Working with Genetically Modified Organisms GMOs

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Working with Genetically Modified Organisms
(GMOs)
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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.

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ENIGMAS!
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 GMOs.
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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.

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History of GMO regulation in Australia.

• Genetic Manipulation Advisory Committee (GMAC)
  1980s-2001
• Established regulatory framework for regulating
  research with GMOs.
• Carried out assessment of proposals.
• Provided advice on containment conditions.
• No statutory powers

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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.

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Purpose

• To ensure that all work with Genetically
  Manipulated Organisms (GMOs) within Australia is
  carried out in such a way that threats to human
  health and the environment are minimised.

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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.

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Structure of OGTR
GTR
Policy Compliance Branch
Evaluation Branch

• Secretariat
• Policy Section
• Business Management
• IT section
• Monitoring Compliance
• Legal section

• 2 evaluation teams
• Contained dealing
• section.
• Review section

Gene Technology Technical Advisory Committee
(GTTAC) Gene Technology Ethics Committee
(GTEC) Community Consultative Committee (CCC)
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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.

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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.

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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.

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Relationship between OGTR and other regulatory
agencies.
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Interaction between OGTR and other regulatory
agencies.
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Operation of the Act
FEDERAL HEALTH MINISTER
OGTR
CEO (VC or PVCR)
IBC
RESEARCHERS
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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.

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Role of the IBC

• Maintains a register of all researchers and
  projects.
• Processes applications to work with GMOs.
• 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 GMOs within that organisation.

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Statutory Requirements

• All dealings with GMOs no matter how trivial
  must be notified to the OGTR through the
  organisations IBC.
• All personnel dealing with GMOs must attend a
  training course.
• Dealings must only be carried out in certified
  premises unless permission is given for other
  facilities (eg., DIRs)
• Failure to notify will incur penalties.

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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.

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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.

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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.

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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.

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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.

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RESPONSIBILITIES IV Researchers.

• Undertake GTR training.
• Adhere to SOPs 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.

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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

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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

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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.
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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

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Types of Dealings

• Exempt
• Notifiable Low Risk Dealing (NLRD).
• Dealings Not Involving Release (DNIR).
• Dealings Involving Release (DIR).

Increasing risk
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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.

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Exempt Dealing Form
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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.

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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.

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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.

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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.

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The application process.
The Regulator
The IBC
NLRD Exempt
DIR DNIR
Applicant
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If your project involves working with, or
creation of GMOs 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.