Risk Assessment and Risk Management Plan


Section 2 Finalisation of the risk assessment and the risk management plan



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Section 2 Finalisation of the risk assessment and the risk management plan


  1. In accordance with Section 51 of the Act, the Regulator has taken into account all written submissions that related to human health and safety and the environment in finalising the risk assessment and risk management plan. The issues raised were considered carefully and weighed against the body of current scientific information in reaching the conclusions set out in this document.

  2. The risk assessment process, detailed in Appendix 8, identified a number of hazards that may be posed by the proposed dealings. The risks posed by these hazards were assessed by considering:

  • the likelihood of the hazard occurring;

  • the likely consequences (impact) of the hazard, were it to be realised; and

  • risk management options to mitigate any identified risks.

  1. The categories used, according to the level of risk are ‘negligible’, ‘very low’, ‘low’, ‘moderate’, ‘high’ or ‘very high’.

  2. The following table, Table 1, lists each of the potential hazards that were considered during the risk assessment process in the Hazard Identification column and summarises the assessment of each hazard under the column headed Risk Level. A comprehensive assessment of each identified hazard is provided in Appendices 2 - 6, as cross-referenced in the column headed Conclusions of the Risk Assessment.

  3. Where it is considered that risk management is necessary to protect the health and safety of humans and/or the environment, the table also summarises risk management options for each hazard (Risk Management (RM) Options), identifies the method that has been selected (Preferred RM Method) and summarises the reason for selecting a particular method (Reason for selecting RM Method). The risk management plan for the proposed dealing will be given effect by specific conditions within the licence. These conditions are summarised in the final column, headed Licence Conditions, and detailed in Appendix 5.

Section 3 Decision on the application


  1. The matters that the Regulator must consider in making a decision are detailed in Appendix 6. It is important to note that the legislation requires the Regulator to base the licence decision on whether risks posed by the dealings are able to be managed so as to protect human health and safety and the environment.

  2. It is concluded that there are no significant risks to human health and safety or to the Australian environment arising from the proposed release of GM papayas that cannot be managed. Detailed risk analyses based on the available scientific information are provided in Appendices 2 - 4 in support of this conclusion.

  3. In accordance with the matters required to be considered under section 58 of the Act, the Regulator has determined that the University of Queensland is suitable to hold a licence for a dealing involving intentional release of a GMO into the environment. Further information on the process of assessing the suitability of the applicant is contained in Appendix 6.

  4. Therefore, the Regulator has issued licence number DIR 026/2002.

Section 3 Identification of issues to be addressed for future releases


  1. Before any application for a larger scale release and/or reduced containment measures involving these GM papayas could be considered, more detailed information would be required on:

  • the levels of expression in both fruit and non-fruit tissues of the introduced etr1-1, uidA, nptII genes, and the introduced and endogenous capacs 1 and capacs 2 genes;

  • genetic segregation and molecular characterisation of the inserted genetic material, including determination of the non-coding vector sequence, if present in the GM papayas;

  • the potential toxicity and allergenicity of the GM papaya for humans, including more information on the toxicity and allergenicity of the introduced ETR1-1 protein and any alterations in the toxicity and allergenicity of the papaya fruit as a result of the modified ripening characteristics;

  • potential toxicity of the GM papaya for non-target organisms including mammals, pests, beneficial organisms and communities of soil microorganisms;

  • the potential for the novel proteins to persist in the environment;

  • the foraging range of known pollinators, particularly hawkmoths;

  • the distances that frugivores disperse papaya fruit and the viability of papaya seeds that may be ingested by these animals;

  • the extent and significance of C. papaya soil seed banks for the population dynamics of naturalised C. papaya populations; and

  • impacts of the genetic modifications on attributes of C. papaya that may affect its weediness including impacts on seed germinability, fruit and seed productivity, susceptibility to pathogens and responses to herbivory.

