
    \53\ In fact, however, there are exceptions to this policy: the 
most notable, perhaps, is the USDA decision to regulate GE crops as 
plant pests based on their incorporation of a pesticide but also on 
their being genetically engineered (see Marden 2003: 769).
---------------------------------------------------------------------------
    There are a number of problems with this approach. First, existing 
statutes have generally been designed to address situations where harm 
or risk has already been quantified, not situations where there remains 
a high degree of scientific uncertainty, such as is the case for 
genetic engineering technology. The ``new animal'' drug laws currently 
being used to regulate GE animals, for example, were written well 
before GE animals were ever conceptualized as a possible food source 
and are woefully outdated. Second, the theory of substantial 
equivalence is predicated on an assumption of safety; that is, it 
starts from a position of assumed safety, the burden of proof falls on 
the public to show harm.\54\ Third, an agency with expertise in one 
area relevant to a permit application may not be best suited to 
evaluate the other potential effects a GEO may have when it is 
commercially released. This potential for problems in regulating 
transgenic fish and livestock under the Coordinated Framework Early was 
recognized as early as 1990.\55\
---------------------------------------------------------------------------
    \54\ Kelso, Dennis Doyle Takahashi. ``Genetically Engineered 
Salmon, Ecological Risk, and Environmental Policy.'' Bulletin of Marine 
Science 74, no. 3 (2004): 509-28.
    \55\ Kapuscinski, Anne R. and Eric M. Hallerman, ``Transgenic Fish 
and Public Policy: Anticipating Environmental Impacts of Transgenic 
Fish,'' Fisheries 12 (1990), p. 3.
---------------------------------------------------------------------------
    Pursuant to the Food, Drug, and Cosmetic Act of 1938 (FDCA), the 
Food and Drug Administration (FDA) is responsible for regulating food 
additives, food, and animal drugs. Within the Coordinated Framework, 
FDA regulates GE animals under the concept of ``new animal drugs.'' 
\56\ The transgene, or recombinant DNA (rDNA) construct, used to 
produce a GE fish is considered the ``new animal drug'' under the 
agency's New Animal Drug Application process.\57\ It is important to 
recognize that the actual drug being regulated is the rDNA construct 
itself in the resulting fish. The fish itself is not a drug. Yet under 
this system, approval of the GE drug equates to approval of the GE fish 
itself. If approved, therefore, the AquAdvantage Salmon would be the 
first genetically engineered animal approved for human consumption.
---------------------------------------------------------------------------
    \56\ 21 U.S.C. Sec. Sec. 301-399a.
    \57\ The New Animal Drug Application (NADA) process, as required 
pursuant to 21 U.S.C. Sec. 360ccc, is detailed in an FDA guidance 
policy document: Guidance for Industry #187, Regulation of Genetically 
Engineered Animals Containing Heritable Recombinant DNA Constructs 
(January 5, 2009).
---------------------------------------------------------------------------
    FDA's authority was designed to provide the agency with oversight 
of traditional pharmaceutical drugs. Applying the new animal drug 
application process to GE salmon intended for interstate commerce and 
human consumption raises a host of problems. FDA's existing process 
does not ensure adequate protections for the environment, such as 
environmental analyses and public participation requirements.\58\ 
Because of concerns about trade secrets, the process is open to public 
comment only after the approval of the new animal drug application, and 
thus, approval of the GE fish has been made.\59\ Unlike applications 
led by USDA or EPA, FDA's approval process occurs almost entirely 
behind closed doors, making it nearly impossible for the public to 
participate meaningfully in an agency decision that could lead to 
devastating and irreversible ecological harm. While this process might 
protect confidential business information, it fails to adequately and 
transparently examine potentially far-reaching and serious consequences 
and environmental risks from GE salmon.
---------------------------------------------------------------------------
    \58\ See, e.g., 21 C.F.R. Sec. 514.11(b)-(c) (stating that FDA will 
not disclose to the public the existence of a NADA file before approval 
has been published in the Federal Register, unless it has previously 
been publicly disclosed or acknowledged); 21 C.F.R. Sec. 25.50(b) 
(asserting that ``unless the existence of applications for . . . animal 
drugs . . . has been made publicly available, the release of the 
environmental document before approval of . . . animal drugs . . . is 
inconsistent with statutory requirements imposed on FDA''). In the case 
of the current GE salmon application, FDA has hosted a public hearing 
and has stated that it will seek public comment on the final 
environmental analysis documents required by the National Environmental 
Policy Act (NEPA) before publishing a final determination. However, 
such opportunities are not presently required by law and therefore may 
not be afforded each time the Agency is considering approval of a GE 
food animal application.
    \59\ FDA provided an opportunity for public comment in September 
2010 before final approval of GE salmon, likely because the agency 
sensed this decision would be highly controversial; FDA, however, is 
not legally required to be similarly forthright when new entities seek 
approval from the agency for additional species or culturing 
conditions.
---------------------------------------------------------------------------
    FDA's existing regulatory process was simply not designed to 
address the complex issues involved in developing genetically 
engineered fish for human consumption. Because the FDA's focus is on 
food and drug safety, the agency does not have the expertise or 
experience to adequately identify and analyze the environmental risks 
and consequences of GE salmon and other fish. In addition, the FDA 
approval process lacks adequate public participation, adequate 
consideration of the full range of environmental hazards, and the 
opportunity for sufficient input from other Federal agencies with 
expertise in fisheries and environmental risk.
    As a result of these inadequacies, FDA's review process does not 
address the far-reaching environmental risks to fisheries and natural 
ecosystems. Among other issues \60\, the current process fails to 
adequately consider threats to wild salmon populations, threats to 
commercial and recreational salmon fisheries, threats to fisheries 
targeting other species that interact with salmon, threats to marine 
and terrestrial food webs in which salmon are embedded, and threats to 
recovery efforts for salmon stocks listed as endangered or threatened 
under the Endangered Species Act.
---------------------------------------------------------------------------
    \60\ Center for Food Safety v. Vilsack, No. C 09-00484 JSW (N.D. 
Cal.) (2009), on sugar beets, found that the USDA had improperly failed 
to consider environmental and economic impacts of GE sugar beets before 
approving its commercialization.
---------------------------------------------------------------------------
    Other Federal agencies with relevant expertise must play a stronger 
leadership role in the approval and regulation of GE fish. These 
include the National Marine Fisheries Service (NMFS), the U.S. Fish and 
Wildlife Service (USFWS), and the Environmental Protection Agency 
(EPA). NMFS and FWS have scientific expertise backed by extensive 
ecosystem research, and have expertise in conservation and protection 
of the natural resources that could ultimately be affected by GE salmon 
and other GE fish. EPA has knowledge and experience in the oversight 
and management of threats to water and watersheds. At a minimum, FDA 
should be required to consult these agencies during all stages of 
development and approval of GE salmon. Furthermore, if FDA is to remain 
the lead agency, FDA should be required not only to consult with these 
agencies, but also to either heed their advice or provide adequate 
rationale for any decisions to the contrary.
    Concerns over the FDA approval process were brought to the 
attention of FDA in September 2010 in a letter from eleven U.S. 
Senators, including Senator Begich.\61\ The letter requested that FDA 
halt the GE salmon approval process, citing concerns over unknown 
impacts to human health and environmental risks. These concerns are 
valid, and FDA is ill-equipped to deal with the environmental and 
biological consequences and risks associated with the farming of 
genetically engineered fish.
---------------------------------------------------------------------------
    \61\ Letter to Commissioner Margaret Hamburg, Commissioner of Food 
and Drugs, FDA (Sept. 28, 2010).
---------------------------------------------------------------------------
Congressional Oversight and the Need for Reform
    Our nation is faced with the prospect of approving genetically 
engineered salmon and future GE fish under statutes that were not 
designed for that purpose, by a Federal agency that doesn't have the 
appropriate expertise to address environmental risk, and through a 
process that doesn't account for many of the major possible stakeholder 
impacts. This is not a judgment on the FDA or its many dedicated and 
capable public servants; we have tremendous respect for the FDA and its 
employees. But like all Federal agencies, the FDA has a specific 
perspective shaped by a particular set of statutes.
    As its name implies, the FDA is charged with addressing issues of 
drug efficacy and safety, not matters of fisheries science, marine 
ecology, and evolutionary biology. So when faced with an application 
for an animal such as GE salmon, the FDA is structured to ask questions 
that reflect the laws that govern and shape the FDA--not those that 
govern, for example, the National Marine Fisheries Service. In the case 
of GE salmon--and the other GE fish that are sure to follow--an initial 
approval under the FDA's limited perspective falls far short of what is 
needed. It does not adequately reflect the full suite of public policy 
considerations, and it clearly does not reflect the body of concerns 
being expressed by citizens throughout Alaska, Maine, and other states 
across this Nation. As representatives of the citizenry at large, then, 
it is the job of members of Congress to step in and ensure that the 
tough questions are asked and answered.
    Given the potential far-reaching consequences of genetically 
engineered fish, it is appropriate for Congress to use the full force 
of both its legislative and oversight powers to tackle this issue. 
Given the shortcomings of existing laws and regulations described 
above, it is essential that Congress take legislative action to ensure 
that genetically engineered salmon and other GE fish are not approved 
unless and until the full suite of environmental risks are thoroughly 
understood. And until the day comes when new legislation is enacted 
into law, Congress should use its oversight authority to rigorously 
scrutinize the FDA approval process, examine the environmental risks, 
evaluate the adequacy of the science being used in decisionmaking, and 
bring to light the possible consequences if worst-case scenarios should 
come to pass.
    When Congress pursues both oversight and legislation, it should 
endeavor to achieve the four following overarching objectives:
    First, Congress should demand more science and a modern, science-
driven environmental risk assessment that treats complexity and 
uncertainty directly and objectively, using the most current 
methodologies \62\ before GE salmon and other GE fish are given 
approval. Possible approval of GE salmon and other GE fish raises a 
whole host of new scientific questions that have not yet been answered. 
Merely sweeping scientific uncertainty under the rug is not an option. 
Comprehensive risk assessment--including a quantitative ``failure 
analysis'' would entail formulating a problem statement; identifying 
and prioritizing all possible risks; defining measurable assessment 
endpoints; estimating exposure, likelihood, and severity of 
consequences; identifying and appropriately treating uncertainties; and 
using this information to characterize the overall risk.\63\ Congress 
should communicate to the Executive Branch that it expects the tough 
scientific questions to be dealt with before GE salmon are approved--
not after. In so doing, the government should not rely solely on data 
from applicant companies without independent verification.
---------------------------------------------------------------------------
    \62\ Burgman, M. 2005. Risks and Decisions for Conservation and 
Environmental Management. Cambridge University Press. Cambridge, UK. 
488 pp.
    \63\ Kapuscinski, A. R., Hayes, K., Li, S., and G. Dana, eds. 200. 
Environmental Risk Assessment of Genetically Modified Organisms, Vol. 
3: Methodologies for Transgenic Fish, CABI Publishing, UK. 304 pp.
---------------------------------------------------------------------------
    Second, Congress should demand that the appropriate Federal and 
state agencies with the necessary expertise be provided a substantive 
role in assessing the environmental risks of GE salmon and other GE 
fish. FDA simply lacks the scientific expertise to identify and 
sufficiently analyze the full range of possible impacts from 
genetically engineered salmon. Other Federal agencies such as NOAA, the 
National Marine Fisheries Service, the U.S. Fish and Wildlife Service, 
and the EPA are far better equipped with the scientific experts and 
institutional history to identify the impacts and assess the risks. It 
may even be appropriate to provide an agency such as the National 
Marine Fisheries Service with veto power over FDA approval if the 
agency concludes there is sufficient risk to wild fisheries or natural 
ecosystems. Other Federal bodies, such as the Regional Fishery 
Management Councils, could also provide valuable perspective given 
their emphasis on sustainable fisheries. Finally, state natural 
resource agencies should be involved, to take advantage of their 
decades of on-the-ground experience in salmon management and 
restoration.
    Third, Congress should demand a far more inclusive and transparent 
approval process. Worst-case escapement and interbreeding scenarios for 
GE salmon could have major impacts across a wide group of stakeholders 
and industries. The ramifications for the public interest are of an 
entirely different scale and nature than those typical for drug 
approval. Stakeholder engagement should begin early in the process, 
during the problem definition phase of the risk assessment; such an 
approach is now considered the ``state of the art'' in addressing 
environmental risk, resulting in questions being asked and answered 
that are directly relevant to stakeholder concerns.\64\ The current FDA 
process that provides for public input only after an approval is made 
is unacceptable and not in the public interest. While FDA is not 
presently required to provide more transparency or comprehensive public 
participation, the policy realities of GE fish demand that the 
government hold itself to a far higher standard than what is currently 
required of the FDA.
---------------------------------------------------------------------------
    \64\ Kapuscinski, Anne. Professor of Sustainability Science, 
Dartmouth College, Hanover, NH. Personal communication, December 10, 
2011.
---------------------------------------------------------------------------
    Finally, Congress should adopt a highly conservative, precautionary 
approach toward a future seafood supply that potentially entails 
genetically engineered fish. Given the uncertainty that surrounds GE 
salmon and other GE fish at this juncture, Ocean Conservancy is 
supportive of efforts to issue a ban or moratorium against GE salmon 
unless and until the scientific evidence demonstrates that GE salmon 
can be produced with little or no risk to wild fish and the marine 
environment. In this regard, we support Senator Begich's legislation, 
S.1717, to ban interstate commerce of genetically engineered salmon. 
Senator Begich's bill is a prudent step, given the considerable risks 
and public policy implications of allowing the production of first 
genetically engineered fish for human consumption.
Conclusion
    Chairman Begich's decision to hold this hearing is a very important 
step toward achieving a better understanding of the full suite of 
environmental risks posed by GE salmon. I commend the Chairman for 
holding this hearing, and Ocean Conservancy encourages future actions 
to pursue rigorous Congressional oversight on this topic.
    The environmental risks posed by GE salmon specifically, and GE 
fish in general, are real. How Congress and the Food and Drug 
Administration address the application for the first genetically 
engineered animal destined for human consumption will set a precedent 
for all applications for GE fish that follow it. While science cannot 
predict with certainty what the outcomes will be if engineered fish 
escape into natural ecosystems, given what is at stake, considerable 
caution is warranted.
    Congress should take legislative action to ensure that the full 
suite of environmental risks is thoroughly understood before we 
proceed. A modern, science-driven environmental risk assessment must be 
applied to this issue, and stakeholder engagement and transparency must 
be at the heart of the process. Congress should ensure that the Federal 
agencies with environmental protection as their core mission--most 
notably the National Marine Fisheries Service--play a substantive role 
in fully assessing these risks. In short, Congress should ensure that 
the hard questions are asked and answered. If those questions cannot be 
satisfactorily addressed, we should not risk our oceans and our seafood 
supply to a future with genetically engineered fish.

    Senator Begich. Thank you very much.
    Our last speaker today, Mr. Greenberg.

STATEMENT OF PAUL GREENBERG, AUTHOR OF ``FOUR FISH: THE FUTURE 
                    OF THE LAST WILD FOOD''

    Mr. Greenberg. Thank you. Thanks, Senator Begich, thanks 
Ranking Member Snowe.
    I'm really glad that you have embraced this issue, because 
it's something that really needs to be put up to the national 
level in a very, very big way.
    I don't have a doctor in front of my name--I'm sort of a 
fish guy.
    Senator Begich. I'll give you a doctor for today.
    Mr. Greenberg. Thank you. You can call me a doctor of 
fishology, fish guy emeritus or whatever.
    But I come here as somebody who has looked not necessarily 
all together from a scientific perspective, but from a social, 
from a historical, from a fishing perspective at aquaculture 
and fisheries around the world.
    I've seen many fish farms; I've seen many fisheries, and 
all these lead me to think that this particular fish is a bad 
idea.
    But I'm not going to get into some of the things that some 
of these great witnesses put forward. Rather, I wanted to put 
out there just one quote from the history of science expert, 
Carl Popper, who said, ``Science may be described as the art of 
oversimplification--the art of determining what we may with 
advantage omit.''
    What I'd argue is that if science is the art of 
oversimplification, science in the service of bringing a 
product to market is an oversimplification of what's already 
been oversimplified.
    And so time and again we've seen products introduced to the 
market where we don't have the time horizon to really 
adequately assess their effect.
    You look at DDT, you know, DDT is synthesized in the 1870s. 
It's not until the 1970s that we realize it's destroyed a lot 
of bird life, and that we ban it. Same thing with PCBs. Not 
synthesized and used in this country until the 1920s, but not 
until the 1970s do we find that it's ruined fisheries in the 
Hudson River and throughout the United States.
    With apologies to Dr. Stotish, if I compare this fish to a 
chemical, well, I mean at the same time they're trying to get 
this fish through FDA as a veterinary drug, so I think it's 
fair game.
    So if we're going to have a genetically modified fish--and 
let's say the risks are not that big, let's go ahead with it--
then I think the real essential question that has to be asked 
is not why shouldn't we have this particular fish, but why 
should we? What does this fish bring to the table?
    You know, we have some genetically modified things out 
there in the world that have done some good. You look at Golden 
Rice, which delivers vitamin A to nutritionally poor countries 
in a very easy, cost effective way. But what does this fish do? 
Nutritionally, in an ideal world, Dr. Stotish says this fish is 
the same.
    But what does it do in terms of addressing all these other 
environmental concerns that we worry about aquaculture? Well, 
first of all, the fish shortage problem--my condolences to 
Senator Snowe, but my enthusiasm to Senator Begich--not because 
of your parties, but because of your situation with salmon.
    Senator Snowe, I have been to Maine, I have seen the 
devastated salmon rivers of Maine, and it's a tragedy. Senator 
Begich, you have a lot of salmon and it's just what you were 
born into. And we have a lot of salmon in Alaska, just a lot. I 
mean, over 200 million fish were caught in 2011--just a lot, a 
lot of fish.
    And what's crazy is that 70 to 80 percent of it gets 
exported. So we do not have a salmon shortage problem in this 
country. The real threat to salmon is actually environmental 
destruction--which, as Senator Snowe has experienced in Maine--
dams and all sorts of pollution have knocked out salmon there. 
In Alaska, it's huge, industrial projects like Pebble Mine, 
which threatened the largest salmon run left in America.
    So those are the things that we're really worried about. 
It's not really overfishing. Alaska salmon is certified 
sustainable by the Marine Stewardship Council. It's a great 
harvest. It endures year after year--we don't have a salmon 
shortage.
    Next problem, the salmon feed problem. OK, one of the big 
problems with salmon and all carnivorous fish aquaculture is 
that they eat a lot of other fish. And in the early days of 
salmon aquaculture it could take as many as five pounds of wild 
fish to grow a single pound of salmon.
    Well, actually, the industry has begun to address this, and 
the feed conversion ratio and the ``fish-in, fish-out'' ratio 
has gone down dramatically, in some places by more than half. 
So, the industry has really cleaned up its act in that respect.
    The AquaBounty fish actually turns out to be not really 
much more feed efficient than the regular, unmodified salmon. 
It eats about the same amount of food. It grows faster, but it 
doesn't eat less fish. So we're kind of getting the wool pulled 
over our eyes in this respect.
    The sea cage problem, the next thing that Dr. Stotish 
brought up: yes, it's potentially a bad thing to grow salmon in 
open net cages where they can be exposed to the wild. Well, 
yes, we could grow some genetically modified fish in some 
containment facilities, but it turns out in the intervening 20 
years--been 20 years since this fish was invented--lots of 
other fish have been found that work well in containment.
    The Arctic char, which is a salmonid--I think it's 
delicious. Anyone have Arctic char? It's great, and it's 
indistinguishable from a salmon on the plate, maybe it's even a 
little more pleasant to eat.
    But if you like salmon, and you want to have salmon, 
there's a company called Sweet Spring in Washington State that 
is now growing salmon in containment, and it only takes them 12 
months to do it. And they're unmodified fish. So, why? Why 
would we have this fish?
    Finally, there's the public perception problem. And this 
might be the most serious of all to both Senator Snowe, and to 
Senator Begich, insofar as you both have product that you're 
trying to put out on the market. In Senator Snowe's case, it's 
aquaculture Atlantic salmon. In Senator Begich's case, it's 
five species of wild, beautiful Pacific salmon.
    The consumer, when they see salmon, they just see salmon. 
They don't make differentiations between it, and I can tell you 
this from dozens of lectures I've made throughout the country. 
What they do perk up with is genetic engineering. Consumers do 
not want genetically engineered fish.
    A Wall Street Journal poll said that only 36 percent of 
consumers would actually eat these fish. And what's really 
interesting, too, is that salmon farmers don't want this 
either.
    I talked to a guy named Scott Nichols, who has a salmon 
farm, and he said this genetically modified fish would be bad 
for the salmon industry and bad for aquaculture, and that 
retailers--their response ranges from ``unease to 
trepidation''.
    There is real concern among retailers that genetically 
engineered salmon might elicit a negative perception of salmon 
as a category. So all of your salmon products in both of your 
states stand to suffer extremely from the introduction of this 
fish.
    So that's basically what I want to say. I guess the last 
thing I'd venture forth is that, you know, some people call 
this the ``Frankenfish.'' I would call this fish the Solyndra 
fish, insofar as this fish represents outdated technology.
    It's been on the market--or it's been in consideration for 
20 years, and in those 20 years, surprise, surprise, the 
industry has improved. Fisheries management in America has 
improved. All these preconditions that we thought were a big 
problem have improved, and we don't need this particular fish 
to address those problems.
    So, in conclusion, I fully support Senator Begich's 
legislation S. 1717, to ban interstate commerce of genetically 
engineered salmon. Senator Begich's bill rightly protects the 
American people from a risk they shouldn't be forced to take.
    Thank you.
    [The prepared statement of Mr. Greenberg follows:]

