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Biosafety Organization
(ORG)
published: 28 Feb 2012
last updated: 08 Apr 2014
Center for Environmental Risk Assessment
EN
CERA
EN
-
Person:Dr. Michael WachSenior Scientific Program Manager,1156 15th Street, NW Second FloorWashington, DC
20005-1743, United States of AmericaPhone: +1 202 659-3306 ext 120,Fax: +1 202 659-3617,Email: mwach@ilsi.org,Website: http://www.cera-gmc.org,Related OrganizationCenter for Environmental Risk Assessment (CERA)Non-governmental organization (NGO)1156 15th Street, NW Second FloorWashington, DC
20005-1743, United States of AmericaPhone: +1 202 659-3306 ext 120,Fax: +1 202 659-3617,Email: mwach@ilsi.org,Website: http://www.cera-gmc.org,
1156 15th Street, NW
Second Floor
Washington,
DC20005-1743, United States of America
- +1 202 659-3306
- +1 202 659-3617
Non-governmental organization (NGO)
-
environmental risk assessment, capacity building,EN
- Africa - Eastern Africa
- Americas - Northern America
- Americas - South America
- Asia - South-Eastern Asia
The Center for Environmental Risk Assessment (CERA) was established by the non-profit International Life Sciences Institute Research Foundation (ILSI RF) in March 2009. CERA builds on that organization’s strengths in risk assessment, tripartite engagement, and developing and disseminating new scientific knowledge.
CERA’s purpose is to develop and apply sound science to the environmental risk assessment of agricultural biotechnologies so their contributions to sustainable production of food, fuel and fiber may be safely realized. The Center’s research projects are currently focused on genetically modified (GM) plants. This scope will be broadened over time to include transgenic arthropods and animals.
CERA’s particular focus on environmental risk assessment is supported by an outstanding Advisory Council of eminent scientists, scientific staff with considerable risk assessment and regulatory expertise, and an international network of regulators and scientists from government, academia and the private sector who contribute to our program of work. CERA works collaboratively with key international and donor organizations like the Secretariat of the Convention on Biological Diversity and the United States Agency for International Development. In October 2009, the Center was officially recognized as an Observer to the Organisation for Economic Cooperation and Development (OECD) Working Group for the Harmonization of Regulatory Oversight of Biotechnology. CERA also works bilaterally with governments, research organizations, and ILSI Branches to ensure that our programs are both relevant and accessible to partners in developing and developed countries.
CERA’s programs are supported by the ILSI RF endowment as well as by extramural grants from the public and private sectors.
EN
CERA’s purpose is to develop and apply sound science to the environmental risk assessment of agricultural biotechnologies so their contributions to sustainable production of food, fuel and fiber may be safely realized. The Center’s research projects are currently focused on genetically modified (GM) plants. This scope will be broadened over time to include transgenic arthropods and animals.
CERA’s particular focus on environmental risk assessment is supported by an outstanding Advisory Council of eminent scientists, scientific staff with considerable risk assessment and regulatory expertise, and an international network of regulators and scientists from government, academia and the private sector who contribute to our program of work. CERA works collaboratively with key international and donor organizations like the Secretariat of the Convention on Biological Diversity and the United States Agency for International Development. In October 2009, the Center was officially recognized as an Observer to the Organisation for Economic Cooperation and Development (OECD) Working Group for the Harmonization of Regulatory Oversight of Biotechnology. CERA also works bilaterally with governments, research organizations, and ILSI Branches to ensure that our programs are both relevant and accessible to partners in developing and developed countries.
CERA’s programs are supported by the ILSI RF endowment as well as by extramural grants from the public and private sectors.
CERA currently has four program platforms that span the continuum of biotechnology from biosafety research through to development impact:
Platform 1: Improving systematic approaches to the environmental risk assessment of genetically modified organisms.
Project Example: CERA convened a symposium to address the topic of surrogate species selection for assessing potential adverse environmental impacts of genetically engineered plants on non‐target organisms (NTOs). The meeting, which included scientists and regulatory risk assessors from 12 countries, covered key concepts such as functional versus species specific approaches to surrogate selection; criteria for surrogate selection for early tier, semi‐field and field testing; and best practices for surrogate testing. This symposium has already resulted in the publication of two papers, and the organizing committee is producing a third paper which will provide an overview of the history of regulatory approaches to NTO impact assessments, analyze current regulatory practices, and propose recommendations to improve the predictive value and efficiency of NTO testing as well as facilitate the transportability of existing datasets across geographies and regulatory regimes.
Platform 2: Understanding the receiving environment.
Project Example: CERA is developing a conceptual framework that explores the questions of “if”, “when,” and “how” environmental risk assessment data collected in experimental field trials are applicable across representative agro-ecosystems. This is of particular importance to regulatory authorities seeking to support regional risk assessment approaches and to public sector product developers who cannot afford to meet unnecessary, duplicative data requirements.
Platform 3: Rationalizing environmental risk assessment in the context of limited releases to the environment.
Project Example: Regulatory approvals of GM crops are not synchronized internationally which means that a new GM crop which is approved for cultivation in one country may end up in commodity or seed shipments to another country where that GM crop has yet to be approved. Although product developers and others in the grain and seed trades actively work to avoid such situations, they can and do occur. When they do it is usual for the government of the importing country to require an environmental risk assessment of the unapproved GM crop. However, the exposure scenario associated with such situations of low-level presence is very different from one associated with a deliberate release of a GM crop for the purpose of cultivation. CERA is developing resources that can assist risk assessors manage risk assessment in low exposure scenarios.
