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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.

Workshop on Microbial Biotechnology for Novel Foods

Boulogne-Billancourt, France

With support from the USDA Foreign Agricultural Service and OECD, the ILSI Research Foundation is organizing this workshop to convene scientists and policymakers from academia, industry, and governments to discuss trade, regulations, and communication of low-risk, well-characterized food/beverages and their ingredients that have been derived from biotech microbes, algae, and fermented products.

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

4th International Conference on Biotechnology in Health and Agriculture

Dhaka, Bangladesh

The ILSI Research Foundation’s South Asia Biosafety Program sponsored a technical session on Biosafety and the Environment at the 4th International Conference of Biotechnology on Health and Agriculture, which was organized jointly by the Global Network of Bangladeshi Biotechnologists and Innovation in Plant and Food Sciences.

Read more

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									Overview			
					
				Overview
							

The New Technologies and Production Methods Division at the USDA Foreign Agricultural Service (USDA FAS) has provided the ILSI Research Foundation with a grant to host a workshop on utilizing microbial biotechnology to produce novel food/beverages and food/beverage ingredients. For decades, microbes have been engineered using rDNA to produce chymosin (rennin), the enzyme required for cheesemaking. Currently, 80-90% of global cheesemaking utilizes chymosin. Biotechnology is now being used to produce a range of foods, beverages, and their ingredients in the food industry, including techniques other than genetic engineering. Biotech microbe-derived ingredients include, but are not limited to: 1) enzymes used to make wine, cheese, beer, and processed products ranging from baked goods to sauces, 2) vitamins used to make infant formula similar to human milk and wellness-enhancing products, and 3) food additives for seasoning, flavoring, coloring, or thickening, including those used for plant-based meat products. These microbial-derived products have been demonstrated to provide yield, purity, and cost competitiveness alternatives, as well as potential resource conservation.

The objective of this workshop is to convene scientists and policymakers from academia, industry, and governments to discuss trade, regulations, and communication of low-risk, well-characterized food/beverages and their ingredients that have been derived from biotech microbes, algae, and fermented products. The outcomes of this workshop will help to inform policy discussions and outreach efforts and enhance science-based regulatory frameworks that ultimately facilitate trade.

The workshop will convene experts from the U.S., Europe, Eurasia, and Asia to help identify areas of existing agreement, challenges, and next steps to implementing science-based, transparent, and functional regulations for novel food and their ingredients. Additionally, connecting experts on scientific communications around microbial-derived products should contribute to efforts to mitigate misinformation about these products. Overall, we hope that this workshop will provide an opportunity to support harmonized and trade-facilitating regulatory policies and technical requirements related to microbial-derived products through a shared understanding of these products and the proportionate risks associated with them.

This workshop will be hosted March 25-26, 2020 immediately following the meeting of the OECD Working Group for the Safety of Novel Foods and Feeds (WG SNFF). This one-and-a-half-day workshop will feature discussions of pre-circulated papers on science, trade and regulatory, and communication issues, targeting regulatory experts and scientists. The outcomes of the work will be a science-based consensus on microbial-derived products that will inform policy and communications strategies. This topic directly aligns with the work of the WG SNFF in assisting countries assess of the risk of transgenic foods. The international expertise of WG SNFF members in participating in this workshop will greatly inform the outcomes of the workshop.

Agenda

March 25, 2020

Time Topic Presenter(s)
9:00-9:10 Meeting Welcome Bertrand Dagallier
OECD ENV/EHS
9:10-9:30 Discussion of Meeting Format and Goals Dr. Andrew Roberts
ILSI Research Foundation
9:30-10:00 Plenary Talk on History and Future of
Microbial Biotechnology for Novel Food
Dr. Jonathan McIntyre
CEO Motif FoodWorks, Inc.
10:00-10:15 Coffee and Tea Break  
Author-Led Question and Answer Sessions on the Pre-circulated Discussion Papers
10:15-11:00 Science of Microbial Products of Biotechnology
Q&A Session
11:00-11:45 Industry and Consumers of Products Derived from Microbial Biotechnology
Q&A Session
11:45-12:30 Trade of Food Products Derived from Microbial Biotechnology
Q&A Session
12:30-13:30 Lunch
13:30-15:00 Breakout Session for the Three Discussion Papers
Two people for each group will be assigned as notetaker and moderator.
15:00-15:15 Coffee and Tea Break
15:15-17:30 Breakout Session for the Three Discussion Papers (continued)
The notetaker and moderator will work with the group to develop a written document that addresses questions related to the discussion papers and provide this to the steering committee at the end of the session.
 
