text:
Gene Technology Bill 2000
Bills Digests
Bills Digest Service
DEL VILLAR, Katrine
MARTYN, Angus
Online Text: 507030
Office of the Gene Technology Regulator
Genetic engineering
Government regulation
Cartagena Protocol on Biosafety
International comparisons
Certification and accreditation
no. 11 (2000/2001)
Department of the Parliamellwry Library INFORMATION AND RESEARCH SERVICES
Bills Digest No.11 2000-01
Gene Technology Bill 2000
© Copyright Commonwealth ofAustralia 2000
Except to the extent of Ihe uses pennined under the Copyright Act /968, no part of this publication may be reproduced or transmitted in any fonn or by any means including infonn::nion storage and retrieval systems, without the prior written consent of the Depanment of the Parliamentary Libmry, other than by Senators and Members oflhc Australian Parliament in the course oftheir official duties.
This paper has been prepared for general distribution 10 SenalOrs and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is wrinen using infonnation publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Infomlation and Research Services (lRS). Advice on legislation or legal poliey issues contained
in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded Ihat the paper is not an official parliamentary or Australian govemment document. IRS staff are available to discuss the paper's contents with Senators and Members and their staff but not with members ofthe pUblic.
Members, Senators and Parliamentary staff can obtain further information from the Infonnation and Research Services on (02) 6277 2434 (Katrine Del Villar) 6277 2764 (Angus Manyn) or 6277 2420 (Rod Pantcr).
Infannation and Research Services publications are available on the Parllnfo database. On the Internet the DepaIlment of the Parliamentary Library can be found at: hltpJ/www.aph.gov.au/libraryl
Published by the Department of the Parliamentary Library, 2000
Bills Digest
No. 11 2000-01
Katrine Del Villar, Angus Martyn Law and Bills Digest Group 16 August 2000
Purpose 1
Background __ __ __ 1
\Vhat is Gene Technology? _ __ 1
How is Gene Technology currently regulated in Australia? 2
Regulation of international trade in GMOs 4
The Agreement on Sanitary and Phytosanitary Measures (SPSA) __ 5
Biosafcty Protocol 5
Development of the Bill 6
Main Provisions 8
Scope and definitions 8
Operation as a national scheme 9
Governance structure for gene technology regulation 10
Gene Technology Regulator 10
Ministerial Council 11
Advisory conllnittees 12
Licensing system 13
Consultation process 14
Intentional release to the environment 14
Contained dealings 15
Licence decision 15
Licence conditions J6
Dealings with GMOs which are not subject to the licensing system 17
Exempt dealings 17
Dealings listed on the GMO Register 17
Notifiable lo\v risk dealings 17
Certification and accreditation 18
Compliance and enforcement 19
Cancellation of licences 19
Criminal offences 19
Categories of offence 19
Offences , , , " ", .. " , , ,.. , , 20
Compliance and 'clean up' directions 21
External monitoring 22
Self-monitoring 23
Review ofdecisions 23
Confidential commercial infonnation 24
Concluding Comnlcnts 25
Operation as a national scheme 26
Cost recovery 28
Independence and impartiality of the Regulator 29
Compliance and enforcement 30
Opt ou( , , , ,.,., 31
Adequacy of approach to risk assessment and management 32
Legal liability for damage caused by GMOs 32
Other avenues of redress 34
The European Union 35
United Kingdom 36
The United States of America 36
Canada 37
New Zealand 37
Japan , , .3 7
Endnotes 38
Glossary ofTerms
Biosafct), Protocol
GM product
Australia New Zealand Food Authority
Cartagena Protocol on Biosafety
deoxyribonucleic acid
genetically modified product
Genetic Manipulation Advisory Committee
genetically modified organism
Gene Technology Agreement
Gene Technology Community Consultative Group
Gene Technology Ethics Committee
Gene Technology Technical Advisory Committee
Institutional Biosafety Committee
Interim Office of the Gene Technology Regulator
National Industrial Chemicals Notification and Assessment Scheme
National Registration Authority
Gene Technology Regulator
WTO Agreement on Sanitary and Phytosanitary Measures
the States, the ACT and Nonhem Territory
Therapeutic Goods Administration
World Trade Organisation
7"I,;S Digesl was preINJr/:dIQl" debale. II rejlecl$ Ihe legis/alioll as imroi!lIcedol/d dQf!5 IlOl ca,,''Qss subsequefllomelldmell/s.
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2 Gene Technology Bill 2000
This Digesl"'PSp"ptl~forddJatr. /, "fleets the Iq:islotioll (IS inlroduudarul does 1I()l can>uss subseqUf'ft1 ammdmml$.
TIlis Digest d0t!5 IIOIlu".... an)' QJliciallq:a1S/OIUS. Othu$QU~Usbld~ ronsullM10 detenni~ fhe Sllfu~IW"( ojJicialSIQ~ oJtlre Bill.
Date Introduced: 22 June 2000
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: On a day fixed by Proclamation, or at the latest 6 months after Royal Assent
The purpose of the Bill is to establish the federal component of what is hoped to be a nationally consistent scheme for regulating certain dealings with genetically modified organisms.
What is Gene Technology?'
Gene technologl refers to a number of ingenious methods whereby genetic material (0 A) in the cells of target organisms is altered in very specific ways. Gene technology works essentially because there is remarkable similarity between the central biochemical systems of plants, animals, bacteria and fungi. In particular, the decoding of molecular sequences in DNA to create thousands of proteins in a cell is virtually the same mechanism in all living organisms. A meaningful sequence in DNA (that is. a gene) leads to production of a specific protein. A gene is therefore able to determine the structure of a protein and features start, stop and control switches for that protein. all in genetic code.
Proteins may have an architectural function in an organism but most types are catalysts enabling the chemical processing of all the sugars. fats. hormones, vitamins. etc.⢠which the organism needs.
Gene technology is extremely precise in that a single foreign gene can be introduced to target host cells which then decode the new gene along with all the natural genes in their DNA. Genetic material can be introduced to host cells by infecting them with genetically engineered viruses and bacteria, or simply by shooting in tiny gold pellets coated with the
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desired gene or genes. This level of precision means that scientists are no longer restricted to genetic shuming which results from cross-breeding between varieties of the same or closely related species. Such traditional methods are used to introduce new traits but the choice of genes is obviously small. lnheritance of undesirable genes is also a problem in
traditional methods. By comparison. through gene technology. scientists can now choose from the entire gene pool· including taking specific genes from unrelated species - in order to add, subtract or alter genetic material in the target organism. Note that, at present, il is difficult to introduce more than a very few complete genes in the onc operation.
By altering the gene content of an organism, the production of specific proteins can also be added. subtracted, strengthened or weakened through the genetic coding mechanism. New proteins may be designed to serve an important purpose such as phannaceutical production, herbicide resistance, flavour improvement or growth stimulation. Alternatively, there may be natural proteins in the target organism which are desired to be weakened or removed· unwanted flavours, fertility in pests or rotting promoters, for example. Switches can also be added so that production of a specific protein is made to depend on a chemical signal (for example, sprayed on a crop).
A distinction is often made between whole organisms or cells which are altered genetically and the purified products from those organisms. The difference is that the whole organism or its cells contain all the genetic alterations and all the new protein differences. However, a purified product cannot reproduce in the environment and is often not altered itself. An example is cottonseed oil from' Bt cotton'.
Putting aside economic issues, there are perhaps three mam issues of popular concern surrounding gene technology. These are:
⢠broad ethical and religious concerns regarding the manipulation of DNA; 3
⢠concerns over the safety ofgenetically manipulated foods; and 4
⢠fears that damaging 'rogue' genes could escape from commercial crops or animal herds into the natural environment. 5
By contrast, the production of phannaceuticals such as human growth honnone using genetically engineered bacteria has been much more readily accepted.
How is Gene Technology currently regulated in Australia?
Legal responsibility for gene technology regulation in Australia is vested in different regulatory bodies depending on the intended end use of the relevant genetically modified organism (GMO) or genetically modified (GM) product·
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TJ,is Digcrl don not ha\y any officia' legal Sla/II$. OtIHtr.wurcnsltould tw consuf/l'd to dele""in~th~ subseqW1llofficial SIt11U$ oflh~ Bill.
Gene Technology Bill 2000 3
⢠Foods (including GM foods) are regulated under State and Territory Food Acts, with the role of developing Food Standards resting with the Australia ew Zealand Food Authority (ANZFA) under the Australia New ZealandFoodAuthorityAct 1991 (Cth).
⢠Therapeutic goods (including GM therapeutic goods) are regulated under the Therapeutic Goods Act 1989 (Cth), administered by the Therapeutic Goods Administration (TGA) within the Commonwealth Department of Health and Aged Care.
⢠Human gene therapy (both clinical research and marketing of products for human gene therapy) is also regulated by the TGA. The National Health and Medical Research Council (NHMRC) also supervises research involving human gene therapy through its Gene and Related Therapies Research Advisory Panel.
⢠Agricultural and veterinary (agvet) chemicals (including GM agvet chemicals) are regulated through a national scheme administered by the National Registration Authority (NRA). Regulation centres around the Agricultural and Veterinary Chemicals (Code) Act 1994 (Cth) and related legislation in all jurisdictions which controls the post·sale use of agvet chemicals.
⢠Industrial chemicals are regulated through the National Industrial Chemicals Notification and Assessment Scheme (NIC AS) under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) and accompanying Stateffemtory legislation.
⢠Imports and export's of GM products or GMOs are regulated under the Quarantine Act 1908 (Clh), the Imported Food Control Act 1992 (Cth) and the Export COlltrol Act 1982 (Cth) administered by the Australian Quarantine and Inspection Service (AQIS).' The Australian Customs Service (ACS), under the Customs Act 1901 (Cth), has a general border control role which it undertakes with the assistance of AQJS. Other regulatory agencies also rely on the ACS to provide primary comrol of imports and exports.
The Genetic Manipulation Advisory Committee (GMAC)8 provides advice to these agencies on the biosafety and environmental implications of GMOs. GMAC is a non statutory body and has no direct legal power 10 enforce its decisions. Jts role extends to any experiment that involves the construction or propagation of a novel substance produced by genetic manipulation, which is either:
⢠unlikely to occur in nature; or
⢠likely to pose a hazard to public health or to the environment.
GMAC thus oversees laboratory based research and the release of GMOs into the open environment, such as field trials and the commercial growing of GMO crops.
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This Digest dof's tW)/ItaIY alf)'oJFK'Klf It'gal status. OthersourceshouldM consulted10 dl"l'nfIilff' the swb$f't(Uf'ft/ o.ffK'ial Status ojtlrl' Bill.
4 Gene Technology Bill 2000
As of February 2000, GMAC had assessed:'
⢠5164 proposals for small scale contained work (mainly laboratory based work by universities and other research bodies)
⢠40 proposals for large scale contained work. The great majority of these proposals were submitted by commercial organisations.
⢠236 proposals for field trials arGMOs, mainly for genetically modified plants such as conon or canola. Most field trials were run either by commercial organisations or the CSIRO, with a smaller number by universities or State government agencies.
⢠8 applications for general (commercial) release of GMOs. Three of these have been approved to dale: 8t cotton (which was subsequently regulated by the NRA); a violet carnation; and a carnation with improved vase life. In addition, the NRA has approved, with the advice of GMAC, the release of a genetically modified plant pesticide (in 1989) and a salmonella vaccine (in 1992).
early 30 per cent of the Australian cotton crop is genetically modified, 10 and it is predicted that this percentage may rise to 80 per cent by 2005. 11 Major biotechnology company Aventis also estimates there may be a million hectares of its GM canola under cultivation by 2005, which would constitute almost the entire Australian canola crop. 12
Other than the issue of food labelling, criticism of the current regulatory system has mainly focussed on the perceived lack of transparency in GMAC's decision-making process and its apparent incapacity to ensure that conditions placed on field trials were strictly complied with. In recent times, it appears there have been four incidents requiring
investigation, including the dumping ofGM canola plants at an open commercial tip in Mt Gambier in March 2000,13 and the inadvertent mixing of 69 toones of GM cotton seed with conventional seed in Queensland in July 2000. 14
The current regulatory regimes for therapeutic goods, agricultural, veterinary and industrial chemicals and food containing GMOs or GM products will continue if the Bill is passed. The purpose of the Bill is to regulate dealings with GMOs, not GM products unless they are not regulated under the existing regimes. However, the informal role of GMAC in providing advice will be formalised, by conferring it on the Gene Technology
Regulator (the Regulator) through legislation. The details of tbe Regulator's advisory role in relation to GM products is set out in the Bills Digest for tbe Gene Technology (Consequential Amendments) Bill 2000.
Regulation of international trade in GMOs
There are no international instruments which set down comprehensive standards for the regulation of GMOs or GM products. However, the international movement and commercial trade of GMOs are regulated by broad policy principles established by the
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Thi~ Dignt dan nQl hOlY an)' affinal legal ~IUll4. Other :JQUfU'S ~houfd bt- (OIlSI
Gene Technology Bill 2000 5
World Trade Organisation (WTO). In addition, the Cartagena Protocol on Biosafety (the Biosafety Protocol) 15, once it comes into force, 16 will introduce more detailed rules for the assessment of the environmental and human health impacts of importing GMOs. The Bill regulates the importation of GMOs, among other things. It is therefore important that any requirements the Bill imposes upon prospective importers into Australia are consistent with the regime established by the WTO in particular.
The Agreement on Sanitary and Phytosanitary Measures (SPSA).
The only WTO instrument directl?, relevant to GMOs is the Agreement on Sanitary and Phytosanitary Measures (SPSA). I It aims in part to ensure that quarantine and related food safety and animal and plant health import rules ('sanitary or phytosanitary measures') are not unnecessarily restrictive or discriminatory in relation to international trade. Any restrictions on importation must be 'based on scientific principles' and 'applied only to the extent necessary 10 protect human, animal or plant life or health'. 18 In general, the SPSA provides that countries should base their protection levels on international standards, such as the Codex Alimentarius which sets standards for food safety. However, in certain siruations, members may also maintain measures which result in a higher level of protection
if these can bejustified on grounds such as the potential economic damage that a disease or pest may cause, the costs of control, or the relative cost·efTectiveness of alternative approaches to limiting risks. 19
The SPSA also allows for a quasi-precautionary principle approach. Where scientific evidence is insufficient to fully assess the risks, countries may adopt provisional measures on the basis of available pertinent information. However, countries are then obliged to seek to obtain the additional infomlation necessary for a more objective assessment of
risk, and then review the sanitary or phytosanitary measure within a reasonable period of time. 20
In summary, the SPSA requires a country's decision whether or not to allow the importation of a good 10 be based on a transparent risk assessment process. Where the outcome of the assessment provides grounds for restricting importation, any measures taken must be designed so that they do not go beyond what is necessary to reduce or eliminate the risk in question. 21 As will he seen in the Main Provisions section of this
Digest, the risk assessment and decision.making process would appear to be more transparent than the current regulatory system. Given that the Regulator is not required to consider Australia's obligations under the SPSA to adopt the least trade-restrictive method of risk management in deciding what conditions to place on the importation of a GMO, it will be interesting to see if there are any complaints about the Regulator imposing conditions which are excessively restrictive of trade. 22
Biosafety Protocol
The Biosafety Protocol is intended to protect the environment against the potential adverse environmental impacts of international trading in GMOS. 23 The focus of the Biosafety
Thu Digest was pn!puredfiJrdebot~. It rrfleas tlt~ legulalKHI us ;mrod"CNand diNS 100I cam'llSS subsequentam~ndm~nlS.
