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GENE TECHNOLOGY AMENDMENT REGULATION 2011 (NO 1) (NO 26 OF 2011)
2011
LEGISLATIVE ASSEMBLY FOR THE
AUSTRALIAN CAPITAL
TERRITORY
GENE TECHNOLOGY AMENDMENT REGULATION 2011 (No
1)
SL2011-26
EXPLANATORY STATEMENT
Presented by the
Minister for
Health
Katy Gallagher MLA
GENE TECHNOLOGY AMENDMENT
REGULATION 2011 (No 1)
SL2011-26
Overview
Under the intergovernmental Gene Technology Agreement 2001 (IGA), all States
and Territories have committed to ensuring a nationally consistent regulatory
scheme for gene technology by maintaining corresponding legislation.
The
Gene Technology Amendment Regulation 2011 (No 1) amends the Gene Technology
Regulation 2004 (the regulation), a component of the national framework for the
regulation of gene technology, to correspond with amendments made to the
Commonwealth Gene Technology Regulations 2001 effected by the Commonwealth Gene
Technology Amendment Regulations 2011 (No 1).
Background
Consistent with the roles and functions of the Gene Technology Regulator
(the regulator) under the Commonwealth Act, the regulator undertook a
review of the Commonwealth Principal Regulations. Sections 32 and 74 of the
Commonwealth Act provide for the Principal Regulations to declare dealing with a
genetically modified organism (GMO) to be an exempt dealing or a notifiable low
risk dealing (NLRD), respectively. Sections 140 and 141 of the Commonwealth Act
provide for the regulator to review the classification of dealings as NLRDs and
exempt dealings, respectively. The regulator undertook consultation on the
amendments pursuant to the requirements of section 142 of the Act.
Paragraph 27(g) of the Commonwealth Act provides that it is a function
of the regulator to advise the Gene Technology Ministerial Council (GTMC) about
the effectiveness of the legislative framework for the regulation of GMOs,
including in relation to possible amendments. Under clause 40 of the
intergovernmental Gene Technology Agreement 2001, amendment of legislation
comprising the nationally consistent regulatory scheme requires approval from
the GTMC. The GTMC agreed to the Commonwealth Regulations which were made on 2
June 2011 and commence on 1 September 2011.
The purpose of the amendments
is to:
• ensure that dealings with GMOs continue to be classified
appropriately according to current scientific understanding of risks which they
may pose;
• improve the efficiency and effectiveness of the regulatory
system; and
• assist users to better understand and comply with their
legislative obligations.
This is achieved by:
• clarifying
requirements for undertaking NLRDs, including introduction of a time
limit;
• reclassifying certain dealings as exempt, NLRDs or as
requiring licensing under
the Act;
• and making some minor
administrative changes.
Consultation
As part of the review
process the regulator consulted widely. Initial consultation with the
organisations accredited under the Commonwealth Act, Institutional Biosafety
Committees (IBCs), State and Territory governments and Australian Government
agencies identified a number of areas in the Commonwealth Principal Regulations
that could be improved. Based on this input and issues identified through
operational experience with the Principal Regulations, proposals for amendment
were presented to the GTMC, which gave approval to draft the amendments. The
Gene Technology Technical Advisory Committee (GTTAC) was consulted on whether
the proposed changes to the classification of dealings were commensurate with
risks.
A second round of consultation on the draft amendments to the
Regulations was conducted according to the requirements of section 142 of the
Commonwealth Act. Comments were sought from GTTAC, accredited organisations,
Institutional Biosafety Committees, State and Territory governments, Australian
Government agencies and individuals and organisations that have registered on
the Office of the Gene Technology (OGTR) mailing list. Public notification and
an invitation for written submissions were undertaken through advertising in
The Australian newspaper, on the OGTR website and in the Government
Notices Gazette.
GENE TECHNOLOGY AMENDMENT REGULATION 2011 (No
1)
NOTES ON CLAUSES
Clause 2 – Commencement – provides that the regulation
commences on 1 September 2011.
This is the date on which the Commonwealth
Gene Technology Regulation Amendment Regulations 2011 (No.1)
commence.
Clause 3 – Legislation amended – provides
that the regulation amends the Gene Technology Regulation 2004.
Clause 4 – Section 6 (1) (e) - omits section 6 (1) (e) to remove reference to retroviral vectors able to transduce human cells. This paragraph is redundant following amendments introduced by the Commonwealth Gene Technology Amendment Regulations 2007 which removed dealings involving retroviral vectors able to transduce human cells from the exempt category.
