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Workshop on Foods Derived from Modern Biotechnology: Context and Safety Assessment

    October 9, 2023-October 11, 2023
    Hotel Le Meridien
    Thimphu, Bhutan

Background

Stakeholders in South Asian countries have discussed regional harmonization of biosafety risk assessment and regulation in the area since 2014. Given the interest in advancing a consensus approach to harmonization of safety assessment of foods derived from genetically engineered (GE) plants, the Agriculture & Food Systems Institute (AFSI) obtained support from the United States Department of Agriculture (USDA) Emerging Markets Program (EMP) to work with these stakeholders towards a formalized approach to regional harmonization in South Asia. AFSI, with support from Biotech Consortium India Limited (BCIL), established an Expert Working Group (EWG) in September 2020 with representation from Bangladesh, Bhutan, India, and Sri Lanka. All experts were nominated by Competent National Authorities in their respective countries; however, they participated in the deliberations in their individual capacities. The EWG, after several rounds of drafting, review, and discussion, developed a guidance document that describes a consensus approach to the safety assessment of foods derived from GE crops for application across the participating countries, based upon the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA. Additionally, tailored approaches for the adoption and operationalization of the regional guidance in each of the respective countries were discussed.

Overview

As part of the operationalization of the consensus approach to safety assessment for Bhutan, a Drafting Committee comprised of members from Bhutan Food and Drug Authority (BFDA), BCIL, and AFSI reviewed Bhutan’s guideline on “Risk Assessment of Food and Feed Products Derived from Genetically Modified Plants” and undertook its revision for alignment with codex and the consensus approach, as well as the preparation of supportive tools for strengthening implementation.

AFSI implemented a half-day consultation meeting and a two-and-a-half-day capacity building training workshop on food and feed safety assessment, in collaboration with the BFDA and BCIL, on October 9-11, 2023. The consultation meeting involved further discussions on Bhutan’s revised guideline on safety assessment of foods derived from GE plants. The capacity building training workshop was structured to provide risk assessors at the BFDA with in-depth technical information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from genetically engineered (GE) plants, aligned with the consensus approach. The programs helped establish a baseline understanding of the concepts and principles of safety assessment for food and feed derived from GE plants. Topics included the whole food safety assessment paradigm, toxicity and allergenicity testing, compositional assessment, animal feeding studies, data transportability, and risk communication.

Speakers

Gyem Bidha
Offtg. Director Bhutan Food and Drug Authority
Jambay Dorji
Dy. Chief Regulatory and Quarantine Officer Bhutan Food and Drug Authority
Dechen Wangmo
Deputy Chief Laboratory Officer, NFTL Bhutan Food and Drug Authority
Flerida Carino, Ph.D.
Consultant Philippine Food and Drug Administration
H.M. Jang, Ph.D.
Chief Director Korea Institute for Promoting Asia Biosafety Cooperation (KIPABiC)
Jason Dietz
Senior Policy Analyst Office of Food Additive Safety, U.S. Food and Drug Administration

Vibha Ahuja, Ph.D.
Senior Advisor South Asia Biosafety Program (SABP)
Bhavneet Bajaj, Ph.D., PMP
Manager, Scientific Programs Agriculture & Food Systems Institute (AFSI)
Andrew Roberts, Ph.D.
Chief Executive Officer Agriculture & Food Systems Institute (AFSI)

Agenda

Workshop on Foods Derived from Modern Biotechnology: Context and Safety Assessment

October 9, 2023 | 8:30 am - 2:00 pm

Time Activity Speaker
8:30 am Registration
9:00 am Welcome Remarks Mr. Jambay Dorji
Dy. Chief Regulatory and Quarantine Officer, Food Quality and Safety Division, Bhutan Food and Drug Authority, Ministry of Health, Bhutan
9:10 am Opening Address Ms. Gyem Bidha
Offtg. Director, Bhutan Food and Drug Authority, Ministry of Health, Bhutan
9:20 am GM Foods: Introduction and Global Status Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, USA
9:40 am Key Concepts in Safety Assessment of GM Foods Dr. Flerida Carino
Consultant, Philippine Food and Drug Administration, The Philippines
Consultant, National Committee on Biosafety, Department of Science and Technology, The Philippines
10:00 am International Guidance for Assessing Foods and Feeds Derived from GM Plants: Role of Codex Alimentarius Dr. Vibha Ahuja
Chief General Manager, Biotech Consortium India Limited, India
Senior Advisor, South Asia Biosafety Program, India
10:20 am Open Forum for Q&A
10:40 am Tea Break
11:10 am Project on Regional Harmonization for the Safety Assessment of Foods Derived from GM Plants: Key Outcomes Dr. Bhavneet Bajaj
Manager Scientific Programs, Agriculture & Food Systems Institute, USA
11:30 am Initiatives Towards Regional Harmonization in Asia: Overview Dr. H.M. Jang
Chief Director, Korea Institute for Promoting Asia Biosafety Cooperation (KIPABiC), South Korea
11:50 am Biosafety Regulations for GM Foods in Bhutan Ms. Dechen Wangmo
Deputy Chief Laboratory Officer, National Food Testing Laboratory, Bhutan Food and Drug Authority, Ministry of Health, Bhutan
12:10 pm Genome Editing for Crop Improvement: Science and Policy Update Dr. Andrew F. Roberts
12:30 pm Open Forum for Q&A  
12:50 pm Concluding Remarks
13:00 pm Lunch  

