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2000
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
GENE TECHNOLOGY BILL
2000
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and
Aged Care,
the Hon. Michael Wooldridge, MP)
ISBN: 0642 438692
This Bill represents a major component of a national scheme established
by Commonwealth, State and Territory legislation to protect the public health
and safety of people and to protect the environment from risks associated with
gene technology. The scheme will operate by identifying and assessing risks
posed by, or as a result of, gene technology, and by managing any risks through
the regulation of certain dealings with genetically modified organisms
(GMOs).
The object of the Bill is to be achieved through a regulatory
framework which:
(a) provides an efficient and effective system for the
application of gene technology; and
(b) operates in conjunction with other
Commonwealth and State regulatory schemes relevant to GMOs and genetically
modified products (GM products) such as the existing schemes for the regulation
of food, therapeutic goods, agricultural and veterinary chemicals and
industrial chemicals.
Consistent with its object, the
Bill:
(a) establishes a statutory officer, to be known as the Gene Technology
Regulator (the Regulator), for the purposes of performing functions and
exercising powers under the Bill;
(b) establishes three key Committees (the
Gene Technology Technical Advisory Committee, the Gene Technology Ethics
Committee and the Gene Technology Community Consultative Group) to provide
scientific, ethical and policy advice respectively to the Regulator and/or the
Ministerial Council established under an Intergovernmental Agreement on Gene
Technology;
(c) prohibits persons from dealing with GMOs unless the dealing
with the GMO is:
(i) exempt;
(ii) a notifiable low risk dealing;
(iii) on the Register of GMOs; or
(iv) licensed by the
Regulator.
(d) establishes a scheme for the assessment of risks to human
health and the environment associated with various dealings with GMOs which
includes opportunities for extensive public input; and
(e) provides for a
centralised, publicly available database of all GMOs and GM products approved in
Australia (the Record of GMOs and GM product approvals).
In the 1999 Budget, the Federal Government committed $7.6 million over 2
years for the
development of the gene technology legislation and the
establishment of the Regulator. Once the Regulator is established, it is
intended that the costs incurred by the Regulator as a result of fulfilling
his/her functions under the legislation be 100% cost recovered from the users of
the regulatory regime (for example, those seeking a license under this Bill).
The fees and charges levied, in order to recover the costs of the regulatory
system, will be prescribed in regulations made under this Bill and the Gene
Technology (Licence Charges) Bill 2000. Regulations will be made following
an independent analysis of the costs associated with the legislative scheme,
extensive consultation with stakeholders and the preparation of a Regulation
Impact Statement detailing the costs, benefits and impacts of the proposed
charges.
REGULATION IMPACT STATEMENT
In early 1999, the Commonwealth Government agreed
that:
§ a national regulatory system for the
control of GMOs and the use of gene technology be developed to replace the
existing administrative system;
§ the regulatory system would be managed by
an independent statutory office holder (the Gene Technology Regulator); and
§ the
Regulator would derive power from both Commonwealth and State and Territory
legislation.
Given past Government consideration of alternatives to a national regulatory system, (including through consideration of relevant RISs), this RIS focuses on the costs and benefits of each component of the proposed regulatory scheme, as reflected in the Gene Technology Bill 2000. Government also provided some direction on various components of the scheme and where such direction was provided this has been noted in this RIS.
This RIS provides a high level of qualitative analysis about the costs and
benefits of the proposed regulatory scheme. In the absence of much of the
detail of the regulatory scheme (to be addressed in regulations) it has not,
however, been possible to undertake a detailed quantitative costing of the
scheme.
The Interim Office of the Gene Technology Regulator (the IOGTR),
will be commissioning an independent analysis of the costs associated with the
Commonwealth component of the regulatory system. The study
will:
• provide a quantitative analysis of each of the components
of the regulatory system as set out in the Bill and the draft
regulations;
• include modelling of options for fees and charges to
recover costs; and
• include an analysis of the expected throughput of
the regulatory system in the first five years, to assist cost projections and
cost-recovery modeling.
The independent costings of the scheme, the options for cost recovery and the
proposed fees and charges (for inclusion in regulations made under the
legislation) will be subject to extensive consultation with governments,
industry and other stakeholders. This will occur before Government makes any
regulations prescribing fees and charges in relation to the scheme.
Regulations prescribing the fees and charges (made under the Gene Technology Bill 2000 and the Gene Technology (Licence Charges) Bill 2000) will be subject to a separate RIS.
Separate RISs will also accompany the Gene Technology (Consequential
Amendments) Bill 2000 and any Codes of Practice developed under the Gene
Technology Bill 2000. Each State and Territory will be responsible for the
production of a RIS in relation to the jurisdiction specific legislation to be
developed in support of the Commonwealth Bill.
Gene technology involves the modification of organisms by the direct
incorporation or deletion of one or more genes to introduce or alter a specific
characteristic or characteristics. Organisms created using gene technology
techniques are commonly referred to as “genetically modified organisms
(GMOs). GM products are things (other than a GMO) derived or produced from a
GMO.
There are a variety of applications of gene technology
including:
§ research, for example, basic
research in biology and medicine with micro-organisms and transgenic animals
(primarily mice at this point in time, however, sheep are also
used);
§ agricultural applications for
example, genetic modification of crops to incorporate pesticide resistance or
herbicide tolerance, or the slowing of the ripening process in fruit and flowers
by inhibiting the action of certain genes;
§ production of therapeutic goods for
example the modification of micro-organisms to produce therapeutic products such
as insulin;
§ bio-remediation for example, the
use of micro-organisms to decompose toxic substances and clean-up industrial
sites or environmental accidents; and
§ industrial uses for example, the
production of enzymes for use in paper pulp production.
A range of sectors currently utilise gene technology in
Australia:
(1) for research and development purposes:
§ Universities and other public research
institutes; and
§ State and Commonwealth agencies (such as
CSIRO and State government agriculture departments).
(2) for commercial
purposes:
§ Industry including biotechnology
companies, pharmaceutical companies and agricultural companies;
and
§ Primary Producers, currently for
agricultural cropping, but potentially in relation to commercial stock ventures
also. For example, in 1991 a company developed a pig with superior commercial
qualities, in particular more rapid growth to sale weight and better meat
characteristics.
Proponents of gene technology identify a range of benefits to be derived
from the various applications of gene technologies in relation to agriculture,
health and the environment.
Proponents of gene technology believe that gene technology advances in
primary production will allow Australia to maintain or improve existing
production efficiency and thus maintain Australia’s share of world
markets, through:
§ increased productivity and yield leading
to reduced or stable prices for consumers;
§ more efficient use of agricultural and
veterinary chemicals;
§ savings in energy inputs to farm
production;
§ recovery of degraded land;
and
§ reduced chemical sprays, with less
exposure of farm workers.
While some of these benefits can be derived
from the application of other technologies, gene technology is more precise than
other conventional techniques (such as mutagenesis and some conventional cross
breeding) and produces results more quickly than can be achieved through, for
example, selective breeding. Gene technology therefore holds the potential to
realise benefits more quickly and cost effectively than other techniques.
Gene technology also produces changes to the characteristics of
agricultural products that are not possible through other techniques.
The Australian health sector is already utilising gene technology as a
diagnostic tool and for disease prevention and treatment as well as to conduct
research into the cause of disease.
Biopharmaceuticals already in use in
Australia, include cytokines, enzymes, hormones, monoclonal antibodies, blood
coagulation factors, and a Hepatitis B vaccine. These GM products have
advantages such as improved efficacy, greater availability, cheaper production,
reduced allergenicity and reduced risks of transmission of infectious
agents.
Biotechnology can also provide safer food. An example includes
the reduction of food contaminants, allergens and natural toxic compounds in
foods, minimising adverse health effects such as allergic reactions and food
poisoning.
Gene technology also promises benefits for the environment
including:
§ reduced use of chemicals/pesticides,
reduced ground water contamination, reclaiming of polluted or salt-affected
land;
§ increased agricultural productivity
reducing the need for land clearing, thus protecting
biodiversity;
§ production of biodegradable plastics and
biodiesel; and
§ bio-remediation.
The very characteristics of gene technology which produce many of the
benefits (such as the ability to introduce genes from one species into a
different species) are also those that cause concern in the community about the
unintended effects the use of the technology may have on the health of the
Australian community and the environment.
While the possible
“costs” of gene technology vary considerably between types of GMOs
and GM products, possible risks identified to date include:
§ increased health risks associated with
allergenicity in genetically modified foods;
§ possible unknown long term or
inter-generational consequences that may not be able to be adequately addressed
once the GMO is widely used;
§ risk to Australia’s capacity to
maintain diverse farming practices because of the impact of contamination to
traditional or organic crops through the use of genetically modified crops in
surrounding areas (that is, increased monoculture in farming practices);
§ the
impact of plants with disease resistance and herbicide tolerance on pest
management;
§ increased use of agricultural chemicals
associated with genetically modified herbicide tolerant crops resulting in
increased environmental damage;
§ possible increase in the ecological
competence of crop species and a resultant increase in the potential of those
crops to become weeds or pests;
§ the potential for GM animals, such as
pigs, containing a growth hormone gene to escape and become feral;
and
§ the
potential for the grazing behaviour of livestock containing a modified rumen
bacteria (designed to detoxify poisonous plants which the animals might graze)
changing the grazing behaviour of these animals such that they cause
environmental damage.
In addition, there are broader, non-scientific
concerns that have been expressed about the use of the technology including
ethical, social and moral concerns relating to the impact of ‘humans
playing God’ by using gene technology.
A range of GMOs and GM products are currently regulated in
Australia:
§ Foods (including genetically modified or
GM foods) are regulated under State and Territory Food Acts with the role of
developing food Standards resting with the Australia New Zealand Food Authority
(ANZFA) under the Australia New Zealand Food Authority Act 1991
(Cth).
§ Therapeutic goods (including genetically modified 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 (GTRAP).
§ 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 (NICNAS) under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) and accompanying State/Territory legislation.
§ Imports/exports are regulated under the Quarantine Act 1908 (Cth), the Imported Food Control Act 1992 (Cth) and the Export Control 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 AQIS. Other regulatory agencies also rely on the ACS to provide primary control of imports and exports.
The role of the Genetic Manipulation Advisory Committee
The
Genetic Manipulation Advisory Committee (GMAC) is a non-statutory expert
advisory body reporting to the Commonwealth Department of Health and Aged Care.
GMAC’s membership includes a wide range of experts in fields such as
molecular biology, ecology, plant genetics, agriculture and biosafety
engineering.
GMAC provides advice to the aforementioned regulators about the biosafety and environmental implications of GMOs. GMAC also receives advice and information from the other regulatory agencies and from Environment Australia.
In addition, since 1975, GMAC (and its predecessors, the Academy of Science Committee on Recombinant DNA and the Recombinant DNA Monitoring Committee) has scrutinised the development and use of novel genetic manipulation techniques in Australia.[1]
Each proposal (whether intended as a research and development project or for the commercial release of a GMO) is considered by GMAC on a case by case basis and judged on the individual merits of the application.
To February 2000, GMAC has assessed:
§ 5164 proposals for small scale contained work. Small scale genetic manipulation work is mostly directed at basic research in biology and medicine and is conducted within contained laboratories. Most small scale work is carried out by Universities and other research organisations.
§ 40 proposals for large scale contained work, such as the production of: hormones, growth factors and vaccines; enzymes for trials in patients with enzyme deficiencies; and enzymes for use in paper pulp production. Most large scale contained work is carried out by commercial organisations (38 of the proposals were from commercial organisations and 2 of the proposals were from Universities)
§ 236 proposals for field trials of GMOs. Most field trials have been for genetically modified plants, with the majority being for cotton or canola. The remainder were for micro-organisms such as bacteria, viruses and yeast. Most field trials are run by commercial companies (44%) or the CSIRO (37%). Of the remainder, 11% of the field trials have been conducted by Universities and 8% by State government agencies.
§ 8 applications for general (commercial) release of GMOs. Three of these have been approved to date: Bt 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).
What are the shortcomings of the current system of controls?
While GMAC has provided reliable scientific advice regarding any risks posed by the application of gene technology and how such risks should be managed, the major weaknesses of the existing system relate to the fact that as an administrative system there is: insufficient capacity for independent legally enforceable auditing and monitoring; insufficient capacity for the imposition of penalties or other action in the event of a breach; and inadequate transparency of decision making.
The problems with the current administrative system, and the necessity for the introduction of a legislative scheme at this time, are discussed in further detail in Section 2. Problems of this RIS.
Given the potential risks to the environment and to human health and
safety generated by the increased use of gene technology, State and Territory
and Commonwealth Governments have been working together for a number of years,
to identify options for improving the administrative system of controls over
gene technology in Australia. Options examined include:
§ retaining
a GMAC-style administrative system with some minor
adjustments;
§ implementing a co-regulatory approach
based on the observance of codes of practice and standards, developed
cooperatively between industry and government; and
§ the
implementation of a more comprehensive legislative system.
RISs were
developed for each of these options and in late 1998 and early 1999, the
Commonwealth Government (and a number of State and Territory Governments)
endorsed the development of a national regulatory system of controls over GMOs
and the use of gene technology. The national regulatory system was to comprise
both Commonwealth and State and Territory legislation.
Given past Government consideration of alternatives to a national regulatory system, (including consideration of relevant RISs), this RIS focuses on analysing the regulatory impact of the Commonwealth component of the national regulatory system: the Gene Technology Bill 2000.
The Bill forms a major part of a nationally consistent legislative scheme (relying on Commonwealth legislation and legislation in all States and Territories). The Bill is designed to protect the health and safety of people, and 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.
Key components of the Gene Technology Bill 2000 include provisions which:
(a) Provide for the legislation to form part of a national legislative scheme, complemented by consistent legislation in each jurisdiction;
(b) Define the scope of the legislation. The legislation applies to:
• all dealings with GMOs (live, viable organisms that have been modified by techniques of gene technology); and
• dealings with GM products that are not regulated by existing regulators.
(c) Establish the Gene Technology Regulator as an independent statutory office holder with responsibility for implementing the legislation;
(d) Establish three key advisory Committees. The Gene Technology Technical Advisory Committee, the Gene Technology Ethics Committee and the Gene Technology Community Consultative Group will, respectively, provide scientific, ethical and policy advice to the Regulator and/or the Ministerial Council (comprising Ministers from each State and Territory and the Commonwealth and established under an Intergovernmental Agreement on Gene Technology) in relation to GMOs;
(e) Prohibit persons from “dealing with”[2] GMOs unless the “dealing” is:
• exempt.
• a notifiable low risk dealing;
• licensed; or
• on the Register of GMOs.
The type of regulation applied in relation to each of the categories is based on an assessment of the risks posed by the proposed dealing with a GMO.
(f) Provide for the certification of facilities to certain containment levels and the accreditation of organisations assessed by the Regulator to have a properly constituted and maintained Institutional Biosafety Committee;
(g) Establish a publicly available database of all approvals of GMOs and GM products in Australia;
(h) Establish comprehensive auditing, monitoring, inspection and enforcement powers that can be adapted to individual circumstances on a case by case basis; and
(i) Provide that approvals granted by GMAC prior to the date the new
legislation takes effect will be recognised under the new regulatory system
until such time as the prior approval expires, or for a period of two years
after the date of effect of the legislation, whichever is sooner.
Each of
the components of the scheme are addressed in more detail in Part 4
– Options and Impact Analysis of this RIS.
Throughout the period of development of the new regulatory system for
GMOs, and particularly since May 1999, States, Territories and the Commonwealth
have recognised that it will not be possible to fully cost the regulatory system
until:
§ the Commonwealth Bill is agreed by the
Federal Government and the regulations under that Bill are
developed;
§ the model State legislation is drafted;
and
§ the
Intergovernmental Agreement on Gene Technology, which underpins the legislative
system and details the respective roles of the Commonwealth and States and
Territories in the scheme, is entered into.
As detailed in Part 1 - Background of this RIS, the IOGTR will
commission an independent analysis of the costs associated with the Commonwealth
component of the regulatory system. The study will be conducted in two stages,
over a period of seven months, with a real-time of approximately four
months:
Part 1 will:
§ be conducted in the period April - May
2000;
§ be
based on the Bill as agreed by the Federal Government and introduced into
Parliament, and the draft Regulations released for public comment in
April;
§ provide a quantitative analysis of each of
the components of the regulatory system as set out in the Bill and the draft
Regulations;
§ include initial modelling of options for
fees and charges to recover costs; and
§ include an analysis of the expected
throughput of the regulatory system in the first five years, to assist cost
projections and cost-recovery modelling.
Part 2 will:
§ be conducted in the period July - August
2000;
§ refine the quantitative costs of the
regulatory system, based on amendments to the Bill agreed by Parliament, and the
final regulations; and
§ include final modelling of options for
cost recovery, based on the analysis of expected throughput.
It is
anticipated that the final report will be delivered in September 2000, at which
time extensive consultation will be undertaken with governments, industry and
stakeholders, regarding the proposed costings and levying of fees and charges.
Regulations, including an accompanying RIS, will then be developed detailing the
fees and charges regime.
GMOs and GM products present a range of possible health and environmental
risks to the community. These risks vary depending on the particular activity
proposed to be undertaken and the particular GMO or GM product.
While
the level of knowledge about possible risks is growing in the community, there
remains inadequate information available to the community and consumers.
Individuals may also have difficulty in assessing and processing available
information to help them make informed choices about what levels of possible
risk they consider to be acceptable to their health and safety.
In
addition, there are possible risks to public health and the environment that may
not be properly taken into account by either the industry involved with GMOs or
GM products, or the consumers, or users of GMOs or GM products.
There
are difficulties in relying upon industry to provide the necessary information
and make appropriate risk assessment and management decisions. This is because,
in an objective aggregate sense, it may not be in their best interests to draw
the possibility of risk to the attention of prospective consumers and the
community generally. Equally, consumers might discount the usefulness of
industry provided information on that basis.
There is, therefore, a case
for government intervention to assess and manage the risks and to provide
information to consumers and the community.
Given the growth in gene
technology, the current government intervention is, however,
inadequate.
When established, the GMAC administrative system was designed
to deal with research into GMOs, or utilisation of GMOs, conducted within
contained facilities.
Currently in Australia, the application of gene
technology is quite different, as there has been an emergence of GMOs which do
not fall within the legislative mandate of existing regulators. Also, there is
an increasing shift from work being conducted in laboratories to GMOs being
released into the environment either for the purposes of field trials or for
commercial release.
The current system lacks credibility in meeting the
broad concerns of the community about the risks posed by not having in place,
sufficient mechanisms to ensure adequate openness and transparency in its risk
assessment and management roles, nor sufficient enforcement capabilities. This
lack of credibility (particularly in relation to the assessment and management
of GMOs for release into the environment) may also harm the ability of industry
to market GMOs and GM products assessed as safe. In addition, unnecessary costs
may be generated through less than optimal coordination between regulators in
the current system.
Activities with GMOs and GM products that are
currently unregulated
Examples of ‘gap’ GMOs which are
currently overseen by GMAC under administrative arrangements but which are not
regulated under any existing legislation
include:
§ the growing of GM agricultural
crops;
§ the
growing or breeding of GM animals or fish;
§ the use of GM micro-organisms designed to
decompose toxic substances (bio-remediation);
§ the use of GM viruses and GM
vaccines.[3]
In addition,
certain GM products (that is, things derived or produced from a GMO) also fall
outside the mandate of existing product regulators. For example, stockfeed
produced from genetically modified agricultural crops.
To date, GMAC has provided advice directly to proponents on these ‘gap’ GMOs. However, as a result of the administrative nature of the GMAC system, Governments have had limited capacity to either monitor proponent’s compliance with GMAC advice or to enforce compliance with that advice.
The objective of Government action is to protect the health and safety of
people and to protect the environment by identifying risks posed as a result of
gene technology and by managing those risks through regulating certain dealings
(or activities) with GMOs.
Against the Government’s broad goal,
and to address the shortfalls in the current regulatory arrangements, the
Government’s objectives are to:
§ pursue an efficient and cost effective
approach;
§ continue a science based approach to the
assessment of risks but including capacity for formal consideration of broader
issues such as ethics;
§ avoid unnecessary duplication with
existing regulators and provide for better coordination of the activities of all
regulators involved in the approval of GMOs and GM
products;
§ provide to industry a more streamlined and
certain pathway for seeking and gaining approval to deal with GMOs and GM
products that can be managed safely;
§ increase enforceability of the
arrangements for managing risk;
§ achieve greater transparency and
accountability; and
§ be more responsive to stakeholders and
community views.
This section sets out the various options for each of the key components
of the Gene Technology Bill 2000. As numerous components of the Bill
are examined, for ease of reference, an assessment of the impacts (including the
costs and benefits of each option) has also been included in this section.
In terms of the impacts of the Bill and the scheme it will support, the
groups most likely to be significantly affected by the initiative
are:
§ government – including Commonwealth,
State/Territory and local governments;
§ business - including large, medium and
small commercial enterprises, universities and researchers and users of gene
technology (including primary producers);
§ consumers;
and
§ community members.
a) National scheme legislation
Option 1 – A
co-operative nationally consistent regulatory scheme
It is anticipated
that the Gene Technology Bill 2000 will be complemented by consistent
legislation in each jurisdiction to form a national regulatory scheme. It is
also anticipated that an Intergovernmental Agreement on Gene Technology (IGA)
will be negotiated between the Commonwealth, State and Territory governments.
The IGA will provide for the establishment of the nationally consistent scheme,
the governance arrangements for the system and the arrangements for ensuring
national consistency of the various pieces of legislation over time. The effect
of the national scheme will be that there is one central national regulator
responsible for all the day-to-day aspects of the regulatory
scheme.
Option 2 - Discrete legislation in each
jurisdiction
Each jurisdiction could enact discrete legislation
regulating GMOs, effectively creating a gene technology regulatory body in each
State and Territory. To provide some degree of national consistency, for
example on the matter of standards, this could also be complemented by an IGA.
Option 3 – Commonwealth legislation
The Commonwealth
could rely on its broad constitutional powers to enact legislation to regulate
GMOs. While the Commonwealth could regulate all imports, activities by
corporations or individuals engaged in interstate trade and commerce, there
would be some ‘gaps’ in constitutional coverage. Those
‘gaps’ would include the dealings with GMOs by certain individuals,
State departments and Universities who were not involved in co-operative
arrangements with corporations, or in interstate trade and commerce. These
‘gaps’ would either remain unregulated or would be subject to
additional legislation enacted by States and Territories.
Impacts of
Option 1 - A co-operative nationally consistent regulatory scheme
On Government - The overall costs to Australian governments of
administering one centralised scheme are likely to be much lower than the costs
of administering discrete schemes in each jurisdiction as economies of scale can
be realised. The differences between jurisdictions (for example, unique flora
or fauna) can be taken into account in the decision-making processes of the
central Regulator to ensure that the unique environments in various Australian
regions are protected. The IGA, underpinning the legislative scheme, will
reduce the possibilities of inconsistent amendments being made to the
complementary legislation in each jurisdiction.
On Business
– A single national system will minimise costs to businesses that conduct
activities across a number of jurisdictions, as they will only need to
understand and comply with one set of rules, as opposed to different rules in
each jurisdiction. Costs to businesses that only operate within one
jurisdiction should also be reduced as the result of economies of scale being
realised through the central administration of the scheme.
On the
Community – Consistency of decision-making across Australia will
provide greater protection of public health and safety and the environment and
therefore lift public confidence regarding the use of gene technology in
Australia. During consultations on the draft legislation, community members
strongly supported a consistent national scheme. They considered it important
that one standard for risk assessment of public health and safety and the
environment be applied across Australia (taking into account any unique
conditions in each jurisdiction) and that different standards should not be
applied in different jurisdictions.