Clause 5 – Section 11A – Time limit for deciding
variation application - substitutes the current section 11A and introduces
limitations on the days counted for the period during which the Gene Technology
Regulator (the regulator) must vary, or refuse to vary, a licence after the
receipt of an application for a variation of the licence. Days not to be
counted in this period are:
• a Saturday, a Sunday or a public holiday
as defined by the Legislation Act
(see Clause 18);
• 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.
In part, this item
corrects the implementation in the Commonwealth Gene Technology Amendment
Regulations 2007 of recommendation 5.9 of the Statutory Review of the
Gene Technology Act 2000 and The Gene Technology Agreement, that there be a
90 working day timeframe within which the regulator must assess applications to
vary a licence. This item also provides that delays due to waiting for
information from the applicant, which are beyond the control of the Regulator,
do not count toward the statutory timeframe for decisions on licence variation
applications.
Clause 6 – Section 12 (1) (a) – this amends references
to the schedules to take into account amendments to schedule 3 introduced by
this amendment regulation.
Clause 7 – Section 13 –
substitutes the current section 13 to clarify the requirements, roles and
responsibilities for people undertaking a notifiable low risk dealing (NLRD).
Some requirements are unchanged from those in the current section, and other
requirements are new or modified as described below.
Section 13 (1)
amends the requirements of the current section 13 (1) to:
• require that NLRD proposals to be assessed by an IBC must be
submitted in writing;
• limit the dealings which may be undertaken to
those described in the IBC’s record of assessment of the
proposal;
• limit the time within which a NLRD may be undertaken to
that specified by the amended section 13A, i.e. 5 years after the date of
assessment for NLRD proposals assessed after commencement of the
regulation;
• limit the people who may undertake the dealing to those
mentioned in the Institutional Biosafety Committee (IBC) record of assessment as
having the appropriate training and experience to undertake the dealing, noting
that this can include classes of persons;
• limit the facilities in
which the dealing may be undertaken to those mentioned in the IBC’s record
of assessment as being appropriate for the dealing, noting that this can include
classes of facilities;
• require that a person undertaking the dealing
must be able to give a copy of the IBC record of assessment to an inspector, on
request;
• require that the person undertaking the dealing does not
compromise containment of a GMO involved in the dealing;
• require that
a person may only undertake a NLRD in accordance with subsections
(2) and
(3); and
• remove references to the project supervisor, consistent with
amendments in clause 8 below.
These amendments clarify that only proposals which have been assessed by
an IBC may be undertaken as NLRDs. IBC assessments include consideration of the
scope of the dealing, the persons (or classes of persons) with appropriate
training and experience to undertake the dealing, and the facilities (or classes
of facilities) appropriate for undertaking the dealing. The responsibility for
ensuring NLRDs are conducted in this way rest with the person undertaking the
dealing. To ensure that this person clearly understands what constitutes the
dealing assessed by an IBC to be a NLRD, that person must have access to a copy
of the IBC’s record of assessment. Responsibility to not compromise
containment of the GMO, and to comply with the requirements of subsections (2)
and (3) also lie with the person undertaking the dealing. If a person
undertakes a NLRD in contravention of the requirements of the regulation, this
may constitute an offence under the Act, section 37.
These amendments
introduce a time limit on the authority to conduct a NLRD following the approval
of a proposal by an IBC, operating in conjunction with section 13A. This
ensures that dealings are periodically reassessed, taking into account any
changes in the scope of the dealings a proponent wishes to undertake and any
later amendments to the Commonwealth Principal Regulations. In addition, this
amendment improves the effectiveness of oversight of NLRDs and improves
transparency of the regulatory system clarifying which NLRDs included in the
Record of GMO and GM Product Dealings may be ongoing at any particular
time.
Section 13 (2) substitutes section 13 (2) to:
• clarify that for facilities to be appropriate for a NLRD it is
necessary to meet the required physical containment level and be of an
appropriate type (eg PC2 plant facilities are appropriate for the conduct of
NLRDs involving GM plants);
• introduce a requirement that NLRDs listed
in schedule 3, part 3.2 (kinds of dealings suitable for at least physical
containment level 3) must be conducted in facilities certified to at least
physical containment level 3 that are appropriate for the dealing. This
includes all dealings involving GMOs for which the unmodified parent organism is
classified as Risk Group 3 by AS/NZS 2243.3:2010. It is not intended to provide
for IBCs to assess any change to risk group classification as a result of
genetic modification, as such case-by-case assessment is considered beyond the
scope of the NLRD category; and
• replace the provision in the
regulation for dealings to be undertaken in another facility, in accordance with
technical and procedural guidelines for undertaking the dealing, with a
provision to allow NLRDs to be conducted in a facility agreed in writing by the
Regulator.
This amendment clarifies the requirements for facilities in
which NLRDs may be undertaken, and provides flexibility for the regulator to
agree to dealings being undertaken in other facilities.
