Notification of a Notifiable Low Risk Dealing

University of Sydney Institutional Biosafety Committee

• This form is to be completed by the Principal Investigator/Project Supervisor and MUST be submitted by the Principal Investigator only.

1.Name of Principal Investigator/Project Supervisor:
2. Project title(s):
3. Type of project proposal:
NLRD
4. Is this application to replace an existing or expiring University of Sydney NLRD?
□Yes (Go to question 5)□ No(Go to Part 1)
5. Expiring project title/s:
6. Expiring NLRD approval number/s:
7. Please confirm that all work covered under your expiring NLRD(s) is covered under this new application:
□Yes□ No (If No please explain your answer)
Please highlight any significant changes between this application and your expiring application within the body of this application.

• For completion by IBC.

IBC Reference Number

University of Sydney Institutional Biosafety Committee – Notification of a Notifiable Low Risk Dealing (NLRD) application form

Part 1:Project Supervisor

Project supervisor’s name:
Position within the organisation:
Relevant qualifications:
Relevant experience:

Contact details of the Project Supervisor

Business telephone number:

Mobile telephone number:

E-mail address:

Part 2:About the dealings with the GMO or GMOs

Any explanatory text below is for guidance. Please delete all explanatory text and replace it with your answers to the questions.

Please note that you must not commence your project without written approval from the IBC.

2.AWhat are the classes of people you wish to be authorised to undertake dealings with the GMO(s)?

“Class of people” includes Research Fellows, senior scientists, research assistants, technical officers, PhD students, Honours students, etc. You need to try and encompass as many classes as you can foresee that might work on this project into the future. Amendments to NLRDs are not permissible. If you are working with animals, you must include animal house staff as a class of person. If you are likely to need to engage a transport provider to transport the GMO anywhere within Australia you must include transport provider as a class of person.

2.B Describe the training and experience of personnel involved in the dealing.

2.CBriefly describe the project, including the purpose and aims of the proposed dealing. Please take no more than half a page for this answer.

Part 3:Type of Notifiable Low Risk Dealing in relation to Schedule 3 (Parts 1 and 2) of the Gene Technology Regulations

Please place an X in the appropriate box/s

Mark item with X / Part 1 – item 1.1
[Please note that any dealings classified in Part 1, must be undertaken in facilities certified to at least physical containment level 1 by the OGTR].
(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 confer an oncogenic modification in humans and does not encode a protein with immunomodulatory activity in humans.
Mark item with X / Part 2 – item 2.1
[Please note that any dealings classified in Part 2, must be undertaken in facilities certified to at least physical containment level 2 by the OGTR].
(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 laboratoryguinea pig;
(B) a genetically modified laboratorymouse;
(C) a genetically modified laboratory rabbit;
(D)a genetically modified laboratory rat;
(E)a genetically modifiedCaenorhabditiselegans
(aa) A dealing involving a genetically modified laboratoryguinea pig, a genetically modified laboratorymouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified laboratory Caenorhabditiselegans, 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 as a host/vector system in Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy human beings, animals, plants or 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 human beings, animals, plants or fungi; and
(ii) the 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 (iii) if, in relation to the capacity of the host or vector to cause harm, it provides an advantage; or adds a potential host species or mode of transmission; or increases its virulence, pathogenicity or transmissibility.
(e)a dealing involving a host/vector system mentioned in Part2 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 human beings, animals, plants or fungi;
(f)A dealing involving a host/vector system mentioned in Part2 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 subitem 4 (2) of Part 1 of Schedule2;
(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;
(h) a dealing involving shotgun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in item1 of Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
(i) a pathogen; or
(ii) a toxinproducing 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;
(i)
(j) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells, other than a dealing mentioned in paragraph1.1 (c), 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 genomie RNAfollowing 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 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 genes gagpol, rev and an envelope protein gene, or a subset of these.

Part 4:Description of the GMO

In this part, a description of the GMO(s) is required. This includes a description of all of the GMO(s) to be generated and/or used during the proposed dealings, for example, bacteria used for subcloning steps, tissue culture cell lines etc.

Use Table 1 at the end of the application form if using multiple GMOs.

The explanatory text below is for guidance. Please delete all explanatory text and replace it with your answers to the questions.

4.AWhat are the common and scientific names of the parent organism/s (host organism/s)?

The “parent organism” means the organism (or tissue derived from an organism) that you propose to genetically modify. You must provide genus and species names. For viruses, you must provide the family name.

To avoid having to submit a new application in case you find you need to work with an additional host in the future, you may add the following text: “Additional hosts may be used in the future. I will notify the IBC by email prior to using a host not originally listed and I will await approval from the IBC before proceeding.” Note that if any new host fits within the category of dealing already approved, the IBC will be able to approve the addition without the need for a new application and without the need to wait for an IBC meeting. You need to wait until you receive email approval from the IBC before proceeding.

4.BWhat vector(s) and methods are to be used for the transfer of genetic material?

