Monday, April 1


09:00 - 09:40


Ariel Alvarez, ISBR President

Esther Esteban Rodrigo, INIA, Spain
Application and Interest on Agricultural Biotechnology in Spain


Session Organizers: Hennie Groenewald, Biosafety South Africa, South Africa and Jennifer Anderson, Corteva Agriscience, USA

Keynote Speaker: JACK A. BOBO, Vice President for Global Policy and Government Affairs
Advancements in the field of modern biotechnology are fostering the rapid development and application of new technologies, which are enabling the deployment of innovative solutions for agricultural and food production challenges. However, as is true for many new technologies, there remains uncertainty associated with public acceptance, policy development, and global adoption of these innovative technological advancements. To harness the full potential of these technologies a social license is required, which in turn is based on trust that can only be gained through effective communication and engagement (C&E) with decision makers and society at large. This session will therefore focus on the science of science communication within a biotech context, to paint a clear picture of the principles and best practice for establishing effective biosafety communication and engagement programs.

10:30 - 11:00 Coffee Break

Jack Bobo ,Intrexon, Germantown, USA
PL I – 1 Can agriculture save the planet before it destroys it?

John Besley, Michigan State University, East Lansing, USA
PL I - 2 How do you want agbiotech science and scientists to be perceived?

Mahaletchumy Arujanan, Malaysian Biotechnology Information Centre (MABIC), Kuala Lumpur, Malaysia
PL I - 3 Agribiotech Proponents: Guilty till Proven Innocent. How do we get a fair chance?

Ben Durham, Bio-innovation Department of Science and Technology, Pretoria, South Africa
PL I – 4 The critical role of C&E in a Developing World, biotech policy context
13:00 Lunch
    PS1: Scientific Assessment of the Food and Feed Safety of Genetically Engineered Crops
    Organizer: Jay S. Petrick, Bayer CropScience, USA

    A robust internationally accepted comparative safety assessment paradigm is utilized to evaluate the food and feed safety of genetically engineered (GE) crops.  This session will discuss key components of the comparative safety assessment for these crops with a focus on historical perspective and the scientific robustness of this approach.  The scientific rationale for the safety assessment endpoints will be discussed along with the suitability of the existing datasets for the assessment of current and future products.  Key topics for discussion will be the role of compositional assessment, protein safety assessment, and feeding studies in the evaluation of GE crop safety.   The appropriateness of rigorous and robust science-based risk assessments for GE crops will be discussed and contrasted with the precautionary evaluation of these products using hazard-based approaches.

    Lisa Kelly
    , Food Standards Australia New Zealand, Canberra, Australia
    PS I – 1 Framework for Food Safety Assessment of GM Crops: Codex and Historical Learnings

    Rod Herman
    , Corteva Agriscience, Indianapolis, USA
    PS I – 2 Compositional Assessment and Safety Assessment in the Light of Natural Variability

    Jay Petrick
    , Bayer Crop Science, Chesterfield, MO, USA
    PS I – 3 Food and Feed Safety Assessment of Proteins Expressed in Genetically Engineered (GE) Crops

    Alison van Enennaam
    , Department of Animal Science at University of California, Davis
    PS I - 4 Risk Assessment vs Precautionary Principle, Putting Hazard and Perception in their Proper Place for GE Crop Assessment
    PS2: New Breeding Technologies: Regulatory Hurdles for Existing Frameworks
    Organizers: Thorben Sprink, Julius Kühn-Institut, Germany and Detlef Bartsch, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany
    Genome editing technologies have been boosting plant and livestock breeding for only a few years but already the first promising products are entering the market. In many countries the current legislation regulating genetically modified plants and animals were established more than 20 years ago, based on clear differentiations between transgenic and conventional breeding. To date, some of this legislation isn’t suitable to face the new challenge of regulating tools of genome editing. This session will discuss the use of genome editing in plant and livestock breeding and will discuss how these techniques will change breeding in the future. The speakers of this session will give an insight into the current legislative frameworks of their countries and will discuss and evaluate the existing frameworks for regulation of genetically modified plants in a worldwide comparison. Furthermore, the speakers will discuss if there is a need for updated legislation, regulating the use of organisms produced by novel genome editing techniques and by genetic engineering and how such legislation could be composed to match the scientific progress.

    Detlef Bartsch, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany
    PS II - 1 New breeding technologies: Regulatory hurdles for existing frameworks

    Georg Leggewie, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany
    PS II - 2 The CJEU ruling on new techniques of mutagenesis - a broad hint to EU law makers?

