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GENE TECHNOLOGY AMENDMENT REGULATION 2008 (NO 1) (NO 17 OF 2008)
Explanatory Statement
SL2008-17
Distributed by Authority of the Minister for Health
and
Katy Gallagher MLA
April 2008
Explanatory Statement for the Gene Technology Regulation (ACT)
2008
OVERVIEW
The Gene Technology Regulation (ACT) 2008
(the regulation) is a component of the national framework for the regulation of
gene technology.
The regulation will be an important component of the
proposed national legislative scheme. The regulation will underpin the
Gene Technology Legislation Amendment Act 2008 (the Act) and will
describe certain aspects of the operation of the legislation in detail. In
particular, the regulation will contain many of the administrative details of
the legislation and will determine the way the legislation will operate on a
day-to-day basis.
The purpose of this Explanatory Statement is
to:
• explain the overall intention of the regulation;
and
• explain the effect of each of the amendments to the
regulation.
The regulation mirrors the Commonwealth Gene Technology
Regulations 2007. A Regulatory Impact Statement (RIS) was prepared by the
Commonwealth as part of the development of the Commonwealth regulations.
Consequently, in accordance with Section 36(1)g of the Legislation Act 2001
a separate RIS for the regulation is not required.
The purpose of the
Act was to amend the Gene Technology Act 2003 in order to improve
its operation without changing the underlying policy intent or overall
legislative framework of the regulatory scheme.
The Act is the ACT
Government's component of the nationally consistent regulatory scheme for gene
technology. Under the Gene Technology Agreement 2001, all States and Territories
have committed to maintaining corresponding legislation. The object of the
Commonwealth Gene Technology Act 2000 (the Commonwealth Act) is to
protect the health and safety of people, and to protect the environment, by
identifying risks posed by or as a result of gene technology, and by managing
those risks through regulating certain dealings with genetically modified
organisms (GMOs).
In 2005-06, an independent statutory review of the
Commonwealth Act and the intergovernmental Gene Technology Agreement 2001 (the
Review) was conducted. The Review found that the Commonwealth Act and the
national regulatory scheme had worked well in the five years following
introduction, and that no major changes were required. However, it suggested a
number of minor changes, aimed at improving the operation of the Commonwealth
Act at the margin.
On 27 October 2006, the Gene Technology Ministerial
Council (GTMC), an intergovernmental body comprised of State, Territory and
Australian Government Ministers, agreed to proposals to implement the
recommendations of the Review. The Commonwealth Act and the Act implemented the
recommendations requiring legislative change, which
included:
• introducing emergency powers, giving the Commonwealth
Minister the ability to expedite the approval of a dealing with a GMO in an
emergency;
• improving the mechanism for providing advice to the Gene
Technology Regulator (the Regulator) and the GTMC on ethics and community
consultations;
• streamlining the process for the initial consideration
of licences;
• reducing the regulatory burden for low risk
dealings;
• providing clarification on the circumstances in which
licence variations can be made;
• clarifying the circumstances under
which the Regulator can direct a person to comply with the
Act;
• providing the Regulator with the power to issue a licence to
persons who find themselves inadvertently dealing with an unlicensed GMO, for
the purpose of disposing of that organism; and
• making technical
amendments to improve the operation of the Act.
FINANCIAL IMPACT
STATEMENT
The amendments to the Commonwealth Act and the Act have no
financial impact.
GENE TECHNOLOGY AMENDMENT REGULATION 2008
(No 1)
NOTES ON CLAUSES
Clause 1: Name of
regulation
This clause provides that the regulation may be cited as the
Gene Technology Amendment Regulation 2008 (No 1).
Clause 2:
Commencement
This clause provides that the regulation commences on the
commencement of Section 3 of the Gene Technology Amendment Act
2008.
Clause 3: Legislation amended
This clause provides
that this regulation amends the
Gene Technology Regulation
2004.
Clause 4: Substitution in Section 4
Omit
“somatic cell nuclear transfer if the transfer does not involve
genetically modified material” in Section 4 Part 2 and substitute “a
technique in Schedule 1A.” This amendment reflects the fact that Schedule
1A has been inserted to list techniques not constituting gene technology for the
purpose of the Act.
The inclusion of Schedule 1A in addition to
Schedule 1 (“Organisms that are not genetically modified
organisms”) will provide for a clearer distinction between
“techniques” and “organisms” that are not regulated
under the Act. The techniques to be listed are those mentioned in regulation 4
or Schedule 1. These are techniques which have a long history of safe use and
which do not involve the direct manipulation of genetic material. Refer also to
the explanatory statement for clause 23.
Clause 5: Omit Section
6(1)(c) from “Dealings exempt from licensing”
This amendment
omits a reference to Australian Standard AS/NZS 2243.3:1995 (Safety in
laboratories: microbiology) in paragraph 6(1)(c), in connection with containment
requirements for exempt dealings, in accordance with recommendation 6.1 of the
Review that there be no legislative requirements on exempt dealings beyond
listing in the regulation.
Clause 6: Substitute section 6(1)(d)
insert new section 6(1)(e) in “Dealings exempt from
licensing”
This amendment will substitute section 6(1)(d) to
replace “.” with “; and” to allow for the addition of
the new section 6(1)(c) and will add a new paragraph (e) to subsection 6(1),
excluding dealings with retroviral vectors able to transduce human cells (i.e.
enter an intact human cell by interaction of the viral particle with the cell
membrane) from exempt dealings. This will clarify an ambiguous reference to
these higher-risk vectors in Schedule 2, Part 2 (Host/vector systems for exempt
dealings), which was intended to exclude them from exempt
dealings.
