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Queensland Parliamentary Library

A New National Scheme toRegulate Gene Technology inAustralia: The Gene TechnologyBill 2001

In the past the development and use of gene technology in Australiawas conducted under a voluntary system. The Commonwealth andState Governments are replacing this scheme with a compulsory andlegally enforceable national system of regulation. The focus of thenew gene technology regulatory scheme is to provide acomprehensive and transparent system of regulating dealings withgenetically modified organisms so as to protect human health andsafety and the environment. The Gene Technology Bill 2001 (Qld)forms Queensland’s legislative component of the scheme.

This Research Brief examines the impetus for, and development of,the new gene technology regulatory scheme in Australia. It alsodescribes the Queensland Bill in the context of national legislativearrangements, the Gene Technology Agreement and the MinisterialCouncil. In addition, this Brief provides a summary of the Code ofEthical Practice for Biotechnology in Queensland, an initiative of theQueensland Government to provide an ethical framework to guidethe conduct of biotechnology in the State.

Cathy Green

Research Brief No 2001/27

Queensland Parliamentary LibraryResearch Publications and ResourcesSection

Ms Mary Seefried, Director (07) 3406 7116

Ms Karen Sampford, Research Publications Officer (07) 3406 7310

Mr Wayne Jarred, Senior Parliamentary Research Officer (07) 3406 7422

Ms Nicolee Dixon, Parliamentary Research Officer (07) 3406 7409

Ms Cathy Green (part time), Parliamentary Research Officer (07) 3406 7641

© Queensland Parliamentary Library, 2001

ISSN 1443-7902ISBN 0 7242 2800 0

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CONTENTS

1 INTRODUCTION ............................................................................................. 1

2 GENE TECHNOLOGY..................................................................................... 1

3 THE CONTROL OF GENETICALLY MODIFIED ORGANISMS IN AUSTRALIA – THE TRANSITION FROM A VOLUNTARY SYSTEM TO A NATIONAL REGULATORY SYSTEM

3.1 THE VOLUNTARY SYSTEM .............................................................................. 3

3.2 PROPOSED CHANGES TO THE VOLUNTARY SYSTEM .......................................... 4

3.3 A NATIONAL REGULATORY SYSTEM FOR GENETICALLY MODIFIED ORGANISMS6

3.4 QUEENSLAND – “THE SMART STATE”............................................................ 6

4 THE GENE TECHNOLOGY BILL 2001 (QLD)............................................ 7

4.1 PRELIMINARY MATTERS ................................................................................ 7

4.1.1 National Scheme...................................................................................... 7

4.1.2 Formatting............................................................................................... 7

4.1.3 Object of the Bill and Regulatory Framework........................................... 8

4.1.4 Key definitions......................................................................................... 9

4.2 THE OFFICE OF THE GENE TECHNOLOGY REGULATOR.................................... 10

4.3 GENE TECHNOLOGY MINISTERIAL COUNCIL................................................... 12

4.4 THE GENE TECHNOLOGY COMMITTEES ......................................................... 12

4.5 LICENSING SYSTEM ...................................................................................... 13

4.5.1 Contained dealings................................................................................. 14

4.5.2 Intentional Release into the Environment ................................................. 14

4.5.3 Decision on Licence............................................................................... 15

4.5.4 Licence Conditions ................................................................................ 16

4.5.5 Suspension, cancellation and variation of licences.................................... 16

4.5.6 Transitional Arrangements...................................................................... 17

4.6 EXEMPTIONS TO THE LICENSING SYSTEM .......................................................17

4.6.1 Exempt dealings .....................................................................................18

4.6.2 Notifiable Low Risk Dealings .................................................................18

4.6.3 The GMO Register ................................................................................18

4.7 CERTIFICATION AND ACCREDITATION..........................................................19

4.8 ENFORCEMENT AND MONITORING................................................................19

4.8.1 Directions ..............................................................................................19

4.8.2 Injunctions .............................................................................................19

4.8.3 Forfeiture...............................................................................................20

4.8.4 Criminal Offences And Penalties.............................................................20

4.8.5 Monitoring.............................................................................................21

4.9 CONFIDENTIAL COMMERCIAL INFORMATION...............................................22

4.10 REVIEW OF DECISIONS...................................................................................23

4.11 CONSEQUENTIAL AMENDMENT ....................................................................23

5 GENE TECHNOLOGY INTERGOVERNMENTAL AGREEMENT........23

6 THE CODE OF ETHICAL PRACTICE FOR BIOTECHNOLOGY INQUEENSLAND................................................................................................24

RECENT PARLIAMENTARY LIBRARY RESEARCH PUBLICATIONS 200127

A New National Scheme to Regulate Gene Technology in Australia Page 1

1 INTRODUCTION

In the past the development and use of gene technology in Australia was conducted undera voluntary system. The Commonwealth and State Governments are replacing thisscheme with a compulsory and legally enforceable national scheme for regulating dealingswith genetically modified organisms (GMOs). The national gene technology regulatoryscheme consists of three components: gene technology legislation, a Gene TechnologyAgreement and a Ministerial council.

On 10 September 2001, the Minister for Innovation and Technology, the Hon PaulLucas MP, introduced the Queensland’s legislative component of the national scheme,the Gene Technology Bill 2001 (Qld), into the Queensland Parliament.

The legislative component of the national gene technology regulatory scheme:

• provides for an independent national regulator to scientifically assess dealings ingene technology

• establishes a series of consultative committees to provide advice on genetechnology to the regulator and the Ministerial council

• prohibits persons from dealing with GMOs (e.g. research, manufacture,production, commercial release and import) unless the dealing is exempt, aspecified low risk dealing on the Register of GMOs or licensed by the Regulator

• establishes a scheme to assess the risks to human health and the environmentassociated with various dealings with GMOs, including opportunities for extensivepublic input

• provides for monitoring and enforcement of the legislation, and

• provides for a centralised, publicly available database of all GMOs and GMproducts approved in Australia (the Record of GMO and GM product dealings).

This Research Brief examines the impetus for, and development of, the new genetechnology regulatory scheme in Australia. It also describes the Queensland Bill in thecontext of the national legislative scheme, the Gene Technology Agreement and theMinisterial council. In addition, this Brief looks at the Code of Ethical Practice forBiotechnology in Queensland, an initiative of the Queensland Government to provide anethical framework to guide the conduct of biotechnology in the State.

2 GENE TECHNOLOGY

Gene technology involves the control or modification of genes through the manipulation ofdeoxyribonucleic acid (DNA), the code of inheritance. It alters the genetic code of an


individual chromosome, cell or organism. Such an alteration of the genetic code may bebrought about by changing the code within a gene, adding information to the code whichturns the gene off or on, moving a gene to a different place in a chromosome within thesame nucleus, or moving a gene from one organism to another.

The alteration of the properties of plants and animal organisms is not a moderndevelopment. People have used techniques such as selective breeding or plant graftingfor hundreds of years to achieve such results. Modern gene technology has greatlyexpanded the number of plant and animal traits that can be manipulated and transferredacross the species barrier.