Thu Digest don /fOI ""''1' any ajJiciQIII!gQ/Sla/us. Other sources sltcHJld M romulledta d~t~rmin~ th~ subsequ..." afflCial s/atus oftlt~ Bill.
6 Gene Technology Bill 2000
Protocol is on the impacts on biodiversity, although jt also refers to risks to human health. Some GM products, such as processed foods and phannaceuticals for human use, are generally excluded from the operation of the Biosafety PrOlaco!.
The central aspect of the Biosafety Protocol is a 'prior notification and consent' regime for trade in GMOs. Subject to certain exceptions, intending exporters will be required to notify the importing country of the proposed GMO shipment if the GMO in question has not previously been intentionally introduced into the importing country's environment (the so-called advance informed agreement procedure). This requirement is designed to allow the importing country time to assess the environmental and human health risks of allowing the GMO into the country and thus allows them to makc a fully informcd decision on whether to permit the import.
Some GMOs are subject to a lesser regulatory scheme. A relatively limited notification procedure applies if the GMO is imported for direct use as 'food, feed or for processing'. This apparently represents the majority of current GMO trade. Rather than the exporter having to notify the importing country of a specific shipment, the exporting country must have notified the International Biosafety Clearing-House that it has approved the GMO for domestic release within its own environment if the GMO in question is one that might be exported.
The Biosafcty Protocol also allows for a quasi.precautionary principle approach. For I . h 24 examp e It states tat:
A lack of scientific certainty due to insufficient relevant scientific infonnation and knowledge regarding the extent of the potential adverse effects of a [GMO]...shall not prevent that Party from taking a decision, as appropriate... in order to avoid or minimize such potential adverse effects.
The comments made above relating to the consistency of the Bill with WTO rules also apply to the Biosafely Protocol. In any case, the issue is 11100t until the Commonwealth makes a decision whether to sign and ratify the Protocol.
Development of the Bill
Formal Commonwealth oversight of gene technology dates back to 198] when the Recombinant DNA Monitoring Comminee was created. This Comminee was replaced by GMAC later in the 19805. In 1992, a report by the House of Representatives Standing Comminee on Indusny, Science and Technology25 recommended that the Commonwealth should pass legislation to regulate GMOs, in particular to regulate the release ofGMOs outside contained facilities. The Government accepted the thrust of the report and commented that it would: 26
propose to the States and Territories that legislation be introduced under which the Commonwealth would establish an independent Genetic Manipulation Authority (GMA) to regulate the release of GMOs, including restricted releases such as field
n,is Digest WliiS prep(uedfordrlJGt~. It rej1«u tlw IrgislatiOl/ as in/rod/.cedand dt:ws not ronnussubs~_/omeN!mellu.
11Iis Digest dQt1s not hOl\l' anyofJicial'rgalstatus. Othrr SOf,ruS should be NHlSulted /0 dr/rm/inr the subs~ul'nl officialstotus oflh~ Bill.
trials. The GMAC will be replaced by a new Genetic Manipulation Research Committee, GMRC. The GMRC will have legislatively defined powers to approve contained research and development of GMOs, taking into account wider issues, such as ethical issues proposed by the GMA. The GMRC will also provide specialist
scientific advice to the authority in respect of release proposals.
During 1992-95, there were ongoing Commonwealth-State discussions regarding legislative options to implement this. However, there was apparently disagreement over the legislation model, leading to a cessation of negotiations by 1995.
The proposal for a 1egislatively·based regulatory system for gene technology was revived in October 1997 by the Commonwealth in a joint statement by Ministers Moore, Anderson and Hil1. 27 The system envisaged involved:
⢠the amendment of current legislation and introduction of new legislation to ensure that gene technology is covered by uniform laws and that compliance is compulsory
⢠the establishment of a Gene Technology Office to administer a national regulation system which will ensure that comprehensive analysis and risk assessment are undertaken before GMOs are released. The Gene Technology Office would coordinate the release of GMOs by existing bodies, make decisions on release of GMOs not covered by existing bodies, and regulate gene technology research
⢠the commencement of consultations with the public and the State and Territory Governments, and
⢠the establishment oran interim Gene Technology Liaison Committee to provide advice on urgent issues which are not able to be addressed under current regulatory systems.
A Commonwealth-State Consultative Group on Gene Technology was fonned shortly thereafter. Thjs Group prepared a paper, Regulation of Gene Technology, which was circulated for 'limited public consultation,.28 The paper included a set of policy principles that were intended to guide the development of the Bill and the administrative mechanisms. In
October 1999, a follow-up paper, Proposed National Regulatory System for GMOs: How should it work?, was prepared by the newly created (Commonwealth) Interim Office of the Gene Technology Regulator (IOGTR) in collaboration with State and Tenitory officials for wider foubJic consultation. 29 Some 200 written submissions were received in response to the
paper. 0
In December 1999, an exposure draft of the Bill was published and distributed. Public fora were held in all capital cities and some regional centres during March 2000. Further details on the main issues debated at these fora are contained in the Explanatory Memorandum to the Bill. 31
It is understood that the Bill, and its accompanying regulations, was originally due to be introduced into Parliament in April 2000. The Bill was eventually introduced into the House of Representatives on 22 June 2000, and on 28 June was referred to the Senate
This Digesl was prepared/ordebole. "refleCIS Ihe legislotion as imroducedand does nOI CO/II'IISS subsequell/ omendmeniS.
This Digesf does nOI halY' Qlry official {egal sloms. Olhersources should be consulted 10 determille the subsequemofficial SIU/uS a/the Bill.
8 Gene Technology Bill 2000
Community Affairs Reference Committee for report by 5 September 2000. 32 An attempt by the Democrats and Senator Brown to have to time for reporting extended to 5 October was defeated.
Main Provisions
The object ofthe Bill is stated to be (proposed section 3):
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.
This object is to be achieved through a regulatory framework which 'provides an efficient and effective system for the application of gene technologies' (proposed section 4).
Because heahh and environmental concerns are the focus, the Bill does not deal with issues such as trade, or intellectual property rights in biotechnology. However, the Bill does not deal with all health and environmental concerns. Specifically, food labelling remains the responsibility of the Australia New Zealand Food Standards Council on advice from ANZFA, and genetic manipulation of humans (for example, human gene
therapy or human cloning) is not covered by the Bill.
Scope and definitions
'GMO' is broadly defined to include any organism]] that has been genetically modified, and the offspring of a GMO (proposed subsection 10(1». A person who has had somatic cell gene therapy is not a GMO. Regulations may declare certain organisms to be GMOs, and others not 10 be GMOs.
The Bill will regulate certain dealings with GMOs, mainly through a licensing system. The definition of 'dealings' in proposed subsection JO(1) is extremely broad, and covers the entire life cycle of GMOs, from laboratory experiment's, growth, development, production or manufacture of GMOs, use of GMOs to manufacture GM products, possession, transport and disposal of trash. The Bill also applies 10 importing of GMOs.
Although the scope of the Bill appears comprehensive, the Bilt only applies 10 those dealings if they are engaged in by persons or bodies who fall within the Commonwealth's legislative power, namely trading, foreign or financial corporations 34 and the Commonwealth and Commonwealth authorities. The Bill also applies 10 all dealings by any person or body (proposed section 13):
⢠in the course of interstate or international trade or commerce (for example, growing a crop of GM canola for sale interstate or in other countries),
This Digest \!ow preparedfordrixllr. 11 rrfloclS Ihl' legislalion as introducrdalld does not CQnwuss..bsrquenlamendments.
This Digesl dOl'S not ha,'/' an),offiriollegalSIOIUS. Othersm.rces shouldbe consulled 10 dl!f","i,,*, thr SJ.bsI'oqllf>nl officiol SIOms o/,h~ Bill.
Gene Technology Bill 2000 9
⢠that may cause the spread of diseases or pests (this would cover most field trials and commercial releases ofGMOs, and may cover some foods and medicines), or
⢠involving the supply ofservices to the CommonwealLh or a Commonwealth authority.
The existing Commonwealth schemes regulating GM products (food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods) referred to in the Background of Ihis Digest, will continue to operate in conjunction with the Bill (proposed sections 4(b) and 15). The Gene Technology (Consequential Amendments) Bill 2000 sets out the relationship between these existing schemes and the proposed gene technology scheme.3s For more infonnation, the reader is referred to the Bills Digest no 10,2000-01 on the Gene Technology (Consequential Amendments) Bill 2000.
The Bill applies throughout the Commonwealth and in every external territory other than Norfolk Island (proposed section 7).36 Although the Bill binds the Commonwealth, States and Territories, these entities cannot be prosecuted for an offence against the Bill (proposed seclion 6).
Operation as a national scheme
In the following discussion of the Bill, 'State' includes the Australian Capital Territory and the orthem Territory (sec the definition of 'State' in proposed subsection 10(1».
It is intended Ihat the Commonwealth and the States will sign a Gene Technology Agreement (the GTA), and that all States will enact com~lementary legislation once the Bill has been passed by the Commonwealth Parliament. 3 Thus, any dealings which the Commonwealth is unable to regulate are intended to be covered by identical State
Additionally, Stale laws which are declared by the Commonwealth Minister for Health to be "corresponding State laws" may have an extended operation in areas which would otherwise be covered by the Bill. If a State with a corresponding law gives a "wind·back notice" to the Commonwealth Minister, activities by State agencies and universities, as well as all acts or omissions that may cause the spread of disease or pests, would be
regulated by State legislation rather than by the Bill (proposed section 14). The Regulator and all three advisory committees may exercise functions, powers or duties conferred on them under corresponding State laws (proposed section 17).
The Commonwealth also has power to preclude a State law from regulating dealings with GMOs if the State law is inconsistent with the national scheme worked out in the GTA (proposed subsection 16(2». The operation of the national scheme, the interrelationship between Commonwealth and State laws, and the constitutionality of the Regulator and the committees exercising functions conferred on them under State laws are issues discussed
further in the Concluding Comments section of this Digest.
1Jlis Digesf ..m pt't'pDredfordeoote. II reflects tile If'gislolion as introducedandd-s tIOI can>un subsequl!tllantendmetfU.
This Digest tIou IfOI how' QnyojJtciallegal nOlla. Other rources shouldbe CVllSllftf'd 10 defe,.",ine tM subsequemofficial stQIILf oftile 8j1J.
10 Gene Technology Bill 2000
Governance structure for gene technology regulation
The Bill establishes the Regulator, who is responsible for making the majority of decisions relating to gene technology and GMOs. The scheme establishes a separation of policy level decision·making from the process of making decisions on panicular licence and other applications. The Regulator is responsible for the decisions on panicular applications, is subject to guidance at a general level from the Ministerial Council, and is
ultimately responsible to Parliament. The Regulator is assisted in his or her duties by three advisory comminees also established by the Bill.
The Regulator is an independent statutory office holder (proposed section 26) and is not subject to direction from anyone in relation to the performance of his or her functions, in particular whether or not to grant a GMO licence with or without conditions (proposed section 30).
The Regulator is appointed by the Governor-General with the approval of the majority of jurisdictions (proposed section 118). It seems that even if a State or Territory does not sign the GTA and does not participate in the national scheme, it will still be able to participate in the decision to appoint the Regulator. He or she will hold office for a fixed
term of three to five years (proposed subsection 118(2)). It is not explicitly stated that the Regulator's appointment may be extended for a further fixed tenn, but in the absence of any indication to the contrary, it may be presumed that the Regulator's appointment may be extended.
The Regulator must disclose to the Minister all interests, pecuniary or otherwise, that could connict with the perfomlance of his or her functions (proposed section 120).
The functions of the Regulator are broad. They include (proposed section 27):
⢠detennining applications for GMO licences,
⢠developing draft policy principles and policy guidelines to be issued by the Ministerial Council,
⢠developing codes of practice, technical and procedural guidelines in relation to GMOs,
⢠providing infonnation and advice to other regulatory agencies and to the public,
⢠undertaking or commissioning research in relation to risk assessment and biosafety of GMOs, and
⢠promoting the harmonisation of risk assessment relating to GMOs and GM products by regulatory agencies.
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Gene Technology Bill 2000 II
The RegulalOr may delegate any of his or her powers or functions to an employee of the Depanment of Health or Aged Care, or an employee of another Commonwealth Department, authority or State agency whose functions relate to GMOs and GM products (proposed section 29). This enables the Regulator to delegate to a relevant agency such as the NRA or ANZFA.
The Regulator has discretion in the perfomlance of his or her functions, and has the ability to obtain scientific, ethical and other advice from the three advisory committees established by the Bill. The Regulator's function is to focus on risks to the environment and to human health and safety. It is no part of his or her function to consider economic or trade issues. However, the Regulator is not entirely free, but is bound by policy principles
issued by the Ministerial Council not to issue a licence if to do so would be inconsistent with a policy principle (proposed section 57). "Policy principles" are dealt with below.
The Regulator must repon to the Minister annually, and give a copy of the repon to each State (proposed section 136). However, the House of Representatives Standing Committee on Primary Industries and Regional Services recommended that the Regulator report at least quarterly for the first three years. Jll The Regulator also has a discretion to cause a repon about matters relating to his or her functions 10 be tabled in either House of
Parliament at any time (proposed section 137). This power is similar 10 that given 10 other fiercely indersendent statutory office-holders, such as the AudilOr-General and the Ombudsman. 9
Ministerial Council
The Ministerial Council will be established under the GTA (see proposed subsection 10(1», and will consist of one or more Ministers from the Commonwealth and each participating State and Territory. The composition of the Ministerial Council (and details such as whether it includes environment Ministers or health Ministers or both) will not be known until the GTA is signed.
The role of the Ministerial Council is to oversee the operation of the Regulator, to consulting on and issue policy principles and policy guidelines to guide the Regulator, and to advise the Regulator on codes of practice and standards for persons conducting dealings with GMOs.40
"Policy principles" are disallowable instruments which deal with ethical issues relating to GMOs or other mailers prescribed by regulations (pl'"oposed section 2]), and are issued by the Ministerial Council after consultation with a number of Commonwealth, State, industry and community organisations, including the three Commonwealth advisory committees (proposed section 22). The Regulator must not to issue a GMO licence if to do so would be inconsistent with a policy principle (pmposed section 57).
"Policy guidelines" are issued by the Ministerial Council, and may deal with matters relevant to the Regulator's functions. The Regulator must have regard to policy guidelines in deciding whether or not to issue a GMO licence (proposed section 56), but is not
This Digest wosP"fKlrrd/orddJote. 1/ ".fleers the ft'gisfQfion as j",roducwJQ/Hi~ Iff)I CQnnussubsequent ament/menU.
