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The Report

The full analysis and sources behind the grade.

At a glance

ItemFinding
BodyThe Gene Technology Regulator, an independent statutory office holder, supported by the Office of the Gene Technology Regulator (OGTR)
TypeA regulator. It licenses and monitors dealings with live and viable genetically modified organisms (GMOs) under a national scheme shared by the Commonwealth, states and territories
Office holderDr Raj Bhula, Regulator since July 2016, reappointed for five years in June 2021 (Annual Report 2024-25 p 15). The Minister's Statement of Expectations of 19 January 2026 is addressed to her. Whether she remains in office at 26 October 2026 was not confirmed
Enabling lawGene Technology Act 2000 (Cth), compilation of 14 October 2024 (includes Act No. 39, 2024); Gene Technology Regulations 2001; corresponding state and territory laws
Where it sits"The OGTR is administered as a separate division of the department and funded by the Gene Technology Special Account" (AR 2024-25 p 13). The department is now Health, Disability and Ageing
Report under reviewOperations of the Gene Technology Regulator Annual Report 2024-25 (published October 2025; tabled in the ACT Legislative Assembly May 2026). No 2025-26 report had been found at 26 October 2026
Record examinedAnnual reports 2017-18 and 2019-20 to 2024-25 (seven reports); quarterly activities reports for July-September 2022, July-September 2023 and April-June 2025; ANAO Audit Report No. 7 2005-06; the Act (2008 and 2024 compilations); the Senate committee report on the Gene Technology Amendment Bill 2015; Department of Health corporate plans 2025-26 and 2026-27; the Statement of Expectations (19 January 2026); OGTR web pages, policies and newsletters; Third Review and amendment consultation pages
Output, 2024-25952 applications and 751 notifications received; 941 approvals; 44 licences issued (12 DIR, 32 DNIR); "All licence decisions were made within statutory timeframes"; 243 monitoring visits reported; 98 reports of possible non-compliance assessed (AR 2024-25 pp 5-6, 23, 27, 33, 49)
Proposed overall gradeB
Short reasonThe Regulator does its core job, deciding licence applications on risk, on time: every licence decision in every year examined was made within the statutory timeframe, and it publishes its risk assessments and names the licence holders it finds in breach. It is held back by a compliance program that inspects a small share of facilities, reports no investigations in most years and has not been found to use a direction or prosecution, by repeat and multiple breaches met with reminders, and by performance measures that were loosened in 2024-25

The grade follows the six criteria settled for Regulator Review on 11 October 2026. Section 10 sets out each criterion, its grade and the reasoning.

1. What the body is for

1.1 What the Act says

The Act has an objects clause: "The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs" (s 3).

The object is to be achieved through a framework that, among other things, "provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation" and "provides an efficient and effective system for the application of gene technologies" (s 4(aa), (a)).

The Regulator's first function is "to perform functions in relation to GMO licences as set out in Part 5" (s 27(a)). The other functions are to develop policy principles and codes of practice, issue technical guidelines, advise other agencies and the public, advise the ministers, commission biosafety research, harmonise risk assessments and maintain international links (s 27(b)-(l)).

Its powers include:

  • Licensing. "The Regulator must issue the licence, or refuse to issue the licence, within the period (if any) prescribed by the regulations" (s 43(3)). If the Regulator does not decide in time, it is "taken … to have made a reviewable decision to reject the application" (s 182).
  • Directions. Where a licence holder is not complying and it is necessary to protect people or the environment, or is in the public interest, "the Regulator may give directions to the licence holder, by written notice" (s 146).
  • Injunctions from the Federal Court, on the application of the Regulator "or any other aggrieved person" (s 147).
  • Suspension and cancellation of licences, certifications and accreditations (ss 68, 88, 96), and monitoring and offence-related powers for inspectors (Part 11).
  • Offences. Dealing with a GMO without authorisation, knowingly or recklessly, carries "imprisonment for 2 years or 500 penalty units", or 5 years or 2,000 penalty units if aggravated (s 32(2)). Prosecution decisions rest with the Commonwealth Director of Public Prosecutions (OGTR Compliance and Enforcement Policy, April 2016).

The annual report "must include information about" licences issued, "any breaches of conditions of a GMO licence that have come to the Regulator's attention during the financial year", and "auditing and monitoring of dealings with GMOs" (s 136(1A)).

