Dear GTMC Secretariat
Thank you for the opportunity to provide input to the Review of the Gene Technology Act 2000 (the Act).
The legislative framework covered by the Act and related State and Territory legislation has now been operational for ten years. Its objectives are being achieved and the Australian regulatory scheme is widely respected nationally and internationally for its science-based approach with regulation appropriately based on robust risk analysis. Through pursuit of the functions prescribed in the Act, the Office of the Gene Technology Regulator (OGTR) has successfully ensures that the application of Australia's gene technology regulatory scheme both reflects and influences contemporary best practices internationally.
In line with the findings of the 2005-2006 review of the Act, this submission therefore proposes that the regulatory system is demonstrably working well and that there is no need for major revision. However, it is timely to consider opportunities for enhancements derived from the operational experience of the past ten years, particularly where they may continue to improve the efficiency of the regulatory system, enhance national coordination, and strengthen its ability to respond to new developments in areas of technology that are intended to be covered by the scheme.
Against the background, brief comments follow against the Terms of Reference for the Review, with more specific information regarding possible areas for enhancement of the operation of the regulatory scheme provided in the Attachment. High-level comments are grouped as they relate to more than one term of reference.
Effectiveness and efficiency of the operation of regulatory scheme
Whether the object of the Act is being achieved
The powers of the Act to ensure they are sufficient to achieve compliance
The national scheme for the regulation of gene technology in Australia operates within a framework that allows for constant monitoring of its efficiency and effectiveness. Reporting requirements, monitoring and compliance activities and consultation processes indicate that the powers of the Act have achieved a high level of compliance. Overall, ten years of regulatory experience has demonstrated that the current scheme has achieved the object of the Act to protect the health and safety of people and the environment.
The focus of the attached proposals is therefore on the future operation of the regulatory scheme within the scope of the states object of the Act. The Review is asked to consider the capacity of the current arrangements to respond expeditiously to challenges that may arise as a result of emerging technologies. The coverage afforded by current definitions, and the ability of the Regulator to respond in a timely and effective manner to new technology through the exercise of current discretionary powers, are important considerations in maintaining an effective and efficient regulatory system in the future.
Also with the intent of enhancing operational efficiency and effectiveness, and reflecting operational experience by the OGTR, some proposals are made for refinements to a small number of exiting provisions that are considered necessary but which might be clarifies or drafted more clearly. The Review is also asked to consider the ongoing value of some of the current administrative requirements in the Act, and whether these continue to be warranted ten years after the commencement of the scheme.
The interface between the Act and other Acts and schemes
Comments here are also relevant to part of the 'effectiveness and efficiency' term of reference. There are two key areas of interface between the Act and other acts and schemes: firstly, the interface with State and Territory legislation to form the nationally consistent scheme as articulated in the Intergovernmental Gene Technology Agreement (the Agreement), and secondly, the interface with existing product regulators such as those responsible for regulating food, therapeutic goods and agricultural and veterinary chemicals.
By and large, both of these areas of interface have worked well, to provide effective national regulatory coverage of the gene technology in a manner that avoids unnecessary duplication. However, it is submitted that there is scope for improvement to enhance the future achievement of national consistency and to clarify some aspects of the interface with different regulators on regulatory coverage of GMOs.
In the context of the Agreement, the constitutional reach of the Commonwealth Act and the existence of corresponding legislation in most jurisdictions ensure that the great majority of dealings are well covered by the national scheme, although the nature of coverage of some dealings with GMOs by certain individuals and by State agencies in jurisdictions without corresponding law may be uncertain. Accordingly, the attached proposals encourage the Review to consider possible approaches to ensuring that all relevant activities in all jurisdictions are fully covered as anticipated in the terms of the Agreement and to use all provisions available under the Commonwealth Act to confirm effective regulatory coverage throughout Australia. The Review is also asked to clarify expectations with respect to responsibilities for certain types of GMOs by different regulators.
