Food Fight : Policy and Politics

1. Food Fight : Policy and Politics R.L. Stotish, AquaBounty Technologies

2. World fisheries and aquaculture production 2006 2007 2008 2009 2010 2011 (Million tonnes) PRODUCTION Capture Inland 9.8 10.0 10.2 10.4 11.2 11.5 Marine 80.2 80.4 79.5 79.2 77.4 78.9 Total capture 90.0 90.3 89.7 89.6 88.6 90.4 Aquaculture Inland 31.3 33.4 36.0 38.1 41.7 44.3 Marine 16.0 16.6 16.9 17.6 18.1 19.3 Total aquaculture 47.3 49.9 52.9 55.7 59.9 63.6 TOTAL WORLD FISHERIES 137.3 140.2 142.6 145.3 148.5 154.0 Notes: Excluding aquatic plants. Totals may not match due to rounding. Data for 2011 are provisional estimates. SOWFA 2012

5. US Census Bureau

6. World Aquaculture Production 2012 SOWFA 2012

7. NOAAFisheries of the United States, 2012 In 2011 Americans consumed 15 lbs. of seafood per person (global per capita consumption is 41.4 lbs.) 91% of that seafood was imported 50% of that seafood was produced by aquaculture Top Ten : Shrimp>Tuna>Salmon>Pollock>Tilapia>Pangasius>Catfish>Crab> Clams

8. Volume of U.S. imports of selected fish and shellfish products USDA ERS

9. 2013 US Imports of Shrimp, Tilapia, and Salmon USDA ERS

10. NOAA NMFS “Marine aquaculture in the United States consists of a vibrant community of researchers and producers that contribute to the seafood supply, support commercial fisheries, enhance habitat and at-risk species, maintain economic activity in coastal communities and at working waterfronts. However, US marine aquaculture is small Relative to overall US and world production. The $1 billion value of total US freshwater and marine aquaculture production pales in comparison to global production of $100 billion. Only 20% of US production is marine species.”

11. National Oceanic and Atmospheric Administration DRAFT AQUACULTURE POLICY (2011) 1. Enable sustainable aquaculture that provides domestic jobs, products, and services and that is in harmony with healthy, productive, and resilient marine ecosystems, compatible with other uses of the marine environment, and consistent with the National Policy for the Stewardship of the Ocean, our Coasts, and the Great Lakes (National Ocean Policy)3. 2. Ensure agency aquaculture decisions protect wild species and healthy, productive, and resilient coastal and ocean ecosystems, including the protecting of sensitive marine areas 3. Advance scientific knowledge concerning sustainable aquaculture 4. Make timely and unbiased aquaculture management decisions based upon the best scientific information available. 5. Support aquaculture innovation and investments that benefit the nation’s coastal ecosystems, communities, seafood consumers, industry, and economy. 6. Advance public understanding of sustainable aquaculture practices; the associated environmental, social, and economic challenges and benefits; and the services NOAA has to offer in support of sustainable aquaculture. (7-9 not shown)

12. The devil is in the details ! $Millions The value opportunity Is $16.4 Billion. The US currently supplies less than $2 Billion of the demand. USDA ERS

13. What are the barriers ? Production economics Environmental concerns a. legitimate b. activists Regulatory Issues Investment Quality

14. AquAdvantage Salmon

15. Why Aquaculture Biotechnology? Fish is a healthy food and an efficient source of high quality protein Many of world’s fisheries are maximally exploited Aquaculture must at least triple by 2030 to hold per capita fish supply constant (FAO) Genetics and husbandry practices generally primitive Biotechnology can improve efficiency and sustainability

16. Atlantic Salmon • Major cultured finfish • Multi-billion dollar industry • 1982: 10,000 tons wild caught; 13,000 farmed • 2007: 3,000 tons wild caught; 1,400,000 farmed • >90% of farmed salmon; >50% of total salmon sold • US imports 97% of consumption (~225,000 tons in 2007) • Nutritional benefits –healthy diet, omega 3 fatty acids • Role for aquaculture in meeting increased demand for seafood – production must increase • Environmental concerns with fish culture • Need reduced costs and reduced environmental impact (coastal impact, effluent, disease, escapes)

