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INSTITUTIONAL BIOSAFETY COMMITTEE
GMO Notifiable Low Risk Dealing (NLRD) Application Form
For questions about whether a dealing should be classified as an Exempt Dealing (ED), Notifiable Low Risk Dealing (NLRD) or Dealing Not involving an Intentional Release (DNIR), please contact the relevant IBC directly, prior to completing forms (Perkins: Kathy Davern [email protected], UWA: [email protected])Submit the completed form to [email protected] or [email protected] Biosafety office at UWA accepts sender’s email or e-signature as a way of authentication without ink signature.
OTHER CLEARANCES – If this section is incomplete your application will be returned.
Clearance Required Yes No Approval period
Start/Finish
APPROVAL NUMBER
Human EthicsAnimal EthicsCarcinogen clearanceRadiation clearanceDept of AgricultureAny other State or Federal PermitsGTAS or other evidence of GM training (please provide certificate or badge)
General information about notifications of a Notifiable Low Risk Dealing
Notification of a notifiable low risk dealing
This notification is for an NLRD under the Gene Technology Act 2000 (Commonwealth) (the Act) and corresponding State law.
According to the Act, to “deal with, in relation to a GMO, means the following:
(a) conduct experiments with the GMO;(b) make, develop, produce or manufacture the GMO;(c) breed the GMO;(d) propagate the GMO;(e) use the GMO in the course of manufacture of a thing that is not a GMO;(f) grow, raise or culture the GMO;(g) import the GMO;
and includes the possession, supply, use transport or disposal of the GMO for the purposes of, or in the course of, a dealing mentioned in any of (a) to (g).”
Providing information to the Office of the Gene Technology Regulator (OGTR)
Accuracy of informationPlease answer all questions unless otherwise indicated. Check carefully before you submit your notification that all the information it contains is accurate.
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The Act provides for penalties to a person who gives information to the Regulator that they know to be false or misleading.
ConfidentialityIf you wish to make an application for a declaration that specifies information is Confidential Commercial Information (CCI) for the purposes of the Act, you must also complete the CCI application form available at www.ogtr.gov.au and place it at the end of this application (after Part 8).
PrivacyAny personal information is safeguarded by the Privacy Act 1988. This prevents the submitted personal information from being used for purposes other than assessing the NLRD notification, or other circumstances specified by the Gene Technology Act 2000 (Commonwealth). In certain circumstances information supplied as part of a NLRD notification may, according to their specific needs, be given to the following:
an officer or employee of the Department of Health and Ageing; an officer or employee of a State government agency or organisation; Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to provide
it; law enforcement authorities; and the relevant Minister.
Information regarding notifications received by the OGTR will be published at www.ogtr.gov.au/ogtr/gmorec/nlrd.htm. This is a public record and includes, for each notification, the project title, organisation name and the kind of NLRD.
Abbreviations:The Act The Gene Technology Act 2000 (Commonwealth)CCI Confidential Commercial InformationNLRD Notifiable Low Risk DealingDIR Dealings involving an Intentional Release of a GMO into the environmentDNIR Dealings NOT involving an Intentional Release of a GMO into the
environmentGMAC Genetic Manipulation Advisory CommitteeGMO Genetically modified organismIBC Institutional Biosafety CommitteeOGTR Office of the Gene Technology RegulatorPC1, 2 etc Physical Containment Level 1, 2 etcThe Regulations The Gene Technology Regulations 2001 (Commonwealth)
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1. PROJECT TITLE:
Is this application? ☐ an initial application; or ☐ a renewal
Previous IBC identifier number(s) if it is a renewal
2. PRINCIPAL INVESTIGATOR OR PROJECT SUPERVISORName and Job title:School or Centre or group:Telephone no:Mobile no:Email:Relevant experience (experience handling GMOs and/or working inside OGTR-certified facilities):Proof of UWA GTAS and/or Biosafety training
Yes ☐ Please indicate the year you did the course(s):No ☐ Please Log on to www.lms.uwa.edu.au to do the course(s)
Other Researchers including students:List all personnel working on this NLRD and the positions they hold, with relevant GM experience. Please note that proof of training in gene technology will be required, and the course is available online via the UWA Biosafety website.Name (incl. title): Role /experience / proof of GTAS and or Biosafety training:
[Insert additional rows for additional investigators]
3. ABOUT THE DEALINGS WITH THE GMO(S):
3A. Expected date of commencement
3B. Expected date of completion (5 years maximum)
3C. Does this project utilise the genome editing tool CRISPR/Cas9?
