ࡱ> K Hbjbj l~8i~8ixq 8dS^t!xp","kRmRmRmRmRmRmR$rV(YR"!"!""RLS111"6kR1"kR11IMNPjd&eN"WR4S0dSN"Y+YDNNjYPD""1"""""RR."""dS""""Y""""""""" X x: GM Dealing Application Form Information Use this form to apply to the 鶹ֱ Institutional Biosafety Committee (IBC) for permission to carry out a Dealing with a genetically modified organism (GMO) at a 鶹ֱ campus. If you want to perform GM Dealings at other locations, you will need to apply to the IBC that cares for those locations. Please then just send a copy of your external approval to the 鶹ֱ IBC. If you need assistance filling in this form then please contact your Biosafety Partner, Dr Bernadette Bradley on 9266 1383 or 0401 103 655 or  HYPERLINK "mailto:bernadette.bradley@curtin.edu.au" bernadette.bradley@curtin.edu.au . When completed, please submit this form to  HYPERLINK "mailto:HazardousMaterials@curtin.edu.au" HazardousMaterials@curtin.edu.au . The Notifying Organisation is 鶹ֱ, Accreditation Number Accr-105. The assessing IBC is the 鶹ֱ Institutional Biosafety Committee. The Chair of the IBC is Dr Rob Steuart. The Executive Officer of the IBC is Dr Bernadette Bradley. Application type Is this an application for a new Dealing? (yes/no) Is this a renewal of an existing Dealing? (yes/no) If yes, then list the previous Dealing number: Confidential Commercial Information (CCI) Does your Dealing include Confidential Commercial Information? (yes/no) (If yes, please contact your Biosafety Partner for advice on how to complete this form.) Dealing Title  Applicant Information The Principal Investigator (PI) of the Dealing must be a Curtin Staff member, not a Student. The PI is ultimately responsible for how the Dealing is performed, who performs it, how they are trained, and stewardship of the GMOs. PI title and full namePosition, Department and FacultyPhone number(s)Email address Summary of previous experience performing GM Dealings and working in OGTR-certified facilities.GMO trainingFor office use only. The PI must nominate a Deputy PI for the Dealing, who will assume stewardship of the Dealing and the GMOs held under it in the absence of the PI. The Deputy can be a Staff member or a HDR Student. DPI Title and full namePosition, Department and FacultyStaff or Student?Phone number(s)Email address Summary of previous experience performing GM Dealings and working in OGTR-certified facilities.GMO trainingFor office use only. Name the other researchers who will perform this Dealing, by copying and pasting the table below. Title and full namePosition, Department and FacultyStaff or Student?Phone number(s)Email address Summary of previous experience performing GM Dealings and working in OGTR-certified facilities.GMO trainingFor office use only. Classes of People Identify all the classes of people who will be performing this Dealing. The IBC has the ability to give approval for classes of people, which would allow you to add or subtract people of that class (e.g. HDR Students) over time without having to reapply to the IBC for permission. Research Staff (yes/no to each) Facility Support StaffHigher Degree by Research StudentsPostgraduate by Coursework StudentsHonours StudentsBachelors Students Dealing Information Describe the Dealing. Please provide enough information about the experimental work that you want to do involving GMOs that the IBC can envision the processes.  Desired start date: Estimated end date: Source of the GMO Identify the source of the GMO. Will it be purchased from a supplier, gifted from a colleague, constructed during the Dealing, or other? Give details of any supplier or donor.  Will the GMO be imported under an Import Permit? (yes/no) (If yes, please attach a copy of the Permit.) Details about the GMO(s) In this section you will describe the GMOs you are applying for. You may apply to use several different kinds of GMOs in this application and we need to collect information about each of them. You will need to describe each of your GMOs using three elements: the living organism (host or parent organism), the genetic modification that will be done or has been done (either DNA donated from a donor organism and stably inserted into the host organism, or DNA originally in the host genome and now deleted from that host), and the vector DNA and method transiently used to make the modification. Firstly you will need to summarise the different kinds of GMOs that you want to use. Then you will need to describe in detail each host, modification, and vector that you want to use. This process is represented in the diagram below.  