Section 13(3)
This amendment also replaces the provisions
of paragraph 13 (2) (b) of the current regulation with a new subsection (3).
Paragraph 13 (2) (b) of the regulation allows the transport of GMOs in
accordance with guidelines issued by the regulator under section 27 (d) of the
Gene Technology Act 2003 (the Act), and subparagraph 13 (2) (a) (iii) of
the regulation requires that dealings undertaken in another facility (including
storage and disposal of GMOs) be undertaken in accordance with guidelines issued
by the regulator under section 27 (d) of the Act. This item combines these
requirements to a single subsection allowing the transportation, storage or
disposal of a GMO outside a facility specified in subsection 13 (2), within the
time limit for the NLRD. This item maintains the current requirement that these
aspects of NLRDs be conducted in accordance with technical and procedural
guidelines issued by the regulator under section 27 (d) of the Act for this
purpose.
The amendment specifies that the applicable guidelines, the
Guidelines for the Transport, Storage and Disposal of GMOs, are those in
force on 1 September 2011. These guidelines, which are yet to be issued by the
regulator, will be available from 1 September 2011 from the Office of the Gene
Technology Regulator (OGTR) website. This item also allows that transport,
storage or disposal may be undertaken in accordance with other requirements
which the regulator agrees in writing are appropriate for the containment of
GMOs.
Section 13 (4) requires that, in granting an agreement to dealings being
undertaken in other facilities, the regulator must consider the capacity of the
facility to contain the GMOs.
Clause 8 – Section 13A – substitutes the existing
section 13A with three new sections which encompass and expand upon the
requirements for NLRDs prescribed by the existing section 13A, and introduce new
requirements. The amendments clarify the roles and responsibilities for persons
or accredited organisations and IBCs regarding assessment and conduct of NLRDs,
notification of NLRDs to the regulator and keeping of records.
Section
13A – Time limits for stopping notifiable low risk
dealings
Section 13A prescribes the time limit within which a NLRD
may be undertaken, operating through paragraph 13 (1) (d). This amendment
provides for a phased introduction of NLRD time limits for those NLRDs assessed
by IBCs prior to the commencement of the regulation, and a time limit of five
years from the date of assessment for NLRDs assessed after commencement. If
people wish to continue to conduct a NLRD beyond the time limit, they have to
make a new written NLRD proposal to an IBC and obtain an assessment from the IBC
that the dealing is a NLRD.
Section 13B – Requirements for
institutional Biosafety committees about records of assessments or notifiable
low risk dealing proposals
Section 13B details the requirements of
IBC assessments of proposals for NLRDs. IBCs are required to make a record of
assessment for NLRD proposals including information specified by the regulator,
and give a copy of the record to the person or accredited organisation that
submitted the proposal. The regulation requires that the record of assessment
be made in a form approved by the regulator. Because the IBC record of
assessment function primarily as a record used by NLRD proponents, it is
intended that the regulator prescribes what information IBCs must include in
their record of assessment, and allow IBCs the flexibility to determine the
manner in which this information is recorded (eg in an electronic database, in a
paper document of their design, or on a proforma made available by the
regulator).
This removes the current requirement that a copy of the
record of assessment be given to the project supervisor. In conjunction with
section 13C, this clarifies that it is the person or accredited organisation
making the NLRD proposal that is responsible for notifying the regulator and
keeping records, and other actions flowing from an IBC assessment that the
dealing is a NLRD. Paragraph 13B (b) requires that a person undertaking the
dealing must have access to a copy of the record of assessment.
Those
aspects of IBC assessment relevant to other parts of the regulation are
specified in this section, for example information required for the Record of
GMO and GM Product Dealings, and considerations related to requirements of
section 13 (1) which limit who may undertake NLRDs and the facilities in which
they may be undertaken. The regulator provides guidance on those matters which
must be addressed by an IBC’s assessment of NLRD proposals through the
regulator’s requirements for the record of assessment.
Section
13C – Information to be kept or given to the regulator by people or
accredited organisations.
Section 13C details the requirements for
people and organisations in relation to notification of NLRDs to the regulator,
the keeping of records, and providing further information to the regulator on
request.
Subsections (1) to (3) clarify that a person or accredited
organisation given a copy of the IBC’s record of assessment, i.e. the
person who submitted the proposal to the IBC, is responsible for:
• notifying the regulator of the NLRD, in a form approved by the
regulator, in an annual report for the financial year;
• keeping a copy
of the IBC’s record of assessment for a period of eight years after the
date of assessment, i.e. for three years following the five year period in which
the NLRD may be undertaken.
