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Objective

Developing and applying sound science to the environmental risk assessment (ERA) of biotechnologies is crucial for safely realizing their contributions to human health and sustainable production of food, fuel, and fiber. Whether it be through improving systematic approaches to inform understanding of plausible risks associated with the use of gene drive strategies or working to maximize the value of data, the ILSI Research Foundation continues its longstanding commitment to serve as a scientific resource for governments, academic institutions, and private sector organizations.

Collaborators & Partners

USDA Foreign Agricultural Service, International Food Policy Research Institute (IFPRI), Foundation for the National Institutes of Health (FNIH), New Partnership for African Development (NEPAD), Common Market for Eastern and Southern Africa (COMESA), Organisation for Economic Co-operation and Development (OECD), and the Government of Australia

Current Actvity

The ILSI Research Foundation's active programs related to environmental risk assessment (ERA) include:

Data Transportability for Field Trial Research

Confined field trials (CFTs) are conducted to inform environmental risk assessments that are required by regulatory authorities before genetically engineered crops can be approved and released for cultivation. Many countries expect CFTs to be conducted as a matter of course, even if satisfactory data are already
available from trials conducted elsewhere. The primary variable that differentiates CFT locations is agroclimate, which means that data from trials cultivated in like agroclimates should be considered relevant and sufficient to satisfy regulatory requirements, irrespective of the country where the CFTs are conducted.

ERA for the Use of Gene Drive

According to the World Health Organization’s 2017 World Malaria Report, an estimated 216 million cases of malaria occurred worldwide in 2016, with 90% of this total concentrated in the African region. Alarmingly, and despite an increased public health focus on the elimination of malaria, it is becoming clear that many countries will not be able to achieve this goal without considering novel management approaches. One control strategy in the early stages of development is the use of gene drive mechanisms to suppress or replace vector mosquito populations.

Past Work

The ILSI Research Foundation's concluded projects in the area of environmental risk assessment include:

Resources

Newsletters

Find out about the work we are doing by reading our monthly newsletter.

eLearning

The ILSI Research Foundation has developed eLearning courses that focus on environmental risk assessment.

OECD Working Group on the Safety of Novel Foods and Feeds (WG-SNFF)

Paris, France

The OECD Task Force on the Safety of Novel Foods and Feeds (WG-SNFF), for which the ILSI Research Foundation is a recognized observer organization, works on technical issues related to the food safety of novel foods and feeds, including the products of agricultural biotechnology.

Read more

2nd Institutional Biosafety Officer Workshop

Dhaka, Bangladesh

The ILSI Research Foundation’s South Asia Biosafety Program arranged a day-long workshop to take stock of the present status at various research institutes and laboratories that are actively involved in GE research in Bangladesh.

Read more

Data Transportability for COMESA Workshop

Entebbe, Uganda

Hosted by the ILSI Research Foundation, in partnership with COMESA and ASARECA, this workshop introduced the online GEnZ Explorer tool, which allows confined field trial (CFT) locations to be characterized with respect to agroclimatic zones to facilitate data transportability of CFTs.

Read more

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									Overview			
					
					
					
				Overview
							

Bangladesh is making progress in ensuring safe food and nutritional security. Modern biotechnology can play a positive role in achieving this goal. However, to ensure the safety of food derived from biotechnology, implementation of biosafety procedures is crucial. Therefore, it is important to understand regulatory requirements and their implementation.

With the establishment of the Bangladesh Food Safety Authority (BFSA), Bangladesh is advancing toward a more organized and coordinated system to ensure food safety in the country. It is worth mentioning that, according to Act no. 31 of the Bangladesh Food Safety Act 2013, genetically engineered (GE) food is subject to laws and regulations. The South Asia Biosafety Program (SABP) works to identify and facilitate awareness and capacity building for GE food, feed, and environmental safety assessment.

Since the BFSA is the facilitating agency tasked with rendering necessary support to relevant entities and organizations in Bangladesh and is directly involved in updating and upgrading the food safety standards or guidelines, SABP was very interested in jointly organizing an activity in order to build awareness and take part in the government’s initiative to strengthen the institutional governance of biosafety, i.e., the regulation of GE organisms and their products. This joint activity also aligned with the theme for 2020’s National Food Safety Day: “Put hands together, ensure safe food.”