In the modern context, gene technology is applied in the areas of research, agriculture (egthe genetic modification of crops to incorporate pesticide resistance or herbicideresistance, or slowing the ripening process in fruit and flowers), the production oftherapeutic goods (eg the modification of micro-organisms to produce therapeutic goodssuch as insulin), medicine (eg the identification and treatment of disease), bio-remediation(eg the use of micro-organisms to decompose of toxic substances and clean-up ofindustrial sites or environmental accidents) and industry (eg the production of enzymesused in paper pulp production).

Advocates of gene technology suggest that the application of a range of gene technologiesis of benefit in the areas of: agriculture (eg with more precise, quicker and cost effectiveresults and the introduction of traits not possible through conventional techniques); theenvironment (eg through the reduced use of conventional chemicals and pesticides andthe use of biodegradable plastics and biodiesel); and health (eg enzymes, hormones,vaccines).

Opponents of gene technology focus on the potential risks (such as the introduction ofunidentified allergens in GM food, the contamination of traditional or organic crops byneighbouring GM crops, the inability to eliminate a GMO once released and found tohave an adverse impact and the transfer of herbicide resistant genes from GM crops torelated species) and the need to ensure that adequate safeguards are in place to manageor eliminate those risks.1 Paradoxically, some of the characteristics of gene technologythat give rise to its benefits (such as the ability to introduce genes across the speciesbarrier) also cause concern in the community about the unintended effects the use of thetechnology may have on human health and safety and the environment. Concerns also

1 These arguments for and against gene technology are abstracted from

http://www.csiro.gov.au/pubgenesite/debate2.htm; http://www.afaa.com.au > Fact Sheets>Paper No 1; Australia, Senate Community Affairs Committee, A report on the Gene TechnologyBill 2000 - A cautionary tale: fish don’t lay tomatoes, November 2000, pp 14 – 23.


exist as to the broader ethical, social and moral concerns relating to the manipulation ofDNA. 2

3 THE CONTROL OF GENETICALLY MODIFIED ORGANISMS INAUSTRALIA – THE TRANSITION FROM A VOLUNTARY SYSTEMTO A NATIONAL REGULATORY SYSTEM

3.1 THE VOLUNTARY SYSTEM

Over the past couple of decades, the development and use of gene technology inAustralia has occurred in the context of a voluntary system. Under the voluntary system,the responsibilities of assessing the risks to human health and the environment that mayhave been presented by the application of the technology and providing advice on howthe risks could be managed rested with a succession of independent committees ofscientific experts, beginning with the Academy of Science on Recombinant DNA in 1975,the Recombinant DNA Monitoring Committee (created in 1981) and by the GeneticManipulation Advisory Committee (GMAC) from 1987 until 21 June 2001.

Over time, the voluntary system has attracted criticism in a number of respects:

• The recommendations of the GMAC were obtained and complied withvoluntarily. In the absence of regulatory powers, the GMAC had limited capacityfor independent, legally enforceable auditing and monitoring of compliance.There was no legal basis for the imposition of penalties or other action in theevent of non-compliance.

• From an industry perspective, there was no clear path to market for products ofgene technology that fell outside the mandate of existing regulators, and there wasno certainty about the rules or standards that may have applied to identify ormanage risks.

• From a community perspective there was inadequate consultation andtransparency in relation to decision making and a lack of confidence in theeffectiveness of the control system.3

2 Commonwealth Department of Health and Aged Care, Interim Office of the Gene Technology

Regulator, Gene Technology Bill 2000: Questions and Answers, June 2000, pp 2-3.

3 Australian Commonwealth Department of Health and Aged Care, Office of the Gene TechnologyRegulator, ‘Voluntary System’, downloaded athttp://www.health.gov.au/ogtr/voluntary/background.htm on 12 September 2001.


3.2 PROPOSED CHANGES TO THE VOLUNTARY SYSTEM4

In 1992, a report by the House of Representatives Committee on Industry, Science andTechnology, Genetic Manipulation: The Threat or the Glory?, recommended that theCommonwealth should pass legislation to regulate genetically modified organisms(GMOs) and, in particular, their release outside contained facilities.5 One of the principalconcerns of the Committee at that stage was that although the existing guidelines forgenetic manipulation therapy appeared to be adequate and comprehensive in theircoverage, they had no legal force. The Committee suggested that the guidelines could beexpressed in regulations under an Act of Parliament thereby allowing greater ease ofamendment to keep up to date with technological changes. The Committee alsorecommended that a wide range of sanctions should be available to act as a deterrent tobreaches of the guidelines.6 During 1992-95 there were on-going Commonwealth-Statediscussions regarding legislative options to implement regulation. However, negotiationsceased in 1995 when agreement could not be reached on a legislative model.

The proposal for a national legally enforceable regulatory system for gene technology wasraised again in October 1997. A Commonwealth-State Consultative Group on GeneTechnology (CSCG) was formed as a result. Community and industry perceptions andexpectations provided much of the impetus to shift from a voluntary to a regulatorysystem for GMOs.7

The States, Territories and the Commonwealth collaborated to develop a nationallyconsistent regulatory scheme for GMOs. The process was approached from a whole-of-government perspective and involved a number of stages. Agencies responsible forhealth, environment, agriculture, industry and primary production across Commonwealth,State and Territory jurisdictions participated in the process and broad consultationoccurred with individuals and organisations, including universities conducting research

4 The Report of the Senate Community Affairs Committee summarises the development of the

Gene Technology Bill 2000 (Cth), the principal Commonwealth Act which underpins thelegislative scheme. This section is partly abstracted from pages 2 –7 of that material.

5 Australia. Parliament, House of Representatives Standing Committee on Industry, Science andTechnology, Genetic Manipulation: ‘The Threat or the Glory?’, Report, February 1992, pp 260-282.

6 House of Representatives Standing Committee on Industry, Science and Technology, GeneticManipulation, pp xvii, 266: Recommendation 37.

7 Senate Community Affairs Committee, pp 5,6.


involving GMOs; consumer, environmental, health professional, industry, retailer and foodindustry, and primary producer groups.8

The CSCG opted for full government regulation to improve the existing administrativecontrols. In November 1998, the CSCG released a consultation paper ‘Regulation ofGene Technology’ that was circulated for public consultation. Consultations were heldthroughout Australia seeking views about the broad policy principles that might underpinthe new regulatory scheme. As a result of these consultations, the CSCG agreed to a setof policy principles that it used to develop proposals for the operational details of the newregulatory system.

The CSCG, in collaboration with the Interim Office of the Gene Technology Regulator(IOGTR)9, prepared another discussion paper entitled ‘Proposed national regulatorysystem for genetically modified organisms – How should it work?’. This paper setout the proposed approach to regulating GMOs, including the proposed scope and formof the legislation, proposed management structures, the proposed system of regulationand the proposed mechanisms to achieve transparency, accountability and communityinvolvement over time. The paper was widely circulated in October 1999 and consultedon in the subsequent months. A draft Gene Technology Bill was released for publicconsultation in late December 1999.

In November 2000, the Senate Community Affairs Committee, acting on a referencefrom the Senate, reported on the proposed Gene Technology Bill 2000 (Cth) andrelated legislation. In its report, the Committee noted that:

The implementation of a nationally effective and enforceableregulatory scheme is critical to the development of genetechnology in Australia and to boost public confidence in thedevelopment and use of gene technology generally.

