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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Hazard Identification

Risk (combines ‘likelihood and impact’)

Summary of Risk Assessment

(refer to appendices for details)

Does risk require management?

Risk Management Method(s) and

Reason(s) for Selection

Is risk managed?

Licence Conditions

(See Appendix 7 for detailed licence conditions)

TOXICITY AND ALLERGENICITY FOR HUMANS:

Food

Very Low

See Appendix 2

  • none of the GM material from the release will be used in human food or therapeutics;

  • the toxicity of VIP3A protein is specific to lepidopteran caterpillars;

  • humans are commonly exposed to VIP3A and Hph, as these proteins are naturally widespread in the environment;

  • VIP3A and Hph are not known to be toxic to humans;

  • VIP3A shows no structural homology to any known toxins or allergens;

  • the introduced proteins are expressed at low levels in the GM cotton;

  • pollen is not wind dispersed and unlikely to be allergenic;

  • no adverse reports from similar previous releases; and

  • exposure of humans to GM cotton will be minimal as the release is small, limited and controlled.

Yes

1) Control access: decreases likelihood of exposure;

2) Limit scale: decreases likelihood of exposure;

3) Prohibit use as human food or in manufacture of therapeutics: prevents human exposure through food;

4) Impose containment, transport and storage conditions: decreases likelihood of exposure;

5) Require applicant to notify personnel dealing with the GMO: decreases the risk of unintentional exposure; and

6) Cleaning of equipment and release sites: clean equipment used in the release and destroy the GMO and GM material from the release site when no longer required decreases likelihood of exposure.


Yes

1) Control access: access restricted to authorised personnel;

2) Limit scale: restrict area to a total of 10 hectares at 30 sites, of no more than 1 hectare;

3) Prohibit use as human food or in manufacture therapeutics: prohibit use of GMO or its by-products as human food or in manufacture of therapeutics;

4) Containment, transport and storage of the GMO and material from the GMO as per the OGTR guidelines;

5) Applicant to notify personnel dealing with the GMO; and

6) Clean equipment and release sites: cleaning equipment used in the release and destroying the GMO and GM material from the release site when no longer required.





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