The report should describe how the requirements of the national regulatory framework were taken into account including which protection goals were identified as relevant in the context of the risk assessment and how assessment endpoints were selected.
In summary, the following information may be included in this section of the report:
- Contact details of the LMO developer;
- Type of approval sought (e.g. introduction into the environment);
- Contact details of the institution responsible for the risk assessment;
- Relevant regulation;
- Relevant protection goals and assessment endpoints;
- Previous approvals or prohibitions of the same LMO;
- Overview of the terms of reference for the risk assessment; and
- Consulted experts or panel of experts, if applicable, and how the involved experts were chosen and how possible conflict of interests were identified and was managed.
In some cases, the bulk of information presented in this section of the report may be extracted from the request triggering the risk assessment, the national regulatory framework, including environmental and biosafety policies or guidelines, and national biosafety-related databases.