The Australian
Democrats have wide-ranging concerns about aspects of current gene regulation
in many of these bodies, the current disparate regulation and artificial
delineations in gene technology processes and products created by the current
regulatory system.
The Gene Technology
Bill 2000 will not act to address this disparity, but will rather add another
tier to the current regulatory system.
Another area of
inadequate protection for the Australian community includes biosafety
regulation currently overseen by the Genetic Manipulation Advisory Council
(GMAC).
The Australian
Democrats welcome the establishment of a public register under the Office of
the Gene Technology Regulator.
However, the Democrats
remain concerned about the extensive classification of information surrounding
GMO trials and applications for release as commercial in-confidence.
Biodiversity Convention.
While it is recognised
that the Cartagena Biosafety Protocol exempts many areas of transboundary
movement of living modified organisms, such as those contained in
pharmaceuticals, it does provide governments wider discretion to restrict
imports than is permitted under the World Trade Organisation’s (WTO) Agreement
on Sanitary and Phytosanitary Measures.
The International
Biosafety Protocol provides the best international legal framework to date for
responsible international regulation and trade of genetically modified
organisms. Australia's endorsement and
signage of the Protocol will provide appropriate foundations for effective
domestic regulation of gene technologies and the first step towards achieving
public assurance that the benefits of biotechnology will be secured without
damage to health and safety or the environment.
3. Gene
Technology - promises & risks
Gene Technology is a
nascent science, in which the potential and pitfalls are still being
determined. Any science or technology is
a tool that can be applied by a community for positive or negative outcomes.
The Chair's Report
recognises “the significant number of and qualifications of scientists opposed
to, or very concerned about, gene technology, its applications and possible
consequences.”[589]
The Australian
Democrats recognise the nature and potential power of gene technology, and that
its precision is hindered by the relative novelty of the science.
It was stated in
Senator Stott Despoja’s submission to the House of Representatives Standing
Committee on Primary Producer and Regional Services inquiry into primary
producer access to gene technology, June 1999 that:
Genetic
engineering is not at present a precise technology and the long-term
consequences of the technology are poorly understood. Current manipulation techniques involve the
insertion of genetic material randomly and do not provide a precise or chosen
location for insertion. Further, the
levels of expression depends to a large extent on the location of insertion and
genes may move outside their intended spaces.
It is
reasonable to expect that pleiotropy (the affect of a single gene product on
more than one trait) and epistasis (the capacity for one gene to modify the
expression of another gene which is not an allele[590] of the first) will also occur in
trangenic crops, as they do in their traditional counterparts. These effects
increase the complexity and difficulty of assessing the risks that transgenic
crops may have on the environment, nutrition, consumer health, etc. This aspect
of gene technology is presently poorly understood, poorly researched and does
not appear to have been adequately assessed in proposed regulatory schemes. For
example, the proposed substantial equivalence for gene food labelling would be
unlikely to detect a predisposition in a food crop to accumulate heavy metals
with its downstream health effects.
Two
examples illustrate this concern:
(a) The production or conferral of
weediness to agricultural and non-agricultural species is one aspect of
agricultural gene technology which holds the potential to cause significant
cost to primary producers in Australia. Scientists have suggested that some
transgenes may confer or enhance the ability of a crop species to become a weed[591]. The risk of transgenic crop weediness is similar to that presented by
the introduction of non-indigenous plant species into an environment, but the
relatively few that can cause significant ecological disruption and a
significant cost to agriculture, for example, through increased herbicide use
and environmental degradation.
(b) Another concerning aspect of first
generation agricultural gene technology is the insertion of virus genes into crop
plants to protect them against disease.
Experiments have shown migrating viruses can acquire the inserted genes
and produce novel viruses with new properties.
Work on inserting virus genes for resistance is advancing in many
countries, including Australia, and is well funded compared to the research
attempting to understand the potential dangers.
Significantly, field tests of transgenic plants are presently not even
independently monitored. This is a major
concern to Australian agriculture and means that we must be concerned about the
genes we are incorporating in the populations of cells and organisms and their
relations.
