Table of Contents
Preamble
Acknowledgements
Module 1: Overview of Biosafety and the Cartagena Protocol on Biosafety | |
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| Introduction to biosafety and the Cartagena Protocol on Biosafety |
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History of the Protocol |
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What is biosafety? |
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What are living modified organisms? |
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Objective and scope of the Protocol |
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Living modified organisms for intentional introduction into the environment – Advanced Informed Agreement (AIA) |
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Living modified organisms for direct use as food or feed, or for processing (LMOs-FFP) |
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Competent national authorities |
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Risk assessment (Article 15 and Annex III) |
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Biosafety Clearing-House |
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Other provisions under the Protocol |
| Other international biosafety-related bodies |
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International Plant Protection Convention |
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Codex Alimentarius Commission |
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Food and Agriculture Organization |
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World Organisation for Animal Health |
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Organisation for Economic Co-operation and Development |
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World Trade Organization |
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Bilateral, regional and multilateral agreements |
| References |
| Annex - Techniques used in modern biotechnology |
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Commonly used methods for genetic modification of plants |
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Examples of commercialized LMOs |
Module 2: Preparatory Work – Understanding the context in which a risk assessment will be carried out | |
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| Introduction |
| National context |
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National protection goals and assessment endpoints |
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National Biosafety Framework |
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Competent national authorities |
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Practices and principles |
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Other national and international obligations |
| Expert advice and the role of the risk assessor(s) |
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Scientific advisory body |
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Responsibilities of the risk assessor(s) |
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Roster of Experts on Biosafety |
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Stakeholder participation |
| References |
Module 3: Conducting the Risk Assessment | |
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| Introduction |
| Overview of the risk assessment methodology |
| Overarching issues |
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Quality and relevance of information |
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Identification and consideration of uncertainty |
| Planning phase |
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Establishing the context and scope |
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Selecting relevant assessment endpoints or representative species |
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Establishing the baseline |
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The choice of comparators |
| Conducting the risk assessment |
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Step 1: Identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects |
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Elements of a case-by-case risk assessment of LMOs |
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Step 2: Evaluation of the likelihood |
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Step 3: Evaluation of the consequences |
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Step 4: Estimation of the overall risk |
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Step 5: Acceptability of risk and identification of risk management and monitoring strategies |
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Risk management |
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Monitoring |
| Preparing a risk assessment report and recommendation |
| References |
Preamble
This training material was developed by the Secretariat of the Convention on Biological Diversity (CBD) in cooperation with other United Nations bodies and international organizations in response to a request by the Parties to the Cartagena Protocol on Biosafety, in their decision
BS-IV/11, paragraphs 13 and 14, to develop training on risk assessment of living modified organisms (LMOs) and to convene training courses to enable countries to gain hands-on experience in preparing and evaluating risk assessment reports in accordance with the Protocol.
The purpose of this material is to provide basic training for environmental risk assessment, taking into account the provisions of the Cartagena Protocol on Biosafety and in particular Annex III of the Protocol. To this end, the training modules attempt to incorporate experience from a variety of national regulatory frameworks and international organizations in a comprehensive manner.
The training material is divided into three modules: (i) Overview of biosafety and the Cartagena Protocol on Biosafety; (ii) Preparatory work – Understanding the context in which a risk assessment is carried out; and (iii) Conducting the risk assessment.
Although this material applies to all types of LMOs and their intended uses within the scope and objective of the Protocol, it has been developed based largely on LM crop plants because of the extensive experience to date with environmental risk assessments for these organisms.
In its decision BS-VI/12, the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP) mandated the Online Forum on Risk Assessment and Risk Management and the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management to “in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual ‘Risk Assessment of Living Modified Organisms’ in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested”.
The Online Forum and the AHTEG held several rounds of discussion with a view to improving the coherence between the Roadmap and the “Manual on Risk Assessment of Living Modified Organisms” (i.e. the Manual).
In response to these requests, and taking into account the fact that the testing of the Guidance, which comprises the Roadmap, was still in progress and the fact that the COP-MOP may wish to establish a process for its improvement, the alignment between the contents of the Roadmap and the Manual was limited to revising and restructuring the Manual alone while keeping the Roadmap untouched throughout the process.
This training material may be further developed, as appropriate, as new information and experience become available.
Acknowledgements
This training material was developed through a collaborative multi-stakeholder process. The Secretariat of the Convention on Biological Diversity wishes to express its appreciation to the following organizations for their valuable inputs and comments: Aarhus Convention of the United Nations Economic Commission for Europe, Food and Agriculture Organization (FAO), International Plant Protection Convention (IPPC), United Nations Environment Programme (UNEP), Global Industry Coalition (GIC), Third World Network (TWN), University of Minnesota and University of Canterbury. Moreover, the Secretariat would like to thank Paul Keese (Office of Gene Transfer Regulator, Government of Australia) and Ulrich Ehlers (Federal Office of Consumer Protection and Food Safety, Germany) for their help in developing the initial outline of the training manual.