Gene Technology Awareness Session

1. Gene Technology Awareness Session Dr Sylvia Lachberg The University of Western Australia Research Services 2010

2. This Course • Aim of course is to ensure all UWA staff and students involved in Gene Technology research are fully aware of legislative requirements, including the recent amendments to the Gene Technology Act and Regulations • Course notes • Short test at the end of the course

3. Why are you here?? If you are working at the bench in a certified facility. If you are responsible for a certified facility. -Including Laboratory Managers, School Mangers, Heads of School

4. UWA is required to provide training on Gene Technology Act and Regulations.As an Accredited Organisation with the Office of the Gene Technology Regulator we are audited to ensure we are providing this training.

5. Who needs to be aware of the legislation • Management • Those who work at the bench and those responsible for OGTR certified facilities • Support services eg wash up and waste disposal • Facility management personnel

6. Gene Technology Act 2000Gene Technology Regulations 2007 Object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology and by managing those risks through regulating certain dealings with GMOs. Does not cover ……

7. What’s not regulated under theGT Act • Human beings, if the human being is a GMO due to somatic cell gene transfer • Somatic cell transfer if the transfer does not involve GM material • Organisms that are prescribed in the Regulations as not being GMOs

8. Review of the Gene Technology Act and Regulations Why have changes been made? • Regulator’s review of the Gene Technology Regulations in response to stakeholders & operational experience – June 2007 • Independent Review of the operation of the Gene Technology Act - June 2007 • More on the changes later

9. Gene Technology Act (1) Does six things • Establishes a statutory officer, Gene Technology Regulator to administer the legislation and make decisions under the legislation.

10. Gene Technology Act (2) • Establishes a scientific committee and a ethics/community consultative committee from which the Regulator and the Ministerial Council on gene technology may request advice.

11. Gene Technology Act (3) Prohibits persons from dealing with GMO unless the dealing is: • Exempt • Notifiable Low Risk Dealing (NLRD) • Licenced by the Regulator Dealing Not Involving Intentional Release (DNIR) Dealing Involving an Intentional Release (DIR) • on a register of GMOs • Inadvertent dealings • Emergency Dealings

12. Gene Technology Act (4-6) • Establishes a scheme to assess the risks to human health and the environment associated with various dealings with GMOs, including opportunities for extensive public input; • Provides for monitoring and enforcement of the legislation; and • Creates a centralised, publicly available database of all GMOs and GM products approved in Australia

13. Prior to the Gene Technology Act Prior to the Gene Technology Act the development and the use of GMOs was overseen by the Genetic Manipulatory Advisory Committee (GMAC). This was a voluntary system and did not impose any legal obligations on people to comply with GMAC recommendations.

14. Penalties Gene Technology Act: Part 4 – Regulation of dealings with GMOs Division 2 -Dealings with GMOs must be licensed • Section 32 -38 • A conviction will lead to imprisonment for 2 years and a $55,000 fine • If convicted of an aggravated offence you are liable for 5 years imprisonment and $1.1 million fine

16. How the System works • Canberra Gene Technology Regulator and the Office of the Gene Technology Regulator (OGTR) • Accredited Organisations (AO) with the OGTR • University of WA is an AO with the OGTR • AO must have access to an Institutional Biosafety Committee (IBC) • UWA has an IBC

17. Roles and Responsibilities (1) Gene Technology Regulator • office holder appointed by the Governor-General • significant independence - similar to the Auditor-General and the Tax Commissioner • assesses the risks to public health and the environment • advises other regulatory agencies • monitors and enforces the legislation • reports annually to the Federal Parliament

18. Roles and Responsibilities (2) OGTR • admin body responsible for the review of proposals for genetic manipulation in Australia • set guidelines for and certify facilities Two advisory committees • Gene Technology Technical Advisory Committee • Gene Technology Ethics/Community Consultative Committee

19. Roles and Responsibilities (3) University Executive The Deputy Vice Chancellor, Research as a delegate of the Vice Chancellor is responsible to ensure: • adequate staffing and resources are available to maintain quality assurance systems for compliance with the legislation • a competent, indemnified IBC is part of the quality assurance system

20. Roles and Responsibilities (4) Heads of School/Sections • ensure safe working procedures are understood and enforced; • ensure all staff handling GMOs attend GT training; • maintain a register of all GMOs in the departments certified facilities; • maintain a register of all current GT dealings by research staff within their school; • maintain a register of all persons working in certified facilities within the school; and • maintain a register of all certified facilities within the school.

21. Roles and Responsibilities (5) Principal Researchers and Laboratory Managers • ensure safe working procedures are understood and enforced; • maintain a register of all GMOs in their research; • advise IBC immediately of any accidents and unexplained illnesses or absences and subsequently provide a report of the investigation of such incidents; and • maintain a record of all past and current projects involving the use or development of GMOs

22. Roles and Responsibilities (6) Researchers and Laboratory Personnel handling or dealing with GMOs • undertake GT training run by Research Services • follow all safe working and GM procedures and instructions • immediately notify Principal Researcher and others of any hazards, incidents or injuries

23. Roles and Responsibilities (7) Office of Facilities Management / Contractors • keeping facilities maintained as required • checking with key laboratory personnel when entering and working on certified facilities

