Process overview

You must not deal with a genetically modified organism (GMO) unless the dealings are approved. Learn about the steps for getting and maintaining approval.

All dealings need approval

The Gene Technology Act 2000 prohibits all dealings with genetically modified organisms (GMOs) unless they are:

  • an exempt dealing
  • a notifiable low risk dealing (NLRD)
  • included on the GMO Register
  • an emergency dealing determination (EDD)
  • licensed.

There are 3 types of GMO dealings that need a licence from the Gene Technology Regulator:

  • dealings not involving intentional release (DNIR)
  • dealings involving intentional release (DIR)
  • inadvertent dealings.

You can view the details of approved dealings (except exempt dealings) on the GMO Record.

All dealings with a genetically modified organism (GMO) need approval. Dealings include:

  • research
  • manufacture
  • production
  • transportation
  • destruction
  • commercial release
  • importation.

How to get approval

Getting and maintaining approval is a 3-step process.

Step 1 – Apply for approval

Organisation accreditation

Licences often require an organisation to be accredited. However, all organisations dealing with genetically modified organisms can benefit from accreditation. Find out more about organisation accreditation and how to apply.

Institutional Biosafety Committees (IBCs)

IBCs play an important role in helping organisations comply with Australia's national gene technology regulatory scheme laws. They provide on-site assessment of low-risk contained dealings that do not need case-by-case consideration by the Regulator. IBCs also review licence applications for higher risk dealings before they are sent to the Regulator. Learn more about the role of IBCs.

Facility certification

Some dealings with GMOs must be undertaken in certified facilities. Find out more about the facility certification process including the requirements for each type of facility and how to apply.

Approval to work with GMOs

How you get approval to work with a GMO depends on the type of dealing. Learn more about the types of dealing and their requirements.

Step 2 – Conduct dealings (if approved)

If approval is granted, you may conduct dealings with the GMO. You must follow any conditions specified in your accreditation, authorisation, certification or licence.

Step 3 – Ongoing regulatory compliance

Our focus is on the prevention of adverse outcomes before they can arise. Learn more about how we work with organisations to monitor and enforce compliance.

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