Hazardous Substances and New Organisms Act 1996

Schedule 3

ss 32(2), 42(2), 45(2)

Part 1 Matters to be addressed by containment controls for importing, developing, or field testing of genetically modified organisms

Schedule 3 Part 1 heading: amended, on 2 July 2001, by section 41 of the Hazardous Substances and New Organisms Amendment Act 2000 (2000 No 89).

1

To limit the likelihood of any accidental release of any organism or any viable genetic material, the controls imposed by an approval shall specify—

(a)

requirements for treatment and decontamination to prevent escape by way of expelled air, discharge of water or liquid waste, removal of solid waste or goods, or breaches in facility boundary:

(b)

equipment and requirements for facility construction to enable the requirements for treatment and decontamination to be readily met:

(c)

requirements to be complied with for the access of persons to the facility:

(d)

procedures and requirements for transport, identification, and packaging for all biological material to and from the facility and within the facility:

(e)

requirements for the disposal of any biological material:

(f)

requirements for facility construction:

(g)

requirements to secure the facility and openings, including securing against failure in the event of foreseeable hazards.

2

To exclude unauthorised people from the facility, the controls imposed by an approval shall specify—

(a)

means of identification of all entrances to the facility:

(b)

the numbers of entrances and access to the facility:

(c)

security requirements for the entrances and the facility.

3

To exclude other organisms from the facility and to control undesirable and unwanted organisms within the facility, the controls shall specify—

(a)

monitoring requirements to establish the presence of other organisms:

(b)

phytosanitary requirements:

(c)

requirements to secure the facility and openings against likely unwanted organisms.

4

To prevent unintended release of the organism by experimenters working with the organism, the controls shall specify—

(a)

requirements to prevent the contamination of work surfaces, equipment, clothing, and the facility generally:

(b)

requirements for laboratory practice to control infection by ingestion or breaks in skin cover:

(c)

means to control infection by inhalation.

5

To control the effects of any accidental release or escape of an organism—

(a)

controls imposed by an approval shall specify an eradication plan for escaped organisms:

(b)

controls imposed by an approval may specify requirements to limit the likelihood of an escaped organism spreading, surviving and breeding, including, but not limited to,—

(i)

exclusion zones (spatial or temporal):

(ii)

location of the facility outside the usual habitat range of the organism.

6

Controls imposed by an approval shall specify inspection and monitoring requirements for containment facilities, including any inspection required before commencement of the development.

Schedule 3 Part 1 clause 6: amended, on 28 May 2002, by section 11(1) of the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Act 2002 (2002 No 13).

6A

Controls imposed on an approval to field test a genetically modified organism—

(a)

must specify—

(i)

inspection and monitoring of containment facilities during the field test; and

(ii)

inspection and monitoring of the site, after the field test, to ensure that all heritable material is removed or destroyed; and

(b)

may specify inspection of the site before field testing commences.

Schedule 3 Part 1 clause 6A: inserted, on 28 May 2002, by section 11(2) of the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Act 2002 (2002 No 13).

6B

Clause 6A applies, with all necessary modifications, to controls imposed on an approval to develop a new organism that is a genetically modified organism, to the extent that the development does not take place in a containment structure.

Schedule 3 Part 1 clause 6B: inserted, on 28 May 2002, by section 11(2) of the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Act 2002 (2002 No 13).

7

Controls imposed by an approval may specify—

(a)

the qualifications required of the person responsible for implementing the controls imposed by an approval:

(b)

the provision of a management plan specifying procedures for implementing controls imposed by an approval.

Part 2 Matters to be addressed by containment controls for new organisms excluding genetically modified organisms

1

To limit the likelihood of any accidental release of any organism or any viable genetic material, the controls imposed by an approval shall specify—

(a)

requirements for treatment and decontamination to prevent escape by way of expelled air, discharge of water or liquid waste, removal of solid waste, or breaches in facility boundary:

(b)

equipment and requirements for facility construction to enable the requirements for treatment and decontamination to be readily met:

(c)

requirements to be complied with for the access of persons to the facility:

(d)

procedures and requirements for transport, identification, and packaging for all biological material to and from the facility and within the facility:

(e)

requirements for the disposal of any biological material:

(f)

requirements for facility construction:

(g)

requirements to secure the facility and openings, including securing against failure in the event of foreseeable hazards.

