GENE TECHNOLOGY AMENDMENT BILL 2007
OUTLINE
The purpose of this Bill is to amend the Gene Technology
Act 2000 (the Act) in order to improve its operation without changing the
underlying policy intent or overall legislative framework of the regulatory
scheme.
The Act is the Australian Government's component of the
nationally consistent regulatory scheme for gene technology. Under the Gene
Technology Agreement 2001, all States and Territories have committed to
maintaining corresponding legislation. The object of the Act is to protect the
health and safety of people, and to protect the environment, by identifying
risks posed by or as a result of gene technology, and by managing those risks
through regulating certain dealings with genetically modified organisms (GMOs).
In 2005-06, an independent review of the Act and the
intergovernmental Gene Technology Agreement 2001 (the Review) was
conducted. The Review found that the Act and the national regulatory scheme
had worked well in the five years following introduction, and that no major
changes were required. However, it suggested a number of minor changes, aimed
at improving the operation of the Act at the margin.
On 27 October 2006, the Gene Technology Ministerial Council
(GTMC), an intergovernmental body comprised of State, Territory and Australian Government
Ministers, agreed to proposals to implement the recommendations of the Review.
This Bill proposes to implement the recommendations requiring legislative
change, which include:
·
introducing emergency powers, giving the Minister the ability to
expedite the approval of a dealing with a GMO in an emergency (Part 1 of
Schedule 1 to the Bill);
·
improving the mechanism for providing advice to the Gene Technology
Regulator (the Regulator) and the GTMC on ethics and community consultations
(Part 2 of Schedule 1 to the Bill);
·
streamlining the process for the initial consideration of licences (Part
3 of Schedule 1 to the Bill);
·
reducing the regulatory burden for low risk dealings (Part 3 of Schedule
1 to the Bill);
·
providing clarification on the circumstances in which licence variations
can be made (Part 4 of Schedule 1 to the Bill);
·
clarifying the circumstances under which the Regulator can direct a
person to comply with the Act (Part 5 of Schedule 1 to the Bill);
·
providing the Regulator with the power to issue a licence to persons who
find themselves inadvertently dealing with an unlicensed GMO, for the purpose
of disposing of that organism (Part 6 of Schedule 1 to the Bill); and
·
making technical amendments to improve the operation of the Act
(Schedule 2 to the Bill).
FINANCIAL IMPACT STATEMENT
GENE TECHNOLOGY AMENDMENT BILL 2007
NOTES ON CLAUSES
Clause 1: Short Title
This clause provides that the Act may be cited as the Gene
Technology Amendment Act 2007.
Clause 2: Commencement
This clause provides that sections 1 to 3 of the Act would
commence on the day on which the Act receives Royal Assent. Parts 1, 3, 4, 5,
and 6 of Schedule 1 and Schedule 2 would commence on 1 July 2007, or on the day
after the day on which the Act receives Royal Assent, whichever is the later.
Part 2 of Schedule 1 would commence on a single day to be
fixed by Proclamation, which must be before 1 January 2008, otherwise this Part
commences on 1 January 2008. It is scheduled to commence after the
rest of the Bill to allow members of the Gene Technology Ethics Committee to
complete their agreed terms of appointment.
Clause 3: Schedule(s)
This clause provides that each Act specified in a Schedule
to the Act is amended or repealed as set out in the applicable items in the
Schedule concerned, and any other item in a Schedule, has effect according to
its terms.
SCHEDULE 1: GENE TECHNOLOGY ACT 2000
PART 1: Emergency dealing determinations
Part 1 of Schedule 1 to the Bill proposes to introduce
emergency provisions into the Act. The object of these provisions is to
increase the effectiveness of the gene technology regulatory system by
increasing its responsiveness.
The emergency provisions give the Minister power to expedite
an approval of a dealing with a GMO in an emergency. This recognises that
situations may arise in which approval of a dealing with a GMO may be required
in a limited time. The emergency provisions also further the objects of the Act
to protect the health and safety of people and to protect the environment.
The introduction of emergency provisions to the Act is also
beneficial because it will improve consistency between regulatory schemes.
Other relevant product regulators for vaccines, such as the Therapeutic Goods
Administration and the Australian Pesticides and Veterinary Medicines
Authority, already possess the ability to expedite approvals in an emergency.
Item 1 would insert a definition of emergency
dealing determination into subsection 10(1) of the Act, providing that
an emergency dealing determination means a determination in force under section
72B of the Act.
Item 2 would insert a new paragraph 31(2)(aa) into
the simplified outline at the beginning of Part 4 of the Act. The proposed new
paragraph makes clear that ‘a dealing specified in an emergency dealing
determination’ is not prohibited under the Part.
Item 3 would repeal the existing subsection 32(1) and
substitute a new subsection 32(1) into the Act. The new subsection would
provide that a person commits an offence if he or she deals with a GMO, knowing
that it is a GMO and without a licence authorising the dealing, unless the
dealing is specified in an emergency dealing determination, it is a notifiable
low risk dealing, it has been specifically exempted from the application of the
legislation under the Regulations, or it has been placed on the GMO register.
The person must either have known, or have been reckless about all of these
things to have committed an offence.
The new subsection 32(1) is substantially the same as the
existing subsection 32(1) except that it inserts an additional paragraph
providing that the dealing with the GMO must not be specified in an emergency
dealing determination, and the person must know or be reckless as to this fact
for an offence to be committed. In addition, the subsection has been redrafted
to clarify that an offence is only committed if the dealing with the GMO is not
authorised by a licence.
Items 4 and 5 would insert a new paragraph 33(1)(ba)
into the Act and insert a reference to the new paragraph 33(1)(ba) into
subsection 33(2) of the Act. These amendments would make clear that a person
will commit a strict liability offence under subsection 33(1) of the Act if the
person deals with a GMO, knowing that it is a GMO, the dealing is not
authorised by a licence, it is not specified in an emergency dealing determination,
it is not a notifiable low risk dealing, it has not been specifically exempted
from the application of the legislation under the Regulations, and it is not on
the GMO register.
