Operations of the Gene Technology Regulator Annual Report 2009-2010
As an introduction to operational activities, the first part of this chapter outlines the types of dealings with GMOs that are defined by the Act, the Regulations and corresponding state and territory laws. It also provides a summary of classes of dealings, the process for authorisations and the statutory timeframe for consideration of each type of application and other statutory functions (such as certification and accreditation) that help the Regulator manage risks to health and safety of people and the environment. The second part of this chapter describes operational performance.
Section 10 of the Act defines ‘deal with’, in relation to a GMO, as:
(b) make, develop or manufacture the GMO
(c) breed the GMO
(d) propagate the GMO
(e) use the GMO in the course of manufacture of a thing that is not the GMO
(f) grow, raise or culture the GMO
(g) import the GMO
(h) transport the GMO
(i) dispose of the GMO
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).
The Act forms the basis of a prohibitory scheme that makes dealing with a GMO a criminal offence unless, as outlined in section 31 of the Act, the dealing is:
Dealings authorised by a licence are further categorised into dealings not involving intentional release (DNIRs) that are conducted in contained facilities, dealings involving intentional release (DIRs) that involve release into the environment and inadvertent dealings.
For both DNIRs and DIRs the legislation requires the Regulator to prepare a RARMP as part of the process of making a decision on whether to issue a licence (sections 47 and 50 of the Act respectively). Part 5 of the Act allows the Regulator to grant a temporary licence (no longer than 12 months and for the purposes of disposing of the GMO) to a person who finds they are inadvertently dealing with an unlicensed GMO.
For dealings to be listed on the GMO Register, the Regulator must determine there are minimal risks and that it is no longer necessary for people undertaking the dealings to be licensed.
The EDD provision in Part 5A of the Act gives the Minister the power to expedite an approval of dealings with a GMO in an emergency.
Table 6 provides a summary of the classes of dealings, outlining the level of risk and the extent of management conditions (such as containment in certified facilities).
Table 6: Classes of GMO dealings under the Gene Technology Act 2000
|Exempt||No, dealings classified as Exempt are scheduled in the Regulations||No intentional release to the environment|
|NLRD||No, dealings classified as NLRDs are scheduled in the Regulations, conduct of NLRDs requires prior assessment by IBC to confirm proper classification; notified in annual report||Yes PC1 or PC2 (usually)|
|DNIR||Yes, applications must be assessed by IBC; RARMP prepared and licence decision by the Regulator||Yes (PC2 (usually)|
|DIR (except for limited and controlled releases)||Yes, applications must be reviewed by IBC; consultation on application, RARMP prepared, consultation on RARMP and licence decision by the Regulator||Containment measures may be required, determined on a case-by-case basis and other licence conditions will apply|
|DIR (limited and controlled)||Yes, applications must be reviewed by IBC; RARMP prepared, consultation on RARMP and licence decision by the Regulator||Containment measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply|
|Inadvertent dealing||Yes, licence decision by the Regulator only for the purposes of disposal of the GMO||Containment and/or disposal measures will apply|
|GMO Register||No, but must be previously licensed Review of related RARMPs||Containment measures may be required|
|EDD||No, determination by the Minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from the Regulator||Containment and/or disposal measures may be included in EDD conditions|
The licensing system is centred on a rigorous process of risk assessment based on scientific evidence. For DIRs, the legislation requires consultation with a wide range of experts, agencies and authorities, as well as the public. These include GTTAC, state and territory governments, Australian Government agencies prescribed in the Regulations, the Environment Minister, and relevant local councils.
The Regulator may, directly or upon application, vary an issued licence or other instruments. Variations involve changes to conditions applied to an instrument or a licence. The Regulator must not vary the licence unless he is satisfied that any risks posed by the dealings proposed to be authorised by the licence as varied are able to be managed in such a way as to protect the health and safety of people and the environment. The Regulator cannot vary a DNIR licence to authorise intentional release of a GMO into the environment.
More information on the various classes of GMO dealings and their assessment process is in Appendix 2.
An organisation undertaking certain dealings with GMOs will be required to be accredited by the Regulator. Accreditation of organisations and certification of individual physical containment facilities helps manage risks that may be associated with dealings with GMOs (see also Appendix 2).
Under section 43(3) of the Act the Regulator must issue or refuse to issue a licence within a time limit prescribed by the Regulations. Similarly, the Regulations prescribe a timeframe for consideration of applications to accredit organisations and to certify facilities. These statutory timeframes are shown in Table 7. Apart from the timeframes for licence variations, they do not include weekends or public holidays in the Australian Capital Territory or periods where the Regulator has sought more information from the applicant, including information to resolve a CCI claim, and the Regulator cannot proceed with the decision-making process until that information is provided. In these instances the statutory timeframe clock is regarded as stopped (clock stop).
Table 7: Prescribed timeframes
|Accreditation||90 working days (Regulation 16)|
|Certification||90 working days (Regulation 14)|
|DIR – limited and controlled, no significant risk||150 working days (Regulation 8)|
|DIR – limited and controlled, significant risk||170 working days (Regulation 8)|
|DIR (except for limited and controlled releases)||255 working days (Regulation 8)|
|DNIR||90 working days (Regulation 8)|
|Licence variation||90 days (Regulation 11A)|
Notes: DIR = dealing involving intentional release of a GMO into the environment; DNIR = contained dealing with a GMO not involving intentional release of the GMO into the environment
The second part of this chapter describes the achievements the Regulator has made against Outcome 1, Population Health, of the Department of Health and Ageing, 2009–10 PBS. It provides details of achievements on deliverables and performance indicators in the key areas of:
Information comparing the actual and predicted numbers of risk assessment and risk management plans, licences issued and variations to licences and other instruments is given in Table 3, Chapter 2.
In 2009–10 the OGTR received 1400 applications and notifications as defined under the Act (see Table 8). Fluctuations in the timing and volume of application lodgement can be influenced by research grant funding cycles and seasonal agricultural factors, as well as changes to legislation, as was the case in 2008–09.