1.2 What the OGTR says it is for

The Regulator is "an independent statutory office holder responsible for administering the Gene Technology Act 2000" and corresponding state and territory laws, and "is appointed by the governor-general only with the agreement of the majority of all jurisdictions" (ogtr.gov.au, About the Regulator). It describes its approach against three regulator best-practice principles, including: "We manage risks proportionately and maintain essential safeguards while minimising regulatory burden" (AR 2024-25 p 11).

1.3 Who it serves

The public, whose health and environment the Act protects; the researchers, universities, hospitals and companies who hold its licences, certifications and accreditations; and the nine governments of the national scheme. At 30 June 2025 there were 66 current DIR licences, 172 current DNIR licences, 2,309 certified facilities, 221 accredited organisations and 3,077 active notifiable low risk dealings (AR 2024-25 pp 23, 42, 44; the ACT-tabled copy gives these at p 24).

1.4 Who holds it to account

  • The Minister and the Gene Technology Ministers' Meeting. A Statement of Expectations from the Assistant Minister was issued on 19 January 2026, and the Regulator's Statement of Intent is dated 5 March 2026 (Department of Finance, Regulator stocktake).
  • Parliament, through tabling of the annual report (s 136) and Senate estimates.
  • The ANAO, which has audited the Regulator once, in 2005 (section 9).
  • Review of decisions. Merits review, internally and then by the Administrative Review Tribunal, is open only to an "eligible person", which in every item of the table in s 179 is the applicant or holder (ss 179-183). A member of the public who objects to a licence has no merits review. States have extended standing for judicial review (s 183A). That is a feature of the law, not held against the Regulator.

2. The test

For a licensing and safety regulator the test has four parts:

  1. Does it decide applications on the evidence and on time?
  2. Does it check that licence conditions are followed, across enough of the regulated field to be credible?
  3. When it finds a breach, does it respond in proportion, including with its formal powers when warranted?
  4. Does it report all of this plainly, including the parts that do not flatter it?

3. Licence decisions and timeframes

The statutory timeframes, in working days and excluding time spent waiting for applicants to answer requests for information, are 150 days for limited and controlled release DIR applications, 170 days where significant risk is identified, and 255 days where release is not limited or controlled (ogtr.gov.au, Apply for a DIR licence). For DNIR licences the timeframe is 90 days (AR 2022-23 p 31).

YearDIR licences issuedDNIR licences issuedTimeframe statementSource
2017-1899All DIR decisions within statutory timeframes; DNIR "made within the statutory time limit"AR 2017-18 pp 21, 23
2019-20320"All of the licence decisions were made within statutory timeframes"AR 2019-20 pp 18, 21
2020-21919"All of the licence decisions were made within statutory timeframes"AR 2020-21 pp 22-23, 26
2021-22713"All of the licence decisions were made within statutory timeframes"AR 2021-22 pp 21, 25
2022-23512"All decisions were made within the statutory timeframe of 90 days" (DNIR)AR 2022-23 pp 26, 31
2023-24626"100% of GMO licence decisions were made within statutory timeframes"AR 2023-24 pp 4, 26, 31
2024-251232"All licence decisions were made within statutory timeframes"AR 2024-25 pp 5, 27, 33

There were "no appeals associated with decisions made on applications" in 2024-25 (AR 2024-25 p 23). The 2018-19 report was not read.

The record goes back further. The ANAO found in 2005 that "OGTR has processed applications within the required timeframes" and that its analysis of OGTR data supported this (ANAO Audit Report No. 7 2005-06, paras 14, 29).

Regulator Review's assessment: on the evidence available, the core licensing job is done on time every year. Two limits on that finding. The timeframes stop while the Regulator waits for the applicant, and the OGTR does not publish total elapsed time, so an applicant's real wait is not known; the ANAO suggested in 2005 that it monitor elapsed time "including days not counted" (para 14). And the figures are the OGTR's own; they have not been independently audited since 2005.

