Communicating the science of GMOs and emerging biotechnology tools

Chair:  Willy Tonui, African Genetic Biocontrol Consortium
Organized by Willy Tonui, African Genetic Biocontrol Consortium

Biotechnology is a rapidly growing field in Africa. Acceptance of emerging
biotechnologies including engineered gene drives, gene editing, and synthetic biology hinges on accurate and effective communication to the public and other stakeholders. However, communicating such topics in Africa presents unique challenges, shaped by social, cultural, economic, and political factors. Genetically modified (GM) crops havebeen in commercial use in Africa since 1996 and continue to contribute to agricultural productivity where cultivated. Numerous GM crop types and technologies have traits that improve agricultural outputs, nutritional qualities for human health, pest resistance, and herbicide and drought tolerance. Regardless of successes, disinformation persists about the value, safety, and efficacy of these technologies and products. Other GM organisms and technologies being considered across the continent face similar barriers despite potential upsides for human, animal, and environmental health. Bridging the gap between stakeholders in media and science remains critical for sharing accurate and science-based information while combating misinformation and disinformation. Providing timely, accurate, comprehensible information will empower African countries to make independent informed decisions on the appropriate path forward regarding emerging biotechnologies. This session will convene scientists, researchers, developers, and science journalists to review experiences, explore barriers in science communication, and share skills to overcome them. Speakers will describe examples of progress made to contextualize GMO acceptance in Africa. They will share communication tools and techniques that build competence in communicating to a variety of stakeholders about research, field trials, and the use of GMOs and other emerging technologies on the African continent. This side event aims to broaden scientists’ communication repertoire and increase media and communicators’ appreciation of scientific concepts to facilitate balanced communication of critical biotechnology topics allowing decision makers, publics, local communities access to these complex science topics.

Coordinating capacity building efforts in biosafety in plant biotechnology for the global south

Chair: Marc Heijde, International Plant Biotechnology Outreach (VIB-IPBO) / Ghent University
Organized by Marc Heijde, International Plant Biotechnology Outreach (VIB-IPBO) / Ghent University

Addressing poverty, hunger, and malnutrition in the Global South requires advancing agricultural research focused on crop improvement and ensuring these innovations are applied safely. Regional programs actively tackle food security challenges with innovative solutions, particularly plant biotechnology-based ones. However, biosafety regulations are critical in protecting public health and the environment. Continental and international institutions are instrumental in building capacity in plant biotechnology and related Biosafety across Africa, aligning with the conference theme, Cultivating Bio-Innovation for a Sustainable Future. To make sustainable progress, it is essential to train professionals (scientists, regulators…, etc.) on topics like risk assessment, food safety, and product traceability, among others. A strong national/regional regulatory framework supported by national expertise is critical for optimally rolling out technologies and innovations. Biosafety regulatory frameworks in Africa are progressing at different rates. For example, Nigeria and Kenya have adopted guidelines for gene-editing, and other countries are on the way. Despite these advances, more capacity is needed to allow the use of biotechnology products with proper national, regional, and international legal frameworks that can enable research, development, and commercialization. Although different actors lead capacity-building efforts, their work often remains fragmented. There is a need for collaboration and increased coordination among institutions to enhance complementarity and improve the effectiveness and impact of capacity-building initiatives. This International Society for Biosafety Research (ISBR) symposium session will provide a platform for stakeholders to exchange expertise, align strategies and build partnerships for tailored capacity building in Biosafety in the South.

