MEETING
GENETIC BASIS OF UNINTENDED EFFECTS IN MODIFIED PLANTS
14-15 January 2014
Lord Elgin Hotel
100 Elgin Street
Ottawa, Canada
Co-sponsored by:
Canadian Food Inspection Agency (CFIA)
HESI Protein Allergenicity Technical Committee (PATC)
ILSI International Food Biotechnology Committee (IFBiC)
ILSI Research Foundation
CropLife International
BACKGROUND AND OBJECTIVES
As transgenic (GM) products worthy of commercialization became available, procedures were
instituted to ensure that these plants were as safe for food, feed, and environmental release as
their conventional counterparts. These procedures addressed the two types of changes that
could be considered in a GM food / feed / environmental release safety assessment.
Of these two possible types of changes, one is referred to as “intended.” This type of change in
a new product is brought about by the introduced transgene. Because many transgenes
express a known and characterized protein, procedures can be developed that directly assess
the protein for toxicity and allergenicity, as well as measure levels of metabolites that may be
associated with the protein’s function.
The other type of change is referred to as “unintended.” This potential change could materialize
as a consequence of gene insertion or from random mutations that take place during the
transformation and tissue culture process. Because the nature of unintended changes is
unknown, there is no direct test for them. However, the potential for an unintended change to
present a food or feed hazard is currently assessed through compositional analyses and
agronomic studies. Some regulatory authorities may also require animal feeding tests.
Thus far, no adverse unintended changes have materialized. Consequently, a reevaluation of
the original premise is merited.
The objectives of this meeting are to explore current knowledge and data gaps on unintended
effects and discuss how this information can inform and improve risk assessments. The
meeting will feature presentations on the molecular basis for unintended changes, a hypothesisdriven look at unintended effects in conventional and GM crops, and the consequences of
unintended effects from a safety assessment perspective. Finally, a panel of experts will
discuss the extent to which unintended or unexpected changes are hazardous.
MEETING
GENETIC BASIS OF UNINTENDED EFFECTS IN MODIFIED PLANTS
14-15 January 2014
Lord Elgin Hotel
100 Elgin Street
Ottawa, Canada
Co-sponsored by:
Canadian Food Inspection Agency (CFIA)
HESI Protein Allergenicity Technical Committee (PATC)
ILSI International Food Biotechnology Committee (IFBiC)
ILSI Research Foundation
CropLife International
PROGRAM
TUESDAY, 14 JANUARY 2014
(Ontario Room, 1:00 pm – 5:15 pm)
1:00 pm
Welcome
Dr. William Anderson, Acting Chief Science Operating Officer, Canadian Food
Inspection Agency
1:10 pm
Unintended effects in genetically engineered plants: what they are and how they
are assessed in Canada
Mr. Phil Macdonald, Canadian Food Inspection Agency



Definition of terms (unintended effects, insertional effects, pleiotropic effects,
risk, hazard, exposure)
How unintended effects are addressed in risk assessments in Canada
Motivation for the meeting: what we don’t know about unintended effects and
how that knowledge could help to improve risk assessments
Program
Ottawa Meeting on Genetic Basis of Unintended Effects in Modified Plants, 14-15 January 2014
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1:50 pm
The molecular basis for unintended changes in plants

The molecular biology of gene function
Dr. Mark Jordan, Agriculture and Agri-Food Canada
 Pleiotropies
 Can mode of action be used to predict the likelihood of pleiotropic
effects?
 Are genes from distantly related species more likely to display pleiotropic
effects than genes from closely related species?
 Central dogma – what is really necessary/essential for expression of a
novel gene?

The molecular biology of plant genomic changes
Prof. Wayne Parrott, University of Georgia, US
 Insertional (including genome plasticity)
 Mutation
 Transpositional
2:50 pm
BREAK
3:10 pm
The molecular basis for unintended changes in plants, continued

What does it take to bring an ag biotech seed product to market?
Dr. Laura Privalle, Bayer CropScience, US

The roles of backcrossing and other breeding strategies in removing
unintended effects caused by the transformation process
Dr. Phil Bregitzer, US Department of Agriculture – Agricultural Research
Service
 What can be done to minimize the occurrence of unintended effects?
 How can breeding procedures be used to remove unintended effects?

How much of a hazardous substance would have to be produced before it
poses a risk?
Prof. Andrew Bartholomaeus, University of Canberra, University of
Queensland, Australia
4:40 pm
Discussion
Moderator: Prof. Wayne Parrott, University of Georgia, US
5:15 pm
Adjourn Day One
5:30 pm – 7:00 pm
RECEPTION (Macdonald Room)
Program
Ottawa Meeting on Genetic Basis of Unintended Effects in Modified Plants, 14-15 January 2014
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WEDNESDAY, 15 JANUARY 2014
(Ontario Room, 8:00 am – 4:00 pm)
7:30 am
Continental Breakfast
8:00 am
Welcome
Dr. Greg Ladics, DuPont Pioneer, US
8:10 am
Hypothesis-driven survey of unintended changes: observed incidences of
unintended effects


Natural processes (e.g., without human intervention)
During crop domestication and conventional breeding practices (includes
mutagenesis)
 The biology of naturally occurring insertions
Dr. Justin Vaughn, University of Georgia, US
 Unintended effects on allergens in carrots and apples
Dr. Thomas Holzhauser, Paul-Ehrlich-Institut, Germany
Q&A
[Moderator tbd]
Hypothesis-driven survey of unintended changes: GM crop case studies
 Single gene traits
Dr. Alan Raybould, Syngenta, UK
10:00 am
BREAK
Hypothesis-driven survey of unintended changes: GM crop case studies,
continued
 Hypothesis-driven evaluations of drought-tolerant corn in safety
assessments
Dr. Elena Rice, Monsanto, US
 Quality traits: altered starch composition in potato
Dr. Christine Wandelt, BASF, Germany
Q&A
[Moderator tbd]
11:40 pm
LUNCH (Grill 41 Restaurant)
Program
Ottawa Meeting on Genetic Basis of Unintended Effects in Modified Plants, 14-15 January 2014
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1:00 pm
Safety assessment of consequences of unintended changes: food / feed safety
 Identification/assessment of possible unintended effect(s) on the overall
allergenicity of GM plants
Prof. Jean-Michel Wal, AgroParisTech, France
 Towards rational assessment of changes in small molecules by
leveraging genomics and metabolic network modeling
Dr. Sue Rhee, Carnegie Institution for Science, US
 Food and feed safety of new plant varieties: how to assess unintended
changes?
Dr. Esther Kok, RIKILT Wageningen UR, Netherlands
Q&A
[Moderator tbd]
Safety assessment of consequences of unintended changes: environmental
 Problem formulation
Prof. Alan Gray, Centre for Ecology and Hydrology, UK
 Can unintended effects lead to increased weediness / invasiveness?
Dr. Paul Keese, Office of the Gene Technology Regulator, Australian
Government
 Studying unintended effects confuses the nontarget risk assessment
Dr. Jörg Romeis, Agroscope, Institute for Sustainability Sciences ISS,
Switzerland
Q&A
[Moderator tbd]
3:30 pm
Panel discussion: Unintended effects in modified plants – key messages
Moderator: Dr. Greg Ladics, DuPont Pioneer, US
Panelists:
Dr. Luc Bourbonnière, Health Canada
Dr. Sue Rhee, Carnegie Institution for Science, US
Dr. Kevin Glenn, Monsanto, US
General Discussion:
 How long can a pathway be dormant before it dies due to mutation
load?
 What evidence is there for dormant pathway activation?
 Has any activation led to a hazard?
4:00 pm
Adjourn
Program
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