Australian Gene Technology Agency updates regulations on some gene modifying technologies reposted

Australian Gene Technology Agency updates regulations on some gene modifying technologies (reposted)

04:45 EDT 13 Apr 2019 | GMO pundit

The Gene Technology Regulator (the Regulator) has conducted a technical review of the Gene Technology Regulations 2001 (the Technical Review) to clarity the regulatory status of organisms developed using a range of new technologies and ensure that the new technologies are regulated in a manner commensurate with the risks they pose.

2019 Amendments to the Gene Technology Regulations 2001

After extensive consultation, the Technical Review has concluded with the Legislative and Governance Forum on Gene Technology (the Forum) approving amendments to the Gene Technology Regulations 2001 (Forum announcement available on their website). The Decision Regulation Impact Statement prepared by the Regulator to support the Forum’s consideration of the proposed amendments is linked below and will become available on the Office of Best Practice Regulation website.

Technical Review of the Gene Technology Regulations 2001 Decision Regulation Impact Statement - PDF 451 KB
Technical Review of the Gene Technology Regulations 2001 Decision Regulation Impact Statement - DOCX 173 KB

The Governor-General has made the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019, which will commence from 8 October 2019. The amendments and an Explanatory Statement are available on the Federal Register of Legislation. The amendments are substantially the same as those put forward for public consultation on 30 November 2017, with minor changes to clarify the drafting and address a possible loophole, ensuring oversight of organisms intended to be regulated as GMOs.

The amendments will commence in three stages:

8 October 2019: the majority of amendments
1 July 2020: minor administrative amendments to Notifiable Low Risk Dealing assessment and reporting requirements
8 October 2020: repeal of an item on the list of organisms that are not GMOs (Schedule 1 item 1).

OGTR will provide information directly to regulated organisations and on the OGTR website in preparation for each commencement stage.

Answers to commonly asked questions on the Technical Review - April 2019 - PDF 125 KB
Answers to commonly asked questions on the Technical Review - April 2019 - DOCX 19 KB

Next steps and legislative position until amendments commence

The amendments will commence from 8 October 2019. Organisations and individuals working with GMOs are cautioned to continue complying with the current Gene Technology Regulations until that time.

Although there are challenges in applying the current definitions to some new technologies, the Regulator is obliged to perform the functions required by the Act and apply the legislation as it stands today. Please see the Regulator’s general advice on regulatory coverage of new technologies.

OGTR continues to monitor scientific developments and you can contact OGTR at any time if you would like to identify an issue for consideration in the next review. The Regulator undertakes periodic reviews of the Regulations and a commencement date for the next review has not been set.

Review of the National Gene Technology Scheme

The Scheme Review is a broad-reaching policy review being undertaken for the Legislative and Governance Forum on Gene Technology, independently of the Regulator. The Technical Review is intended to provide an interim solution whist broader policy considerations associated with new technologies are being progressed through the Scheme Review. The Final Report is available on the Scheme Review website.

Amendment Proposals Consultation

From 30 November 2017 to 21 February 2018 the Regulator invited submissions on proposed amendments to the Regulations for the Technical Review of the Regulations. The Regulator considered the issues raised in submissions in finalising the draft amendments.

The amendments as proposed at consultation and the supporting Consultation Regulation Impact Statement are available on the Regulations Review Proposed Amendments page. Submissions received by the Regulator are available on the Regulations Review Amendment Proposals Submissions page.

Discussion Paper Consultation

The Regulator consulted the public on a discussion paper detailing four options for how new technologies could be regulated, seeking submissions on the paper from 17 October to 16 December 2016. The Regulator considered the information provided in submissions to prepare draft amendment proposals for further consultation.

The discussion paper is available on the Regulations Review Discussion Paper page and the submissions received by the Regulator and a summary of submissions are available on the Regulations Review Discussion Paper Submissions page.