Symposia and Workshops

Below are listed the titles, organizers, and descriptions of nine symposia that will be offered over three afternoons during ISBGMO13. Conference delegates will have the option to attend any of these symposia each day.

More details will be coming about speakers and topics in each of these symposia.

MONDAY, 10 NOVEMBER 2014

Parallel Session I – The Basic Elements of ERA: Practical Approaches

Organizers: Dennis Ndolo Obonyo, International Centre for Genetic Engineering and Biotechnology (ICGEB), South Africa, and John Komen, Program for Biosafety Systems, The Netherlands

This symposium seeks to transfer the experiences and lessons learnt from 20 years of GMO ERAs to counties with an emerging interest in adopting modern biotechnology. Although the fundamentals of ERA are well established there remains a need to provide practical tools that can be used where there is limited experience and resources, but still meet stringent biosafety requirements.

One of the practical tools includes Problem Formulation, which is used to identify significant risks by establishing credible causal pathways between a new GM trait and potential harm. Problem Formulation can be used to examine issues that commonly arise during the ERA, such as gene flow, non-target organism effects, weediness, centres of origin/genetic diversity, etc.

The extensive experience from past releases will also highlight the key differences in the ERA for a field trial, with an emphasis on controls to restrict spread and persistence, from an ERA for a commercial release, which consider risks to the wider environment. In addition, many developing countries are parties to the Cartagena Protocol on Biosafety. Practical guidance will be provided to enable compliance with risk assessment as stipulated in the protocol.

Finally, some simple tools will be described to address central issues that concern any ERA. This includes issues regarding uncertainty and the means to distinguish 'need to know' from 'nice to know' information.

The agenda for Parallel Session I includes:

14:00-14:25 – Introduction to ERA and Problem Formulation
Wendy Craig, International Centre for Genetic Engineering and Biotechnology (ICGEB), Italy

14:25-15:00 – Fit for Purpose Environmental Risk Assessments: Protection Goals and Assessment Endpoints
Monica Garcia-Alonso, Estel Consult Ltd., UK

15:00-15:15 – Practical Approaches to Implementing ERA According to the Cartagena Protocol on Biosafety
Karen Hokanson, University of Minnesota, USA

15:15-15:30 – Q&A / Panel Discussion
Dennis Ndolo Obonyo (moderator), International Centre for Genetic Engineering and Biotechnology (ICGEB), South Africa
John Komen (moderator), Program for Biosafety Systems, The Netherlands

15:30-16:00 – Coffee Break

16:00-16:25 – Problem Formulation for an Environmental Risk Assessment for the Introduction of GE Weevil-Resistant Sweetpotato in Uganda
Barbara Z Mugwanya, Uganda Biosciences Information Center, National Crop Resources Research Institute, Uganda
Rebecca Grumet, Michigan State University, USA
Jim Hancock, Michigan State University, USA
Hector Quemada, Donald Danforth Plant Science Center, USA

16:25-16:50 – Regulatory Aspects of Environmental Risk Assessment – Case Study of Africa Crops
Moussa Savadogo, NEPAD African Biosafety Network of Expertise (ABNE), Burkina Faso

16:50-17:15 – Practical Tools to Address Data Requirements and Uncertainty
Paul Keese, Office of the Gene Technology Regulator (OGTR), Australia

17:15-17:30 – Discussion
Dennis Ndolo Obonyo, (moderator), International Centre for Genetic Engineering and Biotechnology (ICGEB), South Africa
John Komen (moderator), Program for Biosafety Systems, The Netherlands

Parallel Session II – RNAi and Environmental Risk Assessment of GE Plants

Organizer: Andrew F Roberts, Center for Environmental Risk Assessment, ILSI Research Foundation, USA

RNA interference (RNAi) refers to a set of conserved biological processes whereby a dsRNA sequence initiates post-transcriptional silencing of a target gene. There are multiple known variations, but most involve the processing of the dsRNA into multiple short sequences known as small interfering RNAs (siRNA) by one of a family of related proteins known as Dicer. These siRNA molecules then associate with a protein complex known as the RNA Induced Silencing Complex (RISC) which binds to a target sequence on a strand of messenger RNA blocking transcription.

The use of RNAi in genetically engineered plants has included multiple novel viral resistance phenotypes, pest protection methods, and other phenotypes. The technology has generated tremendous interest from researchers, product developers and regulators and there remain uncertainties associated with how these plants will be regulated and how the modalities used for environmental risk assessment of "traditional” GE plants can be applied to plants with RNAi based phenotypes.

This symposium will consider the underlying biology behind the RNAi mechanism, current and near future applications of the technology in GE plants, data on environmental exposure and susceptibility to RNAi as it relates to non-target organisms, as well as regulatory perspectives on the technology.

