Part 1 Preliminary
1 Name
of Regulations [see Note
1]
These Regulations are the Gene Technology
Regulations 2001.
2 Commencement
[see Note 1]
These Regulations commence on the date of
commencement of provisions of the Act to which subsection 2 (3) of the Act
apply.
3 Definitions
In these Regulations:
Act means the Gene Technology Act 2000.
advantage, in relation to an organism that is
genetically modified, means a superior ability in its modified form, relative
to the unmodified parent organism, to survive, reproduce or otherwise
contribute to the gene pool.
animal includes every kind of organism in the
animal kingdom, including non‑vertebrates but not including human beings.
characterised, in relation to nucleic acid,
means nucleic acid that has been sequenced and in respect of which there is an
understanding of potential gene products or potential functions.
code for, for Schedule 2, has the meaning
given in Part 3 of that Schedule.
expert adviser means:
(a) in Part 4 — an expert adviser appointed
under subsection 102 (1) of the Act; and
(b) in Part 5 — an expert adviser appointed
under subsection 112 (1) of the Act.
genetically modified laboratory mouse means a
laboratory strain of mouse of the species Mus musculus that has
been modified by gene technology.
genetically modified laboratory rat means a laboratory
strain of rat of either the species Rattus rattus or Rattus
norvegicus that has been modified by gene technology.
infectious agent means an agent that is
capable of entering, surviving in, multiplying, and potentially causing disease
in, a susceptible host.
known means known within the scientific
community.
non‑conjugative plasmid, for Schedule
2, has the meaning given in Part 3 of that Schedule.
non‑vector system, for Schedule 2, has
the meaning given in Part 3 of that Schedule.
nucleic acid means either, or both,
deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length.
oncogenic modification means a genetic
modification that is capable of inducing unregulated cell proliferation in a
vertebrate cell.
out of session, for regulation 25, has the
meaning given in subregulation 25 (4).
packaging cell line means an animal or human
cell line that contains a gene or genes that when expressed in trans are
necessary and sufficient to complement packaging defects of a replication
defective viral vector in order to produce packaged replication defective
virions.
pathogenic, in relation to an organism,
means having the capacity to cause disease or abnormality.
pathogenic determinant means a characteristic
that has the potential to increase the capacity of a host or vector to cause
disease or abnormality.
physical containment level, followed by a
numeral, is a specified containment level under guidelines made by the
Regulator, under section 90 of the Act, for the certification of facilities.
plasmid means a DNA molecule capable of
autonomous replication and stable extra‑chromosomal maintenance in a host
cell.
shot‑gun cloning means the production of
a large random collection of cloned fragments of nucleic acid from which genes
of interest can later be selected.
toxin means a substance that is toxic to any vertebrate.
toxin‑producing organism means an
organism producing toxin with an LD50
of less than 100 mg/kg.
transduce, in relation to a viral vector or
viral particle, means enter an intact cell by interaction of the viral particle
with the cell membrane.
Note Several
other words and expressions used in these Regulations have the meaning given by
section 10, or another provision, of the Act. For example:
· accredited
organisation
· deal with
· environment
· Ethics and
Community Committee
· facility
· Gene
Technology Technical Advisory Committee
· GMO
· GM product
· Institutional
Biosafety Committee
· intentional
release of the GMO into the environment (see section 11)
· notifiable low
risk dealing
· Regulator.
Part 2 Interpretation
and general operation
4 Techniques
not constituting gene technology
For paragraph (c) of the definition of gene technology
in section 10 of the Act, gene technology does not include a technique
mentioned in Schedule 1A.
5 Organisms
that are not genetically modified organisms
For paragraph (e) of the definition of genetically
modified organism in section 10 of the Act, an organism mentioned in
Schedule 1 is not a genetically modified organism.
Part 3 Dealings
with GMOs
Division 1 Licensing system
6 Dealings
exempt from licensing
(1) For subsection 32 (3) of the Act, a dealing,
in relation to a GMO, is an exempt dealing if:
(a) it is a dealing of a kind mentioned in Part
1 of Schedule 2; and
(b) it does not involve a genetic modification
other than a modification described in Part 1 of Schedule 2; and
(d) it does not involve an intentional release of
the GMO into the environment; and
(e) it does not involve a retroviral vector that
is able to transduce human cells.
(2) For the avoidance of doubt, exemption under
subregulation (1) does not apply to a dealing that does not comply with
subregulation (1), whether or not that dealing is related to a dealing that
does so comply.
Note 1 A dealing affected by this
regulation could be any of the forms of dealing mentioned in the definition of deal
with in subsection 10 (1) of the Act.
Note 2 Exemption from provisions of
the Act does not preclude the application of other Commonwealth and State laws.
7 Application
for licence — prescribed fee
Note At the commencement of the
Regulations, no application fee is prescribed under subsection 40 (6) of
the Act.
8 Time
limit for deciding an application
(1) For subsection 43 (3) of the Act, the period
within which the Regulator must issue, or refuse to issue, a licence is:
(a) in relation to an application to which
Division 3 of Part 5 of the Act applies — 90 days after the day the
application is received by the Regulator; or
(b) for an application to which Division 4 of
Part 5 of the Act applies:
(i) for a limited and controlled
release application for which the Regulator is satisfied that the dealings
proposed to be authorised by the licence do not pose significant risks to the
health and safety of people or to the environment — 150 days after the day
the application is received by the Regulator; and
(ii) for a limited and controlled
release application for which the Regulator is satisfied that at least one of
the dealings proposed to be authorised by the licence may pose significant
risks to the health and safety of people or to the environment — 170 days
after the day the application is received by the Regulator; and
(iii) in any other case — 255 days
after the day the application is received by the Regulator.
