Guidelines for the Transport, Storage and Disposal of GMOs

Mechanically, these Guidelines, issued by the Gene Technology Regulator under paragraph 27(d) of the Gene Technology Act 2000, set prescriptive operational requirements for the transport, storage and disposal of genetically modified organisms (GMOs). They commenced on 1 September 2011 and are expressly issued for the purposes of paragraph 13(3)(b) of the Gene Technology Regulations 2001 and may be invoked in the exercise of the Regulator’s functions (s 27) and powers (s 28) and in the imposition of licence conditions (s 61) and certification conditions (s 86) under the Act. The document covers: what constitutes authorised physical containment facilities; definitions of terms such as sealed, unbreakable, primary/secondary containers, viable and transport; per-containment-level (PC1-PC4) rules for transport (Part 1); storage rules (Part 2); and decontamination and disposal rules (Part 3). The Guidelines also cross‑reference AS/NZS 2243.3:2010 and require compliance with other State/Territory/local regulations where relevant.

The Guidelines do not create criminal penalties within their text. Instead they create mandated operational duties that the Regulator can invoke through licence and certification conditions, and they require reporting and record-making obligations that must be made available to the Regulator on request (for example, transport records and autoclave calibration/monitoring data). Specific procedural requirements include labelling obligations (e.g. 1.1.1.1; 1.2.1.1; 1.3.1.1), containment standards (e.g. sealed, unbreakable primary containers in 1.1.2.1, 1.2.2.1, 1.3.1.5), security restrictions limiting access to persons/classes listed in an Institutional Biosafety Committee (IBC) record of assessment (e.g. 1.1.1.5, 1.2.1.5, 1.3.1.12), mandated actions on loss/spill/escape (e.g. 1.1.1.3, 1.2.1.3, 1.3.1.7), record-keeping horizons (e.g. transport records kept at least three years under 1.3.1.11; autoclave calibration results kept five years under 3.1.8; monthly monitoring results kept 12 months under 3.1.9) and specific decontamination validation and monitoring rules (Parts 3.1.7-3.1.17, 3.1.18).

________________________________________________

I, DR ROLAND JOSEPH SMITH, the Gene Technology Regulator, acting under paragraph 27(d) of the Gene Technology Act 2000, hereby issue these guidelines.

Dated this 2nd day of June 2011

DR ROLAND JOSEPH SMITH

Gene Technology Regulator

Guidelines for the Transport, Storage and Disposal of GMOs

made under the Gene Technology Act 2000

Name of Guidelines

These Guidelines are the Guidelines for the Transport, Storage and Disposal of GMOs

Purpose

Firstly, these guidelines are issued for the purposes of paragraph 13(3)(b) of the Gene Technology Regulations 2001.

Secondly, these guidelines may also be invoked as necessary or convenient in the performance of the Regulator’s functions under section 27 of Gene Technology Act 2000 (‘the Act’), and in the exercise of the Regulator’s powers under section 28 of the Act.

In particular these guidelines may be invoked for the purposes of the imposition of licence conditions in accordance with section 61 of the Act and of certification conditions in accordance with section 86 of the Act.

Commencement

These Guidelines commence on 1 September 2011.

Contents

Name of Guidelines

Purpose

Commencement

Definitions and Acronyms

Summary Table of Applicable Sections for the Transport of GMOs

Part 1 Requirements for Transport of GMOs

1.1 Requirements for Transport of PC1 GMOs

1.1.1 PC1 General Requirements

Labelling

Loss, spill or escape of GMOs during transport

Accounting requirements

Security arrangements

Decontamination of containers

Packaging with coolants

1.1.2 PC1 GM micro-organisms (including plants or animals containing GM micro-organisms)

Containment

Labelling

Decontamination of material transported with GM micro-organisms

1.1.3 PC1 GM animals not containing GM micro-organisms

Containment

Labelling

Segregation

Decontamination of containers

1.1.4 PC1 GM plants not containing GM micro-organisms

Containment

Labelling

Decontamination of material transported with the GMOs

1.2 Requirements for Transport of PC2 GMOs

1.2.1 PC2 General Requirements

Labelling

Loss, spill or escape of GMOs during transport

Accounting requirements

Security arrangements

Decontamination of containers

Packaging with coolants

1.2.2 PC2 GM micro-organisms (including plants or animals containing GM micro-organisms)

Containment

Containment of waste transported inside the same building

Labelling

Decontamination of material transported with GM micro-organisms

1.2.3 PC2 GM animals, not containing GM micro-organisms

Containment

Labelling

Segregation

Decontamination of containers

1.2.4 PC2 GM plants, not containing GM micro-organisms

Containment

Labelling

Decontamination of material transported with the GMOs

1.3 Requirements for Transport of PC3 GMOs

1.3.1 PC3 Requirements

Notice that item to be transported is a GMO

Labelling

Containment

Loss, spill or escape of GMOs during transport

Accounting requirements

Security arrangements

Decontamination of containers

Packaging with coolants

1.4 Requirements for Transport of PC4 GMOs

1.4.1 All GMOs

Part 2 Requirements for the Storage of GMOs

2.1 Storage requirements for PC1 and PC2 GMOs stored outside of authorised physical containment facilities.

Restrictions on storage

Containment

Loss, spill or escape of GMOs during storage

Labelling

Accounting requirements

Security

2.2 Storage requirements for PC3 and PC4 GMOs stored outside of authorised physical containment facilities.

Part 3 Requirements for the Disposal of GMOs.

3.1 Requirements for the Disposal of PC1 & PC2 GMOs

Other regulations

Notice that item to be disposed of is a GMO

Decontamination Prior to Disposal

Decontamination methods

Prohibited decontamination

3.2 Requirements for the Disposal of PC3 & PC4 GMOs

Standards referenced in this document

List of the Australian/New Zealand standards referenced in this document

Definitions and Acronyms

Unless defined otherwise in these guidelines, words and phrases used in these guidelines have the same meaning as in the Act and the Regulations.

Words in the singular include the plural and words in the plural include the singular.

References to any statute or other legislation (whether primary or subordinate) are a reference to a statute or other legislation of the Commonwealth of Australia as amended or replaced from time to time and equivalent provisions, if any, in corresponding State law, unless the contrary intention appears.

Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning.

aerosol	Suspension in air of finely dispersed solids and liquids.
authorised physical containment facilityorauthorised PC(1, 2, 3 or 4) facility	A physical containment facility that is: certified by the Regulator under section 84 of the Act; permitted to contain GMO dealings under conditions of a licence issued by the Regulator; or otherwise authorised in writing by the Regulator under regulation 13(2)(c) of the Regulations.‘PC(1, 2, 3 or 4)’ means Physical Containment level 1, 2, 3 or 4.
decontamination or decontaminate	A physical or chemical process which removes, kills or renders non-viable the GMOs used. In the case of micro-organisms this may not necessarily result in sterility.
disposal	The destruction, discarding, or throwing away of decontaminated GMOs.
GMO	Genetically Modified Organism.
GM	Genetically Modified
flood	For the purposes of these guidelines ‘flood’ includes: mainstream flooding (an event where water from a creek, river, lake, estuary or coastal waters overflows the natural or artificial banks of the principal watercourses in a catchment); flash flooding (flooding that occurs within six hours of the rain which causes the flooding); and stormwater flooding (local runoff exceeding the capacity of an urban stormwater drainage system).
IBC	Institutional Biosafety Committee.
NLRD	Notifiable Low Risk Dealing.
micro-organism	An organism too small to be viewed by the unaided eye, including bacteria, fungi, viruses and some multicellular organisms. For the purposes of these guidelines, this definition includes viral vectors.
PC1	Physical Containment Level 1.
PC2	Physical Containment Level 2.
PC3	Physical Containment Level 3.
PC4	Physical Containment Level 4.
primary container	A container immediately surrounding the GMO.
prone to flooding	For the purposes of these guidelines, the determination of whether the location of a site is prone to flooding or storm surges depends on the expected frequency of these events. A site will be regarded as being prone to flooding if the floor of the site would be inundated by a 100 year Average Recurrence Interval (ARI) flood or storm surge event. (This equates to a 1 in 100 year flood level, or an Annual Exceedance Probability (AEP) of 1%.). If it is not possible to obtain the 100 year ARI flood level from the relevant local authority, then the highest ARI or Defined Flood level used by that authority will be taken to be the level for determining if the location is prone to flooding or storm surges.
qualified person	A person who has acquired through training, qualifications or experience, or a combination of these, the knowledge and skill enabling that person to accomplish the relevant task competently.
sealed	Able to contain all GMOs or the reproductive material of GM plants or GM aquatic organisms (including pollen or gametes) being transported or stored, and able to remain closed during all reasonably expected conditions of transport and storage.
secondary container	The container immediately surrounding the primary container.
storage	The act of holding or keeping of GMOs or parts of GMOs without undertaking any experimentation or other procedures on the GMOs or parts of GMOs.NOTE: It would normally be expected that there would be no metabolic activity or minimal metabolic activity in the GMOs. This may involve low temperatures or freezing of cultures but may also involve the holding of stocks of diapausing insects or cell cultures for relatively short periods of time. It would not include the holding of actively growing plants and animals.
storm surge	For the purposes of these guidelines, a storm surge is a rise in coastal water levels caused by the low pressure area of a storm or cyclone and wind driving water shoreward.
substantive amount of liquid	That amount of liquid more than that which adheres to the inside of a container (such as a bottle) when its contents have been emptied out.
the Act	Gene Technology Act 2000 and, as applicable, corresponding State legislation.
the Regulations	The Commonwealth Gene Technology Regulations 2001.
transport	Includes: movement of GMOs between one authorised physical containment facility and another; movement of GMOs between one authorised physical containment facility and storage outside of an authorised physical containment facility; movement of GMOs between a place of storage outside of an authorised physical containment facility to another place of storage outside of an authorised physical containment facility; movement of GMOs between any points specified in a licence; movement of GMOs from any point specified in a licence to an authorised physical containment facility; movement of GMOs from an authorised physical containment facility, or from storage outside of an authorised physical containment facility, to a place where the GMOs are to be decontaminated or disposed of (e.g. to an autoclave or incinerator); movement of GMOs imported into Australia from the Australian border to: an authorised physical containment facility; storage outside of an authorised physical containment facility; or a point of export from Australia or to a place where the GMOs are to be decontaminated or disposed of; movement of GMOs to be exported from Australia, to the Australian border from an authorised physical containment facility or from storage outside of an authorised physical containment facility; movement of liquid waste containing GMOs via piping or tubing from an authorised physical containment facility to a place outside the boundary of the facility for further transport, storage, decontamination or disposal.Within these guidelines transport does not include movement of GMOs: from an area in an authorised physical containment facility to another area entirely within the same facility; or from one part of an area authorised by a licence to another part of the same area (for example, from one part of a field planting location to another part of the same field planting location).
unbreakable	Able to withstand all reasonably expected conditions of transport and storage such as: the forces, shocks and impacts expected during handling; or changes of temperature, humidity or air pressure.
viable	Micro-organisms, cells and cell cultures: able to survive or multiply even though resuscitation procedures may be required, e.g. when sub-lethally damaged by being frozen, dried, heated, or affected by chemicals, including decontamination agents.Other organisms, whole or part: able to live and grow independently of its parent or source organism, or able to reproduce or contribute genetic material to reproduction (e.g. sperm, ova, pollen, seeds, vegetative propagules).

