A2

Is the GMO capable of causing disease or other ill-health in humans, plants or animals? If so, what are the possible effects?

C2

What is the origin of the inserted DNA? Does the inserted DNA come from an organism that causes disease or other ill-health in humans, plants or animals? If so, what are the possible effects?

A3, B1

General Information

Is the GMO capable of causing disease or other ill-health in humans, plants or animals? If so, what are the possible effects?

General Information

Describe the size of the release, and, where relevant, the area of land to be used, and its location. Include a map, where relevant

D5

What are the reasons for the choice of location?

D1, D5

IDescribe in detail the relevant features of the physical environment, particularly those which may minimize or exacerbate any undesirable effects.

D1, D5

How close is the site to population centres, of agricultural activity, or the habitat of biota that might affect, or be affected by the release?

D3, D5

What is the natural habitat of the parent organism and its range?

Where was the parent organism originally isolated?

IWhat is the distribution of the parent organism in Singapore ?

Is the parent organism already present at or near the site of the release? If so, provide available data on populations (for field trial).

A2, A5

C6

D4

C5 , D8, D4

What genetic modification has been made? Give a detailed description of the steps undertaken.

B1

Does the GMO have a potentially unstable genotype?

B5

ITo what extent is the genetic modification characterized? Provide data to show the extent of characterization.

B2

What is the location of the inserted DNA in the final construct, and how many copies are present?

B2

What markers or sequences will enable the GMO to be identified in the laboratory and under field conditions?

B2

What type of vector was used in the transfer? Provide a description of the vector, showing the position of the inserted DNA and any other control sequences or markers in the vector.

Can the vector transfer to other hosts? If so, provide information on its host range.

Is the recombinant vector present in the final construct? If not, how was it removed?

If no vector was involved: how was the DNA introduced and how many copies of the gene were inserted?

How does the modification change the phenotype of the organism? Present data to demonstrate the effect of the modification, including level of expression and regulation of the genetic insert. What secondary genetic effects may be anticipated?

What intrinsic genetic features, if any, of the GMO regulate its survival in the environment if it is release? How stable are these features?

What genetic changes, if any, have been included in the GMO to limit or eliminate its capacity to reproduce or transfer its genes to other organisms?

C5

On the basis of contained experiments, provide data on:
i) the survival times of the GMO in habitats relevant to the release;

ii) the growth rate (or generation time) of the parent organism and GMO in the ranges of environmental conditions characteristic for the place and date of release;

iii) the frequency of reversion or loss of the genetic change.

Supporting Data

What is the capability of the GMO to disperse from the release area? What are the dispersal mechanisms in air, water and soil?

Can the parent organism form long-term survival structures such as seeds or spores?

Is there any evidence that the inserted genetic trait can be transferred to other organisms found at the release site and surrounding environment? If so:

i)to what organisms and at what frequencies? List the species that have been tested for transfer and explain the rationale for this choice.

ii)what transfer mechanisms are involved?

iii)what techniques have been used to demonstrate transfer?

iv)what are the possible adverse effects of the transfer?

Does the modified trait confer a selective advantage on the GMO under certain conditions?

If so, what are these conditions? Provide data on growth rates with and without selection pressure.

Would you expect the GMO to show any competitive advantages over its unmodified parent in mixed populations under the conditions in the test site? If so, what are the advantages?

Describe in detail the overall experimental protocol for the release , including the protocol for control, test, and challenge organisms, if appropriate.

Supporting Data

How many organisms are to be released?

Supporting Data

How many releases of the GMO are proposed?

Supporting Data

What are the arrangements for producing the GMO in quantity, transporting it to the site and accounting for the transported organisms?

Supporting Data

How will the GMO be released?

Supporting Data

What methods are to be used to test for batch to batch consistency if large scale production is required to produce GMOs for release?

Supporting Data

What specific measures have been taken or will be taken in the production process to ensure the quality/purity of the GMO to be released?

Supporting Data

How will the survival of the GMO be monitored? Provide a description of techniques for monitoring the presence of GMOs or transferred genetic material beyond the primary site, including specificity, sensitivity and reliability of detection methods.

Supporting Data

If the release is likely to affect the characteristics or abundance of other species, how will this be monitored?

Supporting Data

How will transfer of the introduced gene to other species be monitored?

Supporting Data

What potential hazards or deleterious effects can be postulated and how are these to be evaluated during the release?

Supporting Data

Describe any structures or procedures that will be in place to reduce dissemination of the GMO.

Supporting Data

If transfer of the inserted genetic trait to other organisms with adverse consequences is possible, what methods will be used to minimize these effects?

Supporting Data

Will the GMO remain in the environment after the release? If so,

(a) for what period of time, and

(b) what might be the consequences?

Supporting Data

Will measures be taken to reduce populations or dispose of the GMO once the release is completed? If so, provide details.

Supporting Data

What monitoring is to be undertaken after the release is completed?

Supporting Data

What contingency measures will be in place to remove the GMOs if a hazard becomes evident during the course of the release?

Supporting Data

Describe site supervision procedures and any safety procedures undertaken by staff.

Supporting Data

Have the same or similar GMO been used or released before, either within or outside SINGAPORE ?

If so, what were the beneficial or adverse consequences? Provide references or reports of previous assessments.

General Information

Is the GMO capable of causing disease or other ill-health in humans, plants or animals? If so, what are the possible effects?

General Information

What factors might suggest greater or less risk with the proposed use or release in SINGAPORE ?

General Information

Has the GMO been imported? If so, provide documentation of quarantine clearance or assessment.

General Information

Is there any reason to think that the GMO, if used or released in SINGAPORE, could constitute a hazard, not discussed elsewhere in the proposal? If so, please explain.

General Information

Provide any other information you may have that could assist with the assessment of this proposal.

General Information