Yes ☐ or No ☐
3D. Project Description (including the purpose and aims of the dealing)
Extracts from grant proposals are acceptable.
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4. DESCRIPTION OF GMO(S)COMMON NAME OF PARENT ORGANISM
SCIENTIFIC NAME OF PARENT ORGANISM
VECTOR(S) AND METHOD OF TRANSFER
EXEMPT HOST/ VECTOR SYSTEM?
IDENTITY AND FUNCTION OF GENE(S) AND ORGANISM OF ORIGIN
NLRD TYPE* see Appendix 1
e.g. Mouse Mus musculus ‘Knock out’ mice were generated by recombination of the transgene conferring an inactivating mutation of the gene of interest in mouse embryonic stem cells
No Balb/c Rag KOThese mice are mutated in the V(D)J recombination activation gene RAG-1 thus they are unable to generate mature B and T cells
PC1a
e.g. E. coli Gal- SW102 E. colistrain which isunable to usegalactose as acarbon source orDH10B E. Colistrain which isallows forkanamycinselection
Homologous recombination into abacterial artificial chromosome (BAC)expressing the mouse cytomegalovirusMCMV genome
No Epitope tags inserted into the 3’ end of theie1 gene.OVA - (chicken) marker T cell epitopesand marker genes to assess immunity toMCMVHA - (Influenza A/PR/8/1934 (H1N1) -notinfectious in humans, however ispathogenic in mice) marker T cell epitopesand marker genes to assess immunity toMCMVHEL – (chicken) hen egg lysozyme T cellepitopeEalpha – (mouse) IE class II moleculealpha chain T cell epitope
PC2.1d
[Insert additional rows when necessary]
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5. USE OF WHOLE PLANTS (GO TO 6 IF NOT APPLICABLE)
5A. Is the parent organism (that which is to be modified) a weed or closely related to plants that are weeds?
5B. To 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.
5C. What 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.
6. RISK ASSESSMENT AND MANAGEMENT:
HEALTH AND SAFETY OF PEOPLE:
6A. What are the possible hazard(s) to people and the likelihood and consequence of the hazard(s) occurring (i.e. the risk) from the proposed genetic modification(s)?
This relates to the occupational health and safety of people undertaking the dealings, for example, laboratory staff working in labs. If appropriate, include comparisons to the unmodified organism.
6B. What are the possible hazard(s) to people and the likelihood and consequence of the hazard(s) occurring (i.e. the risk) from an unintentional release of the GMO(s) into the environment?
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This relates to the general population exposed to a GMO that is unintentionally released from containment. If appropriate, include comparisons to the unmodified organism.
ENVIRONMENT:
6C. What are the possible hazard(s) to the environment and the likelihood and consequence of the hazard(s) occurring (i.e. the risk) from an unintentional release of the GMO(s) into the environment?
This relates to the environment exposed to a GMO that is unintentionally released from containment. If appropriate, include comparisons to the unmodified organism.
6D. Please provide information for all the facilities to be used:Facility 1 Facility 2 Facility 3
Room Number
Building Name
Facility Type*
Physical Containment Level (eg PC2)OGTR Certification Number**Dates of certification**Facility contact person (name and email/ phone)* Facility type = Laboratory, Animal House, Plant House or Other** OGTR Certification number and dates of certification can be found on the OGTR sticker on the door of the facility.
6E. Do you propose to transport the GMO(s) outside a certified facility? IF YES, provide details.Specify how the OGTR transport guidelines will be met (see: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/transport-guide-1 )
If you propose to transport the GMO(s) please indicate why it will be required and what arrangements will be made. Transport includes: between the facilities listed in your answer to Part 6D; from a laboratory to an autoclave or animal house; across corridors which are not part of a certified facility, to storage facilities etc.