Summary Table of Applicable Sections for the Transport of GMOs

Table 1 Summary of the sections of the guidelines which apply to dealings involving transport

<table cellspacing="0" cellpadding="0" style="width:469.95pt; border-collapse:collapse"><tbody><tr><td style="width:11.7pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TSDBody" style="text-align:left"><span></span></p></td><td style="width:86.1pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TSDBody" style="text-align:left"><span></span></p></td><td colspan="4" style="width:339.75pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:middle"><p class="TSDBody" style="text-align:center"><a id="_Toc264474104"><span style="font-family:Arial, sans-serif; font-weight:bold">Containment level</span></a></p></td></tr><tr><td style="width:11.7pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TSDBody" style="text-align:left"><span></span></p></td><td style="width:86.1pt; border-right:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.4pt; vertical-align:top"><p class="TSDBody" style="text-align:left"><span></span></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:middle"><p class="TSDBody" style="text-align:center"><a id="_Toc264474105"><span style="font-weight:bold">PC1</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:middle"><p class="TSDBody" style="text-align:center"><a id="_Toc264474106"><span style="font-weight:bold">PC2</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:middle"><p class="TSDBody" style="text-align:center"><a id="_Toc264474107"><span style="font-weight:bold">PC3</span></a></p></td><td style="width:74.7pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:middle"><p class="TSDBody" style="text-align:center"><a id="_Toc264474108"><span style="font-weight:bold">PC4</span></a></p></td></tr><tr><td rowspan="3" style="width:11.7pt; height:0pt; writing-mode:tb-rl; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><div style="height:0pt; writing-mode:tb-rl"><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><a id="_Toc264474109"><span style="font-family:Arial, sans-serif; font-weight:bold">Type of GMO</span></a></p></div></td><td style="width:86.1pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474110"><span style="font-weight:bold">Micro-organism</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474111"><span>1.1.1 (page </span><span>11</span><span>)</span></a></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474112"><span>1.1.2 (page </span><span>13</span><span>)</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474113"><span>1.2.1 (page </span><span>16</span><span>)</span></a></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474114"><span>1.2.2 (page </span><span>19</span><span>)</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474115"><span>1.3.1 (page </span><span>23</span><span>)</span></a></p></td><td style="width:74.7pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474116"><span>1.4.1 (page </span><span>26</span><span>)</span></a></p></td></tr><tr><td style="width:86.1pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474117"><span style="font-weight:bold">Animal</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474119"><span>1.1.1 (page </span><span>11</span><span>)</span></a></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474120"><span>1.1.3 (page </span><span>14</span><span>)</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474121"><span>1.2.1 (page </span><span>16</span><span>)</span></a></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474122"><span>1.2.3 (page </span><span>21</span><span>)</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474123"><span>1.3.1 (page </span><span>23</span><span>)</span></a></p></td><td style="width:74.7pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; background-color:#e0e0e0"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><span></span></p></td></tr><tr><td style="width:86.1pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474132"><span style="font-weight:bold">Plant</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><span>1.1.1 (page </span><span>11</span><span>)</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><span>1.1.</span><span>4 </span><span>(page </span><span>15</span><span>)</span></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474133"><span>1.2.1 (page </span><span>16</span><span>)</span></a></p><p class="TSDBody" style="margin-bottom:3pt; text-align:center"><span>and</span></p><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474134"><span>1.2.4 (page </span><span>22</span><span>)</span></a></p></td><td style="width:77.55pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><a id="_Toc264474135"><span>1.3.1 (page </span><span>23</span><span>)</span></a></p></td><td style="width:74.7pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top; background-color:#e0e0e0"><p class="TSDBody" style="margin-bottom:3pt; text-align:left"><span></span></p></td></tr></tbody></table>

Part 1 Requirements for Transport of GMOs

1.1 Requirements for Transport of PC1 GMOs

This Part applies to the following dealings with GMOs:

NLRDs that are listed in Part 1 of Schedule 3 of the Regulations ; or
any other dealings that are permitted, in writing, by the Regulator to be conducted in authorised PC1 facilities or transported under this Part of these guidelines.

1.1.1 PC1 General Requirements

Where any Specific Requirements (Parts 1.1.2, 1.1.3 or 1.1.4) applicable to the dealings conflicts with a General Requirement, the Specific Requirement prevails.

Labelling

1.1.1.1 A person or accredited organisation supplying the GMO for transport must label the material to be transported in a manner capable of notifying any other handler of the material that the item to be transported is, or contains a GMO.

1.1.1.2 Where transport is being undertaken by a service provider then the outermost container must be labelled to clearly show the name, address and contact details of the sender, so that the sender can be contacted should the container be lost, damaged or misdirected.

Loss, spill or escape of GMOs during transport

1.1.1.3 In the event of the escape, unintentional release, spill, leak, or loss of GMOs, including failure of the GMOs to be delivered to the recipient:

efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable; and
the incident must be reported to the Regulator as soon as reasonably practicable.

Accounting requirements

1.1.1.4 Procedures must be in place to ensure that all GMOs or the number of primary containers of cultures of GMOs transported, can be accounted for and that a loss of GMOs during transport, or the failure of delivery, can be detected. These procedures must be implemented for all transport events, except where transport takes place entirely within a building and the GMOs are accompanied by a person mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs at all times.

Security arrangements

1.1.1.5 Access to the GMOs must be restricted, by any means that is effective, to only a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs. This includes situations where containers are left for collection in a loading area, or left unattended prior to decontamination.

NOTE: Access in such cases could be restricted, for example, by keeping the containers in a locked area until collection.

Decontamination of containers

1.1.1.6 The external surface of the outermost container must be decontaminated prior to transport.

NOTE: Where appropriate, visual inspection of the container(s) may be used to confirm whether decontamination is necessary (e.g. in the case of macroscopic organisms which are easy to see).

1.1.1.7 Containers must be decontaminated after transport.

Packaging with coolants

1.1.1.8 If the material being transported is to be cooled using dry ice, liquid nitrogen or any other coolant that will release a gas, then a mechanism to allow the escape of the gas must be included. If water ice is used as a coolant then the outer packaging should be constructed so as to prevent any leakage. All containers must be able to withstand the temperatures to which they will be subjected.

1.1.2 PC1 GM micro-organisms (including plants or animals containing GM micro-organisms)

The following requirements, in addition to the General Requirements (Part 1.1.1), apply to the transport of GM micro-organisms (including GM or non-GM plants or GM or non-GM animals containing GM micro-organisms) to which Part 1.1 of these guidelines apply.

Containment

1.1.2.1 GM micro-organisms to be transported, including plants or animals containing GM micro-organisms, must be wholly contained inside a sealed, unbreakable primary container.

Labelling

1.1.2.2 Animals containing GM micro-organisms or their containers must be tagged or labelled so as to indicate that they contain GMOs. Large animals, such as pigs, sheep, cattle etc., must be individually tagged (e.g. by microchip, tattoos, ear tags or ear notches).

1.1.2.3 Plants containing GM micro-organisms or their containers must be tagged or labelled so as to indicate that they contain GMOs.

Decontamination of material transported with GM micro-organisms

1.1.2.4 Any materials transported with the GM micro-organisms (such as soil, anti-desiccation agents or soil substitute in the case of plants, or bedding materials or feed in the case of animals) must be either retained with the organisms under containment or decontaminated after transport has occurred.

1.1.3 PC1 GM animals not containing GM micro-organisms

The following requirements, in addition to the General Requirements (Part 1.1.1), apply to the transport of GM animals that do not contain GM micro-organisms.

NOTE: Animals containing PC1 GM micro-organisms are dealt with under Part 1.1.2.

Containment

1.1.3.1 GM animals to be transported must be wholly contained inside a sealed, unbreakable primary container.

NOTE: The type of containment necessary to prevent the GM animals from escaping will vary depending on the type of animal being transported. For example, in the case of transgenic mice, the primary container may be a cage that is closed or taped to enable it to maintain its integrity under all reasonably expected conditions of transport. For large grazing animals, such as sheep, cattle, horses etc., a sealed trailer, truck or specialised livestock transport vehicle may be used as the primary container.

1.1.3.2 GM large grazing animals, such as sheep, cattle, horses etc., may be herded or led between two authorised physical containment facilities, or between a transport vehicle and an authorised physical containment facility, provided:

the animals are supervised and adequately controlled to prevent their escape (e.g. by the use of temporary fencing, closed gates, or by keeping doors closed in a corridor); and
the distance being travelled is reasonably short (e.g. transfer from a vehicle to a room in an adjacent building, or transfer across a road between two PC1 Large Grazing Animal facilities where the person conducting the transfer is able to control all movements of people, traffic, and other animals on the road).