The Genetically Modified Food: Requirements for Compliance and Consumers Awareness workshop was co-organized by the BFSA and SABP on February 25, 2020. During the workshop, Dr. Andrew F. Roberts, Deputy Executive Director, ILSI Research Foundation, delivered the keynote presentation on “History and Context for Food Safety Assessment of Foods Derived from Genetically Engineered Plants.” Dr. Vibha Ahuja, Chief General Manager, Biotech Consortium India Limited, discussed the “Indian Food Safety Guidelines for GM Crops and Harmonization Efforts in SARSO.” The status of regulations in Bangladesh was presented by Mr. Monzur Morshed Ahmed, Member (Health and Nutrition), Bangladesh Food Safety Authority. The workshop was chaired by Mr. Rejaul Karim, Member (Joint Secretary), Bangladesh Food Safety Authority, and Mr. Mahbub Kabir, Chairman (In Charge), Bangladesh Food Safety Authority, was present as Chief Guest. The workshop was attended by officials and representatives from various ministries, departments, and agencies of the Government of Bangladesh, as well as researchers from universities and national agricultural research institutions.

Agenda
Time Session Presenter
09:30-10:15 Registration
10:15-10:20 Welcome Address Dr. Aparna Islam
Country Manager
South Asia Biosafety Program
10:20-10:45 History and Context for Food Safety Assessment of Foods Derived from Genetically Engineered Plants Dr. Andrew F. Roberts
Deputy Executive Director
ILSI Research Foundation
10:45-11:05 Indian Food Safety Guidelines for GM Crops and Harmonization Efforts in SARSO Dr. Vibha Ahuja
Chief General Manager
Biotech Consortium India Limited
11:05-11:35 GM Food: Biosafety Aspects, Legal Requirements, and Mandates of BFSA Mr. Monzur Morshed Ahmed
Member
Bangladesh Food Safety Authority
11:35-12:15 Round Table & Open Discussion
12:15-12:20 Speech by the Chair Mr. Rejaul Karim
Member
Bangladesh Food Safety Authority
12:20-12:30 Speech by the Chief Guest Mr. Mahbub Kabir
Chairman (In Charge)
Bangladesh Food Safety Authority
12:30 Adjourn

Photos

Media Coverage "Regulators not ready to deal with GM tech: BFSA." New Age Bangladesh, February 26, 2020.
https://www.newagebd.net/article/100567/regulators-not-ready-to-deal-with-gm-tech-bfsa (accessed March 3, 2020) Read about the event in the SABP Newsletter! [post_title] => Genetically Modified Food: Requirements for Compliance and Consumer Awareness [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => bfsa2020 [to_ping] => [pinged] => [post_modified] => 2020-03-10 16:52:35 [post_modified_gmt] => 2020-03-10 16:52:35 [post_content_filtered] => [post_parent] => 0 [guid] => https://ilsirf.org/?post_type=event&p=11580 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 11572 [post_author] => 65 [post_date] => 2020-03-02 20:20:38 [post_date_gmt] => 2020-03-02 20:20:38 [post_content] => Overview Overview

Bangladesh has engaged in research in plant biotechnology for more than 30 years, beginning with plant tissue culture in the 1980s and toward genetic transformation to develop Genetically Engineered (GE) crops in the mid 2000s. Since then, research has progressed and the number of crops and projects underway has expanded, both at public and private research institutes, as well as universities.

In light of the potential for modern biotechnology to enhance food and nutritional security, while keeping in mind public concerns about human and environmental safety, the Government of Bangladesh has developed a series of policies and procedures intended to facilitate the research, development, and safe application of biotechnology. The regulatory framework in Bangladesh is supported by a series of official publications, including: Biosafety Guidelines (2006), National Biosafety Framework (2007), Bangladesh Biosafety Rules (2012), Guidelines for Food Safety Assessment of GE Foods (2012), and Environmental Risk Assessment Guidelines for GE Plants (2016). All these publications may be accessed at bangladeshbiosafety.org.

