Guidelines for emergency response under the Gene Technology Act 2000 and the Gene Technology Agreement

Guidance on when and how the emergency provisions of Gene Technology Act 2000, and the relevant clauses in the Gene Technology Agreement 2001, will be invoked.

Page last updated: 17 April 2013

Guidelines for Emergency Response Under the Gene Technology Act 2000 and the Gene Technology Agreement


Printable version of Emergency Dealing Determination Guidelines (PDF 97 KB)

Introduction
Aim of This Document
Objective of the Emergency Provisions
Emergency Defined
Types of Emergencies
Process for Minister to Obtain Advice on an Emergency and the Recommended Course of Action
Consultation with States and Territories
Process for Issuing Corresponding State or Territory Emergency Regulations or Emergency Determinations
Organisational Structures and Facilitation of Advice
Extension of Emergency Response
Variation of Emergency Response
Suspension or Revocation of Emergency Response
Review of These Guidelines

Introduction

This document is issued by the Gene Technology Ministerial Council (GTMC). The GTMC was established under the Gene Technology Agreement 2001 (the Agreement) to oversee the scheme for the regulation of genetically modified organisms (GMOs).

The "scheme" as set out in the Agreement, is a cooperative national legislative scheme to protect the health and safety of people and to protect the environment, by identifying risks posed by, or as a result of, gene technology and by managing those risks through regulating certain dealings with GMOs.

More information on the regulatory scheme is available at OGTR Website. These Guidelines should be read in conjunction with Part 5A of the Gene Technology Act 2000 (the ‘Act’), as amended, and the Agreement.

Aim of this document

The aim of this document is to provide guidance on when and how the emergency provisions of the Act and relevant clauses in the Agreement will be invoked.

The Commonwealth Minister responsible for the gene technology regulatory scheme (the Minister) is responsible for two emergency provisions:
  1. The Minister may, subject to advice, issue an emergency dealing determination (EDD) to exempt dealings with a specified GMO(s) from the licensing requirements for a limited period, where the GMO is likely to help address an emergency and, any risks associated with using the GMO for that purpose can be adequately managed.
  2. The Minister may, subject to advice, declare a thing to be a GMO for a limited period where the thing poses a threat, there is uncertainty that the thing meets the definition of a GMO in the Act and it is likely the declaration will address the threat.
    These Guidelines do not address the issue of funding an emergency response or issues related to legal liability for damages caused by an emergency response. However, it is not proposed that if the emergency response causes unintended damage that the Act or the guidelines prevent or affect recourse for compensation for those affected by a decision.

    Objective of the emergency provisions

    The objective of the emergency provisions is to allow a cooperative, effective and rapid response in an emergency situation while ensuring the health and safety of people and the environment.

    Emergency defined

    For the purposes of these guidelines, an emergency is defined as:
    “an actual or imminent threat to health and safety of people or the environment.”
    Top of page

    Types of emergencies

    Emergency Dealing Determinations to Exempt Specified GMOs from Licensing Requirements (Emergency Dealing Determination)


    By issuing an EDD, the Minister can expedite the approval of a GMO in an emergency. The GMO may then be released into the environment without being subject to normal GMO licensing requirements, including the standard 170 day approval process required under the Act.

    Situations in which an EDD may be made include, but are not limited to, the following:
    • a threat from the outbreak of a plant, animal or human disease;
    • a threat from a particular animal or plant, such as a pest or an alien invasive species; or
    • a threat from an industrial spillage.

    The GMO or class of GMOs, which is covered by the EDD may be used for a number of objectives, including:
    • minimising or eradicating a problem organism or its vectors;
    • conveying immunity in humans and/or animals; or
    • aiding in the degradation or dissipation of a hazardous substance.

    The types of activities and measures that could be approved in an EDD to achieve those objectives are limited to those defined in section 10 of the Act and include:
    • conducting experiments with the GMO;
    • making, developing, producing or manufacturing the GMO;
    • breeding the GMO;
    • propagating the GMO;
    • using the GMO in the course of manufacture of a thing that is not the GMO;
    • growing, raising or culturing the GMO;
    • importing the GMO;
    • supplying the GMO;
    • using the GMO;
    • transporting the GMO; and
    • disposal of the GMO.

    Examples of where an EDD could be issued include threat of an avian flu pandemic, or where there is a threat of major environmental damage from an oil spill. In these circumstances, the EDD could cover dealings in relation to a genetically modified vaccine for human or veterinary use, or a genetically modified bacterium to dissolve oil, respectively.

