[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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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.
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\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.
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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.
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\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\
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\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.
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\30\ Davis, M.A. 2009. Invasion Biology. Oxford University Press.
Oxford, UK. 243 pp.
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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\
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\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.
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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.
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\33\ Keller B. C. and R. M. Leslie. 1996. Sea-silver: Inside
British Columbia's salmon farming industry. Horsdal and Shubart
Publishers Ltd., Victoria. .
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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.
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\34\ Volpe, John. 2001. Super un-Natural: Atlantic salmon in BC
waters. David Suzuki Foundation. 31 pp.
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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\
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\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.
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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\
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\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.
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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.
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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\
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\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.
---------------------------------------------------------------------------
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.
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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.
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\4\ http://www.thebetterfish.com/home.
\5\ http://www.sweetspringsalmon.com/local.shtml.
\6\ http://kampachifarm.com/.
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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.
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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.
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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.