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Background materials linked to the Guidance on Risk Assessment of Living Modified Organisms

1. Roadmap for risk assessment of living modified organisms (2)
1.1. Background (2)
1.2. Introduction (44)
1.3. Overarching issues in the risk assessment process (4)
1.3.1. Protection goals, assessment endpoints and measurement endpoints
Protection goals and centres of origin and genetic diversity
1.3.2. Quality and relevance of information (2)
Information requirements in the case of field trials or experimental releases
1.3.3. Identification and consideration of uncertainty (30)
1.4. Planning phase of the risk assessment (5)
1.4.1. Establishing the context and scope (14)
1.4.2. Problem formulation
1.4.3. The choice of comparators (5)
1.5. Conducting the risk assessment (42)
1.5.1. Step 1: “Identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health” (133)
Identifying potential adverse effects to human health arising through environmental exposure
Characterization of LMOs developed through RNAi-based methods
LM crops and the use of herbicides
1.5.2. Step 2: “Evaluation of the likelihood of adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism” (14)
1.5.3. Step 3: “Evaluation of the consequences should these adverse effects be realized” (25)
1.5.4. Step 4: “Estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized” (6)
1.5.5. Step 5: “Recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks” (9)
2. Risk assessment of living modified plants with stacked genes or traits (11)
2.1. Introduction (1)
2.2. Planning phase of the risk assessment
2.2.1. The choice of comparators
2.3. Conducting the risk assessment (3)
2.3.1. Sequence characteristics at the insertion sites, genotypic stability and genomic organization (1)
2.3.2. Potential interactions among the stacked genes, their resulting phenotypic changes and effects on the environment and human health (1)
2.3.3. Combinatorial and cumulative effects (2)
2.3.4. Crossing and segregation of transgenes
2.3.5. Methods for distinguishing the combined transgenes in a stacked event from the parental LM plants (1)
3. Risk assessment of living modified plants with tolerance to abiotic stress (19)
3.1. Introduction (1)
3.2. Planning phase of the risk assessment
3.2.1. The choice of comparators
3.3. Conducting the risk assessment
3.3.1. Unintended characteristics, including cross-talk between stress responses (2)
3.3.2. Testing the living modified plant in representative environments
3.3.3. Persistence in agricultural areas and invasiveness of natural habitats
3.3.4. Effects on the abiotic environment and ecosystem
4. Risk assessment of living modified trees (6)
4.1. Background (1)
4.2. Introduction (11)
4.3. Planning phase of the risk assessment
4.3.1. The choice of comparators (1)
4.4. Conducting the risk assessment (1)
4.4.1. Presence of genetic elements and propagation methods (1)
4.4.2. Long life spans, genetic and phenotypic characterisation and stability of the modified genetic elements (7)
4.4.3. Dispersal mechanisms (2)
4.4.4. The likely potential receiving environment(s) (1)
4.4.5. Exposure of the ecosystem to LM trees and potential consequences (4)
4.4.6. Risk management strategies
5. Risk assessment of living modified mosquitoes species that act as vectors of human and animal diseases (52)
5.1. Introduction
5.2. Objective and scope
5.3. Planning phase of the risk assessment
5.3.1 The choice of comparators
5.4. Conducting the risk assessment
5.4.1. Characterization of the living modified mosquito
5.4.2. Unintended effects on biological diversity (species, habitats, ecosystems, and ecosystem function and services)
5.4.3. Vertical gene transfer (1)
5.4.4. Horizontal gene transfer (2)
5.4.5. Persistence of the transgene in the ecosystem (1)
5.4.6. Evolutionary responses (especially in target mosquito vectors or pathogens of humans and animals)
5.4.7. Unintentional transboundary movement
5.4.8. Risk management strategies
5.4.9. Containment of the living modified mosquito
6. Monitoring of Living Modified Organisms Released into the Environment (36)
6.1. Introduction (2)
6.2. Objective and scope (2)
6.3. Monitoring and its purposes (3)
6.4. Development of a monitoring plan
6.4.1. Choice of indicators and parameters for monitoring (“what to monitor?”) (2)
6.4.2. Monitoring methods, baselines including reference points, and duration of monitoring (“how to monitor?”) (1)
i. Selecting monitoring methods (1)
ii. Establishing baselines, including reference points (1)
iii. Establishing the duration of monitoring (1)
6.4.3. Choice of monitoring sites (“where to monitor?”) (1)
6.4.4. Reporting of monitoring results (“how to communicate?”) (1)