    Emergency Regulation Declaring a Thing to be a GMO (Emergency Regulation)


    The Minister may declare a thing to be a GMO by regulation for a limited period if the Minister believes on reasonable grounds that the thing is an actual or imminent threat to the health and safety of people or the environment and there is doubt that the thing meets the definition of a GMO in the Act.

    If a thing is already being dealt with when the Minister declares that thing to be a GMO, any person dealing with that thing (the ‘emergency GMO’) must apply for a licence from the Regulator, unless the dealings with the emergency GMO are notifiable low risk dealings or otherwise exempt under the Act.

    A person may be eligible to apply for an inadvertent dealings licence to dispose of the emergency GMO, if that person was unaware that it was a GMO when he or she came into possession of it.
    Top of page

    Process for Minister to obtain advice on an emergency and the recommended course of action


    The processes for the making of EDD and emergency regulations are described below and summarised in the flow charts in Appendix 1 of the printable PDF document.

    Emergency Dealing Determination

    The Minister may make an EDD only after receiving advice from the Chief Medical Officer (CMO), the Chief Veterinary Officer (CVO), the Chief Plant Protection Officer (CPPO) and / or a person or class of persons prescribed by the Regulations that:
    • there is an emergency; and
    • issuing an EDD would help respond to the emergency.

    The Regulator will forward to the Minister any advice from the CMO, CVO and / or CPPO regarding the emergency and the ability of the proposed dealings to address the emergency.

    The Minister must also have received advice from the Regulator that any risks posed by the dealings in the EDD are able to be managed so as to protect the health and safety of people and the environment.

    Before issuing an EDD, the Minister must be satisfied that an emergency exists, that issuing an EDD would, or is likely to, adequately address the emergency, and that any risks posed by the GMO dealing authorised under the EDD are manageable. However, the existence of a GMO solution, through the making of an EDD, to an emergency should not automatically justify its making.

    In practice, the Regulator will coordinate the provision of advice to the Minister by obtaining an accurate picture of the nature and extent of the emergency and the ability of the EDD to address the threat, and receiving confirmation of this view from the CMO, CVO and / or the CPPO and other relevant experts in states and territories. The Regulator will then assess whether the risks posed by those dealings are able to be managed to protect the health and safety of people and the environment and forward this advice along with advice received from the CMO, CVO and / or CPPO to the Minister. The Regulator will also consult with the states and territories through the Gene Technology Standing Committee (GTSC) or the GTMC before advising the Minister. No response by states and territories within 48 hours will be taken as tacit consent. In the case of a threat to the environment, the Regulator will consult with the Minister for Environment and Water Resources and the Secretary of the Australian Government Department of Environment and Water Resources.

    Emergency Regulation

    Before making an emergency regulation, the Minister must have received advice from the Commonwealth CMO, the Commonwealth CVO and / or the Commonwealth CPPO that the thing poses an actual or imminent threat to the health and safety of people or the environment. In the case that there is an environmental impact, the Commonwealth CMO, the Commonwealth CVO and / or the Commonwealth CPPO will consult with the Secretary of the Commonwealth Department of Environment and Water Resources. In addition, the Minister must have received advice from the Regulator that declaring the
    thing to be a GMO would help respond to the threat.

    The Minister must not issue an emergency regulation unless he or she is satisfied that the thing poses a threat and that declaring the thing to be a GMO would help respond to the threat.

    As for an EDD, the Regulator will coordinate the provision of advice on the emergency regulation to the Minister, including any advice received from the CMO, CVO and / or CPPO. After the CMO, CVO and / or CPPO have provided advice, the Regulator will assess whether declaring the thing to be a GMO would help respond to the threat posed by it. In the case that there is an environmental impact, the Commonwealth CMO, the Commonwealth CVO and / or the Commonwealth CPPO will consult with the Secretary of the Commonwealth Department of Environment and Water Resources before providing advice to the Regulator. The Regulator will also consult with the states and territories through the GTSC or the GTMC before providing advice to the Minister. No response by states and territories within 48 hours will be taken as tacit consent.
    Top of page

    Consultation with states and territories

    Having either been advised that an emergency exists and that making an EDD or emergency regulation would help respond to that emergency, the Regulator must, through the GTMC Secretariat, notify the members of the GTSC and the GTMC in an emergency out-of-session notification. The Regulator will then consult with states and territories through representatives of the GTSC, unless a State or Territory GTMC member has nominated, in writing, that they should be the representative consulted. No response by states and territories within 48 hours will be taken as tacit consent. After consulting with states and territories through the GTSC or the GTMC, the Regulator must advise the Minister of the outcome of the consultation. The Minister will then consider the
    advice before issuing an EDD or emergency regulation. The Regulator will provide details of the EDD or a licence issued subsequent to the making of, and in relation to, an emergency regulation, as well as any breaches of condition as part of its regular quarterly report.

