Queensland University of Technology Law and Justice Journal
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INFORMATION
ASYMMETRY, GMOS AND
STRICT LIABILITY UNDER THE GENE TECHNOLOGY ACT 2000 (CTH)
CHARLES LAWSON [*]
The significance of this article is to review the important place of
information asymmetry in justifying the Gene Technology Act 2000 (Cth)
(the Act) and the ‘gaps’ in the current liability arrangements under
the Act. A possible resolution to these ‘gaps’
is to reinforce the
existing liability arrangements under the Act by imposing a general statutory
strict liability scheme for any
loss or damage resulting from dealings with GMOs
covered by the Act. A possible amendment to the Act is set out to illustrate how
a more broadly applicable strict liability scheme might be achieved under the
current regulatory arrangements.
Neo-liberal economics has generally considered that the parties to a
bargain are perfectly informed about the quality of the goods
or services being
transacted in the market. However, in practice, in many markets it may be very
costly, or even impossible, to gain
accurate information about the quality of
the goods or services being transacted. As a consequence, consumers may be
reluctant to
conclude a bargain because of their uncertain information about the
quality of goods (information asymmetry), but might be assured
by an institution
that provides some quality standard, contributing positively to market
efficiency and promoting economic
welfare.[1] This article considers
strict liability as a possible resolution, at least in part, to the problems of
information asymmetry in regulating
genetically modified (GM) organisms
(GMOs)[2] under the
Act.[3]
Applying information
asymmetry considerations to GMOs assumes that consumers (and the community) may
be uncertain about the quality
of GMOs, and in particular their possible
detrimental health and safety and environmental
consequences.[4] A further assumption
is that through regulatory intervention under the Act to regulate some GMOs,
consumers (and the broader community)
can be provided with the necessary health
and safety and environmental assurances to conclude bargains involving
GMOs.[5] While it is accepted that
these assumptions are open to question and that there are other factors in
determining consumer choices,[6] the
purpose of the article is to illustrate that a strict liability scheme is
possible under the Act and that it is consistent with
the purpose of dealing
with the market failure of information asymmetry that the Act was intended to
address.
The article is structured as follows: Part II sets out the
information asymmetry theory as it might be applied to GMOs; Part III reviews
the central place of asymmetric information in justifying the Act; Part IV
examines the existing responsibilities under the Act in circumstances likely to
result in loss or damage; while Part V considers the ‘gaps’ in the
current regulatory arrangements; and the following Part VI concludes the article
and sets out a discussion about imposing a strict liability scheme for any loss
or damage resulting from dealings
with GMOs covered by the Act as a possible
resolution to these ‘gaps’, and reinforcing the existing
institutional assurance
arrangements under the Act. A draft amendment which
illustrates how strict liability might be introduced into the Act as an
amendment
is appended to the end of the article.
The significant advance in the economics of information asymmetry was the
recognition that the information available to purchasers,
in a market for goods
and services, about those goods and services, was important in ensuring the
quality of those goods and services
and the ongoing viability of the
market.[7] The traditional conception
of the problem and its solution is usually illustrated by the market for new and
used cars, primarily
‘for its concreteness and the ease in understanding
rather than for its importance or
realism’.[8] According to this
conception, the quality of a new or used car may be difficult for a purchaser to
assess, there being some probability
that the car is either of satisfactory
quality (‘good quality’) or unsatisfactory quality (‘bad
quality’
or ‘a
lemon’).[9] However, the seller
is more likely to be aware of the quality, and because the purchaser does not
have this information, the seller
will be able to sell the unsatisfactory
quality cars at a price at or approaching that of satisfactory quality
cars.[10] The consequence is that
purchasers, unable to tell the difference between satisfactory quality and
unsatisfactory quality, will drive
down the price, paying less for satisfactory
quality as they are concerned about paying too much for unsatisfactory quality,
with
the consequence of ever decreasing market price, market quality and market
size.[11]
The information
asymmetry between the seller and the purchaser can be addressed, at least in
part, through an institution that provides
some kind of guarantee about the
quality.[12] For example, licensing
doctors, lawyers and barbers provides some form of independent assessment about
basic quality standards and
an assurance about a level of proficiency necessary
to have obtained the license.[13]
Thus, governmental intervention in the market may also be desirable to increase
the welfare of all parties in the market, through
providing some form of quality
assurance for purchasers.[14] The
expected consequence of governmental intervention will be to maintain the price
and quality, and also avoid the decline in market
size (and perhaps even market
extinction).[15]
Applying
information asymmetry conceptions to GMOs and GMO regulation might be
characterised as:
(a) The potential purchasers of GMOs might be
uncertain about the ‘quality’ of the GMO, be uncertain about the
possible
detrimental health and safety effects of GMOs on people (whether valid
or not), and the possible detrimental effects of GMOs on the
environment
(whether valid or not).
(b) The differences
between non-GMOs and GMOs are not readily discernable by potential purchasers
(in the absence of clear and meaningful
labelling), so that:
(i) Purchasers are faced with the potential risks of detrimental health
and safety effects from GMOs (such as allergenic reactions,
and so on).
(ii) Purchasers might be promoting detrimental environmental effects
from GMOs by providing a market for GMOs that have detrimental
consequences for
the environment (such as contamination, weediness, and so on).
(c) The
producers and marketers (including the supply chain handlers) of GMOs may not
recognise, or may discount, a purchaser’s
concerns (whether valid or not)
about the possible health and safety and environmental effects.
(d) Governmental intervention through regulating GMOs provides an
independent assurance for purchasers about the likely health and
safety effects
and effects on the environment through an assessment of risk, and imposing of
penalties that operate to ameliorate
a purchaser’s concerns about the
possible health and safety and environmental effects.
(e) Without
governmental intervention, information asymmetry theory suggests that:
(i) The prices of GMOs (and possibly non-GMOs equivalents) will decline
as sceptical purchasers are unwilling to pay for satisfactory
quality (that is
non-GMOs and GMOs with no detrimental health and safety and environmental
effects) when they can not distinguish them from unsatisfactory quality (that is
GMOs with detrimental health and safety and environmental effects).
(ii) The quality of GMOs will decline as producers and marketers
(including the supply chain handlers) do not have the price premium
signals to
favour satisfactory quality that purchasers might otherwise desire from
unsatisfactory quality.
(iii) The size of the market for GMOs will
reduce and possibly extinguish as GMOs with increasingly detrimental health and
safety
and environmental effects (whether valid or not) are placed onto the
market.
Among the legal liability regimes, strict liability is one of
the ways of imposing liability for damage and internalising the costs
of an
activity.[16] Strict liability
provides a means of compensating third parties that suffer damage in the future,
by including those likely future
costs in the price of the GMO (internalises the
costs), as well as providing an incentive for producers and marketers (including
the supply chain handlers) to avoid or minimise those likely risks and prospects
of future damage.[17] Thus, strict
liability may reinforce the existing institutional arrangements by assuring
purchasers that with the prospect of bearing
all the costs of liability,
producers and marketers (including the supply chain handlers) of GMOs, will
only bring quality products to market. Without a reassuring legal
liability regime in some form, information asymmetry theory suggests
that
purchasers will pay a lower price for GMOs as they take on the burden of
the risk or prospect of damage (some of it non-financial), and further reduce
the quality
and size of the market.