The consultation provisions of the Act
Transparency, including widespread consultations on key aspects of the regulation of GMOs, is an important feature and a particular strength of the regulatory system. Consultation provisions are approximately included in several sections of the Act, and operational practice has consistently been to exceed these provisions. However, there is one specific aspect of the consultation provisions that warrants reconsideration.
Over the past decade, there have been major advances in communication technologies that have affected the relevance and impact of print media. It is suggested that the Review considers whether the requirement of the Act to publish notifications in newspapers remains a necessary or effective means of communication with the public. Making the requirements for the methods used to conduct public consultation less prescriptive, while maintaining the general requirement for consultation, would help to optimise the cost-effectiveness and efficiency of public considerations.
It is perhaps more appropriate that other stakeholders of the regulatory scheme comment on the issue of regulatory burden. However, it is noted the the gene technology regulatory scheme is applied practicably in accordance withthe requirementso f the Act, and in a manner that is firmly based on a sound, science-based assessment and management of risk. In this regard, the Act provides for different classifications of dealings with GMOs and a range of regulatory approaches depending on the type of dealings. For example, dealings may reange from being exempt and notifiable low risk dealings, through to those which require more extensive regulatory oversight in the form of comprehenice licences with application-specific conditions. The Act provides for ongoing review of these classifications based on understanding of risk, with the most recent being the Gene Technology Regulator's review of the Gene Technology Regulations which were amdended on 2 June 2011. It is also noted that any proposed changes to the Regulations or to guidelines that the Regulator may pursure in the course of implementing the regulatory scheme are all considered by the Office of Best Practice Regulation in relation to regulatory impact.
Through mechanisms such as this, there is an existing mechanism to ensure that regulatory oversight remains commensurate with risk. However, there may be some benefit in considering mechanisms to facilitate mroe timely amendments to regulatory requirements when new information supports a revised risk classification for a particular type of activity.
Overall, it is suggested that the gene technology regulatory system as articulated in the Act and related legislation continues to function effectively and efficiently, and demonstrably so. However, there is a small number of areas where it could be enhanced to improve its operation. I would welcome the opportunity to discuss this submission, and any other areas of interest, with the Review team.
Dr Joe Smith
Gene Technology Regulator
14 June 2011
2011 REVIEW OF THE GENE TECHNOLOGY ACT 2000
The framework provided by the Gene Technology Act 2000
(the Act) and associated State and Territory legislation has provided a sound basis for the effective regulation of the gene technology in Australia in the ten years since its commencement. The legislative scheme has demonstrably achieved the object of the Act to protect the health and safety of people, and to protect the environment, by identifying risk posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.
Moreover, it has achieves this legislated goal efficiently and effectively, through a robust, science-based and internationally respected approach to regulation that is firmly grounded in contemporary risk assessment and risk management methodology. There have been no threats to public health or the environment since the regulatory scheme began, and ongoing monitoring and reporting confirms a sustained, high level or compliance with specific performance objectives related to compliance with regulatory requirements and efficient regulatory oversight of dealings with genetically modified organisms (GMOs).
Against this background, however, a number of specific areas have been identified where there are opportunities for enhancements which draw on the operational experience of the Office of the Gene Technology Regulator (OGTR) over the last ten years. In particular, proposals for consideration by the Review relate to strengthening the ability of the scheme to respond to relevant new developments in technology, improving efficiency in certain areas, and enhancing national coordination.
The comments that follow are grouped into four general areas, each of which relates to one of more of the Terms of Reference identified for the review, as follows:
(i) New and emerging technologies
(ii) A nationally consistent scheme
(iii) Definitions of certain dealings
(iv) Enhancing operational efficiency and effectiveness
(i) New and emerging technologies
The boundaries of regulatory arrangements associated with the application of gene technologies are being challenged by the emergence of new technologies, and it is timely to consider whether the Act provides the necessary flexibility to respond adequately and quickly to accommodate these challenges. Overarching definitions of technologies requiring regulatory coverage are given in the Act, while more specific details are provided in the Regulations.
