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Gene Technology Amendment Bill 2015



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ISSN 1328-8091

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BILLS DIGEST NO. 9, 2015-16 14 AUGUST 2015

Gene Technology Amendment Bill 2015 Sophie Power and Dr Emily Hanna Science, Technology, Environment and Resources Section

Contents

Purpose of the Bill ............................................................... 2

Structure of the Bill ............................................................. 2

Background ......................................................................... 2

Reviews of the Act ................................................................... 3

Committee consideration .................................................... 4

Community Affairs Legislation Committee .............................. 4

Senate Standing Committee for the Scrutiny of Bills .............. 4

Policy position of non-government parties/independents ..... 4

Position of major interest groups ......................................... 4

Financial implications .......................................................... 4

Human rights consideration ................................................. 4

Key issues and provisions..................................................... 5

Part 1—Reporting requirements ............................................. 5

Part 2—Inadvertent dealings................................................... 5

Part 3—Public notification of risk assessment ........................ 6

Part 4—Records of GM products............................................. 7

Part 5—Restrictions on licence variations ............................... 8

Part 6—Technical amendments .............................................. 9

Concluding comments ....................................................... 10

Date introduced: 18 June 2015

House: House of Representatives

Portfolio: Health

Commencement: The substantive provisions commence on proclamation or the day after six months after Royal Assent, whichever occurs first.

Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill’s home page, or through the Australian Parliament website.

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the ComLaw website.

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Purpose of the Bill The purpose of the Gene Technology Amendment Bill 2015 (the Bill) is to amend the Gene Technology Act 20001 (the Act) to make minor changes to the Act to implement the recommendations of a review of the Act in 2011.

Structure of the Bill The Bill has one Schedule, which is divided into six parts:

• Part 1 discontinues the Gene Technology Regulator’s quarterly reporting requirements

• Part 2 clarifies the activities that may be authorised by ‘inadvertent dealings’ licences

• Part 3 updates advertising requirements for certain public consultation purposes

• Part 4 removes the requirement for information about genetically modified (GM) products authorised by other agencies to be included in the Record maintained by the Gene Technology Regulator

• Part 5 changes licence variation requirements to provide greater flexibility and

• Part 6 updates the considerations required before dealings may be scheduled as notifiable low risk dealings and clarifies ambiguous wording.

Background The Act first came into effect on 21 June 2001 and is the federal component of a nationally consistent system for regulating genetically modified organisms (GMOs).2 The object of the Act is to:

… protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs. 3

The Act establishes the Gene Technology Regulator (the Regulator) as an independent statutory office holder to administer the Act.4 The functions of the Gene Technology Regulator are specified in section 27 of the Act. The Office of the Gene Technology Regulator (OGTR) supports the Regulator in the administration of the Act.5

In short, the legislation regulates all ‘dealings’ (for example, research, manufacture, propagation, transport, import, disposal) with GMOs.6 Under Part 4 of the Act, all dealings with GMOs are prohibited unless the dealing is:

• an exempt dealing7

• a ‘notifiable low risk dealing’ (NLRD)8

• licenced by the Regulator

• included on the GMO Register or

• specified in an Emergency Dealing Determination.9

1. Gene Technology Act 2000, accessed 25 June 2015. 2. Department of Health, Office of the Gene Technology Regulator (OGTR), ‘About the OGTR: Legislation’, OGTR website, 5 February 2015, accessed 15 July 2015. 3. Gene Technology Act, section 3, accessed 25 June 2015. 4. Ibid., section 26. 5. Ibid., Part 9, Division 4 ‘Staffing’. The OGTR’s website explains that the Office has been established ‘within the Australian Government