These are valid
concerns - gene flow to wild relatives has been recorded in quinona, squash,
carrot, maize, sorghum, sunflower, strawberries and sugar beet[592] and there have been 16 reported
international cases of genetic exchange between crops resistant to herbicides,
insects and viruses and wild relatives.[593] Such genetic pollution is now receiving recognition and serious consideration
by international governmental regulatory agencies. It was concluded by the United Kingdom’s
Advisory Committee on Releases to the Environment (ACRE), Department of the
Environment, Transport and the Regions that cross-pollination between adjacent
crops of fodder maize and sweet corn can occur.[594]
This is also a
concern in Australia. The Genetic Manipulation Advisory Committee (GMAC)
1997-98 Annual report documents an incident where transgenic lupins modified
for herbicide resistance were inadvertently released. In Australia no crossing occurs with other
species in this genus and the possibility of genes entering the naturalised
races of lupin are very low. However,
similar release of a transformed subterranean clover is very likely and under
selective pressures and over a period of time as short as several years the
likelihood of an outcross is very likely (it is a matter of numbers...). This may
have significant implications for Australian primary producers and the wider
Australian community.
The consequences
of this “imprecise” technology are likely to significantly affect primary
producer access to the benefits of the technology. An assessment of the exact
impact is difficult because the mechanisms are poorly understood and they are
not being investigated. I am particularly concerned about the long term
consequences to the environment and its ability to sustain viable and
productive agriculture.
An open letter from
World Scientists to all Governments concerning Genetically Modified Organisms
Submitted to the UN Commission on Sustainable Agriculture in New York (April
24-May 5 2000) outlined further concerns by scientists from a plethora of
disciplines about the potential risks and misuse of genetic technologies,
corroborating at an international level the diversity of concerned expert
opinion noted by the Chair's report.
4. Principles
& Objectives of the Office of the Gene Technology Regulator
4.1 Objectives of the Bill
The Object of the Gene
Technology Bill 2000 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.[595]
The Australian
Democrats support these objectives, though consider that stipulation in
regulation of relating principles is required to adequately ensure the
protection of public health and safety and the environment.
The Chair's Report
states at 3.76 that:
The Committee
considers that while the protection of the environment is important, it should
not detract from the paramount objective of protecting the health and safety of
people. The Committee supports the
placement of the OGTR in the Health and Aged Care portfolio.
The Australian
Democrats maintain that environmental protection and public health and safety
are synonymous and can not be conflicting objectives.
Furthermore, the
Democrats maintain that the Commonwealth Environment Minister must play an
active role in the regulation of gene technologies in Australia to ensure that
the environment is appropriately considered in Office of the Gene Technology
Regulatory (OGTR) decisions. In its
current form, the Bill does not provide such involvement and, therefore, does
not provide adequate protection for the environment.
4.2 Role of the Environment Minister
The Democrats note the
commitment given on behalf of the government by the Environment Minister,
Senator Hill to the Senate during the original passage of the Environment
Protection and Biodiversity Conservation Act 1999 (EPBC Act) on 22 June, 1999
that "matters that affect the environment will be referred to the
environment minister for assessment and advice by that independent
regulator. That will ultimately be
provided for through an amendment to this legislation (the EPBC Act), when it
passes in conjunction with the law that is going to be put in place to set up
the new GTR." This government
commitment, provided immediately before the Senate vote on the EPBC Act
legislation, has clearly not been met.
The Australian
Democrats put on the Parliamentary record on June 2000 our concerns regarding
the June 13 Federal Cabinet decision to minimise the role of the Environment
Minister in gene technology regulation in Australia.