Table 8: Applications and notifications, 2009–10
|Application type||Receiveda||Withdrawn||Approvedb||Ceased considerationc||Under considerationd|
|CCI declaration for DIR licence||11||2||4||0||8|
|CCI declaration for DNIR licence||1||0||0||0||1|
|CCI declaration for NLRD notification||1||0||1||0||0|
|Lifting suspension of certification||27||0||28||0||0|
|Surrender of accreditation||4||0||3||0||1|
|Surrender of certification||89||0||104||0||5|
|Surrender of DIR licence||8||1||5||0||4|
|Surrender of DNIR licence||8||1||9||0||1|
|Suspension of certification||36||0||45||0||0|
|Transfer of certification||19||0||19||0||0|
|Transfer of DNIR licence||2||0||3||0||0|
|Variation of accreditation||7||1||6||0||0|
|Variation of certification||249||2||259||0||13|
|Variation of DIR licence||22||0||22||0||2|
|Variation of DNIR licence||76||4||70||3||14|
aIncludes applications initiated by applicants and by the Regulator
bSome applications reported as approved in 2009–10 were received in 2008–09.
cIncludes both ‘ceased consideration’ and ‘not considered’ under section 42 of the Act
dUnder consideration as at 30 June 2010
DIR licence applications have a statutory timeframe of up to 255 working days for processing, unless the application is for a limited and controlled release. The statutory timeframe for limited and controlled release applications is 150 working days, or 170 working days if the proposed dealings may pose a significant risk to the health and safety of people or to the environment. All decisions made during 2009–10 were made within the relevant statutory timeframe. Decisions on applications do not necessarily occur in the same year as applications are received.
Licences for DNIRs authorise dealings with GMOs that are conducted in laboratories and other physical containment facilities. These licence applications have a statutory timeframe of 90 working days within which the Regulator must make a decision. All decisions made during 2009–10 were made within the statutory timeframe.
Notifiable low risk dealings (NLRDs) have been assessed as posing low risk based on previous national and international experience. Dealings classified as NLRDs are specified in the Regulations. Conduct of NLRDs requires prior assessment by an IBC and notification to the Regulator in an annual report.
The GMO Register is a list of dealings with GMOs that the Regulator is satisfied pose minimal risk to human health and safety and the environment and can therefore be undertaken by anyone, subject to any specified conditions, without oversight of a licence holder. The Regulator may, under section 78 of the Act, determine that dealings with a GMO previously authorised by a licence are to be included on the GMO Register. Such determinations are disallowable Legislative Instruments and must be tabled in Parliament. The Regulator entered no new listings on the GMO Register during 2009–10.
More information on the types of dealings conducted under each category is provided in Appendix 22.
The Regulator requires organisations licensed to conduct work with GMOs to remain accredited. To achieve and retain accreditation, the Regulator must be satisfied that an organisation has, or has access to, a properly constituted and resourced IBC and complies with other requirements of the Regulator’s Guidelines for Accreditation of Organisations. Accreditation applications have a statutory timeframe of 90 working days within which the Regulator must make a decision.
Applications for certification of physical containment facilities in accordance with the Regulator’s Certification Guidelines also have a statutory timeframe of 90 working days.
Applications can be made to the Regulator under section 184 of the Act for specified information (that has not previously been made public) to be declared as confidential commercial information (CCI). The extent of CCI claims can be the subject of considerable discussion with the applicant and may require the OGTR to independently verify what information is already in the public domain. The Act does not assign a statutory timeframe for the Regulator to make a decision on CCI applications and the evaluation of a licence application may be paused if significant CCI claims need to be resolved. During 2009–10, the Regulator made five CCI declarations; decisions on nine CCI applications were pending at 30 June 2010.
Surrender of licences and certifications usually occurs when dealings have concluded. Before surrender is approved, the Regulator must be satisfied that all conditions (for example, post-harvest monitoring) have been met and that any required cleaning and/or decommissioning of facilities has taken place. The OGTR received 109 surrender requests during 2009–10 and approved 121. These included approval of 104 applications for surrender of certifications of facilities, and approval of seven applications to surrender DNIR licences as well as approval of five applications to surrender DIR licences.
The Regulator or holder of an instrument (licence, certification or accreditation) issued under the Act can initiate variations to these instruments. Variations to licences range from minor changes to a dealing, such as a change of project supervisor, to major changes, such as a request to grow the GM crop in an additional or new site. Variations also include evaluation of changes arising from renovations to a certified facility or new methods to handle GMOs.
During 2009–10, the Regulator approved 259 certification variations. Approximately 58 per cent of these were to renew facilities previously certified for five years; 19 per cent were to add or remove rooms from the area certified; 15 per cent were to vary standard conditions of certification; and 4 per cent were to change the facility title.
Applications may be withdrawn for various reasons, including when research has changed direction, when the dealings are incorporated within other authorisations, where the application did not meet the specified requirements and/or when the project has no prospect of progressing (for example, unsatisfactory research results, lack of funding).
During 2009–10, the Regulator issued eight DIR licences and at 30 June 2010 he was considering a further seven licence applications (see Table 9). Five of the eight approved applications for DIR licences were received before 1 July 2009. All licences were completed within statutory timeframes (see Table 5, Chapter 2).
Six of the DIR licences approved in 2009–10 were for limited and controlled release of GM plants, and continued the trend of applications focusing on traits intended to provide benefits to agricultural production. DIR licences were issued for limited and controlled releases of GM plants modified to improve tolerance to abiotic stresses, enhance nutrient uptake and to improve agricultural management of crops. The GM plants included wheat, barley and sugarcane.
GM traits intended to provide benefits to consumers are also evident in DIR research work, with one DIR licence involving GM wheat and barley with altered grain composition. Another DIR licence issued included research on GM sugarcane aimed at increasing sucrose accumulation and enhancing efficiency of biofuel production from cellulose.
In addition, one DIR licence was issued for a limited and controlled release to trial a GM vaccine designed to prevent certain childhood respiratory diseases.
A commercial release of a GM cotton modified for insect resistance was also approved in 2009–10.
Of the 10 DIR applications received in 2009–10, four were submitted by private companies, three by government agencies and three by universities. Of the 83 DIR licences issued since commencement of the Act, 43 (51%) have been to private companies, 32 (39%) have been to government agencies, and eight (10%) to universities (see Figure 2).
