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WOMEN’S AND CHILDREN’S HEALTH NETWORK
INSTITUTIONAL BIOSAFETY COMMITTEE / NOTIFIABLE LOW RISK DEALING APPLICATION AND ASSESSMENT FORM

This application form should be completed for all Notifiable Low Risk category GMO dealingsto be undertaken by WCHN personnel or other personnel within WCHN premises.

Completed forms should be submitted in electronic format to: and a signed hard copy forwarded to: IBC Executive Officer

Research Secretariat, Level 2, Samuel Way Building, WCH Campus

IBC Use / IBC Reference Number
Date of IBC Assessment
Expiry Date for NLRD
Organisation responsible for the dealing / Women’s and Children’s Health Network (WCHN)
Institutional Biosafety Committee / WCHN IBC
1. (a) Project Title
NOTE: This may be the name of the grant application which contains GMO work or it might be a descriptive title of the work performed using GMOs if it is not embodied in a grant).
1 (b) / If this is a resubmission of an expiring NLRD you must provide the current IBC Reference number / Current IBC Ref #
2. Project Supervisor proposing to undertake the dealing
Project supervisor/primary investigator
Email address
Telephone (work and after hours)
Department/Research Group and mailing address for correspondence (including building and level)
Describe your background and experience in handling/working with GMOs below.
3. Type of dealing
NOTE:Applicants to read Schedules 1, 2 & 3 of the Gene Technology Regulations to determine which sort of dealing they have (if any). Please refer to - Gene Technology Regulations 2001
a) Is the dealing described in Schedule 1 or 1A?
Yes
No / If yes, you are not working with a GMO. No further action is required.
If no, continue to section 4b.
b) Is the dealing described in Schedule 2?
Yes
No / If yes, it is an Exempt dealing. Please complete anExempt dealing application form instead of this form.
If no, continue to section 4c.
c) Is the dealing described in Schedule 3, parts 1, 2 or 3?
NOTE:Please consult the section on Notifiable Low Risk Dealings.
Part 1 Yes / No / If yes, your dealing is a PC1 NLRD. Provide a justification for your decision, by describing how your dealing fits within the Schedule.
Part 2 Yes / No / If yes, your dealing is a PC2/3 NLRD. Provide a justification for your decision, by describing how your dealing fits within the Schedule.
Part 3 Yes / No / If yes, your dealing is a DNIR. Please complete a DNIR application form instead of this form.
4. Description of dealing
a) Describe the dealing to be undertaken. You should indicate the overall aim of the project and provide a brief background to the study. In describing the GMO, you should provide references where possible. If there have been significant changes to vector/plasmid maps, please provide this information:
b) Common and scientific name(s) of the parent organism(s):
c) Methods and vectors to be used for the transfer of the genetic material:
d)Details about the genetic material that will be inserted or modified in the parent organism including identity of the genetic material; common and scientific names of the sources (donor) of the genetic material; and function of the genetic material (where known):
e) Details of the effect of the genetic modification upon the parent organism:
f) Describe the organisms or tissues to be used in association with the GMO(s):
g) Please provide a risk assessment for the handling of the GMO and associated risk management strategies. You should include an assessment of any risks the GMO might pose to humans, animals and the environment (e.g. escapes, spills, handling etc) and provide details on how you will manage these risks to ensure they are minimised or avoided.
h) Please provide details of any planned transport and disposal of the GMOs and how this will be undertaken etc. Give consideration to risks and ensure compliance with the OGTR Guidelines for the Transport, Storage and Disposal of GMOs -
5. Other details
Will the dealing involve storage of GMOs outside of a facility listed below? / Yes No
If yes, where?
Will the dealing involve the import of GMOs into Australia? / Yes No
NOTE: Investigators should ensure that all proposed transport including importation or exportation of GMOs is included in the dealing, as these aspects of a dealing also require approval.
6. Persons involved in the dealing
List the names of people and the experience they have in handling GMOs.
Do all personnel involved in the dealing have appropriate training and experience? / Yes No
If no, what measures in place to ensure all personnel are adequately trained?
NOTE:All personnel working in an OGTR certified facility must be trained in the OGTR requirements of the Physical Containment Facility Guidelines, irrespective of whether they are working with GMOs. Personnel must indicate to the certification holder that they fully understand their training in the OGTR requirements by signing a record of their training.
7. Facilities to be used
List the classes of facilities required to provide the appropriate physical containment level and type for the dealings(s). E.g. PC1 facility, PC2 facility etc.
List the facilities and physical containment level to be used for the dealing.
Facility 1 / Facility 2 / Facility 3
OGTR Certification No.
Room number(s)
Building
Type of facility
Facility contact
List the type of dealing to be performed in this facility.
Facility 4 / Facility 5 / Facility 6
OGTR Certification No.
Room Number(s)
Building
Type of facility
Facility Contact
List the type of dealing to be performed in this facility.
8. Facility Manager Declaration
  • As Facility Manager I have been informed of the nature of and risks involved with this GMO dealing and after consideration of them, I hereby consent to the work being performed in the listed facility.
  • I will ensure that workers have signed a Training Record indicating that they understand the requirements for undertaking work in the listed facilities. In consultation with project supervisors, I will ensure that appropriate resources are in place to safely perform the dealings.
  • In the event of an unintentional release of GMOs I am aware that I, in conjunction with the project supervisor, must put into place the appropriate responses to contain the release and then inform the IBC as soon as practicable of any incidents, accidents or unintentional releases involving GMOs.

