Gene Technology Variation Regulations 2013 (SA)
South Australia
Gene Technology Variation Regulations 2013
under the Gene Technology Act 2001
Contents
Part 1—Preliminary
1 Short title
2 Commencement
3 Variation provisions
Part 2—Variation of Gene Technology Regulations 2002
4 Variation of regulation 3—Definitions
5 Variation of regulation 6—Dealings exempt from licensing
6 Substitution of regulation 11A
11A Time limit for deciding variation application
7 Variation of regulation 12—Notifiable low risk dealings
8 Substitution of regulations 13 and 13A
13 Requirements for undertaking notifiable low risk dealings
13A Time limits for stopping notifiable low risk dealings
13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
13C Information to be kept or given to the Regulator by persons or accredited organisations
9 Variation of regulation 39—Record of GMO and GM Product Dealings
10 Variation of Schedule 1—Organisms that are not genetically modified organisms
11 Variation of Schedule 2—Dealings exempt from licensing
12 Substitution of Schedule 3
Schedule 3—Notifiable low risk dealings in relation to a GMO
Part 1—Notifiable low risk dealings suitable for at least physical containment level 1
1.1 Kinds of dealings suitable for at least physical containment level 1
Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3
2.1 Kinds of dealings suitable for at least physical containment level 2
2.2 Kinds of dealings suitable for at least physical containment level 3
Part 3—Dealings that are not notifiable low risk dealings
3.1 Kinds of dealings
Part 1—Preliminary
1—Short title
These regulations may be cited as the Gene Technology Variation Regulations 2013.
2—Commencement
These regulations come into operation on the day on which they are made.
3—Variation provisions
In these regulations, a provision under a heading referring to the variation of specified regulations varies the regulations so specified.
Part 2—Variation of Gene Technology Regulations 2002
4—Variation of regulation 3—Definitions
Regulation 3—after the definition of animal insert:
AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, as in force on 1 September 2011;
Regulation 3—after the definition of expert adviser insert:
genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology;
Regulation 3—after the definition of genetically modified laboratory mouse insert:
genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology;
Regulation 3—after the definition of infectious agent insert:
inspector means a person appointed by the Regulator under section 150 of the Act as an inspector;
Regulation 3, definition of oncogenic modification—delete the definition and substitute:
oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
(a)defects in DNA proofreading and repair;
(b)defects in chromosome maintenance;
(c)defects in cell cycle checkpoint mechanisms;
(d)uncontrolled cell proliferation;
(e)resistance to apoptosis;
(f)cellular immortalisation;
5—Variation of regulation 6—Dealings exempt from licensing
Regulation 6(1)(d)—delete "environment; and" and substitute:
environment.
Regulation 6(1)(e)—delete paragraph (e)
6—Substitution of regulation 11A
Regulation 11A—delete the regulation and substitute:
11A—Time limit for deciding variation application
(1)For section 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(2)For the period mentioned in subregulation (1), the following days are not counted:
(a)a Saturday or a public holiday in South Australia;
(b)a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give, will not be counted.
Note—
This subregulation differs from regulation 11A(2) of the Commonwealth regulations.
7—Variation of regulation 12—Notifiable low risk dealings
Regulation 12(1)(a)—delete paragraph (a) and substitute:
(a)it is a dealing of a kind mentioned in Part 1 or 2 of Schedule 3 (other than a dealing also mentioned in Part 3 of Schedule 3); and
8—Substitution of regulations 13 and 13A
Regulations 13 and 13A—delete the regulations and substitute:
13—Requirements for undertaking notifiable low risk dealings
(1)A person may undertake a notifiable low risk dealing only if—
(a)person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(b)the Institutional Biosafety Committee has assessed the dealing to be a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and
(c)the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and
(d)the dealing is only undertaken before the day mentioned in regulation 13A for the dealing; and
(e)the person is mentioned in the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and
(f)the dealing is undertaken in facilities mentioned in the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and
(g)the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(h)the person does not compromise the containment of a GMO involved in the dealing; and
(i)the person undertakes the dealing in accordance with subregulations (2) and (3).