Under the proposed amendments [to
the EPBC Act], which of course the Australian Democrats confirmed last year, we
saw the environment minister-actually the environment minister, I should
acknowledge, is on record as endeavouring to honour them-saying that he
supported the role of the environment minister in relation to an environmental
assessment of GMs before they were released. Under the EPBC Act a licence to
deal with a GMO was required to be issued by the Gene Technology Regulator, the
GTR. This application, if involving a deliberate release of a GMO into the environment-I
think it is clause 43(b)-was required to be referred to the environment
minister, who could then stipulate specific requirements to protect the
environment if the minister believed that that release posed a significant risk
of harm to the environment. The environment minister could accredit an
assessment process for the GTR to pursue or direct an assessment on preliminary
documentation if considered `a controlled action under part 7 of the EPBC Act,
clause 43(c)'.
With respect to the environmental
assessment under clause 43(f), the environment minister could provide advice to
the GTR which must be considered by the GTR when considering the licence
application. Let us compare this now to the new proposal by cabinet which I
think has no amendments to incorporate GMOs into the EPBC Act. The act that was
designed to ensure the most comprehensive environmental assessment at a
Commonwealth level has now been completely undermined-and with it, of course,
the role of the environment minister in the approval of GMs and GMO releases.
The new proposal, under the auspices of the health minister and the department,
does not begin to make up for the ground lost by the rejection of the
Democrats' original proposal. The draft substitute amendments to the Gene Technology
Bill 2000 do not require the environment minister's input in matters of
deliberate release to the environment, nor do they stipulate adherence to any
advice that the minister may volunteer if he or she deems it appropriate to
offer.
The Democrats are on record a
number of times in the past week or so as saying that we regard the latest
cabinet proposal as inadequate; and we will be seeking to rectify the situation
when the bill is debated in this place. What is also questionable is the extent
of the power of proposed amendments to the Gene Technology Bill 2000 without
reciprocal amendments to the EPBC Act, putting the protection of the
environment under the bill into further doubt. We know that consumers, through
the health department's consultations on the Gene Technology Bill, are saying
that they want environmental and health matters to be given equal weighting
when discussing the release of GMOs. Yet basically it is a slap in the face to
those people who participated in those public consultations.
The role of the environment
minister and the role of the environment in terms of assessing the risks and
benefits of GMOs has been completely undermined. The federal cabinet's decision
of 13 June, which did decide to undermine the environment minister's role in
the regulation process, can be construed as being in conflict with the
objectives of the bill as it currently stands...[596]
The Australian
Democrats maintain that amendment to the Bill and the EPBC Act must be
undertaken to ensure the adequate protection of the environment from gene
technologies and that operation of the OGTR is in keeping with the Bills
objectives.
4.3 Precaution: an approach or principle?
The Chair's Report
reflects, at 3.25, the wide variety of precautionary approaches and principles contained
in international agreements, domestic law and environmental legal theory:
The differing
forms of the precautionary principle also impacts on the scope of the
principles application, with some conventions and statements limited to toxic
substances control, while others include any government policy with the
potential to cause environmental degradation.
Epidemiologist and
biochemist, Dr Judy Carman, of the Public Health Association of Australia,
commenting on the current use of caution and a precautionary approach in
approval of genetically modified food products by the ANZFA in an interview
with the Age stated:
“The precautionary
principle that could be described as ‘unsafe until proven to be safe’, has been
around for centuries to guide us in conditions of uncertainty. Yet ANZFA has officially adopted the opposite
approach; that is, they permit 18.7 million Australians to eat GM foods based
on a ‘safe until proven unsafe’ philosophy.”[597]
The ANZFA's current objectives do not
incorporate the precautionary principle, despite the recommendations of public
health and medical groups in the Senate Community Affairs References
Committees’ Inquiry into the Australia New Zealand Food Authority Amendment
Bill 1999.
Attempts by the Senate
minor parties to amend the Bill in the Senate to include a comprehensive
precautionary principle were not supported by the Opposition and Coalition
parties.
The absence of the
precautionary principle in the ANZFA’s objectives increases the exigency for
its inclusion in the objectives of the OGTR.
The Chair's Report
states at 3.72 and 3.73:
The Committee considers that the precautionary approach
would be underpinned in the Bill if the precautionary principle appeared as one
of the objects consistent with the way it appears in the Environment Protection
and Biodiversity Conservation Act. The
Committee does not support the precautionary principle being made a specific
test in the licensing provisions.