(2) For the purpose of determining the end of a period
mentioned in subregulation (1), the following days are not counted:
(a) a Saturday, a Sunday or a public holiday in
the Australian Capital Territory;
(b) a day on which the Regulator cannot proceed
with the decision‑making process, or a related function, because the
Regulator is awaiting information that the applicant has been requested, in
writing, to give;
(c) if, in relation to the application, the
Regulator publishes notice of a public hearing under section 53 of the Act, a
day in the period that:
(i) begins on the day of publication;
and
(ii) ends on the day when the public
hearing ends;
(d) a day on which the Regulator cannot proceed
with the decision‑making process, or a related function, because:
(i) the applicant has requested, under
section 184 of the Act, that information given in relation to the application
be declared confidential commercial information for the purposes of the Act;
and
(ii) the
Regulator is:
(A) considering
the application; or
(B) waiting until any review
rights under section 181 or 183 of the Act, in relation to the
application, are exhausted;
(e) if, in relation to the application, the
Regulator requests the Ethics and Community Committee to provide advice on an
ethical issue, a day in the period that:
(i) begins on the day the request is
made; and
(ii) subject to subregulation
(3) — ends on the day when the advice is given or, if the advice is not
given within the period, if any, specified under subregulation (3), on the last
day of that period.
(3) The Regulator, when seeking advice under subsection
50 (3) or 52 (3) of the Act, or from the Ethics and Community Committee,
may specify a reasonable period within which the advice must be received, and,
if the advice is not received within that period, must proceed without regard
to that advice.
(4) In subregulation (1):
limited and controlled release application
means an application for a licence to which section 50A of the Act applies.
9 Prescribed
authorities
For paragraphs 50 (3) (c) and
52 (3) (c) of the Act, the following Commonwealth authorities and
agencies are prescribed:
(a) Food Standards Australia New Zealand;
(b) Australian Quarantine and Inspection Service;
(d) the Director, National Industrial Chemical
Notification and Assessment Scheme under the Industrial Chemical
(Notification and Assessment) Act 1989;
(e) Australian Pesticides and Veterinary Medicines
Authority;
(f) Therapeutic Goods Administration, Department
of Health and Aged Care.
9A Risks
posed by dealings proposed to be authorised by licence
For paragraph 51 (1) (a)
of the Act, the Regulator must have regard to the following matters:
(a) the properties of the organism to which
dealings proposed to be authorised by a licence relate before it became, or
will become, a GMO;
(b) the effect, or the expected effect, of the
genetic modification that has occurred, or will occur, on the properties of the
organism;
(c) provisions for limiting the dissemination or
persistence of the GMO or its genetic material in the environment;
(d) the potential for spread or persistence of
the GMO or its genetic material in the environment;
(e) the extent or scale of the proposed
dealings;
(f) any likely impacts of the proposed dealings
on the health and safety of people.
10 Risk
assessment — matters to be taken into account
(1) For paragraphs 51 (1) (g) and
51 (2) (g) of the Act, other matters to be taken into account in
relation to dealings proposed to be authorised by a licence include:
(a) subject to section 45 of the Act, any
previous assessment by a regulatory authority, in Australia or overseas, in
relation to allowing or approving dealings with the GMO; and
(b) the potential of the GMO concerned to:
(i) be harmful to other organisms; and
(ii) adversely affect any ecosystems;
and
(iii) transfer genetic material to
another organism; and
(iv) spread, or persist, in the
environment; and
(v) have, in comparison to related
organisms, an advantage in the environment; and
(vi) be toxic, allergenic or pathogenic
to other organisms.
(2) In taking into account a risk mentioned in
subsection 51 (1) of the Act, or a potential capacity mentioned in
subregulation (1), the Regulator must consider both the short term and the long
term.
11 Prescribed
conditions of licence
Note At the commencement of the
Regulations, no conditions are prescribed under paragraph 61 (b) of the Act.
11A Time
limit for deciding variation application
For subsection 71 (7) of the Act, the
Regulator must vary the licence, or refuse to vary the licence, within 90 days
after the day an application for a variation of the licence is received by the
Regulator.
Division 2 Notifiable low risk dealings
12 Notifiable
low risk dealings
(1) For subsection 74 (1) of the Act, a dealing
with a GMO is a notifiable low risk dealing if:
(a) it is a dealing of a kind mentioned in Part
1 of Schedule 3 (other than a dealing also mentioned in Part 2 of
Schedule 3); and
(b) it does not involve an intentional release of
the GMO into the environment.
(2) For the avoidance of doubt, subregulation (1) does
not apply to a dealing that does not comply with subregulation (1), whether or
not that dealing is related to a dealing that does so comply.
Note A dealing affected by this
regulation could be any of the forms of dealing mentioned in the definition of deal
with in subsection 10 (1) of the Act.
13 Requirements
in relation to undertaking notifiable low risk dealings
(1) A person may
undertake a notifiable low risk dealing only if:
(a) a person or an accredited organisation has
requested an Institutional Biosafety Committee to assess whether the proposed
dealing is a notifiable low risk dealing; and
(b) the Committee has assessed the proposed
dealing to be a notifiable low risk dealing; and
(c) the person who proposes to undertake the
proposed dealing and the project supervisor for the proposed dealing have been
notified that the Committee:
(i) has assessed the proposed dealing
to be a notifiable low risk dealing; and
(ii) considers that the personnel to be
involved in the proposed dealing have appropriate training and experience.
