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

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Food Fight : Policy and Politics

R.L. Stotish, AquaBounty Technologies


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




Noaa fisheries of the united states 2012
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




Noaa nmfs
NOAA NMFS products

“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.”


National Oceanic and Atmospheric Administration products

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)


The devil is in the details ! products

$Millions

The value opportunity

Is $16.4 Billion. The US

currently supplies less than

$2 Billion of the demand.

USDA ERS


What are the barriers ? products

Production economics

Environmental concerns

a. legitimate

b. activists

Regulatory Issues

Investment Quality



Why aquaculture biotechnology

Why Aquaculture Biotechnology? products

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
Atlantic Salmon products

  • 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)


ATG products

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


Gains in Growth – Smolts (AAS vs. Nontransgenics products)

  • 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.


Aquadvantage salmon product definition
AquAdvantage products 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.


Fda conclusions vmac september 2010

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


Food water watch fact sheet june 2011

GE salmon may not be a safe or healthy choice any other Atlantic salmon

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


Legislative History any other Atlantic salmon

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]


The any other Atlantic salmonNational 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


August 5, 2011 any other Atlantic salmon

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.


The any other Atlantic salmonEndangered 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


Alaska Politics - Economics any other Atlantic salmon

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’’.


FOOD SAFETY any other Atlantic salmonScience 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

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Indexed price and income


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.


Conclusion from CAST Report, June 20, 2011 Engineered Animals

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.


February 1, 2011 Engineered Animals

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


Letter to Congressional Leadership, July 29, 2011 Engineered Animals

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


AquAdvantage Salmon : A case study Engineered Animals

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


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

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.


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