The Committee considers that there is a balance between the
risks to the community versus the rights of a company, and strongly considers
that, in keeping with a precautionary approach, the onus of proving that GMOs
are not harmful should rest with the proponents of the technology.
The Australian
Democrats do not consider the inclusion of a precautionary ‘approach’ as
preferable to the precautionary principle and support the Chair's
recommendation that the Objectives of the Bill contain the same words that
appear in the EPBC Act 1999 in relation to the precautionary principle.
The Australian
Democrats maintain that stipulation of specific preventative standards and
safeguard measures is essential to the protection of public health and the
environment, and to ensure public confidence in domestic gene technology
regulation.
Furthermore, the
Australian Democrats strongly question the adequacy of the regulatory system as
stipulated by the Gene Technology Bill 2000; Gene Technology (Consequential
Amendments) Bill 2000; Gene Technology (Licence Charges) Bill 2000 and related
regulations to effectively review and assess declarations by parties with
commercial interests in the technology that it is safe (as deemed in keeping by
the Chair with a precautionary approach).
The Chair's Report
states (at 3.64)
While there is
clearly consensus on the need to ensure a cautious approach to the development
and adoption of gene technologies, there is also acknowledgment of the need to
ensure the continuation of research and development on the basis of current
scientific understanding of potential risks:
[The] Regulator’s deliberations must be based on sound, consistent and
reproducible scientific and technical data generated according to world best
practice standards.[598]
The Australian
Democrats, while supporting risk assessment and decision making based on reproducible
scientific and technical data, believe that such scientific standards and
assessment will not be able to be guaranteed under the proposed regulatory
regime as the system does not provide for independent testing of such data in
all cases.
At present, the ANZFA
is responsible for assessment and approval of genetically modified organisms
for farm production and public consumption.
The Australian
Democrats have previously commented on the ANZFA's lack of testing facilities
and the inadequacy of its reliance on applicant scientific data in the approval
of genetically modified food products.[599]
This situation will not be rectified under the gene technology regulation
system proposed.
The findings of a
study conducted for the Public Health Association of Australia support this
concern.
Scientists conducting
the study examined procedures surrounding applications from US-based Monsanto
for release of food produced from:
- insect-protected
corn line MON 810[600];
(ii) glyphosate-tolerant corn line GA21[601]; and, or
(iii) glyphosate-tolerant canola line GT73.[602]
The Public Health
Association’s review of the glyphosate-tolerant canola found that the canola
when fed to laboratory rats, in one instance, caused liver enlargement up to
16%. However, this finding did not warrant
further investigation by the applicant.
It is recognised that
the percentage of modified DNA ingested by the rats in the mash preparation
administered in the laboratory experiment was significantly higher than that
which humans would ingest with the consumption of highly-refined canola
oil. However, this raises further
questions, including:
(i) the scientific rigour of the tests
conducted by applicants;[603]
(ii) the standard of current tests constructed
to extrapolate valuable information regarding possible human health effects;
(iii) the suitability of commercial interests to
determine test models and procedures;
(iv) the value of animal models to ascertain possible human
health effects; and,
(v) the right to cause animal distress for
unusable test information.
These questions are
sustained by the Public Health Association of Australia’s review of the tests
data submitted for application A346 for the insect resistant corn line MON810
finding:
(i) the Bt
protein (produced from the insertion of the cry1(A)b gene into the corn genome) designed to rupture the gut of
lepidopteran insects had not been tested on humans; and,
(ii) testing procedures did not include the
ingestion of raw plants or waste material by other organisms in the human food
chain and whether human ingestion of such organisms posed a health risk.
The scientific data
supporting Application A362 for ‘Round-up ready’ corn acknowledged that the
line possessed a modified protein in which two amino acids differed from those
found in non-modified corn. However,
further details of these differing amino acids were not supplied on the grounds
of commercial in-confidence.