The agenda for Parallel Session II includes:

Section 1: Problem Formulation for RNAi
14:00-14:10 Introduction
Andrew Roberts, Center for Environmental Risk Assessment, ILSI Research Foundation, USA

14:10-14:30 Non-Target Organism Testing, Environmental Fate and Ecological Risk Assessment for an RNAi Plant Incorporated Protectant
Pamela Bachmann, David Carson, Sam Dubelman, Josh Fischer, Jennifer Fridley, Peter Jensen, Geoff Mueller, Mark Paradise, Jianguo Tan, Josh Uffman, Fatima Zapata, Steve Levine, Monsanto Company, USA

14:30-14:50 Biosafety Considerations of RNAi-Mediated Virus Resistance in Fruit-Tree Cultivars and in Rootstock 
Godwin Nana Yaw LemgoNEPAD Agency – African Biosafety Network of Expertise (ABNE), Burkina Faso
Silvia Sabbadini and Bruno Mezzetti, Universita Politecnica delle Marche, Italy
Tiziana Pandolfini, University of Verona, Italy

Section 2: Susceptibility of Organisms to Environmental RNA
14:50-15:10 Differential Response in Non-Target Arthropods to dsRNA-Mediated RNAi
Pan Huipeng and Xuguo "Joe" ZhouUniversity of Kentucky, USA
Ana Veleza and Blair Siegfried, University of Nebraska, USA
Xiaowei Yang, University of Kentucky, USA, Cornell University, USA

15:10-15:30 Evidence for Uptake and Function of Plant-Produced MicroRNAs in Mammals 
Victoria Vance, University of South Carolina, USA

15:30-16:00 Coffee Break

16:00-16:20 Evaluating Oral Uptake and Function of RNAi Effectors in Mammals
Ken Witwer, Johns Hopkins School of Medicine, USA

Section 3: ERA Perspectives
16:20-16:40 Testing International Scientific Workshop "Risk Assessment Considerations for RNAi-based GM Plants" (4-5 June, Brussels)
Yann Devos, Matthew Ramon, Andrea Gennaro, Ana Gomes, Anna Lanzoni, Yi Liu and Elisabeth Waigmann, European Food Safety Authority (EFSA), Italy

Section 4: Moderated Panel Discussion 
16:40-17:30 Panel Discussion
Alan Gray (moderator), Center for Hydrology and Ecology, UK & President-elect International Society for Biosafety Research (ISBR) 

Parallel Session III – The Long and Winding Road for Regulatory Approval of GM Forest Trees

Organizers: Armand Séguin, Canadian Forest Service, Natural Resources Canada, Canada, Steve Strauss, Oregon State University, USA, Zander Myburg, Forestry and Agricultural Biotechnology Institute, University of Pretoria, South Africa, and Hely Häggman, University of University of Oulu, Finland 

Forests are vital to human and ecological health, and also provide valuable fuels, chemicals, and industrial products. Due to mounting human demands, exotic pests, and climatic stresses, pressure on natural forests is increasing, leading to degradation and over-exploitation.

Genetic modification (GM), combined with conventional breeding and biotechnologies, provide valuable tools to help improve forest health, ecological resilience, and productivity. However their use is highly constrained by social mechanisms, most notably regulatory obstacles.

Genetically modified forest trees have been developed and studied in many parts of the world, but field trials are rare and increasingly difficult to get approval for – making commercially relevant research very difficult or impossible to carry out. The only commercial release of GM forest trees that appears to be taking place is in China, where insect-resistant poplars are grown on a small scale. Only two other candidates – eucalypts with modified wood and cold-tolerance/male-sterility – are on the near horizon for commercial deployment.

This session will explore the question: can this change? Several leading transgenic tree development projects will be presented to frame the session, including those for industrial plantations and for improvement of the health of wild forests. These case studies will be complemented by additional presentations that explore the broader regulatory and social framework, including the challenges of performing environmental risk assessments for GM forest trees. This will set the scene for a dynamic discussion about the intersection of science, regulation, and policy in transgenic forest biotechnology.

The agenda for Parallel Session III includes: 

14:00-14:15
 Research Progress in Genetic Engineering of Forest Trees; Where Are We Now?
Armand Seguin, Natural Resources Canada, Canada 

14:15-14:40 Biosafety of a Yield-Enhancing Genetically Modified Eucalyptus
Eugenio Cesar Ulian and Othon Silva Abrahao, FuturaGene Ltd., Brazil 

14:40-15:05 Can Genetically Modified Trees Help Address Forest Health Challenges? The American Chestnut Biological and Regulatory Test Case
Adam CostanzaInstitute of Forest Biotechnology, North Carolina, USA
Scott Merkle, University of Georgia, USA
William Powell, SUNY College of Environmental Science and Forestry, USA

15:05-15:30 Regulatory Challenges of Genetically Engineered Forest Trees: Lessons from the European Union COST Project
Hely HäggmanUniversity of Oulu, Finland
Gilles Pilate, INRA, Amélioration, Génétique, et Physiologie Forestières, France
Fernando Gallardo, Universidad de Málaga, Spain
Luca Ionita, Forest Research and Management Institute, Romania
Marja Ruohonen-Lehto, The Finnish Environment Institute, Finland; 6 RIVM/SEC/GMO Office, Belgium
Boet Glandorf, Stefano Biricolti and Donatella PaffettiUniversity of Florence, Italy
Antoine Harfouche, Università della Tuscia, Italy
Vassiliki Kazana, Department of Forestry & Natural Environment Management, Greece
Mirjana Sijacic-Nikolic, University of Belgrade, Serbia
Lambros Tsourgiannis, Region of Eastern Macedonia-Thrace, Greece
Fabio Migliacci, Organo Metallic Chemistry Compound Institute CNR, Italy
Francesca Donnarumma and Cristina Vettori, Plant Genetics Institute CNR, Italy
Klaus Minol, Genius GmbH, Germany
Matthias Fladung, Thunen-Institute of Forest Genetics, Germany