Clause 7: Omit section 6(3)
This is a consequential
amendment arising from the omission of 6(1)(C) in clause 5.
Clause 8:
Substitute section 7
This item will amend regulation 7 to refer to a
prescribed fee in relation to an application for licence, for the purpose of
subsection 40(6) of the Act, with a note to indicate that at commencement of the
regulation no fee is prescribed.
This item will also remove from
regulation 7 reference to prescribed information in relation to an application
for licence, for the purpose of paragraph 40(2)(a) of the Act. Clause 23 of the
regulation will remove the details of prescribed information requirements by
deleting Schedule 4 (“Prescribed information – application for a
licence”). Paragraph 40(2)(b) of the Act requires an application to
contain such information as is specified in writing by the Regulator. The
application form will specify this information. This will allow the Regulator to
update the information requirements quickly in response to advances in the
knowledge and practice of gene technology, thus enhancing the effectiveness and
efficiency of the regulatory system.
Clause 9: Substitute section
8(1)(b)
Amendments to section 8 change the timeframes in which the
Regulator must issue, or refuse to issue, a licence for intentional release
applications under s 43 of the Act. The amendments implement recommendations
5.7, 5.8 and 5.9 of the Review. The new timeframes are:
• 150 days for
limited and controlled release applications not posing significant risks;
• 170 days for limited and controlled release applications posing
significant risks; and
• 255 days for applications for intentional
releases that are not limited and controlled.
Clauses 10 and
11: Omit “gene technology ethics committee” from section 8(2)(e) and
section 8(3) and substitute “ethics and community
committee”
Clauses 10 and 11 would repeal references to the Gene
Technology Ethics Committee and replace them with references to the Gene
Technology Ethics and Community Committee in line with changes to the Act which
proposed the amalgamation of the Gene Technology Ethics Committee and the Gene
Technology Community Consultative Committee into one advisory committee. The
combined committee will be known as the Gene Technology Ethics and Community
Consultative Committee (the Ethics and Community Committee) and will carry out
the combined functions of both committees as well as providing advice on risk
communication and community consultation in relation to intentional release
licence applications.
Clause 12: New section 8(4)
Clause 12 is
a consequential amendment arising from the insertion of a new section 50A into
the Act. This proposed section would create a new category of licence
application, to be known as “limited and controlled release”
applications.
Clause 13: Omit section 9(c)
In accordance
with recommendation 5.4 of the Review, clause 13 removes the National Health and
Medical Research Council (NHMRC) from the list of prescribed authorities within
s 50(3)(c) and s 52(5)(c) of the Act. This reflects the fact that the role
changed from a prescribed agency to one where the Gene Technology Regulator (the
Regulator) can seek advice as appropriate.
Clause 14: Substitute
section 9(d) and (e)
Clause 14 will amend section 9 to refer to the
current names of authorities and agencies prescribed by the regulation for the
purposes of s 50(3)(c) and s 52(5)(c) of the Act.
Clause 15: Insert
new section 9A
Paragraph 51(1)(a) was amended to provide that the
regulation may prescribe matters that the Regulator must have regard to in
preparing a risk assessment and risk management plan (RARMP). Clause 15 inserts
a new section for this purpose.
S 49 of the Act, which lists matters that
the Regulator must have regard to in satisfying itself as to whether a dealing
may pose significant risk, and which must also be considered in preparing the
RARMP, was amended to clarify processes for initial consideration of licences.
Clause 15 makes the consequential change that ensures these matters are referred
to by the regulation. This change is necessitated by changes to the Act required
to implement recommendation 5.5 of the Review.
Clause 16: Substitute
section 10(1)(a)
Clause 16 will amend paragraph 10(1)(a) to refer to
“any previous assessment by a regulatory authority”, rather
than simply to “any previous assessment”, and to make this paragraph
subject to s 45 of the Act (which restricts consideration of confidential
commercial information). This will mean that the Regulator will not be required
to take into account previous assessments which do not have regulatory
authority, or information that is restricted under the
Act.
Clause 17: Omit section “selective advantage”
in subsection 10(1)(b)(v) and substitute “an
advantage”.
Clause 17 will amend subparagraph 10(1)(b)(v) to refer
simply to an “advantage”, which will be defined by the regulation,
rather than to “selective advantage”, to provide consistent use of
the defined term.
Clause 18: New section 11A
Clause 18 inserts a new section that
introduces a timeframe of 90 days within which the Regulator must notify of its
decision to either vary or refuse to vary a licence made under s 72(7) of the
Act. This change implements recommendation 5.9 of the Review.
