Food Fight : Policy and Politics

R.L. Stotish, AquaBounty Technologies

2006 2007 2008 2009 2010 2011(Million tonnes)PRODUCTIONCaptureInland 9.8 10.0 10.2 10.4 11.2 11.5Marine 80.2 80.4 79.5 79.2 77.4 78.9Total capture 90.0 90.3 89.7 89.6 88.6 90.4AquacultureInland 31.3 33.4 36.0 38.1 41.7 44.3Marine 16.0 16.6 16.9 17.6 18.1 19.3Total 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

World fisheries and aquaculture production

US Census Bureau

World Aquaculture Production 2012

Country Tonnes % Global

China 36,734,215 61.4India 4,648,851 7.8

Vietnam 2,671,800 4.5Indonesia 2,304,828 3.9

Bengladesh 1,308,515 2.2Thailand 1,286,122 2.2Norway 1,008,010 1.7

Egypt 919,585 1.5Myanmar 850,697 1.4Philipines 744,695 1.2

other 7,395,281 12.35Total 59,872,600 100

US 495,499 0.8

SOWFA 2012

NOAA Fisheries 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

Volume of U.S. imports of selected fish and shellfish products

Product2009 2010 2011 2012 2013

Jan-Dec 12

Jan-Dec 13

Volume(1,000 pounds)

Trout, fresh and frozen 12,021 16,326 11,082 19,606 18,699 19,606 18,699Atlantic salmon, fresh 198,260 203,913 192,238 222,310 190,415 222,310 190,415Pacific salmon, fresh 1/ 12,278 18,956 19,704 9,770 12,153 9,770 12,153Atlantic salmon, frozen 7,844 6,058 5,694 4,828 5,604 4,828 5,604Pacific salmon, frozen 1/ 61,750 80,859 85,406 65,491 71,293 65,491 71,293Atlantic salmon, fillets 220,550 178,871 201,601 276,703 318,147 276,703 318,147Salmon, canned and prepared 2/ 32,444 27,222 25,167 27,539 37,052 27,539 37,052

Tilapia 3/ 404,132 474,967 433,162 503,644 504,430 503,644 504,430Shrimp, frozen 896,045 914,925 948,460 923,109 870,934 923,109 870,934Shrimp, fresh and prepared 4/ 321,372 321,800 323,579 253,452 249,131 253,452 249,131

Oysters 5/ 20,503 23,802 26,779 18,566 19,810 18,566 19,810Mussels 5/ 57,062 56,921 63,813 75,384 70,949 75,384 70,949Clams 5/ 37,657 40,145 44,832 45,518 48,586 45,518 48,586Scallops 5/ 56,262 51,865 56,804 34,021 60,373 34,021 60,373

The last two columns contain data for the previous and current year to date.1/ Includes salmon with no specific species noted.2/ Includes smoked and cured salmon.3/ Frozen whole fish plus fresh and frozen fillets.4/ Canned, breaded or otherwise prepared.5/ Fresh or prepared.Source: Department of Commerce, Bureau of the Census.

USDA ERS

Shrimp Tilapia Salmon

Canada 74Chile 120China 36 185 9

Denmark 1Costa RicaColumbia 4Ecuador 82 6Faroe Isl. 17Honduras 9

India 104Indonesia 89 13

Mexico 20Norway 20Thailand 92Taiwan 20

Vietnam 66United Kingdom 14

other 70 6 2

Total 559 243 257

000 tonnes

2013 US Imports of Shrimp, Tilapia, and Salmon

USDA ERS

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 andat-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.”

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 areas3. Advance scientific knowledge concerning sustainable aquaculture

4. Make timely and unbiased aquaculture management decisions based upon the bestscientific information available.5. Support aquaculture innovation and investments that benefit the nation’s coastalecosystems, communities, seafood consumers, industry, and economy.6. Advance public understanding of sustainable aquaculture practices; the associatedenvironmental, social, and economic challenges and benefits; and the services NOAA hasto offer in support of sustainable aquaculture. (7-9 not shown)

National Oceanic and Atmospheric AdministrationDRAFT AQUACULTURE POLICY (2011)

The devil is in the details !  Food group   2012

Total U.S. food imports 1/ 105,971.4

Live meat animals 2,189.6

Meats 6,238.4

Fish and shellfish 16,428.0Dairy 1,604.3

Vegetables 9,797.1

Fruits 12,559.8

Nuts 2,108.3

Coffee and tea 8,902.3

Cereals and bakery 9,083.1

Vegetable oils 6,455.5

Sugar and candy 4,805.6

Cocoa and chocolate 4,096.0

Other edible products 10,979.4

Beverages 2/ 10,724.0

Liquors 7,898.9

Total animal foods 26,460.3

Total plant foods 68,787.1

Total beverages 18,622.9

Total US agricultural imports 102,871.4Nonfood ag. imports 3/ 13,327.9

       

The value opportunity Is $16.4 Billion. The UScurrently supplies less than $2 Billion of the demand.

