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


TOXICITY AND ALLERGENICITY FOR HUMANS



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TOXICITY AND ALLERGENICITY FOR HUMANS:

Wearing & using household items containing cotton products

Very Low


See Appendix 2

  • cotton lint used in clothing and household items contains no proteins or DNA.

No

N/A

N/A

None required

TOXICITY FOR NON-TARGET ORGANISMS:

Mammals and wildlife including birds and fish; non-target invertebrates, including soil insects; and microorganisms

Low

See Appendix 3

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

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

  • toxicity studies with the purified protein or commercial Bt microbial products indicate that the GM cotton containing the VIP3A protein will not be more toxic to mammals, birds or fish than non-GM cotton;

  • laboratory and field studies indicate that populations of key non-target invertebrates are unlikely to be affected by the VIP3A toxin;

  • the release is small in size and surrounded by an area of non-GM cotton;

  • none of the cotton or its by-products will be used for animal feed;

  • the introduced proteins are already widespread in the environment in the microorganisms from which the genes were derived; and

  • no adverse reports from similar previous releases.

Yes

1) Limit scale: decreases likelihood of exposure;

2) Prohibit use in manufacture of animal feed: prevents exposure through food;

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

4) 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; and

5) Further research to assess potential toxicity of the introduced proteins.


Yes

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

2) Prohibit use in manufacture of animal feed: prohibit use of GMO or its by-products in manufacture of animal feed;

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

4) 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;

5) Require further research on potential toxicity of the introduced proteins on non-target organisms.





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