The Gene Technology Act 2000 (Cth) (and its related Acts10) received assent onDecember 2000 and generally commenced on 1 June 2001.

8 Australia. Senate Community Affairs Committee, A report on the Gene Technology Bill 2000 - A

cautionary tale: fish don’t lay tomatoes, November 2000, p 3.

9 The IOTGR was established in May 1999 within the Commonwealth Department of Health andAged Care to oversee the development of the legislation to implement a national regulatorysystem and work with GMAC. The IOTGR was replaced by the Office of the Gene TechnologyRegulator (OTGR) on 20 April 2001 as a result of the Gene Technology Act 2000 (Cth).

10 These Acts are: the Commonwealth Gene Technology (Consequential Amendments) Act 2000(Cth) which ensures that existing regulators of GM products under existing schemes for theregulation of food, therapeutic goods and agricultural, veterinary and industrial chemicals mustrequest advice from the regulator and have regard to that advice when making decisions aboutproducts which are GM products or contain GM products.; and the Commonwealth Gene


3.3 A NATIONAL REGULATORY SYSTEM FOR GENETICALLY MODIFIED

ORGANISMS

The Gene Technology Act 2000 (Cth) (“the Commonwealth Act”) and its associatedActs, together with corresponding legislation enacted, or to be enacted, in each State andTerritory in Australia, as well as subordinate legislation and other instruments comprisethe national scheme for the regulation of gene technology and GMOs in Australia. Aswell as dealings with GMOs, the gene technology scheme covers some GM products(such as stock feed derived from a GM crop such as cotton) not regulated by an existingregulatory agency.

The regulatory framework is designed to operate in conjunction with other existing State,Territory and Commonwealth regulatory schemes relevant to GMOs or GMO productslike food, therapeutic goods, agricultural, veterinary, and industrial chemicals.11

In addition to Queensland, a number of other States have taken steps to implementcomplementary gene technology legislation in their jurisdictions. Tasmania passed theGene Technology Act 2001 (Tas) in July 2001 while New South Wales, Victoria, SouthAustralia and Western Australia have each introduced Gene Technology Bills into theirrespective Parliaments.12

3.4 QUEENSLAND – “THE SMART STATE”

The Queensland Government over the past several years has encouraged the growth ofcompetitive knowledge intensive industries in Queensland with its promotion as the“Smart State” with initiatives such as the $270 million 10 year Queensland BioindustriesStrategy (May 1999) and the creation of the $100 million Smart State Facility Fund(announced in the 2001 Queensland Budget).

Technology (Licence Charges) Act 2000 (Cth) which establishes the capacity for regulations tobe made establishing annual charges to be paid by a GMO licence holder.

11 The relevant regulatory bodies of these respective areas are: foods (including GM foods):Australia and New Zealand Food Authority; therapeutic goods (including GM therapeuticgoods) and human gene therapy: Therapeutic Goods Administration; agricultural and veterinary(agvet) chemicals (including GM agvet chemicals): National Registration Authority; industrialchemicals: National Industrial Chemicals Notification and Assessment Scheme; and, imports andexports: Australian Quarantine and Inspection Service and Australian Customs Service.

12 Gene Technology Act 2001 (Tas), (assented to on 16 July 2001 but not yet commenced as at 29August 2001): Gene Technology (New South Wales) Bill 2001 (NSW), Gene Technology Bill2001 (Vic); Gene Technology Bill 2001 (SA); Gene Technology Bill 2001 (WA) and GeneTechnology Amendment Bill 2001 (WA).


The Gene Technology Bill, in conjunction with the Code of Ethical Practice forBiotechnology in Queensland and proposed legislative measures to regulate the cloning ofhumans, is designed to provide the biotechnology industry with a clear regulatoryframework that also addresses community issues and expectations about the“Biotechnology Revolution”.13

4 THE GENE TECHNOLOGY BILL 2001 (QLD)

4.1 PRELIMINARY MATTERS

4.1.1 National Scheme

The Commonwealth Act is the principal Act in the national regulatory scheme. The GeneTechnology Bill 2001 (Qld) largely mirrors the Commonwealth Act. As a result ofconstitutional limitations (eg relating to activities of State Government agencies or highereducation institutions), the Commonwealth Act does not provide full regulatory coveragefor gene technology. Both State and Commonwealth legislation are needed to achieve anationally consistent scheme that provides full regulatory coverage for gene technology.The Queensland Bill provides for the Queensland component of the scheme14 andincreases its coverage to include Queensland Government agencies and higher educationinstitutions.

4.1.2 Formatting

The provisions of the Commonwealth Act and the Queensland Bill are numberedconsistently. Where a Commonwealth Act contains a section not required in theproposed Queensland Act, the provision number and heading to the section are stillincluded in the body of the Queensland Act even though the body of the section isomitted. This is to maintain consistent numbering with the Commonwealth Act (cl 8A).

13 Queensland, Department of Innovation and Information Economy, ‘Queensland’s Ethical

Approach to Biotechnology Development’, p 2.

14 Gene Technology Bill 2001 (Qld), cl 5 .


4.1.3 Object of the Bill and Regulatory Framework

Clause 3 of the Bill describes its object as to protect the human health and safety and theenvironment by identifying risks posed by or as a result of gene technology, and bymanaging the risks by regulating certain dealings.

Clause 4 provides that this object is to be achieved by a regulatory framework that:

• Provides an efficient and effective system for the application of genetechnologies (cl 4 (a))

• Operates in conjunction with other Commonwealth and State regulatoryschemes relevant to GMOs and GM products (cl 4 (b))

• Provides that where there are threats of serious or irreversible environmentaldamage, a lack of full scientific certainty should not be used as a reason forpostponing cost-effective measures to prevent environmental degradation (cl 4(aa)).

Clause 4 (aa) is a restatement of the “precautionary principle” which is based on theconcept of taking anticipatory action to prevent possible harm under circumstances wherethere is a level of scientific uncertainty. A number of multilateral treaties and internationaldeclarations and protocols (such as the Cartagena Protocol on Biosafety, 2000 andthe 1992 Rio Declaration on Environment and Development) and various pieces ofAustralian legislation and agreements (such as the Environment Protection andBiodiversity Conservation Act 1999 (Cth) and the Intergovernmental Agreement onthe Environment, May 1992) have adopted the precautionary principle.

The Commonwealth Act, when introduced into the Federal Parliament as a Bill, did notcontain a statement of the precautionary principle. The Senate Community AffairsCommittee in its review of the Bill supported the precautionary approach to theintroduction of gene technologies. The Committee noted that:

The paradox of gene technology is that there is considerableuncertainty about the extent of risks at the time. Being toocautious may stifle research that might clarify the extent of suchrisks and unnecessarily restrict work to determine the extent ofbenefits that gene technology may bring. However, unless care istaken, it is possible that if problems are identified in the future theapplications might be too widespread to be able to counter theharmful effects.15

As a result, the Committee suggested the incorporation of the precautionary principle asone of the objects of the Commonwealth legislation. A form of the precautionary

15 Senate Community Affairs Committee, p 45.


principle was included in the Commonwealth Act and was adopted in the QueenslandBill.

4.1.4 Key definitions

Schedule 3 of the Bill contains a number of definitions and phrases used in the Bill.