On Consumers - One of the
potential advantages of minimising structural costs (and having one centralised
national regulator) is to enable any cost-savings which may be generated through
centralised regulation of GMOs to be passed onto consumers as lower prices.
Impacts of Option 2 - Discrete legislation in each
jurisdiction
On Government - Overall costs would be higher as
each jurisdiction would need to establish a regulatory agency. This would allow
Governments in each jurisdiction to establish the level of protection demanded
by their industry and constituents. This would be unlikely to be uniform and
could easily mean that some GMOs considered safe for release in certain
jurisdictions would not be considered safe in others. These impacts could,
however, be reduced if Governments agreed to implement an IGA to underpin the
legislation enacted in each jurisdiction and provide for some level of national
consistency.
On Business - Significant costs and time delays would
be incurred with business having to comply with differing requirements (for
example, for data packages) and assessment processes in each jurisdiction.
Different requirements in each jurisdiction could also lead to “forum
shopping” by businesses who may seek to gain approval for GMOs in the
jurisdiction with minimal (or least costly) regulatory requirements. As
detailed above an IGA could mitigate some of these effects.
Impact of
mutual recognition legislation - If an exemption for GMOs and GM products
was made under mutual recognition legislation, the impact on businesses would be
significant as approvals to sell GMOs or GM products would be needed in each
jurisdiction. Costs would also be increased for supermarkets and businesses in
the distribution chain, as a result of some products being allowed to be sold in
certain States and not in others.
There could also be some labour force
restrictions whereby a company or individual’s licence to undertake
dealings may not be transferable between jurisdictions. If the mutual
recognition legislation operated in respect of GMOs and GM products, (enabling
the sale of GMOs or GM products throughout Australia and the recognition of
licences throughout Australia) the impact on business would be minimal. Given
the commitment of jurisdictions to a national scheme at this time, it is not
possible to project whether an exemption would be sought under mutual
recognition legislation should this option be adopted.
On the
Community - There would be no assurance of consistency of decision making
across Australia. This could undermine the community’s confidence in the
quality of government regulation.
On Consumers - Aside from any
increased costs which industry may pass on to consumers, the impact on consumers
would depend on the operation of mutual recognition legislation. As detailed
above, if an exemption for GMOs and GM products was made under mutual
recognition legislation, the impact on consumers could be significant with
products being available in some jurisdictions and not others.
Impacts of Option 3 – Commonwealth legislation
On
Governments - If this approach is adopted, it would still be necessary for
each State and Territory to introduce legislation to ensure complete coverage of
all dealings with GMOs. This is because the Commonwealth does not have
comprehensive constitutional coverage in respect of GMOs. As such the impacts
detailed at Option 2 would also apply to this option.
On Business -
If States and Territories did not legislate to fill the ‘gaps’
in the Commonwealth coverage of dealings with GMOs, there would be potential for
an ‘uneven playing field’ to emerge as certain enterprises and
research institutes would be caught by the Commonwealth legislation, while
others might escape regulatory oversight entirely. Some businesses would thus
continue to reach acceptable standards while others would not be regulated.
Over time, this could produce distorted business practices and also endanger
both the community and the environment as well as the good reputation of
businesses involved in GM research and commercial activities. If States and
Territories legislate to fill the ‘gaps’ in Commonwealth coverage of
dealings with GMOs, the same impacts on business that are identified at Option 2
would also apply to this option.
On the Community - Community
confidence in the regulatory system could be reduced, given the
‘gaps’ in coverage of the legislation. Refer to the impacts on the
community in relation to Option 2, if States and Territories legislated to fill
the ‘gaps’ in Commonwealth coverage.
On Consumers -
Refer to the impacts on consumers in relation to Option
2.
Conclusion and recommended option:
The Bill reflects a
preference for Option 1. The advantages over other options are that this
Option:
§ increases national consistency of
regulation;
§ provides a more streamlined and certain
pathway for businesses seeking approval for dealings with
GMOs;
§ minimises the costs of compliance to
government and business that operate in more than one jurisdiction;
§ minimises
inefficiencies and distortions in the market place as the result of differing
levels of regulation in different jurisdictions; and
§ minimises
discrepancies between jurisdictions and potential gaps or loopholes in
legislative coverage that could further undermine community confidence in the
safe management of GMOs.
b) Scope of the Act including interface with
existing regulators
Option 1 - the Bill operates as a
‘gap filler’ regulating all dealings with live, viable GMOs and also
GM products not regulated by existing regulators.
The proposed Bill
regulates all “dealings” (including research, manufacture,
production, propagation, commercial release and import) with live viable GMOs
that have been modified by techniques of gene technology, including the progeny
(or descendants) of such GMOs which also share a genetically modified trait.
This recognises that at present most of the “gaps” in legislative
oversight exist in relation to dealings with live viable
organisms[4]. Examples include
laboratory research involving the genetic modification of animals, plants,
bacteria and viruses and the growing of crops, animals and fish.
The
legislation will also regulate GM products (non-live or non-viable products)
where they are not regulated by an existing regulatory scheme. This recognises
that most GM products are regulated by existing regulatory agencies (for
example, GM medicines, foods and chemicals) but that there may be some products
that are not currently regulated (for example, stock feed).
Option 2
- The Bill creating a ‘super-regulator’ or ‘one stop
shop’
Under this approach, the legislation would establish a
‘one stop shop’ for the regulation of GMOs and GM products. All
GMOs and GM products would be comprehensively regulated by a single agency
regardless of whether the GMOs or GM products were also therapeutic goods,
foods, agricultural and veterinary chemicals or industrial
chemicals.
Impacts of Option 1 - the Bill as a ‘gap
filler’
On Government - This option recognises the roles of
each of the existing regulators and the desirability of assessing GM products
along with their non-GM counterparts under the relevant regulatory framework .
For example, GM therapeutic goods are most appropriately assessed for safety,
quality and efficacy under the therapeutic goods scheme, with advice on the
genetic safety of the medicine being provided by the Regulator.
The
Regulator will act as a centralised area of expertise on genetic safety and will
make advice available to other regulators of GM products. This reduces costs to
government by eliminating the need for each regulatory agency to establish a
centre of expertise on gene technology. There will, however, be some cost to
government as a result of the need for the regulatory agencies to work closely
together to harmonise requirements in relation to the assessment of risks posed
by gene technology.
On Businesses - In some cases, businesses will
require approval from a number of regulators in order to market a GM product.
For example, GM crops will be regulated as they are growing in the field by the
Regulator and also by ANZFA if they are intended to enter the food chain.
Additional costs could be incurred by industry if data requirements and
assessment of genetic safety is not harmonised between the Regulator and
existing regulators. A number of mechanisms have been utilised in this Bill and
the Gene Technology (Consequential Amendments) Bill
2000[5] to create a system that is
as seamless as possible, thereby minimising compliance costs to industry. For
example, the legislation requires:
§ exchange of information between
regulators;
§ the Regulator to hold a centralised
database of all approvals for GMOs and GM products; and
§ the
Regulator to work with other agencies to harmonise data requirements, assessment
and standards in relation to risks posed by gene technology.
The
legislation also enables pre-approval conferencing between the proponent and
relevant regulators to improve understanding of the regulatory requirements and
reduce duplication of effort.
On the Community and Consumers -
This option ensures that all aspects of production, manufacture, sale etc of
GMOs and GM products are regulated and that there are no ‘gaps’ in
regulatory coverage. The system also ensures that the Regulator either directly
regulates, or provides advice to other regulators, on all GMOs and GM products.
Furthermore, the Regulator will establish a comprehensive database of all GMOs
and GM products. During consultations, community members expressed the
importance of a comprehensive regulatory system being able to provide a high
level of re-assurance to the community, that any risks posed by the use of gene
technology are properly assessed.
Impacts of Option 2 - The
creation of a ‘super-regulator’ or ‘one stop shop’ for
the approval of all GMOs and GM products.
On Government - The
establishment of a ‘super-regulator’ would require significant time
and resources to reform all of the existing national regulatory schemes. This
is not a simple process as each of the schemes depends on legislation at the
Commonwealth level and in States and Territories. In addition, the skills which
already exist within the TGA, ANZFA, NRA, NICNAS and AQIS would need to be
duplicated, at least to some extent, in the new ‘super-regulator’
for GMOs. The uncertainty associated with wholesale changes, may also generate
unforeseen costs as the result of de-stabilising the operations of the existing
regulators.
On Business - The benefits of the
‘super-regulator’ would lie primarily in the more streamlined
approach to GMOs and GM products under which an approval would only be required
from one regulator. This would deliver some benefits by reducing the time taken
to assess at least some GMO applications and data packages. The disadvantage
would be that GM products would be assessed entirely separately from their
non-GM counterparts even when the effect of the genetic modification was
minimal. This could lead to significant discrepancies in the costs of
compliance (and hence, costs of marketing) between GM products and their non-GM
counterparts. Complete reform of existing systems and the establishment of a
‘super-regulator’ would also take considerable time, meaning that
the existing administrative processes would remain in place for considerably
longer period of time.
On the Community - A
‘super-regulator’ may provide more transparency and certainty for
community members who have serious concerns regarding gene technology.
Community concerns and input about the impacts of GMOs on human health and
safety and the environment could have maximum effect as they would be focused
into a single system.
On Consumers - As a result of the differing
regulatory treatment of GM products and their non-GM counterparts, there may be
distortions in the market place manifested in inconsistent pricing of like
products.
Conclusion and recommended option:
The Bill
reflects a preference for Option 1. The advantages of this option are that it:
§ recognises the role of existing regulators
and ensures that any live and viable GMOs are directly regulated by the
Regulator and that any GM products that are not regulated by existing agencies
are regulated by the Regulator;
§ ensures that like products are treated in
a similar way (reducing market distortions) while also ensuring that any risks
posed by gene technology are considered in all
cases;
§ minimises duplication by implementing
strategies to improve the interface between regulators;
and
§ can be
implemented without delay.
c) Management of the gene technology
scheme
In early 1999, the Federal Government considered a number of
alternatives relating to the management of the scheme including the
establishment of a statutory office holder, a statutory board or ongoing
management of the scheme by GMAC. A RIS was prepared on these issues for
consideration by Government.
On the basis of the information available,
including the RIS, Government endorsed the establishment of a statutory office
holder. It was considered that a statutory office holder who reported directly
to Parliament, is the final decision maker on individual applications, is
responsible for a discrete fund of monies and is responsible for regular public
reporting, would:
§ provide a
high level of independence, transparency and accountability;
and
§ not
incur the level of costs associated with a statutory board flowing from the need
to frequently bring together a group of officials to make decisions and delays
resulting from the greater potential for disagreements on matters of everyday
administration.
As a government decision has already been taken on this
issue, the impacts of alternative options are not explored in detail in this
RIS.
d) Provision of expert advice to the Regulator to inform
decision-making
Option 1 – The establishment of a Gene
Technology Technical Advisory Committee, a Gene Technology Community
Consultative Group and a Gene Technology Ethics Committee to provide expert
advice to the Regulator and the Ministerial Council overseeing the national
legislative scheme.
Option 2 – The Regulator seeks expert
and community advice on an ad hoc basis through, for example, forums rather than
through the establishment of statutory committees.
Impacts of Option 1
- Establishment of a range of expert Committees
On Government -
Significant resources, including a well-staffed secretariat, will be
required to establish and service the Committees. The major advantage of the
expert Committee structure is that it would enable the Regulator to access
necessary advice to inform decision-making and the development of policy to
underpin the regulatory system. This improves the rigour, transparency and
accountability of the system and ensures that it remains fully cognisant of
community views and the latest scientific developments.
On Business -
As the system is proposed to be cost-recovered from the users of the system
(applicants and licence holders), industry will bear the costs of establishment
and operation of the Committees. It is, however, anticipated that increased
consumer and community confidence in the regulatory system as a result of the
involvement of Committees in the assessment of applications and development of
policy, will translate into greater acceptance of GMOs and GM products in the
market place.
On the Community - The community and consumers have an opportunity for
input into the regulatory system at both a policy level (through the Gene
Technology Community Consultative Group) and on a case by case basis through the
proposed assessment process (please refer below). This affords a level of
transparency and accountability.
On Consumers - It is possible
that increased costs incurred by business as a result of funding the operation
of the Committees may be passed on to consumers through increased product
prices.
On Government - This option would reduce the resource implications
associated with establishment and management of the Committees. However, in
making his or her decisions the Regulator would not be able to rely upon the
timely input of scientists who were experts in the required fields. Nor would
the Ministerial Council have ongoing access to community views about gene
technology to inform the development of policy.
On Business -
This option would be cheaper to administer, with associated benefits for
industry from a cost-recovery perspective.
On the Community and
Consumers - This would reduce the transparency in the system as it would not
be clear exactly who the Regulator might seek advice from on any given
application or issue. There would also be no assured opportunity for community
input into policy making. Community members, some of whom are already concerned
about the relationship between Government and business in this area, may become
more cynical. This would potentially have a dramatic impact on the credibility
of the regulatory system over time. This in turn may effect the willingness of
business to market GMOs and GM products reducing consumer
choice.
Conclusion and recommended option:
The Bill
reflects a preference for Option 1. Although probably more costly than ad hoc
sources of advice, the establishment of expert committees in the legislation
will deliver a range of benefits including higher quality and more transparent
decision-making. Mechanisms have been included in the legislation to ensure the
costs of establishing and maintaining the Committees will not “blow
out” including, requirements that the Committees provide advice at the
request of the Ministerial Council or the Regulator. This ensures that the work
of the Committees can be prioritised and that unnecessary expenses are not
incurred.
e) The regulation of dealings with GMOs
Option
1 – A system utilising a range of regulatory tools (including
licensing) commensurate with the risk posed by certain dealings with GMOs.
The Bill proposes that all dealings with GMOs will be prohibited unless
the dealing with the GMO is:
§ exempt from the requirements of the
legislation (on the basis of the negligible risk posed by the dealing with the
GMO. Exemptions will be prescribed in
regulations);
§ a notifiable low risk dealing (on the
basis that the work is to occur within a contained facility and does not present
any significant risks. Notifiable low risk dealings will be prescribed in
regulations and will rely on self-assessment by researchers with the assistance
of IBCs. The Regulator will, however, provide independent oversight of
assessments);
§ licensed (either as dealings involving, or
not involving, release into the environment); or
§ entered on the Register of GMOs (following
a period of licensing, monitoring of any risks and a determination that the GMO
no longer requires licensing based on the ability to successfully manage minimal
risk posed by the dealings with the GMO).
This system
recognises:
§ that different types of dealings with GMOs
present varying levels of risk, and that different levels of assessment and
regulatory oversight are appropriate in relation to each. Similarly, varying
levels of community involvement and statutory timeframes for assessment will be
detailed in the Bill and the regulations, based on the level of risk of the
proposed dealings; and
§ that any risks to public health and safety
and the environment which may be associated with dealings with GMOs should be
identified through a transparent process before those dealings are
undertaken.
Option 2 – Status quo: Assessment based on the
current GMAC model.
Option 3 – Regulation focusing on
post-market monitoring and exclusion rather than pre-market
regulation
Impacts of Option 1 - A system utilising a range of
regulatory tools based on the level of risk posed by the proposed dealing with
the GMO.
On Government - A licensing system is relatively
resource-intensive to establish and maintain. However, Government resources
will be directed towards higher risk activities (for example, any application
involving an intentional release into the environment). A self-assessment and
notification scheme is adopted in relation to low risk contained research
activities (notifiable low risk dealings – as described above). This
reduces resources expended by Government in relation to low risk activities.
Various types of GMOs could move between categories over time, as better
information becomes available about exactly what risks are posed by certain
GMOs.
On Business - The proposed system reflects a sliding
scale of regulatory oversight based on risk. Thus, paperwork burden and
compliance will be kept to a minimum for low-risk activities. Higher risk
activities will, however, incur additional costs, commensurate with the level of
risk posed by the dealing. Such costs will be in excess of the costs currently
incurred by industry in relation to the assessment of higher risk activities by
GMAC (under administrative arrangements). Statutory data requirements, costs of
applying for a licence and timeframes for assessment will be detailed in
regulations made under the Bill providing a high level of statutory certainty
for industry. Such regulations will be subject to extensive consultation and a
further RIS.
On the Community - This is expected to engender a
high level of community confidence that risks associated with a GMO will be
identified and appropriately regulated by the Regulator. There will be extensive
opportunity for community involvement in ‘higher risk’ applications
involving the release of GMOs into the environment. Costs, in particular in
terms of time, will be incurred by community members who wish to contribute to
the Regulator’s assessment of proposals involving release of a GMO into
the environment. The community can be confident that GMOs cannot be trialled in
the field or released into the environment without a thorough assessment by the
Regulator.
On the Consumer - Comprehensive regulatory oversight
of GMOs will reassure consumers that any products available in the market place
have been assessed as safe. This may increase consumer acceptance of such
products and lead to an increased variety of goods bought to market by industry.
Costs carried by industry in relation to the preparation of a comprehensive
application for a licence to deal with a GMO, as well as the Regulator’s
costs of assessment, may be passed on to consumers as increased costs of GMOs
and GM products which proceed to market.
Impacts of Option 2
– Assessment based on the current GMAC model
On Government -
This approach would incur minimal costs to government as it would utilise
the existing GMAC processes. This approach has the potential to undermine
community confidence in the system, if it is perceived to continue the
disadvantages of the existing system. Such as, insufficient transparency,
accountability for decision making and lack of regulatory
certainty.
On Business - This approach would be likely to have a
minimal impact on business in terms of costs. During consultations, however,
industry did not endorse this approach and expressed the benefit of
comprehensive assessment of risks being undertaken by Regulator with advice from
GMAC.
On the Community and Consumers - During community
consultations, the community expressed a very strong desire for an independent
regulator to undertake risk assessments and risk management with advice from a
range of stakeholders including a scientific body.
Impacts of Option 3
- Regulation focusing on post-market monitoring and exclusion rather than
pre-market regulation
On Government - This would involve some
costs to government, through the need to work closely with industry and the
community in developing the standards which would be applied by industry.
Government would also incur costs related to post market monitoring and the
removal of any unsafe GMOs from the marketplace. These costs could be offset by
lower pre-market approval costs.
On Business - This option would
involve minimal cost to industry but like Option 2 would be unlikely to engender
sufficient community confidence to enable the marketing of GMOs and GM products.
On the Community - During consultations, the community expressed
concerns that GMOs present unique risks which must be independently assessed
before they are marketed. They considered that post-market monitoring and
exclusion measures would be inadequate to deal with a situation where
environmental or public health risks are identified after the event, and when it
may not be possible to withdraw the product easily (for example in the case of a
crop).
On Consumers - Consumers (in particular, primary producers
utilising GM seed) would have increased access to GMOs.
Conclusion and recommended option:
The Bill
reflects a preference for Option 1. Community consultations (please refer
Part 6 - Consultation) have demonstrated that only a comprehensive
system utilising prohibitions and licensing for higher risk activities can
deliver the type of comprehensive testing, backed up with appropriate sanctions
for non-compliance, which the Australian community considers is merited by the
potential risks posed by GMOs to public health and safety and the environment.
The proposed system minimises the regulatory burden to industry by adopting a
sliding scale of regulatory oversight based on risk. Higher requirements are
placed on higher-risk activities, such as commercial releases of GMOs. A more
streamlined approach is adopted for lower risk activities such as research in
contained facilities.
To illustrate the practical effect of the Bill on some of the groups who will utilise the legislation, case studies have been included in respect of the impact of the legislation on: dealings with exempt GMOs; notifiable low risk dealings; higher risk work with GMOs within laboratories or other contained facilities; and work involving release of GMOs into the environment.
Impact of the legislation on persons dealing with exempt
GMOs
Currently GMAC:
§ identifies certain contained research as
exempt research (on the basis of negligible risk). Exempt research requires no
approval from GMAC.
The Gene Technology Bill 2000
will:
§ identify certain contained research as
exempt research – it will require no approval from the Regulator. Exempt
work will be identified in the regulations – and will be based on the
current GMAC exemptions.
The impact of the legislative system on
persons dealing with exempt GMOs is expected to be similar to the existing GMAC
arrangements.
Impact
of the legislation on persons undertaking notifiable low risk dealings
Currently GMAC:
§ Identifies certain contained research as
category B research (low risk);
§ Requires that such research be overseen by
an Institutional Biosafety Committee (IBC). The research may commence once an
IBC has authorised it; and
§ Requires the IBC to: notify GMAC of the
research; ensure the research is undertaken within a laboratory certified by the
IBC to be physically contained to Level 2 (the requirements for which are
described in the GMAC guidelines).
Under the Gene Technology Bill
2000:
§ Certain low risk contained research will
be identified in regulations as notifiable low risk dealings (NLRDs). NLRDs
will be based on the current Category B
research;
§ NLRDs will continue to require the same
level of oversight currently provided by IBCs;
and
§ The
regulations will require that NLRDs be overseen by an IBC, be notified to the
Regulator and be conducted in a laboratory certified to a certain containment
level.
The main difference between
the current GMAC system and the new legislative system is that IBCs will have to
belong to an ‘Accredited Organisation’. At present GMAC requires
IBCs to be constituted in a particular way and meet certain requirements set out
in Guidelines. Under the new system, the Regulator will accredit organisations
if they can meet guidelines set by the Regulator relating to the constitution
and maintenance of an IBC. This approach has been adopted because during
consultations, stakeholders expressed the strong view that the organisation in
which the voluntary IBC members reside, needs to be responsible for the
maintenance of the IBC in accordance with guidelines set by the
Regulator.
The increase in costs is likely to be minimal as the new
system will closely mirror the existing system. The benefits of a legislative
approach include increased regulatory certainty and increased capacity for
effective monitoring and enforcement of persons conducting NLRDs.
Impact
of the legislation on persons undertaking higher risk work with GMOs within
laboratories or other contained facilities
Currently
GMAC:
§ identifies some contained research as
Category A research (higher risk);
§ requires that such work may only commence
once advice has been gained from GMAC; and
§ may impose a number of conditions
including requirements that the facility be contained to a certain level and
that the work be overseen by an IBC.
Under the Gene Technology Bill
2000:
§ all existing GMAC approvals will be
carried over into the new system. Further approval from the Regulator will not
be required until the approval from GMAC expires or until 2 years after the Gene
Technology Act commences, whichever is the sooner;
§ higher
risk contained work will continue to be assessed on a case-by-case basis;
and
§ the
Regulator will undertake a risk assessment of the proposed work and apply any
necessary conditions to manage the risks posed by such work. Such conditions
would include a requirement that the facility in which the work is proposed to
be undertaken is certified to the relevant containment level (as per the current
system).
As with NLRDs, higher risk contained work that requires the
oversight of an IBC will need to be undertaken within an Accredited
Organisation.
There is likely to be a small increase in costs
associated with the Regulator’s assessment of higher risk contained work.
The benefits of the new approach include: more comprehensive assessment by the
Regulator of possible risks to workers, the public and the environment; greater
transparency in decision making; timely assessment of applications (in
accordance with statutory timeframes); and increased capacity for effective
monitoring and enforcement.
Impact
of the legislation on persons proposing to release a GMO that may have a
significant impact on the environment (either for research purposes or for
commercial use).
Currently
GMAC:
§ requires an applicant to apply to GMAC for
approval to proceed with a field trial in accordance with guidelines issued by
GMAC;
§ makes a summary of the application
publicly available and invites public submissions on the application;
§ undertakes a risk assessment of the
proposed dealings with the GMO; and
§ on the basis of the risk assessment,
advises the applicant whether they may proceed. If advice to proceed is given,
GMAC may also give advice about conditions to be observed. Conditions may be
made that relate to persons other than the applicant. For example, other people
using the genetically modified seed such as primary producers. The advice of
GMAC is not legally enforceable.