  1. It should be noted that, as a condition of licence, the applicant must develop a research program, in consultation with the OGTR, to produce much of this data. As a minimum, this program must include research to confirm the genes that have been introduced into the GM papayas and the research results must be reported to the OGTR annually. These data could not be collected prior to the proposed limited and controlled release because, as indicated in Chapter 1 and Appendix 1, papaya fruit cannot be produced easily under glasshouse conditions and much of the critical information regarding the GM papayas proposed for release must be derived from the analysis of fruit tissues.

  2. Provision of the above data during the proposed release is not required to ensure the management of risks to human health and safety and the environment. The risk management measures summarised in Table 1 and given effect by the proposed specific licence conditions effectively manage these risks.

Table 1 Summary of the risk assessment and the risk management plan (including summary of proposed licence conditions).

GM papaya: the genetically modified papaya proposed for release



Hazard Identification

Risk Level (combines ‘likelihood’ and ‘impact’)

Conclusions of the Risk Assessment

(refer to appendices for details)

Does risk require management?

Risk Management (RM) Options

[* Preferred RM Method(s)]

Reason(s) for selecting RM method

Is risk managed?

Licence conditions

(see Appendix 5 for detailed licence conditions)

TOXICITY AND ALLERGENICITY FOR HUMANS:

Food

Low

See Appendix 2

  • the GM papayas are not likely to become more toxic or allergenic than non-GM papayas as a result of the introduced proteins or the down-regulation of ethylene biosynthesis or altered ethylene perception;

  • available data to date suggest that the risk of toxicity and allergenicity is low but detailed toxicity and allergenicity studies have not yet been conducted;

  • exposure of humans to the GM papayas will be minimal due to the limited scale and enclosure of the proposed trial within insect-proof netting; and

  • none of the GM material from the release will be used for human consumption.

Yes

  • * Limit scale of release; and

  • * Prohibit use of GM papaya or by-products for human food; and

  • * Impose containment, transport and storage conditions on release.

  • Disallow release.




1) Limit scale: decreases likelihood of exposure;

2) Prohibit use as human food: prevents human exposure through food;

3) Impose containment, transport and storage conditions: decreases likelihood of exposure.

4) Require research: will enable OGTR to evaluate risks to human health and safety.



Yes

1) Limit scale: restrict area to one hectare at one site in the Shire of Redlands;

2) Prohibit use as human food: no fruit from the release to be consumed by humans and all fruit and other GM materials not required for analysis to be destroyed;

3) Impose containment, transport and storage conditions: GM papaya to be grown under insect-proof netting enclosure that is secured at ground level and to be transported and stored according to OGTR requirements; GM products to be prevented from entering waterways;

4) Research program developed in consultation with OGTR.




TOXICITY AND ALLERGENICITY FOR HUMNANS:

Occupational exposure

Low

See Appendix 2

  • the GM papayas are not likely to become more toxic or allergenic than non-GM papayas as a result of the introduced proteins or the down-regulation of ethylene biosynthesis or altered ethylene perception;

  • available data to date suggest that the risk of toxicity and allergenicity is low but detailed toxicity and allergenicity studies have not yet been conducted;

  • exposure of humans to the GM papayas will be minimal due to the limited scale and enclosure of the proposed trial within insect-proof netting; and

  • none of the GM material from the release will be used for human consumption.

Yes

  • * Limit scale of release; and

  • * Require applicant to notify people associated with the release of possible allergenicity/toxicity of the GMOs with appropriate signage and to report allergic/toxic responses to the OGTR; and

  • * Require research to be conducted into toxicity and allergenicity.

  • Disallow release.




1) Limit scale: decreases likelihood of exposure;

2) Notification/signage: ensures that people working with the GMOs are aware of possible allergenicity/toxicity;

3) Reporting allergic/toxic responses: indicates nature and frequency of any allergic/toxic responses and allows Regulator to adapt risk management measures, if necessary.