(2) A notifiable low risk dealing must comply with the
following requirements:
(a) the dealing
must be conducted:
(i) for a kind of dealing mentioned in
Part 1 of Schedule 3 — in a facility that is certified by the Regulator to
at least physical containment level 1 and is of appropriate design for the kind
of dealing being undertaken; or
(ii) for a kind of dealing mentioned in
Part 2 of Schedule 3 — in a facility that is certified by the Regulator to
at least physical containment level 2 and is of appropriate design for the kind
of dealing being undertaken; or
(iii) in another facility in accordance
with any technical and procedural guidelines relating to containment of GMOs,
as in force from time to time under paragraph 27 (d) of the Act, that the
Regulator has determined in writing are appropriate for conducting the dealing;
and
(b) to the extent that the dealing involves
transporting a GMO, the transporting must be conducted in accordance with
applicable technical and procedural guidelines, as in force from time to time
under paragraph 27 (d) of the Act.
13A Requirements
in relation to notifying Regulator of notifiable low risk dealings
(1) An Institutional Biosafety Committee that has
assessed a proposed dealing to be a notifiable low risk dealing must:
(a) make a record of the proposed dealing in a
form approved by the Regulator; and
(b) if the Regulator, by written notice given to
the Committee, requests a copy of the record — give a copy of the record
to the Regulator by the end of the period mentioned in the notice; and
(c) give a copy of the record to:
(i) the person or accredited
organisation that requested the Committee to assess the proposed dealing; and
(ii) the project supervisor for the
proposed dealing.
(2) The person or accredited organisation must:
(a) for the financial year in which the
Committee assessed the proposed dealing, include a copy of the Committee’s
record:
(i) for an accredited organisation —
in the annual report given to the Regulator by the organisation for the
financial year; or
(ii) in any other case — in a
report given to the Regulator, in the form approved by the Regulator, by the
person for the financial year; and
(b) retain a copy of the Committee’s record for 3 years
after the date that the person or accredited organisation ceased to be involved
with the conduct of the dealing.
(3) The Regulator may, by written notice, require:
(a) the Committee; or
(b) the person or accredited organisation; or
(c) any other person involved with the conduct
of the proposed dealing;
to give the Regulator any further information about the dealing
that the Regulator requires in order to be satisfied that the dealing is a
notifiable low risk dealing.
(4) A Committee, person or accredited organisation
receiving a notice under subregulation (3) must, by the end of the period
mentioned in the notice, give the Regulator the information required by the
notice.
Division 3 Certification and accreditation
14 Regulator
to decide certification application within 90 days
(1) For section 84 of the Act, the period within which
the Regulator must consider, and decide, an application for certification of a
facility is:
(a) 90 days after the day the application is
received by the Regulator; or
(b) if the Regulator has given the applicant a
notice under subsection 85 (1) of the Act, 90 days plus the period beginning
on the day the notice is given and ending when the required information is
given to the Regulator.
(2) For the purpose of determining the end of a period
mentioned in subregulation (1), Saturdays, Sundays and public holidays in the
Australian Capital Territory are not counted.
15 Application
for certification — failure to provide section 85 information
If an applicant for certification fails to provide
information required under subsection 85 (1) of the Act within the period
specified in a notice given under subsection 85 (2) of the Act, and gives
no reasonable explanation for the failure, the Regulator may refuse to certify
the facility that is the subject of the application.
Note A refusal to certify a facility is a
reviewable decision (see Division 2 of Part 12 of the Act).
16 Regulator
to decide accreditation application within 90 days
(1) For subsection 92 (1) of the Act, the period
within which the Regulator must consider, and decide, an application for
accreditation of an organisation is:
(a) 90 days after the day the application is
received by the Regulator; or
(b) if the Regulator has given the applicant a
notice under subsection 93 (1) of the Act, 90 days plus the period
beginning on the day the notice is given and ending when the required
information is given to the Regulator.
(2) For the purpose of determining the end of a period
mentioned in subregulation (1), Saturdays, Sundays and public holidays in the
Australian Capital Territory are not counted.
17 Application
for accreditation — failure to provide section 93 information
If an applicant for accreditation fails to provide
information required under subsection 93 (1) of the Act within the period
specified in a notice given under subsection 93 (2) of the Act, and gives
no reasonable explanation for the failure, the Regulator may refuse to accredit
the organisation that is the subject of the application.
Note A refusal to accredit an
organisation is a reviewable decision (see Division 2 of Part 12 of the Act).
Part 4 Gene
Technology Technical Advisory Committee
Division 1 Conditions of appointment
18 GTTAC
members and advisers — term of appointment
(1) The term of appointment of a member of the Gene
Technology Technical Advisory Committee, or an expert adviser, is 3 years,
or a lesser period specified in the instrument of appointment of the member or
adviser.
(2) A member or adviser may be reappointed for a further
term or terms.
19 GTTAC
members and advisers — resignation
A member of the Gene Technology Technical Advisory
Committee, or an expert adviser, may resign by giving the Minister written
notice of resignation.