Many jurisdictions throughout the world have put in place legislative schemes to regulate genetically modified organisms. The question of defining what is subject to regulation is both legal and scientific. The definitions adopted by different countries vary but they have many commonalities and, the for types of GMOs being considered when the Act was first implemented, all achieve broadly similar coverage, for example for plants modified by the insertion of recombinant gene sequences often comprising DNA from two or more unrelated species - 'trans'-genic organisms and which were clearly distinct from conventional plant, animal or microbial breeding processes. However, in the decade since the Act commenced there have been significant advances with a range of new techniques that can be applied to achieve genetic changes in organisms, There has also been an increasing focus on approaches to generate new genetic variants,especially in plants, which do not involve the introduction of foreign DNA and/or which involve very small changes, for example the so-called 'cis'-genic modifications. The development of organisms using these techniques, and the progress towards potential environment release, has been accompanied, internationally, by legal consideration as to whether these new technologies are subject to regulation in different jurisdictions as well as scientific debate as to whether organisms derived from the new technologies should be subject to the same regulatory oversight as the 'classical' transgenic/recombinant organisms for which legislation was originally developed.
For example, in 2008, the European Commission (EC 2008_ established a working group to evaluate a list of new technologies for which it is unclear if they are subject to regulation under EU legislation and the techniques being considered include:
- Zinc Finger Nuclease Technology (ZFN)
- Oligonucleotide Directed Mutagenesis (ODM)
- Cisgenesis (comprising Cisgenesis and Intragenesis)
- RNA-dependent DNA methylation via RNAi/siRNA
- Reverse Breeding
- Synthetic Biology
The advent of these new techniques may also present challenges in relation to harmonisation of regulation internationally if they are subject to regulation in some jurisdictions but not others. For example, the US Environmental Protection Agency recently proposed to exempt from regulation cisgenic plants developed "when genetic material is transferred, using bioengineering technology, between plans that could transfer the genetic material naturally" (US Federal Register 2011, 76 FR 14358). Scientists have argued both for (eg Prins and Kok 2010) and against ) eg Shouten et al 2006) the regulation of cisgenic plants.
In this context it may also be noted that the functions of the Regulator under the Act include: "to promote the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies" (s27(i)) and "to monitor international practice in relation to the regulation of GMOs" (s 27(j)).
The OGTR has received an increasing number of queries from the regulated community over the last few years regarding whether novel organisms developed through the use of some of these new techniques would be subject to regulation under the Act. In liaisons with colleagues from regulatory agencies in other countries similar questions have also been discussed.
The challenge is not related to the capacity to assess potential risks associated with novel technologies that are indisputably within the regulatory reach of the Act. However, new technologies may challenge the capacity of existing definitions in relation to the intended regulatory reach indicated by the object of the Act. The Act already contemplate such challenges by providing for the Regulations to modify the definitional reach of the legislation. Accordingly, pursuant to current definitions, the Regulations can
- Exclude (but not include) a gene technology technique from regulation
- Declare a thing to be a GMO
- Declare a thing not to be a GMO
However, the use of the Regulations as a means of modifying the definitional reach of the Act can have no effect until the requirements of the Gene Technology Agreement and of the Legislative Instruments Act 2003
are discharged. Based on past experience with the introduction of new regulations, these periods are likely to be protracted, up to twelve to eighteen months. Therefore, the capacity to expeditiously assess and address the potential risk of new technologies intended to be regulated under the Act, but arguably falling outside current definitions, may remain uncertain for significant periods.
For example, a number of recent techniques for site specific mutation of plants, including ZFN technology or ODM, allow single nucleotide changes to be made in a DNA sequence-specific way without the direct insertion of any introduced DNA into the genome of the organism. The definitions of the Act (and of other jurisdictions) are framed to preclude regulation of natural processes. For example, the definition of 'gene technology' excludes 'homologous recombination' (a natural phenomenon); however some of these new techniques involve the directed use of homologous recombination, thereby making status of the resulting organisms uncertain. There may also be uncertainty about the application of current definitions in the Regulations, which could be interpreted to exclude the resulting organisms in some cases. These techniques may be used to generate organisms with defined genetic changes that might otherwise meet the criteria for a GMO.