The Act formally regulates dealings with certain organisms that have been
modified through ‘gene
technology’.[18] The Act was
considered necessary because ‘GMOs and GM products present a range of
possible health and environmental risks to
the
community’.[19] The key
concern appears to have been that consumers and the community lacked the
relevant knowledge and information to be able to
assess those
risks:[20]
While the level
of knowledge about possible risks is growing in the community, there remains
inadequate information available to the
community and
consumers;[21]
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;[22]
[T]here 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;[23] and
There are
difficulties in relying upon industry to provide the necessary information and
make appropriate risk assessment and management
decisions.[24]
On this
basis, there was considered to be ‘a case for government intervention to
assess and manage the risks and to provide
information to consumers and the
community’.[25] Perhaps most
significantly, however, the pre-existing voluntary scheme was considered to lack
‘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’,[26] with a
consequence that might ‘harm the ability of industry to market GMOs and GM
products assessed as
safe’.[27] Then in assessing
the costs and benefits of a regulatory
scheme,[28] the benefit for the
community that outweighed any costs was:
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.[29]
In other words,
the Act’s purpose was to promote the quality (or legitimacy) of GMOs (and
GM products) through a governmental
institution making an independent risk
assessment about the likely risks posed by
GMOs.[30] The intended consequence
was to promote commercial transactions in GMOs and GM products as safe for
consumers and the broader
community.[31]
Essentially the Act prohibits all ‘dealings with’
GMOs,[32] unless they are allowed,
either because they satisfy defined
criteria,[33] or they are licensed
by the Gene Technology Regulator (‘the Regulator’), under the
Act.[34] The allowable dealings are
those dealings that are exempt from
licensing,[35] a notifiable low risk
dealing,[36] a licensed
dealing,[37] a dealing on the GMO
Register,[38] or a dealing with an
organism, or class of organisms declared to be outside the definition of a
GMO.[39] However, in considering
information asymmetries and liability arrangements, the Act makes an important
distinction between those
GMOs outside the Act’s prohibitory scheme and
those within the Act’s prohibitory scheme, the Act only applies to
the latter.
The Act does not deal with an organism, or class of organisms, declared
to be outside the definition of a
GMO.[40] This is potentially a large
class and could capture some significant dealings, noting that the Regulator may
have no knowledge of
such dealings as they are outside the scope of the Acts
obligations. For example, the Gene Technology Regulations 2001 (Cth)
provides that ‘an organism mentioned in Schedule 1 is not a genetically
modified organism’,[41] that
includes:
A mutant organism in which the mutational event did not
involve the introduction of any foreign nucleic acid (that is, non-homologous
DNA, usually from another
species).[42]
[43]
Further, the potential class of
organisms excluded from being GMOs for the purposes of the Act may be expanded
by the definition of
the term ‘gene
technology’.[44] Under the
current arrangements this ‘does not include’ organisms that are
modified through the techniques of ‘sexual
reproduction’,[45]
‘homologous
recombination’[46] and
‘somatic cell nuclear transfer if the transfer does not involve
genetically modified
material’.[47]
For those GMOs within the scope of the Act, the Act does not seek to
avoid all risks posed by GMOs, but rather to identify and evaluate risks
(hazards) and manage them, acknowledging that a certain amount of
risk is
acceptable.[48] The assessment of
risk is built into the regulatory framework imposed by the Act that classifies
different dealings according to
their perceived
risks,[49] and consideration of a
‘checklist’ of possible
hazards.[50] For the dealings not
requiring a license, the risks are considered to be ‘negligible’ or
‘not present any significant
risks’.[51] For the licensed
dealings (so-called Dealings Not involving Intentional
Release (DNIR)[52] and
Dealings involving Intentional Release
(DIR)[53] of the GMO into the
environment), a methodology for identifying, evaluating and managing risks
according to a Risk Analysis Framework is
applied:[54]
Risk assessment
involves identifying sources of harm, and assessing the likelihood that harm
will occur and the consequences if it
does occur. Risk management refers to
evaluating which risks require management and selecting and implementing the
plans or actions
that may be taken to ensure that those risks are controlled.
Risk communication involves an interactive dialogue between stakeholders
and
risk assessors and risk
managers.[55]
The Act then
proscribes various offences for the prohibited
dealings,[56] with the elements of
the offence being detailed in the Criminal Code Act 1995
(Cth).[57] This essentially
distinguishes between ‘physical
elements’,[58] and
‘fault elements’.[59] An
offence, consisting of physical elements and fault
elements,[60] is established by
proving:[61] ‘the existence of
such physical elements as are, under the law creating the offence, relevant to
establishing guilt’,[62] and
‘in respect of each such physical element for which a fault element is
required, one of the fault elements for the physical
element’.[63] The elements of
the prohibited dealing offences and maximum penalties are:
(a) Dealing
with a GMO without a licence – A person ‘is guilty of an
offence’ if they deal with a GMO covered by
the
Act,[64] and either
‘knows’ or ‘is reckless as to whether or not the
dealing’ is not exempt from
licensing,[65] not a notifiable low
risk dealing,[66] not authorised by
a GMO licence,[67] and not on the
GMO Register.[68] The maximum
penalties for an ‘aggravated offence’ are:
[69] ‘imprisonment for 5 years or
2,000 penalty units’;[70] and
in other cases ‘imprisonment for 2 years or 500 penalty
units’;[71]
(b) Breaching conditions of a GMO licence – A person ‘is
guilty of an offence’[72] if
they hold a GMO license,[73] or they
are ‘covered by a GMO
licence’,[74] and
‘intentionally takes an action or omits to take an
action’,[75] and either
‘knows’ or ‘is reckless as to whether or not the action or
omission contravenes the
licence’.[76] The maximum
penalties for an ‘aggravated
offence’[77] are
‘imprisonment for 5 years or 2,000 penalty
units’[78] and in other cases
‘imprisonment for 2 years or 500 penalty
units’,[79] with there being a
separate offence for ‘each day (including the day of a conviction for the
offence or any later day) on which
the person is guilty of the
offence’;[80]
(c) Breaching conditions on GMO Register – A person ‘is
guilty of an offence’[81] if
they deal with a GMO on the GMO
Register,[82] ‘knowing that it
is a GMO’[83] and the dealing
contravenes a condition specified in the GMO
Register.[84] The maximum penalty is
‘50 penalty units’;[85]
and
(d) Dealing with a notifiable low risk dealing not according to the
Gene Technology Regulations 2000 (Cth) – A person ‘is guilty
of an offence’[86] if they
deal with a notifiable low risk dealing
GMO,[87] ‘knowing’ that
it is a GMO,[88] and the dealing is
‘not undertaken in accordance with the
Regulations’.[89] The maximum
penalty is ‘50 penalty
