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.
AS/NZS 2243.3:2010 means the
Australian/New Zealand Standard Safety in laboratories Part 3:
Microbiological safety and containment, jointly published by Standards Australia
and Standards New Zealand, as in force on 1 September 2011.
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 guinea pig means
a laboratory strain of guinea pig of the species Cavia porcellus that
has been modified by gene technology.
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 rabbit means
a laboratory strain of rabbit of the species Oryctolagus cuniculus 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.
inspector means a person appointed by the
Regulator under section 150 of the Act as an inspector.
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 capable of contributing to tumour formation, including
modifications that cause at least 1 of the following:
(a) defects in DNA proofreading and repair;
(b) defects in chromosome maintenance;
(c) defects in cell cycle checkpoint mechanisms;
(d) uncontrolled cell proliferation;
(e) resistance to apoptosis;
(f) cellular immortalisation.
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 2A Gene
Technology Regulator
5A Functions
of the Regulator
For paragraph 27 (l) of the Act, the Regulator
has the function of making inspectors available to be appointed as inspectors
under Division 7 of Part 3 of the National Health Security Act 2007.
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.
(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
(1) 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.
(2) For the 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 waiting for information that the applicant has been asked, in writing, to
give.
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 or 2 of Schedule 3 (other than a dealing also mentioned
in Part 3 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
for 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
prepared and submitted a written proposal for an Institutional Biosafety
Committee to assess whether the dealing is a notifiable low risk dealing; and
(b) the Institutional Biosafety Committee has
assessed the dealing to be a notifiable low risk dealing mentioned in Part 1 or
2 of Schedule 3; and
(c) the dealing undertaken is the dealing described
in the Institutional Biosafety Committee’s record of assessment of the
proposal; and
(d) the dealing is only undertaken before the day
mentioned in regulation 13A for the dealing; and
(e) the person is mentioned in the
Institutional Biosafety Committee’s record of assessment as having the
appropriate training and experience to undertake the dealing; and
(f) the dealing is undertaken in facilities
mentioned in the Institutional Biosafety Committee’s record of assessment as
being appropriate for the dealing; and
(g) the person keeps or can give, on request, a
copy of the Institutional Biosafety Committee’s record of assessment to an
inspector; and
(h) the person does not compromise the
containment of a GMO involved in the dealing; and
(i) the person
undertakes the dealing in accordance with subregulations (2) and (3).
Note A person complies with paragraph (e)
if the person is in a class of persons that an Institutional Biosafety
Committee has included in the record of assessment as having the appropriate
training and experience to undertake the dealing. Similarly, a person complies
with paragraph (f) if the facility in which the person undertakes the
dealing is in a class of facilities that an Institutional Biosafety Committee
has included in the record of assessment as being appropriate for the dealing.
(2) A notifiable low risk dealing must be undertaken:
(a) for a kind of dealing mentioned in Part 1
of Schedule 3 — in a facility certified by the Regulator to at least
physical containment level 1 and that is appropriate for the dealing; or
(b) for a kind of dealing mentioned in Part 2
of Schedule 3:
(i) that is not a dealing mentioned in
subparagraph (ii) — in a facility certified by the Regulator to at
least physical containment level 2 and that is appropriate for the dealing; or
(ii) that involves a micro-organism that
satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 —
in a facility certified by the Regulator to at least physical containment level
3 and that is appropriate for the dealing; or
(c) in a facility that the Regulator has agreed
in writing is a facility in which the dealing may be undertaken.
(3) However, if a notifiable low risk dealing involves
the transportation, storage or disposal of a GMO, the transportation, storage
or disposal:
(a) may only be undertaken before the day
mentioned in regulation 13A as being the day on or before which the dealing
must stop being undertaken; and
(b) may happen outside a facility mentioned in
subregulation (2), but in that case must be conducted in accordance with:
(i) the Guidelines for the
Transport, Storage and Disposal of GMOs, as in force on 1 September 2011,
that have been issued by the Regulator for this purpose under paragraph 27 (d)
of the Act; or
(ii) transportation, storage or
disposal requirements that the Regulator has agreed in writing are appropriate
for the containment of the GMO.
(4) For paragraph (2) (c), the Regulator must
consider the capacity of a facility to contain GMOs before deciding whether to
agree, in writing, to a facility.
