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  • Manual Notes

The information presented follows the same logic as that used in conducting steps 2 and 3 of the risk assessment and may include the following information, amongst other relevant information as is fit:
  1. Description of the LMO (e.g. recipient or parental organism(s), transformation method, inserted or modified sequences, novel traits, purpose of the genetic modification), its intended use and the likely potential receiving environment(s), including considerations on how the baselines were established and appropriate comparator(s) chosen;
  2. Considerations of the availability and quality of information used during the risk assessment;
  3. Methodology used in the risk assessment, explaining, if necessary, the use of terms;
  4. Description of the potential adverse effects and risk scenarios arising from the novel characteristics of the LMO;
  5. Analyses of the likelihood and consequences of each identified potential adverse effect; and
  6. Estimation of the overall risk posed by the LMO.

Depending on the specific mandate and scope of the risk assessment, the following information may be included in this section of the report:
  1. Description of the LMO (e.g. recipient or parental organism(s), transformation method, inserted or modified sequences, novel traits, purpose of the genetic modification), its intended use and the likely potential receiving environment(s), including considerations on how the baselines were established and appropriate comparator(s) chosen;
  2. Considerations of the availability and quality of information used during the risk assessment;
  3. Methodology used in the risk assessment, explaining, if necessary, the use of terms;
  4. Description of the potential adverse effects and risk scenarios arising from the novel characteristics of the LMO;
  5. Analyses of the likelihood and consequences of each identified potential adverse effect; and
  6. Estimation of the overall risk posed by the LMO.
The information relevant to each of the items above may vary in nature and level of detail on case-by-case basis, depending on the LMO concerned, its intended use and the likely potential receiving environment.