Human medical research
3.92
Concern was expressed about the
failure to include clinical research which involves gene technology within the
scope of the Bill. Ms Kathy Liddell stated:
It is claimed that these matters are dealt with by the NHMRC in
much the same way that certain activities are handled by the regulatory
authorities mentioned above. However, the regulatory power of the NHMRC is
relatively weak. It is primarily based on Guidelines that are part of funding
agreements. It does not have strong powers to monitor compliance and are only
voluntarily binding on some organisations. If the Bill is not extended to cover
clinical research that uses gene technology, this particularly risky
application of gene technology will be regulated the least stringently of all
GM dealings.[138]
3.93
Canberra Consumers stated that
‘there should be some comment, perhaps along the lines that genetic
modification of humans is excluded but will be picked up in other legislation’.[139]
3.94
The IOGTR advised that the
original draft had defined a GMO to exclude a human being, but that this had
led to concerns that trials involving the use of GMOs in humans would not be
covered by the Bill. This has been clarified in the current Bill which excludes
people who have undergone somatic[140]
cell therapy, who may then, under the previous definition, have been required
to be licensed. Under the current legislation the GTR will regulate all
organisms modified by gene technology including human cell lines and tissue
samples. While the TGA and the NHMRC will have the primary responsibility for
overseeing somatic cell gene therapy, the GTR will also be involved to ensure
that there are no environmental risks posed by GMOs to be used as part of the
human trials.[141]
3.95
While other regulatory
authorities will continue to have carriage of the regulation of GMOs relevant
to their area of responsibility, the Regulator will still play an advisory
role.[142] The Gene Technology (Consequential
Amendments) Bill 2000 requires existing regulators to:
-
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 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 Regulator.[143]
3.96
The confusion over the scope of
the Bill in relation to human medical research highlights a major criticism
expressed in evidence to the Committee - that of the interaction between other
regulatory authorities and the proposed Gene Technology Regulator backed by
calls for a ‘one-stop shop’ approach to be adopted. This is discussed in detail
in Chapter 4. The appropriateness of the advisory role of the Regulator is also
examined.
3.97
The Committee notes that in a
late submission, concerns were raised about the possibility that the Gene
Technology Bill would permit human cloning.[144]
The Committee also notes that there is disquiet about suggestions that human
cloning be covered by the Bill, and concurs with the view expressed by the
Queensland Government that ‘human cloning raises complex and sensitive issues
which are probably best dealt with in separate legislation’.[145] The Committee notes that the House
of Representatives Standing Committee on Legal and Constitutional Affairs is
currently conducting an inquiry into the scientific, ethical and regulatory
aspects of human cloning.
Recommendation
In view of the confusion caused by the lack of clarity on the
status of medical research, and particularly human medical research, under the
legislation the Committee RECOMMENDS that the Bill be amended, where
appropriate, to explicitly state how such research will be dealt with by the
OGTR.
Ethical considerations
3.98
According to some submitters
the social, religious and ethical implications of gene technology, including transgenic organisms,[146]
were issues to be considered in the regulation of GMOs.[147] It was argued that these issues
should be outlined in the object rather than in guidelines or policy directives
of the Gene Ethics Committee.
3.99
The Committee was reminded that
these issues are held very deeply by many people:
While the threat to human health and the environment is of vital
importance, the government must be mindful of the fact that many people believe
that GE involves an immoral meddling with “nature” or “God's creation”.[148]
3.100
The ethical issues associated
with gene technology were accorded a high priority by the First Australian
Consensus Conference held in Canberra in March 1999. The Conference, which
brought together a group of experts and lay people, concluded:
There are many moral and ethical issues raised by gene technology
such as:
- Should
life become a commercial property through patenting?
- Should we create transgenic organisms,
particularly those containing human and animal DNA?
- Who
advocates for nature?
- How do we ensure that our decision-making
processes respect the diverse cultural, moral and religious beliefs within our
multicultural society?