4. Monitoring and compliance

4.1 What is inspected

YearField trial sites inspectedShare statedCertified facility inspectionsCertified facilities at 30 JuneShare of facilities inspected (calc)
2017-1839 of 9641%602,0462.9%
2019-2015about 27%962,0824.6%
2020-2111 of 3829%23 (p 40) or 60 (pp 3, 43)2,0821.1% to 2.9%
2021-225 of 2223%402,1331.9%
2022-2310 of 2442% (p 50); 40% (p 4)492,1892.2%
2023-245 of 12 current (24 operating)42%1552,1557.2%
2024-2513 of 3142%1282,3095.5%

Sources: AR 2017-18 pp 33, 37; AR 2019-20 pp 3, 30, 34, 38; AR 2020-21 pp 3, 20, 40-43; AR 2021-22 pp 19, 40-42; AR 2022-23 pp 4, 24, 49-51; AR 2023-24 pp 5, 24, 50; AR 2024-25 pp 6, 23, 49-50. The last column is Regulator Review's calculation; the other percentages are as printed.

Notes:

  • The 2019-20 and 2020-21 programs were cut back by COVID-19: "we were unable to have a physical presence while conducting our activities" (AR 2019-20 p 3); "lockdowns impacted our monitoring and compliance program again this year" (AR 2020-21 p 3).
  • In 2023-24 the 42% is a share of the 12 sites that were "current" at the start of the year; the report also says 24 sites were operating (AR 2023-24 pp 5, 50). Five of 24 is 21% (calc).
  • In April to June 2025 "the OGTR did not inspect any organisations conducting GMO dealings involving intentional release" (Quarterly activities report April-June 2025). In July to September 2022, "the OGTR did not inspect any GM plant field trial sites" (Quarterly report July-September 2022).
  • Field trial site inspections fell from 39 in 2017-18 to between 5 and 15 a year since. The number of operating sites also fell, from 96 at the start of 2017-18 to 24 to 31 in the latest three years, so the share inspected has held around 40% in those years on the OGTR's basis.

The ANAO recommended in 2005 "that OGTR more fully explain its reported rates of monitoring, including maintaining and publishing information on the number of sites or organisations yet to be visited by OGTR" (Recommendation 4, para 3.39). Health agreed. The annual reports now give a share for field trial sites. No equivalent was found for certified facilities, which are by far the largest group: about 2,300 facilities, of which 2% to 7% are inspected in a year (calc).

4.2 What it finds

YearDIR licences with non-complianceDNIR licences with non-complianceCertified facilities non-compliant (findings)Reports of possible non-compliance assessed
2017-18205 (7)not given
2019-200210 (12)not given
2020-210013 (18)not given
2021-221110 (11)48
2022-232226 (32)70
2023-243344 (66)108 of 109
2024-254518 (87)98

Sources: AR 2017-18 pp 40-42; AR 2019-20 pp 40-41; AR 2020-21 pp 45-46; AR 2021-22 pp 3, 45-47; AR 2022-23 pp 4, 55-58; AR 2023-24 pp 5, 56-61; AR 2024-25 pp 6, 55-65.

The facility findings in 2024-25 were mostly about work practices (37) and structure (33) (AR 2024-25 Table 12, pp 64-65). Findings rise and fall with the number of inspections. Facility findings have generally been assessed as negligible risk (for example AR 2021-22 p 47; AR 2019-20 p 42). The 2021-22 report states "There were no reports of adverse effects on human health or the environment from authorised GMOs" (AR 2021-22 p 2); no report of harm from an authorised dealing was found in any report read.

Regulator Review's assessment: the OGTR finds non-compliance when it looks, and reports it in more detail than most regulators: each finding against a licence is described, with the licence holder named. The question is how much it looks. In most years about 95% or more of certified facilities are not inspected (calc), and the reports do not say how many facilities have gone without an inspection for a given period.

5. Willingness to use its powers

5.1 Investigations, directions and prosecutions

  • 2019-20: "No investigations were undertaken in this reporting period" (AR 2019-20 p 48).
  • 2022-23: "No investigations were undertaken in this reporting period" (AR 2022-23 p 63).
  • 2023-24: "No investigations were undertaken in the reporting period" (AR 2023-24 p 68).
  • Quarterly reports for July-September 2022 and July-September 2023: "No investigations were undertaken during the quarter"; April-June 2025: no practice reviews or investigations.
  • No direction under s 146, no injunction application and no prosecution was found in any report read. The ANAO recorded in 2005 that "there have been no prosecutions commenced for offences against the Act" (para 20). No prosecution since has been found.
  • One accreditation was cancelled in 2023-24 and one in 2024-25 (AR 2023-24 p 48; AR 2024-25 p 42). Whether these were for non-compliance or at the holder's request was not established.