Yes

1) Limit scale: as above;

2) Require applicant to ensure that people working with the GMOs are aware of possible allergenicity/toxicity, with a sign on the door of the enclosure and laboratory;

3) Require immediate reporting of unusual allergic/toxic responses in workers associated with the release.


TOXICITY FOR OTHER ORGANISMS:

Mammals, birds and invertebrates

Low

See Appendix 2

  • the GM papayas are not likely to become more toxic or allergenic than non-GM papayas as a result of the introduced proteins or the down-regulation of ethylene biosynthesis or altered ethylene perception;

  • available data to date suggest that the risk of toxicity and allergenicity is low but detailed toxicity and allergenicity studies have not yet been conducted;

  • exposure of other organisms to the GM papayas will be minimal due to the limited scale and enclosure of the trial within an insect-proof enclosure that also prevents animals that may feed on the fruit from entering the release site; and

  • none of the GM material from the release will be used for animal consumption;

Yes

  • * Limit scale of release; and

  • * Prohibit use of GM papaya or by-products as animal food;

  • * Require release to be enclosed in insect-proof netting; and

  • * Research to be conducted into non-target impacts and persistence in the environment.

  • Disallow release.

1) Limit scale: decreases likelihood of exposure;

2) Prohibit use as animal food: prevents animal exposure through feed

3) Enclose release: decreases likelihood of exposure.

4) Require research: enables OGTR to evaluate risks to other organisms.



Yes

1) Limit scale: as above;

2) Prohibit use as animal food: no fruit or by-products from the GMOs to be use as animal feed and all fruit GM materials not required for analysis to be destroyed;

3) Enclose release: GM papaya to be grown within insect-proof netting enclosure that is secured at ground level. Integrity of enclosure to be monitored every day and repaired immediately, if necessary, throughout release; and

4) Research program developed in consultation with OGTR





Hazard Identification

Risk Level (combines ‘likelihood’ and ‘impact’)

Conclusions of the Risk Assessment

(refer to appendices for details)

Does risk require management?

Risk Management (RM) Options

[* Preferred RM Method(s)]

Reason(s) for selecting RM method

Is risk managed?

Licence conditions

(see Appendix 5 for detailed licence conditions)

TOXICITY FOR OTHER ORGANISMS:

Micro- organisms

Low

See Appendix 2

  • the GM papayas are not likely to become more toxic or allergenic than non-GM papayas as a result of the introduced proteins or the down-regulation of ethylene biosynthesis or altered ethylene perception;

  • available data to date suggest that the risk of toxicity and allergenicity is low but detailed toxicity and allergenicity studies have not yet been conducted;

  • exposure of microorganisms to the GM papayas will be minimal due to the limited scale of the proposed trial;

  • fruit produced during the release will be removed from the site to prevent fruit proteins from entering the soil.

Yes

  • *Prevent fruit from falling to ground; and

  • * Limit scale of release; and

  • * Research to be conducted into non-target impacts and persistence in the environment.

  • Disallow release.

1) Limit scale: decreases likelihood of exposure and potential impact.

2) Prevent fruit falling to ground: decreases likelihood of proteins entering soil and affecting non-target species;

3) Require research: enables OGTR to evaluate risks to other organisms.


Yes

1) Limit scale: as above;

2) Ensure that fruits formed during the trial are harvested before they fall to the ground; and

3) Research program developed in consultation with OGTR


WEEDINESS:

Spread in the environment

Low

See Appendix 3

  • the down-regulation of ethylene biosynthesis, the modification to ethylene perception and the other introduced genes are unlikely to affect attributes of the GM papayas proposed for release that may alter potential weediness;

  • papaya is not a problematic weed in Australia;

  • no closely related species are problematic weeds in Australia;

  • the proposed release is restricted to one hectare; and

  • dispersal of the GM papaya seeds will be limited by containing the release in an insect-proof enclosure that also prevents larger animals accessing the GM plants and their fruit.

Yes

  • * Prevent movement of vegetative propagules or seeds beyond release site; and

  • * Account for all fruit produced; and

  • * Destroy viable material not required for analysis or subsequent release and monitor site to enable removal of volunteers or regrowth.

