PLANT SC 7255WT - Principles and Practice of GM Crop Regulation

Waite Campus - Semester 2 - 2014

Plant biotechnology is widely viewed as a key tool in ensuring world food security. However, throughout the world, the use and access of the technology is subject to strict legislative restrictions and regulatory oversight. This course will help the students develop an understanding of the of principles and approaches used by GM crop regulators in assembling appropriate data and understanding of a particular event to allow for regulatory decision-making. The early part of the course will focus on developing the skills and approaches necessary to identify the protection goals, assessment endpoints and develop risk hypotheses needed to frame a risk assessment for a particular event in a named national territory. The course will next consider the types of information needed to compile effective environmental and health risk assessments. Finally, the students will engage in `role-play team activities in which one team will act as notifier whilst the other will take the role of regulator. Interaction between parties will mimic the notification process in a named national territory. The primary intended learning outcomes are to develop the required skills and understanding to progress a product through the regulatory process to market.

  • General Course Information
    Course Details
    Course Code PLANT SC 7255WT
    Course Principles and Practice of GM Crop Regulation
    Coordinating Unit School of Agriculture, Food and Wine
    Term Semester 2
    Level Postgraduate Coursework
    Location/s Waite Campus
    Units 3
    Contact Up to 15 hours per week for 3 weeks
    Assumed Knowledge PLANT SC 7225WT
    Course Description Plant biotechnology is widely viewed as a key tool in ensuring world food security. However, throughout the world, the use and access of the technology is subject to strict legislative restrictions and regulatory oversight. This course will help the students develop an understanding of the of principles and approaches used by GM crop regulators in assembling appropriate data and understanding of a particular event to allow for regulatory decision-making. The early part of the course will focus on developing the skills and approaches necessary to identify the protection goals, assessment endpoints and develop risk hypotheses needed to frame a risk assessment for a particular event in a named national territory. The course will next consider the types of information needed to compile effective environmental and health risk assessments. Finally, the students will engage in `role-play team activities in which one team will act as notifier whilst the other will take the role of regulator. Interaction between parties will mimic the notification process in a named national territory. The primary intended learning outcomes are to develop the required skills and understanding to progress a product through the regulatory process to market.
    Course Staff

    Course Coordinator: Professor Mike Wilkinson

    Course Timetable

    The full timetable of all activities for this course can be accessed from Course Planner.

  • Learning Outcomes
    Course Learning Outcomes
    Successful students will be able to:
    1 1. Determine the identity of the principle protection goals, associated assessment endpoints and risk hypotheses that are relevant to a national framework by reference to the characteristics of a specific GM event and other appropriate information.
    2 Understand the main elements of an effective risk assessment for regulatory decision-making.
    3 Understand the scientific principles underpinning the regulation of GM crops
    4 Critically evaluate data needs to test risk hypotheses
    5 Apply their knowledge to evaluate the strengths and weaknesses of the case for commercial release by reference to information contained in a dossier
    6 Effectively communicate the needs for additional pertinent data to allow the testing of risk hypotheses (from a regulatory perspective) and to address such requests with maximum efficacy (from a notifier perspective)
    University Graduate Attributes

    This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:

    University Graduate Attribute Course Learning Outcome(s)
    Knowledge and understanding of the content and techniques of a chosen discipline at advanced levels that are internationally recognised. 1,2,3,4
    The ability to locate, analyse, evaluate and synthesise information from a wide variety of sources in a planned and timely manner. 4,5
    An ability to apply effective, creative and innovative solutions, both independently and cooperatively, to current and future problems. 5,6
    Skills of a high order in interpersonal understanding, teamwork and communication. 5,6
    A proficiency in the appropriate use of contemporary technologies. 3,4
    A commitment to continuous learning and the capacity to maintain intellectual curiosity throughout life. 3,4
    A commitment to the highest standards of professional endeavour and the ability to take a leadership role in the community. 5,6
    An awareness of ethical, social and cultural issues within a global context and their importance in the exercise of professional skills and responsibilities. 6
  • Learning Resources
    Required Resources
    This course will require the following texts and other resources:
    ICGEB collection of Biosafety reviews
    Online Learning
    On-line resources (BCH, web sites of national competent authorities, OECD website, ICGEB).

    MyUni.
  • Learning & Teaching Activities
    Learning & Teaching Modes
    This course will be delivered by the following means:
    5 lectures of 1 hour each per week
    2 class exercise (6h per week total)
    2 tutorials of 2h per week
    Workload

    The information below is provided as a guide to assist students in engaging appropriately with the course requirements.