Note—
A person complies with paragraph (e) if the person is in a class of persons that an Institutional Biosafety Committee has included in the record of assessment as having the appropriate training and experience to undertake the dealing. Similarly, a person complies with paragraph (f) if the facility in which the person undertakes the dealing is in a class of facilities that an Institutional Biosafety Committee has included in the record of assessment as being appropriate for the dealing.
(2)A notifiable low risk dealing must be undertaken—
(a)for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or
(b)for a kind of dealing mentioned in Part 2 of Schedule 3—
(i)that is not a dealing mentioned in subparagraph (ii)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or
(ii)that involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or
(c)in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken.
(3)However, if a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal—
(a)may only be undertaken before the day mentioned in regulation 13A as being the day on or before which the dealing must stop being undertaken; and
(b)may happen outside a facility mentioned in subregulation (2), but in that case must be conducted in accordance with—
(i)the Guidelines for the Transport, Storage and Disposal of GMOs , as in force on 1 September 2011, that have been issued by the Regulator for this purpose under section 27(d) of the Act; or
(ii)transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.
(4)For subregulation (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
13A—Time limits for stopping notifiable low risk dealings
For regulation 13(1)(d), the day on or before which the dealing described in the record of assessment of the dealing must stop being undertaken is—
(a)the day 5 years after the date of assessment, if the dealing is assessed by an Institutional Biosafety Committee on or after 1 September 2011; and
(b)31 August 2016, if the dealing is assessed by an Institutional Biosafety Committee in the period 31 March 2008 to 31 August 2011 (inclusive); and
(c)31 March 2015, if the dealing is assessed by an Institutional Biosafety Committee before 31 March 2008.
Note—
A person will have to apply for, and obtain, a new assessment of the dealing as a notifiable low risk dealing from an Institutional Biosafety Committee to continue to undertake the dealing after the applicable day mentioned in this regulation.
13B—Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must—
(a)make a record of its assessment, in a form approved by the Regulator, that includes the following:
(i)the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation proposing to undertake the dealing;
(ii)a description of the dealing to be undertaken;
(iii)its assessment whether the dealing is a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3;
(iv)if the Committee has assessed the dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3, the kind of notifiable low risk dealing that the dealing is, in terms of those Parts;
(v)the date of the Committee’s assessment of the dealing;
(vi)the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;
(vii)the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing;
(viii)the name of the Committee that assessed the proposal;
(ix)the name of the person or accredited organisation that submitted the proposal;
(x)the name of the person or accredited organisation proposing to undertake the dealing; and
(b)give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
13C—Information to be kept or given to the Regulator by persons or accredited organisations
(1)A person or an accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the proposed dealing, in the form approved by the Regulator, that includes—
(a)the particulars, prescribed under regulation 39(1) in relation to the dealing, to be included in the Record of GMO and GM Product Dealings; and
(b)the name of the Committee that assessed the dealing; and
(c)the name of the person or accredited organisation that submitted the proposal for assessment of the dealing to the Committee.
(2)The record of the proposed dealing mentioned in subregulation (1) must be given to the Regulator in the financial year in which the Institutional Biosafety Committee made the assessment—
(a)by an accredited organisation—in the annual report for the financial year to be given by the organisation to the Regulator; or
(b)by any other person—in a report for the financial year to be given by the person to the Regulator, in the form approved by the Regulator.
(3)A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(4)The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:
(a)the person or accredited organisation that submitted the proposal for assessment of the dealing;
(b)any other person involved with undertaking the dealing.
(5)A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.
9—Variation of regulation 39—Record of GMO and GM Product Dealings
Regulation 39(1)(b)—after "Part 1" insert:
or 2
Regulation 39(1)(d)—delete paragraph (d) and substitute:
(d)the date of assessment by an Institutional Biosafety Committee that the dealing is a notifiable low risk dealing.