It would be presumptuous of us to answer these issues or to
assume that we have identified all of them, however we believe that ethical
considerations must assume a prominent role in decision making about gene
technology.[149]
3.101
The Lay Panel’s Report
recommended that an ethicist be involved in the formulation of major decisions
regarding GMO policies.
3.102
The IOGTR advised the Committee
that:
no statutory ethics committee is involved in providing policy
guidance in New Zealand, Japan, South Africa, Canada or the United States.
Likewise, in the United Kingdom there are several advisory committees composed
of a range of individuals, but there is no specific expert committee established
to advise on ethics. Similarly, domestically, AQIS, TGA, NICNAS, ANZFA and the
NRA all operate without the influence of an expert ethics committee.[150]
3.103
Under the Gene Technology Bill,
the Regulator ‘must not accept an application for a licence to deal with a GMO
if it is inconsistent with a prohibitive ethical principle’.[151]
3.104
The proposed Gene Technology
Ethics Committee is to be established to deal with the very issues raised by
some submitters to the inquiry. The Committee notes that the Bill provides that
the Ministerial Council may issue policy guidelines in relation to ethical
issues relating to dealings with GMOs. The appropriateness of this provision
and the relationship between the Ministerial Council and the Gene Technology
Ethics Committee is discussed in Chapter 5.
Animal welfare
3.105
While the Bill’s object
addresses the health and safety of people and the environment, Friends of the
Earth (Fitzroy) raised the issue of animal welfare, recommending that the
object include a reference to the health and safety of animals.[152]
3.106
Avcare Limited, on the other
hand, argued:
It is not necessary for animal health to be included as animals
can be considered as part of the environment into which the GMO is being
released. Furthermore, proponents of GMOs still have to comply with other
relevant legislation such as State animal welfare legislation.[153]
3.107
IOGTR advised that all States
and Territories have legislation in place to protect the welfare of animals and
prevent cruelty to animals, including in the context of animal research. In all
jurisdictions, other than Western Australia, the animal protection legislation
refers to the NHMRC’s Australian code of
practice for the care and use of animals for scientific purposes (the NHMRC
code).[154]
3.108
The NHMRC code covers ‘all
aspects of the care and use of, or interaction with, animals for scientific
purposes in medicine, biology, agriculture, veterinary and other animal
sciences, industry and teaching’. This includes their use in research,
teaching, field trials, product testing, diagnosis, the production of
biological products and environmental studies.[155]
3.109
Additionally, guidelines for
the humane conduct of scientific and teaching activities, and for the
acquisition of animals and their care, including their environmental needs, are
specified in the NHMRC code. All live non-human vertebrates are covered by the
NHMRC code, which requires that ‘eggs, fetuses and embryos must be treated in a
humane manner where development of an integrated nervous system is evident’.[156]
3.110
The IOGTR advised that the Bill,
when enacted, will not exclude the operation of any other State laws, and is in
addition to, not a substitution for, the requirements of other Commonwealth
laws. Any person undertaking research involving genetic modification and
animals must comply with both the Gene Technology Bill and any other relevant
State and Commonwealth legislation.[157]
3.111
The Committee notes that where
issues arise in relation to gene technology and animals that are not adequately
addressed under existing State legislation and the NHMRC code, the Ministerial
Council may, on the advice of the Gene Technology Ethics Committee, issue
policy principles or policy guidelines regarding ethical issues including
animal welfare issues.
3.112
IOGTR further stated that prior
to accepting an application, the Regulator will ensure that the application not
only accords with any ethical guidelines issued by the Ministerial Council but
also that the application is in accordance with relevant State/Territory laws
for the protection of animals.[158] Any
application that is not in accordance with such requirements will be rejected
by the Regulator.[159] The Regulator
may also prescribe certain codes of practice relating to ethics and animal
welfare as a condition of a licence.[160]
3.113
The Committee notes that while
there is state legislation that covers animal welfare, it is concerned that the
Ministerial Council would be left to address any shortfalls in regulations
covering animal welfare.
Recommendation
The Committee RECOMMENDS that 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.