units’.[90]
In
addition to these offences, the Act also proscribes limited strict liability
offences.[91] The Criminal Code
Act 1995 (Cth) sets out that where there is an offence of strict
liability,[92] then ‘there are
no fault elements’ for either ‘any of the physical elements of the
offence’,[93] or ‘that
physical element’.[94] The
‘defence of mistake of
fact’[95] is
available,[96] together with
‘any other defence’.[97]
Essentially the strict liability offences are:
(a) Dealing with a GMO
without a licence – A person ‘is guilty of an
offence’[98] if they deal with
a GMO and they are ‘not authorised by a GMO
licence’,[99] ‘the
dealing is not a notifiable low risk
dealing’,[100] ‘the
dealing is not an exempt [from licensing]
dealing’,[101] and
‘the dealing is not included on the GMO
Register’.[102] The maximum
penalties for an ‘aggravated
offence’[103] is ‘200
penalty units’,[104] and in
other cases ‘50 penalty
units’;[105]
(b) Breaching
conditions of a GMO licence – A person ‘is guilty of an
offence’[106] if they hold a
GMO licence,[107] or they are
‘covered by a GMO
licence’,[108] and
‘takes an action or omits to take an
action’,[109] and the
‘action or omission contravenes the
licence’.[110] The maximum
penalties for an ‘aggravated
offence’[111] is ‘200
penalty units’,[112] and in
other cases ‘50 penalty
units’;[113]
(c) Breaching conditions on GMO Register – A person ‘is
guilty of an offence’[114]
if they deal with a GMO on the GMO Register and the dealing contravenes a
condition specified in the GMO
Register.[115] The maximum penalty
is ‘50 penalty
units’;[116]
and
(d) Dealing with a notifiable low risk dealing not according to the
Gene Technology Regulations 2000 (Cth) – A person ‘is guilty
of an offence’[117] if they
deal with a notifiable low risk dealing GMO and the dealing is ‘not
undertaken in accordance with the
Regulations’.[118] The
maximum penalty is ‘50 penalty
units’.[119]
The Act
also provides the Regulator with express power to ‘give directions’
to a current licence holder or to a person
covered by a current licence where
the Regulator ‘believes on reasonable grounds’ that the licence
holder or person covered
by the licence is ‘not complying with this Act or
the regulations in respect of a
thing’,[120] and that the
exercise of the power is necessary ‘in order to protect the health and
safety of people or to protect the
environment’.[121] However,
the directions are limited to ‘requiring the person, within the time
specified in the notice, to take such steps in
relation to the thing as are
reasonable in the circumstances for the person to comply with this Act or the
regulations’.[122] Failure
by the licence holder or person covered by the licence to comply with the
directions is an offence,[123] and
the Regulator may arrange for the steps specified in the notice to be
taken,[124] and recover an amount
equal to the cost as a debt due to the
Commonwealth.[125] Significantly,
the directions power was expressly intended to deal with containment:
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.[126]
Further
offences arise under the Act where a current licence holder fails to comply with
directions given by the
Regulator,[127] a person
unlawfully discloses ‘confidential commercial
information’,[128] or
another person unlawfully discloses ‘confidential commercial
information’ knowing it is ‘confidential commercial
information’,[129]
submission of false or misleading information or
documents,[130] interference with
dealings with GMOs,[131] refuse or
fail to answer a question about the import or export of
goods,[132] the return of identity
cards,[133] and the application
and use of warrants.[134]
The Regulator may also suspend or cancel a current licence by notice in
writing given to the holder of a GMO licence, if she ‘believes
on
reasonable grounds that the licence holder, or a person covered by the licence,
has committed an offence against this Act or the
regulations’.[135] In these
circumstances any dealing with a GMO will be prohibited because it is ‘not
authorised by a GMO
licence’.[136]
The
significance of the Act’s prohibitory approach is that it reaches
all GMOs, including those non-GMOs defined to be GMOs for the purposes of
the Act,[137] but excluding those
GMOs defined not to be GMOs for the purposes of the
Act,[138] and then provides:
(a) A blanket assessment of ‘negligible’ or ‘no
significant’ risk for exempt from licensing dealings, notifiable
low risk
dealings and dealings on the GMO Register; and
(b) A tailored risk
assessment for those dealings requiring a licence (so-called Dealings
Not involving Intentional Release (DNIR) and
Dealings involving Intentional Release (DIR) of the GMO
into the environment).
Importantly, the Regulator applying the Act makes
no claims that dealings with GMOs pose no risks. Inherent in the Act as a
regulatory scheme is that it accepts that some identified
and some unidentified
risks may occur. As a consequence, some loss or damage might be expected, albeit
that the Regulator may be
minimising or moderating such an eventuality.
The Act addresses some issues of liability by providing for criminal
sanction for breach of the
Act,[139] and gives the Regulator
some powers to require that a problem be rectified when the legislation has been
breached.[140] However, the Act
makes no comprehensive provision for a statutory right of action for a remedy
for those affected by economic, health
or environmental loss or damage resulting
from GMOs. Further the loss or damage is not affected by whether the dealing is
either
authorised by the Act or not authorised by, and breaches the Act. In
other words, the Act may minimise the likely risks posed by
GMOs by identifying
some risks and seeking to minimise their impact through appropriate management,
but the Act does not establish a cause of action for any third parties
affected by economic, health or environmental loss or damage resulting from
GMOs.[141] The recourse in these
circumstances would be through the common law and other existing statutory
schemes:[142]
Specific
legislation relating to liability for the risks posed by gene technology does
not exist, nor has liability been tested in
the courts. Common law provides a
means for redressing problems arising from GMOs. Remedies might also be sought
through environmental
protection and pollution control legislation, and
legislation relating to wild animals and abnormally dangerous activities.
Liability
in relation to food would be caught under the Trade Practices
Act.[143]
As a consequence
of this approach, there remain ‘gaps’ in the Act’s liability
scheme:
(a) The Act’s prohibitions against exempt from licensing
dealings,[144] notifiable low risk
dealing,[145] licensed
dealings,[146] and dealings on the
GMO Register,[147] relate to
‘physical
elements’[148] and
‘fault elements’[149]
of the statutory offence. Any amounts paid as a penalty will be ‘public
money’ for the purposes of the Financial Management and Accountability
Act 1997 (Cth),[150] and form
part of the Consolidated Revenue
Fund.[151] Further, amounts
recovered from the license holder, or a person covered by a GMO licence, by the
Regulator from ‘clean-up’,
remediation, and so on, to comply with
the Act,[152] is merely the amount
to repay an amount expended by the
Regulator.[153] These
prohibitions:
(i) Do not address the loss, damage or injury as a
result of the conduct that is prohibited, or for amounts to be paid to those
suffering loss,
damage or injury as a result of the offence.