    Agustina Whelan, Biotechnology Directorate, State Secretariat of Foodstuff and Bioeconomy, Buenos Aires, Argentina
    PS II - 3 Current situation of NPBTs regulation in Latin America

    Yutaka Tabei, Institute of Agrobiological Sciences, National Agriculture and Food Research Organization (NARO), Tsukuba, Japan
    PS II - 4 The recent regulatory framework of genome editing organisms and foods in Japan
    PS3: Familiarity in the Context of Risk Assessment of Transgenic Crops in the Americas
    Organizers: Deise Capalbo , EMBRAPA Environment, Brazil and Carmen Vicièn , University of Buenos Aires, Argentina

    Criteria and approaches for risk assessment evolve with scientific advances, technological developments and with experience. While problem formulation guides the analytical risk assessment process, “familiarity” and “history of safe use” (HOSU) are concepts that may help in the generation of risk hypotheses that are relevant, plausible and testable. Countries in the Americas are applying these concepts to the risk assessment of genetically modified (GM) crops albeit in different ways, and so there is a need to formalize their definitions and roles in the evaluation process to facilitate harmonization. The purpose of this session is to exchange ideas about the concepts of familiarity and HOSU in the context of problem formulation and their applicability to the practice of risk assessment of GM crops, share experiences of select countries in the Americas regarding the use of tools applied to risk assessment of GM crops, and analyze the impact of different risk assessment working models on the use of familiarity based tools. Sharing the state of science and its application to the practice of risk assessment of GM crops is relevant to strengthen regulatory capacities and promoting harmonization.

    14:00 – Opening Remarks

    Clara Rubinstein, Bayer Crop Science Argentina, Buenos Aires, Argentina
    14:10 – 14:30 PS III - 2 Familiarity in the context of Problem Formulation

    Patricia Fernandes, UFES, Vitoria, Brasil
    14:30-14:50 PS III - 3 The use of familiarity and a history of safe use in the decisions of the Brazilian National Biosafety Technical Commission

    Philip Macdonald, Canadian Food Inspection Agency, Ottawa, Canada
    14:50-15:10 PS III - 4 The regulation of agricultural biotechnology and science: A Canadian perspective on the conceptual tools for problem formulation

    Facundo Vesprini, Biotechnology Directorate of the Secretary of Agroindustry, Buenos Aires, Argentina
    15:10-15:30 PS III - 5 Case study: Transportability of virus resistant transgenic common bean- field studies from Brazil to Argentina
    PS4: Open Session 1 - Building Technical Capacity in Biosafety
    Chair: Craig, Wendy, International Center for Genetic Engineering and Biotechnology, Trieste, Italy

    Hector Quemada, Western Michigan University, Kalamazoo, Michigan, USA
    PS IV - 1 Measuring Effectiveness of Training

    Wendy Craig, International Center for Genetic Engineering and Biotechnology, Trieste, Italy
    PS IV - 2 The ICGEB eLearning portfolio: Key outcomes and lessons learned

    Modupe Adeyemo, AUDA/NEPAD-ABNE, Dakar, Senegal
    PS IV - 3 Post-Release Monitoring: Pathway to Technology Sustainability in Africa

    Vibha Ahuja, Strengthening Biosafety Compliance in Public Sector Research Institutions in India
    PS IV - 4 Strengthening Biosafety Compliance in Public Sector Research Institutions in India
15:30 Coffee Break
    PS5: Science-based Allergenicity Risk Assessment for Food Derived from Genetically Engineered Crops
    Organizer: Ping Song, Corteva Agriscience, USA

    Over the past decade, a weight-of-evidence approach, which encompasses a variety of investigations, has been adopted. This comprehensive evaluation process generally includes determination of the source of the introduced protein, any significant identity between the amino acid sequence of the protein and known allergens, its susceptibility to enzyme-mediated degradation, heat stability, and serum screens using verified sera from individuals allergic to allergen(s) that are similar to the introduced protein or allergic to the same allergenic source organism. This parallel session will cover the following topics: (1) a comprehensive review of the current weight-of-evidence based allergy risk assessment including the principle of allergy risk assessment, components of weight-of-evidence approach, and endogenous allergens; (2) applications of enzyme digestion methodology in the newly expressed proteins including conventional enzyme digestibility in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF); (3) bioinformatics application in identification of potential allergenicity of newly expressed proteins including peer-reviewed databases and review of various algorithms; (4) new regulatory requirements on celiac risk assessment using bioinformatics, its implication, potential issues, and proposed solution.

    Richard Goodman, University of Nebraska-Lincoln, Lincoln, NE, USA
    PS V - 1 Evaluating potential risks of food allergy and celiac disease from intended and unintended changes in genetically engineered food crops

    Ronald van Ree, Amsterdam University Medical Centers, Amsterdam, Holland
    PS V - 2 In vitro gastro-intestinal digestion protocols for allergenicity assessment: are more physiological conditions helpful in separating allergens from non-allergens?