Harnessing bio-Innovation: addressing regulation to tackle global challenges

Chair: Marcos Pupin, Brazilian Association of Bioinovation – ABBI
Organized by Marcos Pupin

Bio-innovation, refers to innovative technologies that use biological and renewable resources to create new products, or business models, promoting social, environmental benefits and sustainable economic development, is pivotal in addressing global sustainability challenges. By leveraging advancements in bio-innovation, we can develop sustainable solutions that reduce environmental impact, enhance food security, and promote health. It could be applied in several areas such as agriculture (GM crops and plants), energy (biofuels), bioag products (biologically active agricultural inputs), to cite a few examples. While bio-innovation holds great promise, it also faces challenges such as ethical considerations, regulatory hurdles, and the need for interdisciplinary collaboration. Addressing these challenges requires a concerted effort from scientists, policymakers, and industry leaders to ensure that bio-innovation is developed and implemented responsibly. Cultivating bio-innovation is essential for building a sustainable future. By harnessing the power of biotechnology, we can create solutions that not only address current environmental and health challenges but also pave the way for a more sustainable and resilient world.

Strategies for Modernizing Biotechnology Regulatory Frameworks

Chair:  Bill Doley, DOLEY Consulting LLC
Organized by Bill Doley, DOLEY Consulting LLC

After 30 years of practical experience and the absence of previously predicted harms, it is now imperative to reform biotechnology regulatory frameworks to alleviate the excessive regulatory burden on biotechnology products. Technological advancements have rendered existing regulatory frameworks obsolete; therefore, modernized frameworks that can accommodate further technological progress need to be developed. This session aims to propose strategies for creating forward-thinking, scientifically based regulatory frameworks. Speakers will review the global status of current regulatory frameworks and highlight innovative approaches being used to reduce data requirements and shorten review timelines. Given that the presence of "foreign DNA" does not inherently increase risk, alternative regulatory triggers will be proposed. The proposed modernized regulatory systems will be trait-based and proportionate to risk, possibly including scientifically justified risk tiers. Broad risk assessments will be replaced with trait-focused risk assessments, based on problem formulation and scientific pathways to harm. Traits that have been previously reviewed in the same crop and found not to present significant risk will be subject to minimal review. The objective of this session is to present compelling arguments that current biotechnology regulatory frameworks are overregulating modified crops and to propose scientifically sound paths forward to ease the regulatory burden.

Safe(r) Innovation Approaches – Non-regulatory approaches fostering safety in innovation

Chairs:  Andrew Roberts, AFSI & Dr. Marco Gielkens, RIVM
Organized by Andrew Roberts, AFSI (Agriculture and Food Systems Institute)

Biotechnology and genetic engineering have a remarkable safety record. One contributing factor to this is high safety awareness during development. This includes recognition by researchers and technology developers that ensuring a culture of safety in laboratories, greenhouses and field trials is important to meet social and ethical obligations as well as enabling future product success. As access to the tools of molecular biology expand and new developers enter the space, pushing the envelope of innovation and developing biotechnology in new organisms and for new applications, it is useful to consider the processes and methods that have been used by developers to ensure safety through the course of product development. “Safe(r) Innovation Approaches” or SIA is the name given to a document in preparation jointly by the OECD Working Party on the Harmonisation of Regulatory Oversight in Biotechnology (WPHROB) and the Working Party on the Safety of Novel Foods and Feeds (WPSNFF). The term is intended to describe a concept of incorporating safety considerations from the earliest design stages through a products lifecycle and is analogous to other terms like “Safe by Design” “Responsible Innovation” etc. The document itself is designed to highlight and exemplify practices and approaches that have been used by developers that reflect this approach. The session will provide an update and overview of the work being done at the OECD. We will also invite speakers from representing diverse kinds of developers to share their experience in implementing safe innovation approaches.

Data Transportability of Confined Field Testing: Current status of discussions and future prospects

Chair: Shuichi Nakai, Bayer Crop Science Japan
Organized by Shuichi Nakai, in partnership with the International Life Science Institute (ILSI) Japan

The concept of Data Transportability (DT) of Confined Field Testing (CFT) to support the Environmental Risk Assessment (ERA) of Genetically Modified (GM) plants was first introduced in the literature by Garcia-Alonso et al. in 2014. Since then, DT has been discussed in various countries and regions as a measure to prevent duplication of regulatory studies without compromising quality of the ERA. However, despite its potential benefits and scientific rationale, DT has not yet been fully adopted in many countries and regions. In this session, experts from five countries and regions actively discussing DT will present their current status, challenges and future prospects. Through this session, we would like to provide an opportunity to share what countries are doing well and what challenges they face, and to consider future directions for the introduction of science-based DT.