                 Prepared Statement of Paul Greenberg, 
     Author of ``Four Fish: The Future of the Last Wild Food'' \1\
---------------------------------------------------------------------------
    \1\ www.fourfish.org and http://www.nytimes.com/2010/08/01/books/
review/Sifton-t.html?pag
ewanted=all.
---------------------------------------------------------------------------
Introduction
    Thank you Chairman Begich, Ranking Member Snowe and other members 
of the Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard. 
It's heartening to see this important issue debated on such a high 
level and I greatly appreciate your invitation to testify.
    The historian Carl Popper once famously wrote, ``science may be 
described as the art of oversimplification--the art of determining what 
we may with advantage omit.'' \2\ I'd argue today that if science is 
the art of oversimplification, then science in the service of bringing 
a product to market is often an oversimplification of the already 
oversimplified. In the drive to get something saleable on supermarket 
shelves, omissions in research will inevitably occur and the time span 
needed to adequately assess the environmental risk of that new product 
is often insufficient. Dichlorodiphenyltrichloroethane or DDT was first 
synthesized in 1874 \3\. It was not banned until 1972 \4\ long after it 
was proven that the insecticide had done profound damage to American 
birdlife \5\. Polychlorinated biphenyls or PCBs were launched 
commercially in this country in 1929. We did not get intimations that 
they were dangerous environmental chemicals until the 1930s and they 
were not determined a pollutant and banned until 1979, long after they 
had damaged Hudson River fisheries and other fisheries throughout the 
United States \6\. The genetic engineering of living organisms is a new 
science. In 1973 the first genetically engineered organism was created 
by humans \7\. We will not know the full environmental impact of their 
introduction into the food supply, for many, many years.
---------------------------------------------------------------------------
    \2\ Popper, Karl, The Open Universe, W.W. Bartley, 1992, p. 44.
    \3\ Center for Disease Control, http://www.cdc.gov/malaria/about/
history/.
    \4\ Environmental Protection Agency, http://www.epa.gov/history/
topics/ddt/01.html.
    \5\ Environmental Protection Agency http://www.epa.gov/
international/toxics/pop.html.
    \6\ Envirmental Protection Agency http://www.epa.gov/osw/hazard/
tsd/pcbs/pubs/about.htm.
    \7\ Modern Genetics: engineering life, Lisa Yount, Chelsea House, 
1997, p. 20.
---------------------------------------------------------------------------
    So if we take as a given that there are many unknowns about 
genetically engineered organisms, many potential downsides, then we 
should carefully weigh the factors that are motivating us to bring a 
genetically engineered organism into the American food system. Does 
that new organism have an over-weighing positive, like, for example, 
Golden Rice which through a gene modification was able to cheaply 
deliver vitamin A to nutrient deprived children in the developing 
world? \8\ Does Aqua Bounty's AquAdvantage salmon offer anything of 
that importance? Nutritionally it is at best the same as other farmed 
salmon. So what else has it got? Instead of asking ``why shouldn't we 
have genetically engineered salmon?'' we should be asking ``why should 
we have it?'' If we look carefully at the arguments proponents of this 
fish have put forward in its defense then I believe a rational person 
would conclude that this fish doesn't really offer us very much. I'll 
touch on four areas where I feel the fish comes up short.
---------------------------------------------------------------------------
    \8\ Ye, X; Al-Babili, S; Kloti, A; Zhang, J; Lucca, P; Beyer, P; 
Potrykus, I (2000). ``Engineering the provitamin A (beta-carotene) 
biosynthetic pathway into (carotenoid-free) rice endosperm''. Science 
287 (5451): 303 5. doi:10.1126/science.287.5451.303. PMID 10634784.
---------------------------------------------------------------------------
1. The Fish Shortage Problem
    The proponents of the Aqua Bounty AquAdvantage salmon emphasize 
that the we are running out of wild fish \9\. Globally speaking it's 
true that there are not enough wild fish to meet demand and we will 
indeed need more aquaculture if we are going to feed 10 billion people. 
But which fish do we need more of? Certainly not salmon. The United 
States still has lots of it. This year's Alaska salmon harvest is 
projected to have been one of the largest since statehood, with over 
200 million fish coming to market.\10\ These salmon were harvested 
under strict supervision of the State of Alaska's Department of Fish 
and Game and nearly the entire Alaska salmon harvest has been certified 
as sustainable by the Marine Stewardship Council.\11\ Even with these 
intense restrictions on salmon fishing in Alaska, we still have much 
more salmon than we can use. 70-80 percent of the United States' wild 
salmon catch is shipped abroad every year.\12\ The real threat to 
American salmon is habitat destruction \13\ or potential habitat 
destruction in the form of large-scale industrial development like the 
one proposed at the so-called Pebble Mine site in America's most 
important salmon fishery, the Bristol Bay watershed.\14\ As long as we 
keep Alaska rivers clean and healthy America will have all the salmon 
it needs. As for the rest of the world, it will not be a cold-water 
Western fish like salmon that will provide protein for three billion 
additional people. It will be a naturally faster growing, feed-
efficient, warm-water species like Indochinese swai and Nile tilapia 
that will do the job.\15\ And lest engineers think tinkering with 
tilapia and swai is a good idea, I would venture that there is much 
improvement that can be made with the husbandry and diet of those fish, 
obviating the need for genetic engineering.
---------------------------------------------------------------------------
    \9\ http://www.aquabounty.com/PressRoom/#l0.
    \10\ Bountiful Alaska salmon harvest forecast for 2011, Reuters, 
March 6, 2011 http://www.reuters.com/article/2011/03/06/us-alaska-
salmon-idUSTRE7252OP20110306.
    \11\ http://www.msc.org/track-a-fishery/certified/pacific/alaska-
salmon.
    \12\ E-mail from Andy Wink, McDowell Group, December 13, 2011 
``regarding the percentage of Alaska salmon harvest sold to export 
markets. It depends on the year and the species of salmon, but in 
total, the majority of Alaska salmon is exported--typically 70-80 
percent or more.'' [email protected].
    \13\ Lichatowich, James A. Salmon Without Rivers, Island Press; 1 
edition (August 1, 1999).
    \14\ ``Alaska's Choice: Salmon or Gold'', National Geographic, 
December, 2010 http://ngm
.nationalgeographic.com/2010/12/bristol-bay/dobb-text.
    \15\ This is a commonly held hypothesis among aquaculture 
scientists. For a discussion of tilapia see Costa-Peirce, Barry 
Ecological Aquaculture, Wiley-Blackwell; 1 edition (January 15, 2003). 
For a discussion of swai also known as tra or Pangasius, see my New 
York Times Magazine article ``A Catfish by Any Other Name'' http://
www.nytimes.com/2008/10/12/magazine/12catfish-t.html?pagewanted=all.
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2. The Salmon Feed Problem
    The overexploitation of wild forage fish for use as salmon feed is 
a grave concern. In the early days of salmon farming it could take 5 
pounds of wild forage fish to grow a pound of salmon. But improvements 
in diet, husbandry, and plain old-fashioned selective breeding have cut 
what's called the ``fish-in, fish-out'' or FIFO ratio on the most 
efficient salmon farms in half.\16\ The AquAdvantage salmon doesn't 
really bring much more in terms of feed efficiency.\17\ This is an 
important point that media doesn't seem to get. Yes, the AquAdvantage 
fish can in ideal conditions grow significantly faster than non-
engineered salmon. But, and this is a major ``but'', the engineered 
fish needs comparable amounts of food as the non-engineered salmon to 
reach market weight. AquaBounty's own predictions (and these are best 
case scenarios) put feed efficiency of the AquAdvantage salmon at only 
10 percent better than unmodified salmon. This is not enough to justify 
the risks it entails. Moreover improved feed efficiency is just one 
pathway to decreasing farmed salmon's footprint. In the decade since 
the AquAdvantage fish was synthesized, vegetable-based salmon diets 
have been created that require no wild fish meal at all. Some of these 
new feeds are made from recycled agricultural byproduct that might 
otherwise go unused.\18\ Developing alternative feed not alternative 
fish is, in my opinion, the critical next step for the aquaculture 
industry.
---------------------------------------------------------------------------
    \16\ Naylor, Rosamond L. et al., ``Feeding aquaculture in an era of 
finite resources'', Proceedings of the National Academy of Sciences, 
2009.
    \17\ Environmental Assessment for AquAdvantage Salmon, Aqua Bounty 
Technologies, August 25, 2010, Page 36.
    \18\ Frederick T. Barrows, USDA Lead Scientist and Nutritionist 
USDA, Agricultural Research Service [email protected].
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3. The Sea Cage Problem
    The AquAdvantage salmon proponents maintain that the modified 
salmon grows so fast that it can be cost-effectively produced in out-
of-ocean tanks.\19\ For many years, conservationists have worried that 
salmon grown in open ocean ``sea cages'' where there is frequent 
interaction with wild fish has led to disease transfer, escapes, and 
pollution.\20\ Tank or ``containment'' growing, many argue is the only 
safe way to farm salmon but it is energy intensive and farmers worry 
that slow-growing fish would not allow a farm to cover its energy 
costs. This barrier has already been broken with two non-engineered 
fish. The arctic char, a fish native to North America and Europe and 
haling from the same taxonomic family as salmon, turns out to have a 
natural adaptation for living in close quarters and does well in 
containment facilities. Nearly all arctic char are grown in containment 
and their flavor, taste, and texture in my experience is so close to 
that of salmon as to be indistinguishable.\21\ And for those who would 
prefer a true salmon over a char SweetSpring of Washington State is now 
growing Pacific coho salmon to harvestable weight entirely in 
containment in just 12 months. This is comparable to the growth speed 
of the AquAdvantage fish.\22\ If these options exist for cost-effective 
containment growing of non-engineered salmonids, why should we even 
broach the possibility of genetic contamination in the form of 
genetically engineered salmon?
---------------------------------------------------------------------------
    \19\ Aqua Bounty Press Room, http://www.aquabounty.com/PressRoom/
#l3.
    \20\ Monterey Bay Aquarium, ``Farmed Salmon'' Seafood Watch Report, 
Mazure, Robert and Elliot, Matthew http://www.montereybayaquarium.org/
cr/cr_seafoodwatch/content/media/MBA
_SeafoodWatch_FarmedSalmonReport.pdf Page 2.
    \21\ Artic Char Assessment, Blue Ocean Institute, http://
www.blueocean.org/seafood/seafood-view?spc_id=94.
    \22\ Sweet Spring http://www.sweetspringsalmon.com/local.shtml and 
e-mail (October 19, 2011) with Per Heggelund, Director, SweetSpring 
[email protected].
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4. The Public Perception Problem
    I support the development of an environmentally sound aquaculture 
sector in the United States. Seafood is a deficit item in the American 
trade portfolio and it is dismaying to me that more than 80 percent of 
our seafood comes from abroad. But there is a major obstacle to the 
growth of American aquaculture: consumer distrust. In the many dozens 
of lectures and presentations I have made throughout the country 
consumers have demonstrated high suspicion of farmed fish and a lack of 
fine-scale distinction of product. To the average consumer salmon are 
salmon. Nevertheless one subject that makes consumers pay attention is 
genetic engineering. People, at least the people who come to my 
lectures, don't want to eat engineered fish. And salmon farmers know 
this. As Scott Nichols, the director of the salmon aquaculture company 
Verlasso wrote me earlier this week, genetically engineered salmon 
would, ``be bad for the salmon industry'' and ``bad for aquaculture.'' 
Nichols goes on to say that the response of supermarkets and other 
retailers to genetically engineered salmon ``ranges from unease to 
trepidation'' and that ``there is real concern among retailers that 
genetically engineered salmon might elicit a negative perception of 
salmon as a category''.\23\ In other words genetically engineered 
salmon could give all American salmon a bad name whether they are 
farmed Atlantic salmon hailing from Maine or wild Pacific salmon from 
Alaska. Moreover the majority of Americans don't want genetically 
engineered salmon. An online poll by the Wall Street Journal showed 
that only about 36 percent of consumers would willingly eat genetically 
engineered salmon if it were labeled as such.\24\ And in European 
markets 0 percent would eat it. Genetically engineered foods are 
heavily restricted in the European Union.\25\ Thus having genetically 
engineered mixed in with non-engineered fish in the American trade 
portfolio would damage American exports--Europe will simply not buy it 
and Europe represents one of the top three markets for salmon in the 
world.\26\
---------------------------------------------------------------------------
    \23\ Nichols, Scott, Director of Verlasso, e-mail December 13, 2011 
[email protected].
    \24\ http://online.wsj.com/community/groups/question-day-229/
topics/would-you-eat-genetically-modified-salmon?commentid=1603615.
    \25\ Wall Street Journal, February 22, 2011 http://online.wsj.com/
article/SB1000142405274
8704476604576158230363494712.html.
    \26\ The Great Salmon Run: Competition Between Wild and Farmed 
Salmon, Knapp, Gunnar et al., World Wildlife Fund, January, 2007 http:/
/www.worldwildlife.org/what/globalmarkets/wildlifetrade/
WWFBinaryitem4985.pdf.
---------------------------------------------------------------------------
Conclusion
    In conclusion I would put forward that the AquAdvantage salmon is 
an idea whose time has passed, even if genetically engineered animals 
are perceived as belonging to the future. The problems that plagued the 
salmon farming industry when the AquAdvantage fish was first conceived 
over a decade ago--poor feed conversion, inability to grow salmon in 
containment, poor management of wild salmon fisheries--have been 
addressed in the intervening period. The AquAdvantage salmon is 
therefore a kind of Solyndra fish. A technology that has been made 
irrelevant by advances elsewhere in the marketplace yet which, for some 
reason still seems to draw taxpayer dollars in the form of research and 
development investment. This in spite its a lack of germane benefits to 
the improvement of the global food system. This fish is not worth the 
risk. We would be better pursuing a course of truly sustainable 
aquaculture and better management and use of our wild fisheries.
    I am therefore fully supportive of Senator Begich's legislation, S. 
1717, to ban interstate commerce of genetically engineered salmon. 
Senator Begich's bill rightly protects the American people from a risk 
they should not be forced to take.