Department of Health to provide administrative support’, and the website’s logo appears so that the OGTR is a subsidiary part of the Department of Health: OGTR, Office of the Gene Technology Regulator, OGTR website, accessed 14 August 2015. 6. ‘Genetically modified organism’ and ‘gene technology’ are defined in section 10 of the Act. Note also that Schedule 1 of the Gene Technology Regulations 2001 contains a list of organisms declared not to be a GMO for the purposes of the Act, while Schedule 1A contains a list of

techniques that are not gene technology. 7. Gene Technology Act, subsection 32(3). Exempt dealings are prescribed in regulation 6 and Part 1 of Schedule 2 of the Gene Technology Regulations 2001. In general, they are dealings with GMOs that pose a very low risk (such as contained research involving very well

understood organisms and processes for creating and studying GMOs). See also: OGTR, ‘What are exempt dealings?’, OGTR website, 10 February 2015, accessed 21 July 2015. 8. Gene Technology Act, section 74. Notifiable low risk dealings are prescribed in regulation 12 and Part 1 or 2 of Schedule 3 of the Gene Technology Regulations. See also: OGTR, ‘What are Notifiable Low Risk Dealings (NLRDs)?’, OGTR website, 5 February 2015, accessed 21 July

2015.

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Under the Act, the Regulator is also required to maintain a publicly accessible record of genetically modified organisms and product dealings (the Record).10 The Record is currently required to contain all GMO dealings in Australia approved by the Gene Technology Regulator, as well as GM product approvals notified by other regulatory agencies. Those agencies are the Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) and National Industrial Chemicals Notification and Assessment Scheme (NICNAS).11

Reviews of the Act Two independent reviews of the Act have been undertaken. The first, in 2006, was required by section 194 of the Act which specifies that a review must occur four years after the Act began operating. The 2006 review found that the Act and associated Gene Technology Regulations 2001 were working well overall.12 Minor changes were recommended to improve operations.13 The 2006 review also recommended that a further review of the Act occur in 2011.14

In accordance with this recommendation, a subsequent review was undertaken in 2011 (the 2011 review). The 2011 review examined:

• emerging trends and international developments in biotechnology and its regulation;

• the efficiency and effectiveness of the operation of the Act consistently across the national scheme for gene technology regulation in Australia; and

• the interface between the Act and other systems (e.g. other Acts and schemes). 15

The 2011 review also found that the Act was working well but made 16 recommendations to improve the effectiveness and efficiency of the operation of gene technology regulation in Australia. Some of the recommendations were administrative, or directed at state and territory jurisdictions. Five of the recommendations form the basis for the Bill. The relevant recommendations are:

• the requirement for quarterly reporting to the Commonwealth Minister, to be tabled in Parliament, be discontinued (recommendation 1)

• the Act be amended so that the Regulator can authorise other appropriate dealings related to inadvertent dealings (recommendation 10)

• changes to advertising requirements relating to applications for dealings involving intentional releases (DIR). The review found that for many DIR applications, advertising in local or state newspapers in the region where the DIR is to occur should be sufficient. For issues/licences of national importance it should be sufficient for OGTR to place advertisements in one national newspaper (recommendation 14)

• the requirement to include GM products approved by APVMA, TGA, FSANZ and NICNAS in the GMO Record be removed (recommendation 15) and

• technical amendments be made to sections 30, 71, 74 and 138 of the Act (recommendation 16).16

9. Gene Technology Act 2000, Part 4, see especially section 31. Further information on the different classes of dealings and the licensing process is available on the OGTR website: OGTR, ‘Regulatory requirements’, OGTR website, 23 February 2015, accessed 21 July 2015. 10. Gene Technology Act, section 138. 11. Allen Consulting Group, Review of the Gene Technology Act 2000, report prepared for Australian Department of Health and Ageing, Australian

Department of Health and Ageing, Canberra, August 2011, p. 35, accessed 16 July 2015. 12. Gene Technology Regulations 2001, accessed 16 July 2015. 13. The Gene Technology Amendment Act 2007 (Cth) amended the Act as a result of the 2006 review: for further information on the 2006 review

and relevant amendments, see S Harris Rimmer and R Polya, Gene Technology Amendment Bill 2007, Bills digest, 131, 2006-07, Parliamentary Library, Canberra, 4 May 2007, accessed 12 August 2015. 14. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 1. 15. Ibid.

