Rapid advances are being made in the field of modern biotechnology, and as is true for many new technologies, there remains uncertainty associated with public acceptance, policy development, and global adoption. This session will explore the interface between science, bioethics, communication, and society. The importance of communication for fostering public acceptance and social license will be explored. This plenary session will serve as a platform for scientists, researchers, academics, and regulators to discuss science, innovative solutions, public acceptance, and policy development for bio-innovations in food, agriculture, and medicine.
Confirmed speakers: Jeantine Lunshof (Harvard Wyss Institute for Biologically Inspired Engineering), Patricia Osseweijer (Delft University of Technology, Netherlands), Brandon McFadden (University of Arkansas, USA) & Julius Ecuru (BioInnovate Africa, Kenya).
This session will focus on risk analysis for persistent engineered genetic traits. The environmental risk assessment framework for genetically modified (GM) crops is well-established and leverages problem formulation to understand potential pathways to environmental harm. Advancing problem formulation for GM crops with potentially persistent traits, e.g. herbicide-tolerant eucalyptus, disease-resistant banana, and drought-resistant sorghum, will be considered. Risk assessment and management of gene drives for disease and pest control is also critical for effective decision-making. This plenary session will serve as a platform for scientists, researchers, academics, and regulators to discuss advances in science, risk analysis, and management for persistent engineered genetic traits.
Confirmed speakers: Andrew Newhouse & Bill Powell (State University of New York, USA), Ana Cristina Pinheiro (FuturaGene, Brazil), Lena Tripathi (International Institute of Tropical Agriculture (IITA), Kenya), Camilla Beech (Cambea Consulting Ltd, UK), Joerg Romeis (Agroscope, Switzerland) & Muthu Bagavathiannan (Texas A&M University, USA).
This session will focus on the importance of fit-for-purpose governance frameworks for sustainable bio-innovation. The importance of flexible and adaptive data requirements, global regulatory harmonization, and science-based risk assessment will be discussed. Additionally, the role of public and private standards in the governance of biotechnology and the environmental and economic costs of delayed adoption of bio-innovation will be considered. This plenary session will serve as a platform for scientists, researchers, academics, and regulators to discuss science, risk analysis, governance frameworks and development for sustainable bio-innovation.
Confirmed speakers: Sheila Ochugboju (Alliance for Science), Jose Falck-Zepeda (IFPRI, USA), Bernadette Juarez (USDA, USA), Danilo Fernandez Rios (Universidad Nacional de Asuncion, Paraguay), Ann Njoki Kingiri (AfricaLics and ACTS, Kenya) & Stuart Smyth (University of Saskatchewan, Canada).
This session will explore the importance of biotechnology for a sustainable future. Topics will be centered on the need for innovation and biotechnology to support food, agriculture and industry in the face of population increase, extreme weather, and changing climate. The need for modernized food systems and informed policies to enable biotechnology advancements (e.g. genetically modified crops, genome editing in plants and animals, biofortified foods, meat alternatives and cell-based meat products, and bioplastic alternatives) will be discussed. This plenary session will serve as a platform for scientists, researchers, academics, and regulators to discuss science, innovative solutions, public acceptance, and policy development for sustainable biotechnologies.
Confirmed speakers: Dr Joe Cornelius (Gates Ag One, USA), Ian Godwin (The University of Queensland, Australia), Judy Chambers (Program for Biosafety Systems, IFPRI, USA), Keri Carstens (Jord BioScience, USA), Alison Van Eenennaam (University of California, Davis, USA) & Sarah Evanega (Pairwise, USA).
Organized by Abby Simmons, CropLife International, USA
Despite scientific consensus around the safety of genetically modified (GM) crops and the myriad of benefits they provide, many promising new GM crops are subject to inconsistent regulatory approval timelines which delay and, in some cases, prevent commercialization. This is partially due to the misalignment of global regulations for GM crops. If different governments had more consistent or similar regulatory frameworks and requirements, agricultural innovations could move more quickly to farmers, which could result in more safe and nutritious foods and the adoption of more sustainable farming practices that benefit biodiversity and the environment. After more than twenty-five years of experience regulating GM crops, the time has come to modernize the safety assessment process for GM crops taking into account their history of safe use. Regulatory harmonization could include the alignment of data requirements or cooperation among authorities. Sharing data and risk assessments between regulatory authorities and recognizing the approval of a product from a different regulatory jurisdiction can increase transparency, reduce regulatory burden, and improve regulatory resource efficiency. Risk-proportionate governance frameworks that evolve and are modernized as the weight of evidence and familiarity with the technology increases would also allow agricultural innovations to reach the market faster which will provide important benefits to farmers, consumers, and the environment. This panel explores models for regulatory cooperation and modernizing approaches to GM regulation.
