When Precaution Becomes Paralysis - Ronald L. Stotish, PhD President and Chief Executive Officer of AquaBounty Technologies, from the 2014 NIAA Annual Conference titled 'The Precautionary Principle: How Agriculture Will Thrive', March 31 - April 2, 2014, Omaha, NE, USA. More presentations at http://www.trufflemedia.com/agmedia/conference/2014_niaa_how_animal_agriculture_will_thrive

1. When Precaution becomes Paralysis
AquAdvantage Salmon: A Case Study
R.L.Stotish, AquaBounty Technologies

2. 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 to
prevent environmental degradation.
Rio Declaration on Environment and Development,
Stockholm, Sweden, United Nations 1992 Publication
E.73.II.A.14

3. 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 Principle
BY CASS R. SUNSTEIN
University of Chicago
REGULATION WINTER 2002-2003

4. AquAdvantage Salmon

5. 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)
Weight(g)
AAS Standard

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

7. 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).

9. "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.

10. 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).

11. 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]

12. 12
AquAdvantage Salmon
Product Definition for AquAdvantage Salmon
1. 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.
2. Claim
Significantly more of these Atlantic salmon grow to at least 100 g within 2700 deg C
days than their comparators.
3. Limitations for Use
These 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

13. • 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

14. 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)

15. 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]
Legislative History

16. 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’’.
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
Alaska Politics - Economics

17. FOOD SAFETY Science 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” ?

18. 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
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.
February 1, 2011

19. 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

20. 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 Assessment
February 28, 2014
There has been a corruption of the risk assessment process

21. Introduction of Innovative Products
Science Base Regulation
Transparency
Risk Assessment
Risk Communication
Risk Mitigation
Enforcement
Opposition
Exploit transparency / FOI
Dispute science / Risk Assess.
Create fear and anxiety
Exaggerate risk
Litigation
Competing / Dueling Interests
Economic and political interests are potent drivers
Precautionary principle is the weapon of choice to prevent innovation

22. INAD 1995
Guidance 187 January 2009
VMAC / CFSAN Part 15 September 2010
Release of Environmental Assessment December 2012
Public 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………….