    Senator Begich. Thank you very much, Mr./Dr. Greenberg for 
your testimony. I will say--I'm going to ask Senator Snowe to 
go ahead and start with questions--she has a time constraint.
    But I want to say first, Mr. Greenberg, and to all your 
comments about--as you said in the 1970s, 1980s, and--late 
1980s, fisheries were under siege in a lot of ways, even in 
Alaska. But a lot of the work we did was to focus on 
sustainability and how to manage our fish stocks for the long-
term sustainability--from stock assessments every year, to 
management through still somewhat controversial--but not as 
much as it used to be--quotas and so forth, CDQs, and many 
other ways to manage the product.
    And because of that, the quantity and the quality has 
increased significantly in how we manage it, how we handle it. 
And we like to say from Alaska that if you're at McDonald's or 
you're at Costco, you're eating our fish. If you're at the 
finest restaurants in the world, the likelihood is you're 
eating our fish, because they like to advertise it.
    So, we think we've done something that in the 1970s, when I 
was growing up, was unheard of--that we thought actually our 
fisheries would go away because of the poor management. And I 
think we have improved significantly in the last 20 years, so 
your point about that is well taken.
    Not only in that end, but other communities that have done 
farm fishing have also improved in a lot of ways. So let me end 
there.
    Before I do my questions I'll ask Senator Snowe--I know she 
has a series of questions, and then I'll ask some. And then, 
depending on time, we'll go back and forth and try to have a 
selection from any of you.
    Senator Snowe. Thank you, Mr. Chairman. I appreciate that.
    And I want to thank all our panelists here today for giving 
some thought-provoking issues to consider in this unprecedented 
issue that clearly raises a number of concerns and questions 
for policymakers, and obviously for this country.
    For example, Dr. Stotish, in your plan, in your confinement 
proposal, did you ever consult, for example, with aquaculture 
operators? In the state of Maine we've had a number of 
organizations that came together on a mutual agreement for the 
aquaculture operators that ultimately has been very successful 
in containing the salmon. We've had no escapes in the last 7 
years.
    Now, as the Maine Aquaculture Association would say, that 
it isn't a question of the type of facility but it is a 
question of how it's managed. So, with respect to your 
proposal, and in particular your land-based containment 
facilities, what suggests to you--in answer to the other 
concerns that have been raised by the other witnesses--as to 
whether or not you can contain it 100 percent? That it is a 
fail proof system? Because I think that is essential, without 
putting the population at risk.
    Dr. Stotish. Thank you, Senator. That's a very good 
question. And the answer is, yes, we have consulted with 
experts in the aquaculture industry and in the fisheries 
sector.
    We've consulted extensively, and a fundamental issue in my 
written testimony that I address at some length is the 
existence of rigorous management procedures, which are 
essential in the operation of any facility. Then the inclusion 
of rigorous, redundant, multiple biological and physical 
containment provisions.
    Now, I think I have an opportunity to also put some of your 
concerns to rest, as well as some of the concerns of some of 
the other panelists, that this is not an FDA only review with 
regard to the environmental assessment. I am aware, although 
not privy to the details, that the environmental assessment 
prepared by the Center for Veterinary Medicine has also been 
reviewed by NOAA, National Marine Fisheries, Fish and Wildlife 
Service, Department of the Interior, as well as the USDA and 
other Federal agencies.
    So, this is not a simple, one-off review by the Center for 
Veterinary Medicine. They've taken their responsibilities under 
NEPA very seriously, and there's been extensive coordinated 
review with other Federal agencies. Those reviews have added 
significantly to the approval timelines.
    As I mentioned in my testimony, our documents and the 
results of the initial FDA reviews were made available nearly 
16 months ago. So there has been extensive, serious reviews by 
professionals within other Federal agencies, who are skilled in 
the art, and I think it's worthwhile to make you aware of that. 
Certainly you can verify that by direct discussions with the 
FDA and with the CVM.
    Senator Snowe. Well, I'll follow up on that issue in one 
moment with the other panelists as well, because it does get to 
the crux of some of the concerns.
    Who would be monitoring these containment facilities?
    Dr. Stotish. Well, one thing that I should also make 
clear--AquaBounty, as I mentioned in my testimony, is a 
technology company. We basically produce--and our product will 
be a triploid, all female egg. That egg will then be sold to 
FDA-approved and inspected facilities for grow-out.
    The first such facility is located in Panama. That facility 
has already been the subject of a detailed environmental 
assessment and an FDA preapproval inspection.
    Additional sites will be approved on a case-by-case basis 
by submission of an environmental assessment, review, and a 
preapproval process, and preapproval inspection by FDA to look 
at the unique attributes of the site, the management provisions 
in place, and the unique containment provisions required.
    So, it is our belief--and we believe that the facts support 
that belief--that we have gone to an unprecedented length to 
demonstrate that not only can this technology be deployed 
safely, but the management procedures and the biological and 
redundant physical containment measures can assure perhaps a 
more sustainable practice than exists today.
    Senator Snowe. Do you believe that the goals of zero risk 
of escapement, or of 100 percent sterility are attainable?
    Dr. Stotish. Senator, as you know, I can't promise you that 
the sun will come up tomorrow. I can tell you that there's a 
high probability that it will.
    I can tell you that we've consulted with experts in the 
field, and we believe--and experts agree with us--that we've 
mitigated, in every possible way, every possible imaginable 
risk, including failure scenarios, by using multiple and 
redundant containment provisions.
    I will remind you, in over 15 years of operation in our 
hatchery we have never lost a single fish.
    Senator Snowe. Well, Dr. Epifanio, am I pronouncing that 
correctly?
    Dr. Epifanio. Absolutely correct, yes.
    Senator Snowe. I'd like to hear from you and the other 
panelists as well on this question. It's something that the 
Chairman and I have discussed as well.
    But in having reviewed the process, I mean, the FDA is 
required to consult with NOAA. But much of that information, to 
our knowledge, is not really available. Now, maybe Dr. Stotish, 
you have information. But in terms of transparency in what NOAA 
contributed to the process, we have no real way of knowing.
    Dr. Stotish. Senator, the only people who would know that 
would be the people in those agencies. As a sponsor I'm not 
entitled to that information, and I only know by inference and 
by information that we've received from other individuals.
    Senator Snowe. And that's one of the issues that we are 
concerned about. Because for example, we have a copy of the 
letter from NOAA to the Center for Veterinary Medicine back in 
July indicating that, in fact, the FDA decided to make a 
different decision on whether or not genetically engineered 
salmon came under the Endangered Species Act. And they said it 
would have no effect on the wild population.
    Originally, they thought it would and then they reversed 
their position and said no. So we have no way of knowing what 
contributed to that decision, whether or not that section of 
the ESA should be triggered when we're talking about what could 
be a potential risk to the wild population.
    Yes?
    Dr. Stotish. If I may, Senator, you also have, I believe, a 
copy of a section of a letter from the FDA to Representative 
Markey from Massachusetts addressing the basis for the review 
and the consulting reviews by other Federal agencies. It's 
sources of information like that upon which we rely for 
information. We have no direct knowledge of that. As a sponsor, 
we're not entitled to that.
    In the discussion of transparency, we've provided far more 
documentation and far more data than we have received in return 
as a drug sponsor.
    Senator Snowe. No, and I wasn't suggesting it's your 
responsibility; it is on the agencies and whether or not we 
should construct a process that requires NOAA, for example, to 
be a stakeholder in this process, not just sort of an ad hoc, 
informal participant.
    So I'd like to have others comment. Dr. Epifanio, Dr. 
Leonard, and Mr. Greenberg.
    Dr. Epifanio. Senator, thank you. That's a great question. 
I was fortunate enough--a year ago I was on a yearlong detail 
with the U.S. Geological Survey, Department of Interior, where 
I ran the fisheries program. And during some public hearing 
process last fall, these discussions were out there within the 
department.
    The level of information that was available to us, even 
internally to the agency--now, I don't know if I was 
specifically withheld from such information, but generally the 
full set of information was not always available to us either 
internally, and we are bound by confidentiality kinds of 
considerations and so on.
    That being said, I also don't want to make FDA the punching 
bag in the situation here. They're very fine scientists, and 
they're veterinarians, et cetera, that when they do their job--
and I've worked with them on traditional aquatic animal drug 
approval process, and it's a very meticulous, very fine process 
that they have.
    And they do reach out. It's not necessarily--I'm not sure 
of the full requirements to do so, but they do. But there is 
some opacity to the process that I think could be improved.
    Senator Snowe. Dr. Leonard?
    Dr. Leonard. Yes, Senator, I would agree with what Dr. 
Epifanio says. I would add, I guess, three specific pieces. 
With respect to this question of 100 percent containment and 
the risk of getting out, I think--the documents that I've seen 
to date that have been released really don't do a full, modern, 
quantitative risk assessment of both those individual 
probabilities and then what the likely impacts are if they do 
get out.
    And, in particular, there's a concept called failure 
analysis, which is a lot like what it sounds. It determines 
where along a production system there is likely to be failure, 
and then what are the consequences of that.
    Dr. Anne Kapuscinski, who I think you invited to come to 
testify, is the world expert on this, and I would encourage the 
Committee to look at the work. She literally wrote the book on 
how to think about risk assessment.
    With respect to the question of consultation with other 
agencies that have expertise in fishery knowledge, you 
mentioned NOAA. I think in an ideal world it would be useful to 
consider having NOAA or Fish and Wildlife actually in charge of 
the environmental assessment side of these kinds of 
applications, and having a very strong--perhaps even have a 
veto role if they can't be convinced that those risks are 
addressed.
    Now there's some consultation, but the final decision is 
ultimately left for NOAA--I'm sorry, for FDA.
    Senator Snowe. Mr. Greenberg.
    Mr. Greenberg. I'm not going to talk about the 
interrelatedness of different departments here. But as a 
citizen, I just see we have a strapped government that can't 
afford the regulation that it has right now.
    And it's very important that you listen to Dr. Stotish's 
words. He's shifting the onus of control of this fish from 
AquaBounty over to the FDA, over to the taxpayer.
    And already when you look at the fish situation, we can't 
afford it. We only test 2 percent of the fish coming into this 
country from abroad, and over 80 percent of our fish comes from 
abroad. So we want to add another regulatory burden on top of 
all this? It just doesn't seem to make any sense to me.
    Senator Snowe. Thank you. Mr. Chairman.
    Senator Begich. Thank you very much. Dr. Stotish, let me--I 
want to walk through. You've described it a little bit in your 
written testimony and you talked about it a little bit today. 
And I know when we met in my office--I want to say thank you 
very much for coming by and having a conversation about the 
product and what you're trying to accomplish.
    I want to walk through two steps here, just make sure I 
understand the process. So the salmon eggs are grown in--is it 
Prince Edward Island? They're grown there in Canada and then 
they're shipped to Panama, and then they are developed there 
for market, maybe U.S. or wherever. Is that----
    Dr. Stotish. Basically, Mr. Chairman--Senator Begich--
that's correct.
    It has to do with the process for new animal drug approval. 
This is the regulatory paradigm, and I will point out there's a 
bit of history here.
    A coordinated framework was agreed to and proposed by the 
Office of Science and Technology Policy, and finally approved 
back in 1986. In the subsequent 25 years, there was not a 
regulatory paradigm for the use of this policy in the 
regulation of transgenic food animals. As you know, there has 
been significant development of agricultural products.
    So, with that in mind it took the majority up until 2009, 
of that time between 1986 and 2009, to arrive on, number one, 
whether these organisms needed to be regulated. As someone 
pointed out, this could be modern breeding technology. And if 
so, who should regulate them?
    And in 2009, the CVM published Draft Guidance 187 that said 
that this was the mechanism that the Federal Government would 
use to regulate this technology.
    Now, in light of that--and there is statutory requirement 
for NOAA involvement and National Marine Fisheries involvement 
in this process. And I think that may be in my----
    Senator Begich. Yes, let me hold on. I'm going to come back 
to the NOAA thing for all the folks here, and fisheries.
    I want to understand the process, which seems somewhat 
complicated.
    Dr. Stotish. Let me answer your question.
    Senator Begich. Go there. That's where I want to go.
    Dr. Stotish. Yes. The brood stock are maintained in Prince 
Edward Island at our hatchery. The fish are bred there, and 
there's a diagram of the process that we use to generate all 
females and triploids. I won't go through that unless you want 
a particularly painful, technical discussion.
    Dr. Stotish. But I can assure you that that process is 
genetically 100 percent fidelity.
    So, then the eggs will be--after release, and this is 
analogous to a drug release--the eggs are assayed for 
triploidy, so that we know the degree of triploidy. The 
method's been validated to greater than 99 percent.
    Then they would be put into a container which contains a 
drug label, a secure container, and they would be shipped to 
the location where the grow-out occurs.
    In this case, the one approved facility--or the one 
proposed facility--is in Panama. That site has been previously 
inspected and an environmental assessment has been submitted.
    So the fish would be grown in tanks in a land-based 
facility there, and if the product were to be approved, those 
fish would be legal for sale in the United States and in any 
other country that chose to accept the imprimatur of the U.S. 
FDA approval.
    Senator Begich. If I can follow--I want to understand, if 
you can describe a little bit, is the Panama facility one that 
is designed specifically for this purpose, or has it been used 
for something else and you're part of--who owns this facility? 
What's the control mechanism here? Is it just another part of 
whatever business is there, they've added a new line of 
business?
    Dr. Stotish. No, that's not it.
    Senator Begich. So, is it specifically for your company to 
utilize?
    Dr. Stotish. We have leased the facility from the owner of 
the land, who is also the largest trout farmer in Panama. And 
the reason that we went to that facility is there was great 
interest in Panama as an economic development tool to be able 
to grow this fish.
    We created a facility there that contains the redundant 
biological and physical containment that is characterized in my 
written testimony, and that site has been then submitted as the 
initial approved productionsite for AquAdvantage salmon.
    Senator Begich. And is the FDA----
    Dr. Stotish. And the control is ours, Senator, I should 
mention that. We're in control of that facility.
    Senator Begich. OK, so you're in control of that component 
of the facility. And FDA doesn't have someone onsite, they come 
and inspect the original facility to check off----
    Dr. Stotish. They have sent a team, including a member of 
the NOAA staff, the field inspection staff, and the FDA 
inspectors and inspected that facility over a year and a half 
ago.
    They can do periodic inspections, and we're periodically 
inspected by authorities in Panama and the United States.
    Senator Begich. And is there a legal requirement, they have 
to do that? Or because it's in Panama--I'm just trying to 
figure out how that works. Because it's a foreign country, so 
does FDA have a legal authority to do that, or is it the 
company's requirement to have them come in order for you to 
sell product in the United States?
    Dr. Stotish. First of all--well, let me try to deal with 
that because you're getting into the weeds of a very thorny 
geopolitical issue.
    Senator Begich. Well, let me pause you there. It's 
important because, I'll tell you, we've sat in this room here 
before on airline inspections with foreign countries and we've 
had to pass legislation because of the lack--even though they 
all tell us they're all inspected, they're great, but they've 
moved all their shipping or their maintenance facilities to 
foreign countries that have less rigorous--because our FDA 
guys, or in that case the FAA folks, can't get over there on a 
regular basis, inspect them at the levels they can here.
    Dr. Stotish. I think I can answer your question and put 
your fears to rest. First of all----
    Senator Begich. That's probably a two-part question. You'll 
probably answer the question by the time I get to the second 
part, but go ahead.
    Dr. Stotish. OK, Senator. First of all, AquaBounty has a 
vested interest in the integrity and credibility of that site, 
so it's important to us that that site be inspected and 
approved. As I pointed out, we're subject to review by 
authorities in Canada, Panama, and the United States, and we 
have cooperated fully.
    And there is a coordinated review process instituted and 
implemented by the Center for Veterinary Medicine and the FDA, 
working with those other two regulatory agencies, including 
meetings here in Washington, including sharing of data and 
sharing of information on a routine basis.
    The second aspect of that is that, in the United States, we 
have a concept that goes back to Jimmy Carter called the Global 
Commons. The U.S.--and this addresses the legality of the 
question that you answered, and this really gets into the fine 
points.
    The U.S. has a responsibility, and any Federal agency has a 
responsibility for the environmental consequences of any action 
anywhere in the world, that's the so-called Global Commons.
    Now, that also bumps up against the issue of sovereignty of 
foreign nations and the right to regulate products within their 
own geography. In this instance, there's been a remarkable 
degree of international cooperation and direct cooperation 
between the regulatory agencies that have worked together, 
shared information, shared inspections.
    And, in fact, the U.S. FDA is training inspectors and 
regulators from Panama as they implement their new regulations 
in this area.
    So, we're not just regulated by the Center for Veterinary 
Medicine--we're regulated by the Environment Canada, by Health 
Canada, and by the Panamanian aquaculture authorities.
    So there's more than enough inspection and oversight at our 
facility, and we have frequent inspections.
    Senator Begich. Let me do this. I'm going to ask Senator 
Snowe if she has some additional questions, only because she 
has to leave by noon, then I'll have a few more.
    Because I want to follow up on the issue of who does 
inspection. I want to really get to the point of NOAA, National 
Marine Fisheries--that component of this that I think is 
severely missing in this equation.
    And so let me pause there and just see if Senator Snowe has 
some additional questions before. I know her time is limited, 
so.
    Senator Snowe. I wanted to ask Dr. Stotish about the fact 
that obviously there have been significant improvements in the 
traditional selective breeding of the salmon and aquaculture, 
and certainly that's been our experience in Maine as I said 
with this very unique agreement between conservationists and 
the aquaculture industry that achieved great success over the 
last 7 years in preventing any escapement of salmon.
    Why is it so important to have GE salmon as opposed to 
pursuing traditional salmon aquaculture?
    Dr. Stotish. If I may, Senator--and that's also a very good 
question. It was raised earlier by one of the other panelists.
    First of all, this is a very precise and specific genetic 
change. The feed efficiency of our fish is 10 to 20 percent 
greater than the wild type unmodified salmon.
    It is true that Cohos are being grown in the Pacific 
Northwest in land-based facilities. And, in fact, land- based 
facilities are the way of the future.
    But one of the barriers to successful land-based 
cultivation of Atlantic salmon are the slow growth rates in the 
early part of the life cycle, the first one to 3 years of life. 
That's specifically the part of the life cycle that is 
accelerated in our rapid growth phenotype.
    So, the opportunity--and because of the way we carry our 
gene, for instance, what you can accomplish by selective stock-
enhancement or breeding in 25 years we can accomplish in a 
single generation. We can characterize the nature of the 
change; we can specifically measure the change, and we can 
basically understand the implications of the change and the 
impact on production.
    So, what this does enable is large scale land-based 
cultivation of salmonids that takes it out of the sea cage and 
puts it into a manageable, we believe environmentally 
sustainable, culture system.
    We think it also create opportunity for economic 
development, for instance, in Midwestern states: South Dakota, 
North Dakota, Wisconsin, Ohio, Minnesota, where these land-
based facilities could produce salmon closer to consumption 
centers without these long transportation lines.
    We haven't talked about the cost of transportation, both 
the direct cost and the environmental cost. It's very 
expensive, Senator, to fly salmon from the south of Chile to 
New York markets in 747s, or to fly them from Oslo to New York 
or to San Francisco.
    The ability to grow these fish would not only create and 
recreate an industry that has been largely lost in the United 
States. As you probably know we produce less than 17,000 tons 
of Atlantic salmon in the United States each year.
    So, the opportunity to create that industry, to create and 
reduce our imports and to produce the food locally--as many 
people think perhaps is the way of the future--we think it's a 
good opportunity, and that's what we think this product will 
bring to the marketplace.
    Senator Snowe. How long have you been in this business? Did 
you submit your first application 15 years ago, is that right?
    Dr. Stotish. Again, Senator, the answer to that question is 
complicated by the lack of a regulatory paradigm.
    The first studies were submitted in 1995. The guidance 
document wasn't published by the Center for Veterinary Medicine 
until 2009. The impetus for that publication was the imminent 
approval by CBER, of a medical product called ATryn, which is 
produced in the milk of transgenic goats.
    So, the CVM released its guidance document, and that was 
the first transgenic animal that was approved in the United 
States.
    I should point out, in a most unique situation, that 
product was approved by the European Medicines Unit 2 years 
before it was approved in the U.S.
    The last thing I'll mention in that regard is 
representatives of the government of China have mentioned that 
they have more than 70 pending applications for transgenic 
animals and fish in China at the moment. Countries like 
Argentina, Brazil, and other countries around the world have 
embraced this technology and are deploying it.
    So there's an opportunity here for American innovation, 
creation of American industry, creation of American jobs, and 
we believe in a safe and sustainable environment.
    Senator Snowe. Thank you. Thank you, Mr. Chairman.
    Senator Begich. Let me, if I can--I guess one of the pieces 
of this equation that I'm still struggling with--and I 
recognize you had to work in a unique paradigm with regards to 
the regulatory process--that's part of the problem.
    And I think of the many industries that we deal with in 
Alaska, and it doesn't matter if it's the natural resource 
development industry or, as you mentioned, Pebble Mine, you 
know, the regulatory process is enormous. And the amount of 
agencies that have to actually sign off on it, not just 
consult, but actually say yea or nay are pretty significant.
    And let me--because you've laid out the regulatory parts. 
Let me ask other folks if they could comment in regards to--my 
instincts tell me I still look at FDA as someone who, maybe 
they consult with NOAA or the National Marine Fisheries or 
Interior, the real question is there is a different kind of 
impact.
    I mean, when you're doing a drug it's not a whole 
environment you're about to touch. And so I'm trying to 
understand why this product should not have some approval 
process or joined approval process with regards to NOAA or the 
National Marine Fisheries in this.
    And I'm struggling with this because I think it's 
different. I mean, when you talk about approving a drug, you 
know, the FDA is very good at that. Maybe they take a long 
time, but they're very good at it.
    And once they produce it, or the result of it, then the 
next result is individual consumption, not a whole environment 
that can be touched. And you can actually pull it off the 
market very quickly.
    And I'm trying to think of one of them that I remember I 
was taking some time ago for a neck pain, and they took it off 
the market very quickly because there were some issues with 
heart attack.
    Well, ended that impact to the environment, which in that 
case was humans. So, let me--before I ask you, Dr. Stotish, to 
answer, I'm curious from the others if they have any comment.
    That's the difference here that is significant to me. 
Because you can't just go back in there and yank the fish out 
of the pond. And I can tell you, I live off, in Anchorage, a 
small--in an urban setting called Cheney Lake that used to be a 
place we could fish.
    Now there's pike in there, and that's over. You know, it's 
a whole different story now. And I remember as mayor we have 
spent a lot of money trying to get them out of there, and 
somewhat successful but not as much as we would like.
    I don't know if folks want to--Dr. Leonard?
    Dr. Leonard. Yes, Senator, I have just a couple of 
comments.
    I would agree with you, the question really is not, ``Is 
there a regulatory structure?'' There certainly is. The 
question is does it address what we as a society want to 
address? And I think the answer is no there.
    In terms of a little bit of specifics, the new animal drug 
provisions within the coordinating framework under FDA, it's 
worth recognizing that those were developed before the concept 
of GE animals for human consumption was sort of on the table.
    So, in that sense, they are essentially sort of antiq--
they're outdated with respect to that particular issue.
    Senator Begich. Can you tell me, how long ago were those 
developed? I don't recall. Do you know?
    Dr. Leonard. I don't have the date right in front of me, 
but I can certainly get that for you.
    With respect to NOAA, I would agree, as we've said before, 
that I think they need a driving role in this whole process, 
more than is currently set up.
    And I think it's also worth again sort of reiterating this 
issue of risk assessment, which is fundamentally what this is 
about. And it touches on Paul's comment about public 
perception.
    If you look at state-of-the-art risk assessment, it 
involves bringing stakeholders into that process from the 
beginning, so that they develop basically the questions that 
need to be answered so that those are relevant to the questions 
that people care about.
    And then when you spend the money and do the work you end 
up with answers that people want. In other words, questions 
they wanted answered, and it builds a lot more public trust 
into the outcome.
    And I think much of the resistance you've seen and you've 
heard, and the letters that Congress has received, is because 
of the secretive nature of this where they haven't--those 
effective stakeholders have not been part of that process from 
the beginning.
    And this is being done in other parts of the world, other 
agencies are beginning about how to do state-of-the-art risk 
assessment, and it would be worth considering for this issue.
    Mr. Greenberg. When I speak about this issue before, you 
know, again laypeople who aren't involved in government at all, 
and I mention that FDA is ultimately the approving agency, I 
just--people can't believe it. They just can't believe it.
    So I would think any politician would be concerned about 
their reputation to like--it just reeks of not going a direct 
and honest pathway.
    And I can understand there must be bureaucratic reasons why 
it's happening, but I'm just saying from outside of government 
perspective it just doesn't feel right.
    Dr. Epifanio. I think ultimately having witnessed the--from 
an agency point of view, an action agency point of view from 
both the research side and the management side, often what we 
have is the regulatory framework playing catch-up ball to the 
state of the science.
    We have potentially a very--even though this technology now 
is 10, 20 years old, the next version of this, the next 
iteration of the science is going to be out there. And the 
regulatory framework needs to catch up with that and needs to 
have the appropriate science agencies involved in it.
    I'm reminded of 20 years ago when the idea of moving 
specific salmon from one river to another seemed absolutely 
logical and not a problem whatsoever.
    Now we fully are beginning--you know, we certainly grasp 
the idea that when we do that and there's commixing and 
interbreeding between them, we have some problems. Populations 
respond and reproductive capacity is down. We're now catching 
up the management with where the science has taken us.
    Ultimately, I think in terms of the regulatory with the 
risk side of things--and I'm not an expert in risk management, 
but it seems to me the information technology universe has what 
they refer to as the law of intelligent failure. Knowing that 
safeguards do fail, they want things to fail in a way that they 
can learn from it, they can improve it, and make sure it's not 
a big problem. We don't want the entire grid to come down, so 
to speak.
    Senator Begich. To manage it.
    Dr. Epifanio. Exactly.
    Senator Begich. Dr. Stotish, I don't know if you want to 
respond to that, but you see the dilemma.
    And I guess I want to agree with the last comment, that 
government isn't very good at keeping pace with technologies as 
they move forward.
    I mean, I sit in this committee--also we deal with IT 
issues here all the time, telecom issues, and we're always 
trying to catch up to where the next Google might be or the 
next Microsoft, and we're never going to be able to do that, 
but we kind of scratch the back end of it as it moves to the 
next phase. But with food product, it just seems--it's a step 
that we have to be very careful about.
    So let me ask you to respond, but I want to add one more 
thing. And I know because I've heard it a couple times here, on 
risk assessment. I know you have applied and I think you 
received a recent grant--I forget the exact amount, $300,000, 
$400,000, $500,000 in risk assessment in regards to this 
product.
    Which, to be frank with you, it gets me a little concerned 
because if it would have been approved last year--how does this 
all link? And maybe you could respond to this other part about 
the--then this other piece about why do you need a risk 
assessment analysis now when the product could have been 
approved last September? That's when it was lined up to be 
approved.
    Dr. Stotish. I'm so happy you asked me that, because I'm 
pleased to clarify that.
    First of all, the grant you refer to is a research grant 
awarded by the USDA. It's a competitive research grant; it's 
based on the science of the application. I've made you aware--
--
    Senator Begich. And the purpose of the grant is?
    Dr. Stotish. Is to explore additional ways to guarantee 
reproductive sterility of fish.
    Senator Begich. So it's not a risk assessment.
    Dr. Stotish. No, sir, it is not. There was a recent request 
for information by the USDA for additional grants to address 
this issue.
    But the grant that we were awarded--and we've been maligned 
in the press--was a competitive grant.
    We have technology that we practice to 99.7 percent 
validation for the production of triploid. We also have 
research that says that we can guarantee 100 percent genetic 
fidelity of sterility. It's a complicated technology; I'd be 
glad to take you through it.
    But it involves the use of, again, genetic technology to 
assure that--it's called a grandchild-less phenotype. You have 
sterile broodstock, or fertile broodstock, which produce 
sterile, 100 percent sterile progeny.
    Senator Begich. Let me pause you there.
    Dr. Stotish. That's the grant.
    Senator Begich. Right, I understand that. And different 
terms for different purposes, but USDA is asking for this 
research through a competitive process, you won, and I'm not 
questioning that. That's irrelevant to me on who gets it.
    I'm just curious why USDA is asking the question in order 
to ensure 100 percent. Because they must have some feeling 
that----
    Dr. Stotish. Senator, I think you're still confused. Allow 
me again.
    The request for information and request for proposals is 
separate from the grant that we've received.
    The request for proposals were grants addressing the issue 
that you're referring to. And the reason they're asking for 
that is because this is an issue that's had so much popular 
attention. The grant that we've received is different----
    Senator Begich. Let me pause you there. I don't think I'm 
confused. I understand there are different things out there. 
What I'm saying is USDA is asking the question, may they be a 
grant that's been approved, and/or in this case a RFP, a 
proposal that's being requested.
    Even--you don't spend a half million dollars just because 
people bring up an issue and you want to just do it. It's 
because they must be concerned in some form. Am I missing 
something?
    Dr. Stotish. The USDA awards competitive grants every year 
based on research.
    Senator Begich. I understand that; we get a lot in Alaska. 
Do you understand, my question is they don't just make a list 
and say, ``Jeeze, we'll do this grant because we got some 
money.'' They do it because there's a reason they're trying to 
get information.
    Dr. Stotish. Again, sir, you misunderstand the system. They 
invite proposals; people submit proposals. Those proposals are 
peer reviewed by reviewers in the USDA and outside the USDA. 
They are awarded based on the scientific merit of the 
application and the value of the science.
    Senator Begich. I understand that.
    Dr. Stotish. And that's the merit, the basis upon which we 
will receive the grant for the next generation of sterility. To 
further improve on the existing technology. The other request 
for information----
    Senator Begich. Let me pause you again. We're saying the 
same thing. I'm just saying that if you were sure about the 
ability to have sterile eggs you're not going to continue to 
ask for more research. You're going to move on to other high 
priorities with the USDA. Because the USDA has about this much 
money, and this many requests of needs.
    Dr. Stotish. I have a simpler answer for your question, 
sir.
    Because opponents of the technology have said 99.7 percent 
or 99.5 percent is not good enough, we've conducted research. 
And we conduct research in a variety of areas. That said, we 
can make it 100 percent.
    Simply because we're aware of the sensitivity and the 
perception--and that's why we continue to do research in this 
area. We believe it's advancing the science, and we believe 
it's good not only for the industry, but we believe it's good 
for America.
    Let me come back to the question about the drug approval 
process. I may be the only person in this room that has any 
experience. I've been involved in more than a dozen new animal 
drug approvals.
    The new animal drug provisions are part of the Federal 
Food, Drug, and Cosmetic Act, and basically they have been used 
and proposed by the FDA to address the issue of genetically 
modified animals. There are other paradigms that are possible.
    For instance, you could regulate this as a novel food, you 
could regulate this as a GRAS (Generally Recognized as Safe) 
substance, you could regulate this in a variety of other ways. 
And there have been proponents of all of those alternatives.
    Firms like mine have waited 25 years for the government to 
decide which paradigm they would use. And the situation that 
we're involved in now, speaking purely as a CEO, purely as 
someone who's involved in the development of what we believe is 
important technology, is a lot of the discussion now is 
basically changing the rules of the game after the game is 
over.
    And we've done everything that we've been asked to do, 
we've supplied all of the information, we've made all of our 
data public, we've participated in the public debate. Not one 
of my colleagues on this panel has made any specific reference 
to the environmental assessment that has been in the public 
domain for more than 16 months.
    The risk assessment, the tools that we used, and the 
methods and the conclusions of that environmental assessment 
have been publicly available, sir.
    So we are disappointed that we're not getting specific 
attention on the merits of the case and on the facts.
    Senator Begich. Let me ask the basic question. I understand 
about the game may change in midstream, I can tell you--I come 
from an oil and gas state. The game changes every day. And when 
you have things that happen in the environment, things change.
    There's a reason why oil and gas development in Alaska got 
delayed because of an oil spill in the Gulf. Now, should we 
have just said whatever happened down there just happened? No, 
we looked at the game and reassess what we needed to do. So, I 
don't buy that argument.
    But let me ask you the specific question here: do you think 
that fisheries, maybe NOAA, or whoever--I mean, I'll say NOAA, 
but National Marine Fisheries are an associated group--should 
be a sign-off on this? Because again, the difference is, as I 
gave that example of the drug that I was taking for my neck 
pain, as soon as we got the notice----
    Dr. Stotish. It was Vioxx.
    Senator Begich. Yes, Vioxx. I stopped, you know, because I 
didn't want to have a heart attack.
    Dr. Stotish. Thank you for reminding me. The same 
provisions that allowed the FDA----
    Senator Begich. I understand they could do the same thing. 
But the difference is I could immediately do that. But if you 
damage the environment and then FDA said, ``Stop,'' at that 
point the environment now is on a course. Because it's a 
different controlled mechanism, is I think the description of 
how you manage the impact of something you produce.
    And in this case, Vioxx you could do right away and they 
did very successfully. Tylenol years ago, I mean, a variety of 
things.
    Dr. Stotish. Your question is a fair one, sir.
    Senator Begich. So do you think NOAA or the Marine 
Fisheries should have a role here? Not just consulting, but an 
actual----
    Dr. Stotish. Sir, they have had a sign-off role in the 
process, but you have to consult with the FDA and the people 
involved.
    I cannot directly testify to that. But I have--it's been my 
understanding that they have not only done the consulting 
reviews, but have signed off as a condition for going forward.
    Senator Begich. Yes I'm not sure.
    Dr. Stotish. So I think this has been taken very seriously, 
and those are responsibilities under NEPA. And that is the 
provision that provides the legal requirement for this 
additional review.
    I suggest if you have an interest in that, you talk to the 
principals involved who can directly communicate to you exactly 
what's happened.
    Senator Begich. Let me finish up with if anyone else wants 
to make some final comments before. I know we have pushed it to 
the limit, but I really appreciate this conversation, but also 
the information in regards to the issue of genetically 
engineered salmon. I think it's an important issue.
    I mean, I could tell you for all the reasons you said, Mr. 
Greenberg--the impact to what we have created as sustainable 
fisheries in Alaska through the right management, the long term 
management of our product, is in my view the right way to do 
this.
    But, any last comments before I close?
    Mr. Greenberg, we'll kind of roll down.
    Mr. Greenberg. Well, in direct comment to Dr. Stotish's 
comment, first of all, if we want to have containment grown 
fish, they don't have to be genetically modified salmon. We 
have striped bass, hybrid striped bass. We have tilapia. All 
kinds of trout that are already grown in containment, and all 
the economic benefits that Dr. Stotish speaks of for Midwestern 
states are all there already there if we want them.
    And fish like tilapia are just endemically more efficient, 
faster growers than salmon anyway. So, if we want a product to 
be produced inland in containment facilities we can do it.
    And my last comment is that, you know, referring to this 
whole question of this is going to be good for America to 
compete with China--well, do we really want to hold up China as 
this beacon of environmental regulation, you know, that we want 
to aspire to also?
    And moreover, if this fish does get developed I have a 
pretty sure feeling that it's going to end up in China one way 
or another, either through direct--if they can steal our 
stealth bomber or stealth fighter, I think they can get a hold 
of this fish.
    So I would rather see us as a country that says no to that 
kind of risk, let somebody else take the risk, and we'll have 
better fish because of it.
    One of the great markets for Alaska salmon traditionally 
has been Asia, because these countries don't have what we have.
    Senator Begich. That's right.
    Mr. Greenberg. And if we really want more salmon in 
America, well, then let's not sell 70 percent of our Alaska 
salmon abroad. We don't need GMO salmon in order to make up for 
that deficit.
    Senator Begich. Thank you very much.
    Dr. Leonard.
    Dr. Leonard. I just have three final comments. One, I would 
like to acknowledge AquaBounty's forthrightness in the 
information that they have put forth to date. It is true that 
information has been in the public realm for well over a year 
now, and that I think is helpful. It's given people a lot of 
opportunity to look at that.
    On the other hand, the process is not obligated to do that, 
and so I think the question is really less about this 
individual application and the specifics of this, and more 
about whether we have a system in place that will allow us to 
deal with the next application that comes down.
    And I think my final comment would be on an issue that we 
haven't touched about, but was alluded in many of the comments 
made by the Chairman--which is fundamentally the question about 
liability, and if harm happens, who's responsible?
    That's really not--it's a legal question, it's not a 
scientific question, but I think that issue has really not been 
addressed at all yet and is worthy of additional consideration.
    Senator Begich. Thank you very much.
    Dr. Epifanio. I guess my final thought on this is--I come 
from the land where three species of nonnative carp, the 
silver, the bighead, and the grass carp, are somewhat 
problematic, two of the species potentially knocking on the 
door of Lake Michigan, the effects of which could be 
devastating.
    Just this past 2 months ago, one of my crew collected a 
gravid female grass carp, which are only supposed to be 
triploid out there, and surely she had eggs. They weren't ripe 
at that particular moment because of the time of year, but she 
was running over with eggs. Partly because of--not that the 
triploidy doesn't work, but it's not 100 percent inefficient, 
which we heard about and we all know. So these things do 
happen.
    The point I want to make with that story is that salmon and 
other fishes are a little bit more difficult to control should 
an escape occur, should there be some unforeseen problem--more 
difficult than a cow or a goat.
    If Dolly the sheep, for example, was to escape, we'd go out 
and get in the pickup truck and go find her.
    Senator Begich. Alaskans would hunt it.
    [Laughter.]
    Dr. Epifanio. And all of these things have been described. 
There's a National Academy of Sciences report, ``Animal 
Technology and Science Based Concerns'', and in one of their 
tables they list out sort of the relative concerns, insects and 
fish being at the top of the high risk, cattle and sheep being 
down at the low risk.
    And there's a continuum based on a number of criteria based 
on their mobility, likelihood to escape, and so on.
    The point being that there are some tractability problems 
here, or issues here, and there are great minds who have been 
thinking about this. There are no less than three National 
Academy reports on this suite of issues that we had, and I 
would urge that the Subcommittee and the agencies involve 
continually refer to these, and I'm sure new ones as they come 
about, these ideas to be deliberated in the scientific court of 
opinion.
    Senator Begich. I want to say thank you very much, and to 
all of you, I think this is a--obviously for Alaska a big 
issue, for Maine a big issue--the ability to have sustainable 
food supplies in a broader sense is a national security issue 
and a very important issue for us.
    I think there is a lot of evidence out there as we're 
developing, and especially today, to ask these questions. And 
they're hard questions. Mr. Stotish, I give you credit for 
surviving this morning. But I would say that it is important 
that we push these questions.
    I will put--just to make sure we're clear--the reason 
you've had 16 months of public deliberation on this, at least 
the information, is because back in August, September of last 
year, some of us said, ``Pause.'' Because FDA was moving that 
170-page document very rapidly with limited public review.
    So I appreciate when you say 16 months, because 13 of those 
months were supplied by myself and many others who signed a 
letter that forced this process to slow down, have more 
discussion, and have more review, which was not really 
occurring.
    Because FDA has a procedure that is designed not for this 
type of product in the sense of its public review, and I think 
that is an important piece of this equation. So I want to make 
sure that's on there.
    The second thing I'll say is I don't think anyone 
underestimates the capacity of American ingenuity, it's a 
question of where to put it to make sure we have the longest 
benefit--may it be for the consumption of food, our 
environment, and a variety of things.
    And so I think this--for us at least, and for the Senate--
to have a review of this issue and the process, which is now 
becoming really a part of the equation. It's not just the 
product.
    The product has actually brought the issue of how do we 
approve or not approve a food product that may have an impact 
that's much different than a drug product, or even a new grain 
that's produced.
    Because as you said, fish are a little harder to catch--
except in Alaska, we have good ability to do that. But compared 
to a sheep, you know, it's a different ballgame.
    And so we have to manage this in the right way, and I think 
we have an important role here as the Subcommittee on Oceans, 
but also as the Commerce Committee in the Senate, to review 
this issue very carefully and make sure that, as we move 
forward, the right kind of input from the agencies is there.
    And I understand the game change, but, you know, 25 years 
ago or 20 years ago a cell phone was as big as a suitcase.
    So we have to put all that in perspective, that we have to 
look at things in a different way as time progresses. And 
there's no better issue than to protect our food supply and our 
natural food supply for the long term.
    And from Alaska's perspective, we have spent 30 years doing 
this successfully, and we do not want to reverse this trend 
because of another market.
    And the last thing I would say on this--and I'm going to 
close it off, and allow that over the next 2 weeks we'll still 
allow additional information and questions for the record from 
other members that I know have--is that we want to make sure 
that--and Mr. Greenberg, you kind of said it.
    Alaska's very good about exporting our product, because 
Asia is anxious to get it. Because we have a high quality 
product. And I think in a lot of ways, as we look at our food 
supply, of how we utilize food in this country, and what 
products we want to consume, also will determine where we sell 
our product.
    And I, of course, am always marketing and bragging about 
Alaska's product for a variety of reasons. But one of them is 
because it's sustainable. It is one of the food products from 
the ocean that we know we can--from a part of this country that 
is sustainable.
    So, let me just say again, I want to say thank you and 
appreciate all the comments. And maybe they've been a little 
rough back and forth, but I think it's important that we have 
this discussion.
    We will continue to be engaged in this issue. I'm not sure 
that sits well with Dr. Stotish because I know you've struggled 
through years of review, but Congress has had very little 
conversation about this.
    And it is a new day of food product, and I will tell you as 
chair of this subcommittee and someone who comes from a state 
that produces 60 percent of the wild stock of this country, we 
are going to be interested in this and figuring out how it 
plays, and what the permitting and process will be.
    Let me say thank you again to all of you that are here, and 
the record will be open for the next 2 weeks for additional 
questions by members.
    This meeting is adjourned.
    [Whereupon, at 12:24 p.m., the hearing was adjourned.]
                            A P P E N D I X