20 GTTAC
members — disclosure of interests
(1) Before the Minister appoints a person as a member of
the Gene Technology Technical Advisory Committee, the Minister must obtain from
the person a declaration setting out all direct or indirect interests,
pecuniary or otherwise, that the person is aware of having in a matter of a
kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory
Committee who is aware of having a direct or indirect interest, pecuniary or
otherwise, in a matter being considered, or about to be considered, at a
meeting of the Committee must, without delay, disclose the nature of the interest
at, or before, the meeting of the Committee.
(3) Disclosure must
include interests that could be perceived to represent a possible conflict of
interest in relation to:
(a) for
subregulation (1) — a matter likely to be considered at a meeting of the
Committee; or
(b) for subregulation (2) — the matter being
considered or about to be considered.
(4) A disclosure under this regulation must be recorded
in the minutes of the meeting and the member must not:
(a) be present during any deliberation of the
Committee about the matter, except to give information requested by the
Committee; or
(b) take part in any decision of the Committee
about that matter.
21 GTTAC
members and advisers — termination of appointment
(1) The Minister may terminate the appointment of a
member of the Gene Technology Technical Advisory Committee, or an expert
adviser, for misbehaviour (including failure to disclose an interest) or
physical or mental incapacity:
(a) in the case of the chairperson of the
Committee — with the agreement of a majority of jurisdictions; or
(b) in any other case — on the initiative of
the Minister.
(2) The Minister must terminate a member’s appointment
if the member:
(a) becomes bankrupt, applies to take the
benefit of any law for the relief of bankrupt or insolvent debtors, compounds
with his or her creditors or makes an assignment of his or her remuneration for
their benefit; or
(b) fails to fulfil his or her obligations, as a
member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave
of absence granted under regulation 22.
Note Under
section 27A of the Administrative Appeals Tribunal Act 1975, a decision‑maker
must give to persons whose interests are affected by the making of the
decision, notice of the decision and of their right to have the decision
reviewed. In notifying such a person, the decision‑maker must have regard
to the Code of Practice determined under section 27B of that Act (see Gazette
No. S 432, 7 December 1994), which is accessible on the Internet at:
http://scaleplus.law.gov.au/html/instruments/0/14/0/IN000020.htm.
22 GTTAC
members — leave of absence
(1) The Minister may grant the Chairperson of the Gene
Technology Technical Advisory Committee leave of absence.
(2) The Chairperson may grant a member of the Gene
Technology Technical Advisory Committee leave of absence.
23 Expert
advisers — disclosure of interests
(1) Before the Minister appoints a person as an expert
adviser to the Gene Technology Technical Advisory Committee, the Minister must
obtain from the person a declaration setting out all direct or indirect
interests, pecuniary or otherwise, that the person is aware of having in a
matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or
indirect interest, pecuniary or otherwise, in a matter being considered, or
about to be considered, at a meeting of the Committee for which he or she is
providing advice must, without delay, disclose the nature of the interest at,
or before, the meeting of the Committee.
(3) Disclosure must include interests that could be
perceived to represent a possible conflict of interest in relation to:
(a) for subregulation (1) — a matter likely
to be considered at a meeting of the Committee; or
(b) for subregulation (2) — the matter being
considered or about to be considered.
(4) A disclosure under this regulation must be recorded
in the minutes of the meeting.
Division 2 Committee procedures
24 Committee
procedures generally
In performing its functions, the Gene Technology
Technical Advisory Committee:
(a) must act according to these Regulations; and
(b) must act with as little formality and as
quickly as the requirements of these Regulations, and a proper consideration of
the issues before the Committee, allow; and
(c) may obtain information about an issue in any
way it considers appropriate, subject to any direction in a request from the
Regulator or Ministerial Council about the extent to which, or manner in which,
information is to be obtained.
25 Committee
meetings
(1) The Chairperson of the Gene Technology Technical
Advisory Committee may, by written notice to the Committee, direct the
Committee to hold a meeting:
(a) at the time and place stated in the notice;
and
(b) to deal with specified matters in the manner
stated in the notice.
(2) In each year, the Committee may have as many
meetings (other than meetings by videoconference or teleconference) as:
(a) before the beginning of the year — the
Regulator and the Chairperson have agreed may be held; and
(b) the Regulator and the Chairperson agree
should be additionally held.
(3) If the Chairperson of the Committee considers it
appropriate and efficient in the circumstances, the Committee may be directed:
(a) to meet, and resolve decisions, by
videoconference or teleconference; and
(b) to meet out of
session.
(4) For this regulation:
out of session, in relation to a meeting,
means a meeting in which the members take part by correspondence, electronic
mail, telephone or in any other way that does not involve formal simultaneous
meeting and voting.
(5) Subject to these Regulations, the procedure of a
meeting is as decided by the Committee.
26 Presiding
member
(1) At a meeting of the Gene Technology Technical
Advisory Committee, the Chairperson of the Committee must:
(a) preside; or
(b) nominate, in writing, a member of the
Committee (other than a member to whom paragraph 100 (7A) (a) or (b)
of the Act applies) to preside.
(2) If the Chairperson is temporarily absent from a
meeting, the members present must choose a member to preside in the
Chairperson’s absence.
27 Quorum
At a meeting of the Gene Technology Technical
Advisory Committee, a quorum exists if half of the members appointed under
subsection 100 (2) of the Act are present.
28 Voting
(1) A decision of the Gene Technology Technical Advisory
Committee is made by a majority of the members present, and voting for the
decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a
deliberative vote and also has a casting vote in the event of an equality of
votes by members present.