“Deal with”, for a GMO, means any of the following:

• conduct experiments with the GMO

• make, develop, produce or manufacture the GMO

• breed the GMO

• propogate the GMO

• use the GMO in the course of manufacturing a thing that is not the GMO

• grow, raise or culture the GMO

• import the GMO.

The concept also includes the possession, supply, use, transport or disposal of the GMOin relation to the dealings listed above.

A “genetically modified organism” is defined as:

• an organism that has been modified by gene technology

• an organism that has inherited particular traits from an organism (the initialorganism), being traits that occurred in the initial organism because of genetechnology, or

• anything declared by the regulations to be a genetically modified organism, or thatbelongs to a class of things declared by the regulations to be genetically modifiedorganisms.16

For the purposes of the Bill, a GMO does not include:

• a human being, if the human being is covered by paragraph (a) only because thehuman being has undergone somatic gene therapy17, or

16 The ability to prescribe things to be genetically modified organisms in regulations (under

subparagraph (c) of the definition of a GMO) ensures there is capacity to regulate GM productsthat are not regulated by existing regulatory agencies. An example of such a ‘gap’ product isGM stockfeed: Gene Technology Bill 2001 (Qld), Explanatory Notes, p 63.

17 Human beings are excluded from the definition of a GMO to make it clear that a person who hasundergone somatic cell gene therapy (for example, treatment for cancer) is not a GMO in atechnical sense (as defined here). Human gene therapy continue is regulated by the TherapeuticGoods Administration and, in the case of research involving human trials, also overseen by theNational Health and Medical Research Council. The Regulator would also be involved if the


• an organism declared by the regulations not to be a genetically modifiedorganism, or that belongs to a class of organisms declared by the regulations notto be a genetically modified organisms.

“GM product” means a thing (other than a GMO) derived or produced from a GMO.

“Gene technology” is defined to cover any technique for the modification of genes orother genetic material, but does not include sexual reproduction, homologousrecombination, or any other technique specified in the regulations for the purposes of thedefinition.

4.2 THE OFFICE OF THE GENE TECHNOLOGY REGULATOR

The Commonwealth Act established the office of the gene technology regulator (“theregulator”) to administer the national scheme to regulate GMOs (Part 3 and Part 9).The Office of the Gene Technology Regulator (OTGR) is located within theCommonwealth Health and Aged Care portfolio.

Clause 27 of the Bill establishes the wide-ranging functions of the regulator as to:

• perform functions relating to GMO licences under part 5 (which describes theprocess for deciding an application for a GMO licence)

• develop draft policy principles and policy guidelines, as requested by theMinisterial council

• to develop codes of practice

• issue technical and procedural guidelines about GMOs

• provide information and advice to other regulatory agencies about GMOs andGM products

• provide information and advice to the public about regulating GMOs

• provide advice to the Ministerial council about the operations of the regulator andthe Gene Technology Technical Advisory Committee and the effectiveness of thelegislative framework for regulating GMOs, including about possible amendmentof relevant legislation

• undertake or commission research about risk assessment and the biosafety ofGMOs

• promote the harmonisation of risk assessments for GMOs and GM products byregulatory agencies

work involves a live or viable GMO (presenting possible occupational health and safety orenvironmental risks): Gene Technology Bill 2001 (Qld), Explanatory Notes, p 64.


• monitor international practice for regulating GMOs

• maintain links with international organisations dealing with the regulation of genetechnology and with agencies regulating GMOs in places outside Australia (or, inthe case of the Queensland Bill, outside the State)

• perform other functions conferred on the Regulator under the gene technologylegislation or any other law.

The regulator must also:

• report to the Parliament quarterly and annually, and at any other time such areport is warranted (cls 136, 136A and 137), and

• monitor and enforce the legislation (Part 10 and Part 11).

The independence of the regulator is variously provided for under a number of provisionsin the Bill. For example, clause 30 confers on the regulator, subject to any statutoryrestriction, the discretion to perform or exercise his or her functions or powers. Theregulator is not subject to direction from anyone in relation to his or her performance, inparticular whether or not to grant a GMO licence with or without conditions. Theregulator is, however, bound by policy principles issued by the Ministerial council not toissue a licence if to do so would be inconsistent with a policy principle (cl 57).

The regulator can delegate any of his or her powers or functions to a public servant or anemployee of a Commonwealth authority or State agency whose functions relate toGMOs and GM products (cl 29). This enables the regulator to delegate to a relevantagency such as the National Registration Authority or the Australia New Zealand FoodAuthority (ANZFA). The regulator is broadly empowered to do anything necessary orconvenient in the performance of his or her functions (cl 28) and may obtain scientific,ethical and other advice from the three advisory committees established by theCommonwealth Act.

Section 129 of the Commonwealth Act provides for the establishment of a GeneTechnology Account and the amounts that must be credited or may be recovered fromthe account (eg licensing fees and amounts received in connection with the performanceof the functions of the regulator).

The regulator must maintain a record of GMO and GMO product dealings (“the GMRecord”). The GM Record contains details of each licence issued, namely: the licenceholder and people covered under the dealings, the licence conditions, the dealingsauthorised under the licence and details about its currency, as well as details of somenotifiable low risk dealings and GM products. The Record does not cover commercialinformation (cl 138). Section 139 of the Commonwealth Act specifies that the GMRecord is available for public inspection.


4.3 GENE TECHNOLOGY MINISTERIAL COUNCIL

The second component of the national regulatory scheme is the Gene TechnologyMinisterial council. The Ministerial council, consisting of one or more Ministers fromeach State and Territory and the Commonwealth, is provided for under the GeneTechnology Agreement. Part 3 of the Gene Technology Agreement establishes theMinisterial council and provides that its functions are to:

• issue policy principles, policy guidelines and codes of practice to govern theactivities of the regulator and the operation of the regulatory framework

The Ministerial council may issue policy principles in relation to prescribedmatters (e.g. ethical issues relating to dealings with GMOs, recognition of areasdesignated under State law for the purposes of identity preservation of particularproduce for marketing purposes) (cl 21). As noted above, the Regulator mustnot issue a licence if to do so is inconsistent with a policy principle issued by theMinisterial council (cl 57).

The Commonwealth Act includes a provision about how policy principles must bedeveloped in consultation with specified stakeholder bodies such as the genetechnology committees, the regulator, Government regulatory agencies andindustry, environmental, consumer and other appropriate groups (CommonwealthAct, s 22). The Ministerial council must be satisfied that the policy principle wasdeveloped with such consultation (cl 21(2)).

• approve proposed regulations for the purpose of the scheme

• consider and, if thought fit, agree to changes where necessary to the nationallegislative framework

• discuss matters related to gene technology regulation with other relevantMinisterial councils

• approve the appointment and dismissal of the regulator and chairpersons of thegene technology committees and advise on the appointment of the members ofthose bodies

• oversee periodic reviews of the legislative framework.18

4.4 THE GENE TECHNOLOGY COMMITTEES

Part 8 of the Commonwealth Act established three advisory groups to provide expertadvice to the regulator and the Ministerial council on gene technology: the Gene

18 Gene Technology Agreement, 10 September 2001, pp 7-8.


Technology Technical Advisory Committee (GTTAC), the Gene Technology CommunityConsultative Committee (GTCCC) and the Gene Technology Ethics Committee (GTEC).