As a result of section 13B (requirements for
IBC records of assessment), the scope of information IBCs must record for NLRD
assessments is greater than that required by the regulator for the purpose of
NLRD notifications. As a consequence, this item amends NLRD reporting
requirements to specify that notification to the regulator must be in a form
approved by the regulator, removing the requirement to provide a copy of the
IBC’s record of assessment. NLRD notifications to the regulator are
required (through the form approved by the regulator) to contain information
extracted from the IBC record of assessment, in order to ensure the records kept
by NLRD proponents and the regulator are consistent. Information to be included
in NLRD notifications to the regulator includes information required for the
Record of GMO and GM Product Dealings, and information necessary for the
regulator to uniquely identify the NLRD.
Subsections (4) and (5) require
that, on written request from the regulator, the people or accredited
organisation that proposed the NLRD or any other person involved with
undertaking the dealing must give the regulator requested information regarding
the conduct of a NLRD. This information must be provided by the end of the
period specified in the written request from the regulator. The scope of
information which may be requested by the regulator will be broadened to include
information about how the NLRD is being undertaken.
This item removes a
requirement that IBCs provide additional information to the regulator on
request. This clarifies that IBCs are not responsible for keeping records or
providing information to the regulator, these are responsibilities of the person
or accredited organisation that proposed the NLRD.
Clause 9 –
Section 39 (1) 9 (b) – allows insertion of a reference as a result of
other amendments.
Clause 10 – Section 39 (1) (d)
–amends paragraph 39 (1) (d) of the regulation to take into account
previous amendments. Section 39 (1) prescribes information which must be
contained in the Record of GMO and GM Product Dealings for NLRDs that are
notified to the regulator. The section removes a requirement that NLRDs be
notified to the regulator prior to dealings being conducted, allowing that NLRDs
may be conducted following their assessment by an IBC to be a NLRD. This clause
amends the information required for the Record of GMO and GM Product Dealings to
remove the requirement for the date of notification of a NLRD, and to instead
require the date of NLRD assessment by an IBC. This supports the implementation
of the NLRD time limit and improves transparency of the regulatory system by
clarifying which NLRDs included in the Record of GMO and GM Product Dealings may
be ongoing at any particular time.
Clause 11 – New part 9 – Transitional
Provisions
Section 45 of this new part provides for the transition of
dealings currently being conducted as exempt or notifiable low risk dealings
(NLRDs) but which become licensable dealings under the regulation on 1 September
2011. A person conducting such a dealing has until
1 September 2012 to
either cease the dealing or obtain a licence to undertake the dealing.
This part also provides for the transition of dealings currently being
conducted as exempt dealings but which become NLRDs under the regulation. A
person conducting such a dealing has until 1 September 2012 to either cease the
dealing or have the dealing assessed by an Institutional Biosafety Committee
(IBC) as a NLRD.
Section 46 of this new part provides that part expires
on 1 September 2013.
Clause 12 – Schedule 1, item 7, subparagraph (b) (i)
–amends the current
subparagraph (b) (i) of schedule 1 item 7, to
accommodate the inclusion of a definition of “AS/NZS 2243.3:2010”
(see Clause 19 below).
Clause 13 – Schedule 2, part 2.1, new
item 3A – This new item provides for dealings with animals whose
somatic cells have been genetically modified in vivo to be classified as
exempt dealings, where certain conditions are met. These dealings present the
same risks as dealings with animals into which genetically modified somatic
cells have been introduced (classified as exempt by schedule 2, part 2.1, item 3
of the regulation), provided that, in addition to conditions applying to item 3,
the replication defective viral vector used in the modification is no longer
present and no germline cells have been genetically modified.
For a
person to be satisfied whether particular dealings are classified as exempt
under this item, it is intended that they should document how the requirements
of subitems (a) to (e) are met. Scientific data generated by the proponent or
drawn from peer-reviewed published scientific literature could be used to
establish that some requirements are met. For example, knowledge of the
half-life of the viral vector could be used to establish that the
replication defective viral vector is no longer in the animal (subitem (b)). It
could be established that no germ line cells have been genetically modified by
reference to data from experiments using the same viral vector and inoculation
methodology (subitem (c)). To establish that the animal is not infected with a
virus that can recombine with the introduced GM nucleic acid (subitem (e)),
proponents could document that the animal was sourced from a colony maintained
so as to be free of relevant pathogens.
Clause 14 – Schedule 2,
part 2.1, item 4 – substitutes a new item which clarifies and modifies
the requirements relating to donor nucleic acid which must be met for a dealing
involving a host/vector system mentioned in schedule 2, part 2.2 to be
classified as an exempt dealing. Consideration of the potential for donor
nucleic acid to increase the ability of a GMO to cause harm in item 4 are
modified as follows:
• The volume of culture of GMOs per vessel which
may be classified as an exempt dealing, for dealings involving host/vector
systems listed in schedule 2, part 2.2 (host/vector systems for exempt dealings)
increases from 10 litres to 25 litres. Experience indicates that dealings
involving culture of these GMOs up to 25 litres with the large-scale
reaction vessels now available are appropriately contained and therefore
appropriate to be classified as exempt. Above this volume, such dealings remain
classified as NLRDs.
