Table of Contents

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Preamble

Acknowledgements

Module 1: Overview of Biosafety and the Cartagena Protocol on Biosafety

1. Introduction to biosafety and the Cartagena Protocol on Biosafety
	1.1. History of the Protocol
	1.2. What is biosafety?
	1.3. What are living modified organisms?
		1.3.1. Examples of commercialized LMOs
	1.4. Objective and scope of the Protocol
	1.5. Living modified organisms for intentional introduction into the environment – Advanced Informed Agreement
	1.6. Living modified organisms for direct use as food or feed, or for processing (LMOs-FFP)
	1.7. Competent national authorities
	1.8. Risk assessment (Article 15 and Annex III)
	1.9. Biosafety Clearing-House
	1.10. Other provisions under the Protocol
2. Other international biosafety-related bodies
	2.1. International Plant Protection Convention
	2.2. Codex Alimentarius Commission
	2.3. Food and Agriculture Organization
	2.4. World Organisation for Animal Health
	2.5. Organisation for Economic Co-operation and Development
	2.6. World Trade Organization
	2.7. Bilateral, regional and multilateral agreements
3. References

Module 2: Preparatory Work – Understanding the context in which a risk assessment will be carried out

1. Introduction
2. The broad national context
	2.1. National protection goals and assessment endpoints
	2.2. Other national and international obligations
3. National biosafety context
	3.1. National biosafety framework
	3.2. Competent national authorities
	3.3. Risk assessment practices and principles
4. Expert advice and the roles of the risk assessor(s)
	4.1. Scientific advisory body
	4.2. Responsibilities of the risk assessor(s)
	4.3. Roster of Experts on Biosafety
	4.4. Stakeholder participation
5. References

Module 3: Conducting the Risk Assessment

1. Introduction
2. Overview of techniques used in modern biotechnology
	2.1. Commonly used methods for genetic modification of plants
3. Overview of the risk assessment methodology
4. Context and scope of the risk assessment
	4.1. Selecting relevant assessment endpoints or representative species
	4.2. Establishing the baseline
	4.3. Establishing the appropriate comparator(s)
5. Elements of a case-by-case risk assessment of LMOs
	5.1. Living modified organism
		5.1.1. Characterization of the recipient organism or parental organisms
		5.1.2. Description of the genetic modification
		5.1.3. Identification of the LMO
	5.2. Likely potential receiving environment(s)
		5.2.1. Physical characteristics
		5.2.2. Biological characteristics
	5.3. Intended use
6. Conducting the risk assessment
	6.1. Identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects
	6.2. Evaluation of the likelihood
	6.3. Evaluation of the consequences
	6.4. Estimation of the overall risk
	6.5. Identification of risk management and monitoring strategies
		6.5.1. Risk management
		6.5.2. Monitoring
6. References

Module 4: Preparing a Risk Assessment Report

1. Introduction
2. Background, context and scope of the risk assessment
3. Characterization and estimation of risks
4. Description of risk management and monitoring strategies
5. Consideration of remaining uncertainty
6. Recommendations as to whether or not the risks are acceptable or manageable
7. References

Preamble

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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 four 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; (iii) Conducting the risk assessment; and (iv) Preparing a risk assessment report.

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.

At their fifth meeting, the Parties welcomed the development of a “Training Manual on Risk Assessment of Living Modified Organisms” in response to their earlier decision BS-IV/11 and further requested the Executive Secretary to, inter alia:

1. Improve the training manual by revising it on the basis of the recommendations provided during the capacity-building activities and feedback from Parties; and
2. Develop an interactive learning tool based on the training manual, and make it available through the Biosafety Clearing-House in all United Nations languages with the view to developing a more cost-effective way for delivering training on risk assessment

In response to these requests, the Secretariat (i) revised and improved the training manual as annexed hereto based on the recommendations provided participants nominated by Parties to risk assessment capacity-building training workshops; and (ii) developed an initial e-training concept available through the Biosafety-Clearing House based on the revised training manual.

This training material may be further developed, as appropriate, as new information and experience become available.

Acknowledgements

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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.