Genetically Engineered Fast-Growing Hype

A Briefing Paper published by The Development Fund, Norway

Genetically Engineered Salmon - Fast-Growing Hype Written by: Food & Water Europe Foreword by The Development Fund Food & Water Europe monitors the practices of multinational corporations Imagine a fish growing twice as fast with less use of feed and with less environmental that impact our food and water. They impact! It would be just what is needed to feed the world. Or is reality somewhat work with grasroots organizations more complicated? The genetically engineered salmon from the American around the world to create a genuinely company AquaBounty is a textbook example of the typical hype surrounding economically and environmentally genetically modified organisms (GMOs). This briefing paper provides the simple viable future. facts about this fish, which demonstrates serious risks to consumer health, animal welfare, fishing economies and the environment. Even the claim about growth Citation: rates is questionable. 3 The Development Fund (2013): The AquaBounty salmon was the very first animal to be patented in Norway, after Genetically Engineered Salmon – Fast the patenting of plants and animals was first legalized in 2004. The Development Growing Hype. Briefing paper. Fund fights patents on plants and animals because they threaten food security. It is illegal to do further breeding using patented material. Patents are thus blocking www.utviklingsfondet.no the cumulative process breeding actually is. Furthermore, it is also illegal to do independent biosafety research on patented material. The briefing paper is financed by Norad and Rather than a technological quick fix in order to meet the challenge of global the Norwegian Network hunger, there is a need to increase investment in sustainable agroecological for GMO-free food and agriculture, where the needs and priorities of small scale food providers are put in feed. the driving seat. No GMO can replace the need for robust systems for continuous plant and animal breeding. Thus, the sustainable use and conservation of genetic ISBN 978-82-91923-49-9 (Printed edition) resources for food and agriculture is a pivotal precondition for future food ISBN 978-82-91923-50-5 (Digital edition) security. GMOs, such as the AquaBounty salmon, put this at risk.

This paper focuses on the regulatory processes of AquaBounty Salmon in North America. The company has yet not applied for approval in the EU and Norway, where different regulatory regimes are in place, e.g. if a GMO is approved in Europe, it must be labeled. The terms genetically engineered (GE) and genetically modified (GM) are used interchangeably in this report.

This paper is part of the information campaign by the Norwegian Network for GMO-free food and feed financed by the Ministry of Food and Agriculture in 2012. A special thanks to the author of this report, Tim Schwab, for great collaboration and impressive delivery in meeting our tight deadline.

Oslo, January 2013

The Development Fund is registered Andrew P. Kroglund Bell Batta Torheim with the Control Committee for Head of Policy and Information advisor Fundraising in Norway. Department Introduction scientists to review AquaBounty’s application rather than those The U.S. Food and Drug Administration (FDA) has indicated with a background in human nutrition, environmental science, 9 that it is nearing regulatory approval of genetically engineered or food science. (GE) salmon, which would be the first GE animal allowed into the food supply—anywhere in the world.1 AquaBounty Technologies, the creator of GE salmon, boasts that the fish’s The Science behind GE salmon fast growth rate will increase food production, feed the world’s The FDA is basing its regulatory decision on scientific studies hungry, reduce ecological pressure on wild salmon harvests, provided by AquaBounty, not independent science conducted create jobs and diminish the carbon footprint of producing by disinterested scientists. Not surprisingly, the data supplied seafood.2 However, the available science does not support by Aquabounty is biased, flawed, misleading and incomplete. these claims. Beyond GE salmon’s uninspiring growth rates, Though rife with major errors, the data still suggests serious the fish also demonstrates serious risks to consumer health, problems with the health and safety of GE salmon. animal welfare, fishing economies and the environment. In addition, GE salmon may diminish the nutrition and taste of the fish, which is one of the most popular and important «Not surprisingly, the data fish in many Western diets.3 Unfortunately, the FDA’s weak regulatory approach has failed to examine both the false supplied by Aquabounty is promises and clear risks of AquaBounty’s GE salmon, leaving biased, flawed misleading and consumers unprotected. incomplete.» Regulating AquAdvantage Salmon Independent scientists invited by the FDA to review the AquAdvantage salmon is the trade name of AquaBounty’s GE data called the overall data analysis lacking in rigor and , which contains genetic material from an eel- poorly designed,10 noted the insufficiently small sample sizes like fish and a , designed to make the fish grow throughout the risk assessment,11 highlighted the potential bias faster.4 The company plans to produce salmon eggs at its facility in several of the studies,12 and criticized the agency’s failure in Prince Edward Island, Canada, then fly them to a facility in to fully investigate the insertion process.13 One invited 4 Panama for grow-out, then ship the final food product to the member—the only scientist with a background in United States for consumption.5 (most of the members were large-mammal experts)—outright called for an entirely new and more rigorous risk-assessment by the FDA, called an Environmental Impact Statement.14 «The risky nature of GE salmon Scientists have been especially critical of the small sample sizes combined with a lack of oversight used by AquaBounty—often only six or seven GE fish were greatly increases the likelihood of used in comparisons.15 These small sample sizes meant that subsequent data analyses by the FDA did not find “statistically environmentally destructive GE significant” differences between GE salmon and non-GE salmon escapes.» salmon, even when GE salmon, for example, manifested 40 percent higher levels of a hormone linked to cancer in humans.16 The FDA, rather than insisting that AquaBounty re-conduct the studies using appropriate sample sizes, accepted AquaBounty’s AquaBounty’s elaborate production plan—involving shipping data and made far-reaching conclusions that there “are no food salmon from Canada to Panama to the United States—is consumption risks” associated with GE salmon.17 designed, essentially, as a demonstration project for FDA 6 approval. Once approved, AquaBounty intends to sell eggs to Major deficiencies in the FDA’s risk assessment—including 7 third parties for their own production. GE salmon will likely gaps in data, missing studies, lack of transparency, dependence be grown in countries where regulatory oversight is weak on industry-produced data and inconsistent regulatory and where the FDA will not have the resources or capacity to coordination—have been highlighted in the scientific and legal monitor. The risky nature of GE salmon combined with a lack community.18 of oversight greatly increases the likelihood of environmentally destructive GE salmon escapes. Human Health Issues The FDA regulatory process is also severely weakened by The limited data that the FDA has released about the food safety the agency’s decision to regulate GE animals as a veterinary 8 and nutritional value of GE salmon show troubling results. GE drug rather than a food, treating the new gene constructs as a salmon exhibited 40 percent higher levels of a hormone called veterinary drug. This regulatory approach severely limits the insulin-like growth factor-1, which has been shown to increase scope of the agency’s risk-assessment on issues like food safety the risk of certain cancers.19 Also troublingly, the fish exhibited and allergies. For example, the agency has not conducted a as much as 52 percent higher levels of “allergenic potency,” single feeding study to assess health risks associated with eating which indicates possible allergic reactions from consumers.20 GE salmon. Moreover, the FDA largely depended on veterinary This is especially relevant in light of evidence that other GE