Clause 19: Substitute section 13 and insert new section 13A
This
item will amend section 13 to:
1.
remove the timeframe within which an Institutional Biosafety Committee (IBC)
must, after completing an assessment of a proposed notifiable low risk dealing
(NLRD), notify the Regulator of the proposed dealing (leaving this detail of IBC
and organisational administration to their
members);
2. require that the above
mentioned notification be in the form approved by the Regulator, rather than
referring to information specified in Schedule 3, Part 3 (Prescribed information
– notification of proposed notifiable low risk dealing) (noting that
clause 23 of the regulation will remove Schedule 3, Part
3);
3. require that a person not
undertake a NLRD unless the written notice which the IBC must provide to the
person and to the project supervisor for the proposed dealing indicates that the
IBC considers that the proposed dealing is a NLRD and that the personnel to be
involved in the dealing have adequate training and
experience;
4. remove the requirement
for the dealing to be properly supervised and details of the dealing recorded
and kept (noting that NLRDs must only be conducted in facilities certified by
the Regulator, which attaches certain conditions such as training and work
practice requirements, and that there is no guidance on what constitutes proper
supervision or what details of the dealing should be recorded, or on how
compliance with this clause might be
assessed);
5. remove the requirement
that dealings with human pathogens only be conducted in accordance with
recommendations for vaccination given in Australian Standard AS/NZS 2243.3:1995
(noting that the Standard provides only recommendations regarding vaccination,
while subsection 13(2)(c) may be interpreted as making such vaccinations
mandatory, and that the appropriateness of vaccination is a medical issue which
should be assessed based on individual
circumstances);
6. remove the current
text of subsection 13(3) relating to the circumstances in which a dealing is
taken to have been assessed by an IBC (noting that the notification of the
dealing will be in a form approved by the Regulator, as described in point 2
above, which will require provision of relevant information on the dealing and
on the IBC assessment); and
7. insert a new requirement at
subsection 13(3) for a notifying an IBC, or a person or organisation involved in
the conduct of a dealing, to provide, within a period specified by the
Regulator, further information requested by the Regulator in order to be
satisfied that the dealing is a NLRD (allowing the Regulator to perform the
function of independent oversight of the consideration of dealings by
IBCs).
The new section 13 of this item removes the requirement to notify
NLRDs to the Regulator before commencing the dealing. This item also inserts a
new section (section 13A) that introduces a requirement to include a report of
all NLRDs assessed in the last financial year in the accredited
organisation’s annual report, and to maintain an up-to-date list of
dealings which have been conducted, for inspection and auditing purposes. These
changes are necessary to implement recommendation 6.2 of the
Review.
Clause 20: Substitute Part 5 for Parts 5 and 6
Clause 20 is a
consequential amendment which would repeal references to the establishment and
operation of Gene Technology Community Consultative Committee (Part 5) and the
Gene Technology Ethics Committee (Part 6) and replace them with references to
the Gene Technology Ethics and Community Committee in line with changes to the
Act as per the amalgamation of committees described at clauses 10 and 11.
Clause 21: Omit “in the GM product; and” in section
39(2)(c)(ii) and substitute “in the GMO from which the GM product is
derived; and”
This clause will amend paragraph 39(2)(c) to refer to
the “GMO from which the GM product is derived” rather than to the
“GM product” itself, since genetically modified (GM) products in the
Record of GMO and GM product dealings generally do not themselves have
introduced traits. Rather, it is the GMO from which the GM product is derived
that has an introduced trait.
Clause 22: Omit Part 8
This clause will omit Part 8, which is now
redundant as it relates to the transitional arrangements from the former
voluntary scheme, overseen by the Genetic Manipulation Advisory Committee
(GMAC), to the current regulatory scheme under the Act.
Clause 23: Substitute revised schedules 1 to 3, including new schedule 1A,
for schedules 1 to 4.
This amendment will substitute current Schedules 1,
2, 3 and 4 with a new Schedule 1A and revised Schedules 1, 2 and 3, as detailed
below.
A new Schedule 1A (“Techniques that are not gene
technology”) will be inserted by this item to support amended section 4.
The inclusion of Schedule 1A in addition to Schedule 1 (“Organisms
that are not genetically modified organisms”) will provide for a clearer
distinction between “techniques” and “organisms” that
are not regulated under the Act. The techniques to be listed are those mentioned
in regulation 4 or Schedule 1, or in the Explanatory Statement in relation to
Schedule 1 items. These are techniques which have a long history of safe use and
which do not involve the direct manipulation of genetic
material.
This item will also substitute a new list at Schedule 1
(“Organisms that are not genetically modified organisms”) in place
of the current Schedule 1, Part 1 (“Organisms”) and Part 2
(“Species known to exchange DNA by a known physiological process”).
The items in Schedule 1 and in the new Schedule 1 (apart from items 2 and 3, see
below) describe organisms which exchange nucleic acid in nature, are commonly
used in biological research and have a long history of safe use in Australia and
overseas. One common element of these organisms is that it can be difficult or
impossible to distinguish between naturally occurring mutant organisms and those
which have been subject to some directed genetic alteration. Thus these
organisms do not present a unique biosafety risk. The items and the rationale
for their listing are as follows:
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).
This item is unchanged from that of Schedule 1,
Part 1.
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.
This is listed because the introduction
of naked nucleic acid into somatic cells of an animal or human is most unlikely
to lead to modification of the genome of the cells, and any modification could
not be passed onto the progeny of the animal. An example of this is the use of
strands of DNA as a vaccine to vaccinate animals against disease. This technique
has the potential to be safer than current non-GM vaccines which use live,
weakened strains of an organism (e.g. polio vaccine or influenza
vaccines).
3. Naked plasmid DNA that
is incapable of giving rise to infectious agents when introduced into a host
cell.
This item makes explicit the current understanding that plasmids,
not being organisms, are not themselves GMOs for the purpose of the Act.
However, an organism into which a genetically modified plasmid has been
introduced will be a GMO, unless it meets the criteria in other items of this
schedule.
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.
This item is unchanged
from that of Schedule 1, Part 1.
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.