(ii) Do
not address activities that are not identified as a risk (hazard) that can
be managed in authorising the dealing at the time it is assessed
by the
Regulator. As an inherently risky product, GMOs and identified and unidentified
risks, and the prohibitions only relate to
the conditions and other limits
placed on them as a result of known risks to the Regulator. Thus, risks unknown
to the Regulator,
but potentially known to the person dealing with the
GMO,[154] that eventuate are not
prohibited.
(iii) Do not address GMOs, or classes of GMOs, that are
declared to be outside the definition of a
GMO.[155]
(b) The
Regulator has power to require ‘clean-up’, remediation, and so on,
as part of the general power to require compliance
with the Act during the
period of a licence.[156] However,
this power:
(i) Only extends to the current licence holder, or a
person covered by the licence, and so will not apply to an expired, suspended,
surrendered
or cancelled
licence.[157]
(ii) Only deals with contamination where the licence holder or a
person covered by the licence is not complying with the Act, and will not
address contamination that has been sanctioned by the Act. For example, a
contamination event that has been assessed as a reasonable
risk.
(iii) Only addresses the licence holder, or a person covered by
the licence, and does not address any dealing with a GMO declared not to be
GMOs
for the purposes of the Act,[158]
exempt from licensing
dealings,[159] or notifiable low
risk dealings, or other persons covered by any of these dealings.
(iv) Only addresses ‘such steps in relation to the thing as
are reasonable in the circumstances for the licence holder [or the person
covered by a GMO licence] to comply with this Act or the
regulations’.[160]
(v) Only, where the licence holder or a person covered by the
licence does not comply with the Regulator’s direction, liability for
a
one-off penalty of up to a maximum of ‘2,000 penalty
units’
($220,000).[161]
(c) Where a person suffers loss or damage resulting from GMOs the
Act does not establish a cause of action, instead leaving the person to
find recourse through a range of statutory and common law liability
arrangements.
While these arrangements may provide an adequate and effective
resolution, in some circumstances they may not. For example, the determination
of liability for simple common law negligence only addresses the loss or damage
resulting from GMOs if the GMO producers and marketers
(including the supply
chain handlers) do not meet or exceed the legal standard of care (defined by the
Court), and if this standard
is met the injurer’s liability for the loss
or damage is zero. In the case of a statutory liability scheme, the injurer will
only be liable if the particular elements of the statutory scheme have been
satisfied. Consumers (and the community) will be unsure
whether their particular
circumstances will necessarily be protected against loss or damage, the
assessment only being possible after
the event.
This article assumed that consumers (and the community) might be
uncertain about the quality of GMOs (and GM products), and that regulatory
intervention under the Act might provide consumers and the broader community
with the necessary health and safety and environmental
assurances to conclude
bargains involving GMOs and GM products. The analysis in this article suggests
that the Act was implemented,
at least in part, to address the information
asymmetry faced by consumers and the community to the introduction of GMOs. The
expectation
from imposing regulation on some dealings with GMOs was that the
benefits from assurances that GMOs had been independently and comprehensively
assessed as safe for health and the environment would be consumer and the
community confidence, and a positive downstream effect
for industry manifest as
acceptance of GMOs as safe.[162]
The response in the Act was to create a separate and independent
institution in the Regulator capable of providing an assessment about
the likely
risks, with the power to control various uses of some GMOs in a way that
minimised the potential loss or damage. Included
in this scheme are criminal
sanctions (including strict liability) for some conduct and a power for the
regulator to clean-up or
remediate some contaminations. However, the analysis in
this article also suggests that significant ‘gaps’ exist in the
statutory liability scheme, leaving other common law and statutory schemes to
provide an uncertain remedy for any economic, health
and safety or environmental
loss or damage resulting from GMOs.
Importantly, the Regulator in
applying the Act makes no claims that dealings with GMOs pose no risks.
Further, in applying the Act and assessing risk under the Risk Analysis
Framework, the Regulator relies on a standard of substantial equivalence and
familiarity to the non-GMO parental organism:
The Regulator can only
consider risk posed by or as a result of gene technology. Therefore risks posed
by a particular GMO need to
be considered in the context of the risks posed by
the unmodified parental organism in the receiving environment. For DIRs this
might
be considered by examining whether the GMO would cause an adverse outcome
over and above that which would occur if the status quo
were maintained, that
is, if the GMO was not deployed in the environment. For DNIRs the contained
facilities prevent exposure to
the environment although the potential for
unintended release must be
considered.[163]
The
effect of applying this standard of substantial equivalence and familiarity is
to avoid a detailed assessment of GMOs by recognising
only those risks posed by
the ‘novel’ GMO, while at the same time promoting biotechnology as
an innovative and competitive
technology and downplaying potential environmental
hazards.[164] For example, in
assessing the risks of releasing GM canola into the environment the Regulator
‘considered’ that ‘the
risks to human health and safety, or to
the Australian environment, from the commercial release of any of Bayer’s
seven GM
canola lines are no greater than those posed by non-GM canola i.e. they
are as safe as conventional
canola’.[165] As a
consequence, the Regulator’s decisions might be interpreted as making no
legitimate claims about the health and environmental
safety of the
products.[166]
This means
that GMOs (and GM products) do pose risks and that some of those risks may
eventuate, possibly causing loss or damage to
third persons and the public good.
In considering information asymmetries and how these apply to consumers (and the
community) in
a way that overcomes the uncertainty about the quality of GMOs,
the ‘gaps’ are likely to undermine the consumer’s
(and the
community’s) acceptance of the assurances that the Act does provide an
adequate assurance. Thus, the question is not
whether GMOs pose a novel threat
that the current liability arrangements can
satisfy,[167] but rather, whether
consumers (and the community) would be better assured by a different liability
arrangement. It is in this context
that a statutory scheme of strict liability
for any economic, health or environmental loss or damage resulting from GMOs is
one possible
solution.
Essentially, the argument is that the producers
and marketers (including the supply chain handlers) of GMOs are best placed to
know
and be aware of the potential and scope of the possible risks of GMOs and
their consequences. Without this information consumers
(and the community) are
unlikely to conclude bargains with GMOs because they are uncertain about the
potential health and safety
and environmental consequences. With a more robust
assurance through a strict liability scheme about the health and environmental
safety of GMOs, consumers (and the community) might be provided with more
confidence about the quality of GMOs and so conclude more
bargains involving
GMOs and GM products.