  • Disallow release.

1) Prevent movement: limits spread of the GM papaya beyond the release site.

2) Account for fruit: decreases likelihood of spread beyond the release site.

3) Destroy and monitor: limits spread beyond the release site.


Yes

1) Prevent movement: impose containment, transport and storage conditions, enclose release (as above).

2) Account for fruit: all fruit set to be numbered, recorded and accounted for and instances of damage or removal of fruit to be recorded.

3) Destroy and monitor: destroy all viable material not required for analysis or subsequent release and monitor the release site after the release and remove any papaya plants that regrow.


WEEDINESS:

Persistence in the environment

Low

See Appendix 3

  • the down-regulation of ethylene biosynthesis, the modification to ethylene perception and the other introduced genes are unlikely to affect attributes of the GM papayas proposed for release that may alter potential weediness;

  • papaya is not a problematic weed in Australia;

  • no closely related species are problematic weeds in Australia;

  • the proposed release is restricted to one hectare; and

  • dispersal of the GM papaya seeds will be limited by containing the release in an insect-proof enclosure that also prevents larger animals accessing the GM plants and their fruit.

Yes

  • * Prevent movement of vegetative propagules or seeds beyond release site; and

  • * Account for all fruit produced; and

  • * Destroy viable material not required for analysis or subsequent release and monitor site to enable removal of volunteers or regrowth.

  • Disallow release.

1) Prevent movement: prevents spread of the GM papaya beyond the release site.

2) Account for fruit: decreases likelihood of spread beyond the release site.



Yes

1) Prevent movement: impose containment, transport and storage conditions, enclose release (as above).

2) Account for fruit: (as above)

3) Destroy and monitor: destroy all viable material not required for analysis or subsequent release and monitor the release site after the release and remove any papaya plants that regrow.




Hazard Identification

Risk Level (combines ‘likelihood’ and ‘impact’)

Conclusions of the Risk Assessment

(refer to appendices for details)

Does risk require management?

Risk Management (RM) Options

[* Preferred RM Method(s)]

Reason(s) for selecting RM method

Is risk managed?

Licence conditions

(see Appendix 5 for detailed licence conditions)

GENE TRANSFER:

Plants

  • Other papaya plants, including plantations and naturalised papaya populations

Negligible

See Appendix 4

  • pollen movement will be very limited because the release will be enclosed within an insect-proof enclosure;

  • potential male flowers will be removed, thereby reducing the availability of pollen; and

  • potential gene flow to commercial plantations and known naturalised papaya populations will be limited by geographic isolation.

Yes

  • * Require release to be enclosed in insect-proof netting;

  • * Immediately repair breaches of enclosure;

  • * Destroy flowers and fruit if enclosure cannot be repaired immediately;

  • * Remove male flowers.

  • Disallow release.

1) Enclose release: limits access for pollinators and movement of pollen beyond release site.

2) Repair breaches: ensures enclosure remains functional

3) Destroy flowers and fruit: prevents gene transfer in event of significant damage to enclosure;

4) Remove male flowers: further limits likelihood of pollen movement beyond release site.



Yes

1) Enclose release: (as above)

2) Immediately repair damage to enclosure.

3) Destroy flowers and fruit if damage to enclosure cannot be repaired immediately.

4) Remove male flowers: all male flowers to be removed prior to anthesis.




GENE TRANSFER:

Plants

  • Other plant genera

Negligible

See Appendix 4

  • In addition to containing the release in an insect-proof enclosure:

  • genetic incompatibility with papaya’s closest relatives (Vasconcella spp.) 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.

No

N/A

N/A

N/A

None required


GENE TRANSFER:

Humans & other animals

Negligible

See Appendix 4

  • 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; and

  • 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. As yet the applicant has not applied to FSANZ for evaluation of the GM material due to the early stage of the work.

    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.



No

N/A

N/A

N/A

None required






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