Benefits of gene
technology
3.114
Concerns were expressed that
the facilitating benefits of gene technology were not included in the object of
the Bill. It was argued that this was contrary to a Commonwealth Government
Ministers’ announcement about the planned legislation, that the purpose of the
gene technology regulatory system should be to ‘realise the benefits of gene
technology for the Australian community, industry and the environment, while
ensuring human safety and environment protection’.[161]
3.115
The Committee acknowledges that
there are potential benefits to the community and the environment from gene
technology, but considers that an important purpose of the Bill is to ensure
public confidence in the regulation of this technology. The Committee notes
that organisations involved in the research, development and commercialisation
of GMOs currently play a role in the dissemination of information and education
of the community about the benefits of gene technology. However, the Committee
considers that it would be more appropriate for an independent organisation to
provide a balanced approach to the provision of information on the benefits and risks of gene technology.
3.116
In addition to the concerns
just discussed relating specifically to the object of the Bill, a number of
other issues were raised in relation to achieving the Bill’s objective and
providing sufficient consumer confidence in the regulation of gene technology.
These are discussed in the remainder of this chapter.
Alternative
regulatory models
3.117
The Australian Centre for
Environmental Law provided the Committee with an alternative model Act for the
comprehensive regulation of all activities and dealings involving gene
technology.[162] A number of witnesses supported this model Act arguing that it
provided a more effective regulatory framework to achieve the Government’s
stated object of the Gene Technology Bill.[163]
3.118
Alternative regulatory models,
including the ‘one-stop shop’ are examined in Chapter 4.
Placement
of a moratorium
3.119
A number of groups supported
the placement of a moratorium on gene technology including a freeze on:
-
the further introduction of genetically
engineered crops or foodstuffs into Australia;[164]
-
the release of GMOs into the environment;[165]
-
GMOs until proven to be benign to humans and
other life forms;[166]
-
the general release of GMOs, including medical
GMOs;[167]
-
gene technology to allow for ‘some sort of
scientific consensus and the market implications of this technology to emerge’;[168] and
-
uncontained field trials or field crops.[169]
3.120
A moratorium was also
considered essential to allow time to inquire into the need to revamp relevant
legislation in the light of the uncertainty and vagueness surrounding the
assessment of the risks associated with gene technology.
I
believe that if we revamp all our acts that underlie this gene technology bill
we can overcome those things because we are going to put into effect greater
securities and greater sureties in practical issues and these should be worked
out. This is what I am saying. We need a five year moratorium in which to do
that and do it appropriately, thoroughly, efficiently properly and ethically.[170]
3.121
The Committee notes that the
Tasmanian Government has instituted a 12 month moratorium on the open research or trialing of GM crops during which time the
Tasmanian Parliament will examine the implications of gene technology for
Tasmania. Tasmania’s position is discussed in Chapter 6 in the context of its
support for the inclusion of an opt-out clause in the Bill.
The role of multinationals
3.122
GE-Free Tasmania stated that
‘to date the interests of biotechnology companies have dictated the nature of
the GE debate...However, this has served to stimulate considerable public concern
about the safety of GE and the intentions of those involved in its development
and commercialisation’.[171]
Submissions pointed to public disquiet over the role of multinational companies
in promoting gene technology onto an unwilling public. NT Bio Dynamic Network
argued that many people ‘have no confidence in science altering our food for
the benefit of Multi National Companies. There are no known benefits for GM
food to be forced onto consumers’.[172]
3.123
The commitment of multinational
corporations to the safety of GMOs and its impact on the agricultural sector
was questioned by Ms Vicki Brooke:
The technology has the potential to undermine our whole
agricultural sector as it has been built up over generations since the early
nineteenth century, since it is promoted by agrichemical companies anxious to
sell their product, clearly acknowledged by Monsanto when its Director of
Corporate Communications said “Monsanto should not have to vouchsafe the safety
of our biotech food. Our interest is in selling as much as possible. Assuring
its safety is the FDA’s job”.[173]
3.124
Concern was also expressed
about the potential misuse of gene technology by multinationals:
Poverty and oppression contribute to famine and hunger. Gene
technology could perhaps in the future promote famine and hunger if it promotes
the need for cash to pay the corporations and if the corporations become
oppressive.[174]
3.125
Dr Tribe commented on the dangers
associated with the potential dominance of gene technology by multinational
companies:
The whole notion of having high regulatory hurdles and the whole
rigour of regulation, arguably out of proportion to risks, encourages only the
very strong to survive that rigorous path. So that has to be realised...If a lot
more encouragement were given to more ventures, more institutes and smaller
activities, and they were able to see a path forward to the market, that would
be good.[175]
3.126
However, according to the IOGTR
concerns about the dominance of multinationals in gene technology have been
addressed:
The legislation has...been drafted so as not to impose unfair
burdens on small industry nor entrench overly restrictive practices between
companies and for example, contract farmers.