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Ohno, Misako, Ohtani, Seiji, and Higaki, Kazutaka. researchers physically examined salmon for health problems, «GE salmon exhibited 5 they selectively killed off irregular fish, biasing the data set and percent less protein but 58 severely compromising the integrity of the data.27 The FDA acknowledged this major scientific error, 28 but never indicated percent greater total fat content that it would require AquaBounty to submit additional studies. compared to non-GE salmon.» The agency concluded it would address this serious issue through “post-approval safety surveillance”29—a dangerous wait-and-see attitude that will allow the fish to go to the marketplace before foods pose novel allergy risks to consumers. A New England the FDA has made a scientific determination about the safety of Journal of Medicine study found that soybeans engineered with the fish. This post-market regulatory approach also appears to Brazil nut proteins caused allergic reactions for consumers treat consumers as guinea pigs. with Brazil nut allergies.21 Another study found that a harmless protein found in certain beans, which acts as a pest deterrent, 5 became dangerous once it was transferred to a pea, causing Escape and Environment allergy-related lung damage and skin problems in mice.22 When GE salmon escape from commercial facilities, their impact on wild salmon and biodiversity could be significant. On nutrition, an independent study found that traditional non- Because fish move freely through bodies of water, escapees are GE salmon contain 14 percent higher rates of beneficial omega 23 essentially impossible to capture. This is especially the case for fats. In a compositional analysis submitted to the FDA by salmon, which spends part of its life in saltwater and part in AquaBounty, GE salmon exhibited 5 percent less protein but 58 freshwater. percent greater total fat content compared to non-GE salmon.24 GE salmon also exhibits large differences in vitamin, mineral Unfortunately, the FDA risk assessment scarcely examined and amino acid levels compared to non-GE salmon, which the the environmental problems associated with GE salmon. The FDA did not rigorously investigate.25 agency has very little scientific expertise related to fisheries or environmental science and has failed to adequately and consistently consult with other government agencies with the Animal Welfare necessary expertise.30 Dartmouth University Professor Anne Not only does GE salmon potentially pose a threat to human Kapucinski, a renown expert on environmental issues related to health, but it may also pose a threat to the health of the modified biotech fish, has noted major deficiencies in FDA’s environmental Atlantic salmon. Data submitted by AquaBounty shows that review, citing three missing analyses: an uncertainty analysis, a GE salmon suffered high rates of malformations and health quantitative failure-mode analysis and an analysis of the possible problems, like jaw erosions and inflammation, which were not environmental impacts.31 observed in non-GE salmon.26 Though the FDA did a cursory examination of the likelihood of GE salmon escaping, the agency did not examine the environmental consequences if salmon do escape. Many of «GE salmon suffered high rates Kapucinski’s criticisms were echoed by the senior scientists of malformations and health at the United States Fish and Wildlife Service (a government agency) who have expressed grave concerns with the problems» environmental implications of GE salmon.32 These scientists called FDA’s risk assessment “overly simplistic” and express having been excluded from the regulatory process, even though the FDA is required by law to consult with the agency.33 This A more complete understanding of animal welfare issues is again casts doubt on how competently the FDA has conducted not possible, however, because of major scientific errors and its regulatory review. bias in AquaBounty’s data collection. Before AquaBounty