2

To exclude unauthorised people from the facility, the controls imposed by an approval shall specify—

(a)

means of identification of all entrances to the facility:

(b)

the numbers of entrances and access to the facility:

(c)

security requirements for the entrances and the facility.

3

To control the effects of any accidental release or escape of an organism—

(a)

controls imposed by an approval shall specify an eradication plan for escaped organisms:

(b)

controls imposed by an approval may specify requirements to limit the likelihood of an escaped organism spreading, surviving, and breeding, including, but not limited to,—

(i)

exclusion zones (spatial or temporal):

(ii)

location of the facility outside the usual habitat range of the organism.

4

Controls imposed by an approval shall specify inspection and monitoring requirements for containment facilities.

5

Controls imposed by an approval may specify the qualifications required of the person responsible for implementing those controls.

Part 3 Matters to be addressed by EPA containment controls for contained hazardous substances

Schedule 3 Part 3 heading: amended, on 1 December 2017, by section 54 of the Hazardous Substances and New Organisms Amendment Act 2015 (2015 No 72).

1

To limit the likelihood of escape of any contained hazardous substances or contamination of the facility by hazardous substances, the EPA controls imposed by an approval shall specify—

(a)

requirements for treatment and decontamination to prevent escape by way of expelled air, discharge of water or liquid waste, removal of solid waste, or breaches in facility boundary:

(b)

equipment and requirements for facility construction to enable the requirements for treatment and decontamination to be readily met:

(c)

requirements to be complied with for the access of persons to the facility:

(d)

procedures and requirements for transport, identification, and packaging of the substance to and from the facility and within the facility:

(e)

requirements for the disposal of any hazardous substance:

(f)

requirements for facility construction:

(g)

requirements to secure the facility and openings, including securing against failure in the event of foreseeable hazards.

Schedule 3 Part 3 clause 1: amended, on 1 December 2017, by section 54 of the Hazardous Substances and New Organisms Amendment Act 2015 (2015 No 72).

2

To exclude organisms from a facility or to control organisms within a facility, the EPA controls shall specify—

(a)

phytosanitary requirements:

(b)

requirements to secure the facility and openings against likely unwanted organisms:

(c)

monitoring requirements to establish the presence of organisms.

Schedule 3 Part 3 clause 2: amended, on 1 December 2017, by section 54 of the Hazardous Substances and New Organisms Amendment Act 2015 (2015 No 72).

3

To exclude unauthorised people from the facility, EPA controls imposed by an approval shall specify—

(a)

means of identification of all entrances to the facility:

(b)

the numbers of entrances and access to the facility:

(c)

security requirements for the entrance and the facility.

Schedule 3 Part 3 clause 3: amended, on 1 December 2017, by section 54 of the Hazardous Substances and New Organisms Amendment Act 2015 (2015 No 72).

4

To prevent unintended release of the substance by experimenters working with the substance, the controls shall specify—

(a)

requirements to prevent the contamination of work surfaces, equipment, clothing, and the facility generally:

(b)

procedures to ensure that no person in the facility is exposed to a sufficient level of the substance to cause harm to that person.

5

To control the effects of any accidental release of the substance, controls imposed by an approval shall specify—

(a)

procedures to recover and dispose of any hazardous substance:

(b)

procedures to minimise the effects of such a release on people and the environment.

6

Controls imposed by an approval shall specify inspection and monitoring requirements for containment facilities.

7

Controls imposed by an approval may specify—

(a)

the qualifications required of the person responsible for implementing the controls imposed by an approval:

(b)

the provisions of a management plan specifying procedures for implementing controls imposed by an approval.