10—Variation of Schedule 1—Organisms that are not genetically modified organisms
Schedule 1, item 7, (b)(i)—delete "AS/NZS 2243.3:2002 (Safety in laboratories, Part 3: Microbiological aspects and containment facilities) (jointly published by Standards Australia and Standards New Zealand" and substitute:
AS/NZS 2243.3:2010
11—Variation of Schedule 2—Dealings exempt from licensing
Schedule 2, Part 1—after item 3 insert:
3A
A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if—
(a) the in vivo modification occurred as part of a previous dealing; and
(b) the replication defective viral vector is no longer in the animal; and
(c) no germ line cells have been genetically modified; and
(d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and
(e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.
Schedule 2, Part 1, item 4(1)—delete "10" and substitute:
25
Schedule 2, Part 1, item 4(2)—delete subitem (2) and substitute:
(2)
The donor nucleic acid—
(a) must meet either of the following requirements:
(i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy—
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and
Example—
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it—
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(b) must not code for a toxin with an LD50 of less than 100 µg/kg; and
(c) must not code for a toxin with an LD50 of 100 µg/kg or more, if the intention is to express the toxin at high levels; and
(d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and
(e) must not include a viral sequence unless the donor nucleic acid—
(i) is missing at least 1 gene essential for viral multiplication that—
(A) is not available in the cell into which the nucleic acid is introduced; and
(B) will not become available during the dealing; and
(ii) cannot restore duplication competence to the vector.
Schedule 2, Part 2—delete Part 2 and substitute:
Part 2—Host/vector systems for exempt dealings
Item
Class
Host
Vector
1
Bacteria
Escherichia coli K12, E. coli B, E. coli C or E. coli Nissle 1917—any derivative that does not contain—
1.
Non‑conjugative plasmids
(a) generalised transducing phages; or
2.
Bacteriophage
(b) genes able to complement the conjugation defect in a non‑conjugative plasmid
(a) lambda
(b) lambdoid
(c) Fd or F1 (eg M13)
3.
None (non‑vector systems)
Bacillus—specified species—asporogenic strains with a reversion frequency of less than 10—7—
1.
Non‑conjugative plasmids
(a) B. amyloliquefaciens
2.
Plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus
(b) B. licheniformis
3.
None (non‑vector systems)
(c) B. pumilus
(d) B. subtilis
(e) B. thuringiensis
Pseudomonas putida—strain KT 2440
1.
Non‑conjugative plasmids including certified plasmids: pKT 262, pKT 263, pKT 264
2.
None (non‑vector systems)
Streptomyces—specified species—
1.
Non‑conjugative plasmids
(a) S. aureofaciens
2.
Certified plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
(b) S. coelicolor
3.
Actinophage phi C31 and derivatives
(c) S. cyaneus
4.
None (non‑vector systems)
(d) S. griseus
(e) S. lividans
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
Agrobacterium radiobacter
1.
Non‑tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors
Agrobacterium rhizogenes—disarmed strains
Agrobacterium tumefaciens—disarmed strains
2.
None (non‑vector systems)
Lactobacillus
Lactococcus lactis
1.
Non‑conjugative plasmids
Oenococcus oeni syn.
Leuconostoc oeni
2
None (non‑vector systems)
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the genus Allorhizobium)
Sphingopyxis alaskensis syn.
Sphingomonas alaskensis
Streptococcus thermophilus
Synechococcus—specified strains:
(a) PCC 7002
(b) PCC 7942
(c) WH 8102
Synechocystis species—strain PCC 6803
Vibrio cholerae CVD103‑HgR
2
Fungi
Kluyveromyces lactis
1.
All vectors
Neurospora crassa—laboratory strains
2.
None (non‑vector systems)
Pichia pastoris
Saccharomyces cerevisiae
Schizosaccharomyces pombe
Trichoderma reesei
Yarrowia lipolytica
3
Slime moulds
Dictyostelium species
1.
Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2
2.
None (non‑vector systems)
4
Tissue culture
Any of the following if they cannot spontaneously generate a whole animal:
1.
Non‑conjugative plasmids
(a) animal or human cell cultures (including packaging cell lines)
2.
Non‑viral vectors, or replication defective viral vectors unable to transduce human cells
(b) isolated cells, isolated tissues or isolated organs, whether animal or human
3.
Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus
(c) early non‑human mammalian embryos cultured in vitro
4.
None (non‑vector systems)
Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:
(a) plant cell cultures
(b) isolated plant tissues or organs
1.
