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 have
been 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

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, processes 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

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 Workshop on the 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 (AFSI)
                           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