Innovation and Modernization on the Safety Assessment of Newly Expressed Proteins in Genetically Modified (GM) Crops

Chair:  Tao Geng, Corteva TM Agriscience  
Organized by Tao Geng, in partnership with CropLife International

Genetically modified (GM) crops have been used for food and feed for around three decades. To date, there have been no adverse health effects from the almost four billion acres of GM crops grown globally. Current assessment of newly expressed proteins based on a weight of evidence approach has been successful in ensuring the food and feed safety of GM crops. Over the past 30 years, significant advances in molecular biology, genomics, bioinformatics, and artificial intelligence have been achieved, which may provide innovative methodologies including in silico and in vitro tools to modernize the safety assessment of newly expressed proteins by using case-by-case, tiered approaches within current principles and frameworks. The objective of this session is to bring together scientists from academia, industry, and regulatory authorities to discuss fit-for-purpose strategies and new developments and scientific advances in the past several years on allergenicity and toxicology safety assessment of newly expressed proteins in GM crops.

Trends, perspectives and recent developments on streamlining the regulatory assessment of GM stacked trait products

Chair: Miguel Vega-Sanchez, Bayer Crop Science
Organized by Miguel Vega-Sanchez, Abby Simmons, CropLife International

Stacked trait products are genetically modified (GM) crops containing multiple, different single GM events combined through conventional breeding. Developers typically breed previously risk-assessed “parental” single GM events to generate the final GM stacked trait commercial product. Stacked trait products enable developers to provide tailor- made solutions for growers, while enhancing the durability of GM traits and the sustainability of farming operations. The process of conventional breeding has evolved over time, creating an effective framework that not only improves crop performance, but also supports the development of foods and feeds that are safe and nutritious to consume. Importantly, in the over 20-year history of breeding stacked trait products, there has never been an instance where the risk assessments of the parental single events failed to predict the plausible risk hypotheses for the breeding stack product. International safety assessments and independent publications indicate that combining single GM traits through conventional breeding poses no greater risk to food and feed compared to combining non-GM traits, barring specific plausible risk hypothesis. Based on this extensive experience and the safety record of conventional breeding practices, several regulatory agencies around the globe have streamlined their approaches for assessing stacked trait products. However, in some geographies, a disproportionate risk assessment is still required for stacked trait products, which often leads to asynchronous approval timelines, delayed access to innovative and sustainable technologies for growers, as well as an increased resource demands for both regulators and developers without clear scientific rationale. This session will provide an opportunity to present trends and recent examples of streamlined stacked trait product assessments by key regulatory agencies and provide a forum for knowledge exchange and sharing of best practices among experts from academia, the private sector and regulatory agencies to promote more efficient, scientifically sound assessment processes for GM stacked trait products globally.

Hands-on experience with Crop Composition Database: A tool used in food and feed safety assessment

Chair:  Bhavneet Bajaj, Agriculture and Food Systems Institute (AFSI)
Organized by Bhavneet Bajaj, Agriculture and Food Systems Institute (AFSI)

Composition studies that assess similarities and differences in levels of nutrients, anti- nutrients, and secondary metabolites are an essential part of the safety assessment of new crop varieties that are used as food and feed. It is important to understand the purpose of the data and its importance in safety assessment. This workshop will provide an opportunity to discuss the rationale for considering composition data, how that data is interpreted in the context of natural variability of crop analytes, and limitations to compositional studies. The workshop will introduce participants to the Crop Composition database (CCDB), a resource for assisting in the interpretation of compositional studies. Participants will be given a demonstration of version 10.0 of the database. They will explore the search function of the database through a series of exercises which will enable them to generate analyte reports for the crops of their interest.