Further, the costs of providing the best
information should be internalised by the producers and marketers (including the
supply chain
handlers), rather than externalised to the broader community and
unfortunate individual consumers. One way to achieve this is through
a statutory
strict liability scheme that avoids the uncertainties about liability from
reliance on the common law and existing statutory
schemes. Where producers and
marketers (including the supply chain handlers) know that they will be strictly
liable for any loss
or damage, they will factor these costs (and risks of being
exposed to those costs) into their considerations about producing and
marketing
GMOs and GM products. Perhaps significantly, without such an effective incentive
to disclose the best information to consumers,
to the community and to the
Regulator under the Act, individual producers and marketers (including the
supply chain handlers) of
GMOs will favour poorer quality goods (some with risks
of adverse health and safety and environmental outcomes), with a consequential
reduction in the size of the market that will
follow.[168]
A possible
amendment to the Act that imposes strict liability so that liability rests with
the person, being the producers and marketers
(including the supply chain
handlers) dealing with the GMO that causes the loss or damage, including
financial loss or damage is
appended at the end of this article. The remaining
parts address vesting of a cause of action, joint and several liability,
survival
of the cause of action, avoidance and consistency requirements, and
co-existence with State and Territory laws and other laws. This
possible
amendment is consistent with the Act maintaining the defined terms and the
limitations inherent in those
terms,[169] the Act’s
existing ‘[n]o doubling-up of liabilities’
arrangements,[170] and the
intergovernmental Gene Technology
Agreement.[171]
While
a comprehensive strict liability scheme under the Act is only one possible
solution, this article shows that it is consistent
with the Act’s purpose
of addressing the information asymmetry market failure. The benefit of a strict
liability scheme will
be to address the existing ‘gaps’ in the
Act’s liability arrangements and reinforce the Regulator’s
assurances
about the quality of GMOs and GM products for the benefit of
consumers and the community.
An Act to amend the Gene Technology Act 2000 and impose strict
liability for activities involving gene technology, and for related purposes.
This Act may be cited as the Gene Technology Amendment (Strict Liability)
Act 2005.
This Act commences on the day on which it receives Royal Assent.
Each item that is specified in the Schedule to this Act has effect according
to its terms.
1 At the end of s 8
Add:
(1) If a person (the first person) deals with a GMO, and another person
(the second person) suffers loss or damage, including financial
loss or damage,
then the first person is liable to compensate the second person for the amount
of the second person’s loss
or damage.
(2) A law of a State or
Territory about the survival of causes of action vested in persons who die
applies.
(3) If 2 or more persons are liable for the same loss or damage
they are jointly and severally liable.
(4) If the loss or damage in a
liability action was caused by an act or omission of the person who suffers the
loss or damage concerned
then the amount of the loss is to be reduced to such
extent (which may be to nil) as the court thinks fit having regard to that
person’s
share in causing the loss or damage. [font size?]
(5) A
person may commence a liability action at any time within 20 years after the
time the person became aware, or ought reasonably
to have become aware, of the
alleged loss or damage.
(6) Any term of a contract, arrangement or
understanding that purports to exclude, restrict or modify, or has the effect of
excluding,
restricting or modifying:
(a) the exercise of a right
conferred by this section; or
(b) any liability under this section;
is void.
(7) This section:
(a) is not intended to
exclude or limit the concurrent operation of any law, whether written or
unwritten, in force in a State or
Territory; and
(b) is not to be taken
to limit, restrict or otherwise affect any right or remedy a person would have
had if this section had not
been enacted.
(8) In this section:
(a) a reference to loss or damage, other than a reference to the amount
of any loss or damage, includes a reference to injury; and
(b) a
reference to loss or damage includes an amount necessary to restore the health
and safety of humans or the environment after
the release of a GMO into the
environment.
[*] B Sc (Hons) ANU, LLB ANU, Phd ANU, LLM QUT.
Senior Research Fellow, Australian Centre for Intellectual Property in
Agriculture, TC Beirne School of Law, University of Queensland.
I appreciate
the valuable comments from the anonymous referees. This work was supported by
an Australian Research Council grant
to research “Gene Patents in
Australia: Options for Reform”.
[1] For the classical statement of this concept see G Akerlof, ‘The Market for “Lemons”: Quality, Uncertainty and the
Market Mechanism’
(1970) 84 Quarterly Journal of Economics 488; for a recent statement in
the context of consumer protection policy see, for example, G Hadfield, R Howse
and M Trebilcock, ‘Information-Based
Principles for Rethinking Consumer
Protection Policy’ (1998) 21 Journal of Consumer Policy
131.
[2] Gene Technology Act
2000 (Cth) s 10 defines ‘GMO’ to mean a ‘genetically
modified organism’, which in turn, is defined to mean: ‘(a) an
organism that has been modified by gene technology; or (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 para (a) only because the human being
has undergone somatic cell
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 genetically modified organisms’. The Gene
Technology Regulations 2001 (Cth) do not presently declare anything to be a
GMO for the purposes of para (c). However, reg 5 does declare a number of
organisms
set out in sch 1 as being not GMOs for the purposes of para (e) of the
GMO definition.
[3] Noting that
some limited liability arrangements have been implemented by State and Territory
governments according to the Gene Technology
(Recognition of Designated Areas)
Principle 2003, Commonwealth Government Special Gazette No S340 (5
September 2003) requiring the Gene Technology Regulator to recognise a
States’ and Territories’ rights to designate
under State law special
areas that are for either GM or non-GM crops for marketing purposes: see K
Ludlow, ‘Cultivating Chaos:
State Responses to Releasing Genetically
Modified Organisms’ [2004] DeakinLawRw 1; (2004) 9 Deakin Law Review 1,
21-36.
[4] Noting that Gene
Technology Act 2000 (Cth) provides that ‘[t]he object of this 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
GMOs’.
[5] See for example S
James and M Burton, ‘Consumer Preference for GM food and other Attributes
of the Food System’ (2003)
47 Australian Journal of Agricultural and
Resource Economics 501, and the references
therein.
[6] For example, price
discounting might be a significant factor in consumer preferences for some GMOs:
see ibid.
[7] There is an
extensive literature on the application of information asymmetry theory, the
foundation author considering insurance,
the employment of minorities, the costs
of dishonesty, and credit markets in under-developed countries: Akerlof, above n
1, 492-499;
for another examination of the theory as it might apply to GMOs, see
K Donat, ‘Engineering Akerlof Lemons: Information Asymmetry,
Externalities, and Market Intervention in the Genetically Modified Food
Market’ (2003) 12 Minnesota Journal of Global Trade 417,
437-439.
[8] Akerlof, above n 1,
489.
[9]
Ibid.
[10]
Ibid.
[11] Ibid
488.
[12] Ibid
499-500.
[13] Ibid
500.
[14] Ibid
488.
[15]
Ibid.
[16] Other statutory and
common law liability schemes (such as negligence laws, and so on) may also
apply, although their application
to internalise the costs of damage is by no
means certain: see, for example, M Lee and R Burrell, ‘Liability for the
Escape
of GM Seeds: Pursuing the “Victim”?’ (2002) 65
Modern Law Review 517, 529-535; N Rogers, ‘Seeds, Weeds and Greed:
An Analysis of the Gene Technology Act 2000 (Cth), Its Effect on Property
Rights, and the Legal and Policy Dimensions of a Constitutional Chellenge’
[2002] MqLawJl 1; (2002) 2 Macquarie Law Journal 1,
3-6.
[17] There is an extensive
economic literature on this issue: see, for examples, M Polinsky, ‘Strict
Liability versus Negligence
in a Market Setting’ (1980) 70 American
Economic Review 363; S Shavell, ‘Strict Liability versus
Negligence’ (1980) 9 Journal of Legal Studies
1.
