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2000
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
GENE TECHNOLOGY (CONSEQUENTIAL AMENDMENTS) BILL
2000
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and
Aged Care,
the Hon. Michael Wooldridge, MP)
ISBN: 0642 438625
This Bill represents one component of a national scheme to be established
to protect the public health and safety of people and to protect the
environment, by identifying risks posed by, or as a result of, gene technology
and managing those risks through regulating certain dealings with genetically
modified organisms (GMOs).
At present there are a range of regulators
who provide regulatory oversight in relation to genetically modified products
(GM products). GM products are things derived or produced from a live or viable
GMO. For example, the Therapeutic Goods Administration regulates therapeutic
goods including genetically modified therapeutics and the Australia New Zealand
Food Authority coordinates the regulation, by States and Territories, of food
including genetically modified food.
As such the Gene Technology
Bill 2000 provides for the direct regulation of all live or viable GMOs
(acknowledging the greater potential risks that may arise in relation to live
organisms that may be able to propagate) and regulation of GM products where
they are not regulated by any existing regulators. Where GM products are
regulated by existing regulators they will continue to be so
regulated.
This Bill ensures, however, that existing regulators of GM
products have access to comprehensive advice on genetic safety from the Gene
Technology Regulator and that the Gene Technology Regulator holds a
comprehensive database of all GMOs or GM products approved in Australia.
The Bill requires that existing regulators of GM products (operating under
existing schemes for the regulation of food, therapeutic goods, agricultural and
veterinary chemicals and industrial chemicals) must:
• seek advice from
the Gene Technology Regulator in relation to any application for approval of a
GM product;
• take such advice into account in decision making under
relevant legislation; and
• notify the Gene Technology Regulator of all
decisions made in relation to GM products to enable those decisions to be
entered on a central, publicly available database of all GMOs and GM products,
held by the Gene Technology Regulator.
For this purpose, the Bill:
(a) amends the Agricultural and Veterinary Chemicals (Administration) Act
1992 and the Agricultural and Veterinary Chemicals (Code) Act
1994;
(b) amends the Australia New Zealand Food Authority Act
1991;
(c) amends the Industrial Chemicals (Notification and
Assessment) Act 1989; and
(d) amends the Therapeutic Goods Act
1989.
The Bill also amends Schedule 3 of the Freedom of
Information Act 1982 to clarify that information that is declared to be
confidential commercial information under the Gene Technology Act 2000 is
also protected under the Freedom of Information Act 1982.
In the 1999 Budget, the Federal Government committed $7.6 million over 2
years for the
development of gene technology legislation and establishment
of the Gene Technology Regulator. Once the Gene Technology Regulator is
established, it is intended that the costs incurred by the Gene Technology
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 licensing under the Gene Technology Bill 2000). The fees and
charges levied, in order to recover the costs of the regulatory system, will be
prescribed in regulations made under the Gene Technology Bill 2000 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.
It is not anticipated that this Bill will result in
any significant costs to government in addition to those incurred as the result
of the operation of the Gene Technology Bill 2000.
REGULATION IMPACT STATEMENT
Recognising the important role of existing regulators, the Gene
Technology Bill 2000 has been drafted to ensure: the protection of public
health and safety and the environment through the effective identification and
management of any risks posed by GMOs; minimum duplication and overlap between
the Gene Technology Regulator and existing regulators; and the harmonisation of
risk assessments relating to GMOs and GM products by regulatory
agencies.
The Gene Technology Bill 2000 provides for the direct
regulation of all live or viable GMOs and regulation of GM products where they
are not regulated by an existing regulator. Where GM products are regulated by
existing regulators they will continue to be regulated by those regulators, with
advice from the GTR.
This Regulation Impact Statement (RIS) assesses the
impact of a range of options, including the option presented in the Gene
Technology (Consequential Amendments) Bill 2000, for minimising duplication
between existing agencies and ensuring that existing regulators of GM products
have access to advice on genetic safety, to assist their consideration of
approvals for GM products.