Item 6 would repeal the existing subsection 34(1) and
substitute a new subsection 34(1). The subsection has been redrafted to
clarify that in order to commit an offence a person’s actions must contravene a
licence and the person must know or be reckless as to that fact.
Item 7 would repeal the existing paragraphs 34(2)(b)
and (c) and substitute new paragraphs 34(2)(b) and (c). The paragraphs have
been redrafted to clarify that in order to commit an offence a person’s actions
must contravene the conditions of a licence and the person must know or be
reckless as to that fact.
Item 8 would insert two new offence provisions into
the Act:
Section 35A: the proposed new section 35A is similar
to existing section 34 of the Act. Proposed subsection 35A(1) creates an
offence for intentionally breaching the conditions of an emergency dealing
determination. Proposed paragraph 35A(2)(a) provides that the penalty for an
aggravated offence is 5 years imprisonment or 2,000 penalty units. Proposed
paragraph 35A(2)(b) provides that if it is not an aggravated offence the
penalty will be 2 years imprisonment or 500 penalty units. These penalties are
consistent with those contained in section 34.
Section 35B: the proposed new section 35B creates a
strict liability offence for breaching the conditions of an emergency dealing
determination. It is similar to the existing section 35 of the Act. In order
to have committed an offence under proposed new subsection 35B(1), the person
must have knowledge of the conditions to which the emergency dealing
determination is subject, but need not know that he or she is breaching that
condition. Proposed paragraph 35B(2)(a) provides that the penalty for an
aggravated offence is 200 penalty units. Proposed paragraph 35B(2)(b) provides
that if it is not an aggravated offence the penalty is 50 penalty units. These
penalties are consistent with those contained in section 35. Proposed
subsection 35B(3) provides that strict liability applies to paragraphs
35B(1)(a) and (b).
New strict liability offence
Item 6 would create a new strict liability offence for breaching
the conditions of an emergency dealing determination. The application of
strict liability to this offence is considered appropriate because any dealings
with a GMO conducted in an unauthorised or unregulated manner could cause
serious harm to the health and safety of people and the environment. Strong
deterrents are needed to discourage persons from dealing with GMOs unless they
are fully aware of any relevant regulatory safeguards.
Item 9 would alter the wording of section 67, to make
clear that the section applies to protect persons who provide information under
the new paragraph 72D(1)(h) from certain civil liabilities.
Item 10 would insert a new Part 5A with the title
‘Emergency dealing determinations’ into the Act.
Section 72A: the proposed new section 72A creates a
simplified outline for the Part. It provides that the Part creates a system
whereby the Minister can make a determination relating to dealings with GMOs in
an emergency.
Section 72B
Subsection 72B(1): the proposed new subsection 72B(1)
gives the Minister power to make an emergency dealing determination in respect
of specified dealings with a GMO, by legislative instrument. The emergency
dealing determination will effectively authorise the specified dealings with the
GMO so that the penalty provisions in Part 4 of the Act will not apply.
A legislative instrument made under subsection 72B(1) is not
to be disallowable because, once States and Territories sign the amended Gene
Technology Agreement 2001, it would fall under the exemption in subsection
44(1) of the Legislative Instruments Act 2003 (the LIA). The exemption
applies because the Act, in conjunction with the Gene Technology Agreement
2001, facilitates an intergovernmental scheme involving the Commonwealth
and all States and Territories. A legislative instrument made under subsection
72B(1) would be made for the purposes of this scheme; this is supported by
paragraph 72B(2)(e) which provides that States must be consulted about the
making of the proposed emergency dealing determination.
Subsection 72B(2): the proposed new subsection 72B(2)
sets out the conditions under which the Minister is permitted to make an
emergency dealing determination. It provides that before making an emergency
dealing determination the Minister must:
·
have received advice from the Commonwealth Chief Medical Officer; the
Commonwealth Chief Veterinary Officer, the Commonwealth Chief Plant Protection
Officer or a person specified in the regulations, that there is an actual or
imminent threat to the health and safety of people or the environment and that
the dealings proposed to be specified in the emergency dealing determination
would, or would be likely to, adequately address the threat;
·
be satisfied that there is an actual or imminent threat to the health
and safety of people or the environment, that the dealings proposed to be
covered by the emergency dealing determination would, or would be likely to,
adequately address the threat; and
·
be satisfied that the risks posed by the proposed dealings can be
managed safely, and have received advice from the Regulator to that effect.
In addition, States (which is defined to include the
Australian Capital Territory and the Northern Territory) must have been
consulted about the proposed emergency dealing determination.
Subsection 72B(3): the proposed new subsection 72B(3)
gives examples of situations in which it may be appropriate to issue an
emergency dealing determination. These include:
·
where there is a threat of disease;
·
where there is a threat from an animal or plant (such as a pest
or alien invasive species); or
·
where there is a threat from industrial spillage.
The Bill makes clear that the threat must be actual and
imminent for the emergency provisions to apply. It is expected that the
provisions will only be utilised if a threat is serious and immediate.
Hypothetical examples situations in which the powers could
be used are if there is a threat of an avian flu pandemic or if there is a
threat of major environmental damage from an oil spill. In these situations
the Minister may wish to issue an emergency dealing determination in relation
to a dealing with a GMO which is intended to address the threat by minimising
or eradicating the problem organism and its vectors, or by conveying immunity
in humans and/or animals. In the hypothetical situations mentioned above, the
determination could cover dealings in relation to a genetically modified
vaccine for human or veterinary use; or a genetically modified bacterium to
dissolve oil.