Non‑tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium tumefaciens, Agrobacterium radiobacter or Agrobacterium rhizogenes
2.
Non‑pathogenic viral vectors
3.
None (non‑vector systems)
Schedule 2, Part 3, definition of non‑vector system—delete the definition and substitute:
non‑vector system means a system in which donor nucleic acid is or was introduced into a host cell—
(a)in the absence of a nucleic acid‑based vector; or
(b)using a nucleic acid‑based vector in the course of a previous dealing and the vector is—
(i)no longer present; or
(ii)present but cannot be remobilised from a host cell.
Example 1—
A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.
Example 2—
A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.
12—Substitution of Schedule 3
Schedule 3—delete the Schedule and substitute:
Schedule 3—Notifiable low risk dealings in relation to a GMO
(regulations 12 and 13)
Part 1—Notifiable low risk dealings suitable for at least physical containment level 1
Note—
Because of regulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.
1.1—Kinds of dealings suitable for at least physical containment level 1
The following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or 13(3)(b) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:
(a)a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless—
(i)an advantage is conferred on the animal by the genetic modification; or
(ii)the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;
(c)a dealing involving a replication defective vector derived from Human adenovirus or Adeno associated virus in a host mentioned in item 4 of Part 2 of Schedule 2, if the donor nucleic acid—
(i)cannot restore replication competence to the vector; and
(ii)does not—
(A)confer an oncogenic modification in humans; or
(B)encode a protein with immunomodulatory activity in humans.
Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3
Note—
Because of regulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.
2.1—Kinds of dealings suitable for at least physical containment level 2
The following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or 13(3)(b) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:
(a)a dealing involving whole animals (including non‑vertebrates) that—
(i)involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and
(ii)does not involve any of the following:
(A)a genetically modified laboratory guinea pig;
(B)a genetically modified laboratory mouse;
(C)a genetically modified laboratory rabbit;
(D)a genetically modified laboratory rat;
(E)a genetically modified Caenorhabditis elegans;
(aa)a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if—
(i)the genetic modification confers an advantage on the animal; and
(ii)the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;
(b)a dealing involving a genetically modified plant;
(c)a dealing involving a host/vector system not mentioned in clause 1.1(c) of Part 1 of this Schedule or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy—
(i)human beings; or
(ii)animals; or
(iii)plants; or
(iv)fungi;
(d)a dealing involving a host and vector not mentioned as a host/vector system in Part 2 of Schedule 2, if—
(i)the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy—
(A)human beings; or
(B)animals; or
(C)plants; or
(D)fungi; and
(ii)the donor nucleic acid is characterised; and
(iii)the characterisation of the donor nucleic acid shows that it is unlikely to increase the capacity of the host or vector to cause harm;
Example—
Donor nucleic acid would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it—
(a)provides an advantage; or
(b)adds a potential host species or mode of transmission; or
(c)increases its virulence, pathogenicity or transmissibility.
(e)a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid—
(i)encodes a pathogenic determinant; or
(ii)is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy—
(A)human beings; or
(B)animals; or
(C)plants; or
(D)fungi;
(f)a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if—
(i)the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and
(ii)the donor nucleic acid satisfies the conditions set out in item 4(2) of Part 1 of Schedule 2;
(g)a dealing involving complementation of knocked‑out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;
Example—
A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism—
(a)provides an advantage; or
(b)adds a potential host species or mode of transmission; or
(c)increases its virulence, pathogenicity or transmissibility.
(h)a dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in item 1 of Part 2 of Schedule 2, if the donor nucleic acid is derived from either—
(i)a pathogen; or
(ii)a toxin‑producing organism;
(i)a dealing involving the introduction of a replication defective viral vector unable to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
(j)a dealing involving the introduction of a replication defective non‑retroviral vector able to transduce human cells, other than a dealing mentioned in clause 1.1(c) of Part 1 of this Schedule, into a host mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
(k)a dealing involving the introduction of a replication defective non‑retroviral vector able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if—
(i)the donor nucleic acid cannot restore replication competence to the vector; and
(ii)the donor nucleic acid does not—
(A)confer an oncogenic modification in humans; or
(B)encode a protein with immunomodulatory activity in humans;
(l)a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into a host mentioned in Part 2 of Schedule 2, if—
(i)all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans; and
(ii)viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and
(iii)either—
(A)the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or
(B)the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;
(m)a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if—
(i)the donor nucleic acid does not—
(A)confer an oncogenic modification in humans; or
(B)encode a protein with immunomodulatory activity in humans; and
(ii)all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans; and
(iii)viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and
(iv)either—
(A)the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or
(B)the packaging cell line and packaging plasmids express only viral genesgagpol, rev and an envelope protein gene, or a subset of these.
