Food Safety Review

A PUBLICATION OF THE CENTER FOR FOOD SAFETY Genetically Engineered : The Next Generation of Industrial

lagued by decades of over-fishing, pollution, agricultural runoff, and deficient management, our marine ecosystems Pand the that depend upon them stand at a crossroads. States like Alaska have taken bold steps to ensure the longevity of their wild fish stocks by prohibiting the factory farming of fish such as salmon or tuna, and instead investing in proper fisheries management. Other states such as and have invested considerably in indus - trial aquaculture as a way to supplement diminishing returns of their wild stocks. The next chapter in this unfolding drama is the private development of genetically engineered (GE) fish, which are designed to be raised under industrial aquaculture conditions. The Food and Drug Administration, entrusted with oversight of GE animals, is currently considering whether to approve a GE salmon engineered to grow faster in industrial fish farming. If approved, the “AquAdvantage” salmon developed by AquaBounty Technologies, Inc. would be the first-ever GE animal approved for human consumption. AquaBounty has W echoed the false promises made by other companies regarding feeding the world or minimizing environmental I

hazards, but alarming red flags suggest quite the contrary, including threats to food safety, the environment, the economic N

wellbeing of fishermen, animal welfare, and the international marketplace. These risks are exacerbated by the fundamentally T

flawed oversight model FDA is applying to this unprecedented transgenic organism. E

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GE FISH AND THE due to the introduction of the eelpout’s anti-freeze DNA, |

“AQUADVANTAGE SALMON” the GE salmon produces growth hormone year-round,

thus creating a fish that its developer claims can grow up 2 GENETIC ENGINEERS are currently experimenting on

to twice as fast as conventionally raised . 0 over 35 species of fish, including trout, catfish, tilapia, However, other salmon breeders have produced salmon 1 striped bass, carp, flounder, and salmon. By selecting 1 that grow as fast without . 3 from a variety of organisms (including other fish, coral, On December 26, 2012, FDA released for public mice, bacteria, and even humans) companies hope to pro - comment a proposed approval of the GE salmon based on duce new breeds of trans genic or genetically engineered a draft risk assessment. 2 (GE) fish that grow faster, produce larger muscles, are dis - ease resistant, and tolerate a wide range of temperatures. FDA SWIMMING IN A Through manipulating certain genes, industry claims DANGEROUS DIRECTION these fish will be better suited for industrial aquaculture systems, also referred to as fish farming. THE PROBLEMS with the AquAdvantage salmon begin The “AquAdvantage” salmon currently being consid - with how our government assesses its risks: with the ered for approval by the Food and Drug Administration wrong agency, old laws, and an unacceptable level of (FDA) was developed by AquaBounty Technologies, Inc. analysis. If a transgenic animal is a square peg, the U.S. is The transgenic salmon is an Atlantic salmon ( salar ) attempting to shove it through a round hole. that has had its DNA spliced with a growth hormone In 2009, FDA announced in a guidance document that from the unrelated ( it would regulate novel GE animals pursuant to its veteri - tshawytscha ) and anti-freeze DNA from an Arctic eelpout nary animal drug authority. FDA declared that companies (Zoarces americanus ). Normally, an Atlantic salmon’s growth who seek Federal approval must file a New Animal Drug hormone stimulates growth in the fish during certain Application (NADA). The agency decided to do this rather months of the year, and will “turn off” growth during other than pursue other more robust regulatory mechanisms . months to devote its resources toward survival. However, For instance, it could have used its food authority (in

