Section 4.1 Conclusions regarding gene transfer to other plants
It is considered that the risk of gene transfer from the GM papayas to papaya plantations, domestically cultivated papayas and naturalised papaya populations is negligible because:
pollen movement will be very limited because the release will be contained within an insect-proof enclosure; and
male flowers will be removed, thereby reducing the availability of pollen.
In addition, potential gene flow to commercial plantations and naturalised papaya populations will be limited by geographic isolation.
It is considered that the risk of gene transfer from the GM papayas to other plant species is negligible because, in addition to being contained within an insect-proof enclosure:
genetic incompatibility with papaya’s closest relatives effectively prevents the formation of hybrids and limits potential for back-crossing to the parental species; and
strong and well-demonstrated genetic differences significantly limit gene transfer to more distantly related plant genera.
Section 4.2 Conclusions regarding gene transfer to microorganisms
It is considered that the risk of the introduced genes transferring from the GM papayas to microorganisms is negligible, because:
horizontal gene transfer is the only possible mechanism for such transfer, yet this has not been demonstrated from plants to microorganisms under natural conditions.
Note that if the gene transfer were to occur it is unlikely that it would have adverse effects on human health and safety or the environment, as these genes are naturally present in microorganisms.
Section 4.3 Conclusions regarding gene transfer to animals, including humans
The most significant route of entry of foreign DNA into animals and humans is through food. The gastrointestinal tract may be exposed to free DNA during digestion. It is considered that the risk of the introduced genes transferring from the GM papayas to animals, including humans, is negligible. This is because:
simulated ruminant digestion studies with model experimental systems indicate that introduced genes and endogenous plant genes are rapidly degraded, representing a considerable barrier to gene transfer;
vertebrate animals will not be exposed to the GM papaya fruits; and
FSANZ approval would need to be obtained before tissues from the GM papayas, including fruits, could be used in human food, yet the applicant has not applied to FSANZ for evaluation of the GM material in this regard.
It should be noted that in the extremely unlikely event of such a transfer occurring, human health and safety and the environment are unlikely to be adversely effected.
Appendix 5 Licence conditions
Note in relation to the approval of genetically modified foods for human consumption
Food Standards Australia New Zealand (FSANZ, formerly the Australia New Zealand Food Authority, ANZFA), is responsible for human food safety assessment. Currently, the University of Queensland has not applied to FSANZ for evaluation of material from the GM papayas for use in human food. FSANZ approval would need to be obtained before any parts of the GM papayas, including the fruits, could be used as human food.
Duration of Licence
This licence remains in force until it is suspended, cancelled or surrendered. No dealings with GMOs are authorised during any period of suspension.
Holder of Licence
The holder of this licence (‘the licence holder’) is the University of Queensland.
Details of Project Supervisor
3.1 The Project Supervisor in respect of this Licence is identified at Attachment A.
3.2 The licence holder must immediately notify the Regulator in writing if any of the contact details of the Project Supervisor change.
No dealings with GMO except as authorised by this licence
4 Persons authorised by this licence must not deal with the GMO except as expressly authorised or contemplated by this licence.
5.1 The GMOs are described at Attachment B.
5.2 The permitted dealings with the GMOs are to, plant, grow and conduct experiments with the GMOs, and the possession, supply, use, transport and disposal of the GMOs for the purpose of any of the permitted dealings, or in the course of any of these dealings.
Persons covered by this GMO licence
6.1 The persons authorised by this licence to conduct dealings with the GMOs are set out in a list at Attachment C. The licence holder may vary the list by notice in writing to the Regulator.
6.2 The licence holder must not allow a person to deal with the GMO unless the person is listed.
Explanatory Note: People named in the list are persons covered by a licence for purposes of the Gene Technology Act 2000. It may be an offence, or a breach of this licence, if a person not on the list deals with a GMO covered by this licence.
Informing people of their obligations
7.1 The licence holder must inform each person covered by this licence of the obligations imposed on them as a result of the conditions in this licence.
7.2 The licence holder must provide the Regulator, on the Regulator’s written request, with a signed statement from each person covered by this licence that the licence holder has informed the person of the conditions of this licence that apply to that person.
Applicant to notify of circumstances that might affect suitability
8 The licence holder must immediately, by notice in writing, inform the Regulator of:
any revocation or suspension of a licence or permit held by the licence holder under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; or
any event or circumstances occurring after the commencement of this licence that would affect the capacity of the licence holder to meet the conditions in it.
Additional information to be given to the Regulator
9 The licence holder must inform the Regulator if he or she:
becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence; or
becomes aware of any contraventions of the licence by a person covered by the licence; or
becomes aware of any unintended effects of the dealings authorised by the licence.
People dealing with GMO must allow auditing and monitoring of the dealing
If a person is authorised by this licence to deal with a GMO and a particular condition of this licence applies to the dealing by that person, the person must allow the Regulator, or a person authorised by the Regulator, to enter premises where the dealing is being undertaken, for the purposes of auditing or monitoring the dealing.