Organized by Benjamin Robinson, Outreach Network For Gene Drive Research, UK.
Gene drives are a genetic technology that promotes the preferential inheritance of specific genetic traits in a target population, thereby increasing their prevalence in that population. They present significant potential for tackling challenges related to public health (for example through control of disease vectors) and for environmental conservation and sustainability (for example through ecosystem restoration and control of invasive species).
In recognition of this potential, interest in gene drive research is considerable and growing rapidly. The global policy and governance environment in which this research takes place is also evolving quickly, with guidance and position statements on how it can be conducted safely, fairly, and responsibly having been published over the last year by several major international organizations, including the World Health Organization and the African Union Development Agency (AUDA-NEPAD).
This session will provide participants with an overview of what these developments mean for gene drive research, and how they can inform risk analysis and management. It will place particular emphasis on the implications for the development of novel environmental conservation technologies, as well as stakeholder consultation and researchers’ engagement with indigenous peoples and local communities. It will be an opportunity to hear from scientists and other experts directly involved in gene drive, and it will seek to provide an accurate picture of the state of this research, relevant regulatory and policy frameworks, and the ways in which these elements interact with stakeholder engagement activities and concerns.
Organized by Szabolcs Ruthner, International Seed Federation, Switzerland
The goal of plant breeders is, and has always been, to develop plant varieties that resist diseases and pests, are more tolerant of environmental stresses, improve quality and yield, and meet consumer expectations of their food. Accomplishing these goals requires both genetic variability (within and across related plant species) and the ability to utilize and “select” desirable genetic variability. Plant breeders are continuing to develop and refine methods in both inducing genetic variability and utilizing it, including using tools such as genome editing. As observed in the 2018 ISBR conference program, there is significant interest in the application of genome editing and other innovative breeding tools to improve crops. However, thinking about these tools – especially in the context of “biosafety” and biosafety research – requires a more robust understanding of the full suite of contemporary plant breeding approaches. This session will focus on the present and future of plant breeding, including:
Organized by Thorben Sprink, Julius Kuehn-Institute, Germany
Novel breeding technologies have been boosting plant breeding for almost a decade and the first promising products are pushing to the market. In contrast to this, in many countries, the current Directives regulating genetically modified plants and animals have been established more than 20 years ago, based on clear differentiation between transgenic and conventional breeding. To date, only a few of those directives are suitable to face the new challenge of genetic engineering. This workshop will discuss the use of new breeding technologies in plant breeding and will discuss how these techniques will further change breeding in the future. Furthermore, this workshop will give an insight into the current legislative frameworks and will discuss and evaluate the existing frameworks for the regulation of genetically modified plants in a worldwide comparison and discuss if there is a need for an updated worldwide harmonized legislation, regulating the use of organisms produced by novel genome editing techniques and by genetic engineering and how such legislation could be composed matching the scientific progress made.
Organized by Antonio Pupin, Brazilian Association of Bio-innovation, Brazil
According to the United Nations, the world population is expected to reach 9.7 billion in 2050 and could peak at almost 11 billion in 2100. Population growth, therefore, will require a greater demand for natural resources, energy, land, among others, which can result in drastic changes in the environment, evidencing the growth of greenhouse gas emissions at levels never seen before, resulting in a global climate disorder. Thus, Bio-innovation offers a viable way for the development of alternative and renewable energy sources, technologies and processes that allow the efficient and sustainable use of natural resources, demanding less energy consumption and that are integrated into business models based on circular economy in production chains, contributing to a more sustainable world. At the same time, Regulators should address efforts to maintain or create regulations that protect consumers´ safety while supporting the creation of sustainable solutions. In this sense, the United Nations in January 2016 adopted the 2030 Agenda for Sustainable Development, which approved the 17 Sustainable Development Goals (SDGs). Among the 17 SDGs, sustainable bio-innovation can be related to SDG 6 (clean water and sanitation), SDG 7 (affordable and clean water), SDG 9, Innovation and industry infrastructure, SDG 12 (responsible consumption and production) and SDG 13 (Climate Action). In this context, the proposed panel aims to discuss the potential of bio-innovation to accomplish Sustainable Goals, providing important solutions to overcome major needs from a growing population. In this scenario, Regulation plays a critical role to enable the adoption and development of sustainable biotechnology to successfully achieve these goals.
Organized by Bhavneet Bajaj, Agriculture & Food Systems Institute, USA
Nutritional composition studies that assess similarities and differences of levels of important nutrients and anti-nutrients 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 context in the safety assessment. This workshop will provide an opportunity to briefly discuss the rationale for considering crop composition data, how that data is interpreted in the context of the safety assessment and what the limitations are to compositional studies. The workshop will also introduce participants to a resource for assisting in the interpretation of compositional studies, the AFSI Crop Composition database. Participants will see a demonstration of the database and its new features included in the current version 9.1. Then, participants will be provided with a series of exercises designed to help them understand the search reporting function of the AFSI Crop Composition Database that they can walk through using their personal laptops during the workshop.