13A Time
limits for stopping notifiable low risk dealings
For paragraph 13 (1) (d), the day on or
before which the dealing described in the record of assessment of the dealing
must stop being undertaken is:
(a) the day 5 years after the date of
assessment, if the dealing is assessed by an Institutional Biosafety Committee
on or after 1 September 2011; and
(b) 31 August 2016, if the dealing is
assessed by an Institutional Biosafety Committee in the period 31 March 2008
to 31 August 2011 (inclusive); and
(c) 31 March 2015, if the dealing is
assessed by an Institutional Biosafety Committee before 31 March 2008.
Note A person will have to apply for, and
obtain, a new assessment of the dealing as a notifiable low risk dealing from
an Institutional Biosafety Committee to continue to undertake the dealing after
the applicable day mentioned in this regulation.
13B Requirements
for Institutional Biosafety Committees about records of assessments of notifiable
low risk dealing proposals
An Institutional Biosafety Committee that has
assessed a proposal as to whether a dealing is a notifiable low risk dealing
must:
(a) make a record of its assessment, in a form
approved by the Regulator, that includes the following:
(i) the identifying name of the
dealing to be undertaken that was given to the dealing by the person or
accredited organisation proposing to undertake the dealing;
(ii) a description of the dealing to be
undertaken;
(iii) its assessment whether the dealing
is a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3;
(iv) if
the Committee has assessed the dealing as being a notifiable low risk dealing
mentioned in Part 1 or 2 of Schedule 3, the kind of notifiable low risk
dealing that the dealing is, in terms of those Parts;
(v) the date of the Committee’s
assessment of the dealing;
(vi) the persons or classes of persons
considered by the Committee to have the appropriate training and experience to
undertake the dealing;
(vii) the facilities or classes of
facilities the Committee considers to be of the appropriate physical
containment level and type for the dealing;
(viii) the name of the Committee that
assessed the proposal;
(ix) the name of the person or
accredited organisation that submitted the proposal;
(x) the name of the person or
accredited organisation proposing to undertake the dealing; and
(b) give a copy of the record of assessment to
the person or accredited organisation that submitted the proposal to the
Committee.
13C Information
to be kept or given to the Regulator by persons or accredited organisations
(1) A person or an accredited organisation that has
been given a copy of a record of assessment by an Institutional Biosafety
Committee must, if the dealing has been assessed by the Committee as a
notifiable low risk dealing, give the Regulator a record of the proposed
dealing, in the form approved by the Regulator, that includes:
(a) the particulars, prescribed under regulation 39 (1)
in relation to the dealing, to be included in the Record of GMO and GM Product
Dealings; and
(b) the name of the Committee that assessed the
dealing; and
(c) the name of the person or accredited
organisation that submitted the proposal for assessment of the dealing to the
Committee.
(2) The record of the proposed dealing mentioned in
subregulation (1) must be given to the Regulator in the financial year in
which the Institutional Biosafety Committee made the assessment:
(a) by an accredited organisation — in the
annual report for the financial year to be given by the organisation to the
Regulator; or
(b) by any other person — in a report for
the financial year to be given by the person to the Regulator, in the form
approved by the Regulator.
(3) A person or accredited organisation given a copy of
a record of assessment by an Institutional Biosafety Committee must keep a copy
of the Committee’s record of assessment for 8 years after the date of the
assessment.
(4) The Regulator may at any time, by written notice,
require from the following persons or organisations further information about
how a notifiable low risk dealing is being undertaken, including information
about a GMO being dealt with:
(a) the person or accredited organisation that
submitted the proposal for assessment of the dealing;
(b) any other person involved with undertaking
the dealing.
(5) A person or organisation given a notice under
subregulation (4) 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 or 2 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 assessment by an Institutional
Biosafety Committee that the dealing is a notifiable low risk dealing.