If individual companies do...engage in unfair or restrictive trade
practices, this will be a matter for consideration by the Australian
Competition and Consumer Commission - the independent statutory watchdog
administering the Trade Practices Act
1974 and the Prices Surveillance Act
1983.[176]
Implications for trade competitiveness
3.127
The Committee received
conflicting views on the impact of the proposed regulatory regime on Australian
trade opportunities.[177] These
included, for example, reports about loss of market share for the sugar
industry, which may be recovered with the assistance of gene technology:
CSIRO researchers...are trying to produce sugarcane which yields
the lower colour sugar that attracts premium prices internationally.
...the key to the research was to regulate an enzyme in the cane
which causes browning in fruit and vegetables.
...lowering the colour even 20 or 30 per cent...will be of benefit
to the industry which has lost market share in recent years to competitors like
Brazil which have produced quite a low colour sugar.[178]
3.128
The NSW Farmers’ Association
warned ‘we do not want to see this issue being used as a weapon against
industries faced with much more rigorous requirements than its competitors’.[179]
3.129
The Committee recognises the
difficulties faced by the Government in ensuring the safety of people and the
environment, and, at the same time, ensuring that Australia’s trade and
economic opportunities are not unnecessarily damaged through over regulation of
this technology. However, the Committee considers that in keeping with the
object of the Bill, the Government must link the health and welfare of the
Australian people and protection of the environment with trade considerations
in a field of science for which the long-term risks and hazards are yet to be
sufficiently understood.
Trial site locations
3.130
Many groups and individuals
criticised the secrecy associated with field trials of GMO crops and argued
that information relating to trials and their site locations should be publicly
available to improve confidence in the system.[180]
3.131
The District Council of Grant
in South Australia expressed concern at the lack of information on trial sites
made available to local councils. The Council submitted that ‘No notification is supplied to the
Council or the public, regarding the location of the trial sites, duration,
size, and conditions pertaining to the trialing of genetically modified crops
(for example Canola)’.[181]
3.132
There was also concern that the location of
dealings involving the general release of GMOs could be declared confidential
commercial information:
The argument that this is necessary to protect property and
personal safety does not outweigh the great harm the gene technology industry
is doing to its public image. It is worth noting that in Europe, where there is
widespread opposition to gene technology, the location of GMO crops is not
concealed as it is here.[182]
3.133
While Tasmanian Alkaloids was
prepared to publicise future trial sites[183],
the NFF drew on overseas experience to argue against this proposition, and
considered that the destruction of or damage to trial sites should be made an
offence under the Bill. Other companies currently involved in gene technology
trials supported the NFF’s position.[184]
3.134
Novartis explained that while
they agreed that there was a ‘genuine need for openness’ with respect to the
location of trial sites to support confidence in the process, their experience
in the UK, where in a spirit of openness the company had supported the practice
of revealing the precise location of sites, was ‘that such disclosure led to
trial site vandalism to such a degree that some of the current farmscale
biodiversity evaluations are now in jeopardy’.[185]
3.135
Others claimed that the
incidence of vandalism of GMO crops should not be used to justify the
non-disclosure of trial site locations, arguing that ‘security alarm systems
may have to be put in place to protect GE crops but farmers as well as the
public have a right to know this information’.[186]
3.136
The Committee condemns any acts
of vandalism against GMO field trials and is concerned that such acts may
themselves facilitate the dispersal of GM pollen resulting in the types of
contamination that must be prevented.[187]
3.137
Avcare, an umbrella
organisation of biotechnology companies, proposed an alternative approach to
providing information on trial site locations:
[that] Avcare members...make the locations of trials available to
an independent third party who could be contacted by a concerned grower. The
grower would then be told whether a trial was nearby and, if so, directed to
the proponent of the trial for information.[188]
3.138
The Organic Federation of
Australia was critical that this proposal required organic farmers to advise
GMAC of the location of their crops around Australia:
...it is going to cost us money to do that. We have farmers
who declare that they grow oilseed but, because we do not know whether they
grow it in that particular year, we have to write to 1,000 or 2,000 farmers who
might grow it. We have a 20,000 tonne organic canola crop, and we ask, ‘Are you
growing it or not?’ So there is a cost involved. We have said that, if the
government is willing to repay us for that cost, we will consider it.
