Full details are required about the manner in which the trial release of the GMO is to be undertaken

The bananas will be planted at the Tropical Agriculture Institute's research facility, which is surrounded by a fence to minimize pilfering. Access to the trial site will require a key and will be by authorized personnel only. A sign on the fence will have a skull and crossbones and say, "Test bananas, not for human consumption."

The trial site is within the grounds of the institute, on a southwest slope. Water drains from the site to the dam. The institute is surrounded by subtropical vegetation to the north, west, south and by a suburb on the east. The R64 road separates the institute from the suburb. The site will have no bordering banana plantings. About 42 clones of each of the 8 transformed varieties will be planted. Plants that die or fail to grow will be replaced by seedlings from the lab stocks. The trial site will be fenced with a 2-meter-high mesh fence and locked with an access gate. Fruit from the plants will be collected and moved to the laboratory for further testing.

The trial will run for three years and will be supervised at all times by trained personnel. A flood

would, at the very worst, wash the plants down to the dam, but this is highly unlikely because no such floods have been recorded in the area.

After the trial the plants will be removed and burnt.

4.2 What potential hazardous or deleterious effects resulting from the trial release of the GMO can be postulated?

The vaccine bananas are not toxic even when consumed at a high rate.

4.3 Have similar releases of similar GMOs been made previously, either within or outside the country?

4.4 Have similar requests or applications for the release of this particular GMO been made previously?

4.5 Is there any evidence that the inserted genetic trait is transferable to other organisms in the release site and surrounding environment?

The banana flowers are mostly sterile, but will be bagged to prevent pollen release into the environment.

4.6 What data are available to suggest that the introduced genetic trait has no deleterious effect in the long term upon the species into which it has been introduced or allied species or any other organisms or the environment in general?

The Hepatitis B epitope protein is being used already as a vaccine, and its lack of toxicity was established before it was approved for medical use.

4.7 Is the GMO intended to modify the characteristics or abundance of other species?

4.8 What experimental results or information exist to show the probable consequences (positive and negative) of the release of such a modified organism, including impacts on:

4.8.1 Human, animal, or plant health?

The protein will increase resistance to Hepatitis B in consumers able to invoke an immune response.

4.8.2 Agricultural production?

None.

4.8.3 Target and nontarget organisms in the area?

None.

4.8.4 The general ecology, environmental quality, and pollution in the area?

None.

4.8.5 The genetic resources (e.g., susceptibility of economically important species to herbicides, pesticides, etc.)?

None.

4.9 Will the trial release have any unlikely but possible impacts?

4.10 What will be the consequences if the organism remains in the environment beyond the planned period?

None.

4.11 Has a trial release been carried out in the country of origin of the GMO?

4.12 Provide a draft copy of a press release informing the public of the trial or general release of the GMO.

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