In addition, if the application was for
a general commercial release of a GMO (rather than, for example, a field trial),
GMACs advice would be provided to the Minister for Health for consideration and
if agreed, the Minister would enter a Deed of Agreement with the applicant
providing some level of enforceability with respect to necessary
conditions.
Under the Gene Technology
Bill 2000:
§ application requirements will be set out
in the legislation;
§ the Regulator will be required to make the
application available to the public (excluding commercial in confidence
information) and invite submissions on the application from the public,
Commonwealth agencies, States and Territories and the Gene Technology Technical
Advisory Committee;
§ the Regulator will prepare a comprehensive
risk assessment and risk management plan and seek public comment on
both;
§ having taken into account relevant
matters, the Regulator would make a decision on the application; and
§ if the
licence is approved, conditions may also be imposed, if necessary, in relation
to persons covered by the licence such as primary producers. The licence
decision would have a statutory basis and will be enforceable at law. Details
of all decisions will be included on a publicly available record.
The
new system provides for greater certainty in application requirements, greater
capacity for public input, more comprehensive risk assessment and identification
of risk management options and improved capacity for monitoring and enforcement.
There are expected to be increased attendant costs in relation to the assessment
of such applications.
g) Certification
of facilities and accreditation of organisations
Option 1 -
Certification of facilities and accreditation of organisations by the Regulator.
The proposed legislation provides for the Regulator
to:
§ Certify facilities: The Regulator may
require, as a condition of licence, that certain work with GMOs is only
conducted in facilities of a certain assessed containment level. The
requirements for certification to Physical Containment (PC) levels 2, 3 and 4
would be spelt out in guidelines issued by the Regulator (just as they are
currently spelt out in guidelines issued by GMAC). The guidelines would be
subject to consultation and a RIS. The Regulator would directly certify
laboratories to PC level 3 and 4 (at present there are 24 facilities certified
to these levels by GMAC) and would utilise IBCs to assist in the monitoring of
PC level 2 facilities.
§ Accredit organisations: At present IBCs
operate within institutions undertaking gene technology work. Currently, there
are 92 IBCs operating in Australia. The IBCs oversee work occurring within
institutions and provide information and advice to researchers and to GMAC.
Under the new system it is intended that this system be continued through the
accreditation of organisations. An Organisation will be accredited by the
Regulator if the Organisation can establish to the satisfaction of the Regulator
that the Accredited Organisation has established and will maintain an IBC in
accordance with guidelines issued by the Regulator. The IBCs will not provide a
regulatory role but they will continue to: assist organisations to understand
regulatory requirements; and provide advice to the Regulator regarding the work
occurring at an institutional level.
Option 2 – Third party
(and/or industry) certification and accreditation.
This approach would
involve the Regulator setting standards for accreditation of institutions and
certification of facilities. Compliance with such standards would then be
monitored by third parties or industry (accredited by the
Regulator).
Impacts of Option 1 - Certification of facilities and
accreditation of organisations by the Regulator.
On Governments -
The proposed system simply formalises existing administrative arrangements
which Governments have acknowledged as operating effectively. Costs related to
administration of the certification and accreditation system should be minimal,
as guidelines issued by the Regulator will be based on the existing GMAC
guidelines in relation to IBCs and the containment of facilities.
On Business - No additional costs, or delays, should be incurred by business. Business is currently required to have facilities certified to certain containment levels by GMAC. Similarly, the establishment and maintenance of IBCs is the responsibility of organisations, overseen by GMAC. The proposed legislation simply formalises an existing administrative practice. Guidelines and standards will provide a high level of certainty for applicants for certification or accreditation. The accreditation process also recognises the value of a co-regulatory approach in relation to low risk activities undertaken within laboratories.
On the Community - The community can be confident that work within
institutions is being carried out in line with standards set by the Regulator.
The standards set by the Regulator will be on the public record, monitored and
enforced.
On Consumers - There should be negligible impacts as
most of the work undertaken in certified facilities is research
work.
Impacts of Option 2 - Third party (and/or industry)
certification and accreditation.
On Governments - This approach
would minimise the resources associated with the Regulator directly accrediting
organisations and certifying facilities. However, costs would be incurred to
recruit and audit third party industry assessors. The small number of
organisations requiring accreditation (presently 92) and facilities to be
certified by the Regulator (presently 24) would probably not justify the costs
of recruiting and accrediting third party assessors and auditors to undertake
this role.
On Industry - Industry noted that in the area of gene
technology (unlike food regulation) there are few organisations that would be
appropriately skilled, and independent, to undertake audits of containment
facilities or organisations. Industry would also incur costs on two levels:
costs as the result of the Regulator accrediting assessors and auditors; and
costs imposed by such assessors and auditors for the work undertaken on behalf
of the Regulator. Given the small number of organisations to be accredited and
facilities to be certified it is also likely that the charges levied by third
parties for providing such a service would be as great, if not greater, than the
charges the Regulator would levy for provision of the same service.
On
the Community - During consultations the community strongly opposed this
model. They felt that at this early stage in the development of GMOs,
certification and accreditation must be undertaken directly by the Regulator to
ensure sufficient independence and proper oversight. It was, however,
recognised that over time, it may be possible to utilize third party auditors,
particularly if the number of organisations undertaking gene technology
increased dramatically.
On Consumers - No significant
impacts are foreseen
Conclusion and recommended option:
The
Bill reflects a preference for Option 1. This option offers a co-regulatory
approach under which institutions will largely continue ‘business as
usual’ with the advantage, for public confidence and the credibility of
the system, of ultimate oversight by the Regulator.
h) Database of
GMOs and GM products
Option 1 – Establishment of a
centralised database of all GMOs and GM products approved in
Australia
The Bill proposes the establishment of a publicly accessible
central database including information about all approvals of GMOs and GM
products in Australia. It is proposed that the database include all relevant
information (including any conditions of licence) excluding confidential
commercial information. The Regulator will make an assessment of whether
information is confidential commercial information on a case by case basis and
in accordance with legislated criteria.
Option 2 – The
status quo
GMAC currently maintains a database, available on the GMAC
website, that contains summary information about field trials and general
releases. The GMAC database does not include information about approvals in
relation to contained work or approvals of GM products by other regulators (such
as TGA and ANZFA).
Impacts of Option 1 - A centralised database
of all GMOs and GM products
On Governments - Costs will be
incurred as the result of establishing and maintaining a comprehensive database
of all GMO approvals. Such a database will, however, assist governments to
discharge responsibilities including under international obligations and in
terms of accountability to the public. All relevant Commonwealth agencies and
State Territory Governments will also have access to the database (including
confidential commercial information) which will assist them in any related
decision making by State based regulatory authorities.
On Business -
The draft legislation ensures that legitimate confidential commercial
information provided by applicants is able to be protected. This provides
benefits to industry by ensuring that information with a commercial value
(including intellectual property) or information that may cause harm to an
applicant if it were released (for example, information that may provide an
unfair advantage to competitors) is protected.
On the Community - The database enables community members interested
in gene technology, to easily access, through a singe national database,
comprehensive information about GMOs and GM products. This will help to empower
community members wishing to actively engage in the development of policies on
gene technology.
On Consumers - Increased information available to
consumers to assist them to make informed choices in the market place.
Impacts of Option 2 - The status quo
On Governments - No significant impact
On Business - No
significant impact
On the Community and Consumers - A
disadvantage of this approach is that community members are not provided with
comprehensive information about GMOs and GM products. This would reduce the
capacity of the community to contribute to the debate surrounding gene
technology and may lead to distrust in the regulatory system as it would be
perceived to be hiding information from the community.
Conclusion and recommended option:
The Bill reflects a
preference for Option 1. In order to instill public confidence in the regulatory
system and enable research and commercial applications of gene technology to
proceed, it is essential that as much information as possible is made available
to the community, while at the same time protecting legitimately confidential
commercial information. Option 1 realizes these benefits at minimal cost.
i) Monitoring and enforcement
Option 1 –
Utilisation of a combination of industry auditing, independent monitoring and
auditing, inspections and power to give directions requiring remedial action to
be taken.
The proposed Bill provides for a combination
of:
§ Auditing by licence holders and Accredited
Organisations. It would be a condition of licence that people undertaking
dealings with GMOs regularly report to the Regulator about compliance with
licence conditions. In addition, a statutory condition would require reporting
of any additional information regarding risks to public health and safety and
the environment. Similarly, Accredited Organisations would report to the
Regulator about ongoing maintenance of an IBC;
§ Independent auditing and monitoring by the
Regulator. The legislation empowers the Regulator to undertake regular
monitoring and/or ‘spot-audits’ as necessary and commensurate with
the level of risk posed by the dealings being undertaken and the history of
compliance of the licence holder. This ensures that the level of oversight
remains commensurate with the risk. Auditing and monitoring may be undertaken
by the Regulator in relation to licensing, notifiable low risk dealings,
certified facilities and Accredited
Organisations;
§ Inspections. The legislation provides for
inspections (including search, seizure etc) where a suspected breach has
occurred;
§ Enforcement action – the legislation
provides for a number of options to deal with breaches of the legislation
including variation, suspension or cancellation of
licence/accreditation/certification, the issue of directions, reporting of
breaches directly to Parliament and criminal penalties;
and
§ Remedial action. The Regulator has a
statutory right to recover costs incurred as a result of the need to issue
directions to a licence holder to remediate following a breach of condition in
order to protect public health and safety and avoid damage to the environment.
Option 2 – Industry-based monitoring and reporting to the
Regulator including the use of third party auditors
Impacts of Option
1 - A combination of industry auditing, independent monitoring and auditing,
inspections and issue of directions.
On Government - The Bill
provides flexibility for the Regulator to undertake any necessary monitoring to
ensure that the legislation is being observed and that public health and safety
and the environment is being protected.
On Business - Costs will
be incurred to business to comply with conditions of licensing determined by the
Regulator and to undertake internal auditing and reporting of results to the
Regulator. However, compliance costs will be commensurate with the level of
risk associated with the particular dealings with GMOs being undertaken.
Further, compliance costs will be minimised over time for those businesses that
demonstrate a strong record of compliance with the legislation (as the result of
decreased audit and inspection by the Regulator on the basis of the proven
record of ability to mange the dealings with the GMO appropriately).
Some of the costs of the system (eg. licensee audits) are likely to be
met by end-users of the system such as farmers in the form of an increased price
for seed and other GMOs.
On the Community - Extensive monitoring
and enforcement powers provides the community with confidence that the Regulator
can take appropriate and rapid action to address any problems which may arise.
On Consumers - Consumers may be required to make a contribution
to the monitoring and enforcement system through higher prices for products
which contain GMOs.
Impacts of Option 2 - Industry-based
monitoring and reporting to the Regulator
On Government - This
would minimise the resources expended by the Regulator. The Regulator could
accredit and oversee the auditors, but would not be required to be involved in
auditing and monitoring on a case by case basis.
On Business -
If industry undertook their own monitoring and auditing, costs (both
financial and paperwork burden) would be minimised. Industry would, however,
incur similar costs whether the auditing and monitoring was undertaken by third
party auditors or by the Regulator directly. Concern has also been expressed,
particularly by researchers, that any third party auditors would need skills in
the relevant area (most likely people active within the industry itself) and
that utilisation of such people may raise conflicts of interest and the
potential for disclosure of information with a significant commercial
value.
On the Community - During consultations, the community
strongly opposed this approach. Given the potential risks posed by GMOs and the
fact that the industry is in its infancy in Australia, community members
expressed the importance of industry being overseen by an independent regulator.
It was considered that industry oversight or third party oversight could result
in a reduction in monitoring, lower standards, and inadequate reporting of
adverse effects or breaches of the legislation.
On Consumers - As
for Option 1.
Conclusion and recommended option:
The Bill
reflects a preference for Option 1. While this option will be more expensive to
establish and maintain, the Regulator will need to have an effective range of
powers to audit, monitor and enforce the legislation. This will help to ensure
that risks to public health and the environment are properly addressed.
Following review of the legislation in 5 years time, the use of third party
auditors may be considered, particularly if the use of gene technology is more
extensive in Australia, history of compliance is strong and community acceptance
of GMOs has increased.
j) Transitional period and Grandfathering of existing GMAC approvals
Option 1 – Grandfathering of existing approvals
The proposed Bill provides that once the new legislative system takes effect,
approvals previously granted by GMAC may continue in force until they expire or
for a period of two years whichever is the sooner. After a maximum of two
years, all dealings with GMOs must be re-assessed and regulated by the
Regulator.
Option 2 – No grandfathering
Under this alternative all dealings with GMOs would be required to be
licensed by the Regulator from the first day of operation of the new legislation
regardless of whether or not the work had been previously approved by
GMAC.
Impacts of Option 1 - Grandfathering of existing
approvals
On Governments - This provides the Regulator with a two
year period during which to reassess any approvals made by GMAC. If a
grandfathering provision was not included the Regulator would need to re-assess
thousands of existing approvals as soon as the legislation takes effect. This
would have a significant impact on the overall available resources of the
Regulator during the first 6-12 months of operation, and might detract from
other activities such as working towards harmonising data requirements and risk
assessments with other agencies, and the preparation of guidelines and codes of
practice.
On Business - This minimises costs to industry associated with having
to re-apply for assessment having already undergone an assessment by GMAC during
the interim period prior to commencement of the legislation. Industry will,
however, have to comply with statutory conditions of licence prescribed in the
Bill. These relate to reporting of adverse effects, granting of permission for
the Regulator to enter premises to undertake inspections and informing persons
covered by the licence of any relevant conditions. These statutory conditions
are unlikely to impose any additional costs of compliance on industry as, under
current administrative arrangements, GMAC expects observance of such
requirements. Should additional information become available regarding risks,
the Regulator may also impose additional conditions following notification to
the licence holder and the provision of opportunity for comment.
On
the Community and Consumers - During consultations, the community recognised
the benefits of grandfathering existing approvals but supported an approach
whereby after a certain defined period of time, all dealings with GMOs would be
approved by the Regulator and entered on a central database.
Impacts
of Option 2 - No grandfathering
On Governments - This would have significant resource implications for
the Regulator who would be required to reassess thousands of applications during
a very short period of time.
On Business - This would impose large
costs on industry. A significant administrative and paperwork burden would be
imposed on industry (in particular researchers) if they were required to
re-apply for licensing of all existing approvals at the time of commencement of
the legislation. In addition to the costs of having to resubmit applications
for ongoing research and other work, all work would need to cease until
approvals had been granted by the Regulator. This might also produce a
situation where some very low risk GMOs could not be used for a period of time,
which would be extremely disruptive in particular for laboratory work.
On the Community and Consumers - No significant
impact.
Conclusion and recommended option:
The Bill
reflects a preference for Option 1. This approach minimises the impact on
industry while ensuring that after a certain period of time, all work will have
been assessed by the Regulator, unless it is exempt or a notifiable low risk
dealing.
6. Consultation
a) The consultation process
Consultation on the proposed
regulatory scheme for GMOs commenced in 1998 and has involved a number of
stages.
In November 1998, a paper prepared by the Commonwealth State Consultative
Group on Gene Technology (CSCG) and entitled “Regulation of Gene
Technology” was circulated for public consultation. Consultations were
held throughout Australia seeking views about the broad policy principles that
might underpin the new regulatory scheme. Some of the general features of the
system of regulation were also discussed. As a result of these consultations,
the CSCG agreed to a set of policy principles which the CSCG has used to guide
it in developing the proposed regulatory system.
Stage 2
On
the basis of the agreed policy principles, the CSCG worked to develop proposals
for the operational details of the new regulatory system.
The CSCG
prepared a discussion paper entitled “Proposed national regulatory system
for genetically modified organisms – How should it work?”. This
document sets out the proposed approach to regulating GMOs, including the
proposed scope and form of the legislation, the proposed management structures,
the proposed system of regulation and the proposed mechanisms for maintaining
transparency, accountability and community involvement in the system over time.
The discussion paper was:
• advertised in a range of national,
States and Territory and regional newspapers;
• direct-mailed to over
2,500 individuals and organisations including the groups referred to below as
well as all MPs and Senators in Federal Parliament; and
• posted on
the website of the IOGTR, which is the Branch of the Commonwealth Department of
Health and Aged Care which is facilitating the development of the
legislation.
Invitations to attend targeted consultations were sent to
approximately 2,500 individuals and organisations across Australia: Vice
Chancellors of all Universities where research involving GMOs is conducted; all
IBCs; State/Territory Inter-Departmental Committees; consumer groups, including
the Australian Consumers Association and the Consumers Health Forum;
environmental groups including the Australian Conservation Foundation and
Friends of the Earth; health professional groups; industry groups; retailers and
food industry groups; and primary producers.
The targeted consultations
were held in all States and Territories during November and December 1999. More
than 200 written submissions were received on the Discussion Paper.
At
each session, participants were asked how they felt the legislation could be
more streamlined and reduce the impact on business, while maintaining the
integrity of the system in terms of protecting public health and safety and the
environment.
A number of issues were raised by participants relating to
the cost and benefits to industry of the proposed legislation. Many of these
issues were reflected in the draft legislation released in late December
1999.
Stage 3
In December 1999 an early draft of the
Gene Technology Bill 2000 and an accompanying Explanatory Guide were
released for public consultation.
Once again, a call for public
submissions was made in newspapers in all jurisdictions, on the IOGTR website
and direct mailed to over 2,500 individuals.
Public forums were also held
in all capital cities and also in Tamworth, Rockhampton and Albury-Wodonga.
Over 750 people attended the public consultations and more than 160 written
submissions were received.
During public consultations, officers from the
IOGTR explained the impact of various parts of the draft Gene Technology Bill
2000 and sought comment on ways that the proposed legislative system could
be improved and any negative impacts minimised. The public forums gave rise to
many suggestions for change and a range of options were discussed.
A
summary of views elicited from the main affected parties as a result of
consultation is described below. Please note that this summary does not attempt
to summarise all of the views of all of the parties involved in consultations on
the draft Gene Technology Bill 2000. Rather it emphasises areas of
support and dissention in relation to options proposed in this RIS and areas
where costs and benefits of various approaches were
raised.
(a) National scheme legislation
This element of the
legislation was widely supported during consultations. Stakeholders from all
sectors (general community, industry including research institutions) supported
the maximum degree of national uniformity possible. Many stakeholders expressed
strong concerns about a lack of uniformity emerging overtime and stressed the
importance of putting structures in place for ensuring a high level of
consistency over time.
(b) Scope of the Act including interface with
existing regulators
Many community groups and individuals supported
the Regulator being a ‘one-stop shop’ regulating all GMOs and GM
products. Such groups articulated the advantages of a ‘one-stop’
shop as:
§ providing a streamlined assessment process
requiring approval from only one regulator;
§ providing greater opportunity for
community input; and
§ addressing the perceived problems with the
existing regulatory systems.
Others supported the gene technology
legislation regulating the ‘gaps’ with capacity to provide advice to
the regulators where they consider GM products. It was considered
that:
§ A ‘one stop shop’ would create
inefficiencies, as areas of expertise in each of the NRA, TGA, NICNAS and ANZFA
would have to be duplicated by the Regulator;
§ A ‘one-stop shop’ assumes that
the ‘GMO-ness’ of a product is its key characteristic. In relation
to most GM products the major risks posed do not relate to the genetically
modified qualities of the product but from other qualities and the proposed
application of the product. For example, in relation to therapeutic goods, the
fact that the good has been derived from a GMO is of minor consequence compared
to the general safety, quality and efficacy of the various constituents of the
drug; and
§ Administrative arrangements could be put
in place to improve the interface between existing regulators without the need
to overhaul the entire system of existing regulation in relation to products.
For example, the paperwork burden of dealing with several different regulators
should be minimised over time. For instance, through the harmonisation of data
requirements across the various systems.
(c) Management of the gene technology scheme
Stakeholder
consultations demonstrated strong support for the creation of an autonomous
regulator of gene technology, independent of the political process. Provided
this could be achieved, most stakeholders did not express a preference for
whether the legislation was administered by a single statutory office holder or
a statutory board.
Some community and environmental groups supported the
involvement of Ministers in decision making on individual applications, however,
this was not supported by all environmental/consumer groups nor at all by
industry groups, researchers, primary producers and government agencies.
(d) Provision of expert advice to the Regulator to inform
decision-making
The establishment of a Gene Technology Technical
Advisory Committee (based on the current GMAC) to provide scientific advice to
the GTR, was strongly supported by all stakeholders. Many stakeholders did,
however, emphasise the importance of stringent conflict of interest and
disclosure of interest provisions applying in respect of Committee members (this
will be addressed in the regulations).
The establishment of a Gene
Technology Community Consultative Group received a mixed response from
stakeholders. While most people supported the establishment of a broadly based
community group there was a range of views expressed regarding the role of the
group. Some community representatives and environmental groups considered that
the Group should be involved in decision making on individual cases while this
was strongly opposed by industry, Universities and primary producer groups.
The Gene Technology Ethics Group was supported by most stakeholders.
Industry, consumer, environmental, primary producer and other groups
acknowledged the need for the legislative system to be underpinned by ethical
guidelines prepared by a properly constituted ethics committee and considered by
the Ministerial Council for endorsement. Concern was expressed however,
regarding the precise terms of reference of such a group and the types of
ethical issues that would be considered.
In relation to all of the
Committees, industry emphasised the need for prioritisation of the work of the
Committees in order to keep costs to a minimum and in order to ensure that the
costs of the Committees do not blow-out.
(e) The regulation of dealings with GMOs
All stakeholders
strongly supported an approach whereby the level of regulation applied to
particular dealings with GMOs was commensurate with the level of risk posed by
the particular dealings. There was considerable support in the community for
the way that GMAC has dealt with research involving GMOs. There was also a
strong call from researchers that the existing system be maintained as far as
possible, in relation to contained work so that unnecessary costs were not
incurred in relation to work that is largely low risk. The assessment process
proposed in relation to notifiable low risk dealings and dealings with GMOs that
do not involve a deliberate release into the environment was generally
supported. It was seen as a streamlined way for dealing with low risk
activities, based on the current GMAC processes, but with capacity for more
comprehensive assessment where necessary.
In relation to the regulation
of higher risk activities involving release into the environment, the proposed
licensing system was generally supported.
There was particular support
for the assessment process involving two stages of public consultation. Many
researchers and industry groups emphasised the importance of retaining some
flexibility in the assessment process. As such, small scale low risk field
trials would not be subject to the same level of public consultation (and
expense) as higher risk proposals. Industry also emphasised the need for the
regulations to detail statutory timeframes and data requirements for
applications, to provide some level of certainty to applicants.
It
should be noted, however, that many individual members of the community felt
strongly that there is insufficient information about the risks that GMOs may
pose. As such, they considered that there should be a moratorium on the release
of GMOs into the environment.
(f) Certification of facilities and
accreditation of organisations
The proposed approach to the
certification of facilities reflects the current process adopted by GMAC but
with additional capacity to take action where an organisation undertakes
research in facilities that are not certified or in facilities that have been
certified but the conditions of certification are not met. This approach was
broadly supported.
With respect to Accredited Organisations, there was
broad support for basing the new system on the existing GMAC system. The
following points were made:
§ researchers and IBC members, emphasised
the importance of the overarching organisations taking responsibility for the
IBCs (in particular in terms of adequate resourcess and the indemnification of
individual voluntary committee members);
§ Universities and other institutions
(including companies) emphasised the important role IBCs play and the costs
incurred by the organisation to maintain the system of IBCs. It was felt that
these expenses should not be overlooked; and
§ recognising the closeness of the
relationship between IBCs and their parent organisations, many people emphasised
the importance of the Regulator providing independent oversight of the IBCs
(through the system of accreditation of organisations).