2. Problem
The package of
legislation for the regulation of GMOs (including the Gene Technology Bill
2000, the Gene Technology (Licence Charges) Bill 2000 and the Gene
Technology (Consequential Amendments) Bill 2000) addresses the problems
associated with the shortcomings in the current administrative arrangements for
the protection of health and safety of people and the environment from any risks
posed by live, viable GMOs and GM products.
As part of a package of
legislation, this legislation specifically addresses the following
problems:
• At present, there is no formal process for existing
regulators of GM products to seek, and take into account, advice on genetic
safety aspects of GM products. The existing Regulators currently use GMAC as a
source of advice but under the new system GMAC will no longer exist.
• In the absence of a capacity for advice to be sought from the Gene
Technology Regulator and taken into account by the existing regulators the
following problems would emerge:
Ø There would be no consistency in the way
that matters of genetic safety are considered by existing regulators in relation
to GM products;
Ø There would be little reassurance to the
community that matters of genetic safety have been adequately addressed during
the assessment process for GM products;
Ø There would be no central repository of
information about those GMOs and GM products that have been approved for
use/sale in Australia which would:
- make it difficult for Australia to
fulfil potential future reporting obligations under the Biosafety Protocol;
and
- reduce the information available to consumers of GMOs and GM products,
making it more difficult for consumers to make informed decisions in the market
place.
In summary, while informal arrangements with existing regulators
could continue under the new system, current problems would also continue
including lack of consistency, inadequate reassurance to the public that issues
of genetic safety are adequately addressed by existing regulators and the
absence of a comprehensive central database.
The objectives of government action in this area are:
• to
minimise duplication of effort and resources between existing regulators (and
clarify the interface between the Gene Technology Regulator and other existing
regulators);
• to ensure that a comprehensive assessment of any risks
posed by, or as a result of, gene technology is undertaken by all regulators of
GMOs and GM products; and
• to enable the public and other stakeholders
to access a comprehensive database of all GMOs and GM products in
Australia.
In summary the objectives are about having an assessment
system for GMOs and GM products that is comprehensive and efficient and provides
an outcome that is transparent.
This would involve amendments being made to the legislation of existing
regulators to ensure that existing regulators of GMOs and GM products (including
the regulators of food, therapeutic goods, agricultural and veterinary
chemicals and industrial chemicals) must:
• seek advice from the GTR in
relation to any application for approval of a GM product;
• take such
advice into account in decision making; and
• notify the GTR of all
decisions made in relation to GM products to enable those decisions to be
entered on a central, publicly available database of all GMOs and GM products,
held by the GTR (the Record of GMOs and GM Products is established in the
Gene Technology Bill 2000).
Legislation requiring amendment to
effect the changes detailed above would include:
a) the Agricultural and
Veterinary Chemicals (Administration) Act 1992 and the Agricultural and
Veterinary Chemicals (Code) Act 1994;
b) the Australia and New Zealand
Food Authority Act 1991;
c) the Industrial Chemicals (notification
and Assessment) Act 1989; and
d) the Therapeutic Goods Act
1989.
This option would give a formal legislative basis for the
interaction between the existing regulators and the Gene technology Regulator in
terms of requesting and providing information, making decisions and establishing
publicly available information systems.
The option would require
amendments to the above-mentioned primary legislation and the implementation of
formal channels of communication between the regulators and the Gene Technology
Regulator.
Option 2 would maintain the key features of the current GMAC system.
That is, the existing regulators (Australia New Zealand Food Authority, the
Therapeutic Goods Administration, the National Registration Authority and the
National Industrial Chemicals Notification and Assessment Scheme) could
informally seek the advice of the Gene Technology Regulator in relation to risks
posed by GM products.
This would be an ad hoc arrangement, whereby the
Gene Technology Regulator’s advice would be requested only if the relevant
agency considered it necessary to seek such input from the Gene Technology
Regulator to assist its decision-making process. There would be no formal
requirement that the information must be sought nor could a regulator be
compelled to seek such information or establish appropriate
networks.