Platform 4: Building technical capacity with a focus on developing strategic programs that strengthen regulatory and scientific communities.
Project Example: The Biosafety Research in Pakistan Grants Program (BRPGP), established in 2012, recognizes the need for biosafety research as part of a broader effort to support science-based decision-making and policy development. The overarching goals of this competitive grants program are to: strengthen the scientific basis for risk assessment in Pakistan by addressing important gaps in local knowledge; improve biosafety research capacity in the public sector; promote research partnerships between institutes; and help identify, support, and train talented scientists whose work will contribute to other areas of agricultural research and development. Six grants were awarded in 2012, five in 2013, and information about grantees and their projects can be found on CERA’s website under the South Asia Biosafety Program.
Our Online Resources
The GM Crop Database provides accurate, factual, safety-related information about regulatory evaluations and approvals of genetically modified (GM) plants. This searchable database is used extensively by regulatory agencies, the academic and product developer communities, civil society organization, members of the value chain and the interested public.
CERA’s Bibliography contains a comprehensive collection of over 4,000 citations from peer-reviewed literature, books, and conference proceedings relevant to agricultural biotechnology. Users may customize their queries by searching the Bibliography by keyword, author, date, and source.
OUR PARTNERSHIPS
CERA works collaboratively with key international and donor organizations like the Organisation for Economic Co-operation and Development, the World Bank, and the United States Agency for International Development.
CERA also works bilaterally with governments, research organizations and ILSI Branches to ensure that our programs are both relevant and accessible to partners in developing and developed countries.
EN
Platform 1: Improving systematic approaches to the environmental risk assessment of genetically modified organisms.
Project Example: CERA convened a symposium to address the topic of surrogate species selection for assessing potential adverse environmental impacts of genetically engineered plants on non‐target organisms (NTOs). The meeting, which included scientists and regulatory risk assessors from 12 countries, covered key concepts such as functional versus species specific approaches to surrogate selection; criteria for surrogate selection for early tier, semi‐field and field testing; and best practices for surrogate testing. This symposium has already resulted in the publication of two papers, and the organizing committee is producing a third paper which will provide an overview of the history of regulatory approaches to NTO impact assessments, analyze current regulatory practices, and propose recommendations to improve the predictive value and efficiency of NTO testing as well as facilitate the transportability of existing datasets across geographies and regulatory regimes.
Platform 2: Understanding the receiving environment.
Project Example: CERA is developing a conceptual framework that explores the questions of “if”, “when,” and “how” environmental risk assessment data collected in experimental field trials are applicable across representative agro-ecosystems. This is of particular importance to regulatory authorities seeking to support regional risk assessment approaches and to public sector product developers who cannot afford to meet unnecessary, duplicative data requirements.
Platform 3: Rationalizing environmental risk assessment in the context of limited releases to the environment.
Project Example: Regulatory approvals of GM crops are not synchronized internationally which means that a new GM crop which is approved for cultivation in one country may end up in commodity or seed shipments to another country where that GM crop has yet to be approved. Although product developers and others in the grain and seed trades actively work to avoid such situations, they can and do occur. When they do it is usual for the government of the importing country to require an environmental risk assessment of the unapproved GM crop. However, the exposure scenario associated with such situations of low-level presence is very different from one associated with a deliberate release of a GM crop for the purpose of cultivation. CERA is developing resources that can assist risk assessors manage risk assessment in low exposure scenarios.
Platform 4: Building technical capacity with a focus on developing strategic programs that strengthen regulatory and scientific communities.
Project Example: The Biosafety Research in Pakistan Grants Program (BRPGP), established in 2012, recognizes the need for biosafety research as part of a broader effort to support science-based decision-making and policy development. The overarching goals of this competitive grants program are to: strengthen the scientific basis for risk assessment in Pakistan by addressing important gaps in local knowledge; improve biosafety research capacity in the public sector; promote research partnerships between institutes; and help identify, support, and train talented scientists whose work will contribute to other areas of agricultural research and development. Six grants were awarded in 2012, five in 2013, and information about grantees and their projects can be found on CERA’s website under the South Asia Biosafety Program.
Our Online Resources
The GM Crop Database provides accurate, factual, safety-related information about regulatory evaluations and approvals of genetically modified (GM) plants. This searchable database is used extensively by regulatory agencies, the academic and product developer communities, civil society organization, members of the value chain and the interested public.
CERA’s Bibliography contains a comprehensive collection of over 4,000 citations from peer-reviewed literature, books, and conference proceedings relevant to agricultural biotechnology. Users may customize their queries by searching the Bibliography by keyword, author, date, and source.
OUR PARTNERSHIPS
CERA works collaboratively with key international and donor organizations like the Organisation for Economic Co-operation and Development, the World Bank, and the United States Agency for International Development.
CERA also works bilaterally with governments, research organizations and ILSI Branches to ensure that our programs are both relevant and accessible to partners in developing and developed countries.
| Record type | Field | Record(s) | |
|---|---|---|---|
| Biosafety Virtual Library Resources | Reference to the authoring organization(s) | 13 | |