11.2 Provide details of any previous and/or current assessments of the GM plants, or products derived from them, by any other regulatory authority in Australia. Include assessments by other regulatory agencies such as FSANZ, APVMA, NICNAS, TGA and Department of Agriculture (Biosecurity). Also provide details of any adverse consequences associated with use of the GM plants or GM products covered in these assessments, including identifying references and reports of assessments. 11.3 Provide details on approvals for human food and/or animal feed use or environmental release of the same GM plants in other countries. If the GM plant(s) has been released overseas, provide details of the approvals (ie countries and type of release/approval), including when and if they are still current. Also provide details of any adverse or unintended consequences associated with the GM plants or their products following their approval in other countries, including identifying references and reports of assessments. 11.4 Have the GM plants been refused an approval, or had an approval for environmental release, or for use in human food or animal feed suspended or revoked in any country? Yes No If yes, provide details including the country, date and rationale for refusal, including identifying references and reports of assessments. Part 12: Spread and Persistence of the GM Plants in the Environment Characteristics that influence the persistence (establishment, survival and reproduction) and spread (dispersal of the plant or its genetic material) of a plant species impact on the degree of its invasiveness. The degree of invasiveness of a plant species in a particular environment gives an indication of the likelihood of it causing harm in that environment. The information required in this Part helps to establish whether plant characteristics relating to spread and persistence might be altered in the GM plant or any of its hybrids compared to the parent species. In the preparation of the risk assessment, this information will contribute to the estimation of the exposure of people or the environment to the GM plant. In the preparation of the risk management plan, this information is used when considering any limits and/or controls proposed in Part 10. Potential adverse effects, ie harms, due to exposure of the GM plant to people or the environment are considered in Part 13.
11.2 Provide details of any previous and/or current assessments of the GM plants, or products derived from them, by any other regulatory authority in Australia. Include assessments by other regulatory agencies such as FSANZ, APVMA, NICNAS, TGA and Department of Agriculture (Biosecurity). Also provide details of any adverse consequences associated with use of the GM plants or GM products covered in these assessments, including identifying references and reports of assessments. 11.3 Provide details on approvals for human food and/or animal feed use or environmental release of the same GM plants in other countries. If the GM plant(s) has been released overseas, provide details of the approvals (ie countries and type of release/approval), including when and if they are still current. Also provide details of any adverse or unintended consequences associated with the GM plants or their products following their approval in other countries, including identifying references and reports of assessments. 11.4 Have the GM plants been refused an approval, or had an approval for environmental release, or for use in human food or animal feed suspended or revoked in any country? Yes No If yes, provide details including the country, date and rationale for refusal, including identifying references and reports of assessments. Part 12: Spread and Persistence of the GM Plants in the Environment Characteristics that influence the persistence (establishment, survival and reproduction) and spread (dispersal of the plant or its genetic material) of a plant species impact on the degree of its invasiveness. The degree of invasiveness of a plant species in a particular environment gives an indication of the likelihood of it causing harm in that environment. The information required in this Part helps to establish whether plant characteristics relating to spread and persistence might be altered in the GM plant or any of its hybrids compared to the parent species. In the preparation of the risk assessment, this information will contribute to the estimation of the exposure of people or the environment to the GM plant. In the preparation of the risk management plan, this information is used when considering any limits and/or controls proposed in Part 10. Potential adverse effects, ie harms, due to exposure of the GM plant to people or the environment are considered in Part 13.
dirform2015-draft.docx