Labelling

1.1.3.3 GM animals or container(s) of GM animals must be tagged or labelled so as to indicate that they are GMOs. Large animals, such as pigs, sheep, cattle etc., must be individually tagged (e.g. by microchip, tattoos, ear tags or ear notches).

Segregation

1.1.3.4 GM and non-GM animals, capable of interbreeding, must be kept physically separated from each other during transport unless they form part of the same dealing. If the separation fails, then any non-GM animals must be transported in accordance with the requirements in these guidelines as if they were GM animals.

Decontamination of containers

1.1.3.5 After the transport of animals, containers must be decontaminated, including by ensuring no individual animals are hidden in any bedding or media.

1.1.4 PC1 GM plants not containing GM micro-organisms

The following requirements, in addition to the General Requirements (Part 1.1.1), apply to the transport of GM plants that do not contain GM micro-organisms.

NOTE: Plants containing GM micro-organisms are dealt with under Part 1.1.2.

Containment

1.1.4.1 GM plants and GM plant material containing living cells must be wholly contained inside a sealed, unbreakable primary container, e.g. leaves or roots in soil.

NOTE: In the case of non-viable GM plant material containing living cells, ‘sealed’ means able to contain the material, e.g. a wheeled bin with a lid that is not leak proof or airtight, but is secured so that it would not fall open if the bin tipped over, and would not allow any of the GM plant material in the bin to escape.

A sealed, unbreakable container can also be a pot, provided that there are no spores, pollen, seeds or cones from GM plants.

Labelling

1.1.4.2 GM plants and other viable GM plant material must be labelled to indicate that they are GMOs. This may be achieved by labelling plants or containers as appropriate.

Decontamination of material transported with the GMOs

1.1.4.3 Any materials transported with the GM plant material (such as soil, anti-desiccation agents, soil substitute, or water) must be either retained with the GM plant materials under containment or decontaminated after transport has occurred.

1.2 Requirements for Transport of PC2 GMOs

This Part applies to the following dealings with GMOs:

NLRDs that are listed in Part 2 of Schedule 3 of the Regulations; and
any other dealings that are permitted, in writing, by the Regulator to be conducted in authorised PC2 facilities or transported under this Part of these guidelines.

1.2.0.1 Dealings that are permitted to be conducted in an authorised PC1 physical containment facility but which are conducted in an authorised PC2 physical containment facility, may be transported according to the requirements relating to the transport of dealings conducted in an authorised PC1 physical containment facility under Part 1.1 of these guidelines, provided:

procedures are implemented to ensure that PC1 dealings are not cross-contaminated or mixed with GMO dealings that are required to be contained in an authorised PC2 physical containment facility; and
the above procedures are documented.

1.2.0.2 If the above documented procedures to prevent cross-contamination are not in place, then PC1 dealings conducted in an authorised PC2 physical containment facility must be transported in accordance with the PC2 transport requirements below.

1.2.1 PC2 General Requirements

These General Requirements apply to all dealings with GMOs to which Part 1.2 of these guidelines apply. Where any Specific Requirements (Parts 1.2.2, 1.2.3 and 1.2.4) applicable to the dealings conflicts with a General Requirement, the Specific Requirement prevails.

Labelling

1.2.1.1 A person or accredited organisation supplying the GMO for transport must label the material to be transported in a manner capable of notifying any other handler of the material that the item to be transported is, or contains a GMO.

1.2.1.2 The outermost container must be labelled to clearly show the name, address and contact details of the sender, so that the sender can be contacted should the container be lost, damaged or misdirected.

This is not required where transport takes place entirely within a building, or when clinical or infectious waste containing viable GMOs is being transported to a place of decontamination by a transport, storage or disposal service provider licensed or otherwise authorised to do so under state or territory legislation.

Loss, spill or escape of GMOs during transport

1.2.1.3 In the event of the escape, unintentional release, spill, leak, or loss of GMOs, including failure of the GMOs to be delivered to the recipient:

efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable; and
the incident must be reported to the Regulator as soon as reasonably practicable.

NOTE: A person consigning the GMO for transport should consider whether the transported material should be accompanied by:

instructions on how to decontaminate any material in the event of a spill or leak;
sufficient volume of effective decontamination agent to decontaminate any spill;
appropriate protective clothing for persons undertaking the decontamination; and
any other equipment necessary to undertake decontamination.

Accounting requirements

1.2.1.4 Procedures must be in place to ensure that all GMOs or, for micro-organisms and cell cultures, the number of primary containers of cultures of GMOs transported, can be accounted for and that a loss of GMOs during transport, or the failure of delivery, can be detected. These procedures must be implemented for all transport events, except where transport takes place entirely within a building and the GMOs are accompanied by a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs at all times.

Security arrangements

1.2.1.5 Access to the GMOs must be restricted, by any means that is effective, to only a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs. This includes situations where containers are left for collection in a loading area, or left unattended prior to decontamination.

NOTE: Access in such cases could be restricted, for example, by keeping the containers in a locked area until collection.

Decontamination of containers

1.2.1.6 The external surface of the primary and any required secondary container must be decontaminated prior to transport.

NOTE: Where appropriate, visual inspection of the container(s) may be used to confirm whether decontamination is necessary (e.g. in the case of macroscopic organisms which are easy to see).

1.2.1.7 Containers must be decontaminated after transport.

Packaging with coolants

1.2.1.8 If the material being transported is to be cooled using dry ice, liquid nitrogen or any other coolant that will release a gas, then a mechanism to allow the escape of the gas must be included. If water ice is used as a coolant then the outer packaging should be constructed so as to prevent any leakage. All containers must be able to withstand the temperatures to which they will be subjected.

NOTE: When transporting with coolants, it is preferable for coolants to be used outside of the secondary container.

1.2.2 PC2 GM micro-organisms (including plants or animals containing GM micro-organisms)

The following requirements, in addition to the General Requirements (Part 1.2.1), apply to the transport of GM micro-organisms (including GM or non-GM plants or GM or non-GM animals containing GM micro-organisms) to which Part 1.2 of these guidelines apply.

NOTE: Consideration should be given to alternatives to the transport of animals or plants that host pathogenic GM micro-organisms, such as transporting cultures of the micro-organisms for later inoculation.

Containment

1.2.2.1 GM micro-organisms to be transported, including plants or animals containing GM micro-organisms, must be wholly contained inside a sealed, unbreakable primary container.

When transporting animals or plants that require ventilation during transport and which contain GM micro-organisms that could form aerosols during transport, consideration must be given to whether the vents of the primary or secondary containers should be HEPA-filtered.

1.2.2.2 The primary container must be packed inside a sealed, unbreakable secondary container. Secondary containment is not required for small animals containing GM micro-organisms (e.g. mice) when transported in a sealed cage fitted with HEPA-filtered vents.

NOTE: The type of containment necessary to prevent the GM micro-organisms from escaping will vary depending on the type of organism being transported. For example, dry waste containing GMOs that does not contain sharps may be contained in two sealed plastic bags that are supported inside a third, unsealed, rigid-sided container that protects the bags from being torn or pierced during transport.

Containment of waste transported inside the same building

1.2.2.3 Waste being transported for decontamination inside the same building, and which has no substantive amount of liquid containing GMOs, and will not give rise to aerosols containing GMOs during transport, must be contained in two unbreakable containers, at least one of which must be sealed.

NOTE: For waste transported in accordance with this requirement, a ‘sealed’ container means one that is able to contain the waste material. An example would be waste in a sealed bag, placed inside a wheeled bin with a lid that is not leak proof or airtight, but is secured so that it would not fall open if the bin tipped over, and would not allow any of the waste in the bin to escape.

Labelling

1.2.2.4 A biohazard label must be attached to the outermost container when transporting any GMOs where the parent organism satisfies the criteria for classification as a Risk Group 2 organism under Section 3.2 of AS/NZS 2243.3:2010.

This is not required where transport takes place entirely within a building.

1.2.2.5 Animals containing GM micro-organisms or their containers must be tagged or labelled so as to indicate that they contain GMOs. Large animals, such as pigs, sheep, cattle etc., must be individually tagged (e.g. by microchip, tattoos, ear tags or ear notches).

1.2.2.6 Plants containing GM micro-organisms must be labelled to indicate that they contain GMOs. This may be achieved by labelling plants or containers as appropriate.

Decontamination of material transported with GM micro-organisms

1.2.2.7 Any materials transported with the GM micro-organisms (such as soil, anti-desiccation agents or soil substitute in the case of plants, or bedding materials or feed in the case of animals) must be either retained with the organisms under containment or decontaminated after transport has occurred.

1.2.3 PC2 GM animals, not containing GM micro-organisms

The following requirements, in addition to the General Requirements (Part 1.2.1), apply to the transport of GM animals that do not contain GM micro-organisms and to which Part 1.2 of these guidelines apply.

NOTE: Animals containing GM micro-organisms are dealt with under Part 1.2.2.

Containment

1.2.3.1 GM animals to be transported must be wholly contained inside a sealed, unbreakable primary container.

NOTE: The type of containment necessary to prevent the GM animals from escaping will vary depending on the type of animal being transported. For example, the primary container may be a cage that is closed or taped to enable it to maintain its integrity under all reasonably expected requirements of transport. As another example, for livestock, a sealed trailer, truck or specialised livestock transport vehicle may be used as the primary container. For large GM animals, such as pigs, sheep, cattle etc., consideration should be given as to whether a single primary container is sufficient, or whether additional measures might be prudent (e.g. tethering animals inside the vehicle; sedation; or attaching remote tracking devices to the animals).

1.2.3.2 Except for GM Drosophila (Sophophora) melanogaster, where transport involves GM invertebrates, the primary container must be packed inside a sealed, unbreakable secondary container.

Labelling

1.2.3.3 GM animals must be tagged or labelled so as to indicate that they are GMOs. Large animals, such as pigs, sheep, cattle etc., must be individually tagged (e.g. by microchip, tattoos, ear tags or ear notches). Small animals must be identified by labelling the cage or container, or individually as above.

Segregation

1.2.3.4 GM and non-GM animals capable of interbreeding, must be kept physically separated from each other unless they form part of the same dealing. If the separation fails, then any non-GM animals must be transported in accordance with the requirements in these guidelines as if they were GM animals.

