Plenary Sessions

Background and Objectives of the ISBGMO14 Plenary Sessions

ISBGMO14 will address the theme "Environmental Risk Assessment of Genetically Modified Organisms: Past, Present and Future”, and aims to advance biosafety research of Genetically Modified Organisms (GMOs) around the world and shape the ways in which GM technology is applied and regulated, so as to limit environmental impacts and ensure safe food/feed. In the four days of the event, we intend to learn from the past, discuss the present and look ahead to future opportunities and challenges associated with GM technology.

Plenary Session I
Advancing ERA of GMOs - Learning from the Past to Further Advance ERA

This session will review the weight of scientific evidence on environmental risks accumulated and familiarity gained with the deliberate release of GM plants into the environment over the last three decades, and build on this experience to further advance pre-market environmental risk assessments (ERAs). Experience gained with the assessment of potential risks will be reviewed critically to assess: its scientific foundation; how potential adverse environmental effects may be best evaluated within the frame of current ERAs; and whether specific data requirements necessitate re-evaluation. Environmental risks associated with the cultivation of GM plants will also be put into the perspective of those of current agricultural systems, so as to contextualise ERAs more.  

Session organisers: Sarah Davis - Bio, Canadian Food Inspection Agency (CFIA) & Yann Devos - Bio, European Food Safety Authority (EFSA)

Keynote: Environmental effects of GM crops: Findings of a National Academies of Sciences, Engineering and Medicine (US-NASEM) report
Keynote Speaker: Fred Gould - Bio, North Carolina (NC) State University

Weeds or wimps? 30 years of experience from evolving ERA, deliberate release, experimental research, the development of theory, unintended free-living transgenic plants, unanticipated products – and a century of experience of non-engineered crops gone wild
Norman Ellstrand, University of California (UC)

Assessing effects of GM plants on valued non-target organisms
Joerg Romeis, Agroscope

Modernizing risk assessment for GM crops – Learning from experience
Phil Macdonald, Canadian Food Inspection Agency (CFIA)
Co-author: Sarah Davis

Resistance evolution in insect pests and weeds in GM crop systems
Nicholas P Storer, Dow AgroSciences
Co-authors: Mark A Peterson, Dwain M Rule, Robert A Masters


Plenary Session II
Advancing ERA of GMOs – Present Challenges                                                                                 

Pre-market ERA is an important analytical scientific tool that helps regulatory decision-making. Robust ERAs begin with an explicit problem formulation where plausible and relevant exposure scenarios and the potential adverse effects from those exposures are identified. Risk is then characterised by testing specific hypotheses about the likelihood and severity of adverse effects. Although significant advances have been made, ERA of GMOs faces a number of challenges. Potential avenues to overcome some of these challenges and further increase coherence in the ERA methodology will be considered, focusing on: the ecosystem services approach to make protection goals operational; problem formulation to enhance the relevance of ERA studies; clear quality criteria to warrant the reliability of ERA studies; data harmonisation and transportability to ensure consistent and coherent generation and use of scientific data across regulatory jurisdictions to support ERAs; and approaches to ensure ERAs remain proportionate to the level of risk or uncertainty. 

Session organisers: Monica Garcia-Alonso - Bio, Estel Consult Ltd & Joerg Romeis - Bio, Agroscope

Keynote: Science and values in governing GMOs: Facts, fictions, and fantasies
Keynote Speaker: Sheila Jasanoff - Bio, Harvard University

Assessment of environmental risks to ecosystem services. Where are we now, and where are we going?
Lorraine Maltby, University of Sheffield

Problem formulation: Identifying data that are relevant to ERA
Alan Raybould, Syngenta Crop Protection

Development of a construct-based risk assessment framework for GM crops
Clara Rubinstein, Monsanto
Co-author: Carmen Enriqueta Vicien

When science meets policy: The undoing of the Guidance on risk assessment developed under the Cartagena Protocol for biosafety
Karen Hokanson, University of Minnesota (UM)

Beyond the OECD Blue Book: Building consensus on Environmental Considerations for risk/safety assessment for the release of transgenic plants
Phil Macdonald, Canadian Food Inspection Agency (CFIA)
Co-author: Sarah Davis

Identifying surrogate environments to facilitate data transportability for ERA
Andrew Roberts, International Life Sciences Institute (ILSI) Research Foundation

Plenary Session III
Advancing ERA of GMOs – Looking Ahead to Future Opportunities and Challenges      

The ERA of GMOs faces a number of challenges. Among these are the questions posed by rapid advances in the science of genetic modification resulting in an expanding range of GMO applications. Emerging new breeding technologies, their applicability to crop improvement and animal breeding, and the technical and regulatory challenges they may present will be discussed. This session will explore new developments in GM technology, future opportunities and challenges new GMO applications may present, and put those into the context of agricultural innovation, agronomic sustainability, the need to feeding the growing world population and climate change. 

Session organisers: Jennifer Anderson - Bio, DuPont Pioneer & Yann Devos - Bio, European Food Safety Authority (EFSA) 

Keynote: Future for food systems
Keynote Speaker: Tim Benton Bio , University of Leeds

Emerging products of agricultural biotechnology for sustainable agriculture, food security and climate change mitigation
Jim Gaffney, DuPont Pioneer
Co-author: Jennifer Anderson

Opportunities to prepare the US regulatory system for future biotechnology products: Findings from a US National Academies of Sciences report
Steven P Bradbury, Iowa State University (ISU)

Enabling sound scientific decision-making for novel and familiar traits with the existing ERA framework
Pamela M Bachman, Monsanto

Gene drives on the horizon – Challenges in science, ethics, and governance
Elizabeth HeitmanUniversity of Texas Southwestern Medical Center 

Impact of synthetic biology and the implications for ERA
Maria Mercedes Roca, Institute for Science on Global Policy
Co-author: Paulo Paes Andrade

ERA and regulatory challenges – Alternative approaches
Paul Keese, University of Ghana
Co-author: Peter Thygesen