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whole, or in part), sought new legislative authorities from risks of escaped GE salmon include the transgenic contam - Congress to address these novel products, or implemented ination of wild fish stocks, out-competing wild fish for specific binding regulations under its existing authority. food and mates, spreading lethal diseases and parasites, and Transgenic animals are plainly very different from vet - disrupting food webs in local environments. While erinary animal drugs, presenting new difficulties in assess - AquaBounty has promised to raise its GE salmon in land- ment and regulation. However, FDA equates approval of an based facilities, the United Nations Food and Agriculture engineered animal, and its risks, with the approval of a drug Organization recommends that the introduction of species injected into animals. This unprecedented mismatch creates for aquaculture be considered as introductions to the wild, numerous inherent oversight problems. even if the facility is considered a closed system. 4 SCOPE : Animals drugs are approved if safe and effec - Scientists have hypothesized that GE salmon escapes tive for intended use, with safe referring to man and the would not just wreak havoc on local ecosystems, but could animal. Essentially, review asks whether the “drug” lead to the eventual extinction of wild populations as a result works and its whether its claims are accurate. The envi - of the “Trojan gene effect.” That is, the introduction of fast- ronmental risks resulting from GE animals are nowhere growing transgenic fish with enhanced mating success but contemplated by FDA’s statutory process, nor are broad - reduced adult viability into a wild population may result in er socioeconomic risks. a rapid population decline. Research published in the Proceedings of the National Academy of Sciences concluded that EXPERTISE : Even if the scope of review were com - a release of just sixty GE fish into a wild population of prehensive, FDA lacks any expertise in the disciplines 60,000 would lead to the extinction of the wild population needed to adequately address impacts. in less than 40 generations. 5 TRANSPARENCY : Because it is a confidential “drug” Even though AquaBounty makes the claim to FDA that approval process, there is a severe lack of transparency and it will only produce sterile female fish, information present - meaningful, timely public participation. FDA cannot ed in FDA’s own draft Environmental Assessment indicates even publicly announce what NADAs may be pending that up to 5% of the fish could be fertile and able to repro - until it proposes approval. Nor is labeling of the food duce. 6 AquaBounty will also keep large stocks of fertile fish necessarily required, likely leaving consumers in the dark to produce offspring, and fish are known to change sex, if GE animals are approved for human consumption. raising additional concerns about fish escaping and 7 FUTURE APPROVALS : Once initial approval is reproducing in the wild. A 2011 study published by given, subsequent approvals may be granted through Canadian scientists concluded that if GE Atlantic salmon supplemental applications, which are limited and ill- were to escape from captivity, they could succeed in breed - 8 suited to cover emerging GE animal risks. ing and passing their genes into the wild. Knowing that these foreseeable impacts would cause The AquAdvantage salmon is the first GE animal being significant regulatory scrutiny, AquaBounty claims that it considered by FDA for human consumption, and the agency will only produce its fish in a scheme involving: growing the has continued to use the inadequate NADA review process eggs at its Prince Edward Island facility in Canada, flying despite overwhelming opposition from the public, scientific them to a land-based facility in Panama to be raised, and community, and Members of Congress. These regulatory finally shipping the processed salmon to U.S. markets. Yet we shortcomings leave much to be concerned about when know that it is not economically viable to farm salmon in considering not only the 35 GE fish species currently in this way. Salmon are commercially farmed in open-water development, but also the numerous other GE animals that net pens, where escapes are a regular occurrence. are possibly under review by FDA, including cattle, chickens, AquaBounty’ s smokescreen is intended to breach the regu - and pigs. The approach also stands in sharp contrast to the latory door, and it has stated its future plans to grow the fish approach of other governments, such as the European elsewhere in the U.S. 9 Union (EU), which show it is possible for transgenic animal In 2010, the FDA convened a meeting of its Veterinary oversight to be comprehensive, precautionary in nature, and Medicine Advisory Committee (VMAC) to review its GE specifically designed to apply to GE organisms. salmon risk assessment. The only scientist with expertise in fisheries explicitly called for the agency to produce a much ENVIRONMENTAL IMPACTS more rigorous risk assessment. 10 To date, the agency has GENETICALLY ENGINEERED FISH pose serious risks to claimed it is not obligated to consider the full range of wild populations of fish and the marine environment. Each impacts that GE salmon would have on the environment, year, an estimated two million salmon escape from open- and claimed it need not even formally consult with our water net pens into the North Atlantic, outcompeting wild expert wildlife agencies—the Fish and Wildlife Service and populations for resources and straining ecosystems. 3 The the National Oceanic and Atmospheric Administration—on

