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GENE TECHNOLOGY AMENDMENT REGULATIONS 2006 (NO. 1) (SLI NO 314 OF 2006)
EXPLANATORY STATEMENT
Select Legislative Instrument 2006 No. 314
Issued by the Authority of the Parliamentary Secretary to the Minister for Health and Ageing
Gene Technology Act 2000
Gene Technology Amendment Regulations 2006 (No. 1)
Subsection 193(1) of the Gene Technology Act 2000 (the Act) provides that the Governor‑General may make regulations prescribing matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act. The regulations may require a person to comply with codes of practice or guidelines issued under the Act as in force at a particular time or from time to time.
The Act represents a major component of a national scheme established by Commonwealth, State and Territory legislation to protect the health and safety of people and to protect the environment from risks associated with gene technology. The scheme operates by identifying and assessing risks posed by, or as a result of, gene technology, and by managing any risks through the regulation of certain dealings with genetically modified organisms (GMOs).
The Gene Technology Regulations 2001 (the Principal Regulations) support the implementation of the Act by providing technical details, such as the categorisation of different dealings with GMOs, as well as specifying administrative processes and procedures.
The Regulations amend the Principal Regulations to remove some obsolete provisions, clarify areas of confusion and provide greater flexibility in relation to information requirements for notifications and licence applications. The list of host/vector systems (hosts and corresponding vectors facilitate the introduction of a foreign gene into the host organism) permitted for exempt dealings have been expanded. Certain types of contained dealings, for example, in glasshouses or laboratories, have also be reclassified based on current understanding of the associated risks. These changes reduce the regulatory burden of the Principal Regulations and streamline their operation, while maintaining the policy objectives of the regulatory system.
Paragraph 27(g) of the Act provides that it is a function of the Gene Technology Regulator (the Regulator) to advise the Gene Technology Ministerial Council about the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments to relevant legislation. The Regulator recently completed a review of the Principal Regulations, with the aim of clarifying definitions and resolving technical issues and inconsistencies in order to improve the efficiency and effectiveness of the regulatory system, and assist user compliance by making them clearer and easier to understand.
The Gene Technology Ministerial Council, comprising one relevant Minister from the Australian Government and each State and Territory government, has approved the will Regulations, as required under the intergovernmental Gene Technology Agreement 2001.
Details of the Regulations are set out in the Attachment.
The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations commence on 31 March 2007. This commencement date will allow time for jurisdictions with corresponding legislation to make appropriate amendments to their regulations, to ensure that the scheme for regulation of gene technology remains nationally consistent.
Consultation
As part of the review process the Regulator consulted widely. Initial consultation with the Gene Technology Technical Advisory Committee (GTTAC) and organisations accredited under the Act identified a variety of areas in the Principal Regulations that would be improved by clarification and streamlining. This input, in conjunction with four years of operational experience with the Principal Regulations, led to development of draft amendments which were the basis for further consultation, supported by a set of discussion papers addressing each of the key areas where changes were proposed.
During the second round of consultation GTTAC, accredited organisations, State and Territory governments, the Gene Technology Ethics Committee and Australian Government agencies were included in the consultation process. Public notification and an invitation for written submissions were undertaken through advertising in The Australian, on the Office of the Gene Technology (OGTR) website and in the Australian Government: Government Notices Gazette, as well as directly to individuals and organisations that have registered on the OGTR mailing list.
Authority: Subsection 193(1) of the
Gene Technology Act 2000
DETAILS OF THE GENE TECHNOLOGY AMENDMENT REGULATIONS 2006 (No. 1)
This regulation provides for the Regulations to commence on 31 March 2007.
This regulation provides for Schedule 1 to amend the Gene Technology Regulations 2001 (the Principal Regulations).
This regulation provides for the transition of dealings currently being conducted as notifiable low risk dealings (NLRDs) but which will become licensable dealings under the Regulations. A person conducting such a dealing will have until 31 March 2008 to either cease the dealing or have the dealing licensed. A NLRD is required to be conducted in a facility that is certified by the Regulator to at least physical containment level 2, or another containment level that the Regulator considers suitable for conducting the dealing, which will ensure that the GMOs remain in containment during the transition period.