6F. How will the GMO(s) be disposed of?
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This includes arrangements for disposing of liquid and solid waste from the dealings, and for disposing of the carcasses of all animals inoculated with GMO(s). If a commercial waste disposal company is involved, name it. Also describe where, and for how long, the bins are stored before being picked up by the disposal company.
6G. What are the steps you will take in the event of an unintentional release of the GMO(s) outside the PC2 certified facility?
Include here spills procedures for liquid spills and plans to deal with the escape of any animals to be used during the proposed dealings.
Note that it is required in the Act that the Regulator must be notified if there has been an unintentional release of the GMO from containment. Your answer must include a sentence indicating that any unintentional release of the GMOs will be reported to the University’s Biosafety Officer who will notify the OGTR.
6H. Are there any other actions and precautions you will take to minimise risks posed by the proposed dealing(s)?
These refer to precautions that are over and above that outlined in PC2 procedures or guidelines. For example, when using pathogenic organisms during the genetic modifications it may be required that, in addition to working in a biological safety hood, gloves will also be required for all manipulations.
7. COMMERCIAL VALUE:Does this research or its commercial outputs have actual or potential commercial value? Please delete all rows that are not applicable to this research on the table below:
IP type Potential Value Range*
Response
Extremely desirable / commercially valuable IP
$10m+ Storage in safe or equivalent with custom designed access lists. Access limited in accordance with specific grant conditions. Data encrypted.
Moderately desirable / commercially valuable IP
$1m - $10m Storage in safe or equivalent with custom designed access lists. Safe/key access restricted to
research team and facilities. Data encrypted.
Low level of desirability or commercial value
$10,000 - $1m Storage in lockable storage and/or secure room. Key access restricted to research team and facilities. Normal data protocols
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Negligible or nil desirability or commercial value
<$10,000 No specific requirements. At discretion of research team. Normal data protocols.
m = million
Have you considered potential critical incident risks of the project and the minimum equipment requirements to deal with those risks? Please go to http://www.staff.uwa.edu.au/procedures/risk/management and indicate below that you have considered risks and how to mitigate them
.Critical incident risk Equipment requirements
8. DECLARATIONI declare that to the best of my knowledge, having made reasonable enquiries, the information herein is true and correct. I understand that providing misleading information to the OGTR, deliberately or otherwise, is an offence under Commonwealth law.
Project Supervisor Name Signature Date
Head of School or Representative Name Signature Date
UWA policy deems this document as signed, if you send it attached to an email from your UWA email address.
For example, the form can be filled out by the CI, emailed as an attachment to the Head of School, and then the HOS Forward to the Biosafety office at biosafety @uwa.edu.au – this method avoids the need for ink signatures, preserves the best available viewing and search quality, saves paper and saves time.If you are submitting this application to the Perkins’ IBC, once you have completed and signed this form, email it to the IBC Office: [email protected]
APPENDIX 1: NLRD TYPE FOR Q4
To determine NLRD type, see the OGTR guidelines here: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/nlrdsSept2011-excerpt-htm(Types of Dealings with GMOs classified as NLRDs: Excerpt from the Gene Technology Regulations 2001).
Physical Containment Level 1 (PC1) is outlined in Schedule 3, Part 1. NLRD type will be either PC1a or PC1c, based on the definitions in these Regulations.
PC2 is outlined in Schedule 3, Part 2, Section 2.1. NLRD type will be PC2.1 (a) or (aa) or … or (m), based on the definitions in these Regulations.
PC3 is outlined in Schedule 3, Part 2, Section 2.2.
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Details of the IBC that has considered the classification of this NLRD:
Name of the IBC: UWAName of the IBC Chairperson: Charlene KahlerBusiness phone number: 08 6457 2058Email address: [email protected] of IBC Manager: Caixia LiBusiness phone number: 08 6488 4701Email address: [email protected] address: 35 Stirling Hwy, Crawley, WA 6009Postal address: M459, UWA, Research Integrity, Biosafety Office, 35 Stirling Hwy,
Crawley, WA 6009
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