This item is modified from item 7 of Schedule 1, Part
1. Transfer of genes between different bacterial species occurs commonly in
nature. Part 2 of Schedule 1 lists groups of species that are known to exchange
genetic information under natural conditions. In order to be exempt, the
exchange of DNA must only occur between members of any one group and the vector
used must not contain DNA from species outside the same group. Schedule 1, Part
2 lists groups of organisms (bacteria) that are known to exchange DNA and which
present only limited risk to human health and the environment. However, such a
list may quickly become outdated due to increasing scientific knowledge about
microbial gene transfer. To avoid a need for frequent updating of such a list,
the amended item 7 refers instead to micro-organisms known to the scientific
community to exchange nucleic acid and which meet the criteria for
classification as Risk Group 1 (“low risk to people and the
environment”) in the relevant Australian/New Zealand Standard. To meet the
conditions of this item, the exchange must either be naturally occurring or
mimic a natural exchange.
Items 2, 3, 4 and 5 of Schedule 1 will be
removed by this amendment but are reflected in the new Schedule 1A
(“Techniques which are not gene technology”), as described above.
Clause 23 of the regulation will also replace Schedule 2, Part 1
(“Exempt dealings”) with an amended list of exempt dealings. Exempt
dealings are dealings with GMOs that have been assessed over many years as
presenting negligible biosafety risks to human health and safety and the
environment. To be exempt the dealings must only be undertaken within
appropriate containment facilities, as specified in regulation 6 and as amended
by clause 6 above (equivalent to physical containment level 1). The following
kinds of dealings will be described in the amended
Part:
1. dealings with a genetically
modified laboratory mouse or a genetically modified laboratory rat (unless an
advantage is conferred on the animal, or the animal is capable of secreting an
infectious agent, as a result of the genetic modification).
The
regulation listed dealings with ‘gene-knockout mice’, that is, mice
whose genetic modification involves deletion or inactivation of a specific gene,
as exempt dealings, provided that no advantage is conferred on the animal. This
item will extend that exemption to all GM laboratory mice and laboratory rats,
provided that they also do not secrete infectious agents as a result of the
modification. This recognises the long history of use of laboratory mice and
rats, their inherent low risk to people and the environment due to extensive
selection and inbreeding, and their ability to be contained in the type of
facilities required for exempt
dealings.
2. dealings with a
genetically modified Caenorhabditis elegans (unless an advantage is
conferred on the animal, or the animal is capable of secreting an infectious
agent, as a result of the genetic modification).
As for item 1 above,
this item recognises the long history of use of C. elegans (a commonly
studied species of free-living nematode or round worm), their inherent low risk
to people and the environment, and their ability to be contained in the type of
facilities required for exempt dealings.
3. dealings with an animal
into which genetically modified somatic cells have been introduced (unless the
somatic cells are capable of giving rise to an infectious agent as a result of
the genetic modification, or the animal is infected with a virus which is
capable of recombining with the genetically modified nucleic acid in the somatic
cells).
This is very similar to item 3 of Schedule 2, Part 1, modified to
clarify that the conditions which must be met in order to be classified as an
exempt dealing relate to the genetic modification in the somatic cells. The
risks posed by dealings with animals into which genetically modified somatic
cells are introduced are minimal because the modification does not involve any
changes to the genome of the animal. However the exemption does not apply if the
somatic cells are capable of giving rise to infectious agents as a result of
the genetic modification, or if the animal is infected with a virus which is
capable of recombining with the genetically modified nucleic acid in the
somatic cells, as these circumstances may increase risk and necessitate higher
level containment conditions.
4.
dealings involving approved host/vector systems (as listed in Part 2 of Schedule
2) and producing no more than 10 litres of GMO culture in a single vessel,
provided that the donor nucleic acid presents a low risk (for example, it must
not be uncharacterised nucleic acid from a pathogenic organism, or code for a
toxin).
This is very similar to item 4 of Schedule 2, Part 1. A
host/vector system is a system facilitating introduction of a foreign gene or
nucleic acid sequence into the host organism. Part 2 of Schedule 2 (Host/vector
systems for exempt dealings) contains a list of hosts and corresponding vectors
that have been studied and are considered to offer a high level of biological
containment. This means that it is very difficult for the foreign nucleic acid
to spread outside the host/vector system or the resulting GMO (the host with
foreign nucleic acid in it), and unlikely that the GMO could survive outside a
laboratory.
While the use of such host/vector systems minimises risks,
other criteria must be met in order for the dealing to be exempt. For example,
in addition to using an approved host/vector system, the dealing must not use
uncharacterised donor nucleic acid that is derived from an organism that is
toxic or is implicated in disease in humans, animals, plants or fungi, or code
for a product toxic to vertebrates. If the donor nucleic acid includes viral
sequences, these must not be capable of leading to the production of replication
competent virus particles, either on their own or through correcting a defect in
the approved host/vector system. If the vector is able to transduce human cells
(i.e. enter an intact human cell by interaction of the viral particle with the
cell membrane), the donor nucleic acid must also not confer an oncogenic
modification, as this has the potential to increase risk to the person
undertaking the dealing.
5. dealings
involving shot-gun cloning, or the preparation of a cDNA library, in approved
host/vector systems (as listed in item 1 of Part 2 of Schedule 2) provided that
the donor nucleic acid is not from a pathogen or a toxin-producing
organism.