15:30-16:00 Coffee Break

16:00-16:25 Regulation of Genetically Engineered Forest Trees in the United States
Pauline Spaine, Subray Hegde, Donna Lalli, Susan Koehler, John Turner, Kham Vongpaseuth, USDA/APHIS, USA

16:25-16:50 Stepping Back: How Can We Improve Regulatory Reviews to Promote Innovative and Safe Uses of Genetically Modified (GM) Trees?
Steven H Strauss, Oregon State University, USA

16:50-17:30 Discussion
Cristina Vettori (moderator), Institute of Bioscience and Bioresources - CNR, Italy 

TUESDAY, 11 NOVEMBER 2014

Parallel Session IV – Risk Assessment Experiences and Capacity Building in Africa

 Organizers: Karim Maredia, Michigan State University, USA, and Julius Ecuru, Uganda National Council for Science and Technology, Uganda

Governments in Africa and development agencies are working towards building functional biosafety systems so that regulatory decisions can be made and millions of smallholder farmers in Africa can benefit from safe biotech crops towards enhancing their productivity and food security.

This session will present case studies and practical experiences on risk assessment of genetically modified crops in four countries in Sub-Saharan Africa (Ghana, Burkina Faso, Uganda, and South Africa). It will also present the AU/NEPAD and ICGEB perspectives and biosafety capacity building programs of NEPAD African Biosafety Network of Expertise (ABNE) and ICGEB currently implemented in Sub-Saharan Africa.

The agenda for Parallel Session IV includes:

14:00-14:10 – Introduction
Julius Ecuru, Uganda National Council for Science and Technology, Uganda

14:10-14:30 – The ICGEB Biosafety Capacity Building Project for Sub-Saharan Africa: Experiences, Challenges and Lessons Learnt over the Last Five Years
Dennis Ndolo Obonyo, International Centre for Genetic Engineering and Biotechnology (ICGEB), South Africa
Wendy Craig, Decio Ripandelli, Francesca Farolfi, ICGEB, Italy

14:30-14:50 – Matching National Biosafety Regulatory Norms with International Best Practices: The Work of the Uganda National Biosafety Committee
Yona Baguma, Julius Ecuru, Charles Mugoya, Gilbert Gumisiriza, Uganda National Council for Science and Technology, Uganda

14:50-15:10 – Bt Cowpea Risk Assessment Experiences in Burkina Faso
Oumar Traore, Jean-Baptiste Tignegre, Institut de l'Environnement et de Recherches Agricoles (INERA), Burkina Faso

15:10-15:30 – Practical Human Capital Development – Lessons from South African GMO Introductions
Ben Durham, Department of Science and Technology, South Africa

15:30-16:00 – Coffee Break

16:00-16:20 – Risk Assessment of GM Crops – The Ghana Experience
Yaa Osei,University of Ghana-Legon, Ghana

16:20-16:40 – Challenges Facing Development and Implementation of Biosafety Systems in Africa
Diran Makinde, NEPAD Agency African Biosafety Network of Expertise (ABNE), Burkina Faso

16:40-17:00 – Enhancing Regulatory Systems for Science-based Biosafety Decision-making on Genetically Engineered Crops in Africa
Samuel Timpo, NEPAD Agency African Biosafety Network of Expertise (ABNE), Burkina Faso; Michigan State University
Hashini Galhena, Michigan State University, USA; University of Idaho, USA
Joseph Guenthner, University of Idaho, USA
Godwin Lemgo, NEPAD Agency African Biosafety Network of Expertise (ABNE), Burkina Faso
Karim Maredia, Michigan State University, USA

17:00-17:30 – Discussion
Karim Maredia (moderator), Michigan State University, USA 

Parallel Session V – Quality of Scientific Studies Supporting the Non-target Risk Assessment of Transgenic Plants

Organizers: Yann Devos, GMO Unit, European Food Safety Authority (EFSA), Italy and Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Switzerland

Laboratory and field experiments are a major part of the risk assessment studies performed to assess potential adverse effects of genetically modified (GM) plants on non-target organisms (NTO) and the ecological and anthropocentric functions they provide. Yet, the critical evaluation of the quality of such studies remains a contentious issue of debate in some juristictions.

To ensure that robust and reliable data are generated and that informative studies are conducted, any study should be reproducible, and be carried out in such a way that it minimises the probability of erroneous or inconclusive results. It is therefore important that studies comply with defined quality standards and procedures, as this increases confidence in the results and adds certainty to the conclusions drawn.

This workshop will consider good practices to comply with when designing laboratory and field studies on non-target effects of GM plants, and when analysing/interpreting the generated data. Moreover, criteria to appraise the quality of NTO studies will be proposed and discussed.

