National Biosafety Frameworks, when established, define the conditions that trigger the need for a risk assessment. Without prejudice to any right of a country to subject all living modified organisms to a risk assessment, under the Cartagena Protocol two specific cases require mandatory risk assessments prior to making a decision: a) the first intentional transboundary movement of a living modified organism for intentional introduction into the environment of the Party of import, and b) a final decision regarding the domestic use of a living modified organism, including its placement on the market, that may be subject to transboundary movement for direct use as food or feed, or for processing.
Upon receiving a request that triggers a risk assessment, the CNA takes several actions as part of a process to ensure that a scientifically sound risk assessment is carried out by risk assessors. These may include the following:
- Reviewing the LMO notification for completeness against a pre-determined list of information;
- Specifying the terms of reference of the risk assessment and the information expected in the final report;
- Identifying one or more risk assessors who will conduct and manage the risk assessment.
The risk assessment process includes practices and principles that may differ between countries.