Step 1 - Summarise all your GMOs Refer to the tables at the end of this document to identify the types of GM Dealings that you wish to do. Fill out the table below for each kind of GMO you want to use. Copy the table to describe all your GM Dealing types. Remember to include all the GMOs you use to make your final GMO, such as E. coli, yeast or Agrobacterium. The Dealing described in this table involves:GM Dealing type Exempt Dealing: 2, 3, 3A, 4, 5 Notifiable Low Risk Dealings: 1.1a, 1.1c, 2.1a, 2.1aa, 2.1b, 2.1c, 2.1d, 2.1e(i), 2.1e(ii), 2.1f, 2.1g, 2.1h(i), 2.1h(ii), 2.1i, 2.1j, 2.1k, 2.1l(A), 2.1l(B), 2.1m(A), 2.1m(B), 2.2 Contact your Biosafety Partner for help to choose.Host organism(s) of this GM Dealing typeList all the new DNA/RNA that will remain in the GMO(s) after the modificationList all the vector(s) to be used in this GM Dealing type Step 2 Detail your host organisms Consider all the living host (parent) organisms that will be the GMOs. Fill out the table below for each host organism, by replicating the table. You will need the Risk Group (RG) of your microorganisms, which you can find in Section 3 of the Australian/New Zealand Standard 2243.3:2010, accessed through Curtin Librarys  HYPERLINK "https://databases.library.curtin.edu.au/?letter=T" Techstreet enterprise database, by searching for 2243.3:2010. Common and scientific name of a host organismRisk Group of the host organism if a microorganism RG1, RG2, RG3, RG4, N/AThis organism been shown to be pathogenic towards: (a) No other organisms (d) Plants (b) Humans (e) Fungi (c) Animals (f) Bacteria (g) Other organismsIf this organism produces spores then provide the spore size and normal method of transmission.If this organism produces pollen then provide the pollen size and normal method of transmission.Will this organism be placed onto or into another organism, and if so, name that organism? Step 3 Detail the genetic modifications Consider all the types of genetic modification that the GMO will have. All the DNA, RNA, genes and gene segments that will be stably modified, inserted, or deleted in the organism. Fill in the information below for each modification, by replicating the table. For inserted DNA, the donor organism is the one that the inserted DNA originated from. DNA/RNA nameWill this DNA/RNA be inserted or deleted in the host?If inserted: what donor organism does the DNA/RNA originate from?If inserted and the donor is a microorganism: what is the Risk Group of the donor organism?This organism been shown to be pathogenic towards: (a) No other organisms (d) Plants (b) Humans (e) Fungi (c) Animals (f) Bacteria (g) Other organisms Primary function of DNA? (promoter, enhancer, protein-coding, terminator, non-coding, selectable marker, other DNA, unknown, not DNA)If RNA: primary function of RNA?Hazard potential (virulence factor, pathogenic determinant, oncogene, immune modifier, not hazardous, unknown function) Step 4 - Detail your vectors Is this a vector system? (yes/no) If yes, consider all the vector(s) and method(s) to be used to transfer the genetic material. Fill in the table below for each vector, replicating the table for as many as you need. Vector nameVector supplier or sourceVector type (viral, plasmid, cosmid, phage, baculovirus, vector not sequenced, other)Selectable marker(s) on the vectorConjugative or non-conjugativeReporter gene(s) on the vectorTags on the vectorTransfection method(s)Promotor(s) on the vectorTransiently expressed? (yes or no)Please attach the vector map of this vector. Risk assessment and management Does the GMO, or the vector used to make the GMO, pose a threat to the health and safety of the people handling the GMO? What are the possible hazards from the proposed genetic modifications, and the likelihood and consequence of the hazards occurring? Note: GMOS and vectors that are made from organisms that are pathogenic to humans may be hazardous.  If unintentionally released from containment, does the GMO, or the vector used to make the GMO, pose a threat to the health and safety of people in the community or general population? What are the possible hazards from the proposed genetic modifications, and the likelihood and consequence of the hazards occurring? Note: GMOS and vectors that are made from organisms that are pathogenic to humans may be hazardous.  