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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 

( 

(II) 

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

JOHN D. ROCKEFELLER IV, West Virginia, Chairman 

DANIEL K. INOUYE, Hawaii 

JOHN F. KERRY, Massachusetts 

BARBARA BOXER, California 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

FRANK R. LAUTENBERG, New Jersey 

MARK L. PRYOR, Arkansas 

CLAIRE MCCASKILL, Missouri 

AMY KLOBUCHAR, Minnesota 

TOM UDALL, New Mexico 

MARK WARNER, Virginia 

MARK BEGICH, Alaska 

KAY BAILEY HUTCHISON, Texas, Ranking 

OLYMPIA J. SNOWE, Maine 

JIM DEMINT, South Carolina 

JOHN THUNE, South Dakota 

ROGER F. WICKER, Mississippi 

JOHNNY ISAKSON, Georgia 

ROY BLUNT, Missouri 

JOHN BOOZMAN, Arkansas 

PATRICK J. TOOMEY, Pennsylvania 

MARCO RUBIO, Florida 

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 

JOHN F. KERRY, Massachusetts 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

FRANK R. LAUTENBERG, New Jersey 

AMY KLOBUCHAR, Minnesota 

MARK WARNER, Virginia 

OLYMPIA J. SNOWE, Maine, Ranking 

ROGER F. WICKER, Mississippi 

JOHNNY ISAKSON, Georgia 

JOHN BOOZMAN, Arkansas 

MARCO RUBIO, Florida 

KELLY AYOTTE, New Hampshire 

DEAN HELLER, Nevada 

(III) 

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 

(1) 

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. 

2 

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. 

3 

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-andrelease 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 

4 

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. 

5 

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 

6 

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. 

7 

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 conVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00011 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
8 

sequences 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 α-locus) in a specific line of salmon (the EO– 

1α 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–1α) 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 pressureshocked 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. 

9 

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 sexreversed, 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). 

Figure 1. Production plan for AquAdvantage Salmon. 


1215STOT1.eps
10 

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-ofaction, 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 

11 

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 freVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00015 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
12 

quency 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 

13 

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 drawdown 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 growout (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 

14 

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 water Collar-sleeve screens inserted into top of standpipes to prevent 

fish 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 fry tanks by 

The building is covered and sealed by netting 

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 

grow-out tanks via water 

A 1 cm thick, rigid PVC slotted drain plate affixed by screws to 

the 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 

grow-out tanks by avian predators 

Each tank is entirely covered by netting stretched over and 

around the tank on a rigid support structure 

Netting stretched taut over the top of each tank 

Secondary containment 

To prevent escape from 

fry tanks into drains 

Sock filter (500 μm) on the terminal end of the only drain pipe 

receiving effluent from the fry tanks 

To prevent escape from 

grow-out tanks into drains 

Sealed metal cage (affixed to ground) through which all effluent 

from grow-out tanks must pass before entering drain canal 

To prevent escaped fish from passing 

through the drain canal to the 

sedimentation ponds 

Concrete structure and containment sump through which all 

water must pass 

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 

the river from the drain canal 

Four sedimentation ponds in series, each with its own outlet 

screen 

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 

entering the fish rearing area 

A narrow pedestrian bridge crosses the river, with access controlled 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 

15 

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

Facility 

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 growout 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 


1215STOT2.eps
16 

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. 

Point Elev 

(m) 

Temp (°C) 

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 wellheads, back-up generators, liquid oxygen containment, and the storage facility. 

A service entry adjacent to the storage building remains secured by a doubleswing, 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 firstfloor 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. 

17 

• 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 

unit or incubator water overflow 

Screens on stand pipes, top and bottom (where 

appropriate for size of fish to be contained) 

Incubator tray screens 

Screened tank overflows 

Cover nets 

To prevent escape over the side of 

a tank or incubator 

Jump fences 

Tank covers 

Incubator tray screens 

Chemically lethal environment (chlorine puck) in 

To prevent downstream passage spawning area drain 

of newly fertilized eggs 

and/or gametes 

Perforated metal drain cover in spawning area 

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 

of fish within the drains 

Double screens within the sump 

Mesh filter on drum-filter gray water 

Heat exchanger 

18 

Table 3.—Key Components of Physical Containment at the Production Facility—Continued 

Purpose Feature or Component 

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 

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 physicochemical measures (e.g., chlorine) and environmental tolerances (e.g., temperature). 