Table 9: DIR applications approved, 2009–10
|DIR number||Applicant||Parent organism||Introduced trait||Type of release||Date received||Date issued|
|DIR-102||University of Adelaide||Wheat and barley||Abiotic stress resistance and enhanced nutrient utilisation||Limited and controlled release||10-12-2009||29-6-2010|
|DIR-100||CSIRO||Wheat||Enhanced carbon assimilation, grain weight, heat tolerance and/or water use efficiency, herbicide tolerance||Limited and controlled release||11-11-2009||23-6-2010|
|DIR-099||CSIRO||Wheat and barley||Altered grain composition, nutrient utilisation efficiency||Limited and controlled release||9-11-2009||11-6-2010|
|DIR-097||PPD Australia Pty Ltd||Bovine Parainfluenza Vaccine||Attenuation, foreign antigen expression||Limited and controlled release||22-6-2009||15-1-2010|
|DIR-096||BSES Limited||Sugarcane||Herbicide tolerance||Limited and controlled release||14-4-2009||11-11-2009|
|DIR-095||BSES Limited||Sugarcane||Altered plant growth, enhanced drought tolerance, enhanced nitrogen use efficiency, altered sucrose accumulation, and improved cellulosic ethanol production from sugarcane biomass||Limited and controlled release||18-12-2008||24-7-2009|
|DIR-094||CSIRO||Wheat and barley||Enhanced nutrient utilisation efficiency||Limited and controlled release||16-12-2008||10-7-2009|
|DIR-091||Dow AgroSciences Australia Pty Ltd||Cotton||Insect resistance||General and commercial release||23-7-2008||25-11-2009|
Figure 2: DIR licences issued since commencement of the Act
Much of the research conducted under DNIR licences is aimed at improving the understanding of the mechanisms of disease, including the ways in which pathogenic organisms cause disease and how host organisms respond to infection. Other areas of research explore the normal and abnormal operation of fundamental biological processes, such as organ development, in order to understand diseases such as cancer. Some DNIR licences involve dealings to investigate how to detect and prevent disease and can involve production of diagnostic agents and therapeutic products for use in clinical trials.
DNIR licences include research with human and animal pathogens. Dealings with GMOs where the parent organism is classified as Risk Group 2 under the AS/NZ Standard 2243.3:2002 Safety in laboratories, Part 3: Microbiological aspects and containment facilities are usually required to be conducted in certified PC2 facilities while GMOs derived from Risk Group 3 organisms require certified PC3 facilities. A high proportion of research conducted under DNIR licences may never lead to release of the GMOs to the environment under a DIR licence.
In 2009–10, the Regulator approved 18 DNIR licence applications (see Table 10). All were assessed within the statutory timeframe of 90 working days. The Regulator was considering a further eight DNIR applications at 30 June 2010. The research focus of DNIRs approved in 2009–10 is shown in Figure 3.
Figure 3: Research focus of DNIRs approved in 2009–10
Three DNIR licence applications approved dealings with GMOs for pre-clinical development of vaccines against cancer and infectious diseases. Eight DNIR licences authorised dealings with GM viral vectors for basic and applied research into treatment of human diseases and seven licences were approved for study of virulence and replication of human and animal pathogens.
Five DNIR applications were withdrawn during the reporting period. In most cases, the OGTR determined that the proposed dealings were more appropriately classified as lower risk work (NLRD). The submission of applications for the higher classification reflects the cautious approach of researchers and accredited organisations.
Most DNIR licences issued in 2009–10 were to publicly funded organisations, the largest group of which was universities. Government and health service/hospitals were also represented, with two DNIR licences.
Table 10: DNIR applications approved, 2009–10
|DNIR number||Applicant||Title||Date received||Date approved|
|DNIR-483||University of Queensland||Manipulation of the immune system in mouse skin using immunoregulatory cytokines||25-1-2010||1-6-2010|
|DNIR-482||Telethon Institute for Child Health Research||Comparative analysis of human and kangaroo Leishmania: defining human pathogenicity genes||18-1-2010||28-5-2010|
|DNIR-480||University of Queensland||In vivo modification of target cell populations to study signalling pathways||17-12-2009||5-5-2010|
|DNIR-479||University of Melbourne||Modulation of brain activity for understanding cardiovascular diseases||18-11-2009||30-3-2010|
|DNIR-478||Australian National University||Interferon-adjuvanted flavivirus vaccine||11-11-2009||23-3-2010|
|DNIR-477||Children, Youth and Women’s Health Service||Human immunodeficiency vaccine studies||23-10-2009||12-4-2010|
|DNIR-476||Murdoch Childrens Research Institute||Developing lentiviral vectors for gene therapy of friedreich ataxia||21-10-2009||2-3-2010|
|DNIR-475||Bernard O’Brien Institute of Microsurgery||Targeting NADPH oxidase in angiogenesis||8-10-2009||15-2-2010|
|DNIR-474||University of Melbourne||The impact of influenza A virus PB1-F2 protein on host immunity and potential for therapeutic targeting||24-9-2009||15-1-2010|
|DNIR-473||University of Melbourne||Cardiovascular reactivity to stress: role of redox signalling in the hypothalamus and brainstem||14-8-2009||21-12-2009|
|DNIR-472||University of Queensland||Vector competence studies on selected flavivirus mutants||6-7-2009||9-11-2009|
|DNIR-471||University of Sydney||Adeno-associated virus expression of immunosuppressive genes in rodent livers||15-7-2009||16-10-2009|
|DNIR-470||University of Melbourne||Pathogenesis in staphylococcus aureus||13-7-2009||13-11-2009|
|DNIR-469||University of Melbourne||Complementation of mycobacterium spp. and streptomyces spp with genes required for the synthesis of mycolactones||13-7-2009||26-10-2009|
|DNIR-468||Queensland Institute of Medical Research||Investigation of malaria parasite proteins||8-7-2009||30-10-2009|
|DNIR-467||St Vincent’s Institute of Medical Research||The role of LIMK1 and its interacting proteins in cancer metastasis||17-6-2009||13-10-2009|
|DNIR-465||South Eastern Sydney and Illawarra Area Health Service||Investigation of polymerase (PB1) fidelity from different influenza strains||19-5-2009||6-9-2009|
|DNIR-463||Griffith University||Engineering anaerobic bacteria for multimodal cancer therapy||30-3-2009||30-9-2009|
Figure 4: Types of organisations that received DNIR licences in 2009–10
NLRDs involve genetic modifications that are unlikely to significantly increase the virulence, infectivity or pathogenicity of the original organism. Most NLRDs involve research into the fundamentals of cellular process and are mostly undertaken in PC2 facilities. As a result of the 2007 amendments to the Regulations, certain NLRDs can now be conducted in PC1 facilities.