The GTTAC replaces the GMAC which, until June 2001, was the expert advisorycommittee which provided recommendations on all applications for contained research,field trials and general releases involving GMOs.

The GTTC is responsible for providing expert scientific and technical advice to theregulator on applications made under the legislation. On the request of the regulator, orthe Ministerial council, the GTTC will also provide advice on other matters related togene technology, GMOs and GM products and on the need for, and proposed contentof, policy principles, policy guidelines, codes of practice and technical and proceduralguidelines for GMOs and GM products.

The GTCCC is a broadly based consultative committee which, on the request of theregulator or the Ministerial council, provides advice on: community concerns regardinggene technology and the need for, and content of, policy principles, policy guidelines andcodes of practice to the development of the procedural and policy documents which willguide the regulator’s decision-making.

The GTEC on the request of the regulator or the Ministerial council provides advice onthe ethics of gene technology, appropriate ethics guidelines and any necessary prohibitivedirectives.

4.5 LICENSING SYSTEM

Part 5 of the Bill provides a licensing system under which a person may apply to theRegulator for a licence authorising dealings with GMOs. The licensing process is basedon a system of scientific risk assessment and extensive consultation with expert advisorycommittees, Government agencies and the public. An annual charge is payable for aGMO licence ( cl 72A).

Any dealings with a GMO must be authorised under a licence unless they are:

• notifiable low risk dealings

• exempt dealings (prescribed under regulation)

• dealings included on the GMO Register.

The level of regulation applied to particular dealings with GMOs is related to the level ofrisk posed by the particular dealings. The process for the approval of dealings withGMOs varies based on whether the dealing is to occur under contained conditions orwhether the dealing involves a deliberate release of the GMO into the environment. TheExplanatory Notes to the Bill state:


This flexibility has been built into the scheme because of the potential fordifferent, or more serious, risks developing in relation to public health andsafety and the environment from dealings involving a release into theenvironment, hereby necessitating a more comprehensive public consultationand risk assessment process.19

4.5.1 Contained dealings

Where a licence application relates to a contained dealing, the regulator must prepare arisk assessment and a risk management plan for the proposed dealing before issuing thelicence (cl 46). The risk assessment must take into account the risks posed by thedealings including any risks to human health and safety and the environment. The riskmanagement plan must take into account how such risks may be managed so as toprotect human health and safety and the environment. The regulator may consult withrelevant Government bodies, the GTAC and any other appropriate person on any aspectof the application (cl 47).

4.5.2 Intentional Release into the Environment

A more rigorous approval process applies where a licence application relates to anintentional release of a GMO into the environment20 (such as a GMO crop field trial orthe commercial release of a GMO for commercial propagation and sale21). If theregulator is satisfied that such a dealing may pose significant risks to human health andsafety or to the environment, the regulator must consult with stakeholders and the publicabout whether the licence should be issued (cls 49(1)(3), 50, 51, 52). The regulator mayalso hold public hearings about the application (cl 53). The matters to which theregulator must take into account in deciding if the dealing does pose the requisite risksinclude:

• the properties of the organism

• the effect of genetic modification on the properties of the organism

• provisions for limiting the dissemination or persistence of the GMO or its geneticmaterial in the environment

19 Gene Technology Bill 2001 (Qld), Explanatory Notes, p 8.

20 Intentional release of a GMO into the environment” is defined in cl 11 of the Gene TechnologyBill 2001 (Qld). It involves the intentional release of a GMO into the open environment whetheror not it is released with provision for limiting the dissemination or persistence of the GMO or itsgenetic material in the environment.

21 Gene Technology Bill 2001 (Qld), Explanatory Notes, pp 20, 21.


• the potential for spread or persistence of the GMO or its genetic material in theenvironment

• the extent and scale of the proposed dealing

• any likely impacts of the proposed dealing on human health and safety (cl 49(2)).

Before issuing a licence for the proposed dealing, the Regulator must prepare arisk assessment and a risk management plan. Although the Bill does not setspecific buffer zones around GM crops to protect organic or non-GM cropsgrowing nearby, it is suggested that the regulator could impose stringentconditions on a licence (eg to limit the geographical area used) for the release of aGMO to avoid the risk of contamination.22

4.5.3 Decision on Licence

The regulator must decide whether to issue a licence after the consultation process iscompleted (cl 55). Clause 30 makes it clear that that Regulator is not subject todirection in relation to individual decisions about the issue of a licence.

The Regulator is prohibited from issuing a license unless satisfied that:

• any risks posed by the proposed dealings can be managed to protect humanhealth and safety and the environment. The Regulator must take into account theresults of any relevant risk assessment or risk management plan, related publicsubmissions and specified Ministerial council policy guidelines (cl 56).

• the issue of the licence is not inconsistent with a relevant policy principle made bythe Ministerial council under cl 21 in relation to gene technology (cl 57(1)).

• the applicant is a suitable person to hold the licence (cl 57(2)). The mattersrelevant to deciding the suitability of a licence applicant (including a bodycorporate) encompass any relevant conviction,23 history of relevant licenceholdings and capacity to meet to meet any conditions attached to the licence (cl58).


23 A relevant conviction is a conviction for an offence against a law concerning human health andsafety or the environment which is committed in the period up to 10 years immediately prior tothe making of the application and is punishable by a minimum fine of $5 000 or minimum of 1 yearimprisonment: Gene Technology Bill 2001 (Qld), Schedule 3: “relevant conviction”.


4.5.4 Licence Conditions

A GMO licence is issued subject to conditions imposed under the Bill, prescribed byregulation or any conditions imposed by the Regulator (cl 61).

The types of licence conditions that may be made relate to:

• Conditions that may be prescribed or imposed (cl 62). Examples of theseconditions include the level of containment, waste disposal, measures to managerisks, research, auditing and reporting, actions to be taken if a GMO is releasedto the environment, geographic constraints, contingency planning for unintendedeffects of the authorised dealings, external monitoring and compliance with thecode of practice issued by the Ministerial council or technical or proceduralguidelines issued by the Regulator. Such conditions may also relate to GMproducts derived from a GMO for which particular dealings are licensed.

• Conditions about informing any person covered by the licence (eg an employee)of any relevant licence conditions and changes to the condition or the licence (cl63).

• Conditions about monitoring and audits to allow the regulator or an authorisedperson to enter premises where a person is authorised to deal with a GMO as acondition of the licence and make an audit of, and monitor, the dealing (cl 64).

• Conditions requiring the licence holder or a person covered by a licence to giveadditional information to the regulator if he or she becomes aware of any risksposed to human health or safety or the environment related to an authoriseddealing, any breaches of the licence or unintended effects of the authoriseddealings (cl 65). Such conditions impose a form of self-monitoring on the licenceholder and people covered under the licence. The licence holder is madeaccountable as he or she is taken to have become aware of the existence of thematters constituting reportable information if reckless as to whether suchadditional information existed.

