This module provides an overview of the risk assessment methodology. It is structured into four sections. The first section provides an overview of the general methodology for environmental risk assessment and reviews some of the terms used. The second section provides elements that form the basis for a scientifically sound risk assessment conducted on a case-by-case basis. For each of these elements, this section also includes the points to consider of Annex III of the Protocol, along with a short rationale as to how this information may be useful. The third section explains some common actions that are undertaken when setting the context and scope of the risk assessment. The final section discusses the process of conducting the risk assessment per se, and follows the methodology and steps of Annex III of the Protocol along with a short description on how risk assessors may proceed in each of these steps. It is noted that this module does not replace Annex III, but it aims at assisting risk assessors in the practical use of the concepts contained therein.
Any methodology or terminology that is used in this module but that is not included in Annex III or in the Protocol does not reflect a particular regulatory approach to risk assessment of LMOs, but rather draws from a variety of academic and regulatory experiences. As in the other modules, examples from various approaches to risk assessment are provided in the boxes.
Although many of the principles included in this module are applicable to a wide range of LMOs, due to the experience available, this module focuses primarily on risk assessment of LM plants produced through the application of in vitro nucleic acid techniques.
