||PLENARY SESSION I - COMMUNICATIONS AND ENGAGEMENT WITH POLICY AND PUBLIC AUDIENCES
Session Organizers: Hennie Groenewald, Biosafety South Africa, South Africa and Jennifer Anderson, Corteva Agriscience, USA
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
- PS1: Scientific Assessment of the Food and Feed Safety of Genetically Engineered CropsScientific 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.
- PS2: New Breeding Technologies: Regulatory Hurdles for Existing FrameworksNew Breeding Technologies: Regulatory Hurdles for Existing Frameworks
Organizers: Thorben Sprink, Julius Kuehn-Institut, Germany and Detlef Bartsch, Federal Office of Consumer Protection and Food Safety, German
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.
- PS3: Open Session 1
Abstracts will be selected from the open call.
- PS4: 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.
- PS5: Familiarity in the Context of Risk Assessment of Transgenic Crops in the Americas
Organizers: Deise Capalbo, EMBRAPA Environment and Carmen Vicièn, University of Buenos Aires
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.
- 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
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.
- PS7: Open Session 2
Abstracts will be selected from the open call