[18] Where ‘gene
technology’ means ‘any technique for the modification of genes or
other genetic material, but does
not include: (a) sexual reproduction; or (b)
homologous recombination; or (c) any other technique specified in the
regulations for
the purposes of this paragraph’: Gene Technology Act
2000 (Cth) s 10.
[19]
Explanatory Memorandum, Gene Technology Bill 2000 (Cth)
12.
[20] Although this sentiment
was not reflected in the second reading speech: see Commonwealth, House of
Representatives Hansard, 22 June 2000, 18105-18106 (Minister for Health and
Aged Care).
[21] Explanatory
Memorandum, above n 19, 12.
[22]
Ibid.
[23]
Ibid.
[24] Ibid;
‘because, in an objective aggregate sense, it may not be in their
[industries’] 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’ (12).
[25]
Ibid.
[26] For a review of the
early developments eventually leading to the Gene Technology Act 2000
(Cth) see generally R Hindmarsh, Genetic Manoeuvres: Bio-utopian
Visions (Curtain University Books
2005).
[27] Explanatory
Memorandum, above n 19, 13.
[28] This was the founding
principle articulated in the Independent Committee of Inquiry into
Competition Policy in Australia (see Independent Committee of Inquiry into
Competition Policy in Australia, National Competition Policy (1993)
206-208) and the subsequent codification of this principle in the Competition
Principles Agreement binding the Commonwealth, States and Territories to
facilitate effective competition to promote economic efficiency and benefits
for
consumers (Competition Principles Agreement cl 5(1)), as part of the
National Competition Policy: see National Competition Council,
Compendium of National Competition Policy Agreements (1997).
[29] Explanatory Memorandum,
above n 19, 42.
[30] House of
Representatives Hansard, above n 20, 18104; see also M Hain, C Cocklin and D
Gibbs, ‘Regulating Biosciences: The
Gene Technology Act 2000’ (2002)
19 Environmental and Planning Law Journal 163,
165.
[31] There is a
considerable literature on this issue, see for example P Newell,
Biotechnology and the Politics of Regulation, IDS Working Paper 146
(2002) 5-7.
[32] Gene Technology Act 2000
(Cth) s 10 defines ‘deal with, in relation to a GMO, means the
following: (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; (g) import the GMO; and 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 paras (a) to (g)’.
[33] See Gene Technology Act
2000 (Cth) s 78 (declared to be a GMO) and Gene Technology Regulations 2001
(Cth) rr 5 (organisms that are not genetically modified organisms), 6
(dealings exempt from licensing) and 12 and 13 (notifiable low
risk
dealings).
[34] See Gene
Technology Act 2000 (Cth) pt
5.
[35] See Gene Technology
Act 2000 (Cth) ss 32(1) and 32(4) and Gene Technology Regulations 2001
(Cth) r 6.
[36] See
Gene Technology Act 2000 (Cth) ss 32(1) and 76 and ibid rr 12 and
13.
[37] See Gene Technology
Act 2000 (Cth) s 32(1) and pt 5 and ibid rr
7-11.
[38] See Gene
Technology Act 2000 (Cth) s 32(1) and s
76.
[39] See Gene Technology
Act 2000 (Cth) s 10 and Gene Technology Regulations 2001 (Cth)
r 5.
[40] See Gene
Technology Act 2000
(Cth).
[41] See Gene
Technology Act 2000 (Cth) r
5.
[42] Gene Technology
Regulations 2001 (Cth) sch 1 pt 1 (item
1).
[43] Another example is the
exemption from licensing of ‘[a] plant formed by: (a) embryo rescue; or
(b) in vitro fertilisation;
or (c) zygote implantation; or (d) protoplast
fusion’: Gene Technology Act 2000 (Cth) sch 1 pt 1 (item 5).
This could include a plant that was ‘modified by gene technology’
and as a final step relied on the technique of embryo
rescue or protoplast
fusion, thereupon ceasing to be a GMO for the purposes of the
Act.
[44] See Gene Technology
Act 2000 (Cth) s 10 (definition of ‘gene technology’) and
Gene Technology Act 2000 (Cth) r
4.
[45] Gene Technology Act
2000 (Cth) s 10 (para (a) of the definition of ‘gene
technology’).
[46] Gene
Technology Act 2000 (Cth) s 10 (para (b) of the definition of ‘gene
technology’).
[47] Gene
Technology Regulations 2001 (Cth) r
4.
[48] See Explanatory
Memorandum, above n 19, 39.
[49]
Gene Technology Act 2000 (Cth) s 32(1) providing for exempt from
licensing dealings (ss 32(1) and 32(4) and Gene Technology Regulations 2001
(Cth) rr 6-11), notifiable low risk dealings (s 32(1) and pt 6 div 2 and rr
12-13), licensed dealings (s 32(1) and pt 5 and rr 7-11), dealings with GMOs on
the Register of GMOs (ss 32(1) and 76), or dealings with an organism, or class
of organisms, declared to be outside the definition of a GMO (s 10 and r sch 1
pt 1); other formal statutory elements of the regulatory scheme for GMOs (and GM
products) include the Agricultural and Veterinary Chemicals Code Act 1994
(Cth) and the Therapeutic Goods Act 1989 (Cth); there is, however, a
‘mass’ of non-legal rules, codes, circulars, practice notes,
international conventions and
ethical codes: see also J Black, ‘Regulation
as Facilitation: Negotiating the Genetic Revolution’ (1998) 61 Modern
Law Review 621, 621.
[50]
Gene Technology Act 2000 (Cth) ss 49(2) and 51(1) and Gene Technology
Act 2000 (Cth) r 10; noting that other risks may also be identified through
the consultation process (ss 50, 52 and 56), and in considering the application
and preparing the risk assessment according; see also K Hayes, Robust
Methodologies for Ecological Risk Assessment: Best Practice and Current Practice
in Ecological Risk Assessment for Genetically
Modified Organisms (2004)
32.
[51] Explanatory Memorandum,
above n 19, 22.
[52] See Gene
Technology Act 2000 (Cth) pt 5 div
3.
[53] See Gene Technology
Act 2000 (Cth) pt 5 div
4.
[54] See Office of the Gene
Technology Regulator, Risk Analysis Framework (2005); this is a
methodology of ‘risk analysis’, being ‘risk analysis = risk
assessment + risk management + risk
communication’.
[55] Ibid
5.
[56] Gene Technology Act
2000 (Cth) ss 32-37; except the Crown (s 6(2)); noting that there is
provision for no doubling-up of liabilities (s 18) and conduct by directors,
employees and agents (s
188).
[57] Gene Technology
Act 2000 (Cth) s 8(1); see Criminal Code Act 1995 (Cth) sch (ch 2)
setting out the general principles of criminal responsibility with effect on and
after 15 December 2001 (s
2.2).
[58] Criminal Code Act
1995 (Cth) sch (s 4.1); ‘[a] physical element of an offence may be:
(a) conduct; or (b) a result of conduct; or (c) a circumstance
in which conduct,
or a result of conduct, occurs’ (s
4.1(1)).
