Basic information
Outline of the system
The Gene Technology Act 2000 (GT Act), the Gene Technology Regulations 2001 (GT Regulations) and corresponding state and territory laws provide a nationally consistent system to regulate work (dealings) with genetically modified organisms (GMOs) in Australia. This includes the creation or import, transport, disposal, growth and propagation of GMOs.
Other Australian government regulators also oversee work with GMOs, depending on the use of the GMO. These regulators include:
•Australian Pesticides and Veterinary Medicines Authority (APVMA) (https://apvma.gov.au/) covers agricultural chemicals and veterinary products, including those produced in, or used on, genetically modified (GM) crops and live GM veterinary products. See also Agricultural & Veterinary Chemicals Code Act 1994 (https://www.legislation.gov.au/Details/C2022C00173) and Agricultural & Veterinary Chemicals (Administration) Act 1992 (https://www.legislation.gov.au/Details/C2022C00117)
• The Department of Agriculture, Fisheries and Forestry regulates the import and quarantine of all animal, plant and biological products that could pose a risk if they were imported. See also Biosecurity Act 2015 (https://www.legislation.gov.au/Details/C2021C00355) and Imported Food Control Act 1992 (https://www.legislation.gov.au/Details/C2021C00497)
•Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au/) covers food issues, including labelling and mandatory pre-market safety assessments for GM foods. See also Food Standards Australia New Zealand Act 1991 (https://www.legislation.gov.au/Details/C2018C00243)
•Therapeutic Goods Administration (TGA) (https://www.tga.gov.au/) regulates all therapeutics, including those which are GMOs (for example, live GM vaccines). See also Therapeutic Goods Act 1989 (https://www.legislation.gov.au/Details/C2021C00376)
Product coverage
The National Gene Technology Scheme covers all dealings with all live/viable GMOs as defined in the GT Act. The GT Act defines GMO dealings to include experiments, manufacture, production, breeding, growing, transport, destruction and import.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The gene technology legislation is not intended to restrict the quantity or value of imports but to manage the risks of working with GMOs. In administering the National Gene Technology Scheme, the Gene Technology Regulator (the GT Regulator), has specific responsibility 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. The National Gene Technology Scheme also implements Australia's obligations under Article 8(g) the UN Convention on Biological Diversity.
A voluntary system/industry self-regulation is not appropriate due to the level of public concern over the potential risks posed by GMOs. However, some work with specified categories of GMOs does not require licensing and can be carried out under a notification process with the appropriate institutional oversight (for example using GM cell lines to manufacture GM pharmaceutical products within certified facilities).
Questions for products under restriction as to the quantity or value of imports
Not applicable
The system applies to products originating from which country?
All GMOs, whether created in Australia or imported, are covered by the Gene Technology legislation.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The nationally consistent legislative scheme for gene technology is comprised of the Commonwealth GT Act and GT Regulations, and corresponding State and Territory legislation.
The scope and nature of gene technology regulation is specified in the GT Act. Schedules contained within the GT Regulations further clarify the scope of the GT Act and specify the type of authorisations required for work with different categories of GMOs.
The legislation was developed in consultation with all Australian jurisdictions and the scheme is supported by the inter-governmental Gene Technology Agreement between the Australian Government and each State and Territory (https://www.genetechnology.gov.au/resources/publications/gene-technology...)
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Anyone can apply for a licence, however, the GT Regulator is required to consider the suitability of the applicant to hold a licence. Section 58 of the GT Act provides information on applicant suitability.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
Application forms to work with GMOs can be found on the OGTR website at https://www.ogtr.gov.au/apply-gmo-approval
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
DNIR licences carry a 90-working day processing time and approval must be obtained prior to import.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Licence applications can be made at any time of the year.
Issuing the license
Can a licence be granted immediately on request?