          Prepared Statement of Hon. John D. Rockefeller IV, 
                    U.S. Senator from West Virginia
    Good morning. We're holding this hearing today to discuss the 
potential environmental risks of genetically engineered fish. The 
hearing could not be timelier: as I speak, the FDA may be finalizing 
approval of the first genetically engineered animal for human 
consumption in the United States. This fish, the ``AquAdvantage'' 
Salmon, has been engineered to grow faster and be heartier than its 
natural counterpart by mixing genes from three different fish species 
so its filets can quickly get from the fish pen to your dinner table.
    Yet, concerns abound with opening the door to the creation of 
genetically engineered animals for food. Food safety is an obvious 
nexus of contention, but a more insidious consequence of these fish is 
the havoc they could wreak on our natural fish stocks and aquatic 
ecosystems. Were these fish ever to escape into the wild, the impacts 
could be disastrous.
    At a minimum, the escaped fish would have effects similar to 
invasive species by competing with other fish for food, territory, and 
mates, or by otherwise altering the food chain. Worse, if GE salmon 
were to escape into wild habitats, they could mate with wild fish, 
passing their artificially engineered DNA into the wider gene pool and 
fundamentally altering the naturally occurring species as a whole. 
There may also be ramifications of escapement not yet realized, given 
the unprecedented nature of these fish.
    Now, AquaBounty, the company that developed these GE fish, has made 
significant investments to minimize the risks of escapement and genetic 
contamination. In their application to the FDA, they've touted 
techniques that render the fish sterile and infrastructure that thwarts 
escapement. They've even decided to breed them far from our shores--all 
the way in Panama--to alleviate these concerns. But even the 
establishment of a ``Salmon Republic'' may not be enough--evidence 
suggests that AquaBounty's sterilization process is not 100 percent 
effective, and history shows that no aquaculture containment measures 
are foolproof or immune from human error.
    Moreover, approval of these genetically engineered animals would be 
precedent-setting, likely ushering in a wave of aquaculture operations 
here and around the world for raising genetically engineered food fish. 
Production on such a large scale would make the risk of GE fish 
escaping into the wild a near certainty.
    It's clear to me that we need to operate under the assumption that 
these fish will escape, and that warrants a thorough examination of the 
harm of escapement. And I'm very concerned that these fish haven't 
received the scrutiny that's due.
    The FDA review process required AquaBounty to submit an 
environmental assessment as part of its application. But that 
assessment assumed AquaBounty's escapement precautions would be 100 
percent effective, avoiding the likely ``what if'' scenarios of 
escapement that have preoccupied so many people's minds. It's also 
troubling to me that the FDA is the sole agency leading this effort. As 
the guarantor of our food safety, they may be ill-equipped to oversee 
the kind of comprehensive environmental assessment that's needed to 
spell out the risks.
    Hopefully, this hearing will serve as a call to reason and bring 
greater attention to these concerns. Because again, it's not just about 
this one company or this one fish. It's about the precedent that may be 
set. There is potential in GE animals, but we need to make sure that we 
fully understand the risks involved, so that we do not live to regret 
unleashing the environmental equivalent of a Pandora's Box.
                                 ______
                                 
Response to Written Questions Submitted by Hon. John D. Rockefeller IV 
                           to Dr. Ron Stotish
Liability for Environmental Harm from Escaped GE Fish
    Examples of escapement of non-GE exotic fish species reveal the 
high economic and environmental costs of these events. In the case of 
the Asian carp, the Federal government currently spends over $7 million 
in electricity bills alone to maintain an underwater electric barrier 
to keep the fish from invading the Great Lakes. Another example in the 
Great Lakes is the Atlantic sea lamprey, on which the Federal 
government spends $20-30 million dollars annually to keep this fish 
under control.