(g) Database
of GMOs and GM products
The centralised database of GMOs and GM
products was strongly supported. Industry and Universities emphasised the
importance of the legislation including provisions for the protection of
confidential commercial information. Existing regulators favoured the
establishment of a database that interacted with databases of existing
regulators so that the transfer of information between regulators was as
streamlined and cost efficient as possible.
(h) Monitoring,
enforcement and remediation
Consultations provided strong support for
the Regulator to have a range of options for monitoring and enforcing the
system. Several stakeholders also noted
that:
§ the Regulator should develop guidelines
regarding the regularity of monitoring and auditing for various classes of
dealings with GMOs in order to provide some certainty of costs to industry;
and
§ the
use of third parties may reduce the effectiveness of the feedback loop which
would be critical to inform the Regulator’s future decisions (for example,
the Regulator needs to know what is happening in the field after approval, to
inform his future decisions on similar GMO applications).
(i) Transitional period and Grandfathering of existing GMAC
approvals
This was universally supported. Researchers and
Universities, in particular, noted that the impact of not having grandfathering
provisions would be significant, as it would not only delay research but also
impose significant additional costs on
researchers.
8. Implementation and review
The regulatory system is expected to be fully operational by 3 January
2001.
It is proposed that certain parts of the Bill (for example, those
creating the Regulator and advisory Committees) will be commenced in advance of
the prohibitions and licensing provisions. This would allow the Regulator to
commence critical activities (for example, the development of application
guidelines) prior to the actual commencement of the scheme.
It is proposed that the new legislative scheme will be comprehensively
reviewed after 5 years to make any necessary changes to the system. It is
proposed that the process for review of the system be included in the IGA on
Gene Technology.
The IGA will also contain provisions for agreement by
Ministers of any necessary changes to the Acts and regulations during the
initial 5 year period, with the agreement of the States and Territories
Much of the day-to-day impacts of the new scheme will be through
regulations (for example, the Licence Charges Regulations are still to be
developed) and Guidelines and Codes of Practice (for example, what information
must be presented to the Regulator in conjunction with the application). The
impacts of these associated aspects will be separately assessed.
9. Competition Principles Agreement Statement
Where proposals maintain or establish restrictions on
competition, the Competition Principles Agreement requires the responsible
agency to establish that:
§ the benefits to the community outweigh the
costs; and
§ the Governments’ objective can only
be achieved by restricting competition.
The Gene Technology Bill
2000 restricts competition by requiring new entrants into the market to
seek a licence from the Regulator for their proposed dealings with GMOs.
Institutions wishing to conduct GMO research must also gain accreditation from
the Regulator before undertaking those activities. Accreditation will be
granted where an organisation can establish that they have, and will maintain, a
properly constituted IBC in accordance with guidelines issued by the Regulator.
These requirements restrict competition to the extent
that:
§ the Regulator is the only person able to
grant such licences and accreditations. The assessment of risk is not open to
competition;
§ they increase regulatory barriers to entry
into the field of dealings with GMOs and GM
products;
§ they create a disadvantage for firms
dealing with GMOs and GM products who wish to compete in markets where the
non-GM counterpart products have not had to incur the additional costs of
regulation by the Regulator; and
§ a fee will attach to the granting of
licences and accreditation.
As detailed throughout this RIS, the major benefits of the legislation
include:
§ For the community at large -
Assurances that all GMOs used in Australia have been comprehensively
assessed by an independent Regulator as being safe in terms of the health of
people and the impact on the environment. Public confidence in the regulation
of GMOs also has positive downstream effects for industry, manifesting in
increased consumer acceptance of GMOs assessed to be safe. For consumers this
also translates to increased consumer choice in relation to GMOs and GM products
and potential access to a broader range of products with improved quality or
health benefits;
§ For industry - The proposed regime
establishes a clear and efficient assessment process for GMOs ensuring a high
level of regulatory certainty. Industry has emphasised the need for an
efficient, rigorous, regulatory system that ensures the proposed assessment of
all GMOs in order to enable the benefits of gene technology to be captured for
the Australian community.
The overall cost impact of these restrictions
would include:
§ some diminution of GMOs and GM products
coming into the market which are judged to pose unacceptable risks to health or
the environment or to raise unacceptable ethical concerns;
§ possible
impact on research, if charges are levied by the Regulator in relation to
applications to undertake research with GMOs. This may reduce the long term
benefits of research to the community and may hinder the development of GMOs for
the public good which lack commercial attractiveness; and
§ in
markets where GMOs and GM products were competing with non-GM products, the
regulatory costs disadvantage may result in less than optimal market share for
the GMOs and GM products. This would be offset by increased marketability as a
result of increased consumer confidence in the products coming to market. The
GMOs and GM products could also rely on any cost or quality advantages produced
from gene technology.
Given the substantial benefits to the community, in
terms of the protection of health and safety and the environment, and to
industry, in terms of providing a pathway to market for GMOs judged to be safe,
it is anticipated that the benefits will outweigh the costs of regulation.
As described in Part 1 – Background, a
comprehensive independent analysis of the costs of the full regulatory system
(including the regulations) will be undertaken between April and September 2000.
The analysis of costs will be subject to extensive consultation with
Governments, industry and other stakeholders.
The regulatory scheme will
also be the subject of ongoing monitoring (regarding its effectiveness in
meeting its objectives including cost efficiency) and a comprehensive review
after 5 years. The review will be directed at ensuring the legislation
maximises benefits while minimising costs.
Can the Governments
objective only be achieved through restricting competition?
As
detailed in Part 1 - Background to this RIS, an administrative
scheme (based around the Genetic Manipulation Advisory Committee) has been
operating for a number of years providing oversight in relation to research with
GMOs, field trials involving GMOs and the commercial release of GMOs not
regulated under existing regulatory schemes.
This administrative scheme
was based on voluntary compliance by industry and as such did not restrict
competition. However, as outlined in Part 2 – Problems of
this RIS, there are a number of problems associated with continuing a voluntary
administrative scheme of this nature (including regulatory uncertainty, an
inability to enforce conditions and compliance with GMAC requirements
etc).
Governments’ examined a range of options for addressing these
problems as detailed in Part 1 - Background of this
RIS.
The approach adopted, whereby high risk dealings must be licensed by
the Regulator and undertaken within accredited organisations (who have an IBC)
is the only option that ensures:
§ a comprehensive assessment of the risks
posed to public health and safety and the environment in relation to dealings
with GMOs;
§ assessment by an independent regulator
with access to advice from a range of sources. The potential risks that may be
posed by dealings with GMOs are sufficiently great that their assessment and
management cannot be left to industry
self-regulation;
§ responsibility for ensuring that the
dealings are managed safely rests with an identified organisation (the licence
holder);
§ regulatory certainty for industry in terms
of timeframes, assessment processes, protection of confidential commercial
information;
§ a high level of transparency and
stakeholder involvement in decision making;
§ capacity for enforcement in the case of a
breach. The consequences of a breach of licence may be severe and as such the
Regulator needs to have a range of enforcement options open to
them;
§ ensures that risks are effectively
communicated to consumers and others to allow them to make informed decisions on
the basis of all the facts. Effective risk assessment and communication by the
Regulator reduces potential imbalance in the market place. This occurs where,
for example, information is unavailable to one party (ie consumers/the
public).
GENE TECHNOLOGY BILL 2000
NOTES ON
CLAUSES
Clause 1 – Short title
This is a formal provision
that specifies the short title of the Act as the Gene Technology Act
2000.
Clause 2 – Commencement
Sub-clause
2(1) provides that clauses 1 and 2 of the Act commence on the day on which
the Act receives Royal Assent.
Sub-clauses 2(2) and (3) enable
various provisions of the Act to commence at a date to be fixed by Proclamation.
If any provisions of the Act do not commence within six months of Royal Assent,
those provisions commence on the first day after the end of that period.
The effect of these provisions is to enable different parts of the Act
to commence at different times. For example, to assist with transitional
arrangements it may be desirable to commence the provisions of the Act
establishing the Regulator and the advisory committees before the prohibition
and licensing provisions commence. This would enable those bodies to prepare
necessary technical guidelines in advance of the licensing provisions taking
effect.
This clause provides that the object of this Bill is to protect the
health and safety of people, and to protect the environment, by identifying
risks posed by, or as a result of, gene technology, and by managing those risks
through regulating certain dealings with genetically modified organisms
(GMOs).
The terms “environment”, “gene
technology”, “dealings” and “genetically modified
organisms” are defined in clause 10.
This clause makes it clear that it is intended that the object of the
Bill be achieved through a regulatory system that will be based on an efficient
and effective system of assessment. Furthermore, the regulatory framework is to
operate in conjunction with other Commonwealth and State regulatory schemes
relevant to GMOs and genetically modified (GM) products. For example:
• foods (including GM foods) are regulated under State and Territory
food Acts with the role of developing food Standards (for consideration by the
Australia New Zealand Food Standards Council) resting with the Australia New
Zealand Food Authority under the Australia New Zealand Food Authority Act
1991;
• therapeutic goods (including GM therapeutic goods) are
regulated under the Therapeutic Goods Act 1989 administered by the
Therapeutic Goods Administration;
• agricultural and veterinary
chemicals (including GM agricultural and veterinary chemicals) are regulated
through a national scheme administered, in cooperation with all States and
Territories, by the National Registration Authority under the Agricultural
and Veterinary Chemicals (Administration) Act 1992 and the Agricultural
and Veterinary Chemicals (Code) Act 1994; and
• industrial
chemicals are regulated through the National Industrial Chemicals Notification
and Assessment Scheme under the Industrial Chemicals (Notification and
Assessment) Act 1989 and accompanying State/Territory
legislation.
The Bill will also operate alongside current import
arrangements for GMOs (which are administered by the Australian Quarantine and
Inspection Service in accordance with the Quarantine Act 1908) and in
conjunction with existing State and Territory legislation which may also effect
the use of GMOs (for example, general biological control legislation,
environment legislation and fisheries legislation).
This clause notes that it is intended that this Bill form a component of
a nationally consistent scheme for the regulation, by the Commonwealth, States
and Territories, of certain dealings with GMOs. It is expected that each State
and Territory will enact its own gene technology legislation to complement, or
apply, the Commonwealth legislation within its own jurisdiction. It is also
expected that an Intergovernmental Agreement on Gene Technology (the Gene
Technology Agreement) will be signed by the Commonwealth, States and Territories
to ensure the national system maintains a high degree of consistency over
time.
Sub-clause 6(1) provides that the Bill will bind the Crown in each
of its capacities.
Sub-clause 6(2) provides that the Crown may not
be prosecuted for a criminal offence against this Bill or regulations.
This clause provides that the Bill will have application in every
external Territory, excluding Norfolk Island. Therefore, the legislation will
cover, for example, the Indian Ocean Territories (Cocos and Christmas Islands),
Macquarie and Heard Islands, the Australian Antarctic Territory and the Jervis
Bay Territory. Norfolk Island has advised that a decision on the application of
this Bill to Norfolk Island will be postponed pending the outcome of
consultations on Norfolk Island.
This clause describes how the criminal offences established by the Bill
will operate.
Sub-clause 8(1) provides that Chapter 2 of the
Criminal Code Act 1995 (the Criminal Code) applies to all
offences against the Bill. This means that where it is alleged an offence has
been committed under the Bill, it will be necessary for the prosecution to
establish a fault element (for example, intent or recklessness), except where
the necessity to establish fault in relation to an element of the offence is
explicitly excluded in the Bill.
Sub-clause 8(2) provides that, if
a maximum penalty is specified at the foot of a clause or sub-clause of this
Bill then the offence referred to in the clause or sub-clause is punishable, on
conviction, by a penalty not exceeding that maximum.
DIVISION 1 – Simplified outline
This clause gives a simplified outline of the Part.
DIVISION 2
- Definitions
This clause sets out a number of definitions for words and phrases used
in the Bill. These definitions determine the meaning that is to be attributed
to certain words or phrases whenever they are used in the Bill or regulations.
Key definitions, which are essential to defining the scope of the legislation
and describing how it will be administered, include:
“deal
with”, which, in relation to a GMO, is
defined to mean:
(a) conduct experiments with the GMO;
(b) make, develop,
produce or manufacture the GMO;
(c) breed the GMO;
(d) propagate the
GMO;
(e) use the GMO in the course of manufacture of a thing that is not the
GMO;
(f) grow, raise or culture the GMO; and
(g) import the GMO;
and
also includes the possession, supply, use, transport or disposal of the GMO for
the purposes of, or in the course of, a dealing mentioned in any of paragraphs
(a) to (g).
“environment”
includes:
(a) ecosystems and their constituent parts; and
(b) natural and
physical resources; and
(c) the qualities and characteristics of locations,
places and areas.
It is intended that the definition of environment
include all animals (including insects, fish and mammals), plants, soils and
ecosystems (both aquatic and terrestrial).
“gene
technology” is defined to cover any technique for the modification
of genes or other genetic material, but does not include:
(a) sexual
reproduction;
(b) homologous recombination; or
(c) any other technique
specified in the regulations for the purposes of this
paragraph.
“genetically modified organism” is
defined as:
(a) an organism that has been modified by gene
technology;
(b) an organism that has inherited particular traits from an
organism (the initial organism), being traits that occurred in the initial
organism because of gene technology; or
(c) anything declared by the
regulations to be a genetically modified organism, or that belongs to a class of
things declared by the regulations to be genetically modified organisms;
but
does not include:
(d) a human being, if the human being is covered by
paragraph (a) only because the human being has undergone somatic gene therapy;
or
(e) an organism declared by the regulations not to be a genetically
modified organism, or that belongs to a class of organisms declared by the
regulations not to be a genetically modified organisms.
The ability to
prescribe things to be genetically modified organisms in regulations (under (c)
of the definition of a GMO) ensures there is capacity to regulate GM products
that are not regulated by existing regulatory agencies. An example of such a
‘gap’ product is GM stockfeed.
Human beings are excluded from
the definition of a GMO to ensure that a person who has undergone somatic cell
gene therapy (for example, treatment for cancer) is not a GMO (as defined in
this legislation), thus requiring the person to be licensed for the rest of
their lives because they have been modified by techniques of gene technology.
The conduct of human gene therapy will, however, continue to be regulated by the
TGA and, in the case of research involving human trials, also overseen by the
National Health and Medical Research Council. The Gene Technology Regulator
would also be involved if the work involves a live or viable GMO (presenting
possible occupational health and safety or environmental
risks).
“GM product”, which is defined as a
thing (other than a GMO) derived or produced from a GMO.
Clause 11 describes the circumstances in which a dealing will be
considered to involve an intentional release into the environment. The clause
provides that a dealing with a GMO involves the intentional
release of the GMO into the environment if the GMO is intentionally released
into the open environment, whether or not it is released with provision for
limiting the dissemination or persistence of the GMO or its genetic material in
the environment. This definition is intended to cover field trials of GM crops
and animals and any commercial release of a GMO into the
environment.
This definition is important for identifying the appropriate
assessment path to be applied in relation to the dealing with the GMO. The
process for approval of dealings with GMOs (as described in Part 5) varies
depending on whether the dealing is to occur under conditions of containment or
whether the dealing involves a deliberate release of the GMO into the
environment. This flexibility has been built into the scheme because of the
potential for different, or more serious, risks developing in relation to public
health and safety and the environment from dealings involving a release into the
environment, thereby necessitating a more comprehensive public consultation and
risk assessment process.
Sub-clause 12(1) provides that a corresponding State law means a
State law that is declared by the relevant Commonwealth Minister (the Minister),
by notice in the Gazette, to correspond to this Bill and the regulations,
including such a law as amended from time to time.
Sub-clause
12(2) provides that the Minister may, under certain circumstances, revoke a
Gazette notice which is declared under sub-clause 12(1). These circumstances
include: if the Minister is requested by the State concerned to revoke the
notice; or the State law has been amended otherwise than as agreed by a majority
of the members of the Ministerial Council (where that majority includes the
Commonwealth); or amendments to the State law have been agreed by a majority of
the members of the Ministerial Council (where that majority includes the
Commonwealth) and the State law has not been amended in accordance with that
agreement within a reasonable period after the agreement.
This clause describes the consitutional powers on which this legislation
is based. It specifies that the Bill applies to things done by: constitutional
corporations; a person that may cause the spread of diseases or pests; and the
Commonwealth and Commonwealth authorities. It also provides that the Bill covers
things done in the course of constitutional trade or commerce and for purposes
relating to the collection, compilation, analysis and dissemination of
statistics. It further provides that the Bill applies to things authorised by
the legislative power of the Commonwealth under paragraph 51(xxxix) of the
Constitution (which contains the ‘incidental’ power) in relation to
the aforementioned matters.
This clause ensures that the Bill has broad
coverage in all jurisdictions until such time as each State and Territory enacts
corresponding State laws at which time this legislation will
“wind-back” in respect of specified bodies and things (thereby
recognising the role, powers and functions of States and Territories). This
“wind-back” of the Commonwealth law is described in clause 14.
This clause provides for a “wind-back” of the reach of this
Bill, where States or Territories have enacted corresponding State laws.
This clause provides that, once a State or Territory enacts a
corresponding State law (as defined in clause 12) and the State has given a
notice to the Minister stating that this clause is to apply (a “wind-back
notice”), this Bill will “wind-back” its operation in respect
of:
(a) dealings with GMOs that would only have been regulated under this
Bill as a result of the application of the power in relation to limiting the
spread of pests and diseases; and
(b) dealings with a GMO undertaken by a
higher education institution or a State agency, and by persons authorised to
undertake the dealing by a licence held by a higher education institution or
State agency.
This clause clarifies that this Bill is not intended to “cover the
field” in respect of GMOs. This clause makes it clear that the provisions
of the Bill are in addition to, and not in substitution for, the requirements of
any other law of the Commonwealth, whether that law has been passed or made
before or after the commencement of the Bill.
Sub-clause 16(1) provides that the Bill is not intended to exclude
the operation of any State law, to the extent that the State law is capable of
operating concurrently with the Bill, other than a State law prescribed by the
regulations for the purposes of this section.
Sub-clause 16(2)
provides that the Governor-General may prescribe a State law under sub-clause
16(1) only if there is no corresponding State law in effect in relation to that
State. In addition, the Governor-General must be satisfied that either: the
State law relates specifically to dealings with GMOs; or for the purposes of a
decision under the State law as to whether or not a licence, authority or
approval is granted under the State law, the State law distinguishes between
dealings with GMOs and dealings with other things.
The intention of these
provisions is to ensure that existing and future State legislation (such as
general environmental, fisheries, and land management legislation) continues to
operate concurrently with this Bill, provided it is capable of doing so.
However, where State legislation is enacted that is inconsistent with the
national scheme of regulation for GMOs, or effectively establishes a dual
licensing regime, there is capacity for such laws to be prescribed as not
operating concurrently with this Bill.
Sub-clause 17(1) provides that a corresponding State law
may confer functions, powers and duties on: the Regulator or another officer of
the Commonwealth; a Commonwealth authority; and any of the Committees
established under the legislation (the Gene Technology Technical Advisory
Committee, the Gene Technology Ethics Committee and the Gene Technology
Community Consultative Group).
Sub-clause 17(2) empowers an
authority, officer or body on whom a function, power or duty is conferred, under
sub-clause 17(1), to perform the function or duty, or exercise the power.
Sub-clauses 17(3), (4) and (5) have been included to enable
corresponding State laws to empower the Regulator to include matters on the GMO
Register, or vary matters already on the Register and enter information on the
Record of GMO and GM Product Dealings, in accordance with a corresponding State
law.
Sub-clause 17(6) provides that the Regulator may annotate the
GMO Register or Record of GMO and GM Product Dealings to identify which entries
on the Register or Record relate to decisions made by the Regulator under a
corresponding State law.
Sub-clause 18(1) provides that if an act or omission is an offence
against the Bill and is also an offence against a corresponding State law, and
the offender has been punished for the offence under the corresponding
State law, then the offender is not also liable to be punished for the
offence under the Bill.
Sub-clause 18(2) provides that, if a
person has been ordered to pay a pecuniary penalty under a corresponding State
law because of certain conduct, the person is not liable to a pecuniary penalty
under the Bill for the same conduct.
This clause establishes that there
be no ‘double jeopardy’ under the Bill or a corresponding State law.
This clause provides the capacity for the Administrative Appeals Tribunal
to review decisions made under a corresponding State law, for example, where the
‘wind-back’ of this Bill has taken effect (in accordance with clause
14) and the decision by the Regulator is made under State legislation.
Sub-clause 19(2) provides that a decision of the Regulator is a
‘reviewable State decision’ where the State law provides for review
by the Administrative Appeals Tribunal and where the decision is declared in the
regulations to be a ‘reviewable State decision’.
Sub-clause 19(3) provides that for the purposes of this clause
the Administrative Appeals Tribunal Act 1975 has effect as if a
corresponding State law were an enactment of the Commonwealth.
This clause provides that licences, certificates and other things issued
or done under the Bill remain valid although they may have been done for the
purposes of a corresponding State law.
Sub-clause 21(1) enables the Ministerial Council to issue policy
principles in relation to ethical issues relating to dealings with GMOs and to
other matters relating to dealings with GMOs which are detailed in the
regulations. The Regulator will be required to observe such principles and must
not issue a licence under the legislation if he or she considers that to do so
would be inconsistent with a policy principle issued by the Ministerial
Council.
Sub-clause 21(2) sets out the criteria which must be
satisfied before the Ministerial Council. The Ministerial Council must be
satisfied that adequate consultation on the proposed principle has occurred in
accordance with the requirements of clause 22.
Sub-clause 21(3)
clarifies that regulations made describing issues in relation to which policy
principles may be made, may relate to matters beyond public health and safety
and the environment (such as cultural matters), but that the principles must not
detract from the protection of public health and safety and the environment.
For example, policy principles could not be made in relation to trade if the
effect of the principles were to override the primary object of the Bill which
is the protection of the health and safety of people and the
environment.
Sub-clause 21(4) specifies that these policy
principles are disallowable instruments for the purposes of section 46A of the
Acts Interpretation Act 1901.
This clause describes the consultation process that must be observed
before the Ministerial Council may issue a policy principle under clause 21. The
clause provides that the policy principles must be developed in consultation
with each of the three Committees established under the legislation (the Gene
Technology Technical Advisory Committee, the Gene Technology Ethics Committee
and the Gene Technology Community Consultative Group). The clause also requires
consultation with the Regulator and appropriate Commonwealth and State agencies.
Consultation must also be undertaken with industry, environmental, consumer and
other groups, as determined by the Ministerial Council.
The clause does
not describe who will be responsible for developing the draft policy principles,
as this will vary depending on the subject matter of the policy principles. For
example, it is anticipated that policy principles related to ethical matters
would be developed by the Gene Technology Ethics Committee, while other policy
principles may be developed by the Regulator or the Gene Technology Community
Consultative Group. Once drafted and following extensive consultation, the
proposed policy principles would be put to the Ministerial Council for
consideration and issuing.
Sub-clause 22(2) anticipates that the
Ministerial Council will issue more detailed guidelines regarding consultation
processes, and provides that where such guidelines are issued, they must be
observed by the Committees or other bodies developing policy principles.
This clause allows the Ministerial Council to issue policy guidelines in
relation to matters relevant to the functions of the Regulator. Such policy
guidelines are distinguishable from policy principles (described in clause 21)
as these guidelines will not be binding on the Regulator. The Regulator will,
however, be required to take such guidelines into account when deciding on an
application for a licence under the legislation.
This clause allows the Ministerial Council to issue codes of practice in
relation to gene technology.
Sub-clause 24(2) describes the
requirements for consultation which must be met before the Ministerial Council
may issue a code of practice. The Regulator must develop the codes of practice
in consultation with the three committees established under the legislation (the
Gene Technology Technical Advisory Committee, the Gene Technology Ethics
Committee and the Gene Technology Community Consultative Group). The Regulator
must also consult with Commonwealth and State agencies, regulatory agencies and
industry, environmental, consumer and other groups as determined by the
Commonwealth and the States.