Dealings classified as NLRDs are listed in Schedule 3 Part 1 (NLRDs appropriate for PC1 facilities) and Schedule 3 Part 2 (NLRDs appropriate for PC2 facilities) of the Regulations. Conduct of NLRDs does not require prior authorisation from the Regulator but the dealings must have been assessed by an IBC as meeting the NLRD classification, must not involve intentional release of GMOs into the environment, and must comply with the requirements specified in the Regulations.
The Regulator received 629 NLRD notifications during 2009–10. Of these, 609 were for NLRDs assessed as meeting NLRD classification by IBCs during 2009–10. Twenty were additional NLRDs reported by IBCs for dealings assessed before 1 July 2008.
A considerable proportion of NLRD work is primarily for research purposes only and not intended for commercialisation. It includes examination of how complex processes, such as cell function, gene expression and disease progression, occur. Therefore, as with dealings undertaken through DNIR licences, work undertaken as NLRDs may never proceed beyond contained research.
Sections 78 and 79 of the Act allow the Regulator to place GMOs on the GMO Register provided they have been licensed, pose minimal risks to people or the environment, and are safe for anyone to use without the need for a licence.
During 2009–10 the Regulator received no applications to place any dealings on the GMO Register and none were under consideration.
An Emergency Dealing Determination (EDD) is a legislative instrument made under the Act; the Regulator does not make an EDD. Sections 72A to 72E of the Act, which commenced on 1 July 2007, give the responsible Minister the power to expedite an approval of dealings with a GMO in an emergency. This recognises that situations may arise in which a rapid approval of a dealing with a GMO may be required. An EDD can only be made to have effect for up to six months but may be extended by the Minister. The emergency provisions further the object of the Act: to protect the health and safety of people and to protect the environment.
Before making an EDD, the Minister must be satisfied that: (a) there is an actual or imminent threat to the health and safety of people or to the environment; (b) the dealings proposed to be specified in the EDD would, or would be likely to, adequately address the threat; and (c) any risks posed by the dealings proposed to be specified in the EDD are able to be managed in such a way as to protect the health and safety of people and to the environment.
The Minister must have received advice in relation to (a) (the threat) and (b) (addressing the threat) from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, or the Commonwealth Chief Plant Protection Officer; and in relation to (c) (management of risks) from the Gene Technology Regulator. The states and territories must also have been consulted.
Under the Act, the Regulator has powers to monitor compliance with the conditions of the EDD.
During 2009–10, the Regulator did not receive any requests for advice in relation to making any EDDs, and none were in effect.
As at 30 June 2010, 159 organisations were accredited. These ranged from organisations with one IBC overseeing a few NLRDs to large organisations with several IBCs conducting a range of dealings with GMOs at multiple locations.
Although companies comprise the largest proportion (33%), of all accredited organisations, Figure 5 shows that 67 per cent of accredited organisations are primarily public sector funded. This is similar to last year and the largest single group of these is universities.
Figure 5: Organisations accredited as at 30 June 2010, by type of organisation
Eight new organisations were accredited in 2009–10 (see Table 3, Chapter 2). Newly accredited organisations were SGS Australia Pty Ltd, AstraZeneca Pty Ltd, Calimmune Australia Pty Ltd, vivoPharm Pty Ltd, Australian Centre for Plant Functional Genomics Pty Ltd, The Royal Women’s Hospital, ANZAC Health and Medical Research Foundation, and Asbestos Disease Research Institute.
Accreditations surrendered during 2009–10 were from Stem Cell Sciences Limited, Cytopia Pty Ltd, and Cerylid Pty Ltd.
Figure 6: Organisations accredited as at 30 June 2010, by location of headquarters
Physical containment (PC) facilities are classified according to levels of stringency in the containment measures for GMOs. The classifications relate to structural integrity of buildings and equipment used as well as the handling practices employed by those working in the facility. Level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment. PC4 facilities provide the most secure and stringent containment conditions. The type and number of facilities certified as at 30 June 2010 are provided in Table 11.
As a result of amendments to the Regulations that took effect on 1 July 2007, which now permit certain NLRDs (including knockout mice and rats) to be conducted in PC1 facilities, the percentage of certified PC1 facilities at 30 June 2010 is now approximately 13 per cent of all certified facilities, up significantly from 2 per cent as at 30 June 2007.
Consequently, the percentage of PC2 facilities has fallen to 85 per cent at 30 June 2010, from 95 per cent at 30 June 2007. Most (68%) certified PC2 facilities are laboratories that mainly handle microorganisms (such as certain bacteria or viruses) and cell tissue cultures while other PC2 facility types incorporate requirements specific to handling particular organisms (for example, animals 14 per cent, plants 10 per cent, aquatic 1 per cent, and arthropods 2 per cent).
PC3 facilities comprise approximately 2 per cent of the total number of certified physical containment facilities respectively, while only three PC4 facilities were certified to conduct work with GMOs at 30 June 2010.
During 2009–10, 182 physical containment facilities were certified (see Table 3, Chapter 2).
Table 11: Number of facilities certified as at 30 June 2010, by physical containment level and type
|Constant temperature room||70||70|
|Large grazing animal||35||35|
OGTR certified physical containment facilities are located in all Australian jurisdictions (see Figure 7). The relatively large proportion of facilities in the Australian Capital Territory relates to the significant level of research undertaken by the CSIRO, and the Australian National University.
Figure 7: Physical containment facilities certified as at 30 June 2010, by location
Physical containment facilities range from a small, single room to a large suite of contiguous laboratories and associated support rooms that are encompassed by one certification instrument. In one year a single organisation can redevelop its old containment facilities and build a new building, thereby skewing the proportion of applications received from that organisation type in a given year. While companies form the largest proportion of accredited organisations (33%), they submit the least number of applications for certification (less than 4%). This reflects the commercial focus of company dealings, as opposed to the greater research focus of universities, where most dealings require physical containment.
