Commonwealth Numbered Regulations

GENE TECHNOLOGY REGULATIONS 2001 2001 NO. 106 - SCHEDULE 3

(regulations 12 and 13)

Part 1 Dealings that are notifiable low risk dealings

1.1 Kinds of dealings
The following kinds of dealings are notifiable low risk dealings:

(a)

any dealing involving whole animals (including non-vertebrates) that:

(i)

involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and

(ii)

does not involve gene-knockout mice;

(b) any dealing involving a genetically modified flowering plant, if:

(i)

the dealing does not involve the plant being grown to flowering stage; or

(ii) for a dealing that does involve the plant being grown to flowering stage:

(A) the plant is male sterile and is unable to set seed; or
(B) if the plant is male sterile and can set seed — all vents and drains in the facility are screened with mesh or filters that block the escape of viable pollen and seed; or
(C) before flowering, all inflorescences are wholly enclosed in bags designed to prevent escape of viable pollen and seed; or
(D) if the plant can be wind-pollinated — all vents and drains in the facility are screened with mesh or filters that block the escape of viable pollen and seed; or
(E) if the plant can be vector-pollinated only — all vents and drains in the facility are screened with mesh or filters that block the escape of viable seed and exclude pollen vectors from the facility;

(c) any dealing involving a host and vector that are not mentioned as a host/vector system in Part 2 of Schedule 2, if:

(i)

the host is incapable of causing disease in human beings, animals, plants or fungi; and

(ii)

the vector is incapable of causing disease in human beings, animals, plants or fungi;

(d)

any dealing involving a host and vector that are not mentioned as a host/vector system in Part 2 of Schedule 2, if, although the host or vector is capable of causing disease in human beings, animals, plants or fungi, the donor DNA is fully characterised and will not increase the virulence of the host or vector;

(e) any dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the gene inserted:

(i)

is a pathogenic determinant; or

(ii)

is uncharacterised DNA from a micro-organism that is capable of causing disease in human beings, animals, plants or fungi; or

(iii)

is an oncogene.

1.2 Definitions
In this Part:

"characterised", in relation to DNA, means that the DNA has been sequenced and that there is an understanding of potential gene products of the DNA.

"gene-knockout mice", has the same meaning as in item 1 in Part 1 of Schedule 2.

Part 2 Dealings (higher risk) that are not notifiable low risk dealings

2.1 Kinds of dealings
A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:

(a)

a dealing involving cloning of DNA encoding a toxin for vertebrates having an LD50 of less than 100 µg/kg;

(b)

a dealing involving high level expression of toxin genes, even if the LD50 is greater than 100 µg/kg;

(c)

a dealing involving cloning of uncharacterised DNA from toxin-producing micro-organisms;

(d)

a dealing involving a viral vector (except a vector that is used in the dealing as part of a host/vector system mentioned in Part 2 of Schedule 2), containing one or more inserted sequences, that codes for a product known to play a role in the regulation of cellular growth or to be toxic to mammalian cells;

(e) a dealing involving, as host or vector, a micro-organism that is capable of causing disease in humans, animals plants or fungi, unless:

(i)

the host/vector system is a system mentioned in Part 2 of Schedule 2; or

(ii)

the dealing involves only the cloning of DNA that is fully characterised and is known not to increase the virulence of the host and vector;

(f)

a dealing involving the introduction into a micro-organism, other than a host mentioned in Part 2 of Schedule 2, of genes that determine pathogenicity;

(g)

a dealing involving the introduction into a micro-organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products have a heightened risk of inducing an autoimmune response;

(h)

a dealing involving cloning or transfer of fragments of a viral or viroid genome that are capable, in the host/vector system to be used, of giving rise to infectious agents that are capable of infecting cells of human, animal, plant or fungal origin;

(i)

a dealing involving recombination between whole viral genomes, viroids or complementing fragments of such genomes (if one or more fragments contain virulence or pathogenic determinants);

(j)

a dealing involving use of a viral vector to produce a transgenic animal, plant or fungus that secretes or produces infectious recombinant viral agents;

(k)

a dealing involving the production of more than 10 litres of GMO culture;

(l)

a dealing that is inconsistent with a policy principle issued by the Ministerial Council.