11015 Digestdon lOOt 1Io,'t'QIf)' ojJicial Jegol StQIIa. Other sourcessh
12 Gene Technology Bill 2000
bound to follow them. Unlike policy principles, policy guidelines are not required to be made in consultation with anyone, although the Ministerial Council may choose to consult, and are not disalJowable instruments (proposed section 23).
"Codes of practice", with which GMO licence-holders may be required to comply (proposed paragraph 62(2)(1)), are developed by the Regulator after extensive consultation and issued by the Ministerial Council. They will be disallowahJe instruments (proposed section 24) and will be of key importance in selling the standards to be complied with and outlining measures to be taken to minimise risks.
Advisory committees
Proposed Part 8 oCthe Bill establishes three committees:
⢠the Gene Technology Technical Advisory Committee (GTTAC),
⢠the Gene Technology Community Consultative Group (GTCCG), and
⢠the Gene Technology Ethics Committee (GTEC).
The GTTAC will be composed of up to 20 scientific and technical experts and one layperson (proposed section 100), and will replace the current GMAC. Its function is to provide scientific and technical advice on gene technology, GMOs and GM products, including the biosafety aspect's of gene technology (proposed section 10 I).
The GTCCG will be composed of up to 12 persons, mainly representatives of a range of sectors of the community (including the environment, public health. primary industry, local government and consumers), and one member of GTTAC and GTEC (proposed section 108). lts function is to provide advice on matters of general concern regarding
GMOs (proposed section 107).
The GTEC's function is to provide advice on ethical issues relating to gene technology. It will be composed of up to 12 persons with ethical, religious or legal expenise, including one member of GTTAC and one member of the Australian Health Ethics Committee with expertise in medical research (proposed section 111). The lOGTR has commented that the GTEC:
will be modelled on the Australian Health Ethics Committee which is established under the National Health and Medical Research Council legislation in relation to human health. 41
Only the GTTAC will be directly involved in providing advice on GMO licences and other applications (proposed section 101). The GTCCG and the GTEC will be consulted only in relation to general principles or guidelines, not in relation to specific decisions. All three committees may be consulted in relation to the need for and content of policy principles guiding the ethical decisions of the Regulator, and codes of practice applicable generally to dealings with GMOs. Only GTTAC and the GTCCG may be consulted on the
11Iu Digest MUS f'"pDtnlfor deba,~. 11 reflO'tClS 1M It'gisltJtiOtl as itlJrodue«JtJnd does noI Olnl'l2U subseqwnttJlflendmenlS.
n,is Digest does '101 hUll(' tJn)'officio/ It'gol Siotus. Olhersaurusshould be C'CH/su/ted to determine 11r~ suluequentofflcitJI SlOWS oflh~ 8iJJ.
Gene Technology Bill 2000 13
need for and content of policy guidelines and technical or other specific guidelines relating to GMOs and GM products. The GTEC does not have a function to advise on policy guidelines or specific guidelines. 42
Both GTTAC and GTEC have the ability to call on expert advisers to assist them (proposed sections 102 and] 13). The advice of all three comminees can only be provided if requested by the Regulator or the Ministerial Council.
All members of these three committees are appointed by the Minister after consultation with the States, the Regulator, scientific, health, environmental and industry groups, and other Ministers if the Minister considers it appropriate. All members hold part-time paid appointments. No procedures for disclosure of conflicting interests and other matters are
contained in the Bill, but they may be covered by regulations (proposed paragraphs 104(1)(c), 110(1)(c) and 115(1)(c)) or detcnnined by the eomminees themselves. The lOGTR expressed the view that the disclosure of conflict of interest provisions will be 'stringent' ,43 but until the draft regulations are available, it is not possible to verify this.
Licensing system
Dealings with GMOs which were approved by GMAC prior to the commencement of the Bill may proceed for up to two years aner the Bill commences. GMAC·approved dealings do not require a GMO licence and will not have to undergo the consultation and approval process described below, as they are deemed to have been approved and granted a GMO
licence (proposed section 190).44 There is a possibility, although the likelihood is unclear, that there may be a rush for approvals from GMAC prior to the commencement of the Bill.
Aside from GMAC-approved dealings, all dealings with GMOs are prohibited (proposed s('('tions 32 and 33), unless they are:
⢠authorised by a GMO licence,
⢠notifiable low risk dealings,
⢠exempt dealings, or
⢠dealings included on the GMO Register.
A person wishing 10 conduct dealings with one or more specified GMOs must apply to the Regulator for a GMO licence, paying an application fee and providing information as required by the regulations and by the Regulator (proposed section 40). The Regulator has power to require an applicant for a GMO licence to provide further information (proposed section 42). The Regulator has a discretion to consult the applicant or another regulatory agency on any aspect of the licence application, before considering the application (proposed section 44).
11ris Digat .."OS prepared/ord~bot~. It reJ1n:u Ih~ If'gislalion as introducedolld does ffOI comvsssubseqUf'nt amelldm~nts.
This Digal does ffOI M'~ an)' official If'gQI statu3. Oth~r soulTa should~ lXNrsulled /Q dete""i~ IJw s"bseq"elltoffICial SlQtu3 ofthl' 8ill.
14 Gene Technology Bill 2000
A different consultation process applies to the intentional release of a GMO into the environment from that which applies to contained dealings. The different procedures are described below.
Consultation process
Intentional release to the environment
An extensive consultation process, requiring input from the States. the Environment Minister. scientific experts, loc.al government and the community, must be undertaken prior to the Regulator issuing a licence authorising the intentional release of a GMO into the environment. "Intentional release" includes all commercial releases of a GMO.
including viruses and bacteria, as well as field trials of GM crops and animals, even jf such trials include measures for limiting the spread of the GMO (proposed section ]]).45
First, the Regulator must detennine whether the dealing is one which may pose a significant risk to the environment or human health and safety (proposed section 49). A number of criteria are specified which the Regulator must consider in fonning an opinion about whether there may be a significant risk, including the potential for spread of the GMO, and the extent or scale of the proposed dealings (proposed subs£'ction 49(2». If in the RegulalOr's opinion there may be a significant risk, as a first step in the consultation
process the Regulator must invite written submissions from the public on whether the licence should be issued. The submissions should cover Ihe risks and means of managing those risks.
Whether or not there is a significant risk, the Regulator must prepare a risk assessment and a risk managemenl plan to manage any risks so as to protect the health and safety of people and the environment (proposed section 50). In preparing a risk assessment and risk management plan, the Regulator is obliged to consult:
⢠the States
⢠the GTIAC
⢠the Environment Minister, and
⢠any Commonwealth authorities or agencies prescribed in the regulations.
The Regulator must also consult any local councils that he or she considers appropriate (proposed subsection 50(3». However, it is up to the Regulator to consider which local councils it is "appropriate" to include.
The Regulator must take into account any advice given by any of these bodies, as well as any advice given by the public in writlen submissions under proposed section 49 (if written submissions were called for) (proposed section 51).
This Dig~1 WVlS prqKlrwJfordeba/~. It reflects /M legislarion as inlroduudamidoa fI(N Ollfl'llSS subsl'f/unl/ amendmenu.
11lis Diges/ dews IIQl hll\~ any aJJiciallegafSia/us. OtherSOtlrT:t'S shollfd W C'OlInIf,nI to d('le""iM /11(' SUbsl'f/unll official StQIUS ofth~ Bill.
Gene Technology Bill 1000 15
After preparing the risk assessment and risk management plan, the Regulator must invite wrinen submissions from the public on those documents. The Regulator must also seek advice on the risk assessment and risk management plan from the States, the GlTAC, the Environment Minister, any Commonwealth authorities or agencies prescribed in the regulations (proposed section 52).
The Regulator also has a discretion to take other action, such as hold public hearings (proposed section 53). It is important to note that, although the Regulator is required to take into account the advice given by these persons and bodies, he or she is not required to follow the advice given by any of them. The ultimate decision remains the Regulator's, not the Environment Minister's, the States' or local government's.
Coniained dealings
When the dealings to be authorised by licence do not involve intentional release of a GMO into the environment, the Regulator simply prepares a risk assessment and risk management plan. The Regulator may, but does not have to, consult the States, the GlTAC, relevant Commonwealth authorities or agencies, local councils or any other person (proposed section 47).
Licence decision
After conducting the consultation process as required, the Regulator must decide whether or not to issue a licence, with or without conditions (proposed section 55). A number of safeguards exist in the Bill. The Regulator must not issue a licence if:
⢠he or she is not satisfied that the risks can be managed so as to protect the environment or the health and safety of people, having regard, among other things, to any policy guidelines issued by the Ministerial Council (proposed section 56),
⢠issuing the licence would be inconsistent with a policy principle made by the Ministerial Council (proposed subsection 57(l», or
⢠he or she is not satisfied that thc person applying for a licence is a suitable person (for example, having regard to any previous licence suspensions or revocations, or convictions relating to health, safety or the environment) (proposed subsection 57(2) and section 58).
Thus, the Regulator is bound by policy principles issued by the Ministerial Council under proposed section 21. He or she is not bound to follow, but must have regard to, policy guidelines issued by the Ministerial Council under proposed section 23, as well as public submissions.
The Bill does not specify the standard of evidence which will be required by the Regulator in making decisions. Environment Australia and other bodies have recommended:
⢠basing assessments on replicable findings only, and
n,is Digesl WQS prepilretiforJeOOll'. It rl'J1«ts Ihl' Il'gisls/ion lIS introducedrJlld d_s tIOf C'Q''''QSS subsequent om...Jdml'nlS.
11Iis Digestdon 1f(1I1u1l'l' QIr)' oJIicialll'gaistotus. Other SOllrrrs should be COIuulll?d to Jell'""ine IhI' subsl'f{ul'nt oJFlC'iol SIQIUS of/III' Bill.
16 Gene Technology Bill 2000
⢠requiring the same type of peer review of the research evidence submitted by commercial companies to the regulatory bodies as is applied to published rescarch. 46
If a GMO licence is issued, the Regulator will be able to levy annual licence fees, under the Gene Technology (Licence Charges) Bill 2000. The amount of the licence fee will be prescribed by the regulations. However, the fees will be significant. The fact that they have been imposed in a separate statute indicates that they will not simply be a fee for service (as the application fees for licences are), but arc in the nature of taxation. 47 The
Explanatory Memorandum states that it is the Government's intention that the Regulator recover 100% of his or her costs from users of the regulatory regime, for example, through licence charges. 48
Licence conditions
A GMO licence may cover the licence-holder and additional persons (such as employees) and will be subject to such conditions as are included in the licence, in the Regulator's discretion. These conditions may include specific provisions about waste disposal, specified cOnlainment levels, specific measures to manage risks, contingency planning, documentation, record-keeping, research, auditing and reporting (proposed section 62).
Particular GMO licence conditions may include requirements that a facility be certified to a particular containment level, or that dealings must be supervised by an Institutional Biosafcty Committee established by an accredited organisation. The procedures for certification and accreditation are discussed below, and will depend on the content of guidelines to be issued by the Regulator.
Compliance with «technical guidelines" issued by the Regulator (proposed section 27) after consultation with GTIAC and the GTCCG, may also be a condition of a GMO licence (proposed paragraph 62(2)(1». These documents, which arc not currently available, will be instrumental in setting the standards to be complied with and outlining measures to be taken to minimise risks.
The Bill does not set specific buffer zones around GM crops to protect organic and GM free crops growing nearby. However, the JOGTR considers that:
aCling on a broad definition of the environment, the [Regulator] will be able to set conditions to limit contamination of non GM by GM crops and punish breaches. The bill defines the environment as including 'ecosystems and their constituent pans, and natural and physical resources, and the qualities and characteristics of locations,
places and areas,!9
Certainly the Regulator will have power to impose conditions to limit contamination. It will be up 10 the Regulator whether it does so, what conditions to impose, and the level of stringency required, although Regulator must be satisfied that any risks to the environment or to human health and safety can be adequately managed (proposed subsection 56(1»).
This Digest wus pnpo.-NIOI'debolt!. 11 "fleets',", It'gislo,iOll os i",roduadond don IfOl CIlm'lJS3" SUbsl"qUelll amendments.
This Digesl dO>n 1/01 lr(nT OllJ' oJfiriol legol SIOIUS. Orhersou~ s~/d be NNU"lted10 dt!ler",i"e lire s"bseque'''/ oJfiriQ/ SIOIUS of/lit! Bill.
Gelle Technology Bill 2000 17
The Regulator has power to vary a licence, including imposing additional conditions or removing or varying existing conditions. The Regulator cannot vary a licence for contained dealings to authorise the intentional release of a GMO, and must be satisfied that any variations to the licence enable risks to be managed adequately (proposed section
The licence·holder has a statutory obligation to inform any person covered by the licence of particular conditions which apply to the person, any variations of those conditions, or if the licence is cancelled, suspended or surrendered (proposed section 63).
Dealings with GMOs which are not subject to the licensing system
Exempt dealings, dealings listed on the GMO Register and notifiable low risk dealings wiJl be able to be conducted without going through the consultation and licensing process.
Exempt dealings
Dealings which are stated in the regulations to be exempt wiJl not require a GMO licence (proposed subsection 32(3». 0 grounds are specified in the Bill on which certain dealings or classes of dealings with a GMO may be exempted. The IOGTR has proposed that dealings currently exempt under GMAC's guidelines for very low risk work conducted in contained facilities 50 will continue to be exempt under the Bill.
Dealings listed on the GMO Register
Certain dealings with GMOs which are of minimal risk may be included on a GMO Register maintained by the Regulator. An example of a minimal risk dealing provided by the IOGTR is a nower which has been genetically modified 10 enhance vase life, which has been grown subject pursuant to a GMO licence for a period of years, demonstrating that it is safe. 51 The GMO Register is open to inspection by the public (proposed section 8]). The dealing must have previously been authorised by a GMO licence. Any person may undertake a dealing listed on the GMO Register without a GMO licence. subject to any conditions specified in the GMO Register (proposed sections 32 and 79).
The Regulator makes a determination that a certain dealing with a GMO be listed on the GMO Register either on his or her own initiative, or after receiving an application from a GMO licence-holder in respect of a dealing which is currently covered by a GMO licence (proposed section 78). Determinations are disallowable instruments, thus subject to the
. fr I· " scrutmy 0 ar lament.
Notifiable low risk dealings
Certain low risk dealings with GMOs may be regulated by regulations, and do not need to go through the licensing system. The types of dealings which will be covered by regulalions are experiments with GMOs in contained facilities that arc of low risk, but are
Tlris Digest ...0.1 prqKIredJordebote.It rrj1eas the Ier;is/oticllt (l$ illlrodt-eedalld doD toOl ClJIII'lJSS subsequetftamendments.
This Digat does not hOI" an)' ofJicWllegal StOtus. Orhersowrt:eJ shQuldbe consulted10 dr't'mti~ tMSUbsequMtoff-eiol stOfUS oft/rt! Bill.
18 Gene Technology 8ill2000
not so low risk as to be exempt or included in the GMO Register. The regulations may restrict the class of persons who may undertake notifiable low risk dealings, or contain provisions requiring persons undertaking notifiable low risk dealings to notify the Regulator. Notifiable low risk dealings may be supervised by Institutional Biosafety Committees (lBCs) (pl'"oposed section 75).
