1 July 2007

DEFINITIONS

Unless defined otherwise in this document, words and phrases used in the requirements have the same meaning as in the Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the regulations).

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

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.

Where a word in the text is bolded, it indicates that the word has been defined (see below).

dealings or deal with
In relation to a GMO, means the following:
  1. conduct experiments with the GMO;
  2. make, develop, produce or manufacture the GMO;
  3. breed the GMO;
  4. propagate the GMO;
  5. use the GMO in the course of manufacture of a thing that is not the GMO;
  6. grow, raise or culture the GMO;
  7. import the GMO;
  8. transport the GMO;
  9. dispose of the GMO;
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (i).

facility
The whole of the space that is to be certified by the Regulator to a specific level of containment.

INTRODUCTION

Section 84 of the Act allows Gene Technology Regulator (the Regulator) to certify faclities to a specified containment level if the facility meets the containment requirements specified in guidelines issued by the Regulator under section 90 of the Act.

This document describes the Physical Containment (PC) levels used by the Regulator in the certification of facilities under the Act and explains the categories of organisms and types of dealings intended to be contained in each facility type and PC level.

Applicants may use this section to guide their decision about which PC level and facility type to apply for. If you have any queries about the different categories, please contact the Office of the Gene Technology Regulator (OGTR) to discuss the options.

PART 1 – PC LEVELS

1.1 There are four levels of physical containment applied to facilities certified by the Regulator. These are arranged in order of ascending stringency of containment requirements, which reflect the level of risk involved in the dealings that can be undertaken at each level. The four levels are:
  • Physical Containment Level 1 (PC 1)
  • Physical Containment Level 2 (PC 2)
  • Physical Containment Level 3 (PC 3)
  • Physical Containment Level 4 (PC 4)
1.2 These levels are intended to harmonise as closely as possible with the PC levels described in AS/NZS 2243.3 1.

1.3 The required PC level for the containment of a dealing is governed by the gene technology legislation as follows:
  • Conditions of licences can specify the level of containment required for the conduct of the dealing. Typically such conditions will be found in a licence to conduct dealings not involving an intentional release into the environment. However licences permitting direction intentional release of a GMO may also contain conditions requiring containment of a GMO to a specific level of containment.
  • Notifiable Low Risk Dealings (NLRDs) mentioned in Part 1 of Schedule 3 of the regulations, as in force from 1 July 2007, must be undertaken in a facility certified by the Regulator to at least PC level 1.
  • NLRDs mentioned in Part 2 of Schedule 3 of the regulations, as in force from 1 July 2007, must be undertaken in a facility certified by the Regulator to at least PC level 2.
1.4 When determining the required PC level for a DNIR involving GM micro-organisms, or GM animals or plants containing pathogenic organisms, the Regulator may be guided by the PC levels described in AS/NZS 2243.3.

1.5 The tables of example organisms in AS/NZS 2243.3 are not exhaustive and so, if applicants have any queries about which PC level is likely to be appropriate for the GMOs being dealt with in the facility, they should contact the OGTR to discuss the matter.

1.6 A PC level determined by one of the above methods is the minimum PC level at which a dealing can be conducted. A dealing may be conducted in a facility that is certified to a higher PC level, provided the higher level facility type is appropriate for the organisms involved, is certified by the Regulator, and that the conditions of certification do not prevent the dealing being conducted there.

1.7 Table 1 summarises the dealings that can be conducted at the four PC levels.

Table 1 - Physical Containment Levels

PC level Type of GMO dealings that can be conducted at PC level

NLRDs involving large grazing animals that do not contain GM micro-organisms
1NLRDs mentioned in Part 1 of Schedule 3 of the regulations, as in force from 1 July 2007, must be undertaken in a facility certified by the Regulator to at least PC 1.
Some DNIRs - only when permitted by licence

2 NLRDs mentioned in Part 2 of Schedule 3 of the regulations, as in force from 1 July 2007, must be undertaken in a facility certified by the Regulator to at least PC 2.
DNIRs - when specified by licence

3 NLRDs - not recommended - these dealings must be conducted under PC 3 conditions while the facility is certified by the Regulator
DNIRs - when specified by licence

4 DNIRs - when specified by licence

PART 2 – FACILITY TYPES

2.1 For the purposes of an application for a licence to conduct a dealing with a GMO, or for the conduct of a NLRD, the following categories of PC level and facility type can be used as a guide to the appropriate certified facility.

2.2 There may be reasons to depart from these categories where the dealings in a facility are proposed to involve more than one category of organism. Applications for certification, or for variation to the conditions of certification, should include the reasons for needing to contain the different categories of organisms, along with supporting information about how the facility is designed to contain them and how any risks of escape will be managed.

