World Trade Organization

Import Licensing Procedures

Genetically modified organisms

Document symbol
G/LIC/N/3/AUS/16
Original language
English
Published on
27/11/2023

Outline of Systems

Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another 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:

Purposes and Coverage of Licensing

Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.

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.

Q3. The system applies to goods originating in and coming from which countries?

All GMOs, whether created in Australia or imported, are covered by the Gene Technology legislation.

Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?

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).

Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?

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.

It is not possible for the government or executive branch to abolish the systems without legislative approval.

Procedures

Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):

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Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?

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Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?

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Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)

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Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?

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Q6.V. What are the minimum and maximum lengths of time for processing applications?

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Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?

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Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?

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Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?

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Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?

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Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?

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Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?

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Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:

Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?

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) into the environment may be required. DNIR licences carry a 90-working day processing time and approval must be obtained prior to import.

All other commercial dealings where the GMO is likely to be released into the environment would require a licence for Dealings Involving Intentional Release (DIR) into the environment. The GT Regulator must decide whether to issue a DIR 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.

Q7.b. Can a licence be granted immediately on request?

The GT Act does not contain provisions for immediate licence approvals.

Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.

Licence applications can be made at any time of the year.

Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?

The Australian GT Regulator, supported by the Office of the Gene Technology Regulator (OGTR), has sole responsibility for issuing licences for work with GMOs. 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 DAFF may also be required.

Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?

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;

- the environment, and that;

(ii) the applicant is a suitable person to hold the licence.

The GT Regulator must inform the applicant of the reasons for their decision. 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.

Alternatively, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.

Eligibility of Importers to Apply for Licence

Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?

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.

Documentational and Other Requirements for Application for Licence

Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?

Application forms to work with GMOs can be found on the OGTR website at https://www.ogtr.gov.au/apply-gmo-approval.

Q11. 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-intentional-release. A copy of the licence should accompany all shipments of GMOs unless the licence specifies otherwise.

Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?

Currently no fees apply to applications for licences under the GT Act.

Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.

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Conditions of Licensing

Q14. What is the period of validity of a licence? Can the validity of a licence 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.

Q15. 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.

Q16. 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.

Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?

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.

Other Procedural Requirements

Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

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Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?

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