There is no procedure for a person to apply to have particular activities declared to be
⢠the GMO is biologically contained, and would not be able 10 survive or reproduce without human intervention,
⢠the dealing wilh the GMO would involve minimal risk 10 the environment or the health and safety of people, and
⢠minimal or no conditions would be necessary 10 manage any risks.
Ahhough the Regulator must consider these matters, he or she does not have to be satisfied that the proposed dealing with a GMO will satisfy one or all three criteria before a dealing is declared to be a 'notifiable low risk dealing'. The only thing Ihe Regulator must positively be satisfied of before regulations are made is that the dealing would not
involve an intentional release of a GMO into the environment (proposed subsection 74(2)).
As the draft regulations are currently unavailable, it is not possible to ascertain whether there are sufficient safeguards in the system for regulating low risk GMOs.
Certification and accreditation
The Bill provides procedures for certifying a facility to a particular containment level, and for the accreditation of organisations which have an IBe. Both of these procedures may permit certain dealings with GMOs to be conducted under internal supervision, with minimal supervision by the Regulator, once the Regulator is satisfied that adequate standards and supervisory mechanisms are in place. Certification or accreditation may be conditions imposed on the grant of a GMO licence (proposed section 62), or may be conditions imposed in the regulations for the conduct of notifiable low risk dealings (proposed subsection 75(2».
The Regulator may certify a facility to a specified containment level after an application is received, together with an application fee (proposed section 83), if the facility meets the containment guidelines issued by the Regulator (proposed sections 84 and 90). Certification may be unconditional or subject to conditions (proposed section 86).
This Diges/ It~S pr("fJDrNfordeIHl/e. /I ref1t!C1S /he lq:islariOlI as inlrodU('e(/ anddoes not (W"''lJU SUbYqumlam....dm....u.
This Digest does nO' ha,'(' a",I'official'egalSla/us. OIliersources shouldbr lxmsul,ed 10 dtre,.",;"e th~ SUbseqlOt>/11 of[i6alSlaws of/he Bill.
Gene TechnologyBill 2000 19
No application fee is payable on an application 10 become an accredited organisation (proposed section 9]). Before deciding to accredit an organisation, the Regulator must consider whether Ihe organisation has or will establish an IBC, is able to maintain the IBC, and will indemnify the members of the IBC in respect of their decisions (proposed section 92). The Regulator must also consider any other matters which are contained in guidelines issued by the Regulator under proposed section 98. As with notifiable low risk dealings, because of the way the Bill is drafted il seems the Regulator is only required to consider these maners, and is not required to be positively satisfied that an organisation
has and willmainlain an IBC, before making a decision 10 accredit the organisation.
Neither the guidelines issued by the Regulator for certification to a specified containment level, nor the guidelines for Ihe accreditation of organisations with IBCs, are disallowable instruments.
Compliance and enforcement
Cancellation of licences
Under proposed section 68, the Regulator has power to suspend or cancel a licence for a number of reasons. Importantly, these include, if the Regulator:
⢠believes on reasonable grounds that the licence-holder or a person covered by the licence has breached a condition of the licence (including by not providing additional infonnation to the Regulator),
⢠believes on reasonable grounds that the licence-holder or a person covered by the licence has committed an offence against the Bill or the regulations, or
⢠becomes aware of risks which the licence-holder is not in a position to deal with adequately.
Criminal offences
Categories of offence
Proposed Part 4 of the Bill creates both mens rea and strict liability offences. In this context, a mens rea offence means an offence where it is proven that a person intentionally, knowingly or recklessly did a prohibited action. A strict liability offence is one where the offence is committed simply by doing the prohibited action. The penalties
are significantly greater for mens rea offences than for strict liability offences.
The Bill further divides offences into ordinary and aggravated offences. An "aggravated offence" is one which causes, or is likely to cause, significant damage to human health and safety or to the environment (proposed section 38), and heavier penalties may be imposed. However, for an aggravated offence, the prosecution must prove that the person
l1,j$ Diges/ was prepared/or deba/t>. II rej/"cts '''e legis/OliO', 0$ hl/mdr/cedalld doe$ 1IQ/ camYJS$ su!Mequemamelldnreflf$.
TIlis Dige$l does na//IO'V! any ofJicial legal SIOIIIS. Olllt>r so"rCt>J' $hould be c Iht> subseqll(.'111 ofJicial slOms ofille Bill.
20 Gene Technology Bill 2000
either intended to cause significant damage or was reckless as to whether his or her conduct would cause significant damage to human health and safety or to the environment (proposed subsection 38(2»). This applies even where a person is being prosecuted for a strict liability offence which has caused significant damage. This could be a significant hurdle. In many, perhaps most, cases, a person may have intended to conduct certain dealings (for example, to plant a crop of GMOs), but may not have intended to cause the significant damage which in fact resulted.
It is an offence to deal with a GMO if the dealing is not authorised by a GMO licence (unless the dealing is a notifiable low risk dealing, an exempt dealing, or is included on the GMO Register) (proposed sections 32 and 33).
Whereas compliance with conditions imposed by GMAC was voluntary, 53 under the Bill it is a criminal offence to breach a condition imposed on a GMO licence (proposed sections 34 and 35). This includes failure to tell the Regulator of information that subsequently comes to light about risks or contraventions of the GMO licence in relation to the dealing which is covered by a GMO licence (proposed section 65).
The maximum penalty for each of these offences for an individual is a fine of up to:
⢠2000 penalty units (culTenlly $220,000)54 for an aggravated offence where mens rea is proven.
⢠200 penalty units (currently $22,000) for an aggravated offence of strict liability.
⢠500 penalty units (currently $55,000) for an ordinary offence where mens rea IS proven, or
⢠50 penalty units (currently $5,500) for an ordinary offence of strict liability.
A penalty of up 10 5 times the maximum amount that could be imposed on an individual may be imposed on a corporation which is found guilty of these offences. 55 A corporation can be convicted of a mens reo offence if a director, employee or agent had the relevant state of mind (proposed section ] 88). However, if the corporation took 'reasonable precautions and exercised due diligence' to avoid the conduct, it cannot be prosecuted for an offence against the Act or regulations arising out of conduct of an employee, director or agent of the corporation (proposed subsection ]88(2».
The Bill also creates two less serious strict liability offences, namely:
⢠contravening a condition on the GMO Register when dealing with a GMO which is on the GMO register (proposed section 36), and
⢠undertaking a notifiable low risk dealing otherwise than In accordance with the regulations (proposed section 37).
Tllis Digest was prepared/ordebate. It reflects the legislatian as imroducedand does nQI ca",'Oss subseqllell/ ametldmems.
Tilis Digest does not hal~ any afficial legal status. Other saurcesshould be col/slilted to determine the subsequent official SlaWS a/the Bill.
Gene Technology Bill 2000 21
The maximum penalty for commilting either of these offences is a fine of 50 penalty units (currently 55,500).
Other offences contained in the Bill include:
⢠Inspectors giving false infonnation in relation to a warrant, or presenting a false warrant (proposed section J 75). Maximum penalty: imprisonment for two years or a fine of 120 penalty units.
⢠Unauthorised disclosure by officials of confidential commercial information they have access to as part of their jobs (proposed section 187). Maximum penalty: imprisonment for two years or a fine of 120 penalty units.
⢠Providing false or misleading information or documents in relation to an application or in reporting required under the Act (proposed section 192). Maximum penalty: imprisonment for one year or a fine of 60 penalty units.
]f a person is convicted of an offence against the Act or regulations, the court may order forfeiture to the Commonwealth of any 'thing' involved in the commission of the offence (proposed section 148). 'Thing' is broadly defined to include a substance. The Commonwealth thus has power to seize GMOs and other things, which become property of the Commonwealth. The Commonwealth must keep them until the Regulator gives a direction to sell or otherwise dispose of or destroy them.
If a person has already been punished for an offence or has paid a pecuniary penalty under a corresponding State law, that person is not liable for an offence or pecuniary penalty under the Bill in respect of the same conduct (proposed section 18).
Compliance and 'clean up' directions
The Regulator has power to give directions to a GMO licence-holder or a person covered by a GMO licence, if there are reasonable grounds to believe that the person is not complying with the Act or regulations and a direction is necessary to protect the environment or human health and safety (proposed section 146). A direction requires the
person to take steps within a specified time period to comply with the Act and regulations. Such a direction could be a
It is a strict liability offence not to take the steps required within the specified time. The maximum fine is 500 penalty units (currently S55,000), or 2000 penalty units (currently S220,OOO) if the failure to remediate causes significant damage (proposed subsection 146(3)).
If the person does not take the required steps within the time specified, the Regulator has power to arrange for those steps to be taken, and can recover the costs of any such action from the person (proposed subsections 146(4) and (5». 0 monetary limit is imposed on the Regulator's ability to take action and recover the costs.
1his Digest MYJ$ prt'ptlIWlJorIlrbatl'. 11 rl'jf«ls Ihr Irg;sla/jo" as introducrdund~s otOI mm'O.uSUbseqllnlt ami>fJlJmrnts.
1his Digest dors not hlnor any officiollegalsta/us.. Otllrr ofOIlTCrS shouldbr consultffl to drtf!l'minr /fw sllbsrqll{'nt ofFICiol SlafUS oftlrr Bill.
22 Gene Teclinology Bill 2000
The Regulator or any other aggrieved person may also apply to the Federal Court of Australia for an injunction (proposed section 147) either:
⢠restraining a person from committing an offence against the Act or regulations, or
⢠requiring a person to do something, ifnot doing that thing would be an offence against the Act or regulations.
External monitoring
The Bill provides a number of mechanisms for post.approval monitoring of compliance with the conditions imposed on persons dealing with GMOs.
The Regulator has power to appoint Commonwealth or State public servants as inspectors (proposed section J SO) to independently monitor compliance with the Act and regulations (proposed section 152). Given that it is an offence to breach a condition of a GMO licence (proposed sections 34 and 35), this power also enables inspectors to monitor compliance with licence conditions. Inspectors have broad powers to enter and search
premises, to examine and take measurements, take samples or conduct tests, to inspect records and documents and to secure evidence before obtaining a warrant (proposed section J53). Inspectors do not necessarily need to have a warrant or consent of the occupier to enter premises. If the occupier is a GMO licence· holder or a person covered by
a GMO licence, and the entry is at a reasonable time, the inspector has statutory authority to enter (proposed pa..-ag..-aph 152(2)(c». This cn
Inspectors may also enter premises to investigate the suspected commission of an offence, including suspected breaches of licence conditions, but only with the permission of the occupier or pursuant to a search warrant 56 (proposed section 154). In investigating an offence, inspectors may search premises, examine and take measurements, take samples or conduct tests, inspect records and documents. They may only seize material as evidence if entry to the premises was pursuant to a warrant (proposed sections 154, 155).
Inspectors also have emergency powers to deal with suspected breaches where necessary to avoid an imminent risk of death, serious illness or serious injury, or to protect the environment. These powers include power to enter and search premises, secure a thing before obtaining a warrant to seize it, or require a person to take steps to remedy breach of the Act or regulations. Inspectors also have power to take steps themselves, or arrange for someone else to rcmediate damage, and recover the cost from the person responsible (proposed section 158).
Further powers of inspectors are to search goods or baggage entering Australia from overseas (proposed section ]64) and to seize goods if they are reasonably suspected of being evidence of the commission of an offence (proposed section 165). It is an offence for a person who owns or is associated with goods not to answer questions asked by an
This DigeJt ",as prepared[QI" debole. 11 reflects tile legislation as inlrodlle«lDmJ does not camuus..bs~uem Dmi'nd",ents.
This Digest does not halY' an}' tJ.Dkialli'gDI Status. Of"" sou~ should~ crHulI/,N It> di'fermine the subs~lIl'nt t>.fJiciof status t!fl"e Bill.
Gene Technology Bill 2000 23
inspector in relation to the goods (proposed subsection 164(4». The maximum fine is 30 penalty units (currently $3,300).
There is no provision in the Bill for a comprehensive independent auditing process to check the quality assurance syslems being used by the licencc·holder, and ensure the licence conditions and risk management plans are being followed. 51
The licence-holder has a statutory obligation to inform the Regulator of any additional information as to risks, any contraventions of the licence or any unintended effects of the dealings, that he or she becomes aware of (proposed section 65). A person, such as an employee, who is covered by the licence who is not the licence-holder also has power to
inform the Regulator of these things, although, unlike the licence-holder, other persons are not legislatively obliged to provide information (proposed section 66).
If a GMO licence contains a particular condition relating to monitoring or auditing, persons authorised by the licence have an obligation to allow the Regulator into premises to undertake such auditing or monitoring (proposed section 64).
GMO licences may also contain conditions requiring licence holders to conduct regular monitoring, conduct periodic reviews of risk management plans, or undertake sampling and testing to check for unintended environmental effects. 58
Review of decisions
Broadly, decisions of the Regulator relating to the following mailers are reviewable (proposed section 179):
⢠licences and licence conditions,
⢠certification ofa facility and conditions ofcertification,
⢠accreditation of an organisation and conditions of accreditation,
⢠decisions relating to confidential commercial information, and
⢠decisions of the Regulator performing functions under State laws (for example, making licensing decisions under a State law) (proposed section 19).
Decisions are only reviewable by the applicant for, or holder of, the relevant approval, not by other persons aggrieved by the Regulator's decision. Thus, a neighbouring farmer cannot apply for review of conditions imposed on a GMO licence issued for a field trial in the vicinity of his or her farm.
This Digest waspntpart'dfordebole. II reflecu the It'gisfution as inlrod~and does n()I CQn.UD" 5ubsntuenlammdmenlS.
This Digesl does IIf)1 ha..... allyofFlriaf Il'gal Slaws. (hI>" S()Ilf'«S shcN.ld M crHmllrl'd 10 dnermineliN! SUbsnt"eI" ofFICial Slaws of/lte Bill.
24 Gene Technology Bill 2000
Decisions are first reviewed internally by the Regulator (proposed section 181), and if the applicant is not satisfied with the result, he or she may apply to the Administrative Appeals Tribunal for review (proposed section 183). Decisions of the Administrative Appeals Tribunal may be appealed to the Federal Court on a question of law. 59
Alternatively, a person may apply to the Federal Court for judicial review of a decision of the Regulator, under the AdministrativeDecisions (Judicial Reviell~ Act /977.
Confidential commercial information
A difficult aspect afme Bill is the exemption from disclosure of 'confidential commercial infonnation·. A member of the public will be able 10 obtain copies of a GMO licence application, risk assessment and risk management plan, except those parts of the documents that contain confidential commercial infonnation (proposed section 54).
Under proposed Division 3 of Part 12, a person may apply to the Regulator for a declaration that certain infonnation is confidential commercial information (proposed section 184). Subject to the discretion mentioned below, the Regulator is obliged to declare information to be confidential commercial information if it is (proposed section
⢠a trade secret,
⢠information with commercial or other value which would be destroyed or diminished by disclosure, or
⢠information about the commercial or financial affairs of an organisation or person if disclosure would unreasonably affect that person or organisation.
