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HLPDAB: Workshop on Reducing Redundancies and Facilitating Efficiencies – Regulatory and Policy Solutions for Oversight of Agricultural Biotechnologies

    July 30, 2023-July 31, 2023
    8:45 pm - 5:00 pm
    Seattle Convention Center Summit Building (Hybrid)
    Seattle, USA

This two-day, in-person workshop continued the tradition of working together across APEC economies to identify regulatory and policy solutions for science-based and risk-proportionate oversight of agricultural biotechnologies that mitigate climate change, strengthen supply chains, increase food security, and facilitate trade. Participants explored the potential impacts of regulatory redundancies and ways to reduce these redundancies, and the feasibility of developing a “Policy Approaches Document” to promote regulatory efficiencies and sustained information sharing to help streamline agricultural biotechnology product approvals and facilitate trade.

Agenda

Day 1 – Sunday, July 30 (Time in PDT/UTC-7)

Session 1 - Facilitating Regulatory Cooperation: Key Concepts

8:45 am

Welcome and Opening Remarks

Ms. Jennifer Lappin
Director, New Technologies & Production Methods Division, Foreign Agricultural Service, U.S. Department of Agriculture, The United States

9:05 am

Overview of Agenda

Dr. Bhavneet Bajaj
Manager – Scientific Programs, Agriculture & Food Systems Institute, The United States

9:15 am

Keynote Presentation: Necessary Ingredients for Successful Regulatory Cooperation

Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, The United States

9:45 am

Moderated Q&A Session

Dr. Bhavneet Bajaj

10:00 am

Tea Break

Session 2 - Regulatory Cooperation Success Stories

10:20 am

Opening Remarks for Session 2

Dr. Andrew Roberts

10:30 am

India’s Journey to the OECD Mutual Acceptance of Data and towards Excellence

Dr. Ekta Kapoor (recorded presentation)
Scientist “E”, National GLP Compliance Monitoring Authority, Department of Science and Technology, India and Vice-Chair, OECD Working Group on Good Laboratory Practice

10:50 am

African Medicines Regulatory Harmonization Programme (AMRH)

Ms. Chimwemwe Chamdimba (recorded presentation)
Head, African Medicines Regulatory, Harmonization (AMRH) Programme, South Africa

11:10 am

Towards a Harmonized Approach to Safety Assessment of Food Derived from Genetically Engineered Plants in South Asia

Dr. Bhavneet Bajaj

11:30 am

Moderated Q&A Session

Dr. Andrew Roberts

12:00 pm

Lunch Break

Session 3 - Potential for Regulatory Cooperation in the APEC HLPDAB

1:00 pm

Opening Remarks for Session 3

Dr. Andrew Roberts

1:10 pm

Breakout Groups

All Participants

2:30 pm

Tea Break

2:50 pm

Breakout Groups (continued)

All Participants

4:00 pm

Recap of Session 3

Dr. Andrew Roberts

4:30 pm

Wrap Up of Day 1 and Closing Remarks

Dr. Bhavneet Bajaj

Day 2 – Monday, July 31 (Time in PDT/UTC-7)

8:45 am

Recap of Day 1 and Overview of the Agenda for Day 2

Dr. Bhavneet Bajaj

Session 4 - Regulatory Cooperation, Safety Assessments, and Trade in Products of Agricultural Biotechnology

9:00 am

Opening Remarks for Session 4

Dr. Andrew Roberts

9:05 am

International Guidance on Safety Assessment of Foods Derived from rDNA Organisms

Dr. Flerida Carino
Consultant, Philippine Food and Drug Administration
Consultant, National Committee on Biosafety, Department of Science and Technology, The Philippines

9:30 am

Elements of Environmental Risk Assessment of Products of Agricultural Biotechnology

Dr. Kylie Tattersall
Director – Plant Evaluation Section, Office of the Gene Technology Regulator, Australia

9:55 am

Trade in Agricultural Biotechnology: Role of the Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) Agreements

Mr. Robert Ahern
Director – WTO Agricultural Affairs, Office of the United States Trade Representative, The United States

10:20 am

Moderated Discussion

Dr. Andrew Roberts

10:45 am

Tea Break

Session 5 - Building Trust: Knowledge Sharing and Enabling Regulatory Cooperation

11:05 am

Opening Remarks for Session 5

Dr. Bhavneet Bajaj

11:10 am

Development of Health Canada – Food Standards Australia New Zealand (FSANZ) Safety Assessment Sharing Initiative

Mr. Jordan Bean (virtual)
Senior Scientific Project Coordination Biologist, Health Canada, Canada

11:35 am

Regulation of Genetically Engineered Crops in Paraguay

Prof. Danilo Fernandez Rios
Research Professor, University of Asuncion, Paraguay

12:00 pm

Knowledge Sharing and Enabling Regulatory Cooperation: Argentina’s Perspective

Ms. Perla Godoy
Coordinator for Innovation and Biotechnology, Directorate of Bioeconomy, Secretariat of Agriculture, Livestock & Fisheries, Argentina

12:30 pm

Moderated Q&A Session

Dr. Bhavneet Bajaj

12:45 pm

Lunch Break

1:45 pm

Honduras - Guatemala - El Salvador Agreement

Dr. Pedro Rocha
International Specialist in Biotechnology & Biosafety, Inter-American Institute for Cooperation on Agriculture, Costa Rica

2:10 pm

Genome Editing Policies, Research and Development in Japan

Mr. Yukio Uchida
Deputy Director-General, Agriculture, Forestry and Fisheries Research Council, Ministry of Agriculture, Forestry and Fisheries, Japan

2:35 pm

Moderated Q&A Session

Dr. Bhavneet Bajaj

Session 6 - Benefits of Regulatory Cooperation for Agricultural Biotechnology

2:45 pm

Opening Remarks for Session 6

Dr. Andrew Roberts

2:50 pm

Regulatory Collaboration: Types, Benefits, and Challenges

Dr. Abby Simmons
Regulatory Manager, CropLife International, The United States

3:15 pm

Outline of Policy Approaches Document for Regulatory Cooperation and Alignment on Agricultural Biotechnology

Mr. Jeffrey V. Nawn
Chief Executive Officer/Founder, North Hill Group, The United States

3:40 pm

Moderated Discussion

Dr. Andrew Roberts

4:10 pm

Workshop Summary and Closing Remarks

Ms. Jennifer Lapin

4:20 pm

Meeting Adjourns

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