The agenda for Parallel Session V includes: 

Section 1: Introduction
14:00-14:05 Introduction
Yann Devos, European Food Safety Authority (EFSA), Italy
Joerg Romeis, 
Agroscope, Institute for Sustainability Sciences ISS, Switzerland

14:05-14:20 Steps to Assure Data Quality from Problem Formulation Through Risk Characterization
Raymond Layton, DuPont Pioneer, USA 

Section 2: Laboratory Studies
14:20-14:35 Good Practices for the Experimental Design of Laboratory Studies
Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Switzerland 

14:35-14:50 An Index for the Critical Appraisal of Ecotoxicological Laboratory Studies Supporting the Environmental Risk Assessment of GM Plants
Yann DevosEuropean Food Safety Authority (EFSA), Italy
Adinda De Schrijver, Scientific Institute of Public Health, Belgium
Patrick De Clercq, Ghent University, Belgium
Achim Gathmann, Federal Office of Consumer Protection and Food Safety (BVL), Germany
Michael Meissle and Joerg Romeis,
Agroscope, Institute for Sustainability Sciences ISS, Switzerland 

Section 3: Field Studies
14:50-15:05 Good Practices for the Experimental Design of ERA-GMO Field Studies
Richard L Hellmich, USDA–ARS & Iowa State University, USA 

15:05-15:20 Appraisal Criteria for the Experimental Design of Field Studies on Non-Target Effects of GE Crops
Michael Meissle, Judith Riedel and Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Switzerland 

15:20-15:30 Panel Discussion 

15:30-16:00 Coffee Break 

Section 4: Challenges
16:00-16:15 Testing for Synergism Among Multiple Insecticidal Proteins Produced in Stacked Transgenic Crop Events
Gerson GraserSyngenta Crop Protection, USA
Alan Raybould, Syngenta, Jealott’s Hill International Research Centre, UK

Section 5: Perspective of Risk Assessors from the Public and Private Sector
16:15-16:30 Study Quality and Regulatory Decision-Making: Evaluating Ecotoxicological Data Supporting the Non-Target Risk Assessment of Plant Incorporated Protectants (PIPs)
Steven L Levine and Pamela M Bachman, Monsanto Company, USA 

16:30-16:45 The Australian Regulatory Approach to Quality Appraisal of NTO Studies 
Alison Wardrop and Joe Smith, Office of the Gene Technology Regulator, Australia 

16:45-17:00 European Risk Assessor Perspective on the Quality of in vivo Bioassays 
Adinda De Schrijver, Scientific Institute of Public Health, Belgium
Patrick De Clercq, Ghent University, Belgium
Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Switzerland

Session 6: Moderated Discussion
17:00-17:30 Panel Discussion on Appraisal Criteria
Andrew Roberts (moderator), Center for Environmental Risk Assessment, ILSI Research Foundation, USA

Parallel Session VI – Science Communication: A Global Perspective on Best Practice

Organizers: Kristina Sinemus, Quadriga University, Germany, Liezel Gouws, Biosafety South Africa, South Africa, and Hennie Groenewald, Biosafety South Africa, South Africa

Risk and science communication is increasingly being identified as the most critically neglected aspects of the risk analysis process for genetically modified organisms (GMOs). On the one hand, science-driven innovations and applications are important for the society, but on the other hand, it has become a highly politically charged endeavour. The imbalance in the messages that are communicated to policy makers and the general public, via accessible communication platforms such as the internet, results in inaccurately informed decision makers.

It is important to develop effective and practical tools to communicate different aspects of science, its strategies and results/products in a more targeted, resolute and comprehensible manner. In addition, the scientific community, and specifically biosafety researchers, should be perceptive to the requirements, concerns, ambiguities, etc. of the general public and regulators, i.e. risk communication should always be a two-way street.

The goal of the workshop will therefore be to:

  • give participants an opportunity to learn from each other’s experiences; and
  • develop a science/risk communication roadmap, which focuses on the biosafety of GMOs, by drawing from the experiences of different countries/individuals and the lessons that they have learnt.

The agenda for Parallel Session VI includes:

14:00-14:10 – Introduction
Hennie Groenewald, Liezel Gouws, Biosafety South Africa, South Africa
Kristina Sinemus, Quadriga University, Germany

14:10-14:25 – TBA
Martin Lema, Ministry of Agriculture, Livestock and Fisheries, Argentina

14:25-14:40 – Risk Communication – Tanzania/ Africa
Flora Ismail Tibazarwa, Tanzania Commission for Science and Technology, Tanzania

14:40-14:55 – Science & Risk Communication on Gmos in the EU- Our Experience
Kristina Sinemus, Quadriga University, Germany

14:55-15:10 – The Importance of Social Media: Twitter 101
Elizabeth Williams, Center for Environmental Risk Assessment, ILSI Research Foundation, USA

15:10-15:30 – General Discussion
Kristina Sinemus (moderator), Quadriga University, Germany
Hennie Groenewald (moderator), Biosafety South Africa, South Africa

15:30-16:00 – Coffee Break

16:00-17:00 – Interactive Discussion and Workshopping
Kristina Sinemus, Quadriga University, Germany

 17:00-17:20 – Reflection and Analysis
Hennie Groenewald, Liezel Gouws, Biosafety South Africa, South Africa
Kristina Sinemus, Quadriga University, Germany

 17:20 -17:30 – Summary and Conclusion
Hennie Groenewald, Liezel Gouws, Biosafety South Africa, South Africa
Kristina Sinemus, Quadriga University, Germany 

WEDNESDAY, 12 NOVEMBER 2014

Please note that to accommodate a special series of submitted presentations on the morning of November 12th, the parallel sessions on November 13th have been renumbered. All other details of the sessions on that date are unchanged.