16. Ibid., p. vii.

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These recommendations are discussed in further detail as relevant in the ‘Key issues and provisions’ section of this Digest.

Committee consideration Community Affairs Legislation Committee The Bill has been referred to the Senate Community Affairs Legislation Committee for inquiry and report by 18 August 2015. Details of the inquiry are available here.17 The committee received only five submissions. These are discussed further under ‘Position of major interest groups’ and the ‘Key issues and provisions’ sections of this Digest.

Senate Standing Committee for the Scrutiny of Bills The Senate Standing Committee for the Scrutiny of Bills had no comment on the Bill.18

Policy position of non-government parties/independents At the time of writing, non-government parties and independents do not appear to have commented on the Bill.

Position of major interest groups There appears to have been little public comment on the Bill, other than submission to the Senate Community Affairs Legislation Committee inquiry, which, as noted above, received only five submissions. These submissions were generally supportive of the Bill. For example, the Australian Academy of Science expressed the view that the changes proposed by the Bill are ‘conservative and justified’ and would ‘improve the Act’s operation without changing the underlying policy intent or overall legislative framework of the regulatory scheme’.19 CropLife Australia expressed concern that it ‘has taken four years to implement what amounts to relatively minor administrative changes’. Nevertheless, CropLife Australia submitted that it fully supported the ‘minor and technical amendments’ proposed by the Bill to ‘make gene technology regulation in Australia more efficient, more effective and clearer’.20 The CSIRO did not have any specific comments on the Bill itself, but took the ‘opportunity to reiterate CSIRO’s support for strong and clear legislation overseeing this area’.21

Financial implications The Explanatory Memorandum states that the amendments made by the Bill will not have any financial impact on the Commonwealth.22

Human rights consideration As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.23 The Parliamentary Joint Committee on Human Rights had no comment on the Bill.24

17. Senate Community Affairs Legislation Committee, Inquiry into the Gene Technology Amendment Bill 2015, The Senate, Canberra, 2015, accessed 29 June 2015. 18. Senate Standing Committee for the Scrutiny of Bills, Alert digest, 7, 2015, The Senate, Canberra, 12 August 2015, accessed 13 August 2015. 19. Australian Academy of Science, Submission to the Senate Community Affairs Legislation committee, Inquiry into the Gene Technology

Amendment Bill 2015, no date, p. 3, accessed 10 August 2015. 20. CropLife Australia, Submission to the Senate Community Affairs Legislation committee, Inquiry into the Gene Technology Amendment Bill 2015, 24 July 2015, p. 1, accessed 10 August 2015. 21. CSIRO, Submission to the Senate Community Affairs Legislation committee, Inquiry into the Gene Technology Amendment Bill 2015, 7 July

2015, accessed 10 August 2015. 22. Explanatory Memorandum, Gene Technology Amendment Bill 2015, p. 1, accessed 25 June 2015. 23. The Statement of Compatibility with Human Rights can be found at page 2 of the Explanatory Memorandum to the Bill. 24. Parliamentary Joint Committee on Human Rights, Twenty-fourth report of the 44th Parliament, Canberra, 23 June 2015, p. 1, accessed 25 June

2015.

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Key issues and provisions Part 1—Reporting requirements Section 136A of the Act currently requires the Gene Technology Regulator to prepare and give the Minister quarterly reports on the operations of the Regulator. These quarterly reports must be tabled in Parliament within 15 sitting days. Under subsection 136A(2), the report must include information about:

• the GMO licences issued during the quarter

• any breaches of conditions of a GMO licence that have come to the Regulator’s attention during the quarter

• emergency dealing determinations made by the Minister during the quarter

• any breaches of conditions of an emergency dealing determination that have come to the Regulator’s attention during the quarter and

• the auditing and monitoring of dealings with GMOs under this Act by the Regulator or an inspector during the quarter.