This is similar to item 5 of Schedule 2, Part 1 but
additionally encompasses cloning of nucleic acid from organisms other than
mammals, including cDNA. This item recognises that nucleic acid from
non-pathogenic and non-toxin-producing organisms pose negligible biosafety risks
in approved bacterial host/vector systems, and that shot-gun cloning and cDNA
library construction (which produce large random collections of cloned nucleic
acid fragments) have been occurring for many years in laboratories world-wide
without any safety problems.
Clause 23 will also amend the list of
approved host/vector systems at Schedule 2, Part 2 (“Host/vector systems
for exempt dealings”). A host/vector system is a system facilitating
introduction of a foreign gene or nucleic acid sequence into the host organism.
Part 2 of Schedule 2 contains a list of hosts and corresponding vectors that
have been studied and are considered to offer a high level of biological
containment. This means that it is very difficult for the foreign nucleic acid
to spread outside the host/vector system or the resulting GMO (the host with
foreign nucleic acid in it), and unlikely that the GMO could survive outside a
laboratory. Some additional hosts and vectors meeting these criteria will be
added to the list by this amendment. An error in the numbering within this Part
will also be corrected.
Further, item 5 of this Part (any host
listed in items 1 - 4 with a “non-biological vector”) will
be replaced by the listing of “none (non-vector systems)” as a
vector option for each listed host, as item 5 has caused some confusion within
the regulated community. “Non-vector system” will be defined in
Schedule 2, Part 2.3 (Definitions) as a system by which donor nucleic acid is
introduced into a host in the absence of a nucleic acid-based vector. These
amendments will thus specify a system facilitating introduction of nucleic acid
into a listed host organism without a nucleic acid vector. Such a system offers
a level of biological containment at least as high as a system involving a
vector.
Clause 23 of the regulation will also amend Schedule 2, Part 3
(Definitions) by removing terms which are to be added to regulation 3 (Clause 5)
or will no longer be used in the regulation, and by adding new definitions
relevant to the amended Schedule 2 (“Dealings exempt from
licensing”).
Clause 23 of the regulation will also replace
Schedule 3, Part 1 (“Dealings that are notifiable low risk
dealings”) with an amended list of dealings, and will correct a reference
to a subsection in the note in this Part. NLRDs are dealings with GMOs that
present minimal biosafety risks to human health and safety and the environment
due to their pathogen, pest and biological containment properties. NLRDs must
only be undertaken within appropriate, certified containment facilities, as
specified in subsection 13(2) of the regulation (physical containment level 2 or
other level considered suitable by the Regulator). Twelve kinds of dealings will
be described as NLRDs in the amended Part (subject to them not also
falling within Schedule 3, Part 2 – “Dealings that are not
notifiable low risk
dealings”):
(a)
dealings involving modification of the genome of a whole animal to produce a
novel whole organism, other than a laboratory mouse, laboratory rat or
Caenorhabditis elegans.
This is very similar to paragraph (a) of
Schedule 3, Part 1. The amended paragraph will not encompass dealings with GM
mice, rats and C. elegans, as some dealings with these organisms are
to be listed as exempt dealings by amendment to items 1 and 2 of Schedule 2,
Part 1 (Exempt dealings), as described above.
(aa) dealings involving genetically
modified laboratory mice or rats if an advantage is conferred on the animal by
the genetic modification, provided that the animal is not capable of secreting
an infectious agent as a result of the genetic modification;
(ab)
dealings involving genetically modified Caenorhabditis elegans if an
advantage is conferred on the animal by the genetic modification, provided that
the animal is not capable of secreting an infectious agent as a result of the
genetic modification.
These two paragraphs will classify as NLRDs
dealings with genetically modified mice, rats and C. elegans, which have
an advantage (an increased ability to survive or reproduce) relative to the
unmodified animal, as physical containment level 2 is appropriate to the risk
posed by such
GMOs.
(b) dealings
involving a genetically modified plant if the dealing occurs in a facility
designed to contain pollen, seed, spores and other propagules, and the
invertebrate vectors of these;
(ba) dealings involving a
genetically modified flowering plant if, before flowering, all inflorescences
(groups or clusters of flowers) are enclosed so as to prevent escape of viable
pollen and seed.
Paragraphs (b) and (ba) are similar to paragraph (b) of
Schedule 3, Part 1. The amended paragraphs will additionally cover plants other
than flowering plants. Dealings involving genetically modified plants being
grown in physical containment level 2 facilities under conditions able to
contain their reproductive material will be classified as
NLRDs.
(c) dealings
involving a host and vector that are not mentioned as a host/vector system in
Schedule 2, Part 2 (Host/vector systems for exempt dealings), provided that the
host and vector are not pathogenic organisms.
This is very similar to
paragraph (c) of Schedule 3, Part 1. The amended wording is not intended to
change the meaning but to improve clarity of this paragraph. Non-pathogenic
organisms can be used as hosts and vectors in a
NLRD.
(d) dealings involving a
host and vector that are not mentioned as a host/vector system in Schedule 2,
Part 2 (“Host/vector systems for exempt dealings”) if, while the
host or vector is a pathogenic organism, the donor nucleic acid is characterised
and will not alter the host range or mode of transmission, or increase the
virulence, pathogenicity or transmissibility of the host or vector.
This
is very similar to paragraph (d) of Schedule 3, Part 1. The amended wording is
intended to improve clarity of this paragraph and ensure that potentially higher
risk dealings are not included in NLRDs. Pathogenic organisms can only be used
as hosts and vectors in a NLRD if the introduced nucleic acid is known not to
lead to new or increased disease risk from the host or
vector.
