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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.

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
							

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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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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