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