(e) dealings
involving a host/vector system mentioned in Schedule 2, Part 2
(“Host/vector systems for exempt dealings”), if the donor nucleic
acid encodes a pathogenic determinant, is uncharacterised nucleic acid derived
from a pathogen or, if the vector is able to transduce human cells, confers an
oncogenic modification.
This is very similar to paragraph (e) of Schedule
3, Part 1. The amended wording is intended to improve clarity of this paragraph.
Dealings involving particular types of inserted nucleic acid in approved
host/vector systems merit higher containment than is required for exempt
dealings, and are therefore classified as NLRDs. Thus dealings with nucleic acid
which may increase the disease risk from the host or vector are classified as
NLRDs. If the vector being used is able to transduce human cells (i.e. enter an
intact human cell by interaction of the viral particle with the cell membrane),
then a dealing involving an oncogenic modification will be classified as a NLRD,
as this combination of factors has the potential to increase risk posed by the
vector to the person undertaking the
dealing.
(f) dealings
involving a host/vector system mentioned in Schedule 2, Part 2
(“Host/vector systems for exempt dealings”) and producing more than
10 litres of GMO culture in a single vessel, provided that the donor nucleic
acid presents a low risk (for example, it must not be uncharacterised nucleic
acid from a pathogenic organism, or code for a toxin) and that the dealing is
conducted in a facility that is certified by the Regulator as a large scale
facility to at least physical containment level 2.
This paragraph will
classify as NLRDs those dealings which will be exempt dealings (under Schedule
2, Part 1 item 4) except for the fact that they involve large-volume cultures.
These dealings are of low risk but the large culture volumes warrant higher
containment conditions than are normally required for exempt dealings. Risk
management conditions required by physical containment level 2 guidelines, which
is the default for NLRDs, are
appropriate.
(g) dealings
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.
This paragraph will classify as NLRDs
those dealings where an organism (which may be a pathogen), which has previously
had gene(s) deleted (or “knocked-out”), has the same or equivalent
gene(s) reintroduced, as long as this does not lead to new or increased disease
risk relative to the organism before the genes were knocked-out. This
recognises that dealing with the GMO will not be more risky than dealing with
the original, un-modified
organism.
(h) dealings
involving shot-gun cloning, or the preparation of a cDNA library, in a
host/vector system mentioned in item 1 of Schedule 2, Part 2
(“Host/vector systems for exempt dealings”), if the donor nucleic
acid is derived from either a pathogen or a toxin producing
organism.
This paragraph will classify as NLRDs those dealings involving
shot-gun cloning and cDNA library construction (which produce large random
collections of cloned nucleic acid fragments), in approved bacterial host/vector
systems, that are excluded from being exempt dealings due to the origin of the
donor nucleic acid. This recognises that shot-gun cloning and cDNA library
construction has been occurring for many years in laboratories world-wide
without any safety problems but provides for higher containment conditions
(physical containment level 2, the default for NLRDs) than is required for
exempt dealings, due to potential risks associated with source of the donor
nucleic
acid.
(i) dealings
involving introduction of a replication defective retroviral vector able to
transduce human cells into a host mentioned in Schedule 2, Part 2
(“Host/vector systems for exempt dealings”) if the donor nucleic
acid is incapable of correcting a defect in the vector leading to production of
replication competent virions.
This paragraph will classify as NLRDs
those dealings in approved hosts involving retroviral vectors which are only
excluded from being exempt vectors due to their ability to transduce human cells
(i.e. enter an intact human cell by interaction of the viral particle with the
cell membrane). Risk management conditions required by physical containment
level 2 guidelines, which is the default for NLRDs, are appropriate for such
dealings with replication defective retroviruses.
Clause 23 of the
regulation will also delete clause 1.2 (Definitions) of Schedule 3, Part 1
as there will no longer be any definitions specific to this
part.
Clause 23 of the regulation will also replace Schedule 3,
Part 2 (“Dealings that are not notifiable low risk dealings”) with
an amended list of dealings. This Part qualifies Part 1, describing higher
risk dealings that must be licensed before being conducted. Under subsection
47(1) of the Act, the Regulator must prepare a risk assessment and risk
management plan before issuing a licence. If the Regulator decides to issue a
licence, the Regulator may, under paragraph 55(b) of the Act, impose risk
management conditions on the licence. Fourteen kinds of dealings are described
as not NLRDs in the amended Schedule 3, Part 2, as detailed
below:
(a) dealings involving
cloning of nucleic acid encoding a toxin having an LD50 of less than
100 μg/kg, except for shot-gun cloning or cDNA library
preparation;
(b) dealings
involving high level expression of toxin genes, even if the LD50 is
100 μg/kg or more;
(c) dealings involving cloning of
uncharacterised nucleic acid from toxin-producing organisms, except for shot-gun
cloning or cDNA library preparation.
These paragraphs are very similar to
paragraphs (a), (b) and (c) of Schedule 3, Part 2, which require licensing for
most dealings involving cloning and expression of toxin genes, due to potential
risks posed by the toxins. However the amended wording in paragraphs (a) and (c)
will provide that a dealing mentioned in new paragraph 1.1(h) of
Schedule 3, Part 1 (“Dealings that are notifiable low risk
dealings”), relating to shot gun cloning and construction of cDNA
libraries, will not be excluded from being a NLRD by these
provisions.