...if
you do that for organic farmers, then you have to do that for beekeepers, and
why shouldn’t you do that for any conventional canola farmer out there around
Australia?[189]
3.139
The Committee considers that
Avcare’s proposal may undermine confidence in the GTR and confuse the public in
relation to where information on trials and other issues concerning the
regulation of gene technology should be sought. The Committee supports the
views of the Organic Federation of Australia and considers that it is more
appropriate for GM growers to make details of trial site locations available to
those who may be affected.
Commercial-in-confidence information
3.140
Environs Kimberley felt that
the commercial-in-confidence provisions of the Bill would undermine the object
of the Bill to protect human health and safety.[190]
3.141
The importance of transparency
was also stressed by Professor Adrian Gibbs:
If
the public is to have faith in the regulation of gene technology, very little
of the data upon which the Regulator has made a decision should be permitted to
be hidden from scrutiny on the grounds that it is commercially sensitive
information, and even if it is, then the type of each item of information must
be declared, even though the specific details may be hidden. Thus, for example,
an interested member of the public must be able to determine for an approved
GMO whether a particular type of safety feature has been examined and
considered by the Regulator, even though the details of the outcome of the test
may be hidden. Otherwise, if there is no
public record of the type of information being withheld, then the public record,
in toto, is valueless.[191]
3.142
Others, while recognising that
the public has a right to information about the development of GMOs, were
concerned at the ramifications of revealing too much in a competitive
market-place:
sooner
or later you will reach a point where all we will see in Australia is last
year’s technology or 10-year-old technology. It will be absolutely generic and
fully disclosed. We will never see state-of-the-art, highly competitive
technology-especially if we are looking for technology that will give products
a competitive edge in the international marketplace.[192]
3.143
Mr Kim Healy considered that the Bill should
include a ‘precise definition of commercial confidentiality’ and added:
The
GTR should always have the power to override the claim for confidentiality in
the public interest, as when human lives or environmental damage are
threatened.[193]
3.144
The IOGTR advised that the current Bill requires
the GTR to refuse to declare information to be confidential commercial
information if the public interest in disclosure outweighs the prejudice the
disclosure would cause.[194]
Recommendation
The Committee would consider it undesirable if commercial in
confidence information compromised the objectives of the Bill or the
transparency of the regulatory regime, and RECOMMENDS that where an application
for an intentional release of a GMO into the environment includes the size and
location of this proposed release, the information should be made available
publicly providing that the penalties for any intentional damage to that
release are an effective deterrent against eco-terrorism.
3.145
The issue of the information to
be taken into account by the Regulator when making a decision on whether a
licence should be granted is discussed in Chapter 4.
Cost recovery
3.146
The proposed full cost recovery to fund the OGTR
was identified as one of the measures that could potentially undermine the
objective of the Bill.[195] The Committee notes that this proposal has recently been
assessed by KPMG. The issue of cost recovery, the KPMG report and implications
for parliamentary accountability, are discussed in Chapter 4.
