Problem formulation framework
The first step in ERA is problem formulation (USEPA 1998), which has also been referred to as hazard identification (Hill 2005; OECD 2003). We use the term problem formulation because it better reflects the broad base of information regarding the type and nature of potential adverse effects considered in an ERA for GM plants. A generic framework for PF is described in this section and shown in Fig. 1, recognizing that the case-by-case and comparative nature of ERAs for GM plants requires that many aspects of the problem be shaped by case-specific considerations as detailed in Developing the Problem Formulation. At the core of the PF process is the establishment of the ERA’s parameters (problem context) and the identification of risks of greatest relevance (problem definition).
Problem context
The problem context for risk assessment reflects values derived from the broad environmental policies and goals that direct risk analysis. Establishing the problem context sets the parameters for the risk assessment, including; protection goals, environmental scope, standard assessment endpoints (Suter 2000), and assessment methodology (see Glossary of Terms for definitions). In addition, the problem context describes case-specific details of the GM crop and certain baseline information used to determine the relative risk that can be attributed to the modification. This baseline information can include details of the biology of the parent organism and the nature of the receiving environment (e.g., presence of sexually