The OGTR's stated approach is "cooperative compliance": it "aims to apply a cooperative regulatory approach which builds effective compliance performance capacity by regulated parties", with suspension, cancellation, injunctions, directions and prosecution available as escalation (Compliance and Enforcement Policy, April 2016). It also says "Non-compliance is not regarded as a breach of the licence conditions unless proven to be so after investigation" (AR 2024-25 p 55).

5.2 How findings were handled: examples from 2024-25

  • Grasslanz Technology Australia Pty Limited (DIR 176) "failed to meet inspection timeframes specified by the licence (condition 27)" on 12 occasions and "failed to meet reporting timeframes specified by the licence (condition 54)" on 9 occasions, and cleaned and replanted a site without notifying the Regulator. Response: it "has been reminded of its obligation to ensure licence conditions are understood and met" (AR 2024-25 pp 55-57).
  • Monsanto Australia Pty Ltd (DIR-164): eight flowering volunteer canola plants were found at one site during post-harvest monitoring. Response: "Monsanto is required to increase the frequency of post-harvest monitoring inspections for Site 6", by senior authorised persons approved in writing (AR 2024-25 p 58). The same licence had findings in 2022-23 and 2023-24; in 2023-24 the Regulator said "Monsanto will also be subject to enhanced responsive monitoring by the OGTR" (AR 2022-23 p 55; AR 2023-24 p 58).
  • Novotech (Australia) Pty Ltd (DIR-177) missed a reporting timeframe and "must update its policies and procedures regarding mandatory reporting" (AR 2024-25 p 57).
  • RMIT University (DNIR-560) and CSIRO (DNIR-496) were "reminded" of their obligations; CSIRO was retraining staff (AR 2024-25 pp 59-61).
  • In six instances organisations had not conducted notifiable low risk dealings in line with requirements; "In all cases the organisations took corrective and preventive measures, and no further actions were recommended" (AR 2024-25 pp 64-65).

5.3 Unapproved GM petunias

From 2017 the Regulator dealt with GM petunias imported into Australia without approval. Its fact sheet (first version 17 May 2017, fifth version November 2021) says "at least twenty varieties of GM petunia have been imported into Australia". It assessed them as posing no risk, said they "must not be marketed", issued licences to allow people to dispose of them, and worked with importers, suppliers and industry bodies to remove them from sale (OGTR, GM petunias in Australia, version 5). No investigation outcome was found in the 2017-18 annual report as read.

Regulator Review's assessment: cooperative compliance is a defensible policy for a regulated community made up largely of universities, hospitals and research bodies, and the risks found have generally been rated negligible. But a policy of escalation that, on the published record, has not escalated to a direction or prosecution in the years examined, together with years with no investigations at all, and 21 missed licence obligations at one field trial answered with a reminder, suggests the formal powers are rarely if ever used. The Monsanto case shows graduated responses do occur.

6. The people it is there for

  • Applicants get decisions on time (section 3). No satisfaction survey of applicants, licence holders or the public was found in the parts of the reports read.
  • The public is consulted on risk assessment and risk management plans for releases into the environment, which the reports for 2019-20 and 2020-21 recorded as done for all assessments against the PBS target (AR 2019-20 p 2; AR 2020-21 p 2).
  • The OGTR gives information to the public when confusion arises. On 4 September 2025 it published a clarification that "The baits do not contain GMOs", after a statement on the National Fire Ant Eradication Program website led some people to believe GMOs had been released without approval (OGTR, Fire ant baits are not GMOs). A list of OGTR records produced for the Senate shows an estimates brief on "Compliance monitoring – Fire Ant baits" (Senate Order No. 12 list, July-December 2025).
  • No count of complaints about the OGTR, or of public allegations of unauthorised dealings it received, was found.
  • Year-end work on hand: Table 1 appears to show 5 DIR and 7 DNIR licence applications under consideration at 30 June 2025 (AR 2024-25 Table 1, pp 24-25). The column layout could not be read reliably from the text extraction, so these two figures are to be checked against the printed table.