Please note: Participants should bring their laptops to the workshop.
Organized by Samantha O'Loughlin, Imperial College London, UK.
Gene drive research has been progressing rapidly in the last years making the prospects of future potential field evaluations more plausible. And with this prospect comes the need for a robust and science-based risk assessment. The question of whether risk assessment for gene drive research is possible and of the adequacy of the existing risk assessment frameworks for doing so have been a recurring topic in the last years, whether at the Convention on Biological Diversity, the European Union, or other national policy discussions. In 2021, researchers from Target Malaria, a not-for-profit consortium developing genetic approaches to suppress malaria-transmitting mosquitoes, has published a paper presenting its problem formulation exercise for the investigational releases of a suppression drive to control malaria-transmitting mosquitoes in West Africa. In this session, we will examine the journey to and from this paper and how it represents another step in the important process of risk assessment. This session will provide the audience an understanding of the method followed by these researchers to identify and analyze plausible pathways to potential harm but also examine the value of engaging stakeholders in this process. It will be an opportunity to demonstrate the importance of early identification of these pathways to potential harm in the research and development progression as well as in the dialogue with risk assessors and regulators. It is hoped to contribute to the broader dialogue on responsible research for gene drive development.
Organized by Shuichi Nakai, Bayer Cropscience, Japan
Data transportability is the concept by which data generated in one geography can be transported to another to support environmental risk assessments (ERA) of GM plants. Regulatory agencies generally require local field studies prior to decision-making related to GM plant cultivation. In a small number of countries, local field studies are required even for food and feed import. For example, regulatory agencies in China and Japan require local field studies for import approvals. In recent years, several peer-reviewed scientific publications (Garcia-Alonso et al. 2014, Nakai et al. 2015, Ahmad et al. 2016, Vesprini et al. 2020, Bachman et al. 2021) have described the appropriate conditions and considerations for the transportability of field data and/or conclusions from one geography to another. Also, utilization of transportable data across geographies/products has been successfully implemented or examined in multiple countries to eliminate redundancy, create efficiencies at regulatory bodies and enable the timely realization of the benefits of GM crops. The purpose of this parallel session is twofold, first to introduce the two examples of conditions for transportability of field data/conclusions advocated in the peer-reviewed scientific publications by renowned experts. And second, to introduce examples and challenges to implement data transportability in some countries/regions such as Japan, Argentina, and Africa with their competent authorities. The parallel session is to conclude with a discussion about conditions for Data Transportability, including the applicability of trial outcomes across environments and the unique challenges in each country/region and its scientific solutions.
Organized by Rachel Melnick, Agriculture & Food Systems Institute, USA and Naima Sykes Imperial College London, UK
Biosafety is informed by science but driven by human values. Perceptions of risk and value judgments about what must be protected and what constitutes harm are incorporated into biosafety decision-making. The need to engage and understand public values and attitudes is increasingly recognized explicitly in biosafety literature (such as article 23 of the Cartagena Protocol). As new applications of technologies enter the public discourse, there is a desire on the part of developers, regulators, and research scientists to improve efforts to engage the public and affected communities. In recent years several guidance frameworks have been published regarding stakeholder engagement and consultation for LMOs for public health, but a clearer establishment of roles and responsibilities for a consultation is needed. This symposium will examine both public consultations and social perceptions around different applications of biotechnology, including the use of gene drive technology for managing species that cause significant harm to the environment and human health, and applications of genome editing in agriculture and livestock animals. It will reflect on how a better understanding of public views on biotechnology can be beneficial for managing useful and effective public engagement.
Organized by Szabolcs Ruthner, International Seed Federation, Switzerland
An increasing number of countries have finalized policies focused on specific applications of genome editing. Still, others are in the process of reviewing current policies, legislation and regulations to determine if any revisions or changes are needed. At the same time, the range of possible uses of genome editing in breeding programs is evolving and expanding as the technology matures. Genome editing is known for its use in precisely inducing change to a specific gene(s) in a plant’s genome. However, it can also be used by researchers for basic gene discovery. It can be used to identify a gene in a plant’s wild relatives and then precisely recreate that gene into existing commercial varieties. It may be used in the future to maximize the performance of a crop in a given set of environments. And it may be used in the future to make breeding processes themselves more efficient by breaking detrimental genetic linkages. This workshop will focus on:
The session is meant to be interactive with adequate time allowed for panel discussions and open interaction with workshop participants. The goal is to use the session as a start toward discussions on learning from current policy implementation and how best to “future proof” policies.