    Question 1. If AquaAdvantage salmon were to escape into the wild, 
would AquaBounty take responsibility for compensating the public for 
any environmental harm that is done by these fish?
    Answer. We understand and appreciate concern about the possibility 
of an ``escape of GE fish''. Accordingly, as our submissions to FDA 
reveal, we have implemented safeguards with respect not only to the 
production and security controls and practices we follow but also with 
respect to the fish itself. These safeguards serve to, respectively, 
render any such ``escape'' a remote possibility and protect the 
environment in the extremely unlikely event of such an escape.
    The NADA for AquaAdvantage includes specific conditions for use 
which require cultivation in land based physically contained 
facilities. In addition, AquAdvantage are all female and triploid 
(unable to reproduce). The conditions for use are enforced, as are all 
approved drugs under the Federal Food Drug & Cosmetic Act (FFDCA).
    Secondly, although the two examples cited in the question were 
undoubtedly selected for their inflammatory impact upon the reader, 
neither are biologically relevant examples for Atlantic salmon. The 
Asian carp is a known adaptable and invasive warm water fish originally 
deliberately introduced into the environment to clear vegetation in the 
areas of catfish ponds in the Southern U.S. The Atlantic lamprey is a 
parasitic primitive fish that gained access to the Great Lakes in the 
19th Century, probably through the system of canals constructed at that 
time.
    Atlantic Salmon are, however, a cold water species that are known 
NOT to be highly invasive. On the contrary, attempts to introduce 
Atlantic salmon into non-native or native habitats over the years have 
been singularly unsuccessful. In the past century, there have been 
numerous unsuccessful attempts in the U.S. and elsewhere to establish 
Atlantic salmon outside their native range (Fisheries & Oceans Canada, 
2005). At least 170 attempts occurred in 34 different states where 
Atlantic salmon were not native, including Washington, Oregon, and 
California. None of these efforts was successful (Waknitz et al., 
2002). No reproduction by Atlantic salmon was verified after 
introductions of fertile, mixed sex populations of Atlantic salmon in 
the waters of these states. The risk of anadromous Atlantic salmon 
establishing self-perpetuating populations anywhere outside their home 
range has been shown to be extremely remote, given that substantial and 
repeated efforts over the last 100 years have not produced a successful 
self-reproducing anadromous population anywhere in the world (Lever, 
1996). In the Pacific Northwest, there have been no reports of self-
sustaining populations resulting from deliberate or accidental Atlantic 
salmon introductions (Waknitz et al., 2002).
    Lastly, publications from laboratories exploring the specific 
abilities of AquAdvantage salmon to compete in an ecosystem have 
concluded that AquAdvantage are less fit than nontransgenic Atlantic 
salmon in competing for mates. This work was cited in my original 
testimony, but I include it again for the record.
    Moreau DTR, Fleming IA, Fletcher GL, et al. (2011a). Growth hormone 
transgenesis does not influence territorial dominance or growth and 
survival of first-feeding Atlantic salmon Salmo salar in food-limited 
stream microcosms. Journal of Fish Biology 78: 726-740.
    Moreau DTR, Conway C, & Fleming IA (2011b). Reproductive 
performance of alternative male phenotypes of growth hormone transgenic 
Atlantic salmon (Salmo salar). Evolutionary Applications 4: 736-748.
    Moreau DTR & Fleming IA (2011c). Enhanced growth reduces precocial 
male maturation in Atlantic salmon. Functional Ecology Online View:1-7 
(doi: 10.1111/j.1365-2435.2011.01941.x).
    Thus, there are no facts which suggest the examples you cite are 
relevant to AquAdvantage salmon. Moreover, as I testified at length, 
the science-based petition we have pending before FDA includes specific 
conditions for use which requires any cultivation of fish must be in 
FDA inspected and certified land based physically contained facilities. 
AquAdvantage salmon grown from AquAdvantage eggs are all female and 
triploid (unable to reproduce). The conditions for use are rigorously 
enforced under the FFDCA.
    The question of compensation or liability in light of the above 
facts appears to be intended to inject controversy where there is no 
evidence to suggest controversy exists. The short answer to this 
question must be there would have to be a demonstration of harm and 
established negligence to justify liability or compensation. This 
product will be regulated as all other FDA regulated products, under 
the FFD&C.

    Question 2. Who would pay the costs associated with containing the 
spread of these fish and minimizing their potential environmental 
damage?
    Answer. Again, this question assumes harm where the likelihood of 
such harm is extremely remote and is entirely hypothetical.
                                 ______
                                 
   Response to Written Questions Submitted by Hon. Maria Cantwell to 
                            Dr. Ron Stotish
Farming Methods and Probability of Escapement
    Question 1. What is the most cost effective method for rearing 
genetically engineered salmon: net pens, hatcheries or terrestrial 
above ground facilities? Please provide estimates for how much it would 
cost to rear genetically engineered salmon using each of the above 
methods.
    Answer. Without question, the method we have developed is a cost 
effective method for ensuring the production of securely contained and 
safe fish. First, all aquacultured fish are spawned, hatched, and their 
early life stages reared in hatcheries, which are by definition land-
based facilities. Following the hatchery stage, the salmon fingerlings 
or smolts can be grown to market size in different facilities, some of 
which are land-based, and some are located off-shore.
    AquAdvantage salmon will only be approved for cultivation in FDA 
inspected and licensed land-based contained facilities, and will not be 
grown out in net pens or other systems that are not land-based.
    Well designed and sited land-based systems for rearing salmon are 
very competitive with traditional net pen rearing systems. A technical 
conference in British Columbia showcased environmentally friendly, 
land-based, recirculating rearing systems for producing salmon for as 
little as US$3-$4 per kg, similar to the production costs in modern net 
pen systems. These systems were producing conventional salmon with 
growth and productivity performance that is inferior to AquAdvantage 
salmon, whose superior growth characteristics improve the economics for 
land based cultivation.
    There are a wide variety of designs and associated costs for land-
based systems, but our calculations of the specific cost of rearing 
AquAdvantage salmon in land based versus sea cage (conventional) 
demonstrates a significant savings of $0.50-$0.75 per kg when 
AquAdvantage salmon are reared in contained, land based systems versus 
traditional net pens. This does not include the further benefits of 
production systems closer to markets, further reducing the cost and 
environmental impact of transportation. Including benefits from reduced 
transportation costs in the comparison could provide an additional 
savings of $0.75 per kilo exclusive of the ``carbon footprint'' 
benefit.

    Question 2. How does the probability of escapement vary between 
each method? It has been well documented in the salmon farming industry 
that floating net pens are susceptible to breaches and escape of the 
fish.
    Answer. Not only is the net pen material vulnerable to invasive 
predators (e.g., seals, sea lions, sharks) and destructive forces in 
the open ocean, but once breached, loss of the entire captive 
population is almost inevitable. Conversely, contained, land-based 
systems such as the kind proposed in AquaBounty's NADA possess an 
extremely low probability of escape risk due to the multiple 
containment barriers in place, and the on-land location. For example, 
AquaBounty's production facility in Panama possesses 21 individual 
containment barriers confining the fish to the rearing facility, and 
making escape into the environment essentially impossible
Labeling of Genetically Engineered Fish Species
    Over 400,000 Americans have commented on an FDA petition which 
would require the labeling of genetically labeled foods. In addition, A 
survey conducted in 2010 by Thomson Reuters 
PULSETM Healthcare Survey, ``National Survey of Healthcare 
Consumers: Genetically Engineered Food'' showed that 93 percent of 
Americans believe GE foods should be labeled. Genetically engineered 
foods are required to be labeled in the 15 European Union nations, 
Russia, Japan, China, Australia, New Zealand, and many other countries 
around the world.

    Question 3. What are your thoughts on labeling genetically 
engineered food so that consumers can make an informed decision?
    Answer. The U.S. has a long standing policy of truth in labeling, 
and another long standing policy requiring regulation based upon 
product attributes rather than method of production. The cited Thomson 
Reuters survey does not accurately reflect the public sentiment, as 
there are other surveys which suggest Americans are more intelligent 
and discerning than the Thomson poll portrays. The responses on this 
issue depend on how the question is asked. In a 2010 International Food 
Information Council (IFIC) poll for example, more than half the 
respondents would likely purchase food from a genetically modified 
organism if that product had been found to be safe by the FDA.
    FDA's policy, affirmed by the agency and upheld in the courts, is 
that food labeling must be truthful and not mislead the consumer. 
AquaBounty supports this policy. The predicate for the potential to 
mandate labeling for a genetically modified food or food ingredient is 
that the food or ingredient is ``materially different,'' i.e., claims 
of higher protein, lower fat, nutrition, etc. from the conventional or 
traditional version of the food. In FDA's evaluation of AquaBounty's 
application, in which no claim other than faster growth is contained, 
the agency's Center for Veterinary Medicine (CVM) found no material 
difference between AquAdvantage salmon and other Atlantic salmon.
    However, in the interest of full transparency and supported by 
AquaBounty, FDA's Center for Food Safety & Applied Nutrition (CFSAN) 
held a full-day public hearing on September 21, 2010, at which the 
public was invited to bring compelling legal or scientific arguments to 
support a call for mandatory labeling. (It should be noted CFSAN will 
make no decision on the parochial question of mandatory for 
AquAdvantage salmon unless CVM approves the long-pending AquAdvantage 
NADA). At that hearing, invited speaker Greg Jaffe, director of 
biotechnology for the Center for Science in the Public Interest (CSPI) 
made the following statement:
    ``So, now I turn my attention to the AquAdvantage salmon and the 
two questions presented to the public today by FDA. Based on the 
documents from FDA about the AquAdvantage salmon, the data and risk 
assessment released by the FDA's CVM earlier, and the FDA's current 
policy regarding mandatory labeling, as discussed this morning and also 
provided to the public, CSPI does not believe the AquAdvantage salmon 
requires any special mandatory labeling. CSPI cannot identify in the 
public record any material differences between the food from this 
salmon and from other Atlantic salmon that would require a mandatory 
labeling that is consistent with the FDA policy. However, if FDA does 
determine that there are material differences between food from this 
salmon and from other salmon that requires some mandatory labeling, 
CSPI believes it is very important that the language required by that 
label be neutral and informative. FDA should not necessarily require 
that label include the word ``genetically engineered.'' As I mentioned 
earlier, there are many production methods for food products and many 
production methods for salmon. Identifying this production method 
without requiring all the other production methods to be identified 
would needlessly discriminate against genetic engineering and not 
provide the consumer with information about the material difference in 
this particular salmon.''
    As to mandatory labeling of all foods sold in the U.S. which are 
the product of or contain an ingredient that is the product of 
biotechnology, such a policy could impact a vast majority of foods 
grown or processed in the U.S.
    Keeping in mind there are no approved biotech food animals, there 
are currently 89 commercial plant varieties produced using 
biotechnology and deregulated by the USDA, though not all have been 
commercialized. The overwhelming majority of all corn, soybeans, and 
sugar beets grown in the U.S. for both domestic and export purposes are 
biotech varieties, which means the by-products--oils, meals, etc.--used 
in food production are by definition ``biotech'' as well. This is 
testament to the broad adoption of this technology in the U.S. and in 
most parts of the world, and suggests ``biotech'' is the new 
``conventional.'' Other crops grown in the U.S. using biotechnology 
include alfalfa, papaya, and some varieties of squash. The exact 
percentages of our major crops used both domestically and exported are:

   88 percent of all corn

   95 percent of all sugar beets

   94 percent of all soybeans

   90 percent of all cotton

    Globally, 15.4 million farmers in 29 countries grow some form of 
biotech crop on 366million acres and these numbers are increasing.
    AquaBounty is not deaf to the concerns of the many consumers who 
are sincerely troubled by the type of technology the company employs in 
producing the AquAdvantage salmon. Those concerns reveal the very real 
fact that the use of such technology has social implications. Those 
implications, however, I respectfully submit, are now and should 
continue to be beyond the scope of governing legal authorities.
    Public education on the other hand is a shared responsibility and 
clearly appears to have a role in addressing consumer concerns and 
informing consumer decisions. Once the AquAdvantage application is 
approved by FDA, we have reason to believe a number of organizations 
will join AquaBounty in the education process. These include 
organizations such as the Biotechnology Industry Organization (BIO), 
the National Fisheries Institute (NFI), the Global Aquaculture Alliance 
(GAA), as well as government agencies like FDA, USDA and NOAA. In fact, 
all responsible parties can serve a valuable role in helping to 
demystify the technology and allay consumer concerns.
    Simply put, we believe that effective meaningful and true education 
calls for approaches well beyond the grocery store fresh fish counter 
and the restaurant menu. Requiring labeling without first insuring an 
informed consumer public would, in effect, create a tool for simply 
fostering the fear that meaningful education can reasonably address.
                                 ______
                                 
    Response to Written Questions Submitted by Hon. Mark Begich to 
                            Dr. Ron Stotish
Infectious Salmon Anemia in AquaBounty
    Canada's Department of Fisheries and Oceans recently released a 
document confirming that samples from AquaBounty's land-based research 
and GE fish egg production facility on Prince Edward Island (PEI) 
tested positive for the Infectious Salmon Anemia (ISA) virus in 2009.

    Question 1. How did the virus get into the Prince Edward Island 
facility?
    Answer. We do not know. There are many strains of ISA virus (ISAV) 
which are naturally occurring and endemic to salmon growing regions of 
the world. There are ISAV strains known to be present in Atlantic 
Canada, as well as Norway, Chile, the U.K., etc. The biology of these 
viruses is complex, and in some ways comparable to the influenza 
viruses that infect a variety of organisms, including man. ISAV is not 
a zoonotic or human health risk as it does not affect humans.

    Question 2. Was the virus detected in the AquAdvantage salmon?
    Answer. Yes. Both AquAdvantage salmon and non-transgenic salmon in 
our facility were equally affected.

    Question 3. What other types of fish in the PEI facility tested 
positive for ISA?
    Answer. Only Atlantic salmon, and the virus was detected in equal 
frequency in transgenic and non-transgenic salmon.

    Question 4. Did these fish test positive for any other types of 
viruses or diseases?
    Answer. Our stock are tested on a routine basis several times each 
year for a large number of diseases known to occur in salmon. There 
have been no other positive results for infectious viral diseases in 
nearly16 years of operation.

    Question 5. What is known about whether AquAdvantage salmon are 
more or less susceptible to ISA and other viruses than non-transgenic 
Atlantic salmon?
    Answer. AquAdvantage salmon differ from other Atlantic salmon in a 
single genetic locus, the additional copy of the salmon growth hormone 
gene. AquAdvantage are the same as other Atlantic salmon in every other 
measurable respect and there is no data suggesting either enhanced or 
reduced susceptibility to disease compared to Atlantic salmon. The 
Target Animal Safety studies--as part of AquaBounty's formal 
application--were summarized and released by the CVM for the purposes 
of the 2010 VMAC meeting illustrate this point.

    Question 6. What was done with the fish that tested positive for 
ISA or other viruses?
    Answer. The fish testing positive were systematically destroyed and 
incinerated as required by relevant regulation and company standard 
operating procedures (SOPs). Our entire facility was cleaned using 
virucidal materials, and enhanced biosecurity procedures were 
implemented as corrective action to further reduce the possibility of a 
similar event.

    Question 7. How will AquaBounty ensure that ISA-infected salmon are 
not shipped to grow-out facilities?
    Answer. AquaBounty is inspected regularly by the Canadian Food 
Inspection Agency (CFIA) and the Department of Fisheries and Oceans 
(CDFO) under the Canadian Fish Health Program. Under Canadian 
regulations, a facility must have a valid Fish Health Certificate in 
order to export fish. Additionally, AquaBounty has its own SOPs and 
procedures for continually monitoring fish health. In the 2009 event, 
AquaBounty detected the problem and immediately advised the appropriate 
Federal and provincial authorities, and worked closely with these 
Canadian authorities to resolve the issue. The Fish Health Regulations 
are analogous to other Federal sanitary and public health laws, 
programs and procedures utilized around the world to assure the health 
of livestock and the safety of food. These regulations are separate and 
distinct from considerations employed for the purposes of a NADA or 
Environmental Assessment (EA).

    Question 8. When was the latest date that fish at the PEI facility 
were tested for ISA?
    Answer. Our hatchery has a ``clean'' health certificate, and the 
most recent certificate was issued in December 2011. ISAV is among the 
agents tested in that inspection. We have had eight successful 
inspections since the first quarter of 201, with no findings of any of 
the tested pathogens, including ISAV.

    Question 9. When is the latest date that fish at the PEI facility 
tested positive for ISA?
    Answer. November 2009 was the only inspection which detected ISAV 
in our hatchery. Our subsequent eradication efforts, in cooperation 
with the Canadian government, were apparently completely successful.

    Question 10. Are any fish at the PEI facility known to still be 
infected with ISA at this time?
    Answer. Absolutely not.

    Question 11. Under Canadian, U.S., and Panamanian law, could fish 
or fish eggs that test positive for ISA or other viruses be transported 
into or out of any of these countries?
    Answer. No, nor would AquaBounty even consider shipping materials 
known to be infected with any infectious agents.
                                 ______
                                 
  Response to Written Questions Submitted by Hon. Roger F. Wicker to 
                            Dr. Ron Stotish
    Question 1. Scientists and the aquaculture industry underscore the 
need to address the potential problems of genetically engineered (GE) 
fish, such as the impact on wild stocks. However, they also highlight 
the benefits of innovation in this area such as lowering costs, 
expanding industry, increased health benefits, and feeding a growing 
global population. The FDA currently has a process to address these 
issues on a case-by-case basis through scientific review. Would a 
blanket ban on commerce in genetically engineered fish inhibit 
innovation and competition for U.S. aquaculture companies?
    Answer. A blanket ban on the use of U.S.-developed biotechnology to 
enhance food production both in this country and around the globe would 
likely bring to a complete halt all investment in research and 
development of new food production technologies, including aquaculture. 
Effectively banning the use of biotechnology in the entire food animal 
sector would have a chilling impact on innovation. Furthermore it would 
signal to the world the U.S. no longer employs science-based review and 
regulation, but rather has decided to politicize the technology review 
process and seriously marginalize innovation in food production.
    Global animal biotechnology is on the rise. For instance, in China 
today there are more than 60 applications for genetically engineered 
animals, including several for fish, advancing through its regulatory 
agencies. A ban on GE fish in the U.S. would provide China with a 
global competitive advantage to launch similar products into 
international commerce--without the same Federal oversight expected in 
the U.S.--and would only serve to further inhibit innovation and job 
creation in this country.