The GT Act does not contain provisions for immediate licence approvals.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The National Gene Technology Scheme provides for a number of different kinds of authorisations dependent upon the nature of the GMO and the proposed use: https://www.ogtr.gov.au/apply-gmo-approval/types-gmo-dealings
In relation to commercial-scale import of GMOs, in most cases a licence would be required. If the GMO is imported for use within contained facilities (e.g. GM seed imported for immediate processing into non-viable products) a licence for Dealings Not involving Intentional Release (DNIR) (https://www.ogtr.gov.au/apply-gmo-approval/types-gmo-dealings#dealings-n...) into the environment may be required.
All other commercial dealings where the GMO is likely to be released into the environment would require a licence for DNIR into the environment. The GT Regulator must decide whether to issue a DNIR licence within 255 working days.
If the GT Regulator is satisfied that a person has come into possession of a GMO inadvertently, the GT Regulator may, with the agreement of the person, treat the person as having made an Inadvertent Dealings application, or the person may apply for a licence themselves. The GT Regulator may issue a temporary licence (no longer than 12 months) to the person for the purposes of disposing of the GMO in a manner which protects the health and safety of people and the environment.
Which administrative body is responsible for approving application of licences?
The Australian GT Regulator, supported by the Office of the Gene Technology Regulator, has sole responsibility for issuing licences for work with GMOs.
Must the applications be passed on to other organs for visa, note or approval?
However, separate approvals would be needed if the end use of the GMO is regulated by another agency, e.g. therapeutic or veterinary products, agricultural products, human food, etc. (see answer to question 1). Approval for import under the Biosecurity Act 2015, from the Department of Agriculture, Fisheries and Forestry may also be required.
Are there any other conditions attached to the issue of a licence?
Division 6 of part 5 of the GT Act contains information on conditions that may apply to a licence. This includes (but is not limited to):
(i) the scope of the dealings authorised by the licence;
(ii) the purposes for which the dealings may be undertaken;
(iii) variations to the scope or purposes of the dealings;
(iv) documentation and record-keeping requirements;
(v) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels;
(vi) waste disposal requirements;
(vii) measures to manage risks posed to the health and safety of people, or to the environment;
(viii) data collection, including studies to be conducted;
(ix) auditing and reporting;
(x) actions to be taken in case of the release of a GMO from a contained environment;
(xi) the geographic area in which the dealings authorised by the licence may occur;
(xii) requiring compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27;
(xiii) supervision by, and monitoring by, Institutional Biosafety Committees;
(xiv) contingency planning in respect of unintended effects of the dealings authorised by the licence;
(xv) limiting the dissemination or persistence of the GMO or its genetic material in the environment;
(xvi) requiring the licence holder to inform people of licence requirements;
(xvii) requiring the licence holder to provide the GT Regulator with relevant information; and
(xviii) allowing the GT Regulator to monitor dealings with GMOs.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Currently no fees apply to applications for licences under the GT Act.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
Not applicable
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
The GT Regulator must not issue the licence unless satisfied that:
(i) any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect:
- the health and safety of people; and
- the environment; and that
(ii) the applicant is a suitable person to hold the licence.
Are the reasons for any refusal given to applicants?
The GT Regulator must inform the applicant of the reasons for their decision.
Have applicants a right of appeal in the event of refusal to issue a licence?
A decision not to issue a licence, or to impose a licence condition, is a reviewable decision under the GT Act, and the applicant may apply to the Administrative Appeals Tribunal for review of the merits of the decision.
If so, to what bodies and under what procedures?
Alternatively, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.
Importation
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
Each DIR licence is made available on the OGTR website at https://www.ogtr.gov.au/what-weve-approved/dealings-involving-intentiona.... A copy of the licence should accompany all shipments of GMOs unless the licence specifies otherwise.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Not applicable.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The period of the licence will be determined on a case by case basis during the assessment of the application. Typically commercial licences do not have an expiry date.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
Licences permit, but do not require, persons to deal with the specified GMOs. All licence conditions must be followed when dealing with GMOs. It is a criminal offence to knowingly breach the conditions of a licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Section 70 of the GT Act allows for the transfer of a licence. A 90-working day assessment period applies to applications to transfer a licence. When deciding whether to transfer a licence, the GT Regulator must consider the suitability of the receiving applicant to hold the licence.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.