[59] Criminal Code
Act 1995 (Cth) sch (s 5.1); ‘[a] fault element for a particular
physical element may be intention, knowledge, recklessness or negligence’
(s 5.1(1)).
[60] Criminal
Code Act 1995 (Cth) sch (s
3.1(1)).
[61] Criminal Code
Act 1995 (Cth) sch requires that the prosecution prove the existence of the
matter (s 13.1(1)) beyond reasonable doubt (s
13.2(1)).
[62] Criminal Code
Act 1995 (Cth) sch (s
3.2(a)).
[63] Criminal Code
Act 1995 (Cth) sch (s
3.2(b)).
[64] Gene Technology
Act 2000 (Cth) s 32(1).
[65]
Gene Technology Act 2000 (Cth) s
32(1)(d).
[66] Gene
Technology Act 2000 (Cth) s
32(1)(c).
[67] Gene
Technology Act 2000 (Cth) s
32(1)(b).
[68] Gene
Technology Act 2000 (Cth) s
32(1)(e).
[69] Gene
Technology Act 2000 (Cth) s 38; where ‘the commission of the offence
causes significant damage, or is likely to cause significant damage, to the
health and
safety of people or to the environment’ (s
38(1)).
[70] Gene Technology
Act 2000 (Cth) s 32(2)(a); noting that ‘penalty units’ are
defined in the Crimes Act 1914 (Cth) s 4AA(1) where ‘penalty unit
means $110’.
[71] Gene
Technology Act 2000 (Cth) s
32(2)(b).
[72] Gene
Technology Act 2000 (Cth) ss 34(1) and
(2).
[73] Gene Technology Act
2000 (Cth) s 34(1).
[74]
Gene Technology Act 2000 (Cth) s 34(2); and additional requirement is
that the person ‘has knowledge of the conditions of the licence’ (s
34(2)(c)).
[75] Gene
Technology Act 2000 (Cth) ss 34(1)(a) and
(2)(a).
[76] Gene Technology
Act 2000 (Cth) ss 34(1)(b) and
(2)(b).
[77] Gene Technology
Act 2000 (Cth) s 38.
[78]
Gene Technology Act 2000 (Cth) s
34(3)(a).
[79] Gene
Technology Act 2000 (Cth) s
34(3)(b).
[80] Gene
Technology Act 2000 (Cth) s
34(4).
[81] Gene Technology
Act 2000 (Cth) s 36(1).
[82]
Gene Technology Act 2000 (Cth) s
36(1)(b).
[83] Gene
Technology Act 2000 (Cth) s
36(1)(a).
[84] Gene
Technology Act 2000 (Cth) s
36(1)(c).
[85] Gene
Technology Act 2000 (Cth) s
36(1).
[86] Gene Technology
Act 2000 (Cth) s 37(1).
[87]
Gene Technology Act 2000 (Cth) s
37(1)(b).
[88] Gene
Technology Act 2000 (Cth) s
37(1)(a).
[89] Gene
Technology Act 2000 (Cth) s
37(1)(c).
[90] Gene
Technology Act 2000 (Cth) s
37(1).
[91] Gene Technology
Act 2000 (Cth) ss 33, 35, 36(2) and
37(2).
[92] Criminal Code Act
1995 (Cth) sch (ss 6.1(1) and
(2)).
[93] Criminal Code Act
1995 (Cth) sch (s
6.1(1)(a)).
[94] Criminal
Code Act 1995 (Cth) sch (s
6.1(2)(a)).
[95] Being the
defence that ‘(a) at or before the time of the conduct constituting the
physical element, the person considered
whether or not facts existed, and is
under a mistaken but reasonable belief about those facts; and (b) had those
facts existed, the
conduct would not have constituted an offence’:
Criminal Code Act 1995 (Cth) sch (s
9.2(1)).
[96] Criminal Code
Act 1995 (Cth) sch (ss 6.1(1)(b) and
6.1(2)(b)).
[97] Criminal
Code Act 1995 (Cth) sch (s
6.1(3)).
[98] Gene Technology
Act 2000 (Cth) s 33(1).
[99]
Gene Technology Act 2000 (Cth) s
33(1)(b).
[100] Gene
Technology Act 2000 (Cth) s
33(1)(c).
[101] Gene
Technology Act 2000 (Cth) s
33(1)(d).
[102] Gene
Technology Act 2000 (Cth) s
33(1)(e).
[103] Gene
Technology Act 2000 (Cth) s
38.
[104] Gene Technology
Act 2000 (Cth) s
33(3)(a).
[105] Gene
Technology Act 2000 (Cth) s
33(3)(b).
[106] Gene
Technology Act 2000 (Cth) s 35(1) and
(2).
[107] Gene Technology
Act 2000 (Cth) s
35(1).
[108] Gene
Technology Act 2000 (Cth) s 35(2); and additional requirement is that the
person ‘has knowledge of the conditions of the licence’ (s
32(2)(c)).
[109] Gene
Technology Act 2000 (Cth) ss 35(1)(a) and
(2)(a).
[110] Gene
Technology Act 2000 (Cth) ss 35(1)(b) and
(2)(b).
[111] Gene
Technology Act 2000 (Cth) s
38.
[112] Gene Technology
Act 2000 (Cth) s
35(4)(a).
[113] Gene
Technology Act 2000 (Cth) s
35(4)(b).
[114] Gene
Technology Act 2000 (Cth) s
36(1).
[115] Gene
Technology Act 2000 (Cth) s
36(2).
[116] Gene
Technology Act 2000 (Cth) s
36(1).
[117] Gene
Technology Act 2000 (Cth) s
37(1).
[118] Gene
Technology Act 2000 (Cth) s
37(2).
[119] Gene
Technology Act 2000 (Cth) s
37(1).
[120] Gene
Technology Act 2000 (Cth) ss 146(1)(a) and
(2)(a).
[121] Gene
Technology Act 2000 (Cth) ss 146(1)(b) and
(2)(b).
[122] Gene
Technology Act 2000 (Cth) ss 146(1) and
(2).
[123] Gene Technology
Act 2000 (Cth) s 146(3); the maximum penalties for an ‘aggravated
offence’ is ‘2000 penalty units’ and in other cases ‘500
penalty units’, although the Crimes Act 1914 (Cth) s 4K (dealing
with continuing and multiple offences) does not apply so this is not a daily
offence committed until the requirement is
complied with (s
146(6)).
[124] Gene
Technology Act 2000 (Cth) s
146(4).
[125] Gene
Technology Act 2000 (Cth) s
146(5).
[126] Explanatory
Memorandum, above n 19,
90.
[127] Gene Technology
Act 2000 (Cth) ss 53(4) and
146(3).
[128] Gene
Technology Act 2000 (Cth) s
187(1).
[129] Gene
Technology Act 2000 (Cth) s
187(2).
[130] Gene
Technology Act 2000 (Cth) s
192.
[131] Gene Technology
Act 2000 (Cth) s
192A.