    Question 1a. What impact would a ban on international commerce in 
GE fish and GE fish products have on our country's current trade 
relations and treaty agreements?
    Answer. Currently, the U.S. works with other ``like-minded 
countries'' to support innovation and new technology in agriculture. 
One of the primary tenets of U.S. policy is to regulate products based 
on their characteristics rather than on their methods of production. 
The Coordinated Framework for Regulation of Biotechnology, proposed in 
1984 by the White House Office of Science & Technology Policy (OSTP), 
and finalized in 1986, spells out Federal policy for regulating the 
development and introduction of products derived from biotechnology. A 
key principle of the framework is that genetically engineered organisms 
would continue to be regulated according to their characteristics and 
unique features, and not according to their method of production. In 
other words, if a food product produced through biotechnology is 
substantially the same as one produced by more conventional means, that 
food is subject to no additional (or no different) regulatory 
processes. The framework also maintains that new biotechnology products 
are regulated under existing Federal statutory authorities and 
regulation.
    A U.S. ban on genetically modified fish would not only be 
contradictory to our long standing policy on trade in innovative 
agricultural products, it would constitute the type of non-tariff trade 
barrier the U.S. government has always opposed and is counter to 
American policy and values. In short, the impact on our trade and our 
trade agreements would be significant.

    Question 2. If the FDA reviews potential environmental impacts of 
GE fish prior to approval of sale, and private companies are taking 
necessary steps to safeguard the environment, why should Congress ban 
all GE fish from entering the market?
    Answer. There is no environmental, food safety or efficacy reason 
for Congress to take action or interfere in the marketing of GE fish. 
Pre-approval review of this technology rigorously evaluates all aspects 
of the product--including safety, allergenicity and environmental 
impact--and its intended use. Intervention by Congress constitutes 
political interference in this objective, science-based process, and 
sets a dangerous precedent for any Federal government review of a new 
human or animal drug application, a new device application or any 
application for production of a service. The U.S. objective, science-
based regulatory processes developed and used by FDA, USDA, EPA and 
other Federal departments and agencies are recognized as global 
standards for science-based regulatory review, and subverting those 
regulatory processes for political or economic self interest not only 
undermines innovation and competition in the U.S., but would seriously 
undermine our credibility in the international community.

    Question 3. The scientific review process by the FDA is designed to 
assess risks associated with commercial sale of GE fish and find 
whether such activity would pose no significant impact prior to 
approval--a process it has not yet completed. Could a preemptive ban on 
commercial production of genetically engineered fish (in this case 
salmon) prior to an FDA ruling undermine the scientific review process?
    Answer. There is no question politicizing the objective, science-
based FDA review process would undermine its effectiveness and 
credibility. Such action would set a precedent for Congress to 
unilaterally interfere in the regulatory process for political or 
market competition reasons to stop any application by any company or 
group. The impact on the regulatory process and on U.S. credibility 
abroad would be significant.

    Question 4. The FDA is reviewing AquaBounty's application to 
commercially produce genetically engineered (GE) salmon, which your 
company calls AquAdvantage salmon. Is there a timeline for when the 
FDA will complete its review of AquAdvantage salmon?
    Answer. FDA has been reviewing the AquaBounty application for more 
than 10 years. FDA published its preliminary review in 2010. It is our 
understanding the only remaining element prior to a final agency 
decision is FDA's decision to issue an Environmental Assessment (EA), 
publish it in the Federal Register for public comment--though this is a 
not a regulatory requirement--and review the comments. The Company 
supplied a draft EA, which was also published by FDA, in 2010. FDA has 
taken more than 16 months since the publication of the results of its 
scientific review and has still not issued its EA. The continued delay 
has been punitive for the Company, and threatens its economic survival.

    Question 5. How soon do you expect to offer AquAdvantage salmon on 
the market, once the FDA approves its sale?
    Answer. The Company has eggs available for sale in its hatchery at 
present. Fish from those eggs will not be market size for approximately 
two years, or late in 2014.

    Question 6. In your opinion would an outright ban on GE fish be yet 
another example of government overreach and unnecessary regulation of 
American companies?
    Answer. Yes, undoubtedly. The delays encountered to date constitute 
onerous and burdensome Federal regulation, and demonstrate political 
involvement in what should be a purely science-based, objective 
process. A ban would be seriously damaging to American innovation, 
American competitiveness and to the credibility of the American 
regulatory process.

    Question 7. Does the U.S. possess, sell, and ship other GE products 
meant for consumption?
    Answer. There are currently 89 commercial plant varieties produced 
using biotechnology and deregulated by USDA, though not all have been 
commercialized. To single out one biotech product for such a ban would 
be indefensible; it can be argued any action taken to inhibit or stop 
the marketing of a product not yet approved FDA could be taken against 
those food crops which already enjoy GE crops.
    The overwhelming majority of all corn, soybeans and sugar beets 
grown in the U.S. for both domestic and export purposes are biotech 
varieties. This is testament to the broad adoption of this technology 
in the U.S. and in most parts of the world, and proof ``biotech'' is 
the new ``conventional.'' Other crops grown in the U.S. using 
biotechnology include alfalfa, papaya and some varieties of squash. The 
exact percentages of our major crops--used both domestically and for 
export--are the following:

   88 percent of all corn

   95 percent of sugar beets

   94 percent of all soybeans

   90 percent of all cotton

    Globally, 15.4 million farmers in 29 countries grow some form of 
biotech crop on 366 million acres, and these numbers are increasing.

    Question 8. If so, how has genetic engineering advanced 
competitiveness?
    Answer. Genetic engineering has enhanced competitiveness through 
improvement of productivity and efficiency. Examples of the advantages 
of biotechnology include plants and animals which can thrive in 
drought-affected regions; those that withstand disease and infestation, 
and those that bring food crops to market far more quickly and cheaply. 
This technology is making a safe and sustainable food supply possible 
at a time of increasing population demand and diminishing natural 
resources.
    In addition, biotechnology has led to the creation of hundreds of 
human and animal pharmaceuticals, and through this process 
pharmaceutical development saves natural resources, i.e., raw 
ingredients, from over-exploitation. The first genetically enhanced 
animal approved by FDA is for the production of a therapeutic protein 
derived from goat's milk. These animals have been genetically 
engineered by introducing a segment of DNA into their genes with 
``instructions'' for the goat to produce human antithrombin--a critical 
enzyme necessary in blood clotting--in its milk.

    Question 9. How have advances in biotechnology helped the 
aquaculture industry?
    Answer. Biotechnology is relatively new to aquaculture because 
modern aquaculture is a relatively new industry. Early aquaculture 
primarily grew wild marine species in captivity. The environmental 
consequences of expanding the scale of these relatively low-technology 
operations is significant, and there is a need for improved 
productivity, improved efficiency and reduced environmental impact of 
large-scale aquaculture. The use of genetic analysis and modification 
are uniquely suited to address these problems allowing aquaculture to 
meet the increased food demands of an expanding global population. 
Biotechnological innovation in the development of vaccines, probiotics, 
improved feeds, and other products has allowed aquaculture to 
accelerate its growth curve.

    Question 10. What benefits can be gained from genetically 
engineered fish?
    Answer. In the U.S., there is the prospect of commercial-scale 
salmon production in inland-based facilities inspected and approved by 
FDA which would reduce U.S. dependence on imported salmon, reduce the 
product's carbon footprint, create U.S. jobs and economic development, 
while producing the fresh and desirable product demanded by American 
consumers. More than 97 percent of farmed Atlantic salmon consumed in 
the U.S. is imported, primarily from Chile, Norway, Canada, Scotland 
and the Faroe Islands, and reduced transportation requirements--an 
automatic result by growing U.S. Atlantic salmon--would reduce the 
carbon footprint of salmon aquaculture. It would also reduce the 
potential impact on the ecology and biological diversity of wild 
populations. Globally, application of this technology can produce more 
food more efficiently and in an environmentally sustainable fashion to 
meet global food demands in the future.

    Question 11. How competitive is U.S. aquaculture production 
compared to other countries and how would a ban on GE fish affect the 
domestic industry's competitiveness and future direction?
    Answer. The U.S. already lags far behind other countries in 
embracing aquaculture. One of the major reasons behind this 
underdevelopment is the excessive regulatory burden placed on 
aquaculturists in the U.S. As stated earlier, the U.S. imports almost 
all seafood it consumes.
    The U.S. enjoys a successful domestic catfish industry, a small 
domestic trout industry, a domestic wild-caught shrimp industry in the 
Gulf, and a robust salmon fishing industry in Alaska. Although Alaska 
``ranches'' salmon--releasing five billion young fish each year into 
the Pacific Ocean, catching some of these as three or four-year-old 
fish when they return to spawn--more than 60 percent of the Alaskan 
product is exported to Japan and China. As stated, the U.S. currently 
imports approximately 60 percent of all salmon consumed (97 percent of 
the Atlantic salmon consumed) from Canada, Chile, Norway, Iceland, 
Scotland, and the Faroe Islands. The National Oceanic & Atmospheric 
Administration (NOAA) last year proposed a national aquaculture policy 
to address this national priority. We believe exploiting a new, U.S.-
developed technology, coupled with a progressive national policy, will 
help stimulate the growth of American aquaculture, creating U.S. jobs, 
Federal tax revenues, reducing our dependence on imports, and 
addressing future food needs.
                                 ______
                                 
   Response to Written Questions Submitted by Hon. Maria Cantwell to 
                          John Epifanio, Ph.D.
FDA Approval Process
    Question 1. Does the Food and Drug Administration's (FDA) approval 
process for farming genetically engineered salmon adequately assess 
potential environmental impacts?
    Answer. Thank you for your question, Senator Cantwell. Given the 
precedent-setting nature of this specific case, the current scientific 
review process is not as complete as it should be. In my previous 
testimony, I asserted the importance including formal and rigorous 
environmental risk assessment as part of the approval review process. 
Moreover, I identified the absence of a technical peer-review of the 
science addressing ecological and genetic impacts and likelihood of a 
genetically engineered species escaping into the environment. This part 
of the science review and application has no obvious ``trade secrets'' 
value and therefore would benefit from an open review process to bring 
the brightest and most appropriate expertise to bear. To my knowledge, 
FDA has little history or institutional culture in handling the 
complexities of salmon life-history or its ecosystem requirements to 
satisfy a rigorous assessment of environmental risks. This presently 
resides with NOAA-Fisheries and coastal states for marine fishes or 
USFWS and inland states for freshwater fishes.

    Question 2. For example, is the FDA evaluating how escapement of 
genetically engineered fish may impact ecosystems and ecosystem 
processes?
    Answer. The FDA documents made public to date do not present a 
substantial assessment of the impacts from escapement of modified 
organisms. Much of the technical work and review is found within 
technical journals and several reports by the National Academy of 
Sciences.

    Question 3. If approval is granted, will the FDA regulate how the 
engineered fish can and cannot be farmed (near or offshore net pens, in 
cages, hatcheries or in terrestrial above ground facilities)?
    Answer. While the current application is specific to producing 
Atlantic salmon with the growth-gene construct at a site in Panama, 
this application will be precedent-setting more broadly. The question 
identifies an important uncertainty in the regulatory framework of 
marine vertebrates and warrants an analysis by experts in FDA rule-
making. As a scientist, I do not claim sufficient expertise.
    This case is complex case because the species in question is 
derived from and can interbreed potentially with its wild counterpart. 
Moreover, the wild counterpart is presently listed and protected under 
the Endangered Species Act. Additionally, under the current proposal, 
the modified salmon will be reared in Panama, for which FDA has no 
obvious authority. Finally, the farming in coastal or inland waters may 
be regulated as much by the individual states as by the Federal 
government. Therefore, the regulatory framework for coastal and inland 
farming needs to be fully described before approval granted for these 
kinds of activities (beyond the current application) to avoid 
jurisdictional conflicts or insufficient oversight.
Farming Methods and Probability of Escapement
    Question 4. What is the most cost effective method for rearing 
genetically engineered salmon: net pens, hatcheries or terrestrial 
above ground facilities? Please provide estimates for how much it would 
cost to rear genetically engineered salmon using each of the above 
methods.
    Answer. To answer this question fully requires the results from the 
formal risk assessment--specifically to determine both the probability 
of escapement occurring, the magnitude of escapement, and the resulting 
acute and chronic impacts if escapement occurs. The reason for this 
contention is because an undetermined part of the full-range farming 
costs for genetically engineered salmon will be associated with bio-
containment and reduction of escapement risks and associated impacts. 
These containment or security costs are in addition to common 
operational costs (e.g., food, water, facilities, pharmaceticals, 
etc.).

    Question 5. How does the probability of escapement vary between 
each method?
    Answer. Yes, the probability of escapement varies among methods, 
although I am unaware of a specific estimate. As stated previously, the 
results of a formal risk assessment can help to estimate such a 
probability. Ultimately, the probability of escapement likely varies 
for each method. Therefore, setting a performance standard for 
escapement (i.e., what level is ``acceptable'') is really a policy 
matter that that is informed by the probability and magnitude of the 
ecological risks.
Labeling of Genetically Engineered Fish Species
    Question 6. Over 400,000 Americans have commented on an FDA 
petition which would require the labeling of genetically labeled foods. 
In addition, A survey conducted in 2010 by Thomson Reuters 
PULSETM Healthcare Survey, ``National Survey of Healthcare 
Consumers: Genetically Engineered Food'' showed that 93 percent of 
Americans believe GE foods should be labeled. Genetically engineered 
foods are required to be labeled in the 15 European Union nations, 
Russia, Japan, China, Australia, New Zealand, and many other countries 
around the world. What are your thoughts on labeling genetically 
engineered food so that consumers can make an informed decision?
    Answer. While this is not an issue informed by my scientific 
expertise, my general opinion on the matter as someone who routinely 
consumes fish is that disclosure and informative labeling permit me as 
a consumer the opportunity to select a product appropriate to my own 
preferences and consistent with consumption of farmed food produced in 
an environmentally sensitive manner.
                                 ______
                                 
    Response to Written Questions Submitted by Hon. Mark Begich to 
                          John Epifanio, Ph.D.
S. 1717 and the Prevention of Escapement
    Question 1. Dr. Epifanio, you have recommended to us in your 
written statement that it would be prudent to treat any transgenic 
modification of fishes as a controlled experiment that: (a) is actively 
monitored for impacts on an ongoing basis; and (b) can be terminated 
should the need arise without lingering environmental effect. Dr. 
Leonard and Mr. Greenberg have each expressed support for a bill I 
introduced in the Senate, S. 1717. This bill, as I've proposed to amend 
it here in Committee, would make it illegal to sell, ship, possess, or 
release genetically engineered salmon or other marine fish, but would 
provide a broad, categorical exemption for scientific research. It 
sounds like the bill I've described meets your recommended criteria--
allowing only for controlled experiments that can be actively monitored 
and easily terminated with no environmental impacts. Do you agree?
    Answer. Thank you, Senator Begich. I affirm the need for allowing 
legitimate medical and genetic research using fishes as experimental 
models. Such research should be and generally is conducted in 
controlled settings (that is, bio-containment) for the same reasons we 
have concerns about genetically engineered salmon escaping. That said, 
my call for treating any genetic engineering activity as ``a controlled 
experiment'' is in fact aimed more broadly at any private commercial or 
even public production--rather than solely on research.
    As a hypothetical example to illustrate this distinction, let's say 
a private company or government entity can produce a genetically 
engineered sterile version of an undesirable pest species for the 
purpose of its eradication as part of an Integrated Pest Management 
approach (or IPM). Even if the formal risk assessment was to show a low 
risk for releasing such a modified species, it would be prudent if we 
treated the release as ``experimental.'' As such, continued monitoring 
following release is warranted to assess effectiveness and any 
unanticipated impacts. If an undesired impact was observed, being able 
to not only suspend, but also to reverse, the release would be prudent 
as well to minimize longer-term impacts.

    Question 1a. Do you support S. 1717?
    Answer. I am supportive of the concept for holding-at-bay the 
potential long-term ecological and genetic hazards posed by genetically 
engineered Atlantic salmon (and other species as well) to their wild 
counterparts and to recipient ecosystems. I am supportive also of 
ensuring imposition of a well-crafted review process that requires the 
Federal and state agencies with appropriate expertise on the species' 
biology and ecosystem requirements to conduct rigorous risk assessments 
prior to approval.
    Ultimately, banning the possession, sale, or importation can help 
to achieve these precautionary goals while rigorous risk assessments 
and a more comprehensive review process is developed.
                                 ______
                                 
  Response to Written Questions Submitted by Hon. Roger F. Wicker to 
                          John Epifanio, Ph.D.
    Question 1. Scientists and the aquaculture industry underscore the 
need to address the potential problems of genetically engineered (GE) 
fish, such as the impact on wild stocks. However, they also highlight 
the benefits of innovation in this area such as lowering costs, 
expanding industry, increased health benefits, and feeding a growing 
global population. The FDA currently has a process to address these 
issues on a case-by-case basis through scientific review. Would a 
blanket ban on commerce in genetically engineered fish inhibit 
innovation and competition for U.S. aquaculture companies?
    Answer. I am not an expert on commerce-related issues, especially 
related to innovation and competition for the aquaculture industry. My 
expertise is in the area of genetic and ecological impacts on recipient 
ecosystems (and the services they provide) associated with 
translocation and propagation/release of fishes. Ultimately, I assert 
that it is critical any legislative action or regulatory rule-making 
adequately define the activities or products being banned (or 
conversely, permitted) as ``commercial'' with a full benefit of a 
formal risk assessment. For example, there may be advances and products 
that emerge from medical research using fishes as a model organism. I 
further assert a need to define what kinds of manipulations would be 
prohibited (or permitted) under the moniker of ``genetically 
engineered'' (that is, will this be directed solely at recombinant or 
transgenesis processes only, or more broadly to include chromosome-set 
manipulation, hybridization, or other more ``traditional'' modes of 
gene pool manipulation).

    Question 2. What impact would a ban on international commerce in GE 
fish and GE fish products have on our country's current trade relations 
and treaty agreements?
    Answer. I have no true expertise to bring to bear on this question, 
although I am aware that the European Union has attempted to address 
the international commerce issues in part.

    Question 3. If the FDA reviews potential environmental impacts of 
GE fish prior to approval of sale, and private companies are taking 
necessary steps to safeguard the environment, why should Congress ban 
all GE fish from entering the market?
    Answer. While FDA excels at examining the risks to humans from 
food, cosmetics, and drugs, we need to ask whether the agency alone has 
the expertise and institutional culture to competently assess the 
environmental impacts through a formal risk assessment to recipient 
ecosystems. The legitimate expertise on the interaction of fishes in 
their environments presently resides with NOAA, USFWS, and USGS at the 
Federal level, with the individual state and tribal governments, and 
informed by experts within the academic community. A formal risk 
assessment goes beyond a ``paper'' impact review to include scientific 
modeling and controlled testing of assumptions (see Environmental Risk 
Assessment of Genetically Modified Organisms, Vol. 3, ``Methodologies 
for Transgenic Fishes,'' by AR Kapuscinski et al., CAB International).

