This module aims to provide students with the principles of environmental risk assessment, knowledge of the processes required to compile a risk dossier in different geographic regions and an understanding of how to evaluate the relevance of underpinning scientific data. The aim of the module is to provide a conceptual grounding by GM crop regulators, scientists tasked with preparing formal submission for deregulation, governmental and non-commerical scientists seeking to provide generic data for use in risk assessment and governmental drivers of GM policy.

The module begins with an introduction to the main principles of GM crop risk assessment. Students then receive training on the risk assessment process from the perspective of a GM regulator, a commercial breeder of GM crops, a governmental funding body of GM risk assessment research or a publicly-funded research scientist. The importance of context will be illustrated through a series of case studies covering a diversity of crop-transgene-location combinations. Students will be introduced to the concept of tiered risk assessment and to the various sources of data available for risk assessment purposes.

Through a series of lectures and workshops students will be provided with a rigorous training in process of risk assessment. The module will consider the principles of GM risk assessment, definition of terms (e.g. risk, hazard, exposure, assessment endpoint) and explore the needs of regulators in contrast to those of fundamental scientists. Students will then be introduced to the main categories of risk (food safety, environmental safety, co-existence). Students will explore the concept of problem formulation and exposure pathway analysis. Various approaches to problem formulation will be investigated and their various merits evaluated against the needs of the relevant local regulators. Difficulty in identifying relevant endpoint species and assessment endpoints will be explored. Students will be introduced to a series of contrasting examples (different crop-transgene-location combinations) to illustrate how pathway analysis can be used to eliminate certain scenarios on the basis of minimal exposure. Case studies will also be used to illustrate how seemingly relevant data from the literature may actually prove to be unhelpful from a risk assessment perspective. Finally, students will be introduced to the current main global regulatory frameworks and will explore the implications arising from the key differences.