Subsection 72B(4): the proposed new subsection
72B(4) sets out the types of dealings for which the Minister may make a
determination. It makes clear that the determination may be in respect of all
dealings with a GMO, a specified class of dealings, or one or more specified
dealings and may relate to a specific GMO or a 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. This provision is drafted in similar terms to the
existing subsection 32(4) of the Act.
Section 72C
Subsection 72C(1): the proposed new subsection 72C(1)
sets out that a determination can take effect on the day on which it is made or
at a specified later date. In other words, the determinations cannot apply
retrospectively.
Subsection 72C(2): the proposed new subsection 72C(2)
provides that a determination ceases to have effect on: a date specified in the
determination; when the determination is revoked; or after six months;
whichever comes first.
Subsection 72C(3): the proposed new subsection 72C(3)
provides that the Minister may extend an emergency dealing determination.
Subsection 72C(4): the proposed new subsection 72C(4)
provides that the Minister may extend the emergency dealing determination more
than once, for up to six months each time. The process set out in subsection
72C(5) must be repeated for each extension.
Subsection 72C(5): the proposed new subsection 72C(5)
provides that the Minister may only extend an emergency dealing determination
if:
·
he or she has received advice from the person who originally
provided advice under paragraph 72B(2)(a) (the “original adviser”) that the
threat still exists and that extending the emergency dealing determination
would, or would be likely to, adequately address the threat; and
·
he or she is satisfied that threat still exists and that
extending the emergency dealing determination would, or would be likely to,
adequately address the threat; and
·
he or she is satisfied that the risks posed by the proposed
dealings can be managed safely, and have received advice from the Regulator to
that effect; and
·
the majority of jurisdictions (including States, Territories and
the Australian Government) agree to the extension.
Subsection 72C(6): the proposed new subsection 72C(6)
provides that the extension of the emergency dealing determination takes effect
when the original emergency dealing determination was scheduled to end.
Subsection 72C(7): the proposed new subsection 72C(7)
defines original adviser in subsection 72C(5) as the person who gave the advice
under paragraph 72B(2)(a).
Section 72D
Subsection 72D(1): the proposed new subsection 72D(1)
allows conditions to be imposed on an emergency dealing determination.
Paragraphs 72D(2)(a) to (v) give examples of the conditions that may be imposed.
These include conditions relating to the quantity of GMO, the scope of
dealings, the source of GMO, the person who may deal with the GMO, information
required to be given to persons permitted to deal with a GMO, additional
information that must be provided to the Regulator, and the storage and
security of the GMO amongst other things. The new paragraph (w) clarifies that
the conditions the Minister may impose are not limited to the matters listed in
paragraphs (a) to (v), but that the Minister may impose conditions over any
other matter he or she considers appropriate.
The proposed new paragraphs 72D(2)(a) to (v) correspond to
the existing sections 62, 63, 64 of the Act, which relate to the conditions
that may be imposed on licences:
·
the proposed new paragraphs 72D(2)(b) to (d) correspond to the
existing subsections 62(1)(a) to (c);
·
the proposed new paragraph 72D(2)(g) is the equivalent of the
existing section 63;
·
the proposed new paragraph 72D(2)(h) corresponds to the existing
section 65;
·
the proposed new paragraphs 72D(2)(j) and (k) correspond to the
existing paragraphs 62(1)(e) and (f);
·
the proposed new paragraphs 72D(2)(m) to (o) correspond to the
existing paragraphs 62(1)(g) to (i); and
·
the proposed new paragraphs 72D(2)(q) to (v) correspond to the
existing paragraphs 62(1)(j) to (o).
Subsection 72D(3): the proposed new paragraph
72D(2)(f) provides that a condition may specify the person who may deal with
the GMO. The proposed subsection 72D(3) makes clear that it is not necessary
to specify a single person, that a condition can specify persons or a class of
persons who may deal with the GMO. There are no restrictions on who may be
included in the class of persons who may deal with the GMO, or how large the
class may be.
Subsection 72D(4): the proposed new subsection 72D(4)
is drafted on similar terms to the existing section 64 of the Act. It provides
that it is a condition of an emergency dealing determination that a person
permitted to deal with a GMO under an emergency dealing determination, must
allow the Regulator (or delegate) to enter premises where the dealing is being
undertaken, in order to conduct audits, or monitor the dealings covered by the
emergency dealing determination. This allows the Regulator to undertake
routine or ‘on-the-spot’ auditing or monitoring of dealings covered by an
emergency dealing determination.
Subsection 72D(5): the proposed new subsection 72D(5)
makes clear that subsection 72D(4) does not limit the conditions that may be
placed on an emergency dealing determination.
Section 72E
Subsection 72E(1): the proposed new subsection 72E(1)
provides that the Minister may vary the conditions of an emergency dealing
determination by legislative instrument, including by imposing new conditions
on a determination.
A legislative instrument issued under subsection 72E(1) is
not disallowable because the exemption in subsection 44(1) of the LIA applies.
This exemption applies for the reasons set out in relation to subsection
72B(1), above.
Subsection 72E(2): the proposed new subsection 72E(2)
provides that the Minister may suspend or revoke an emergency dealing
determination by legislative instrument, in three circumstances:
·
if the Minister becomes aware of risks to the health and safety of
people or the environment posed by the dealing that cannot be adequately
addressed;
·
if the Minister is satisfied that the threat no longer exists or is no
longer sufficiently serious as to warrant an emergency dealing determination;
or
·
if the Minister is no longer satisfied that the dealings covered by the
determination are likely to adequately address the threat.
Subsection 72E(3): the proposed new subsection 72E(3)
provides that the Minister must consult the States (which is defined to include
the Territories) before varying, suspending or revoking an emergency dealing
determination unless the proposed variation is of a minor technical nature.
Subsections 72E(4) and 72E(5): the proposed new
subsection 72E(4) provides that a suspension, revocation, or variation may take
effect immediately only if the Minister states that it is necessary to prevent
imminent risk of death, serious illness or serious injury or serious damage to
the environment. Subsection 72E(5) provides that otherwise, it must take
effect on a date specified, which must be 30 days or more after it is made.