Agencies would seek the Gene Technology Regulator’s
advice and consider that advice under existing legislation. Administrative
processes would be likely to evolve differently in accordance with the
individual needs of the ‘principal’ regulator and the capacity of
the Gene Technology Regulator to provide the advice requested (the amount and
type of advice provided would be uncertain in this
environment).
Impact group identification
The
following groups are relevant to the
proposal:
• Governments;
• Industry;
• Consumers;
and
• Community.
Assessment of Impacts of Option 1
|
Affected Group
|
Advantages
|
Disadvantages
|
|
Government
|
• The requirements are clear on the face of the
legislation
• No need to establish centres of expertise on genetic safety in each agency, thus avoiding costs of duplication and realising economies of scale • Ready access to expert advice on genetic safety • Capacity for the establishment of a consolidated database in relation to GMOs and GM products within Australia |
• Processes for meeting the legal requirements will need to be
developed – ie for requesting advice and taking such advice into
account
• Potential increase in information technology and human resource infrastructure requirements to ensure smooth exchange of information consistent with the legislative requirements. |
|
Industry
|
• Requirement that the Gene Technology Regulator provide advice
within the timeframes of the ‘primary’ regulator ensures that
product development processes are not affected
|
|
|
Consumers
|
• Consumers of products produced using gene technology can be
confident that risks have been comprehensively assessed by the
‘primary’ regulator in close co-operation with the Gene Technology
Regulator. All live, viable GMOs would also be directly regulated by the Gene
Technology Regulator
• Capacity to gain information in relation to GMOs and GM products in Australia via the consolidated database |
|
|
Community
|
• Can be confident that, as new technologies emerge, any regulatory
gaps are effectively ‘filled’ and that risks associated with GM
products are comprehensively assessed.
• Capacity to gain information in relation to GMOs and GM products in Australia via the consolidated database |
|
|
Affected Group
|
Advantages
|
Disadvantages
|
|
Government
|
• Lower costs associated with setting up administrative processes for
exchange of information and advice.
• No amendments to primary legislation of the existing regulators necessary. |
• May lead to duplication as some agencies may choose to establish
their own units to assess genetic risks rather than utilise the Gene Technology
Regulator’s services.
• May cause inconsistency and uncertainty in both assessments and processes for considering genetic safety. |
|
Industry
|
• Assessment of GM products by existing regulators remains
unchanged.
|
• Less transparent system may produce consumer uncertainties about
particular products and a possible reluctance to purchase such
products
• Potential for inconsistent decision-making between the different regulatory systems in relation to genetic safety |
|
Consumers
|
|
• May lead to consumer uncertainties and an unwillingness to purchase
certain products – where there is no guarantee that the Gene Technology
Regulator has been consulted and his/her advice taken into account
|
|
Community
|
|
• May be seen as ‘trivialising’ the risks posed by GM
products
• May lead to suspicions as to whether a full and proper assessment of any risks posed to human health and safety and the environment as a result of gene technology has been carried out for a particular GM product |
Extensive consultations have been undertaken during the development of
the Gene Technology Bill 2000. This has provided an opportunity to raise
with various stakeholders the policy intent behind the proposed Gene
Technology (Consequential Amendments) Bill 2000. Consultations took the
following forms:
1. Targeted consultations held with industry,
environmental, consumer and other groups;
2. Public consultations held in all
capital cities and in three regional centres;
3. Public submissions (on the
form of the legislation) called for;
4. Intensive consultations with the
existing regulators, relevant Commonwealth agencies and States and
Territories.
During consultations, stakeholders emphasised the need
for:
• Comprehensive regulation of all GMOs and GM
products;
• Capacity for existing regulators to access the advice of
the GTR;
• Consistency in decision-making concerning genetic safety;
and
• A comprehensive database of all GMOs and GM
products.
6. Conclusion and Preferred Option
The Bill
reflects a preference for Option 1. The advantages of this option are that
it:
• minimises duplication of effort and resources between existing
regulators to a greater extent than Option 2;
• ensures that an
assessment of any risks posed by, or as a result of, gene technology is
undertaken by all regulators of GMOs and GM products;
• imposes no
foreseeable additional costs on industry; and
• provides for the
collection of comprehensive information about GMOs and GM products approved in
Australia, for inclusion on a centralised database.
