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HLPDAB: Successful, Efficient, and Effective Regulatory Cooperation on Agricultural Biotechnology in APEC

    August 8, 2025
    8:30 am - 1:00 pm
    Songdo Convensia (Room: 204 - 205)
    Incheon, Republic of Korea

Background

Asia-Pacific Economic Cooperation (APEC) member economies continue to work together towards reducing resource costs, increasing efficiencies in regulatory processes, and lowering barriers to innovation and trade. On July 30-31, 2023 in Seattle, at the workshop on Reducing Redundancies and Facilitating Efficiencies: Regulatory and Policy Solutions for Oversight of Agricultural Biotechnologies, participants from APEC member economies explored potential mechanisms to align the oversight of agricultural biotechnologies and the feasibility of developing a “Policy Approaches Document.” The outline for this document was presented at the 2023 Asia-Pacific Economic Cooperation High Level Policy Dialogue on Agricultural Biotechnology (APEC HLPDAB) plenary meeting.

To develop a draft of the Policy Approaches Document, the Agriculture and Food Systems Institute (AFSI) conducted the following virtual consultative meetings in 2024 and 2025 to gather input from APEC member economies, with the aim of ensuring the document is fit for purpose and represents policy approaches that have real opportunities for practical uptake:

  • Session 1:  Information Sharing (May 6, 2024)
  • Session 2: Aligning Data Requirements, Standardizing  Application/Dossier Templates, and Harmonizing Risk Assessment Methodologies (May 29, 2024)
  • Session 3: Mutual Recognition of Risk Assessments (June 18, 2024)
  • Session 4: Advancing the Policy Approaches Document (January 15, 2025)

Additionally, on August 14, 2024 in Trujillo, Peru, AFSI implemented the workshop on Moving Forward on Agricultural Biotechnology through Continuing Efforts on Regulatory Cooperation in APEC. At this full-day, in-person workshop leading up to the 2024 APEC HLPDAB plenary meeting, AFSI introduced a draft of the Policy Approaches Document and its companion online portal (biotechpolicyportal.org). Workshop participants had the opportunity to browse and provide feedback on the website, which highlighted case studies of successful approaches to regulatory cooperation.

Program

Organized prior to the 2025 APEC HLPDAB plenary meeting, this in-person workshop on Successful, Efficient, and Effective Regulatory Cooperation on Agricultural Biotechnology in APEC builds upon previous discussions on regulatory solutions for oversight of agricultural biotechnologies that took place from 2023 to 2025. The workshop continues those discussions to further regulatory alignment and streamline systems to reduce resource costs, increase efficiency, and facilitate development, adoption, use, and trade of products derived from agricultural biotechnology. It also provides an opportunity to review the Policy Approaches Document, last updated on October 15, 2024, and share information on innovative, cost-saving approaches economies are utilizing. Discussions are expected to encourage regulatory cooperation and streamline approvals processes, thereby lowering costs and increasing trade and economic benefits within the APEC region.

Agenda

Opening Session

8:30 am

Welcome and Introductions | Overview of the Workshop

Dr. Bhavneet Bajaj
Senior Manager – Scientific Programs, Agriculture & Food Systems Institute (AFSI), USA

8:40 am

Keynote | The First Released GM Banana: The Science and the Regulation

Prof. Dr. James Dale AC FTSE
Distinguished Professor, Centre for Agriculture and the Bioeconomy, Queensland University of Technology, Australia

9:20 am

High-Level and Technical-Level Regulatory Alignment and the Role of the HLPDAB

Dr. Andrew Roberts
Chief Executive Officer, Agriculture and Food Systems Institute (AFSI), USA

9:40 am

Review of the Policy Approaches Document and Policy Approaches Portal

Dr. Bhavneet Bajaj

Session 1: Regulatory Cooperation in Latin America

10:00 am

General View of Some Regulatory Cooperation Schemes for Agricultural Biotechnology in Latin America

Dr. Pedro Rocha
Coordinator for Biotechnology and Biosecurity, Inter-American Institute for Cooperation on Agriculture (IICA), Costa Rica

10:15 am

Regulatory Convergence Between Argentina and Brazil

Ms. Florencia Goberna
Coordination of Innovation and Biotechnology, Secretariat of Agriculture, Livestock, and Fisheries, Argentina

10:30 am

From Shared Challenges to Joint Solutions: Building ABRE-Bio – A Network of Biosafety Agencies for Agro-Biotechnology to Strengthen International Cooperation

Dr. Alejandra Ferenczi
Biosecurity Risk Assessment Advisor and Coordinator/Plant Physiology Assistant, Ministry of Livestock, Agriculture, and Fisheries, Uruguay

10:50 am

Tea Break

Session 2: Breakout Discussions

11:10 am

Breakout Discussions: Information Exchange Between APEC Economies

Dr. Andrew Roberts and All Groups

12:40 pm

Menti-Guided Poll to Summarize Breakout Discussions

Dr. Andrew Roberts

1:00 pm

Vote of Thanks and Close of Workshop

Dr. Bhavneet Bajaj

Speaker Bios

Dr. Bhavneet Bajaj

Senior Manager – Scientific Programs, Agriculture and Food Systems Institute (AFSI), USA

Dr. Bhavneet Bajaj is a Senior Manager, Scientific Programs at the Agriculture and Food Systems Institute (AFSI). She has been involved in projects related to safety assessment of foods and feeds derived from genetically engineered plants since 2018 and serves as a resource person in providing technical support for capacity building programs in biotechnology. She was also the program lead for USDA-funded technical training for Chinese and Indonesian regulators and manages operations for both the Crop Composition Database and the World Nutrient Databases for Dietary Studies.