(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 2243.3:2010 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.
|
|
3A
|
A dealing with an animal whose
somatic cells have been genetically modified in vivo by a replication
defective viral vector, if:
|
|
|
(a) the in vivo modification occurred as part of
a previous dealing; and
(b) the replication defective viral vector is no longer
in the animal; and
|
|
|
(c) no germ line cells have been genetically modified;
and
|
|
|
(d) the somatic cells cannot give rise to infectious
agents as a result of the genetic modification; and
(e) the animal is not infected with a virus that can
recombine with the genetically modified nucleic acid in the somatic cells of
the animal.
|
|
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 25
litres of GMO culture in each vessel containing the resultant culture.
|
|
|
(2) The donor nucleic acid:
(a) must meet either of the following requirements:
(i) it must not be derived from organisms
implicated in, or with a history of causing, disease in otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) it must be characterised and the information
derived from its characterisation show that it is unlikely to increase the
capacity of the host or vector to cause harm;
|
|
|
Example
Donor nucleic acid would not
comply with subparagraph (ii) if its characterisation shows that, in relation
to the capacity of the host or vector to cause harm, it:
(a) provides an
advantage; or
(b) adds a potential host
species or mode of transmission; or
(c) increases its virulence, pathogenicity or
transmissibility; 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) cannot restore replication competence to the
vector.
|
|
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, E.
coli C or E. coli Nissle 1917 — 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
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
|
1. Non‑conjugative
plasmids
2. Certified
plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
3. Actinophage
phi C31 and derivatives
4. None
(non‑vector systems)
|
|
|
|
Agrobacterium radiobacter
Agrobacterium rhizogenes —
disarmed strains
Agrobacterium tumefaciens —
disarmed strains
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors
2. None
(non‑vector systems)
|
|
|
|
Lactobacillus
Lactococcus lactis
Oenococcus oeni syn. Leuconostoc
oeni
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the
genus Allorhizobium)
Sphingopyxis alaskensis syn.
Sphingomonas alaskensis
Streptococcus thermophilus
|
1. Non‑conjugative
plasmids
2. None
(non‑vector systems)
|
|
|
|
Synechococcus —
specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species —
strain PCC 6803
Vibrio cholerae CVD103‑HgR
|
|
|
2
|
Fungi
|
Kluyveromyces
lactis
Neurospora
crassa — laboratory strains
Pichia
pastoris
Saccharomyces
cerevisiae
Schizosaccharomyces
pombe
Trichoderma
reesei
Yarrowia lipolytica
|
1. All vectors
2. None
(non‑vector systems)
|
|
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
|
Any of the following if they cannot spontaneously generate
a whole animal:
(a) animal or human cell cultures (including packaging
cell lines);
(b) isolated cells, isolated tissues or isolated organs,
whether animal or human;
(c) early non-human mammalian embryos cultured in
vitro
|
1. Non‑conjugative
plasmids
2. Non‑viral
vectors, or replication defective viral vectors unable to transduce human
cells
3. Baculovirus
(Autographa californica nuclear polyhedrosis virus), polyhedrin minus
4. None
(non‑vector systems)
|
|
|
|
Either of the following if they are not intended, and are
not likely without human intervention, to vegetatively propagate, flower or
regenerate into a whole plant:
(a) plant cell cultures;
(b) isolated plant tissues or organs
|
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 in which
donor nucleic acid is or was introduced into a host cell:
(a) in the absence of a nucleic acid-based
vector; or
(b) using a nucleic acid-based vector in the
course of a previous dealing and the vector is:
(i) no longer present; or
(ii) present but cannot be remobilised
from a host cell.
Example 1
A system mentioned in paragraph (a) might involve the
use of electroporation or particle bombardment.
Example 2
A system mentioned in paragraph (b) might involve
cells that were transduced with a replication defective retroviral vector in
which no vector particles remain.
Schedule
3 Notifiable low risk dealings in
relation to a GMO
(regulations 12 and 13)
Part 1 Notifiable
low risk dealings suitable for at least 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.
|
1.1 Kinds of dealings suitable for at least
physical containment level 1
The following kinds of notifiable low
risk dealings must be undertaken, unless paragraph 13 (2) (c) or 13 (3) (b)
applies, in facilities certified to at least physical containment level 1 and
that are appropriate for the dealings:
(a) a dealing involving a genetically modified
laboratory guinea pig, a genetically modified laboratory mouse, a genetically
modified laboratory rabbit or a genetically modified laboratory rat, unless:
(i) an advantage is conferred on the
animal by the genetic modification; or
(ii) the animal is capable of secreting
or producing an infectious agent as a result of the genetic modification;
(c) a dealing involving a replication defective
vector derived from Human adenovirus or Adeno associated virus in
a host mentioned in item 4 of Part 2 of Schedule 2, if the donor
nucleic acid:
(i) cannot restore replication
competence to the vector; and
(ii) does not:
(A) confer an oncogenic
modification in humans; or
(B) encode a protein with
immunomodulatory activity in humans.