Items 11 and 12 would amend the simplified outline to
make clear that the conditions of an emergency dealing determination could
require a facility to be certified and accredited under Division 2 of the Act,
or an organisation to be accredited under Division 3 of the Act.
Item 13 would insert words into the note in
subsection 83(2) to make clear that the conditions of an emergency dealing
determination could require a facility to be certified under Division 2.
Item 14 would replace the note in subsection
91(1) to make clear that the conditions of an emergency dealing determination
could require supervision by an Institutional Biosafety Committee.
Item 15 would insert two new paragraphs 136A(2)(ba)
and 136A(2)(bb) into the Act providing that quarterly reports prepared by the
Regulator and given to the Minister must include information about any emergency
dealing determinations issued by the Minister and any breaches of conditions of
an emergency dealing determination that have come to the Regulator’s attention
during the quarter.
Item 16 would insert a new subsection 138(3A) into
the Act providing that the Record of GMO and GM Product dealings required under
Division 6, must include comprehensive information, except confidential
commercial information, on the content of emergency dealing determinations.
Item 17 would insert a new paragraph into the simplified
outline in section 145 of the Act. This makes clear that Part 10 of the Act
enables the Regulator to give directions to a person permitted to deal with a
GMO under an emergency dealing determination.
Item 18 would amend paragraph 146(2)(a) to provide
that the Regulator may give directions to a person dealing with, or who has
dealt with, a GMO specified in an emergency dealing determination.
Item 19 would insert a reference to emergency dealing
determinations into the simplified outline in section 149 of the Act. This
makes clear that Part 11 does not limit the conditions to which an emergency
dealing determination can be subject.
Item 20 would insert a new paragraph into subsection
152(2) of the Act to make clear that an inspector may enter premises and
exercise the monitoring powers set out in section 153, for the purpose of
finding out whether the Act or regulations have been complied with, if the
occupier of the premises is a person dealing with, or who has dealt with, a GMO
specified in an emergency dealing determination and entry is at a reasonable
time.
Item 21 would insert a reference to the Minister’s
power to impose conditions on an emergency dealing determination into section
177 of the Act. This clarifies that Part 11 does not limit the Minister’s
power to impose conditions on an emergency dealing determination.
Item 22 would insert a new paragraph into subsection
192A(2) of the Act to provide that authorised GMO dealings
include dealings that are specified in an emergency dealing determination and
are not prohibited from being undertaken at the premises or facility by a
condition of the emergency dealing determination.
Item 23 would amend paragraph (d) of the definition
of authorised GMO dealings in subsection 192A(2) of the Act, to refer
to ‘dealings included on the GMO Register’ instead of ‘deregulated GMO
dealings’.
PART 2: Creation of Gene Technology Ethics and Community
Consultative Committee
Part 2 of Schedule 1 to the Bill proposes amendments which
will combine the Gene Technology Ethics Committee (the Ethics Committee) and
the Gene Technology Community Consultative Committee (the Consultative
Committee) into one advisory committee. The combined committee will be known
as the Gene Technology Ethics and Community Consultative Committee (the Ethics
and Community Committee) and will carry out the combined functions of both
committees as well as providing advice on risk communication and community
consultation in relation to intentional release licence applications.
The object of these proposed amendments is to increase
efficiency by addressing the overlap between the roles of the Ethics Committee
and the Consultative Committee. The new committee would also allow relevant
skills to be distributed across its membership so that the committee is able to
provide clear, balanced, appropriate, and more coordinated advice.
The GTMC will review the performance of the new advisory
committee after 18 months, but before it has been operating for two years.
Item 24 would repeal the definition of Consultative
Committee in subsection 10(1) of the Act.
Item 25 would insert a definition of Ethics and
Community Committee into subsection 10(1) of the Act. It would be
defined to mean the Gene Technology Ethics and Community Consultative Committee
established by section 106 of the Act (inserted by tem 34).
Item 26 would repeal the definition of Ethics
Committee in subsection 10(1) of the Act.
Items 27-31 and 33 would repeal references to the
Consultative Committee and the Ethics Committee in the Act and replace them
with references to the Ethics and Community Committee.
Item 32 would make a consequential amendment to
subsection 100(5) of the Act to make clear that subsection 100(5) is subject to
both subsection 100(6) and subsection 100(7A).
Item 34 would repeal Divisions 3 and 4 of Part 8 of
the Act and insert a new Division 3, which establishes the Ethics and Community
Committee, and provides for its functions and membership, as well as the
remuneration of its members.
Section 106: the proposed new section 106 establishes
the Gene Technology Ethics and Community Consultative Committee, to be known as
the Ethics and Community Committee.
Section 107: the proposed new section 107 provides
that the function of the Ethics and Community Committee will be to provide
advice, at the request of the Regulator or the Ministerial Council, on:
·
matters on which the Ethics Committee currently advises;
·
matters on which the Consultative Committee currently advises;
·
community consultation matters relating to intentional release
licence applications; and
·
risk communication matters relating to dealings that involve the
intentional release of a GMO into the environment.
Risk communication involves an interactive dialogue between
risk assessors, risk managers and stakeholders. It underpins the processes of
risk assessment and risk management.
The proposed new section 107 is not intended to mandate the
examination of every intentional release application, instead it is intended to
permit the Regulator to seek advice in relation to certain types of releases
that might be precipitated by such an application.
The matters on which the Ethics Committee currently advises
are set out in section 112 of the existing Act. These are: ethical issues
relating to gene technology; the need for, and content of, codes of practice in
relation to ethics in respect of conducting dealings with GMOs; and the need
for, and content of, policy principles in relation to dealings with GMOs that should
not be conducted for ethical reasons. It is proposed that these matters will
be incorporated into proposed paragraphs 107(a), (b) and (c) of the Act.