4.3 Ecological Sustainability
The Australian
Conservation Foundation’s Gene Ethics Network recommended:
The Objects of the GT
Bill 2000 should also be amended to include the principle of ecological
sustainability, to ensure genetically engineered organisms do not contribute to
the long-term destabilisation and decline of our food and fibre production
systems, the natural environment and biological diversity.
The Australian
Democrats support the inclusion of ecological sustainable principles in the
regulation and promotion of gene technologies in Australia.
5. State 'opt-out' clause
The Democrats believe
that a successful gene technology regulatory system must allow choice for
consumers. This choice is facilitated
most effectively by an 'opt out' provision for states with clear interests and
concerns primarily in the regulation of agricultural GMOs. An 'opt-out' clause provides domestic market
differentiation and clear 'safehavens' for GM free production which consumers
can clearly identify and place confidence in.
A state 'opt out'
clause would not prevent industry pursuing isolated identity preserved
production lines in States or Territories pursuing GMO production and
processing, though allow for areas with natural geographic or other advantages
to pursue GM-free products.
The Democrats have
acknowledged that a moratorium would have to be carefully considered as a
moratorium may hinder positive Australian innovation and ecological sustainable
gene technology applications.[604]
Section 99 provides
that:
The Commonwealth shall
not, by any law or regulation of trade, commerce, or revenue, give preference
to one State or any part thereof over another State or any part thereof.
While the Australian
Government Solicitor provided advice that there was:
...a significant
possibility that Commonwealth legislation to regulate GMOs would be regarded as
a law of trade and commerce for the purposes of section 99 and the opt-out
provision in that legislation would infringe that constitutional limitation.[605]
The Democrats
acknowledge the legal advice supplied to the Tasmanian Government concluding
that an 'opt out' provision for States and Territories from the regulatory
system, as proposed under the OGTR, is in keeping with WTO requirements:
The advice obtained
indicates that the opt-out as proposed in Principle 7(d) probably would not
offend against section 92 of the Constitution.
Section 92 of the Constitution requires that trade, commerce and
intercourse between the States be free.
In order for a law to discriminate against interstate trade it must be
protectionist in the relevant sense, by placing a discriminatory burden on
trade in order to protect trade within the State (Cole v Whitfield (1988) 165 CLR 360 is authority for this
proposition).
Accordingly, where a
state has declined to allow release within its own territory of a GMO, that
would apply to trade within the State and trade with other States, therefore
the law would not be protectionist in the relevant sense.
In any event, legal
authority exists for the principle that laws for the protection from a real
danger or threat, or some other legitimate object of a State, not offend
section 92, if the law is appropriate for the achievement of that objective.
Section 99
In order to offend section 99 of the Constitution, two elements must be made
out. Firstly a law or regulation must be
one of trade, commerce or revenue. Legal
opinion obtained by Tasmania suggests that, as the laws in the Gene Technology Bill 2000 are to
regulate the safe release of GMOs within Australia, it is not a law that can be
classed as 'trade or commerce' for the purposes of section 99.
World Trade
Organisation Agreements
As yet no jurisprudence exists on GMOs in the context of World Trade
Organisation (WTO) Agreements.[606]
The Australian
Democrats, therefore, maintain that a State and Territory 'opt out' provision
is the most appropriate mechanism to ensure domestic and export market
diversity while effectively containing the impact of gene technologies on the
environment.
6. The Gene Technology Regulator
This will be a
position of great power, not only within the scientific community but also with
immense responsibilities for the long-term safety of the Australian and world
environment, given that GMOs, once released, may not be able to be recalled.[607]
The Australian
Democrats believe that, in order to maximise the likelihood of public
confidence in Australia’s gene technology regulatory system the Gene Technology
Regulator should be required to possess the following characteristics and
abilities:
(i) Independence;
The Regulator must be at arms length from Government its research wing the
CSIRO and independent of sectoral interests (ie, not holding employment with
sectoral interests a minimum of 5 years before assuming the position, and not
being employed by a sectoral interest for more than 5 years in total).
The position
must be of a fixed, non-renuable tenure to ensure independence.
(ii) Contributor
to public debate;
The Regulator
must be able to make public his or her views on any issue relating to gene
technology and its regulation.
