Instructions on Reporting Requirements for Notifiable Low Risk Dealings (NLRDs).
Version 8
Purpose
This document has been prepared to assist persons or accredited organisations in the completion of Version 8 of the record of NLRDs. This is the record required to be submitted to the Gene Technology Regulator (the Regulator) under regulation 13C of the Gene Technology Regulations 2001 (effective 1September2011).
NLRD Reporting Process
Reporting of NLRDs to the Regulator is required under Regulation 13C of the Gene Technology Regulations 2001.
· Regulation 13C(1) requires that a person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee (IBC) that has assessed a proposed dealing to be a NLRD must give a copy of a record to the proposed dealing to the Regulator in the form approved by the Regulator.
· Regulation 13C(2)(a) requires that an accredited organisation must provide a copy of this form to the Regulator in the annual report for the financial year to be given by the organisation to the Regulator.
· Regulation 13C(2)(b) requires that any other person (including non-accredited organisations) must provide a copy of this form to the Regulator in a report for the financial year to be given by the person to the Regulator.
· Regulation 13C(3) requires that a person or accredited organisation that has been given a copy of a record of assessment by an IBC must keep a copy of the IBC’s record of assessment for 8 years after the date of the assessment.
The Regulator’s approved form for the IBC record of assessment is the form provided with this email and can be located on the OGTR website. The content of the form is detailed on the following page, along with a guide to the completion of the form fields.
Completing NLRD form
Version 8
The NLRD notification spreadsheet can be found on the OGTR website www.ogtr.gov.au under
Forms – NLRDs.
IBC NLRD Identifier / Enter a unique identifier (this can include letters and numerals and other characters),
eg. "COL 2011/43"
Please do not enter extraneous information in this field such as project titles/purpose.
Date of IBC Assessment / This must be a date only (no text) between 21 June 2001 and today's date (future dates not permitted).
Use any date format you wish - the cell will format the date automatically.
Name of IBC / This is the IBC used by the organisation. e.g. ABCD Institutional Biosafety Committee
Name of Organisation Notifying Dealing * / Name of the organisation that submitted the NLRD proposal to the IBC. This should also be the organisation that notifies the Regulator. See Regulation13C, effective 1 Sept 2011.
Project Title * / Brief project title, for listing on OGTR website (exclude name of the supervisor).
DO NOT include any CCI information in the title.
GMO details / Genus and species (where known) and for viruses, the family. If not known, describe the GMO as best you can. For multiple GMOs, please separate by a comma, or semi colon.
PC1 NLRD TYPE (a)– (c) * / Paragraph number(s) relating to the kinds of dealing detailed in Part 1 of Schedule 3 of the Gene Technology Regulations 2001 (as amended).
For multiple types, enter each type separated by a comma,
eg. "(a), (c)".
PC2 NLRD TYPE (a)– (m) * / Paragraph number(s) relating to the kinds of dealing detailed in Part 2 of Schedule 3 of the Gene Technology Regulations 2001 (as amended).
For multiple types, enter each type separated by a comma,
eg. "(d)(i)(B), (g), (h)(ii)".
PC3 NLRD * / (For dealings assessed on or after 1 September 2011 under the Regulations as amended on 3 June 2011). Indicate if the dealing is a dealing described in Part 2.2 of Schedule 3. This field can be filled by indicating “yes” or “PC3”.
Name(s) of Project Supervisor(s) / Title, First Name, Surname
Has the IBC assessed the proposed dealing to be an NLRD? / Only submit NLRDs to the Gene Technology Regulator in the organisation annual report that have actually been assessed to be an NLRD.
(The answer to this should be "Yes".)