It seems likely (hat a broad range of infonnation in applications for research and development in new genetic technology would encompass trade secrets and commercial infonllation. However, the Regulator has a discretion to refuse to declare the information confidential commercial information if, in the Regulator's opinion, the public interest in disclosure would outweigh the prejudice (proposed subsection 185(2».
There are significant limitations on the use of confidential commercial information. It:
⢠cannot be used by the Regulator in considering other GMO licence applications, unless the information owner gives written consent (proposed section 45),
⢠cannot be disclosed in the information provided to the public during the community consuhation on GMO licence applications (proposed section 54), and
⢠is not recorded on the Record of GMO and GM Product Dealings (proposed subsections 138(3), (4) and (5».
",is Dig~1 WQS J'N'ptlredfor debal~. II reflects IIw fq:isloriOll as jfl,l'"Odllm fmd dOft IfOl COIll-'WS su1ul'qlletfl ummdmetfrs.
This Diges/ dOll!s IlQl hQIY' all)' oJfidallt>gal SID/US. O,hersourresshould IN co,uulledto dl!/_ill~ /h~ sllbsnJlIM/ ofJiriol S/Drus of/h~ Bill.
Gene Technology Bill 2000 25
The 10GTR states that it has "attempted to strike a balance between the legitimate protection of confidential infonnation and the need for a high levcJ of transparency, openness and accountability of decision· making". 60
Concluding Comments
Clearly, regulation of all aspects of gene technology in Australia is long overdue, having been recommended as long ago as 1992. 61 Whether the best f0I111 of regulation of this experimental technology is prohibition on the release of GMOs into the environment, at least in the short tenn until sufficient scientific evidence has been gathered to make an
infonned decision, is an open question. Critics often point to dangers such as herbicide resistant weeds, harmful effects on beneficial insects, or the risk of losing natural genetic diversity in crops {o a single genetically modified variety. which could lead to devastating crop failures if that variety succumbs to disease. 62 On the premise that there has been little adequate or long-tenn testing in relation to these or other. as yel unforeseen, environmental risks or risks to human health. some commentators are questioning the desirability of gene technology. or at least the speed of its introduction. The Organic
Federation of Australia has called for a moratorium on dealings with GMOs while these issues are investigated. 63 and one member of Parliament has advocated a five year moratorium on development of GMOs, to enable adequate independent research to be carried out. 64
Separate from these environmental and health concerns are the trade issues. Some fanners have expressed concern that Australia will lose its "clean green" reputation, and that trade with countries such as the United Kingdom and Japan may be detrimentally affected as a result. 65 Tasmania, in announcing a temporary moratorium on GMO field trials, indicated that commercial marketing considerations were behind its policy. 66
Assuming that prohibition is too extreme a reaction, the Bill needs to be examined to ascertain whether it adequately achieves its objectives of protecting the environment and human health and safety through its identification and management of the risks associated with gene technology.
The precise operation of the Bill is in some instances difficult to detennine in the absence of a concluded GTA and draft regulations, guidelines and policy documents. It is anticipated that the GTA and draft regulations will not be available before the middle of August. Accepting these limitations, this section provides some discussion of broader
issues arising from the Bill and whether the Bill meets its stated objectives. Other comments on specific aspects of the Bill, which have been made in the Main Provisions section above, are summarised for the reader's convenience in the following footnotc. 67
This Digest .."tiS pt'l!'poredfor debole. 11 rejlects thl!' Iq;islation IlS i",roduadfind don noI ca"'1U.J subsequentaml!'ndml'l/fs.
71Iis Digesl does noI hQI~ Qn}'oJIiC'iaf kgQIS/Qtus. Otller $(WT'CnshouldIw COflSl
26 Gene Technology Bill 2000
The Bill is intended to operate as a national scheme, requiring complementary legislation at Commonwealth, State and Territory levels. The advantage of a national cooperative scheme is ils ability to regulate comprehensively all dealings with GMOs. Although the Commonwealth's constitutional powers relevant 10 gene technology are extensive, 68 nevertheless, the federal Government does nol have constitutional power to regulate every dealing with a GMO.69
The Bill explicitly states it is not intended to exclude the concurrent operation of any State law (proposed subsection 16(1». State legislation on general environmental, fisheries and land management issues, which may indirectly or incidentally regulate GMOs, will be able to coexist with the Bill. State laws which directly regulate dealings with GMOs in confonnity with the national scheme agreed to under the GTA will operate concurrently
with the Bill. They may even have an extended operation if they correspond sufficiently to the Bill and a "wind-back notice" is served on the Commonwealth under proposed section 14.
If a State law gets out of step with the national scheme, either because amendments agreed to nationally under the GTA are not passed, or because other amendments which have not been agreed to under the GTA are made, the Minister may revoke a declaration that the State law is a corresponding law (proposed subsection 12(2». In that situation, the Bill
would apply to the full extent ofCommonwealth power.
Additionally, State laws that specifically regulate dealings with GMOs or contain specific provisions relating to dealings with GMOs, but do not correspond with the national scheme, may be listed in re~ulations and precluded from operating alongside the Bill (proposed subsection 16(2»). 0
Despite these powers to revoke a declaration in relation to a "corresponding State law" and to make regulations excluding the operation of non·confonning State laws, the Commonwealth has no ability to ensure that the national scheme is unifonnly amended. The continued operation of the national scheme relies on further inter·governmental agreements to approve amendments, and the passage of legislation incorporating those amendments in every jurisdiction. If one or more of the States and Territories choose not to enact complementary legislation, or not to amend the legislation in line with other jurisdictions, the scheme quickly ceases to be unifonn and national in its scope. The
potential for disunity is exacerbated by the existence of a "wind-back" option, allowing State legislation to regulate matters which could legitimately come under Commonwealth control.
The anticipated inter-governmental agreement on which the scheme is 10 be based has not yet been signed. Indeed, Tasmania has recently announced an interim moratorium on the field trials and general release of GMOs, which may affect the ability to negotiate such an
This Digest "US prepormfOTdt'bote. It rpflecu the legislutiQIIIIS jlltroducedullddoes root m",UU" subsequentamendments.
This Digest does 1/01 hu."t' any ojJiciullegulstu/us. OtherSOUI"US shQuldbe ('QIlSulwd 10 det('r7rfill(' the slIbseqllent oflkial Slams ofthe Bill.
Gene Technology Bill 2000 27
agreement. 71 The future of a consistent national scheme rests on uncertain foundations if agreement cannot even be concluded prior to the commencement of the scheme.
In spite of the difficulties experienced to date in achieving inter-governmental agreement, the Bill does not even operate to the full extent of Commonwealth constitutional power. In particular, the Commonwealth has chosen not to rely on its plenary constitutional power to legislate for the territories (section 122 of the Constitution) to apply the Bill throughout the ACT and Northern TelTitory, but is instead relying on complementary legislation being passed by both telTitories. This reflects the Commonwealth's preference for a cooperative nationally consistent regulatory scheme, rather than Commonwealth legislation relying on every possible head of constitutional power. 72
A further constitutional problem arises after the decision in R v Hughes. Under the Bill, the Regulator and all three advisory committees may exercise functions, powers or duties confelTed on them under corresponding State laws (proposed section 17). It is clear that State laws may confer functions on Commonwealth officers or Commonwealth
authorities, so long as a Commonwealth law consents to the conferral of power. 73 However, in R v Hughe/4 the High Court held that where State laws confer a duty on a Commonwealth officer or authority to exercise functions under State law, the Commonwealth must have a specific head of constitutional power in relation to those State
functions before it may consent to exercise those functions.
The legal ramifications of the R v Hughes decision have yet to be explored. 7s It may be that the decision only applies where the duty which the Commonwealth has accepted "adversely ... affect[s] the rights of individuals",76 Certainly, the functions conferred on the Regulator under the Bill are not coercive in the same sense as the power to conduct a
criminal prosecution is. However, decisions whether or not to grant a GMO licence, to approve certification 10 a specified containment level, or to accredit a facility all have the potential to adversely affect individual rights.
It may also be argued that the Bill does not impose a duty on the Regulator, but merely confers power. Proposed section J 7 in tenns provides that a State law "may" confer functions on the Regulator or another Commonwealth body, and that body "may" exercise those functions. Nevertheless, it is possible Ihat a duty may anse. Although the Bill does
not preclude the States from conferring functions on a State agency, if there is no officer or body at State level with the ability to perfonn those functions relating to gene technology, the Regulator may effectively come under a duty to perfonn those functions. 77
If the Regulator has a duty to exercise functions conferred under State law, there must be a specific constitutional head of power that would cover those functions. However, the very reason for the cooperative national scheme is that the Commonwealth does not have constilutional power to cover all areas in which dealings with GMOs may arise. Although the Regulator will be able to exercise State functions in many cases, as Commonwealth constitutional power covers a significant proportion of the regulation envisaged by the Bill, in some cases he or she may not constitutionally be able to do so, The only solutions
77lis Digest was preparedfordebale. II rr.jleclS Ihe Il'gis/alion as introducedand does 1101 call''l1SS sub.l"equellf amendments.
This Digesl does 1101 hal't" allY official legal J'WIUS. Olher SOl/rces should Ix? collsulled 10 defermjlle Ihe s/lbsequell/ official slo/UJ' oflhe Bill.
28 Gene Technology Bil/lOaO
to this problem are either changes to the current position, giving the Commonwealth full constitutional power to legislate with respect to gene (echnology,78 or accepting the impossibility of ensuring consistent regulation, and acknowledging that differences between jurisdictions are inevitable in a federation such as ours.
Cost recovery
In May 1999 the Commonwealth Government committed $7.6 million over 2 years for the development of gene technology legislation and the establishment of the Regulator. After these two years, that is, from May 2001, the Government anticipates that the Regulator will recover J 00% of his or her costs from users of the regulatory regime, for example, through licence charges. 79
Although the Regulator will be able to charge application fees for GMO licences (proposed section 40) and for certification of a facility to a specified containment level (proposed section 83), the Regulator will not be able to fund his or her administrative costs solely or even mainly through application fees. This is because the application fees are contained in the Bill itself, and thus must be set at appropriately modest levels so as to be described as a "fee for service" and avoid being charactcrised as a tax and thus held
invalid. By contrast, the annual GMO licence fees are separately contained in the Gene Technology (Licence Charges) Bill 2000, so can be set as high as the Regulator desires.
In practical terms, therefore, the Regulator will be required to approve a sufficient number of GMO liccnces to obtain the annual licence fees to continue to operate the day-to-day activities of the office and fund the Regulator'S staff and administration needs. Further, and paradoxically, the Regulator will only be able to obtain the funds required to conduct
independent scientific research into the risks posed by GMOs by approving enough dealings with GMOs to raise the money required.
The proposal that the Regulator operate on a full cost recovery basis has been criticised, on a number of grounds. Consumer groups have expressed concern that this will effectively make the Regulator a "captive" of industry, constrained to a~rove dealings with GMOs from wealthy corporations in order to continue its existence. Although full cost recovery is successful for agencies such as the Therapeutic Goods Administration
without compromising the standards or independence of the regulatory body, because gene technology is still in its infancy there is not the same base of accepted dealings from which licence fces may be gained.
There are also concerns that annual fees may act as a disincentive for research and development in genetic technology, as research and development by their very nature are experimental and are usually subsidised by government and encouraged by tax benefits, rather than being taxed. 81 Finally, concerns have been expressed that fuJI cost recovery may work to the advantage oflarge corporations and as a deterrent to small biotechnology companies, which may not have the same capacity to pay significant licence fees. Il2 Even at the commercial release stage, it is possible that the licence fees will outweigh any
TJ,is Digest k·as p'~paredfordebate. It rej1eas the legisfotiOll as j",roduudtmddOf!S ffOt COII\'OSS subsequentomendments.
11Iis Digest does not hOIO(' onyoffiriol fegol sto/us. OIliersourcesshould lw consultedto dett>rmine the subsequentofficial sto/us ofthe Bill.
Gene Technology Bill 2000 29
financial benefits of participating in trials or commercial release of GM products. For example, it was recently reported that a farmer growing GM cotton currently pays a licence fee of S150 per hectare, and saves S II 0 per hectare (including by using 6 litres less of pesticide). As the cotton yields are identical,83 then unless the purchase price for GM cotton is higher than for standard cotton, growing GM cotton and paying annual licence
fees is not commercially profitable. 84
A study has been commissioned by the JOGTR, and is being conducted by KPMG, to investigate the cost of the proposed system for the regulation of gene technology.8s Once this has been completed, it will be possible to ascertain whether it is feasible to fund the Regulator's activities through application and licence fees. The first part of the study, which was 10 provide various cost-recovery options, was originally due to be completed by about June 2000. 86 However, it has not yet been completed, in part due to delay in
producing dran regulations for public comment. The completion of the second and final stage of the study was anticipated 10 be September 2000, although this date may also have been moved back.
Independence and impartiality of the Regulator
The Regulator is a statutory office holder, independent of the direction of the Government, and with slrong powers including the ability to report directly 10 Parliament. However, the decision to require the Regulator to be 100% self-funding aOer mid-2001 imposes a very significant restriction on his or her independence.
Another potential derogation from the Regulator's independence is the power of delegation. The Regulator has the ability to delegate any of his or her powers or functions to an employee of the Department of Health or Aged- Care, or an employee of another Commonwealth Department, authority or State agency whose functions relate to GMOs and GM products (proposed section 29). This includes functions conferred on the
Regulator under other laws, such as the advising functions in relation to GM products under the existing legislation regulating food, therapeutic goods, agricultural, veterinary and industrial chemicals. 87 It could compromise the independence of the advice on the risks related to GM products if the Regulator delegated his or her functions under these schemes to the NRA, ANZFA, the TGA or the Director of ICNAS. The Explanatory Memorandum itself recognises the need for advice on GM products to be given by a body
independent of the regulatory agency involved. 88 As the Bill currently stands, however, there are no limits on the Regulator's power to delegate.
Some critics complain that GMAC and the institutional biosafety committees that oversee gene technology research in individual companies and institutions, will be "dominated by proponents of gene lechnology.,,89 As GTTAC (the successor to GMAC) will be staffed by part-time members who will also be practising scientists, and may themselves be involved
in gene technology research and development, this is certainly an issue to consider. However, State and Commonwealth government bodies have expressed the view that the
This Digesl ..-as prfpar..dJordt!bolf'.1i ,-,.jll"ClS lhe legislQIi(m as introducedomJ don lfOI.:umvssS..bs.-qu.... , o",endm,.,,'$.
17Iu DigeJI does N)l hoI'" OR)' oJIiciDl kgolSWIllS. OtherSOUf'tTS shouldbe OOIU"l'N10 d"'f'nIli"" 1M SUbseqlU'nt ojJiciDl SIQ/ltS oflhe 8if1.
30 Gene Technologynil/20aO
skills and expertise of members of GMAC, as well as the standards it enforces, are among the best in the world. 90 The House of Representatives Standing Committee on Primary Industries and Regional Services considers that the three advisory committees ',",viII possess the expertise to assess the broader impact of GMOs.',91
It is also possible that GITAC may provide scientific advice which the Regulator may ultimately choose not to follow. In Ihis important respect, the powers of GTTAC arc much more restricted than those of GMAC. Under the current system, GMAC, composed of scientists, is responsible for making licensing and other decisions relating to dealings with GMOs. Under the proposed system, the final decision is made by the Regulator, a public servant who does not necessarily have scientific expertise.
