COP-17 / CP-MOP-12 Side Event: A Simplified Procedure – Identification of Organisms Not Likely to have Adverse Effects in a Decision by the COPMOP of the Cartagena Protocol on Biosafety
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October 19, 2026
4:30 pm - 6:00 pmMeridian Expo and Event Centre | Talin: Side-event Room 1
Yerevan, Armenia (AMT)
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Overview
The Agriculture & Food Systems Institute (AFSI) is hosting a side event at the UN Biodiversity Conference 2026 (COP-17 / CP-MOP-12) on October 19, 2026.
With more than twenty years of experience with implementation of the Protocol and introductions of LMOs, Parties may consider establishing a process by which such a decision of the COPMOP on ‘organisms not likely to have adverse effects’ can be taken. In this side event, we will consider two Cry proteins, Cry1Ab and Cry2Ab, expressed by genes from the bacterium Bacillus thuringiensis in LM crops for insect resistance as a case to consider in the development of such a process. By the end of 2025, multiple maize events and breeding stacks, and other crops including cotton, cowpea, eucalyptus, rice, and sugarcane, expressing Cry1Ab have been assessed for environmental safety and approved as safe for cultivation in more than 20 countries. Maize, cotton, and soybean events and breeding stacks expressing Cry2Ab have also been approved for cultivation in more than 20 countries. These safety assessments have considered similar potential adverse effects on the environment, and on biodiversity, due to the expression of the Cry proteins and possible pathways to harm in different crops and diverse environments. They all reached the same conclusion: that adverse effects on biodiversity are not likely. This has included application of a common approach to non-target organism (NTO) assessment, which is the primary adverse effect on biodiversity considered in the case of crops modified to produce a pesticidal substance.
Background
Simplified Procedures Under the Protocol
The advance informed agreement (AIA) procedure for transboundary movement of living modified organisms (LMOs) intended for introduction into the environment, as set forth in the Cartagena Protocol on Biosafety, includes (in Article 7 paragraph 4) an opportunity for exemptions of LMOs ‘identified in a decision of the COPMOP to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity…’ In addition, Article 13 of the Cartagena Protocol on Biosafety describes a ‘simplified procedure’ by which ‘a Party of import may…specify in advance to the BCH:… (b) Imports of living modified organisms to it to be exempted from the advance informed agreement procedure.’ Article 7(4) and Article 13 create an opportunity for Parties to coordinate risk assessments in order to increase the efficiency of the Protocol as it is intended to both provide for access to and transfer of, while enhancing the safety of biotechnology.
Data Transportability and Information Sharing
Closely tied to this discussion is the concept of data transportability for environmental risk assessment, which along with the concept of simplified procedures, has been a point of discussion in the online forum and by the AHTEG for risk assessment and risk management. The concept of data transportability, which relies on identifying specific, hypothesis-driven risks associated with a specific LMO rather than gathering general, extraneous data, is gaining considerable attention in the regulatory community as experience with safety assessments for LM crops has increased. Article 14 of the Protocol also specifically encourages bilateral, regional, and multilateral agreements among Parties, which may serve as a starting point for more broad agreements among Parties of the Protocol. Finally, Article 20 addresses information sharing, including summaries of risk assessments, among Parties through the BCH. Examples of processes for information sharing and sharing of risk assessments in bilateral, regional and multilateral agreements exist that could possibly be extended to similar processes for the Parties of the Protocol. We will discuss these points as they relate to the Cry proteins in this side event.
Agenda
Monday, October 19, 2026 | 4:30 pm – 6:00 pm (AMT)
| Time | Title/Activity | Presenter/Lead | |
| 4:30 pm | Introduction – Building on Experience With Risk Assessments of LM Crops to Simplify Procedures of the Protocol, Considering Relevant Articles (7(4), 13, 14, 20) | Dr. Karen Hokanson Senior Manager, Scientific Programs Agriculture & Food Systems Institute (AFSI) USA |
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| 4:40 pm | Assessing Adverse Effects of Bt Crops to Biodiversity | Dr. Jörg Romeis Head, Biosafety Group Agroscope Switzerland |
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| 4:55 pm | Data Transportability for Environmental Risk Assessments of LMOs | Dr. Andrew F. Roberts Chief Executive Officer Agriculture & Food Systems Institute (AFSI) USA |
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| 5:10 pm | Expedited Review of Familiar Plants and Traits in Argentina | Ms. Maria Florencia Goberna Dirección Nacional de Bioeconomía Subsecretaría de Producción Agropecuaria y Forestal Secretaría de Agricultura, Ganadería y Pesca Argentina |
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| 5:25 pm | Regional Regulatory Cooperation: Streamlining Decision-Making Through Shared Risk Assessments | Dr. Luciana P. Ambrozevicius Member Brazilian National Biosafety Commission (CTNBio) Ministry of Agriculture and Livestock Brazil |
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| 5:40 pm | Discussion – Q&A and Conclusions | Dr. Andrew F. Roberts |
Resources
AFSI Protein Monographs
AFSI’s protein monographs review global approvals of proteins expressed in genetically engineered crops, with links to the publications, regulatory dossiers, and decision documents behind them. The two proteins discussed in this side event are covered in both series:
- Cry1Ab: Environmental Safety | Food & Feed Safety
- Cry2Ab: Environmental Safety | Food & Feed Safety
Browse all AFSI protein monographs
Conference Information
Speakers
Dr. Luciana P. Ambrozevicius
Member, Brazilian National Biosafety Commission (CTNBio), Ministry of Agriculture and Livestock, Brazil
Dr. Luciana P. Ambrozevicius is an agronomist with a Ph.D. in Genetics and Plant Breeding. She joined the Brazilian Federal Public Service in 2007 as a Federal Inspector at the Ministry of Agriculture and Livestock (MAPA). Since then, she has represented Brazil in various international forums on biosafety and biotechnology, including the Synthetic Biology and Risk Assessment AHTEGs. Dr. Ambrozevicius is currently a member of the Brazilian National Biosafety Commission (CTNBio). Her professional experience encompasses risk assessment, biosafety regulation, biotechnology, and international agricultural trade.