**personal laptops are preferred for demonstration and hands-on learning in the composition database tool. The database is compatible with smartphones too**

Design considerations for non-target risk assessment studies – Lessons learned from insect resistant GE crops and challenges for new traits and technologies

Chair(s): Michael Meissle, Agroscope & Christopher Brown, Bayer
Organized by Michael Meissle and Christopher Brown

When considering environmental safety of insect resistant genetically engineered (GE) plants, potential adverse effects on beneficial invertebrate species need to be assessed. In early tier non-target studies, selected species are typically exposed to purified proteins, such as Cry or VIP proteins from Bacillus thuringiensis, that are equivalent to those expressed by GE plants. Different life-table parameters of the tested species in the GE treatment are compared with a treatment without the stressor. Higher tiers include studies with the engineered plants and a suitable non-engineered counterpart. Finally, communities of non-target species are assessed in field studies. Non-target studies need to be designed carefully to be meaningful for risk assessment. First, robust study designs should minimize the likelihood of producing artifacts and confounding factors that mask the comparisons of concern (risk for bias). Second, the study needs to result in data that are useful to address the risk hypothesis derived from the problem formulation of the risk assessment (study relevance). Study design considerations include the choice of test organisms, test substance characterization, method of delivery (exposure), negative and positive controls, measurement endpoints, test duration, and finally the ability to interpret the results regarding expected environmental concentrations and biological relevance. With the vast experience in ecotoxicological studies that is available for purified insecticidal proteins and GE plant material producing Bt proteins, the goal of this session is to review the characteristics of high-quality and relevant non-target studies using up-to-date examples from research. In addition, particular emphasis will be given to new biotechnological applications, including plants expressing RNAi traits, plants with non-insecticidal traits, or plants engineered with genome editing techniques that may pose new challenges for the design of meaningful studies.

Plant Breeding Innovation: Enabling applications and regulatory frameworks

Chair:  Raymond Dobert, Harambe Ag.  
Organized by Khaoula Belhaj-Fragnière, International Seed Federation
                           John McMurdy, CropLife International

This session focuses on the role of plant breeding innovation as a tool for crop improvement and the critical need to evolve regulatory frameworks. For example, genome editing is poised to revolutionize plant breeding by offering unprecedented efficiency throughout the entire breeding process. Key applications include generating genetic variation within the breeding germplasm pool to accelerate the genetic gain early in the breeding process, as well as precise edits in elite germplasm conferring valuable plant characteristics, such as drought tolerance, disease resistance, or improved nutritional profile. In this session, experts will discuss both current and future applications of genome editing as a breeding tool, assessing the suitability of the current regulatory paradigms. The discussion will emphasize forward-looking, risk-proportionate and innovation-enabling regulation to unlock the genome editing potential to drive innovation and advance agriculture. This discussion further aims to identify existing gaps between current individual edit-based regulations and regulations needed to support a broader range of genome editing applications.

Public-Private-Producer Perspectives on Gene Editing Innovation

Chair:  Dr. Stuart Smyth, Univ of Saskatchewan.  
Organized by Dr. Stuart Smyth, Univ of Saskatchewan

Reports and publications of improved yield, nutrition, drought tolerance, disease resistance and a host of other traits from gene editing are rapidly increasingly. These trait improvements are occurring in a broad range of food crops, from cereals and oilseeds, to fruits and vegetables. Parallel to this has been growing international agreement on the regulation of gene-edited varieties, with the majority of countries following the framework first enacted by Argentina. This panel will provide perspectives on uptake and enabling environment including R&D, scaling up and deployment of gene editing from public breeders, private companies and producer organizations. The objective of the panel will be to provide a diversity of perspectives on the importance of regulatory harmonization, which will allow for the full potential of gene editing technologies to be realized. It is estimated that only one-third of the potential of genetically modified technologies have been realized. For gene editing technologies to fully contribute to reducing food insecurity and contributing to climate change mitigation, as close to full adoption of gene editing technologies needs to be realized. Panelists will include individuals from the CGIAR system involved in the use of gene editing in variety development programs. Additional panelists will represent the private sector, particularly smaller firms that are beginning to commercialize gene-edited food products and the European seed sector to highlight the importance of regulatory harmonization for European research and production.

