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


Section 1 Nature of the Potential Toxicity or Allergenicity Hazard



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Section 1 Nature of the Potential Toxicity or Allergenicity Hazard


  1. Toxicity is the cascade of reactions resulting from exposure to a dose of chemical sufficient to cause direct cellular or tissue injury or otherwise inhibit normal physiological processes (Felsot 2000). Allergic responses are immune system reactions, resulting from stimulation of a specific group of antibodies (known as IgE) or sensitisation of specific tissue bound lymphocytes (Taylor & Lehrer 1996; FAO & WHO 2000). Allergy has a well-defined etiology (ie. biochemical cause) that is quite different from toxicity.

  2. The GM insecticidal cotton differs from conventional cotton in the expression of two additional proteins, the VIP3A and Hph proteins. The potential for cotton expressing these proteins to be toxic or allergenic to humans has been considered in detail in this Appendix. This could occur if the genetically modified cotton were toxic or allergenic because of the novel gene products expressed in the plants or because of unforeseen, unintended effects of the genetic modification.

  3. The APVMA has responsibility for agricultural chemical use, including insecticides and herbicides in Australia under the Agricultural and Veterinary Chemicals (Code) Act 1994 (Refer to Chapter 1 for details). As part of their assessment of chemical use, the APVMA considers any potential human health effects, for example risks arising through occupational exposure or residues in food. Thus risks associated with the use of the insecticide are not considered in the risk assessment of this GM cotton.



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