4.5.5 Suspension, cancellation and variation of licences

The regulator may vary, suspend or cancel a GMO licence according to proceduresprovided in Part 5, Division 7 of the Bill. The regulator can suspend or cancel a licencewhere:

• the regulator reasonably believes that a licence condition has been breached, orthat a licence holder or person covered by the licence has committed an offenceunder the proposed Act

• the annual licence fee is unpaid

• the licence was improperly obtained


• the regulator becomes aware of risks associated with the continued dealingsauthorised by the licence which cannot be adequately managed by the licenceholder

• the licence holder is no longer a suitable person to hold the licence (cl 68).

A GMO licence may be transferred from a licence holder to a transferee. The regulatoris prohibited from transferring the licence unless satisfied that any risks posed by thedealings authorised by the licence will continue to be managed so as to protect humanhealth and safety and the environment and that the transferee is a suitable person to holdthe licence (cl 70).

The Regulator may vary a GMO licence to add, remove or change any conditions orchange the extent of the authority granted by the licence, if the regulator is satisfied thatany risks posed as a result of the changes are able to be managed so as to protect humanhealth and safety and the environment (cl 71). A licence for a contained dealing cannotbe varied to authorise dealings involving the intentional release of a GMO (cl 71(2)).

4.5.6 Transitional Arrangements

A dealing with a GMO approved by the GMAC under an advice to proceed before thecommencement of the Bill may proceed up to 1 June 2003. Unless the dealing is anotifiable low risk dealing, an exempt dealing or a dealing on the GMO Register, theadvice to proceed is taken to be a GMO licence (cl 190).

4.6 EXEMPTIONS TO THE LICENSING SYSTEM

Certain low risk dealings with GMOs are not subject to the licensing system. Suchdealings are those which are declared exempt, notifiable low risk dealings and dealings onthe GMO Register. Part 6 of the Bill regulates notifiable low risk dealings and dealingson the GMO Register.

The exclusion of these types of dealings from the licensing process acknowledges thatdifferent types of dealings with GMOs present varying levels of risk and that it isappropriate to exempt low risk dealings.24



4.6.1 Exempt dealings

Where the Regulator is satisfied that a certain dealing with a GMO involves a very lowrisk, the dealing will be recorded in the regulations as exempt (e.g. contained researchinvolving a very well understood process for creating and studying a GMO) (cl 32(d),Schedule 3: “exempt dealing”). In this case, no licence is required, provided that theactivity remains within the specified parameters. There will be no exemptions for anyrelease of a GMO into the environment (eg field trials and commercial releases). Thisreflects the former approach under the voluntary GMAC system.

4.6.2 Notifiable Low Risk Dealings

A notifiable low risk dealing may be declared by regulation where:

• the GMO is biologically contained so as to be unable to survive or reproducewithout human intervention

• the dealing with the GMO would be of very low risk to human health or safetyand to the environment

• minimal or no conditions would be needed to manage any such risk (cl 74).

The regulations may also prescribe that a notifiable low risk dealing is undertaken only incontained facilities, overseen by institutional biosafety committees and notified to theregulator (cl 75(2)). The Bill does not allow dealings that involve the intentional releaseof a GMO into the environment to be declared as a notifiable low risk dealing (cl 74 (2)).

4.6.3 The GMO Register

Section 76 of the Commonwealth Act establishes the GMO register. The GMO registeris a register of low risk dealings with GMOs that is maintained by the regulator anddescribes each dealing and its associated conditions (cl 77).

A dealing with a GMO may be entered on the GMO Register once it is licensed for acertain period of time or the GMO is a GM product (and is prescribed by regulation as aGMO) (cl 78, Schedule 3: definition of “genetically modified organism”,paragraph (c)). Dealings will not be entered onto the register until the regulator issatisfied that the dealings are sufficiently safe that they can be undertaken by anyone, andthat safety does not depend on oversight by a licence holder.


4.7 CERTIFICATION AND ACCREDITATION

Part 7 of the Bill establishes a system under which the regulator may certify facilities tostated containment levels under guidelines issued by the regulator. Part 7 alsoestablishes procedures for the accreditation of organisations under accreditationguidelines issued by the regulator. Certification of a facility to a specified containmentlevel or accreditation may be conditions imposed on the grant of a licence (clause 62) ormay be conditions imposed in the regulations for the conduct of notifiable low riskdealings (clause 75(2)).

4.8 ENFORCEMENT AND MONITORING

The Bill adopts a number of measures to enforce compliance with the regulatory schemesuch as the variation, cancellation or suspension of a GMO licence, directions,injunctions, criminal sanctions and penalties, and monitoring. The variation, cancellationor suspension of a GMO licence is discussed in section 4.5.5 of this Brief.

4.8.1 Directions

Where the regulator reasonably believes that a licence holder or person covered under alicence is not complying with the Act and a direction is reasonably necessary to protecthuman health and safety or the environment, the regulator is empowered to direct thatperson to take reasonable steps to comply with the Act and regulations (cl 146). Thisprovision enables a “clean-up” or remediation to be undertaken, either by the regulator orat the direction of the regulator.25 Any costs incurred by the Regulator may be recovered(cl 146(4), (5)). There is no monetary limit on the amount of costs that may berecovered or the Regulator’s ability to take recovery action.

A significant monetary penalty is imposed under the Bill for failure to take the requiredsteps within the specified time.

4.8.2 Injunctions

The Regulator, or any other aggrieved person, may apply to the Supreme Court for aninjunction to restrain a person from engaging in conduct that is, or may, be an offenceagainst the proposed Act or regulations. An injunction may also require a person to do



something where the failure or refusal to do the thing is an offence against the Act (cl147).

4.8.3 Forfeiture

If a court convicts a person of an offence against the Act or regulations, the court mayorder the forfeiture to the State of any thing used or otherwise involved in the commissionof the offence (cl 148).

4.8.4 Criminal Offences And Penalties

The Bill creates a number of offences that attract a range of penalties according to theseriousness of the offence. The penalties range from 73 penalty units ($5,475) in the caseof a less serious offence, while the most serious category of offence attracts a maximumof 5 years’ imprisonment or 2933 penalty units ($219 975) for an individual or 14,665penalty units ($1,099,875) for a body corporate. 26

The Bill makes it an offence to:

• deal with a GMO without a licence unless the dealing is a notifiable low riskdealing, an exempt dealing as prescribed by regulation, or is included in the GMOregister (cls 32, 33).

• breach the conditions of a GMO licence (cls 34, 35).

The Bill takes a tiered approach in respect of the offences described in clauses 32 –35based on whether a person acts with full knowledge or is reckless27 as to whether or notthe dealing was prohibited (cls 32, 34); or, whether the fault of the person is notestablished (cls 33, 35). In the latter case, strict liability applies. This means that asmaller penalty may be applied in relation to a lesser offence (like a breach of more minorlicence conditions) without the need to establish the fault elements of the offence.28

26 s 181B(3) of the Penalties and Sentences Act 1992 (Qld) allows a court in specified

circumstances to impose a maximum fine on a body corporate of up to five times the maximumfine for an individual.

27 As the criminal law in Queensland is governed by the Criminal Code (Qld), the Queensland Billincludes a definition of “recklessness” based on that provided in the Criminal Code (Cth) toensure that prosecutions carried out in different jurisdictions are carried out in a consistentmanner: Gene Technology Bill 2001 (Qld), Explanatory Notes, p 8.