Decontamination of containers

1.2.3.5 After the transport of small animals, containers must be decontaminated, including by ensuring no individual animals are hidden in any bedding or media.

1.2.4 PC2 GM plants, not containing GM micro-organisms

The following requirements, in addition to the General Requirements (Part 1.2.1), apply to the transport of GM plants that do not contain GM micro-organisms and to which Part 1.2 of these guidelines apply.

NOTE: Plants containing GM micro-organisms are dealt with under Part 1.2.2.

Containment

1.2.4.1 GM plants and GM plant material (e.g. leaves or roots in soil) containing living cells must be wholly contained inside a sealed, unbreakable primary container.

A sealed, unbreakable container can also be a pot, provided that there are no spores, pollen, seeds or cones from GM plants.

1.2.4.2 GM plants and GM plant material that is viable must also be packed inside a sealed, unbreakable, secondary container, except when:

transported within a building; and
the GM plants or GM plant material does not contain spores, pollen, seeds, or cones from GM plants.

Labelling

1.2.4.3 GM plants and other viable GM plant material must be labelled to indicate that they are GMOs. This may be achieved by labelling plants or containers as appropriate.

Decontamination of material transported with the GMOs

1.2.4.4 Any materials transported with the GM plant material (such as soil, anti-desiccation agents, soil substitute, or water) must be either retained with the GM plant materials under containment or decontaminated after transport has occurred.

1.3 Requirements for Transport of PC3 GMOs

The requirements in this Part apply to all dealings with GMOs that are:

required to be contained in a PC3 facility certified by the Regulator; or
have been involved in dealings conducted in a PC3 facility certified by the Regulator, whether or not the dealings would be permitted to be conducted in an authorised PC1 or PC2 facility.

1.3.1 PC3 Requirements

Notice that item to be transported is a GMO

1.3.1.1 A person or accredited organisation supplying the GMO for transport must label the material to be transported in a manner capable of notifying any other handler of the material that the item to be transported is, or contains a GMO.

1.3.1.2 The transport of animals or plants containing GM microorganisms that are required to be contained in an authorized PC3 containment facility is not permitted without prior, written approval from the Regulator.

Labelling

1.3.1.3 The outermost container must be labelled to clearly show the name, address and contact details of the sender, so that the sender can be contacted should the container be lost, damaged or misdirected.

1.3.1.4 A biohazard label must be attached to the outermost container.

Containment

1.3.1.5 GMOs to be transported must be wholly contained inside a sealed, unbreakable primary container.

1.3.1.6 The primary container must be packed inside a sealed, unbreakable secondary container, which must be packed inside a sealed tertiary container.

Loss, spill or escape of GMOs during transport

1.3.1.7 In the event of the escape, unintentional release, spill, leak, or loss of GMOs, during transport or failure of the GMOs to be delivered to the recipient:

the GMOs must be contained to prevent further dispersal, including preventing any insect vectors from coming in contact with the spill;
efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable;
in the case of a spill or leak, efforts must be made to isolate the area to prevent inadvertent ingress by persons or animals;
the exposed area must be immediately decontaminated with an appropriate decontaminating agent effective against the GMOs;
any material used in the clean up of a spill or personal protective clothing worn during the clean up of the spill must be decontaminated;
the incident must be reported to the Regulator as soon as reasonably possible; and
if water ice coolants were used during transportation, these must be decontaminated after transport has occurred.

1.3.1.8 A person consigning the GMO for transport must take into account the risk associated with the GMOs being transported and must transport the material with accompanying:

instructions on how to decontaminate any material in the event of a spill or leak;
sufficient volume of effective decontamination agent to decontaminate any spill;
appropriate protective clothing for persons undertaking the decontamination; and
any other equipment necessary to undertake decontamination.

1.3.1.9 Persons accompanying the GMOs being transported must also carry a functioning means of communication (e.g. mobile phone) to enable communication with the sender in the event of the unintentional release, spill, leak, or loss of GMOs.

Accounting requirements

1.3.1.10 Documented procedures must be in place to ensure that all GMOs or, for micro-organisms, the number of primary containers of cultures of GMOs transported, can be accounted for and that a loss of GMOs during transport, or the failure of delivery, can be detected. These procedures must be implemented for all transport events.

1.3.1.11 Except for transport entirely within a building, records of the transport of GMOs must be made and kept for at least three years after the transport event. These records must be made available to the Regulator, if requested.

The record of transport must include:

the name of the parent species of the GMO;
the genetic modification(s);
the number of individual containers transported and total amount: if the GMO is in a liquid such as a microbiological culture then the total volume; alternatively, if the consignment were a solid in a bulk amount, then the total net mass of the contents being transported;
the mode of transport (e.g. by hand, rail and road, road and air);
the name and contact details of the transporter(s) if transport or other service providers are used;
the name and contact details of the sender;
the name and contact details of the recipient;
the date sent; and
confirmation that the full consignment was received.

Security arrangements

1.3.1.12 Access to the GMOs must be restricted, by any means that is effective, to only a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs.

Decontamination of containers

1.3.1.13 The external surface of the primary and secondary containers must be decontaminated prior to transport.

1.3.1.14 Secondary containers must be decontaminated after transport.

Packaging with coolants

1.3.1.15 If the coolant used is dry ice, liquid nitrogen or any other coolant that will release a gas, then a mechanism to allow the escape of the gas must be included. If water ice is used as a coolant then the outer packaging must be constructed so as to prevent any leakage. All containers must be able to withstand the temperatures to which they will be subjected.

1.3.1.16 Coolants must not be used inside either the primary or secondary container.

1.4 Requirements for Transport of PC4 GMOs

1.4.1 All GMOs

The transport of GMOs that are required to be contained in a PC4 facility certified by the Regulator is not permitted without prior, written approval from the Regulator.

Part 2 Requirements for the Storage of GMOs

2.1 Storage requirements for PC1 and PC2 GMOs stored outside of authorised physical containment facilities.

Part 2 applies to the following dealings with GMOs:

NLRDs that are permitted to be stored outside of authorised PC1 or PC2 facilities by regulation 13(3)(b) of the Regulations; or
any other dealings that are permitted, in writing, by the Regulator to be stored under Part 2 of these guidelines.

NOTE: If any of the above are held in an authorised PC3 or PC4 physical containment facility then Part 2.2 applies.

Restrictions on storage

2.1.1 Whole, viable GM animals must not be stored outside of an authorised physical containment facility without permission, in writing, from the Regulator. This restriction does not apply to the sperm, fertilised eggs or embryos of GM animals.

2.1.2 Whole, viable GM plants must not be stored outside of an authorised physical containment facility without permission, in writing, from the Regulator. This restriction does not apply to the pollen, seeds, tubers, bulbs, corms or dormant stems of GM plants.

2.1.3 GMOs must not be stored in a site that is prone to flooding, storm surges or other natural disasters.

Containment

2.1.4 GMOs, including organisms containing GMOs, being stored must be wholly contained inside a sealed, unbreakable primary container.

NOTE: The type of containment necessary to prevent the GMO from being released will vary depending on the type of organism being stored. For example, in the case of plant seeds or tubers the primary container may be a bag that is closed or taped to enable it to maintain its integrity under all reasonably expected requirements of storage. A sealed plastic tube or bottle may be used as the primary container for a culture of micro-organisms.

2.1.5 GMOs for which the minimum permitted physical containment level is PC2, must be packed inside a sealed, unbreakable secondary container. In the case of a small storage unit, such as a refrigerator, freezer, or cryogenic storage container, the storage unit is permitted to be the secondary container.

Loss, spill or escape of GMOs during storage

2.1.6 In the event of the escape, unintentional release, spill, leak or loss of GMOs from storage:

efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable; and
the incident must be reported to the Regulator as soon as reasonably practicable.

NOTE: Consideration should also be given to the type of surfaces in the storage unit or room. Ideally they would be smooth, impermeable to water, cleanable, and resistant to damage by the decontamination agents that would be used to decontaminate any spill.

2.1.7 GMOs must not be stored unless a supply of decontamination agents effective against the GMOs being stored is readily available for decontamination purposes. All containers of decontamination agents, including any solutions for decontaminating hands, must be labelled with the contents and, where necessary, the expiry date. Decontamination agents must not be used after their expiry date.

NOTE: Consideration should also be given to whether the stored material should be accompanied by:

instructions on how to decontaminate any material in the event of a spill or leak;
appropriate protective clothing for persons undertaking the decontamination; and
any other equipment necessary to undertake decontamination.

Labelling

2.1.8 A person or accredited organisation supplying the GMO for storage must label the material to be stored in a manner capable of notifying any other handler of the material that the item to be stored is, or contains a GMO.

2.1.9 The primary container must be labelled to clearly show the name or other identifier of the GMO being stored.

2.1.10 The storage unit, or any other secondary container, must be labelled to clearly show the name and contact details of the person responsible for the dealings, so that the person can be contacted should any GMOs be spilled or lost.

2.1.11 A biohazard label must be attached to the storage unit when storing any GM micro-organisms that satisfy the criteria for classification as a Risk Group 2 organism under Section 3.2 of AS/NZS 2243.3:2010.

Accounting requirements

2.1.12 Procedures must be in place to ensure that all GMOs stored can be accounted for.

2.1.13 A record(s) of GMOs being stored must be maintained and made available to the Regulator upon request.

2.1.14 The record(s) of GMOs being stored must allow the person storing the GMOs to find the exact location of where the GMO is being stored.

Security

2.1.15 During the storage of GMOs outside of an authorised physical containment facility, access to the GMOs must be restricted, by any means that is effective, to only a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs.

2.2 Storage requirements for PC3 and PC4 GMOs stored outside of authorised physical containment facilities.

Part 2.2 applies to GMOs that require containment in a PC3 or PC4 facility certified by the Regulator.

2.2.1 Organisms to which Part 2.2 applies must not be stored outside of the relevant certified facility unless permitted, in writing, by the Regulator, for example by way of a licence condition.

2.2.2 If storage of any of the GMOs under 2.2.1 is permitted, in writing, by the Regulator, the storage must comply with any conditions specified in the written approval.

