Examples of regulatory modernization for GM Crops

Organizers: Abby Simmons, CropLife International;
                       Gabi Levitus, ArgenBio

For nearly 30 years genetically modified (GM) crops have provided benefits to farmers,
consumers, and the environment, without harm to humans, animals or the environment.
Despite this excellent record of safety, the level of regulatory scrutiny has routinely
increased, and farmers in many countries are unable to access GM crops due to long
regulatory approval timelines and commercialization delays. Modernized regulatory
approaches that are risk-proportionate, consider the history of familiarity and safe use of
agriculture biotechnology, as part of established plant breeding, are necessary so that
agricultural innovations are available to those who would benefit the most. In support of
regulatory policies that are predictable, science-based, and risk proportionate, CropLife
International has developed recommendations focused on a core set of studies for GM
Crops, leveraging problem formulation and determining plausible pathways to harm, to
determine whether additional supplementary studies may be warranted to inform on the
food, feed and environmental risk assessment. Several countries have adopted or are
considering following a more streamlined approach for GM crop risk assessment. This
workshop will highlight examples of regulatory streamlining from multiple countries in
Latin America, as well as the United States. Regulators from select Latin American
countries as well as the United States will share their experiences regulating GM crops,
highlighting best practices in the region. Following brief presentations, the regulators will
discuss a series of brief case studies that address what data is needed to make a
conclusion on safety. The audience will also participate in the discussion of the case
studies via a question-and-answer session. Participants will leave the workshop with a
better understanding of using problem formulation to determine which data truly
provides value to the risk assessment of GM crops.

Government perspective on implementation of genome edited plant regulatory policies: Challenges and solutions

Facilitator: Jean-Paul Judson, Nowmore
Organized by Khaoula Belhaj-Fragnière, International Seed Federation;
                           John McMurdy,CropLife International

The successful global deployment of plant breeding innovation hinges on the effective
implementation of regulatory policies, and the ability of researchers and developers to
navigate them. In the last decade, an increasing number of countries are adopting and
implementing innovation enabling regulatory frameworks pertaining to plant breeding
innovation, such as genome editing. This session will showcase government regulatory
implementation experiences, highlighting challenges and sharing best practices.
Discussions will explore opportunities for science-based and future-proofing regulatory
policies and implementation through international collaboration and industry-
government dialogue. By minimizing divergence in regulatory decision making and
aligning implementation, the development and adoption of solutions enabled through
genome editing can be accelerated and trade can be facilitated.

Ethics and evolution workshop: considerations for human intervention

Organizers: Detlef Bartsch, Federal Office for Consumer Protection and Food Safety
                       René Custers, Regulatory & responsible research manager, VIB
                       Peter Thygesen, Principal Regulatory Scientist, Office of the Gene Technology Regulator

Our abilities to intervene in the genetic material of organisms have gradually grown and
have gained additional momentum with the introduction of technologies such as
CRISPR and now also artificial intelligence. This enables us to develop organisms with
certain characteristics more precisely. Until now, GMOs have almost all been introduced
into heavily managed environments such as agricultural cropland. These GMOs have
not been introduced with the intention to have effects outside agricultural fields, on the
contrary. And the risk assessments for those GMOs were heavily focused on preventing
undesired effects outside agricultural fields. But now with the advent of these new
techniques, organisms may be proposed and developed with the goal to introduce them
to have intended effects on the natural environment, including potentially on biodiversity
and evolution. Currently, most focus is mitigating diseases that are transmitted by for
instance insects. Other proposals are aimed at benefits for the environment e.g.
protecting endangered species and environmental remediation. But such interventions
might have lasting effects on the environment and could in some cases lead to the
establishment of engineered organisms in the environment. These developments raise
intricate questions concerning ethics and sustainability. Biodiversity is declining and the
amounts of natural habitats are decreasing. The workshop aims to address this
question: Given the crisis for biodiversity, should we be engineering organisms for the
natural environment and what is ethical and what is sustainable in this context? Key
issues and further questions are:

• What is “Evolution”?
• Humans playing God?
• Humans and Nature – anthropocentric or nature focus
• Societal values and biodiversity conservation
• Concepts of “Evolutionary integrity”
• Intrinsic value (“Eigenvalue”) of Nature
• What is “Environmental damage” in relation to evolution?

The workshop is separated into three introductory talks and will include an interactive
“world café” with all participants

Interactive workshop on practical regulatory solutions for animal biotechnologies in Europe and beyond

Organizers: Geena Cartick, European Forum of Farm Animal Breeders (EFFAB

Animal biotechnologies, including New Genomic Techniques (NGTs), are essential tools
for advancing sustainable livestock and aquaculture systems, improving animal health,
and reducing environmental impact. Effective regulation of these technologies, however,
requires scientific, evidence-based frameworks that address technological challenges
while fostering public trust. This workshop, aligned with the ISBR2025 theme
"Cultivating Bio-Innovation for a Sustainable Future," will focus on solutions-oriented
discussions around the regulation of animal biotechnologies. It will provide a
collaborative environment to explore technological challenges such as implementation
in breeding programs, detection and traceability of NGTs in animals, with practical input
from stakeholders including regulators, breeders, and policymakers. The workshop will
involve interactive activities, group discussions, and case study analyses, giving
participants the opportunity to engage with real-world scenarios and learn about the
regulatory developments and landscapes of key regions including the EU, UK, Norway,
and beyond on the following aspects:

• Key technological challenges, including implementation at large scale.
• Policy and public technological challenges; detection, traceability, and risk assessment.
• Updates on current technical regulatory developments in the EU, UK, and Norway, including insights from EFSA's anticipated 2025 scientific opinion on NGTs in animals and the Animal welfare declaration in the UK
• Practical insights from breeders on the application and commercialization of NGTs.

The goal is to develop actionable strategies for science-based policy making and the
effective application of animal biotechnology regulations. By the end of the workshop,
participants will have a clearer understanding of the regulatory processes involved and
be equipped with practical tools to contribute and to advocate for science-based policy
making in their own regions.

AI-Driven innovations: Potential for risk analysis in biosafety research 

Facilitator & Session Organisers: Pieter Windels, BASF

The workshop has the objective to investigate, together with participants and invited speakers, the potential applications of artificial intelligence (AI) in biosafety research and will include sessions focusing on the use of AI for risk assessment, risk management, and risk communication. The workshop will review and discuss real-world examples of AI in action today, assess feasibility for biosafety related risk analysis and provide insights into future developments. Attendees will gain insights from current examples and future possibilities, tailored to both technology developers and governmental regulators. The workshop is designed to have an explorative and engaging character, combining thought-provoking presentations with interactive activities. To begin, the presentations will serve to set the stage by providing participants with foundational knowledge and real-world examples of how AI is currently being applied in biosafety research. These presentations aim to stimulate fresh thinking and inspire participants by showcasing innovative use cases. Following this, the workshop will transition into interactive sessions where participants will take an active role in shaping the discussion. These sessions are intended to foster creative thinking by encouraging attendees to share their ideas, voice concerns, and propose potential solutions. Moreover, the workshop's structure is carefully designed to emphasize the critical importance of collaboration and open dialogue between all stakeholders, including researchers, regulators, and technology developers. By providing a platform for meaningful exchange, we aim to highlight how collective efforts can support the integration of these transformative tools into existing frameworks. This collaborative approach ensures that diverse perspectives are considered, helping to build trust and consensus on how to use AI's potential while addressing potential uncertainties. The workshop acts a roadmap for continued dialogue and innovation.

Important Dates