Risk Assessment and Risk Management Plan



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part 2


Interpretation and Definitions

Words and phrases used in this licence have the same meanings as they do in the Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001.


Words importing a gender include any other gender.
Words in the singular include the plural and words in the plural include the singular.
Words importing persons include a partnership and a body whether corporate or otherwise.
References to any statute or other legislation (whether primary or subordinate) are a reference to a statute or other legislation of the Commonwealth of Australia as amended or replaced from time to time unless the contrary intention appears.
Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word or phrase has a corresponding meaning.
In this licence:
Cage’ means a self-supporting enclosure designed to eliminate key pollinating insects, comprising transparent nylon netting no greater than 2.0 mm2 pore size, sealed to the ground.
Clean’ (or ‘Cleaned’ or ‘Cleaning’) means, as the case requires:

  1. in relation to a Location or an area, the Destruction of the GMOs or Material from the GMOs to the reasonable satisfaction of the Regulator; or

  2. in relation to Equipment, the removal and Destruction of the GMOs, and Material from the GMOs, to the reasonable satisfaction of the Regulator.

Destroy’, (or ‘Destroyed’, or ‘Destruction’) means, as the case requires, killed by autoclaving or incineration.


Equipment’ includes planting equipment, harvesting equipment, storage equipment, transport equipment (eg. bags, containers, trucks), clothing and tools.
GM’ means genetically modified.

GMOs’ mean the genetically modified organisms covered by this licence.


Location’ means the location referred to in Clause 1.1 of Part 3 of this licence.
Material from the GMOs’ means stem sections, leaves, pollen or any other genetically modified material (including parts of GMOs) that are derived from or produced by the GMOs.
OGTR’ means the Office of the Gene Technology Regulator.
QDPIRRS’ means Queensland Department of Primary Industry Redlands Research Station.
Regulator’ means the Gene Technology Regulator.
Waterways’ includes streams, rivers and open irrigation channels.

Part 3 Conditions of Licence


Location and size of release

1.1 Planting of GMOs must be confined to a single planting area (‘the Location’) within the QDPIRRS in the Shire of Redlands.

1.2 The QDPIRRS must be secured against public access by fencing with a lockable gate.

1.3 The Location must have appropriate signage to indicate that GM papayas are being grown in it and that the GMOs and Material from the GMOs (eg. fruit) must not be removed from the Location except as expressly authorised by the Licence.

1.4 The total area of the Location must not exceed one hectare.

1.5 No more than 300 GMOs in total may be planted under this Licence.

1.6 The perimeter of the Location must be at least 100 metres from the nearest Waterway and the licence holder must not allow Material from the GMOs to enter any Waterway.

Cage

2.1 The GMOs must be grown under a Cage that prevents key pollinating insects and vertebrate animals (other than humans) from accessing the GMOs.

2.2 The integrity of the Cage must be inspected every day for the duration of the licence. Any damage to the Cage must be repaired immediately.

2.3 If the Cage cannot be repaired immediately, all inflorescences and fruit must be removed from the GMOs immediately and Destroyed.

2.4 Within 30 days of issuing this Licence, the licence holder must install in the Cage at least two insect light traps able to collect hawkmoths in the family Sphingidae (Lepidoptera). The light traps must be located in opposite corners of the Cage and must be inspected at least once every week until the Location is cleaned for the presence of sphingid moths.

2.5 The presence (or absence) of sphingid hawkmoths in the light traps must be determined by someone able to recognise moths in the family Sphingidae (Lepidoptera).

2.6 A log book must be maintained recording each date and time of inspection of the Cage, the results of the inspection, the nature and location of any repairs to the Cage that may have been required under Part 3, condition 2.2, and the GMOs from which inflorescences or fruit may have been removed, as required under Part 3, condition 2.3. The log book must also record each date on which the insect light traps were inspected and the total number sphingid hawkmoths present at each inspection. The log book must be available on request for examination or photocopying by OGTR inspectors or authorised officers.



Explanatory note: As insects often accumulate in corners of insect-proof enclosures, it is advisable to concentrate inspections for damage to the cage in the uppermost corners of the Cage. Regarding the insect light traps, it would be advisable to verify the effectiveness with which the traps collect hawkmoths, by positioning at least one additional trap outside, and about 50 m from, the Cage. These considerations are not required by the Licence but may assist the licence holder to fulfil its obligations under the Licence.

Access and control of the Location

3 The licence holder must be able to access and control the Location to the extent necessary to comply with this licence, for the duration of the life of the licence.

GMOs must not be eaten

4 The licence holder must ensure that any fruit or other Material from the GMOs is not used as food for humans or other vertebrate animals.

Notification of commencement of planting

5 The licence holder must notify the OGTR at least 7 days, but not more than 20 days, in advance of each day on which the GMO is planted.

Notification of commencement of flowering

6 The licence holder must notify the OGTR at least 7 days, but not more than 20 days, in advance of the expected commencement of each flowering season of the GMOs that is to occur.

Management of Flowers

7 All male flowers must be removed prior to anthesis and Destroyed.



Explanatory Note: Conditions 2.3 and 2.4 of Part 3 of this Licence describe further actions that must be taken to manage flowers and fruit, including their removal and destruction, in the event that the Cage is damaged and cannot be repaired immediately.

Notification of commencement of fruiting and harvesting

8.1 The licence holder must notify the OGTR at least 30 days, but not more than 60 days, in advance of the expected commencement of harvest of fruit in each fruiting season.