• By specifying that donor nucleic acid must not
be derived from organisms implicated in, or with a history of causing, disease
in otherwise healthy human beings, animals, plants or fungi, the scope of
this item is broadened to include consideration of donor nucleic acid from those
organisms which may cause disease only in unusual situations, for example in
immunocompromised hosts.
• The requirement in the regulation that donor
nucleic acid is characterised and ‘not known to alter’ features
contributing to the ability of a pathogen to cause harm is replaced with a
requirement that ‘the information derived from its characterisation show
that it is unlikely to increase the capacity of the host or vector to cause
harm’. This amendment clarifies that the requirements for classification
as an exempt dealing are met in situations where donor nucleic acid is
characterised and known to reduce the ability of a pathogen to cause harm.
Additionally, describing this requirement in terms of outcomes (i.e. the
capacity to cause harm, illustrated by examples) ensures this requirement is
applicable to an appropriately broad range of characteristics which may
contribute to the ability of an organism to cause harm.
The wording of
subparagraph (2) (e) (ii) is also amended. The amended wording is intended to
improve the clarity of this subparagraph without changing its
meaning.
This item removes the requirement in paragraph (2) (f) that
donor nucleic acid must not confer an oncogenic modification. This amendment is
consistent with the need to protect the health and safety of laboratory workers
because, with the removal of avipox vectors from
schedule 2, part 2.2 (see
clause 15), none of the host/vector systems permitted for use in exempt dealings
is able to transduce human cells. Without the potential for GMOs to transduce
human cells, the theoretical risk of laboratory workers developing cancer
following inadvertent exposure to a GMO carrying an oncogenic modification is
extremely low, and so these dealings are considered appropriate for the exempt
classification.
Clause 15 – Schedule 2, part 2.2 -
substitutes the current schedule 2, part 2.2, amending the list of approved
host/vector systems for exempt dealings. Some paragraphs are unchanged. Other
paragraphs are new or modified, as listed below:
• New hosts are
added to the list of approved 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. The hosts which are added have
been assessed to pose negligible risks to human health and safety or the
environment, and to offer a high level of biological containment. The new hosts
are:
o Escherichia coli Nissle 1917;
o Lactococcus lactis;
o Streptococcus thermophilus;
o Synechococcus strains PCC 7942, PCC 7002 & WH 8102;
o Synechocystis sp. strain PCC
6803;
o Yarrowia lipolytica.
• An error in the
spelling of the host Pseudoalteromonas tunicata is
corrected.
• The descriptions of tissue culture hosts is expanded to
clarify the dealings with animal or human and plant tissue cultures which may be
classified as exempt dealings. This amendment is not intended to change the
scope of dealings which may be classified as exempt by the Principal
Regulations. In addition to listing types of cultures, the descriptions specify
appropriate limits for exempt dealings. Animal tissue cultures are restricted
to those which cannot spontaneously generate a whole animal. Plant tissue
cultures are restricted to those which are not intended, and do not without
human intervention, reproduce vegetatively or sexually. Tissue culture dealings
not meeting these requirements are not considered appropriate for classification
as exempt dealings, e.g. dealings involving whole GM plants or animal embryos
sufficiently developed to be able to survive to form a whole animal without
human intervention. Dealings in which it was intended to produce a whole GM
plant or animal is not appropriate for classification as exempt. These
restrictions reflect the requirement under
paragraph 6 (d) that exempt
dealings involve no intentional release of a GMO into the environment, by the
inclusion of only those hosts offering a high level of biological containment.
The descriptions are intended to be applicable to a broad range of host species
with different developmental and physiological characteristics.
• Avipox vectors (attenuated vaccine strains) are removed from the
list of approved vectors for animal tissue culture hosts. These vectors are the
only vectors listed in schedule 2, part 2.2 able to transduce human cells.
Their removal allows for the removal of a restriction on the use of donor
nucleic acid conferring oncogenic modifications in exempt dealings involving
host/vector systems listed in schedule 2, part 2.2 (see clause 14
above).
Clause 16 – Schedule 2, part 2.3, definition of
non-vector system, except note - amends the definition of
non-vector system to include situations where a vector was used to
genetically modify a host but the vector is no longer present in, or is present
and unable to be remobilised from, the host. In such a situation, any risk
associated with the potential for the donor nucleic acid to be transferred to a
new host cell is the same as that for situations in which a GMO was generated
without the use of a nucleic acid-based vector. If no free vector is
present, the risks posed by the dealing relate solely to the characteristics of
the host and the donor nucleic acid, features which form the basis of
classification of dealings involving non-vector systems in schedules 2
and 3.