29 Records
and Reports
(1) The Gene Technology Technical Advisory Committee
must keep a record of its proceedings, and must give to the Regulator a copy of
each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the
Regulator in a form accessible to the public, except to the extent that
information in a resolution is considered by the Regulator to be confidential
commercial information.
(3) The Committee must prepare any other report about
its activities that is requested by the Ministerial Council or the Regulator.
Division 3 Subcommittees
30 Operation
of subcommittees
(1) Regulations 24, 25, 26 and 28 apply to a
subcommittee established under subsection 105 (1) of the Act as if a
reference in those regulations to the Gene Technology Technical Advisory
Committee were a reference to the subcommittee.
(2) At a meeting of a subcommittee, a quorum exists if
half of the members of the subcommittee are present.
(3) A subcommittee must keep a record of its
proceedings, and must give to the Gene Technology Technical Advisory Committee
a copy of each resolution passed by the subcommittee.
Part 5 Ethics
and Community Committee
31 Ethics
and Community Committee — conditions of appointment
Division 1 of Part 4 applies to the conditions of
appointment of a member of the Ethics and Community Committee, or an expert
adviser, as if:
(a) a reference to the Gene Technology Technical
Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene
Technology Technical Advisory Committee were a reference to a member of the
Ethics and Community Committee; and
(c) the reference, in paragraph 21 (2) (b), to
section 101 of the Act were a reference to section 107 of the Act.
32 Ethics
and Community Committee — Committee procedures
Division 2 of Part 4 applies to the procedures of
the Ethics and Community Committee as if:
(a) a reference to the Gene Technology Technical
Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the
Gene Technology Technical Advisory Committee were a reference to a member or
Chairperson of the Ethics and Community Committee; and
(c) the reference, in
paragraph 26 (1) (b), to paragraph 100 (7A) (a) or (b)
of the Act were a reference to paragraph 108 (4) (a) or (b) of the Act; and
(d) the reference, in regulation 27, to
subsection 100 (2) of the Act were a reference to subsection 108 (1) of the
Act.
33 Ethics
and Community Committee — operation of subcommittees
(1) Regulations 24, 25, 26 and 28 apply to a
subcommittee established under subsection 111 (1) of the Act as if a reference
in those regulations to the Gene Technology Technical Advisory Committee were a
reference to the subcommittee.
(2) At a meeting of a subcommittee, a quorum exists if
half of the members of the subcommittee are present.
(3) A subcommittee must keep a record of its
proceedings, and must give to the Ethics and Community Committee a copy of each
resolution passed by the subcommittee.
Part 7 Miscellaneous
37 Reviewable
State decisions
Note At the commencement of these
Regulations, no decisions of the Regulator are reviewable State decisions under
section 19 of the Act.
38 Review
of decisions
Subject to the Administrative Appeals Tribunal
Act 1975, a person whose interests are affected by a decision of the
Minister under regulation 21, or that regulation as applied to Part 5 of these
Regulations, may apply to the Administrative Appeals Tribunal for review of the
decision.
39 Record
of GMO and GM Product Dealings
(1) For subsection 138 (4) of the Act, the
following particulars are prescribed in relation to a notifiable low risk
dealing that is notified to the Regulator:
(a) the name of the organisation proposing to
undertake the notified dealing;
(b) in terms of Part 1 of Schedule 3 — the
kind of notifiable low risk dealing proposed;
(c) the identifying name given to the proposed
undertaking by the organisation;
(d) the date of the notification.
(2) For subsection 138 (5) of the Act, the
following particulars are prescribed in relation to a GM product mentioned in a
designated notification:
(a) the name of the organisation producing the
GM product;
(b) a description of the GM product, with
reference to:
(i) the applicable Act
(that is, whichever of the following Acts is applicable):
(A) Agricultural and
Veterinary Chemicals (Administration) Act 1992;
(B) Australia New Zealand
Food Authority Act 1991;
(C) Industrial Chemicals
(Notification and Assessment) Act 1989;
(D) Therapeutic Goods Act
1989; and
(ii) its common name as a product, or
type or class of product (for example, bread or insulin);
(c) information about the GM product,
including:
(i) the common name and the scientific
name of the parent organism involved; and
(ii) details of the introduced trait in
the GMO from which the GM product is derived; and
(iii) the identity of the introduced
gene responsible for conferring the introduced trait;
(d) the date on which a decision under the
applicable Act, that enables supply of the GM product in Australia, takes
effect;
(e) details of any conditions attaching to that
permission.
40 Inspector
identity card
For paragraph 151 (2) (a) of the Act, an
inspector’s identity card must:
(a) display a recent photograph of the
inspector’s face; and
(b) state the date of issue; and
(c) state the period of its validity.
Schedule
1A Techniques that are not gene
technology
(regulation 4)
|
Item
|
Description of technique
|
|
1
|
Somatic cell nuclear transfer,
if the transfer does not involve genetically modified material.
|
|
2
|
Electromagnetic radiation‑induced mutagenesis.
|
|
3
|
Particle radiation‑induced
mutagenesis.
|
|
4
|
Chemical‑induced
mutagenesis.
|
|
5
|
Fusion of animal cells, or human cells, if the fused cells
are unable to form a viable whole animal or human.
|
|
6
|
Protoplast fusion, including fusion of plant protoplasts.
|
|
7
|
Embryo rescue.
|
|
8
|
In vitro fertilisation.
|
|
9
|
Zygote implantation.
|
|
10
|
A natural process, if the
process does not involve genetically modified material.