Clause 38 creates an “aggravated offence”: an offence that causes significant damage,or is likely to cause significant damage, to human health and safety or to the environment.This concept was included in the Bill to recognise that some offences are more seriousthan others and that where significant consequences may flow from a particular action thata higher penalty is justified.29 An aggravated offence encompasses a mental element ofknowledge or recklessness on the part of the offender (cl 38(2)).

• breaching a relevant condition on the GMO register (cl 36)

• breaching a prescribed regulation about a notifiable low risk dealing (cl 37).

The Bill also prohibits a person from:

• Submitting false or misleading information or material on an application made tothe regulator under the Bill (cl 192)

• Interfering with dealings with GMOs (including damage or interference to thepremises at which the dealings with GMOs are undertaken or removal of a thingfrom the site) (cl 192A). This clause protects the property rights of peopleauthorised to deal with GMOs.

4.8.5 Monitoring

Part 11 of the Act empowers the regulator to appoint Commonwealth or State publicservants or Commonwealth appointees as inspectors to monitor compliance with the Act(cl 150). The inspectors may enter any premises to exercise a broad range of“monitoring powers”(cl 153). The premises may be entered with the owner’s consent,under a monitoring warrant issued under cl 172, or by right if the premises is listed as alicence-holder’s place of business under a GMO licence and is open or required to beopen for inspection as a condition of the licence (cl 152).

If an inspector reasonably suspects that there may be evidential material on any premises,the inspector is entitled to use a range of “offence-related” powers to enter the premisesand gather evidence of the commission of an offence against the proposed Act. Entry tothe premises must be with the consent of the owner or under an offence-related warrantissued under cl 173. Evidential material may only be seized if the entry is made undersuch a warrant. (cl 154).

In dangerous situations, an inspector may exercise a range of “emergency powers” totake immediate action. These powers (such as the power to enter premises without awarrant or the consent of the owner and the power to require a person to take steps to

29 Gene Technology Bill 2001 (Qld), Schedule 3: “recklessness”; Gene Technology Bill 2001 (Qld),

Explanatory Notes, p 16.


remedy a breach of the Act) can only be used to deal with suspected breaches of the Acton any premises where necessary to avoid an imminent risk of death, serious illness,serious injury or to protect the environment (cl 158).

The Bill also provides that it is a condition of a licence to deal with a GMO that a licenceholder inform the Regulator if the licence holder becomes aware of any additionalinformation as to any risks to human health and safety or the environment associated withdealings under the licence, any contraventions of the licence or any unintended effects ofthe dealings under the licence. A person covered by a licence may also inform theRegulator of similar matters (cls 65, 66).

4.9 CONFIDENTIAL COMMERCIAL INFORMATION

Public consultation related to the development of the Commonwealth Act identifiedconflicting views on the handling of commercially sensitive information about GMOs (egthe development of new gene technologies) provided under the legislation.30 The issuesraised related to the desirability of transparent assessment procedures in the regulatoryregime and the balancing of the public interest in knowing about dealings with GMOsagainst the proprietary interests of the developers of the gene technology to protect theirproperty in the technology in a competitive market place.

Part 12, Division 3 of the Bill relates to confidential commercial information.

On application, the regulator must declare that specified information is confidentialcommercial information for the purposes of the Bill (cl 184). A broad range ofinformation in applications in new gene technology could fall into this category.

The regulator is obliged to make the declaration if the information is a trade secret,information that has a commercial or other value that may reasonably expected to bedestroyed or diminished by disclosure; or information about the commercial or financialaffairs of a person, organisation or undertaking which if disclosed could unreasonablyaffect that person, organisation or undertaking (cl 185(1)).

The regulator may refuse to make the declaration if the public interest in disclosureoutweighs the prejudice the disclosure would cause to any person (cl 185(2)). In thiscase, the information must be treated as confidential commercial information until anyreview rights are exhausted. The regulator must make public the location of all field trialsof GMOs unless satisfied that significant damage to human health and safety, theenvironment or property would be likely to occur if the location was disclosed. Where

30 Senate Community Affairs Committee, pp 59, 60.


the regulator decides not to disclose the location of a field trial, the location must be madepublic (cl 185(2A), (3A)).

It is an offence to disclose confidential commercial information unless it is done: in theperformance of functions under the gene technology legislation, with the consent of theapplicant for the declaration, or by court order (cl 187). The declaration may berevoked if the regulator is satisfied the information is no longer confidential commercialinformation or if the public interest in disclosure outweighs the prejudice disclosure wouldcause to any person (cl 186).

4.10 REVIEW OF DECISIONS

Decisions made under the Bill may be reviewed under the procedures provided in Part12, Division 2 of the Bill. There is a provision for internal review by the regulator of areviewable decision (other than a decision made by the regulator personally).Reviewable decisions are described in Schedule 1 of the Bill. A system of externalreview to the Administrative Affairs Tribunal is also available in relation to a reviewabledecision made by the regulator personally or as a result of an internal review of areviewable decision.

4.11 CONSEQUENTIAL AMENDMENT

Schedule 2 of the Bill amends the Agricultural and Veterinary Chemical(Queensland) Act 1994 (Qld) to impose a duty on the National Registration Authorityfor Agricultural and Veterinary Chemicals to consult with the regulator in relation to theassessment of GM agricultural or veterinary chemicals.

5 GENE TECHNOLOGY INTERGOVERNMENTAL AGREEMENT

The Gene Technology Agreement constitutes the third component of the nationalregulatory scheme. The Agreement was made to facilitate the introduction andmaintenance of the scheme.

The Agreement:

• describes the main components of the cooperative national scheme and commitsall participating governments to introduce substantially similar legislation

• describes the roles and responsibilities of each jurisdiction in the administrationand enforcement of the national scheme, including arrangements for thereimbursement of costs incurred by jurisdictions for services provided as part ofthe legislative scheme


• establishes the Gene Technology Ministerial council and sets out its membershipand functions31

• provides for the maintenance of a nationally consistent scheme over time, andincludes specific provisions as to the proposed amendment by any party of anylegislation that forms part of the scheme32

• provides for the review of the implementation and effectiveness of the nationalscheme within four years of the commencement of the Agreement and thereafterat intervals of no more than five years33

• provides mechanisms for the resolution of disputes arising between the partieswhich relate to the Agreement or associated matters34, the amendment orvariation to the Agreement and the withdrawal by any party from theAgreement.35

The Agreement came into effect on 10 September 2001 (when it was signed by the HonPeter Beattie MP, Premier of Queensland).

6 THE CODE OF ETHICAL PRACTICE FOR BIOTECHNOLOGY INQUEENSLAND

In June 2001, the Queensland Government released a Code of Ethical Practice forBiotechnology36 in Queensland to complement its legislative initiatives in thebiotechnology area. The Code, which is the first of its kind implemented in Australia,became effective on 1 September 2001.

The Code sets out a number of ethical principles to guide biotechnology research anddevelopment in all major sectors of the biotechnology industry in Queensland. Theprinciples in the Code include obligations on biotechnology organisations to:

• comply with all relevant State and Commonwealth legislation

31 Gene Technology Agreement, Part 3 (cls 13-25).

32 Gene Technology Agreement, Part 5 (cls 32 –36).

33 Gene Technology Agreement, cl 37.

34 Gene Technology Agreement, cl 4; Part 8 (cl 41).

35 Gene Technology Agreement, Part 7 (cls 39,40); Part 9 (cl 42).

36 Queensland. Department of Innovation and Information Technology, Code of Ethical Practicefor Biotechnology in Queensland: Advancement through Safe and Ethical Science, June 2001,p 3.