212625242322 FDAYoung,Nordlee, Briefing E. J. “GEet al. Packetpea “Identification causes at TableTables allergic 6 22-24.2128. andof damageand a pageBrazil-Nut 28. 41. inComparisons mice.” Allergen New inScientist.made Transgenic to independent November Soybeans.” science21, 2005.The where New available England (omegas).Journal of Medicine. March 14, 1996. 333231pdf30292827 U.SFoodJoeFDA Palca.Senate Briefing& Water “DebatingSubcommittee Watch.Packet Genetically at Records 60.33.26, on 33. Oceans, received Modified Atmosphere, through Salmon.” the Fisheries, Freedom National and of Public InformationCoast RadioGuard Science Act.Oversight LetterSee Friday. summary fromHearing December Fish of on documentsand the Wildlife 9,Environmental 2011. at Service . RisksConservation of Genetically Engineered Community Fish.” of DecemberPractice to 15, unspecified 2011. Comments recipients. from October Olympia 6, Snowe,2010. Mark Begich, John, Epifanio and George Leonard. Recording available online; Food & Water Watch. Emails retrieved from the Fish and Wildlife Services Freedom of Information Act Request. Summary available at http://documents.foodandwaterwatch.org/doc/FOIA-FWW-GEsalmon-letter-FDA. Also disconcerting, a news report in 2012 reported that in 2010 criticized the agency’s failure to assess GE salmon’s AquaBounty may have already experienced an escape event of disease resistance, and it is unclear why the FDA did not inform GE salmon at their experimental facility in Panama. A storm these scientists or the public about the ISAV outbreak at that in 2008 caused a tree to fall on the facility, which caused a time, waiting two years to disclose this information.43 Just mechanical failure, which resulted in all GE salmon being as the agency has failed to meaningfully address the weather “lost,” according to the company.34 The FDA never publicly and natural disaster issues surrounding AquaBounty’s “lost” acknowledged the existence of this major event, and has salmon, so, too, has the agency failed to examine the critical failed to publicly verify AquaBounty’s claim in 2012 that the issue of disease resistance in GE salmon.44 “lost” GE salmon actually suffocated rather than escaped.35 AquaBounty’s Panamanian facility is located in an area that Lacking an understanding of disease resistance of GE salmon routinely experiences severe weather and major flooding, means the FDA cannot assess the volume of that suggesting the possibility of future natural disasters and more AquaBounty may use to commercially produce GE salmon. The “lost” salmon.36 over-application of antibiotics in animal agriculture has caused widespread resistance that are of major concern to public health. «Once GE salmon escape, they Sterility and Containment could out-compete wild salmon Acknowledging the threat of escape, AquaBounty has for food and even mates, quickly attempted to render GE salmon sterile, which would prevent driving down wild populations.» sexual reproduction in the event they are released into the wild. However, the company’s regulatory submissions indicate that up to five percent of GE salmon will not be sterile.45 If millions of GE salmon eggs are going to end up in commercial production, Moreover, AquaBounty intends to sell GE salmon eggs to third as industry cheerleaders contend,46 this would mean hundreds parties for commercial production,37 which may produce the of thousands of fertile GE salmon eggs will likely be production. fish in a variety of models, including the dominant industrial As the company acknowledges, “No single containment measure 47 6 model of open-water net-pen . The FDA, whose can be assured of 100% effectiveness.” job it is to oversee future production, does not have the resources to comprehensively evaluate, audit or review the Adding more doubt to AquaBounty’s sterilization plan, in 2011 the USDA awarded the company a controversial $494,000 grant dozens or hundreds of new GE salmon facilities that may enter 48 production. This lack of oversight creates additional likelihood to improve its sterilization procedures for GE fish. When asked of escape. An estimated 2 million farmed salmon escape into at a U.S. Senate hearing whether this grant was an indication North Atlantic waters every year while millions of others escape the current ineffectiveness of AquaBounty’s current sterilization into the Pacific.38 process, the company’s president said the grant will be used for “next generation” of fish sterilization, which will strive for 100 Once GE salmon escape, they could out-compete wild salmon percent sterilization.49 for food and even mates, quickly driving down wild populations. A 2011 study of GE salmon mimicked an escape event and AquaBounty also has created a physical containment plan to 39 prevent escape, claiming that the salmon will be grown in closed, found that GE salmon would survive if released in the wild. 50 Even if salmon fail to survive or reproduce in the wild, their in-land facilities like the facility it has in Panama. However, most short-term presence could have myriad and insidious impacts commercially raised salmon are grown in big nets in open water, on native fish populations and a variety of marine life, which the notorious for salmon escapes. The company’s largest investor, the FDA did not examine.40 biotech company Intrexon, has cited the potential of the company to contribute to “large-scale” and “global” aquaculture,51 which An additional concern about escaping GE salmon is the would seem to translate to the dominant industrial model of net- disease they could spread to wild populations. Farmed salmon pen aquaculture, which is prone to escapes. More than 330,000 currently in production, which are raised in stressful, densely salmon escaped from a large-scale sea-cage salmon farm in crowded environments, have already been linked to the spread Scotland in a single event in 2011 because of bad weather.52 of disease, like infectious hematopoictic necrosis, sea lice and furunculosis.41 In 2009, AquaBounty’s Canadian facility tested Even if GE salmon are grown in closed, in-land facilities, positive for the lethal infectious salmon anemia virus (ISAV), as AquaBounty promises, they could easily escape. Because which ravaged the company’s fish stocks, leading the company fish eggs are miniscule in size, they would be easy to steal, 42 by employees or intruders, a concern raised to the FDA by to completely depopulate entire parts of the facility. The 53 company’s struggles to contain this major outbreak, which independent scientists. Likewise, mechanical failure—due appears to have happened only 12 months after AquaBounty’s to things like power outages during storms—could result in “lost” salmon in Panama, again calls into question competently escapes from closed facilities. Both of AquaBounty’s facilities, in Canada and Panama, are located close to bodies of water that the company can manage the many biosafety measures needed 54 to raise GE salmon in a safe manner. could support escaped GE salmon.