[132] Gene Technology
Act 2000 (Cth) s
164(4).
[133] Gene
Technology Act 2000 (Cth) s
151.
[134] Gene Technology
Act 2000 (Cth) ss 175(1) and
(2).
[135] Gene Technology
Act 2000 (Cth) s
68(b).
[136] See Gene
Technology Act 2000 (Cth) ss 32(1)(b), 33(1)(b) and
60.
[137] Gene Technology
Act 2000 (Cth) s 10 (para (c) of ‘genetically modified organism’
definition).
[138] Gene
Technology Act 2000 (Cth) (para (e) of ‘genetically modified
organism’ definition) and Gene Technology Regulations 2001 (Cth) r
5.
[139] Gene Technology
Act 2000 (Cth) ss 32(1), 33(1), 33(2), 34(1), 34(2), 35(1), 35(2), 36(1),
36(2) and 37.
[140] Gene
Technology Act 2000 (Cth) s
146.
[141] Notably, the
Australian Government asserts the view that ‘[l]iability for environmental
damage (such as loss of biodiversity)
and personal injury (eg allergenicity,
toxicity) has been excluded as a regulatory system has been implemented to avoid
such dangers
and thus the risk to those in the agricultural community is
minimal’: Department of Agriculture, Fisheries and Forestry, Liability
Issues Associated with GM Crops in Australia (2003)
1.
[142] See also Department
of Agriculture, Fisheries and Forestry, ibid
6-14.
[143] House of
Representative Standing Committee on Primary Industries and Regional Services,
Work in Progress: Proceed with Caution – Primary Producer Access to
Gene Technology (2000)
159.
[144] Gene Technology
Act 2000 (Cth) s 32(1) and s 32(4) and Gene Technology Regulations 2001
(Cth) r 6.
[145]
Gene Technology Act 2000 (Cth) s 32(1) and pt 6 div 2 and Gene
Technology Regulations 2001 (Cth) pt 3 div
2.
[146] Gene Technology
Act 2000 (Cth) s 32(1) and pt 5 and Gene Technology Act 2000 (Cth) rr
7-11.
[147] Gene Technology
Act 2000 (Cth) s 32(1) and s
76.
[148] Criminal Code Act
1995 (Cth) sch (s 4.1); ‘[a] physical element of an offence may be:
(a) conduct; or (b) a result of conduct; or (c) a circumstance
in which conduct,
or a result of conduct, occurs’ (s
4.1(1)).
[149] Criminal
Code Act 1995 (Cth) sch (s 5.1); ‘[a] fault element for a particular
physical element may be intention, knowledge, recklessness or negligence’
(s 5.1(1)).
[150] Financial
Management and Accountability Act 1997 (Cth) s 5 provides ‘public
money means: (a) money in the custody or under the control of the Commonwealth;
or (b) money in the custody
or under the control of any person acting for or on
behalf of the Commonwealth in respect of the custody or control of the money;
including such money that is held on trust for, or otherwise for the benefit of,
a person other than the
Commonwealth’.
[151]
Australian Constitution s 81 provides ‘all revenues or moneys
raised or received by the Executive Government of the Commonwealth shall form
one Consolidated
Revenue Fund, to be appropriated for the purposes of the
Commonwealth in the manner and subject to the charges and liabilities imposed
by
this
Constitution’.
[152]
See Gene Technology Act 2000 (Cth) ss 146(1) and
(2).
[153] See Gene
Technology Act 2000 (Cth) s
146(5).
[154] Noting that
Gene Technology Act 2000 (Cth) s 192 a person must not, in an application
or complying with the Act, give or produce false or misleading information or
document, subject
to a criminal sanction for the offence; there is not, however,
any positive requirement to give or produce information or documents
that is
known to the person and might materially affect the application or compliance
with the Act.
[155] Gene
Technology Act 2000 (Cth) s 10 and Gene Technology Regulations 2001
(Cth) r 5.
[156]
See Gene Technology Act 2000 (Cth) ss 146(1) and
(2).
[157] Gene Technology
Act 2000 (Cth) s 60.
[158]
See Gene Technology Act 2000 (Cth) s 10 (para (e) of ‘genetically
modified organism’
definition).
[159] See Gene
Technology Regulations 2001 (Cth) r
6.
[160] Gene Technology
Act 2000 (Cth) ss 146(1) and
(2).
[161] See Gene
Technology Act 2000 (Cth) ss 146(3) and (6); see also Crimes Act 1914
(Cth) s 4AA(1).
[162] See
Explanatory Memorandum, above n 19,
42.
[163] Office of the Gene
Technology Regulator, above n 54,
31.
[164] See K Barrett and E
Abergel, ‘Breeding Familiarity: Environmental Risk Assessment for
Genetically Engineered Crops in Canada’
(2000) 27 Science and Public
Policy 2; although the merits of ‘substantial equivalence’
remain hotly contested, compare for examples, H Miller, ‘Substantial
Equivalence: Its Uses and Abuses’ (1999) 17 Nature Biotechnology
1042 and E Millstone, E Brunner and S Mayer, ‘Beyond
“Substantial Equivalence”’ (1999) 401 Nature 525; see
generally T McGarity, ‘Seeds of Distrust: Federal Regulation of
Genetically Modified Foods’ (2002) 35 University of Michigan Journal of
Law Reform 403.
[165]
Bayer CropScience Pty Ltd, Commercial Release of Genetically Modified
(InVigor hybrid) Canola: Risk Assessment and Risk Management Plan,
DIR 021/2002 (2003) 10; see also C Lawson, ‘Risk Assessment in the
Regulation of Gene Technology under the Gene Technology Act 2000 (Cth)
and the Gene Technology Regulations 2001 (Cth)’ (2002) 19
Environmental and Planning Law Journal
195.
[166] See Millstone et
al, above n 164.
[167]
This appears to have been the principal conclusion of various reviews: see
Department of Agriculture, Fisheries and Forestry, above
n 141, 2-6 and the
references therein.
[168] See,
for example, Akerlof, above n 1,
488.
[169] For example, the
term ‘GMO’ would not include GMOs that have been declared not to be
GMOs for the purposes of the Act
and would include GMOs that have been declared
to be GMOs for the purposes of the Act: see Gene Technology Act 2000
(Cth) s 10 (para (c) and (e) of ‘genetically modified organism’
definition).
[170] Gene
Technology Act 2000 (Cth) s 18(1); further provision is also made for a
‘a pecuniary penalty under a corresponding State law’ (s
18(2)).
[171] The Gene
Technology Act 2000 (Cth) is the Commonwealth’s component of this
regulatory scheme; mirror legislation is required in each State and Territory
for a comprehensive regulatory scheme (s 5); see also Gene Technology Act
2001 (Vic), Gene Technology Act 2001 (SA) and Gene Technology Act
2001 (Qld); see also Office of the Gene Technology Regulator, Handbook on
the Regulation of Gene Technology in Australia: A User’s Guide to the Gene
Technology Act 2000 and Related Legislation (2003) 22-24.
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