2| those potential impacts. More recently, previously hidden documents surfaced during a Canadian investigation that revealed that AquaBounty’ s Prince Edward Island facility was contaminated in 2009 with a new strain of Infectious Salmon Anemia (ISA) 11 , the deadly fish flu that is devastating fish stocks around the world. This information was hidden from the public and the VMAC. Serving Size:1 AquAdvantage Frankenfish FOOD SAFETY CONCERNS     [ Hazard Factor UNKNOWN ] FDA H AS YET TO REQUIRE or conduct any studies to assess the possible long-term health impacts of eating GE # ( & *''&$%'&  animals; however, several independent studies have produced '*$*  % !  **,#)    findings that leave cause for serious concern. For instance, ('* #&   '#+%  the routine use of to control disease in factory '*$('",(*   farm operations (like the AquAdvantage salmon conditions) &1:)314    521++1,    may adversely impact human health. 12 Research suggests )2+1;3   854   transgenic fish may be even more susceptible to diseases than (14+   !05960585;9    conventional farmed fish. 13 Increased disease susceptibility $01)314   "1*5.2)<14    could mean transgenic fish may then require more antibi - &1:)314  otics. Human health could also be jeopardized as a result of 99-4:1)23145+1,9 -resistant bacteria, and exposure to certain classes 19:1,14-   !0-4>2)2)414-   of antibiotics that may cause allergic reactions. 14 952-;+14-    $08-5414-   Genetically Engineered salmon also presents problems -;+14-  $8>6:560)4   for consumers who have certain allergies. Allergenicity con - >914-   &)214-  cerns are twofold: the possible allergenicity with newly -:015414-   expressed protein(s); and endogenous allergenicity that  1..-8-4+-:5 54#)2354*)9-,547;,<)4:)/-#)2354 comes from the insertion of a growth hormone construct )4,7;)5;4:>94549654958+54:852,):))<)12)*2-): ===.,)/5<,5=425),9,<1958>5331::--95331::--9--:14/ possibly changing the level of allergenic proteins normally ):-81)29&-:-814)8>-,1+14-,<1958>5331::--%  6,. found in Atlantic salmon. Consumers need to know if this  3-/) )::>+1,9*)9-,54,):)+536)8-,:5'12,#)2354 new fish is more likely to cause allergic reactions. Even the INGREDIENTS: GENETICALLY ENGINEERED ATLANTIC SALMON, INDUCED GROWTH small sample sizes used by the company in their allergenicity HORMONE GENE FROM CHINOOK SALMON (ONCORHYNCHUS TSHAWYTSCHA), tests (only 6 fish) showed that GE fish were likely to cause ANTI-FREEZE DNA FROM OCEAN POUT (ZOARCES AMERICANUS). GROWN AND PROCESSED IN A TOP SECRET FACILITY IN PANAMA. heightened allergic responses. In 2009, a study commissioned by the E.U. indicated several potential food safety concerns with GE fish and their are a crucial economic and public resource for commercial, ability to grow faster and possess a higher tolerance to envi - recreational, and subsistence fishers throughout California, the ronmental toxins. 15 The study’s authors expressed concerns Pacific Northwest, and Alaska. Thousands of men and women that both toxins and growth hormones had a high potential depend on salmon fishing for their livelihoods. While some to end up in consumers’ bodies and called for fur ther tests Pacific salmon fisheries are healthy, many are already threat - to determine safety. This demand for additional data is crit - ened with extinction. Similarly, in the past several decades, ical in light of FDA’s 2010 data release, where results indi - significant investments have been made to restore wild cated that GE salmon possess 40% higher levels of the hor - salmon populations in the Northeast U.S., where Atlantic mone called IGF-1 (insulin-like growth factor 1), which has salmon is currently listed as an endangered species and com - been shown to increase the risk of certain cancers. 16 Finally, mercial fishing is restricted. On both coasts, approval of GE nutritionally speaking, GE salmon lack many of the benefi - salmon and its subsequent entrance into the market will cial qualities that salmon boast: specifically, wild salmon have pose serious threats to our nation’s marine economy. 189% higher levels of beneficial omega fats than GE salmon These economic concerns are especially alarming for can produce. 17 states like Alaska, where the seafood industry is the state’s largest private sector employer and creates 56,600 direct and ECONOMIC IMPACTS 22,000 indirect jobs annually (more jobs than the oil, gas, ANOTHER CLEAR DEFICIENCY in FDA’s review is the and mining industries combined). 19 A 2010 study published in absence of any assessment of economic impacts. Wild salmon the Journal of Bioeconomics found that the success of wild fish -