Parallel Session VII – Submitted Presentations 1 

Section 1: Target and Non-Target Effects of GM Plants
Moderator: Nora Eckermann, Bayer CropScience, Monheim, Germany 

9:00-9:15 – Potential Use of an Arthropod Database to Support the Non-Target Risk Assessment and Monitoring of Transgenic Plants
Michael Meissle, Judith Riedel, Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland 

9:15-9:30 – Transportability of Relevant Laboratory and Field Data for the Environmental Risk Assessment of Genetically Modified Crops
David Carson, Duska Stojsin, Aqeel Ahmad, Peter Asiimwe, Sarah Donelson, Chris Brown, Michael Horak, Bernard Sammon, Monsanto Company, St. Louis, USA 

9:30-9:45 – Development of a Dietary Toxicity Assay for Assess the Potential Effects of Insecticidal Proteins on the Ladybird Beetle Propylea Japonica
Yunhe Li, State Key Laboratory for Biology of Plant Diseases and Insect Pests, Institute of Plant Protection, Chinese Academy of Agricultural Sciences, Beijing, China
Joerg Romeis, State Key Laboratory for Biology of Plant Diseases and Insect Pests, Institute of Plant Protection, Chinese Academy of Agricultural Sciences, Beijing, China; Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland
Yufa Peng, State Key Laboratory for Biology of Plant Diseases and Insect Pests, Institute of Plant Protection, Chinese Academy of Agricultural Sciences, Beijing, China

9:45-10:00 – Target and Non-Target Effects of a Spider Venom Toxin (Ω-Hexatoxin-Hv1a) Produced in Transgenic Cotton and Tobacco Plants
Inaam Ullah, National Institute for Biotechnology and Genetic Engineering (NIBGE), Faisalabad, Pakistan; Pakistan Institute of Engineering and Applied Sciences (PIEAS), Islamabad, Pakistan; Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland
Fernando Alvarez-Alfageme, Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland
Steffen Hagenbucher, Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland
Muhammad Ashfaq, National Institute for Biotechnology and Genetic Engineering (NIBGE), Faisalabad, Pakistan
Joerg Romeis, Agroscope, Institute for Sustainability Sciences ISS, Zurich, Switzerland

10:00-10:15 - Inerational Effects of Cry1Ab Released from Bt-Corn Straw on Life-History Traits of Eisenia Fetida
Yinghua Shu,Yanyan Zhang, Jianwu Wang, College of Agriculture, South China Agricultural University, Guangzhou, China

 10:15-11:00 – Coffee Break

 Moderator: Richard L Hellmich, USDA–ARS & Iowa State University, USA

 11:00-11:15 – Field Evaluations of Maize Expressing Rnai-Based Insect Protected Trait on Non-Target Organisms
Aqeel Ahmad, Peter Asiimwe, Monsanto Company, USA
Wladecir Oliveira, Vertuan Hallison, Daniel Soares, Monsanto do Brasil Ltda., Brazil
Damian Grimi, Ignacio Negri, Monsanto Argentina SAIC, Argentina
Changjian Jiang,Monsanto Company, USA

11:15-11:30 – Post Marked Field Monitoring and Evolution of Occurrence of Spodoptera Frugiperda (Smith) (Lepidoptera: Noctuidae) in Bt Maize in Brazil
Fernando H Valicente, Embrapa Milho e Sorgo, Sete Lagoas, Brazil
Camila SF Souza, Marcos AM Fadini, Priscilla T Nascimento, Donald Manigat, André HC Mourão, Arthur AG Torres, Priscila M. de Paiva, Universidade de São João Del Rei, Sete Lagoas, Brazil

 Section 2: Disease-Resistant GM Plants
11:30-11:45 – Biological Safety Assessment of a Novel Antifungal Protein, mASAL the Mutant Variant of Allium Sativum Leaf Agglutinin (ASAL)
Sampa Das, Prithwi Ghosh, Bose Institute, Kolkata, India

 11:45-12:00 – Potatoes with Late Blight Resistance: Risk Assessment for R-Proteins
Susan Collinge, Jeffrey Habig, Jingsong Ye, Nikolaos Georgelis, Matt Pence, Pete Clark, J.R. Simplot Co., Boise, Idaho, USA

 12:00-12:15 – Assessing the Impact of Genetically Modified Plants on the Environment Using NGS: A Case Study on Transgenic Grapevine Rootstocks Expressing Viral Coat Protein and Bacterial NPTII Transgenes
Sandrine Demanèche, Ecole Centrale de Lyon, UMR CNRS 5005 Laboratoire Ampère, ‘Génomique Microbienne Environnementale’, Ecully Cedex, France 
M Beuve, S Djennane, O Lemaire, INRA, UMR 1131 ‘Santé de la Vigne et Qualité du Vin’, Université de Strasbourg, Colmar, France
P Simonet, Ecole Centrale de Lyon, UMR CNRS 5005 Laboratoire Ampère, ‘Génomique Microbienne Environnementale’, Ecully Cedex, France