A number of comments can be made about the adequacy of the penalties and enforcement mechanisms provided for in the Bill. The penalties for the major offences of dealing with a GMO without a licence, or breaching a condition of a GMO licence, are in monetary terms substantial. However, environmental statutes commonly impose a further penalty for each day a breach continues, thus creating a strong incentive to remedy breaches as quickly as possible.92 This approach has not been adopted in the Bill.
Further, environmental statutes often provide for terms of imprisonment in addilion to substantial fines. 93 Whereas other, less serious, offences contained in the Bill 94 may result in a term of imprisonment, no ternlS of imprisonment are available as an alternative penalty for the major offences (proposed sections 32 to 38), even though they may result
in substantial environmental damage or health hazards.
The Bill provides for monitoring through random inspections and an obligation on licence holders to report any breaches of the licence or unintended effects (proposed Part II and proposed section 65). However, comprehensive independent auditing to ensure compliance with licence conditions is not required unless it is made a condition of the GMO licence.
The Regulator has power to make remediation or "clean up" orders, or to clean up contamination himself or herself and recover the cost from the person in breach (proposed section 146). However, if a dealing \\'ith a GMO was approved by the Regulator and the person or organisation complied with all the conditions imposed, but nevertheless damage resulted, the Regulator has no power to order remediation, as there has been no breach of the legislation or the GMO licence conditions. The Regulator does have power to vary GMO licence conditions to impose additional conditions, and to suspend or cancel a GMO
licence. However, the Regulator must give wrinen notice of his or her intention to do so. and if the Regulator gives the licence holder an opportunity to make written submissions, he or she must wait at least 30 days before varying, suspending or cancelling the licence (proposed section 72). This may not assist the immediate remediation of contamination. The Regulator's emergency powers only apply if a breach of the Act or regulations is
This Dignl "'OS P"PDrw/fordrlKll~. /1 riflects 1M /rgis/alion as illtrodu«dandd(W:$1tOI ('OllllUJ sum6(lIellt amf!1ldmf!1lU-This Digeslhs1101 hove 0'9' official /l"gol status. Otll,.,. sourres shouldM a:m....lfl-d to dl'tl'nnill~tll~ S..bs6(1Ie1l1 o.fJicia/ SlaWS ofth~ 8m.
Gelle Technology Bill 2000 31
suspected (proposed section 158). The effectiveness of the Regulator's remediation powers has come into question after the IOGTR took morc than two months mcrcly to investigate allegations that GM canola plants were dumped at an open commcrcial tip in Mt Gambier.95
Opt out
As part of the initial consultations between the Commonwealth, States and Territories about developing a new scheme for regulation of Gene Technology, a series of 'without prejudice' principles were agreed and subsequently included in the 1998 Regulation oj Gene Teclmologydiscussion paper. One of these principles stated:
7(d) If a participating jurisdiction considers that the release of a GMO or a GMO product will pose an unacceptable risk within its territory, then it may decline to allow release within its own territory or impose additional conditions on release within its own territory.
In subsequent debate over the form of the Bill, Tasmania and some other groups 96 have called for this principle to be incorporated into the Bill in the fonn of an 'opt out' clause. This would presumably enable a State or Territory to declare that either the Bill in its entirety, or a particular decision of the Regulator, did not apply to that jurisdiction.
However, the IOGTR has suggested there are potential constitutional and international trade law impediments to including such an opt out c1ause. 97
In relation to the constitutional issue, it is understood that the IOGTR is concerned that a clause in the Bill permitting States to opt out could infringe either the freedom of trade and commerce between the States (section 92)98 or the prohibition on the Commonwealth giving preference to one State over another (section 99). It is difficult to see how an opt out provision of itself could infringe section 92, although a State law attempting to give effect to the provision might infringe this freedom, depending on the nature of the law. 99
In relation to section 99, on current authority,lOO an opt out provision should also be constitutionally valid as it is not clear from a fonnal reading of the law on its face that it confers a 'tangible commercial advantage'. 101
In relation to Australia's obligations under WTO rules, it is unlikely that an opt out clause would be contrary to the SPSA. This is because the clause itself is not a sanitary or phytosanitary measure. Rather, it only enables a State Government to enact a measure different to that applying elsewhere in Australia.
In any case, there may be alternative methods of giving effect to the "unacceptable risk" principle, rather than resorting to an opt out. For example, a State Government could use its influence within the proposed Ministerial Council to persuade the Council to develop policy principles under the Bill that would operate to support the establishment of one or
more GM free zones 10 protect the diversity of Australian fanning practices, including
Tbis Digesl was prcplIredfordebale. 1/ reflectS Ihe legis1alioIJ lIS ;lll,.oOlIcedalld does 1/01 ClIm'llss subsequemame"dmellfS.
This Digt>sl does 1101 hm'e""Y ojficiallt>gal SlUIllS. OIlier sources shouldbe C:OIJsulled /Q ((elermi"e Ihe subsequemofficiol SlalWi oflhe Bill.
32 Celie Techl/%gy Bill 2000
organic and non GM falllling. I02 The fact that the Regulator must seek the advice of State governments and relevant local governments in preparing risk assessments for intentional releases into the environment should also give States substantial opportunity to ensure their jurisdiction is not placed al risk by decisions of tile Regulator.
Adequacy of approach to risk assessment and management
A large number of important decisions are left to the discretion of the Regulator. Some decisions are given little statutory guidance, for example which dealings with GMOs are declared to be exempt or are declared to be "notifiable low·risk dealings". While the consultation process for deliberate release of GMOs is extensive, the Regulator is not bound to follow any advice he or she receives, including the technical or scientific advice provided by GTTAC. There is no requirement for any consultation prior to issuing a GMO
licence for contained dealings with GMOs. Containment standards and risk management measures will depend largely on the licence conditions imposed at the discretion of the Regulator. Similarly, the agencies regulating GM foods, GM industrial, agricultural and veterinary chemicals, and GM therapeutic goods are required to obtain and consider the
Regulator's advice, but are nol bound to follow it. In responsible hands, discretion can be valuable in tailoring approvals to specific circumstances. Whether this system is effective in assessing and managing risks depends on the confidence reposed in the Regulator and other agencies to make the right decisions in the exercise of their discretion.
The Bill does not contain the "precautionary princiPcle" enshrined in the Environment Protection and Biodiversity Conservation Act 1999 03 and other legislation. However, arguably the entire Bill represents a precautionary approach to the regulation of gene technology. The Regulator must not issue a GMO licence unless the Regulator has
prepared a risk assessment and risk management plan (including an extensive consultation process in the case of an intentional release), and is satisfied that any risks to the environment or human health and safety can be adequately managed (proposed section 56). It is a matter for Parliament to consider whether the detailed provisions of the Bill covering exempt dealings, dealings listed on the GMO Register, notifiable low risk dealings governed by the regulations, contained dealings and the intentional release of
GMOs into the environment adopt a sufficiently precautionary approach.
Legal liability for damage caused by GMOs
A bond may be imposed as a condition of a licence. In the event of a breach of the Act or ofa licence condition, it may be possible to use bond money to defray some of the costs of remediation or to partly compensate persons affected.
The Regulator also has the power to order a licence holder to remediate a breach. In the case of a licence holder breaching a condition of their licence with the consequence of a nearby GMO-free crop was contaminated, it is not clear how far this remediation power
This Digest was preporedfordebate. It reflects the legislalioll as i"'roducedand does nO/ C01ll'l1$$ .ruhsequelllamendments.
This Digest does 110/ ha.'i! allY official legal SIOIlIS. Othersources sholild be corlSlIl'ed fO determine{he sul"c,/uent official statliS oJthe Bill.
Gene Technology Bill 2000 33
would go as far as restoring the cultivator of the GMO-frec crop to a 'pre-breach situation'. It may not always be possible to restore land or crops to their pre-contaminated state. It is far from clear that the Regulator's power to order remediation would extend to require the payment ofdamages for loss of a crop or loss of use of the land.
Even if damages were payable under the Regulator's remediation power, it is unlikely that damages would be payable for future damage, such as diminution in the value of land, or inability to grow and sell GMO·free crops for a specified future period because of market suspicion. In the recent Scottish case ofGM-free rapeseed growers who were 'accidentally' supplied with a GMO seed variety, there was considerable controversy over whether the compensation offered by the company responsible accurately reOected some growers'
long-term losses, including the value of the land. 104
In another, Canadian case. a Canadian canola grower is being sued by agrochemical company Monsanto, which aJleges he has been illegally growing Monsanto's patented GM canola seed on his land. The famler is arguing that the wind carried the GM seeds onto his fann from adjoining fields. 105
There is no provision in the Bill for a statutory right of action or a compensation fund to compensate those affected by a breach of the legislation, nor is there provision for liability or immunity of GM-free fanners who inadvertently use GM products. Persons affected by GMO contamination will continue to have recourse to the common law of tTespass, public or private nuisance, and negligence. 106 This position was supported in the majority report of the House of Representatives inquiry. 107
There have been several instances in which liability clauses have been suggested for GMO regulation legislation. As part of the review of the EU laws on GMO, the EU Environment Committee proposed that companies be strictly liable for any damage caused by their GM products. lOS This was subsequently rejected by the EU Parliament, reportedly out of concerns that it would impose too high a financial burden on companies and act as a disincentive to the GMO industry in Europe. 109 A private member's Bill was introduced in
the UK Parliament in 1999 along similar lines.
Given that the open release of GMOs. particularly GM crops and animals. into the environment is a relatively recent trend. it seems questionable that the issue of potential liability for damage is left solely to the vagaries of the common law. Legal liability for negligently inflicted economic loss is still in a state of uncertainty. 110 In this climate of uncertainty, it is at least arguable that the potential cost of damage from instances of GMO contamination should be incorporated into the regulatory system, perhaps by establishing a statutory compens3lion schemel II or by creating a statutory cause of action specifying in what circumstances and against whom a suit could be brought. 112
17lis Digest '0"11$ preparedfordehuEI'. II rl'flocts fhl' fq:is!QI/on as imroduud QmI don not co"vau SUbseqUMl Qml'fll!m4'l1/S.
This Dignl doI's not hQIY' Q"J'ofJiriDf lega! SlQfus. Dlha MHlfCff should M COIIsultl'd 10 d4'f4'nnill4' 1114' subsequl'm ofFlCiQ! SfQIIU oflll4' Bill.
Other avenues of redress
A number of decisions of the Regulator are reviewable on their merits by the Administrative Appeals Tribunal (proposed sections 179 and 183). However. decisions are only reviewable by the applicant for or holder of the GMO licence or other certification or approval, not by other persons aggrieved by the Regulator's decision, such as neighbouring landholders. Landholders can apply to the Federal Court under the Administrative Decisions (Judicial Review) Act /977 only jf they can demonstrate a ground for judicial review of the Regulator's decision. Possible grounds may include allegations that the Regulator failed to consider a relevant mallcr. or made a decision iliat
was so unreasonable that no reasonable person in the Regulator's position would have made it.
71ris Digesl lOW prffJ(JredJordrbat,. Jt rf'J1ec:rs th, l"CisJation a5" introdU«dalld dtJei II()/ (Unl'lJ.t,f SUMl'f{uent amendments.
1lIis Diges' d«s not haW!' a"yoffirial'ega'Sla/us. OtJ",.sourcnshouldIw ronslfltffl 10 d,t"",;,w th, S..bMquenlofficialsla/us oflhe 8i//.
Appendix: Regulation of Gene Technology in Other Countries
The following provides a brief snapshot of how gene technology is regulated in a range of other countries and the European Union. It focuses on the issue of the release of gene technology into the environment through field trials and general commercial release rather than the regulation of laboratory-based gene technology research. The regulation of GM
food is included in a soon to be published Current Issues Brief by Rosemary Polya. Science, Technology, Environment and Resources Group, which will provide an update on issues related to genetic engineering.
None of the countries examined has a single system which comprehensively regulates all GMOs and GM products. Like Australia, most countries regulate GM products under the existing schemes which cover similar, GM-free products. Some countries, notably the USA and Canada, even regulate GMOs themselves under a number of disparate regulatory regimes.
The European Union 113
Directive 90/220/EEC"4 , passed in 1990, regulates deliberate releases both for research and development and for placing GMOs on the market. 115 There are other Directives applying to, for example, the assessment of GMO derived foods, but these follow a reasonably similar process to that outlined below.
Before deliberately releasing a GMO into the environment or placing it on the market, a manufacturer or importer must submit a notification to the relevant agency of the European Union (ElI) member State where the product is intended to be first released into the environment or placed on the market. The notification is required to contain a technical dossier of information, including a risk assessment of the product. The notification then
undergoes whatever statutory or other approval process is required by the member State.
If the application is approved by the member State, it is forwarded to the European Commission and the individual member States. If no State objects to the application, the original member State's approval then effectively allows the GMO to be released or marketed anywhere in the EU.
If there are objections, the application is reviewed by a series of Scientific and Regulatory ED Committees. The application may be approved by a majority even if not all member States agree. In some cases where a GMO has been approved by the EU, individual member States have apparently invoked a 'safety clause' contained within 901220lEEC to temporarily ban the release of certain GM products in their territories. 116 These cases have been referred to a Scientific Committee. II?
Directive 90/220/EEC is currently under review with the final fonn to be decided by the European Parliament later this year. Proposed changes include improving the transparency of decision-making through the increased involvement of the public in the authorisation process, and improving monitoring of approved organisms. Pending finalisation of these
This Dige:1I was prqxsredfardebate. II ref/eCIS the leg;$IU1;oll as ;mrodllcedand does nUl CQIIIYJSS slibseqlU?1I/ ame"dments.
This Digest does .WI/WW' allY aiJiciallegal Slatus. Olhersources shouldbe comiUlted [Q determinethe subsequent aiJicial status oflhe Bill.
36 Gene Technology Bill 2000
changes, the EU - or at least some member Stales - has apparently adopted a de facto moratorium on the approval of new GMOS. 118
United Kingdom 119
Directive 90/220lEEC is implemented by Part VI of the Environmental Protection Act 1990 (the EPA Act) and the associated GMO (Deliberate Release) Regulations 1992. 120 Issues such as food safety, chemicals or medicines that may involve GM products are covered by separate legislation.
The EPA Act and associated regulations require, with a few exceptions, that anyone intending to release or market GMOs must first obtain the consent of the appropriate Minister. In most cases this is the Environment Minister. Applications to the Minister are to be accompanied by a risk assessment. Applicants are required to advertise their applications in the locality of the intended release. Field trial sites are disclosed in the United Kingdom.
The Environment Minister is advised by the Advisory Committee on Releases to the Environment (ACRE), which is a statutory body. The Minister may place legally enforceable conditions on any approval for release.
In 1999, the United Kingdom announced the outcome of a review of the regulatory framework for biotechnology. III The changes recommended mainly dealt with the perceived lack of a forward-looking strategic framework for the development of biotechnology rather than changes to the assessment process for the release of GMOs.