(d) dealings
involving viral vectors with nucleic acid encoding oncogenic modifications,
immunomodulatory molecules, cytokines or growth factors/signalling molecules
that may lead to cell proliferation, unless the host/vector systems is listed in
Schedule 2, Part 2 (“Host/vector systems for exempt dealings”) or in
new paragraph 1.1(i) of Schedule 3, Part 1 (“Dealings that are
notifiable low risk dealings”).
This paragraph is similar to
paragraph (d) of Schedule 3, Part 2. The amended wording is intended to improve
clarity and specificity with respect to the types of nucleic acid that are of
particular concern when used in viral vectors other than as part of an approved
host vector system, and which will therefore require licensing. For example,
nucleic acid which may lead to unregulated cell growth or interfere with the
function of the immune system. For this paragraph, approved host/vector systems
include those listed in Schedule 2, Part 2 and those described in new
paragraph 1.1(i) of Schedule 3, Part 1 (relating to certain replication
defective retroviral vectors in hosts listed in Schedule 2, Part
2).
(e) dealings involving
a pathogenic micro-organism as host or vector, except where: (i) the host/vector
system is a system mentioned in Schedule 2, Part 2 (“Host/vector
systems for exempt dealings”); or (ii) the donor nucleic acid is
characterised and is not known to lead to new or increased disease risk
from the host or vector; or (iii) the dealing is mentioned in
paragraph 1.1(g) of Schedule 3, Part 1 (“Dealings that are notifiable
low risk dealings”).
This paragraph is similar to paragraph (e) of
Schedule 3, Part 2. The amended wording is intended to improve clarity of this
paragraph with respect to what characteristics of a host or vector may be
associated with new or increased disease risk, and therefore which dealings are
required to be licensed. The amendment will also provide that a dealing
mentioned in paragraph 1.1(g) of Schedule 3, Part 1, relating to
complementation of knocked-out genes, will not be excluded from being a NLRD by
this
provision.
(f) dealings
involving the introduction, into a micro-organism, of nucleic acid
encoding a pathogenic determinant, unless the micro-organism is a host mentioned
in Schedule 2, Part 2 (“Host/vector systems for exempt
dealings”), or the dealing is mentioned in paragraph 1.1(g) of
Schedule 3, Part 1 (“Dealings that are notifiable low risk
dealings”).
This paragraph is very similar to paragraph (f) of
Schedule 3, Part 2. The amended wording will improve clarity with respect to
what nucleic acid is of concern for pathogenicity of host micro-organisms, other
than approved hosts, and therefore which dealings are required to be licensed.
The amendment will also provide that a dealing mentioned in
paragraph 1.1(g) of Schedule 3, Part 1, relating to
complementation of knocked-out genes, will not be excluded from being a NLRD by
this
provision.
(g) dealings
involving the introduction into a micro-organism, other than a host mentioned in
Schedule 2, Part 2 (“Host/vector systems for exempt dealings”),
of genes whose expressed products have a heightened risk of inducing an
autoimmune response.
This paragraph is unaltered from paragraph (g) of
Schedule 3, Part 2. It requires dealings to be licensed if the GMO may pose a
high risk, to an individual who is accidentally exposed to the GMO, due to its
potential to induce an autoimmune
response.
(h) dealings
involving use of part(s) of viral or viroid genomes to produce a novel
replication competent virus with altered host range or mode of transmission, or
increased virulence, pathogenicity or transmissibility relative to any parent or
donor organism.
This paragraph combines paragraphs (h) and (i) of
Schedule 3, Part 2. The paragraph will improve clarity regarding the types of
risks which must be considered in relation to genetically modifying viruses and
viroids, requiring licensing where there is new or increased disease risk from a
GM replication competent virus or viroid, relative to the unmodified virus or
viroid.
(i)
dealings involving a lentiviral vector able to transduce human cells unless the
vector and packaging cell line have been specifically developed to reduce the
risk of formation of replication competent viral particles.
This is a new
paragraph which will require licensing of certain dealings with vectors derived
from lentiviruses, a subfamily of retroviruses. Lentiviral gene delivery
vectors, based on the human or animal immunodeficiency viruses, are being
explored for gene therapy and for the production of genetically modified
animals. Recombination between these vectors and endogenous viral sequences has
the potential to generate replication competent lentivirus, presenting a risk to
the people involved in the dealing. However, characteristics incorporated into
recently developed lentiviral vector systems (removal of certain genes and
regulatory sequences) greatly reduce the possibility of this happening. This new
paragraph will require licensing for dealings with lentiviruses able to
transduce human cells if they do not have these safety features. Lentiviral
vector systems having these safety features will be regulated in the same manner
as other defective retroviral
vectors.
(j) dealings
involving a genetically modified animal, plant or fungus that is capable of
secreting or producing infectious agents as a result of the genetic
modification.
This paragraph is very similar to paragraph (j) of Schedule
3, Part 2. The amended wording will improve clarity. Dealings where the genetic
modification of an animal, plant or fungus leads to production of an infectious
agent are required to be
licensed.
(k) dealings
producing more than 10 litres of GMO culture in a single vessel, other than a
dealing mentioned in paragraph 1.1 (f) of Part 1 (“Dealings that
are notifiable low risk dealings”) of this Schedule.
This paragraph
is very similar to paragraph (k). It requires licensing for dealings involving
large-volume GMO cultures. The amended paragraph will provide that dealings in
which the donor nucleic acid presents a low risk (for example, it must not be
uncharacterised nucleic acid from a pathogenic organism, or code for a toxin),
are not excluded from being NLRDs by this
paragraph.
(l) dealings
that are inconsistent with a policy principle issued by the Ministerial
Council.