Adequacy of public reporting provisions
3.147
The Bill includes a number of
public reporting provisions that must be observed by the Regulator. These
include requirements to:
-
report to Parliament annually, and on other
occasions as may be required, about matters relating to the function of the
Regulator;[196]
-
establish a GMO Register;[197] and
-
provide a Record of GMO and GM Product Dealings.[198]
3.148
The IOGTR advised that the Record of GMOs and GM product dealings would list all dealings with GMOs and GM products approved for use in Australia, regardless of whether they were produced domestically or imported. Approval must be sought
from the Australian Quarantine and Inspection Service (AQIS) for the
importation of a live or viable GMO, to ensure there are no pest and disease or quarantine risks. Approval must
also be sought from the Regulator who is required to check the biosafety
of the GMO. If either AQIS or the GTR considers that the risks of import are too high, on either quarantine or biosafety
grounds, the GMO cannot be imported. In the event that the
importation of the GMO is approved, details of the approval will be entered on the Record.[199]
3.149
GE-Free Tasmania argued that
the Record should also include the location of all dealings. They further suggested
that:
-
the wording of sub-clause 138(3) should
explicitly provide that ‘the information regarding licences must include all
variations, cancellations and suspensions made to licences’;
-
information about exempt dealings should also
appear on the Record;
-
the scope of the Record should include all
accredited organisations and certified facilities; and
-
the term ‘GM product dealings’ be clarified for
the purpose of clause 138.[200]
3.150
The Australian Conservation
Foundation was also critical of information that would not be available on the
Record and recommended the inclusion of the following information:
(a) the application for the licence, and if the
application is denied, the reasons why the Regulator decided to refuse the
licence;
(b) all information submitted in support of an
application for a licence authorising dealings with GMOs issued under Part 5 of
the GT Bill;
(c) the name of the licence holder;
(d) the persons covered by the licence;
(e) the activities or dealings authorised by the
licence;
(f) licence conditions;
(g) the date on which the licence was issued, and
the reasons why the Regulator decided to issue the licence;
(h) all information collected in the course of
monitoring and/or auditing of the licence; and
(i) any
variations, suspensions or cancellations of the licence.[201]
3.151
The IOGTR advised that, in the
1999 draft Bill, the Record of GMOs and GM product dealings would only have
included information about the licences issued by the GTR. However, after the
consultation process, this had been expanded to include information about:
-
notifiable low risk dealings; and
-
all approvals granted by any other regulatory
agency in relation to GM products.
3.152
The IOGTR also advised the
Committee that the Record of GMOs will not include a list of failed
applications for approvals to deal with GMOs and GM products. It stated that
the purpose of the Record is to provide the Australian public with easy and
immediate access to a comprehensive list of those dealings with GMOs and GM
products that have been approved in Australia, and which may directly affect
them, including approvals of GM products made by other regulators, which must
be notified to the Gene Technology Regulator.[202] The Record will take the form of a comprehensive publicly available
database on the GTR’s website.
3.153
The IOGTR indicated that while the Record will not
contain a list of failed applications, the public will have access to the
failed applications through the public consultation process. For example, in
the case of applications involving intentional release of a GMO into the
environment, the GTR will consult the public on the application and the draft
decision. As such the public will have access to, and be able to comment on,
the full reasons for non-approval as set out in the GTR’s draft decision (risk assessment
and risk management plan).[203]
3.154
Mr Greg Whitten was critical of
the Register of GMOs, claiming that ‘there is no public consultation process
involved - the Regulator can make a decision on whether a GMO is listed on the
Register without consulting anyone’. He also expressed concern that such a
Register would allow ‘easy access of these GMOs into GE free zones’.[204]
3.155
There was also a suggestion
that a register of accidental releases of GMOs into the environment should be
established.[205]
3.156
Mr Anton from the Australian
Centre for Environmental Law noted that the Register required under the EPBC
Act was more comprehensive than the one proposed under the Gene Technology
Bill, and argued that the Register of GMOs should include ‘as a minimum...details
involving the application, where the release is going to take place, and those
things for public protection’.[206]
3.157
However, Mr Burgess,
representing the SA Farmers Federation, argued against the Register containing
details of a licence, stating:
...while supporting the need for transparency in the licensing
system, there is also a need to protect those seeking and who have been granted
a licence to utilise gene technology.[207]
3.158
The 1999 draft of the Gene
Technology Bill did not include a provision for a Register of GMOs. The Register
was included in the current Bill following concerns raised during public
consultations. It had been argued that in cases where a GMO, for example a
cut-flower, was considered to be safe and dealt with (as defined by the Bill)
by millions of people, that a single company should not be required to hold a
licence for that product.