Part 3 Requirements for the Disposal of GMOs.

3.1 Requirements for the Disposal of PC1 & PC2 GMOs

Part 3.1 applies to the decontamination or disposal of GMOs or waste containing GMOs, and the decontamination of equipment involved in procedures with GMOs related to:

NLRDs that are assessed as being able to be conducted in authorised PC1 facilities by Part 1 of Schedule 3 of the Regulations; or
NLRDs that are assessed as being able to be conducted in authorised PC2 facilities by Part 2 of Schedule 3 of the Regulations; or
any other dealings that are permitted, in writing, by the Regulator to be decontaminated and disposed of under this Part of these guidelines.

The following requirements principally cover the decontamination of GMOs prior to their subsequent disposal. Decontamination may be part of the disposal process where the disposal process also decontaminates the GMO (e.g. incineration), or a separate process prior to later disposal.

Other regulations

Other regulations may need to be complied with for the disposal of GMOs including, where relevant, State, Territory or Local Government regulations.

Notice that item to be disposed of is a GMO

3.1.1 A person or accredited organisation supplying the GMO for disposal must label the material in a manner capable of notifying any other handler of the material that the item to be disposed of is, or contains a GMO.

Decontamination Prior to Disposal

3.1.2 GMOs, or non-GM organisms containing GMOs, must be rendered non-viable prior to disposal if the method of disposal is not also the method of decontamination.

3.1.3 Any wastes containing GMOs must be decontaminated prior to disposal if the method of disposal is not also the method of decontamination.

3.1.4 Decontamination and disposal of GMOs must only be undertaken by a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs.

3.1.5 Following use for transport or storage, the primary container, and any secondary container that is not itself a storage unit, must be decontaminated prior to reuse of the container or its disposal (if the method of disposal is not also the method of decontamination).

NOTE: Where appropriate, visual inspection of the container(s) may be used to confirm whether decontamination is necessary (e.g. in the case of macroscopic GMOs which are easy to see).

Decontamination methods

3.1.6 A person who personally conducts the decontamination process must ensure the requirements outlined below, for the respective method of decontamination, are complied with.

3.1.7 Decontamination may be effected by autoclaving using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.

3.1.8 The temperature and time controls of an autoclave used for decontaminating GMOs must be calibrated by a qualified person at least once every 12 months to determine the actual temperature and time at which the autoclave runs as compared to the autoclave gauges. The results of each year’s calibration must be kept for the previous 5 years and made available to the Regulator if requested.

NOTE: Calibration does not necessarily require adjustment of the autoclave controls. If the autoclave cannot be adjusted and is significantly out, then the set temperature, for example, can be adjusted to compensate the difference by using the data from the calibration.

3.1.9 If an autoclave is used to decontaminate GMOs, the effectiveness of decontamination by the autoclave must be monitored at least once per month by the use of:

(a) thermocouples or resistance thermometers, to ensure that the required temperature has been achieved; or

(b) chemical indicators which use a combination of moisture, heat and time and which progressively change colour with the time exposed at the specified temperature; or

(d) enzyme indicators.

The results of each month’s monitoring tests must be kept for the previous 12 months and made available to the Regulator if requested.

NOTE: Autoclaving is considered the most reliable means of decontamination, however, it is recognised that this method is not applicable in all situations. The reliability of autoclaves is predicated on correct usage and monitoring of the process. AS/NZS 2243.3:2010, Section 10.6, is a recommended source of guidance on using autoclaves.

3.1.10 If using other heat-based equipment for decontaminating GMOs, the effectiveness of decontamination equipment must be monitored at least once per month. The results of each month’s monitoring tests must be kept for the previous 12 months and made available to the Regulator if requested.

3.1.11 Decontamination may be effected by incineration in a high temperature, high efficiency incinerator that has been approved by the relevant government authority in the jurisdiction where the incinerator is located.

3.1.12 Decontamination may be effected by any other heat-based equipment using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.

3.1.13 If using other heat-based equipment for decontaminating GMOs the temperature and time controls of the equipment must be calibrated by a qualified person at least once every 12 months to determine the actual temperature and time at which the equipment runs as compared to the equipment gauges. The results of each year’s calibration must be kept for the previous 5 years and made available to the Regulator if requested.

3.1.14 Decontamination may be effected by any chemical decontamination agent that has been validated as effective for the decontamination of the GMOs.

NOTE: AS/NZS 2243.3:2010, Appendix F, is a recommended source of information when selecting and using chemical decontamination agents.

3.1.15 Decontamination of GM plant material that does not contain any GM micro-organisms may also be effected by composting of the GM plant material, along with soil and other associated material, provided:

the process is validated as effective for killing and/or decomposing the GM plant material;
the composting occurs in a dedicated concrete bay;
the concrete bay is not in a site that is prone to flooding or storm surges;
the concrete bay is free of any gaps or cracks that could be penetrated by the plants being composted;
the surface of the concrete bay is able to be easily cleaned and decontaminated;
access to the concrete bay is restricted to a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs;
all seeds have been removed from the GM plant material prior to placing in the concrete bay;
the concrete bay is protected from entry by animals that would be able to distribute any undecomposed GM plant material beyond the concrete bay;
the concrete bays containing composting GM plant material are monitored every month for volunteer GM plant growth;
any volunteer GM plants are removed and destroyed;
monitoring continues until six months has passed, after the last addition of GM plant material to the bay, without the emergence of any volunteer GM plants.

3.1.16 Decontamination of GM plant material that does not contain any GM micro-organisms may be effected by shredding the GM plant material provided:

all seeds have been removed from the GM plant material prior to shredding it;
shredding has been validated as effective in rendering the GM plant material non-viable.

3.1.17 Decontamination may only occur by any other method if approved in writing by the Regulator.

Prohibited decontamination

3.1.18 Decontamination of GMOs must not be performed using:

decontamination equipment that is defective;
any heat based decontamination equipment for which the results of each month’s monitoring tests for the previous 12 months and the results of each year’s calibration are not available to the Regulator;
chemical decontamination agents that are past their expiry date; or
any method that has not been validated as effective for the decontamination of the GMOs.

3.2 Requirements for the Disposal of PC3 & PC4 GMOs

Part 3.2 applies to GMOs that require containment in a PC3 or PC4 facility certified by the Regulator.

3.2.1 Prior to disposal, the GMOs to which Part 3.2 applies must be decontaminated inside a relevant facility certified by the Regulator, unless otherwise permitted, in writing, by the Regulator.

3.2.2 Requirements for the decontamination of the GMOs to which Part 3.2 applies will be those applied by the licence or other authority issued by the Regulator that permits the conduct of the dealing and/or by the guidelines for certification of the relevant facility, issued by the Regulator.

Standards referenced in this document

List of the Australian/New Zealand standards referenced in this document

‘AS/NZS’ followed by a number or other identification is a reference to the Australian/New Zealand Standard so numbered or identified.

AS/NZS 2243.3:2010	Safety in laboratoriesPart 3: Microbiological safety and containment

1 Guidelines for the Transport, Storage and Disposal of GMOs

Guidelines for the Transport, Storage and Disposal of GMOs

________________________________________________

I, DR ROLAND JOSEPH SMITH, the Gene Technology Regulator, acting under paragraph 27(d) of the Gene Technology Act 2000, hereby issue these guidelines.

Dated this 2nd day of June 2011

DR ROLAND JOSEPH SMITH

Gene Technology Regulator

Guidelines for the Transport, Storage and Disposal of GMOs

made under the Gene Technology Act 2000

Name of Guidelines

These Guidelines are the Guidelines for the Transport, Storage and Disposal of GMOs

Purpose

Firstly, these guidelines are issued for the purposes of paragraph 13(3)(b) of the Gene Technology Regulations 2001.

Commencement

These Guidelines commence on 1 September 2011.

Contents

Name of Guidelines

Purpose

Commencement

Definitions and Acronyms

Summary Table of Applicable Sections for the Transport of GMOs

Part 1 Requirements for Transport of GMOs

1.1 Requirements for Transport of PC1 GMOs

1.1.1 PC1 General Requirements

Labelling

Loss, spill or escape of GMOs during transport

Accounting requirements

Security arrangements

Decontamination of containers

Packaging with coolants

1.1.2 PC1 GM micro-organisms (including plants or animals containing GM micro-organisms)

Containment

The Guidelines are conceptually organised around containment levels PC1-PC4 and three activity domains: transport (Part 1), storage (Part 2) and disposal (Part 3). Key definitional concepts in the Guidelines allocate responsibilities and set compliance thresholds.

Physical containment levels (PC1-PC4). These are the central taxonomy. Sections throughout apply differently depending on whether the GMO must be handled at PC1, PC2, PC3 or PC4. Where a dealing is authorised in writing to be transported or stored under a particular Part, that Part prescribes the applicable obligations (see opening of Part 1 and Part 2).
Authorised physical containment facility. Defined to include a facility certified under s 84 of the Act, a facility permitted to contain GMO dealings under licence conditions, or a facility otherwise authorised in writing under regulation 13(2)(c). This definition links the Guidelines to administrative certificates and licences.
Transport. Defined broadly to cover movement between facilities, storage locations, points specified in licences, movement from import border to facility or storage, movement to points of export, and movement of liquid waste via piping to a place outside a facility for further handling. Importantly, the definition carves out internal movements entirely within the same authorised facility or within the same authorised field area (transport does not include movement within the same facility).
Storage. Defined as holding without experimentation or procedures, normally implying minimal or no metabolic activity (which may be achieved by low temperature or dormancy). The Guidelines explicitly say storage does not include holding of actively growing plants and animals.
Primary/secondary/tertiary containers. Primary container is the immediate container surrounding the GMO; secondary is the container immediately surrounding the primary; tertiary is used explicitly for PC3 transport (1.3.1.6). The concepts “sealed” and “unbreakable” are normative performance descriptors: sealed must be able to contain reproductive material and remain closed under expected conditions; unbreakable must withstand reasonably expected shocks, temperature and pressure.
Viable. Defined differently by organism type: for micro-organisms, able to survive or multiply (even if resuscitation is required); for other organisms, able to live and grow independently or reproduce or contribute genetic material. The viability definition is operational: decontamination requirements hinge on rendering material non‑viable.
Decontamination. Defined as a physical or chemical process that removes, kills or renders non‑viable the GMO used. For micro-organisms this may not mean sterility. The Guidelines specify validated methods, monitoring and calibration requirements for common decontamination techniques (autoclave, heat-based equipment, incineration, validated chemical agents) and prohibit decontamination where monitoring/calibration data are not available (3.1.18).
IBC record of assessment. Persons or classes of persons permitted access to GMOs must be the ones mentioned in an IBC’s record of assessment as having appropriate training and experience. Multiple duties (access restriction, accompaniment during transport within buildings, decontamination competence) are explicitly tied to the IBC record.

