Tuesday, April 2


09:00 - 13:00


Session Organizers: Heidi Mitchell , Office of the Gene Technology Regulator, Australia and Joerg Romeis , Agroscope, Switzerland

Keynote Speaker: DR. JEFF WOLT, Professor Emeritus of Agronomy at Iowa State University
“Current Environmental Risk Assessment for Genetically Modified Organisms and Implications for Gene Edited Products”
Genome editing allows very precise alterations of genomes and the first products have already been commercialized. This session will address the challenges these products pose to regulators and risk assessors. In particular, we are interested in how genome edited organisms differ from those developed by conventional breeding or genetic engineering. The session will address how genome editing helps to derive desired traits, whether existing regulations are fit-for purpose to deal with such products and how problem formulation can support the risk assessment.

Jeffrey Wolt, Professor Emeritus of Agronomy at Iowa State University
PL II - 1 Current Environmental Risk Assessment for Genetically Modified Organisms and Implications for Gene Edited Products.

Mitch Abrahamsen,
Recombinetics Inc., USA
PL II – 2

David Hamburger, University of Passau, Faculty of Law, Passau, Germany
PL II - 3 Normative Criteria and Their Inclusion in a Regulatory Framework for New Plant Varieties Derived From Genome Editing.

Alan Raybould, Syngenta Crop Protection AG, Basel, Switzerland
PL II - 4 Problem formulation and phenotypic characterisation for the development of gene-edited crops.

Martin Lema, Biotechnology Directorate, Ministry of Production, Argentina
PL II - 5 Argentine Practical Experience in the Regulation of gene-edited Products for Agroindustry.

10.30-11:00 Coffee Break
13:00 Lunch
14:00 - 17:30
WORKSHOPS (All workshops will run concurrently)
    Workshop 1. Gene Editing and Gene Drives for Managing Unwanted Vertebrates – Current Status and Biosafety Considerations
    Organizers: Allison Snow, Ohio State University, USA and Tim Harvey-Samuel, Pirbright Institute, United Kingdom

    Allison Snow, Ohio State University, USA
    WS I - 1 Ecological context for the proposed release of Lyme-resistant, white-footed mice: a case study of gene editing.

    Owain Edwards, CSIRO, Australia
    WS I - 2 Determining the feasibility of gene drives for feral cat control in Australia.

    Gus McFarlane, Roslin Institute, University of Edinburgh, United Kingdom
    WS I - 3 A CRISPR-Cas9 split drive targeting female reproduction in mice.

    Paul Thomas, University of Adelaide, Australia
    WS I – 4 Safe development of CRISPR gene drives for invasive rodent population suppression.

    Michael Smanski, University of Minnesota, USA
    WS I – 5 Engineering genetic incompatibility and applications for controlling invasive fish populations.

    Keith Hayes, CSIRO, Australia
    WS I – 6 Principles of probabilistic risk assessment for genetic biocontrol.

    Panel Discussion
    Chair: Tim Harvey-Samuel, Pirbright Institute, United Kingdom; Owain Edwards, CSIRO, Australia; Neil Gemmel, Univ. Otago, New Zeland and Keith Hayes, CSIRO, Australia
    Workshop 2. Benefits and Strategies for Global Regulatory Data Streamlining, Harmonization, and Collaboration
    Organizer: Laurie Goodwin, CropLife International, Washington, DC, USA

    Karen Hokanson, Department of Horticultural Science, University of Minnesota, USA
    WS II –1 Introductory remarks

    Laurie Goodwin, Director of Regulatory Affairs, CropLife International

    WS II – 2 Benefits of regulatory streamlining and harmonization & Current timeline trends for global GM approvals

    Jeff Wolt, Iowa State University
    WS II – 3 Problem formulation approach to environmental risk assessments

    John Teem, ILSI Research Foundation, Washington DC, USA
    WS II – 4 Data transportability (overview, key concepts, terms)

    Clara Rubinstein, Bayer Crop Science, Buenos Aires, Argentina
    WS II – 5 Concept of familiarity

    Angela Culler, Bayer Crop Science, USA
    WS II – 6 Global alignment of data requirements for risk assessments