If unintentionally released into the environment, does the GMO, or the vector used to make the GMO, pose a threat to the health of plants, animals, fungi, microorganism or other organisms in the environment, or their position in the ecosystem? What are the possible hazards from the proposed genetic modifications, and the likelihood and consequence of the hazards occurring? Note: GMOS and vectors that are made from organisms that are pathogenic to animals, plants or fungi may be hazardous. GMOs might outcompete non-GMOs in the environment. Over and above the precautions that are outlined in the OGTR PC2 Guidelines, are there any other actions and precautions you will take to minimise risks posed by the proposed dealing(s)? In addition to those actions listed below, which are required, what are the steps will you take in the event of an unintentional release of the GMO(s)? In the event of an unintentional release of GMOs from containment, I will notify the Manager of the Certified Facility that housed the GMO, plus my Biosafety Partner Dr Bernadette Bradley as soon as possible by phone on 0401 103 655 and by email  HYPERLINK "mailto:bernadette.bradley@curtin.edu.au" bernadette.bradley@curtin.edu.au .  Facility Information Identify which OGTR-Certified facility or facilities you will perform the Dealing in. Note that use of a facility is at the discretion of the Facility Manager. Facility nameFacility typeCert numberFacility ManagerWill the Dealing be done here? (yes/no)B308 Rm 140-144PC2 lab2405Rob SteuartB305 L2 East WingPC2 lab3489Rob SteuartB305 L2 West WingPC2 lab3490Rob SteuartB300 Animal FacilityPC2 animal facility2406Dumindi DalugodaB300 Rm111-123PC2 lab2407Dumindi DalugodaB300 PC3 FacilityPC3 lab2541Dumindi DalugodaB126G Glasshouse FacilityPC2 plant facility3370Sandra HuynhB126K Conviron FacilityPC2 lab3832Sandra HuynhB126Q Plant Growth FacilityPC2 plant facility4866Sandra HuynhB304 Lab 1PC2 lab4172Sandra HuynhB304 Lab 2PC2 lab4177Sandra HuynhB304 Lab 3PC2 lab4175Sandra HuynhB304 Conviron 1PC2 plant facility4173Sandra HuynhB304 Conviron 2PC2 plant facility4176Sandra HuynhB304 Conviron 3PC2 plant facility4174Sandra HuynhB304 PC3 FacilityPC3 lab4509Sandra Huynh Do you wish to perform the dealing in any other facilities at Curtin? (yes/no) If yes, provide the building number, room number(s) and facility contact: Storage outside the Certified facility Will you store the GMOs outside a Curtin Certified facility? (yes/no) If yes, provide the building number, room number(s) and facility contact: If you will be storing your GMO using methods that differ from those described in the Guidelines for Transport, Storage and Disposal of GMOs, then describe the conditions by replacing the text below. Leaving the text below indicates that you will comply with the Guidelines.I will be storing my GMOs following the methods described in the OGTR Guidelines for Transport, Storage and Disposal of GMOs. Transport outside of a Certified facility If you will be transporting your GMO using methods that differ from those described in the Guidelines for Transport, Storage and Disposal of GMOs, then describe the transport methods by replacing the text below. Leaving the text below indicates that you will comply with the Guidelines.I will be transporting my GMOs following the methods described in the OGTR Guidelines for Transport, Storage and Disposal of GMOs. Disposal of the GMO If you will be disposing of your GMO using methods that differ from those described in the Guidelines for Transport, Storage and Disposal of GMOs, then describe the disposal methods by replacing the text below. Leaving the text below indicates that you will comply with the Guidelines.I will be disposing of my GMOs following the methods described in the OGTR Guidelines for Transport, Storage and Disposal of GMOs.Which chemical disinfectant(s) will be used to decontaminate surfaces that the GMO is handled over? (Chemical disinfectants can be found in Appendix F of the Australian / New Zealand Standard 2243.3:2010) Describe the procedure to decontaminate a spill of your GMO.   