Before anyone in Australia can grow a genetically modified crop in a field trial, give a GM vaccine to patients or keep GM organisms in a laboratory, they need permission from the Gene Technology Regulator. The Regulator is a statutory office holder, supported by a small office inside the federal health department. Its job, in the words of the Gene Technology Act 2000, is "to protect the health and safety of people, and to protect the environment", by identifying the risks of gene technology and managing them through licences.
On that job, the record is very good.
On time, every year
The law sets deadlines. A limited field trial must be decided within 150 working days, or 170 if the Regulator finds significant risk. A commercial release gets 255 days. A laboratory licence gets 90. The clock stops while the Regulator waits for an applicant to answer questions, and if the Regulator misses the deadline the law treats the application as refused.
In each of the seven annual reports Regulator Review examined, from 2017-18 to 2024-25, the Regulator reported that every licence decision was made in time. In 2024-25 it issued 44 licences, 12 for releases into the environment and 32 for contained work, and "All licence decisions were made within statutory timeframes" (Annual Report 2024-25, p 27). No one appealed a decision that year. The Australian National Audit Office found the same in 2005: "OGTR has processed applications within the required timeframes."
The Regulator publishes a risk assessment for every proposed release and consults the public on it. No report of harm to people or the environment from an authorised GMO was found in the annual reports examined.
There are two limits on this. The figures are the Regulator's own, and no independent audit has tested them since 2005. And because the clock stops during information requests, an applicant's real wait is not published. The ANAO suggested in 2005 that the office keep track of total elapsed time. No such figure was found in the reports.
Checking the licences
A licence is only as good as the checking behind it. The Regulator's inspectors visit field trial sites, licensed laboratories and certified facilities.
They find problems, and the Regulator says so in unusual detail. Each annual report describes every finding against a licence and names the licence holder. In 2024-25 there were findings against four field trial or clinical licences and five laboratory licences, and 87 findings at 18 certified facilities.
What is less clear is how much of the field they cover. About 2,300 facilities are certified to handle GMOs. In 2024-25 inspectors carried out 128 facility inspections. Across the last seven years examined, the share of certified facilities inspected in a year has ranged from about 1% to about 7% (Regulator Review's calculation). In the April to June quarter of 2025 the office "did not inspect any organisations conducting GMO dealings involving intentional release".
Field trial inspections have fallen from 39 sites in 2017-18 to 13 in 2024-25. The number of trial sites has also fallen, and the office reports inspecting about 42% of current sites in each of the last three years.
In 2005 the ANAO recommended that the office publish "the number of sites or organisations yet to be visited". The reports now give a share for field trials. They give nothing comparable for laboratories and facilities.
Reminders, not directions
The Act gives the Regulator real powers: written directions, suspension and cancellation of licences, Federal Court injunctions, and criminal offences carrying up to five years' jail. Its stated policy is "cooperative compliance", with those powers held in reserve.
On the published record they stay there. The annual reports for 2019-20, 2022-23 and 2023-24 each record that no investigations were undertaken. No direction, injunction or prosecution was found in any report examined, and the ANAO recorded in 2005 that no prosecution had ever been commenced under the Act. None since has been found.
The handling of individual cases shows what cooperative compliance means in practice. In 2024-25 one company running a GM plant field trial missed its licence's inspection deadlines 12 times and its reporting deadlines nine times, and cleaned and replanted a site without telling the Regulator. It "has been reminded of its obligation to ensure licence conditions are understood and met" (Annual Report 2024-25, pp 55-57).
The Regulator does escalate in some cases. Monsanto's GM canola licence had findings three years in a row. In 2023-24 the company was put under "enhanced responsive monitoring", and in 2024-25, after volunteer GM canola plants were found flowering at a trial site, it was required to inspect that site more often, using senior staff approved in writing.
Most of the people the Regulator oversees are universities, hospitals and research bodies, and most findings are assessed as negligible risk. Cooperative compliance may be the right approach for them. The published record does not let a reader judge whether the powers are held in reserve or simply not used.
Measures loosened
The Regulator reports two headline performance measures. In 2023-24 the first was the share of licence decisions made on time, with a target of 100%. From 2024-25 it covers all "application decisions", which takes in 941 approvals in 2024-25 rather than 44 licences, and the target is 98%. The second measure, the share of non-compliance reports assessed, also went from 100% to 98%. No reason was found for either change.
The 2024-25 annual report says the office "conducted 243 monitoring visits". The categories listed beneath that figure add up to 145. The report, as read, does not explain the difference.
The Regulator also kept publishing quarterly reports on its monitoring after Parliament removed the legal requirement in 2015, which is to its credit. The latest one found covers April to June 2025.
The grade
Regulator Review's proposed grade is B: the Regulator does its core licensing job on time every year and reports its findings openly, but its checking covers a small part of the field, its formal enforcement powers have not been seen in use, and its performance measures were loosened in 2024-25 without explanation. The office is about to move to partial cost recovery, with its first increase in base funding since 2002, $6.8 million over four years, starting in July 2026. Reform of the Act, recommended by a review whose 27 recommendations ministers endorsed after 2017, is still at the draft bill stage. Those are matters for governments, not the Regulator.
The full analysis and sources are in the accompanying report.