7. Systemic impact

The OGTR's systemic work is through guidance and scheme-wide programs: technical and procedural guidelines, facility certification rules, the OGTR Regulatory Science Strategy 2024-2027 (ogtr.gov.au), the National IBC Forum (the 11th was set for 14-15 October 2026), and audits of Queensland seed breeding companies under the Low Level Presence Strategy, which review their quality assurance (Quarterly report April-June 2025; Newsletter Issue 13). It published a Load Validation Profile Fact Sheet on autoclave load validation (Newsletter Issue 13). It also states that it "does not use AI to evaluate or make decisions on applications" (Newsletter Issue 13).

The Third Review of the National Gene Technology Scheme, announced on 27 July 2017, found the scheme "working well", with participants saying it would benefit from "increasing transparency to ensure public confidence". Ministers endorsed all 27 recommendations (genetechnology.gov.au, The third review).

Regulator Review's assessment: the record shows sound scheme-wide guidance, and no harm from authorised GMOs was found reported. The limited inspection coverage (section 4) limits what can be said about how widely the rules are followed.

8. Transparency about itself

The OGTR publishes a good deal: every licence and its risk assessment and risk management plan, a public register, detailed non-compliance findings naming licence holders, its compliance and enforcement policy, and quarterly activities reports. It kept publishing quarterly reports after Parliament removed the requirement in 2015.

8.1 What stopped being published

ItemWhat happenedSource
Statutory quarterly reports to the Minister and ParliamentRequired by s 136A, which was in the Act as passed in 2000 and amended in 2007, including breaches and monitoring, with each report tabled in Parliament. Repealed by the Gene Technology Amendment Act 2015 (No 121, 2015), with the content moved to the annual report (s 136(1A)). The Senate committee report describes the bill as one that "discontinues quarterly reporting to the Minister"Act endnotes (2024 compilation); Senate Community Affairs Legislation Committee, Gene Technology Amendment Bill 2015, paras 1.10-1.13
Non-compliance findings in quarterly reportsQuarterly reports state that findings "are provided in the Regulator's Annual Report in accordance with section 136"; no findings appear in themQuarterly reports July-September 2022, July-September 2023, April-June 2025
Quarterly activities reports after June 2025The latest found is April-June 2025 (file dated August 2025). No later report was found at 26 October 2026. The collection page lists 2025 as its latest year. Whether the series has stopped was not confirmedogtr.gov.au, Quarterly activities reports
InvestigationsReported as none in 2019-20, 2022-23 and 2023-24. No count was found in the parts of the 2024-25 report readAR 2019-20 p 48; AR 2022-23 p 63; AR 2023-24 p 68

8.2 Changed definitions and lowered targets

  • Licence timeliness. In 2023-24 the measure was "Percentage of GMO licence decisions made within statutory timeframes", planned 100%, result 100% (AR 2023-24 p 69, Measure 1.8C a). From 2024-25 the target is ">=98% of application decisions" (printed with a greater-than-or-equal sign) and in the corporate plans it is "Percentage of statutory timeframes met for decisions on applications" (AR 2024-25 p 4; Health Corporate Plan 2025-26 and 2026-27, Measure 1.8C). The OGTR issued 44 licences and granted 941 approvals in 2024-25 (AR 2024-25 pp 5, 23). The measure now covers all approvals, not only licences, and the target is lower. No reason was found.
  • Non-compliance assessment. Target 100% in 2023-24, result 99.1%, with the report explaining that "one report was received in the last 3 business days of the financial year and assessed after June 30" (AR 2023-24 pp 5, 69). Target ">=98%" from 2024-25 (AR 2024-25 p 4). No reason was found. Whether the new target was set before or after the 2023-24 result was known was not established.
  • A "Substantially achieved" band of 90% to under 98% applies to both measures in 2025-26 (Health Corporate Plan 2025-26).
  • Both measures count process (decisions on time; reports assessed). Neither measures inspection coverage or the outcome of non-compliance.

8.3 Inconsistencies

  • 2024-25: "During 2024-25 the OGTR conducted 243 monitoring visits, comprising" 6 DIR inspections, 9 DNIR inspections, 128 certified facility inspections and 2 practice reviews (AR 2024-25 p 49). Those items sum to 145 (calc). The difference of 98 is not explained in the text as read. It equals the number of non-compliance reports assessed that year (98), which may or may not be coincidence. To be checked against the original.
  • 2022-23: 6 DIR inspections on p 49 but 5 described on p 50; field trial inspection share 42% on p 50 and 40% on p 4.
  • 2020-21: 23 certified facility inspections (p 40) against 60 certified facilities inspected (pp 3, 43); 3 practice reviews (p 3) against 1 (p 40).
  • 2023-24: "a total of 10 findings of non-compliance with the conditions of DIR licences" (p 56), while the licence-by-licence findings described on pp 56-59 appear to total 8.
  • 2019-20: 2,082 certified facilities (pp 18, 30) against 2,079 (p 16).