    Question 4. The scientific review process by the FDA is designed to 
assess risks associated with commercial sale of GE fish and find 
whether such activity would pose no significant impact prior to 
approval--a process it has not yet completed. Could a preemptive ban on 
commercial production of genetically engineered fish (in this case 
salmon) prior to an FDA ruling undermine the scientific review process?
    Answer. I appreciate the Senator's concern for safe-guarding 
objective scientific review--rigorous and transparent examination of 
methodologies, analyses, results, and interpretation are pillars of the 
modern scientific enterprise. In general, independent scientific review 
adds important value to the scientific enterprise by bringing the best 
and brightest expert thinking to bear on a proposal and final 
reporting.
    Regarding the Senator's question about whether a legislatively-
mandated ban undermines the scientific review--it appears that a ban 
would reinforce the need for a more well-defined framework that 
incorporates scientific review of environmental impacts by an action 
agency well-versed on salmon life-history and ecosystems. The 
requirements of food and drug safety laws designed to protect trade 
secrets from would-be competitors lead to a FDA review process 
differing from expert-based peer review more traditionally applied to 
ecological and natural resource sciences. As such, the FDA approach 
appears to be appropriate for the science behind the methods and 
findings for production, efficacy, and health effects of transgenesis 
(recombinant genetic modification) of the target organism. Conversely, 
this approach is not appropriate to evaluating impacts and risks to the 
environment by modified organisms. Importantly, a competitor gains no 
real or unfair advantage if information from environmental review and 
results of formal risk assessment were to be made public.
    A legislative ban can have a time component to permit the 
implementation of an institutional framework for shared review. Also, 
should the evidence for sufficient safety become available, escapement 
of a few individuals or a whole population of modified salmon may not 
be as reversible. A comparison of the levels of concern for transformed 
animals is presented in a National Academy of Sciences report (Table 
5.1; Animal Biotechnology: Science Based Concerns, 2002). In this 
table, fish rank just below insects as the group with highest level of 
concern because of their capacity to establish to breeding populations 
in the wild, a likelihood of escaping captivity, overall mobility, and 
ecological disruptions to complex communities. Therefore, if scientific 
evidence comes forth to demonstrate that the product and technology are 
benign, the law can be repealed. However, if salmon or other species 
escapes, recapture or eradication may not be possible.
                                 ______
                                 
  Response to Written Questions Submitted by Hon. Roger F. Wicker to 
                        George H. Leonard, Ph.D.
    Question 1. Scientists and the aquaculture industry underscore the 
need to address the potential problems of genetically engineered (GE) 
fish, such as the impact on wild stocks. However, they also highlight 
the benefits of innovation in this area such as lowering costs, 
expanding industry, increased health benefits, and feeding a growing 
global population. The FDA currently has a process to address these 
issues on a case-by-case basis through scientific review.
    Would a blanket ban on commerce in genetically engineered fish 
inhibit innovation and competition for U.S. aquaculture companies?
    Answer. There is little reason to believe that preventing the 
commercial proliferation of GE fish until the important environmental 
and regulatory questions are fully answered would undermine innovation 
and competitiveness within the U.S. aquaculture industry. Firstly, GE 
fish are not yet part of the seafood marketplace, meaning that a short-
term delay or a longer-term ban would not affect the status quo.
    Secondly--and most importantly--this question is based on the false 
premise that the only way for U.S. aquaculture to innovate or become 
cost competitive is through the broad application of genetic 
engineering technology. All current evidence is to the contrary. 
Although it ranks only 13th globally in terms of production, the U.S. 
aquaculture industry is vibrant, with over 4,000 farms in nearly every 
state in the nation, supplying nearly 500,000 mt of plants and animals 
with a value that exceeds $1.3 billion.\1\ In contrast to foreign 
imports, many of these U.S. aquaculture products have been ranked 
``Best Choices'' for their environmental sustainability by the well-
respected Monterey Bay Aquarium.\2\ Furthermore, the U.S. is also an 
important exporter of technology and ``know how'' to other countries; 
this intellectual capital emanates from research conducted at many of 
the Nation's Sea Grant colleges and universities. A key example of the 
level of innovation in the U.S. aquaculture industry is the annual 
``Aquaculture America'' conference,\3\ where the industry and 
scientists meet to discuss trends in fish farming, the status of the 
seafood marketplace, and innovation in U.S. fish farming that will help 
ensure a viable future for U.S. aquaculture. Very little of the 
discussion at this conference centers on the supposed need for 
genetically engineered fish.
---------------------------------------------------------------------------
    \1\ http://www.fao.org/DOCREP/003/AB412E/ab412e23.htm; http://
aquaculture.noaa.gov/pd
f/econ/econ_rpt_all.pdf.
    \2\ http://www.montereybayaquarium.org/cr/seafoodwatch.aspx.
    \3\ https://www.was.org/WasMeetings/meetings/
Default.aspx?code=AA2012.
---------------------------------------------------------------------------
    Three real world examples of U.S. companies further highlight the 
ability of U.S. aquaculture to innovate without the need to resort to 
engineering their fish. Australis Aquaculture, located in western 
Massachusetts, is one of the largest recirculating fish farms in the 
world.\4\ Growing barramundi in a state-of-the-art facility, this 
company has increased seafood choices for U.S. seafood consumers by 
taking advantage of this fish's naturally high growth rates. In 
Washington State, Sweet Spring Aquaculture \5\ has pioneered a land-
based salmon farm that is both cost competitive and whose product has 
been extremely well received by the marketplace and seafood consumers. 
By growing non-engineered coho salmon in freshwater systems, this 
innovative company has found little need for genetically engineered 
fish. And finally, Kampachi Farms \6\ has recently field tested a new 
method of growing yellowtail in the offshore ocean waters near Hawaii. 
In free floating ocean cages, growth and survival rates of this species 
were extremely high. These three examples are but a few of many in the 
current U.S. aquaculture industry. In none of these examples is genetic 
engineering central to their success.
---------------------------------------------------------------------------
    \4\ http://www.thebetterfish.com/home.
    \5\ http://www.sweetspringsalmon.com/local.shtml.
    \6\ http://kampachifarm.com/.
---------------------------------------------------------------------------
    Lastly, it is important to emphasize that not all innovation is 
responsible or desirable; the government's role is to ensure that the 
public and its natural resources are protected from potentially 
deleterious business practices that may cause harm to other citizens 
and economic sectors. With respect to GE fish, a recent publication in 
the prestigious journal Science showed that there has not been 
sufficient analysis done to determine if the proliferation of 
genetically engineered fish would ultimately be beneficial or 
deleterious for society.\7\ Until that analysis is done, it is entirely 
appropriate for the government to ban or limit private initiatives that 
have the potential to harm society.
---------------------------------------------------------------------------
    \7\ Smith, M.D., Asche, F., Guttormsen, A. G., J. B. Wiener. 2010. 
Genetically Modified Salmon and Full Impact Assessment. Science 
330:1052-1053.

    Question 2. What impact would a ban on international commerce in GE 
fish and GE fish products have on our country's current trade relations 
and treaty agreements?
    Answer. Given that GE fish are not currently a part of the 
international fish trade, a ban on such fish or products would not have 
any foreseeable impacts on current trade relations or treaty 
agreements. The absence of GE fish would merely maintain the status 
quo. One specific concern, however, that has been raised by proponents 
of GE salmon is the notion that an import/export ban would constitute a 
``non-tariff barrier to trade'' that could bring a WTO penalty or trade 
enforcement mechanism. As you may know, Article 20 of the General 
Agreement on Tariffs and Trade (GATT) allows governments to act on 
trade to protect human, animal or plant life or health, provided they 
do not discriminate or use this as disguised protectionism. Any import/
export ban of GE fish would be motivated by the need to protect human, 
animal, and environmental life and health, and not be motivated by 
protectionism.
    Such a ban, then, would not constitute a non-tariff barrier to 
trade for at least two specific reasons. First, a ban would be applied 
domestically as well as on imports/exports, giving no specific 
protectionist advantage to domestic producers and not giving any 
preference or disadvantage to specific trading partners. Second, such a 
ban would be based on a scientific demonstration of the risks posed to 
the environment and human and animal life and health, as required by 
WTO. In the extremely unlikely event that a WTO panel ignores those 
facts and finds a U.S. GE fish ban to be in violation, the U.S. would 
still have significant flexibility: the government could decide whether 
to adjust its policy, negotiate a compromise with the complaining 
parties, or accept retaliatory trade sanctions while maintaining the 
ban.
    It is extremely important, however, to also ask the inverse of your 
question. Namely, what impact would U.S. Federal approval of GE fish 
have on our current trade relations and treaty agreements?
    Answer. If FDA approves genetically engineered salmon at this time, 
and refuses to require the product to be labeled, a number of impacts 
on international relations--including trade--could result. First, the 
Nation's ability to export farmed salmon to Europe could be seriously 
undermined. The European market is generally opposed to GE food 
products and has strict requirements that GE food be labeled. If there 
is uncertainty about the genetic status of U.S. farmed salmon, European 
importers may simply refuse to accept U.S. product as a precautionary 
measure, undermining the U.S. salmon farming industry which currently 
does not utilize GE fish and has publically indicated it has no 
interest in doing so.\8\
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    \8\ http://www.workingwaterfront.com/articles/Wild-to-Transgenic-
Salmon-in-Maine/14105/.
---------------------------------------------------------------------------
    Approval of GE salmon could also affect a number of multilateral 
treaties that pertain to wild salmon management and ecosystem 
protection. For example, the Pacific Salmon Treaty, signed in 1985, 
sets long-term goals for the benefit of wild salmon in both the U.S. 
and Canada. Interception of Pacific salmon bound for rivers of one 
country in fisheries of the other has been the subject of discussion 
between the two countries since the early part of the last century. 
Should GE fish escape and impact wild salmon in the Pacific Ocean, 
existing goals of the Pacific Salmon Commission could be undermined. In 
an analogous way, expansion of GE fish in the U.S. could undermine the 
ongoing work of the North American Commission of the North Atlantic 
Salmon Conservation Organization (NASCO). NASCO was established in 1984 
as an inter-governmental body to conserve, restore, enhance, and 
rationally manage salmon in the Atlantic Ocean. Through this body, 
regulations and other measures have greatly reduced harvests of salmon 
throughout the North Atlantic. Escaped GE fish could require a 
reevaluation of the measures currently in place by Canada and the U.S. 
to restore wild Atlantic salmon.
    Lastly, escaped GE fish could undermine the collaboration between 
the U.S. and Canada to effectively manage the Great Lakes ecosystem and 
their associated fisheries. The Great Lakes Fishery Commission was 
established by the Convention on Great Lakes Fisheries between Canada 
and the United States in 1955. The Commission's primary goal is to 
develop coordinated research programs between the two countries and 
make recommendations to ensure sustained productivity of fish stocks of 
common concern.
    In all three of the examples above, the potential negative 
consequences of the proliferation of GE salmon farming on treaty 
outcomes has not been sufficiently evaluated by the FDA, the State 
Department, or any other Federal agency. This type of analysis must be 
done before approval to ensure that our government understands the full 
suite of possible ramifications of such an approval on trade relations 
and treaty agreements.

    Question 3. If the FDA reviews potential environmental impacts of 
GE fish prior to approval of sale, and private companies are taking 
necessary steps to safeguard the environment, why should Congress ban 
all GE fish from entering the market?
    Answer. This question assumes that the United States has a 
regulatory process in place that can anticipate, evaluate, and guard 
against the potentially far-reaching environmental risks posed by 
genetically engineered fish. However, the existing regulatory framework 
under the Federal Food, Drug, and Cosmetics Act is woefully inadequate. 
As I pointed out several times during my appearance before the 
Subcommittee, the FDA's environmental review process is ignoring a 
large proportion of the potential environmental impacts. Many of the 
key environmental impact questions are not only going unanswered by the 
FDA's review--those questions are not even being asked. Therefore, 
approval should not proceed until a full analysis of the environmental, 
economic, and societal impacts of the expansion of GE fish farming is 
done. To date, the FDA has indicated it will not evaluate the full 
range of environmental impacts (instead focusing only on the specific 
application from AquaBounty Technologies, Inc.) allowing the 
segmentation of environmental harms and ignoring the broader concerns 
of full-scale commercialization. Rather than being intentionally near-
sighted, our government agencies should be forward thinking.
    Under the 1986 Coordinated Framework for the Regulation of 
Biotechnology (``Coordinated Framework''), genetically engineered 
organisms (GEOs) are regulated according to the concept of ``product, 
not process.'' This means that Federal agencies evaluate GEOs as 
products like any other--``substantially equivalent'' to their non-
engineered analogues--not as a special category distinguished by their 
development using the process of recombinant DNA technology. The 
Coordinated Framework assumes that the existing agencies, using 
existing authority, have the ability and expertise to review 
commercialization applications.
    There are a number of flaws with this approach. First, existing 
statutes have generally been designed to address situations where harm 
or risk has already been quantified, not situations where there remains 
a high degree of scientific uncertainty, such as is the case for 
genetic engineering technology. The ``new animal'' drug laws currently 
being used to regulate GE animals, for example, were written well 
before GE animals were ever conceptualized as a possible food source 
and are woefully outdated. Second, the theory of substantial 
equivalence is predicated on an assumption of safety; that is, it 
starts from a position of assumed safety, where the burden of proof 
falls on the public to show harm.\9\ Third, an agency with expertise in 
one area relevant to a permit application may not be best suited to 
evaluate the other potential effects a GEO may have when it is 
commercially released. This potential for problems in regulating 
transgenic fish and livestock under the Coordinated Framework Early was 
recognized as early as 1990.\10\
---------------------------------------------------------------------------
    \9\ Kelso, Dennis Doyle Takahashi. ``Genetically Engineered Salmon, 
Ecological Risk, and Environmental Policy.'' Bulletin of Marine Science 
74, no. 3 (2004): 509-28.
    \10\ Kapuscinski, Anne R. and Eric M. Hallerman, ``Transgenic Fish 
and Public Policy: Anticipating Environmental Impacts of Transgenic 
Fish,'' Fisheries 12 (1990), p. 3, 5.
---------------------------------------------------------------------------
    FDA's authority was designed to provide the agency with oversight 
of traditional pharmaceutical drugs. Applying the new animal drug 
application process to GE salmon intended for interstate commerce and 
human consumption raises a host of concerns. Because of matters of 
trade secrets, the process is open to public comment only after the 
approval of the new animal drug application, and thus, approval of the 
GE fish has been made.\11\ Unlike applications led by USDA or EPA, 
FDA's approval process occurs almost entirely behind closed doors, 
making it nearly impossible for the public to participate meaningfully 
in an agency decision that could lead to devastating and irreversible 
ecological harm. While this process might protect confidential business 
information, it fails to adequately and transparently examine 
potentially far-reaching and serious consequences and environmental 
risks from GE salmon.
---------------------------------------------------------------------------
    \11\ FDA provided an opportunity for public comment in September 
2010 before final approval of GE salmon, likely because the agency 
sensed this decision would be highly controversial; FDA, however, is 
not legally required to be similarly forthright when new entities seek 
approval from the agency for additional species or culturing 
conditions.
---------------------------------------------------------------------------
    FDA's existing regulatory process was simply not designed to 
address the complex issues involved in developing genetically 
engineered fish for human consumption. Because the FDA's focus is on 
food and drug safety, the agency does not have the expertise or 
experience to adequately identify and analyze the environmental risks 
and consequences of GE salmon and other fish. In addition, the FDA 
approval process lacks adequate consideration of the full range of 
environmental hazards, and the opportunity for sufficient input from 
other Federal agencies with expertise in fisheries and environmental 
risk. Among other issues, the current process fails to adequately 
consider threats to wild salmon populations, threats to commercial and 
recreational salmon fisheries, threats to fisheries targeting other 
species that interact with salmon, threats to marine and terrestrial 
food webs in which salmon are embedded, and threats to recovery efforts 
for salmon stocks listed as endangered or threatened under the 
Endangered Species Act.
    Other Federal agencies with relevant expertise must play a stronger 
leadership role in the approval and regulation of GE fish. These 
include the National Marine Fisheries Service (NMFS), the U.S. Fish and 
Wildlife Service (USFWS), and the Environmental Protection Agency 
(EPA). NMFS and FWS have scientific expertise backed by extensive 
ecosystem research, and have expertise in conservation and protection 
of the natural resources that could ultimately be affected by GE salmon 
and other GE fish. EPA has knowledge and experience in the oversight 
and management of threats to water and watersheds. At a minimum, FDA 
should be required to consult these agencies during all stages of 
development and approval of GE salmon. Furthermore, if FDA is to remain 
the lead agency, FDA should be required not only to consult with these 
agencies, but also to either heed their advice or provide adequate 
rationale for any decisions to the contrary.
    Concerns over the FDA approval process were brought to the 
attention of FDA in September 2010 in a letter from eleven U.S. 
Senators, including Senator Begich.\12\ The letter requested that FDA 
halt the GE salmon approval process, citing concerns over unknown 
impacts to human health and environmental risks. These concerns are 
valid as FDA is ill-equipped to deal with the environmental and 
biological consequences and risks associated with the farming of 
genetically engineered fish. Preventing GE fish from entering the 
marketplace at this time would provide 6 Congress the time to craft 
proper laws and ensure that FDA develops regulations based on these new 
laws that will be appropriate for this new method of farming animals.
---------------------------------------------------------------------------
    \12\ Letter to Commissioner Margaret Hamburg, Commissioner of Food 
and Drugs, FDA (Sept. 28, 2010).

    Question 4. Could a preemptive ban on commercial production of 
genetically engineered fish (in this case salmon) prior to an FDA 
ruling undermine the scientific review process?
    Answer. If the existing review process were sufficiently rigorous 
there would be little need to prevent the commercialization of GE fish 
at this time. But, as explained in detail in Question 3 above, the 
process is woefully inadequate and lacks credibility. Given the 
limitations of the existing regulatory system, the most prudent course 
of action is to not move forward with approval. This does not undermine 
the review process; it merely acknowledges its deficiencies. Should the 
review and regulatory process for GE animals, including fish, be 
revised to address our full range of concerns--including the need for 
additional scientific review--Ocean Conservancy would be supportive of 
completing the review. In the absence of such changes, however, we 
remain supportive of Congress' efforts to institute a ban.
                                 ______
                                 
Response to Written Questions Submitted by Hon. John D. Rockefeller IV 
                             to Tom Iseman
Access to Climate and Weather Data
    Question 1. How does NOAA disseminate their climate and weather 
data to state and local entities such as the WGA? Please provide 
examples.
    Answer. NOAA employs a range of tools and partnerships to 
disseminate weather and climate information, ranging from weather 
forecasts and websites to on-the-ground engagement with states, private 
sector and local communities.
    The most visible form of outreach is television and radio, and 
specifically the local weather forecast, where NOAA's National Weather 
Service field offices provide information on day to day conditions. 
Citizens tune into their forecast every day to decide whether to bring 
an umbrella or how long their morning commute might be.
    Another tool is websites, like weather.gov, climate.gov, or 
drought.gov (which was a direct outgrowth of our partnership on the 
National Integrated Drought Information System (NIDIS)). These websites 
are designed to collect and aggregate relevant information and to make 
it available as a `one-stop shop' for states and users. They allow 
interested viewers to find a range of information and to focus on 
geographic or topical issues of interest. However, these are passive 
services that require some user initiative and knowledge to exploit.
    NOAA also provides periodic Climate Outlook Forums. In these 
forums, NOAA experts provide the latest climate forecasts to interested 
users, and they are available for dialogue and Q&A with the audience. 
These vary in geographic and temporal scale, from an annual climate 
outlook for the Nation to a seasonal climate outlook for a particular 
region of interest, for example, drought in the Southwest or flooding 
in the Upper Missouri.
    Finally, NOAA works directly with states and local users to engage 
in the development of information services, for example in the case of 
`Early Warning Systems' being developed by NIDIS. In these cases, NOAA 
works with stakeholders to understand the key weather and climate 
variables of interest for a relevant geography, and they `co-develop' a 
system to monitor and report on those variables over time. NOAA's 
Regional Integrated Sciences and Assessments (RISAs) conduct 
stakeholder-driven research needed to inform these systems at the scale 
of watersheds, cities, and local communities where managers make 
decisions. Early Warning Systems are being developed for the Upper 
Colorado River, the Apalachicola-Chattahoochee-Flint Basin in the 
Southeast, and the ongoing drought in the Southern U.S.
    These are the services that WGA is trying to promote through its 
MOU with NOAA: regional services that more actively engage states and 
other on-the-ground stakeholders in the identification and development 
of new tools to track and respond to key weather and climate events. By 
engaging states and other stakeholders, tools will address the key 
issues of interest--like how drought may affect a municipal water 
supply, or when flooding may delay the shipping of goods by rail, or 
whether infrastructure design criteria are sufficient to address severe 
storm events--and will be more widely adopted and employed than 
national websites. We recognize that regional, stakeholder-designed 
services may require additional resources and time; however, they are 
the best way to address the regional variability inherent in climate 
and its impacts to on-the-ground decision-making.