    Panel discussion – Q&A with regulators
    Panellists: Karen Hokanson, Heidi Mitchell, Ryo Ohsawa, Martin Lema, Le Huy Ham, Maria Sueli Felipe Soares (to be confirmed)
    Workshop 3. Crop Composition as a Component of Food and Feed Safety Assessment and Hands on with the ILSI Crop Composition Database
    Organizers: Andrew Roberts and Bhavneet Bajaj, ILSI Research Foundation, USA

    This workshop will introduce participants to the ILSI Crop Composition database, an important resource for assisting in the interpretation of compositional studies such as those used in regulatory dossiers.  Participants will be given a demonstration of the database and its features, highlighting updates and additions to Version 7 which was released in January 2019.  Participants will then be provided with a series of exercises designed to help them understand the search reporting function of the ILSI Crop Composition Database which they can walk through using their personal laptop during the workshop. 
    Note: The workshop is limited to 20 participants, and so will be conducted twice (at 2:00 p.m. and 4:00 p.m.).  If you would like to pre-register to ensure your place, please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. You must bring your own laptop.

    Andrew Roberts
    Bhavneet Bajaj
    Workshop 4. Real-world Biosafety Communication and Engagement
    Organizers: Jill Kuehnert, Seed Stories, USA and Hennie Groenewald, Biosafety South Africa, South Africa

    Hennie Groenewald, Biosafety South Africa, South Africa
    WS IV – 1 Introduction & goals: Real-world biosafety communication & engagement

    Jill Kuehnert, Seed Stories
    WS IV – 2 Communication & engagement as an integrated aspect of R&D projects

    Sam Timpo, African Biosafety Network of Expertise, Senegal
    WS IV – 3 Communication & engagement for policy and regulation development

    Sarah Evanega, Cornell Alliance for Science, Cornell University, USA
    WS IV – 4 Communication & engagement that moves people to action

    Hennie Groenewald, Biosafety South Africa, South Africa
    WS IV – 5 Communication & engagement results - monitoring & evaluation

    Petra Jorasch, European Seed Association, Belgium
    WS IV – 6 Embracing Nature: Communication & engagement in plant breeding innovation, from lab to fork

    John Besley, Michigan State U
    WS IV – 7 Science of science communications perspectives on the practice of communications and engagement

    Panel Discussion on common approaches and areas of differentiation; Audience participation.
    Jill Kuehnert
    Wrap-up and Conclusion
    Workshop 5. Access to Crop Biotech Innovations: Exchange and Learnings from GM Cultivation in the EU, South Asia, and Africa
    Organizers: Sarah Davidson Evanega, Cornell Alliance for Science; Coen Frederiks and Petra Kostolaniova,The European Association for Bio-Industries (EuropaBio)

    Session 1 - GM cultivation in Spain
    Chair: Esther Esteban Rodrigo, INIA, Spain
    José Luis Romeo, Bt maize grower and AGPME president
    Experience of a farmer cultivating Bt maize

    Felix Ortego, CIB-CSIC
    Monitoring programs: Lessons from implementation in Spain

    Francisco Areal, Reading University
    Environmental benefits of Bt maize cultivation in Spain

    Roundtable Discussion Moderated by Esther Esteban Rodrigo

    Session 2 - GM cultivation in Africa and South Asia

    Chair: Patricia Nanteza, Alliance for Science, Uganda
    Molatsi Musi, Farmer (South Africa)
    The Impact of Access in South Africa

    Patience Koku, Replenish Farms (Nigeria)
    Demanding Access to Innovations to Beat Fall Armyworm

    Md. Milon Mla, Bangladesh
    The Benefits of Bt Eggplant in Bangladesh

    M.T. Narain, India
    Lost Opportunity in India?

    Evans Okomeng, Millennium Farms (Ghana)
    Engaging Youth in Agriculture Through Access to Ag Innovations

    Session 3 – Access to crop biotech
    Chair: Soledad de Juan Arechederra, Fundación Antama

    Moderated discussion with Molatsi Musi, Patience Koku, Esther Esteban Rodrigo, Francisco Areal and Patricia Nanteza
    Workshop 6. Biosafety of RNAi Applications for Plant Protection
    Organizers: Salvatore Arpaia, Italian National Agency for New Technologies, Energy and Sustainable Economic Development (ENEA), Italy, Antje Dietz-Pfeilstetter, Julius Kuehn-Institut (JKI), Germany and Jeremy Sweet, JTEC Ltd., United Kingdom

    Jeremy Sweet, JT Environmental Consultants Ltd, Cambridge, UK
    WS VI - 1 A review of baseline information on RNAi that supports the environmental risk assessment of some RNAi-based GM plants.