Table 12 shows a return to average approvals of DIR and DNIR licences, and certifications and accreditations.
The increase in the number of NLRDs is a continuation of an upward trend that flows from introduction of new categories of PC1 NLRDs in July 2007. The July 2007 Regulation changes also saw introduction of annual reporting of NLRDs to the Regulator. NLRDs assessed by IBCs during 2007–08 were received in the OGTR during 2008–09, hence the low number received in 2007–08. Likewise, the NLRDs assessed by IBCs in 2008–09 were received in the OGTR during 2009–10.
Table 12: Trend data for main types of applications, 2006–07 to 2009–10
The Regulator’s quarterly reports3 provide detailed information, on a quarter-by-quarter basis, of monitoring inspections the OGTR conducted. This section provides information on the range of inspection activities the OGTR conducted during 2009–10.
The OGTR strategy for conducting field trial monitoring draws on accumulated operational experience of compliance risk profiling4.
During 2009–10, 16 accredited organisations held the 55 DIR licences in force. Six licences were for commercial release of GMOs. These licences do not impose conditions that necessitate monitoring. Four were for disease–vaccine trials, and 45 were in force for limited and controlled trials of GM crop varieties. The OGTR inspected 21 of the 45 licences for limited and controlled trials of GM crop varieties. Each licence may contain a number of trial sites.
The OGTR’s operational objective is to monitor 20 per cent of all limited and controlled field trial locations annually. A further target within this operational benchmark is to inspect 5 per cent of all limited and controlled field trial sites during each quarter of the year. In 2009–10, the Monitoring Section exceeded the operational benchmark and either met or exceeded the quarterly objectives. At the beginning of 2009–10, 64 licensed field trial sites were operating, 18 of which were current, and 46 of which were subject to post-harvest monitoring conditions. The Monitoring Section inspected 34 sites during 2009–10, 16 current and 18 post-harvest monitoring sites representing 53 per cent of total sites, thereby exceeding the minimum target of 20 per cent of field trial sites each year (see Table 5, Chapter 2). A breakdown of the number and proportion of inspections is given in Table 13.
Table 13: Number and proportion of inspections performed in each quarter of 2009–10
|Quarter||No. and proportion of current sites inspected||No. and proportion of PHM sites inspected|
|July–September 2009||6/18 (33%)||5/46 (11%)|
|October–December 2009||2/22 (9%)||5/40 (13%)|
|January–March 2010||4/28 (14%)||3/41 (7%)|
|April-June 2010||4/20(20%)||5/46 (11%)|
The licences in force authorised the limited and controlled release of a range of crop and plant types including GM barley, banana, canola, cotton, grapevine, Indian mustard, maize, papaya, perennial ryegrass, pineapple, sugarcane, tall fescue, torenia, wheat and white clover. Although licences were in force, planting has not occurred in all cases. Cotton was the most prevalent crop, collectively trialled at 24 sites. The OGTR performed 34 inspections of field trial sites across eight crop types during 2009–10 (see Table 14 and Figure 8).
Table 14: Number of licensed DIR sites, by crop type/parent organism at beginning of 2009–10 and end of 2009–10; and number of inspections conducted during the period
|Crop type/parent organism||No. of DIR trial sites at beginning of 2009–10||No. of DIR trial sites at end of 2009–10||No. of DIR trial sites inspected in 2009–10|
|Canola, Indian mustard*||3||3||0|
|Perennial ryegrass/tall fescue*||1||1||0|
|Wheat and barley*||1||3||3|
Figure 8: Number of DIR field trial sites inspected in 2009–10, by crop type
During each year, the status of limited and controlled trials of GM crops undergoes significant change; new trials are planted, some trials are harvested and enter into a post-harvest monitoring period, and licence obligations for other trial sites cease. When the latter occurs, OGTR signs off the location as having completed all necessary licence obligations.
Figure 9 provides a summary of the number of field trial sites at the beginning and end of 2009–10, and the transition of location status during the year.
Note: PHM = post-harvest monitoring
During 2009–10 the OGTR undertook 34 inspections in 64 field trial sites (see Table 15) across a number of states and territories. Queensland (22) and Victoria (19) contained the highest numbers of trial sites. Victoria contained the highest numbers of plant/crop types with eight different species being trialled. Figure 11 shows the location and diversity of field trials and includes information on the local government areas where trials proceeded.
Table 15: Number of field trial sites and OGTR inspections in 2009–10, by state and territory
|Jurisdiction||No. of field trial sites, as at 1 July 2009||No. of field trial sites inspected during 2009–10|
|New South Wales||16||9|
|Australian Capital Territory||2||3|
Figure 10: Location by local government area and field trial types during 2009–10
The Monitoring Section performed inspections in four states and one territory (see Figure 11), reflecting the higher proportion of field trial sites in those states. Of the 25 local government areas where field trials took place in 2009–10, OGTR inspected trials in 15 (see Figure 12).
Figure 11: Number of field trial sites inspected in 2009–10, by state and territory
Figure 12: Field trial sites and locations inspected in 2009–10, by local government area
The monitoring program also encompasses dealings conducted in contained facilities under DNIR licences, as NLRDs, and exempt dealings. As part of these activities a minimum of 20 per cent of higher-level physical containment (PC) facilities (PC4, PC3 and PC2 large-scale) are monitored annually.
As well as examining the integrity of the physical structure of the facility, inspections also cover the general work practices employed in handling DNIR and NLRDs.
At the end of 2009–10, 128 accredited organisations held 1951 certification instruments for containment facilities. During the course of the year, certified facilities operated by 19 accredited organisations were monitored. For the purposes of monitoring, certified facilities are grouped into higher and lower containment types; that is, PC4, PC3 and PC2 large-scale laboratories are categorised as higher-level containment facilities, and the remaining facility types are categorised as lower-level containment facilities. The OGTR conducted 40 inspections across the range of facility types (see Table 16). Of the 54 higher-level containment facilities that had certification instruments in force at the beginning of 2009–10, 12 were inspected. This figure represented 22 per cent of higher-level containment facilities and exceeding the minimum target of inspecting 20 per cent of such facilities each year (see Table 5, Chapter 2).