1215STOT3.eps
19 

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) 

Recommended element 

Use at Production & Grow-Out Sites 

PEI Egg Production Panama Grow-Out 

Commitment by top management ✓ ✓ 

Written plan for implementing backup measures in 

case of failure, including documentation, monitoring, 

and remediation 

✓ ✓ 

Training of employees ✓ ✓ 

Dedication of permanent staff to maintain 

continuity 

✓ ✓ 

Use of standard operating procedures for 

implementing redundant confinement measures 

✓ ✓ 

Periodic audits by an independent agency ✓ ✓ 

Periodic internal review and adjustment to allow 

adaptive modifications 

✓ ✓ 

Reporting to an appropriate regulatory body ✓ ✓ 

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 

20 

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 nontransgenic 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 nontransgenic 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 fastgrowing 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). 

21 

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; Sundstro ̈m 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 

22 

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, 

parasites or predation 

Reduced disease resistance 

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-deploylayout_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 

23 

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 selfsustaining 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 barVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00027 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
24 

riers 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 

cultivation 

Transgenic organisms able to spread and 

maintain self-sustaining populations 

could disrupt biotic communities & 

ecosystems, leading to a loss of biological 

diversity. 

AAS are all sterile females unable to 

reproduce; a self-sustaining population 

cannot be established. 

NO SIGNIFICANT RISK. 

Interbreeding 

with related taxa 

Incorporation of transgenes could result 

in greater invasiveness or loss of 

biodiversity, depending on particular 

transgenic trait and gene flow from 

generation to generation. 

AAS are all sterile females unable to 

breed with wild Atlantic salmon or 

related taxa. 

NO SIGNIFICANT RISK. 

Horizontal gene 

flow 

Non-sexual gene transfer is common in 

some microbes but rare in plants & 

animals; ecological consequence would 

depend on particular transgenic trait and 

gene flow. 

Integrated transgene in AAS is incapable 

of being passed thru non-sexual means. 

NO SIGNIFICANT RISK. 

Change in viral 

disease 

In virus-resistant transgenic organisms, 

genetic recombination could lead to 

increased virulence of viral disease and 

undesirable effects on natural hosts. 

rDNA construct used for AAS had no 

viral component; this type of 

recombination is not possible. 

NO SIGNIFICANT RISK. 

Non-target & 

indirect effects 

Loss of biodiversity, altered community 

or ecosystem function, reduced biological 

pest control, reduced pollination, and 

altered soil carbon and nitrogen cycling. 

AAS escape minimized by redundant 

containment; low probability of 

establishment due to poor fitness and 

reproductive incapacity; likelihood of 

further spread is nil. 

NO SIGNIFICANT RISK. 

25 

Table 6.—Risk of Environmental Impact of GE Organisms*—Continued 

Process Potential Ecological Consequence Risk Associated with AAS 

Evolution of 

resistance 

Pesticide resistance leading to greater 

reliance on damaging chemicals or other 

controls for insects, weeds, and other 

pests. 

Not applicable for fish. 

NO SIGNIFICANT RISK. 

*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. 

29 

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 

30 

1The 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 peerhas 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 othVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00034 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
31 

reviewed journals by numerous research groups, including my own, as well as a number of reviews by the National Academy of Sciences. 

ers 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. 

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 

32 

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. 

33 

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? 

34 

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 

35 

1Smith, M.D., Asche, F., Guttormsen, A. G., J. B. Wiener. 2010. Genetically Modified Salmon 

and Full Impact Assessment. Science 330:1052–1053. 2FAO 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. 4Ford 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. 5http://www.montereybayaquarium.org/cr/seafoodwatch.aspx. 

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. 

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. 

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 

36 

6 Coates, P. A. 2006. Salmon. Reaktion Books Ltd. London. 216 pp. 

7Devlin, 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. 9Devlin, 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. 10Muir, 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. 11Sundstro ̈m, 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. 12McGinnity, 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. Maoile ́idigh, 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. 13McGinnity, 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 

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? 

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

37 

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. Maoile ́idigh, 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. 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. 15De 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. 16Fleming, 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. 18Sundstro ̈m, L. F., M. Lo ̈hmus, 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. 19Muir, 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. 20Muir, 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. 

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

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. 

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 

38 

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. 22Moreau, 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. 23McGinnity, P., P. Prodohl, A. Ferguson, R. Hynes, N. Maoile ́idigh, 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. 24Kapuscinski, 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. 25http://www.nwr.noaa.gov/marine-mammals/whales-dolphins-porpoise/killer-whales/esastatus/. 

