Workshop 2: Harmonization of global data requirements: a modernized approach to GM Crop Risk Assessment
Tracks
Breakaway 2
| Tuesday, May 2, 2023 |
| 14:00 - 15:30 |
| Frisco / Burlington |
Details
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. Chair: Abby Simmons
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. Chair: Abby Simmons
Speaker
Dr Abby Simmons
Senior Regulatory Manager
CropLife International
Harmonization of global data requirements: a modernized approach to GM Crop Risk Assessment
14:00 - 17:00Biography
Dr. Simmons coordinates and manages projects and teams focused on developing and implementing science-based, globally harmonized regulatory strategies for plant biology and crop protection products. Before joining CropLife International, she was an AAAS Science and Technology Policy Fellow with the United States Department of Agriculture Foreign Agricultural Service (USDA FAS) covering trade issues related to agricultural biotechnology. Dr. Simmons received her Ph.D. in biology from Stanford University, where she studied stomatal development in the model plant Arabidopsis thaliana, and her B.S. in biological sciences from Carnegie Mellon University. Dr. Simmons is based in Washington, D.C.
Chair
Abby Simmons
Senior Regulatory Manager
CropLife International