Scientists invited by the FDA to review AquaBounty’s data A biotech operation doing experimental work in New Zealand

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GE salmon’s purported growth rates has failed to impress the Consumer Opposition farmed-salmon industry, where commercial growers have Hundreds of thousands of consumers in the United States have used (non-GE) techniques for decades to formally objected to FDA’s review of GE salmon, submitting develop fast-growing salmon that can grow as fast or faster than comments that criticize the agency’s regulatory process, express AquaBounty purports GE salmon can grow.60 Norwegian grower concern over the safety of the salmon as a food, and insist that Salmobreed issued a press release showing that its own salmon the fish be labeled.66 These comments are bolstered by several grow as fast or faster than GE salmon purports to grow.61 A senior consumer surveys, which have revealed overwhelming opposition scientist at Norway’s NOFIMA institute has called AquaBounty’s to the approval of GE salmon. A Reuters survey found that almost growth rates misleading.62 Marine Harvest and Cermaq, both in two-thirds (65 percent) of consumers would not eat GE fish and Norway, which together produce 65 percent of the world supply 93 percent of consumers want it labeled.67 This mirrors the results of salmon, have also expressed opposition to GE salmon.63 of a poll commissioned by Food & Water Watch, which found that 78 percent of consumers oppose GE salmon.68 Even an online poll from the conservative Wall Street Journal found that 7 No increased growth in GE salmon 60 percent of its readers would not eat GE salmon.69

Loudly, clearly and consistently, consumers have voiced their opinion that they see GE salmon as a fish with potential food safety and environmental risks, which deserves better regulation and mandatory labeling if the FDA does approve it.

And How Does it Taste? Completely absent from the FDA’s review of GE salmon is an analysis of its consumer and industry desirability— its taste, smell, texture, quality and costs of production. The commercial success of meat products, including salmon, depend on their having marketable characteristics associated with taste, smell and texture.70 Given the large differences in the fat, protein and nutritional content of GE salmon, it is unclear why the FDA did not examine such characteristics.

Salmonbreed growth curves vs. Aquabounty’s Lobbying and Political Influence As AquaBounty’s poor data has inspired many critics, the company’s false promises have also inspired several angel investors. The synthetic company, Intrexon, acquired a close to half of the company’s stock in November 2012.71 Intrexon is run by the former CEOs of and Pfizer,72 and the company’s vice-president is a 20-year veteran from Monsanto who worked on the company’s highly controversial biotech product recombinant bovine growth hormone (rBGH).73

Intrexon bought all of the shares controlled by Kahka Bendukidze,74 a former economics minister from the Republic of Georgia who made his fortunes in Russia and who today maintains several SalmoBreed is questioning the growth curves used by investments in and aquaculture.75 Bendukidze AquaBounty. Source: SalmoBreed newsletter november 2011

