Module Information

Module Identifier
Module Title
Academic Year
Semester 2

Course Delivery

Delivery Type Delivery length / details
Lecture 20 x 1 hour lectures
Other 3 x 2 hour workshops


Assessment Type Assessment length / details Proportion
Semester Assessment Study Report  (2500 words)  50%
Semester Exam 2 Hours   50%

Learning Outcomes

On completion of this module, students should be able to:
- identify the basic principles of environmental risk assessment
- identify the main sources of information relating to crop biology and GM regulatory process
- identify the principles and process of endpoint assessment analysis
- compare and contrast the main regulatory frameworks
- distinguish between generic supporting information and that which aides the decision-making process
- recover data of relevance to decision-making for specific crop-transgene-location combinations
- critically evaluate the data secured from the literature for decision-making


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.

Module Skills

Skills Type Skills details
Application of Number The evaluation and/or acquisition of data is essential for this module. This will be one of the assessment elements for reports.
Communication Writing skills will be developed and assessed through the project report.
Improving own Learning and Performance Students will take responsiblity for their learning from published materials, and will set realistic goals and targets for successful submission of reports.
Information Technology Students will use a variety of software packages for report production and this will be assessed in relation to the quality of these reports.
Personal Development and Career planning Techniques and skills developed during this module will have important vocational value.
Problem solving Students will be presented with problem-based case studies and will be responsible for finding appropriate solutions. This will be one element of report assessment.
Research skills All case studies will involve the setting of objectives, elements of information retrieval and data evaluation. These skills will form part of the report assessment.
Subject Specific Skills Application of the principles underlying risk assessment of GM crops. Identification of key global regulatory frameworks.
Team work Students will develop their team working skills during this module (e.g. small group discussion of case studies). This is not assessed.


This module is at CQFW Level 7