17. ATG TAG 1989 Microinject // // Promoter GH cDNA Terminator P 1 AATAA TATA 1992 1994 F 1 1996 F 2 1998 F 3 Transgene DNA Microinjection Transgenic Founder F 2000 4 F 5 Milt F 6 Selection F 2008 2006 2002 2004 7 Fertilized Microinjected Eggs F Non-transgenic Progeny 8 Regulatory sequences from ocean pout AFP gene & coding domain from chinook salmon GH-1 cDNA

18. Gains in Growth – Smolts (AAS vs. Nontransgenics) • Pooled growth data collected at ABT-PEI for year classes 2004-2006. • Full sibs • Triploid transgenics, diploid controls • NOTE: these growth studies were carried out at an average annual temp. of 9-10° C.

19. AquAdvantage Salmon Product Definition Product Identity: Triploid hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 rDNA construct at the α-locus in the EO-1α lineage. Claim: Significantly more of these Atlantic salmon grow to at least 100 g within 2700 deg C days than their comparators. Conditions of Use: These Atlantic salmon are produced as eyed-eggs for grow-out in FDA-approved, physically-contained fresh water culture facilities.

20. AAS is an Atlantic salmon, and as safe to consume as food as any other Atlantic salmon AAS represents no significant risk to the environment under conditions of use in application an approval FDA Conclusions VMAC September 2010

21. GE salmon may not be a safe or healthy choice AquaBounty’s GE salmon would be raised in farms and would likely have many of the same nutritional differences that unaltered farmed salmon already have in comparison to wild salmon. These differences include lower levels of omega-3 fatty acids and higher levels of contaminants like polychlorinated biphenyls (PCBs). GE salmon have different vitamin, mineral and amino acid levels than non-GE salmon, and GE salmon also have slightly higher levels of insulin-like growth factor 1 (IGF-1), which has been shown to increase the risk of certain cancers. Food & Water Watch “Fact Sheet” June 2011

22. Legislative History 1.  6/2011 House amendment by Rep. Don Young to HR 2112 (FY 2011-12 ag approps) passes on voice vote (10 members on floor) 2. 10/2011  S. 2286 introduced by Sen. Mark Begich (“Prevention of Escapement of Genetically Altered Salmon in the U.S. Act” (PEGASUS)) introduced 3. 11/2011 Senate Commerce Committee markup of S. 1717 – forced the bill off the markup agenda 4 12/2011 Hearing Before the Senate Commerce Subcommittee on Oceans, Atmosphere, Fisheries & Coast Guard on “Potential Environmental Risks of Genetically Engineered (GE) Fish” 5. 11/2012 House-Senate appropriations conference – dumped Young amendment 6  4/2012 Senate HELP Committee markup of FDA drug/device user fees – stopped Murkowski amendment 7. 5/2012  FY2012-13 Senate appropriations – stopped Murkowski amendment   8. 5/2012 Senate floor action on drug/device user fees – defeated Murkowski amendment on recorded vote 51-45 9. 7/2012 Senate Commerce Committee markup of S. 1717 – Begich again withdraws bill from markup In addition, there are the various bills (House and Senate versions) introduced in the 111th and 112th Congress on preventing approval, labeling, etc. 1 . [111th] To amend the Federal Food, Drug, and Cosmetic Act to prevent the approval of genetically engineered fish. (Introduced in House - IH)[H.R.6265.IH ][PDF]2 . [111th] To amend the Federal Food, Drug, and Cosmetic Act to prevent the approval of genetically-engineered fish. (Introduced in Senate - IS)[S.3971.IS ][PDF]3 . [112th] To amend the Federal Food, Drug, and Cosmetic Act to prevent the approval of genetically-engineered fish. (Introduced in Senate - IS)[S.230.IS ][PDF]4 . [112th] To amend the Federal Food, Drug, and Cosmetic Act to require labeling of genetically engineered fish. (Introduced in House - IH)[H.R.520.IH ][PDF]5 . [112th] To amend the Federal Food, Drug, and Cosmetic Act to prevent the approval of genetically engineered fish. (Introduced in House - IH)[H.R.521.IH ][PDF]6 . [111th] To amend the Federal Food, Drug, and Cosmetic Act to require labeling of genetically engineered fish. (Introduced in House - IH)[H.R.6264.IH ][PDF]7 . [111th] To amend the Federal Food, Drug, and Cosmetic Act to require labeling of genetically-engineered fish. (Introduced in Senate - IS)[S.3969.IS ][PDF]8 . [112th] To amend the Federal Food, Drug, and Cosmetic Act to require labeling of genetically engineered fish. (Introduced in Senate - IS)[S.229.IS ][PDF]

