Freedom of information disclosure log

In relation to the determination of self-amplifying mRNA (sa-mRNA) as a GMO, provide:

• All documentation since 01 January 2018, including OGTR internal or external correspondence, concerning the interpretation and application of the Gene Technology Act and Gene Technology Regulations as applicable to injectable sa-mRNA vaccines for use in Humans.
• In relation to the Gene Technology Act’s definition of ‘organism’, all documentation since 01 January 2018, including OGTR internal or external correspondence, on which the OGTR has determined that injectable sa-mRNA vaccines for use in Humans are capable of reproduction.
• All documentation since 01 January 2018, including OGTR internal or external correspondence, on which the OGTR has based their position that injectable sa-mRNA vaccines for use in Humans have an innate capacity to transfer genetic material.

All annual and occasional reports that licensees lodged with the OGTR up to December 13, 2023 in fulfilment of all licence conditions included in the following: Canola and mustard licences DIR178, DIR175, DIR155, DIR149, DIR139 and DIR138, and DIR127 for commercial release of genetically manipulated canola and/or mustard, cotton licences DIR173, DIR157, DIR145; DIR143, DIR091, DIR066/2006, and DIR062/2005 for commercial release of genetically manipulated cotton and Safflower licence DIR158 for commercial release of genetically manipulated safflower.

Seeking all internal documents relating to the publication 'Addressing misinformation on the regulation of mRNA vaccines’ published 6th December 2023 and updated 7th December 2023 at the following site https://www.ogtr.gov.au/resources/publications/addressing misinformation-regulation-mrna-vaccines

Annual and occasional reports to meet the reporting requirements in the following commercial release licences: Canola and mustard (DIR 178, DIR 175, DIR 155, DIR 149, DIR 139, DIR 138, DIR 127), cotton (DIR 091, DIR 066, DIR 062, DIR 143, DIR 145, DIR 157, and DIR 173) and Safflower (DIR158)

Under the FOI Act, I would like request your response on the below questions:

• where can I obtain a copy of the initial phases of the trial preceding this human trial?
• when and where did the trial take place? which hospitals (including what specific areas of the hospital) and other clinical sites?
• is there notifications at the hospital and clinical sites' entrance stating the trial is taking place?
• how many participants started in the trial? and how many are still in the trial?
• where can I obtain a list of criteria for which this trial was approved?
• what are the specific ingredients of this trial vaccine?
• how were the participants selected? and what information were they given to be able to provide informed consent?
• how was the dispersion of the trial vaccine controlled to restrict the spread and persistence of the GM vaccine to persons not in the trial? eg.to restrict particles from trial GM vaccine travelling through air-conditioning vents.
• what adverse reactions have occurred since the commencement of the trial? what mechanism is in place for the recording of post-trial adverse reactions?

Annual and occasional reports lodged with the OGTR during 2021 in fulfillment of conditions in the licences DIR 155, DIR 139, DIR 138 and DIR 127 for release of commercial genetically manipulated canola.

Annual and occasional reports lodged with the OGTR during 2021 in fulfillment of conditions in the licences DIR 157, DIR 145, DIR 143, DIR 124, DIR 118, DIR 091, DIR 066 and DIR 062 for commercial release of genetically manipulated cotton.

Evidence used when reaching the decision that the applicant for Licence DIR 173 is suitable to hold that licence.

Annual and occasional reports lodged with the OGTR up to and during 2020, in fulfillment of conditions in the licences DIR 157, DIR145, DIR143, DIR124, DIR118, DIR091, DIR066 and DIR062, for commercial release of genetically manipulated cotton.

Annual and occasional reports lodged with the OGTR up to and during 2020 in fulfillment of conditions in the licences DIR 155, DIR139 and DIR138, and DIR127 for release of commercial genetically manipulated canola.

Annual and occasional reports lodged with the OGTR during 2020 in fulfilment of conditions in the licences DIR020, DIR021 and DIR108, for release of commercial genetically manipulated canola.