24. UWA’s Institutional Biosafety Committee

25. UWA IBC (1) Assists UWA and Affiliates to comply with the GeneTechnology Act and Regulations • Maintain a register of all exempt dealings, NLRD and licensed dealings undertaken • Maintain a list of all facilities certified with the OGTR and carry out annual inspections • Assessment and review of proposed GM dealings including containment and qualifications and experience of persons involved • Liaise with OGTR regarding accreditation, compliance and licensing

26. UWA IBC (2) • Provide advice to proponents about the Gene Technology Act and Regulations • Provide an annual report to the OGTR

27. Institutional Biosafety Committee (IBC) 2010 • Dr Charlene Kahler, Microbiologist (Chair) • Prof Craig Atkins, Plant Science • Dr Patrick Finnegan, Plant Science • Mr Doug Hall, External Member • Dr Richard Lugg, ex Health Department of Western Australia • Dr Thomas Martin, Plant Biochemist • Dr Sue Fletcher, CNND, Molecular Biologist • Dr Jane Allan, Medicine and Pharmacology, Microbiologist • Dr James Wun, Office of Facilities Management • Dr Malcolm Lawson, Animal Care Unit - By Invitation • Dr Sylvia Lachberg, RS Secretary

28. Biological Safety Officer • provide training about the Gene Technology Act and Regulations; • provide administrative and technical support for the University’s IBC; • inspect certified facilities.

30. Undertaking Gene Technology work at UWA

31. What is a Dealing? Conducting experiments with or, making or breeding any GMO and includes the possession, use, transport or disposal of the GMO.

32. Types of Dealings • Exempt Dealings IBC • Notifiable Low Risk Dealings (NLRD) IBC Annual Report to OGTR Licence • Dealing Not Involving Intentional Release (DNIR) IBC OGTR (90 days) • Dealing Involving an Intentional Release (DIR) IBC OGTR (170 days)

33. Application times • Facility Certification Application: 90 working days • Accreditation application: 90 working days • NLRD or Exempt Dealing : 1 Month • Licences….

34. Exempt Dealings All Exempt Dealings are required to be submitted and assessed by the IBC: • to minimise the possibility of misclassification of dealings

35. Exempt Dealing • Guidance notes for containment of Exempt Dealings (OGTR Website) • Staff Sign Off for the IBC All the undersigned personnel working on Exempt Dealing entitled: Title of Exempt Dealing have read and understood and will abide by the Guidance Notes for the containment of Exempt Dealings pursuant to regulation 6 of the Gene Technology Regulations 2001 in force as from 1 July 2007.

36. NLRD • There is a new NLRD form available on the Biological Safety webpage • Received written advice from the IBC that the NLRD has been approved. • Work on the NLRD can only take place within a facility that has a current certification and is nominated within the NLRD; • Dealings are properly supervised and a record of the dealings are retained;

37. NLRD forms The following forms are required to be completed when submitting an NLRD • NLRD Application Form • NLRD – OGTR Form • GM Compulsory Dealing Form

38. DNIR & DIR • Work can only begin once a licence is received from the OGTR. i.e. a written document that outlines the conditions of the licence. • Work can only be done on a DNIR in the facility nominated on the DNIR licence • Work on any licence requires proper supervision and that records of the dealing are retained.

39. DNIR The following forms are to be submitted to the IBC DNIR Application Form GM Compulsory Dealing Form

40. Applications (1) • Application forms are available on the Research website under staff / biological • > Biological Safety http://www.research.uwa.edu.au/staff/biological or on the OGTR website www.ogtr.gov.au • If you unsure speak to the Manager Biological Safety ph 6488 8782 sylvia.lachberg@uwa.edu.au or the Biological Compliance Officer ph 6488 4701 bernadette.bradley@uwa.edu.au • Complete all questions

41. Application (2) • Attachments to a licenced dealing should be written in word and accompany the application, the title of the attachment should appear on the application form • Exempt Dealing, NLRD and DNIR forms are now available as a word documents • DIR forms are as a word document or PDF file

42. Applications (3) • All statements made should be supported with references to published work, unpublished work, expert advice etc. • Application forms that have been altered will not be accepted. • Applications must be typed.

43. Applications (4) DNIR and DIR forms are signed by • Project supervisor • Chair of IBC • Deputy Vice Chancellor (Research and Innovation) - as the organisation’s delegate not the head of school

44. Applications (5) GM Dealing Compulsory Form UWA form available on the Research Services website Every GM dealing must be accompanied by this form. It provides information about other clearances that are required and must be signed by the Project Supervisor and the Head of School. Please check the website and if necessary download the latest version.

45. Commencing GM work • Licence DIR or DNIR work must not commence until you have been notified by the Regulator that a licence has been approved. • DNIR : 90 working days • DIR: 170 working days

46. Facility Inspections

47. Facility Inspections • PC3/4 facilities inspected by the OGTR • PC2 facilities inspection done by the IBC OGTR can undertake spot inspections • Checklist mainly dealing with procedures that need to be completed for all OGTR certified facilities

48. PC2 Certified Facilities • Floors and walls are sealed and washable • All bench tops are impervious • All wooden cupboards are sealed (varnished) • All surfaces inside and out of cupboards must be sealed • Winchesters are stored below waist height • Hand washing and eye washing facilities available • Coat hooks available near to the entry door

49. OGTR Certified Facilities

50. Facility Practices