Developments in Gene Drive – Advances in risk assessment, regulatory frameworks and field trial design

Chair:  Andrew Roberts, AFSI (Agriculture and Food Systems Institute)
Organized by Andrew Roberts (AFSI)
                           Zaira Lanna (Outreach Network for Gene Drive Research)
                           Brinda Dass (FNIH)

While the concept of a driving genetic element is not new, the discovery of the CRISPR -Cas system of molecular tools greatly increased interest in pursuing such technologies to address intractable biological problems, including long term challenges in disease prevention and conservation. This has also been accompanied by the recognition that gene drives pose questions for environmental and ecological risk that are different than many of the biotechnology applications that have come before. While no gene drives have been released in the environment yet, research initiatives have made substantial progress in demonstrating the effectiveness of gene drive technologies in laboratory settings that closely mimic natural environments. These successes underscore the technology's promise but also highlight the critical to consider how to transition from controlled experiments to real-world field evaluations. The purpose of this session is to provide ISBR Symposium participants with an update on current efforts to develop and implement gene drives, as well as to update them on the status of risk assessment and biosafety research aimed at ensuring they are safe and effective while also allowing these innovative mechanisms to eventually be released in order to address the environmental and health challenges they are hoping to address.

Advancing community engagement in gene drive research: Bridging perspectivesand practices

Chair: Claudia Emerson, Institute on Ethics & Policy for Innovation (IEPI), McMaster University
Organized by Samantha O'Loughlin, Target Malaria
                           Claudia Emerson, Institute on Ethics & Policy forInnovation                               (IEPI), McMaster University

Recent advances in research on gene drive approaches, which hold potential for addressing global health and conservation challenges, are bringing the field closer to possible real-world applications. Community support for the use of these new approaches will be critical to their success in the long term, as well as during field evaluations. Stakeholder engagement is key to enabling communities to make informed choices about the use of gene drive approaches, and to address communities’ questions and concerns about this research. There is a wealth of literature on responsible community engagement, including a growing body of academic publications on engagement around gene drive technologies. However, it is essential to inform engagement with the knowledge that stems from practice. Practitioners who have firsthand experience working directly with communities, can offer crucial insights into what successful engagement looks like on the ground. Their perspectives help bridge the gap between high-level frameworks and practical realities, ensuring that community concerns and needs are fully addressed as gene drive research moves closer to implementation. This event will provide a forum for practitioners to share best practices, lessons learned, and innovative approaches that bring field-based insights into alignment with theoretical considerations on community engagement in gene drive research. By drawing on the real-world experiences of those working directly with communities, the panel will illustrate what inclusive engagement can look like in practice, offering valuable, practical context, on how to effectively engage communities as gene drive technologies progress.

Building capacity for risk assessment of Engineered Gene Drive Mosquitoes in Africa post-COP16/CP MOP11

Chair:  Irméan Moussa Savadogo, Mathurin Rouamba Burkina Faso.  
Organized by the Burkina Faso Integrated Vector Management Platform in partnership with The National Biosafety Agency (ANB) and the African Institute for Development Policy (AFIDEP)