In addition, 21 DNIR licences that were in force during the reporting period were monitored.
Table 16: Number of certification types at end of 2009–10 and inspections conducted during the period
|Containment type||Physical containment level and facility type||No. of certifications||No. of inspections|
|Lower-level containment facilities||PC1 Large grazing animal||35||0|
|PC2 Aquatic organism||23||0|
|PC2 Constant temperature room||70||0|
|PC2 Large scale||17||1|
Certified facilities are located in each Australian state and territory (see Figure 13). In 2009–10, monitoring activities were carried out in each, except Tasmania and the Northern Territory (see Figure 14). The number of OGTR inspections of facilities reflects, as far as practicable, the number of facilities located in each state and territory.
Figure 13: Number of certified facilities as at 2009–10, by state and territory
Figure 14: Number of certified facility inspections in 2009–10, by state and territory
Of the five OGTR categories of applicant organisation, universities held the greatest number of certifications during 2009–10 (see Figure 15). In 2009–10, monitoring activities were carried out in each category (see Figure 16). The number of OGTR inspections of facilities in each category reflects, as far as practicable, the number of facilities present in each category.
Figure 15: Number of certified facilities as at 2009–10, by organisation type
Figure 16: Number of certified facility inspections in 2009–10, by organisation type
During 2009–10, the regulated community demonstrated a high level of compliance with gene technology legislation (see Table 5, Chapter 2).
In conducting routine inspections, the OGTR found inconsistencies between an event or state of affairs and the requirements imposed by licence or certification conditions, which are referred to here as non-compliances. However, non-compliance is not regarded as a breach of the Act unless, after investigation, it is proven to be so. Each incident of non-compliance was assessed according to established OGTR protocols and found to present negligible risk to human health and safety or to the environment5.
The Regulator’s response to all non-compliance incidents is informed by the OGTR’s Non-Compliance Protocol to ensure consistent responses proportional to the risks posed to human health and safety or to the environment.
This section provides a summary of the types of non-compliances found and the responses implemented. The results and findings of all OGTR inspections are reviewed and used to inform future monitoring activities and to continue improving accredited organisations’ compliance with the Act.
Four findings of non-compliance were identified during monitoring of DIR licences during 2009–10. These non-compliances related to transport of material to an unapproved location, planting of unapproved crops, failure to destroy plant material according to licence conditions, incorrect transport procedures and contraventions of reporting requirements.
In addition, four findings of non-compliance were identified during monitoring of DNIR licences. These included contraventions of the requirement for staff to undergo appropriate training and provide signed statements, conducting dealings in facilities not listed on the licence, and failure to update contact details as required.
A number of minor non-compliances were also identified during routine monitoring of containment facilities (see Table 17). Non-compliances in such facilities were due to defects in structural components of facilities, defects and incorrect maintenance and operation of equipment and incorrect transport procedures.
Table 17: Number of non-compliances identified in certified facilities during 2009–10, by non-compliance type
|Nature of non-compliance||No. of non-compliances|
|Personal protective equipment||1|
In all instances the Regulator determined that findings of non-compliance presented negligible risk to human health and safety or to the environment, were minor in nature, involved negligible or zero culpability, and were resolved by reminders, education and/or cooperative compliance.
The OGTR recognises that both compliance and enforcement mechanisms are necessary to provide an effective and flexible regulatory system that enables the most appropriate response to be chosen for a given issue or incident. The OGTR Compliance and Investigation Section assesses and manages contraventions of the Act through:
During 2009–10, the OGTR undertook a number of investigations, audits and practice reviews. They are discussed below.
During 2009–10, three cases of non-compliances (alleged breaches) with the gene technology legislation required formal investigation; all were investigated within the 10 working day target (see Table 2, Chapter 5). The Queensland Institute of Medical Research made one self-report about a possible non-compliance occurring in relation to an NLRD. Details about this investigation were provided in the 1 October to 31 December 2009 Quarterly Report to Parliament. The other two were investigated and found to be unsubstantiated.
An allegation that do-it-yourself biological researchers were conducting dealings under the Act. While no evidence was found to support the allegation at that time, a number of people with a possible interest in do-it-yourself biological research were identified. These parties were advised about the compliance requirements related to dealings with GMOs. Additionally, the OGTR has provided compliance advice for such researchers on the OGTR Monitoring and Compliance website page.
The Biosecurity Service Group (BSG) of the Department of Agriculture, Forestry and Fisheries (now incorporating the Australian Quarantine and Inspection Service) refers any possible importations of suspected GM ornamental fish to the OGTR for assessment. No offence applies where the importation of a GMO is not intended, and where the importation is terminated during the importation through voluntary surrender of the organisms for humane destruction. Where necessary, the OGTR provides biological testing to determine the GMO status of these imports. During 2009–10, importers voluntarily surrendered all imports found to be genetically modified to BSG for humane destruction. A small number of importers voluntarily surrendered imports to BSG for destruction without testing.
Three audits were conducted in 2009–10. The audited parties were Cargill Australia Pty Ltd, Imugene Pty Ltd and Flinders University. The audits confirmed that the audited parties’ compliance management arrangements were adequate to support compliance under the national regulatory system. In each case, the audit team proposed a number of compliance performance risk management techniques to be considered as part of ongoing improvement. As part of these audits, the audited parties also contributed to the 2009–10 People Management Practice Review discussed below.
A People Management Practice Review was conducted to assess the policies, instructions, procedures and corporate culture of organisations in relation to people management risks to compliance under the Act. The review team proposed adoption of a number of compliance risk management techniques to be considered as part of ongoing improvement.
An Equipment Practice Review has commenced into the efficacy of key equipment. It will be completed in 2010–11, and aims to assess the adequacy of the supply, use and maintenance of equipment for regulatory compliance purposes and to inform ongoing development of regulatory specifications.
In 2005, the Australian Government Biotechnology Ministerial Council endorsed a risk-based national strategy to manage the unintended presence of unapproved GMOs in imported seeds for sowing. The strategy was developed by an interdepartmental working group chaired by Biotechnology Australia and comprising the Department of Agriculture, Fisheries and Forestry; the Department of the Environment and Heritage8; the Department of Foreign Affairs and Trade; the Department of Education, Science and Training9; the Department of Industry, Tourism and Resources;10 the Department of Health and Ageing; Food Standards Australia New Zealand; and the OGTR.