The matters on which the Consultative Committee currently
advises are set out in existing section 107 of the Act. These are: matters of
general concern identified by the Regulator in relation to applications,
matters of general concern in relation to GMOs, and the need for policy
principles, policy guidelines, codes of practice and technical and procedural
guidelines in relation to GMOs and GM products and the conduct of such
principles, guidelines and codes. It is proposed that these matters will be
incorporated into proposed paragraphs 107(d), (g), and (h) of the Act.
Section 108: the proposed new section 108 relates to
the membership of the Ethics and Community Committee. The proposed new
subsection 108(1) is the same as the existing subsections 108(1) and 111(2) of
the Act, except that it refers to the Ethics and Community Committee instead of
the Ethics Committee or the Consultative Committee. With the same exception,
the proposed new subsection 108(2) is the same as the existing subsections
108(2) and 111(4) of the Act; the proposed new subsection 108(5) is the same as
the existing subsections 108(5) and 111(3) of the Act; and the proposed new
subsection 108(6) is the same as the existing subsections 108(6) and 111(7) of
the Act.
Subsection 108(3): the proposed new subsection 108(3)
lists the areas of experience members of the Ethics and Community Committee are
required to have. It specifies that, with the exception of a member appointed
under the proposed new subsection 108(4), the Minister must not appoint a
person as a member of the Ethics and Community Committee unless the Minister is
satisfied that the person has skills or experience relevant to gene technology
in one or more of the following areas:
·
community consultation;
·
risk communication (i.e. the facilitation of communication
between risk assessors, risk managers and stakeholders);
·
the impact of gene technology on the community;
·
issues relevant to businesses developing or using biotechnology;
·
issues relevant to gene technology research;
·
issues relevant to local government;
·
issues of concern to consumers;
·
law;
·
religious practices;
·
human health;
·
animal health and welfare;
·
primary production;
·
ethics; and
·
environmental issues.
Regulations may also prescribe additional areas of skill or
experience. With the exception of community consultation and risk
communication, all of these areas of experience were previously listed as areas
of experience members of either the Ethics Committee or the Consultative
Committee were required to have.
Subsection 108(4): the proposed new subsection 108(4)
provides that the Minister must ensure that the Ethics and Community Committee
includes a member of the Gene Technology Technical Advisory Committee and a
member of the Australian Health Ethics Committee.
Section 109: the proposed new section 109 provides
for remuneration of the Ethics and Community Committee and its expert
advisers. It is the same as existing sections 109 and 114 of the Act, except
that it refers to the Ethics and Community Committee instead of the Ethics
Committee or the Consultative Committee.
Section 110: the proposed new section 110 relates to
the membership and procedures of the Ethics and Community Committee. This
section is similar to the existing section 115 of the Act.
Subsections 110(1) and 110(2): the proposed new
subsections 110(1) and (2) provide that the regulations may prescribe matters
relating to the membership and operation of the Ethics and Community Committee.
Subsection 110(3): the proposed new subsection 110(3)
provides that if no regulations are in force, the Ethics and Community
Committee must operate in a way determined by the Regulator in writing.
Subsection 110(4): the proposed new subsection 110(4)
provides that in the absence of regulations made under subsections 110(1) and
(2), or a determination made under subsection 110(3), the Ethics and Community
Committee may operate as it, itself, determines in writing.
Subsection 110(5): the proposed new subsection 110(5)
makes clear that determinations made under subsections 110(4) and 110(5) are
not legislative instruments.
Determinations made under subsections 110(3) and (4) not
legislative instruments
Subsection 110(5) is intended to assist readers by making
clear that a determination made under subsection 110(3) or 110(4) is not a
legislative instrument. This is because the instruments made under these
sections would be administrative rather than legislative in nature and
therefore would not meet the definition of a legislative instrument in section
5 of the LIA (subsection 15AE(3) of the Acts Interpretation Act 1901
deals with a provision of a law which requires or permits an instrument that is
described as not being a legislative instrument to be made).
Sections 111 and 112: the proposed new sections 111
and 112 provide for the establishment of subcommittees and the appointment of
expert advisers. The sections are the same as the existing sections 116, 110A,
and 113 of the Act except that they refer to the Ethics and Community Committee
instead of the Ethics Committee or the Consultative Committee.
Item 35 is a transitional provision. This provision
makes clear that where State laws confer functions on the former Ethics
Committee or the Consultative Committee, the new Ethics and Community Committee
can exercise those functions. This will ensure that the new Committee can
perform the functions that are conferred by the State laws on the old
Committees until the State laws are amended to refer to the new Committee.
PART 3: Assessment of applications: limited and
controlled release and consultation on significant risk
Part 3 of Schedule 1 to the Bill proposes two types of
amendment. The first type of amendment would alter the order of events during
the initial licence consultation process, so that the Regulator is no longer
required to consider whether an application poses a significant risk to the
health and safety of people or the environment before developing a risk
assessment and risk management plan (RARMP). The object of these amendments is
to improve the process by which licences are initially considered by giving the
Regulator more time to consider whether dealings pose a significant risk. The
second type of amendment would introduce a new category of licence to
distinguish between licences for a limited and controlled release, and licences
for intentional release. The object of these amendments is to increase the
efficiency of the regulatory system by streamlining the application process for
licences involving a limited and controlled release of a GMO.
Item 36 would repeal section 49 of the Act. Under
this section, the Regulator is currently required to assess whether a proposed
dealing may pose a significant risk before developing a RARMP. This has proved
problematic, as it can be difficult for the Regulator to make a judgment on the
risk of a GMO prior to the development of the comprehensive RARMP. Item 36
would repeal this requirement, thereby allowing the Regulator to identify the
significant risk after he or she has developed a RARMP under section 50
of the Act.