The Guidelines thereby convert those conceptual elements into operational actions: labelling (various clauses), containment packaging and segregation (e.g. GM vs non-GM animals capable of interbreeding), reporting and retrieval obligations on escape/spill, validation and monitoring of decontamination processes, and document retention timeframes. Several provisions narrow applicability (for example, exemptions where transport/storing occurs entirely within a building and GMOs are accompanied by an authorised person), creating a two-tier scheme: lighter internal controls versus heavier controls for cross‑facility transport, external storage and high containment levels (PC3/PC4).

The Guidelines allocate duties to several identifiable actors. The following groups are directly affected by explicit provisions in the Guidelines:

Persons or accredited organisations supplying GMOs for transport, storage or disposal. These suppliers bear primary labelling duties (see 1.1.1.1; 1.2.1.1; 1.3.1.1; 3.1.1), decontamination obligations before reuse or disposal (3.1.5), and the obligation to provide instructions and decontamination materials for transport where relevant (1.2.1 Note; 1.3.1.8).
Regulated entities holding authorisations under the Gene Technology Act and Regulations, including licence-holders and those with certified facilities. The Guidelines are intended for use in imposing licence and certification conditions (front matter), and many duties (records, access restrictions, storage location restrictions) apply to dealings permitted in writing by the Regulator or as NLRDs listed in Schedule 3.
Institutional Biosafety Committees (IBCs) and persons listed on their records of assessment. The Guidelines repeatedly require that access and specified activities be limited to persons/classes identified in an IBC’s record as having appropriate training and experience (for example, 1.1.1.5, 1.2.1.5, 1.3.1.12, 3.1.4). The IBC therefore functions as the internal control mechanism for authorising human resources.
Transport and logistics service providers. Outermost container labelling must show sender contact details so sender can be contacted if misdirected (1.1.1.2; 1.2.1.2; 1.3.1.3). The Guidelines oblige suppliers to consider whether transported material should be accompanied by decontamination instructions, decontamination agents, protective clothing and equipment (1.2.1 Note; 1.3.1.8). For PC3 and PC4 dealings, prior written approval from the Regulator is required to transport animals or plants (1.3.1.2; 1.4.1).
Facility operators and storage managers. Storage rules (Part 2) restrict where GMOs can be stored (not in flood-prone locations , 2.1.3), mandate containment (2.1.4-2.1.5), ensure supply of decontamination agents (2.1.7), and require labelling of primary containers and storage units (2.1.8-2.1.11). Where PC3/PC4 organisms are involved, storage outside certified facilities is prohibited unless written approval is granted (2.2.1-2.2.2).
Waste management and disposal providers. Decontamination rules require validated methods and impose monitoring and calibration record-keeping (Part 3). For example, autoclave calibration at least annually by a qualified person with results kept for five years (3.1.8), monthly monitoring and retention of results for the previous 12 months (3.1.9), and prohibition of decontamination with expired chemical agents or defective equipment (3.1.18). Composting of GM plant material is permitted only under detailed conditions (3.1.15).
Regulators and auditors. The Guidelines set out records that must be made available to the Regulator on request. Transport records must be kept at least three years (1.3.1.11), autoclave calibrations and monitoring retained for specified periods (3.1.8-3.1.10), and storage records must be maintained and locatable (2.1.13-2.1.14). The Regulator’s power to require availability of these records is implicit in the repeated direction that data be "made available to the Regulator if requested."
Importers/exporters. Transport definitions explicitly cover imported GMOs moved from the border to facilities or storage and exported GMOs moved to the border (transport definition in Definitions). Those movements must comply with the relevant Parts (Part 1 and containment-specific requirements).

Notably excluded or limited actors: the Guidelines expressly exempt certain internal movements within the same authorised facility and movements within a single authorised field area (transport definition), reducing regulatory burden for purely intra-facility logistics. The Guidelines also allow certain lighter treatments for small animals (e.g. exceptions for small animals containing GM micro-organisms fitted with HEPA-filtered vents , 1.2.2 Note), and for transport entirely within a building accompanied by persons noted in an IBC’s record (various exceptions to accounting/label rules).

The Guidelines impose recurring, concrete duties across transport, storage and disposal. The document is written in mandatory language ("must") and specifies exceptions where applicable. Below are the key duties and the limited rights or discretions the Guidelines recognise.

Key duties

Labelling and notice duties. A supplier must label material to notify handlers that the item is, or contains, a GMO (1.1.1.1; 1.2.1.1; 1.3.1.1). For transport, the outermost container must show sender name, address and contact details (1.1.1.2; 1.2.1.2; 1.3.1.3). A biohazard label is required where parent organism meets Risk Group 2 criteria (1.2.2.4; 1.3.1.4). Disposal labels are required as well (3.1.1).
Containment and packaging. GM micro-organisms and material containing them must be wholly contained in sealed, unbreakable primary containers (1.1.2.1; 1.2.2.1). PC2 and PC3 require layered containment: primary inside sealed unbreakable secondary (1.2.2.2; 1.3.1.6) and for PC3 a tertiary container as well (1.3.1.6). For plants and animals not containing GM micro-organisms, sealed unbreakable primary containers apply (1.1.3.1; 1.1.4.1; 1.2.3.1; 1.2.4.1), with secondary containers required in many PC2 circumstances (1.2.4.2).
Security and restricted access. Access must be limited by effective means to persons/classes listed in an IBC’s record of assessment as having the appropriate training and experience (1.1.1.5; 1.2.1.5; 1.3.1.12; 2.1.15). This covers situations where containers are left for collection or unattended.
Accounting and record-keeping. Procedures must be in place to account for all GMOs or number of primary containers and to detect loss or failure of delivery (1.1.1.4; 1.2.1.4; 1.3.1.10). For PC3 transport, records must be kept at least three years and include specified particulars (1.3.1.11). Storage records must allow exact location finding and be available to the Regulator (2.1.12-2.1.14).
Incident response and reporting. On escape, spill, leak, loss or failure of delivery, immediate efforts to retrieve and return to containment or render non‑viable must be made and the incident reported to the Regulator as soon as reasonably practicable (1.1.1.3; 1.2.1.3; 1.3.1.7; 2.1.6).
Decontamination validation, monitoring and retention. Decontamination must render GMOs non‑viable prior to disposal if disposal is not itself decontamination (3.1.2-3.1.5). Autoclaves require annual calibration by a qualified person with results available for five years (3.1.8). Monthly monitoring of autoclave effectiveness is required with results retained 12 months (3.1.9); similar monthly monitoring is required for other heat-based equipment with records retained 12 months and calibration results kept five years (3.1.10, 3.1.13). Chemical agents must be validated and not used past expiry (3.1.14; 3.1.18).
Storage restrictions. Whole viable GM animals and whole viable GM plants must not be stored outside authorised facilities without written permission from the Regulator (2.1.1-2.1.2). Storage sites must not be prone to flooding or storm surge (2.1.3). PC3/PC4 organisms may not be stored outside certified facilities unless approved in writing (2.2.1).
Specific procedural duties for certain methods. Composting of GM plant material is permitted only under a list of detailed requirements, including removal of seeds prior to composting and monitoring for volunteers for monthly inspections and a six‑month volunteer-free interval after last addition (3.1.15). Shredding of plant material is permitted only if validated for non-viability and after seed removal (3.1.16).

Rights and discretions

Regulator discretion to require written approval. The Guidelines create an expectation that the Regulator’s prior written approval is required for transport or storage of PC3 and PC4 organisms (1.3.1.2; 1.4.1; 2.2.1-2.2.2). The Guidelines may be invoked to impose licence conditions (s 61) and certification conditions (s 86), giving the Regulator discretion to tailor requirements for specific dealings.
Limited operational exceptions. The Guidelines allow lighter measures when transport or storage takes place entirely within a building and the GMO is accompanied by a person/class in an IBC record. In such cases, some accounting, labelling or containment layering obligations are relaxed (e.g. exceptions to accounting requirements at 1.1.1.4 and 1.2.1.4; labelling not required where transport entirely within building in 1.2.2.4 Note).
Approval of alternative decontamination methods. The Guidelines permit alternate decontamination methods if approved in writing by the Regulator (3.1.17), preserving an avenue for operational flexibility where validated methods are unavailable.

Procedural implications of these duties: obligations create predictable administrative cycles (regular records, monthly monitoring, annual calibration), capital and operational investments (sealed/unbreakable containers, autoclaves, HEPA-filtered vents), and contractual constraints on third-party transporters and waste handlers. Rights are primarily administrative and procedural , the Regulator retains the power to authorise exceptions, impose licence or certification conditions, and to request records. The document itself does not list monetary penalties; enforcement is a function of the Act and the Regulator’s statutory powers.