556362605958575661 Gibbs,Salmobreed.Thodesen,Gurian-Sherman, Pollock,FoodDeBiotechnology Boni, & Walter. WaterAndrew. Dita. Jorn “Salmobreed Watch “Europe“’Frankenfish’Industry and Doug.“Genetically TrygveFreedom scorns Organization. Union challenges Gjedrem. ‘supersalmon’AlteredofProgramme of Information Concerned GMO Salmon“Breeding “Increasing salmon.”Canned.” as Act Scientists.Get GM programs request Closercrop battle NovemberNew yield“Failure yieldedwides.”to Zealandon the andAtlantic Table2011. to nocommercializingReutersReuters. Yield.”Herald. documents.” salmon New. AprilAprilFeb-ruary York in 22,2009 over TimesNorway—Lessons cellulosic2011. aat25, five .2-5. June2000. biofuelsmonth 25, 2010. learned.”period are key on tothisDevelopment meeting question. demand of Aquatic for feed, Animal fiber Geneticand transportation Improvement fuels.” and JuneDissemnation 12, 2008; Programs:Gurian-Sherman, Current Doug.Status andUnion Action of Concerned Plans. At Scientists.22; “Salmon “Failure egg producer to Yield.” questions April 2009 AquaBounty’s at 1. claims.” Intrafish. November 1, 2011; Personal Correspondence with Marine Harvest. 6968676665Action70647574737271 Plans. At 22. LakeThomsonCenter Ashton,WallPollock,AquaBountyIntrexon.FDAResponse StreetTranscriptResearch for ThomasAndrew. “Company.” givenReuters.FoodJournal Technologies, Partners. atbySafety. et “An 119-120; Question John al.“National entrepreneurAvailable “NovelPress Buchanan, “Attitudes Inc. Cook,of Release. Survey theTensile “Updateat“Update Intrexon. Day.J.T.and formerbankrolls Toward “Coalition“GrowthofTest on on“Would onHealthcare file. lead Change ChangeMethod“Company.” athe geneticallyrate,researcher youAccessedreveals FDA’s to in in body eat Consumers: ShareholdingAssessShareholding immensegeneticallyPlan Available compositionengineeredNovemberfor Texture onAquaBounty Genetically opposition Geneticallyat –modified and and 7,and andsalmon.” and2012. ProposedProposed onGaping Technologies,feed file.Engineeredto EngineeredNew salmon Transgenic digestibility/conversionin Offer.” Offer.” AccessedSalmonYork if Timesapproved to Fish.” Fish, Food.”NovemberaNovemberFillets.” Novemberpublic. MayDemandsSeptember Octoberby Journal question 21,the16, 16,7, of 2012.2012.FDA?”2012. Mandatorygrowth-enhancedof 1-13, 20, Foodat andthe 2010. 2010.Undated Science Secondon Labeling.” file. . but AnnualJanuary transgenic Accessedrelated November BARC-UMD2010 to NovemberAtlantica atSeptember Introduction. 18, 2010.salmon Fall7, 2012. Symposium.21, (2010Salmo article. salar October ).”Available Aquaculture 18, 2012.at and. July on 14,file. 1999 at Methods; “Salmon egg producer questions AquaBounty’s claims.” Intrafish. November 1, 2011; Thodesen, Jorn and Trygve Gjedrem. “Breeding programs on Atlantic salmon in Norway—Lessons learned.” Development of Aquatic Animal Genetic Improvement and Dissemnation Programs: Current Status and injected a million dollars into AquaBounty in 2011 to keep the Patenting company afloat and, in return, the company spun off its research It is unclear the entire scope of AquaBounty’s patent regime arm into a separate organization called the Center for Aquaculture surrounding GE salmon, but when the company went public on 76 Technologies, which Bendukidze purchased for one dollar. the London Stock Exchange in 2006, it reported having obtained This spin-off included AquaBounty’s egg-production facility in a “worldwide exclusive licence” to the patent over GE salmon.81 77 Prince Edward Island. The restructuring of the company was The company reported that this would enable its production of designed to reduce the operating costs of AquaBounty because GE salmon in the United States, Spain, France, Great Britain, the company was facing financial difficulties while awaiting FDA Netherlands, Canada, Chile, Japan and Australia.82 As of its 2006 78 regulatory approval. filing with the London Stock Exchange, AquaBounty reported that the patent over GE salmon was still pending in Norway.83 Because GE salmon would be the first-ever GE animal to The company also claimed that a patent had been issued or was enter the food supply, the stakes of FDA approval go beyond pending in Chile.84 AquaBounty. The biotechnology industry as a whole has a tremendous interest in seeing GE salmon approved and setting a low bar for future GE animal applications with the FDA. And the influence the wider biotechnology industry has over policy «BIO spent close to $8 million and regulation cannot be understated. Biotech corporations spent nearly $550 million in campaign contributions and lobbying Congress in 2011 on lobbying expenditures in the last decade in an effort to secure issues including GE salmon.» favorable rules, regulations and policies.79

AquaBounty has also found a major ally in the Biotechnology The company also reported in 2006 an agreement with Oxford Industry Organization (BIO), a powerful American trade Insect Technologies (Oxitec) to eventually patent a “molecular organization that represents the interests of biotech companies. sterility system.”85 Oxitec is currently doing controversial work BIO spent close to $8 million lobbying Congress in 2011 on issues testing GE mosquitoes, designed to reduce malaria and dengue including GE salmon.80 fever through population reduction of mosquitoes.86 8 AquaBounty has filed an Australian patent for “maternally Labeling induced sterility in animals” that uses transgenics to achieve In the United States, the FDA has, thus far, declared that all GE 100 percent sterility, according to the company’s claims.87 food products are similar enough to non-GE food products that AquaBounty’s sister company, A/F Protein,88 holds a patent for they do not need to be labeled. Though the FDA has said it will “determination of genomic sex in salmonids.”89 make a separate labeling decision on GE salmon, which will set a precedent for all GE animals entering the food supply, it seems The patent in Europe was filed in 1992 on “transgenic fish almost certain that the agency will allow the product to be sold comprising a promoter and a fish growth hormones gene without a label. sequence”, but since 20 years have passed, the patent has now expired.90 Also the patent in Norway has expired. The US patent The economic consequences of such a labeling decision by the is still valid until August 2013. FDA could be great for non-GE salmon producers. Consumers may react to the FDA’s decision by choosing to avoid salmon altogether, hurting markets for wild salmon and traditional non-GE salmon.