Section 136 of the Act also requires the Regulator to prepare and give to the Minister an annual report on the operations of the Regulator as soon as practicable after the end of each financial year. The annual report must also be tabled in Parliament within 15 sitting days.

Item 2 of Part 1 of Schedule 1 of the Bill repeals the quarterly reporting requirements in section 136A. Item 1 amends the annual reporting requirement in section 136 to ensure that the annual report must contain the same information which was previously listed under subsection 136A(2) of the Act.

This amendment reflects the 2011 review’s first recommendation that the requirement for quarterly reporting to the Commonwealth Minister, to be tabled in Parliament, be discontinued. The review reasoned that:

While this requirement was logical in the early years of the regulatory arrangements, there is now sufficient experience with their operation to form the view that these quarterly reports are no longer necessary.

The OGTR’s annual report contains most of the information currently provided in the quarterly reports. In addition, the OGTR publishes extensive information about its regulatory activities on its website. 25

The Australian Academy of Science is supportive of these amendments, noting that they would ‘represent a significant reduction to the administrative overheads of the regulatory scheme without compromising the transparency and accountability of the regulatory system’.26

Part 2—Inadvertent dealings Part 5 of the Gene Technology Act sets out a licensing system. Under section 40, in Part 5 of the Act, applications may be made to the Regulator for a licence authorising specific ‘dealings’ with GMOs. Part 5 then sets out the processes to be followed by the Regulator in relation to applications involving two kinds of dealings: those that involve the intentional release of a GMO into the environment and those that do not involve the intentional release of a GMO into the environment.

Section 40A provides for licences related to ‘inadvertent dealings’. Under subsection 40A(1), if the Regulator is satisfied that a person has come into possession of a GMO inadvertently the Regulator may, with the agreement of the person, treat the person as having made an inadvertent dealings application.27 Sections 46A and 49 of the Act have the effect that the Regulator may expedite consideration of an application to dispose of a GMO that has come into a person’s possession inadvertently. Items 4 and 5 amend paragraphs 46A(a) and 49(a) respectively to clarify the dealings which may be authorised by inadvertent dealings licences for purposes relating to disposing of a GMO.

25. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 20. 26. Australian Academy of Science, op. cit., p. 1. 27. An ‘inadvertent dealings application’ is then defined in section 10 of the Act to mean an application for a GMO licence to which Division 3 or 4 of Part 5 does not apply because of the operation of sections 46A or 49. Divisions 3 and 4 of Part 5 deal with the initial consideration of

licences not involving the intentional release of GMOs into the environment, and those involving such release, respectively.

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These amendments reflect recommendation 10 of the 2011 review which suggested that the Act be amended ‘so that the Regulator can authorise other appropriate dealings related to inadvertent dealings’. The 2011 review explained:

Following the 2006 Review, the Act was amended to provide for temporary licences for inadvertent dealings for the purposes of GMO disposal. The OGTR believes that this needs to be extended so that other dealings can be authorised that relate to disposal of inadvertently obtained GMOs. For instance, when a business believes that it may have inadvertently come in to the possession of a GMO, it may need to sample and perform tests to confirm this, store the GMO while test are being undertaken, and even propagate or ‘grow out’ the GMO (in appropriate containment) to obtain material for testing.

Such dealings would be considered reasonable and part of the disposal process, but may not be permitted under the current provisions of the Act. 28

Part 3—Public notification of risk assessment Under Division 3 of Part 5 of the Act, before issuing a licence for dealings involving intentional release (DIR) of a GMO into the environment, the Regulator must prepare a risk assessment and a risk management plan in relation to the dealings proposed to be authorised by the licence. Section 52 requires the Regulator to publish a notice inviting submissions in relation to the risk assessment and risk management plan. Under subsection 52(1), these notices must currently be published in the Australian Government Gazette; in a newspaper circulating generally in all States; and on the Regulator’s website (if any).29 Item 7 of the Bill amends section 52 of the Act to repeal the requirement to publish the notice ‘in a newspaper circulating generally in all States’. Instead, there will be a requirement to publish the notice in ‘one or more newspapers that the Regulator considers appropriate, having regard to the geographic area in which the dealings proposed to be authorised by the licence may occur’.