Subsequently, the Government established the Agriculture and Environment Biotechnology Commission.
The United States of America
Responsibility for regulation of GMOs is shared between three agencies.
Under the Plant Pests Act and Plal1t Quarantine Act, the Department of Agriculture has responsibility for both approving the importation of GMOs and overseeing the planting and field testing of most genetically modified crops. 111
The Toxic Substances Control Act and the Federal Insecticide. Fungicide andRodenticide Act confer responsibility on the Federal Environmental Protection Agency (EPA) for pesticides, including crops that have been genetically modified to introduce substances toxic to pests.
Th.e Food and D:ug Agency (FDA) is rel~onsible for safety. an~ lab.eHing of all foods and alllmal feeds denved from GM sources. - The relevant legIslation IS the Food, Drug and Cosmetic Act. The FDA is currently reviewing its requirements for testing of, and labelling of foods that have GM ingredients. Under the proposals, manufacturers would have to prove the food is 'safe'. However, there is disagreement among various groups on whether GMO foods should require more or different testing than other related GMO-free foods.
This Digesl WQS preparedJordebate. It rejlects the legislation as inlroducedand does 1101 canvasssubsequent amendmell/s.
This Digest does Itot hol'f! any official legal Sial/IS. Olher sources should be consulled to determi"e /he subst>quell/ official Sta/ltS oj/he Bill.
Cene Technology Bill JOOO 37
Canada The general approach to the regulation of GMOs in Canada appears to be similar to the United States. The 1993 Federal Regulatory Framework for Biotechnology 124 essentially sets oul the respective responsibilities for the various federal regulatory agencies. Like the
United States, there is no cenlral gene technology legislation or regulator. Under the 1993 framework, agencies regulating products developed using traditional techniques and processes were given responsibility for regulating similar products developed using gene technology.
The four main agencies responsible for the assessment of GMOs are Environment Canada, Health Canada, the Canadian Food Inspection Agency and the Department of Fisheries and Oceans. Gene technology applications are assessed for health and environmental impacts under the Canadian EnvironmentalProtection Act, administered by Environment Canada, 'where they are nOI subject to assessment by the other agencies. For example, GMO crops and the issue of any negative impacts of biodiversity would appear to be regulated under the Seeds Act (administered by the Canadian Foods Inspection Authority) rather than the Canadian EnvironmentalProtection Act.
New Zealand
The Hazardous Substances and New Organisms Act 1996 (HSNO Act) regulates the importation, experimentation with, and release of GMOs other than GM food. 125 The HSNO Act requires that the release or importation of, or other dealing with, any type of organism that was not present in New Zealand before 29 July] 998 must first be approved by the Environmental Risk Management Authority (ERMA).
Applicants are required to demonstrate to the ERMA that the benefits of the introduction of the GMO outweigh the risks. Public hearings are held to allow both the applicants and objectors to put their respective cases. Applications for trials of sugar beet. potatoes and the development of transgenetic sheep and cattle herds have been approved to date. 126
In April 2000 the New Zealand Government announced a 12 month Royal Commission into genelic modification. 127 Pending the result of the Commission. New Zealand has also instituted a voluntary moratorium in relation to field tests and open release of GMOS.1 28
The regulation of gene technology is primarily the responsibility of Ihe Ministry of Agriculture. Forestry and Fisheries (MAFF). Food and phannaceuticals are regulated by the Ministry of Health and Welfare.
MAFF has issued a range of guidelines which deal variously with contained experimental research, use in industrial applications (for example, processed stock feed), field trials and general release. 129 It appears the process to gain the necessary approval varies with the applicable guidelines. Japan has also recently introduced more stringent requirements for
the importation of foods. Importers will have to label a prescribed range of GM food items
This Digest wos prepuredfordebale. {I reflecls the legislUlioli as introducedond d()('s not CUIll'tlSS subseqlU:'11l amendments.
This Digest does trOf hare ,my officiollegol SIOlIlS. Othersourcesshould be CUI/suIted 10 deu.'mti"e Ihe subseqllelll official SIll!US oflhe Bill.
38 Gene Tecllllology Bill 2000
(particularly certain soybean and com products) from April 2001. In addition, safety tests relating to GM foods, which to date have been voluntary, will be mandatory.
This section, "'har is gene leclmology, has been authored by Dr Rod Panlcr, Director, Science, Technology, Environment and Resources Group.
2 Further infonnation on the basic technical concepts underlying gene technology can found in Healey, J (cd) 'Genetically Modified Food' (2000) 122 Issues in Society; or on the CSIRQ Gene Technology Webpage at ht!O:/Iwww.csiro.aulpubgenesileJindex.hnn
3 See for example, Reiss, M and Straughan, R, Improl'ing Nature: The Science and Ethics of Genetic Engineering. Cambridge Press (1996).
4 See Moynihan, R, 'How safe are GM foods', Australian Financial Redell', 29·30 July 2000. p. 28.
5 Brookes, M, 'Running Wild', NewScie11lisI, 31 October 1998, p. 38.
6 Broadly speaking, a GM product is a thing derived from a GMO that is not capable of reproduction or of transferring genetic material.
7 AQIS's current policy is to refuse an application for importation ofa GMO unless it is accompanied by documentation showing approval by the Commonwealth Genetic Manipulation Advisory Committee.
8 GMAC was formed in the late 1980s. Its mandate covered all novel genelic tcchnologies, not just recombinant DNA procedures as its predecessor committee had. The inlention was Ihat GMAC would develop guidelines for GMO research and provide advice on human health and environmcntal safcty to those exisling regulatory agencies thai had legal responsibility for
approving the release ofthe genetically modified subject. For futher background on GMAC see http://www.heallh.gov.aultga/gene/gmaclgmac.hlm .
9 £TplallaloryMemorandum to the Gene Technology Bil12ooo, pp. 8·9.
10. Stevenson, Andrew, "Fearful or not, there is nowhere 10 hide", Sydney Morning Herald, 25 July 2000.
11. Fraser, Andrew, "Most cotton will be GM by 2005: marketer", The Australian, 27 July 2000.
12. Woodford, James. "Crop target 2005: a million hectares", Sydney Morning Herald, 24 July 2000.
13. The IOGTR's response to this incident has been criticised as tardy and lacking in lransparency: Report of the House of Representatives Standing Comminee on Primary Industries and Regional Services, Work in Progress: Proceed with Caution. Primary ProducerAccess to Gene Technology(published 19 June 2000), pp. 129, 167-168. The report can be found al htlo:/Iwww.aph.I!.ov.aulhouselcommillcclprimindlgting/rcDOrt/contents.hnn.
This Digest wasP"PD~JOI' dmat~. 11 r~jln:ts tM {rgis{Qtion as introdu«dQlld d«$ IfOf rom'O.JS SUbuqw>II' Qmem!mertr.s.
This Digest dou nOl' hQ\~ QIIJ'QfficiQ{ legal status. Other sourcesshouldw t"Onsulted to d~urmin~ th~ subuqUi'ntofficial SIQ!U.J oflh~ Bill.
Gene Technology Bill 2000 39
14. Metherell, Mark "Alarm over GM seed mistake", Sydney Morning Herald, 25 July 2000.
15 The Biosafety Protocol was adopted in January 2000 and opened for signature in May 2000. More information can be found at hnp:llwww.biodiv.orglbiosafe/Protocolllndex.html.
16 This is probably unlikely to occur before 2002. Australia has not indicated whether it intends to sign 10 Protocol in the immediate future.
17 See http://\vv.'w.wlo.om/enQlish/docs ellegal e/15-sps.pdf.
18 Article 2.2 of the SPSA.
19 Article 5.3 of the SPSA.
20 Article 5.7 of the SPSA.
21 In lay terms, WTO rules provides that if two alternative measures are equally effective in reducing risk and are equally cost-effective, the importing country must choose the one that in practice is least restrictive on importers. This aims to prevent countries erecting protectionist measures in the guise of valid quarantine and other regulations.
22 This might be an issue on which the Ministerial Council may choose to provide advice to the Regulator through policy principles or guidelines, although pOlicy principles could not be framed in a manner which derogates from the health and safety of people or the environment (proposed subsection 2](3». Policy principles and guidelines are discussed later in this
23 The Protocol actually uses the term 'living modified organisms' (LMOs), but for our purposes there is little substantive difference.
24 Article 10.6 of the Biosafety Protocol.
25 Report of the House of Representatives Standing Committee on Industry, Science and Technology, Genetic Manipulation: The Threat or the GIOIy? (February 1992).
26 The Hon Ross Free, Minister for Science and Technology, House of Represent atives Debates, p. 2270, 15 October 1992
27 'New Regulation of Gene Technology', Joint Statement, 30 October 1997. See hllp://www.isT.eov.au/media/archive/october97/327-97.html.
28 A copy of this paper can be found at:
ht10://www.health.gov.au/l galgenel!len et ec h/consu Itat ion. him
29 A copy of this paper can be found at http://www.he3lth.Qov.3u/tgalgene/genetech/discuss.pdf.
30 Explanat01YMemorandum 10 the Gene Technology Bill 2000, p. 36.
31 Ib;d.,pp.37-41.
32 Terms of reference for the inquiry can be found at:
ht tv:1/www.aoh.gov.au/senat e/comIni"eelA0 VERTIG en elcch. od f.
This Diges/ It'll.! prepared/ordebale. "refleclS ,"e legislation as imrodllced{lnd does 'WI canmsssllbsequenlamendments.
This Digest does ,to/ haw! auy officiul legal slatus. OilIer sQllrces should be consulted /0 determi"e Ihe subsequemofficial SIUIIIS o/the Bill.
40 Gene Technology Bi/l2000
33 An 'organism' only includes a biological entity which is viable (capable ofliving or growing), or capable of reproduction or of transferring genetic material (proposed subsection 10(1)).
34 Universities are commonly constituted as corporations. It is an unresolved issue in canstitutionallaw whether a university could be characterised as a "trading corporation" by vinue of aspects such as selling educational services, or selling the results of research. If they do fall within this delinition, all the activities of universities would fall under Commonwealth control.
35. In summary, the relevant agency (the IRA, ANZFA, the Director ofNICNAS or the TGA) must seek advice from the Regulator in relation to products which consist afar contain GM products. There is no minimum threshold for GM content, so presumably a product containing even traces of a GMO or GM product must be referred to the Regulator for his or
her advice. The agency must ensure that the advice of the Regulator is taken into account in making a decision, such as to grant an approval, registration or a licence. However, although the agency must inform the Gene Technology Regulator of the decision it ultimately makes, it is not obliged to follow the advice given by the Regulator.
36 Consultations are needed to detennine whether the Bill will also apply in Norfolk Island: E\"planatol)' Memorandum to the Gene Technology Bill 2000, pp. 46-47.
37 See Work in Progress: Proceed with Caution, op. cit., note 13, p. 138; and Minister for Health and Aged Care, Dr Wooldridge, Second Reading Speech on the Gene Technology Bill 2000, House of Representatives Hansard, p. 16737, 22 June 2000.
38 Work in Progress: Proceed with Caution, op. cit. note 13, p. 139.
39 See section 17 of the OmbudsmanAct 1976.
40 Interim Office of the Gene Technology Regulator, Discussion Paper: Proposedna1ional reglllaIory systemfor genetically modifiedorganisms. How should it work? (October 1999) p. 19.
41 Work ill Progress: Proceed with Cautioll, op. cit. note 13, p. 139.
42 See proposed sections 101, 107, 112.
43 Work ill Progress: Proceed with Cautioll, op. cit. note 13, p. 137.
44 otifiable low risk dealings, exempt dealings and dealings on the GMO Register will not be deemed to have been granted a GMO licence, as they would not require one.
45 See also £xplullotOlyMemorandum to the Gene Technology Bill 2000, p. 49.
46 Work in Progress: Proceed with Caution, op. cit. note 13, p. 130.
47 Section 55 of the Constitution requires all taxes to be levied by separate legislation. This does not apply to a 'fee for service', which may be contained in the same statute as general regulatory provisions.
48 £:tplanatory Memorandum 10 the Gene Technology (Licence Charges) Bill 2000, p. 1.
49 Work in Progress: Proceed with Calltioll, op. cit. note 13, pp. 138.
This Digesl was preparedjorJebme. II ref/i'e,s '''e legislmion as imrodllcedanddoes /101 com"aSS slibseque'll ome"dmelUs.
This Digesl does I/O/ ha,"£, a"y officiol tegat Slatus. O/her sources should be consulted fa df!wrmine Ihe subseq/lemofficiol SIa/liS ojIhe Bill.
Gene Technology Bill 2000 41
50 IOGTR, ExplonatOlY Guide to the Gene TechnologyOil/2000, (July 2000) p. 33. GMAC's guidelines are available at hltp://www.health.gov.au/tQa/gene/gmac/gmacguid.htm (25 July 2000). Dealings which are currently exempt include: the fusion of mammalian cells which does not generate a viable organism; protoplast fusion benveen non·pathogenic
microorganisms; protoplast fusion, embryo-rescue, in vitro fertilisation or zygote implantation involving plant cells; the production or use of gen.e 'knockout' mice; the introduction of naked nucleic acids into plants or animals, unless the nucleic acid sequences are both recombinant and capable of giving rise to infectious agents; and the introduction of genetically manipulated somatic cells into animals, unless they are capable of giving rise to infectious agents.
51. IOGTR, ExplanatOlY Guide to the Gene Technology Bil/200a, (July 2000) p. 46.
52 See section 46A of the Acts lntelpretation Act 1901.
53 Work in Progress: Proceed with Caution, op. cit. nole 13, pp. 127·128.
54 See section 4AA of the Crimes Act 1914.
SS Subsection 4B(3) of the Crimes ACl1914.
S6 The provisions relating to monitoring warrants and offence-related warrants are contained in proposed Part 11 Division 10.
57 The Discussion Paper which preceded the Bill stated that all licence-holders would be subject to independent audits: Proposed natiollal regulatOlYsystemfor genetically modified organisms: How should it work? (October 1999), pp. 32-33.
58 These types of conditions were mentioned in the Discussion Paper which preceded the Bill: Proposed notiollal regulatorysystemfor genetically modified organisms: How should it work? (October 1999), p. 32. These conditions are not legislatively required under the Bill, but may be imposed on a licence at the discretion of the Regulator.
59 Section 44 of the AdministrativeAppeals Tribunal Act 1975.
60. IOGTR, ExplanatolY Guide to the Gene Technology Bil/2000, (July 2000) p. 67.
61 See discussion in 'Development of the Bill' in Background section of this Digest.
62 See Anderson, Clifton E, "Genetic Engineering" (2000) 34(2) The Futurist, 20; Froggat, Antony and Rankine, Kerry, "Brave New World Revisited" (1999) 29(8) The Ecologist 464.
63 Miller, Claire, "GM food: minister may lack say", The Age, 28 February 2000. These concerns have been echoed by Jeremy Rifkin, author of Biotech Century: Harnessing the Gene and Remaking the World (1998), in Rifkin, Jeremy, "Flying blind into the genetic age", The Age, 25 July 2000.