Prior to joining AFSI, Dr. Bajaj was a Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in tomatoes. Before then, she was Associate Investigator with the Plant Protection group at (then) DuPont, where she devised a metabolic engineering strategy for insect control in soybean. While in India, she was an Assistant Professor at Jaipur National University, where she taught genetic engineering, enzymology, and biochemistry courses to M.Sc. level students. Her research work involved plant secondary metabolites of nutritional, agricultural, and medicinal importance.

Prof. Dr. James Dale AC FTSE

Distinguished Professor, Centre for Agriculture and the Bioeconomy, Queensland University of Technology, Australia

James is an agricultural biotechnologist working on developing the next generation of banana cultivars for the banana industry and for resource poor farmers in developing countries. He leads the Banana Biotechnology Program at Queensland University of Technology. The major outcomes include disease resistant bananas and bananas with enhanced levels of micronutrients. The “golden bananas,” developed in collaboration with Ugandan colleagues and the support of the Bill & Melinda Gates Foundation, have elevated levels of pro-vitamin A as a strategy to overcome vitamin A deficiency in Uganda. The program has also developed Cavendish bananas with resistance to Fusarium wilt tropical race 4 (TR4), a disease which threatens the continued production of Cavendish worldwide. The best line, QCAV-4, was developed using genetic modification and has been approved for cultivation and consumption in Australia. This is the first genetically modified bananas released to farmers in the world. James was the 2019 Queensland Senior Australian of the Year and is a Companion of the Order of Australia (AC).

Dr. Alejandra Ferenczi

Biosecurity Risk Assessment Advisor and Coordinator/Plant Physiology Assistant, Ministry of Livestock, Agriculture, and Fisheries, Uruguay

Dr. Alejandra Ferenczi is an agronomist with a Ph.D. in environmental risk assessment of transgenic crops from Michigan State University in the USA. She has twenty years of experience in teaching and research in the field of plant physiology at the School of Agronomy, University of the Republic in Uruguay and eighteen years of service at the Ministry of Livestock, Agriculture, and Fisheries (MGAP). She currently serves as the Risk Assessment Coordinator for GM plants at the National Biosafety System (SNB), a position she has held for eighteen years, and as the Biosafety Manager of the General Directorate of Biosafety and Food Safety (DIGEBIA) at MGAP, overseeing the Biosafety Area, a position she has held since its creation nine years ago. Her expertise is in risk analysis and biosafety related to agrobiotechnology products, including transgenic, genome editing, and other emerging technologies. Additionally, she actively contributes to the coordination of Uruguay’s recently approved National Bioinputs Plan, is involved in international cooperation agreements in sectors such as biosafety, biotechnology, and bioinputs, and represents MGAP in various international commissions. She also serves as a member of the Compliance Committee of the Cartagena Protocol under the Convention on Biological Diversity for the 2025-2028 period.

Ms. Florencia Goberna

Coordination of Innovation and Biotechnology, Secretariat of Agriculture, Livestock, and Fisheries, Argentina

Florencia Goberna is a biotechnologist with a strong background in regulatory affairs, biosafety, and risk assessment of GMOs and New Breeding Techniques (NBTs). She has extensive experience in policy development, international regulatory harmonization, and capacity building for government agencies. Her fields of expertise include scientific communication, public engagement, and advising policymakers on biotechnology governance. She is passionate about the bioeconomy, sustainability, and technology-driven innovation in agriculture and food security.

Dr. Andrew Roberts

Chief Executive Officer, Agriculture and Food Systems Institute (AFSI), USA

Dr. Andrew Roberts joined the Agriculture and 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 and 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 of Biotechnology Regulatory Services (BRS), the group responsible for regulating genetically engineered plants at USDA’s Animal 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. Pedro Rocha

Coordinator for Biotechnology and Biosecurity, Inter-American Institute for Cooperation on Agriculture (IICA), Costa Rica

Dr. Pedro Rocha is a biologist from the National University of Colombia, with a Ph.D. in plant biotechnology and molecular biology from the University of East Anglia and the John Innes Centre in the United Kingdom. He currently serves as International Specialist and Coordinator in Biotechnology and Biosafety at the Inter-American Institute for Cooperation on Agriculture (IICA) in Costa Rica. In this role, he supports agricultural ministries across 33 IICA member countries, offering guidance on policy, training, and communication in biotechnology and biosafety. He has contributed to developing regulatory frameworks on bioinputs, living modified organisms (LMOs), and genome editing (GnEd) in 14 Latin American nations. His extensive professional background includes postdoctoral research at the Sainsbury Laboratory in the United Kingdom, roles in Colombia as a researcher at Corpoica (now Agrosavia), Research Assistant at CIAT, Director of Biotechnology at Cenipalma, and Consultant to the National Planning Department (DNP), demonstrating a strong track record in science, regulation, and international cooperation.

 *AFSI’s participation in this workshop is supported by a grant from the USDA FAS New Technologies and Production Methods Division.