    This course will require approximately 156 hours comprising scheduled contact time, and private study.
    Learning Activities Summary
    The course content will include the following:

    Week 1 Defining the risk environment:
    Lecture topics:
    • Problem formulation with reference to case studies
    • Strategies for the identification of protection goals, assessment endpoints and setting risk hypotheses
    • Approaches to measure fitness, weediness and invasiveness to test risk hypotheses
    • Interpreting plant characterisation data
    • Targeting the useful elements of generic data on biodiversity to test risk hypothese

    Class exercises:
    • Dossier case studies (interpreting different forms and formats of data wrt testing risk specific risk hypotheses)
    Tutorials:
    • Setting risk hypotheses from archive dossiers


    Week 2 Principles of Risk Analysis:
    Lecture topics:
    • Building an Environmental Risk Assessment 1
    • Building an Environmental Risk Assessment 2
    • Building a Risk Assessment for human and animal health
    • Risk Communication: when to ask for more information
    • Dossier case studies

    Class exercises:
    • Gap analysis: Identifying what data is missing (time-limited formative exercise)
    Tutorials:
    • Introduction to the dossier to be used in the individual assignment


    Week 3 Implementation:
    Lecture topics:
    • Limits and strengths of Tiered risk assessment (2)
    • Limits and strengths of data from confined field trials (2)
    • Limits and strengths of molecular characterisation (1)


    Class exercises:

    • Team meetings for assignment: guidance through the building of mini-dossiers and notifier-regulator communication
    Tutorials:
    • Team assignment meetings and assessment


  • Assessment

    The University's policy on Assessment for Coursework Programs is based on the following four principles:

    1. Assessment must encourage and reinforce learning.
    2. Assessment must enable robust and fair judgements about student performance.
    3. Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
    4. Assessment must maintain academic standards.

    Assessment Summary
    Assessment Task Task Type Weighting Learning Outcome
    Test Summative 35% 1,2,3,4
    Individual Assignment  Formative & Summative 30% 1,3,4,5
    Group Assignment (presentation) Formative & Summative 10% 1,2,3,4,5
    Group Assignment (Communication report) Summative 10% 1,2,3,4,5,6
    Individual final report of Group Work Summative 15% 1,2,3,4,5,6
    Assessment Detail
    Tests: (35% of total course grade). A written summative test (short answer questions and short essays) will be given during a dedicated tutorial session to address understanding of the principles of problem formulation, methods leading to the identification of protection goals and assessment endpoints and of how to formulate and test a risk hypothesis by reference to case studies.

    Individual assignment: (30% of total course grade). Written evaluation of a case study dossier in the context of its proposed release into a named new national territory. Students will be expected to use e-resources, the hard literature and the dossier to identify information within the dossier that applies to the risk hypotheses that they have built and to determine whether there are valid grounds to request additional information from the notifier (if so, in what form). In this way, they will demonstrate a working practical understanding of the technology, the legal context and the principles underlying regulatory oversight.

    Group Assignment
    Presentation: 10%
    This will take the form of teams adopting the role of notifiers or regulators. Both teams will be given basic characterisation data relating to an event that is proposed for release in a named territory. The notifier group will first compile a mini dossier covering a defined section of a full dossier (e.g non-target organisms). During this time, the regulator group will use the same data to compile risk hypotheses relevant to the national priorities of the receiving nation. Each team will then make an oral presentation (formative task) of their findings.

    Communication Report 10%
    The regulators will make a written request for more information of the notifiers (report 500 words) to which the notifiers will respond with a report response (500 words) that describes data from the literature or new (hypothetical) results (the aim will be to minimise the use of expensive or protracted experiments).

    Individual Final Report 15%.
    Each individual in the group will compile a final report outlining whether/why the data presented in the notifier response warrants full release, request for more data, risk management or rejection (1000 words)
    Submission

    No information currently available.

    Course Grading

    Grades for your performance in this course will be awarded in accordance with the following scheme:

    M10 (Coursework Mark Scheme)
    Grade Mark Description
    FNS   Fail No Submission
    F 1-49 Fail
    P 50-64 Pass
    C 65-74 Credit
    D 75-84 Distinction
    HD 85-100 High Distinction
    CN   Continuing
    NFE   No Formal Examination
    RP   Result Pending

    Further details of the grades/results can be obtained from Examinations.

    Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.

    Final results for this course will be made available through Access Adelaide.

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