8079787677 CenterFoodAquaBountyPollock, & for WaterAndrew. Responsive Technologies. Watch. “An “FoodentrepreneurPolitics. “Proposed and Lobbying Agriculture bankrolls fundraise database Biotechnology a genetically of available $2.0 million engineered at Industry . Accessed before Spends salmon.” expense November More Newand than 7,inssuance Yor 2012. kHalf Times a of Billion. fundraisingMay 21,Dollars 2012. circular.” to Influence February Congress.” 22, 2012. November 2010. 86858483828190898887 Pollack,AquaBountyEmailcorrespondanceU.S.Austalia Patent Andrew.Patent and AdmissionTechnologies. Office.Trade “Concerns Office.with atPatent 23,2289Ruth Admission“The are 26. Patent raisedTippe,Application Company: number abouttoNo Trading patents Numbergenetically History.”5,480,774. on on the2010321582. seedAvailable engineered Alternative “Determinationcoalition, at and“Maternallymosquitoes.” InvestmentDecember on offile. Genomic induced 2012. Market AccessedNew YorSexsterility of k thein NovemberTimes Salmonids.” Londonin . animals.”October 21, Stock 2012.January Filed30, Exchange. 2011. 2,November 1996. March 23, 15, 2010. 2006 at 22. (HEREAFTER: AquaBounty Admission.) Notes