    1. All fruit must be harvested before they fall to the ground, removed from the Location and either transported to a laboratory certified by the Regulator to at least physical containment level 2 (PC2) for analysis, or Destroyed.

8.3 If harvested, the GMOs or Material from the GMOs must be harvested and stored separately from any other papaya fruit or material from papaya plants.

8.4 A log book must be kept by the licence holder recording, for each season, the following information:



  1. the number of fruit set on each tree;

  2. the number of fruit on each tree that sustain damage consistent with being eaten by fruit-eating vertebrate animals;

  3. the number of fruit removed from each tree and transported to a laboratory for further experiments;

  4. the number of fruit removed from the tree and destroyed; and

  5. the number of fruit missing without explanation.

8.5 The log book must be available on request for examination or photocopying by OGTR inspectors or authorised officers.

8.6 The findings recorded in the log book must be included in the licence holder’s annual report to the OGTR.

Reporting of toxic and allergenic responses

9.1 All persons exposed to the GMOs must be notified by the licence holder (eg. by signage at doors into the Location and laboratories) that they should report to the licence holder any unusual allergenic responses that could be attributed to contact with the GMOs.

9.2 Any such reports (to the Licence holder) must be provided to the OGTR immediately.

Reporting of plant disease incidence

10.1 GMOs must be inspected at least every month for disease. A record of all inspections must be entered in a log book. The log book must be available on request for examination or photocopying by OGTR inspectors or authorised officers. The log book must record the date of inspections, reports of any disease symptoms, (eg. foliar chlorosis or necrosis, dieback, root rot, loss of fruit set), severity of symptoms, disease control measures, if any, carried out and which GMO shows which disease symptoms.

10.2 The results of findings with respect to disease and disease control measures must be included in the licence holder’s annual report to the OGTR.

Cleaning

11 All Equipment used in the planting, growing and harvesting of GMOs must be Cleaned immediately after use, within the Cage.



Storage and Transportation
12.1 Transportation of GMOs outside the Cage must be in accordance with the Guidelines for the Transport of GMOs June 2001 issued by the Regulator.

12.2 Material from the GMOs (including fruit) may only be stored in a facility that is certified by the Regulator.

Clean-up of location

13 During the period 1-15 November 2006:



  1. all flowers and fruit of the GMOs must be removed from the GMOs and destroyed.

  2. after flowers and fruit from the GMOs have been removed, the GMO must be cut off at ground level and raked into piles together with any other Material from the GMOs.

  3. cut stumps must be immediately treated with herbicide to kill them.

  4. the raked piles must be left to dry for at least a month, after which they must be burned. The raked piles may be taken out of the Cage to be burned, but must be burned within the confines of the QDPIRRS.

  5. the raked piles must be burned no later than 31 December 2006.

Inspection

14.1 During the 12 months following the clean up of the location, the Location must be inspected to establish whether any GMOs or Materials from the GMOs have survived at the Location (whether by regrowth of herbicide-treated stumps or some other regrowth).

14.2 Inspection must take place at least every 3 months during the 12 month period.

14.3 Any GMOs or Material from the GMOs found to have survived at the Location during the 12 month period must be killed by herbicide treatment, incineration, hand weeding or autoclaving.

14.4 A log must be kept of all inspections carried out recording the date of inspection and findings. The log must be available on request for examination or photocopying by OGTR inspectors or authorised officers.

14.5 The findings of the log book kept under the above clause must be included in the licence holder’s annual report to the OGTR.

14.6 The Cage must remain in place during the 12 month period.

14.7 Inspections must be carried out by a person qualified to identify GMO seedlings, the GMO and Material from the GMOs.

14.8 The Location must not be planted with any other papaya plants while the inspections are continuing. The Location may be planted to a legume crop while the inspections are continuing.

Testing Methodology

15 The licence holder must provide a written instrument to the Regulator describing an experimental method that is capable of reliably detecting the presence of GMOs and the presence of the genetic modifications described in Attachment B in a recipient organism. The instrument must be provided within 24 months of the issuing of the licence.

Contingency Plan

16.1 Within 30 days of the date of the commencement of this licence, a written Contingency Plan must be submitted to the Regulator detailing measures to be taken in the event of:


  1. damage to the enclosure that cannot be repaired immediately;

  2. the unintended presence of the GMO or Material from the GMO at places not contemplated by this licence

16.2 The Contingency Plan must include details of procedures to:

  1. ensure the Regulator is notified immediately if the licence holder becomes aware of an event;

  1. remove flowers and fruits from the GMOs and prevent potential gene transfer from the Location; and

  2. eradicate the GMOs or Material from the GMOs from places not contemplated by the licence.

16.3 The Contingency Plan must be implemented in the event that the unintended presence of the GMO, or Material from the GMOs is discovered.

Compliance

17 A written Compliance Management Plan must be provided to the Regulator within 30 days of the date of commencement of this licence. The Compliance Management Plan must describe in detail how the licence holder intends to ensure compliance with these conditions and document that compliance.

Research Requirements



    1. The licence holder must, in consultation with the OGTR, develop an agreed research program that includes, but need not be limited to, confirming the genes that have been introduced into the GMOs.

    2. The results of the research program must be included in the licence holder’s annual report to the OGTR.

Annual Report

  1. The licence holder must provide an annual report within 90 days of each anniversary of this licence to the OGTR containing all the information required by these conditions to be reported.






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