Items 37 and 40-43 would make consequential
amendments to the Act by repealing subsection 50(2), and paragraphs 51(1)(b)
and 51(2)(b) which relate to actions required by section 49; and by omitting
the references to section 49 in subsection 51(2) and paragraph 51(1)(a).
Item 44 would insert a new paragraph (ba) into
subsection 52(2) of the Act. The new paragraph would provide that if the
Regulator is satisfied that dealings with a GMO pose a significant risk, then
the Regulator should make a statement to that effect in the notice published
under subsection 52(1). Thus, under this paragraph, the Regulator is required
to assess whether there is a significant risk after the RARMP has been
developed under section 50, but before he or she has consulted on it under
section 52(3).
Item 45 would provide for a longer consultation
process where the Regulator considers that the GMO poses a significant risk to
the health and safety of people or the environment and the RARMP contains a
statement to that effect. The item proposes to insert two new subparagraphs
into paragraph 52(2)(d) of the Act. The proposed subparagraph 52(2)(d)(i)
would provide that the time period for submissions must be at least 50 days if
the Regulator is satisfied that the dealings pose a significant risk. The
proposed subparagraph 52(2)(d)(ii) would provide for a thirty day time period
for all other dealings.
Items 38 and 39
Item 39 would insert a new section 50A into the Act. This
section would create a new category of licence application, to be known as
‘limited and controlled release’ applications. Item 38 would amend subsection
50(3) of the Act to make clear that if an application is a limited and
controlled release application, the Regulator does not need to seek advice from
the States (including the Australian Capital Territory and the Northern
Territory), the Gene Technology Advisory Committee, prescribed agencies, the
Environment Minister, or local councils on the preparation of an RARMP.
These amendments recognise that an application for a release
of a GMO for the purposes of obtaining experimental data will generally be
limited in terms of time, spatial scale and location and have containment
measures to restrict dissemination. In contrast, applicants wishing to
intentionally release a GMO may wish to produce that GMO commercially and will
generally seek a licence with as few restrictions as possible. Hence, licences
for intentional release would need to undergo a more rigorous risk assessment
process than licences for a limited and controlled release.
Subsection 50A(1): the proposed subsection 50A(1)
provides that the new section 50A will apply if the Regulator is satisfied of
three things: firstly, that the principal purpose of the licence sought is to
enable experiments to be conducted; secondly, that the release of the GMO under
the licence would be limited and that controls would be in place to limit the
dissemination of the organism; and thirdly, that it is appropriate for section
50(3) of the Act not to apply to the licence.
Subsection 50A(2): the proposed subsection 50A(2)
gives guidance on the meaning of the term ‘controls’ in subsection 50A(1). It
provides that controls can relate to the dissemination and persistence of the
GMO, the disposal of the GMO, the studies that can be conducted on the GMO, the
geographic area in which dealings may be conducted, and compliance with a code
of practice or a technical and procedural guideline.
Subsection 50A(3): the proposed subsection 50A(3)
gives guidance on the meaning of the term ‘limits’ in subsection 50A(1). It
provides that limits can include limits on the scope, scale, location and
duration of dealings with a GMO, as well as the persons who are permitted to
conduct dealings with the GMO.
Subsection 50A(4): the proposed subsection 50A(4)
provides that in determining whether the principal purpose of the licence is to
conduct experiments (or, in other words, in determining whether subsection
50A(1) applies to a licence), the Regulator must have regard to whether the
applicant proposes to test hypotheses; to gain scientific or technical
knowledge; or to gain data for regulatory purposes or for product development
or marketing. An undertaking to conduct any of these forms of research would
help establish that a licence is for the purposes of conducting experiments.
However, the Regulator still needs to consider whether conducting experiments
is the principal purpose of the licence. Paragraph 50A(4)(b) makes clear that
the Regulator may also consider any other matters that he or she considers to
be relevant.
PART 4: Provisions relating to variation
Part 4 of Schedule 1 to the Bill proposes amendments which
would give the Regulator the power to permit licence variations in certain
circumstances. While it is apparent from the existing subsection 72(5) that
licence-holders can request variations to their licences, this is not
explicitly stated in the Act. The introduction of amendments to explicitly
permit licence variations is intended to increase the clarity of the Act.
Furthermore, the imposition of limits on the circumstances in which Regulator
can vary a licence is intended to prevent a variation being used to
unreasonably extend the coverage of a licence.
Item 46 would repeal the existing subsection 71(1)
and insert a revised subsection 71(1) and a new subsection 71(1A) into the
Act. The proposed new subsection 71(1) clarifies that the Regulator has the
power to vary a licence either unilaterally, or after receiving an application
from a licence-holder. The proposed new subsection 71(1A) provides that the
licence holder’s application must be in writing and include any information
prescribed by the Regulations or required by the Regulator in writing.
Item 47 would make a consequential amendment to
subsection 71(2) of the Act.
Item 48 would insert new subsections 71(2A)
and 71(2B) into the Act. These subsections describe circumstances in which the
Regulator is not permitted to vary a licence.
Subsection 71(2A): the proposed new subsection 71(2A)
provides that the Regulator must not vary a licence if the original application
was for a limited and controlled release unless the licence as varied is also
for a limited and controlled release. In other words, the object of this
section is to prevent a variation turning a licence for a limited and
controlled release into a licence permitting intentional release of a GMO into
the environment.
Subsection 71(2B): the proposed new subsection 71(2B)
provides that the Regulator must not vary a licence if the licence, as varied,
would pose new risks which were not covered in the original risk assessment and
risk management plans.
Item 49 would make a consequential amendment to
subsection 71(4) of the Act.
Item 50 would insert four new subsections into the
Act.
Subsection 71(5): the proposed new subsection 71(5)
provides that the Regulator must consult with any appropriate local council
before varying a licence.
Subsection 71(6): the proposed new subsection 71(6)
provides that the Regulations may impose additional limitations on the
Regulator’s power to vary the licence.
