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Creating Confidence in Biosafety Assessments to Inform Reliable and Predictable Regulatory Outcomes

The Issue

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.

What We Are Doing

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 utility of confined field trial data, we serve as a scientific resource for governments, academic institutions, and private sector organizations.

Why It’s Important

Any new technology comes with potential benefits and potential risks for the environment. Understanding these is essential to making informed decisions about what should or should not move from research to field to market.

Program Staff

Andrew Roberts, Ph.D.
Andrew leads the development and management of AFSI’s extensive international portfolio of biotechnology-related analytical and capacity building programs, open access resources, and relationships with key partner organizations and stakeholder groups.
Rachel Melnick , Ph.D.
Rachel contributes to the development and implementation of AFSI’s current and future applied research and capacity building programs. She is responsible for developing strategies and budgets for these projects, identifying associated personnel requirements, and is accountable for ensuring the program/project meets its stated objectives. She also serves as liaison between AFSI management and staff, implementing partners, and other applicable parties.

Where We Operate

Collaborators & Partners

  • Australian Government
  • Common Market for Eastern and Southern Africa (COMESA)
  • Foundation for the National Institutes of Health (FNIH)
  • International Food Policy Research Institute (IFPRI)
  • New Partnership for African Development (NEPAD)
  • Organisation for Economic Co-operation and Development (OECD)
  • University of British Columbia
  • University of Edinburgh
  • USDA Foreign Agricultural Service
Rationalizing the use of field trial data to inform ERA.

Programs

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Data Transportability for Field Trial Research

Promoting Use of Relevant Field Trial Data Across Geographies

Confined field trials (CFTs) are conducted to inform environmental risk assessments of genetically engineered crops. But instead of repeating trials in every country where a GE crop might be grown, data from previous trials, including those cultivated in similar agroclimates, may provide all that is necessary.

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Global Environmental Zones (GEnZ) Explorer

Rationalizing the Location of CFTs to Maximize Data Utility

Our online tool allows users to visualize agroclimatic zonations and their relationships to CFT locations in order to help determine where to best locate CFTs and maximize data utility. This can be used by CFT managers and risk assessors to provide context for the relevance of CFT data produced at remote locations.

VISIT TOOL
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Gene Drives in Mosquitoes

Identifying Priorities for Risk Assessment

With 228 million cases of malaria worldwide in 2018, novel approaches to managing this debilitating disease are needed. We are advancing understanding of the underlying technology and helping stakeholders identify priorities for risk assessment of the use of gene drive to control the mosquito vectors that spread this disease.

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Our Successes

Issue

Because it is not possible to measure, monitor, and test every organism in every environment, surrogate species play an important role in evaluating the potential for adverse environmental impacts of new technologies. This includes assessing the potential effects of genetically engineered (GE) crops on non-target organisms (NTOs). Surrogate species must be selected appropriately to represent key taxonomic or functional groups and testing must be done with sufficient rigor to ensure that tests address the potential impact being investigated.

What We Did
  • The Agriculture & Food Systems Institute facilitated expert working groups, training workshops, and publications addressing the proper use of surrogate species for testing in support of environmental risk assessment of GE crops.
  • In 2016, the Agriculture & Food Systems Institute produced a peer-reviewed publication that provides an overview of the history of regulatory approaches to NTO assessments and analyzes current regulatory practices. The paper proposes recommendations to improve the predictive value and efficiency of NTO testing, as well as facilitating the transportability of existing datasets across geographies and regulatory regimes.
Issue

Genetically engineered Ae. aegypti have been developed to control populations of this mosquito, which is the main vector of yellow fever, dengue fever, Zika, and chikungunya. In order to facilitate risk assessments for the use of these GE mosquitoes, regulators need access to succinct, summary information of biosafety-relevant aspects of the biology of the species.

What We Did

The OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology (WGHROB) develops and publishes consensus documents that provide internationally agreed upon baseline information for understanding key aspects about the biology of specific organisms. Each document identifies and describes important characteristics of its subject, usually a plant species, which are typically considered when undertaking a comparative risk assessment of its genetically engineered counterpart. 

The Agriculture & Food Systems Institute approached the OECD Environment Secretariat about developing a biology document for Aedes aegypti, the first insect species and only the second animal species to be the subject of an OECD biology document. The idea was put to the WGHROB and agreed, with the Governments of Brazil and Mexico as convening leads together with the Agriculture & Food Systems Institute. The OECD Consensus Document on the Biology of Mosquito Aedes aegypti was declassified in July 2018 and is now available on the OECD website.

Issue

RNA interference, or RNAi, refers to a set of biological processes that make use of conserved cellular machinery to silence genes. The use of RNAi to develop plants with desirable traits has fueled a discussion about how best to address environmental considerations that might arise with these products.