3.159
The IOGTR advised that the GTR
would be able to enter GMOs on the Register after a period of licensing and
demonstration of the absence of risk, which would allow anyone to deal with the
GMO without the need for a single licence holder.[208]
3.160
Both the Record and the
Register will be accessible via the GTR’s website and the public will also be
able to request that extracts from the Record or the Register be mailed to
them.[209]
3.161
There was also some
misunderstanding as to the frequency of reports to be made and to whom, whether
the Minister or the Parliament directly.[210]
Under clause 136 of the Bill, the Regulator must prepare for the responsible
Commonwealth Minister a report on the operations of the Regulator as soon as
practicable after the end of the financial year. The Minister must table the
report to each House within 15 days of receipt of the report. The
Regulator must also provide a copy of the report to each State.
3.162
Under clause 137 of the Bill,
the Regulator may cause a report about matters relating to the Regulators’
functions to be tabled in either House of the Parliament, and must give any
such report to the Minister for Health and Aged Care and the States.
3.163
The Committee understands this
clause to mean that where a report on a matter was requested by the Parliament,
the Regulator must provide such a report directly to the Parliament. The
Committee considers that the clause would benefit from clarification to ensure
that any such report is provided to both
Houses of Parliament. The Committee also considers that the Regulator must
report on any breaches of licence conditions or guidelines which have caused
serious environmental damage or harm to human health or safety as soon as
practicable after the breach.
3.164
The Committee considers that
annual reporting by the Gene Technology Regulator is insufficient. The
Committee notes that in May 2000, the IOGTR advised the Minister for Health
and Aged Care that it would, in future, report on a quarterly basis in line
with the it’s aim of providing interested people with more timely and
comprehensive information about current oversight of GMOs.[211]
3.165
The Committee believes that the
Bill should be amended to add a requirement for quarterly reports on compliance
with the legislation which includes information on who received licences and
for what purposes, and details of any investigations into breaches of licence
conditions (see Chapter 4).
3.166
The Committee supports the
extended use of the OGTR’s website to provide timely information, in addition
to the publication of quarterly and annual reports.
Public confidence
3.167
Many of the concerns about the
Bill’s object are tied to the ability of the Regulator to deliver a system that
will restore and maintain public confidence in the proposed regulatory
arrangements. Two of the most important factors bearing on the public
acceptance of the proposed regulatory regime are the transparency of the
assessment process and the independence of the Regulator.[212]
3.168
The Australian Food and Grocery
Council stated:
...for the maximum benefit and confidence of consumers we require
a regulatory framework which is transparent, fully accountable, and, very
importantly, independent of commercial, political and sectoral influence.
Consumer confidence in the application of gene technology and the safety of its
products is fundamental to investment in, and the subsequent commercialisation
of, the technology.[213]
These issues are discussed in detail Chapters 4 and 5 of
this report.