 1:15-12:30 – Cost Analysis of Producing a Transgenic Late Blight Resistant Potato Variety By Non-Profit Institution Reveals Much Lower Cost Than That of the Private Sector
Benjamin Schiek, Marc Ghislain,Sub-Saharan Africa regional office, International Potato Center, Nairobi, Kenya

Parallel Session VIII – Submitted Presentations 2

Part 1: Vertical Gene Flow, Weediness and Invasiveness 

Moderator: Patrick Rudelsheim, Perseus, Belgium 

9:00-9:15 – Relevance of Crop Biology for Environmental Risk Assessment (ERA) of Genetically Modified Crops in Africa
Olalekan Akinbo, NEPAD African Biosafety Network of Expertise, Abuja, Nigeria
James F Hancock, Michigan State University, East Lansing, Michigan, USA

9:15-9:30 – There is More to Fitness Than Fecundity: Demographic Analysis to Evaluate Genetically Modified Crops
Linda Hall, Brendan Alexander, University of Alberta, Edmonton, Canada
Hugh Beckie, Agriculture and Agri-Food Canada, Saskatoon, Saskatchewan, Canada
Marie-Josée Simard, Agriculture and Agri-Food Canada, Quebec City, Quebec, Canada
David Clements, Trinity Western University, Langley, British Columbia, Canada
Robert Nurse, Agriculture and Agri-Food Canada, Harrow, Ontario Canada
Mark Lewis, University of Alberta, Edmonton, Canada

9:30-9:45 – Sugarcane Seed and Seedling Physiology: Knowledge to Support Environmental Risk Assessment for GM Deployment
Johann S Pierre, JM Perroux, AL Rae, GD Bonnett, CSIRO, St Lucia, Australia

9:45-10:00 – Regulatory Compliance: Confined Field Trial of Africa Biofortified Sorghum in Kenya and Nigeria and Impact of Gene Flow on the Environment
Silas D Obukosia, Africa Harvest Biotechnology Foundation International
Esther Kimani, Kenya Agricultural Research Institute
Mary Yeye, Institute of Agricultural Research
Florence Wambugu, Daniel Kamanga, Africa Harvest Biotechnology Foundation International
Titus Magomere, University of Nairobi
Jim Gaffney, DuPont Pioneer Incl
Michael Njuguna
Kenneth Mburu, Africa Harvest Biotechnology Foundation International
Simon Gichuki, Kenya Agricultural Research Institute
Rose Gidado, BO Solomon, National Biotechnology Development Agency
Daniel Aba, Institute of Agricultural Research
Antony Aseta, Anthony Korir, Evans Mwasame
Marc Albertsen, Che Ping, Zhao, Zuo-Yu, DuPont Pioneer Incl
Christopher Ngichabe and Dominique Nzeve

11:00-11:15 – Assessing Genetically Engineered Insect-Resistant Rice in China: Potential Environmental Impacts from Transgene Flow

Bao-Rong Lu, Ministry of Education Key Laboratory for Biodiversity Science and Ecological Engineering, Department of Ecology and Evolutionary Biology, Fudan University, Shanghai, China

10:15-11:00 – Coffee Break

Moderator: Joachim Schiemann, Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Germany

11:00-11:15 – Brassica napus Culture and Potential Hybridization with Sinapis arvensis
Anna Buonamici, Institute of Bioscience and Bioresources - CNR, UOS FI, Sesto Fiorentino, Italy
Donatella Paffetti, Stefano Biricolti, Dipartimento di Scienze delle Produzioni Agroalimentari e dell'Ambiente (DISPAA), University of Florence, Florence, Italy
Davide Travaglini, Dipartimento di Gestione dei Sistemi Agrari, Alimentari e Forestali (GESAAF), University of Florence, Florence, Italy
Elena Balducci, Institute of Bioscience and Bioresources - CNR, UOS FI, Sesto Fiorentino, Italy
Valeria Tomaselli, Institute of Bioscience and Bioresources - CNR, Bari, Italy
Mariaceleste Labriola, Institute of Bioscience and Bioresources - CNR, UOS FI, Sesto Fiorentino, Italy; Dipartimento di Scienze delle Produzioni Agroalimentari e dell'Ambiente (DISPAA), University of Florence, Florence, Italy
Francesca Bottalico, Dipartimento di Gestione dei Sistemi Agrari, Alimentari e Forestali (GESAAF), University of Florence, Florence, Italy
Alessandro Materassi, Gianni Fasano, Institute for Biometeorology - CNR, Sesto Fiorentino, Italy
Cristina Vettori, Institute of Bioscience and Bioresources - CNR, UOS FI, Sesto Fiorentino, Italy

11:15-11:30 – Pollen-Mediated Gene Flow from Genetically Modified Wheat Plants

Dmitry Miroshnichenko, Biotron, Branch of Institute of Bioorganic Chemistry RAS, Pushchino, Russia
Sergey Dolgov, All-Russian Research Institute of Agricultural Biotechnology, Moscow, Russia

Part 2: Varia
11:30-11:45 – Risk Assessment of a Novel Aquatic Animal for Commercial Production in Canada
Colin McGowan, C Mimeault, I Stefanov, R Leggatt, J Beardall, Department of Fisheries and Oceans, Ottawa, Canada