What We Did

The Agriculture & Food Systems Institute convened a multi-sectoral, multi-disciplinary team of scientists to help identify and clarify the relevant safety considerations and risk assessment methodologies for environmental risk assessment of plants with RNAi traits. 

  • This resulted in the publication of a peer-reviewed paper that identifies research informative for environmental risk assessments of these plants, with a particular focus on non-target organism assessment.
  • This important work was highlighted during scientific sessions at the 2012 Entomological Society of America Annual Meeting and the 13th International Symposium for the Biosafety of Genetically Modified Organisms.

Discover

Publications

Biosafety Regulation and Processes in Bangladesh: A Guide for Researchers in Agricultural Biotechnology
Biosafety Resource Book Series | November 19, 2020

Part of the South Asia Biosafety Program’s capacity development interventions, this publication aims to inform researchers about the prevailing regulatory administrative system of Bangladesh and outlines the regulatory processes functioning at different stages of research and development of GE crops.

Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
Frontiers in Bioengineering and Biotechnology | August 18, 2020

This paper presents the recent evolution of the regulatory system in Paraguay toward the establishment of a simplified procedure for GE crops that have been already assessed by sound and experienced regulatory systems, taking into account several scientific criteria. Dr. Carmen Vicién, Agriculture & Food Systems Institute in-country partner, was a co-author of this paper, which references the Agriculture & Food Systems Institute’s involvement in the Partnership for Biosafety Risk Assessment and Regulation in Paraguay.

Sublethal Endpoints in Non-Target Organism Testing for Insect-Active GE Crops
Frontiers in Bioengineering and Biotechnology | June 9, 2020

This review paper focuses on the current status and history of sublethal endpoint use in insect-active GE crops and evaluates the future use of sublethal endpoints for new and emerging technologies.

Genetic Biocontrol for Invasive Species
Frontiers in Bioengineering and Biotechnology | May 25, 2020

This publication provides an overview of the state of genetic biocontrol, focusing on several approaches that were the subject of presentations at the Genetic Biocontrol for Invasive Species Workshop, which was sponsored by the OECD’s Co-operative Research Program on Biological Resource Management for Sustainable Agricultural Systems.

Agricultural Biotechnology and Biosafety in South Asia: Progress and Prospects
SAARC Agriculture Centre | September 30, 2019

This book contains the papers and proceedings of the SAARC Regional Consultative Meeting on the Progress and Prospects of Agricultural Biotechnology and Biosafety in South Asia, which took place on June 18- 20, 2019 in Dhaka, Bangladesh.

Problem Formulation for Gene Drive Mosquitoes Designed to Reduce Malaria Transmission in Africa: Results from Four Regional Consultations 2016–2018
Malaria Journal | October 15, 2019

This summary publication captures the findings from four African consultations organized by the New Partnership for Africa’s Development (NEPAD) to identify risk hypotheses and data needs for future environmental risk assessment of gene drives in the mosquito Anopheles gambiae.

OECD Consensus Document of the Biology of Mosquito Aedes aegypti
Safety Assessment of Transgenic Organisms in the Environment (Volume 8) | June 23, 2018

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.

Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems
Frontiers in Bioengineering and Biotechnology | April 5, 2018

The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. Dr. Carmen Vicién, Agriculture & Food Systems Institute in-country partner, was a co-author of this paper, which references the Agriculture & Food Systems Institute’s involvement in the Partnership for Biosafety Risk Assessment and Regulation in Paraguay and the use of Agriculture & Food Systems Institute eLearning courses in Kenya.

Results from the Workshop “Problem Formulation for the Use of Gene Drive in Mosquitoes”
American Journal of Tropical Medicine and Hygiene | November 29, 2016

Reducing the incidence of malaria has been a public health priority for nearly a century. However, before new technologies and associated vector control strategies  can be developed and exploited, it will be necessary to understand and assess the likelihood of any potential harms to humans or the environment. To begin this process, the Foundation for the National Institutes of Health and the Agriculture & Food Systems Institute organized an expert workshop to consider the potential risks related to the use of gene drives in Anopheles gambiae for malaria control in Africa.

Information Tools for Environmental Risk Assessment of Low Level Presence
| December 31, 2011

In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.

Recommendations for the Design of Laboratory Studies on Non-Target Arthropods for Risk Assessment of Genetically Engineered Plants
Transgenic Research | October 13, 2010

This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs).

Genetically Modified Crops and Aquatic Ecosystems: Considerations for Environmental Risk Assessment and Non-Target Organism Testing
Transgenic Research | November 26, 2011

The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study.

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Biosafety Capacity Building
Environmental Risk Assessment
Sustainable Nutrition Security
Food and Feed Safety Assessment
Plant Biologicals for Sustainable Agriculture