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Capacity Building Workshop on Food Safety Assessment of Genetically Engineered Plants

    September 5, 2023-September 6, 2023
    9:30 am - 6:30 pm
    India Habitat Centre - Marigold Hall
    New Delhi, India

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 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 established an Expert Working Group (EWG) in September of 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, a two-day technical training program on food and feed safety assessment was implemented by the Agriculture & Food Systems Institute (AFSI), in collaboration with the Food Safety and Standards Authority of India (FSSAI) and Biotech Consortium India Limited (BCIL), on September 5-6, 2023. This training program was structured to provide risk assessors on the FSSAI GM panel 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 program 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

Sunil Bakshi
Head (Regulations) FSSAI
Donald MacKenzie, Ph.D.
Executive Director Institute for International Crop Improvement (IICI), Donald Danforth Plant Science Center
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)
Andrew Roberts, Ph.D.
Chief Executive Officer Agriculture & Food Systems Institute (AFSI)
Bhavneet Bajaj, Ph.D., PMP
Manager, Scientific Programs Agriculture & Food Systems Institute (AFSI)

Agenda

Day 1

September 5, 2023 | 9:30 am - 5:30 pm

Time Activity Presenter
9:30 am Welcome and Introductions Mr. Sunil Bakshi
Head (Regulations), FSSAI
Introductory Remarks and Overview of the Agenda Dr. Andrew F. Roberts
Chief Executive Officer, AFSI
Remarks Dr. Dinesh Kumar
Chair, Scientific Panel on GM Foods
10:30 am Whole Food Safety Assessment and International Guidance for Assessing Foods Derived from Genetically Engineered Plants Dr. Donald MacKenzie
Executive Director, Institute for International Crop Improvement (IICI), Donald Danforth Plant Science Center
11:00 am Overview of the India Food Safety Guideline
• Comparison with Codex Plant Guideline
• Consensus Statement: Report of the Expert Working Group As Part of the South Asia Harmonisation Initiative		 Dr. Vibha Ahuja
Chief General Manager, BCIL and Senior Advisor, SABP
11:30 am Tea Break  
11:45 am Problem Formulation and Key Concepts for Food Safety Assessment

Breakout Exercise 1

 Dr. Andrew F. Roberts
1:15 pm Lunch  
2:00 pm Characterization of the Genetic Modification and Newly Expressed Proteins

Breakout Exercise 2

 Dr. Andrew Roberts
3:30 pm Key Concepts: Assessing Potential Toxicity of Proteins

Breakout Exercise 3

 Dr. Andrew F. Roberts
5:00 pm Understanding Animal Feeding Studies in the Context of Food Safety Assessment  Mr. Jason Dietz (recorded presentation)
Senior Policy Analyst, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
5:30 pm Q&A Session and Wrap-up of Day 1 All

 

Day 2

September 5, 2023 | 9:30 am - 5:30 pm

Time Activity Presenter
9:30 am Recap of Day 1

Review of Agenda for Day 2

 Dr. Andrew Roberts
9:45 am Key Concepts: Allergenicity Assessment

Breakout Exercise 4

 Dr. Donald MacKenzie
11:15 am Tea Break
11:30 am Key Concepts: Compositional Assessment

AFSI Crop Composition Database

Exercise 5

 Dr. Bhavneet Bajaj
Manager Scientific Programs, AFSI
1:30 pm Lunch  
2:30 pm Transportability of Data for Risk Assessments of Genetically Modified Plants Dr. Andrew F. Roberts
3:00 pm Internet Resources for Food Safety Assessment

Exercise 6

 Dr. Bhavneet Bajaj
4:30 pm Tea Break  
4:45 pm Risk Communication
• Communicating Proposed Regulatory Decisions
• Communicating with Applicants		 Dr. Donald MacKenzie
5:15 pm Wrap-up Questions and Discussion  
6:00 pm Close of Program  

 

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