Risk Assessment and Risk Management Plan


Reasons for licence Conditions



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Reasons for licence Conditions


The reasons for inclusion of the specific licence conditions follow (with reference to the numbering of the conditions in the licence).

Location and size of release


Conditions 1.1- 1.5 are to limit the size and location of the release and to ensure the location is secure. Limiting the scale of the release and securing the location decreases the likelihood of exposure of humans and other organisms to the GMOs. Condition 1.3 requires appropriate signage at the location to decrease the likelihood of unauthorised access to the location and removal of GMO material from the location.
Condition 1.6 is to prevent the entry of Material from the GMOs into waterways. This condition decreases the likelihood of spread of GMOs and Materials from the GMOs.

Cage


Conditions 2.1 – 2.6 require the GMOs to be grown under a Cage to limit access to the GMOs for pollinators and other animals. Limiting access for pollinators prevents movement of pollen beyond the release site and limits the possibility of gene transfer from the GM papayas to other papayas in the local area. Limiting the ability of other animals to access the GMOs prevents inadvertent movement of viable Material from the GMOs beyond the release site and also decreases the likelihood of exposure of animals to the GMOs.
Conditions 2.2, 2.4 and 2.5 require monitoring of the Cage to ensure that the ability of the Cage to limit access for pollinators and other animals is maintained at all times. Condition 2.3 ensures that if the Cage is damaged to the extent that it cannot be immediately repaired, movement of pollen and fruit from the location by pollinators and other animals will be prevented. Condition 2.6 ensures that compliance with the licence conditions can be monitored by the OGTR.

Access and control of the Location


Condition 3 ensures that the licence holder or persons covered by the licence have access to the release site and enables them to monitor the release site so as to comply with the licence conditions.

GMOs must not be eaten


Condition 4 prevents fruit and other Material from the GMOs being used as food for humans or other animals. This is because there is insufficient data to evaluate the safety of the GMOs for use in human or animal food at this stage in the experimental program.

Notification of commencement of planting, flowering, fruiting and harvesting


Conditions 5, 6 and 8.1 ensure that minimum advance information about the likely higher risk times of the trials (namely the likely planting, flowering and harvest dates) is provided to the OGTR to ensure proper planning of the OGTR monitoring of the release sites.

Management of flowers


Condition 7 requires that all male flowers must be removed prior to anthesis to limit the likelihood of pollen movement beyond the release site. As with Conditions 2.1 – 2.6, this condition limits gene transfer from the GM papayas to other papayas in the local area.

Management of fruiting and harvesting


Condition 8.2 prevents fruit from falling to the ground and decreases the likelihood of exposing soil organisms to the introduced proteins.
Condition 8.3 prevents Material from the GMOs becoming mixed with non-GM Material and decreases the likelihood of exposing humans and other organisms to the GMOs.
Conditions 8.4 – 8.6 decreases the likelihood of spread of viable Material from the GMOs beyond the release site and allows the OGTR to monitor compliance with the licence conditions.

Reporting of toxic and allergenic responses


Conditions 9.1 requires appropriate signage to ensure that people working with the GMOs are aware of possible allergenicity or toxicity of the GMOs and Condition 9.2 ensures that reporting of any allergic or toxic responses will allow the Regulator to adapt risk management measures to protect human health and safety, if necessary.

Reporting of plant disease incidence


Conditions 10.1 – 10.2 ensure that any unexpected alteration in the response of the GM papayas to pathogenic or non-pathogenic microorganisms will be recorded. This data will allow the Regulator to evaluate risks to the environment for future larger scale releases of the GMOs, subject to separate assessments and approvals.

Cleaning


Condition 11 requires cleaning of all equipment used in conjunction with the GMOs to prevent spread of Material from the GMOs beyond the release site.

Storage and Transportation


Conditions 12.1 – 12.2 describe conditions for transport of the GMOs or Material from the GMOs to prevent escape and the spread or persistence of the GMOs outside the release site or certified laboratory in which research is conducted with the GMOs.

Clean-up of Location and Inspection


Conditions 13 and 14.1 – 14.8 require the release site to be cleaned of all Material from the GMOs and prevents persistence of the GMOs at the release site after completion of the trials. Conditions 14.1, 14.2, 14.3, 14.7 and 14.8 ensure that any GMOs surviving at the release site after completion of the trial will be identified and Destroyed. Conditions 14.4 and 14.5 ensure that the OGTR will be able to determine whether the licence conditions have been complied with and whether further licence conditions need to be imposed if clean-up of the release site is inadequate. Condition 14.6 requires the Cage to remain in place during the post-release monitoring period to ensure that the GMOs do not spread beyond the release site during this period.

Testing Methodology


Condition 15 requires that the licence holder develop a method capable of detecting the GMOs and provide this method to the Regulator in writing. This method will allow detection of the GMOs in a situation where the GMO or Material from the GMOs may be present outside of the release site.

Contingency Plan


Conditions 16.1 - 16.3 describe requirements of the applicant in the event of an unintentional release of the GMOs. Condition 16.1 requires the licence holder to develop a contingency plan to deal with damage to the Cage that cannot be immediately repaired or the unintended presence of the GMOs or GM material outside the release site and to provide the Regulator with a written copy of this plan. This is so that the Regulator is aware of the contingency plan and can, if necessary, revise it or impose licence conditions to require any other measures that might be necessary to prevent the continued spread or persistence of the GMOs outside the release site and protect the health and safety of people and the environment. Condition 16.2 requires that the plan must have procedures to ensure immediate notification of the Regulator, so that the Regulator can take any actions necessary to protect the health and safety of people and the environment. The contingency plan must also provide for the destruction of flowers and fruit from the GMOs in the event of damage to the Cage that cannot be repaired and destruction of any GMOs or GMO Material from places not contemplated by the licence, to prevent the continued spread and persistence of the GM cotton in the environment. Condition 16.3 obliges the licence holder to implement the plan.

Compliance


Condition 17 requires the licence holder to provide a compliance management plan to the Regulator. This is so that the Regulator is aware of the procedures that the licence holder has in place to ensure and document compliance with the licence conditions so that the Regulator can, if necessary, impose additional licence conditions to amend these.

Research Requirements


Condition 18.1 requires the licence holder to develop a research program that will allow the Regulator to evaluate risks to human health and safety and the environment that might be posed by future larger scale releases of the GMOs, which would be subject to separate assessments and approvals. Condition 18.2 ensures that the results of the research program are communicated to the Regulator.

Annual Report


Condition 19 requires the licence holder to provide an annual report to the Regulator for administrative and auditing purposes.



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