23. The National Environmental Policy Act (NEPA) is a United States environmental law that established a U.S. national policy promoting the enhancement of the environment and also established the President's Council on Environmental Quality (CEQ). NEPA's most significant effect was to set up procedural requirements for all federal governmentagencies to prepare Environmental Assessments (EAs) and Environmental Impact Statements (EISs). EAs and EISs contain statements of the environmental effects of proposed federal agency actions.[1] NEPA’s procedural requirements apply to all federal agencies in the executive branch. NEPA does not apply to the President, to Congress, or to the federal courts.[2] NEPA has become a weapon for activist groups

24. August 5, 2011 Suit targets U.S. over fish farm permitBy Steven Hedlund Food & Water Watch and the Hawaiian-Environmental Alliance are suing the U.S. government for granting a permit to a Hawaiian yellowtail farmer. According to the complaint, the National Oceanic and Atmospheric Administration’s (NOAA) Fisheries Service lacked the authority to grant the permit and failed to adequately assess the environmental impacts of Kona Blue’s fish farm; a regional fishery management plan is required to issue the one-year permit. The complaint alleges that the agency lacks the statutory authority under the Magnuson-Stevens Fishery Conservation and Management Act to issue such a permit and that it acted “arbitrarily and capriciously” in doing so.

25. The Endangered Species Act of 1973 (7 U.S.C.§ 136, 16 U.S.C.§ 1531 et seq. , ESA) is one of the dozens of United States environmental laws passed in the 1970s. Signed into law by President Richard Nixon on December 28, 1973, it was designed to protect critically imperiled species from extinction as a "consequence of economic growth and development untempered by adequate concern and conservation." The Act is administered by two federal agencies, the United States Fish and Wildlife Service (FWS) and the National Oceanic and Atmospheric Administration (NOAA). ESA has also become a weapon to oppose new aquaculture technology

26. Alaska Politics - Economics A BILL To prevent the escapement of genetically altered salmon in the United States, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Prevention of Escapement of Genetically Altered Salmon in the United States Act’’. SEC. 2. PROHIBITION ON SALE OF GENETICALLY ALTERED SALMON. (a) PROHIBITION.—It shall be unlawful for a person- (1) to ship, transport, offer for sale, sell, or purchase a covered fish, or a product containing covered fish, in interstate or foreign commerce; (2) to have custody, control, or possession of with the intent to ship, transport, offer for sale, sell, or purchase a covered fish, or a product containing covered fish, in interstate or foreign commerce; (3) to release a covered fish into a natural environment; or (4) to have custody, control, or possession of a covered fish AMENDMENT intended to be proposed by Ms. MURKOWSKI Viz: On page 60, line 9, strike ‘‘and’’ and insert ‘‘; (10) not less than $150,000 shall be used to implement a requirement that the labeling of genetically engineered salmon offered for sale to consumers indicate that such salmon is genetically engineered; and’’.