Part 3 Prescribed information — notification of proposed notifiable low risk dealing
3.1 Information about proponent and proposed dealing
For a notification made under paragraph 15 (1) (b) of these Regulations, the following information must be included:
3.1.1 General information

(a)

name, address, telephone number and other contact details, of the proponent organisation;

(b)

name, position within the organisation and contact details, of the proponent's project supervisor for the proposed dealing, or dealings, with the GMO or GMOs involved;

(c)

title of the project involving the proposed dealing or dealings;

(d)

with reference to the kinds of dealings set out in Part 1 of this Schedule — the kind of dealing or dealings proposed;

(e)

description of each GMO involved;

(i)

the common name of the parent organism; and

(ii)

the scientific name of the parent organism; and

(iii)

the modified trait; and

(iv)

the identity of the gene responsible for the modified trait;

(f)

description of the proposed dealing or dealings;

(g)

description of the purposes and aims of the proposed dealing or dealings;

(h)

address of the premises where the dealing is, or dealings are, proposed to be undertaken;

(i)

proposed date of commencement, and proposed date of completion, of the dealing or dealings.

3.1.2 Genetics of GMO
(a) details of the biological system intended to be used, including:

(i)

the biological source of the donor DNA; and

(ii)

the intended host organism, or tissue; and

(iii)

the vector or vectors, or the method, intended to be used for the transfer of DNA; and

(iv)

whether the intended host/vector system is a system mentioned in Part 2 of Schedule 2.

3.1.3 Risk assessment information

(a)

details of all risks that could arise from the genetic modification, including occupational health and safety risks for persons involved;

(b) details of all risks that could arise from an unintentional release of the GMO or GMOs into the environment, including:

(i)

risks to the health and safety of people; and

(ii)

risks to the environment.

3.1.4 Risk management information

(a)

details of the facility in which the proposed dealing or dealings are to be undertaken, and of its physical containment level (as certified under Division 2 of Part 7 of the Act);

(b) in relation to certification of the facility:

(i)

the date of certification; and

(ii)

the certification number allocated to the facility by the Regulator; and

(iii)

the date of the most recent inspection of the facility by the Regulator or the facility's Institutional Biosafety Committee;

(c)

if the GMO is, or GMOs are, intended to be transported or moved outside the facility, details of the arrangements for that transport or movement;

(d)

details of any arrangements for disposal of the GMO or GMOs;

(e)

details of action proposed to be taken in the case of an unintentional release of the GMO, or GMOs, from containment;

(f)

details of other actions and precautions proposed to be taken by the applicant to minimise any risks posed by the proposed dealing or dealings;

(g)

details of the qualifications and experience of the project supervisor for the proponent organisation.

3.2 Additional information if GMO is a whole plant, or is to be used in conjunction with a whole plant
For a notification about a proposed notifiable low risk dealing that will involve a GMO that is a whole plant, or the use of a GMO in conjunction with a whole plant, the following additional information must be included:

(a)

a statement on whether the parent organism is a weed or closely related to plants that are weeds and, if so, identification of the weeds that are closely related;

(b)

details of the stage of development that the plant, or plants, used in the dealing will be allowed to reach;

(c)

details of the method that will be used to dispose of the plant, or plants, used in the dealing;

(d)

a statement on whether soil, or soil substitute, will be used as the growing medium for the plant, or plants, used in the dealing, and, if so, details of how that medium will be subsequently sterilised or disposed of.

3.3 Supporting information from IBC for a proponent
The information required for a notification about a proposed notifiable low risk dealing includes the following information to be given in relation to the Institutional Biosafety Committee ( IBC ) concerned:

(a)

confirmation that the information given to the Regulator in relation to the proponent has been checked by the IBC and found to be complete;

(b)

confirmation that the IBC considers that personnel intended to be involved in dealing with the GMO or GMOs have adequate training and experience for the task;

(c) a statement that the IBC has evaluated the proposed project, and that includes the following details:

(i)

the date of the evaluation;

(ii)

the full name of the IBC;

(iii)

the name and contact details of the chairperson and of the secretary of the IBC;

(d)

a copy of the evaluation report, prepared in accordance with any guidelines issued by the Regulator;

(e)

a statement that the IBC is established in accordance with the Regulator's guidelines under section 98 of the Act.

Note
The IBC giving the information could be an IBC established by the proponent, or by another accredited organisation.