Subsection 71(7): the proposed new subsection 71(7)
provides that the Regulations may set a time limit in which the Regulator must
vary a licence.
Subsection 71(8): the proposed new subsection 71(8)
makes clear that the terms ‘controls’ and ‘limits’ have the same meaning in
subsection 71(2A) as in the proposed section 50A of the Act.
Item 51 would insert a new item 4A into the table in
section 179 of the Act. This makes clear that the Regulator’s decision to
refuse to vary a licence is a reviewable decision, and that the licence holder
can apply to the Administrative Appeals Tribunal under section 183 of the Act
for review of the decision.
PART 5: Regulator’s power to direct
Part 5 of Schedule 1 to the Bill proposes amendments which
would increase the circumstances under which the Regulator may direct a
licence-holder, or a person covered by a licence, to comply with the Act or
Regulations.
The object of these proposed amendments is to reduce
ambiguity in the Act, by clarifying that the Regulator may direct a
licence-holder to comply, even if there is no immediate risk to the health and
safety of people or the environment.
The effect of the proposed amendments will be to increase
the Regulator’s compliance tools and ensure that all breaches of licences can
be dealt with under the Act. This recognises that it is important to maintain
the integrity of licences, even if there is no immediate risk to the health and
safety of people or the environment.
Item 52 would add the phrase “or for certain other
reasons” to the end of paragraph 145(b) in the simplified outline at the start
of Part 10 of the Act. This would make clear that the circumstances under
which the Regulator may give directions have been expanded.
Item 53 would insert new subparagraphs 146(1)(b)(ii)
and 146(2)(b)(ii) into the Act. These subparagraphs provide that the Regulator
may give directions to a person, requiring that he or she take steps to comply
with the Act and Regulations, if it is desirable in the public interest to do
so.
Item 54 would insert a new paragraph 146(2A) into the
Act, setting out the matters that the Regulator should consider in deciding
whether it is in the public interest to make a direction. These matters would
include:
·
the type of the GMO dealing and whether it is a one-off or
ongoing dealing;
·
whether any steps have been taken to address the non-compliance
issue;
·
the likelihood of a repeat of the non-compliance;
·
the severity of the non-compliance issue;
·
the compliance history of the licensee or the person covered by
the licence;
·
whether it would be more appropriate to address the
non-compliance by another means such as variation, suspension or cancellation
of the licence;
·
whether the non-compliance was deliberate; and
·
the need for deterrence.
These matters are similar to those listed in the OGTR’s Non-Compliance
Protocol of 10 May 2002. The protocol gives the Regulator
guidance on what matters he or she should consider in deciding whether to
conduct a criminal investigation.
PART 6: Inadvertent dealings
Part 6 to the Bill proposes amendments to allow the
Regulator to grant a temporary permit to a person who finds himself or herself
inadvertently dealing with an unlicensed GMO. The licence will be issued to
the person for the purposes of disposing of the GMO in a manner which protects
the health and safety of people and the environment.
The object of these proposed amendments is to allow a person
who has unintentionally come into possession of a GMO to dispose of the GMO
without breaching the Act. Under the current Act, the Regulator can rely on
the offence provisions or injunctions to deal with unapproved dealings with a
GMO. However, these tools are not suited to a case where a person wishes to
act cooperatively and dispose of the GMO in accordance with the Regulator’s
requirements to protect the health and safety of people or the environment.
Item 55 would insert a definition of inadvertent
dealings application into subsection 10(1) of the Act.
Item 56 proposes to insert a new section 40A into the
Act. This would provide for a new category of licence: licences relating to
inadvertent dealings.
Subsection 40A(1): the proposed new subsection 40A(1)
provides that a person does not need to apply for a licence in respect of
inadvertent dealings with GMO. The Regulator may treat a person as having
applied for a GMO licence without having received an application, as long as
that person agrees. This recognises that a person who inadvertently deals with
GMOs may not be aware of the legislative framework for GMOs, and hence may not
be equipped to apply for a licence under the Act.
Subsection 40A(2): the proposed new subsection 40A(2)
makes clear that a person may also apply for a licence under section 40 of the
Act in respect of an inadvertent dealing.
Items 57 and 58 would insert new sections 46A and 49
into the Act. These sections would make clear that if:
·
the Regulator is satisfied that the licence applied for will only
authorise the disposal of the GMO; and
·
the Regulator is satisfied that the applicant has come into the
possession of the GMO inadvertently;
the normal processes for the initial consideration of
licences, which are set out in Divisions 3 and 4 of Part 5 of the Act, will not
apply.
An example of a situation in which the new sections 46A and
49 could apply is where a particular GMO has been licensed for use in a certain
restricted area and remnants of the GMO become lodged in transporting or
handling equipment. In this situation, the GMO crop could conceivably become
mixed with non-genetically modified seeds. Thus, a farmer could purchase what
he or she believes to be non-genetically modified seeds but subsequently
discover GMOs growing amongst his or her crop. A farmer in this situation
could apply to the Regulator under section 40 for a licence to dispose of the
GMO. If the Regulator was satisfied that the farmer had come into possession of
the GMO inadvertently, and the licence sought was only for the purposes of
disposal of the GMO, then sections 46A and 49 would apply, meaning that the
Regulator could issue a licence for disposal without having to observe the
usual process for the initial consideration of licences in Divisions 3 or 4.
Item 59 would add a note to section 56 of the Act.
The note makes clear that paragraphs 56(2)(a),(b) and (c), which relate to risk
assessment and risk management plans, do not apply to inadvertent dealings
applications.
Item 60 would insert a new subsection 57(3) into the
Act. The new subsection would make clear that subsection 57(2), which requires
the Regulator to be satisfied that an applicant is a suitable person before
issuing a licence, does not apply to inadvertent dealings applications. This
means that section 58 of the Act, which expands upon subsection 57(2), also
does not apply.