    Annette Niehl, Julius Kühn-Institut (JKI), Institute for Epidemiology and Pathogen Diagnostics, Braunschweig, Germany
    WS VI - 2 Phage-based bacterial production and exogenous application of dsRNAs for plant protection.

    Olivier Christiaens, Ghent University, Ghent, Belgium
    WS VI - 3 Viral-based dsRNA delivery systems for use in pest and disease control.

    Alan Raybould, Syngenta Crop Protection AG, Basel, Switzerland
    WS VI - 4 Problem formulation for environmental risk assessment of spray applications of insecticides containing double-stranded RNA.

    Achim Gathmann, Federal Office for Consumer Production and Food Safety, Bruanschweig, Germany
    WS VI - 5 Authorisation of sprayable RNAi based plant protection products: Challenges for environmental risk assessment and risk management.

    Huw Jones, Institute of Biological, Environmental & Rural Sciences (IBERS), Aberystwyth University, UK
    WS VI - 6 Silencing an essential gene involved in infestation and digestion in grain aphid through plant-mediated RNA interference generates aphid-resistant wheat plants.

    Felix Moronta-Barrios, Biosafety Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), Trieste, Italy
    WS VI - 7 Problem Formulation in the ERA of RNAi-based GM Wheat with Resistance to Fusarium Pathogens.

    Antje Dietz-Pfeilstetter, Julius Kühn-Institut (JKI), Institute for Epidemiology and Pathogen Diagnostics, Braunschweig, Germany
    WS VI - 8 Data requirements for the environmental assessment of RNAi plants: introduction to a discussion.

15:30-16:00 Coffee Break
  • Sium Ahmed, Department of Biotechnology and Genetic Engineering, Jahangirnagar University, Savar, Bangladesh
    PK II - 1 Public Perceptions of Bt Brinjal in Bangladesh
  • Eduardo de Andrade Bressan, Luiz de Queiroz Agriculture College, University of São Paulo (USP), Piracicaba, SP, Brazil
    PK II - 2 Prospective Biosafety Evaluation Regarding Genetic Modified Cultivars of Sugarcane: Gene Flow Assessment and Nutritional Composition
  • Marina Lee, Agrotecnio Center, Department of Plant Production and Forestry Science, University of Lleida, Lleida, Spain
    PK II - 3 Inter-species sensitivity variation of non-target Lepidoptera affects risk assessment of Bt maize
  • Erina Yanagi, Graduate School of Life and Environmental Sciences, University of Tsukuba, Ibaraki, Japan,
    PK II - 4 Variations in resistance to the diamondback moth of feral Brassica napus growing around the ports in Japan
  • Muhammad Imran, Agricultural Biotechnology Division, National Institute for Biotechnology and Genetic Engineering, Faisalabad, Pakistan
    PK II - 5 Characterization of CP4-EPSPS, Cry1Ac and Cry2Ab Genes Pyramid Transformed in to Tobacco Plants
  • D. Hashini Galhena Dissanayake, College of Agrculture and Natural Resources, Michigan State University, East Lansing, USA
    PK II - 6 Socioeconomic considerations - a benefit or hindrance to advancing agricultural biotechnology
  • Paulus Mungeyi, National Commission on Research Science and Technology (NCRST), Windhoek, Namibia
    PK II - 7 A critical review of the namibian biosafety regulations and their implication on processed food importers
  • Sivabalan Karthik, School of Biotechnology and Genetic Engineering, Department of Biotechnology, Bharathidasan University, Tiruchirappalli, India
    PK II - 8 Pea p68, a DEAD-box helicase, enhances salt tolerance in marker-free transgenic soybean
  • Erasmus Reynardt, North West University, Potchefstroom, South Africa
    PK II – 9 Effect of Busseola fusca on Cry1Ab protein expression levels in Bt maize plants and Bt maize crosses
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