What went right?

Lessons from the approval

process for the release of
genetically engineered moths
Carolyn Plunkett, MA, ABD
Research Associate, Division of Medical Ethics,
NYU Langone Medical Center
PhD Candidate, Department of Philosophy, The
Graduate Center, CUNY

Overview
Genetically Engineered Diamondback Moth
Why is it developed?
How does it work?
What process led to its approval for release?

Ethically Salient Features of Approval

Process
Location & Type of Release
Perceived Burden of Insect on Local Population
Public Engagement Strategy

Conventional Pesticide Use

Sterile Insect Technique

Self-Limiting Genes

Source: Wilke & Marelli 2012

Source: www.oxitec.com

USDA - APHIS Approval Process

A plant pest is any living insect, mite,
nematode, slug, snail, invertebrate
animal, bacteria, fungi, other parasitic
plants which can directly or indirectly
injure or cause disease or damage in
any plants or parts thereof
(US Federal Regulation 7.B.III.340)

September 30, 2014:

Public comment
period closes. 287
comments received.

EA Prepared

October 24, 2013:

Cornell University
submits application
to APHIS for permit
to release GE moth

August 28, 2014:

APHIS announces
release of
Environmental
Assessment. Public
comment period
opens.

November 10, 2014:

APHIS approves
caged and open
release of GE moth
on NYSAES

Ethically Salient Aspects of Approval Process

Location & Type of
Release

Cornell University/New York State Agricultural Experiment

Station.
Caged release would be limited to 6 sites, not exceeding
10 acres per site, surrounded by other agricultural fields
within NYSAES 870 total acres. Open releases only upon
establishing safety in caged release.

Perceived Burden
of Insect

High. Diamondback moth is a serious problem for farmers

in New York State.

Public
Engagement

Public engagement limited to official comment period

through APHIS.

Location & Type of Release

Moth releases will take
place in incremental
steps on NYS Agricultural
Experiment Station in
Geneva, NY.
Highly unlikely that moths
could fly into private land.
Incremental Steps
Lab

Caged
Release

Limited
Open
Release in
Designated
Area

Open
Release in
Suboptimal
Ecosystem

Open
Release

What are endpoints at each step indicating safe to move on?

Perceived Burden to Local Population

Powell, Replacing Pesticides with Genetics, NYT 8/31/15

As with clinical trials and other kinds of research, risks to

participants (and in this case the immediate environment)
are outweighed by the expected benefits.
There is a stronger justification for exposing participants
to risk when benefits are expected to accrue to the same
participants (and immediate environment).

Public Engagement Strategy

Clearly, more is needed than the official public

comment period. But how much more?

Each proposed release?

Each species?
Each use?

What are good models for engaging/educating?

Suggestions Going Forward

Uniformity

Create standardized procedure for testing safety

and efficacy of genetically engineered/edited insects
(and other organisms intended for release, but not
consumption), regardless of agency overseeing
application. Need scientific consensus on endpoints.

Transparency

Communicate regulatory process, safety and

efficacy standards, and public engagement
strategies clearly to both public and
scientists/industry partners

Public Engagement

Engage in meaningful public debate and education.

Public comment period not enough, but what is?

TRUST
Presentation Title Goes Here

11

Select References
Caplan, A.L., Parent, B., Shen, M., & Plunkett, C. EMBO Rep (8 Oct 2015).
Esvelt, K.M., Smidler, A.L., Catteruccia, F., & Church, G.M. Elife e03401 (2014)
Ledford H (2015) CRISPR, the disruptor. Nature 522: 2024
Lunshof J (2015) Regulate gene editing in wild animals. Nature 521: 127
Oye, K.A. et al. Science 345, 626628 (2014).
Resnik, D.B. Dev World Bioethics 14, 37-46 (2014).
Shaw, D. Experiment Station Defends Moth. Finger Lakes Times (1 July 2015).
Oxitec Diamondback Moth Website: http://www.oxitec.com/agriculture/our-products/diamond-back-moth/
Shelton Lab, Cornell University: http://shelton.entomology.cornell.edu/diamondbackmoth/