Item [1]
Regulation 3 of the Principal Regulations provides definitions for terms which have specific meaning in the Principal Regulations.
This item will substitute a new set of definitions. Some definitions will be unchanged from those in the Principal Regulations (either at regulation 3 or elsewhere). Other definitions will be new or modified (as listed below). This list will also provide references to terms which are defined elsewhere in the Regulations, due to their relevance to only a particular part or schedule. The definitions of some terms will also be deleted, as their use will be removed from the Principal Regulations by other items in the Regulations.
The following terms are used but not defined in the Principal Regulations, and will be defined in this item: infectious agent; known; non-conjugative plasmid; nucleic acid; pathogenic; plasmid; and toxin. The definitions will increase clarity of clauses where these terms are used.
The use of the following terms will be introduced by the Regulations, and will be defined in this item: genetically modified laboratory mouse; genetically modified laboratory rat; non-vector system; oncogenic modification; packaging cell line; pathogenic determinant; and transduce.
The definitions of the following terms will be amended by this item: advantage (to refer to ‘organism’ rather than to ‘adult animal’); characterised (to refer to ‘nucleic acid’ rather than to ‘DNA’); and shot-gun cloning (to remove reference to ‘mammalian DNA’, thus making the definition more general).
Item [2]
This item will amend regulation 4 (Techniques not constituting gene technology) of the Principal Regulations to refer to a new schedule, Schedule 1A, in which techniques not constituting gene technology for the purpose of the Act will be listed. Item [13] includes the new Schedule 1A.
Item [3]
This amendment will replace reference to Australian Standard AS/NZS 2243.3:1995 (Safety in laboratories: microbiology) in paragraph 6(1)(c) of the Principal Regulations, in connection with containment requirements for exempt dealings, with a reference to a guideline in force and issued by the Regulator under paragraph 27(d) of the Act. This guideline, unlike the Standard, will be designed specifically to suit the class of dealings with GMOs (exempt dealings) to which this regulation relates. The guidelines will also be able to be made freely available by the Regulator, unlike the Standards which must be obtained from a third party.
In addition, this item will clarify, in paragraph 6(1)(c) of the Principal Regulations, that if exempt dealings involve transport, any transport must be done in accordance with guidelines in force and issued by the Regulator under paragraph 27(d) of the Act.
This amendment will further add a new paragraph (e) to subregulation 6(1) of the Principal Regulations, 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) of the Principal Regulations, which was intended to exclude them from exempt dealings.
Item [4]
This item will amend regulation 7 of the Principal Regulations 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 Regulations 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. Item [13] of the Regulations will remove the details of prescribed information requirements from the Principal Regulations, 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.
Items [5] and [6]
These items will amend regulation 9 of the Principal Regulations to refer to the current names of authorities and agencies prescribed by this regulation.
Item [7]
This item will amend paragraph 10(1)(a) of the Principal Regulations to refer to ‘any previous assessment by a regulatory authority’, rather than simply to ‘any previous assessment’, and to make this paragraph subject to section 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.
Item [8]
This item will amend subparagraph 10(1)(b)(v) of the Principal Regulations to refer simply to an ‘advantage’, which will be defined by item [1] of the Regulations, rather than to ‘selective advantage’, to provide consistent use of the defined term.
Item [9]
This item will amend regulation 13 of the Principal Regulations to:
1. remove the timeframe within which an Institutional Biosafety Committee (IBC) must, after completing an assessment of a proposed 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 item [13] of the Regulations 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 in the Principal Regulations 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 paragraph 13(2)(c) of the Principal Regulations 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 subregulation 13(3) of the Principal Regulations 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 subregulation 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).
Item [10]
This item will amend subregulation 29(3) of the Principal Regulations, to refer to the ‘Ministerial Council’ rather than to the ‘Minister’, in relation to reports which must be prepared by the Gene Technology Technical Advisory Committee. This reflects the Committee’s function under section 101 of the Act to provide advice to the Ministerial Council and to the Regulator. Regulations 32 and 35 also refer to subregulation 29(3), such that this amendment will also apply to the Gene Technology Community Consultative Committee and the Gene Technology Ethics Committee procedures, respectively.