It is intended that the properties of the GMO and vector are the
primary consideration in determining whether a system meets the amended
definition of non-vector system. Vectors which could be remobilised only
through human intervention (e.g. by using experimental procedures to retrieve
vector sequences) are not considered to have an innate ability to be
remobilised, and meet the amended definition of non-vector
system.
Clause 17 – Schedule 3 - substitutes the current
schedule 3 (Notifiable low risk dealings in relation to a GMO) to the regulation
with an amended schedule 3, as detailed below.
Part 3.1 –
Notifiable low risk dealings suitable for at least physical containment level
1
This item replaces the current schedule 3, part 3.1 with an amended
list of NLRDs suitable for at least physical containment level 1. Amendments to
each paragraph are as follows:
• The wording of part 3.1 is amended
to require that dealings must be undertaken in facilities certified to at least
physical containment level 1 and that are appropriate for the dealing, unless
allowed otherwise under sections 13 (2) or (3), for consistency with the wording
of NLRD containment requirements in section 13 (2).
• Amendments to
paragraph 3.1(a) includes dealings involving GM laboratory rabbits and
laboratory guinea pigs in this category of NLRDs, unless an advantage is
conferred on the animal by the genetic modification, or the animal is capable of
secreting or producing an infectious agent. Physical containment level 1 is
appropriate to the risk posed by such GMOs.
• Paragraph 3.1 (b) is
removed, consequential to the removal of a restriction on exempt dealings
involving donor nucleic acid conferring oncogenic modifications (see clause 14
above).
• Paragraph 3.1 (c) is amended to restrict the dealings which
may be conducted as NLRDs in physical containment level 1 facilities to those
involving non-retroviral vectors able to transduce human cells in a host
mentioned in item 4 of schedule 2, part 2.2 (animal or human tissue culture
hosts for exempt dealings). The amended paragraph only encompasses dealings
with vectors derived from Human Adenovirus or Adeno associated
virus involving donor nucleic acid which cannot restore replication
competence and does not confer an oncogenic modification or encode an
immunomodulatory protein. Dealings involving other replication defective
non-retroviral vectors able to transduce human cells, or other donor nucleic
acid, which were formerly encompassed by this paragraph are classified as NLRDs
suitable for physical containment level 2.
Part 3.2 – Notifiable
low risk dealings suitable for at least physical containment level 2 or
3
This item replaces the current schedule 3, part 3.2 with an amended
list of NLRDs suitable for at least physical containment level 2 or 3. Some
paragraphs are unchanged from those in the regulation. Other paragraphs are new
or modified, as listed below:
• The title of this part is amended
to refer to facilities certified to at least physical containment level 2 or 3
and that are appropriate for the dealing, for consistency with the NLRD
containment requirements of section 13 (2).
• The wording of section
3.2 is amended to require that dealings must be undertaken in facilities
certified to at least physical containment level 2 and that are appropriate for
the dealing, unless allowed otherwise under sections 13 (2) or (3), for
consistency with the wording of NLRD containment requirements in subsection
13(2).
• Current paragraphs 3.2 (aa) and (ab) are combined into
paragraph 3.2 (aa), which does not alter the classification of the dealings
described in these paragraphs. Additional changes to paragraph 2.1(aa) are
consequential to the amendment to schedule 1, part 1.1 allowing some NLRDs
involving GM laboratory rabbits and laboratory guinea pigs in physical
containment level 1.
• The requirements for NLRDs involving GM plants
described in the current paragraphs 3.2 (b) and (ba) are combined and simplified
in paragraph 3.2 (b). References to specific containment measures for
reproductive material are removed because they are redundant with conditions
imposed upon PC2 plant facilities certified by the regulator. Dealings with GM
plants must be undertaken in these facilities or other facilities approved by
the regulator, in accordance with an amendment to subsection 13 (2). The
classification of dealings involving GM plants does not change as a result of
this amendment.
• Paragraphs 3.2 (c) and (d) are amended to specify
that dealings described are those where neither the host nor vector has been
implicated in, or has a history of causing, disease in otherwise healthy
human beings, animals, plants or fungi. The reference in paragraph 3.2 (e) to
donor nucleic acid characteristics is similarly amended. These amendments allow
for the classification as NLRDs of dealings involving hosts or vectors or donor
nucleic acid sources which may cause disease only in extreme situations, for
example in immunocompromised hosts.
• Paragraphs 3.2 (d) and (g) are
amended to clarify descriptions relating to the ability of a GMO to cause harm,
as described for clause 14 above.