This amendment implements recommendation 14 of the 2011 review which stated:

For many DIR applications, advertising in local or state newspapers in the region where the DIR is to occur is sufficient (given OGTR’s established electronic communications channels with interested parties). For issues/licences of national importance it should be sufficient for OGTR to place advertisements in one national newspaper. The OGTR could experiment with using social media to communicate with stakeholders in appropriate situations.

30

The 2011 review also noted that:

The communication strategy followed by the OGTR in relation to individual proposals exceeds that required by the Act. For instance, in addition to the requirement to publish notifications in the Gazette, in newspapers and on the OGTR website, the Regulator engages in direct communication techniques (such as emails and letters). The OGTR currently has a list of approximately 700 people and organisations (covering the entire spectrum of views on gene technology) that receive every OGTR notification by email. …

Gazette notices have minimal impact, but provide a low costs permanent public record. Advertising in state and national high-circulation newspapers is significantly more expensive, but provides greater exposure. While some advertising should remain, it is apparent that most interest generated from the public consultation process arises from OGTR contacting and advising those on their circulation email list (of 700 people and organisations).

31

The Australian Academy of Science supports these amendments, suggesting that they will provide the Regulator with ‘more flexibility’ to ‘select publications that are most likely to reach people’ in the relevant geographic

28. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 29. 29. Note that item 8 removes the words ‘(if any)’ in relation to the requirement to publish on the Regulator’s website, reflecting the fact that the Regulator does have a website. 30. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 34. 31. Ibid., p. 33.

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area(s), which in turn will ‘improve the efficiency, accountability and cost effectiveness of the regulatory system’.32

Part 4—Records of GM products Section 138 of the Act requires the Regulator to maintain a Record of GMO and GM Product Dealings (the GMO Record). Under subsection 138(2), the purpose of the GMO Record is to maintain a comprehensive record of all dealings in Australia that involve GMOs or GM products. A ‘GM product’ is defined in section 10 of the Act to mean ‘a thing (other than a GMO) derived or produced from a GMO’.

Subsection 138(5) provides that the Record must contain such information as is prescribed by the regulations (other than confidential commercial information) in relation to GM products mentioned in designated notifications given to the Regulator under the Agricultural and Veterinary Chemicals (Administration) Act 1992; the Food Standards Australia New Zealand Act 1991; the Industrial Chemicals (Notification and Assessment) Act 1989; and the Therapeutic Goods Act 1989.

The main substantive amendment in Part 4 is item 17, which repeals subsection 138(5). This removes the requirement that the Regulator maintain a record of GM product approvals made by other agencies, while retaining the requirement to record the Regulator’s own approvals for dealings with GMOs.

The Explanatory Memorandum notes that information about GM product approvals can be sought directly from the relevant agency (that is, the Australian Pesticides and Veterinary Medicines Authority, the Therapeutic Goods Administration, Food Standards Australia New Zealand and the National Industrial Chemicals Notification and Assessment Scheme).33 Note that all these agencies use the same definitions of GMOs and GM products.34

Items 9-16 are consequential amendments which reflect this change by removing references to GM products in relation to the GM Record. Item 18 makes a similar consequential amendment, but also adds a requirement that information about emergency dealing determinations be entered on the Record as soon as practicable. The Explanatory Memorandum states that ‘the latter was an apparent oversight when amendments were made to introduce emergency dealing determination provisions’.35

Item 19 contains a transitional provision to provide that the Regulator may remove all historical information about GM products from the GMO Record.