The changes proposed in this Bill will become part of the existing
legislative schemes for foods, therapeutics, industrial chemicals and
agricultural and veterinary chemicals. As such, the effectiveness of the
arrangements will be subject to periodic review under the existing systems.
However, it is proposed that the effects of the Bill would also be reviewed at
the end of the first five-year period when the gene technology scheme is
comprehensively reviewed by governments in accordance with the
Inter-governmental Agreement on Gene Technology as referenced in the Gene
Technology Bill 2000.
8. Competition Principles Agreement
Statement
There is arguably some potential to limit competition
because the proposed consequential amendments require the regulators to seek
advice from the GTR in relation to the genetic safety of GM products. However,
this is extremely unlikely to have any impact on competition since there is no
bar on the regulators seeking advice from numerous other relevant bodies and
taking that advice into account in decision-making. The proposed amendments
simply recognise that the GTR will be the central repository of expertise in
this area.
The recommended option does not restrict competition by adding
costs or delays to the assessment of GMOs and GM products which compete in
markets with non-GM products over and above costs and delays inherent in current
arrangements.
NOTES ON CLAUSES
PART 1 - PRELIMINARY
Clause 1 - Short title
This is a formal provision that specifies the short title of the Act as
the Gene Technology (Consequential Amendments) Act 2000.
Clause
2 - Commencement
This clause provides that the Act will commence
immediately upon the commencement of clause 55 of the Gene Technology Act
2000. Clause 55 of the Gene Technology Act 2000 requires the Gene
Technology Regulator to make a decision on any licence application received and
assessed by him or her.
Clause 3 - Schedule(s)
This
clause provides that every Act specified in the Schedule to this Bill is either
amended or repealed as set out in that Schedule, and any other item included in
the Schedule is to have effect according to its terms.
SCHEDULE 1 -
CONSEQUENTIAL AMENDMENTS
Agricultural and Veterinary Chemicals
(Administration) Act 1992
Items 1 and 2 insert in section
4 the definitions of “Gene Technology Regulator” and “GM
product”. These terms have the same meaning as in the Gene Technology
Act 2000.
Item 3 inserts a new clause, clause 8A, which
requires the National Registration Authority (NRA) to consult the Gene
Technology Regulator for the purposes of making a range of decisions under the
Agricultural and Veterinary Chemical (Administration) Act 1992. This
clause requires the NRA to consult the Gene Technology Regulator when deciding
whether to grant an application, make a variation or reconsider any of the
following:
(a) approval of an active constituent that is, or contains, a GM
product;
(b) registration of a chemical product that is, or contains, a GM
product; and
(c) approval of a label for containers for a chemical product
that is, or contains, a GM product.
The NRA must also consult the Gene
Technology Regulator before deciding whether to issue a permit in respect of an
active constituent or chemical product where either the active constituent or
the chemical product is, or contains, a GM product.
Sub-clause 3 of the
new clause 8A describes the formal process for the NRA to consult with the Gene
Technology Regulator. It provides that the NRA must give written notice to the
Gene Technology Regulator stating that the application has been made, a
reconsideration is to be undertaken or the permit is being considered and
requesting the Gene Technology Regulator to provide advice about the
application, reconsideration or issue of a permit.
Sub-clauses 8A(4) and
(5) provide that the Gene Technology Regulator may give written advice in
response to a request for advice from the NRA and that the advice must be given
in the time period specified by the NRA.
Sub-clause 8A(6) provides that
if the Gene Technology Regulator provides advice to the NRA on an application,
reconsideration or permit, the NRA must take the advice into account in making
the decision on the application, reconsideration or issue to which the notice
relates. The NRA must inform the Gene Technology Regulator of the decision.
This will then enable the Gene Technology Regulator to enter information
relating to the decision on the Record of GMOs and GM products established under
the Gene Technology Bill 2000.
