The final set of considerations that need to be understood before embarking on conducting a risk assessment is the idea of a case-by-case risk assessment and all the factors that go into making a determination of risk on this basis.

There are three factors that define the case-by-case approach:

• Living modified organism
• Likely potential receiving environment(s)
• Intended use

The case-by-case approach in risk assessment is based on the premise that risks that may arise from the release of an LMO depend on three main elements:

1. the LMO itself,
2. the likely potential receiving environment and
3. the intended use of the LMO in question.

In order to identify and assess risks, each of these elements needs to be characterized in a concerted manner and as appropriate for the specific risk assessment. Moreover, it is important to note that while these three elements may be sufficient to establish the boundaries of a risk assessment, potential adverse effects may extend beyond these elements, for instance, to unintended receiving environments and uses.