64 This has been recommended by Independent member for Calare, Peter Andren, in his dissenting report in Work in Progress: Proceed with Caution, op. cit. note 13, p. 169.
65 Stevenson, Andrew and Millett, Michael, "Farmers push ahead with GM crops", Sydney Morning Herald, 19 July 2000.
nils Digesl was preparedfordebate. 'I rejleCIS Ihe legistalion as imroducedQlld does /101 cam'U$$$ubsequellf amendments.
This Digesl does '1OIIww' (my officiallegat Sla/US. Olher sources shouldbe consulted 10 determiue Ihe $Ubseqlle/1/officiat SlOWS oflhe Bill.
42 Gene Technology 8ill2000
66 The relevant press release by Minister Llewellyn of30 June 2000 slated: 'Our concern is with the risk of genetically modified material reaching non·modified crops... we need to take great care with the way Tasmanian food products are perceived in the market places that accept OUT commodities'. See also Darby, Andrew "Hoban argues for a new approach", Sydney Morning Herald, 25 July 2000.
67 It is unclear whether the Regulator may be appointed for a subsequent fixed term (p. II). The Regulalor is only required to rcpon annually, not more frequently (p. 12). Policy guidelines made by the Ministerial Council are not disallowable instruments and do not have a mandatory consultation process (p. 13). The advisory committees will only be consulted in the devclopmcnt of policy if requested by the Regulator or Ministerial Council (p. 14). No provision for disclosure of the interests of committee members is required by the Bill (p. 14). It may be difficult to prove the commission ofan aggravated offence, causing significant damagc to the human health and safety or to the environment (p. 21).
68. Probably the majority of dealings with GMOs may need to be evaluated to consider whether they may cause the spread of pests or disease. This is covered by the Commonwealth's quarantine power (section 51 (ix) of the Constitution). Dealings that might not pose a risk of the spread ofpcsts or disease could include therapeutic goods such as medicines and vaccines, organisms which are modified to enhance taste or for health rcasons (such as sweeter tomatoes or vitamin-enhanced rice), and genetically modified bacteria (such as those used in the production of human growth honnone). Of those dealings, the Commonweallh can still
regulate the activities ofCommonwealth departments and authorities, trading, financial and foreign corporations (section 51 (xx», and any activities conducted in the course of interstate or international trade and commerce (section 51(i».
69. Activities which may fall outside Commonwealth power include contained research with GMOs conducted by State government agencies, such as State Dcpartments of Agriculture. Field trials ofGM crops conducted by State government bodies would presumably fall within Commonwealth power, because of the risk of spread of pests or disease. Contained research or release of risk-free GMOs (such as some phannaceuticals) conducted by individuals, partnerships, research institutes and perhaps universities may also fall outside Commonwealth power.
70 Making a regulation gives the Bill the maximum constitutionally pennitted coverage, and excludes the operation of the non-corresponding State laws to the extent they are inconsistent with the Bill, by operation of section 109 of the Constitution. In proposed section 16, the Commonwealth has stated its intention not to 'cover the field'. that is, to preserve the operation of State law as far as is consistent with the Bill. However, once a regulation is made in respect of a State law, the Commonwealth's intention is reversed, that is, it intends to cover the field and constitutionally exclude the operation of that named State law. Although the Commonwealth has no constitutional power to preclude the operation of State legislation in areas which it has no power to regulate, the operation of this provision would be restricted to be within Commonwealth power.
71 Sec discussion in 'Opt Out' in the Concluding Comments section of this Digest.
72 £Tplol1a1ory Memoral1dlllll to the Gene Technology Bill 2000, pp. 14~ 15.
TIIis Digest MlU prepored!OTddH>te. /t refled$ t~ l~isl(J/ion as inlrodu«d (J,1d don IIOt CIlmws sNbuq~nta",endmmlS.
TIIis Digcsl d«s,1O/ h(J'oe (Jnyofficial It'gal Slalus. Othu saurcushouldbit rons"IIH ta detennine 110, subuquenlafficial status oJthf' Bill.
Gelle Technology Bil/20aO 43
73 Byrnes v The Queen; Hopwood v The Queen (1999) 73 ALJR 1292; Bond v The Queen (2000) 74 ALJR 597.
74 [2000] HCA 22; (2000) 74 ALJR 802 at 809-810.
75 A case raising some of the unresolved issues in respect oCthe powers conferred by State law on the Australian Securities and Jnvestment Commission, CPS First Mortgage, is apparently listed for argument before the High Court later in the year.
76 [2000] HCA 22; (2000) 74 ALJR 802 at 812.
77. In R v Hughes [2000] HCA 22; (2000) 74 ALJR 802, a duty was implied from the mere power to prosecute, because of the circumstance that the State Director of Public Prosecutions was not to exercise any functions or powers conferred on the Commonwealth Director of Public Prosecutions. In effect, this imposed a duty on the Commonwealth Director of Public
Prosecutions to exercise the power to conduct prosecutions, because no other body \\'as able 10 exercise the power.
78 Either through becoming a signatory to an international treaty dealing in detail with gene technology, through a reference of powers from the Slates to the Commonwealth, or by constitutional alteralion through referendum.
79 Explanat01YMemorandum to the Gene Technology (Licence Charges) Bi112000, p. I.
80. Sce IOGTR, ExplanatOlY Guide /0 the Cene TechnologyOil/lOaO, (July 2000) p. 75.
81. See seclion 73B of the Income Tax AssessmentAct 1936, which provides for tax concessions of 100%,125% and 150% in relation to certain costs associated with research and development.
82 See, for example, Work ill Progress: Proceed with Caution, op. cit. note 13, p. 140; IOGTR, ExplanalO1YGuide 10 the Gene TechnologyBill 2000, (July 2000) p. 75.
83 Stevenson, Andrew, "Fanner puts his faith in science and necessity", Sydney Morning Herald, 18 July 2000.
84 The issue of the cost ofGM seed varieties was brieny addressed in Work in Progress: Proceed wilh COIl/iol1, op. cit. nOle 55, pp. 89-91.
85. IOGTR, Explanalory Guide to the Gene Techl1ology Bill 2000, (July 2000) p. 76.
86 Explanat01YMemorandumto the Gene Technology Bill 2000, p. 11.
87 Proposed subsection 27(1) of the Gene Technology Bill 2000.
88 Explanat01YMemorandum to the Gene Technology (Consequential Amendments) Bi112000, p.7.
89 See comments of Australian GeneEthics Network, Organic Federation of Australia, Senator latasha Stott-Despoja, summarised in Work in Progress: Proceed wilh Caution, op. cit. note 55, p. 128.
90 See submissions of Environment Australia, CSIRO and the Western Australian government, ibid., p. 152.
This Digest was prcparedjQrdebate. 't rejlects the legislalion as iruroduced anddoes not rom'Qss subsequclIIamendmerus.
This Digest does not ha'-e any officiallegol ~'tU/llS. Other sources should be collsulted to determine rhe subsequenlofficial stal/1$ ojthe Bill.
44 Gene Technology Bill 2000
9\ Ib;d., p. 141.
92 For example, under the Protection o/the £nvironmenr Operalions Act 1997 (NSW) the penalties for individuals who cause water and air pollution are $120,000 and $60,000 for each day the offence continues (sections 123, 132).
93 For example, the Environment Protection and Biodiversity Conservation Act 1999 (Cth) prescribes gaolteons of up to 2 years for offences relating to endangered or threatened species (sections 196, 1968, I 96D), listed migrato!)' species (sections 211, 211 B, 211 D), whales (sections 229, 229B, 2290, 230) and listed marine species (sections 254, 254B, 2540). The maximum fine payable for these offences is 1000 penalty units. Under the Protection oflhe EnvirolllJlelll Operations Act 1997 (NSW) the maximum penalty for wilfully or negligently causing haon to the environment by disposal of waste, leaks or spillage, or emission of ozone depleting substances is S250,OOO or 7 years imprisonment (section 119).
94. Proposed sections 175, 187 and 192. See discussion in the Main Provisions section of this Digest under the heading "Offences".
95 See Work in Progress: Proceed with Caution, op. cit. note 13, p. 129.
96. Including Senator Natasha Stott-Despoja of the Australian Democrats, "Democrats back farmers concerns on GMOs", AAP, 20 July 2000.
97 IOGTR, Discussion Paper: Proposed nalional regulalOry jySlem for genetically modified organisms: How should it work? (October 1999), p 29.
98. Scction 92 of the Constitution provides, relevantly, that "trade, commerce, and intercourse among the States ... shall be absolutely free."
99. For example, a State law which prohibited growing GMO crops in field trials or commercial relcasc would clearly be a law for an impennissible protectionist purpose if its purpose was to protect local agriculturc and enable local growcrs to market themselves as "GMO free". It would also infringe section 92 if it was intended to protect the local environment, but the restriction went funher than necessa!), to achieve the environmental aim. A State law prohibiting the sale of GMOs and GM products in a particular State might also infringe section 92 ifno local businesses
in that State manufactured or sold GMOs or GM products, as the sole burden ofthe law would fall on interstate traders.
100. However, there have been no cases on section 99 of the Constitution since the 1960s. Accordingly, it is unclear if the narrow interpretation would continue to be applied today, panicularly in light of the substantive and purposive interpretation now given to section 92. There have been suggestions that section 99, like section 92, is one of a series of constitutional provisions giving effect to the creation and maintenance of a free trade area
throughout the Commonwealth: Capital Duplicators Pry Ltd v Australian Capital Territory (1992) 177 CLR 248 at 276~277 per Brennan, Deane and Toohey JJ. It may then be seen as a source of an individual right not to be treated differently in matters of trade and commerce merely on the basis ofa person's Statc of residence. If this interpretation were to be adopted, it raises some doubts as to the constitutional validity of a Commonwealth "opt out" clause.
101. Elliolt v Commonwealth(1936) 54 CLR 657.
This Digest was preparedfordebme. II ref/eels Ihe legis/miOlI as imrodllced(mddoes nat canvass slIbseqllellt amendments.
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Gelle Technology Bill 2000
102. IOGTR, £vplal1aroryGuide ro Ihe Gene Technology Bill 2000, (July 2000) p. 29.
103 Section 39 J.
104 Buglass, Dan, 'GM Cash deal fair, says NFU President', 6 July 2000 hItp :llwww.ficotsman.com/taf/farming. ta f.
105. See Kleiner, Kun "Blowing in the wind", New Sciel/lisl, 14 August 1999, p. 18; Steinke, Darren, "Round one starts in farmer's GM fight with Monsanto", Reulers News Service, 5 June 2000.
106 Evidence given by the IOGTR to the House of Representatives Standing Committee on Primary Industries and Regional Services, 5 April 2000, p. 266. There are no obvious examples of reported cases involving actions over damage caused by GMO contamination. However, it is clearly established that, under certain circumstances. the spread of dust, smells, noise or other things which restrict an occupier's enjoyment of his or her land will give rise to a suit of private nuisance.
107 Work in Progress: Proceed with Caution, op. cit note 13, p. 159.
108 Lean, Geoffrey, 'Europe to act on GM pollution oforganic fanns', The II/dependent, 26 March 2000.
109 Evans, David, â¢EU Parliament Rejects GMO Liability Clause', Yahoo Science Headlines, 12 April 2000.
110. This is clearly illustrated by a recent case involving a claim for damages for contamination, although not by GMOs. Perre v Ap{mdPty Ltd (1999) 164 ALR 606 involved South Australian potato fanners who were prevented from selling their crop in the lucrative Western Australian market because a neighbouring farmer's potatoes contracted blight, and their
potatoes fell within the zone of quarantine. It took 7 years from the time the damage occurred before the final court decision was handed down. Judicial opinion was divided at all levels as to whether the damage was actionable at all, and whether the company that supplied the contaminated potato seed was liable. Even in the High Court, the Justices were unable to agree which of the plaintifTs were sufficiently directly affected to be able to recover for their loss.
III. This has been done in unrelated areas such as workers' compensation. There is no precedent in other jurisdictions for the establishment of a statutory compensation scheme in relation to GMOs, and difficult questions arise as to who may be required to contribute to the scheme.
112. Statutory liability currently exists in areas such as criminal injuries compensation and civil aviation carriers' liability, both in relation to personal injury or death and property damage. The rationale behind such schemes is that it is desirable that persons who suffer loss or damage be compensated for their loss, however, it is also desirable that the level of liability be capped. We can think of no precedent for such a scheme in relation to environmental damage or injury to human health.
113 A useful summary of European Union policy and procedures regarding GMOs can be found in 'Facts on GMOs in the EU' Memo/OO/43, 13 July 2000, at:
http://ellTora. ell. int/com mid !!~lhea ItIt consumer/l ibrary/press/rrcss63 en. pd f.
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T1Iis Digatdoes ItQl hQâ¢..,. Qnyojfu:ialtegQIStQIUS. Other sou.-enshaufdbf't:QnSUI'ed 10 de'erm;~ the subseqlll'fl/ ojf.ciQI stQtus afthe Bill.
46 Gene Technology Bill 2000
I J4 Directive 90J2191EEC deals with 'contained' releases.
115 Thc scope of Directive 901220/EEC includes the placing on the market of GMOs and products consisting of or containing a GMO such as GM tomatoes, but docs not extend to products derived from GMOs such as tomato paste: 'Facts on GMOs in the EV', op. cit. note 113.
116 The GMOs in qucstion were genetically modified maize and oilseed rape: 'Facts on GMOs in the EV', op. cit. nole 113.
117 To date, in all the cases so referred, the Committee decided the bans were not justified on the basis of the infonnation provided to them: 'Facts on GMOs in the EV', op. cit. note J 13.
118 'GM food debate continues in EV', Reuters, 20 July 2000.
119 General infonnalion on gene technology regulation in the VK can be found at http://www.cabinet-office.gov.uk/e:rn-info/.
120. Research and devclopment are covered by the GMO (Comained Use) Regulations /992.
12 J See htln:/Iwww.dli.gov.uklostlostbusinesslindex.htm.
122 See the Department of Agriculture's Biotechnology Website for more infonnation at hnp:llwww.anhis.usda.l.!.ovlbiolechlusda biOiech.llIml.
123 More informntion can be found at http://www.fda.gov/oclbiotcch/default.htm.
124 See hllp:llcbnc.gc .calcbac/cbacweb.nsfIbSa5bbe305b2f7c98525681800116fd9/ddea7299beefd6fd 85256Se3006dcOa8?OpcnDocumcnt.
125 See l11tp:/lwww.ennanz.govt.nzlNewOrganismsl.
126 Christensen, M and Williams, M 'First GMO approvals for New Zealand under New Law' (1999) 9(2) Auslralian Biotechnology98; 'ERMA decision on Cattle Released', Press Release, 25 July 2000. See:
http· /Iwww.erma.govl.nzlNewslssues/fileslPressRelcases/2000/pr20000725.htm .
127 See hnp://www.mfe.govl.nzlnew/inquirv into geneticmod.htm .
I28 See http://www.ennanz.govt.nzlNewslssueslfi JeslPressReleasesl2000/pr2000061 5.htrn.
129 More infonnation can be found at http://ss.s.afTrc.go.jp/docslsentan/eintro/intro.htm
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