It is intended that such codes of practice
will form the basis for certain conditions imposed under a licence (under clause
62). Given the legislative intent of the codes of practice, sub-clause
24(3) provides that codes of practice are disallowable instruments for the
purposes of section 46A of the Acts Interpretation Act 1901.
This clause gives a simplified outline of the Part.
This clause establishes the Regulator. The Regulator will be a statutory
office holder with significant independence. This position is expected to be
akin to the Auditor General, Commonwealth Ombudsman, and the Chief Executive
Officer of the Australian Radiation Protection and Nuclear Safety
Agency.
This clause sets out the functions of the Regulator. The Regulator will
be responsible for:
(a) performing functions in relation to GMO licences as set out in Part 5. Part 5 describes the process for initial consideration, assessment and decision making in relation to applications for licences under the Bill;
(b) developing draft policy principles and policy guidelines as requested by the Ministerial Council;
(c) developing codes of practice;
(d) issuing technical and procedural guidelines in relation to GMOs;
(e) providing information and advice to other regulatory agencies about GMOs and GM products;
(f) providing information and advice to the public about the regulation of GMOs;
(g) providing advice to the Ministerial Council about the operations of the Regulator and the Gene Technology Technical Advisory Committee; and about the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation;
(h) undertaking or commissioning research in relation to risk assessment and the biosafety of GMOs;
(i) promoting the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies;
(j) monitoring international practice in relation to the regulation of GMOs;
(k) maintaining links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia; and
(l) performing such other functions as are conferred on the Regulator by this
Bill, the regulations or any other law.
This clause clarifies that the Regulator has power to do all things
necessary or convenient to be done in connection with the performance of the
Regulator’s functions.
This clause allows the Regulator to delegate the Regulator’s powers
or functions to Commonwealth officers and State and Territory officers where the
functions of such officers relate directly or indirectly to GMOs or GM products.
This is important so that, with their agreement, Commonwealth and State officers
can be enlisted to assist the Regulator in, for example, undertaking monitoring
activities. While the Regulator will be responsible for assessing applications
and issuing licences, the Regulator may need to delegate some functions to, for
example, officers of the Australian Quarantine and Inspection Service to enable
them to inspect imported GMOs at Australia’s border to ensure compliance
with any licence issued by the Regulator.
Sub-clause 29(2)
requires that delegates comply with any directions issued by the Regulator.
Clause 30 - Independence of the Regulator
This clause
entrenches the Regulator’s independence and discretion in relation to the
exercise of his or her powers or functions. It specifically provides that the
Regulator may not be directed by anyone in respect of whether or not a
particular application for a GMO licence is issued or refused, nor in respect of
conditions to which a particular GMO licence may be subject.
DIVISION 1 – Simplified outline
Clause 31 –
Simplified outline
This clause gives a simplified outline of the
Part.
Clause 32 - Person not to deal with a GMO without a
licence
This clause describes the central prohibition in this
legislation. It provides that a person is guilty of an offence if:
(a) the
person deals with a GMO knowing that it is a GMO; and
(b) the person knows
that the dealing with the GMO is not authorised by a GMO licence or is reckless
as to whether or not the dealing is so authorised; and
(c) the person knows
that the dealing is not a notifiable low risk dealing (as described in clause
74) or is reckless as to whether or not the dealing is a notifiable low risk
dealing; and
(d) the person knows that the dealing is not an exempt dealing
(as specified by the regulations) or is reckless as to whether or not the
dealing is an exempt dealing; and
(e) the person knows the dealing is not
included on the GMO Register (as established under clause 76) or is reckless as
to whether or not the dealing is included on the GMO Register.
A person
must not, therefore, deal with a thing they know to be a GMO without a licence
authorising that dealing, unless the dealing is a notifiable low risk dealing,
has been specifically exempted from the application of the legislation under the
regulations, or has been placed on the GMO Register.
The note at the end
of sub-clause 32(1) alerts readers to Chapter 2 of the Criminal Code
which sets out the principles of criminal responsibility which must be met for a
successful prosecution. Chapter 2 of the Criminal Code sets out the
“mental” or “fault” elements that are necessary for the
prosecution to establish in relation to an offence (such as intent or
recklessness).
Sub-clause 32(2) describes the maximum penalties
that may be imposed in relation to an offence under sub-clause 32(1). If the
offence is an aggravated offence (as defined in clause 38 as being an offence
that causes significant damage, or is likely to cause significant damage, to the
health and safety of people or the environment) the penalty is 2,000 penalty
units. This equates to $220,000 for an individual and $1.1 million for a body
corporate (the Crimes Act 1914 provides that a penalty unit is currently
equivalent to $110).
In any other case, the maximum penalty is 500
penalty units which equates to $55,000 for an individual and $275,000 for a body
corporate.
Sub-clause 32(3) defines “exempt dealing”
to be a dealing specified in the regulations as an exempt
dealing
Sub-clause 32(4) provides that regulations may exempt all
dealings with a GMO, a class of GMOs, a class of dealings with a GMO or class of
GMOs, or one or more specified dealings with a GMO or with a specified class of
GMOs. A class of dealings or a class of GMOs may be defined by a range of
matters. For example, an exempt class of dealings with a GMO may be limited by
the type of GMO, who deals with the GMO, how the GMO is dealt with and whether
the GMO is regulated under existing legislation.
Clause 33 - Person
not to deal with a GMO without a licence—strict liability
offence
This clause describes the same offence as clause 32 but
enables strict liability to apply in respect of the offence. This means that a
smaller penalty (200 penalty units in the case of an aggravated offence and 50
penalty units in any other case) may be applied in relation to lesser offences
without the need to establish all of the fault elements of the offence.
While it is necessary to establish that the person dealt with the GMO
knowing that it was a GMO, the fact that they dealt with the GMO without a
licence or without the dealing being a notifiable low risk dealing, exempt
dealing or dealing on the GMO Register, is sufficient. It will not be necessary
to establish that they knowingly or recklessly dealt with the GMO without
approval under the legislation.
Clause 34 - Person must not breach
conditions of a GMO licence
Sub-clause 34(1) provides that a
holder of a GMO licence is guilty of an offence if they intentionally do
something, or fail to do something, that they know will result in a breach of a
condition of licence or that they do being reckless as to whether or not the
action or omission will contravene the licence.
Sub-clause 34(2)
establishes a similar offence for persons covered by a GMO licence who do
something, or fail to do something, which results in a breach of a condition of
licence. However, in this case it is also necessary for the prosecution to
establish that the person had knowledge of the conditions of licence. By
contrast, in relation to offences committed by holders of a licence (under
sub-clause 34(1)) it is assumed that all licence holders would necessarily have
knowledge of the conditions of a licence.
Sub-clause 34(3)
describes the maximum penalties that may be imposed in relation to an offence
under sub-clauses 34(1) and (2). If the offence is an aggravated offence (as
defined in clause 38 as being an offence that causes significant damage, or is
likely to cause significant damage, to the health and safety of people or the
environment), the penalty is 2,000 penalty units. This equates to $220,000 for
an individual and $1.1 million for a body corporate (the Crimes Act 1914
provides that a penalty unit is currently equivalent to $110). In any other
case, the maximum penalty is 500 penalty units, which equates to $55,000 for an
individual and $275,000 for a body corporate.
Clause 35 - Person must
not breach conditions of a GMO licence—strict liability
offence
This clause describes the same offences as clause 34 but
enables strict liability to apply in respect of the offences. This means that a
smaller penalty (200 penalty units in the case of an aggravated offence and 50
penalty units in any other case) may be applied in relation to lesser offences
(such as a breach of more minor conditions of licence) without the need to
establish all of the fault elements of the offence.
Under this clause,
if a licence holder breaches a condition of licence, it is not necessary to
establish that they did so knowingly or recklessly in order for the penalty to
be applied.
If a person covered by a licence breaches a condition of
licence, provided it can be established that they had knowledge of the
conditions of licence, it is not necessary to establish that they breached the
condition of licence knowingly or recklessly in order for the penalty to be
applied.
Clause 36 - Person must not breach conditions on GMO
Register
This clause provides that a person is guilty of an offence
if the person deals with a GMO knowing that it is a GMO, and the dealing is in
breach of a condition specified on the GMO Register (described in Part 6,
Division 3) relating to the dealing.
Recognising that dealings with
GMOs are only entered on the GMO Register after a period of licensing and after
the Regulator is satisfied that any risks are minimal and that it is no longer
necessary for the GMO to be licensed directly, the penalty for breach of any
condition is smaller than the penalties for breach of a condition of licence.
Sub-clause 36(1) provides that the maximum penalty is 50 penalty
units.
Sub-clause 36(2) provides that the person must have dealt
with the GMO knowing that it is a GMO. However, strict liability applies in
relation to establishing that the dealing is on the GMO Register and that the
dealing contravened a condition on the Register.
Clause 37 - Offence
relating to notifiable low risk dealings
Notifiable low risk dealings
are described in clause 74. Notifiable low risk dealings are categories of
dealings with GMOs that are low risk dealings. For example, research with low
risk GMOs occurring within facilities that are entirely contained. The types of
dealings which are notifiable low risk dealings will be set out in regulations,
along with any conditions that must be complied with in respect of such
dealings.
Sub-clause 37(1) provides that a person is guilty of an
offence if they deal with a GMO knowing that it is a GMO, that the dealing is a
notifiable low risk dealing, and that the dealing has been undertaken in
contravention of the regulations (which describe the conditions to be observed).
The maximum penalty is 50 penalty units.
Sub-clause 37(2)
provides that strict liability applies in relation to establishing that the
dealing is a notifiable low risk dealing and that the dealing was not undertaken
in accordance with the conditions prescribed in the
regulations.
Clause 38 - Aggravated offences—significant damage
to health or safety of people or to the environment
This clause
describes the concept of an “aggravated offence”, as referenced in
clauses 32, 33, 34 and 35. An aggravated offence is one that causes significant
damage, or is likely to cause significant damage, to the health and safety of
people or to the environment. This recognises that some offences against the
Bill are potentially more serious than others (given the possible significant
consequences that may flow from an action), and that in the event of such
serious offences there should be higher penalties.
Sub-clause
38(2) provides that in order to prove an aggravated offence, the prosecution
must prove that the person who committed the offence intended his or her conduct
to cause significant damage to the health and safety of people, or to the
environment or that the person was reckless as to whether his or her conduct
would cause such significant damage.
This clause gives a simplified outline of the Part.
This clause describes the requirements for applying to the Regulator for
a licence to undertake certain dealings with GMOs.
Sub-clause
40(2) provides that the licence applicant must apply in writing and must
provide all of the information requested by the Regulator and prescribed in the
regulations. The applicant will be required to provide the Regulator with all
of the information that is necessary to support the assessment of the
application including information about potential risks associated with the
proposed dealings and how the applicant proposes to manage any such
risks.
Sub-clause 40(3) requires that the application specify
whether any of the dealings proposed to be authorised by the licence would
involve the intentional release of a GMO into the environment. This is important
as it determines the assessment process applied in relation to the
application.
Sub-clause 40(4) clarifies that an application may be
made in respect of one dealing, one or more specified dealings, or in respect of
a class of dealings with specified GMOs or classes of GMOs.
Sub-clause
40(5) clarifies that the applicant may apply for authorisation for the
dealings with the GMO to be undertaken by a named person, a class of persons or
all persons.
Sub-clause 40(6) provides that the application must
be accompanied by an application fee if such an application fee is prescribed in
the regulations.
Clause 41 - Application may be
withdrawn
This clause allows the applicant to withdraw a licence
application at any time before the licence is issued.
Sub-clause
41(2) provides that the application fee is not refundable if the applicant
withdraws the application.
This clause enables the Regulator to require an applicant for a licence
to give the Regulator such further information in relation to the application as
the Regulator requires. The request for further information must be by notice
in writing and may specify the period within which information is to be
provided.
This clause enables the Regulator to undertake an initial
“screening” of an application before he or she accepts the
application. As part of this initial screening, the Regulator looks at
whether:
• the application contains the required information, including
any further information previously requested by the Regulator;
• the
application indicates whether it involves a deliberate release into the
environment or not (as this will be important for determining the assessment
process undertaken);
• it is accompanied by the requisite application
fee; and
• the application is inconsistent with a policy principle
issued by the Ministerial Council under clause 21.
If the application
is inadequate on any of these grounds, the Regulator may refuse to undertake any
further consideration of the application.
Sub-clause 43(3)
provides that the Regulator must issue the licence or refuse to issue the
licence within any statutory timeframe described in the regulations.
This clause allows the Regulator to consult with the applicant on an
application before considering that application. This provides capacity for the
Regulator to hold ‘pre-conferences’ with applicants to assist their
understanding of the regulatory requirements. If the application relates to a
GMO that will also require approval from an existing regulator or regulators at
some point during the life cycle of the GMO or its products, the Regulator may
also involve these other relevant regulators to ensure an effective and
efficient interface between the relevant regulatory agencies.
Clause
45 - Regulator must not use certain information in considering licence
application
This clause provides that, where a person provides
confidential commercial information in support of a licence application, the
Regulator must not use that information to consider a licence application by
another person unless the first person has given written consent for the
information to be used.
This clause is intended to combat the
‘free rider’ effect, where it would be possible for a second
applicant to minimise the resource implications of a licence application by
referring to, or using, information already made available to the Regulator in
support of another application.
Whilst the Regulator may not consider
the information submitted by the first party in relation to an application by a
second party (without the written permission of the first party) this does not
preclude the Regulator from utilising resources generated by the Regulator in
relation to the first application (eg literature searches) in considering the
second application. Further, the Regulator may use information he or she learns
about risk in respect of the first application, to aid consideration of the
second.
DIVISION 3—Initial consideration of licences for
dealings not involving intentional release of a GMO into the
environment
This clause provides that Division 3 applies to an application for a GMO
licence where the Regulator is satisfied that none of the dealings proposed to
be authorised by the licence would involve the intentional release of a GMO into
the environment. This would include, for example, applications in respect of
dealings with GMOs within a contained laboratory.
The term
‘intentional release of a GMO into the environment’ is defined in
clause 11.
This clause sets out the steps that the Regulator must take in assessing
an application and before a decision on the application is
made.
Sub-clause 47(1) provides that before issuing a licence, the
Regulator must prepare a risk assessment and risk management plan in relation to
the GMO and the proposed dealings in the licence application. The risk
assessment must take into account any risks posed to health and safety of people
or the environment, by the proposed dealing with the GMO. The risk management
plan must take into account how any such risks may be managed so as to protect
the health and safety of people and the environment.
Sub-clause
47(4) provides that the Regulator may consult the States, the Gene
Technology Technical Advisory Committee, relevant Commonwealth authorities and
local councils, as well as any other person, on any aspect of the
application.
DIVISION 4 - Initial consideration of licences for
dealings involving intentional release of a GMO into the environment
This clause provides that Division 4 applies where the Regulator is
satisfied that at least one of the dealings proposed to be authorised by the
licence involves the intentional release of a GMO into the environment. For
example, this Division applies to small-scale experimental trials of GMO crops
conducted in fields or waterways and applications for commercial release of a
GMO, for example, large scale growing of crops for commercial sale.
The
term ‘intentional release of a GMO into the environment’ is defined
in clause 11.
Clause 49 - Dealings that may pose significant risks to
the health and safety of people or the environment
This clause
describes the process that the Regulator must follow, and the matters the
Regulator must consider, where at least one of the dealings proposed to be
authorised by the licence may pose significant risks to the health and safety of
people or the environment.
Recognising that applications for licences
involving the intentional release of GMOs into the environment may be varied,
and that the risks posed by applications also vary, it is important that the
Regulator have the capacity to apply an assessment process appropriate for
considering the risks posed by the particular application. For example, the
risks posed in relation to an application seeking authorisation to hold two
genetically modified cows in a double-fenced holding pen are very different to
the risks that may be posed by the extensive growing of genetically modified
crops in open fields. While both involve the deliberate release of a GMO into
the environment, this clause enables the Regulator to apply a higher level of
public scrutiny to applications which pose greater potential
risks.
Sub-clause 49(1) requires that the Regulator inform
stakeholders and the community of the receipt of all applications relating to
dealings that may pose significant risks to the health and safety of people or
to the environment via a wide publication of a notice in respect of the
application. The Regulator must provide public notification of such
applications by notice in the Gazette, by advertisement in a newspaper
circulating nationally and by notice on the Regulator’s website. The
Regulator may also choose to notify receipt of such an application through other
means, such as direct mailing individuals and organisations who have registered
an interest in receiving such information from the
Regulator.
Sub-clause 49(2) sets out the matters that the
Regulator must have regard to in determining whether the dealings proposed to be
authorised by the licence may pose significant risks to the health and safety of
people or the environment. The Regulator must, for example, consider the
potential for spread of the GMO, the scale of the proposed dealings, and the
effects of the genetic modification on the properties of the
organism.
Sub-clause 49(3) sets out certain requirements for the
content of the public notification in respect of the application. The notice
must: state that an application has been made; state that a person may request
further information about the application; invite written submissions on the
application; and specify the closing date for submissions (being no earlier than
30 days after the date on which the notice was published). The Regulator may
however decide on a longer period of consultation.
Sub-clause 50(1) provides that, before issuing a licence, the
Regulator must prepare a comprehensive risk assessment and risk management plan.
The risk assessment would:
• identify any hazards to public health and
safety or the environment associated with the dealing, based on objective
information;
• estimate the probabilities of hazards occurring;
and
• estimate the risk that is a function of the above two
factors.
Following the estimation of risk, a risk management plan would
identify measures for managing any risks identified in order to reduce the
probability of hazards occurring. The risk management plan may provide that the
risks cannot be managed and, as such, a licence should not be granted.
Alternatively the plan could set out conditions that would be necessary for the
risks to be effectively managed.
It is intended that the Regulator will
issue detailed guidelines regarding the process for risk assessment and risk
management, following extensive public consultation on these matters.
Sub-clause 50(2) clarifies that, regardless of the
Regulator’s initial consideration regarding the risks of the proposed
dealings and whether or not a first round of public consultation was therefore
necessary, the Regulator must prepare a comprehensive risk assessment and risk
management plan (such assessments and plans must then be notified publicly under
clause 52).
Sub-clause 50(3) provides that, in preparing a risk
assessment and risk management plan, the Regulator must seek advice from a range
of parties, including the Gene Technology Technical Advisory Committee, the
States, the Commonwealth Environment Minister, prescribed Commonwealth agencies
and relevant local councils.
Clause 51 - Matters Regulator must take
into account in preparing risk assessment and risk management
plan
Sub-clause 51(1) details a range of matters which must be
considered by the Regulator in preparing the risk assessment. Those matters
include the risks posed by the proposed dealings, submissions made to the
Regulator, and any advice provided by the Gene Technology Technical Advisory
Committee and Commonwealth, State and local government agencies.
Sub-clause 51(2) details the range of matters which must be
considered by the Regulator in preparing the risk management plan. Those matters
include the means of managing any risks to the health and safety of people and
the environment posed by the proposed dealings, submissions made to the
Regulator, and any advice provided by the Gene Technology Technical Advisory
Committee, the Commonwealth Environment Minister and Commonwealth, State and
local government agencies. Regulations may also prescribe other matters to be
taken into account by the Regulator in preparing the risk assessment or risk
management plan.
Sub-clause 51(3) provides that, in ascertaining
the best means of managing the risks associated with the GMO, the Regulator is
not limited to considering submissions or advice made or given to him or her,
and may inform him or herself through other means such as independent research.
This clause describes the process the Regulator must follow after having
prepared a draft risk assessment and risk management plan. The Regulator must
notify the public stating that a risk assessment and risk management plan has
been prepared. The notice must: inform people that they are able to request a
copy of the risk assessment and risk management plan (in accordance with clause
54); invite written submissions on the risk assessment and risk management plan;
and specify the closing date for submissions (which may not be earlier than 30
days after the notice was published).
The Regulator must publish the
notice in the Government Gazette, a newspaper circulating in all States and on
the Regulator’s website. The Regulator may also supplement this
notification by, for example, direct mailing all persons who have registered an
interest in receiving notification of applications and placing advertisements in
the papers of regional areas affected by the application.
Sub-clause
52(3) also requires the Regulator to seek the views of the Gene Technology
Technical Advisory Committee, the States, Commonwealth agencies prescribed in
regulations, the Commonwealth Environment Minister and such local councils as
the Regulator considers appropriate.
This clause allows the Regulator to take other actions to determine
whether the range of dealings proposed by the application do indeed pose risks
to the health and safety of people or the environment. These actions may include
a public hearing.
Sub-clauses 53 (2) – (4) set out certain
requirements in relation to public hearings, including the capacity for the
Regulator to give directions restricting the publication of evidence given at a
public hearing (sub-clause 53(3)) and a penalty where such directions are
contravened.
This clause clarifies that when a person requests a copy of a licence
application or risk assessment or risk management plan, the Regulator must
provide the person with the information, excluding any confidential commercial
information and any information about the applicant’s relevant convictions
(within the meaning of clause 58).
DIVISION
5 - Decision on licence
etc.
Clause
55 - Regulator must make a decision on licence and licence
conditions
This clause provides that, after taking the steps required
in Division 3 or 4 of part 5 in relation to an application for a GMO licence,
the Regulator must decide whether or not to issue a licence. If the Regulator
decides to issue a licence, he or she may impose conditions in relation to the
dealings with the
GMO.
Clause
56 - Regulator must not issue the licence unless satisfied as to risk
management
Sub-clause 56(1) provides that the Regulator must
not issue the licence unless he or she is satisfied that any risks posed by the
proposed dealings are able to be managed in such a way as to protect the health
and safety of people and the environment.
Sub-clause 56(2)
specifies the matters that the Regulator must have regard to in making a
decision under sub-clause 56(1) as including: a risk assessment; the risk
management plan; any submissions received on the risk assessment and risk
management plan; and any policy guidelines in force under clause 23 (as issued
by the Ministerial Council).
Clause
57- Other circumstances in which Regulator must not issue the
licence
This clause sets out the other circumstances in which the
Regulator must not issue the licence. These circumstances include:
(a) where
the issue of the licence would be inconsistent with a policy principle issued by
the Ministerial Council under clause 21; and
(b) where the Regulator is not
satisfied that the applicant is a suitable person to hold the licence. Matters
that the Regulator must take into account when determining an applicant’s
suitability are described in clause 58.
Clause
58
- Matters to be taken into account in deciding whether a person is suitable to
hold a licence
This clause allows the Regulator to consider a range
of matters in deciding whether a natural person or a corporation is suitable to
hold a licence.
Sub-clause 58(1) specifies that, in relation to a
natural person, the Regulator must have regard to any relevant conviction of the
person, and any revocation or suspension of a licence or permit relating to the
health and safety of people or the environment which is or was held by the
person under a law of the Commonwealth, a State, or a foreign country. The
Regulator must also consider the capacity of the person to meet the conditions
of the licence. This may include, for example, a consideration of the
person’s financial viability, personal skills and experience, and any
other matters that may influence the capacity of the applicant to fulfill any
conditions of licence imposed by the Regulator.
Sub-clause 58(2)
specifies that, for a body corporate, the Regulator must have regard to any
relevant conviction of the body corporate, and where there is a relevant
conviction, whether the offence was committed at a time when any person who is
presently a director, officer or shareholder of the corporation was a director,
officer or shareholder. This sub-clause also requires the Regulator to consider
any revocation or suspension of a licence or permit relating to the health and
safety of people or the environment which is or was held by the corporation
under a law of the Commonwealth, a State, or a foreign country. The Regulator
must also consider the capacity of the corporation to meet the conditions of the
licence.