Part 2 Notifiable
low risk dealings suitable for at least physical containment level 2 or 3
|
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.
|
2.1 Kinds of
dealings suitable for at least physical containment level 2
The following kinds of notifiable low
risk dealings must be undertaken, unless paragraph 13 (2) (c) or 13 (3) (b)
applies, in facilities certified to at least physical containment level 2 and
that are appropriate for the dealings:
(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 guinea pig;
(B) a genetically modified
laboratory mouse;
(C) a genetically modified
laboratory rabbit;
(D) a genetically modified
laboratory rat;
(E) a genetically
modified Caenorhabditis elegans;
(aa) a dealing involving a genetically modified
laboratory guinea pig, a genetically modified laboratory mouse, a genetically
modified laboratory rabbit, a genetically modified laboratory rat or 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;
(c) a dealing involving a host/vector
system not mentioned in paragraph 1.1 (c) or Part 2 of Schedule 2, if
neither host nor vector has been implicated in, or has a history of causing,
disease in otherwise healthy:
(i) human beings; or
(ii) animals; or
(iii) plants; or
(iv) fungi;
(d) a dealing involving a host and vector not
mentioned as a host/vector system in Part 2 of Schedule 2, if:
(i) the host or vector has been
implicated in, or has a history of causing, disease in otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) the donor nucleic acid is
characterised; and
(iii) the characterisation of the donor
nucleic acid shows that it is unlikely to increase the capacity of the host or
vector to cause harm;
Example
Donor nucleic acid would not
comply with subparagraph (iii) if, in relation to the capacity of the host
or vector to cause harm, it:
(a) provides an
advantage; or
(b) adds a potential host
species or mode of transmission; or
(c) increases its
virulence, pathogenicity or transmissibility.
(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 otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(f) a dealing involving a host/vector system
mentioned in Part 2 of Schedule 2 and producing more than 25 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 as a large scale facility; and
(ii) the donor nucleic acid satisfies
the conditions set out in subitem 4 (2) of Part 1 of Schedule 2;
(g) a dealing involving complementation of
knocked‑out genes, if the complementation is unlikely to increase the capacity
of the GMO to cause harm compared to the capacity of the parent organism before
the genes were knocked out;
Example
A dealing would not comply
with paragraph (g) if it involved complementation that, in relation to the
parent organism:
(a) provides an advantage;
or
(b) adds a potential host
species or mode of transmission; or
(c) increases its
virulence, pathogenicity or transmissibility.
(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 unable to transduce human cells into a host
not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore
replication competence to the vector;
(j) a dealing involving the introduction of a
replication defective non-retroviral vector able to transduce human cells,
other than a dealing mentioned in paragraph 1.1 (c), into a host mentioned
in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication
competence to the vector;
(k) a dealing involving the introduction of a
replication defective non-retroviral vector able to transduce human cells into
a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot
restore replication competence to the vector; and
(ii) the donor nucleic acid does not:
(A) confer an oncogenic
modification in humans; or
(B) encode a protein with
immunomodulatory activity in humans;
(l) a dealing involving the introduction of a
replication defective retroviral vector able to transduce human cells into a
host mentioned in Part 2 of Schedule 2, if:
(i) all viral genes have been removed
from the retroviral vector so that it cannot replicate or assemble into a
virion without these functions being supplied in trans; and
(ii) viral genes needed for virion
production in the packaging cell line are expressed from independent, unlinked
loci with minimal sequence overlap with the vector to limit or prevent
recombination; and
(iii) either:
(A) the retroviral vector
includes a deletion in the Long Terminal Repeat sequence of DNA that prevents
transcription of genomic RNA following integration into the host cell DNA; or
(B) the packaging cell line
and packaging plasmids express only viral genes gagpol, rev and
an envelope protein gene, or a subset of these;
(m) a dealing involving the introduction of a
replication defective retroviral vector able to transduce human cells into a
host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid does not:
(A) confer an oncogenic
modification in humans; or
(B) encode a protein with
immunomodulatory activity in humans; and
(ii) all viral genes have been removed
from the retroviral vector so that it cannot replicate or assemble into a
virion without these functions being supplied in trans; and
(iii) viral genes needed for virion
production in the packaging cell line are expressed from independent, unlinked
loci with minimal sequence overlap with the vector to limit or prevent
recombination; and
(iv) either:
(A) the retroviral vector
includes a deletion in the Long Terminal Repeat sequence of DNA that prevents
transcription of genomic RNA following integration into the host cell DNA; or
(B) the packaging cell line
and packaging plasmids express only viral genes gagpol, rev and
an envelope protein gene, or a subset of these.