The OGTR is responsible for implementing the strategy, which has six components (see Table 18) and employs a risk management approach, with resources dedicated to the areas posing the highest likelihood of unintended presence. The focus to date has been on seeds for sowing, which has been assessed as the highest priority.
In recent years, the OGTR has worked with the Australian Seed Federation to develop a voluntary auditing and testing program of existing industry quality assurance measures and has assessed the effectiveness of the first stage of reviews completed in 2007. No issues of concern were identified for the five companies that participated in the quality assurance reviews.
In 2010, the OGTR commenced quality assurance reviews of Australian and state government breeding programs. The breeding programs of the Tasmanian Department of Primary Industries, Parks, Water and Environment; the Victorian Department of Primary Industries; and the CSIRO’s Plant Industry Division were assessed and no issues of concern were identified.
Table 18: Components of national strategy for unintended presence of unapproved GMOs
|Risk profiling – identifying seed imports posing the highest likelihood of unintended presence||The OGTR has established a memorandum of understanding with BSG (formerly AQIS) to access data on imports. Data on imported seeds for sowing, together with information on overseas commercial production of GMOs and input from the Department of the Environment, Water, Heritage and the Arts, and other relevant agencies was used to identify 12 priority crops.|
|Quality assurance and identity preservation||Industry uses quality assurance and identity preservation systems for seed quality purposes. The OGTR has developed a program for auditing and testing industry quality assurance systems that industry has agreed and adopted.|
|Laboratory testing||The OGTR’s voluntary code of conduct refers to industry testing programs. Industry needs to be able to assure itself that it is managing the risk of importing unapproved seeds. Discussions between the OGTR and the National Measurement Institute about appropriate testing methodologies are ongoing.|
|Approvals/advance risk assessments for Australia’s regulatory agencies||The OGTR has prepared GMO incident response documents for 12 crops identified through risk profiling as having the highest likelihood of unintended presence in imports of seeds for sowing (canola, cotton, maize, potato, tomato, papaya, soybean, squash, alfalfa, grasses, rice and wheat). These documents will provide a basis for rapid risk assessment and management actions, should an unintended presence of an unapproved GMO be detected.|
|Post market detection||The OGTR recognises the legislative limitations of preventing unintended imports of unapproved GMOs and has worked cooperatively with industry to develop a voluntary code. The code aims to isolate risks as early as possible in the commercial seed supply chain. This is supported by the standard OGTR practice of investigating information about potential and possible incidents.|
|Enforcement action||In the event of detection of unapproved GMOs, appropriate responses would be determined on a case-by-case risk management basis. The OGTR continues consultation with Australian Government agencies, relevant industry organisations and states and territories to develop an incident response plan.|
The Regulator’s functions, as prescribed by section 27 of the Act, include:
In order to advise GTMC about possible amendments to legislation, the Regulator initiated a technical review of the Gene Technology Regulations 2001 in 2008–09, which was progressed during 2009–10. The scope of the review was limited to issues that do not affect the policy settings of the regulatory scheme and that are consistent with achieving the object of the Act, with a primary focus on classification of GMO dealings in the exempt and notifiable low risk dealing (NLRD) categories. Proposals for amendment were developed based on operational experience of the office and a targeted stakeholder consultation undertaken in 2008–09.
GTMC provided policy approval for drafting amendments in May 2009. The Regulator sought advice from GTTAC in October 2009 on risk assessments prepared in respect of proposals for reclassification of dealings. The Office of Legislative Drafting and Publishing subsequently prepared the Draft Gene Technology Amendment Regulations 2010 based on instructions from the Regulator. The proposed changes are intended to ensure that dealings with GMOs continue to be classified appropriately according to current understanding of risks they may pose; improve the efficiency and effectiveness of the system; and help users better understand and comply with their legislative obligations. It is expected that the net effect of the proposed changes will be to reduce the regulatory burden on organisations undertaking dealings with GMOs.
In May–June 2010, in accordance with the requirements of section 142 of the Act, the Regulator undertook public consultations on the draft Gene Technology Amendment Regulations 2010. The consultation was supported by comprehensive papers explaining the rationale and intended operation of proposed changes in five key areas of amendment; specifically, classification of exempt and notifiable low risk dealings (NLRDs), classification of dealings with viral vectors, oversight of NLRDs, and administrative changes.
Advice was sought from a wide range of stakeholders including all regulated organisations and IBCs, state and territory governments, Australian Government agencies, GTTAC, and the general public. A range of stakeholders contributed 32 submissions; most indicated broad support for the proposed changes. A number of technical and other issues have been raised that will be taken into account in finalising the amendment regulations. Pending agreement of the GTMC, it is anticipated that the amendments will be made by mid 2010–11 and take effect by the end of 2010–11.
The National Health Security Act 2007 implements a scheme for regulating security sensitive biological agents (SSBAs). The SSBA Regulatory Scheme effects recommendations agreed by the Council of Australian Governments (COAG). The Office of Health Protection within the Department of Health and Ageing has responsibility for administering the National Health Security Act 2007. Because of the similarities between elements of gene technology regulation and the SSBA Regulatory Scheme, inspectors from the OGTR undertake inspections under the scheme, in line with COAG recommendations.
The Gene Technology Regulations 2001 were amended (the Gene Technology Amendment Regulations 2009) in April 2009 to allow inspectors from the existing Gene Technology Regulatory Scheme to monitor laboratories and facilities handling the SSBA for compliance with the National Health Security Act 2007.
The amendment enables payment to the Regulator for SSBA monitoring activities from the SSBA Regulatory Scheme funds. The OGTR has worked with the Office of Health Protection to develop operational monitoring requirements and inspection activities commenced from early 2009–10.
Operational policies provide information to stakeholders on the Regulator’s approach to specific issues and activities under the Act. During 2008–09 the OGTR revised the operational policies on variation of GMO licences (to clarify the Regulator’s approach to variations to these legislative instruments) and on post-harvest crops11.
During 2009–10, the OGTR completed revision of the Guidelines for the Certification of a PC3 Animal Facility after consultation with relevant stakeholders.