Annual and occasional reports lodged with the OGTR during 2018 and 2019 in fulfillment of conditions in the licences DIR 020, DIR 021 and DIR 108, for release commercial GM canola.

Annual and occasional reports lodged with the OGTR since 1 December 2017 to meet the conditions in the licences DIR 020, DIR 021 and DIR 108, to release commercial GM canola.

All annual and occasional reports that the licensee has lodged with the OGTR during 2017 and/or 2018 to meet conditions in the licence DIR-108, for release of commercial genetically manipulated canola.

All correspondence discussing the regulation of RNA interference, null segregants and SDN-1 techniques in Australia between the OGTR and a range of individuals and institutions, from January 2015.

Annual and occasional reports lodged by licensees to OGTR during 2016 – 2017 in fulfilment of licence conditions for DIR-020 (Monsanto Australia Ltd, GM canola), DIR-021(Bayer CropScience Pty Ltd, GM canola) and DIR-108 (Bayer Crop Science Pty Ltd, GM canola).

All communication since January 2014 from the Gene Technology Technical Advisory Committee (GTTAC) to the Gene Technology Regulator regarding new plant breeding techniques.

All annual reports submitted to the OGTR during timeframes stipulated by the applicant and any correspondence sent by the OGTR to local authorities regarding compliance issues for licences DIRs 133, 114, 120 and DNIRs 386 and 478. Additionally, any reports that describe the incident highlighted in the OGTR's March 2013 quarterly report DIR 114.

All documents contained within the file “E16-613 Nuseed incidents” as outlined on the departmental records listing for January – June 2016.

All annual reports that the licensee has lodged with the OGTR in fulfilment of this condition in licence DIR 126. All reports of significant adverse events arising from the conduct of DIR 126 trials.

All annual and occasional reports that the licensees have lodged with the OGTR during 2015 and 2016 in fulfillment of conditions in the licences DIR 020, DIR 021 and DIR 108, for release of commercial genetically manipulated canola.

All correspondence with non-governmental organisations, for profit companies, academic and research institutions, individuals, the US Government and the Department of Foreign Affairs and Trade relating to whether several new techniques are currently subject to regulation or should be subject to regulation in Australia.

Seek access to all documents pertaining to application DIR 072/2007 Commercial release of GloFish^™ expressing red, green or yellow fluorescent proteins made by Yorktown Technologies.

All the annual reports that licences have lodged with the OGTR since 1996, in fulfilment of conditions in all licences issued for commercial release of genetically manipulated cotton, including licences DIR 102, DIR 062, DIR 066, DIR 091, DIR 118 and DIR 124 and including all others that may exist.

All documents relating to the forthcoming public consultation process on New Plant Breeding Techniques.

All annual and occasional reports that the licensees have lodged with the OGTR during 2014 and 2015 in fulfilment of conditions in the licences DIR 020, DIR 021 and DIR 108, for release of commercial genetically manipulated canola.

All documents relating to the OGTR’s Advice to Dow AgroSciences in 2012 regarding the regulatory status of its EXZACT Delete technology. All documents from January 2014 to the present regarding oligo-directed mutagenesis: nuclease-mediated site-directed mutagenesis – including zinc-finger nucleases, transcription activator-like nucleases, and CRISPR/Cas-nucleases; and cisgenesis and intragenesis. All documents relating to the planned public consultation process on New Plant Breeding Techniques this year, including the techniques mentioned above.

The documentation sought is all documents, including transcripts of all interviews, in relation to the reporting and subsequent investigation of two incidents reported to the Office of the Gene Technology Regulator concerning incidents that occurred at the University of Queensland.

Request OGTR to publish the name, registration and formulation of the herbicide to be used on sugarcane in the proposed DIR 129 trials.

Annual and other reports lodged by the licensees, in fulfillment of conditions in the licences DIR020 and DIR021 for release of commercial genetically manipulated canola.



Reports in fulfillment of any licences and their requirements for commercial GM canola that may have superceded DIR020 and DIR021, including replacement licences or licence variations.