Guidelines for the Transport, Storage and Disposal of GMOs

Administered by Department of Health, Disability and Ageing

Legislation au F2011L00992 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

Gene Technology Act 2000

 

Guidelines for the Transport Storage and Disposal of GMOs

 

It is a function of the Gene Technology Regulator under paragraph 27(d) of the Gene Technology Act 2000 (‘the Act’) to issue technical and procedural guidelines in relation to GMOs.

 

Such guidelines are used for the purposes of imposing conditions and requirements associated with the risk management of dealings with GMOs authorised by the Act. Transport and disposal of GMOs are defined as dealings under section 10 the Act, as is the storage of GMOs in the course of, or for the purpose of, dealings with GMOs.

 

Amendments to the Gene Technology Regulations include a requirement at subparagraph 13(3)(b)(i) that a Notifiable Low Risk Dealing involving the transport, storage or disposal of a GMO, be undertaken in accordance with the Guidelines for the Transport, Storage and Disposal of GMOs issued for that purpose and as in force on 1 September 2011. These are the Guidelines that are issued for that purpose.

 

These Guidelines are also issued for the purpose of being invoked either wholly or in part as conditions of licensed dealings with GMOs which are imposed under section 61 of the Act, and as conditions of certification of a facility which are imposed under section 86 of the Act.

 

Details of the Guidelines are in the Attachment.

 

While applications for licences and for certification of facilities, and the nature of conditions necessary to manage risk, are assessed on a case by case basis, the availability of a uniform set of requirements in respect of transport, storage and disposal of GMOs, which can be invoked as the case requires, is an efficient and effective means of conditioning those dealings in a manner commensurate with the level of identified risk.

 

The Guidelines refer to Australian / New Zealand Standard 2243.3:2010, Safety in laboratories Part 3: Microbiological safety and containment. This standard is available for online purchase from the publisher, SAI Global, at their website http://www.saiglobal.com/. Australian / New Zealand standards are also often available at public libraries in Australia.

 

As part of the consultation with respect to the draft Guidelines, requests for comments were sent to stakeholders, including all 199 organisations accredited by the Gene Technology Regulator, under the Act and their Institutional Biosafety Committees, 21 relevant government agencies, and a group of seven AQIS-approved third party assessors and bio-containment experts.

 

A public invitation to comment was also posted on the OGTR website.

 

In response, 19 submissions were received. Most comments were constructive offering suggestions on definitions, points of clarification, and feedback on technical and procedural issues that assisted in refining the requirements.  A small number of comments related to existing legislative requirements.

 

These Guidelines commence on 1 September 2011.

 

These Guidelines are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

 

 

THE GENE TECHNOLOGY REGULATOR    

DEPARTMENT OF HEALTH AND AGEING

June 2011

 


ATTACHMENT

 

GUIDELINES UNDER SUBSECTION 27(D) OF THE GENE TECHNOLOGY ACT 2000 FOR THE TRANSPORT STORAGE AND DISPOSAL OF GMOS.

 

Details of the Guidelines

 

The Guidelines are structured into three (3) main parts covering:

 

  transport;

  storage; and

  disposal.

 

Each of these parts is variously separated into sub-parts covering different risk levels for GMOs.  The risk levels broadly correspond to the levels of physical containment facilities such as laboratories.  There are four (4) such levels.  The lowest level is Physical Containment Facility Level 1 (PC1) and the highest being PC4. 

 

Within each of these sub-parts there are separate sections which are applicable to different types of organisms such as micro-organisms, animals or plants that are GMOs.

 

These sections contain requirements covering areas such as:

 

 obligations to inform persons handling the containers of GMOs that they are dealing with a GMO;

 labelling requirements for containers;

 procedures to ensure that all containers of GMOs can be accounted for;

 requirements limiting access to the GMOs to persons considered suitable by the Institutional Biosafety Committee (IBC) that has assessed the dealing;

 levels of containment required;

 decontamination requirements for containers and spillages; and

 requirements to keep GMOs separated from non-GM organisms.

 

Definitions and Acronyms

 

This section provides definitions and acronyms for specified terms used in the guidelines.

 

Part I

 

Part 1 specifies the requirements for the transport of Notifiable Low Risk Dealings (NLRDs) with genetically modified organisms (GMOs) outside of a containment facility that is certified by the Gene Technology Regulator (the Regulator).  The requirements in this part are to ensure that when GMOs are transported there is minimal risk of loss or release to the environment and that they safely arrive at their destination.

 


Part II

 

Part 2 specifies the requirements for the storage of NLRDs outside of a containment facility that is certified by the Regulator.  The requirements in this part are to ensure that when GMOs are stored they are done so in a safe manner, that access is restricted to only persons with appropriate training and expertise and that the GMOs can be accounted for and retrieved.

