How will the Bill apply to various people undertaking activities with GMOs?


Case Study 1:
Researchers who want to undertake work with exempt GMOs

  • The regulations will describe exempt activities (such as certain contained research).
  • Exempt activities will be based on the current GMAC arrangements.
  • No approval will be required from the GTR.

Case Study 2:
People who want to undertake notifiable low risk dealings

  • Certain low risk contained work will be described in regulations as notifiable low risk dealings (NLRDs).
  • NLRDs will be based on the current GMAC Category B activities.
  • The organisation or institution within which NLRDs are proposed to be undertaken must be accredited by the GTR. The GTR will accredit organisations if they have, and can maintain, an Institutional Biosafety Committee (IBC) in accordance with guidelines issued by the GTR. An organisation need only apply for accreditation once – once they are accredited they do not need to apply every time they wish to undertake a NLRD.
  • The NLRDs must only be undertaken in a facility that has been certified by the GTR to a minimum of physical containment level 2 (PC2).
  • Each NLRD must be considered by the IBC and notified to the GTR.
  • The GTR will monitor compliance with the conditions applied to NLRDs (e.g. that the activity is undertaken in a certified PC2 laboratory and overseen by an IBC).

Case Study 3:
People undertaking higher risk work with GMOs within laboratories or other contained facilities

  • All existing GMAC approvals will be carried over into the new system. Further approval from the GTR will not be required until the approval from GMAC expires or until 2 years after the Gene Technology Act commences, whichever is the sooner.
  • People who want to undertake higher risk contained work with GMOs must:
    • submit an application (in accordance with guidelines issued by the GTR) to their IBC for initial consideration; and
    • submit the application and the IBCs comments to the GTR for assessment.
  • The GTR will undertake a risk assessment of the proposed work and apply any necessary conditions to manage the risks posed by the work. The conditions would include a requirement that the facility in which the work is proposed to be undertaken be certified to the necessary containment level.
  • The GTR will monitor compliance with conditions imposed.

Case Study 4:
Importers of GMOs

  • In addition to requiring approval from the Australian Quarantine Inspection Service (AQIS) to import the GMO, the importer must apply for a licence from the GTR before the GMO is imported. Alternately the end user of the GMO may apply for a licence on behalf of the importer.
  • The assessment process employed by the GTR will depend on whether the GMO is to be imported for release into the environment or for use in a contained environment (e.g. to be processed into food).
  • If the GMO is being imported for processing, the GTR will undertake a risk assessment of the GMO and apply any necessary conditions to manage the risks posed by the GMO. Such conditions would include a requirement that the GMOs be contained so that they cannot escape into the environment during transport to the facility in which the GMOs are to be used.
  • If the GMO is intended for release into the environment, the GTR will undertake the risk assessment process described in Case Study 5.
  • The importer may also need approval from ANZFA if the imported GMO is to be used in food.

Case Study 5:
People proposing to release a GMO into the environment (either for research purposes or for commercial use).

  • An application must be made to the GTR in accordance with requirements set out in regulations and guidelines issued by the GTR.
  • The GTR will:
    • undertake an initial examination of the application to ensure that all of the necessary information has been included and that the application is not inconsistent with policy principles issued by the Ministerial Council (for example, on ethics);
    • call for public comment on the application (if the application involves the release of a GMO into the environment that may pose significant risks to the environment);
    • seek advice on the application from the Commonwealth Environment Minister, relevant Commonwealth agencies, States and Territories and the Gene Technology Technical Advisory Committee;
    • prepare a comprehensive risk assessment and risk management plan;
    • make the risk assessment and risk management plant (the draft decision) available for public comment and seek advice from the Commonwealth Environment Minister, relevant Commonwealth agencies, States and Territories and the Gene Technology Technical Advisory Committee;
    • take into account all submissions, relevant policy guidelines issued by the Ministerial Council and the suitability of the applicant and make a decision on the application.
  • If the application for licence is approved, the GTR would impose conditions to manage any risks posed by the GMO.
  • Each person who wanted to use the GMO would not need to apply for a separate licence. Only the first person who proposes to release the GMO into the environment would apply for a licence and, if approved, this would cover all persons who deal with the GMO.
  • Details of the decision will be included on a publicly available record.
  • The GTR will monitor compliance with conditions imposed.