These are recorded as printed (in text extraction). None changes the findings above.

8.4 Not found in the parts read

The text extraction available to Regulator Review ended at about page 61 to 66 of each annual report, before the management and accountability chapter. Staffing, expenses, freedom of information and website figures were therefore not read (section 11). The finances of the OGTR are not published as a set of its own financial statements; it is funded through the Gene Technology Special Account within the department (AR 2024-25 p 13), and the 2017-18 report states that its financial statements "are consolidated into the department's financial statements" (AR 2017-18 p vi, footnote 1).

Regulator Review's assessment: the OGTR is more open than most regulators about what it finds, and it names names. It is less open about how much it looks, how long applicants really wait, and how often, if ever, it uses its formal powers. Its headline performance measures were broadened and lowered in 2024-25 without a stated reason, and its 2024-25 headline count of monitoring visits does not add up as printed.

9. Money, independence and the stalled reform

  • Funding. The government will "increase OGTR funding by $6.8 million over 4 years from July 2026", then "$1.7 million per year ongoing from 2030-31", described as "the first increase in base funding since 2002" (OGTR, Cost Recovery and Sustainable Funding of the GT Regulatory Scheme, May 2026). The scheme "has been funded by government for nearly 25 years". Phase 1 cost recovery will charge commercial licence applications at "50% of actual costs" and pre-commercial work such as trials at "25%", with research-only licences exempt and annual licence fees introduced; a Cost Recovery Implementation Statement is "expected to occur by the end of this calendar year" (same document).
  • Independence. The Regulator is a statutory office holder, but the OGTR's staff are departmental staff and its corporate services come from the department (AR 2024-25 p 13). The Statement of Expectations asks the Regulator to support "the performance reporting obligations of the Secretary as the Accountable Authority under the PGPA Act" (Statement of Expectations, 19 January 2026).
  • ANAO. The only ANAO audit found is Audit Report No. 7 2005-06, Regulation by the Office of the Gene Technology Regulator (covering letter 25 August 2005). It concluded "Overall, OGTR has developed and implemented policies and procedures for the efficient and effective discharge" of the functions examined, and made five recommendations, all agreed, including the monitoring disclosure recommendation in section 4.1 (paras 29-32, 3.39). No later ANAO audit was found.
  • Legislative reform. Ministers endorsed the Third Review's 27 recommendations; the 2019-20 Budget funded 50% of implementation costs; an exposure draft Gene Technology Amendment Bill 2024 was open for consultation from 13 September to 8 November 2024 (genetechnology.gov.au). Amendments to the Regulations were consulted on from 5 January to 1 March 2026. No bill had been found introduced to Parliament at 26 October 2026. The Statement of Expectations asks the Regulator to work with the department to "progress legislative reforms to implement the recommendations of the Third Review", in line with "the Government's legislative priorities".
  • In 2019 the Senate rejected, 13 votes to 42, a motion to disallow the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 (theyvoteforyou.org.au, 13 November 2019). Making regulations is a matter for governments, not the Regulator.

The funding level, the departmental arrangements and the pace of legislative reform are decisions of governments, not of the Regulator, and are not held against it.

10. Assessment and proposed grade

Findings of fact are in sections 1 to 9. This section is Regulator Review's assessment.

Scale used: A excellent; B good; C adequate; D poor; E failing; F not performing the function.

