Working with Genetically

Modified Organisms (GMO’s)

 Genetically Modified Organism (GMO)

• An organism modified by gene technology.

• An organism that has inherited particular traits from
an organism (the initial organism) being traits that
occurred in the initial organism because of gene
technology.
• Anything declared by the regulations to be a
genetically modified organism, or that belongs to a
class of things declared by the regulations to be a
genetically modified organism.
 ENIGMA’S!
If DNA is taken from an organism, spliced to a vector, and
replaced in the same organism, then that organism is a GMO.

Just because an organism is not considered to be a GMO in

another jurisdiction (USA,. EU) does not mean it is not a GMO in
Australia.

Just because someone else has permission to work with a GMO

does not mean that you do. You still have to apply for
permission.

Although you may not have constructed the GMO, if you are
working with it you still have to apply for permission.
Plant, animal, or fungal cells containing recombinant DNA
are considered to be GMO’s.
 What is not a GMO?
• Does not include
– mutants.
– fusion of animal cells unless the product
can form an animal.
– plants formed x protoplast fusion.
– plants formed by embryo rescue or invitro
fertilisation or zygote implantation.
– organisms formed by natural DNA transfer.
 History of GMO regulation in
Australia.
• Genetic Manipulation Advisory
Committee (GMAC) 1980’s-2001
• Established regulatory framework for
regulating research with GMO’s.
• Carried out assessment of proposals.
• Provided advice on containment
conditions.
• No statutory powers
 The Gene Technology Act
2000
• Establishes a uniform regulatory system
throughout the states and territories.
• The object of this 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.
 Purpose
• To ensure that all work with Genetically
Manipulated Organisms (GMO’s) within
Australia is carried out in such a way
that threats to human health and the
environment are minimised.
 The Regulator.
• To administer the regulations under the act, the
Federal government established the Office of the
Gene Technology Regulator (OGTR).
• The OGTR is a statutory office-holder independent
from commercial or political influences.
• The regulator cannot be directed by anyone when
making a decision on whether to grant a licence.
• Reports direct to Fed Health Minister.
• Currently Dr Sue Meek.
 Structure of OGTR
GTR

Evaluation Branch Policy & Compliance

Branch

•2 evaluation teams •Secretariat

•Contained dealing •Policy Section
section. •Business Management
•Review section •IT section
•Monitoring & Compliance
•Legal section

Gene Technology Technical Advisory Committee (GTTAC)

Gene Technology Ethics Committee (GTEC)
Community Consultative Committee (CCC)
 Function of GTTAC
• To provide scientific and technical
advice on
– Gene technology, GMO and GMO products
– Applications made under the act
– The biosafety aspects of gene technology
– The need for policy principles, policy
guidelines, in relation to GMOs and GMO
products and the content of such principles
guidelines and codes.
 Role of the CCC
• To provide advice on:
– Matters of general concern in relation to
applications made under this act.
– Matters of general concern in relation to
GMOs
– The need for policy principles, guidelines,
codes of practice and technical and
procedural guidelines in relation to GMOs
and GM products.
– The content of such principles guidelines
and codes.
 Function of GTEC

• To provide advice on:

– Ethical issues relating to Gene Technology
– The need for, and content of Codes of
Practice in relation to ethics in respect of
dealings with GMOs
– The need for and content of policy
principles in relation to dealings with GMOs
that should not be conducted for ethical
reasons.
 Relationship
between OGTR
and other
regulatory
agencies.
 Interaction between OGTR and other regulatory agencies.

AGENCY PURPOSE OVERLAP WITH

OGTR
TGA, Therapeutic Goods Human therapeutic product GM derived therapeutic
Administration safety products
FSANZ, Food safety Regulation of food quality Safety of GM derived
Australia New Zealand and safety foods.
NHMRC, Nat Health & Med Funding for med research Gene Therapy
Res Council
NICNAS Regulation of industrial GM and GM derived
chemicals industrial chemicals
APVMA Regulation of agric GM crops and GM
chemicals incl vet veterinary products.
therapeutic products
AQIS, Aust Quarantine & Regulates importation of Importation of GMOs and
Inspection Service organisms and products GMO derived products.
derived from organisms
 Operation of the Act
FEDERAL HEALTH MINISTER

OGTR

CEO (VC or PVCR)

IBC

RESEARCHERS
Organisations.
• All organizations involved in dealings
are accredited by the OGTR.
• Every accredited organisation has
access to an Inst. Biosafety Committee
(IBC) which monitors compliance with
the regulations within that organisation.
 Role of the IBC
• Maintains a register of all researchers and projects.
• Processes applications to work with GMO’s.
• Notifies the OGTR of all such work.
• Ensures compliance with regulations.
• Carries out inspection of facilities.
• Provides training to researchers.
• Provides an annual report to the OGTR.
• Advises the CEO on matters relating to dealings with
GMO’s within that organisation.
 Statutory Requirements
• All dealings with GMO’s no matter how trivial
must be notified to the OGTR through the
organisation’s IBC.
• All personnel dealing with GMO’s must attend
a training course.
• Dealings must only be carried out in certified
premises unless permission is given for other
facilities (eg., DIR’s)
• Failure to notify will incur penalties.
 Penalties
• For dealing without a licence.
– fines up to $55,000
– imprisonment for 2 years
• Aggravated offence.
– fine of $1.1m
– imprisonment up to 5 years.
 More Likely Penalties
• Loss of accreditation by organisation.
– corporate culture of non-compliance.
• Rejection of subsequent applications.
– breaches must be indicated on each
proposal.
• Adverse publicity.
– breaches of the regulations are reported in
parliament.
 RESPONSIBILITIES I: The Organisation

• CEO (or delegate) is responsible to ensure:

• Adequate staffing and resources are available to
maintain quality assurance systems for compliance.
• A competent indemnified IBC is part of the quality
assurance system.
• That facilities are appropriate for the conduct of work
with GMOs.
 RESPONSIBILITIES II:
Heads of Schools/Sections.