PC 1 Facility

2.3 A facility certified as a PC 1 Facility is appropriate for the conduct of the dealings listed below, provided it meets the specific requirements described in the PC 1 Facility guidelines for the dealing type:
  • GM micro-organisms (when there is less than 25 litres of culture of any one GMO);
  • GM animals (whether or not they contain micro-organisms);
  • non GM animals containing GM micro-organisms; and
  • non-GM plants that contain or host GMOs.
2.4 A PC 1 Facility is not appropriate for the following:
  • dealings with any GMO that under the Act, or under the conditions of a licence, requires containment in any PC level higher than PC 1
PC 1 Large Grazing Animals Facility

2.5 Permission may be given by the Regulator to use facilities of this type in certain limited circumstances in connection with dealings involving large grazing animals, which may include animals such as sheep, cattle, goats, pigs and horses. A person proposing to conduct such dealings may apply to the Regulator to conduct the dealings in this facility type.

2.6 The Regulator will not authorize the use of this containment level where a proposed dealing involves large grazing animals which could potentially shed or transmit GMOs.

PC 1 Large Scale Facility

2.7 A facility certified as a PC 1 Large Scale Facility is appropriate for the conduct of dealings when there is greater than or equal to 25 litres of culture of any one GMO.

2.8 A PC 1 Large Scale Facility is not appropriate for the following:
  • dealings with any GMO that under the Act, or under the conditions of a licence, requires containment in any PC level higher than PC 1;
  • the housing/keeping/rearing of any animals or aquatic organisms; or
  • the growing of any plants.
PC 2 Animal Facility

2.9 A facility certified as a PC 2 Animal Facility is appropriate for the conduct of the dealings listed below:
  • the housing/keeping/rearing of GM animals (except arthropods and aquatic organisms - including amphibians); or
  • the housing/keeping/rearing of animals (except arthropods and aquatic organisms - including amphibians) that contain GMOs.
2.10 A PC 2 Animal Facility is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 2;
  • the housing/keeping/rearing of any arthropods, or aquatic organisms, for longer than the minimum time required to complete procedures on them;
  • dealings with GMO cultures greater than 25 litres; or
  • any other dealings notified in writing by the Regulator.
PC 2 Aquatic Organism Facility

2.11 A facility certified as a PC 2 Aquatic Organism Facility is appropriate for the conduct of the dealings listed below:
  • the keeping or rearing of GM aquatic organisms (including amphibians); or
  • the keeping or rearing of aquatic organisms (including amphibians) that contain GMOs.
2.12 A PC2 Aquatic Organism Facility is not appropriate for the following:
  • dealings with GM non-aquatic micro-organisms, unless they are integral to the dealings being conducted in the facility;
  • the housing/keeping/rearing of terrestrial animals or terrestrial arthropods; or
  • the growing of any terrestrial plants.
PC 2 Arthropod Facility

2.13 A facility certified as a PC 2 Arthropod Organism Facility is appropriate for the conduct of the dealings listed below:
  • the keeping or rearing of GM terrestrial arthropods; or
  • the keeping or rearing of terrestrial arthropods that contain GMOs.
2.14 A PC 2 Arthropod Facility is not appropriate for the following:
  • dealings with any GMO that under the Act, or under the conditions of a licence, requires containment in any PC level higher than PC 2;
  • dealings with GM micro-organisms, unless they are integral to the dealings being conducted in the facility;
  • the housing/keeping/rearing of animals (other than terrestrial arthropods) or aquatic organisms (including amphibians); or
  • the growing of any plants, other than non-GM plants that are required as part of a dealing with GM arthropods.
PC 2 Constant Temperature Room

2.15 Constant Temperature Rooms are intended to store or grow GMOs, and/or allow a limited range of procedures to be performed on GMOs, in controlled temperature conditions.

2.16 The most common use of Constant Temperature Rooms is for growing plants, but cultures of micro-organisms may need to be stored in constant temperature rooms.

2.17 Certification would not generally be approved for housing/keeping/rearing of animals, arthropods or aquatic organisms (including amphibians) in constant temperature rooms. It would be expected that the appropriate facility type would be used to house them and the required temperature regime provided there.