When completed, please submit this form to  HYPERLINK "mailto:HazardousMaterials@curtin.edu.au" HazardousMaterials@curtin.edu.au . ------------ This is the end of the Application Form. ----------- (Office use only) Date application received: Date application approved: The reference material that follows comes from the Gene Technology Regulations 2001. EXEMPT DEALINGS TypeDescription of dealing2A dealing with a genetically modifiedCaenorhabditis elegans, unless: (a) anadvantageis conferred on the animal by the genetic modification; or (b) as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.3A dealing with an animal into which genetically modified somatic cells have been introduced, if: (a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and (b) the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.3AA dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if: (a) the in vivo modification occurred as part of a previous dealing; and (b) the replication defective viral vector is no longer in the animal; and (c) no germ line cells have been genetically modified; and (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and (e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.4(1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture. (2) The donor nucleic acid: (a) must meet either of the following requirements: (i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy: (A) human beings; or (B) animals; or (C) plants; or (D) fungi; (ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; 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 micrograms per kilogram; and (c) must not code for a toxin with an LD50 of 100 micrograms per kilogram 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) if the donor nucleic acid includes a viral sequence cannot give rise to infectious agents when introduced into any potential host species, without additional non host genes or gene products that: (i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and (ii) will not become available during the dealing; and (f) if the donor nucleic acid includes a viral sequencecannot restore replication competence to the vector.5A dealing involving shotgun cloning, or the preparation of a cDNA library, in a bacterial exempt host/vector system, if the donor nucleic acid is not derived from either: (a) a pathogen; or (b) a toxinproducing organism. HOST/VECTOR SYSTEMS FOR EXEMPT DEALINGS ClassHostVectorBacteriaEscherichia coliK12,E. coliB,E. coliC orE. coliNissle 1917any derivative that does not contain: (a) generalised transducing phages; or (b) genes able to complement the conjugation defect in a nonconjugative plasmidAny of the following: (a) nonconjugative plasmids; (b) lambda bacteriophage; (c) lambdoid bacteriophage; (d) Fd, F1 or M13 bacteriophageBacillusasporogenic strains of the following species with a reversion frequency of less than 107: (a)B. amyloliquefaciens; (b)B. licheniformis; (c)B. pumilus; (d)B. subtilis; (e)B. thuringiensisAny of the following: (a) nonconjugative plasmids; (b) other plasmids and phages whose host range does not includeB. cereus,B. anthracisor any other pathogenic strain ofBacillusPseudomonas putidastrain KT2440Nonconjugative plasmidsThe followingStreptomycesspecies: (a)S. aureofaciens; (b)S. coelicolor; (c)S. cyaneus; (d)S. griseus; (e)S. lividans; (f)S. parvulus; (g)S. rimosus; (h)S. venezuelaeAny of the following: (a) nonconjugative plasmids; (b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives; (c) actinophage phi C31 and derivativesAny of the following: (a)Agrobacterium radiobacter; (b)Agrobacterium rhizogenes(disarmed strains only); (c)Agrobacterium tumefaciens(disarmed strains only)Disarmed Ri or Ti plasmidsBacteriaAny of the following: (a)Allorhizobiumspecies; (b)Corynebacterium glutamicum; (c)Lactobacillusspecies; (d)Lactococcus lactis; (e)Oenococcus oenisyn.Leuconostoc oeni; (f)Pediococcusspecies; (g)Photobacterium angustum; (h)Pseudoalteromonas tunicata; (i)Rhizobiumspecies; (j)Sphingopyxis alaskensissyn.Sphingomonas alaskensis; (k)Streptococcus thermophilus; (l)Synechococcusspecies strains PCC 7002, PCC 7942 and WH 8102; (m)Synechocystisspecies strain PCC 6803; (n)Vibrio choleraeCVD103HgR; (o)Zymomonas mobilisNonconjugative plasmidsFungiAny of the following: (a)Kluyveromyces lactis; (b)Neurospora crassa(laboratory strains); (c)Pichia pastoris; (d)Saccharomyces cerevisiae; (e)Schizosaccharomyces pombe; (f)Trichoderma reesei; (g)Yarrowia lipolyticaAll vectorsSlime