    Process for issuing corresponding state or territory emergency regulations or emergency determinations


    An emergency meeting of the GTSC will be called by the GTSC Secretariat as soon as possible after the Minister has issued an EDD or an emergency regulation under Commonwealth law. At this meeting, members will discuss the procedure for issuing equivalent EDD or emergency regulations under State or Territory law.

    Organisational structures and facilitation of advice


    Existing committees and office holders, providing State and Territory representation, that may facilitate the provision of advice to the Regulator and Minister include, but are not limited to:
    • Australian Health Protection Committee (AHPC);
    • State and Territory counterparts of the Chief Veterinary Officer;
    • State and Territory counterparts of the Chief Plant Protection Officer;
    • Australian Health Ministers’ Advisory Committee (AHMAC);
    • Primary Industry Standing Committee (PISC);
    • Natural Resource Management Standing Committee (NRMSC);
    • Australian Maritime Safety Authority (AMSA);
    • Environment Protection and Heritage Council (EPHC);
    • Gene Technology Technical Advisory Committee (GTTAC); and
    • Gene Technology Ethics and Community Consultative Committee (GTECCC).

    Other groups may be also be contacted depending on the nature of the emergency include Plant Health Australia, Animal Health Australia, other bodies representing potentially affected sectors. In all cases, AHPC should be contacted immediately in the event of an emergency which is likely to affect the health and safety of people.

    Extension of emergency response


    Emergency Dealing Determination

    An EDD is valid for a maximum period of six months. The Minister may extend the EDD in writing for up to six months if the majority of jurisdictions agree.

    To extend an EDD the Minister must have received advice from the person who originally provided advice on the making of the EDD that the emergency still exists and that extending the EDD would, or is likely to, adequately address. In addition, the Minister must have received advice from the Regulator that any risks posed by the dealings are able to be managed. Before extending the EDD, the Minister must be satisfied that the threat still exists, that the EDD would adequately deal with the threat and that any risks can be managed safely.

    The Minister may extend the EDD more than once providing that the consultation process is repeated each time and the majority of jurisdictions agree.

    Persons covered by an EDD will be advised that the determination will not necessarily be extended and that it is recommended that they apply for a licence under Part 5 of the Act as soon as practicable. This could remove the need to extend the EDD as the standard 170 day licence approval process could have concluded before the EDD has expired.

    Emergency Regulation

    The GTMC must review the regulation within six months and as a result of the review can decide, by special majority, whether to amend, revoke or maintain the emergency regulation.
    Top of page

    Variation of emergency response


    Emergency Dealing Determination

    The Minister may vary the conditions of an EDD in writing. If a variation is substantive rather than administrative in nature, then the states and territories must be consulted about the variation. No response by states and territories within 48 hours will be taken as tacit consent.

    A substantive variation could include, for example, a variation to allow the GMO in the dealing to be released in a different or new location. An administrative variation could include a variation to correct a typographical error in a determination or to update the name of a position-holder.

    Emergency Regulation

    The Commonwealth may amend the contents of an emergency regulation after consulting with states and territories. No response by states and territories within 48 hours will be taken as tacit consent.

    Suspension or revocation of emergency response


    Emergency Dealing Determination

    An EDD will come to an end after six months, or on a day specified in the determination. The Minister may suspend or revoke an EDD before it is due to come to an end, if the states and territories have been consulted* and the Minister:
    • becomes aware of risks posed by the dealings that cannot be managed safely;
    • is satisfied that the emergency no longer exists or is no longer sufficiently actual or imminent to justify an EDD; or
    • is no longer satisfied that the dealings adequately deal with the threat.

    *No response by states and territories within 48 hours will be taken as tacit consent.

    Emergency Regulation

    The GTMC must review the Regulation within six months.

    The Commonwealth may revoke an emergency regulation if the Minister:
    • receives advice that the thing no longer poses an actual or imminent threat to the health and safety of people or the environment; and
    • is satisfied that the thing no longer poses a threat and that the declaration of the thing to be a GMO would no longer help respond to the threat; and

    • has consulted* with states and territories through the GTSC or GTMC.
    *No response by states and territories within 48 hours will be taken as tacit consent.

    Review of these guidelines


    These Guidelines will be reviewed by the GTMC after their first practical use in an
    emergency situation, or if a need to review them arises, as identified by the GTMC.
    Top of page