The Guidelines themselves do not set out monetary penalties, fines or specific criminal offences. They operate as a source of mandatory operational standards to be applied by the Regulator in the exercise of statutory functions and powers under the Gene Technology Act 2000 and its Regulations. The text makes several enforcement channels explicit or implicit:

Regulatory incorporation into licences and certifications. The Guidelines are expressly available to be "invoked for the purposes of the imposition of licence conditions in accordance with section 61 of the Act and of certification conditions in accordance with section 86 of the Act" (front matter). This means non‑compliance with guideline-derived licence or certification conditions can be enforced through the statutory compliance and sanctions regime attached to licences and certifications under the Act.
Record availability to the Regulator. Multiple clauses require that records (transport records, autoclave calibrations and monitoring results, storage inventories) be kept and made available to the Regulator if requested (see 1.3.1.11; 3.1.8-3.1.10; 2.1.13). The requirement to produce records on request creates documentary evidence for enforcement action under the Act.
Reporting obligations for incidents. The Guidelines require reporting to the Regulator as soon as reasonably practicable after escape, spill, leak or loss (1.1.1.3; 1.2.1.3; 1.3.1.7; 2.1.6). Timely reporting is framed as a duty; failure to report could feed into the Regulator’s formal enforcement regime under the Act.
Mandatory operational controls that constrain behaviour. Access restrictions (IBC-based), packaging/containment requirements, and validation and monitoring regimes are mandatory; non-compliance with those duties where they are imposed as licence or certification conditions will be actionable within the Act’s enforcement framework.

What the Guidelines do not do, within their own text

They do not set out penalties, fines, or criminal sanctions. No clause enumerates pecuniary penalties or enforcement steps such as injunctions or prosecutions; those mechanisms, if applicable, derive from the Act and Regulations rather than this instrument.
They do not describe the Regulator’s process for issuing approvals or the procedural timeline for seeking prior written approval for PC3/PC4 transport or storage. The Guidelines require prior written approval (e.g. 1.3.1.2, 1.4.1, 2.2.1) but do not specify the application process, criteria or expected timeframes; those processes are governed by the Act, Regulations and administrative practice outside the text.

Operational enforcement risk and compliance monitoring implied by the text

Documentary audit focus: multiple retention periods (for example, three years for transport records, five years for autoclave calibration, 12 months for monthly monitoring) indicate that enforcement and compliance activity is likely to be documentation/audit heavy.
Reliance on license/certification conditions: because the Guidelines are invoked to set licence and certification conditions, enforcement will be tied to whether the Regulator has chosen to embed a given guideline requirement within a particular licence or certification.
Discretion-driven compliance burden: the need for prior written approval for PC3/PC4 movements and the Regulator’s ability to tailor conditions create uncertainty and require administrative engagement with the Regulator for higher containment dealings.

For lawyers and compliance teams, the practical takeaway from the Guidelines is that enforcement will be documentary and administrative: ensure records exist and are producible, maintain monitoring/calibration logs for prescribed retention windows, and treat written approvals and licence conditions as the primary mechanisms through which non‑compliance will be addressed under the statutory framework.

The Guidelines repeatedly anchor themselves to the Gene Technology Act 2000 and the Commonwealth Gene Technology Regulations 2001. Specific interaction points in the text include:

Statutory source and scope. The Guidelines were issued under paragraph 27(d) of the Gene Technology Act 2000 and for the purposes of paragraph 13(3)(b) of the Gene Technology Regulations 2001. They are therefore subordinate regulatory guidance authorised by the Act and Regulations and intended to be used in implementing statutory functions and powers (front matter).
Licence and certification conditions. The Guidelines are intended to be used in imposing licence conditions under s 61 of the Act and certification conditions under s 86 (front matter). That means the Guidelines do not operate in isolation; their operative force will typically be through explicit incorporation into licences or certification instruments issued under the Act.
Cross-reference to facility certification and Regulation permissions. The definition of "authorised physical containment facility" refers to certification under s 84 of the Act, licence permissions, or written authorisation under regulation 13(2)(c) of the Regulations. Those cross-references tie the Guidelines directly to the statutory certification and authorisation schemes.
Interaction with State and Territory law. The Guidelines explicitly state that references to statutes include federal statutes "as amended or replaced from time to time and equivalent provisions, if any, in corresponding State law" (Definitions). For disposal, the Guidelines acknowledge "Other regulations may need to be complied with for the disposal of GMOs including, where relevant, State, Territory or Local Government regulations" (3.1 Other regulations). This means that disposal, transport and storage activities must be compliant both with the Guidelines (and any licence conditions derived from them) and with applicable state/territory/local waste, biosecurity, environmental protection, transport and occupational health and safety laws.
Standards. The Guidelines reference AS/NZS 2243.3:2010 (Safety in laboratories Part 3: Microbiological safety and containment) and invoke specific sections of the standard (e.g. classification as Risk Group 2 under Section 3.2 in 1.2.2.4). The Guidelines use the standard as a technical compliance anchor for labelling, handling and autoclave guidance. Where the standard is referenced, compliance with the standard will be an operational way to meet the Guidelines’ technical expectations.
Transport law interactions. While the Guidelines set packaging and labelling requirements and restrict coolants and containment, they do not displace general transport safety and hazardous goods rules administered by transport regulators. The obligation to include sender contact details on outer packaging and to provide mechanisms for gas escape when dry ice or liquid nitrogen are used (e.g. 1.1.1.8; 1.2.1.8; 1.3.1.15) creates points of overlap with transport and dangerous goods rules (air/road/sea), which must be observed concurrently.
Occupational health and safety (OHS). The Guidelines require appropriate protective clothing for persons undertaking decontamination and reference appropriate training and qualifications (qualified person; persons named in an IBC record). Those duties sit alongside OHS duties and state-level workplace health and safety legislation. The Guidelines note that a person who conducts decontamination must ensure method requirements are complied with (3.1.6), which obliges enterprises to coordinate compliance across the biosafety and OHS regimes.
Biosecurity and quarantine. The Guidelines cover movement of imported GMOs from the border to authorized facilities and movement to the border for export. These movements will also intersect with Australian Quarantine and Inspection Service (AQIS)/biosecurity and customs requirements; the Guidelines do not displace border biosecurity obligations.

Takeaways on interaction effects

Parallel obligations: operators must comply with the Guidelines, any licence/certification conditions the Regulator imposes using these Guidelines, and relevant state/territory/local laws and technical standards. Compliance programmes should be cross‑mapped across all applicable instruments.
Evidence-focused enforcement: due to the Guidelines’ emphasis on records and monitoring, regulatory interaction will often be documentary (standards, calibration records, monitoring logs) rather than only inspection of processes.
Administrative discretion: regulatory approvals and written authorisations under the Regulations are gateways that determine whether storage/transport activities may occur outside certified facilities, making early engagement with the Regulator important for dealings at higher containment levels.

The Guidelines as provided were issued by Dr Roland Joseph Smith, Gene Technology Regulator, dated 2 June 2011 and are stated to commence on 1 September 2011. They are made under the Gene Technology Act 2000 and the Gene Technology Regulations 2001 for the purposes explicitly noted at the front of this document.

The text of the Guidelines itself contains no express amendment history, no subsequent amendment notes within the document and no list of modifications or versioning beyond the initial issue and commencement dates. Where the Guidelines reference statutes and standards, they do so with a saving that those references are to the Commonwealth statutes "as amended or replaced from time to time" and equivalent provisions in State law (Definitions). That language signals that the Guidelines are intended to operate against the live body of statutory law and standards rather than a frozen legislative snapshot, but the Guidelines do not provide a schedule of later changes or amending instruments within their own text.

Practical implications for compliance teams

Treat this copy as the issued version dated 2 June 2011, commenced 1 September 2011. Because the Guidelines reference external statutes and standards "as amended or replaced", compliance teams should check the current versions of the Gene Technology Act 2000, the Gene Technology Regulations 2001 and referenced standards (notably AS/NZS 2243.3:2010) and confirm whether any later versions, amendments, or replacement guidelines have been published by the Regulator. The Guidelines themselves do not list later changes.
Where licence or certification conditions incorporate these Guidelines, the operative document for compliance may be the licence/certification instrument as issued. Licence conditions may be more specific than the Guidelines; those conditions, not the Guidelines alone, will govern the holder’s legal obligations where a licence or certification is in place under the Act (front matter referencing s 61 and s 86).

The Guidelines contain no litigation history, no citations to judicial or tribunal decisions, and do not reference any specific enforcement actions or legal challenges. There are no cases named in the text, and no description of any disputes, precedent, or adjudicative interpretation relating to the Guidelines themselves. The document is an administrative instrument providing technical and procedural requirements; it does not include summaries of contested applications or judicial determinations.

For legal research or compliance review, this absence means:

You cannot rely on this document to understand how courts, tribunals or administrative bodies have interpreted the Guidelines or their integration into licence/certification disputes. Any case law that addresses how the Regulator uses or enforces these Guidelines will need to be sourced elsewhere, for example from administrative law decisions under the Gene Technology Act 2000 or from decisions that involve licence or certification conditions derived from these Guidelines.
The Guidelines’ wording should therefore be treated as the authoritative technical administrative standard issued by the Regulator, but questions about statutory enforcement, penalties, or judicial review will require analysis of the Act, the Regulations and any public enforcement record or decisions not contained in this document.

This section flags concrete operational traps and contentious friction points that arise directly from the Guidelines’ text. Each item below quotes or points to the clause that creates the risk.