11:45-12:00 – Lack of Transparency on Environmental Risks Assessment of Genetically Engineered Crops before Their Commercial Release
Borys Sorochynskyi, Biotron;Ukrainian Club of Agrarian Business” Association, Kyiv, Ukraine

12:00-12:15 – Stakeholder Scrutiny of GMO Toxicity Studies
Armin Spoek, Gloria Adduci, IFZ-Inter-University Research Centre for Technology, Work and Culture, Alpen-Adria Universitaet Klagenfurt- Wien-Graz, Graz, Austria
Greet Smets, Perseus BVBA, Zwijnaarde, Belgium
Sandra Karner, IFZ-Inter-University Research Centre for Technology, Work and Culture, Alpen-Adria Universitaet Klagenfurt- Wien-Graz, Graz, Austria
Christian Kohl, Ralf Wilhelm, Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Quedlinburg, Germany
Patrick Ruedelsheim, Perseus BVBA, Zwijnaarde, Belgium
Joachim Schiemann, Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Quedlinburg, Germany

12:15-12:30 – Challenges with Uncertainty in Biosafety Decisions
Anne Ingeborg Myhr, GenOk – Centre for Biosafety, Tromso, Norway

 

Details of Parallel Session IX Submitted Presentations 3 will be posted shortly.

 

THURSDAY, 13 NOVEMBER 2014

Please note that the Parallel Sessions below have been renumbered to accommodate a special series of submitted presentations on the morning of November 12th. All other details of the sessions are unchanged.

Parallel Session X – Evidence Synthesis: A New Tool Informing the Impact Assessment of GMOs

Organizers: Joachim Schiemann, Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Germany, and Neal Haddaway, Bangor University, UK

Evidence synthesis approaches, such as systematic reviews (SR) and systematic maps (SM), represent powerful tools to identify, collect, summarise and appraise primary research in an objective, transparent and reproducible manner. Thus, they allow evidence to be synthesised to answer questions regarding a specific issue of concern and are especially valuable in informing decision-making processes for controversial or high profile topics.

Workshop participants will get an insight into the methods underlying the different evidence synthesis approaches, the importance of active stakeholder involvement throughout the process, and how SRs and SMs are currently applied by the EU-funded project GRACE (GMO risk assessment and communication of evidence) to inform the impact assessment process of GMPs. An example of the influence of evidence syntheses on policy-making (a SR on the impact of urban greening on mitigating heatwaves, which informed the Heatwave Plan for England) will be provided. Furthermore, participants will be familiarized with the open-access database CADIMA (Central Access Database for Impact Assessment of Crop Genetic Improvement Technologies), which supports review teams and stakeholders in preparing, undertaking and using reviews.

The workshop will finish with a discussion on the adequacy of the presented evidence synthesis approaches in contributing to an evidence-based impact assessment process.

The agenda for Parallel Session X includes: 

14:00-14:05 Introduction
Joachim Schiemann, Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Germany 

14:05-14:25 An Introduction to Evidence Synthesis Approaches and Their Suitability in Solving Specific Problems 
Neal Haddaway, Bangor University, UK 

14:25-15:05 Evidence Synthesis and its Capability to Inform Evidence-Based Decision Making Processes
Neal Haddaway, Bangor University, UK

15:05-15:30 Evidence Synthesis: The GRACE Approach 
Christian Kohl, Ralf Wilhelm and Joachim Schiemann, Julius Kuhn Institute, Federal Research Centre for Cultivated Plants, Germany
Armin Spoek, IFZ-Inter-University Research Centre for Technology, Work and Culture, Austria

15:30-16:00 Coffee Break

16:00-16:20 Systematic Reviews and Evidence Synthesis of Environmental Impacts of GM Plants in the GRACE Project
Jeremy Sweet, Sweet Environmental Consultants, UK
Kaloyan Kostov, Agrobio Institute, Bulgaria
Michael Meissle, Judith Riedel and Joerg Romeis,
 Agroscope, Institute for Sustainability Sciences  ISS, Switzerland
Steven E Naranjo, USDA-ARS, Arid-Land Agricultural Research Center,USA
Christian Kohl, Julius Kuhn Institute, Federal Research Centre for Cultivated Plants, Germany
Christian Frolund Damgaard and Paul Henning Krog, Aarhus University, Department of Bioscience, Denmark
Niels Bohse Hendriksen, Aarhus University, Department of Environment, Denmark 
Achim Gathmann and Kai Priesnitz, Federal Office of Consumer Protection and Food Safety (BVL), Germany

16:20-16:45 An Introduction to "CADIMA” and Online Tools Developed to Support Evidence Synthesis
Stefan Unger and Steffen Kecke, Julius Kuhn Institute, Federal Research Centre for Cultivated Plants, Germany
Wendy Craig, International Centre for Genetic Engineering and Biotechnology (ICGEB), Italy

16:45-17:00 Discussion
Joachim Schiemann (Moderator), Julius Kuhn Institute (JKI), Federal Research Centre for Cultivated Plants, Germany

 Parallel Session XI – The Design and Implementation of IRM Programs for GM Crops

Organizers: Graham Head, Monsanto Company, USA, Johnnie van den Berg, North West University, South Africa, and Richard L Hellmich, USDA–ARS & Iowa State University, USA

Insect-protected GM crops (Bt crops) have been broadly adopted in more than 15 countries, providing growers with an a simple and effective alternative to conventional insecticides. The primary threat to these technologies is insect resistance.

