When Precaution becomes Paralysis

AquAdvantage Salmon: A Case Study

R.L.Stotish, AquaBounty Technologies

Principle 15 In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures toprevent environmental degradation.

Rio Declaration on Environment and Development, Stockholm, Sweden, United Nations 1992 Publication

E.73.II.A.14

The problem with the Precautionary Principle is not that it leads in the wrong direction, but that – if taken for all it is worth – it leads in no direction at all.

The Paralyzing PrincipleBY CASS R. SUNSTEIN

University of Chicago

REGULATION WINTER 2002-2003

AquAdvantage Salmon

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

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Wei

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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

////

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MicroinjectMicroinject

P1

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The Coordinated Framework for Regulation of Biotechnology, proposed in 1984 by the White House Office of Science and Technology Policy and finalized in 1986, spells out the basic federal policy for regulating the development and introduction of products derived from biotechnology.A key principle of the framework is that genetically engineered organisms would continue to be regulated according to their characteristics and unique features, and not according to their method of production. In other words, for example, if a food product produced through biotechnology is substantially the same as one produced by more conventional means, that food is subject to no additional (or no different) regulatory processes. The framework also maintains that new biotechnology products are regulated under existing federal statutory authorities and regulation.

Since 1986 there has been one GE animal approved, a goat that produces human anti-thrombin A in its milk (2009).

"The number of wild Atlantic salmon in Maine rivers is at an all-time low, placing them in danger of extinction," officials at the NOAA Fisheries Service and the U.S. Fish and Wildlife Service said in announcing the decision to list the salmon as endangered under the Endangered Species Act. Atlantic salmon in eight Maine rivers were declared "endangered" on November 13, 2000.

There are no commercial “wild catch” Atlantic salmon fisheries in the US

With the exception of a small “wild catch” Atlantic salmon industry in Iceland, there are no commercial wild caught Atlantic salmon fisheries anywhere in the world.

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).

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]

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AquAdvantage Salmon

Product Definition for AquAdvantage Salmon

1. Product IdentityTriploid 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.

2. ClaimSignificantly more of these Atlantic salmon grow to at least 100 g within 2700 deg C days than their comparators.

3. Limitations for UseThese Atlantic salmon are produced as eyed-eggs for grow-out only in the FDA-approved physically-contained fresh water culture facility

R.Stotish, Sept. 20, 2010, VMAC

• 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

Conclusion FDA has carefully considered the potential environmental impacts of the proposed action and at this time has made a preliminary determination that this action would not have a significant effect on the quality of the human environment in the United States. Therefore, FDA has made a preliminary determination that an environmental impact statement will not be prepared.

Preliminary Finding of No Significant Impact (FONSI) for AquAdvantage Salmon

4 May 2012 Draft

The CVM’s draft EA was held for two years before release after a Jon Entine expose. (Slate 2012, Forbes 2013)

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

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” ?

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

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

In reply to XXXXX, the question of "how to proceed" is addressed by the suggestion that we make sure to fold socio-economic considerations into an assessment.  Not because they are "interesting" etc, but because Art 26 of the Protocol urges us to do so. And in the real world, the politics of GE is driven by the perceived economic and social gains and/or losses of different affected parties.

After all, every LMO which the Protocol procedures address is in front of us because of ECONOMIC considerations--some company thinks it can make money by producing and selling it. So the economic concerns of other affected parties are just as integral to assesing the overall risks (and benefits, which would also be assessed of course--and presumably have been already by one party, the company).

Assessors are responsible to society (at least in democracies) as agents of the government.  They need to assure that ALL of society's interests are reflected in their work, not just the interests of some (the more powerful).

BioSafety Clearing House Guidelines for Risk AssessmentFebruary 28, 2014

There has been a corruption of the risk assessment process

Introduction of Innovative Products

Science Base RegulationTransparencyRisk AssessmentRisk CommunicationRisk Mitigation Enforcement

OppositionExploit transparency / FOIDispute science / Risk Assess.Create fear and anxietyExaggerate riskLitigation

Competing / Dueling Interests

Economic and political interests are potent drivers

Precautionary principle is the weapon of choice to prevent innovation

INAD 1995Guidance 187 January 2009VMAC / CFSAN Part 15 September 2010Release of Environmental Assessment December 2012Public comment closed EA April 2013

$80 million over 18+ years with no decision

AquaBounty Experience

Supporters : Ag production states, Production Associations, Academics, Animal Health Companies, Scientific Associations

Opponents : NGOs, Organic Growers, Alaskan Fisheries, California, Oregon, Washington, activist lawyers

The battle continues………….