2.18 Applicants are welcome to contact the OGTR to discuss their needs prior to making an application.

PC 2 Laboratory

2.19 A facility certified as a PC 2 Laboratory is appropriate for the conduct of the dealings listed below:
  • dealings with GM micro-organisms;
  • dealings with GM plant tissue culture or GM plants contained in a plant growth cabinet;
  • performance of laboratory procedures involving small terrestrial animals and non-adult forms of terrestrial arthropods, if not otherwise prohibited by licence conditions; and
  • performance of laboratory procedures involving aquatic organisms (including amphibians), subject to additional conditions and if not otherwise prohibited by licence conditions.
2.20 A PC 2 Laboratory is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 2;
  • the housing/keeping/rearing of any animals, arthropods, or aquatic organisms for longer than the minimum time required to complete laboratory procedures on them;
  • the growing of any plants (except those in tissue culture, or contained in a plant growth cabinet or other containment device approved in writing by the Regulator); or
  • dealings with GMO cultures greater than 25 litres.
PC 2 Large Scale Facility

2.21 A facility certified as a PC 2 Large Scale Facility is appropriate for the conduct of dealings when there is greater than or equal to 25 litres of culture of any one GMO.

2.22 A PC 2 Large Scale Facility is not appropriate for the following:
  • dealings with any GMO that under the Act, or under the conditions of a licence, requires containment in any PC level higher than PC 2;
  • the housing/keeping/rearing of any animals or aquatic organisms; or
  • the growing of any plants.
PC 2 Plant Facility

2.23 A facility certified as a PC 2 Plant Facility is appropriate for the conduct of the dealings listed below:
  • the growing of GM terrestrial plants; or
  • the growing of terrestrial plants that contain GMOs.
2.24 A PC 2 Plant Facility is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 2;
  • dealings with any GM micro-organisms unless they are integral to the dealing being conducted in the facility;
  • the housing/keeping/rearing of any animals, arthropods, or aquatic organisms unless they are integral to the dealing being contained in the facility;
  • dealings with GMO cultures greater than 25 litres; or
  • any other dealings notified in writing by the Regulator.
PC 3 Animal Facility

2.25 A facility certified as a PC 3 Animal Facility is appropriate for the conduct of the dealings listed below:
  • the housing/keeping/rearing of GM animals (except arthropods and aquatic organisms - including amphibians); or
  • the housing/keeping/rearing of animals (except arthropods and aquatic organisms - including amphibians) that contain GMOs.
2.26 A PC 3 Animal Facility is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 3;
  • the housing/keeping/rearing of any arthropods, or aquatic organisms, for longer than the minimum time required to complete procedures on them;
  • dealings with GMO cultures greater than 25 litres; or
  • any other dealings notified in writing by the Regulator.
PC 3 Arthropod Facility (Insectary)

2.27 A facility certified as a PC 3 Arthropod Facility is appropriate for the conduct of the dealings listed below:
  • the keeping or rearing of GM terrestrial arthropods; or
  • the keeping or rearing of terrestrial arthropods that contain GMOs.
2.28 A PC 3 Arthropod Facility is not appropriate for the following:
  • dealings with any GMO that under the Act, or under the conditions of a licence, requires containment in any PC level higher than PC 3;
  • dealings with GM micro-organisms unless they are being used in conjunction with the arthropods being contained in the facility;
  • the housing/keeping/rearing of animals (other than terrestrial arthropods) or aquatic organisms; or
  • the growing of any plants, other than non-GM plants that are required as part of a dealing with GM arthropods.
PC 3 Laboratory

2.29 A facility certified as a PC 3 Laboratory is appropriate for the conduct of the dealings listed below:
  • dealings with GM micro-organisms;
  • laboratory procedures involving small terrestrial animals and non-adult forms of terrestrial arthropods, if not otherwise prohibited by licence conditions; and
  • laboratory procedures involving aquatic organisms (including amphibians), subject to additional conditions and if not otherwise prohibited by licence conditions.
2.30 A PC 3 Laboratory is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 3;
  • the housing/keeping/rearing of any animals, arthropods, or aquatic organisms for longer than the minimum time required to complete laboratory procedures on them;
  • the growing of any plants (except those in tissue culture, or contained in a plant growth cabinet or other containment device approved in writing by the Regulator); or
  • dealings with GMO cultures greater than 25 litres.
PC 3 Plant Facility

2.31 A facility certified as a PC 3 Plant Facility is appropriate for the conduct of the dealings listed below:
  • the growing of GM terrestrial plants; or
  • the growing of terrestrial plants that contain GMOs.
2.32 A PC 3 Plant Facility is not appropriate for the following:
  • dealings with any GMO that under the conditions of a licence requires containment in any PC level higher than PC 3;
  • dealings with any GM micro-organisms unless they are integral to the dealing being contained in the facility;
  • the housing/keeping/rearing of any animals, arthropods, or aquatic organisms unless they are integral to thedealings being contained in the facility;
  • dealings with GMO cultures greater than 25 litres; or
  • any other dealings notified in writing by the Regulator.
PC 4 Facility

2.33 A facility certified as a PC 4 Facility is appropriate for the conduct of dealings that require containment in a PC 4 facility.



1Australian/New Zealand Standard 2243.3 Safety in laboratories Part 3: Microbiological aspects and containment facilities.