Organized by Abby Simmons, CropLife International, USA
Agricultural biotechnology is helping meet the world’s growing need for food, feed, and fiber while reducing farming’s environmental footprint. However, farmers in many countries are unable to access genetically modified (GM) crops due to long regulatory approval timelines and commercialization delays. CropLife International supports sustainable bio-innovation by promoting regulatory policies that are predictable, science-based, and risk proportionate so that agricultural innovations are available to those who would benefit the most. Government policies and data requirements for the safety assessment of GM crops vary across regulatory authorities globally. The CropLife International regulatory harmonization project has identified studies and approaches that constitute a science-based data package that is sufficient for regulatory decision-making. Leveraging the history of safe use and the familiarity of the technology, data from a core set of studies should be considered first, and additional hypothesis-driven supplementary studies should only be performed if necessary, to inform the safety assessment. This focused approach for the evaluation of GM plants is risk-proportionate and can be used as a basis for harmonization of data requirements, providing a more transparent, predictable, and consistent framework for global regulation. During the workshop, we will explore the recommendations of the CropLife International Regulatory Harmonization Project through a hands-on activity. Participants will break into groups to analyze an environmental risk assessment case study and food and feed risk assessment case study for a GM Crop. These case studies will introduce a problem formulation-based approach to risk assessment and will include a thorough exploration of technical regulatory topics such as when composition data and dietary exposure assessments should be required. The workshop will foster discussion on the principles of risk analysis, as well as fit-for-purpose governance frameworks, and science-based data requirements.
Case study links
Participants in Workshop 2 (Harmonization of global data requirements: a modernized approach to GM Crop Risk Assessment) will work through a case study using the core and supplementary study approach proposed in the CropLife International in a series of papers that were published in the Journal of Regulatory Science in 2021. Participants are invited to review the paper on the safety assessments for food and feed uses and the paper on environmental risk assessment in advance of the meeting.
Organized by Dave O'Brochta, Foundation for the National Institutes of Health, USA.
In this workshop participants will learn about causal knowledge mapping and how it could be well suited for risk analyses of emerging applications of genetically modified organisms through short expository lectures and hands-on exercises featuring qualitative (signed digraphs), semi-quantitative (fuzzy cognitive maps) and quantitative (Bayesian networks) approaches. This workshop is intended for those with little or no familiarity or experience with these approaches. Advances in genome editing and modification, transgenic technologies and synthetic biology are enabling the creation of genetically modified organisms intended to persist in environments, complicating risk analyses and decision-making. While commonly used risk matrices have proven utility as a decision-support tool for the analyses of risks presented by genetically engineered organisms, various causal knowledge mapping approaches (e.g. signed digraphs, fuzzy cognitive maps, and Bayesian networks) used in many domains to support risk assessment and management decisions could help to better organize thought processes during problem formulation and other phases of risk assessment, enable broad stakeholder input to be incorporated into risk analyses, capture uncertainty and promote transparency. These tools have much in common with the "pathways to harm" methodology that is familiar to those assessing risks of genetically engineered crops and draw upon graphical representation of cause-and-effect relationships that can either be characterized qualitatively or with varying degrees of quantitative representation, leading to more probabilistic expression of risk scenarios. These tools enhance risk assessors’ abilities to systematically map risk scenarios, thereby improving not only the quality of their risk analyses but also their ability to transparently communicate those analyses to decision-makers and other stakeholders. These improvements will be especially useful when dealing with genetically engineered organisms that are less familiar to regulators, and where decisions based on limited data might be required.
Organized by Karen Hokanson, University of Minnesota, USA
Potato is the third most important food crop worldwide. Late blight is still the most prominent, ubiquitous, and devastating disease of potato since its outbreak in the 1840’s provoked the Irish famine. Genetic engineering using 3 R genes from wild relatives provides durable resistance for existing popular varieties greatly reducing the average 15-30% production loss while cutting the need for fungicides by up to 90%. The 3 R-gene late blight resistant potato offers a solution for controlling the disease with significant economic benefit and less risk to human health and the environment. The Feed the Future Global Biotech Potato Partnership aims to contribute to a sustainable reduction of late blight disease, while helping emerging economies in Asia and Sub-Saharan Africa (SSA) accelerate their progress towards self-reliance through local leadership and local ownership of product development objectives and implementation. This workshop brings together key individuals involved with this project to share experiences and discuss some of the biosafety issues particularly associated with the release of the 3 R-gene potatoes in the target countries, including the use of cisgenics, stacked genes, intractable proteins, and data transportability. Building on familiarity with conventional potato varieties, the nature of R genes, and use of wild relative germplasm to incorporate R genes through traditional breeding, a strong weight-of-evidence exists for safety of these late blight resistant potatoes. The key regulatory question is about what remains to be documented for food and environmental safety assessments in order to consider these potatoes safe as food and for cultivation.
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