mouldsDictyosteliumspeciesDictyosteliumshuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2Tissue cultureAny of the following if they cannot spontaneously generate a whole animal: (a) animal or human cell cultures (including packaging cell lines); (b) isolated cells, isolated tissues or isolated organs, whether animal or human; (c) early nonhuman mammalian embryos culturedin vitroAny of the following: (a) plasmids; (b) replication defective viral vectors unable to transduce human cells; (c) polyhedrin minus forms of the baculovirusAutographa californicanuclear polyhedrosis virus (ACNPV)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 organsAny of the following: (a) Disarmed Ri or Ti plasmids inAgrobacterium radiobacter,Agrobacterium rhizogenes(disarmed strains only) orAgrobacterium tumefaciens(disarmed strains only); (b) nonpathogenic viral vectors NOTIFIABLE LOW RISK DEALINGS 1.1(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;1.1(c) a dealing involving virions of a replication defective vector derived fromHuman adenovirusor fromAdenoassociated virus, either without a host or with an exempt host, if the donor nucleic acid: (i) cannot restore replication competence to the vector; and (ii) does not confer an oncogenic modification or immunomodulatory effect in humans.2.1(a) a dealing involving whole animals (including nonvertebrates) 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 modifiedCaenorhabditis elegans;2.1(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 modifiedCaenorhabditis 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;2.1(b) a dealing involving a genetically modified plant;2.1(c) a dealing involving a not-exempt host/vector system, 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;2.1(d) a dealing involving a not-exempt host/vector system, 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 genetic modification is characterised; and (iii) the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm; Example: A genetic modification 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.2.1(e) a dealing involving an exempt host/vector system, if the donor nucleic acid:(i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; 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;2.1(f) a dealing involving an exempt host/vector system 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: (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 (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and (c) must not code for a toxin with an LD50 of 100 micrograms per kilogram 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) if the donor nucleic acid includes a viral sequence cannot give rise to infectious agents when introduced into any potential host species, without additional non host genes or gene products that: (i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and (ii) will not become available during the dealing; and (f) if the donor nucleic acid includes a viral sequencecannot restore replication competence to the vector.2.1(g) a dealing involving complementation of knockedout 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.2.1(h) a dealing involving shot gun cloning, or the preparation of a cDNA library, in a bacterial exempt host/vector system, if the donor nucleic acid is derived from either:(i) a pathogen; or(ii) a toxin producing organism;2.1(i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a not-exempt host, if the donor nucleic acid cannot restore replication competence to the vector;2.1(j) a dealing involving virions of a replication defective non retroviral vector able to transduce human cells, either without a host or with an exempt host, if: (i) the donor nucleic acid cannot restore replication competence to the vector; and (ii) the dealing is not a dealing mentioned in paragraph 1.1(c);2.1(k) a dealing involving virions of a replication defective nonretroviral vector able to transduce human cells and a not-exempt host, if: (i) the donor nucleic acid cannot restore replication competence to the vector; and (ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;2.1(l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with an exempt host, if: (i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being suppliedintrans; 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)  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