    Andre Silvanovich, Bayer Crop Science, St. Louis, MO, USA
    PS V - 3 Bioinformatic evaluation of newly introduced proteins in GM crops.

    Ping Song, Corteva Agriscience, USA
    PS V - 4 Celiac risk assessment of newly expressed proteins in GM crops using bioinformatics, its implications, potential issues, and proposed solutions
    PS6: Regulation and Sustainability: Enabling an Innovative and Sustainable Bio-economy through a Harmonized Global Biosafety Framework for Industrial Biotechnology
    Organizer: Thiago Falda Leite, Brazilian Industrial Biotechnology Association, São Paulo, Brazil

    It is estimated that by 2030 the world’s population will reach more than 9 billion with 70 percent expected to be living in urban areas, and with life expectancies reaching more than 90 years in developed countries. The inherent demands for natural resources, energy and consumer goods arising from this scenario will require a paradigm shift in the global industrial model.  Industrial biotechnology, which encompasses the production and processing of materials, chemical products and energy through biological processes, should allow for the replacement of fossil raw materials with renewable ones.  Unlike with plant biotechnology, where standardized approaches to risk assessment have been established around the world, the requirements for commercialization of industrial biotechnology products change significantly depending on the country or region. As a result, increased costs associated with regulation have been experienced, reducing the competitiveness of promising products when compared with products derived from non-renewable materials. This session will discuss differing regulatory approaches from across the world, and try to identify a path forward that might help harmonize or standardize risk assessment of genetically engineered microorganisms, key tools for industrial biotechnology.

    Maria Sueli Soares Felipe, CTNBio - Comissão Técnica Nacional de Biossegurança, Brasilia, Brasil
    PS VI - 1 The New Regulatory Framework of Genetically Modified Microorganism in Brazil: Impact to Industrial Biotechnology Development and its Consequences to Environment

    Patrick Rudelsheim, Perseus BVBA, Sint-Martens-Latem, Belgium
    PS VI - 2 Advances in science and biosafety to build a green economy

    Fred Wondergem, DuPont Industrial Biosciences, Leiden, Holland
    PS VI - 3 Combining advances in science and biosafety - impacts on the market
    PS7: Open Session 2 -  Risk Assessment and New Technologies
    Chair: Andrew Roberts, ILSI Research Foundation, Washington DC, USA

    Boet Glandorf, National Institute of Public Health and the Environment, Bilthoven, Holland
    PS VII - 1 Assessment of risks for human health and the environment of new developments in modern biotechnology

    Pamela M. Bachman, Jay Petrick, Bayer Crop Science, Chesterfield, MO, USA 
    PS VII - 2 Hazard Characterization and Risk Assessment Considerations for dsRNA Agricultural Products

    Yann Devos, European Food Safety Authority (EFSA), Parma, Italy
    PS VII - 3 EFSA’s updated explanatory note on literature searching – Learning from experience.

    John Teem, ILSI Research Foundation, Washington DC, USA
    PS VII - 4 Sublethal Endpoint Assessment for NTOs - Results from a Workshop on Non-Bt GE Plants

    Phillip Wharton, University of Idaho, Aberdeen Research &Extension Center, USA
    PS VII - 5 Managing adaptation of the potato late blight pathogen to disease resistance genes.
  • Naseer Ahmad, COMSATS University/IUE-CAS, Abbottabad, Pakistan
    PK I – 1 Comparative evaluation of bacterial diversity from GM and Non-GM maize rhizosphere
  • Danilo Fernandez Ríos, Universidad Nacional de Asunción, Facultad de Ciencias Exactas y Naturales, San Lorenzo, Paraguay
    PK I – 2 Mutual acceptance of food and feed safety assessments of transgenic crops: an attainable goal
  • Reynardt Erasmus, North West University, Potchefstroom, South Africa
    PK I – 3 Introgression of cry1Ab into open-pollinated maize and its effect on Cry protein expression levels and target pest survival
  • Sahu Vinod Kumar, College of agriculture, RVSKVV, Gwalior, Madhya pradesh, Gwalior, India
    PK I – 5 Cross Compatible Transferability Of Ground Nut Microsatellite Primers (SSR) Across With Pearl Millets And Chickpea Crops
  • Habiba Most Umme, University of Dhaka, Bangladesh
    PK I – 7 Exploring Porteresia coarctata (Roxb.) Tateoka, a promising salt-oving plant for developing highly salt tolerant
  • Rubi Guta, Assam Agricultural University, Jorhat, India
    PK I – 8 Biosafety of Helicoverpa resistant transgenicchickpea lines expressing either a Cry1Ac or a Cry2Aa gene
  • Kim Young-Joong, National Institute of Ecology, Seochon, South Korea
    PK I – 9 Effects of mCry51Aa2-producing cotton on the nontarget spider mite Tetranychus urticae and the predatory bug Orius majusculus
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