Examples
Examples of natural processes include conjugation,
transduction, transformation and transposon mutagenesis.
|
Schedule
1 Organisms that are not genetically
modified organisms
(regulation 5)
|
Item
|
Description of organism
|
|
1
|
A mutant organism in which the
mutational event did not involve the introduction of any foreign nucleic acid
(that is, non‑homologous DNA, usually from another species).
|
|
2
|
A whole animal, or a human
being, modified by the introduction of naked recombinant nucleic acid (such
as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is
incapable of giving rise to infectious agents.
|
|
3
|
Naked plasmid DNA that is
incapable of giving rise to infectious agents when introduced into a host
cell.
|
|
6
|
An organism that results from
an exchange of DNA if:
(a) the donor species is
also the host species; and
(b) the vector DNA does not
contain any heterologous DNA.
|
|
7
|
An organism that results from
an exchange of DNA between the donor species and the host species if:
(a) such exchange can occur
by naturally occurring processes; and
(b) the donor species and
the host species are micro‑organisms that:
(i) satisfy the criteria in AS/NZS 2243.3:2002
(Safety in laboratories, Part 3: Microbiological aspects and containment
facilities) jointly published by Standards Australia and Standards New
Zealand, for classification as Risk Group 1; and
(ii) are known to exchange nucleic acid by a
natural physiological process; and
(c) the vector used in the
exchange does not contain heterologous DNA from any organism other than an
organism that is involved in the exchange.
|
Schedule
2 Dealings exempt from licensing
(regulation 6)
|
Note Subregulation 6 (1) sets
out other requirements for exempt dealings.
|
Part 1 Exempt dealings
|
Item
|
Description of dealing
|
|
2
|
A dealing with a genetically
modified Caenorhabditis elegans, unless:
(a) an advantage is conferred on the animal by
the genetic modification; or
(b) as a result of the genetic modification, the animal
is capable of secreting or producing an infectious agent.
|
|
3
|
A dealing with an animal into
which genetically modified somatic cells have been introduced, if:
(a) the somatic cells are not capable of giving rise to
infectious agents as a result of the genetic modification; and
(b) the animal is not infected with a virus that is
capable of recombining with the genetically modified nucleic acid in the
somatic cells.
|
|
4
|
(1) Subject to subitem (2), a dealing involving a host/vector
system mentioned in Part 2 of this Schedule and producing no more than 10
litres of GMO culture in each vessel containing the resultant culture.
|
|
|
(2) The donor nucleic acid:
(a) must satisfy either of
the following requirements:
(i) it must not be derived
from organisms implicated in, or with a history of causing, disease in human
beings, animals, plants or fungi; or
(ii) it must be characterised and not known to alter
the host range or mode of transmission, or increase the virulence,
pathogenicity or transmissibility of the host or vector; and
|
|
|
(b) must not code for a
toxin with an LD50 of less
than 100 mg/kg; and
(c) must not code for a
toxin with an LD50 of 100 mg/kg or more, if the intention is to
express the toxin at high levels; and
(d) must not be uncharacterised
nucleic acid from a toxin‑producing organism; and
(e) must not include a viral
sequence unless the donor nucleic acid:
(i) is missing at
least 1 gene essential for viral multiplication that:
(A) is not available in the cell into which the
nucleic acid is introduced; and
(B) will not become available during the dealing; and
(ii) is incapable of correcting
a defect in the host/vector system leading to production of replication
competent virions; and
(f) must not confer an
oncogenic modification.
|
|
5
|
A dealing involving shot‑gun
cloning, or the preparation of a cDNA library, in a host/vector system
mentioned in item 1 of Part 2 of this Schedule, if the donor nucleic acid is
not derived from either:
(a) a pathogen; or
(b) a toxin‑producing
organism.
|
Part 2 Host/vector systems for exempt dealings
|
Item
|
Class
|
Host
|
Vector
|
|
1
|
Bacteria
|
Escherichia coli K12, E. coli B or
E. coli C – any derivative that does not contain:
(a) generalised transducing phages; or
(b) genes able to complement the conjugation defect in
a non‑conjugative plasmid
|
1. Non‑conjugative
plasmids
2. Bacteriophage
(a) lambda
(b) lambdoid
(c) Fd or
F1 (eg M13)
3. None
(non‑vector systems)
|
|
|
|
Bacillus – specified species –
asporogenic strains with a reversion frequency of less than 10–7:
(a) B. amyloliquefaciens
(b) B. licheniformis
(c) B. pumilus
(d) B. subtilis
(e) B. thuringiensis
|
1. Non‑conjugative
plasmids
2. Plasmids
and phages whose host range does not include B. cereus, B.