1. Pollock, Andrew. “An entrepreneur bankrolls a genetically 18, September 20, 2000, at 1472-1489; Moschos S. and Mantzoros engineered salmon.” New York Times. May 21, 2012. C. “The Role of the IGF System in Cancer: From Basic to Clinical 2. AquaBounty Technologies, Inc. “AquaBounty AquAdvantage Fact Studies and Clinical Applications.” Oncology. Vol. 63 No. 4, Sheet.” September 2010. November 4, 2002, at 317-332. 3. Knapp, Gunnar. “Overview of U.S. Salmon Consumption.” Chapter 20. FDA Briefing Packet at Table 30. VIII from The Great : Competition Between Wild and 21. Nordlee, J. et al. “Identification of a Brazil-Nut Allergen in Transgenic Farmed Salmon. University of Rhode Island, January 2007 at 131. Soybeans.” The New England Journal of Medicine. March 14, 1996. 4. Appel, Adriane. “Genetically engineered salmon facing fierce 22. Young, E. “GE pea causes allergic damage in mice.” New Scientist. opposition.” Boston Globe. February 20, 2012. November 21, 2005. 5. Food and Drug Administration Center for Veterinary Medicine. 23. FDA Briefing Packet at Tables 28. Veterinary Medicine Advisory Committee. “Briefing Packet: 24. FDA Briefing Packet at Tables 21 and 28. Comparisons made to AquAdvantage Salmon.” September 20, 2010 (pre-released independent science where available (omegas). September 3, 2010) at 110. (HEREAFTER: FDA Briefing Packet) 25. FDA Briefing Packet at Tables 22-24. 6. Food and Drug Administration. Transcript of Veterinary Medicine 26. FDA Briefing Packet at Table 6 and page 41. Advisory Committee Meeting on AquAdvantage Salmon. Monday, September 20, 2010 at 112-113. 27. FDA Briefing Packet at 26, 33. 7. FDA Briefing Packet at 113. 28. FDA Briefing Packet at 33. 8. FDA. Guidance 187. “Guidance for Industry Regulation of 29. FDA Briefing Packet at 60. Genetically Engineered Animals Containing Heritable Recombinant 30. U.S Senate Subcommittee on Oceans, Atmosphere, Fisheries, and DNA Constructs.” January 15, 2009. Coast Guard Oversight Hearing on the Environmental Risks of 9. Food and Drug Administration Center for Veterinary Genetically Engineered Fish.” December 15, 2011. Comments Medicine. Veterinary Medicine Advisory Committee. from Olympia Snowe, Mark Begich, John, Epifanio and George “Meeting Participants for Aquadvantage Salmon Veterinary Leonard. Recording available online; Food & Water Watch. Medicine Advisory Committee.” Available at http://www.fda. Emails retrieved from the Fish and Wildlife Services Freedom of gov/AdvisoryCommittees/CommitteesMeetingMaterials/ Information Act Request. Summary available at http://documents. VeterinaryMedicineAdvisoryCommittee/ucm224765.htm and on foodandwaterwatch.org/doc/FOIA-FWW-GEsalmon-letter-FDA. 9 file. Accessed December 15, 2011. pdf 10. Food and Drug Administration. Transcript of Veterinary Medicine 31. Joe Palca. “Debating Genetically Modified Salmon.” National Public Advisory Committee Meeting on AquAdvantage Salmon. Monday, Radio Science Friday. December 9, 2011. September 20, 2010 at 355. (HEREAFTER: FDA Transcript) 32. Food & Water Watch. Records received through the Freedom of 11. FDA Transcript at 373. Information Act. See summary of documents at http://documents. foodandwaterwatch.org/doc/FOIA-FWW-GEsalmon-letter-FDA. 12. FDA Transcript at 186, 187 and 340. pdf. 13. FDA Transcript at 150-153. 33. Food & Water Watch. Records received through the Freedom of 14. FDA Transcript at 383. Information Act. Letter from Fish and Wildlife Service Conservation 15. FDA Transcript at 373-374. Genetics Community of Practice to unspecified recipients. October 16. FDA Briefing Packet at 68; Yu H. and Rohan T. “Role of the Insulin- 6, 2010. Like Growth Factor Family in Cancer Development and Progression.” 34. AquaBounty Technologies. “Operations Update.” Press Release. Journal of the National Cancer Institute, Vol. 92, No. 18, September August 15, 2008; LeVaux, Ari. “The genetically engineered salmon 20, 2000, at 1472-1489; Moschos S. and Mantzoros C. “The Role that could soon run wild.” Outside Online Magazine. June 6, 2012. of the IGF System in Cancer: From Basic to Clinical Studies and 35. FDA Briefing Packet at 120-121. Clinical Applications.” Oncology. Vol. 63 No. 4, November 4, 2002, 36. LeVaux, Ari. “The genetically engineered salmon that could soon at 317-332; Kimura, Toshikiro, Murakawa, Yusuke, Ohno, Misako, run wild.” Outside Online Magazine. June 6, 2012; ”Trout farm back Ohtani, Seiji, and Higaki, Kazutaka. “Gastrointestinal absorption of in business.” La Prensa. November 30, 2008. recombinant human insulin-like growth factor-1 in rats.” Journal of Pharmacology and Experimental Therapeutics. Vol. 283 No. 37. FDA Transcript at 113. 2, July 1997 at 611-618; Anderle, Pascale, Langguth, Peter, Rubas, 38. Naylor, R. et al. “Fugitive Salmon: Assessing the Risks of Escaped Fish Werner, and Merkle, Hans. “In Vitro Assessment of Intestinal IGF-1 from Net Pen Aquaculture,” Bioscience. May 2005 at Introduction. Stability.” Journal of Pharmaceutical Sciences, Vol. 91 No. 1, January 39. Moreau, Darek. “Reproductive performance of alternative male 2002, at 290-300; Hansen, Michael, Ph.D, et al. “Potential Public phenotypes of growth hormone transgenic Atlantic salmon.” Health Impacts Of The Use Of Recombinant Bovine Somatotropin Evolutionary Applications. May 2, 2011 at Abstract. In Dairy Production.” Consumers Union. September 1997. 40. Joe Palca. “Debating Genetically Modified Salmon.” National Public 17. FDA Briefing Packet at 108. Radio Science Friday. December 9, 2011. 18. Joe Palca. “Debating Genetically Modified Salmon.” National 41. R. Naylor et al. “Fugitive Salmon: Assessing the Risks of Escaped Public Radio, Science Friday. December 9, 2011; Homer, Michael Fish from Net Pen Aquaculture,” Bioscience. May 2005 at 431. Bennett. “Frankenfish…It’s What’s for Dinner: the FDA, Genetically Engineered Salmon, and the Flawed Regulation of Biotechnology.” 42. FDA. AquAdvantage Salmon. Draft Environmental Assessment. Columbia Journal of Law and Social Problems. Fall 2011 at 83. Dated May 4, 2012, released Dec 21, 2012. At 43-44. 19. FDA Briefing Packet at 68; Yu H. and Rohan T. “Role of the 43. FDA (September 20, 2010) at 338 and 343; FDA. AquAdvantage Insulin-Like Growth Factor Family in Cancer Development and Salmon. Draft Environmental Assessment. Dated May 4, 2012, Progression.” Journal of the National Cancer Institute, Vol. 92, No. released Dec 21, 2012. At 43-44. 44. AquAdvantage Salmon. Draft Environmental Assessment. Dated “Breeding programs on Atlantic salmon in Norway—Lessons May 4, 2012, released Dec 21, 2012. At 43-44. learned.” Development of Aquatic Animal Genetic Improvement and 45. FDA Briefing Packet at 50. Dissemnation Programs: Current Status and Action Plans. At 22. 