27. FOOD SAFETYScience November 19, 2010 Genetically Modified Salmon and Full Impact Assessment Martin D. Smith, Frank Asche, Atle G. Guttormsen, Jonathan B. Wiener Health and environmental impacts of GM salmon hinge on aggregate market size,which current regulatory processes ignore. Introduce social and economic considerations into a regulatory process. “Euro regulation” ? 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Indexed price and income

28. The Science and Regulation of Food from Genetically Engineered Animals Authors: Alison L. Van Eenennaam (Chair) Eric M. Hallerman William M. Muir University of California Davis Virginia Polytechnic Institute Purdue University and State University West Lafayette, Indiana Blacksburg , VA Reviewers: David Edwards Gregory Jaffe Paul G. Olin Mark Walton Biotechnology Industry Center for Science in University of California MWalton Enterprises Organization the Public Interest San Diego Austin, Texas . Wash. , D.C. Wash. D.C.

29. Conclusion from CAST Report, June 20, 2011 Despite the FDA’s attempts to increase transparency and public participation in the regulatory process, opposition to the GE salmon from environmental and consumer groups, food safety advocates, and commercial and recreational fisheries associations remains. The current regulatory approach, coupled with the prolonged and unpredictable time frame, has resulted in an inhibitory effect on commercial investment in the development of GE animals for agricultural applications with ramifications for U.S. agriculture and food security.

30. February 1, 2011 Commissioner Margaret Hamburg, M.D. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, Maryland 20993 Cc: Secretary Kathleen Sebelius, U.S. Department of Health and Human Services Dr. Jane Lubchenco, Administrator, National Oceanic and Atmospheric Administration Rowan W. Gould, Acting Director, U.S. Fish and Wildlife Service Re: AquaBounty Technologies’ Genetically Engineered AquAdvantage Salmon Dear Commissioner Hamburg: We write in further support of our November 8, 2010 letter urging the U.S. Food and Drug Administration (FDA) to fully assess the potential environmental impacts associated with genetically engineered (GE) salmon before taking final action on AquaBounty Technologies’ (ABT’s) application for the first-ever approval of a GE animal intended for human consumption. In light of continued and considerable concerns surrounding ABT’s application, FDA must complete a comprehensive environmental impact statement (EIS) that reaches far beyond the scope of the narrow environmental assessment (EA) submitted by ABT and evaluates the full range of threats that stand to confront wild fish populations if AquAdvantage Salmon are released into the natural marine environment. Erich Pica Trip Van Noppen Phil Radford President President Executive Director Friends of the Earth Earthjustice Greenpeace Andrew Sharpless Vikki Spruill Josh Reichert CEO President & CEO Managing Director Oceana Ocean Conservancy Pew Environment Group Kevin Knobloch President Union of Concerned Scientists

31. Letter to Congressional Leadership, July 29, 2011 A coalition of about 30 animal agriculture groups asked lawmakers in Congress to allow the FDA to decide on its own whether to approve a biotech salmon for human consumption. A House bill that would block the FDA from using federal funds to assess the biotech fish "would disrupt the FDA's congressional mandate to base its assessments of human and animal drugs, devices, vaccines, and process applications on the best-available science underlying an application. Such a disruption would diminish the credibility of the FDA approval process at home and overseas," the Animal Agriculture Coalition wrote in the letter. Los Angeles Times (8

32. AquAdvantage Salmon : A case study Superior production characteristics All female, sterile populations reared in physical confined systems Regulated by CVM as an animal drug Detailed Environmental Assessment Data published for public comment 19 years and counting in regulatory review 3 years from VMAC meeting disclosing CVM review 2 year delay publishing Environmental Assessment 1 year delay since close of public comment period More than $70 million invested to date with no approval

33. It’s not just about one product or one technology….. Aquaculture represents a $16B + opportunity the US has ceded to international suppliers : We have ceded the market due to : lack of competitive production systems lack of will to accept new production paradigms resistance by anti-technology groups resistance by environmental activist groups lack of integrity in regulatory process “politicization” of the regulatory process Our choice is to either demand science based regulation or accept dependence upon foreign sources of our food supply. Our biggest challenge is most Americans demand high quality food but have no idea of the origins of their food. This ignorance has been the vehicle for marketing platforms geared to appeal to the consumer’s emotions.