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eries can also cause positive economic ripples in other sectors, engineering. These include the likelihood of GE fish expe ri - such as agriculture, forestry, manufacturing, and financial encing more health problems; increased likelihood of dis ease; services. 19 Given these serious threats to our nation’s fishing high rates of physical deformities and other abnormalities; industry and the economic market as a whole, FDA must and premature death, especially when compared to conven - complete a comprehensive analysis of these impacts. tionally farmed fish. FDA data and reports from AquaBounty There are also significant market ramifications to be indicate that GE salmon have already suffered deformities, considered in terms of consumer opinion. Since the U.S. such as jaw erosions and inflamed tissues. However, numer - does not yet require labeling for GE foods, there is likely to ous animal welfare issues are also not analyzed by FDA in be consumer confusion about which salmon or fish at the their review process and the health of the Aquabounty's supermarket are in fact genetically engineered, perhaps salmon through its full life cycle remains unknown. resulting in consumers not purchasing any salmon or farmed fish entirely. In an international context, this lack of labeling CONCLUSION could impede foreign markets and result in trade disparities OUR FISHERIES are at a crossroads. While some companies with governments that do require labeling for GE foods are looking to genetic engineering as a panacea, the solution (such as the EU). A 2008 Consumer Reports poll indicated to declining fisheries is not to engineer salmon to “fit” more that 95% of respondents felt food from genetically engi - efficiently in our factory farm systems. The solution is to 20 neered animals should be labeled. These findings are sup - bring our wild salmon populations—and the ecosystems ported by a 2010 poll from Lake Research Partners, indicat - they depend upon—back to sustainability. The real question ing that 91% of Americans felt FDA should not introduce GE is: do we continue down the road toward further industrial - 21 fish and meat into the marketplace. ization, consolidation, and ecological degradation? Or can we muster the political will to reject the notion that a single ANIMAL WELFARE ISSUES technology, like genetic engineering, will solve the complex NUMEROUS FACTORS must be considered when assessing problems that face our fisheries, and instead advocate for pol - the animal welfare and health issues associated with genetic icy changes that will effectively protect them?