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

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

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. 

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 

39 

26http://www.defenders.org/wildlifelandlhabitat/wildlife/belugalwhale.php; http://www 

.biologicaldiversity.org/species/mammals/CooklInletlbelugalwhale/index.html. 27 Hocking, M. D., and J. D. Reynolds. 2011. Impacts of salmon on riparian plant diversity. 

Science. 331:1609–1612. 28Gende, S. M., Edwards, R. T., Willson, M. F., and M. S. Wipfli. 2002. Pacific salmon in 

aquatic and terrestrial ecosystems. BioScience 52:917–928. 29Pimental, 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. 30Davis, M.A. 2009. Invasion Biology. Oxford University Press. Oxford, UK. 243 pp. 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. 

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. 

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

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. 

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

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 

40 

33Keller B. C. and R. M. Leslie. 1996. Sea-silver: Inside British Columbia’s salmon farming 

industry. Horsdal and Shubart Publishers Ltd., Victoria. . 34 Volpe, John. 2001. Super un-Natural: Atlantic salmon in BC waters. David Suzuki Foundation. 31 pp. 35 Ibid. 36 Ibid. 

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. 

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. 

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

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 aquaculturereared 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. 

Nile tilapia 

Today, tilapia is likely the world’s most widely distributed non-indigenous 

ﬁsh species—having invaded every tropical and subtropical environment to 

41 

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. 40FAO (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. <http://www.issg 

.org/database/species/ecology.asp?si=813&fr=1&sts=sss.> 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. 43 ‘‘Oreochromis niloticus Factsheet.’’ United States Geological Survey. 9 Dec. 2011. <http:// 

nas.er.usgs.gov/queries/factsheet.aspx?SpeciesID=468>. 44 Ibid. 45McDonald, 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. 46Schofield, 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. 47McDonald, 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. 48Peterson, 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. 

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

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

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. 

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, 

42 

49See Myths, Dangers, U.S. Failures: The Truth About Asian Carp, 6 Part Series, Detroit 

Free Press (July 20, 2011). 50See, 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). 51 Injurious Wildlife Species: Silver Carp and Largescale Silver Carp, Federal Register: July 

10, 2007 (volume 72, number 131). 52http://www.startribune.com/local/135259173.html?page=1&c=y. 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). 54Kelso, Dennis Doyle Takahashi. ‘‘Genetically Engineered Salmon, Ecological Risk, and Environmental Policy.’’ Bulletin of Marine Science 74, no. 3 (2004): 509–28. 55Kapuscinski, Anne R. and Eric M. Hallerman, ‘‘Transgenic Fish and Public Policy: Anticipating Environmental Impacts of Transgenic Fish,’’ Fisheries 12 (1990), p. 3. 

more wholesome form of biological control than that provided by traditional chemical treatments.49

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

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

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 nonengineered 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. 

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

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 

43 

56 21 U.S.C. §§ 301–399a. 57The New Animal Drug Application (NADA) process, as required pursuant to 21 U.S.C. 

§ 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). 58See, e.g., 21 C.F.R. § 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. § 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. 59FDA 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. 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. 

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. 

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. 

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 farreaching 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. 

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 

44 

61Letter to Commissioner Margaret Hamburg, Commissioner of Food and Drugs, FDA (Sept. 

28, 2010). 62 Burgman, M. 2005. Risks and Decisions for Conservation and Environmental Management. 

Cambridge University Press. Cambridge, UK. 488 pp. 63Kapuscinski, 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. 

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. 

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. 

45 

64Kapuscinski, Anne. Professor of Sustainability Science, Dartmouth College, Hanover, NH. 

Personal communication, December 10, 2011. 

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. 

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. 

46 

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. 

47 

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 

48 

1www.fourfish.org and http://www.nytimes.com/2010/08/01/books/review/Sifton-t.html?pag 

ewanted=all. 2Popper, 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. 

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

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 

49 

7Modern Genetics: engineering life, Lisa Yount, Chelsea House, 1997, p. 20. 

8 Ye, X; Al-Babili, S; Klo ̈ti, 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. 9http://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. 11http://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.’’ 

AndyW@mcdowellgroup.net. 13Lichatowich, 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. 15This 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. 16 Naylor, Rosamond L. et al., ‘‘Feeding aquaculture in an era of finite resources’’, Proceedings 

of the National Academy of Sciences, 2009. 

was created by humans 7. We will not know the full environmental impact of their 

introduction into the food supply, for many, many years. 

