Risk Assessment and Risk Management Plan

APPENDIX 6 legislative requirements for assessing dealings involving intentional releases

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APPENDIX 6 legislative requirements for assessing dealings involving intentional releases

Section 1 The regulation of gene technology in Australia

  1. The Gene Technology Act 2000 (the Act) took effect on 21 June 2001. The Act, supported by the Gene Technology Regulations 2001, an inter-governmental agreement and corresponding legislation that is being enacted in each State and Territory, underpins Australia’s nationally consistent regulatory system for gene technology. Its objective is to protect the health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology, and managing those risks by regulating certain dealings with genetically modified organisms (GMOs). The regulatory system replaces the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC).

  2. The Act establishes a statutory officer, the Gene Technology Regulator (the Regulator), to administer the legislation and make decisions under the legislation.

  3. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR), a Commonwealth regulatory agency located within the Health and Ageing portfolio.

  4. The Act prohibits persons from dealing with GMOs unless the dealing is exempt, a Notifiable Low Risk Dealing, on the Register of GMOs, or licensed by the Regulator (see Section 31 of the Act).

  5. The requirements under the legislation for consultation and for considering and assessing licence applications and preparing risk assessment and risk management plans are discussed in detail in Division 4, Part 5 of the Act and summarised below.

  6. Detailed information about the national regulatory system and the gene technology legislation is also available from the OGTR website (www.ogtr.gov.au)

Section 2 The licence application

  1. Applications for DIR licence must be submitted in accordance with the requirements of Section 40 of the Act. As required by Schedule 4, Part 2 of the Regulations, the application must include information about:

  • the parent organism;

  • the GMOs;

  • the proposed dealing with the GMOs;

  • interaction between the GMOs and the environment;

  • risks the GMOs may pose to the health and safety of people;

  • risk management;

  • previous assessments of approvals; and

  • the suitability of the applicant.

  1. The application must also contain:

  • additional information required for a GMO that is:

  • a plant;

  • a microorganism (not living in or on animals and not a live vaccine);

  • a microorganism that lives in or on animals;

  • a live vaccine for use in animals;

  • a vertebrate animal;

  • an aquatic organism;

  • an invertebrate animal;

  • to be used for biological control;

  • to be used for bioremediation; and

  • intended to be used as food for human or vertebrate animal consumption;

  • supporting information from the Institutional Biosafety Committee.

Section 3 The initial consultation processes

  1. In accordance with Section 50 of the Act, the Regulator must seek advice in preparing a risk assessment and risk management plan (RARMP) from prescribed agencies:

  • State and Territory Governments;

  • the Gene Technology Technical Advisory Committee (GTTAC);

  • prescribed Commonwealth agencies (Regulation 9 of the Gene Technology Regulations 2001 refers);

  • the Environment Minister; and

  • relevant local council(s) where the release is proposed..

  1. Section 49 of the Act requires that if the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment, the Regulator must publish a notice in respect of the application inviting written submissions on whether the licence should be issued.

  2. As a measure over and above those required under the Act, in order to promote the openness and transparency of the regulatory system, the Regulator may take other steps. For example, receipt of applications is notified to the public by posting a notice of each application’s receipt on the OGTR website and directly advising those on the OGTR mailing list. A copy of applications is available on request from the OGTR.

Section 4 The evaluation processes

  1. The risk assessment process is carried out in accordance with the Act and Regulations, using the Risk Analysis Framework (the Framework) developed by the Regulator (available on the OGTR website). It also takes into account the guidelines and risk assessment strategies used by related agencies both in Australia and overseas. The Framework was developed in consultation with the States and Territories, Commonwealth government agencies, GTTAC and the public. Its purpose is to provide general guidance to applicants and evaluators and other stakeholders in identifying and assessing the risks posed by GMOs and in determining the measures necessary to manage any such risks.

  2. In undertaking a risk assessment, the following are considered and analysed:

  • the data presented in the proponent’s application;

  • data provided previously to GMAC, the interim OGTR or the OGTR in respect of previous releases of relevant GMOs;

  • submissions or advice from States and Territories, Commonwealth agencies and the Environment Minister and the public;

  • advice from GTTAC;

  • information from other national regulatory agencies; and

  • current scientific knowledge and the scientific literature.

  1. In considering this information and preparing the risk assessment and risk management plan, the following specific matters are taken into account, as set out in Section 49 and required by Section 51 of the Act:

  • the risks posed to human health and safety or risks to the environment;

  • the properties of the organism to which the dealings relate before it became, or will become, a GMO;

  • the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;

  • provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment;

  • the potential for spread or persistence of the GMO or its genetic material in the environment;

  • the extent or scale of the proposed dealings;

  • any likely impacts of the proposed dealings on the health and safety of people.

  1. In accordance with Regulation 10 of the Regulations, the following are also taken into account:

  • any previous assessment, in Australia or overseas, in relation to allowing or approving dealings with the GMO;

  • the potential of the GMO concerned to:

  • be harmful to other organisms;

  • adversely affect any ecosystems;

  • transfer genetic material to another organism;

  • spread, or persist, in the environment;

  • have, in comparison to related organisms, a selective advantage in the environment; and

  • be toxic, allergenic or pathogenic to other organisms.

  • the short and long term when taking these factors into account.

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