CriterionGradeReason
1. Doing the core job: deciding GMO licence applications on riskAEvery licence decision in every year examined (2017-18, 2019-20 to 2024-25) was made within the statutory timeframe; the ANAO found the same in 2005; risk assessments are published and consulted on; no harm from authorised GMOs found reported
2. Service to the people it is there forBApplicants get decisions on time and no appeals were lodged in 2024-25. But real elapsed time, including clock-stopped days, is not published; no satisfaction measure was found; no count of complaints or public allegations was found
3. Willingness to use its powersCFinds and names non-compliance and has escalated on a repeat case (Monsanto). But no investigations in several years, no direction or prosecution found in the years examined, and 21 missed licence obligations at one trial answered with a reminder
4. Systemic impactBScheme-wide guidance, facility rules, seed company audits under the Low Level Presence Strategy, and a scheme the Third Review found "working well". Limited inspection coverage limits what can be known about compliance across the field
5. Transparency about itselfCBetter than most: names licence holders, publishes detailed findings and kept quarterly reports after the legal duty ended. But the headline measure was broadened from licence decisions to all approvals and lowered to 98% without a stated reason, the 2024-25 monitoring total does not add up as printed, facility inspection coverage and elapsed times are not published, and no quarterly report after June 2025 was found
6. AccountabilityBStatement of Expectations and Statement of Intent published; the one ANAO audit's recommendations were agreed; consults publicly on decisions and reform. No independent audit in 21 years and merits review is limited to applicants, both features of the law and the audit program, not held against it

Proposed overall grade: B.

Reasoning. The criterion closest to the Regulator's core job, deciding licence applications on risk and on time, carries the most weight, and on it the record is excellent on every year examined. That is why the grade is not C. It is not A because a regulator's licences are only as good as the checking behind them, and on the published record the checking is thin and the enforcement tools are rarely if ever used: most certified facilities are not inspected in a given year, several years record no investigations, and serious repeated failures to meet licence conditions have been met with reminders. The OGTR's reporting about itself is good by the standards of bodies reviewed so far, but its main performance measures were loosened in 2024-25 without an explanation, and its 2024-25 count of monitoring visits does not reconcile. The low level of formal enforcement may reflect a low-risk, largely institutional regulated community; the published record does not let a reader tell.

What would change the grade:

  • Up: publishing elapsed time for licence decisions including clock-stopped days; publishing the share of certified facilities inspected and how long since each was last inspected, as the ANAO recommended in 2005; reporting the number of investigations, directions and referrals each year; restoring a licence-only timeliness measure at 100% or explaining the change; reconciling the 2024-25 monitoring total; an independent audit confirming the timeliness record.
  • Down: a missed statutory timeframe not disclosed; evidence of harm from an authorised dealing; confirmation that the quarterly reports have stopped without explanation; further loosening of measures; cost recovery leading to slower decisions or reduced monitoring.

11. What is not known

  • The 2025-26 annual report, not found at 26 October 2026.
  • Whether Dr Bhula remains Regulator after the end of her five-year reappointment from June 2021, or whether an acting or new Regulator is in place.
  • Staff numbers, OGTR expenses, the Gene Technology Special Account balance, freedom of information figures and complaints: in the management chapters of the annual reports (from about p 66 on), which the text extraction available did not reach.
  • The number of investigations in 2020-21, 2021-22 and 2024-25, and their outcomes.
  • Whether the Regulator has ever given a direction under s 146, applied for an injunction, or referred a matter to the CDPP. None found.
  • The reason the 2024-25 monitoring visits total (243) differs from its listed components (145).
  • Why the timeliness measure changed from licence decisions to all application decisions, and why both targets fell from 100% to 98%.
  • Whether quarterly activities reports were published after April-June 2025.
  • Total elapsed time for licence decisions, including time the clock was stopped.
  • What share of certified facilities have not been inspected in, say, five years.
  • What the Senate estimates brief on fire ant bait compliance monitoring said, and what questions on notice were answered.
  • The outcome of the Monash University audit and the Low Level Presence Strategy audits of seed companies.
  • Whether a Gene Technology Amendment Bill has been introduced or is scheduled.
  • Page references were taken from text extractions of the OGTR PDFs. For 2024-25 the ACT-tabled copy gave several of the same items one page higher (for example p 24 rather than p 23 for application totals). All page references should be checked against the originals before publication.

Reporting-gaps register candidates (for My Drive/Projects/RegulatorReview/Reporting-gaps-register.md): measure broadened from licence decisions to all application decisions (blurred denominator); targets lowered from 100% to 98% (soft or shifting KPI); 2024-25 monitoring total not reconciling with its parts (headline error); facility inspection coverage and elapsed time not published (outcome left unreported); statutory quarterly reporting repealed in 2015 and later quarterly reports not found after June 2025 (measure stopped being published; stated reason in 2015 was a move to annual reporting).

12. Sources