Ms. Maria Florencia Goberna
Dirección Nacional de Bioeconomía, Subsecretaría de Producción Agropecuaria y Forestal, Secretaría de Agricultura, Ganadería y Pesca, Argentina
Ms. Maria Florencia Goberna is a biotechnologist with the Dirección Nacional de Bioeconomía, Subsecretaría de Producción Agropecuaria y Forestal, Secretaría de Agricultura, Ganadería y Pesca, Argentina. She specializes in regulatory affairs, biosafety, and the risk assessment of genetically modified organisms and new breeding techniques, with experience spanning policy development, international regulatory cooperation, and capacity building for regulatory authorities. Ms. Goberna is also active in science communication and stakeholder dialogue, and advises policymakers on biotechnology governance and innovation.
Dr. Karen Hokanson
Senior Manager, Scientific Programs, Agriculture & Food Systems Institute (AFSI), USA
Karen joined the Agriculture & Food Systems Institute (AFSI) as a Senior Scientific Program Manager in October 2023. She contributes to the development and implementation of AFSI’s current and future applied research and capacity building programs. She is responsible for developing strategies and budgets for these programs, identifying associated personnel requirements, and is accountable for ensuring the program/project meets its stated objectives. She also serves as liaison between AFSI management and staff, implementing partners, and other applicable parties. She is the main point person for AFSI’s USDA-funded capacity building activities related to the Cartagena Protocol on Biosafety.
Prior to joining AFSI, Karen was a Senior Research Specialist in the Department of Horticultural Sciences at the University of Minnesota (UMN) for 22 years, where she worked mainly on projects related to biotechnology regulation and biosafety, with a focus on risk assessment. After spending her early career at USDA-APHIS as a biotechnologist, most of her career has been devoted to capacity building for the regulation of biotechnology in developing countries in Africa and Asia. She has worked over the years on projects to develop national biosafety frameworks and implement the Cartagena Protocol on Biosafety, and as a biosafety advisor on various crop improvement projects.
Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute (AFSI), USA
Dr. Andrew Roberts joined the Agriculture & Food Systems Institute (AFSI) in December 2009 as the Deputy Director of the Center for Environmental Risk Assessment (CERA), where he developed tools and materials for use in training and capacity building related to the problem formulation approach to environmental risk assessment and served as the coordinator for CERA’s capacity building projects under the USAID-funded South Asia Biosafety Program (SABP) and the World Bank-funded Partnership for Biosafety Risk Assessment and Regulation, in Bangladesh, Pakistan, and Vietnam. He also provided technical support for capacity building work in Brazil, India, Japan, Chile, and South Africa. In January 2015, he became the director of CERA, as well as the Center for Safety Assessment of Food and Feed (CSAFF), which worked on food and feed safety assessment for foods derived from genetically engineered plants. The two centers were later consolidated under the Research Foundation, for which he became Deputy Executive Director in January 2017. When the organization became the Agriculture & Food Systems Institute in 2020, his title shifted to Vice President – Biotechnology, and he assumed the role of Chief Executive Officer later that year.
Prior to joining AFSI, Dr. Roberts worked at the U.S. Department of Agriculture (USDA) in several different capacities, all related to the regulation of agricultural biotechnology. He began his career at USDA as an AAAS Risk Policy Fellow in the Office of Science at Biotechnology Regulatory Services (BRS), the group responsible for regulating genetically engineered plants at USDA’s Animal and Plant Health Inspection Service. After spending a year in the New Technologies office of the Foreign Agricultural Service serving as the lead for USDA’s efforts related to the Cartagena Protocol on Biosafety, he returned to BRS to serve in the International Affairs branch where he remained until joining AFSI.
Dr. Jörg Romeis
Head, Biosafety Group, Agroscope, Switzerland
Jörg Romeis is the head of the Biosafety Group at Agroscope in Zurich, Switzerland. Agroscope is the Swiss center of excellence for agricultural research and is affiliated with the Federal Office for Agriculture. He has an M.Sc. in biology and has been trained as an applied entomologist with a focus on biological control and multi-trophic interactions. He has more than 20 years of experience in non-target risk assessment of transgenic crops and the design and execution of non-target laboratory studies in particular. Besides research projects to investigate non-target impacts of selected transgenic plants and insecticidal compounds, he has also been actively involved in developing testing protocols and guidelines for non-target risk assessment. He is past president of the International Society for Biosafety Research (ISBR), which aims to promote scientifically sound research that supports biosafety assessment.