PLANT SC 7250WT - Regulatory Approval for GM Plants

Waite Campus - Semester 2 - 2017

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 examine the various requirements and processes related to commercialisation of materials generated by plant biotechnology necessary to remain compliant within regulatory frameworks. The regulatory requirements of plant biotechnology both within Australia and overseas will be covered and discussed in conjunction with related regulation on quarantine and food safety. This course will also consider the management of plant biotechnology development. A key intended learning outcome is to develop a solid grounding in the processes and requirements imposed by the various regulatory authorities to allow the practitioners of plant biotechnology to bring a product to the market place.

  • General Course Information
    Course Details
    Course Code PLANT SC 7250WT
    Course Regulatory Approval for GM Plants
    Coordinating Unit School of Agriculture, Food and Wine
    Term Semester 2
    Level Postgraduate Coursework
    Location/s Waite Campus
    Units 3
    Contact Up to 10 hours per week for 6 weeks
    Available for Study Abroad and Exchange Y
    Assumed Knowledge PLANT SC 7225WT
    Restrictions Available to Biotechnology (Plant Biotechnology) students only
    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 examine the various requirements and processes related to commercialisation of materials generated by plant biotechnology necessary to remain compliant within regulatory frameworks. The regulatory requirements of plant biotechnology both within Australia and overseas will be covered and discussed in conjunction with related regulation on quarantine and food safety. This course will also consider the management of plant biotechnology development.
    A key intended learning outcome is to develop a solid grounding in the processes and requirements imposed by the various regulatory authorities to allow the practitioners of plant biotechnology to bring a product to the market place.
    Course Staff

    Course Coordinator: Dr Carlos Rodriguez Lopez

    Course Timetable

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

    This course is a short intensive course that runs over three weeks and 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
  • Learning Outcomes
    Course Learning Outcomes
    Successful students will be able to:
    1

    Discuss and analyse Australian and international approaches to the regulation and management of plant biotechnology and evaluate the strengths and weaknesses of different legislative approaches.

    2 Understand and evaluate the impact of international treaties, legislation and protocols on management of plant biotechnology.
    3 Understanding of the scientific principles underpinning the regulation 
    4 Design and manage data generation leading towards the deregulation of transgenic plants
    5 Apply their knowledge to practical problems in management or regulation of plant biotechnology
    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)
    Deep discipline knowledge
    • informed and infused by cutting edge research, scaffolded throughout their program of studies
    • acquired from personal interaction with research active educators, from year 1
    • accredited or validated against national or international standards (for relevant programs)
    1,2,3
    Critical thinking and problem solving
    • steeped in research methods and rigor
    • based on empirical evidence and the scientific approach to knowledge development
    • demonstrated through appropriate and relevant assessment
    4,5
    Teamwork and communication skills
    • developed from, with, and via the SGDE
    • honed through assessment and practice throughout the program of studies
    • encouraged and valued in all aspects of learning
    4,5
    Career and leadership readiness
    • technology savvy
    • professional and, where relevant, fully accredited
    • forward thinking and well informed
    • tested and validated by work based experiences
    3,5
    Intercultural and ethical competency
    • adept at operating in other cultures
    • comfortable with different nationalities and social contexts
    • Able to determine and contribute to desirable social outcomes
    • demonstrated by study abroad or with an understanding of indigenous knowledges
    1
    Self-awareness and emotional intelligence
    • a capacity for self-reflection and a willingness to engage in self-appraisal
    • open to objective and constructive feedback from supervisors and peers
    • able to negotiate difficult social situations, defuse conflict and engage positively in purposeful debate
    n/a
  • 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 is a short intensive course that runs over three weeks and 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 Legislative context:
    Lecture topics:
    • Protection of germplasm and IP – Patents; copyrights; plant breeders’ rights; traditional knowledge
    • Regulatory framework and requirements in Australia
    • Cartagena Protocol on Biosafety and its requirements
    • Regulation in other parts of the world
    • International standards for dossier compilation (Familiarity, Substantial Equivalence, ERA)

    Class exercises:
    • Patent searching; Accessing and utilising germplasm databases
    Tutorials:
    • Description of biosafety activity in named countries based on information retrieved from Biosafety Clearing House


    Group assignment:
    • Presentation on the reconstruction of the history of an event (from development to proposed introduction into a named territory) using the BCH and other internet resources


    Week 2 Principles of Risk Analysis:
    Lecture topics:
    • Problem formulation
    • Risk Assessment
    • Risk Management and compliance
    • Risk Communication
    • Dossier compilation for submission to regulators

    Class exercises:
    • Compile application for confined field trials
    Tutorials:
    • Scope information needs for named deregulations

    Individual Assignment:
    • Written report: partial dossier compilation for release of a named event in a country other than Australia

    Week 3 Implementation:
    Lecture topics:
    • Generating risk scenarios and risk hypotheses
    • Gap analysis
    • Tiered risk assessment
    • Dossier-relevant data gathering from confined field trials
    • Effective testing of risk hypotheses


    Class exercises:

    • Visit to a plant breeding program to examine its structure and management
    • Visit to a food processing organisation
    Tutorials:
    • Case studies: using substantial equivalence as a baseline for food safety
    • Design of CFTs to optimise plant characterisation

    Individual Assignment:
    • Written scoping plan to compile a complete deregulation dossier

    Class exercise/tutorial report:
    • Written report on class exercises/tutorials will be compiled by each student
  • 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
    Group Assignment, (Retracing history of an event) Formative/Diagnostic 20% 1,2
    Individual Assignment (Partial Dossier report) Formative & Summative 20% 1,3,4,5
    Individual Assignment (Dossier scoping plan) Summative 30% 1,2,3,4,5
    Reports on class exercises Summative 30% 1,2,3,4,5
    Assessment Detail
    Group Assignment (retracing the history of an event using authorised internet resources): (20% of total course grade). In this problem-solving task, the students will use critical thinking and understanding of the e-resources and regulatory processes to retrace the history of a real event as if it were to be imported into a named country under the Cartagena Protocol. The students will prepare and deliver an oral presentation followed by questions and answers. The presentation will be embedded in a tutorial and they will receive instant feedback.

    Individual Assignment (partial dossier report): (20% of total: 1000-1500 words). Written reports representing a section of a dossier (as compiled by notifiers) will be handed in at the end of the week and rapidly assessed for content and relevance to regulatory obligations. This report will integrate the various elements of the course (scientific basis underpinning regulation, the regulatory process and data gathering and interpretation) to assemble a key section of a dossier in a suitable form for regulatory oversight.
    Students will receive written feedback within 3 days of the assessment.

    Individual Assignment (Scoping dossier report 1000-1500 words):(30% of total). In this exercise, the student will compile and order all of the key elements required to assemble a complete dossier in support of deregulation of a GM crop within a named country. This will require creative thinking (problem formulation) integrated with the structural and regulatory elements required by the relevant regulatory authority. Written feedback will be given within 5 days.

    Class Exercise and Tutorial Report (30% of total:1000-1500 words) : Here the students will be expected to retrieve the essential elements of each of the exercises into a coherent and integrated report relating to the vital information for inclusion in a submission dossier. Feedback will be given within 5 days of completion.
    Submission

    If an extension is not applied for, or not granted then a penalty for late submission will apply.  A penalty of 10% of the value of the assignment for each calendar day that the assignment is late (i.e. weekends count as 2 days), up to a maximum of 50% of the available marks will be applied. This means that an assignment that is 5 days late or more without an approved extension can only receive a maximum of 50% of the marks available for that assignment.

    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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