46. Kaufman, Marc “Frankenfish for Tomorrow’s Dinner.” Washington 65. Response given by John Buchanan, former lead researcher for Post. October 17, 2000; AquaBounty. “Result of Annual General AquaBounty Technologies, to a public question at the Second Annual Meeting 2011 and Directorate Change.” July 20, 2011. BARC-UMD Fall Symposium. October 18, 2012. 47. AquaBounty Technologies, Inc. “Environmental Assessment for 66. Center for Food Safety. Press Release. “Coalition reveals immense AquAdvantage® Salmon.” Submitted to the Center for Veterinary opposition to Transgenic Fish, Demands Mandatory Labeling.” Medicine US Food and Drug Administration. August 25, 2010 at at November 18, 2010. 72. 67. Thomson Reuters. “National Survey of Healthcare Consumers: 48. United States Department of Agriculture. Current Research Genetically Engineered Food.” October 1-13, 2010. Information System. Project Number MASW-2011-02218. 68. Lake Research Partners. “Attitudes Toward the FDA’s Plan on “Validation of a maternally mediated sterilization platform for Genetically Engineered Fish.” September 20, 2010. reproductive containment of GE fish with initial application to 69. Wall Street Journal Question of the Day. “Would you eat genetically tilapia.” September 11, 2011; Pollock, Andrew. “An entrepreneur –modified salmon if approved by the FDA?” Undated but related bankrolls a genetically engineered salmon.” New York Times. May to a September 21, 2010 article. Available at http://online.wsj.com/ 21, 2012. community/groups/question-day-229/topics/would-you-eat- 49. U.S Senate Subcommittee on Oceans, Atmosphere, Fisheries, and genetically-modified-salmon and on file. Coast Guard Oversight. Hearing on the Environmental Risks 70. Ashton, Thomas et al. “Novel Tensile Test Method to Assess Texture of Genetically Engineered Fish.” Comments from Ron Stotish. and Gaping in Salmon Fillets.” Journal of Food Science. January 2010 December 15, 2011 at 1hour, 41 minutes. at Introduction. 50. FDA Transcript at 109 and 113. 71. AquaBounty Technologies, Inc. “Update on Change in Shareholding 51. AquaBounty. “Change in Shareholding and Proposed Offer.” October and Proposed Offer.” November 16, 2012. 31, 2012; Intrexon. “Intrexon to acquire 48% stake in AquaBounty 72. Intrexon. “Company.” Available at http://www.dna.com/company/ Technologies.” October 31, 2012; AquaBounty Technologies, Inc. board and on file. Accessed November 7, 2012. “Update on Change in Shareholding and Proposed Offer.” November 73. Intrexon. “Company.” Available at Intrexon. “Company.” Available 16, 2012. at http://www.dna.com/company/board and on file. Accessed 52. Morpol. Annual Report. 2011 at 88 and 133; Government of Scotland. November 7, 2012. and on file. Accessed November 7, 2012. Marine and Fisheres. “Confirmed reported Escapes from Fish 74. AquaBounty Technologies, Inc. “Update on Change in Shareholding 10 Farms in Scotland.” Excel spreadsheet of escapes available at http:// and Proposed Offer.” November 16, 2012. www.scotland.gov.uk/Topics/marine/Fish-Shellfish/18364/18692/ escapeStatistics and on file. Accessed November 20, 2011. 75. Pollock, Andrew. “An entrepreneur bankrolls a genetically engineered salmon.” New York Times. May 21, 2012. 53. FDA Briefing Packet at 254-255 and 383-384. 76. Pollock, Andrew. “An entrepreneur bankrolls a genetically engineered 54. FDA Briefing Packet at 120-123. salmon.” New York Times. May 21, 2012. 55. De Boni, Dita. “’Frankenfish’ Programme Canned.” New Zealand 77. AquaBounty Technologies. “Proposed fundraise of $2.0 million Herald. Feb-ruary 25, 2000. before expense and inssuance of fundraising circular.” February 22, 56. Food & Water Watch Freedom of Information Act request yielded no 2012. documents over a five month period on this question. 78. AquaBounty Technologies. “Proposed fundraise of $2.0 million 57. Pollock, Andrew. “Genetically Altered Salmon Get Closer to the before expense and inssuance of fundraising circular.” February 22, Table.” New York Times. June 25, 2010. 2012. 58. Biotechnology Industry Organization. “Increasing crop yield and 79. Food & Water Watch. “Food and Agriculture Biotechnology Industry commercializing cellulosic biofuels are key to meeting demand for Spends More than Half a Billion Dollars to Influence Congress.” feed, fiber and transportation fuels.” June 12, 2008; Gurian-Sherman, November 2010. Doug. Union of Concerned Scientists. “Failure to Yield.” April 2009 80. Center for Responsive Politics. Lobbying database available at www. at 1. opensecrets.org. Accessed November 7, 2012. 59. Gurian-Sherman, Doug. Union of Concerned Scientists. “Failure to 81. AquaBounty Technologies. Admission to Trading on the Alternative Yield.” April 2009 at 2-5. Investment Market of the London Stock Exchange. March 15, 2006 at 60. Thodesen, Jorn and Trygve Gjedrem. “Breeding programs on Atlantic 22. (HEREAFTER: AquaBounty Admission.) salmon in Norway—Lessons learned.” Development of Aquatic 82. AquaBounty Admission at 22 Animal Genetic Improvement and Dissemnation Programs: Current Status and Action Plans. At 22; “Salmon egg producer questions 83. AquaBounty Admission at 89 AquaBounty’s claims.” Intrafish. November 1, 2011; Personal 84. AquaBounty Admission at 22 Correspondence with Marine Harvest. 85. AquaBounty Admission at 23, 26. 61. Salmobreed. “Salmobreed challenges GMO salmon.” November 86. Pollack, Andrew. “Concerns are raised about genetically engineered 2011. mosquitoes.” New York Times. October 30, 2011. 62. Gibbs, Walter. “Europe scorns ‘supersalmon’ as GM battle wides.” 87. Austalia Patent Office. Patent Application Number 2010321582. Reuters. April 22, 2011. “Maternally induced sterility in animals.” Filed November 23, 2010. 63. Gibbs, Walter. “Europe scorns ‘supersalmon’ as GM battle wides.” 88. AquaBounty Technologies. “The Company: History.” Available at Reuters. April 22, 2011. http://www.aquabounty.com/company/company-292.aspx and on 64. FDA Transcript at 119-120; Cook, J.T. “Growth rate, body file. Accessed November 21, 2012. composition and feed digestibility/conversion of growth-enhanced 89. U.S. Patent and Trade Office. Patent number 5,480,774. transgenic Atlantic salmon ( salar).” Aquaculture. July 14, 1999 “Determination of Genomic Sex in Salmonids.” January 2, 1996. at Methods; “Salmon egg producer questions AquaBounty’s claims.” Intrafish. November 1, 2011; Thodesen, Jorn and Trygve Gjedrem. 90. Email correspondance with Ruth Tippe from No patents on seeds coalition, December 2012. «Beyond GE salmon’s uninspiring growth rates, the fish also demonstrates serious risks to consumer health, animal welfare, fishing economies and the environment.»

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