• practise integrity (the organisation must report accurately on the results ofresearch, including negative results, declare funding sources, and discloseconflicts of interest)

• co-operate with relevant authorities to ensure that biotechnology products arefully assessed for adverse impacts on human safety or the environment

• provide clear and honest information to consumers about their products

• ensure that genetically modified crops do not damage the environment

• minimise harm or suffering to animals where the use of animals is essential forbiotechnology research and product testing.

In addition, the principles in the Code prohibit:

• disclosure of the results of genetic tests to insurance companies and employerswithout the consent of the person tested

• conduct of so-called "germ line therapy" by altering the genes of human sperm oreggs (or using other techniques) to pass on inheritable characteristics to futuregenerations

• cloning or attempting to clone whole human beings, although the Code allows"therapeutic" cloning of genes and cells for tissue regeneration

• "xenotransplantation" of animal organs into humans if to do so would carryunacceptable risks from animal retroviruses, and

• pre-natal diagnosis and genetic screening for non-medical reasons; i.e. parentswould not be permitted to use biotechnology to choose or engineer physicalcharacteristics in their offspring (height, colour of hair, choice of sex etc) unlessthe procedure is done for sound medical reasons.

The Queensland Cabinet has stipulated that the Code applies to:

• All Queensland Government agencies, research centres, laboratories and publichospitals that conduct biotechnology activities

• All private sector companies, academic institutions and research bodies thatreceive funding from the Queensland Government to undertake biotechnologyactivities


• All cooperative research centres that receive funding from the QueenslandGovernment to undertake biotechnology activities or which have the State as aparticipating member.37

Non-adherence to the Code by any such organisation could result in the suspension ofstate funding and a review of funding arrangements. Additionally, statutory penalties mayalso apply if the conduct is not in compliance with the relevant legislation (eg the GeneTechnology Bill, future legislation about the cloning of humans and the food labellingstandards).

Other companies and research institutions that undertake biotechnology activities are alsoexpected to subscribe to the Code as a demonstration of their commitment to ethicalpractice. These organisations, together with the organisations bound by the Code underCabinet direction, are identified in a Public Register administered by the Department ofInnovation and Information Technology. These organisations will be subject to statutorypenalties under the relevant legislation whether or not they subscribe to the Code.

The Code also incorporates guidelines for the management of potential conflicts ofinterest that may affect biotechnology researchers and organisations such as conflictsbetween the commercial and research objectives of a project.

37 Queensland, Department of Innovation and Information Economy, ‘Code of Ethical Practice for

Biotechnology in Queensland’, downloaded athttp://www.iie.qld.gov.au/biotechnology/bioregulation/coe.html on 12 September 2001.

RECENT PARLIAMENTARY LIBRARY RESEARCH PUBLICATIONS 2001RESEARCH BRIEFS

RBR 2001/26 Environmental Protection Legislation Amendment Bill (No. 2) 2001: EncouragingRecycling and Waste Minimisation Practices to Extend the Life of Landfill Sties

Oct 2001

RBR 2001/25 The Health Legislation Amendment Bill 2001 and the amendments to the MentalHealth Act 2000

Oct 2001

RBR 2001/24 ‘Paddock to the Plate’(Part 2) - Amendment of the Food Act 1981 (Qld) by theHealth Legislation Amendment Bill 2001 (Qld).

Oct 2001

RBR 2001/23 Duty and the Beast: Animal Care and Protection Bill 2001 Sep 2001

RBR 2001/22 Government Funding for Non-State Schools: the Education (Accreditation of Non-State Schools) Bill 2001

Sep 2001

RBR 2001/21 Accreditation of Non-State Schools: the Education (Accreditation of Non-StateSchools) Bill 2001

Sep 2001

RBR 2001/20 Penalties and Sentences (Non-Contact Orders) Amendment Bill 2001 Sep 2001

RBR 19/01 Current and prospective treatments for heroin dependence in the light of a recentnational evaluation (the NEPOD Report)

Aug 2001

RBR 18/01 Community Benefits Associated with the Gaming Machine Industry: The GamingMachine Amendment Bill 2001

July 2001

RBR 17/01 The Emergence of Community Style Banking as a Response to the Closing of BankBranches

June 2001

RBR 16/01 High Court Abolishes Negligence Immunity for Highway Authorities June 2001

RBR 15/01 Greenhouse Gases Emission Abatement and Carbon Credits – Australia’s Responseand the Queensland Forestry and Land Title Amendment Bill

June 2001

RBR 14/01 Regulating Pay Day Lending: The Consumer Credit(Queensland) Amendment Bill200

June 2001

RBR 13/01 The Allocation of Parliamentary Seats for Indigenous Minority Groups June 2001

RBR 12/01 Employees and the Internet – Issues for Public and Private Sector Employers June 2001

RBR 11/01 Valuers Registration Amendment Bill 2001 May 2001

RBR 10/01 The New South Wales-Queensland Border Rivers Amendment Bill 2001 May 2001

RBR 9/01 The Dating Game: The Introduction Agents Bill 2001 (Qld) May 2001

RBR 8/01 Dangerous Goods Safety Management Bill 2001: Implementing the NationalApproach to the Handling of Dangerous Goods

May 2001

RBR 7/01 The Future of the Kyoto Protocol: The Lead Up to the Resumed Climate ChangeTalks in Bonn in July 2001

May 2001

RBR 6/01 The Status of Children Amendment Bill 2001 April 2001

RBR 5/01 The Crimes at Sea Bill 2001: National Legislation for Crimes in Australian Waters April 2001

RBR 4/01 Innovation Strategies of the Queensland and Commonwealth Governments Mar 2001

RBR 3/01 Drug Courts Mar 2001

RBR 2/01 E-Democracy and Election Campaigns: Recent Case Studies from USA andDevelopments in Australia

Feb 2001

RBR 1/01 E-Voting: Elections via the Internet? Feb 2001

RESEARCH BULLETINS

RB 4/01 Violence in the Mass Media: Are There Negative Consequences? Jun 2001

RB 3/01 Towards improved Public Health: The Tobacco and Other smoking Products(Prevention of Supply to Children) Amendment Bill 2001

April 2001

RB 2/01 Towards the ‘Smart State’: The Electronic Transactions (Queensland) Bill April 2001

RB 1/01 Laws against inciting Racial or Religious Vilification in Queensland and Australia: theAnti-Discrimination Amendment Bill 2001

Mar 2001

A complete listing of research papers is available at the following site: http://www. parliament. qld. gov. au/parlib/research/index. htmParliamentary Library - Research Publications & Resources Telephone (07) 3406 7108Orders may be sent to Maureen McClarty, Maureen. McClarty@parliament. qld. gov. au

Research Papers are available as PDF files:• to members of the general public abstracts are available on the parliamentary web site, URL,

http://www. parliament. qld. gov. au• http://www. parliament. qld. gov. au/Library/Query. exe – ResearchPubs -Library

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