Item 61 would insert a new subsection 60(3) into the
Act. This subsection would provide that a licence issued for an inadvertent
dealing cannot be valid for a period of longer than 12 months. This is a
maximum time period and the Regulator may specify a shorter time period where
appropriate. In determining the relevant time period, the Regulator should
bear in mind that a licence for an inadvertent dealing will only be issued for
the purposes of disposal of the GMO.
SCHEDULE 2: TECHNICAL AMENDMENTS
Items 1 and 2 would amend the definition of deal
with in relation to a GMO by including transport of a GMO, and disposal
of a GMO, as a dealing. Possession, supply and use of the GMO remain dealings
when used for the purposes of, or in the course of a dealing described in the
definition.
Item 3 would amend subsection 10(1) of the Act with
the intention of clarifying the meaning of Institutional Biosafety Committee by
defining it as an organisation established in accordance with guidelines issued
by the Regulator under section 98 of the Act.
Item 4 would add a new subsection 42(3) to the Act
with the intention of removing any doubt as to when the Regulator may request
further information in respect of an application. It would provide that the
Regulator may request further information at any time before the application is
decided, whether before or after the Regulator has begun to consider the
application.
Item 5 would insert a new paragraph 43(2)(f) into the
Act providing that where the Regulator is satisfied that an applicant is not a
suitable person to hold a licence (having regard to the matters listed in section
58 of the Act such as whether the applicant has any relevant convictions or
licence revocations, and the capacity of the person to meet the conditions of
the licence) then the Regulator is not required to consider the application.
Item 6 would amend subsection 43(2) of the Act with
the intention of expressly allowing the Regulator to cease (as well as to not
commence) the consideration of an application if one of the ensuing
paragraphs applies to the application.
Item 7 would provide that, for the purposes of
being satisfied that any risks posed by the dealings proposed to be licensed
are able to be managed in such a way as to protect the health and safety of
people and the environment, the Regulator is required to have regard to:
·
under new paragraph 56(2)(a), the risk assessments prepared under
section 47, for dealings not involving intentional release, or prepared under
section 50, for dealings involving intentional release; and
·
under new paragraph 56(2)(b), the risk management plans prepared
under section 47, for dealings not involving intentional release, or prepared
under section 50 for dealings involving intentional release.
Item 8 would add a new subsection 72(7) which
provides that section 72 of the Act, which includes, among other things,
requirements of notice of proposed variations to licences, does not apply where
the proposed variation is of minor significance or complexity.
Item 9 amends subsection 78(3) of the Act to remove
the requirement that a registration of a dealing, made on the application of a
licence holder, can only take effect if the licence authorising the dealing
ceases to be in force.
Item 10 adds subsection 89(7), which provides that
section 89 of the Act, which includes, among other things, requirements of
notice of proposed variations of certification, does not apply where the
proposed variation is of minor significance or complexity.
Item 11 would provide for the insertion of:
·
subsection 89A(1) which provides for transfers of certification
by way of a joint application between the holder of the certification and the
transferee;
·
subsection 89A(2) which requires the application to be in writing
and contain information prescribed by the regulations or specified in writing
by the Regulator;
·
subsection 89A(3) which prohibits the Regulator from transferring
certification unless satisfied that the conditions to which the certification
is subject will continue to be met;
·
subsection 89A(4) which requires the Regulator to give written
notice of his or her decision to the applicants; and
·
subsection 89A(5) which provides for the transfer, if approved,
to take effect on the date specified in the notice, for the certification to
continue in force and for the certification to be subject to the same
conditions which applied before the transfer.
Item 12 would amend paragraph 92(2)(a) of the Act to
remove the obligation for the Regulator to have regard to whether or not an
organisation proposes to establish an Institutional Biosafety Committee (IBC)
for the purposes of deciding whether to accredit an organisation.
Item 13 would amend paragraph 92(2)(b) of the Act to
require the Regulator, for purposes of accrediting organisations, to have
regard to whether an organisation will be able to maintain an IBC already
established.
Item 14 would amend paragraph 92(2)(c) of the Act to
require the Regulator, for the purposes of accrediting organisations, to have
regard to whether an organisation has appropriate indemnity arrangements if the
organisation has established an IBC.
Item 15 would insert a new paragraph 92(2)(ca) into
the Act which includes a consideration of whether or not the organisation will
be in a position to use an IBC established by another accredited organisation
as a matter to which the Regulator must have regard in deciding whether to
accredit an organisation.
Item 16 would add a new subsection 97(7) which
provides that section 97 of the Act, which includes, among other things,
requirements of notice of proposed variations of accreditation, does not apply
where the proposed variation is of minor significance or complexity.
Item 17 would insert Item 1A into the table at
section 179 of the Act, which adds to the list of reviewable decisions under
section 179, a decision by the Regulator under paragraph 43(2)(f) to refuse to
consider an application on the basis that the applicant is not a suitable
person to hold a licence.
Item 18 would insert Item 3A into the table at
section 179 of the Act which adds to the list of reviewable decisions under
section 179, a decision by the Regulator under section 70 to refuse to transfer
a licence.
Item 19 would insert Item 7A into the table at
section 179 of the Act which adds to the list of reviewable decisions under
section 179, a decision by the Regulator under section 89A to refuse to
transfer a certification.
Item 20 would amend the wording of paragraph 182(a)
so as to extend the application of section 182 to all applications to
the Regulator, not just applications to the Regulator to make a reviewable
decision.
Item 21 would insert into section 182 of the Act the
wording ‘reviewable decision to reject the application’, thereby removing any
doubt that a deemed rejection of an application on account of elapse of time is
reviewable under the Act.
Item 22 would add a new subsection 185(3B) into the
Act which would provide that information specified for purposes of an
application for a declaration that information is confidential commercial
information (‘CCI’), is treated as CCI until the Regulator has made a decision
on the application.