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Workshop III: Environmental Safety Concepts and the Bangladesh Guidelines for Environmental Risk Assessment of Genetically Engineered Plants

    October 13, 2023-October 14, 2023
    9:00 am - 5:00 pm
    BCDM Rajendrapur
    Gazipur, Bangladesh

The Agriculture & Food Systems Institute (AFSI), in partnership with the Department of Environment, Ministry of Environment, Forest and Climate Change, Government of Bangladesh, under the auspices of the South Asia Biosafety Program (SABP), is conducting a workshop series titled “Origins of Biosafety Internationally, the Relevant Policies and Regulations in Bangladesh, and the Necessary Regulatory Process During Each Phase of Biotechnology Research, Development, and Release.” The purpose of these training activities was to engage with experts at the Department of Environment in Bangladesh who are involved with the biosafety regulatory system. This program aimed to help them better understand their regulatory responsibility and how to best work with developers of genetically engineered (GE) organisms. Biosafety compliance while working with GE organisms was discussed throughout this series of workshops.

The first workshop focused on the fundamentals of biosafety, with presentations on the history and context of biosafety, the development process for GE plants, regulatory responsibility, and biosafety obligations during GE plant development. The second workshop was structured to give risk assessors in-depth technical information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE plants, covering the whole food safety assessment paradigm, problem formulation, toxicity and allergenicity testing, compositional assessment, and animal feeding studies. This third workshop provided a platform for discussing the considerations that inform the environmental risk assessment (ERA) of GE plants. The two-day technical training program for risk assessors delivered in-depth technical information about the structured approach to ERA, beginning with a scoping process called problem formulation. Through a series of presentations and exercises on problem formulation, considerations for ERA, and non-target organism assessment evaluation, participants gained a baseline understanding of the relevant concepts in ERA.

Guests and Speakers

Abdul Hamid, Ph.D.
Honorable Director General Department of Environment
Rakha Hari Sarker, Ph.D.
Country Coordinator South Asia Biosafety Program
Andrew Roberts, Ph.D.
Chief Executive Officer Agriculture & Food Systems Institute
Aparna Islam, Ph.D.
Professor Brac University
Flerida Carino, Ph.D.
Consultant Philippine Food and Drug Administration
Vibha Ahuja, Ph.D.
Senior Advisor South Asia Biosafety Program

Agenda

Day 1

October 13, 2023 | 9:00 am - 5:30 pm

Time Topic Presenter/Facilitator
9:00 am Welcome & Introductions and Recap of Workshops I and II Prof. Dr. Rakha Hari Sarker
Professor, Dhaka University and Country Coordinator, South Asia Biosafety Program, Bangladesh
9:30 am Environmental Safety Assessment and International Considerations in the Context of Genetically Engineered (GE) Plants Dr. Andrew F. Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, USA
10:15 am Bangladesh Guidelines on Environmental Risk Assessment (ERA) of Genetically Engineered Plants Dr. Aparna Islam
Professor, Biotechnology Program, Brac University and AFSI Fellow, Bangladesh
10:45 am Tea Break  
11:15 am Introduction to Concepts in ERA and Assessment of Risks Posed by Genetically Modified (GM) Plants  Dr. Flerida Carino
Consultant, Philippine Food and Drug Administration and the National Committee on Biosafety of the Department of Science and Technology, The Philippines
11:45 am Exercise 
1:00 pm Lunch and Prayer Break  
2:30 pm Structured Approach to ERA of GE Plants: Problem Formulation and Pathway to Harm Dr. Andrew F. Roberts
3:00 pm Exercise
4:15 pm Tea Break  
4:30 pm Readouts from Exercise on Problem Formulation Modification and Newly Expressed Proteins
5:00 pm Q&A Session All
5:30 pm End of Day 1  

 

Day 2

October 14, 2023 | 9:00 am - 5:00 pm

Time Topic Presenter/Facilitator
9:00 am Recap of Day 1 and Review of Agenda for Day 2 Dr. Andrew F. Roberts
9:15 am Data Quality and Transportability Dr. Vibha Ahuja
Chief General Manager, Biotech Consortium India Limited and Senior Advisor, South Asia Biosafety Program, India
9:45 am Useful Resources for ERA Dr. Bhavneet Bajaj
Manager–Scientific Programs, Agriculture & Food Systems Institute, USA
10:15 am Exercise
11:00 am Tea Break  
11:30 am ERA Case Studies: Evaluating Impact to Non-Target Organisms Dr. Andrew F. Roberts
12:15 pm Exercise  
1:o0 pm Lunch  
2:00 pm Evaluating Weediness and Invasiveness Dr. Flerida Carino
2:30 pm Exercise
3:30 pm Tea Break  
4:30 pm Q&A Session All
5:00 pm Adjourn  

 

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