These amendments implement recommendation 15 of the 2011 review, which found that:

Maintaining GM products approved by these other agencies on the GMO Record duplicates the record keeping of these other agencies and is administratively inefficient. The requirement to include GM products in the GMO record could be removed from the Act. 36

Stakeholders expressed support for these amendments in submissions to the Senate inquiry. The Australian Academy of Science expressed the view that ‘including information on GM product approvals by other agencies represents considerable practical difficulties and unnecessary duplication’ and considered that the proposed amendments represent a ‘pragmatic solution’.37 FSANZ also expressed support for these amendments, noting that the current arrangements represent a ‘duplication of effort’ and that ‘information on approved GM food products can readily be obtained from FSANZ’.38

While the proposed amendments may reduce duplication, there would seem to be some advantages from the public’s perspective in information on GMO dealings and GM Products being contained in a centralised information source. However, the Office of the Gene Technology Regulator noted that ‘operational experience over almost 15 years indicates that the public is most interested in releases of GMOs into the Australian

32. Australian Academy of Science, op. cit., p. 2. 33. Explanatory Memorandum, op. cit., p. 5. 34. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 35. 35. Explanatory Memorandum, op. cit., p. 5. 36. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 35. 37. Australian Academy of Science, op. cit., p. 2. 38. FSANZ, Submission to the Senate Community Affairs Legislation Committee, Inquiry into the Gene Technology Amendment Bill 2015, 24 July

2015, p. 3, accessed 10 August 2015.

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environment, and in GM food approvals’.39 This information will still be readily publicly available from the OGTR and FSANZ respectively.

Part 5—Restrictions on licence variations Section 71 of the Act provides for the Regulator to vary licences issued under the Act in certain circumstances. Under subsection 71(1), the Regulator may vary a licence on application by the licence-holder; or at any time, on the Regulator’s own initiative. However, the Regulator is restricted in how licences can be varied ‘so that variations cannot be used to extend the coverage of licences unreasonably’.40 For example, subsection 71(2B) provides that the Regulator must not vary a licence if the Regulator is satisfied that the risk assessment and the risk management plan (RARMP) in respect of the original application for the licence did not cover the risks posed by the dealings proposed to be authorised by the licence as varied. In other words, the Regulator must not vary a licence if the licence, as varied, would pose new risks which were not covered in the original risk assessment and risk management plans.41

Item 20 proposes to amend subsection 71(2B) to provide that, if an application has been made for variation of a licence, the Regulator must not vary a licence unless satisfied that the risks posed by the dealings proposed to be authorised by the licences as varied are covered by either the RARMP in respect of the original application for the licence OR the RARMP in respect of an application for another licence, but only if that other licence was issued. The Explanatory Memorandum explains that:

As the same or similar GMOs and dealings may be subject to more than one application and assessment, Item 20 would allow the Regulator to take into account RARMPs prepared for licence applications (for which licences have been issued) other than the licence to be varied. This would allow licence variations to proceed provided potential risks associated with the dealings are adequately assessed in an existing RARMP, and would avoid some circumstances where applicants would need to seek a new licence.

42

In considering licence variation applications that utilise risk assessments contained in RARMPs for other licences, the Regulator would consider whether the two licences involve similar GMOs or similar dealings.43 The Explanatory Memorandum gives the following example:

For example, a limited and controlled plant DIR licence could potentially be varied to include dealings with a GMO of the same parent species carrying another gene or new methods of destroying GMOs, provided that these dealings had been assessed in the RARMP for another licence relating to the same parent species. For DNIRs, licences could potentially be varied to include, for example, in vivo experiments with a GMO which is licenced for in vitro experiments, provided another RARMP considers in vivo dealings with the same GMO or with GMOs from the same parent organism with similar modifications.

