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Providing Training & Resources to Promote Science-Based Risk Assessments of Biotechnology Products

The Issue

Modern technologies have the promise to transform agriculture and food systems, improving the lives of millions. But how can products developed using these new techniques be introduced responsibly? Many governments lack the risk assessment experience needed to assure decision-makers and the public that environmental and food safety concerns have been properly addressed.

What We Are Doing

The Agriculture & Food Systems Institute develops knowledge resources and provides customized training to scientists, risk assessors, and regulators, to promote science-based risk assessments of products of biotechnology.

Why It’s Important

Governments and others need to have the tools to evaluate products of new technologies in order to make appropriate decisions for their populations so that the sustainable production of food, fuel, and fiber may be safely realized.

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.
Bhavneet Bajaj, Ph.D., PMP
Bhavneet contributes to the continued development and implementation of AFSI’s applied research and capacity building programs related to agricultural and other biotechnologies. Additionally, she manages AFSI’s highly acclaimed open access databases – the Crop Composition Database and the World Nutrient Databases for Dietary Studies. In these roles, she works closely with AFSI’s scientific staff and external partners to ensure that programs are science-focused, have broad participation from multiple sectors and disciplines, and are directed toward concrete and achievable outcomes.

Where We Operate

Collaborators & Partners

  • Bangladesh Ministry of Environment, Forest and Climate Change
  • Bangladesh Department of Environment
  • Bangladesh Agricultural Research Council
  • Biotech Consortium India Limited
  • Indian Council of Agricultural Research (ICAR)
  • India Ministry of Environment, Forest and Climate Change
  • International Food Policy Research Institute (IFPRI)
  • International Maize and Wheat Improvement Center (CIMMYT)
  • Organisation for Economic Co-operation and Development (OECD)
  • US Agency for International Development (USAID)
  • US Department of Agriculture (USDA)
  • University of Dhaka
  • Philippines Bureau of Plant Industry
  • Philippines Department of Agriculture
  • Philippines Department of Science and Technology
  • Philippines Food and Drug Administration
  • Philippines Department of Environment and Natural Resources
  • Biosafety Coalition of the Philippines
Discover our training and information resources on science-based risk assessment of biotechnology for agriculture.

Programs

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South Asia Biosafety Program (SABP)

Strengthening Governance of Biotechnology in India & Bangladesh

We provide technical assistance to biosafety risk assessment and research communities and support government efforts to implement functional and scientifically sound regulatory processes for agricultural biotechnology.

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Online Biosafety Training

Empowering Regulators with E-Learning Courses in Biosafety & GE Food Safety

Our open access, interactive, self-paced courses provide training to help regulatory agencies, academics, and the private sector to better understand regulatory issues.

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Workshops

Advancing the Understanding of Biotechnology Issues

We regularly conduct trainings and workshops on a variety of topics to advance understanding of biotechnology issues. Programs are developed in collaboration with in-country partners to ensure they meet local needs.

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Our Successes

Outcome

Supported the development and adoption of three key documents that improve transparency of risk assessment and regulation of agricultural biotechnology in India.

At the request of the Government of India, and in close collaboration with partners in India, we provided additional technical support, including:

  • Workshops on problem formulation and other aspects of environmental risk assessment (ERA).
  • A survey of the pipeline of genetically engineered crops in development in India.
  • A comprehensive set of resource documents, including eight crop-specific biology documents.
  • An expert study tour to share experiences and learnings with the Office of the Gene Technology Regulator (Australia).
  • An e-learning training program that serves both as a stand-alone resource for self-guided education and as a complement to India’s face-to-face training programs to raise awareness about the ERA guidelines.
  • Project Name:
    UNEP-GEF Phase II Capacity Building Project on Biosafety
  • Years:
    2014-2017
  • Funding:
    Global Environment Facility through the United Nations Environment Program
  • Parties:
    Ministry of Environment, Forests and Climate Change, Government of India
  • Country:
    India
Outcome

Supported evidence-based decision-making by advancing technical capacity in eight countries. The goal of the program was to enable partner country stakeholders to better promote harmonization and rationalization of biosafety regulations in their countries. This goal was not only met, but resulted in:

  • 2 OECD consensus documents, on the biology of cassava and common bean, which are important tools that are being used to inform risk assessments.
  • 26 national and regional workshops focusing on biosafety, risk assessment, and regulatory harmonization.
  • 2 e-learning courses developed on relevant biosafety topics.
  • More than 600 regulators, risk assessors, and other scientists received technical support and training.
Key Results
  • Regulators from project countries are enabled to substantively participate in regional and global biosafety forums.
  • Improved the efficiency of national regulatory systems in partner countries:
    • Paraguay reduced its decision-making time by the national regulatory authority from two years to three months.
    • Vietnam developed internal capacity to complete environmental review of new maize cultivars and approve these for cultivation.
  • Project Name:
    The Partnership for Biosafety Risk Assessment and Regulation (PBRAR)
  • Years:
    2011-2014
  • Funding:
    Development Grant Facility of the World Bank
  • Parties:
    Environment Directorate of the Organisation for Economic Co-operation and Development, World Bank, and Eight countries that had adopted or were considering the adoption of agricultural biotechnology.
  • Countries:
    Bangladesh, Colombia, Kenya, Paraguay, Tanzania, Uganda, Uruguay, and Vietnam

“There has been an improvement of the capabilities of a large number of participants and the updates of the regulatory framework that are being implemented as a result of the activities that are being developed in the framework of the Partnership Program.”

Mr. Santiago Bertoni, Director, Unidad De Comercio Internacional E Integración Del Ministerio De Agricultura Y Ganadería Del Paraguay, Paraguay
Outcome

The Biosafety Research in Pakistan Grants Program, managed by the Agriculture & Food Systems Institute, supported research projects designed to improve understanding about the environmental parameters and agricultural practices that serve as a baseline to inform environmental risk assessment of GE plants.

Active from 2012-2014, 16 grantees from academic institutions worked to develop important baseline data on agroecosystems and management practices to build a knowledgeable community of practice to facilitate regulatory decision-making in Pakistan.

  • Project Name:
    The Biosafety Research in Pakistan Grants Program
  • Years:
    2012-2014
  • Funding:
    United States Agency for International Development
  • Parties:
    Academic researchers
  • Country:
    Pakistan
Outcome

In June of 2013 and 2014, the Agriculture & Food Systems Institute, in cooperation with the USDA Agricultural Research Service, Iowa State University, and DuPont Pioneer, convened technical training workshops on non-target organism testing of transgenic crops. This program provided regulatory scientists and environmental risk assessors with an experiential learning opportunity that included practical experiments and data collection for both laboratory and field testing to evaluate risks to non-target organisms.

Participants were surveyed prior to the workshop to establish a baseline of their knowledge and experience on the topics that would be presented during the five-day program. Surveys were subsequently conducted four months and twelve months after the workshop in order to evaluate the longer-term impact on the participants’ professional development.

  • Project Name:
    Practical Training in NTO Assessment for GE Plants
  • Funding:
    Development Grant Facility of the World Bank, USAID, (USDA Agricultural Research Service)
  • Parties:
    Scientists from academic and government research organizations
  • Countries:
    Bangladesh, China, Ghana, India, Malawi, Nigeria, Pakistan and Uganda

“I am working on starting to collaborate with the Commission of Science and the Department of Environmental Science in Malawi, to make environmental risk assessment an integral part of agricultural production. Soon, Malawi will be rolling out Bt cotton in most parts of the country. This training program came at the perfect time.”

Dr. Elizabeth Bandason, Lecturer, Entomology, Lilongwe University of Agriculture and Natural Resources, Bunda College Campus, Lilongwe, Malawi

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.

A Review of the Environmental Safety of the PAT Protein
| December 31, 2011

This document provides a comprehensive review of information and data relevant to the environmental risk assessment of the protein phosphinothricin-N-acetyl transferase (PAT) produced in genetically engineered (GE) plants by genes isolated from Streptomyces viridochromogenes (pat gene) or Streptomyces hygroscopicus (bar gene) and presents a summary statement about the environmental safety of this protein.

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).

Search Resources

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