Please list the name of all vectors to be used. Please provide copies of references (or vector maps) for novel vectors or methods of transfer. Also include the name of the company supplying any commercially obtained vectors.

To avoid having to submit a new application,in case you find you need to work with an additional vector in the future, you may add the following text: “Additional vectors may be used in the future. I will notify the IBC by email prior to obtaining a vector not originally listed and await approval before proceeding.” Note that if any new vector fits within the category of dealing already approved, the IBC will be able to approve the addition without the need for a new application and without the need to wait for an IBC meeting. You need to wait until you receive email approval from the IBC before proceeding.

4.Ci)For projects involving the use of replication defective non-retroviral vectors (eg AAV) are the vectors made using plasmids only or a combination of plasmids and an adenoviral helper virus?

Not applicable

Plasmids only

Plasmids + helper virus

Is the helper virus also replication defective?

Yes

No

4.Cii)For projects involving the use of replication defective retroviral vectors, are third generation replication defective viral vectors used?

Not applicable

Yes

No – please provide an explicit description of the assay you intend to perform to exclude the presence of replication competent virus. Please provide a copy of the reference for your intended assay.

Your description should include details on the sensitivity of detection.

4.Ciii)For projects involving the use of a replication defective viral vector, is the vector able to transduce human cells?

Not applicable

Yes

No - please provide evidence eg information from supplier or information regarding the protein envelope.

4.DWhat are the identity and function of the gene(s) responsible for the modified trait?

The primary interest here is in the gene or genes under study and the function of these gene(s). Please provide a list of all known genes to be used and a description of their function.

Functional details are not required about gene(s) commonly used as markers, for selection and/or any other routine procedures. However it is necessary to identify generally which type of gene will be used. For example,amp gene (ampicillin resistance), neo gene (neomycin resistance), gfp gene (green fluorescent protein) etc.

To avoid having to submit a new application, in case you find you need to work with additional genes in the future,you may add the following text: “Additional genes may be used in the future. I will notify the IBC by email prior to working with a gene not originally listed and await approval before proceeding.” Note that if any new gene fits within the category of dealing already approved, the IBC will be able to approve the addition without the need for a new application and without the need to wait for an IBC meeting. You need to wait until you receive email approval from the IBC before proceeding.

If you are planning to work with transgenic or knockout mice strains, please list the strains that you currently wish to use. If you may need to work with additional strains in the future, please add a paragraph to the effect: “Additional mouse strains may be required in the future. Any additional mouse strain will comply with the requirements of Part 1, item 1.1 of Schedule 3 of the Gene Technology Regulations (ie no advantage will be conferred on the animal as a result of the genetic modification and the animal will not be capable of secreting or producing an infectious agent as a result of the genetic modification. If I become aware that any of the mouse strains confers an advantage on the animal or if it is discovered that any of the strains are capable of secreting or producing an infectious agent as a result of the genetic modification I will cease work on the dealing and notify the IBC immediately.” If you choose to add this paragraph, you will not be required to notify the IBC or submit a new application each time you wish to work withadditional compliant transgenic or KO mice not currently listed on this application.

4.EFrom what organism were the gene(s) responsible for the modified trait(s) isolated?

In regards to gene(s) commonly used as markers, for selection and/or any other routine procedures, please indicate the plasmid from which these gene(s) were derived.

4.FWhat are the organisms or tissues to be used in association with the GMO(s)?

Please list all the organisms you intend to use in association with the GMO(s), for example, mice to be inoculated or fed with the GMO(s). In this case ‘mouse’ must be listed here.

4.G Containment Facilities

Provide details of all facilities to be used for this NLRD. Add extra rows if required. Please ensure that this table is complete. If you do not know the OGTR Certification number, please obtain the information from the OGTR sticker on the room door.

Facility No. / Room Number and Building Number / Facility Type (eg animal house, laboratory etc) / Physical Containment Level (eg PC1, PC2) / OGTR Certification Number
1
2
3
4

Part 5:Additional information for a GMO that is a whole plant or is to be used in conjunction with a whole plant

The following information is required if you propose to deal with a GMO that is a whole plant or is to be used in conjunction with a whole plant.

ApplicableNot applicable

5.ATo what stage of development are the plants to be grown?

This relates to the potential spread of the GMO, for example, if the plant produces pollen or seed.

5.BWhat will be used as the growing medium for the plants?

Please indicate the type of medium (soil or soil substitute) to be used and how it will be subsequently sterilised or disposed of.

5.CIf plants are to be grown to seed, what procedures are in place to prevent accidental release of seeds into drains?

5.DIf plants are to be grown to seed, what procedures are in place to prevent seeds escaping onto the floor/ground and being walked out of the facility on shoes?

Part 6:Risk assessment and management

In this Part please briefly describe, in no more than half a page, the risks the proposed dealings pose to the health and safety of people and the environment

The explanatory text below is for guidance. Please delete all explanatory text and replace it with your answers to the questions.

6.AWhat are the possible hazards and the likelihood and consequence of the hazards occurring (ie the risk) from the proposed genetic modification(s)?