About the approval process

Containment facility requirements

Learn about the types of facilities and certification levels you need when working with certain genetically modified organisms (GMOs).

Facility certification levels 

We classify physical containment (PC) facilities at 4 levels based on: 

  • the structural integrity of buildings 

  • what equipment is used 

  • how facility workers handle GMOs. 

PC level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. 

PC level 4 (PC4) facilities provide the most secure and stringent containment conditions. 

The Gene Technology Regulator certifies PC facilities to ensure that: 

  • they meet appropriate standards for GMO containment 

  • trained and competent staff carry out the procedures and practices. 

You must inspect all certified facilities before applying for certification. You must inspect PC2, PC3 or PC4 certified facilities annually. 

Types of facilities 

The facility type is based on the containment level and the type of organism being contained. 

The following table provides an overview of the facility types. 
Type Level Appropriate for

Animal facility

PC2, PC3
  • The housing/keeping/rearing of GM animals (except invertebrates and aquatic organisms – including amphibians).
  • The housing/keeping/rearing of animals (except invertebrates and aquatic organisms – including amphibians) that contain GMOs.

Aquatic facility

PC2
  • The keeping or rearing of GM aquatic organisms (including amphibians).
  • The keeping or rearing of aquatic organisms (including amphibians) that contain GMOs.

Constant temperature room

PC2
  • Storing samples, cultures and seeds and incubating cultures.
  • Growing plants tissue and cell shaking.

Facility

PC1
  • GM micro-organisms (when there is less than or equal to 25 litres of culture of any one GMO).
  • GM animals (whether or not they contain micro-organisms) as permitted by the Gene Technology Regulations 2001.
  • Non-GM animals containing GM micro-organisms.
  • Non-GM plants that contain or host GMOs.
Facility PC3
  • Dealings requiring PC3 containment including work with micro-organisms, animals and invertebrates. New guidelines effective 1 December 2022.

Facility

PC4
  • Dealings requiring a licence need this level of containment.

Invertebrate facility

PC2, PC3
  • The keeping or rearing of GM terrestrial invertebrates.
  • The keeping or rearing of terrestrial invertebrates that contain GMOs.

Laboratory

PC2, PC3
  • Dealings with GM micro-organisms.
  • Dealings with GM plant tissue culture or GM plants contained in a plant growth cabinet or other containment device approved in writing by the Regulator.
  • Laboratory procedures involving animals, invertebrates, or aquatic organisms if not otherwise prohibited by licence conditions.
  • The growing of plants for no more than the minimum time required for conducting dealings with GMOs (PC3 only).

Large grazing animals facility

PC2
  • Dealings involving large grazing animals such as sheep, cattle, goats, pigs and horses.

Large scale facility

PC2
  • Conduct of dealings when there is greater than 25 litres of culture of any one GMO.

Plant facility

PC2
  • The growing of GM terrestrial plants.
  • The growing of terrestrial plants that contain GMOs.

What dealings must be contained

Some GMO dealings must not involve intentional release of GMOs into the environment. Generally, this means that they are undertaken in physical containment (PC) facilities. The Regulator may need to certify the facilities.

This table shows the containment requirements for each type of dealing.
Category Containment requirements

Exempt

Yes
No intentional release to the environment

NLRD

Yes
PC1 or PC2 (usually)

DNIR

Yes
≥ PC2 (usually) or appropriate clinical facilities, and other conditions will apply

DIR (limited and controlled release)

Generally no containment measures, but confinement measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply

DIR (except for limited and controlled release)

Generally no containment measures, but confinement measures may be required, determined on a case-by-case basis, and other licence conditions will apply

Inadvertent dealing

Containment and/or disposal measures will apply

GMO Register

Containment measures may be required

EDD

Containment and/or disposal measures may be included in EDD conditions

What certification you must have

The Guide to Physical Containment Levels and Facility Types will help you decide which PC level and facility type to apply for.

There are guidelines for each level and type of certification. They explain the requirements described in the Gene Technology Act 2000.

You can also find out more about PC facilities certification in the Regulator’s explanatory note.

If you have any questions about certification, contact us.

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