The purpose of these comments is not to propose amendments to the Act and Regulations to capture such technologies automatically, However, with the continues development of new techniques, it may be desirable to provide a mechanism to facilitate more expeditious clarification of the need for, and degree of, regulatory oversight of the resulting organisms, where that is consistent with the scope and object of the Act.
The existing constraints on a more timely response to new technologies are also not in the interests of the regulated community. Stakeholders wishing to ascertain the regulatory requirements associated with proposals involving the application of emerging and new gene technologies are disadvantaged where the Regulator is unable to provide advice with legal certainty until requisite legislative amendments are in place.
In asking the Review to consider this matter is it submitted that arrangements capable of expeditiously removing uncertainty about regulatory reach will not only assist with the timely management of relevant risks but will promote the efficiency and effectiveness of the regulatory scheme in accordance with the aspirations for the regulatory framework as expressed in section 4 of the Act. Use of legal instruments capable of being amended in a timely manner at the discretion of the Regulator and amenable to scrutiny by expert committee and by way of appeal rather than under requirements of the Legislative Instruments Act 2003
and the Gene Technology Agreement may be an option for the Review to explore.
Responding to changes in risk status
Following assessment by the Regulator, the Act and Regulations allow for the scheduling of certain dealings as 'exempt' or as 'notifiable low risk dealings' (NLRSs). These dealings are thereby excluded from licensing and subject instead to generic regulatory arrangements are regulatory requirements proportionate to their risk status. Dealings originally not schedules and therefore obliged to be undertaken under licence can be the subject of a disproportionate regulatory burden where intervening new technologies have diminished their risk status. For example, the continual advancement in technologies involving viral vectors has outpaces amendments to the Regulations, such that dealings involving viral vectors with newly developed safety features remain unclassified as licensable dealings, rather than perhaps being more appropriately classified as NLRDs.
For reasons discussed above, the appropriate adjustment of regulatory requirements to reflect developments that change risk status cannot be done expeditiously under current arrangements associated with the requirements of the Gene Technology Agreement and of the Legislative Instruments Act 2003
. The Review is asked to consider the possibility of legal instruments capable of being amended in a timely manner and in particular the option suggested in the previous section.
Application of risk management standards
Some lack of flexibility is also manifest in the capacity of the Regulator to invoke current Australian Standards as a risk management strategy. Section 14 of the Legislative Instruments Act 2003
effectively prevents a legislative instrument from applying standards 'as in force from time to time' unless the contrary intention appears. Since no contrary intention appears in the Act, the adoption of Australian Standards in the regulations as a risk management strategy is confined to standards existing at the time of drafting. For example, if updates to an Australian Standard resulted in the reclassification of a pathogen from Risk Group 2 to Risk Group 3, the ability to automatically incorporate the updates Standard would automatically exclude any genetic modifications of such pathogens from classification as a Physical Containment (PC) 2 NLRD and require those GMOs to be contained within a higher containment level PC3 facility.
The capacity to invoke standards 'as in force from time to time' would be a means of efficiently maintaining currency in the risk management of new technologies and it is recommended the review consider possible amendments to achieve this.
(ii) A nationally consistent scheme
A national scheme
The constitutional reach of the Commonwealth Act and the passing of corresponding State legislation by most jurisdictions allows for the national scheme to adequately cover the bulk of dealings with GMOs in Australia. The vast majority of organisations conducting dealings with GMOs are captured by the Commonwealth Act, with a small number (for example some State government institutions) subject to corresponding State and Territory legislation). Full consistency in national coverage will be achieved when all States have fully corresponding State legislation.
Amendments to the legislation comprising the national scheme cannot proceed without the scrutiny and ultimate agreement of the Gene Technology Ministerial Council, which has representation from the Commonwealth and all States and Territories. Once the amendments are agreed to, they are required to be introduced into the legislation of the participating jurisdictions.