Sub-clause 58(3) clarifies the meaning of a
‘relevant conviction’. Not only must the offence have related to a
law concerning the health and safety of people or the environment, but the
offence must have been committed within the period of 10 years immediately
before the making of the application for the licence, and the offence must have
been punishable by a fine of $5,000 or more, or by a term of imprisonment of one
year or more.
Sub-clause 58(4) clarifies that the clause does not
affect the operation of Part VIIC of the Crimes Act 1914, which relieves
persons of disclosing spent convictions in certain circumstances.
Clause
59 - Notification of licence decision
This clause requires
that the Regulator provide a written notification to the applicant of the
Regulator’s decision, including any conditions imposed.
Clause
60 - Period of licence
This clause specifies that a licence
issued under the Bill remains valid either until the end of a specified period,
or until it is cancelled or surrendered.
Sub-clause 60(2) provides
that a licence is not in force during any period of
suspension.
DIVISION
6 - Conditions of
licences
Clause
61 - Licence is subject to conditions
This clause provides
that licences may be subject to a range of conditions, including conditions set
out in clauses 63, 64 and 65, conditions prescribed by the regulations and
conditions imposed by the Regulator at the time of issuing the licence or at any
time
thereafter.
Clause
62 - Conditions that may be prescribed or
imposed
Sub-clause 62(1) enables the Regulator to impose
conditions in relation to the GMO that relate to the ‘full
life-cycle’ of the GMO, including any products derived from that GMO.
Sub-clause 62(2) lists some of the possible licence conditions
which may be imposed. Licence conditions may, for example, relate to: limiting
the scope of the dealings authorised by the licence, the purposes for which the
dealings may be undertaken, and the geographic area in which the dealings
authorised by the licence may occur; labeling of the GMO; limiting the
dissemination or persistence of GMO in the environment; and contingency planning
in respect of unintended effects of the dealings authorised by the
licence.
Clause
63 - Condition about informing people of
obligations
Sub-clause 63(1) makes it a condition of a licence
that the licence holder inform any person covered by the licence, and to whom a
particular condition of the licence applies, of several matters. These are: the
particular conditions applying to the person (including any variations of
conditions); the cancellation or suspension of the licence; and the
licence-holder’s surrender of the licence.
Sub-clause 63(2)
allows the Regulator or the regulations to specify particular requirements for
the way that people covered by a licence must be informed of their obligations
by the licence holder.
Sub-clause 63(3) notes that such
requirements may include measures relating to labelling, packaging, conducting
training and providing information in relation to the dealings with the
GMO.
Sub-clause 63(4) makes it a condition of licence that, where
requirements for informing people covered by a licence have been prescribed or
specified, the licence holder must comply with those requirements.
Clause
64 - Condition about monitoring and audits
This clause
requires that, where a person is authorised to deal with a GMO, and a particular
licence condition applies to that dealing, the person authorised to deal with
the GMO must allow the Regulator (or his or her delegate) to enter premises
where the dealing is being undertaken, for the purposes of auditing or
monitoring the dealing.
This condition enables the Regulator to undertake
routine or “on-the-spot” auditing and/ or monitoring of licensed
dealings with GMOs to ensure that any conditions imposed are being complied with
and that the activity with the GMO is being conducted safely. The auditing and
monitoring powers of the Regulator (provided for by this clause) are also
supplemented by the inspection powers of inspectors in the case of a possible
breach of the legislation. Part 11 of the Bill describes these additional
powers of
inspection.
Clause
65 - Condition about additional information to be given to the
Regulator
This clause makes it a condition of a licence, and
therefore compels the licence holder, to provide information to the Regulator in
the following circumstances:
• where he or she becomes aware of
additional information as to any risks to the health and safety of people or to
the environment associated with the dealings authorised by the licence; or
• where he or she becomes aware of any contraventions of the licence
by a person covered by the licence; or
• where he or she becomes aware
of any unintended effects of the dealings authorised by the
licence.
Sub-clause 65(2) specifies that the licence holder is
taken to have become aware of additional information as to risks if he or she
was reckless as to whether such information existed. The licence holder is also
taken to have become aware of contraventions or unintended effects of the
licence if he or she was reckless as to whether such contraventions had occurred
or unintended effects existed.
This clause provides that a person covered by a licence may inform the
Regulator if he or she becomes aware of additional information as to any risks
associated with the dealings authorised by the licence that may pose risks to
the health and safety of people or to the environment. A person who becomes
aware of any contraventions of the licence by a person covered by the licence,
or becomes aware of any unintended effects, may also provide such information to
the
Regulator.
Clause
67 - Protection of persons who give information
This clause
provides that civil proceedings may not be brought against a person who has
given information to the Regulator because another person has suffered loss,
damage or injury as the result of the disclosure of information to the
Regulator. This clause does not, however, affect any rights a person may have
against an informer who published the information more broadly than just to the
Regulator – this clause only provides protection in respect of civil
proceedings in relation to the disclosure of the information to the Regulator.
DIVISION
7 - Suspension, cancellation and variation of
licences
Clause
68 - Suspension and cancellation of licence
This clause gives
the Regulator the power to suspend or cancel a licence. This power may be
exercised by the Regulator by giving written notice to the licence holder. The
grounds for the exercise of this power are listed in this clause and include:
suspected breach of a licence condition; suspicion that an offence has been
committed against the Bill; or where the Regulator becomes aware of new
information about the risks associated with the licensee’s dealings, and
he or she is satisfied that the licensee does not have adequate measures to deal
with those risks.
Clause 69 - Surrender of licence
This
clause allows a licence holder to surrender a licence, with the consent of the
Regulator.
Clause 70 - Transfer of licences
This clause
allows for a licence to be transferred from the licence holder to a
‘transferee’ provided that certain requirements are
met.
Sub-clause 70(1) provides that a licence holder and the
person to whom it is proposed that the licence be transferred (the transferee)
may jointly apply to the Regulator for the licence to be
transferred.
Sub-clause 70(2) specifies that the application must
be in writing and must include information specified by the Regulator and/or
prescribed in the regulations.
Sub-clause 70(3) requires that, in
deciding whether to approve the transfer of the licence, the Regulator must be
satisfied that any risks posed by the dealings will continue to be managed in
such a way as to protect the health and safety of people, and the
environment.
Sub-clause 70(4) also requires that the Regulator
decide whether the transferee is a ‘suitable person’ to hold the
licence. The criteria described in clause 58 would be used by the Regulator in
making such an assessment.
Sub-clause 70(5) requires that the
Regulator provide written notice of his or her decision to the licence holder
and the transferee.
Sub-clause 70(6) sets out the effect of a
transfer. The transfer takes effect on the date specified in the written notice
provided to the licence holder and the transferee by the Regulator and the
licence continues in force under clause 60 subject to the same conditions as in
force immediately before the transfer. The Regulator may however subsequently
vary the conditions of licence (if necessary) in accordance with clause
71.
Clause 71 - Variation of licence
This clause allows the
Regulator to vary a licence where he or she is satisfied that any variation will
have the effect of ensuring that any risks to the health and safety of people
and the environment are properly managed.
Sub-clause 71(2)
provides that the Regulator’s discretion to vary the licence is limited.
The Regulator must not vary a licence so as to authorise dealings involving the
intentional release of a GMO into the environment if the application for the
licence was originally considered under Division 3 (which deals with licence
applications where there is to be no release of the GMO into the environment).
Sub-clause 71(3) allows the Regulator to vary a licence in a
number of ways, including: by imposing additional licence conditions; removing
or varying conditions; or by extending or reducing the authority granted by the
licence.
Sub-clause 71(4) provides that the Regulator must not
vary a licence if to do so would mean that any risks posed by a dealing
authorised by the licence could not be properly managed so as to ensure the
continued protection of the health and safety of people and the
environment.
Clause 72 - Regulator to notify of proposed suspension,
cancellation or variation
Sub-clauses 72(1), (2) and (3)
specify that the Regulator must give written notice of a proposed suspension,
cancellation, or variation of a licence to the licence holder. The notice must
state the Regulators intentions regarding the suspension, cancellation or
variation of the licence. The notice may also require the licence holder to
give the Regulator specified information which is relevant to the proposed
changes to the licence, and may invite the licence holder to make a written
submission to the Regulator about the proposed suspension, cancellation or
variation. The licence holder must be given at least 30 days in which to
provide the requested information or make a written
submission.
Sub-clause 72(4) requires that the Regulator consider
any submission made by the licence holder in making the decision to suspend,
cancel or vary the licence.
Sub-clause 72(5) clarifies that the
requirements set out in this clause are not necessary where the suspension,
cancellation or variation has been requested by the licence
holder.
Sub-clause 72(6) waives the formal requirements for
notification to the licence holder where the Regulator considers that the
suspension, cancellation or variation is necessary in order to avoid an imminent
risk of death, serious illness, serious injury or serious damage to the
environment.
PART
6 - REGULATION OF NOTIFIABLE LOW RISK DEALINGS AND DEALINGS ON THE GMO
REGISTER
DIVISION 1 – Simplified
outline
Clause 73 – Simplified outline
This
clause gives a simplified outline of the
Part.
DIVISION
2—Notifiable low risk
dealings
Clause
74 - Notifiable low risk dealings
This clause allows
regulations to be made which declare a particular dealing with a GMO to be a
‘notifiable low risk dealing’ for the purposes of this Bill. These
would be low risk dealings in contained facilities that the Regulator determines
to be low risk on the basis of experience and previous risk assessments of the
class of dealings.
Sub-clause 74(2) provides that a notifiable
low risk dealing can never involve the intentional release of the GMO into the
environment. That is, dealings with GMOs may only be prescribed in the
regulations as notifiable low risk dealings if the dealings are carried out
within contained facilities.
Sub-clauses 74(3) specifies the
matters to be considered by the Regulator before regulations are made
prescribing notifiable low risk dealings. Relevant considerations include:
whether the GMO is ‘biologically contained’ (because it is not able
to survive or reproduce without human intervention); whether the dealing
involves minimal risk (taking into account the properties of the GMO as a
pathogen or pest and its capacity to produce toxic proteins); and whether
proposed conditions will be adequate to manage any risk associated with the
proposed dealing.
Sub-clause 74(4) provides that where
regulations are made prescribing certain dealings as notifiable low risk
dealings, the regulations may be expressed to apply to a single dealing, a class
of dealings or all dealings with a GMO or a class of
GMOs.
Clause
75 - Regulation of notifiable low risk dealings
Sub-clause
75(1) allows regulations to be made which regulate one notifiable low risk
dealing, or a specified class of notifiable low risk dealings.
Sub-clause 75(2) specifies that the regulations may contain
certain conditions which must be complied with by persons undertaking notifiable
low risk dealings, including requirements in relation to: the class of person
who may undertake notifiable low risk dealings; notification of the dealings to
the Regulator; the need for supervision by an Institutional Biosafety Committee;
and the containment level of facilities in which such dealings are undertaken.
The role of Institutional Biosafety Committees, set up within Accredited
Organisations, is explained in more detail in Part 7, Division
3.
DIVISION
3—The GMO
Register
Clause
76 - GMO Register
This clause establishes the GMO Register,
which is to be kept in a computerised form and maintained by the Regulator.
As described in this Division, the purpose of the GMO Register is to
enable certain dealings with GMOs to be undertaken without the requirement for a
licence to be held by a named individual or organisation. Dealings with GMOs
may be entered on the GMO Register once they have been licensed for a certain
period of time, and once the Regulator is satisfied that the dealings with the
GMO are sufficiently safe that they can be undertaken by anyone without the GMO
being dependent on oversight by a licence holder).
For example, a
company who wished to market a flower that had been genetically modified to
extend vase life, would initially apply for a licence to do so. If any risks
posed by the flower could be managed, the Regulator would grant the applicant a
licence subject to, as a minimum, conditions requiring provision of any further
information about risks or unintended effects by the licence holder and a
requirement that the Regulator be allowed to enter premises to undertake
auditing and monitoring. After a period of time (for example, 5 years), the
Regulator could re-examine the licence and determine that, on the basis of the
absence of risks posed by the flower, it is no longer appropriate for the flower
to be subject to the licensing regime and that the flower should be entered on
the Register, enabling unrestricted use.
Clause
77 - Contents of Register
This clause provides that, where the
Regulator determines that a dealing with a GMO is to be included in the GMO
Register, the Register must contain: a description of the dealing with the GMO;
and any condition(s) to which a particular dealing with a GMO is
subject.
Clause
78 - Regulator may include dealings with GMOs on GMO
Register
Sub-clause 78(1) provides that the Regulator may
place a GMO on the Register where the dealing with the GMO is, or has previously
been, authorised by a GMO licence.
Under sub-clause 78(2), a
determination to place something on the GMO Register may be made on application
by a GMO licence holder, or on the initiative of the
Regulator.
Sub-clause 78(3) provides that a determination takes
effect on the day specified in the determination. Further, in the circumstances
whereby a licence holder has applied to have certain licensed dealings with GMOs
entered on the Register, the date specified in the determination must not be
before the licence ceases to be in force. That is, the licence must “run
its course” before the dealing with the GMO may be placed on the Register.
Sub-clause 78(4) provides that a determination to include a GMO
dealing on the GMO Register is a disallowable instrument for the purposes of
section 46A of the Acts Interpretation Act
1901.
Clause
79 - Regulator not to make determination unless risks can be
managed
This clause prevents the Regulator from placing a dealing
with a GMO on the Register unless the Regulator is satisfied that any risks
posed by the dealing are minimal, and that it is not necessary for the persons
undertaking the dealing to hold, or be covered by, a GMO licence in order to
protect the health and safety of people and the environment.
In making a
determination to place a dealing on the GMO Register, the Regulator must have
regard to all available information about the possible need for a licence,
including: any data about adverse effects posed by the dealing; any other
information as to risks associated with the dealing of which the Regulator is
aware; and whether there is a need for the dealing to be subject to conditions.
The Regulator may also have regard to any other matters the Regulator considers
relevant.
Clause
80 - Variation of GMO Register
This clause allows the
Regulator to vary the GMO Register by written determination so as to: remove a
dealing from the GMO Register; revoke or vary conditions to which the dealing is
subject; or impose additional conditions on the dealing. A written determination
varying the GMO Register in any of these ways is a disallowable instrument for
the purposes of section 46A of the Acts Interpretation Act 1901.
This clause requires the Regulator to permit any person to inspect any
part of the GMO Register.
DIVISION 1 – Simplified outline
Clause 82 –
Simplified outline
This clause gives a simplified outline of the
Part.
This clause allows a person to apply to the Regulator for certification of a facility to a particular containment level. The application must be in writing, must contain such information as the Regulator requires, and be accompanied by the appropriate application fee (as prescribed by the regulations).
Certification of a facility to a certain containment level will be required of any organisation who wishes to undertake notifiable low risk dealings, or who holds a licence for dealings with GMOs where the licence includes a condition that the work with the GMO be conducted in a facility certified to a particular containment level.
The containment levels to which the Regulator may certify a facility will be documented in guidelines issued by the Regulator (as described in clause 90).
This clause allows the Regulator to certify the facility to a specified containment level where the facility meets the requisite containment standards, which are to be specified in guidelines issued by the Regulator under clause 90.
This clause allows the Regulator to request an applicant for certification of
a facility to provide the Regulator, within a specified period, with additional
information to assist the Regulator’s consideration of the application.
Clause
86 - Conditions of certification
This clause provides that the
certification of a facility is subject to several types of conditions: those
imposed by the Regulator at the time of certification; those imposed after
certification as a variation to the original certification; and any conditions
prescribed in the regulations.
Clause
87 - Variation of certification
This clause allows the
Regulator to vary the certification of a facility, by notice in writing, to the
holder of the certification. The Regulator has a discretion to impose additional
conditions or remove or vary the conditions originally imposed.
Clause
88 - Suspension or cancellation of certification
This clause
allows the Regulator to suspend or cancel the certification of a facility where
the Regulator believes that, on reasonable grounds, a condition of the
certification has been breached.
Sub-clause 89(1) requires that, before suspending, cancelling or
varying a certification, the Regulator will provide written notice to the holder
of the certification. The formal requirements of the notice are specified in
sub-clause 89(2), and include the requirement that (within a designated
period) any relevant information be provided by the holder of the certification
to the Regulator, and a requirement to invite the holder of the certification to
make a written submission concerning the proposed suspension, cancellation or
variation.
Sub-clause 89(3) requires that the notice provided to
the holder of certification must specify the period in which the holder of
certification must give information or make submission. The period must not be
less than 30 days.
Sub-clause 89(4) provides that the Regulator
must consider any written submissions made to him or her.
Sub-clauses
89(5) and (6) exclude the requirements of this clause where the suspension
or variation is requested by the holder of the certification, or where the
Regulator considers that the action is necessary to avoid an imminent risk of
death, serious illness, serious injury or serious damage to the environment.
Clause
90 – Guidelines
This clause allows the Regulator to
issue technical or procedural guidelines (for example, about the requirements
for the certification of facilities to specified containment levels) and to vary
or revoke those guidelines by written
instrument.
DIVISION
3 - Accredited
organisations
Clause
91 - Application for accreditation
This clause enables a
person to apply to the Regulator for accreditation of an organisation. The
application must be in writing, and contain such information as the Regulator
requires.
It is anticipated that the regulations will provide that
notifiable low risk dealings may only occur within accredited organisations.
Similarly, the Regulator may impose as a condition of licence, a requirement
that the work be conducted within an accredited organisation. As described in
this Division, an organisation will be accredited if it can establish to the
satisfaction of the Regulator that it has a properly constituted Institutional
Biosafety Committee (operating in accordance with guidelines issued by the
Regulator).
The role of Institutional Biosafety Committees will be to
provide day to day advice and assistance to, and oversight of, people
undertaking dealings with GMOs within organisations. Regulatory responsibility
will continue to rest with the Regulator (including responsibility for
independent monitoring and auditing of the dealings with GMOs). The
Institutional Biosafety Committee will, however, play an important role in
ensuring the safety of dealings with GMOs and in providing assistance and advice
both to applicants and licence holders and also to the
Regulator.
Clause
92 - Regulator may accredit organisations
Sub-clause
92(1) enables the Regulator to accredit an organisation (by written
instrument).
Sub-clause 92(2) provides that in making the decision
whether to accredit the organisation, the Regulator must have regard to matters
such as: whether the organisation has established, or proposes to establish, and
whether it will be able to maintain, an Institutional Biosafety Committee and;
whether the organisation has, or will have, appropriate indemnity arrangements
for Institutional Biosafety Committee members. The Regulator may also take into
account any other matters specified in guidelines issued by the
Regulator.
Clause
93 - Regulator may require applicant to give further
information
This clause enables the Regulator to require an applicant
for accreditation of an organisation to give the Regulator, within a designated
period, relevant further information in relation to the application.
Clause
94 - Conditions of accreditation
This clause specifies that
the conditions to which accredited organisations are subject are: those imposed
by the Regulator at the time of accreditation; those imposed by the Regulator
later by variation; and those prescribed by the regulations.
Clause
95 - Variation of accreditation
This clause gives the
Regulator power to vary the organisation’s accreditation, at any time, by
notice in writing.
Sub-clause 95(2) allows the Regulator to
impose additional conditions or remove or vary conditions that were originally
imposed.
Clause
96 - Suspension or cancellation of accreditation
This clause
enables the Regulator to suspend or cancel the accreditation of an organisation
if the Regulator believes, on reasonable grounds, that a condition of the
accreditation has been breached.
This clause provides that the Regulator must provide notice in writing of
the proposed suspension, cancellation or variation to the holder of the
accreditation. The notice may request relevant information and invite a written
submission from the holder of the accreditation, within a designated timeframe.
The Regulator must consider any written submissions made to him or
her.
Sub-clauses
97(5) and (6) exclude the requirements of the clause where the suspension,
cancellation or variation is requested by the holder of the accreditation, or
where the Regulator considers that the action is necessary to avoid an imminent
risk of death, serious illness, serious injury or serious damage to the
environment.
This clause enables the Regulator to issue guidelines containing
requirements that must be met in order for an organisation to be
accredited.
Sub-clause 98(2) provides that such guidelines may
relate to, but are not limited to, the establishment and maintenance of
Institutional Biosafety Committees.
Sub-clause 98(3) also allows
the Regulator to vary or revoke the guidelines by written
instrument.
PART
-
THE
GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE, THE GENE TECHNOLOGY COMMUNITY
CONSULTATIVE GROUP AND THE GENE TECHNOLOGY ETHICS
COMMITTEE
DIVISION
1 – Simplified outline
Clause 99 – Simplified
outline
This clause gives a simplified outline of the
Part.
DIVISION
2 - The Gene Technology Technical Advisory Committee
Clause
100 - The Gene Technology Technical Advisory Committee
This
clause establishes the Gene Technology Technical Advisory Committee as a
committee comprising up to 20 part-time members appointed by the
Minister.
The Minister must appoint a chair to the Committee and before
appointing any members must consult a range of stakeholders including: the
States; the Regulator; scientific, consumer, health, environmental and industry
groups as considered appropriate by the Minister; and any Ministers the Minister
considers appropriate.
Sub-clause 100(5) lists the areas of
experience required on the Gene Technology Technical Advisory Committee, and
specifies that the Minister must not appoint a person as a member of the
Committee unless the Minister is satisfied that the person has skills or
experience in one or more of a range of scientific and technical areas.
The areas of expertise to be reflected on the Committee include:
molecular biology; ecology; plant, microbial, animal or human genetics;
virology; entomology; agricultural or aquacultural systems; biosafety
engineering; public health; occupational health and safety; risk assessment;
clinical medicine; biochemistry; pharmacology; plant or animal pathology;
botany; microbiology; animal biology; immunology; toxicology; and any other
areas specified by the regulations.
Sub-clause 100(6) provides
that the Minister must also appoint a layperson as a member of the Committee.
The Minister need not be satisfied that the person has skills or experience in
an area mentioned in sub-clause 100(5).
Sub-clause 100(7) provides
that, in appointing the members of the Committee, the Minister must ensure, as
far as is practicable, that among the members as a whole there is a broad range
of skills and experience in the areas mentioned in sub-clause
100(5).
Sub-clause 100(8) also provides that the Minister must not
appoint a member to chair the Committee unless a majority of jurisdictions agree
to the appointment.
Clause
101 - Function of the Gene Technology Technical Advisory
Committee
This clause specifies that the function of the Gene
Technology Technical Advisory Committee is to provide advice, on the request of
the Regulator, or of the Ministerial Council, on a range of matters which
include:
(a) gene technology, GMOs and GM products;
(b) applications made
under the Bill;
(c) the biosafety aspects of gene technology; and
(d) the
need for policy principles, policy guidelines, codes of practice and technical
and procedural guidelines in relation to GMOs and GM products and the content of
such principles, guidelines and
codes.
Clause
102 - Expert advisers
This clause allows the Minister to
appoint one or more ‘expert advisers’ to the Gene Technology
Technical Advisory Committee. These advisers may be appointed on an ad hoc or
continuing basis and will be expected to supplement the expertise of the
Committee where this is necessary in relation to the consideration of particular
applications. The expert advisers will play a supporting role to the Committee
and will not have voting rights on the
Committee.
Clause
103 – Remuneration
Sub-clause 103(1) requires
that members of the Gene Technology Technical Advisory Committee, and expert
advisers to the Committee, are to be remunerated at a rate set by the
Remuneration Tribunal. If no determination of that remuneration by the Tribunal
is in operation, members are to be paid the remuneration as prescribed in the
regulations.
Sub-clause 103(2) specifies that members of the
Committee and their expert advisers are to be paid the allowances that are
prescribed in the regulations.
Sub-clause 103(3) provides that
this clause is subject to the Remuneration Tribunal Act
1973.