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. 

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, feedefficient, 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. 

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 

50 

17 Environmental Assessment for AquAdvantage® Salmon, Aqua Bounty Technologies, August 

25, 2010, Page 36. 18Frederick T. Barrows, USDA Lead Scientist and Nutritionist USDA, Agricultural Research 

Service Rick.Barrows@ARS.USDA.GOV. 19 Aqua Bounty Press Room, http://www.aquabounty.com/PressRoom/#l3. 20Monterey Bay Aquarium, ‘‘Farmed Salmon’’ Seafood Watch Report, Mazure, Robert and Elliot, Matthew http://www.montereybayaquarium.org/cr/crlseafoodwatch/content/media/MBA 

lSeafoodWatchlFarmedSalmonReport.pdf Page 2. 21 Artic Char Assessment, Blue Ocean Institute, http://www.blueocean.org/seafood/seafoodview?spclid=94. 22Sweet Spring http://www.sweetspringsalmon.com/local.shtml and e-mail (October 19, 2011) 

with Per Heggelund, Director, SweetSpring per@sweetspringsalmon.com. 23 Nichols, Scott, Director of Verlasso, e-mail December 13, 2011 scott@Verlasso.com. 

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. 

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? 

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 finescale 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 enVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00054 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
51 

24http://online.wsj.com/community/groups/question-day-229/topics/would-you-eat-genetically-modified-salmon?commentid=1603615. 25Wall Street Journal, February 22, 2011 http://online.wsj.com/article/SB1000142405274 

8704476604576158230363494712.html. 26The 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. 

gineered 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

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. 

52 

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. 

53 

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? 

54 

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 

55 

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. 

56 

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 

57 

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. 

58 

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. 

59 

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. 

60 

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. 

61 

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 

62 

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. 

63 

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. 

64 

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. 

65 

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. 

66 

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 

67 

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. 

68 

This meeting is adjourned. 

[Whereupon, at 12:24 p.m., the hearing was adjourned.] 

(69) 

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 precedentsetting, 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. 

70 

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 nonnative 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 firstfeeding 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 feVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00074 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
71 

male 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. 

72 

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. 

73 

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? 

74 

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 

75 

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? 

76 

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. 

77 

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 fouryear-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 

78 

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. 

79 

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 methVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00083 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
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1http://www.fao.org/DOCREP/003/AB412E/ab412e23.htm; http://aquaculture.noaa.gov/pd 

f/econ/econlrptlall.pdf. 2http://www.montereybayaquarium.org/cr/seafoodwatch.aspx. 3https://www.was.org/WasMeetings/meetings/Default.aspx?code=AA2012. 4http://www.thebetterfish.com/home. 5http://www.sweetspringsalmon.com/local.shtml. 

ods 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. 

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 sysVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00084 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
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6http://kampachifarm.com/. 7Smith, M.D., Asche, F., Guttormsen, A. G., J. B. Wiener. 2010. Genetically Modified Salmon 

and Full Impact Assessment. Science 330:1052–1053. 8http://www.workingwaterfront.com/articles/Wild-to-Transgenic-Salmon-in-Maine/14105/. 

tems, 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. 

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. 

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

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 raVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00085 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
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9Kelso, Dennis Doyle Takahashi. ‘‘Genetically Engineered Salmon, Ecological Risk, and Environmental Policy.’’ Bulletin of Marine Science 74, no. 3 (2004): 509–28. 10Kapuscinski, Anne R. and Eric M. Hallerman, ‘‘Transgenic Fish and Public Policy: Anticipating Environmental Impacts of Transgenic Fish,’’ Fisheries 12 (1990), p. 3, 5. 

tionally 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 nonengineered 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

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 

83 

11FDA 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. 12Letter to Commissioner Margaret Hamburg, Commissioner of Food and Drugs, FDA (Sept. 

28, 2010). 

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. 

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. 

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. 

84 

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-theground 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. 

85 

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 

86 

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 caseby-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. 

87 

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 

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keters 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/ABD2011ConsumerSurveylSScomNEWl00000282.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 entre ́es, and fillets are the most popular prodVerDate Nov 24 2008 11:19 Jan 18, 2013 Jkt 075679 PO 00000 Frm 00092 Fmt 6601 Sfmt 6621 S:\GPO\DOCS\78022.TXT JACKIE
89 

uct 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. 

90 

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. 

Æ