1 See chart in “Salmobreed Challenges GMO 9 Suzanne Goldenberg, Obama Administration Research (2009) “Ecological Risk Assessment of Salmon”, Newsletter from Salmobreed, Year 7, nr. “bailed out” GM Salmon Firm, The Guardian Transgenic Salmon.” Study commissioned by the 5, November 2011 available at: http://www.salmo - (UK) October 18, 2011 available at: European Union, the Swedish Research Council breed.no/newsletters/en/newsletter_5_2011.pdf http://www.guardian.co.uk/environment/2011/oc Fromas and the University of Gothenburg. 2 Federal Register, Vol. 77, No. 247. “Draft t/18/gm-salmon-aquabounty According to the Vancouver, Canada. Environmental Assessment and Preliminary article, the company president, Ron Stotish said 16 Yu H. and T. Rohan. “Role of the Insulin-Like Finding of No Significant Impact Concerning a the company had prospective fish farmers lined up Growth Factor Family in Cancer Development Genetically Engineered Atlantic Salmon.” Docket for the GM Salmon in South Dakota, West and Progression.” Journal of the National Cancer No. FDA–2011–N–0899, Wednesday, December Virginia, Wisconsin and Ohio. “We have people in Institute , vol. 92, iss. 18. September 20, 2000; and 26, 2012. the in the United States who are interested in Moschos, S. and C. Mantzoros. “The Role of the growing these fish right now.” 3 IGF System in Cancer: From Basic to Clinical Schiermeier Q. 2003. Fish farms’ threat to salmon 10 stocks exposed. Nature 425:753; and Naylor, R et Veterinary Medicine Advisory Committee Studies and Clinical Applications.” Oncology , vol. 63 al. “Fugitive Salmon: Assessing the Risks of Meeting Transcript, Center for Veterinary iss. 4. November 4, 2002. Escaped Fish from Net Pen Aquaculture,” Medicine, Food and Drug Administration. 17 U.S. Food and Drug Administration (FDA) Bioscience . May 2005. Recorded by Audio Associates at the Double Tree Center for Veterinary Medicine. Veterinary Hotel in Rockville, MD, Sept. 20, 2010, p. 383. 4 Medicine Advisory Committee. “Briefing Packet: FAO, 1995, Code of Conduct for Responsible 11 Fisheries, United Nations Food and Agriculture Living Oceans Society, Media Release. “ISA AquAdvantage Salmon.” September 20, 2010, at Organisation, Rome, Italy, 41pp. virus confirmed in AquaBounty’s genetically-engi - Table 28. neered salmon.” Reposted on December 20, 2012. 18 5 Northern Economics of Anchorage (January William Muir et al., Possible ecological risks of Available at: transgenic organism release when affect 2009) The Seafood Industry in Alaska’s Economy . http://www.livingoceans.org/media/releases/salm Commissioned by the Marine Conservation mating success: Sexual selection and the Trojan on-farming/isa-virus-confirmed-aquabounty’s- gene hypothesis, 96 PNAS 13853-13856, at 13853 Alliance, At-sea Processors Association and the genetically-engin Pacific Seafood Processors Association. (Nov. 23, 1999). 12 Ian Phillips et al., “Does the use of antibiotics in 19 6 Dyck, A.J. and U.R. Sumaila. “Economic impact U.S. Food and Drug Administration Center for food animals pose a risk to human health? A criti - Veterinary Medicine. “Draft Environmental of ocean fish populations in the global .” cal review of published data.” Journal of Journal of Bioeconomics . August 19, 2010. DOI: Assessment: AquAdvantage Salmon.” May 4, 2012 Antimicrobial Chemotherapy vol. 53, 28–52. DOI: (published December 26, 2012), at page 86. 10.1007/s10818-010-9088-3 Available at: 10.1093/jac/dkg483. December 4, 2003. ftp://ftp.fisheries.ubc.ca/FCWebsite2010/Publicati 7 James J. Nagler et al., “High Incidence of a Male- 13 William Muir et al., “Possible ecological risks of ons/Dyck_Sumaila_Economic_impact_ocean_fish. Specific Genetic Marker in Phenotypic Female transgenic organism release when transgenes affect pdf Chinook Salmon from the Columbia River.” mating success: Sexual selection and the Trojan 20 Consumer Reports. 11/11/08 Environmental Health Perspectives , Vol. 109, no. 1, gene hypothesis,” 96 PNAS 13853-13856, at January 2001. http://www.greenerchoices.org/pdf/food - 13853. November 23, 1999. poll2008.pdf 8 Darek T. R. Moreau, Corinne Conway, Ian A. 14 Rebecca Goldberg and Tracy Triplett. “Murky 21 Lake Research Partners, Commissioned by Food Fleming. (2011) “Reproductive performance of Waters: The Environmental Effects of Aquaculture alternative male phenotypes of growth hormone and Water Watch. September 20, 2010. Available at: in the U.S.” (p.44). Environmental Defense Fund , http://documents.foodandwaterwatch.org/release- transgenic Atlantic salmon (Salmo salar).” 1997. Evolutionary Applications , Blackwell Publishing, Ltd. FWW-Omnibus.pdf 15 Centre for Aquaculture and Environmental

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