The International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO) is a biennial, international meeting which “…brings together academics, technology developers, regulatory authorities, non-government organizations and other credible stakeholders involved in all aspects of biosafety and offers a unique opportunity to share information and experiences and engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters.”
Contributed by Clara Rubinstein, PhD, ILSI Argentina
The 14th ISBGMO, held in June 2017 in Guadalajara, Mexico, focused on key global topics of interest to risk assessment, discussed at plenary and parallel sessions. Learnings from experience to advance environmental risk assessment (ERA), modernization of risk assessment; unintended effects; non-target-organism studies; familiarity; problem formulation; and transportability were among these.
Gene editing and gene drives also were given dedicated sessions to discuss the need for risk assessment and the current situation at the global level. It was agreed that the starting point to advance, was to have a clear definition of a GMO.
Latin America was well represented, with participants from Brazil; Argentina; Uruguay; Paraguay; Colombia; Peru; and, of course, Mexico.
ILSI Argentina was invited to present a plenary talk on the Similar Constructs Framework for simplified risk assessment based on familiarity and problem formulation, as outlined in the 2016 Transgenic Research article “Development of a construct-based risk assessment framework for genetic engineered crops.” This paper is Open Access and available here: Construct-Based Risk Assessment. A main point discussed was a need for agencies that may adopt this, or similar frameworks, to inform developers on these criteria; this could be effectively done through pre-consultations.
In addition, a session on the Sustainability of Capacity Building Efforts was organized and moderated by ILSI Argentina, with participation of regulators from developing countries, Michigan State University, and the International Centre for Genetic Engineering and Biotechnology representatives. The need to develop metrics was discussed, to assess the utility of training efforts to the agencies work and to identify measures that could be taken to make these efforts sustainable in time, considering high rotation of regulators, challenges in honorary expert panels, and other issues.
Among the meeting highlights were:
- Canada's presentations showed consistent positions on the need to evolve and use familiarity in risk assessment. Process as the trigger for regulation was considered not reasonable and the need for consensus was repeatedly brought up in the audience. An upcoming publication was announced on the Modernization of Data for Novel / Familiar Traits (2018).
- Results were presented from the GMO Risk Assessment and Communication Evidence project, confirming no adverse effects in GMO-fed animals.
- The National Academy of Sciences, Engineering, and Medicine (NASEM) report Gene Drives on the Horizon was presented, and an upcoming new report on future products was announced. Some points and recommendations were challenged, like the proposal to use omics in risk assessment. There were additional presentations on the NASEM report recommendations, including opinions on gene drives and the role of public engagement.
The next ISBGMO will be held in Barcelona, Spain, in 2019.
Abstracts and presentations from ISBGMO14 can be found online at: http://isbr.info/ISBGMO14