Agricultural and Veterinary
Chemicals (Code) Act 1994
Item 4 inserts a new paragraph
after paragraph 14(3)(c), to cross reference the changes to the Agricultural
and Veterinary Chemicals (Administration) Act 1992 detailed at Item
3.
Item 5 inserts a new paragraph after paragraph 29(1)(c), to
cross reference the changes to the Agricultural and Veterinary Chemicals
(Administration) Act 1992 detailed at Item 3.
Item 6 inserts a
new paragraph after paragraph 34(1)(d), to cross reference the changes to the
Agricultural and Veterinary Chemicals (Administration) Act 1992 detailed
at Item 3.
Item 7 inserts a new paragraph after paragraph 114(1),
to cross reference the changes to the Agricultural and Veterinary Chemicals
(Administration Act) 1992 detailed at Item 3.
Australia New
Zealand Food Authority Act 1991
Item 8 inserts a new
paragraph after paragraph (b) of the definition of appropriate government agency
in subsection 3(1). The new paragraph includes the Gene Technology Regulator in
the list of appropriate government agencies.
The effect of this change
(in combination with the changes referred to at Item 11) is that the Australia
New Zealand Food Authority (the Authority) must, after accepting an application
for the development and variation of food regulatory measures in relation to
GMOs or GM products, give written notice to the Gene Technology Regulator
inviting written advice from the Gene Technology Regulator on the application.
The Authority must then have regard to such advice in making an assessment of
the application.
The Authority must advise the Gene Technology
Regulator of the nature of the recommendations made to the Australia New Zealand
Food Standards Council (the Council). The final decision of the Council is
publicly notified in the Government Gazette. The decision, as it relates to
GMOs or GM products, would then be entered on the Gene Technology
Regulator’s Record of GMOs and GM products (established under the Gene
Technology Act 2000).
Items 9, 10 and 11 insert three further
definitions in subsection 3(1). The terms “Gene Technology
Regulator”, “GMO” and “GM product” are defined as
having the same meaning as in the Gene Technology Act 2000.
Item 12 inserts a new clause (clause 11A – Notices to be
given to the Gene Technology Regulator) after section 11. Clause 11A provides
that the Authority is only required to give notice to the Gene Technology
Regulator in relation to an existing or proposed food regulatory measure if the
measure relates to food that is or contains a GMO or GM product.
Freedom of Information Act 1982
Item 13
inserts in Schedule 3 of the Freedom of Information Act 1982 (the FOI
Act), references to subsections 187(1) and 187(2) of the Gene Technology Act
2000.
The effect of this amendment is to clarify that information
that the Gene Technology Regulator declares to be confidential commercial
information under the Gene Technology Act 2000 is protected as such under
the FOI Act. Including a reference to the relevant provisions of the Gene
Technology Act 2000 in Schedule 3 of the FOI Act clarifies that these
provisions are provisions to which section 38 of the FOI Act applies. Section
38 of the FOI Act provides an exemption for certain documents to which secrecy
provisions apply.
It is also proposed that an equivalent provision will
be included in corresponding State laws to ensure national consistency regarding
the treatment of confidential commercial information.
Industrial
Chemicals (Notification and Assessment) Act 1989
Items 14 and
15 insert two new definitions in section 5. The terms “Gene
Technology Regulator” and “GM product” are defined as having
the same meaning as in the Gene Technology Act 2000.
Item
16 inserts three new clause (clauses 10A, 10B and 10C) after section 10.
The new clause 10A (Consultation with Gene Technology Regulator)
requires the Director of Chemicals Notification and Assessment to give written
notice to the Gene Technology Regulator requesting the Gene Technology Regulator
to provide advice in relation to an application for assessment of an industrial
chemical that is, or contains, a GM product or an application for a permit in
relation to an industrial chemical that is, or contains, a GM
product.
Sub-clauses 10A(3) and (4) provide that the Gene Technology
Regulator may give written advice in response to a request for advice from the
Director about the assessment or application and that the advice must be given
in the time period specified by the Director in the written notice provided to
the Gene Technology Regulator requesting the advice.
