working with genetically modified organisms (gmo’s)

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Working with Genetically Modified Organisms (GMO’s)

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Working with Genetically Modified Organisms (GMO’s). Genetically Modified Organism (GMO). An organism modified by gene technology . - PowerPoint PPT Presentation

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Page 1: Working with Genetically Modified Organisms (GMO’s)

Working with Genetically Modified Organisms (GMO’s)

Page 2: 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.

Page 3: Working with Genetically Modified Organisms (GMO’s)

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.

Page 4: Working with Genetically Modified Organisms (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.

Page 5: Working with Genetically Modified Organisms (GMO’s)

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

Page 6: Working with Genetically Modified Organisms (GMO’s)

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.

Page 7: Working with Genetically Modified Organisms (GMO’s)

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.

Page 8: Working with Genetically Modified Organisms (GMO’s)

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.

Page 9: Working with Genetically Modified Organisms (GMO’s)

Structure of OGTR

Evaluation Branch Policy & ComplianceBranch

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

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

GTR

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

Page 10: Working with Genetically Modified Organisms (GMO’s)

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.

Page 11: Working with Genetically Modified Organisms (GMO’s)

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.

Page 12: Working with Genetically Modified Organisms (GMO’s)

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.

Page 13: Working with Genetically Modified Organisms (GMO’s)

Relationship between OGTR

and other regulatory agencies.

Page 14: Working with Genetically Modified Organisms (GMO’s)

Interaction between OGTR and other regulatory agencies.

AGENCY PURPOSE OVERLAP WITH OGTR

TGA, Therapeutic Goods Administration

Human therapeutic product safety

GM derived therapeutic products

FSANZ, Food safety Australia New Zealand

Regulation of food quality and safety

Safety of GM derived foods.

NHMRC, Nat Health & Med Res Council

Funding for med research Gene Therapy

NICNAS Regulation of industrial chemicals

GM and GM derived industrial chemicals

APVMA Regulation of agric chemicals incl vet therapeutic products

GM crops and GM veterinary products.

AQIS, Aust Quarantine & Inspection Service

Regulates importation of organisms and products derived from organisms

Importation of GMOs and GMO derived products.

Page 15: Working with Genetically Modified Organisms (GMO’s)

Operation of the Act

CEO (VC or PVCR)

IBC

RESEARCHERS

OGTR

FEDERAL HEALTH MINISTER

Page 16: Working with Genetically Modified Organisms (GMO’s)

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.

Page 17: Working with Genetically Modified Organisms (GMO’s)

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.

Page 18: Working with Genetically Modified Organisms (GMO’s)

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.

Page 19: Working with Genetically Modified Organisms (GMO’s)

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.

Page 20: Working with Genetically Modified Organisms (GMO’s)

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.

Page 21: Working with Genetically Modified Organisms (GMO’s)

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.

Page 22: Working with Genetically Modified Organisms (GMO’s)

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.

Page 23: Working with Genetically Modified Organisms (GMO’s)

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.

Page 24: Working with Genetically Modified Organisms (GMO’s)

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.

Page 25: Working with Genetically Modified Organisms (GMO’s)

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

Page 26: Working with Genetically Modified Organisms (GMO’s)

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

Page 27: Working with Genetically Modified Organisms (GMO’s)

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.

Page 28: Working with Genetically Modified Organisms (GMO’s)

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

Page 29: Working with Genetically Modified Organisms (GMO’s)

Types of Dealings

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

Increasingrisk

Page 30: Working with Genetically Modified Organisms (GMO’s)

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.

Page 31: Working with Genetically Modified Organisms (GMO’s)

Exempt Dealing Form

Page 32: Working with Genetically Modified Organisms (GMO’s)

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.

Page 33: Working with Genetically Modified Organisms (GMO’s)

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.

Page 34: Working with Genetically Modified Organisms (GMO’s)

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.

Page 35: Working with Genetically Modified Organisms (GMO’s)

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.

Page 36: Working with Genetically Modified Organisms (GMO’s)

The application process.

The Regulator

The IBC

Applicant

NLRDExempt

DIRDNIR

Page 37: Working with Genetically Modified Organisms (GMO’s)

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.