Genetically Engineered Salmon: Background and Issues

197 Pages·2014·3.491 MB·English

by  Diedra P. Tharp

FOOD SCIENCE AND TECHNOLOGY

G E S
ENETICALLY NGINEERED ALMON

B I
ACKGROUND AND SSUES

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F S T
OOD CIENCE AND ECHNOLOGY

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FOOD SCIENCE AND TECHNOLOGY

G E S
ENETICALLY NGINEERED ALMON

B I
ACKGROUND AND SSUES

DIEDRA P. THARP
EDITOR

New York
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CONTENTS

Preface vii
Chapter 1 Genetically Engineered Salmon 1
Harold F. Upton and Tadlock Cowan
Chapter 2 Briefing Packet AquAdvantage Salmon 29
Veterinary Medicine Advisory Committee
Index 177

PREFACE

This book discusses the genetically engineered salmon; the background of the techniques
and the issues that go along with it.
Chapter 1 – If approved by the Food and Drug Administration (FDA), Atlantic salmon
would be the first genetically engineered (GE) animal to be marketed in the United States for
human consumption. Genetic engineering techniques are used by scientists to insert genetic
material from one organism into the genome of another organism. Genetically engineered
salmon have been modified to grow more quickly and use feed more efficiently. However,
some are concerned that, in this rapidly evolving field, current technological and regulatory
safeguards are inadequate to protect the environment and ensure that these products are safe
to be used as food.
Over seventeen years ago, AquaBounty Technologies Inc. first applied to the FDA for
approval of a genetically engineered Atlantic salmon. In 2009, AquaBounty submitted to the
FDA the last required study for their new animal drug (NAD) application. The FDA is
regulating GE Atlantic salmon as an NAD under the Federal Food, Drug, and Cosmetic Act
(FFDCA; 21 U.S.C. §321). An NAD is approved by the agency only after the drug is shown
to be safe and effective. On September 19-21, 2010, the FDA‘s Veterinary Medicine
Advisory Committee (VMAC) met to consider the AquaBounty application for approval of
GE salmon, trademarked as AquAdvantage salmon, for human consumption, and held a
public hearing. On December 20, 2012, FDA announced the availability for public comment
of (1) a draft environmental assessment of the proposed conditions specified by AquaBounty
and (2) FDA‘s preliminary finding of no significant impact (FONSI) for AquaBounty‘s
conditions. In the FONSI, FDA reiterated that food from AquAdvantage salmon is as safe as
food from non-GE salmon and determined that there are no significant food safety hazards or
risks associated with AquAdvantage salmon. FDA may still require a full environmental
impact statement (EIS) prior to approval of AquaBounty‘s application. No further action has
been taken by FDA, and the Aquabounty NAD application is still under consideration.
Environmental concerns related to the development of GE salmon include the potential
for competition and interbreeding with wild fish. According to some, escaped GE salmon
could spawn with wild Atlantic salmon and introduce the modified genetic material to the
wild population. Sterilization and bioconfinement have been proposed as a means of isolating
GE salmon to minimize the likelihood of harm to wild fish populations. To address these
concerns, AquaBounty proposes to produce salmon eggs (all sterile females) in Canada, ship
these eggs to Panama, grow and process fish in Panama, and ship table-ready, processed fish
viii Diedra P. Tharp
to the United States for retail sale. Additional concerns have been voiced concerning food
safety, labeling of GE salmon, and economic effects on existing wild salmon fisheries.
Some have asserted that FDA approval of AquAdvantage salmon is overdue and that
delays have hindered investment and development of the U.S. biotechnology sector. Others
have questioned the adequacy of the FDA‘s review of GE salmon and whether the existing
approval process is equipped to fully evaluate the risks of this technology, especially potential
environmental harm. In response to food safety and environmental concerns, legislation has
been introduced during the 113th Congress, including S. 246 and H.R. 1667, which would
prohibit the transport, sale, possession, release, or use of GE fish. H.R. 584 and S. 248 would
amend Section 403 of the FFDCA by adding a requirement to label genetically engineered
fish, while H.R. 1699 and S. 809 would require labeling of foods produced using genetic
engineering, including fish. No further action has been taken on these or other bills which
would require additional regulation of genetically engineered organisms.
Chapter 2 – Report of the Veterinary Medicine Advisory Committee on Briefing Packet
AquAdvantage Salmon.