anthracis or any other pathogenic strain of Bacillus
3. None
(non‑vector systems)
|
|
|
|
Pseudomonas putida –
strain KT 2440
|
1. Non‑conjugative
plasmids including certified plasmids: pKT 262, pKT 263, pKT 264
2. None
(non‑vector systems)
|
|
|
|
Streptomyces – specified species:
(a) S. aureofaciens
(b) S. coelicolor
(c) S. cyaneus
(d) S. griseus
(e) S. lividans
|
1. Non‑conjugative
plasmids
2. Certified
plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
3. Actinophage
phi C31 and derivatives
|
|
|
|
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
|
4. None
(non‑vector systems)
|
|
|
|
Agrobacterium radiobacter
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors
2. None
(non‑vector systems)
|
|
|
|
Agrobacterium rhizogenes — disarmed strains
|
|
|
|
Agrobacterium tumefaciens — disarmed strains
|
|
|
|
Lactobacillus
|
1. Non‑conjugative
plasmids
2. None
(non‑vector systems)
|
|
|
|
Oenococcus oeni syn. Leuconostoc oeni
|
|
|
|
Pediococcus
|
|
|
|
Photobacterium angustum
|
|
|
|
Pseudoalteromonas tunicate
|
|
|
|
Rhizobium (including the genus Allorhizobium)
|
|
|
|
Sphingopyxis alaskensis syn. Sphingomonas
alaskensis
|
|
|
|
Vibrio cholerae CVD103‑HgR
|
|
2
|
Fungi
|
Neurospora
crassa – laboratory strains
|
1. All
vectors
2. None (non‑vector systems)
|
|
|
|
Pichia pastoris
|
|
|
|
Saccharomyces cerevisiae
|
|
|
|
Schizosaccharomyces pombe
|
|
|
|
Kluyveromyces lactis
|
|
|
|
Trichoderma reesei
|
|
3
|
Slime moulds
|
Dictyostelium species
|
1. Dictyostelium
shuttle vectors, including those based on the endogenous plasmids Ddp1 and
Ddp2
2. None
(non‑vector systems)
|
|
4
|
Tissue culture
|
Animal or human cell cultures
(including packaging cell lines)
|
1. Non‑conjugative
plasmids
2. Non‑viral
vectors, or defective viral vectors unable to transduce human cells
3. Avipox
vectors (attenuated vaccine strains)
|
|
|
|
|
4. Baculovirus
(Autographa californica nuclear polyhedrosis virus), polyhedrin minus
5. None
(non‑vector systems)
|
|
|
|
Plant cell cultures
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium
tumefaciens, Agrobacterium radiobacter or Agrobacterium rhizogenes
|
|
|
|
|
2. Non‑pathogenic
viral vectors
3. None
(non‑vector systems)
|
Part 3 Definitions
In this Schedule:
code for, in relation to a toxin, means to specify the amino acid sequence of
the toxin.
non‑conjugative plasmid means a
plasmid that is not self‑transmissible, and includes, but is not limited
to, non‑conjugative forms of the following plasmids:
(a) bacterial artificial chromosomes (BACs);
(b) cosmids;
(c) P1 artificial chromosomes (PACs);
(d) yeast artificial chromosomes (YACs).
non‑vector
system means a system by which donor nucleic acid is introduced
(for example, by electroporation or particle bombardment) into a host in the
absence of a nucleic acid‑based vector (for example, a plasmid, viral
vector or transposon).
Schedule
3 Notifiable low risk dealings in
relation to a GMO
(regulations 12 and 13)
Part 1 Notifiable low risk dealings suitable for physical
containment level 1
|
Note Because of subregulation 12 (1)
a dealing mentioned in this Part is not a notifiable low risk dealing if it
is also a dealing of a kind mentioned in Part 3 of this Schedule.
|
1.1 Kinds of dealings
The following kinds of notifiable low
risk dealings may be conducted in physical containment level 1 facilities:
(a) a dealing involving a genetically modified
laboratory mouse or a genetically modified laboratory rat, unless:
(i) an advantage is conferred on the
animal by the genetic modification; or
(ii) because of the genetic
modification, the animal is capable of secreting or producing an infectious
agent;
(b) a dealing involving a host/vector system
mentioned in Part 2 of Schedule 2, if the donor nucleic acid confers an
oncogenic modification;
(c) a dealing involving a defective viral vector
able to transduce human cells in a host mentioned in item 4 of Part 2 of
Schedule 2 (animal or human cell culture), unless:
(i) the vector is a retroviral vector;
or
(ii) the donor nucleic acid confers an
oncogenic modification.
Part 2 Notifiable low risk dealings suitable for physical
containment level 2
|
Note Because of subregulation 12 (1)
a dealing mentioned in this Part is not a notifiable low risk dealing if it
is also a dealing of a kind mentioned in Part 3
of this Schedule.
