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 Agriculture & Food Systems Institute 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 Agriculture & Food Systems Institute'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 Agriculture & Food Systems Institute's concluded projects in the area of environmental risk assessment include:



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The Agriculture & Food Systems Institute has developed eLearning courses that focus on environmental risk assessment.

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

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.

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OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology (WG-HROB)

The OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology (WG-HROB), for which the Agriculture & Food Systems Institute is a recognized observer organization, works on technical issues related to the environmental risk/safety assessment of organisms that are produced through modern biotechnology.

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Genetically Modified Food: Requirements for Compliance and Consumer Awareness

The Agriculture & Food Systems Institute’s South Asia Biosafety Program and the Bangladesh Food Safety Authority jointly organized a workshop to build awareness and strengthen institutional governance of biosafety in Bangladesh.

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2nd Institutional Biosafety Officer Workshop

The Agriculture & Food Systems Institute’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.

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Data Transportability for COMESA Workshop

Hosted by the Agriculture & Food Systems Institute, 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.

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The Partnership for Biosafety Risk Assessment and Regulation: External Evaluation

The Partnership for Biosafety Risk Assessment and Regulation (PBRAR) is one of the few biotechnology and biosafety programs that has successfully created bridges between the agricultural sector and the environmental sector.  Strong program leadership by the Director of the Center for Environmental Risk Assessment and senior technical and communications staff leading the PBRAR’s various activities contributed to the success of the program. Read this evaluation report from Dr. Gabrielle Persley about the program.

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Transportability of Confined Field Trial Data for Environmental Risk Assessment of Genetically Engineered Plants: A Conceptual Framework

It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere.

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Low Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment

The Agriculture & Food Systems Institute organized a workshop held in Buenos Aires, Argentina on December 18-19, 2013 on low level presence (LLP) in seed. This document contains the conference proceedings to address the potential adverse environmental impacts that might arise from an LLP in seed situation using a consistent and scientifically defensible approach to environmental risk assessment.

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A Review of the Environmental Safety of the Cry3Bb1 Protein

This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of Cry3Bb1, a protein encoded by a gene isolated from Bacillus thuringiensis (Bt), and it presents a summary statement about the environmental safety of this protein when produced in genetically engineered (GE) maize (Zea mays) plants.

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Surrogate Species Selection for Assessing Potential Adverse Environmental Impacts of Genetically Engineered Insect-Resistant Plants on Non-Target Organisms

Most regulatory authorities require that developers of genetically engineered insect-resistant (GEI R) crops evaluate the potential for these crops to have adverse impacts on valued non-target organisms (NTOs), i.e., organisms not intended to be controlled by the trait.

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