• Ensure safe working procedures are

understood and enforced.
• Involves provision of training to new
researchers and
• Requires compliance by researchers.
 RESPONSIBILITIES III:
Principal Researchers

• Ensure safe working and GM procedures are understood and

enforced.
• Provide an SOP manual.
• Ensure that all dealings are licenced/ notified.
• Ensure that all staff are aware of specific licence conditions.
• Advise the IBC immediately of breaches of
conditions/regulations, unexplained illnesses or absences or
changes to dealings (names of new staff).
• Maintain a register of all GM projects.
• Inform IBC when projects terminate.
 RESPONSIBILITIES IV: Researchers.

• Undertake GTR training.

• Adhere to SOP’s for GM facilities.
• Notify your supervisor or the IBC of any
hazards, incidents or injuries.
• Notify your supervisor and the IBC of any
changes to the project.
• Check that your project has been notified to
the IBC.
 RESPONSIBILITIES V: IBC

• Maintain a register of all dealings and staff.

• Maintaining a list of facilities.
• Inspecting facilities.
• Provide training.
• Assess proposals and advise CEO.
• Liase with OGTR.
• Provide an annual report to OGTR.
• Develop procedures to ensure compliance
 Facilities
• All work with GMOs (except emempt dealings) must
be carried out in certified premises
• Apply to OGTR to have facilities approved
• Facilities must conform to the standards specified in
ASNZ standards 2243.3 2002
• Facilities must be inspected every year by the IBC.
• Facilities will also be spot inspected by OGTR
• Work practices must conform to ASNZ std 2243.3
2002
 Required work practices for certified labs!
Access to the lab is restricted to authorised personnel.
Must always wear a lab coat and remove it before leaving the lab.
Must wash hands before leaving the lab.
If storing cultures outside the facility they must be stored in
an unbreakable container in a lockable fridge/freezer/room.
If transporting GM material between facilities or to the autoclave
they must be contained in an unbreakable container.

Any breaches of containment must be reported to the IBC

immediately.
 If I fail to notify how would
they find out?
• Published papers.
• Theses
• Annual Report from University.
• Information from funding agencies.
• Conference presentations.
• Press releases.
• Informants
Types of Dealings
• Exempt
• Notifiable Low Risk Dealing (NLRD).
• Dealings Not Involving Release (DNIR).
• Dealings Involving Release (DIR).

Increasing
risk
 Exempt Dealings
• Notify the IBC of the dealing using the exempt
form on the IBC website (Edusafe).
• Start work.
• You do not need permission of the IBC or the
OGTR. The only requirement is to notify
them.
• Can apply to have dealings added to the
exempt list.
Exempt Dealing Form
Notifiable Low Risk Dealings (NLRD)
• Obtain form from OGTR website
• Fill in form and submit to IBC.
• Proposal is evaluated by the IBC.
• Cannot start work until permission is
granted by the IBC.
• The proposal is approved by the IBC
and OGTR notified in annual report.
 Dealings Not Involving Release (DNIR)
• Submit proposal to IBC.
• Proposal is evaluated and submitted to OGTR.
• Proposal is sent out for public consultation.
• OGTR prepares a Risk Assessment Risk
Management Plan (RAMP).
• This is sent out for consultation.
• The conditions of the proposal are finalised.
• A licence is issued within 90 working days.
• Work cannot start until the licence is issued.
 Dealings Involving Release (DIR)
• Submit proposal to IBC.
• Proposal is evaluated and submitted to OGTR.
• Proposal is sent out for public consultation.
• OGTR prepares a Risk Assessment Risk
Management Plan (RAMP).
• This is sent out for consultation.
• The conditions of the proposal are finalised.
• A licence is issued within 180 working days of receipt
of proposal.
• Work cannot start until the licence is issued.
 DIR Considerations
• Potential for spread through pollen and
seeds.
• Presence of pollinator species.
• Proximity of compatible species.
• Persistence in seed bed.
• Weediness.
• Proximity to waterways.
 The application process.

The Regulator

The IBC

NLRD DIR
Exempt DNIR

Applicant
If your project involves working with, or creation
of GMO’s then:
• Check with your supervisor that appropriate permission has
been obtained.
– Projects (unless exempt) will have an OGTR reference number.
Ask your supervisor for that number. This number should be listed
alongside all organisms used in the project.
• If permission has not been obtained, then you should apply for
permission.
• To do this visit the IBC website
• Even if your project is exempt you need to notify the IBC of the
project.
• Changes to the project should be notified as a variation to the
licence.