• Paragraph 3.2 (f) is amended,
consequential to an amendment to increase the volume of culture of GMOs
involving host/vector systems listed in schedule 2, part 2.2 (host/vector
systems for exempt dealings) which may be classified as an exempt dealing, from
10 litres to 25 litres per vessel (see clause 14 above). There is no change to
the classification of dealings involving GMO cultures of more than 25 litres.
The requirement that dealings be carried out in at least physical containment
level 2 are removed because it is redundant with the requirements of subsection
13 (2) for undertaking NLRDs.
• Paragraph 3.2 (i) is a new paragraph
that classifies as NLRDs all dealings involving the introduction of a
replication defective viral vector unable to transduce human cells into a host
not mentioned in schedule 2, part 2.2, if the donor nucleic acid is unable to
restore replication competence to the vector. This recognises that these
dealings pose negligible risks to human health and safety, in particular to
laboratory workers, because these vectors cannot efficiently enter human cells.
• Paragraphs 3.2 (j) and (k) are new paragraphs that classify as NLRDs
particular dealings involving replication defective non-retroviral
vectors able to transduce human cells. Paragraph 3.2 (j) classifies as NLRDs
suitable for at least PC2 containment dealings involving the introduction of
these vectors into a host mentioned in schedule 2, part 2.2, except where the
dealing is classified as a NLRD suitable for PC1 containment according to
paragraph 1.1 (c) (particular dealings with vectors derived from Human
adenovirus or Adeno associated virus). Paragraph 3.2 (k)
classifies as NLRDs dealings involving the introduction of these vectors into
any other host, including animals, provided that the donor nucleic acid does not
present specific risks (ie confers an oncogenic modification, or encodes an
immunomodulatory protein).
• Paragraphs 3.2 (l) and (m) are new
paragraphs that classify as NLRDs particular dealings involving replication
defective retroviral vectors (including lentiviral vectors) able to transduce
human cells. These dealings are limited to dealings involving these viral
vectors with specific safety features which reduce the likelihood of adverse
outcomes for laboratory workers inadvertently exposed to the vectors. These
safety features primarily reduce the potential for replication competence to be
regained. Paragraph 3.2 (l) classifies as NLRDs dealings involving the
introduction of these vectors into a host mentioned in schedule 2, part 2.2.
Paragraph 3.2 (m) classifies as NLRDs dealings involving the introduction of
these vectors into any other host, including animals, provided that the donor
nucleic acid does not present specific risks (ie confers an oncogenic
modification, or encodes an immunomodulatory protein).
• Section 3.2A
requires that any dealing classified as a NLRD under schedule 3, part 3.2
involving a Risk Group 3 microorganism (according to the criteria of AS/NZS
2243.3:2010) must be undertaken in facilities that are certified to at least
physical containment level 3 and that are appropriate for the dealing, unless
allowed otherwise under sections 13 (2) or (3). Risk group 3 microorganisms
pose high risk to individuals, and AS/NZS 2243.3:2010 indicates that work with
these microorganisms should be carried out in PC3 facilities to manage risks to
human health and safety. This paragraph encompasses all dealings involving GMOs
for which the unmodified parent organism is classified as Risk Group 3, and does
not provide for IBCs to assess any change to risk group classification as a
result of genetic modifications. Such case-by-case assessment is
considered beyond the scope of the NLRD category.
Part 3.3 –
Dealings that are not notifiable low risk dealings
This item replaces
the current schedule 3, part 3.3 with an amended list of dealings that are not
NLRDs. Some paragraphs are unchanged from those in the regulation. Other
paragraphs are new or modified, as listed below:
• Paragraphs 3.3
(d) and (e) replace the current paragraph 3.3 (d). The amended wording is
intended to improve clarity and specificity with respect to dealings involving
viral vectors where the donor nucleic acid may pose increased risks to human
health and safety and the environment, and which therefore require licensing.
• Paragraph 3.3 (d) requires a licence for dealings involving the
introduction of a replication defective viral vector into a host not mentioned
in schedule 2, part 2.2, including animals, where the donor nucleic acid
presents specific risks (i.e. confers an oncogenic modification, or encodes an
immunomodulatory protein). This paragraph complements NLRDs described by
paragraphs 3.2 (k) and (m) of schedule 3, part 3.2 (which specifically exclude
these types of donor nucleic acid), and does not apply to dealings classified as
NLRDs by paragraph 3.2 (i) (dealings involving replication defective viral
vectors unable to transduce human cells where the donor nucleic acid is unable
to restore replication competence).
• Paragraph 3.3 (e) requires a
licence for dealings involving replication competent viral vectors, where the
donor nucleic acid presents specific risks (i.e. confers an oncogenic
modification, or encodes an immunomodulatory protein). This requirement does
not apply to dealings involving viral vectors mentioned in schedule 3, part
3.2.