Clause
104 - Members and procedures
This clause enables regulations
to be made prescribing a range of matters relating to the members of the Gene
Technology Technical Advisory Committee, and to expert advisers, such as: terms
of appointment; resignation; disclosure of interests; termination of
appointment; and leave of absence.
Sub-clause 104(2) states that
regulations may also be made on matters relating to the operation of the
Committee, such as: procedures for convening meetings of the Committee; the
constitution of a quorum for a meeting of the Committee; the way in which
matters are to be resolved by the Committee; Committee records; and reporting
requirements.
Sub-clauses 104(3) and (4) provide that, where no
regulations have been made to guide the operations of the Committee, the
Regulator may determine how the Committee must operate and, in the absence of
such a determination by the Regulator, the Committee may operate in the way it
determines.
Clause
105 – Subcommittees
This clause allows the formation of
subcommittees to assist in the performance of the Committee’s functions,
and provides for the making of regulations to deal with the constitution and
operation of such subcommittees.
Clause
106 - The Gene Technology Community Consultative Group
This
clause establishes the Gene Technology Community Consultative Group, to be known
as the Consultative Group.
Clause
107 – Function of Consultative Group
This clause
provides that the function of the Consultative Group is to provide advice, on
the request of the Regulator or the Ministerial Council, on matters of general
concern in relation to GMOs, and on the need for (and content of) policy
principles, guidelines, codes of practice and technical and procedural
guidelines in relation to GMOs and GMO
products.
Clause
108 – Membership
This clause specifies that the Minister
is to appoint up to 12 members of the Consultative Group on a part-time basis,
including one of the members as chair.
Sub-clause 108(2) provides
that, prior to appointing a member of the Consultative Group, the Minister must
consult: the Regulator; the States; such scientific, consumer, health,
environmental and industry groups as the Minister considers appropriate; and
such other Ministers as the Minister considers appropriate.
Sub-clause
108(3) provides a list of areas of experience for members of the
Consultative Group. It specifies that, with two exceptions, the Minister must
not appoint a person as a member of the Consultative Group unless the Minister
is satisfied that the person has skills or experience pertaining to gene
technology in one or more of the following areas: environmental issues; consumer
issues; the impact of gene technology on the community; issues relevant to the
biotechnology industry; issues relevant to gene technology research; public
health issues; issues relevant to primary production; and issues relevant to
local government. Regulations may also be made prescribing additional areas of
skill or experience.
It is not intended that the appointees to the Consultative Group be
scientific experts in gene technology. Rather, it is expected that they will be
able to speak to certain issues that are relevant to gene technology (such as
environmental or consumer issues).
Sub-clause 108(4) specifies
that the Consultative Group must include: a person who is a member of the Gene
Technology Technical Advisory Committee (to provide scientific assistance to the
Group); and a person who is a member of the Gene Technology Ethics Committee (to
assist with advice on ethics issues).
Sub-clause 108(6) requires
that the Minister not appoint a chair for the Consultative Group unless a
majority of jurisdictions have agreed to that
appointment.
Clause
109 - Remuneration
This clause provides that members of the
Consultative Group are to be paid remuneration as determined by the Remuneration
Tribunal. If no determination of that remuneration by the Tribunal is in
operation, members are to be paid the remuneration that is prescribed by the
regulations.
Sub-clause 109(2) specifies that members of the
Consultative Group are to be paid allowances as prescribed.
Sub-clause
109(3) provides that this clause is subject to the Remuneration Tribunal
Act 1973.
This
clause enables regulations to be made prescribing a range of matters relating to
the members of the Consultative Group, such as: terms of appointment;
resignation; disclosure of interests; termination of appointment; and leave of
absence.
Sub-clause 110(2) states that regulations may also be
made on matters relating to the operation of the Consultative Group such as:
procedures for convening meetings of the Consultative Group; the constitution of
a quorum for a meeting of the Consultative Group; the way in which matters are
to be resolved by the Consultative Group; records; and reporting
requirements.
Sub-clauses 110(3) and (4) provide that, where no
regulations have been made to guide the operations of the Consultative Group,
the Regulator may determine how the Consultative Group must operate and in the
absence of such a determination by the Regulator, the Consultative Group may
operate in the way it
determines.
DIVISION
4 - The Gene Technology Ethics Committee
Clause
111 - The Gene Technology Ethics Committee
This clause
establishes the Gene Technology Ethics Committee (the Ethics Committee) as a
Committee of up to 12 part-time members, including a chair.
Sub-clause
111(4) requires that before appointing a member of the Ethics Committee, the
Minister must consult: the Regulator; the States; such scientific, consumer,
health, environmental and industry groups as the Minister considers appropriate;
and such other Ministers as the Minister considers
appropriate.
Sub-clause 111(5) also requires that the Minister not
appoint a person as a member of the Ethics Committee unless the Minister is
satisfied that the person has skills or experience in one or more of the
following areas: ethics and the environment; health ethics; applied ethics; law;
religious practices; population health; agricultural practices; animal health
and welfare; issues of concern to consumers in relation to gene technology; and
environmental systems.
Sub-clause 111(6) also requires that the
Ethics Committee include: a person who is a member of the Gene Technology
Technical Advisory Committee; and a person who is a member of the Australian
Health Ethics Committee who also has expertise in medical
research.
Sub-clause 111(7) provides that the Minister must not
appoint a member to chair the Ethics Committee unless a majority of
jurisdictions agree to the
appointment.
Clause
112 - Function of the Gene Technology Ethics Committee
This
clause provides that the function of the Ethics Committee is to provide advice,
on the request of the Regulator or of the Ministerial Council, on: ethical
issues relating to gene technology; the development of codes of practice in
relation to ethics in respect of conducting dealings with GMOs; and the
development of policy principles in relation to dealings with GMOs that should
not be conducted for ethical
reasons.
Clause
113 - Expert advisers
This clause allows the Minister to
appoint one or more expert advisers to the Ethics Committee. These advisers may
be appointed on an ad hoc or continuing basis and will be expected to supplement
the expertise of the Committee where this is necessary in relation to the
consideration of particular matters. The expert advisers will play a supporting
role to the Committee and will not have voting rights on the
Committee.
Clause
114 - Remuneration
This clause requires that a person who is a
member of the Ethics Committee or an expert adviser be paid the remuneration
that is determined by the Remuneration Tribunal. If no determination of that
remuneration by the Tribunal is in operation, the member is to be paid the
remuneration that is prescribed in the regulations.
Sub-clause
114(2) provides that a person who is a member of the Ethics Committee or an
expert adviser is to be paid the allowances that are prescribed in the
regulations.
Sub-clause 114(3) provides that this clause is
subject to the Remuneration Tribunal Act
1973.
Clause
115 - Members and procedures
This clause enables regulations
to be made prescribing a range of matters relating to the members of the Ethics
Committee, such as: terms of appointment; resignation; disclosure of interests;
termination of appointment; and leave of absence.
Sub-clause
115(2) states that regulations may also be made on matters relating to the
operation of the Ethics Committee, such as: procedures for convening meetings of
the Committee; the constitution of a quorum for a meeting of the Committee; the
way in which matters are to be resolved by the Committee; records; and reporting
requirements.
Sub-clauses 115(3) and (4) provide that, where no
regulations have been made to guide the operations of the Ethics Committee, the
Regulator may determine how the Committee must operate and, in the absence of
such a determination by the Regulator, the Committee may operate in the way it
determines.
Clause
116 - Subcommittees
This clause allows the Ethics Committee to
establish subcommittees, with the Regulator’s consent, to assist in the
performance of its functions.
Sub-clause 116(2) specifies that
matters relating to the constitution and operation of such subcommittees may be
prescribed by regulations.
This clause gives a simplified outline of the Part.
Clause 118 - Appointment of the Regulator
This clause
provides that the Regulator is to be appointed by the Governor-General for a
term specified in the instrument of appointment, being a term not less than
three years and no more than five years.
Sub-clause 118(3)
provides that the Regulator holds office on a full-time
basis.
Sub-clause 118(4) provides that a person must not be
appointed as the Regulator unless a majority of jurisdictions agree to the
appointment.
Clause 119 - Termination of
appointment
Sub-clause 119(1) provides that the
Governor-General may terminate the appointment of the Regulator for misbehavior
or physical or mental incapacity.
Under sub-clause 119(2), the
Governor-General must terminate the Regulator's appointment if the Regulator
does any of the things listed in paragraphs 119(2)(a) to (d) inclusive. This
includes: being absent from duty (except on leave of absence) for 14 consecutive
days, or for 28 days in any period of 12 months; becoming bankrupt; compounding
with his or her creditors; assigning his or her remuneration for the benefit of
his or her creditors; failing to disclose interests as required under clause
120; or engaging in employment outside the duties of his or her office without
the Minister's approval.
Sub-clause 119(3) further provides that
the Governor-General must not terminate the Regulator’s appointment on the
grounds of misbehavior or physical or mental incapacity (in accordance with
sub-clause 119(1)) without the agreement of a majority of
jurisdictions.
Sub-clause 119(4) provides that if the Regulator is
either, an eligible employee for the purposes of the Superannuation Act
1976 or a member of the superannuation scheme established by deed under the
Superannuation Act 1990, the Governor-General may, with the
Regulator’s consent, retire the Regulator from office on the grounds of
physical or mental incapacity.
Sub-clauses 119(5) and (6) set out
the circumstances in which the Regulator is taken to have been retired from
office on the grounds of invalidity under the Superannuation Act 1976 and
the Superannuation Act 1990.
Clause 120 - Disclosure of
interests
This clause provides that the Regulator must give written
notice to the Minister of all financial or other interests that the Regulator
has prior to, or that he or she acquires during, tenure as the Regulator, that
could conflict with the proper performance of the Regulator's functions under
the Bill and regulations.
Sub-clause 121(1) permits the Minister to appoint a person to act
as the Regulator if, firstly, there is a vacancy in that office, whether or not
an appointment has previously been made to the office, or, secondly, during any
period, or all periods, when the Regulator is absent from duty or from Australia
or is, for any reason, unable to perform the duties of the
office.
Sub-clause 121(2) provides that anything done by a person
purporting to act as the Regulator under this provision is not invalid merely
because:
(a) the occasion for the appointment had not
arisen;
(b) there was a defect or irregularity in connection with the
appointment;
(c) the appointment had ceased to have effect; or
(d) the
occasion to act had not arisen or had ceased.
This clause provides that in respect of matters not specifically provided
for by this Bill, the Regulator holds office on such terms and conditions (if
any) as are determined by the Governor-General.
This clause provides that the Regulator must not engage in any paid
employment outside the duties of the office without the Minister's written
approval.
Clause 124 - Remuneration
This clause
establishes the basis for determining the Regulator’s remuneration and
allowances.
Sub-clause 124(1) provides that the Regulator is to be
paid the remuneration that is determined by the Remuneration Tribunal. Where no
determination of that remuneration by the Tribunal is in operation, the
Regulator is to be paid the remuneration prescribed by the
regulations.
Sub-clause 124(2) provides that the Regulator is to
be paid such allowances as are prescribed by the
regulations.
Sub-clause 124(3) provides that this clause has
effect subject to the Remuneration Tribunal Act 1973.
Clause
125 – Leave of absence
Sub-clause 125(1) provides that
the Regulator has the recreation leave entitlements determined by the
Remuneration Tribunal.
Sub-clause 125(2) enables the Minister to
grant the Regulator leave of absence, other than recreation leave, on such terms
and conditions as the Minister determines. The terms and conditions may include
those relating to remuneration.
Clause 126 -
Resignation
This clause provides that the Regulator may resign by
giving the Governor-General a written notice of resignation.
DIVISION
3 - Money
Clause 127 – Regulator may charge for
services
This clause provides that the Regulator may charge for
services provided by, or on behalf of, the Regulator in the performance of the
Regulator’s functions.
Clause 128 - Notional payments by the
Commonwealth
As the Bill applies to the Crown in all its capacities
including the Crown in right of the Commonwealth, sub-clause 128(1) has
been included to clarify that fees and charges under this Bill and regulations,
and charges levied under the Gene Technology (Licence Charges) Act 2000
are notionally payable by the Commonwealth (or parts of the Commonwealth).
Sub-clause 128(2) provides that the Minister for Finance and
Administration may give written directions for the purposes of this clause,
including directions relating to the transfer of amounts within, or between,
accounts operated by the Commonwealth.
Clause 129 – Gene
Technology Account
This clause sets up the Gene Technology Account,
which is a Special Account for the purposes of the Financial Management and
Accountability Act 1997.
Sub-clause 130(1) sets out the amounts that must be transferred to
the Gene Technology Account. These include: monies appropriated by the
Parliament for the purposes of the Account; amounts equal to amounts received by
the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
amounts equal to fees received by the Commonwealth under sub-clauses 40(6) and
83(3); amounts equal to amounts received by the Commonwealth in connection with
the performance of the Regulator’s functions; and amounts recovered by the
Commonwealth under sub-clause 146(5) and 158(4), to the extent that they are
referable to costs paid out of the Account.
Sub-clause 130(2)
provides that the purposes of the Account are to make payments to further the
object of the Bill, as set out in clause 3, and to make payments connected to
the performance of the Regulator’s functions under this Bill under
regulations made under the Bill, or under a corresponding state
law.
Clause 131 – Recovery of Amounts
This clause
provides that the following amounts may be recoverable in a court as debts due
to the Commonwealth:
(a) amounts payable to the Commonwealth under the
Gene Technology (Licence Charges) Act 2000;
(b) fees payable to the
Commonwealth under this Bill, the regulations or a corresponding State law;
and
(c) amounts payable to the Commonwealth in connection with the
performance of the Regulator's functions.
Clause 132 - Purposes of
Account
DIVISION 4 – Staffing
This clause provides that staff necessary to assist the Regulator are to
be persons engaged under the Public Service Act 1999 and are to be made
available by the Secretary of the Department for this purpose. This does not
preclude the Regulator undertaking his or her own recruiting to ensure that he
or she attracts suitably skilled and qualified employees. Technically however,
the staff would be employed under the certified agreement of the relevant
Secretary, their positions being funded by the Regulator.
Clause 134
- Consultants
This clause enables the Regulator to appoint suitably
qualified and experienced consultants to assist the Regulator.
Sub-clause 134(2) provides that the Regulator may determine the
conditions of engagement of such consultants.
This clause provides that the Regulator may be assisted in the
performance of his or her functions or powers, by officers seconded from other
Commonwealth Departments or authorities or State agencies, with the agreement of
such agencies.
Clause 136 - Annual Report
This clause requires the
Regulator to prepare and give to the Minister, as soon as practicable after the
end of each financial year, an annual report on the operations of the Regulator
during the year.
Sub-clause 136(2) requires the Minister to
cause a copy of the Report to be tabled before each House of Parliament within
15 sitting days of the day on which the report was given to the Minister.
The Regulator must also provide a copy of the annual report to each
State.
Clause 137 - Reports to Parliament
Sub-clause
137(1) provides that the Regulator may, at any time, cause a report about
matters relating to the Regulator's functions to be tabled in either House of
Parliament.
Sub-clause 137(2) requires the Regulator to give a
copy of such a report tabled in Parliament to the Minister and to each
State.
This clause provides that the Regulator must maintain a comprehensive
record of GMO and GM product dealings, to be known as ‘the Record’.
This Record would be likely to take the form of a computerised database.
In relation to GMO licences, sub-clause 138(3) requires that the
Record contain certain information (other than confidential commercial
information) in relation to every GMO licence which has been issued. That
information shall include details such as: name of licence holder; persons
covered by the licence; and any licence conditions.
In relation to
notifiable low risk dealings, sub-clause 138(4) requires that the Record
contain the following information (other than confidential commercial
information): the name of the person who notified the dealing; and relevant
particulars of the dealing as prescribed in regulations.
In relation to
GM products, sub-clause 138(5) requires that the Record contain details
of approvals of GM products made by other regulators and notified to the Gene
Technology Regulator. Under the Gene Technology (Consequential Amendments)
Bill 2000 certain GM products will be notified to the Regulator under the
following pieces of legislation:
• the Agricultural and
Veterinary Chemicals (Administration) Act 1992;
• the Australia
New Zealand Food Authority Act 1991;
• the Industrial Chemicals
(Notification and Assessment) Act 1989;
• the Therapeutic Goods
Act
1989.
Sub-clause
138(6) provides that the Record must also include a description of each
dealing on the GMO Register, including any conditions to which the dealing is
subject.
Sub-clause 138(7) and (8) provide that the record maybe
kept in a computerised form and that information must be entered on the record,
by the Regulator, as soon as reasonably practicable.
Clause 139 -
Inspection of Record
This clause requires that the Regulator permit
any person to inspect any part of the Record. It is, however, also intended that
the Record be available on the Regulator’s
website.
DIVISION
7 - Reviews of notifiable low risk dealings and
exemptions
Clause
140 - Regulator may review notifiable low risk dealings
This
clause allows the Regulator, at any time, to consider whether a dealing with a
GMO should become a notifiable low risk dealing, or whether an existing
notifiable low risk dealing should no longer be recognised as such. This
enables the legislation to respond to changes in technology and to any
additional information that becomes available regarding the risks of certain
dealings with GMOs, or the absence thereof.
Sub-clause 140(2)
requires that, in making these decisions, the Regulator must consider the
matters in sub-clause 74(2) and sub-clause 74(3). These sub-clauses require the
Regulator to consider matters, such as: whether the proposed dealings involve an
intentional release into the environment; whether the GMO can be biologically
contained; whether the GMO is a pathogen or pest; and whether any risks can be
managed with minimal, or no,
conditions.
Clause
141 - Regulator may review exemptions
This clause allows the
Regulator, at any time, to consider whether a dealing with a GMO should be an
exempt dealing, and whether an existing exemption should no longer be such.
Clause
142 - Regulator may give notice of consideration
This clause
enables the Regulator to place a public notice, at any time, calling for
submissions from the public about what dealings with GMOs should be removed or
added to the list of notifiable low risk dealings or exemptions, including
submissions on any reasons for the proposed change. This clause also sets out
the matters that the Regulator must include in a public notice, and a
requirement for the Regulator to also notify the States, the Gene Technology
Technical Advisory Committee, and prescribed Commonwealth
agencies.
Clause 143 – What Regulator may do after
consideration
This clause allows the Regulator, after completion of
the process outlined at clause 140, to recommend to the Ministerial Council
that:
• a dealing be declared a notifiable low risk dealing, or
• an existing declaration under regulations be withdrawn, where the
dealing should no longer be a notifiable low risk dealing; or
• a
dealing be exempted; or
• an existing exemption be retained or
removed.
The Regulator is required to advise the Ministerial Council
because it will be the Ministerial Council who agree any changes to the national
legislative scheme, and who make recommendations to each of the Parliaments to
adopt such changes.
Clause 144 – Regulator not required to
review matters
This clause clarifies that the requirement to review notifiable low risk
dealings or exemptions is at the discretion of the Regulator.
This clause gives a simplified outline of the Part.
This clause provides that, if a licence holder or a person covered by a
licence is not acting in compliance with the legislation, and their actions are
likely to cause, or are causing harm to the health and safety of people or to
the environment, then the Regulator may give written directions to the person
directing them to do things necessary to ensure compliance or to bring the
person back into compliance with the legislation. If the person does not take
the necessary action within the period of time specified by the Regulator, the
Regulator may take the necessary steps, or arrange for the necessary steps to be
taken, to ensure compliance with the legislation.
This provision
effectively enables a “clean-up” or remediation to be undertaken,
either by the Regulator or via the direction of the Regulator, where, for
example, a condition of licence has been breached resulting in the accidental
release of a GMO, and there is a need to re-contain the GMO.
The clause
further provides that if costs are incurred by the Regulator in taking steps to
bring the activity back into compliance with the legislation, such costs may be
recovered from the licence holder or the person covered by the licence (as
applicable).
This clause should also be read in conjunction with clause
158, which enables an inspector to take immediate action where there is an
imminent risk of danger to health and safety of people or to the environment.
In such circumstances, the inspector can take such steps as are necessary
without first giving written notice to the licence holder or applicant requiring
them to take the necessary steps. Such action, by the inspector or others, is
also cost recoverable from the offending party.
Clause 147 –
Injunctions
If a person has engaged, or is engaging, or is proposing
to engage in any conduct that is or would be an offence against the Bill or
regulations, sub-clause 147(1) provides that the Federal Court may grant
an injunction, on application by the Regulator or any other aggrieved person, to
restrain that person from engaging in that conduct.
Likewise, if a person
has refused or failed, or is refusing or failing, or is proposing to refuse or
fail, to do any thing, and such a refusal or failure is or would constitute an
offence against this Bill, then the Federal Court may, on application by the
Regulator or any other aggrieved person, grant an injunction requiring the
person to do the thing.
Sub-clause 147(3) provides that the
Court's powers to grant injunctions under this section may be exercised whether
or not it appears to the Court that the person intends to engage, or to continue
to engage, in conduct of that kind, and whether or not the person has previously
engaged in conduct of that kind.
Sub-clause 147(4) empowers the
court to discharge or vary any injunction granted under this section, and
sub-clause 147(5) enables the Court to grant an interim injunction pending
the determination of an application for an injunction under sub-clause 147(1).
Sub-clause 147(6) makes it clear that the powers of the Court set
out under this section are in addition to, and not in derogation of, any of the
other powers of the Court.
Sub-clause 148(1) states that if a court convicts a person of an
offence against this Bill or regulations, or makes an order under section 19B of
the Crimes Act 1914 in respect of a person charged with an offence
against this Bill, then the court may, on application by the Commonwealth, order
forfeiture to the Commonwealth of any substance or thing used, or otherwise
involved in the commission of the offence.
Sub-clause 148(2)
provides that a thing ordered by a court to be so forfeited becomes the property
of the Commonwealth, and may be sold or otherwise dealt with in accordance with
the directions of the Regulator.
Sub-clause 148(3) states that,
until the Regulator gives such a direction, the thing must be kept in such
custody as the Regulator directs. “Thing” is widely defined in
clause 11 to refer to something that also includes a substance, and a thing in
electronic or magnetic form.
This clause gives a simplified outline of the Part.
Sub-clause 150(1) enables the Regulator to appoint, by instrument
in writing, appropriate officers to be inspectors for the purposes of exercising
all the powers under this Part. The persons the Regulator may appoint as
inspectors are Commonwealth employees or State or Territory employees.
Sub-clause 150(2) requires a person appointed as an inspector to
comply with any directions of the Regulator when exercising powers or performing
functions in that capacity.
Sub-clauses 151(1) and 151(2) require the Regulator to issue an
identity card, in a form prescribed by the regulations, to every person
appointed as an inspector. The identity card must have a recent photograph of
the inspector.
Sub-clause 151(3) provides that it is an offence
for a person who ceases to be appointed as an inspector to fail to return his or
her identity card to the Regulator, as soon as practicable. The offence
attracts a maximum penalty of $110.
Sub-clause 151(4)
requires the inspector to carry his or her identity card at all times when
exercising powers or performing functions as an inspector.
DIVISION 3
– Monitoring powers
Clause 152 - Powers available to
inspectors for monitoring compliance
Sub-clause 152(1) confers
powers upon an inspector to enter any premises and to exercise any or all of the
powers set out in clause 153 for the purposes of establishing whether or not the
Bill or regulations are being complied with.
Sub-clause 152(2)
provides that an inspector may only enter premises under this clause if: he or
she has the consent of the occupier of the premises; or where the inspector has
obtained a warrant under clause 172 to make that entry; or where the occupier of
the premises is a licence holder, or a person covered by a licence, and the
entry is at a reasonable time.
This clause describes the monitoring powers that an inspector may
exercise for the purposes of finding out whether the Bill or regulations have
been complied with. Some of these powers may be exercised without a warrant and
others require a warrant.
