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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The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations) set out requirements which the Gene Technology Regulator (the Regulator) must follow when considering an application for a licence to intentionally release a genetically modified organism (GMO) into the environment.

For a licence to be issued, the Regulator must be satisfied that the release will not pose any risks to human health and safety or the environment that can not be managed. To this end, Section 51 of the Act requires the Regulator to prepare a risk assessment and risk management plan (RARMP) for each licence application, in consultation with a wide range of expert groups and stakeholders.

Under Section 52 of the Act, the Regulator is required to seek comment on the RARMP from those consulted in its preparation and to invite submissions from the public. Matters raised relating to the protection of human health and safety or the environment are taken into account in finalising the RARMP, which then forms the basis of the Regulator’s decision on whether, or not, to issue a licence.

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