Risk Assessment and Risk Management Plan Application for licence for dealings involving intentional release of a genetically modified organism into the environment dir 034/2003 Title: Field Trial of Genetically Modified Cotton

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Fresh Weight (mg/g)

Dry Weight (mg/g)



















  1. These values have not been corrected for extraction efficiency (information provided by applicant). The limit of quantification of the VIP3A ELISA ranged from 0.02 – 0.270 mg/g fresh weight depending on tissues and development stage analysed. On a dry weight basis the limit of quantification was around 0.3 mg/g. These results indicate that highest expression occurs in leaves but overall expression is low.

  2. The vip3A gene expressed in the GM insecticidal cotton is derived from a common soil bacterium Bacillus thuringiensis. The vip3A protein is present at low levels in the tissues of all GM insecticidal cotton and represents only around 1% of the total extractable protein in the leaves. Expression data on VIP3A protein showed that the stems and leaves of GM insecticidal cotton expressed the highest amounts of the novel protein when compared to the roots and pollen.

  3. In a field survey conducted as part of DIR 017/2002, the VIP3A insecticidal protein in COT102 plants showed high and consistent efficacy against Helicoverpa spp. with no deleterious effects on non-target insect numbers.

Section 7.2 Hph Protein

  1. Preliminary data indicate that Hph protein from hph gene is either not detectable in most COT102 plant tissues or the levels are too low to quantify. The limit of quantification of the Hph ELISA ranged from 10-137 ng/g fresh weight across the tissues and stages analysed. This corresponded to a limit of quantification of 150ng/g dry weight.

  2. More detailed information on the levels of expression of both the introduced proteins, VIP3A and Hph, in various plant parts, would be required before any application for reduced containment and/or significantly larger scale or commercial release of this GM cotton could be evaluated.

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