This paragraph is unaltered from paragraph (l) of Schedule 3,
Part 2. It requires licensing for dealings that are inconsistent with a policy
principle issued by the Ministerial Council, so that these dealings will be
individually assessed by the
Regulator.
(m) dealings involving the
intentional introduction of a GMO into a human being.
This is a new
paragraph which will require dealings involving intentional introduction of a
GMO into a human (e.g. a clinical trial of a live GMO vaccine) be licensed.
Risks to human health associated with such dealing warrant individual assessment
by the
Regulator.
(n) dealings
involving a genetically modified pathogenic organism, if the practical treatment
of any disease or abnormality caused by the organism will be impaired by the
genetic modification.
This is a new paragraph which will require
licensing for dealings involving a genetically modified pathogenic organism,
where the genetic modification could make the disease more difficult to treat.
Risks to human health and the environment associated with possible impairment of
treatment of disease warrant assessment by the Regulator.
Clause 23
of the regulation will also omit Schedule 3, Part 3 (“Prescribed
information – notification of proposed notifiable low risk
dealing”). Clause 19 will require the notification be in the form approved
by the Regulator, rather than providing the information specified in Schedule 3,
Part 3, allowing the form to specify the information requirements related to the
notification. This will allow the Regulator to update the information
requirements quickly in response to advances in the knowledge and practice of
gene technology, thus enhancing the effectiveness and efficiency of the
regulatory system.
Clause 23 of the regulation will also omit
Schedule 4 (“Prescribed information – application for a
licence”). Clause 4 of the regulation will omit reference to Schedule 4.
Subsection 40(2) of the Act requires an application for licence to contain such
information as is: (a) prescribed in the regulation; and (b) specified in
writing by the Regulator. The application form will specify the information
required by the Regulator under paragraph 40(2)(b) of the Act. This will allow
the Regulator to update the information requirements quickly in response to
advances in the knowledge and practice of gene technology, thus enhancing the
effectiveness and efficiency of the regulatory system.
Clause 24:
Insert “ethics and community committee” in Dictionary, note
3
Clause 24 is a consequential amendment with the insertion required due
to the amalgamation of committees discussed in clauses 10 and 11 resulting in
the formation of the ethics and community committee.
Clause 25:
Substitute a modified definition of “advantage” in Dictionary in
Dictionary, note 3
The definition of “advantage” has been
modified to reflect its specific meaning in the regulation (to refer to
“organism” rather than to “adult
animal”).
Clause 26: Substitute a modified definition of
“characterised” in Dictionary
The definition of
“characterised” has been modified to reflect its specific meaning in
the regulation (to refer to “nucleic acid” rather than to
“DNA”).
Clause 27: Omit definitions of “division 5.3
application” and “division 5.4 application”
The
definitions of “division 5.3 application” and “division 5.4
application” will be deleted as a consequential amendment
required by the omission of schedule 4 as described in clause
23.
Clause 28: Substitute a modified definition of “expert
adviser” in Dictionary
This clause makes a consequential amendment
so that the definition of expert advisers in the regulation refers to the new
section of the proposed Act relating to the creation of the new Gene Technology
Ethics and Community Consultative Committee (GTECCC) that mentions expert
advisers.
Clause 29: Omit definition of
“gene-knockout mice”
The definition of “gene-knockout
mice” will be deleted, as its use will be removed by other items in the
regulation, namely the fact that exempt dealings will extend to all GM
laboratory mice and laboratory rats, provided that they also do not secrete
infectious agents as a result of the modification. This is a consequential
amendment (refer clause 23).
Clause 30: Omit definition of
“genetic manipulation advisory committee”
The definition of
“genetic manipulation advisory committee” will be deleted as it is
now redundant. References to this committee related to the transitional
arrangements from the former voluntary scheme, overseen by the Genetic
Manipulation Advisory Committee (GMAC), to the current regulatory scheme under
the Act.
Clause 31: New definitions of “genetically modified
laboratory mouse” and “genetically modified laboratory
rat”
The use of these terms will be introduced by the regulation,
and will be defined in this item (refer to clauses 23 and
28).
Clause 32: Omit definition of
“inclusion-negative”
This is a consequential amendment. The
term “inclusion-negative” is no longer used in the regulation as a
result of amendments in clause 23 to schedule 2.
Clauses 33 and 34:
Insert new dictionary definitions for “infectious agent”;
“known”; “non-conjugative plasmid”; “nucleic
acid”; “pathogenic”; “plasmid”; “non-vector
system”; “oncogenic modification”; “packaging cell
line”; and “pathogenic determinant”.
The following
terms are used but not defined in the regulation, and will be defined in this
clause: infectious agent; known; non-conjugative
plasmid; nucleic acid; pathogenic; and plasmid. The
definitions will increase clarity of clauses where these terms are used.
The use of the following terms will be introduced by the regulation and
will be defined in this clause: non-vector system; oncogenic
modification; packaging cell line; and pathogenic
determinant.
Clause 35: Omit definition of
“recombinant”
This is a consequential amendment required due
to amendments proposed in clause 23 as this term is no longer used in the
context previously referred to in the regulation.
Clause 36:
Substitute definition of “shot-gun cloning”
The definition of
this term will be amended by this clause (to remove reference to
“mammalian DNA”, thus making the definition more
general).
Clause 37: Insert new dictionary definitions for
“toxin”, “toxin producing organism” and
“transducer”
The use of these terms will be introduced by the
regulation and will be defined by this clause.