44

This amendment reflects part of recommendation 16 in the 2011 review which found that subsection 71(2B):

…precludes regard being had to risk assessment for licences other than the one to be varied. In reality, the same or similar GMOs and dealings may be subject to more than one application and assessment. The requirement to confine the new risk assessment to the previously assessed risk should be removed. 45

Note that amended subsection 71(2B) would only apply to variations which have been applied for, not to variations initiated by the Regulator. So, if the Regulator becomes aware of risks posed by licenced dealings which are not covered in the original RARMP or any other RARMP, the Regulator would be able to initiate a variation to manage those risks.46

39. OGTR, Submission to the Senate Community Affairs Legislation Committee, Inquiry into the Gene Technology Amendment Bill 2015, 23 July 2015, p. 3, accessed 10 August 2015. 40. Explanatory Memorandum, op. cit., p. 5. 41. Subsection 71(2B) was inserted by the Gene Technology Amendment Act 2007 when the Act was amended following the 2006 Statutory

Review.

42. Explanatory Memorandum, op. cit., p. 5. 43. Ibid., pp. 5-6. 44. Ibid., pp. 5-6. 45. 2011 review, op. cit., p. 37. 46. Explanatory Memorandum, op. cit., p. 6.

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The Australian Academy of Science strongly supported ‘the removal of the unintended constraint on the Regulator’s ability to initiate licence variations to enable newly identified risks to be managed’.47

Part 6—Technical amendments Subsection 74(1) provides that regulations may be made to declare a dealing with a GMO to be a ‘notifiable low risk dealing’ (NLRD) for the purposes of the Act. Section 74 also sets out a number of criteria before such regulations may be made. Subsection 74(2) provides that before the Governor-General makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must be satisfied that the dealing would not involve the intentional release of a GMO into the environment. In addition, under subsection 74(3), 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 produced by the GMO and

• whether no conditions, or minimal conditions, would be necessary to be prescribed to manage any risk referred to in the above paragraph.

Item 23 proposes to repeal the list of considerations for the Regulator under subsection 74(3) and replace it with a requirement for the Regulator to consider:

• whether the dealing with the GMO would involve any risk to the health and safety of people, or 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

• if there is such a risk—whether one or more of the requirements prescribed in the regulations48 would be sufficient to manage that risk and

• any other matter the Regulator considers appropriate.

Notably, this removes the requirement to consider whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention. However, the OGTR explained in its submission to the Senate inquiry that ‘this notion does not contribute significantly to assessment of whether dealings are appropriate for the NLRD category’. Indeed, the OGTR remarked that ‘GMOs that are not biologically contained form a significant portion of the dealings scheduled as NLRDs’. The OGTR further noted that the proposed amendment would re-frame the considerations in subsection 74(3) to ‘provide more definitive language which aligns with current scientific understanding of risk assessment and risk management of GMOs’.49

This amendment reflects part of recommendation 16 in the 2011 review which found in relation to section 74 that:

…experience has shown that these considerations are not necessarily relevant to all types of GMOs (particularly to dealings considered to be low risk). A more effective approach could be 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.

50

47. Australian Academy of Science, op. cit., p. 2. 48. Subsection 75(2) provides that the regulations may prescribe different requirements to be complied with in different situations or by different persons, including requirements in relation to: the class of persons who may undertake notifiable low risk dealings; notifying the Regulator of notifiable low risk dealings; supervision by Institutional Biosafety Committees of notifiable low risk dealings; or the containment level of

facilities in which notifiable low risk dealings may be undertaken. 49. OGTR, Submission to Senate Community Affairs Legislation Committee, Inquiry into the Gene Technology Amendment Bill 2015, 23 July 2015, p. 5, accessed 10 August 2015. 50. Allen Consulting Group, Review of the Gene Technology Act 2000, op. cit., p. 37.

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Concluding comments The amendments proposed by the Bill reflect the recommendations of the 2011 review of the Act. They are relatively minor amendments which draw on the practical experiences of the Regulator and are designed to improve the efficiency of the gene technology regulatory regime.

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