|
2.1 Kinds of dealings
The following kinds of notifiable low
risk dealings may be conducted in physical containment level 2 facilities:
(a) a 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 any of the
following:
(A) a genetically modified laboratory
mouse;
(B) a genetically modified laboratory
rat;
(C) a genetically modified Caenorhabditis
elegans;
(aa) a dealing involving a genetically modified laboratory
mouse or a genetically modified laboratory rat, if:
(i) the genetic modification confers
an advantage on the animal; and
(ii) the animal is not capable of
secreting or producing an infectious agent as a result of the genetic
modification;
(ab) a dealing
involving a genetically modified Caenorhabditis elegans, if:
(i) the genetic modification confers
an advantage on the animal; and
(ii) the animal is not capable of
secreting or producing an infectious agent as a result of the genetic
modification;
(b) a dealing involving a genetically modified
plant (including a genetically modified flowering plant), if the dealing occurs
in a facility that is designed to prevent the escape from the facility of:
(i) pollen, seed, spores or other
propagules which may be produced in the course of the dealing; and
(ii) invertebrates that are capable of
carrying the material mentioned in subparagraph (i);
(ba) a dealing involving a genetically modified
flowering plant, if, before flowering, all inflorescences are wholly enclosed
in bags designed to prevent escape of viable pollen and seed;
(c) a 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 has not been implicated
in, or had a history of causing, disease in human beings, animals, plants or
fungi; and
(ii) the vector has not been implicated
in, or had a history of causing, disease in human beings, animals, plants or
fungi;
(d) a dealing involving a host and vector that
are not mentioned as a host/vector system in Part 2 of Schedule 2, if:
(i) either:
(A) the host has been
implicated in, or has a history of causing, disease in human beings, animals,
plants or fungi; or
(B) the vector has been
implicated in, or has a history of causing, disease in human beings, animals,
plants or fungi; and
(ii) the
donor nucleic acid is characterised and is not known to alter the host
range or mode of transmission, or increase the virulence, pathogenicity or
transmissibility of the host or vector;
(e) a dealing involving a host/vector system
mentioned in Part 2 of Schedule 2, if the donor nucleic acid:
(i) encodes a pathogenic determinant;
or
(ii) is uncharacterised nucleic acid
from an organism that has been implicated in, or has a history of causing,
disease in human beings, animals, plants or fungi;
(f) a dealing involving a host/vector system
mentioned in Part 2 of Schedule 2 and producing more than 10 litres of GMO
culture in each vessel containing the resultant culture, if:
(i) the dealing is undertaken in a
facility that is certified by the Regulator:
(A) as a large scale
facility; and
(B) to at least physical
containment Level 2; and
(ii) the donor nucleic acid satisfies the
conditions set out in item 4 of Part 1 of Schedule 2;
(g) a dealing involving complementation of
knocked‑out genes, if the complementation does not alter the host range
or mode of transmission, or increase the virulence, pathogenicity, or
transmissibility of the host above that of the parent organism before the genes
were knocked‑out;
(h) a dealing involving shot‑gun cloning,
or the preparation of a cDNA library, in a host/vector system mentioned in item 1
of Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
(i) a pathogen; or
(ii) a toxin‑producing organism;
(i) a dealing involving the introduction of a
replication defective viral vector able to transduce human cells into a host
mentioned in Part 2 of Schedule 2 if:
(i) the donor nucleic acid is
incapable of correcting a defect in the vector leading to production of
replication competent virions; and
(ii) either:
(A) the vector is a
retroviral vector; or
(B) the donor nucleic acid
confers an oncogenic modification.
Part 3 Dealings that are not notifiable low risk dealings
|
Note 1 The
following list qualifies the list in Parts 1
and 2, and is not an exhaustive list of dealings that are not
notifiable low risk dealings.
Note 2 A dealing that is not a
notifiable low risk dealing, or an exempt dealing, can be undertaken only by
a person who is licensed, under the Act, for the dealing (see Act, section
32).
|
3.1 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 (other than a dealing
mentioned in paragraph 2.1 (h) of Part 2 of this Schedule) involving
cloning of nucleic acid encoding a toxin having an LD50 of less than 100 mg/kg;
(b) a dealing involving high level expression of
toxin genes, even if the LD50
is 100 mg/kg or more;
(c) a dealing (other than a dealing mentioned in
paragraph 2.1 (h) of Part 2 of this Schedule) involving cloning of
uncharacterised nucleic acid from a toxin‑producing organism;
(d) unless the viral vector is part of a
host/vector system mentioned in Part 2 of Schedule 2 or in paragraph
1.1 (c) of Part 1 or 2.1 (i) of Part 2 of this Schedule — a
dealing involving donor nucleic acid in a viral vector if the donor nucleic
acid:
(i) confers an oncogenic modification;
or
(ii) encodes:
(A) immunomodulatory
molecules; or
(B) cytokines; or
(C) growth factors, or
components of a signal transduction pathway, that, when expressed, may lead to
cell proliferation;
(e) a dealing involving, as host or vector, a
micro‑organism that has been implicated in, or has a history 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 donor nucleic acid is
characterised and is not known to alter the host range or mode of
transmission, or increase the virulence, pathogenicity or transmissibility of
the host or vector; or
(iii) the dealing is a dealing
mentioned in paragraph 2.1 (g) of Part 2 of this Schedule;
(f) a dealing involving the
introduction, into a micro‑organism, of nucleic acid encoding a
pathogenic determinant, unless:
(i) the dealing is a dealing
mentioned in paragraph 2.1 (g) of Part 2 of this Schedule; or
(ii) the micro‑organism is a host
mentioned in Part 2 of Schedule 2;
(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 use of a viral or
viroid genome, or fragments of a viral or viroid genome, to produce a novel
replication competent virus with altered host range or mode of transmission, or
increased virulence, pathogenicity or transmissibility in relation to any parent
or donor organism;
(i) a dealing involving a lentiviral vector unless:
(i) all structural and accessory genes
have been removed from the vector to render it incapable of replication or
assembly into a virion without these functions being supplied in trans;
and
(ii) the vector includes a deletion
that results in a transcriptionally inactive vector which, even when packaging
functions are supplied in trans, cannot be converted into full
length viral RNA; and
(iii) the packaging cell line and
packaging plasmids used contain only viral genes gag, pol, rev
and a gene encoding an envelope protein;
(j) a dealing involving a genetically modified
animal, plant or fungus that is capable of secreting or producing infectious
agents as a result of the genetic modification;
(k) a dealing producing, in each vessel
containing the resultant GMO culture, more than 10 litres of that culture,
other than a dealing mentioned in paragraph 2.1 (f) of Part 2 of this
Schedule;
(l) a dealing that is inconsistent with a
policy principle issued by the Ministerial Council;
(m) a dealing involving the intentional
introduction of a GMO into a human being;
(n) a dealing involving a genetically modified
pathogenic organism, if the practical treatment of any disease or abnormality caused
by the organism would be impaired by the genetic modification.