 

 

Part III

 

Part 3 specifies the requirements for the decontamination or disposal of GMOs, or waste containing GMOs, and the decontamination of equipment involved in procedures with GMOs related to NLRDs.

 

The requirements principally cover the decontamination of GMOs prior to their subsequent disposal, which ensures that no viable GMOs are discarded as waste, or in waste that was associated with the dealings. However, decontamination may be part of the disposal process where the disposal process also destroys the GMO (e.g. incineration).  The requirements focus on ensuring that the decontamination is effective.

 

 

 

 

 

 

 

 

THE GENE TECHNOLOGY REGULATOR    

DEPARTMENT OF HEALTH AND AGEING

June 2011

 

Overview

The Gene Technology Act 2000 was enacted to address the regulatory gap concerning the handling, transport, storage, and disposal of genetically modified organisms (GMOs). This Act empowers the Gene Technology Regulator to issue guidelines for managing the risks associated with GMOs. The Act was enacted by the Parliament of Australia to provide a regulatory framework that ensures the safe handling and use of GMOs, while also addressing potential risks to human health and the environment. The policy objective of the Act is to balance the promotion of biotechnology advancements with stringent risk management to protect public health and the environment. The Guidelines for the Transport, Storage and Disposal of GMOs, issued under the authority of the Act, serve to provide uniform, risk-based requirements that can be applied to various dealings with GMOs, ensuring they are conducted in a manner commensurate with the level of identified risk. These guidelines, issued in June 2011, are structured to cover transport, storage, and disposal of GMOs, with different requirements based on the risk levels associated with the organisms. They incorporate feedback from stakeholders, including accredited organisations, government agencies, and bio-containment experts, ensuring that the guidelines are practical and effective. The guidelines also reference Australian/New Zealand Standard 2243.3:2010, providing a technical basis for the safety and containment measures. The guidelines are intended to be invoked as conditions in licensed dealings and facility certifications, ensuring compliance with the Act's objectives.

Scope and Application

The Gene Technology Act 2000, as supplemented by Guidelines for the Transport, Storage and Disposal of GMOs, applies to any dealings with genetically modified organisms (GMOs) that are categorised as Notifiable Low Risk Dealings (NLRDs). These guidelines are intended to ensure that the transport, storage, and disposal of GMOs are conducted in a manner that minimises the risk of environmental contamination and ensures the safe handling of GMOs. The Act applies to both individuals and entities involved in the transport, storage, or disposal of GMOs, including researchers, companies, and institutions, across Australia. The geographic reach of these regulations is national, covering all states and territories of Australia. The guidelines are applicable to all types of GMOs, irrespective of their intended use or the level of risk associated with them. Subordinate instruments may extend or restrict the application of these guidelines further. However, the primary focus remains on ensuring the safe and controlled management of GMOs in a way that aligns with the national regulatory framework.

Key Provisions

The Guidelines for the Transport, Storage and Disposal of GMOs issued under section 27(d) of the Gene Technology Act 2000 (the Act) provide detailed technical and procedural instructions for handling genetically modified organisms (GMOs) safely. These Guidelines, which commenced on 1 September 2011, are structured into three main parts: transport (Part I), storage (Part II), and disposal (Part III). Each part is further divided into sub-parts that correspond to different risk levels of GMOs, ranging from Physical Containment Facility Level 1 (PC1) to PC4. The Guidelines cover various requirements including obligations to inform handlers, labelling, accountability, access restrictions, containment levels, decontamination, and separation from non-GM organisms. Under the Act, these Guidelines impose several obligations on parties and entities dealing with GMOs. For transport (Part I), the Guidelines ensure that GMOs are transported with minimal risk of loss or release and safely arrive at their destination. For storage (Part II), they ensure that GMOs are stored safely, access is restricted to trained personnel, and they can be properly accounted for and retrieved. For disposal (Part III), the Guidelines mandate effective decontamination to ensure that no viable GMOs are discarded as waste. These requirements apply to Notifiable Low Risk Dealings (NLRDs) involving GMOs and are intended to manage the risks associated with their transport, storage, and disposal. Breaches of these Guidelines can result in significant consequences. While the Guidelines themselves do not explicitly list penalties, the Act provides a framework under which non-compliance with the Guidelines can lead to enforcement actions. Under the Gene Technology Regulations, a Notifiable Low Risk Dealing that does not comply with the Guidelines can result in enforcement actions by the Regulator. Additionally, failure to adhere to the Guidelines as conditions of licensed dealings or facility certification can lead to the revocation of licenses or certifications. The Act also allows for civil and criminal penalties for serious breaches, although the specific penalties are not detailed within the Guidelines but are subject to the overarching provisions of the Act and related regulations.

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