The ongoing capacity of the national scheme to remain totally consistent turns on the capacity of these jurisdictions to pass the agreed amendments into law promptly.
In this respect, the approach taken by the NSW and the Northern Territory of automatically adopting into law any amendments made to the Commonwealth Act is an efficient means of maintaining uniformity. A similar approach by other participating jurisdictions would avoid the periods of legislative inconsistency which may occur across the national scheme as jurisdictions individually arrange for the passage of each agreed amendment through their respective parliaments. If Sate legislation is not amended contemporaneously, it can become inconsistent 'in face'. In such situations the Regulator is faced with the prospect of regulating the conduct of the same GMO dealings differently within one jurisdiction, and potentially between jurisdictions, unless the relevant dealings are captured by Commonwealth legislation.
It is recommended that the Review encourages participating jurisdictions to adopt Commonwealth legislation in as timely a manner as possible, noting the efficiency of the approach adopted by NSW and the Northern Territory.
A significant number of organisations, public and private, conduct dealings. While, as indicated above, most are captured by the Commonwealth Act, in come cases, there may be uncertainty about the constitutional status of organisations and whether Commonwealth or State corresponding law applies to them. Some of these uncertainties about whether Commonwealth or State legislations applies to particular dealings however capable of being resolved by wind-back
as provided for under section 14 of the Commonwealth Act. On wind-back
, any uncertainties with respect to dealings conducted by, for example, State agencies or some higher education institutions are resolved by the Act which effectively provides for their regulation under State rather than Commonwealth legislations irrespective of constitutional status.
It is recommended that the Review encourages participating States and Territories in which changes to Commonwealth legislation are not automatically adopted to wind-back their legislation. This would provide for greater certainty of application of legislation, especially in a compliance context.
(iii) Definitions of certain dealings
Is discussing the proposed coverage of the Gene Technology Bill 2000
, the explanatory memorandum noted the intention of the legislation was to ask as a 'gap filler' (to avoid duplication of regulatory oversight by existing regulators for food, therapeutic goods and agricultural and veterinary chemicals who appropriately have primary responsibility for regulating use of GMOs outside of the primary dealings listed in the Act) and to thereby cover only activities with GMOs and GM products that were currently unregulated. The explanatory memorandum provided examples of such gaps, including examples which suggested that the legislation would have adequate coverage to address existing regulatory gaps.
With the benefit of ten years' operation, it is proposed that it is timely for the Review to consider the effectiveness of the coverage of such gaps within the overall existing regulatory system.
The review is also asked to note that under current definitions, it is not an offence to deal with a GM product without a licence. However, the Regulator is capable of conditioning a GM product that is derived from a GMO in respect of which particular dealings are licensed (subsection 62(1)) and it is an offence not to comply with licence conditions. In this respect, the legislation is not clear in relation to the extent of the Regulator's capacity to condition GM products, and in particular whether that capacity includes the capacity to condition the use of the GM product.
It is proposed that the Review considers and clarifies these arrangements.
Similar comments are made in relation to the aspirations accompanying the recommendations for the introduction of emergency dealing determinations made by the previous review of the Act which also appeared to assume a capacity to regulate the use of a GMO. This assumption has been carried over into the document produces under the Gene Technology Agreement entitled 'Guidelines for emergency response under the Gene Technology Act 2000
and the Gene Technology Agreement'.
It is proposed that the Review examines these assumptions and considered whether Part 5A of the Act is capable of giving full effect to the aspirations behind its introduction.
(iv) Enhancing implementation and operational efficiency
Matters required to be considered in stipulating Notifiable Low Risk Dealings ('NLRDs')
Under section 74, and again for purposes of review under section 140, the Regulator must consider a stipulated list of matters before the Governor General can declare dealings to be NLRDs, viz,
Before the Governor-General makes regulations declaring a dealing with a GMO to be notifiable low risk dealing, the Regulator must consider the following matters:
- whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention;
- whether the dealing with the GMO would involve minimal risk to the health and safety of people and to the environment, taking into account the properties of the GMO as a pathogen or pest and the toxicity of any proteins produces by the GMO;
- whether no conditions, or minimal conditions, would be necessary to be prescribed to manage any risk referred to in paragraph (b).