$Millions

USDA ERS

What are the barriers ?

Production economicsEnvironmental concerns

a. legitimateb. activists

Regulatory IssuesInvestment Quality

AquAdvantage Salmon

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

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)

Regulatory sequences from ocean pout AFP gene Regulatory sequences from ocean pout AFP gene &&coding domain from chinook salmon GH-1 cDNAcoding domain from chinook salmon GH-1 cDNA

SelectionSelection

MiltMilt

Non-transgenic ProgenyNon-transgenic Progeny

Transgenic FounderTransgenic Founder Transgene DNATransgene DNAMicroinjectionMicroinjection

FertilizedFertilizedMicroinjectedMicroinjected

EggsEggs

Promoter TerminatorGH cDNAGH cDNA

TATATATA

TAGTAGATGATG

AATAAAATAA

////

1989

1992

1994

1996

1998

2000

2002

MicroinjectMicroinject

P1

F 1

F 2

F 3

F 4

F 5

2004

2006

2008

F 6

F 7

F 8

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.

Growth Curves (smolts)

AquAdvantage® salmon

Standard salmon

0

100

200

300

400

500

600

0 50 100 150 200 250 300 350 400 450

Days (from first feeding)

Wei

gh

t (g

)

AAS Standard

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.

AquAdvantage Salmon Product Definition

• 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

• 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

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)) introduced3. 11/2011 Senate Commerce Committee markup of S. 1717 – forced the bill off the markup agenda4 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 amendment7. 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 51-459. 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]

Legislative History

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 government agencies 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

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.

August 5, 2011

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

AMENDMENT intended to be proposed by Ms. MURKOWSKIViz: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’’.

A BILLTo 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 containingcovered 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

Alaska Politics - Economics

FOOD SAFETY Science November 19, 2010Genetically Modified Salmon and Full Impact AssessmentMartin 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.

Indexed price and income

19811982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009

Introduce social and economicconsiderations into a regulatory process.

“Euro regulation” ?

The Science and Regulation of Food from Genetically Engineered Animals

Authors:Alison L. Van Eenennaam (Chair) Eric M. Hallerman William M. MuirUniversity of California Davis Virginia Polytechnic Institute Purdue University

and State University West Lafayette, IndianaBlacksburg , VA

Reviewers:David Edwards Gregory Jaffe Paul G. Olin Mark WaltonBiotechnology Industry Center for Science in University of California MWalton Enterprises Organization the Public Interest San Diego Austin, Texas .Wash. , D.C. Wash. D.C.

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.

Conclusion from CAST Report, June 20, 2011

Erich Pica Trip Van Noppen Phil Radford President President Executive DirectorFriends of the Earth Earthjustice Greenpeace

Andrew Sharpless Vikki Spruill Josh Reichert CEO President & CEO Managing Director Oceana Ocean Conservancy Pew Environment Group

Kevin Knobloch PresidentUnion of Concerned Scientists

Commissioner Margaret Hamburg, M.D.U.S. Food and Drug Administration10903 New Hampshire AvenueSilver Spring, Maryland 20993

Cc: Secretary Kathleen Sebelius, U.S. Department of Health and Human ServicesDr. Jane Lubchenco, Administrator, National Oceanic and Atmospheric AdministrationRowan W. Gould, Acting Director, U.S. Fish and Wildlife ServiceRe: 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 thescope 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.

February 1, 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

Letter to Congressional Leadership, July 29, 2011

AquAdvantage Salmon : A case study

Superior production characteristicsAll female, sterile populations reared in physical confined systemsRegulated by CVM as an animal drugDetailed Environmental AssessmentData published for public comment

19 years and counting in regulatory review3 years from VMAC meeting disclosing CVM review2 year delay publishing Environmental Assessment1 year delay since close of public comment period

More than $70 million invested to date with no approval

Aquaculture represents a $16B + opportunity the US has ceded to international suppliers :

We have ceded the market due to :lack of competitive production systemslack of will to accept new production paradigmsresistance by anti-technology groupsresistance by environmental activist groupslack 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.

It’s not just about one product or one technology…..