Gene Technology Awareness Session

Gene Technology Awareness Session

Dr Sylvia Lachberg

The University of Western Australia

Research Services

2010

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

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

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.

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

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 ……

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

Review of the Gene Technology Act and Regulations

Why have changes been made?(1) Regulator’s review of the Gene

Technology Regulations in response to stakeholders & operational experience – June 2007

(2) Independent Review of the operation of the Gene Technology Act - June 2007

(3) More on the changes later

Gene Technology Act (1)

Does six things

• Establishes a statutory officer, Gene Technology Regulator to administer the legislation and make decisions under the legislation.


• Establishes a scientific committee and a ethics/community consultative committee from which the Regulator and the Ministerial Council on gene technology may request advice.


Prohibits persons from dealing with GMOunless 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

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

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.

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

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

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

Roles and Responsibilities (2)

OGTR• admin body responsible for the review of

proposals for genetic manipulation in Australia• set guidelines for and certify facilitiesTwo advisory committees

– Gene Technology Technical Advisory Committee– Gene Technology Ethics/Community Consultative

Committee


University ExecutiveThe 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


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.


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


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


Office of Facilities Management / Contractors• keeping facilities maintained as required • checking with key laboratory personnel when entering

and working on certified facilities

UWA’s

Institutional Biosafety Committee

UWA IBC (1)

Assists UWA and Affiliates to comply with the Gene Technology 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

UWA IBC (2)

• Provide advice to proponents about the Gene Technology Act and Regulations

• Provide an annual report to the OGTR

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

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.

Undertaking Gene Technology work at UWA

What is a Dealing?

Conducting experiments with or, making or breeding any GMO and includes the

possession, use, transport or disposal of the GMO.

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)

Application times

• Facility Certification Application: 90 working days

• Accreditation application: 90 working days

• NLRD or Exempt Dealing : 1 Month

• Licences….

Exempt Dealings

All Exempt Dealings are required to be submitted and assessed by the IBC:

• to minimise the possibility of misclassification of dealings

Exempt Dealing

• Guidance notes for containment of Exempt Dealings (OGTR Website)

• Staff Sign Off for the IBCAll the undersigned personnel working on Exempt Dealing entitled: Title of Exempt Dealinghave 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.

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;

NLRD forms

The following forms are required to be completed when submitting an NLRD

• NLRD Application Form

• NLRD – OGTR Form

• GM Compulsory Dealing Form

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.

DNIR

The following forms are to be submitted to the IBC

DNIR Application Form

GM Compulsory Dealing Form

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 [email protected] or the Biological Compliance Officer

ph 6488 4701 [email protected] • Complete all questions

mailto:[email protected]

mailto:[email protected]

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

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.

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

Applications (5)

GM Dealing Compulsory FormUWA form available on the Research

Services websiteEvery 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.

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

Facility Inspections

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

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

OGTR Certified Facilities

Facility Practices

Certified Facilities

• All certified facilities have a certification number allocated by the OGTR

• Each facility has a date that certification was given by the OGTR

• These will appear on the Research Services website once facilities have been certified.

OGTR Certified PC2 laboratories

• Each certified facility requires a file with a copy of the current Guidelines for Certification of Facilities/Physical Containment Requirements and the Guidelines for the Transport of GMOs

• All facility personnel need to sign a sheet stating that they have read and understood and will abide by these Guidelines

OGTR Certified PC2 laboratoryGuidelines for Certification of a PC2 laboratory

• Part C: Behavioural Requirements• All doors and windows must be closed• Working with Non GMs in certified

facility– Prevent cross contamination

• Any work that produces an aerosol must be performed in a Biological Safety Cabinet



Personal Protective Clothing• A laboratory gown which covers the front part of

the body must be worn by personnel undertaking dealing in a certified facility

• Gloves, must be worn if working with GMOs at risk group 2 or higher

• All PPC must be removed when leaving the certified laboratory unless you are moving directly to another certified facility


Decontamination• All GMOs must be decontaminated prior to disposal• Work benches , surfaces where GMOs have been must be

decontaminated when dealings are completed• Any chemical disinfectant treatment must be effective in

rendering the GMO non viable -AS/NZS 2243.3:2002 provides good information about the correct chemicals to use

• Decontaminate your hands when leaving the certified facility


Labelling

• All cultures must be clearly labelled. Any unlabelled viable material should be treated as a GMO and handled as such.

Storage

• GMOs being stored outside the certified facility must be double contained

Infectious material

• Any dealing involving organisms that may produce disease in humans, are conducted in accordance with the vaccination requirements set out in the Australian Standard AS/NZS 2243.3:2002 (Safety in laboratories: microbiological)

AQIS

• IMPORT PERMITS• APPROVED PREMISES

• AQIS and the OGTR are both federal government organisations and both have similar requirements for maintaining records and accountability. OGTR is trying to harmonise their guidelines with AQIS.

SSBA

• National Health Security Act 2007It builds on Australia's obligations under the Biological and Toxins Weapons Convention and UN Security Council Resolution 1540.

Part 3: Regulation of Security Sensitive Biological Agents

• Tier 1 and Tier 2 agents• http://www.health.gov.au/SSBA#background

Transport of GMOs

Applies to the movement of all GMOs • Movement from one certified facility to

another certified facility• Movement of the GMO from the certified

facility to a place where the GMO is destroyed or disposed (autoclave)

• Movement from the certified facility to another area of the building or different organisation’s certified facility (the IBC will need to be informed)

Major requirement

• Need 2 containers

• The outer container should be sealed and be unbreakable

• The outer container must be labeled with the contents and the contact details of the person responsible

Transport Log

• Date

• Number of GMOs leaving one facility

• Number of GMOs arriving at the other facility

• Signed by someone from each organisation

• Vehicle or package should be labelled with a contact number in case of emergency

Reporting requirementsProject supervisors must advise the IBC:• any additional information as to risks to the health

and safety of people or the environment associated with any dealing;

• contraventions of the licence by a person covered by a licence;

• unintended effects of the dealings authorised by the licence;

• any breach of containment conditions;• changes to research staff, and;• at the completion or surrender of a project.

Annual Report

UWA as an Accredited Organisation (AO) must submit an Annual Report to the OGTR. It will include:

• IBC membership• All certified facilities with the date of the

last inspection• All NLRDs starting in the reporting year• Due 30 September each year

Breaches

• Project Supervisors or Heads of Schools are required to report any breaches to the Manager of Biological Safety within 48 hours of the incident.

• The Manager will notify the IBC and the OGTR

• A formal report will be required by the IBC and the OGTR

Gene Technology Awareness Session

Documents

Transcript of Gene Technology Awareness Session