2.2 Kinds of dealings suitable for at least
physical containment level 3
Any kind of dealing mentioned in this
Part involving
a micro‑organism that satisfies the criteria in
AS/NZS 2243.3:2010 for classification as Risk Group 3
must be undertaken, unless paragraph 13 (2) (c) or (3) (b)
applies, in facilities that are:
(a) certified to at least physical containment
level 3; and
(b) appropriate for the dealing.
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 only be undertaken 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)) 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)) involving cloning of uncharacterised nucleic acid from
a toxin‑producing organism;
(d) a dealing involving the introduction of a
replication defective viral vector into a host not mentioned in Part 2 of
Schedule 2, other than a dealing mentioned in paragraph 2.1 (i), if the
donor nucleic acid:
(i) confers an oncogenic modification
in humans; or
(ii) encodes a protein with
immunomodulatory activity in humans;
(e) a dealing involving a replication competent
virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2,
if the donor nucleic acid:
(i) confers an oncogenic modification
in humans; or
(ii) encodes a protein with
immunomodulatory activity in humans;
(f) a dealing
involving, as host or vector, a micro‑organism, if:
(i) the
micro-organism has been implicated in, or has a history of causing, disease in
otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) none of the following
sub-subparagraphs apply:
(A) the host/vector system
is a system mentioned in Part 2 of Schedule 2;
(B) the donor nucleic
acid is characterised and its characterisation shows that it is unlikely to
increase the capacity of the host or vector to cause harm;
(C) the dealing is a dealing
mentioned in paragraph 2.1 (g);
Example
Donor nucleic acid would not comply
with sub‑subparagraph (B) if, in relation to the capacity of the host or vector
to cause harm, it:
(a) provides an advantage;
or
(b) adds a potential host
species or mode of transmission; or
(c) increases its
virulence, pathogenicity or transmissibility.
(g) 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); or
(ii) the micro‑organism is a host
mentioned in Part 2 of Schedule 2;
(h) 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 are likely to increase the capacity of the micro-organisms
to induce an autoimmune response;
(i) 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 an increased capacity to cause harm compared
to the capacity of the parent or donor organism;
Example
A dealing would comply with
paragraph (i) if it produces a novel replication competent virus that has
a higher capacity to cause harm to any potential host species than the parent
organism because the new virus has:
(a) an advantage; or
(b) a new potential host
species or mode of transmissibility; or
(c) increased virulence,
pathogenicity or transmissibility.
(j) a
dealing, other than a dealing mentioned in paragraph 2.1 (l) or (m), with
a replication defective retroviral vector (including a lentiviral vector) able
to transduce human cells;
(k) 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;
(l) a dealing producing, in each vessel
containing the resultant GMO culture, more than 25 litres of that culture,
other than a dealing mentioned in paragraph 2.1 (f);
(m) a dealing that is inconsistent with a policy
principle issued by the Ministerial Council;
(n) a dealing involving the intentional
introduction of a GMO into a human being, unless the GMO:
(i) is a human somatic cell; and
(ii) cannot secrete or produce
infectious agents as a result of the genetic modification; and
(iii) if it was generated using viral
vectors:
(A) has been tested for the
presence of viruses likely to recombine with the genetically modified nucleic
acid in the somatic cells; and
(B) the testing did not
detect a virus mentioned in sub-subparagraph (A); and
(C) the viral vector used to
generate the GMO as part of a previous dealing is no longer present in the
somatic cells;
(o) 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;
(p) a dealing involving a micro-organism that
satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4.