These considerations are intended to inform the Regulator's ultimately discretionary decision about the contents of the NLRD schedule in the regulations. However, experience has shown that the above considerations are not necessarily relevant to all types of GMOs or dealings which may be considered as low risk and may inappropriately constrain the assessment of dealings. It is submitted that a more effective and efficient construct is to consider whether the risk profile of particular dealings necessitates assessment and regulation on a case by case basis, and therefore under licence, or whether it can be safely undertaken pursuant to a set of generic requirements stipulated in the regulations.
It is recommended that the review consider the merits of an amendment along the following lines.
Before the Governor-General makes regulations declaring a dealing with a GMO to be notifiable low risk dealing, the Regulator must consider the following matters:
- whether the dealing with the GMO would involve any risk to the health and safety of people and to the environment, taking into account the properties of the GMO as a pathogen or pest and the toxicity of any proteins produced by the GMO; and,
- whether requirements stipulated in the regulations pursuant to subsection 75(2) would manage any risks identified as a result of considering paragraph (a).
Dealings incidental to disposal of inadvertent dealings
Section 49 is designed to exempt licences for disposal of inadvertent dealings from the application assessment requirements of Division 4 is the Regulator is satisfied that the dealings proposed to be authorised by the licence are limited to dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO.
While dealings such as transport are arguably capable of being captured as 'dealings to be undertaken for the purposes of, or relating to, disposal', it may be necessary it expressly authorise other dealings. Testing, for example, to determine if an organism is indeed a GMO is arguably not covered as 'a purpose relating to disposal' and while technical legal arguments can be raised about knowledge and intention to deal with a GMO prior to conclusively determining the character of an organism, it is submitted that it is preferable to remove doubt by authorising whatever testing is necessary to the extent that such testing might otherwise constitute illegal dealing under the Act.
The Review is therefore asked to consider whether other dealings (such as testing) should be expressly authorised in relation to section 49.
71(2B) and unintended restriction on variations
Subsection 71(2B) was inserted by way of amendment to the Act following its review in 2006. The review found that there should be constraints included in the Act to prevent a variation being used to unreasonably extend the coverage of a licence and that a variation should be able to be assessed by the original RARMP as a means of ensuring that variations not present risks that have not been assessed.
Accordingly, section 71(2B) reads as follows:
(2B) The Regulator must not vary a licence is the Regulator is satisfied that the risk assessment and the risk management plan in respect of the original application for the licence did not cover the risks posed by dealings proposed to be authorised by the licence as varied.
The effect of this provision is that it precludes regard being had to risk assessment for licences other than the one to be varied. However the same or similar GMOs and dealings may be the subject of more than one application and assessment. If the object of 71(2B) is to ensure that variations not present unassessed risks, there is no reason why the consideration of previously assessed risk should be confined to the risk assessment associated with the licence to be varied.
An amendment along the following lines could be considered.
(2B) The Regulator must not vary a licence unless satisfied that a risk assessment and risk management plan prepared under section 47 or 50 has considered the risks posed by the dealings proposed to be authorised by the licence as varied.
It is recommended that the review consider the merits of the continuing with the current legislative requirement for the Regulator to prepare a quarterly report to provide to the Minister and table in Parliament (section 136A). It is recognised the information specified in section 136A is important in relation to the transparency of, and increasing public confidence in, the GMO regulatory system. However, the OGTR produces a comprehensive annual report which contains most of the information contained in the quarterly reports and publishes extensive information on its website about its ongoing operations. The current reporting requirements specified in section 136A(2) could be legislative requirement for inclusion in the OGTR annual report (which is also publicly available on the OGTR website).