The most advanced use case for engineered gene drive containing organisms (EGDOs) is in malaria vectoring mosquitoes in sub-Saharan Africa. African nations with a high malaria burden are in urgent need of new methods to combat the disease and are therefore motivated to explore technologies such as EGDOs. These concerns and needs are further reflected in their role as Parties to the United Nations Convention on Biological Diversity (CBD) and its Cartagena Protocol, which has called for the development of guidance material for risk assessments of EGDOs. In response, the CBD has undertaken the development of guidance materials to support case-by-case risk assessments of EGDOs with a particular emphasis on mosquitoes. This additional voluntary guidance was welcomed with appreciation in October 2024 at COP 16/CP MOP11/NP MOP5. Some African countries such as Burkina Faso, Mali, Uganda, and Tanzania have some experience with assessing applications for genetically modified mosquitoes and find the CBD guidance comprehensive and well structured. They would like to encourage other countries to utilize this material in their capacity building initiatives, to extract critical principles and incorporate them in their policies and communication materials. This session will convene select members of regulatory agencies, members of the risk assessment ad hoc technical expert group, scientists, developers, and those interested in genetic biocontrol of disease vectors to begin disseminating the voluntary guidance among the biosafety community. The goal is to introduce the voluntary guidance and highlight key principles and concepts it describes such as the problem formulation approach and pathways to harm and to discuss how it can be used in the current African genetic biocontrol landscape. The intent is to foster dialog on the safe and responsible assessment and use of EGDOs and build a community of practice among researchers and regulators.

Global status of animal biotechnology regulations

Chair: Alison Van Eenennaam, University of California, Davis
Organized by Alison Van Eenennaam

The approach that is taken to the regulation of animal biotechnologies, including gene editing, will greatly influence the types of products that come to market, the size and nature of the companies that develop and commercialize them, and even the market acceptance received by these products. The ISBR2025 theme is “Cultivating Bio- Innovation for a Sustainable Future”. Ideally animal biotechnology regulations will be proportionate to risk, focused on novel product risks (if any), and agnostic to the process that used to produce that product. Ultimately, regulations should facilitate the commercialization of safe animal bio-innovations, and preclude the sale of unsafe products to protect public health. This session will bring together representatives from different regions (North America, Europe, Oceania/Asia, Africa and South America) to summarize the Status of Animal Biotechnology Regulations in that region. This session summarizes the outcome of a series of six “Workshops for International Animal Biotechnology Regulatory Engagement” the first of which was hosted by Argentina in 2011, and all of which can be found summarized at the ISAAA website https://www.isaaa.org/kc/proceedings/animalbiotechnology

Safety considerations for agricultural microbial products derived from new genomic techniques (NGTs)

Chairs:  Andrew Roberts, AFSI & Natasha Dixon, Bayer Cropscience
Organized by Andrew Roberts, Agriculture and Food Systems Institute                                   Natasha Dixon, Bayer Cropscience

Agricultural biologicals encompass a wide range of crop production and protection tools derived from natural sources such as microbes, biochemicals, plant extracts, or pheromones. These products serve various functions including biofertilizers, biostimulants, and biopesticides. In this session, we will concentrate on the safety of microbial products created through new genomic techniques (NGTs). We will start by providing an overview of the different types of biological products and the existing regulatory frameworks. Subsequently, we will address both human and environmental safety considerations. Regarding human safety, our speaker will highlight some challenges in testing microorganisms using new approach methodologies (NAMs) and discuss industry efforts to minimize animal testing where possible. Another speaker will cover research into methods for assessing the environmental fate, including mobility and persistence, of microbial products. Finally, we will compare plants and microbes developed through NGTs, examining their similarities and differences. Ensuring the safety of microbial biological products aligns with the theme “Cultivating Bio-Innovation for a Sustainable Future,” as these products help farmers improve crop yield and quality and enhance resilience to climate changes. In addition, agricultural biologicals, global regulations, policy, and governance are listed as relevant topics. Throughout the parallel session we hope to infuse global perspectives and experiences. We aim to partner with academia, and regulators to offer diverse perspectives throughout the parallel session.

Important Dates