To address this threat, insect resistance management (IRM) programs have been proactively implemented wherever Bt crops have been released. After 17 years of global experience with Bt crops, and with a number of recent cases of resistance identified, an evaluation of IRM strategies for Bt crops is timely, all the more so because new releases of Bt crops are greatest in developing countries where the IRM challenges are greatest. Experience from developing countries has shown that the large number of small-holder farmers and the limited scientific and technical capacity in such countries poses special challenges for stewardship programs.

This session will examine the design and implementation of Bt crop IRM programs, and stewardship programs more generally. A variety of perspectives will be presented, with data drawn from various regions and including public and private sector speakers. Data from known resistance cases will be discussed. Emphasis will be placed on the needs and challenges related to implementing stewardship programs in developing countries and Africa in particular.

The agenda for Parallel Session XI includes:

14:00-14:10 – Introduction
Johnnie van den Berg, North West University, South Africa

14:10-14:30 – Applications of New Insights on Bacillus thuringiensis Toxin Mode of Action to Resistance Management
David G Heckel, Max Planck Institute for Chemical Ecology , Germany

14:30-14:50 – Increasing Levels of Resistance in Weed and Pests – What Can Be Learned from the Use of Antibiotics in Medicine
Orjan Olsvik, University of Tromso and GenOk – Centre for Biosafety, Norway

14:50-15:10 – Designing and Implementing IRM Programs for Bt Crops
Graham Head, Monsanto Company, USA
Nick Storer, Dow Agroscience, USA

15:10-15:30 – Experiences with Bt Crop IRM in the United States
Richard L Hellmich, USDA-ARS and Iowa State University, USA

15:30-16:00 – Coffee Break

16:00-16:20 – African Maize Stem Borer Resistance to Bt Corn in South Africa: Implications for IRM in Africa
Johnnie van den Berg, North West University, South Africa

16:20-16:40 – Challenges for the Design and Implementation of IRM and Stewardship Programs within Public-Private Partnerships
James A Okeno, Sylvester Oikeh, Gospel Omanya, African Agricultural Technology Foundation (AATF), Kenya
Steven Mugo, Bruce Anani, Tadele Tefera, International Maize and Wheat Improvement Center (CIMMYT), Kenya

16:40-17:00 – Stewardship Programs for Bt Crops in Africa
Kulani Machaba, DuPont Pioneer, South Africa

Parallel Session XII – Capturing and Addressing Public Input to Biosafety Decisions: Realities and Useful Experiences

Organizers: Megan Quinlan, Imperial College London, UK, and Joe Smith, former Gene Technology Regulator, Australia 

Public engagement is encouraged and desired by most parties involved in biosafety decisions. Engaging with the public, however, can be complex and inconclusive. This symposium provides insights into engaging the public based on ERAs for biosafety decision making, including practical advice and personal experiences.

The speakers from national biosafety frameworks have faced the challenge of discerning which input is representative of the general public or has arisen from outside the affected communities; and of considering everything from intricate scientific debate to highly emotional and contentious statements of values. Recognizing the values underlying the frameworks helps to clarify best approaches for engagement, e.g., public comment, public education, or two-way communication. Industry, similarly, seeks engagement for various purposes. An ERA can be an effective tool for engagement by industry, or provide a chink for opponents to leverage.

Speakers will share what has worked and what has not. The symposium should be of interest to regulators tasked with addressing public input, industry and researchers whose applications will be affected by the public input, educators, and other participants in civil society. Participants in the symposium will be asked to consider best practices for addressing both the technical issues and social values raised by the public, in a final panel discussion.

The agenda for Parallel Session XII includes: 

14:00-14:10 Introduction: Who is the Public? Why are We Asking for Input? 
Megan Quinlan, Imperial College London, UK

14:10-14:30 Efficient Methods for Collecting and Classifying Public Input to Biosafety Decisions
Louise Ball, Department for Environment Food & Rural Affairs, UK 

14:30-14:50 Making Decisions in the Face of External Influences to Public Input
Merle B Palacpac and Ma Lorelie U Agbagala, Bureau of Plant Industry-Plant Quarantine Service, Philippines 

14:50-15:10 The Value and Effectiveness of Risk Communication in Biosafety Decision-Making: An Industry Perspective 
Raymond Layton, DuPont Pioneer, USA 
 
15:10-15:30 Acknowledging Public Input – The Importance of a Systemic Approach to Both Technical Issues and Social Values 
Paul Keese, Office of the Gene Technology Regulator, Australia 

15:30-16:00 Coffee Break

16:00-16:20 Public Input into US Biotechnology Regulatory Decisions
Kham Vongpaseuth and Susan Koehler, United States Department of Agriculture, Animal and Plant Health Inspection Service, USA 

16:20-16:55 Discussion
Joe Smith (Moderator) Former Gene Technology Regulator, Australia 

16:55-17:00 Conclusions
Megan Quinlan, Imperial College London, UK