This clause sets out the powers of an inspector who enters and conducts
searches of premises to obtain evidence of a commission of an offence, and the
circumstances under which those powers may be exercised.
Sub-clause
154(1) states that the powers under this clause may be exercised if an
inspector has reasonable grounds for suspecting that there may be evidential
material on any premises.
Sub-clause 154(2) provides that an
inspector may enter premises, either with the consent of the occupier or under a
warrant issued under clause 173, to do any of the things described in sub-clause
154(3) and clause 155, including, if the entry is under a warrant, seizing the
evidential material if the inspector finds it on the
premises.
Sub-clause 154(3) provides that if, in the course of
searching for a particular thing at premises in accordance with a warrant, an
inspector finds something else that he or she believes on reasonable grounds to
be evidential material which the inspector also reasonably believes must be
seized to prevent its concealment, loss or destruction, or use in the commission
or continuation of an offence against this Bill or regulations, then the warrant
is taken to authorise the inspector to seize that thing.
Clause 155
– Offence-related powers of inspectors in relation to
premises
This clause sets out the general powers inspectors may
exercise under paragraph 154(2)(b). These include the power to: search premises
and any thing found on premises for evidential material; to inspect, examine,
take measurements of, conduct tests on, or take samples of the evidential
material; take photographs or other forms of recordings of the premises or the
evidential material; and take onto the premises such equipment and materials as
the inspector requires for the purposes of exercising powers in relation to the
premises.
Clause 156 – Use of equipment at
premises
This clause provides that an inspector may operate
equipment at the premises to see whether evidential material is accessible, if
he or she believes that the equipment may be operated without damaging it.
Sub-clause 156(2) provides that, if evidential material is so
accessible, the inspector may seize equipment or any disk, tape or other
associated device, or operate the equipment, in order to obtain the evidential
material, or to copy such evidential material to another storage device, and
remove it from the premises.
Sub-clause 156(3) is intended to
facilitate the seizure of printouts or duplicate discs wherever possible, rather
than the original material. It provides that an inspector may seize equipment
under paragraph 156(2)(a) only if it is not practicable to put the material into
documentary form or to copy it to a storage device, or if possession by the
occupier of the equipment could constitute an offence.
Sub-clause
156(4) provides that an inspector may seize equipment under paragraph
156(2)(a) or documents under paragraph 156(2)(b), only if the inspector entered
the premises under a warrant.
DIVISION 5 – Expert
assistance
Clause 157 – Expert assistance to operate a
thing
This clause provides that an inspector may secure the thing
(for example, certain equipment) by locking it up or guarding it, if he or she
believes on reasonable grounds that evidential material may be accessible by
operating the thing at the premises, but that expert assistance is needed to
operate the thing and the evidential material may be destroyed or otherwise
interfered with if the thing is not secured in the meantime. This is necessary
to ensure that where, for example, the equipment is more sophisticated than
expected and cannot be accessed or moved, the opportunity to obtain expert
assistance and to preserve evidential material is not lost.
Sub-clause 157(2) requires the giving of notice to the occupier
in cases where equipment may be secured for a period not exceeding 24
hours.
Sub-clause 157(3) allows the thing to be secured for either
24 hours or until the thing is operated by an expert, whichever happens
first.
Sub-clause 157(4) allows an inspector to apply to a
magistrate for an extension of the time needed for securing the equipment if he
or she believes, on reasonable grounds, that the expert assistance will not be
available within the 24 hour period. The occupier must be given notice under
sub-clause 157(5) that the inspector intends to apply for an extension, and
the occupier has a right to be heard in relation to the
application.
DIVISION 6 – Emergency
powers
Clause 158 – Powers available to inspectors for
dealing with dangerous situations
Sub-clause 158(1) describes
the circumstances in which an inspector may exercise powers under this clause.
These are where the inspector has reasonable grounds for suspecting that there
may be, on any premises, a particular thing that is not in compliance with the
requirements of the Bill or regulations, and where it is necessary to exercise
the powers under this clause to avoid an imminent risk of death, serious
illness, serious injury or to protect the environment.
Sub-clause
158(2) provides that, in such circumstances, an inspector may, without a
warrant or the consent of an occupier: enter premises; search the premises for
the thing; secure the thing if the inspector finds it on the premises until a
warrant is obtained to seize the thing; if the inspector believes on reasonable
grounds that a person has failed to comply with any requirements of the Bill or
regulations in relation to the thing, require the person to take such steps, or
arrange for such steps to be taken, as the inspector considers necessary for the
person to comply with the Bill or the regulations; and take such steps in
relation to the thing as the inspector considers
appropriate.
Sub-clause 158(3) requires the inspector to exercise
his or her powers under sub-clause 158(2) only to the extent necessary for the
purposes of avoiding an imminent risk of death, serious illness, serious injury
or serious damage to the environment.
Sub-clause 158(4) provides
that, where the Regulator incurs costs as the result of the inspector taking
steps, or arranging for steps to be taken, under paragraph 158(2)(e), the
Regulator can recover any costs incurred as a result of taking such steps.
This clause makes it clear that an inspector cannot exercise any of the
powers under this Part in relation to premises unless he or she produces his or
her identity card upon being requested to do so by the occupier of those
premises.
This clause provides that, before obtaining consent from a person to
enter premises (under paragraphs 152(2)(a) or 154(2)(a)), the inspector must
inform the person that he or she may refuse consent.
Sub-clause
160(2) clarifies that any consent given by a person to enable entry to
premises by the inspector must be voluntary.
Clause 161 –
Details of warrant to be given to occupier etc.
This clause provides
that, if a warrant in relation to premises is being executed, a copy of the
warrant must be made available to the occupier of the premises or another person
who represents the occupier, where the occupier or their representative are
present at the premises. The inspector responsible for the execution of the
warrant must identify himself or herself. Sub-clause 161(3) provides that
the copy need not include the signature of the Magistrate who issued the
warrant.
This clause provides that, before an inspector enters premises under a
warrant they must announce that they are authorised to enter and give any person
at the premises an opportunity to allow entry to the premises, unless there are
reasonable grounds to believe that immediate entry to the premises is required
to ensure the safety of a person or to prevent serious damage to the
environment, or so that the effective execution of the warrant is not
frustrated.
This clause provides that if damage is caused to a thing as a
result of it being operated as mentioned in clauses 153 or 156 and the damage
resulted from insufficient care being exercised by the inspector either in
selecting the person to operate the equipment or by the person operating it,
compensation is payable to the owner.
Compensation is payable out of
money appropriated by the Parliament. In determining the amount payable, regard
is to be had as to whether the occupier (or his or her employees and agents) had
provided any warning or guidance as to the operation of the thing. This is to
minimise compensation in cases where there has been a deliberate programming of
software to destroy or cause damage if not accessed in a particular manner, or
where the occupier failed to mitigate damage by providing warning or
guidance.
DIVISION 8 – Power to search goods, baggage
etc.
Clause 164 – Power to search goods, baggage
etc.
This clause empowers an inspector to search goods and baggage
taken off ships or aircraft travelling from a place outside Australia to
Australia or from a place outside an external Territory to that Territory.
Failure or refusal to answer a question relating to such goods or baggage is
punishable by up to 30 penalty units, which equates to $3,300 for individuals
and $16,500 for a body corporate.
This clause has been included to
enable inspectors (who may be officers of the Australian Quarantine and
Inspection Service appointed as inspectors under this legislation) to search
goods and baggage imported into Australia.
This clause provides that an inspector may seize any goods if there is a
reasonable suspicion that the goods have been used, or otherwise involved, in
the commission of an offence against the Bill or the regulations, or that the
goods will provide evidence of an offence against the Bill or the
regulations.
This clause provides that if an inspector seizes, under a warrant,
documents, film, computer files or storage devices etc, the inspector must, on
request of the occupier or their representative who is present when the warrant
is executed, give a copy of the thing or the information seized to the occupier
or their representative as soon as practicable after the
seizure.
Sub-clause 166(2) provides that this clause does not
apply where the thing seized was seized under paragraphs 156(2)(b) or (c), or
where possession by the occupier of the thing seized could constitute an
offence.
This clause provides that occupiers or their representatives may choose
to observe the searching of the premises providing they do not impede the
conduct of the search in any way. The right to search does not preclude
inspectors from searching 2 or more areas of the premises at the same
time.
This clause provides that receipts are to be issued to occupiers
for things seized. Under this provision, it will be possible for the items to
be listed on the same receipt. It is not envisaged that inspectors would be
required to identify absolutely every item individually where those items can be
adequately identified by a class description.
This clause describes when things seized under this Part of the Bill must
be returned. Unless a court has ordered otherwise, or it is forfeited or
forfeitable to the Commonwealth, the seized thing must be returned where the
reason for its seizure no longer exists, or where it will not be used as
evidence, or after 60 days have expired from the day it was
seized.
Sub-clause 169(2) provides that an inspector must take
reasonable steps to return the thing to the person from whom it was seized after
the 60 days referred to in sub-clause 169(1), unless proceedings in which the
seized thing will be used have been brought against an offender within the 60
day limit and the proceedings have not finished, or an extension of time for the
retention of the seized thing has been granted by a magistrate, or returning the
thing could cause an imminent risk of death, serious illness, serious injury or
serious damage to the environment, or an inspector is otherwise authorised to
dispose of it pursuant to some law or court order.
Sub-clause
169(3) provides that where the seized thing is returned, it may be returned
unconditionally or on such terms and conditions as the Regulator sees
fit.
This clause describes how an inspector may apply to a magistrate for an
order to retain a seized thing beyond the 60 day retention period (or before the
end of a period specified in an order of a magistrate) where proceedings in
respect of which the thing may afford evidence have not commenced.
Sub-clause 170(2) provides that if the magistrate is satisfied
that it is necessary for an extension of time to be granted to enable an
inspector to investigate whether or not an offence has been committed against
the Bill or to enable the evidence to be secured for the purposes of a
prosecution, the magistrate may grant an extension for such period as is
specified in an order. Before making an application under this section, an
inspector must take reasonable steps to establish who has an interest in the
retention of the seized goods and, if practicable, notify such persons.
This clause provides that the Regulator may dispose of a thing seized
under this Part, in a manner the Regulator considers appropriate, if there is no
owner of the thing or the Regulator has made reasonable efforts to locate the
owner and cannot locate the owner.
This clause enables a magistrate to issue a warrant that permits
more than one inspector to enter the same premises for the purposes of
establishing whether the Bill and regulations have been complied
with.
Sub-clause 172(3) provides that the magistrate must not
issue the warrant unless the inspector or some other person has given the
magistrate any information the magistrate requires concerning the grounds on
which the issue of the warrant is being sought.
Sub-clause 172(4)
describes the matters that must be contained in a warrant issued by a magistrate
under this clause. For example, the warrant must: authorise the inspectors to
enter the premises and exercise powers under clause 153; state when the entry is
authorised to be made; specify the day on which the warrant ceases to have
effect; and state the purpose for which the warrant is issued.
This clause describes how an inspector may apply to a magistrate for a
warrant under this clause in relation to premises for the purposes of
identifying and/or seizing evidence.
Sub-clause 173(1) provides
that an inspector may apply to a magistrate for a warrant in relation to
premises.
Sub-clause 173(2) enables the magistrate to issue a
warrant if he or she is satisfied, by information given under oath, that there
are reasonable grounds for suspecting that there is, or there may be within the
next 72 hours, evidential material in or on the premises in relation to which an
application for a warrant is being made.
Sub-clause 173(3)
prevents the magistrate from issuing a warrant unless the inspector or some
other person has given to the magistrate, either verbally or by affidavit, such
further information (if any) as the magistrate should require concerning the
grounds on which the issue of the warrant is being sought.
Sub-clause
173(4) prescribes what must be included in a warrant. The warrant must
include the name of one or more inspectors and it must authorise all those named
to enter the premises and exercise the powers set out in sub-clause 154(3) and
in clause 155, and to seize the evidential material. The warrant must also
state whether the entry is authorised to be made at any time during the night or
day, or whether entry is restricted to specified hours of the day or night. The
warrant must also specify when the warrant ceases to have effect (being a day
not later than a week after the issue of the warrant), and also state the
purposes for which the warrant is being issued.
This clause sets out the circumstances in which a warrant may be obtained
over the telephone or by telex, facsimile or other electronic
means.
Sub-clause 174(1) provides that, in urgent cases where an
inspector considers it necessary, the inspector may apply to a magistrate for a
warrant under clause 173 either by telephone, telex, facsimile or other
electronic means.
Sub-clause 174(2) provides that the magistrate
may require communication by voice to the extent that it is practicable in the
circumstances.
Sub-clauses 174(3) and (4) require the inspector to
prepare any information mentioned in sub-clause 173(2) setting out the grounds
on which the warrant is sought. The inspector may apply for the warrant before
the information is sworn, where this is necessary in the
circumstances.
Sub-clause 174(5) provides that, if the magistrate
is satisfied that there are reasonable grounds for issuing the warrant (after
having considered relevant information), the magistrate may issue the same
warrant that the magistrate would issue under clause 173 as if the application
for the warrant had been made under that clause.
Sub-clause 174(6)
provides that, if the magistrate completes and signs the warrant for the
inspector, the magistrate must inform the inspector what the terms of the
warrant are, the day on which and the time at which the warrant was signed, the
day on which the warrant ceases to have effect (being a day not more than a week
after the magistrate completes and signs the warrant), and must record on the
warrant the reasons for granting the warrant. The inspector must also complete
a form or warrant in the same terms as the warrant completed and signed by the
magistrate, and must write on the form the name of the magistrate and the day on
which and the time at which the warrant was signed.
Sub-clause
174(7) requires the inspector to send to the magistrate the form of warrant
completed by the inspector under this clause, and the information required to be
prepared when the inspector applied for the warrant over the telephone, the
information prepared must have been duly sworn. The inspector is required to
send this to the magistrate not later than the day after the expiry or the
execution of the warrant, whichever is the earlier day.
Sub-clause
174(8) provides that when the magistrate receives these documents, the
magistrate must attach them to the warrant, completed and signed, and deal with
the documents in the same way the magistrate would have dealt with the
information if the application for the warrant had been made under clause
173.
Sub-clause 174(9) provides that a form of warrant completed
in accordance with sub-clause 174(6) is authority for any entry, search, seizure
or other exercise of power that the warrant signed by the magistrate
authorises.
Sub-clause 174(10) states that, in any proceedings
where the court must be satisfied that the exercise of a power was authorised by
this clause, and the warrant signed by the magistrate authorising the exercise
of that power cannot be produced, the court must assume, unless the contrary is
proved, that the exercise of the power was not authorised by such a
warrant.
Sub-clause 174(11) states that any reference in this Part
to a warrant under clause 173 is taken to include a warrant signed by a
magistrate under this clause.
This clause sets out offences in relation to an application for a
warrant.
Sub-clause 175(1) provides that it is an offence,
attracting a maximum penalty of imprisonment for 2 years or 120 penalty units,
if a person makes a statement, when applying for a warrant, that he or she knows
to be false or misleading in a material particular.
Sub-clause
175(2) sets out other actions that attract a maximum penalty of 2 years
imprisonment or 120 penalty units. These include:
(a) a person stating
in a document purporting to be a form of warrant under clause 174 the name of a
magistrate who was not the magistrate that issued the warrant;
(b) stating,
for the purposes of clause 174, on the form of warrant something that, to the
person's knowledge, departs in a material particular from the form authorised by
the magistrate;
(c) purporting to execute or present to another person a
document purporting to be a form of warrant under clause 174 when the person
knows it had not been approved by the magistrate under that clause or where it
departs in a material particular from the terms authorised by a magistrate under
clause 174; or
(d) giving to a magistrate a form of warrant under clause 174
that was not the form of warrant the person purported to execute.
This clause clarifies that nothing in this Part affects the right of a
person to refuse to answer a question, give information, or produce a document
on the ground that the answer to the question, the information or the production
of the document, might tend to incriminate him or her, or make him or her liable
to a penalty.
This clause makes it clear that the powers exercisable under this Part in
no way affect the ability of the Regulator to impose licence conditions. For
example, the Regulator may impose additional conditions relating to auditing and
monitoring requirements.
This clause gives a simplified outline of the Part.
This clause sets out a table describing those decisions under the Bill
that are subject to review by the Administrative Appeals Tribunal (reviewable
decisions), and those persons who are able to seek review in relation to
reviewable decisions (eligible persons).
This clause provides that, as soon as practicable after making a
reviewable decision under the Bill, the Regulator must notify each eligible
person in writing. The notification must include information about the terms of
the decision, the reasons for the decision and a statement setting out the
review rights of the person.
Sub-clause 180(2) provides that, if
the Regulator fails to properly notify eligible persons of their review rights
(under sub-clause 180(1)), this does not affect the validity of the
decision.
This clause provides that an eligible person may apply to the Regulator
for an internal review of a reviewable decision within 30 days after the
decision came to the notice of the applicant, or within some further period, if
any, specified by the Regulator.
If a person seeks internal review by the
Regulator, the Regulator must conduct such a review personally and may affirm,
vary or revoke the original reviewable decision. If the Regulator revokes the
original reviewable decision, the Regulator may make such other decisions as the
Regulator considers appropriate.
A person may not seek internal review of
a reviewable decision if the Regulator personally made the original decision (as
opposed to a delegate of the Regulator having made the original
decision).
This clause provides that, if a person applies to the Regulator for
internal review of a reviewable decision and the Regulator does not notify the
applicant of the Regulator's decision within any time period set out in the Bill
or regulations for the Regulator to advise the applicant of the outcome of the
internal review, then the Regulator is taken to have rejected the application
for internal review.
Clause 183 – Review of decisions by
Administrative Appeals Tribunal
This clause provides that an eligible
person may apply to the Administrative Appeals Tribunal in relation to a
reviewable decision if they have exhausted their rights of internal review
(under clause 181), or if the original reviewable decision was made personally
by the Regulator and, as such, there is no opportunity for internal
review.
DIVISION 3 – Confidential commercial
information
Clause 184 – Application for protection of
confidential commercial information
This clause provides that a
person may apply to the Regulator for a declaration that specified information
to which this Bill relates is confidential commercial information for the
purposes of this Bill. Such an application must be made in writing in the
approved form.
Clause 185 – Regulator may declare that
information is confidential commercial information
This clause
describes the circumstances in which the Regulator must declare information to
be confidential commercial information for the purposes of the
Bill.
Sub-clause 185(1) sets out the criteria in relation to which
the Regulator must be satisfied before they can declare information to be
confidential commercial information. The person applying for a declaration must
satisfy the Regulator that the information in the application for declaration
is: a trade secret; information that has a commercial or other value that would
be, or could reasonably be expected to be, destroyed or diminished if the
information were disclosed; or other information that concerns the commercial or
financial affairs of a person, organisation or undertaking which if disclosed,
could unreasonably affect the person, organisation or
undertaking.
Sub-clause 185(2) enables the Regulator to consider
the public interest and, if satisfied that the public interest in disclosure
outweighs the prejudice that the disclosure would cause to any person, the
Regulator may refuse to declare that the information is confidential commercial
information.
Sub-clauses 185(3) and (4) provide that the Regulator
must give the applicant written notice of his or her decision about the
application and that, if the Regulator refuses to declare the information to be
confidential commercial information, the Regulator must, nevertheless, continue
to treat the information as confidential commercial information until such time
as any review rights under clauses 181 (internal review) and 183 (review before
the Administrative Appeals Tribunal) have been exhausted.
Clause 186
– Revocation of declaration
This clause enables the Regulator
to revoke a declaration made under clause 185 if the Regulator is satisfied that
the information no longer meets the criteria set out in sub-clauses 185(1)(a),
(b) or (c), or that the public interest in disclosure of the information
outweighs the prejudice that disclosure would cause to any person. As for a
decision made under clause 185, the revocation of a declaration does not take
effect until any review rights have been exhausted.
Clause 187
– Confidential commercial information must not be
disclosed
This clause provides that a person who has access to
confidential commercial information must not disclose such information unless:
it is in the act of carrying on the course of their duties under the Bill; or is
in relation to a Court order; or they have received the consent of the person
who applied to have the information declared as confidential commercial
information.
This provision enables the Regulator to provide confidential
commercial information to Commonwealth agencies or authorities, State agencies
and the Gene Technology Technical Advisory Committee but ensures that such
agencies may not disclose the information outside their organisations unless
compelled to by court order or with the consent of the person who applied to
have the information treated as confidential commercial
information.
Notes following sub-clauses 187(1) and 187(2) clarify
that for the purposes of the Freedom of Information Act 1982,
confidential commercial information (information to which sub-clause 187(1)
or 187(2) applies) is information to which section 38 of the Freedom of
Information Act 1982 applies.
DIVISION 4 – Conduct by
directors, employees and agents
Clause 188 – Conduct by
directors, employees and agents
Clause 189 – Meaning of terms
This clause defines
terms used in clause 188 of the Bill, including “the state of mind of a
person”, “a director of a body corporate”, “engaging in
conduct” and “an ancillary offence”.
Clause 190 – Transitional provision – dealings covered by
Genetic Manipulation Advisory Committee advice to proceed
The effect of sub-clauses 190(1) and (2) is that if a dealing with
a GMO received advice to proceed from the Genetic Manipulation Advisory
Committee before the commencement of the licensing provisions of this Bill, then
that dealing is deemed to be licensed under this Act. The licence is taken to
be subject to any conditions imposed by the Genetic Manipulation Advisory
Committee ‘s advice to proceed.
The ‘deemed’ licence
continues in force until the period ending at the earliest of the following
times: the time the advice to proceed expires, at the end of two years beginning
when this Bill received Royal Assent, or when the licence is cancelled or
surrendered.
If, at the time when the licence ceased to be in force,
the licence holder wished to continue the dealings with the GMO, the licence
holder would need to apply to the Regulator for another
licence.
Sub-clause 190(3) defines the terms “advice to
proceed” and “transition period”.
Clause 191 –
Regulations may relate to transitional matters
This clause provides
that regulations may be made in relation to transitional matters arising from
the enactment of this Bill.
DIVISION 6 –
Other
Clause 192 – False or misleading information or
document
This clause provides that a person must not give false or
misleading information, or produce a document that is false or misleading in a
material particular, in connection with any application made to the Regulator
under this Bill or the regulations, or in compliance or purported compliance
with this Bill or the regulations. The penalty for knowingly providing such
false or misleading information or documents is 60 penalty units (which equates
to $6,600 for an individual and $33,000 for a body corporate) or 1 year
imprisonment.
Clause 193 – Regulations
This clause
empowers the Governor-General to make regulations prescribing matters required
or permitted to be prescribed by the Bill, or necessary or convenient to be
prescribed for carrying out or giving effect to the Bill.
Sub-clause
193(2) clarifies that, without limiting the matters that may be prescribed
in regulations by the Governor-General, regulations may be made requiring a
person to comply with codes of practice or guidelines issued under this.
[1] GMAC oversees any work involving the construction and/or propagation of viroids, viruses, cells or organisms of novel genotype produced by genetic manipulation which are either: unlikely to occur in nature; are likely to pose a hazard to public health or to the environment.
[2]
“deal with” is defined to include, in relation to a GMO,
conducting experiments with, making, developing, producing, manufacturing,
breeding, propagating, using in the course of manufacture of a thing, growing,
raising, culturing or
importing.
[3] While the TGA
regulates the safety, quality and efficacy of vaccines (and GTRAP also oversees
clinical trials utilising viruses), they do not regulate occupational health and
safety risks to the producer of the vaccine or virus nor do they examine any
environmental risk which may be associated with the use of the GM vaccine. At
present advice on these issues is provided by
GMAC.
[4] It should, however, be
noted that GMAC currently oversee these activities under administrative
arrangements.
[5] Note that a
separate RIS has been prepared to accompany the Gene Technology
(Consequential Amendments) Bill 2000