(iii) Powerful
'watchdog'
The regulator must able to have the power
to provide a Commissioner/Ombudsman of gene technology service. The regulator must possess wide ranging
powers to commission research and surveillance and propose legislation to
ensure public and environmental safety, monitor and enforce responsible
application of gene technology.
7. Public Participation & the Community
Consultative Committee
It is of course,
impossible to neatly separate the technical, community, ethical and
environmental aspects of the new technology.
This was eventually recognised, even by the early biased GMAC, and
specialists in most such issues were eventually appointed to GMAC. Thus the committee structure, or the
committee responsibilities, proposed under the present Bill must be changed -
either a single committee should be empowered to cover all aspects listed in
the Bill or all three committees should consider and report to the Regulator on
all applications for GM work.[608]
The Gene Technology
Technical Advisory Committee (GTTAC), The GT Community Consultative Committee
(GTCCG) and the Gene Technology Ethics Committee (GTEC) are the engines of the
new regulatory authority and will over see public participation in the
regulation of Australian gene technology.
they [the committees]
will considerably diminish public involvement in gene technology regulation compared
with the existing GMAC system[609]
The Australian
Democrats, therefore, conclude for the afore-mentioned reasons that the
regulatory system, outlined in the Gene Technology Bill 2000, does not provide
the protection that the community requires and as a result fails to provide
community confidence, domestically or internationally, on which Australia’s
biotechnology research community and related agri-industries rely.
7. Summary of Recommendations contained in the
Chair's Report;
The
Australian Democrats support the recommendations contained in the Chair's
Report with the following exceptions and comments:
Chapter 3
the
relevant State and Territory animal welfare legislation and the NHMRC code of
practice for the care and use of animals for scientific purposes, be examined
to determine whether more stringent provisions need to be applied with respect
to animals and genetic modification.
(i) The Australian Democrats believe current
animal welfare legislation and NHMRC codes of practice are inadequate to ensure
the ethical scientific use of animals, as they are often not enforceable
The Australian Democrats support
increasing regulation of genetic modification practices and testing involving
animals, increasing animal welfare protection and translating the NHMRCs
current voluntary ‘guidelines’ into law.
that an independent organisation conduct a national public
education campaign to provide information on the benfits and risks of gene
technology, drawing on, but not limited to, the expertise of scientists, primary
producers, academics and consumer organisations.
(ii) The Australian Democrats consider such a
role as integral to an effective regulator. Rather than another independent entity provide such information, the
Australian Democrats recommend that Bill be amended to ensure that the
Regulator is first and foremost, the protector of public health and the
environment, and instigator of public interest and independent information
distribution.
Chapter 4
that an individual who has worked for a regulated entity be
precluded from holding the office of Gene Technology until the expiration of a
two-year period.
(iii) The Australian Democrats consider this
recommendation worthy of consideration and further examination.
In some cases
the passing of two years, after a life career in a regulated scientific body,
may not remove the shared knowledge, political and ethical values and vested
interests established in a career of such standing.
Similarly employment in an industry does
not guarantee sympathy with certain industry practices or directions.
The
Australian Democrats further recommend:
(iv) That
the Bill be amended to require that the Gene Technology Community Consultative
Group is a Committee of equal standing and funding to the GTTAC and and GTEC.
(v) That
the Bill be amended to grant the Gene Technology Community Consultative
Committee greater public participation powers.
(vi) That
the Regulator accept State and Territory self-determination to quarantine
against genetically modified organisms or to ‘opt-out’ of the OGTR if deemed
desirable and to facilitate dialogue and agreements between states to pursue
GM-differentiated products.
(vii) That
the ANZFA is fitted with the independent laboratory facilities to review and
test applications for release of genetically modified food products.
Senator Stott Despoja - Deputy Leader
Australian Democrats
Spokesperson for
Biotechnology
Full Member of the Committee forthe purposes
of the Inquiry
Senator Andrew Bartlett - Spokesperson for the Environment
Participating Member for this Inquiry