Revised certification guidelines issued from 2006 have been restructured to provide greater clarity about requirements to be met before certification and conditions that apply after certification. Overall, the revised guidelines adopt an outcome-oriented approach that focuses specifically on containment of GMOs. Where appropriate, the guidelines are also consistent with the requirements of Standards Australia and BSG (formerly AQIS).
The GTMC did not meet in 2009–10. The Gene Technology Standing Committee (GTSC) supports the GTMC. During 2009–10 the OGTR:
The Act provides that the term of appointment for members of the two statutory advisory committees – GTTAC and GTECCC – is for up to three years and the Minister makes the appointments. In 2009-10, the process for the nomination, selection and appointment of members for the next triennium of GTTAC and GTECCC, with the OGTR providing secretariat support. A call for nominations was placed in newspapers, on the OGTR website, and circulated to some 400 organisations and individuals in April 2010. Nominations closed on 31 May 2010. It is anticipated that new appointments will be made by mid 2010–11.
The National Framework for the Development of Ethical Principles in Gene Technology (the framework) was published in 2006 and was developed by the former Gene Technology Ethics Committee and published to provide a resource to inform and facilitate consideration of ethical issues in decision making at all levels of gene technology activity. The framework provides the Australian community, and particularly scientists working in gene technology, with a national reference point for ethical considerations.
GTECCC is currently reviewing the framework. ORIMA Research Pty Ltd was commissioned to undertake an online survey in March–April 2010 to obtain stakeholders views to inform the review. The survey was open to the public via a notice on the OGTR website. Input was also sought by direct invitation from stakeholders including:
During 2009–10 the OGTR provided advice on GMOs and GM products to other regulatory agencies and to the public.
The OGTR has memoranda of understanding with the Australian Pesticides and Veterinary Medicines Authority, Food Standard Australia New Zealand and the Therapeutic Goods Administration. These facilitate reciprocal exchange of information on assessment and approval of GMOs and GM products required by their respective legislation13.
The OGTR also has a memorandum of understanding with the Department of the Environment, Water, Heritage and the Arts, in relation to consultation with the Environment Minister on DIR licence applications prescribed under the Act.
In line with recommendations from the 2006 Statutory Review, a Regulators’ Forum has been established to promote and facilitate information sharing between these regulatory agencies and the Regulator. The forum met in November 2009 and again in May 2010 discussing a work program for enhancing overall regulatory effectiveness through improved cross-agency collaboration.
The Act requires the Regulator to maintain a record of approved GMO and GM product dealings (the GMO Record). Details of licences issued, information about NLRDs, GMO dealings included on the GMO Register, EDDs and information about GM products approved by other Australian regulatory authorities, are included on the GMO Record. The GMO Record was maintained and updated throughout 2009–10 to incorporate approvals of GMOs under the Act and GM product approvals notified to the Regulator by other agencies (see Appendix 8)14.
The OGTR maintains a comprehensive website that includes extensive information on the regulatory system and decisions made by the Regulator. This information includes a number of fact sheets on relevant issues and copies of the full risk assessment and risk management plans for each GMO released into the environment. Details of use and statistics are provided in Appendix 8.
The OGTR also has a 1800 free call number (1800 181 030) and an OGTR email address or inbox email@example.com that provide points of contact for members of the public and other interested parties. Assistance with specific questions and additional mechanisms for public feedback are among some of the services provided by these facilities. On average, 102 emails and 108 free calls were received each month in 2009–10 (126 emails and 109 free calls in 2008–09; see Appendix 8).
The OGTR maintains a client register, which is a list of individuals and organisations that have registered their interest in regulation of gene technology with the office. Members receive notifications of new GMO applications and licences issued to release a GMO into the environment, significant changes to the gene technology legislation, and an invitation to comment on consultation risk assessment and risk management plans developed for each application to release a GMO into the environment. Approximately 620 individuals and organisations are listed on the OGTR client register. Interested parties may also register on the OGTR client register to receive notifications from the Office.
During 2009–10, the Regulator and the OGTR participated in a range of presentations and meetings on gene technology wherever possible to inform users, the Australian community and stakeholders, about the regulatory system (see Appendix 7).
Under section 27 of the Act, the Regulator’s functions include:
During 2009–10, senior OGTR officials presented papers at a number of international forums about aspects of Australia’s gene technology regulatory system. This included a presentation at the Canadian Food Inspection Agency symposium ‘Getting ready for tomorrow: Integrating foresight and emerging trends into timely science advice for plant risk assessments’.
The OGTR continued to interact directly with key regulatory counterparts in many other countries through bilateral discussions and participation in international forums in 2009–10. In particular, the OGTR participated in the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology (WGHROB), providing input to a number of documents being prepared by the group. In addition, in October 2009 the WGHROB agreed to OGTR proposals to develop two consensus documents on the biology of Eucalyptus spp. and sugarcane respectively. OGTR is currently coordinating development of these documents.
The OGTR provides expert advice to the Department of Foreign Affairs and Trade on the Australian regulatory system for GMOs in relation to relevant international treaties. During 2009–10, OGTR officers participated in online conferences on risk assessment and risk management of living modified organisms under the United Nations Cartagena Protocol on Biosafety (the Biosafety Protocol) and an OGTR officer participated in a meeting of the Ad Hoc Technical Experts Group on Risk Assessment and Risk Management under the Biosafety Protocol held in October 2009 in The Hague, Netherlands, and via teleconference, in April 2010 in Ljubljana, Slovenia.
A full list of OGTR activities at international meetings, forums and conferences is in Appendix 6.
The Act requires the Regulator to undertake functions that contribute to the OGTR’s capacity to conduct high quality assessments based on regulatory best practice and relevant scientific data. Section 27 of the Act provides for the Regulator to:
The OGTR is represented on the subcommittee for revision of Australian/New Zealand Standard Safety in Laboratories, Part 3: Microbiological aspects and containment facilities to provide expertise in relation to these requirements. Involvement in this subcommittee contributes to harmonisation of OGTR requirements for physical containment facilities with those of other national agencies, such as BSG and more broadly with those organisations complying with Standards Australia.
8 Now the Department of the Environment, Water, Heritage and the Arts
9Now the Department of Education, Employment and Workplace Relations
10Now the Department of Innovation, Industry, Science and Research