*The steering committee will meet in the evening to synthesize the notes from the breakout groups and determine the discussion topics for the second day.
 

March 26, 2020

Time Topic Presenter(s)
9:00-9:05 Meeting Welcome Steering Committee
9:05-10:15 Review and Discussion of Highlights from the Breakout Session ILSI Research Foundation
10:15-10:30 Coffee and Tea Break
10:30-12:30 Moderated Session
Responses to notes from the breakout groups and previous panel and discussion of challenges and future concerns.
Dr. Laura White
USDA Foreign Agricultural Service (USDA FAS) New Technologies and Production Methods Division
12:30-13:00 Meeting Wrap-Up OECD
USDA FAS
ILSI Research Foundation
[post_title] => Workshop on Microbial Biotechnology for Novel Foods [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => oecd-mbnf [to_ping] => [pinged] => [post_modified] => 2020-02-20 20:46:55 [post_modified_gmt] => 2020-02-20 20:46:55 [post_content_filtered] => [post_parent] => 0 [guid] => https://ilsirf.org/?post_type=event&p=11566 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 11551 [post_author] => 65 [post_date] => 2020-02-05 16:29:13 [post_date_gmt] => 2020-02-05 16:29:13 [post_content] => Overview Overview

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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Advancing from research to product development and eventual commercialization requires regulatory approval from designated national government agencies. However, information on how to navigate international and national regulatory frameworks is not widely shared among oversight review committees, principal investigators, senior scientists, post-docs, and other investigators. On November 19, 2019, the Foundation for the National Institutes of Health (FNIH) organized a workshop in Baltimore, Maryland with the aim of providing a basic understanding of regulatory considerations and internationally recognized issues related to field trials of investigational genetically engineered organisms and their derived products, for applications in public health, agriculture, and protection to the environment. This workshop was designed for those who have limited experience with regulatory processes within and external to the United States. During the workshop, regulatory sciences and decision-making processes that will help bridge the gap between conducting basic research and translating that research into product development were discussed.

As part of Session 3: Risk Assessment and Mitigation Tools, Dr. Andrew Roberts, Deputy Executive Director, was invited to conduct a guided problem formulation exercise with participants.

Social Media

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The ILSI Research Foundation's South Asia Biosafety (SABP) Program sponsored the technical session on Biosafety and the Environment at the 4th International Conference of Biotechnology on Health and Agriculture (4th IPFS-ICBHA 2019). Jointly organized by the Global Network of Bangladeshi Biotechnologists (GNOBB) and Innovation in Plant and Food Sciences, the 4th IPFS-ICBHA 2019 took place at Nabab Nawab Ali Chowdhury Senate Bhaban, Dhaka University, on November 11-13, 2019. Convened every two years, the conference provides a platform for Bangladeshi biotechnologists from around the world to meet and exchange thoughts, ideas, and experimental findings, as well as build capacity and create awareness about the latest trends in biotechnology. The three-day event included 22 sessions and concurrent workshops.

During the technical session on Biosafety and the Environment, Dr. Andrew Roberts, ILSI Research Foundation Deputy Executive Director, delivered a presentation about the context of biosafety for biotechnology researchers, and Dr. Aparna Islam, SABP Country Manager, discussed the regulatory system in Bangladesh.

More information about the conference is available on the GNOBB website.

Abstract Presentation: Biosafety for the Biotechnologist – Navigation Biosafety Requirements as a Researcher
Dr. Andrew F. Roberts, Deputy Executive Director, ILSI Research Foundation

It has been nearly 50 years since the first use of recombinant DNA technology to modify the genome of a bacterium. Since then, the use of recombinant DNA organisms, together with a suite of other biotechnologies, has changed the face of biological and medical research. However, as biotechnology has moved from the laboratory into practical application, an array of political, social and regulatory issues have emerged which can confound research and development of recombinant DNA organisms. This presentation will review the history and context for biosafety regulation of recombinant DNA organisms and provide some insight into how a modern biotechnology researcher can effectively navigate biosafety regulatory requirements in pursuit of their research and the development of recombinant DNA organisms for use in food or the environment.