Currently, many public research institutions, individually or in collaboration with foreign research partners, are developing GE crops in Bangladesh. One of the successful examples of collaborative research is Bt brinjal, which got approved by the Government of Bangladesh on October 30, 2013 for limited cultivation in the field. Since 2014, this trait has been cultivated commercially for human consumption, making Bangladesh a pioneer in the arena of GE food crop commercialization in South Asia. Many other crops are now ready to be assessed or already under trial to evaluate their performance. To support such activities, the Government of Bangladesh has developed supporting documents, such as the Standard Operation Protocols (SOPs) for Confined Field Trial (CFT), Data Recording Formats for CFT, and Manual for Confined Field Trial. As per the Biosafety Guidelines, institutions conducting research and development with GE plants need to operate in accordance with these documents, and it is the responsibility of Institutional Biosafety Officers (IBOs) or Institutional Biosafety Committees (IBC) to ensure that individual researchers are in compliance. But, as the number of crops are diversifying in the field of GE research, it is important to periodically review and update these documents, and to develop appropriate additional materials to ensure that research can continue unhindered while meeting standards for biosafety.

Against the backdrop of continued developments in both research and regulation of biosafety in Bangladesh, the South Asia Biosafety Program (SABP) arranged a day-long workshop on February 20, 2020 in Dhaka, to take stock of the present status at various research institutes and laboratories that are actively involved in GE research in Bangladesh. This was carried out through open discussion among the practitioners, the network established in 2019 during SABP's first IBO Workshop. Through exchanging experiences, participants increased their knowledge of biosafety compliance during the research and development of GE plants. Moreover, they identified areas where there are gaps are in terms of capacity building and/or document requirements. Finally, they received hands-on training in SOP development for CFTs, as new institutes are getting engaged in this stage.

Agenda
Time Session Facilitator/ Instructor/ Presenter
9:30-10:00 Registration
Session 1: Introduction to SABP's IBO Program in Bangladesh
10:00-10:20 Welcome and Introduction Dr. Aparna Islam
10:20-10:40 Biosafety Regulation for GE crops in Bangladesh Mr. Solaiman Haider
10:40-11:00 Institutional Biosafety Officers:
Roles, Expectations and Challenges in Bangladesh
Dr. Andrew F. Roberts
11:00-11:30 Tea Break
Session 2: Taking Stock of Research Initiatives and Need Identification 
11:30-12:15 Taking Inventory of Relevant Biosafety Documents Dr. Aparna Islam
12:15-13:00 Introduction to Plant Biology Documents and Confined Field Trial SOPs Dr. Andrew F. Roberts
13:00-14:00 Lunch break
Session 3: Confined Field Trials 
14:00-14:30 Group Discussion
Identification of needs in documentation, resources, and best practices for institutional biosafety.
14:30-15:15 Group Work
Prioritizing future crop biology and CFT SOP documents.
 Dr. Andrew F. Roberts
Session 4: The Biosafety Research in Bangladesh Grants Program 2020 (BRBGP2020)
15:15-15:30 Introduction to the Biosafety Research in Bangladesh Grants Program Dr. Andrew F. Roberts
15:30-15:45 Conclusion Dr. Andrew F. Roberts
15:45-16:00 Tea Break  
16:00 Adjourn  

Photos

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Confined field trials (CFTs) are conducted to determine whether a trait introduced through genetic engineering (GE) of a plant results in unintended environmental effects. CFTs are historically performed locally within each country that is considering cultivation of the GE plant, and data from CFTs is used to inform an environmental risk assessment used for regulatory decision-making. As all CFTs are designed to compare the GE crop to its non-GE comparator, data collected on the same traits from CFTs in new countries generally duplicate previous studies and do not further inform risk assessment.  One way to reduce the duplication of CFTs is to use pre-existing CFT data obtained from an environment similar to that of the host country.

The ILSI Research Foundation hosted the Data Transportability for COMESA Workshop in Entebbe, Uganda on February 12-13, 2020, in partnership with the Common Market for Eastern and Southern Africa (COMESA) and the Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA), to discuss the online GEnZ Explorer tool. This free tool allows CFT locations to be characterized with respect to agroclimatic zone to facilitate data transportability of CFTs. Participants received hands-on experience with the tool to identify the location of CFT data generated outside of their country that were conducted in similar environments to those found in their country. Participants also provided updates on the regulatory systems and approval process from COMESA countries. The second day of the workshop included discussions, facilitated by ASARECA, on how data transportability concepts and the GEnZ Explorer can be applied to the COMESA Regional Risk Assessment Policy.

Agenda

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OECD Consensus Document of the Biology of Mosquito Aedes aegypti

Volume 8 of the series Safety Assessment of Transgenic Organisms in the Environment contains the first OECD biosafety consensus document to deal with the biology of an insect, the mosquito Aedes aegypti.

Read more

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