While the value of quarterly reporting as a means of monitoring a new and untested regulatory system is acknowledged, the regulation if gene technology has not been successfully undertaken for ten years under arrangements which are mature and proven. Removing the requirement for the Regulator to provide a quarterly report while still making the information publicly available would be a more efficient and effective way to provide transparency while reducing duplication in reporting.
It has long been the Regulator;s practice to implement a communications strategy which exceeds the consultation provisions specified in the Act. For example, in addition to the legislative requirements to public notifications in the Gazette
, in newspapers and on the Regulator's website, the Regulator engages extensively in direct communication techniques including email and letters.
The Regulator's communications strategy, including methods of consultation, is currently undergoing a review to ensure that information is accessible to all members of the public, and that the maximum number of people are being engaged. Various methods of communication, including new electronic methods such as social networking tools, are being considered. These methods may assist the Regulator to conduct public consultation in a more efficient and cost effective manner, and to target a wider audience.
It is suggested that the Review considered whether the requirement of the Act to publish notifications in newspapers remains a necessary means of communication with the public. Making the requirements for the methods for conducting public consultation less prescriptive will assist the Regulator to optimise their effectiveness and efficiency.
GM product record
The Regulator must maintain a Record of GMO and 'GM Product Dealings' under section 138.
OGTR's experience over 10 years is that overwhelmingly the enquiries received from the community relate to information on the assessments and approvals of environmental release of GMOs, and in also relation to GM food, but there has been very little interest in GM product approvals made by other regulatory agencies. FSANZ publishes comprehensive information about GM food approvals through the Standard 1.5.2 of the Australia New Zealand Food Standards Code as well as on its website.
It is submitted that placing information about GM products on the product regulator's website is a more effective and efficient approach to maintaining a GM product record and that its reproduction in the Regulator's records serves no further purpose and is administratively inefficient. While there are reciprocal statutory requirements for consultation on assessments of GMOs by the Regulator and of GM products by other agencies there is no statutory requirement for those agencies to provide the detailed information listed in s138(5) to the Regulator.
It is therefore proposed that the review consider removed from the Act the obligations for inclusion of GM products in the GMO Record.
The review is also asked to note that there appears to be no legislative basis for the expression 'GM Product dealings' in subsection 138(1). A GM product is not, by definition, a GMO, and only dealings with GMOs are contemplated by the Act under the definition of 'deal with'.
'Issue' of Application
Section 30 contains the phrase "whether or not a particular application for a GMO licence should be issued or refused" which suggests that issue of the application
for a licence is the subject of the consideration rather than the licence itself. Changing the phrase to "whether a GMO licence is issued or refused to a particular application" would perhaps resolve the problem.
European Commission (2008)
. ENV B3/AA/ D(2008). Working Group on the Establishment of a List of Techniques Falling Under the Scope of Directive 2001/19/EC on the Deliberate Release of Genetically Modified Organisms into the Environment and Directive 90/219/EEC on the Contained Use of Genetically Modified Micro-organisms. Term of Reference
(accessed 14 June 2011)
see also - More Recent Developments - "Working Group on New Techniques
- (accessed 14 June 2011)
Prins, T.W. & Kok, E.J. (2010). Food and feed safety aspects of cisgenic crop plant varieties
. RIKILT report (2010.001) RIKILT, Institute of Food Safety. Wageningen University & Research centre, Netherlands.
(accessed 14 June 2011)
Schouten, H.J.; Krens, F.A.; Jacobsen, E. (2006).
Do cisgenic plants warrent less stringent oversight?
Nature Biotechnology 24,
(accessed 14 June 2011)
US Federal Register, 16 March 2011.
Pesticides; Data Requirements for Plant-Incorporated Protectants (PIPs) and Certain Exemptions for PIPs; Notification to the Secretaries of Agriculture and Health and Human Services.
76 FR 14358 Volume: 76, Number: 51 (pages 14358 to 14359).
(accessed 14 June 2011)
Original submission in PDF format (PDF 5906 KB)