Internal-movement exceptions do not absolve documentation in many cases. Movements "entirely within a building" are exempted from some accounting and labelling duties (for example, 1.1.1.4 and 1.2.1.4 provide exceptions when the GMO is accompanied by a person in an IBC record). However the boundaries of "entirely within a building" and whether a person accompanying the consignment is properly recorded in an IBC may be contested. Do not assume internal movement removes all compliance obligations , several duties (such as containment and access restrictions) still apply.
PC1 dealings conducted in PC2 facilities default to PC2 transport unless cross-contamination prevention is documented. Clause 1.2.0.1 allows PC1 dealings that are carried out in PC2 facilities to be transported under PC1 rules only if documented procedures are in place to prevent cross-contamination. If the documented procedures do not exist, PC2 transport requirements apply (1.2.0.2). The practical risk is misclassification or insufficient documentation leading to an unexpected stricter regime.
Record retention periods are staggered and specific. PC3 transport records must be kept for at least three years and include detailed data points (1.3.1.11). Autoclave calibration results must be kept for five years (3.1.8). Monthly monitoring records for autoclaves and other heat-based equipment must be kept for the previous 12 months (3.1.9-3.1.10). Non-compliance with these retention windows leaves organisations unable to respond to Regulator requests.
Decontamination cannot use expired agents or defective equipment. Clause 3.1.18 prohibits decontamination using defective equipment or expired chemicals and specifically disallows heat-based equipment for which monthly monitoring and yearly calibration results are not available to the Regulator. This creates a strict documentary pre-condition for use of decontamination equipment.
Composting and shredding are conditional and narrowly permitted. Composting of GM plant material (3.1.15) is allowed only if a long list of criteria are met, including removal of seeds prior to composting and monthly monitoring for volunteer growth continuing for six months after the last addition. Shredding is only allowed if validated (3.1.16). These are operationally demanding and likely to be impractical for many operators.
Coolants require specific arrangements and may be limited. For PC1/PC2 transport, mechanisms to allow gas escape must be included when dry ice or liquid nitrogen are used (1.1.1.8; 1.2.1.8). For PC3 transport, coolants must not be used inside either primary or secondary containers and must not be used in primary or secondary (1.3.1.15-1.3.1.16). Air transport rules and dangerous goods rules also interact here; the Guidelines do not override transport safety regimes.
Access restriction tied to IBC records creates resourcing constraints. Multiple duties limit access to persons/classes "mentioned in an IBC’s record of assessment" as competent to handle the GMOs (1.1.1.5; 1.2.1.5; 1.3.1.12; 2.1.15). That means reliance on an accurate, up-to-date IBC record is procedural and may limit the use of third-party transporters unless they are specifically accounted for in the IBC documentation.
Transport of PC3/PC4 organisms requires prior written Regulator approval. For PC3 and PC4, the Guidelines forbid transport of animals or plants containing GM micro‑organisms without prior written approval (1.3.1.2; 1.4.1). Operationally, that approval requirement can create delays and requires administrative engagement with the Regulator.
Flood-prone storage prohibition. Storage is disallowed at sites "prone to flooding" as defined (2.1.3 and Definitions). The Guidelines use the 100‑year ARI as a determinative metric; inability to obtain that level from the local authority defaults to the authority's highest ARI or Defined Flood level. Failure to apply this test could expose GMOs to environmental risks, and non-compliance will be readily discoverable.
Segregation obligations for interbreeding animals have an escalation clause. If separation of GM and non‑GM animals capable of interbreeding fails, the non-GM animals must be transported in accordance with GMO requirements (1.1.3.4; 1.2.3.4). This raises operational complexity when mixed consignments or escapes occur.
Transport records must contain precise genetic data. For PC3 transport, records must include the name of the parent species and the genetic modification(s) (1.3.1.11). That requires traceability within supply chains and careful control of information shared with third-party handlers.
The Guidelines rely on external standards and other laws. They reference AS/NZS 2243.3:2010 and require compliance with State/Territory/local regulations for disposal (3.1 Other regulations). Ignoring these interactions can lead to apparent compliance with the Guidelines but breach of other legal requirements.

Below is a practical compliance checklist and implementation guidance grounded in the specific clauses of the Guidelines. It is structured as operational steps and document controls tied to clause references.

Classify the dealing and containment level
- Determine whether the dealing is an NLRD listed in Part 1 or Part 2 of Schedule 3 of the Regulations or a dealing otherwise permitted in writing by the Regulator. Use the appropriate Part of the Guidelines (Part 1 for transport, Part 2 for storage, Part 3 for disposal).
- Confirm the minimum permitted physical containment (PC1-PC4). For PC3/PC4 dealings, arrange for prior written Regulator approval before transport or storage outside certified facilities (1.3.1.2; 1.4.1; 2.2.1).
Update IBC records and personnel authorisations
- Ensure the Institutional Biosafety Committee (IBC) record of assessment lists all persons/classes authorised to access, transport, decontaminate or dispose of the relevant GMOs. The Guidelines tie access and competence obligations to persons named in the IBC record (1.1.1.5; 1.3.1.12; 3.1.4).
- Review training records to ensure persons listed meet the "qualified person" definition and document competence.
Packaging and containment
- For micro-organisms and organisms containing them, ensure sealed, unbreakable primary containers are used (1.1.2.1; 1.2.2.1; 1.3.1.5).
- For PC2 and PC3 shipments, add sealed, unbreakable secondary containers; for PC3 include tertiary containers (1.2.2.2; 1.3.1.6).
- Where ventilation is required, evaluate HEPA-filtered vents for primary/secondary containers (1.2.2.1 Note).
- Ensure "sealed" and "unbreakable" containers meet expected handling conditions; document the rationale and testing where appropriate.
Labelling and sender information
- Label primary material to indicate it is, or contains, a GMO (1.1.1.1; 1.2.1.1; 1.3.1.1).
- Affix sender name, address and contact details to the outermost container for transport unless movement occurs entirely within a building or certain clinical waste exceptions apply (1.1.1.2; 1.2.1.2).
- Where Risk Group 2 parent organisms are present, apply a biohazard label to the outermost container (1.2.2.4; 1.3.1.4).
- Tag individual large animals and label containers for plants and small animals as required (1.1.2.2-1.1.4.2; 1.2.2.5-1.2.4.3; 1.2.3.3).
Security and access controls
- Implement access controls (locked storage, restricted loading areas) so only persons/classes in the IBC record can access containers (1.1.1.5; 1.2.1.5).
- For containers left for collection, keep them in a locked area until collection or transfer.
Accounting, records and traceability
- Implement documented procedures to account for all GMOs or primary containers transported and stored. For PC3 transport specifically, maintain the prescribed transport record fields and retain for at least three years (1.3.1.10-1.3.1.11).
- Maintain storage inventory records that allow immediate location of stored GMOs and produce these records on request (2.1.12-2.1.14).
- Keep transport records, decontamination validation data, calibration and monitoring results according to the retention schedules: three years (transport records for PC3), five years (autoclave calibration results), 12 months (monthly monitoring results) (1.3.1.11; 3.1.8-3.1.10).
Incident response and reporting procedures
- Create and document spill/escape response procedures that implement immediate retrieval or rendering non‑viable, area isolation, decontamination steps and notification to the Regulator as soon as reasonably practicable (1.1.1.3; 1.2.1.3; 1.3.1.7; 2.1.6).
- Provide transport consignments with decontamination instructions, adequate decontamination agent volume, protective clothing and equipment where appropriate (1.2.1 Note; 1.3.1.8).
- Ensure persons accompanying consignments carry functional communication devices to contact the sender during incidents (1.3.1.9).
Decontamination validation and equipment maintenance
- Validate chosen decontamination methods against the GMO type. Autoclaving remains the recommended and monitored method where applicable (3.1.7).
- Implement annual calibration schedules for autoclaves and other heat-based equipment by a qualified person and retain five years of calibration records (3.1.8; 3.1.13).
- Run monthly monitoring of autoclave effectiveness (thermocouples, chemical, biological or enzyme indicators) and retain monitoring results for at least 12 months (3.1.9).
- Ensure chemical decontamination agents are validated for effectiveness, stored and labelled with contents and expiry dates and not used past expiry (3.1.14; 2.1.7; 3.1.18).
- Do not use defective decontamination equipment or equipment lacking required monitoring and calibration records (3.1.18).
Disposal and special methods
- Decontaminate GMOs prior to disposal if the disposal method does not itself decontaminate (3.1.2-3.1.4).
- For composting GM plant material, meet each requirement in 3.1.15 (dedicated concrete bay, seed removal, monitoring, animal exclusion, monthly monitoring and six-month volunteer-free period). Document validation of the composting process.
- Validate shredding or other alternative decontamination methods before use and, if using a method not in the Guidelines, seek written Regulator approval (3.1.16-3.1.17).
Storage site selection and engineering controls
- Avoid storage sites that are "prone to flooding" as defined by 100-year ARI or the highest ARI defined by local authority (Definitions; 2.1.3).
- For PC2 organisms, ensure storage is within sealed secondary containers or appropriate small storage units (2.1.4-2.1.5).
- Label storage units with responsible person's contact details and apply biohazard labels for Risk Group 2 micro-organisms (2.1.10-2.1.11).
Contracting and third‑party service providers
- Ensure contracts with transporters and waste handlers require compliance with the relevant parts of the Guidelines, specify required labelling and containment, and ensure transporter personnel are included in the IBC record if they will have access to GMOs (1.1.1.2; 1.2.1 Note; 1.3.1.12).
- Include provisions requiring suppliers of decontamination or disposal services to provide validation evidence, calibration and monitoring records on request.
Engage the Regulator early for high‑risk dealings
- For PC3 and PC4 dealings, seek prior written approval from the Regulator for transport or storage outside certified facilities (1.3.1.2; 1.4.1; 2.2.1). Prepare to incorporate conditions the Regulator may impose under s 61 or s 86.
Cross-check with other legal regimes and standards
- Map obligations under the Guidelines against state/territory/local waste, transport, environmental and workplace safety laws and the referenced AS/NZS 2243.3:2010 standard. Ensure procedures meet both the Guidelines and other applicable law (3.1 Other regulations; Definitions).
Audit and continuous improvement
- Run internal audits at intervals consistent with monitoring responsibilities (monthly monitoring for autoclaves and heat-based equipment; document audits aligned to retention windows).
- Keep documentation demonstrating validation of alternative methods and risk assessments supporting exceptions or engineering choices.

Minimum document set to maintain and present on request

IBC record of assessment and named personnel competence records.
Transport records (including the PC3 content list where applicable) for three years.
Storage inventories with locational mapping and IBC authorisations.
Autoclave and heat-equipment calibration certificates (5 years).
Monthly monitoring logs for decontamination equipment (12 months).
Decontamination validation reports for chemical, autoclave, composting or shredding methods.
Incident response procedures and records of any spill/escape and notifications to the Regulator.
Written Regulator approvals and licence/certification conditions where applicable.

Following these steps will align operational practice with the specific mandatory provisions of the Guidelines and prepare organisations for documentary review by the Regulator.

Guidelines for the Transport, Storage and Disposal of GMOs

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Guidelines for the Transport, Storage and Disposal of GMOs

Source text: opening excerpt

1 Guidelines for the Transport, Storage and Disposal of GMOs

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Penalties and enforcement

How it interacts with other laws

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How to comply