Item [11]
This item will amend paragraph 39(2)(c) of the Principal Regulations 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.
Item [12]
This will omit Part 8 (regulations 41 and 42) of the Principal Regulations, 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.
Item [13]
This amendment will substitute current Schedules 1, 2, 3 and 4 to the Principal Regulations with a new Schedule 1A and revised Schedules 1, 2 and 3, as detailed below.
A new Schedule 1A (Techniques which are not gene technology) will be inserted by this item to support amended regulation 4. The inclusion of Schedule 1A in addition to Schedule 1 (Organisms that are not genetically modified organisms) to the Principal Regulations 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 to the Principal Regulations, or in the Explanatory Statement to the Principal Regulations 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) of the Principal Regulations. The items in Schedule 1 to the Principal Regulations 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 of the Principal
Regulations. The Explanatory Statement to the Principal Regulations states in
part in relation to this item that ‘Organisms resulting from such technology
are not considered to be GMOs for the purposes of the legislation because the
process mimics natural mutation processes’.
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.
(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 of the Principal
Regulations. The Explanatory Statement to the Principal Regulations states in
part in relation to this item that ‘Organisms that result from exchange of
DNA within the same species (and where no genetic material from any other
species is introduced) are not, therefore considered to be GMOs for the
purposes of the regulatory scheme.’
(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 of the Principal Regulations. The Explanatory Statement to the Principal Regulations states in relation to this item that ‘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 of the Principal Regulations list 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 to the Principal Regulations will be removed by this amendment but are reflected in the new Schedule 1A (Techniques which are not gene technology), as described above.
Item [13] of the Regulations will also replace Schedule 2, Part 1 (Exempt dealings) of the Principal Regulation 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 of the Principal Regulations and as amended by item [3] above (equivalent to physical containment level 1). Six 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 Principal Regulations list 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 of the Principal
Regulations, 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 of the Principal
Regulations. 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 of the Principal Regulations
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.
Item [13] of the Regulations will also amend the list of approved host/vector systems at Schedule 2, Part 2 (Host/vector systems for exempt dealings) of the Principal Regulations. 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 in the Principal Regulations will also be corrected.
Further, item 5 of this Part in the Principal Regulations (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 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.
Item [13] of the Regulations will also amend Schedule 2, Part 3 (Definitions) of the Principal Regulations by removing terms which are to be added to regulation 3 (by item [1] of the Regulations) or will no longer be used in the Regulations, and by adding new definitions relevant to the amended Schedule 2 (Dealings exempt from licensing).
Item [13] of the Regulations will also replace Schedule 3, Part 1 (Dealings that are notifiable low risk dealings) of the Principal Regulations with an amended list of dealings, and will correct a reference to a subregulation of the Principal Regulations 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 subregulation 13(2) of the Regulations (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 of the Principal
Regulations. 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 of
the Principal Regulations. 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 of the Principal
Regulations. 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 (defined by item [1] of the Regulations) 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 of the Principal
Regulations. 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 (defined by item [1] of the
Regulations) 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 of the Principal
Regulations. 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.
Item [13] of the Regulations will also delete clause 1.2 (Definitions) of Schedule 3, Part 1 of the Principal Regulations as there will no longer be any definitions specific to this part.
Item [13] of the Regulations will also replace Schedule 3, Part 2 (Dealings that are not notifiable low risk dealings) of the Principal Regulations 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 mg/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 mg/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 of the Principal Regulations, 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 of the Principal
Regulations. 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 of the Principal
Regulations. 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 of the Principal
Regulations. 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 of the Principal
Regulations. 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 of the Principal
Regulations. 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 (defined by item [1] of the
Regulations) 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 of the Principal
Regulations. 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) of the Principal Regulations.
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 of the Principal
Regulations. 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.
Item [13] of the Regulations will also omit Schedule 3, Part 3 (Prescribed information – notification of proposed notifiable low risk dealing) from the Principal Regulations. Item [9] of the Regulations 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.
Item [13] of the Regulations will also omit Schedule 4 (Prescribed information – application for a licence) from the Principal Regulations. Item [4] of the Regulations 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 Regulations; 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.