    Question 2. What concrete improvements can be made to increase 
access to this information?
    Answer. While portals like drought.gov have broad utility and 
should be continued, we support efforts to promote more active, 
stakeholder-initiated services that address key regional priorities. 
Regional systems provide a targeted assessment of key indicators, along 
with the expertise and resources to interpret and apply them to on-the-
ground decision-making. Regional systems can stimulate efforts to plan 
and prepare for climate and weather events, rather than simply 
responding after the fact. We want to get to the point where a farmer 
uses the seasonal outlook to decide whether to plant certain crops, or 
a water utility uses long-range snowpack projections to design new 
infrastructure--just like you or I listen to the weather forecast to 
decide whether to carry an umbrella.
    We recommend a rigorous assessment of existing regional early 
warning systems, including those developed under NIDIS, to inform the 
design and implementation of future efforts.
                                 ______
                                 
   Response to Written Questions Submitted by Hon. Maria Cantwell to 
                             Paul Greenberg
Farming Methods and Probability of Escapement
    Question 1. What is the most cost effective method for rearing 
genetically engineered salmon: net pens, hatcheries or terrestrial 
above ground facilities?
    Answer. If your question is which method of salmon farming has the 
lowest direct cost to the producer, then the easy answer is net pen 
aquaculture. Net pens are placed directly in a marine environment that 
is naturally the appropriate temperature. Wastes from said farms are 
released directly into the marine environment. The farmer therefore 
does not have to bear the costs of temperature costs and waste 
disposal. Those costs are passed on to the surrounding environment. 
That being said, AquaBounty has not proposed the growing of its GE fish 
in net pens. Rightly understanding the risk of escapement, they have 
said publicly that their fish will be grown in containment structures. 
However, it should be noted that AquaBounty itself is not a salmon 
farmer. The company is a producer of seed stock and it will be up to 
individual farmers that buy that stock and state and Federal regulators 
to determine whether individual farmers may grow the AquaBounty fish in 
a net pen. I am deeply concerned that the cost efficiencies of net pen 
culture may compel some farmers to attempt growing the GE salmon in the 
wild marine environment where escapement is a considerable risk. Many 
millions of farmed salmon have escaped from net pens in salmon 
farming's modern 40+ year history.

    Question 2. How does the probability of escapement vary between 
each method?
    Answer. As stated above, net pen growing of salmon has a much 
greater risk of escape. Seals, storms and other natural events quite 
frequently rupture net pens and even with technological advancements 
it's reasonable to assume that escapes will continue from net pens. 
Terrestrial above ground facilities have a lower risk of escape but in 
the event of a major flood (as occurred in the Northeast in September 
of this year) a contained facility good easily be flooded and fish 
could escape.
Labeling of Genetically Engineered Fish Species
    Question 3. Over 400,000 Americans have commented on an FDA 
petition which would require the labeling of genetically labeled foods. 
In addition, A survey conducted in 2010 by Thomson Reuters 
PULSETM Healthcare Survey, ``National Survey of Healthcare 
Consumers: Genetically Engineered Food'' showed that 93 percent of 
Americans believe GE foods should be labeled. Genetically engineered 
foods are required to be labeled in the 15 European Union nations, 
Russia, Japan, China, Australia, New Zealand, and many other countries 
around the world. What are your thoughts on labeling genetically 
engineered food so that consumers can make an informed decision?
    Answer. I fully support the labeling of genetically modified food. 
The American economic system is one based on freedom of choice. If 
Americans cannot obtain information about the food they are eating in 
an easy to recognize format then they are being denied that basic right 
of free choice.
                                 ______
                                 
   Response to Written Question Submitted by Hon. Roger F. Wicker to 
                             Paul Greenberg
    Question 1. Scientists and the aquaculture industry underscore the 
need to address the potential problems of genetically engineered (GE) 
fish, such as the impact on wild stocks. However, they also highlight 
the benefits of innovation in this area such as lowering costs, 
expanding industry, increased health benefits, and feeding a growing 
global population. The FDA currently has a process to address these 
issues on a case-by-case basis through scientific review. Would a 
blanket ban on commerce in genetically engineered fish inhibit 
innovation and competition for U.S. aquaculture companies?
    Answer. No, quite the contrary. It's my opinion that poorly 
regulated countries like China will pursue GE fish at their peril. As 
affluence grows around the world, consumers will grow more discerning. 
Products that are produced naturally will gain higher value. The United 
States with its abundant wild fisheries has a unique opportunity to 
secure the high ground in the global seafood system. Already the vast 
majority of Alaska's wild seafood is sold abroad and prices are only 
rising for those foods. But this is not only the case for wild product. 
America's shellfish growers, aquaculturists all, are having resounding 
success selling their product abroad. Taylor Shellfish Farms of 
Washington state sells something like 35% of its product abroad, much 
of it going to China. These environmentally friendly products fetch a 
high premium and their prices will only grow. The path forward for 
American seafood is quality and purity, not brute quantity.

    Question 2. What impact would a ban on international commerce in GE 
fish and GE fish products have on our country's current trade relations 
and treaty agreements?
    Answer. Very little. As state above we already have rich trade 
agreements for our wild fisheries and our products have extremely high 
value abroad and are greatly esteemed. In fact allowing GE fish into 
our food system would, I fear, negatively impact the reputation (and 
therefore pricing) of our products abroad.

    Question 3. If the FDA reviews potential environmental impacts of 
GE fish prior to approval of sale, and private companies are taking 
necessary steps to safeguard the environment, why should Congress ban 
all GE fish from entering the market?
    Answer. As I said in my written testimony, the effects of 
environmental pollutants are never realized until many years after 
their release into the environment. PCBs and DDT were not proven to 
have adverse environmental effects until many years after their wide-
scale use. Furthermore with the regulatory burden due to be placed on 
an already overly burdened FDA I do not feel this country has the 
resources to adequately monitor the cultivation of this fish. While 
AquaBounty promises containment-only growing of the GE salmon, farmers 
will be tempted to grow the fish in open water net cages and FDA or 
whoever the responsible regulatory agency will be at the time will not 
have the human resources to monitor. It's my opinion that this fish 
will end up being farmed in the open ocean and that it will eventually 
escape.

    Question 4. The scientific review process by the FDA is designed to 
assess risks associated with commercial sale of GE fish and find 
whether such activity would pose no significant impact prior to 
approval--a process it has not yet completed. Could a preemptive ban on 
commercial production of genetically engineered fish (in this case 
salmon) prior to an FDA ruling undermine the scientific review process?
    Answer. I do not believe so because as Senator Begich pointed out 
during the hearing, the assessment of this organism's fitness for 
distribution in the United State should not lie solely in the hands of 
FDA. FDA by definition does not take responsibility for the health of 
wild salmon stocks. That is a job for NOAA/NMFS, the EPA and other 
agencies more closely attuned to the risks to wild animals. Therefore I 
believe the ban would as Senator Begich suggested, slow down the 
process to a point whereby more relevant agencies could have an 
opportunity to enhance the scientific review process.

    Question 5. In your written testimony you state specific reasons 
why the GE salmon produced by AquaBounty Inc. should not be approved 
for commercial production. You then conclude with strong support for 
legislation that would ban ALL GE marine fish--not just AquaBounty's 
salmon. Is it really necessary for Congress to ban all GE fish from 
commercial production when the FDA considers approval on a case-by-case 
process?
    Answer. I believe that the US should take a precautionary and 
sensible approach to GE fish. As I stated in my written testimony a GE 
fish is not necessary for the American food system at this point in 
time and even AquaBounty admits that they cannot be 100% certain that 
the fish will not escape. So, my point is, why should we introduce any 
GE fish into the American food system until it is absolutely necessary. 
There are many many ways to improve American aquaculture outside of 
genetic modification. Aquaculture is a new science and we have great 
strides ahead of us to improve feed, husbandry techniques and all the 
myriad factors that go into making a productive farm. GE fish is a 
dangerous short cut that provides only a few modest benefits alongside 
a host of potential risks.
                                 ______
                                 
                                            State of Alaska
                                                  December 14, 2011
Hon. Mark Begich,
Chairman,
U.S. Senate Subcommittee on Oceans, Atmosphere, Fisheries, and Coast 
Guard,
Washington, DC.
Hon. Olympia Snowe,
Ranking Member
U.S. Senate Subcommittee on Oceans, Atmosphere, Fisheries, and Coast 
Guard,
Washington, DC.

     Re: Environmental Risks of Genetically Engineered Fish

Dear Chairman Begich and Ranking Member Snowe,

    I commend the Subcommittee for its attention to the environmental 
risks associated with genetically engineered fish. My administration 
continues to have strong concerns regarding AquaBounty's application to 
market genetically engineered Atlantic salmon. Due to the significant 
potential threats genetically engineered salmon pose to the 
environment, consumer health, and the wild seafood industry, we have 
urged the United States Food and Drug Administration (FDA) to withhold 
approval of this application. Furthermore, we question whether the 
application has received sufficient scientific and public scrutiny, and 
are troubled by the Zack of transparency that has marked the review 
process.
Threat to Wild Salmon Stocks
    Like many, we fear genetically engineered salmon could jeopardize 
the health of wild salmon stocks if released into the wild. Genetically 
engineered salmon could spread disease, cross-breed with wild salmon, 
and out-compete them for food and mates. The United States Fish and 
Wildlife Service (FWS) and National Oceanic and Atmospheric 
Administration (NOAA) have recognized these risks, and warned the FDA 
about the potential dangers associated with escaped genetically 
engineered fish in a joint letter to the FDA in 2001, and the National 
Academy of Sciences in a 2002 study.
    While AquaBounty proposes containment measures to reduce the chance 
of genetically engineered salmon escapes, these measures would not 
eliminate the risk. That risk would grow if AquaBounty supplies 
genetically engineered salmon eggs to a network of commercial farms, as 
the company intends. Juneauskans are well aware that fish farming 
containment measures are not fail-safe. Commercial fishermen in Alaska 
have caught hundreds of Atlantic salmon, escaped from fish farms in 
Canada and the state of Washington.
Insufficient Consultation with National Marine Fisheries Service (NMFS)
    We have urged the FDA to honor a provision authored by the late 
Senator Ted Stevens and Senator Lisa Murkowski, which became law as 
part of the Food and Drug Administration Amendments Act of 2007 (P.L. 
110-85). The provision requires the Commissioner of FDA ``to consult 
with the Assistant Administrator of the NMFS of the National Oceanic 
and Atmospheric Administration to produce a report on any environmental 
risks associated with genetically engineered seafood products, 
including the impact on wild fish stocks.'' This statutory language was 
intended to ensure NOAA played a role in the FDA's approval process for 
genetically engineered seafood products. We are not convinced that this 
statutory obligation has been fully met.
Threat to Human Health and Consumer Confidence in Salmon
    Before genetically engineered salmon is allowed into the United 
States' food supply, more rigorous scientific research is necessary to 
ensure its long-term consumption is safe for a large cross section of 
the population, including sensitive populations such as young children 
and expectant mothers. As you know, salmon is widely recognized for its 
health benefits, and many consumers purchase salmon for this reason. 
Allowing a company to sell a genetically engineered product that has 
not been the subject of sufficient long-term testing would undermine 
consumer confidence in all salmon products as well as the health 
benefits of salmon consumption.
Economic Impact on Wild Seafood Industry
    Genetically engineered salmon could also erode the strength of the 
wild seafood industry, especially if appropriate labeling is not 
mandated. For Alaska, the results could be devastating. Alaska's salmon 
industry is critically important to the state's economy, and is the 
primary source of employment and revenue in many of our coastal 
villages. Farmed salmon has already threatened the position of Alaska's 
wild salmon in the seafood market. Alaska salmon, however, regained its 
status thanks to significant investments in infrastructure, product 
quality, and marketing. Marketers focused on distinguishing the health 
benefits and taste properties of Alaska salmon. Studies still show, 
however, that consumers struggle to distinguish seafood in the 
marketplace. Adding genetically engineered salmon to the store shelf 
could further complicate the efforts of consumers seeking healthy, wild 
seafood products.
Lack of Public Participation and Transparency
    In addition, my administration is disturbed by the process employed 
by the FDA to review AquaBounty's application. The environmental and 
public health implications associated with genetically engineered 
salmon and the significance of approving the first genetically modified 
animal for consumption in the United States warrants the highest level 
of public participation and transparency. We do not believe that FDA's 
review process for veterinary drugs allows for a sufficiently public 
and transparent process.
Lack of Genetically Engineered Labeling
    FDA's statements that suggest it may not be able to require 
labeling for AquaBounty's genetically engineered salmon is also 
troubling. The State of Alaska does not support approval of genetically 
engineered salmon for sale. If, despite significant environmental and 
human health concerns, the FDA approves such an application, 
genetically engineered salmon sold in the United States should be 
clearly labeled ``genetically modified,'' so consumers can make an 
informed choice. This label should be prominently displayed on the 
front of the package in a contrasting color, and a minimum print size 
should be required. Alaska statutes require the conspicuous labeling of 
such products sold in the state.
    For the reasons mentioned above, I support legislation to prevent 
the FDA's approval of genetically engineered salmon for human 
consumption and to require appropriate labeling for any genetically 
engineered seafood products.
    I appreciate your consideration of Alaska's position on this 
important issue and respectfully request that this letter be included 
in the hearing record.
            Sincerely,
                                              Sean Parnell,
                                                          Governor.
cc: The Honorable John Rockefeller, Chairman, United States Senate 
Committee on Commerce,Science, and Transportation

The Honorable Kay Bailey Hutchison, Ranking Member, United States 
Senate Committee on Commerce, Science, and Transportation

The Honorable Lisa Murkowski, United States Senate

The Honorable Don Young, United States House of Representatives

The Honorable Cora Campbell, Commissioner, Alaska Department of Fish 
and Game

The Honorable Larry Hartig, Commissioner, Alaska Department of 
Environmental Conservation
                                 ______
                                 
    [Hon. Mark Begich, U.S. Senator from Alaska, requested that the 
following information, submitted by SeafordSource.com, be placed in the 
record. The entire report is available from SeafoodSource.com. or at 
http://www.egeliihracatcilar.com/images/menu11-page/
ABD2011ConsumerSurvey_SScomNEW_00000282.pdf.]
``American Consumers' Finfish-Purchasing Behaviors at the Retail 
        Level''
    This SeafoodSource.com-commissioned survey gauges American 
consumers' finfish-purchasing behaviors at the retail level. In an 
online survey, 400 respondents were asked how often they buy finfish, 
what's preventing them from purchasing more, what finfish species and 
product forms they prefer and where they buy their finfish, among other 
questions. Additionally, dozens of independent variables were analyzed 
to determine what consumers are willing to pay for certain attributes, 
resulting in a ``willingness to pay'' model that seafood professionals 
can use to help them make smarter decisions.
Executive Summary and Key Insights
    More than half of consumers purchase finfish at least once a month 
or more frequently for consumption at home, according to a new 
SeafoodSource.com survey of U.S. consumers who are the primary grocery 
shoppers for their household. But what are they buying? Where are they 
buying it? And what is most important to them when buying finfish?
    By a wide margin, the U.S. consumers surveyed prefer to purchase 
fresh finfish over frozen finfish or prepared finfish entrees, and 
fillets are the most popular product form in both the fresh and frozen 
categories. Furthermore, salmon and tilapia are by far the most 
frequently purchased species of finfish to prepare and enjoy at home. 
When it comes to shopping for finfish, consumers appear to be 
comfortable and confident in familiar channels. The supermarket/grocery 
store is the most popular channel for finfish purchases, and is 
distantly followed by club stores and mass merchandisers. Additionally, 
almost all consumers say they are confident in the safety of the 
finfish that they purchase at these retailers. Although most consumers 
consider themselves familiar with the terms ``aquaculture'' and ``fish 
farming,'' it does not engender strong feelings or reactions from 
consumers. The majority of U.S. consumers surveyed describe themselves 
as neutral, without positive or negative feelings, about purchasing 
seafood produced by a farm.
    When asked what, if anything, is keeping them from buying more 
finfish for home consumption, consumers most often point to the cost, 
saying that ``fish is too expensive.'' However, quite a few consumers 
admit that they or another member of their household simply do not like 
to eat fish. When they are selecting finfish to bring home and prepare 
for themselves, consumers are actively engaged in looking at labels and 
understanding more than just the species and product form. Overall, the 
factors most important to consumers are that the finfish is fresh and 
free of hormones and antibiotics. They also do not favor genetically 
modified (GM) fish, though currently no GM fish is approved for human 
consumption in the United States. Other attributes, such as fish that 
has been produced and processed in the United States and is wild 
caught, are also important. While consumers may indicate that a wide 
range of attributes are very or somewhat important when selecting 
finfish to purchase, in truth consumers are only willing to actually 
pay extra for a few of those attributes, which are unveiled in the 
survey results. It is interesting to note that while there are slight 
differences in fish tastes and preferences due to consumers' geographic 
region or age/generation, there are rarely any significant differences 
in consumers' opinions and preferences about finfish purchases due to 
gender, marital status, education level, income level or household 
size.
                                 ______
                                 
                        Biotechnology Industry Organization
                                                  December 13, 2011
Hon. Jay Rockefeller,
Chairman,
Senate Committee on Commerce, Science, and Transportation,
Washington, DC.

Hon. Mark Begich,
Chairman,
Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard,
Washington, DC.
Hon. Kay Bailey Hutchison,
Ranking Member
Senate Committee on Commerce, Science, and Transportation
Washington, D.C. 20510

Hon. Olympia Snowe,
Ranking Member,
Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard,
Washington, DC.

Dear Senators,

    The Biotechnology Industry Organization (BIO), which is the world's 
largest biotechnology association with over 1,100 members worldwide, 
supports science-based regulation of innovative food and drug 
applications that have the potential to benefit the American people.
    BIO members research, develop, and commercialize technologies to 
help heal, feed, and fuel the world. To ensure the safety and efficacy 
of new biotechnology products, it is essential to have in place 
science-based regulatory oversight, as applied by the U.S. government. 
Well-trained scientists within the Federal agencies are best equipped 
to fairly evaluate food, human, and environmental safety determinations 
associated with product applications.
    BIO is therefore concerned by any attempt by Congress to short-
circuit scientific reviews and urges you to oppose any legislative 
initiative that would restrict the science-based review process for 
genetically engineered fish at the Food and Drug Administration (FDA). 
Such an effort would upend the current scientifically rigorous review 
system and unnecessarily vilify new technologies in the eyes of the 
public.
    The disruption of the FDA's Congressional mandate to base its 
assessments of applications on the best-available science underlying an 
application would devalue all of the research that has gone into this 
area over the years. Such a disruption would also diminish the 
credibility of the FDA approval process at home and overseas. The 
global reputation of FDA's science-based review procedure is based on 
the Agency's objectivity.
    Based on projections for the year 2050, the rapidly growing global 
population will make it necessary to double the annual amount of food 
that is produced as compared to today. The adoption of new agricultural 
technologies, including animal biotechnology, will help to meet the 
challenge of sustainably achieving food security so that hungry people 
get enough to eat. Estimates suggest that as much as 70 percent of the 
required food supply in 2050 must come from new and existing 
technologies, which is why it is essential that FDA scientists are 
permitted to conduct thorough science-based reviews without political 
interference.
    BIO urges the Senate to support science-based regulation of 
innovative food and drug applications and oppose any effort to weaken 
the government's ability to base its assessments on the best-available 
science.
            Sincerely,
                                        James C. Greenwood,
                                                 President and CEO,
                                   Biotechnology Industry Organization.

                                  
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