Sub-clause 10A(5)
provides that if an advice is in force from the Gene Technology Regulator under
clause 10B in relation to a class of GM products, the Director is not required
to seek the advice of the Gene Technology Regulator on a case by case basis
provided that the application or assessment falls within the class of GM
products in relation to which the Gene Technology Regulator issued an advice
under clause 10B.
The new clause 10B (Director may seek advice about
classes of GM products) provides that the Director may request advice from the
Gene Technology Regulator regarding a class of GM products that are also
industrial chemicals. The Gene Technology Regulator may provide advice in
relation to such a request and the advice remains in force until it is withdrawn
by the Gene Technology Regulator by written notice given to the
Director.
The effect of this provision is that if the same genetic
modification or GM product occurs within a range of industrial chemicals, the
Director does not need to seek advice from the Gene Technology Regulator in
relation to every application but may seek advice from the Gene Technology
Regulator about the class of GM products and then apply such advice to each
assessment or application undertaken by the Director.
The new clause 10C
(Director to take advice into account) provides that if the Gene Technology
Regulator provides advice to the Director (either in response to an individual
application or assessment under clause 10A or in response to a request for
advice about a class of GM products under clause 10B), the Director must take
that advice into account in undertaking an assessment or in making a decision on
the application for a permit.
This clause also provides that the
Director must inform the Gene Technology Regulator of the assessment or the
decision on the application. This will then enable the Gene Technology
Regulator to enter information relating to the assessment or the decision on the
Record of GMOs and GM products established under the Gene Technology Bill
2000.
Items 17 and 18 insert two new definitions in subsection 3(1).
The terms “Gene Technology Regulator” and “GM product”
are defined as having the same meaning as in the Gene Technology Act
2000.
Item 19 inserts three new clauses (clauses 30C, 30D and
30E) after section 30.
The new clause 30C (Consultation with Gene
Technology Regulator) requires the Secretary to give written notice to the Gene
Technology Regulator requesting the Gene Technology Regulator to provide advice
in relation to an application for listing or registration of a therapeutic good
under section 23 of the Therapeutic Goods Act 1989 if the therapeutic
good is, or contains, a GM product.
Sub-clauses 30C(3) and (4) provide
that the Gene Technology Regulator may give written advice in response to a
request for advice from the Secretary and that advice must be given in the time
period specified by the Secretary in the written notice provided to the Gene
Technology Regulator requesting the advice.
Sub-clause 30C(5) provides
that if an advice is in force from the Gene Technology Regulator under clause
30D in relation to a class of therapeutic goods that are also GM products, the
Secretary is not required to seek the advice of the GTR on a case by case basis
provided that the application for listing or registration falls within the class
of GM products in relation to which the Gene Technology Regulator issued an
advice under clause 30D.
The new clause 30D (Secretary may seek advice
about classes of GM products) provides that the Secretary may request advice
from the Gene Technology Regulator regarding a class of GM products that are
also therapeutic goods. The Gene Technology Regulator may provide advice in
relation to such a request and the advice remains in force until it is withdrawn
by the Gene Technology Regulator by written notice given to the
Secretary.
The effect of this provision is that if the same genetic
modification or GM product occurs within a class of therapeutic goods, the
Secretary does not need to seek advice from the Gene Technology Regulator in
relation to every application but may seek advice from the Gene Technology
Regulator about the class of GM products that are also therapeutic goods and
then apply such advice to each assessment of an application for registration or
listing undertaken by the Secretary.
The new clause 30E (Secretary to
take advice into account) provides that if the Gene Technology Regulator
provides advice to the Secretary (either in response to an individual
application for registration or listing under clause 30C or in response to a
request for advice about a class of GM products under clause 30D), the Secretary
must take that advice into account in undertaking an assessment of an
application for registration or listing of the therapeutic good.
The
clause also provides that the Secretary must inform the Gene Technology
Regulator of the decision on the application for registration or listing. This
will then enable the Gene Technology Regulator to enter information relating to
the listed or registered therapeutic good on the Record of GMOs and GM products
established under the Gene Technology Bill 2000.