Photos

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Dr. Morven McLean, ILSI Research Foundation Executive Director, delivered a presentation on Environmental Risk Assessment of Gene Edited Plants at the Symposium on Risk Assessment and Regulation of Genome Edited Plants, which took place on October 8-9, 2019 in Manila, the Philippines. The symposium was convened by the Bureau of Plant Industry, Department of Agriculture, Government of the Philippines to provide an opportunity for Filipino scientists, risk assessors, and regulators to learn about the science of gene editing, as well as how risk assessment and regulation of products of new plant breeding techniques are being considered in key countries, such as Australia, Germany, Japan, and the United States. The two-day symposium concluded with a discussion about considerations for the regulation of genome edited plants in the Philippines

Agenda and Presentations

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The New Technologies and Production Methods Division at the USDA Foreign Agricultural Service (USDA FAS) has provided the ILSI Research Foundation with a grant to host a workshop on utilizing microbial biotechnology to produce novel food/beverages and food/beverage ingredients. For decades, microbes have been engineered using rDNA to produce chymosin (rennin), the enzyme required for cheesemaking. Currently, 80-90% of global cheesemaking utilizes chymosin. Biotechnology is now being used to produce a range of foods, beverages, and their ingredients in the food industry, including techniques other than genetic engineering. Biotech microbe-derived ingredients include, but are not limited to: 1) enzymes used to make wine, cheese, beer, and processed products ranging from baked goods to sauces, 2) vitamins used to make infant formula similar to human milk and wellness-enhancing products, and 3) food additives for seasoning, flavoring, coloring, or thickening, including those used for plant-based meat products. These microbial-derived products have been demonstrated to provide yield, purity, and cost competitiveness alternatives, as well as potential resource conservation.

The objective of this workshop is to convene scientists and policymakers from academia, industry, and governments to discuss trade, regulations, and communication of low-risk, well-characterized food/beverages and their ingredients that have been derived from biotech microbes, algae, and fermented products. The outcomes of this workshop will help to inform policy discussions and outreach efforts and enhance science-based regulatory frameworks that ultimately facilitate trade.

The workshop will convene experts from the U.S., Europe, Eurasia, and Asia to help identify areas of existing agreement, challenges, and next steps to implementing science-based, transparent, and functional regulations for novel food and their ingredients. Additionally, connecting experts on scientific communications around microbial-derived products should contribute to efforts to mitigate misinformation about these products. Overall, we hope that this workshop will provide an opportunity to support harmonized and trade-facilitating regulatory policies and technical requirements related to microbial-derived products through a shared understanding of these products and the proportionate risks associated with them.

This workshop will be hosted March 25-26, 2020 immediately following the meeting of the OECD Working Group for the Safety of Novel Foods and Feeds (WG SNFF). This one-and-a-half-day workshop will feature discussions of pre-circulated papers on science, trade and regulatory, and communication issues, targeting regulatory experts and scientists. The outcomes of the work will be a science-based consensus on microbial-derived products that will inform policy and communications strategies. This topic directly aligns with the work of the WG SNFF in assisting countries assess of the risk of transgenic foods. The international expertise of WG SNFF members in participating in this workshop will greatly inform the outcomes of the workshop.

Agenda

March 25, 2020

Time Topic Presenter(s)
9:00-9:10 Meeting Welcome Bertrand Dagallier
OECD ENV/EHS
9:10-9:30 Discussion of Meeting Format and Goals Dr. Andrew Roberts
ILSI Research Foundation
9:30-10:00 Plenary Talk on History and Future of
Microbial Biotechnology for Novel Food
Dr. Jonathan McIntyre
CEO Motif FoodWorks, Inc.
10:00-10:15 Coffee and Tea Break  
Author-Led Question and Answer Sessions on the Pre-circulated Discussion Papers
10:15-11:00 Science of Microbial Products of Biotechnology
Q&A Session
11:00-11:45 Industry and Consumers of Products Derived from Microbial Biotechnology
Q&A Session
11:45-12:30 Trade of Food Products Derived from Microbial Biotechnology
Q&A Session
12:30-13:30 Lunch
13:30-15:00 Breakout Session for the Three Discussion Papers
Two people for each group will be assigned as notetaker and moderator.
15:00-15:15 Coffee and Tea Break
15:15-17:30 Breakout Session for the Three Discussion Papers (continued)
The notetaker and moderator will work with the group to develop a written document that addresses questions related to the discussion papers and provide this to the steering committee at the end of the session.
 
*The steering committee will meet in the evening to synthesize the notes from the breakout groups and determine the discussion topics for the second day.
 

March 26, 2020

Time Topic Presenter(s)
9:00-9:05 Meeting Welcome Steering Committee
9:05-10:15 Review and Discussion of Highlights from the Breakout Session ILSI Research Foundation
10:15-10:30 Coffee and Tea Break
10:30-12:30 Moderated Session
Responses to notes from the breakout groups and previous panel and discussion of challenges and future concerns.
Dr. Laura White
USDA Foreign Agricultural Service (USDA FAS) New Technologies and Production Methods Division
12:30-13:00 Meeting Wrap-Up OECD
USDA FAS
ILSI Research Foundation
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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.

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