2.2—Kinds of dealings suitable for at least physical containment level 3
Any kind of dealing mentioned in this Part involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 must be undertaken, unless regulation 13(2)(c) or (3)(b) applies, in facilities that are—
(a)certified to at least physical containment level 3; and
(b)appropriate for the dealing.
Part 3—Dealings that are not notifiable low risk dealings
Note 1—
The following list qualifies the list in Part 1 and Part 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.
Note 2—
A dealing that is not a notifiable low risk dealing, or an exempt dealing, can be undertaken only by a person who is licensed, under the Act, for the dealing (see section 32 of the Act).
3.1—Kinds of dealings
A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:
(a)a dealing (other than a dealing mentioned in clause 2.1(h) of Part 2 of this Schedule) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 µg/kg;
(b)a dealing involving high level expression of toxin genes, even if the LD50 is 100 µg/kg or more;
(c)a dealing (other than a dealing mentioned in clause 2.1(h) of Part 2 of this Schedule) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;
(d)a dealing involving the introduction of a replication defective viral vector into a host not mentioned in Part 2 of Schedule 2 (other than a dealing mentioned in clause 2.1(i) of Part 2 of this Schedule), if the donor nucleic acid—
(i)confers an oncogenic modification in humans; or
(ii)encodes a protein with immunomodulatory activity in humans;
(e)a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the donor nucleic acid—
(i)confers an oncogenic modification in humans; or
(ii)encodes a protein with immunomodulatory activity in humans;
(f)a dealing involving, as host or vector, a micro‑organism, if—
(i)the micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy—
(A)humans; or
(B)animals; or
(C)plants; or
(C)fungi; and
(ii)none of the following subsubparagraphs apply:
(A)the host/vector system is a system mentioned in Part 2 of Schedule 2;
(B)the donor nucleic acid is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;
(C)the dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule;
Example—
Donor nucleic acid would not comply with subsubparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it—
(a)provides an advantage; or
(b)adds a potential host species or mode of transmission; or
(c)increases its virulence, pathogenicity or transmissibility.
(g)a dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless—
(i)the dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule; or
(ii)the micro‑organism is a host mentioned in Part 2 of Schedule 2;
(h)a dealing involving the introduction into a micro‑organism (other than a host mentioned in Part 2 of Schedule 2) of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response;
(i)a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;
Example—
A dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has—
(a)an advantage; or
(b)a new potential host species or mode of transmissibility; or
(c)increased virulence, pathogenicity or transmissibility.
(j)a dealing, other than a dealing mentioned in clause 2.1(l) or (m) of Part 2 of this Schedule, with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;
(k)a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;
(l)a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in clause 2.1(f) of Part 2 of this Schedule;
(m)a dealing that is inconsistent with a policy principle issued by the Ministerial Council;
(n)a dealing involving the intentional introduction of a GMO into a human being, unless the GMO—
(i)is a human somatic cell; and
(ii)cannot secrete or produce infectious agents as a result of the genetic modification; and
(iii)if it was generated using viral vectors—
(A)has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and
(B)the testing did not detect a virus mentioned in subsubparagraph (A); and
(C)the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;
(o)a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;
(p)a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4.
Note—
As required by section 10AA(2) of the Subordinate Legislation Act 1978, the Minister has certified that, in the Minister's opinion, it is necessary or appropriate that these regulations come into operation as set out in these regulations.
Made by the Governor
with the advice and consent of the Executive Council
on 25 July 2013
No 188 of 2013
HEAC-2012-00028
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