Facility Manager – Facility 1 / Print Name:
Facility number: / Signature: Date:
Facility Manager – Facility 2 / Print Name:
Facility number: / Signature:Date:
Facility Manager – Facility 3 / Print Name:
Facility number: / Signature:Date:
Facility Manager – Facility 4 / Print Name:
Facility number: / Signature:Date:
Facility Manager – Facility 5 / Print Name:
Facility number: / Signature:Date:
Facility Manager – Facility 6 / Print Name:
Facility number: / Signature:Date:
9. Project Supervisor Declaration
Please initial each of the following statements to indicate that you understand your responsibilities when dealing with GMOs and then sign the application form.
I have read, considered and understand my responsibilities under the Gene Technology Act 2000 and agree to undertake the GMO dealing outlined in this application in accordance with the relevant Office of the Gene Technology Regulator guidelines and regulations (including, but not limited to all disposal, transport and storage).
I am aware of my responsibilities in relation to ensuring that any personnel conducting this work are appropriately trained and are aware of and also follow the relevant guidelines and regulations.
I have considered the potential risks that the conduct of this dealing could pose to people and/or the environment and will implement appropriate actions and precautions to minimise these risks.
Where a GMO is received from sources outside the institution responsible for the project, I will take steps to confirm its identity.
In the event of an unintentional release of GMOs I am aware that I, in conjunction with the Facility Manager, must put into place the appropriate responses to contain the release and then inform the IBC as soon as practicable of any incidents, accidents or unintentional releases involving GMOs.
I am aware that breaches of the legislation are serious matters and that penalties could include loss of OGTR Accreditation status for the organisation, imprisonment and/or substantial fines.
Project Supervisor Signature: / Date:

Office use only:

Women's and Children's Health Network Institutional Biosafety Committee Record of Assessment (IBC ref number - )

10 IBC Record of Assessment
Is the dealing an NLRD mentioned in Part 1 or Part 2 of Schedule 3?
(As an NLRD may involve a number of scheduled kinds of dealings, all relevant items must be listed).
/ Yes / No
If the proposed dealing has been assessed as not being an NLRD, the dealing must not be undertaken without obtaining an appropriate authorisation under the Gene Technology Act 2000.
(For a dealing to be an NLRD it must be listed in Part 1 or Part 2 and not listed in Part 3 of Schedule 3. Dealings which are not NLRDs may be either exempt dealings or licensable dealings; A RofA is not required for such dealings).
Are the facilities or classes of facilities considered to be appropriate physical containment level and type for the dealing? / Yes / No
11. WCHN IBC Chair or delegate with authority to sign
The WCHN IBC has assessed and approved this NLRD dealing and a copy of this record of assessment has been sent to the Chief Investigator (or accredited organisation if relevant).
Printed name: / Signature:
Job title: / Date:
12. Record of receipt of copy of assessment
I, the person who submitted the NLRD application, have received a signed copy of the record of assessment and correspondence from the WCHN IBC.
IBC Identifier Number and title: / Printed name:
Date: / Signature:

Explanatory Information (to assist applicants in the completion of this form and the IBC in its assessment of the application). Copied fromthe OGTR Guidance on making a record of Assessment for NLRDs and on responsibilities for those undertaking NLRDs.

