Parallel session 1: Fit-for-purpose regulatory frameworks – a modernized approach to GM crop regulation
Tracks
Breakaway 1
| Monday, May 1, 2023 |
| 14:00 - 15:30 |
| Illinois / NY Central |
Details
Organized by Abby Simmons, CropLife International, USA
Despite scientific consensus around the safety of genetically modified (GM) crops and the myriad of benefits they provide, many promising new GM crops are subject to inconsistent regulatory approval timelines which delay and, in some cases, prevent commercialization. This is partially due to the misalignment of global regulations for GM crops. If different governments had more consistent or similar regulatory frameworks and requirements, agricultural innovations could move more quickly to farmers, which could result in more safe and nutritious foods and the adoption of more sustainable farming practices that benefit biodiversity and the environment. After more than twenty-five years of experience regulating GM crops, the time has come to modernize the safety assessment process for GM crops taking into account their history of safe use. Regulatory harmonization could include the alignment of data requirements or cooperation among authorities. Sharing data and risk assessments between regulatory authorities and recognizing the approval of a product from a different regulatory jurisdiction can increase transparency, reduce regulatory burden, and improve regulatory resource efficiency. Risk-proportionate governance frameworks that evolve and are modernized as the weight of evidence and familiarity with the technology increases would also allow agricultural innovations to reach the market faster which will provide important benefits to farmers, consumers, and the environment. This panel explores models for regulatory cooperation and modernizing approaches to GM regulation.
14:00 - 14:05 Chair: Abby Simmons Introduction
Despite scientific consensus around the safety of genetically modified (GM) crops and the myriad of benefits they provide, many promising new GM crops are subject to inconsistent regulatory approval timelines which delay and, in some cases, prevent commercialization. This is partially due to the misalignment of global regulations for GM crops. If different governments had more consistent or similar regulatory frameworks and requirements, agricultural innovations could move more quickly to farmers, which could result in more safe and nutritious foods and the adoption of more sustainable farming practices that benefit biodiversity and the environment. After more than twenty-five years of experience regulating GM crops, the time has come to modernize the safety assessment process for GM crops taking into account their history of safe use. Regulatory harmonization could include the alignment of data requirements or cooperation among authorities. Sharing data and risk assessments between regulatory authorities and recognizing the approval of a product from a different regulatory jurisdiction can increase transparency, reduce regulatory burden, and improve regulatory resource efficiency. Risk-proportionate governance frameworks that evolve and are modernized as the weight of evidence and familiarity with the technology increases would also allow agricultural innovations to reach the market faster which will provide important benefits to farmers, consumers, and the environment. This panel explores models for regulatory cooperation and modernizing approaches to GM regulation.
14:00 - 14:05 Chair: Abby Simmons Introduction
Speaker
Dr Andrew F. Roberts
Chief Executive Officer
Agriculture & Food Systems Institute
All Roads Lead to Rome: Understanding the Variety of National Regulatory Mechanisms for Genetically Modified Organisms
14:05 - 14:20Biography
Andrew leads the development and management of AFSI’s extensive international portfolio of biotechnology-related analytical and capacity building programs, open access resources, and relationships with key partner organizations and stakeholder groups.
Prof. Danilo Fernández Ríos
Research Professor
Universidad Nacional de Asunción
Regulation of Genetically Engineered Crops in Paraguay: A Science-Based Approach for Adequate Access and Safe Use
14:20 - 14:35Biography
Danilo Fernández Ríos has a degree in Science (Biology) from the National University of Asunción. He did his postgraduate studies in Biological Sciences (Genetics) at the Federal University of Rio de Janeiro, working with plant molecular genetics. He has a postgraduate diploma in Biotechnology, Industries and Business from the National University of Quilmes. He also has a Diploma in Science, Technology and Society CTS from the National Council of Science and Technology (CONACYT-Paraguay). He was a technical advisor in the curricular design of the Biotechnology Degree at the National University of Asuncion and later coordinator of that degree. He has been the coordinator of the Ad Hoc group of Safety Evaluation of the Agricultural Biosafety Commission of the Ministry of Agriculture and Livestock. He has been a referee for specialized journals in the agricultural area and has directed undergraduate and postgraduate theses on subjects related to biotechnology. He has published in international indexed scientific journals. His work is mainly related to biotechnology and agri-food safety. He is a categorized researcher of the National Program of Incentive to Researchers (PRONII-CONACYT). He is currently a research professor at the National University of Asunción and a professor of Molecular Cell Biology, Genetics and Biosafety of Biotechnology at the same university. He also serves as Scientific Advisor in Biotechnology and Biosafety for the National Commission of Agricultural and Forestry Biosafety of the Ministry of Agriculture and Livestock.
Prof. Hiroaki Kodama
Professor
Chiba University
The case for deregulation of Category 1x1 stack
14:35 - 14:50Biography
Professor of Chiba University.
A Technical advisor of Genetically Modified Food Expert Panel of Food Safty Commission of Japanese Government Cabinet. A Member of of Pharmaceutical Affairs and Food Sanitation Council of Ministry of Health, Labour and Welfare. Main major of research: Plant RNA silencing.
Dr Carl Ramage
Rautaki Solutions
Rautaki Solutions
Challenges and opportunities for regulatory cooperation and coherence across Asia Pacific
14:50 - 15:05Biography
Carl is the Managing Director of Rautaki Solutions, an Australian based consultancy business that supports national and international biotech organisations across public and private sectors. He focuses on providing strategic direction and operational support in biosafety and the commercialisation of biotech products. This includes the development of regulatory strategy and the drafting regulatory dossiers for submission and assessment by regulatory authorities.
Carl sits on several agriculture industry committees, is a former board member of the Association of Biosafety Australia and New Zealand and is a Graduate of the Australian Institute of Company Directors.
His career has focused on building sustainable capability and capacity in biosafety and bio-risk management. He is actively involved in the development and implementation of compliance management frameworks and compliance plans for biosafety containment facilities as well as programs for the intentional release of genetically modified organisms into the environment. More recently he facilitated the introduction and study of Australia’s first gene edited cattle.
Carl is the only south pacific Excellence Through Stewardship auditor, a program that promotes the universal adoption of product stewardship programs and quality management systems for the full life cycle of agricultural technology products.
Dr Michael Stulberg
Senior Biological Scientist
USDA-APHIS-BRS-BRAP
Case studies of modified plants not subject to the USDA modernized biotechnology regulations
15:05 - 15:20Biography
Michael is a Senior Biological Scientist at the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Biotechnology Regulatory Services (BRS). He reviews the regulatory status of plants modified using genetic engineering in BRS’s Biotechnology Risk Analysis Program (BRAP).
Chair
Abby Simmons
Senior Regulatory Manager
CropLife International