 

Capacity Building Workshop on Safety Assessment of Foods Derived from GM Plants - Day 1

October 9, 2023 | 2:30 pm - 4:15 pm

Time Activity Speaker
TECHNICAL SESSION I
2:30 pm Welcome and Introductions Mr. Jambay Dorji
Dy. Chief Regulatory and Quarantine Officer, Food Quality and Safety Division, Bhutan Food and Drug Authority, Ministry of Health, Bhutan
3:15 pm Recap of Key Concepts and Overview of the Workshop Dr. Bhavneet Bajaj
Manager Scientific Programs, Agriculture & Food Systems Institute, USA
3:30 pm Applying Problem Formulation to the Safety Assessment of Genetically Engineered Foods and Feeds Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, USA
4:00 pm Open Forum for Q&A
4:15 pm Close of Day 1

 

Capacity Building Workshop on Safety Assessment of Foods Derived from GM Plants - Day 2

October 10, 2023 | 9:30 am - 4:45 pm

Time Activity Speaker
9:30 am Welcome and Introductions Dr. Bhavneet Bajaj
TECHNICAL SESSION II
9:40 am Characterization of the Genetic Modification and Newly-Expressed Proteins for Food and Feed Safety Assessment Dr. Flerida Carino
Consultant, Philippine Food and Drug Administration, The Philippines
Consultant, National Committee on Biosafety, Department of Science and Technology, The Philippines
Breakout Groups: Exercise 1  
11:00 am Tea Break
11:30 am Assessing Potential Toxicity  Dr. Andrew F. Roberts
Breakout Groups: Exercise 2  
1:00 pm Lunch
TECHNICAL SESSION III
2:00 pm Assessing Potential Allergenicity
• Bioinformatics
• Protein Digestibility
• Serum Testing		 Dr. Vibha Ahuja
Chief General Manager, Biotech Consortium India Limited, India
Senior Advisor, South Asia Biosafety Program, India
Breakout Groups: Exercise 3
3:30 pm Tea Break
3:45 pm Understanding Animal Feeding Studies in the Context of Genetically Engineered Food/Feed Safety Assessments Mr. Jason Dietz
Senior Policy Analyst, Office of Food Additive Safety, Centre for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, USA
4:15 pm Open Forum for Q&A Dr. Bhavneet Bajaj
4:30 pm Close of Day 2  

 

Capacity Building Workshop on Safety Assessment of Foods Derived from GM Plants - Day 3

October 11, 2023 | 9:00 am - 4:00 pm

Time Activity Speaker
9:00 am Recap and Questions from Day 2 Dr. Andrew F. Roberts
TECHNICAL SESSION IV
9:15 am Key Concepts in Genetically Engineered Food/Feed Assessment: Compositional Analyses Dr. Bhavneet Bajaj
Accessing Crop Compositional Data to Inform Genetically Engineered Food/Feed Safety Assessment
• AFSI Crop Composition Database		  
Breakout Groups: Exercise 4  
11:00 am Tea Break
11:30 am Accessing Information: Useful Resources for Genetically Engineered Food/Feed Safety Assessment Dr. Vibha Ahuja
Breakout Groups: Exercise 5
1:00 pm Lunch
2:00 pm Transportability of Data for Risk Assessments of Genetically Modified Plants Dr. Andrew F. Roberts
2:30 pm Risk Communication
• Communicating Proposed Regulatory Decisions
• Communicating with Applicants		 Dr. Andrew F. Roberts
3:00 pm Open Forum for Q&A Dr. Bhavneet Bajaj
3:30 pm Post-Event Survey Dr. Bhavneet Bajaj
4:00 pm Tea and Workshop Closure  

 

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