1)
Type of dealing
Further to Section 3 of the form.
Is the dealing is a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3 / Should be a simple answer of ‘Yes’ or ‘No’ (i.e. the dealing is described within Parts 1 and 2 of Schedule 3, or it is not).
Note – In determining whether particular dealings are NLRDs, IBCs and those submitting proposals should have regard to the entirety of Schedule 3. Schedule 3, Part 3 lists dealings that are not NLRDs but would require a licence from the Regulator. Therefore, to be an NLRD, the dealing must be of a kind listed in Part 1 or 2 but not listed in Part 3 of Schedule 3. The properties of the GMOs and the specific activities proposed can impact on whether the dealings meet the criteria for an NLRD or need a licence.
If the dealing is not described within Parts 1 and 2 of Schedule 3, it cannot be conducted as an NLRD. However, if it is not an NLRD, the IBC should use the RoA to inform the person/accredited organisation of their assessment and reasoning that the proposed dealing is not an NLRD (e.g. it is exempt (as defined in Schedule 2) or a DNIR (as defined in Schedule 3, Part 3)).
2)
Description of Dealing
Further to section 4 of the form - a description of the dealing to be undertaken must be clearly explained / Both the GMO(s) and the dealings must be described. The description of the proposed project should be written using clear language and in sufficient detail so that researchers, organisations, the IBC and the OGTR can understand what is authorised (and what is not authorised). The following details should be included:
  • common and scientific names of the parent organism(s) of GMO(s)
  • identity and source of donor nucleic acid, including common and scientific names of donor organisms, if relevant
  • method of genetic modification, including any vectors used
  • details of the genetic modification(s), (e.g. combinations of genetic material introduced, any mutations made in introduced genes, changes to endogenous genes)
  • expected phenotype/trait/outcomes
  • a list of the dealings proposed and assessed (in relation to dealings listed in the definition of ‘deal with’ in Section 10 of the Act)
  • intended experiments/activities/use/purpose of the GMOs (e.g. inoculation into a laboratory animal, culturedin vitro,isolation of gene products,etc.)
In preparing a proposal (proponent) or describing the dealings to be authorised IBC, careful consideration should be given to ensuring that it will include all the activities intended to be undertaken. It should not be so narrow as to preclude foreseeable and intended work (which would then need a separate NLRD) nor so broad or general as to lead to confusion about what dealings with the GMOs have actually been proposed and assessed (i.e. what is authorised). Any need for import, transport, storage and disposal of GMOs should not be overlooked.
3)
Persons involved in the Dealing
Further to section 6 of the form an applicant should be considered to have the appropriate training and experience to undertake the dealing (per OGTR / In assessing a proposed NLRD, the IBC will give consideration to the following:
  • all persons that may be involved with the dealing for the entire duration of an NLRD. This includes persons beyond those conducting the research, such as persons involved with importation, transportation and decontamination/disposal of the GMO.
  • training conducted at the institution/organisation, as well as qualifications and previous experience (e.g. conducting NLRDs).
  • dealings that involve activities that would require specialist training (e.g. animal handling, use of specialised equipment, use of sharps).
  • the training requirements of the Guidelines for the Transport, Storage and Disposal of GMOs (Regulation 13(3)(b).
  • other training requirements such as those specified in the guidelines for certification of physical containment facilities.
Consideration should also be given to classes of persons when assessing appropriate training and experience.
For example, the IBC may consider the following questions:
  • If a service provider is involved in the decontamination and disposal of laboratory waste, are the provider’s corporate training and procedures appropriate for the dealings of transport and disposal of the GMOs?
  • If research staff/students are required to complete specific training before working in the institute’s laboratories, is a person who has successfully completed this training considered to be appropriately trained for conducting some dealings with the GMOs?
  • If dealings involve working with animals/injecting animals, do staff/students require additional specific training?

4)
The facilities or classes of facilities
Further to section 7 of the form. / The individual facilities or classes of facilities that are considered appropriate for the dealings should be listed here. It is important to consider all certified facilities that could be involved with the dealing for the entire duration of an NLRD. IBCs must consider both the certification level and type of facility.
Apart from the dealings of storage, transport and disposal, NLRDs must be conducted in a certified facility (or a facility agreed in writing by the Regulator,pursuant to regulation 13(2)(c), which is only intended for exceptional circumstances).
Particular classes of NLRDs must be conducted in a facility of at least Physical Containment level 1 (PC1), PC2 or PC3 (see Regulation 13(2)).
Requirements for working in each type of certified facility are generally as per the relevant certification guidelines for the type of facility (noting that individual certified facilities are subject to the conditions of the individual certification instrument).
Dealings with GM plants will generally require housing in certified PC2 Plant Facilities, while large-scale dealings (i.e. dealings involving more than 25 litres of GMO culture in any single vessel) will require the use of a certified PC2 Large Scale facility. However, specific requirements for the particular GMOs/dealings should also be considered in relation to individual facilities or classes of facilities (e.g. specific equipment or procedures). For example, a PC2 laboratory that does not contain a biological safety cabinet may not be appropriate for the conduct of some specific dealings, depending on the GMO(s) involved.

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