• Paragraph 3.3 (f) is similar to paragraph 3.3 (e), with amended
wording to clarify references to the donor nucleic acid increasing the capacity
of a GMO to cause harm and the ability of a host or vector microorganism to
cause disease, as described for clause 14 above.
• Paragraph 3.3 (g) is
very similar to paragraph 3.3 (f), with a minor amendment to the wording of a
cross-reference.
• Paragraph 3.3 (h) is very similar to paragraph 3.3
(g), with amended wording intended to clarify but not change the meaning of the
paragraph.
• Paragraph 3.3 (i) is similar to paragraph 3.3 (h), with
amended wording to clarify a reference to the capacity of a GMO to cause harm,
as described for clause 14 above.
• Paragraph 3.3 (j) amends paragraph
3.3 (i), broadening its scope to require a licence for particular dealings
involving any retroviral vector, in addition to lentiviral vectors, which are
replication defective and able to transduce human cells. This requirement does
not apply to dealings involving replication defective retroviral vectors
carrying particular safety features, which are classified as NLRDs according to
paragraphs
2.1 (l) and (m) of schedule 3, part 3.2. This recognises that, in
the absence of these safety features, retroviral vectors have the potential to
regain replication competence, which presents a risk to the people involved in
the dealing.
• Paragraph 3.3 (k) is relettered from current paragraph
3.3 (j) and remains unaltered.
• Paragraph 3.3 (l) is very similar to
paragraph 3.3 (k), and increases the minimum volume of GMO culture for which
dealings must be licensed from 10 to 25 litres, other than those dealings
classified as NLRDs according to paragraph 2.1(f) of schedule 3, part
3.2.
• Paragraph 3.3 (m) is relettered from paragraph 3.3 (l) and
remains unaltered.
• Paragraph 3.3 (n) is similar to paragraph 3.3 (m),
amended to exclude particular dealings involving the introduction of a GMO into
a human being for somatic cell gene therapy from the requirement for licensing.
This exclusion is limited to situations involving the introduction of human GM
somatic cells that are incapable of secreting any infectious agents into a human
being. Ex vivo dealings involving GM human cells prior to introduction
into the patient continues to be regulated according to their classification in
schedules 2 and 3 of the regulation. The definition of a GMO in section 10 of
the Act specifically excludes people who have undergone somatic cell gene
therapy from being considered GMOs in the regulatory scheme, so a patient into
whom GM somatic cells have been introduced (including the GM somatic cells) is
not subject to regulation under the Act.
• Paragraph 3.3 (o) is
relettered from paragraph 3.3 (n) and remains unaltered.
• Paragraph
3.3 (p) requires a licence for a dealing involving a genetically modified
microorganism derived from an unmodified parent organisms which is classified as
Risk Group 4 according to the criteria of AS/NZS 2243.3:2010. Risk group 4
microorganisms pose high risk to individuals and the community, and AS/NZS
2243.3:2010 indicates that work with these microorganisms should be carried out
in PC4 facilities to manage risks to human health and safety. Licensing of
dealings with these microorganisms ensures that appropriate containment
requirements can be imposed upon such dealings. This paragraph encompasses all
dealings involving GMOs for which the unmodified parent organism is classified
as Risk Group 4, and does not provide for IBCs to assess any change to risk
group classification as a result of genetic modifications. Such case-by-case
assessment is beyond the scope of the NLRD category.
Clause 18 –
Dictionary, note 2 – adds ‘public holiday’ as one of the
definitions or other provisions defined by the Legislation Act relevant
to this regulation.
Clause 19 – Dictionary, new definition of
AS/NZS 2243.3:2010 –inserts a definition of Australian/New
Zealand Standard (AS/NZS) 2243.3:2010 to support the use of the term elsewhere
in the Regulation.
Clause 20 – Dictionary, new definitions
– this inserts definitions of ‘genetically modified laboratory
guinea pig’ and ‘genetically modified laboratory
rabbit’ to support the use of the term elsewhere in the regulation.
A definition of ‘inspector’ as a ‘person appointed by the
regulator under the Act, section 150 as an inspector’ is also
inserted.
Clause 21 – Dictionary, new definition of oncogenic
modification – This item amends the definition of ‘oncogenic
modification’ to increase clarity where this term is used. The amended
definition provides examples of the types of genetic modifications which may
contribute to tumour formation, thus making the modification fall within the
amended definition of ‘oncogenic modification’. The amended
definition removes reference to ‘vertebrate cells’, instead allowing
the situation in which a modification is oncogenic to be specified in
conjunction with the use of this term elsewhere in the regulation.