3.169
The Committee received evidence
from those who want greater regulation in order to meet the objective of the
Bill and ensure consumer confidence in the regulation of GMOs, and those who
feel that the problem lies with insufficient public education.[214] Others considered that the Bill had
been drafted with public safety in mind and provided adequate safeguards
designed to enhance consumer confidence.[215]
3.170
CSIRO stated that, in addition
to ensuring ‘rigor and scientific underpinning’ of the Regulator’s
decision-making:
Ensuring consumer confidence will require significant attention
to implementing the broader strategic issues as encompassed in the recently
launched National Biotechnology Strategy and, in particular, urgent and
decisive action on enhancing public awareness by unbiased information being
provided by community, industry and government organisations. Without such
information, the public acceptance and adoption of gene technologies and their
products into Australia could be delayed or even prevented in the immediate
future.[216]
3.171
Valley Seeds also considered
public education important despite other measures included in the Bill aimed at
ensuring consumer confidence in the regulation of GMOs:
All these measures, however will account for little if the
public is not educated about the process. A high level of education is more
likely to prevent public concern than any level of reporting on its own.[217]
3.172
This view was supported by Mr
Buz Green of Serve-Ag Pty Ltd:
I am finding that there is a profound lack of knowledge and
understanding of the technology and the science behind it in the community. I
think that if more effort were made to educate the public, then that would, I
am sure, improve their confidence. Over history fear is one of the first things
with any new technology, but as knowledge is increased, fear tends to be
reduced.[218]
3.173
The assumption that more
information will automatically ensure greater public acceptance of gene
technology was criticised:
...attempts to cast the debate as a battle of beneficent and
knowledgeable cleverness versus ignorant and superstitious anxiety should be
resisted. Regulators need to acknowledge that the public has well founded
grounds to be ambivalent about genetic technology. No amount of instruction in
molecular biology, education on the economic benefits of research and
innovation, and the need to be internationally competitive can allay legitimate
human concerns.[219]
3.174
This view was supported by Mr
Hankin from Heritage Seed Curators Australia who argued that a lack of
technical understanding of gene technology should not be used to disparage the
opinions of people opposed to GMOs.[220]
3.175
The Committee notes the
Commonwealth Industry Minister’s strategy for responding to the concerns held
by some in the community about gene technology:
...we have an obligation to demonstrate the opportunities for
improvements to our health, in benefits to the environment and in enhancing the
competitiveness of our industries as a result of biotechnology.[221]
3.176
The CSIRO noted that the pace
of technological change also affected public confidence:
What we see...is that some citizens in countries around the world
feel very uncomfortable with technological change. It happens that
biotechnology is one raft of technological change which is currently moving
past us. One hundred years ago we felt equally uncomfortable in societies about
the advent of the internal combustion engine and the loss of horses and
carriages; we do not bemoan that now.[222]
3.177
The Committee considers that
there is more substance to the concerns of opponents for them to be dismissed
as the views of a ‘noisy minority’.[223]
While acknowledging the complexity of concepts and techniques used in gene
technology and understanding the need to provide explanations in a way that
lay-people can understand them, the Committee considers that it is time to move
from the provision of overly simplistic descriptions to more detailed and
objective accounts of the processes associated with the development of GMOs,
particularly those likely to enter the food chain.
3.178
The Committee notes the
observations of GE-Free Tasmania:
To date, the interests of biotechnology companies have dictated
the nature of the GE debate and the actions of the Federal government. However,
this has served to stimulate considerable public concern about the safety of GE
and the intentions of those involved in its development and commercialisation.
The GT Bill must facilitate public involvement in the application of gene
technology so as to ensure that it can be applied in an effective and
prosperous manner. The current provisions of the GT Bill will only add to the
public distrust and scepticism and potentially stifle the adoption of
beneficial uses of gene technology.[224]
3.179
Concern over the involvement of
biotechnology companies in the dissemination of public information was
emphasized Ms Herminie Swainston, who stated:
The electorate needs to have enough balanced information about
gene technology to make informed decisions. This may reduce the extent to which
people are manipulated and indoctrinated by vested interests who have lots of
money to spend on persuading us that their GMOs are OK, safe and fully tested,
even if they aren’t. We need protection by responsible government that has not
done deals with the corporations.[225]
3.180
In Europe, information on gene
technology is disseminated by consumer and environmental organisations,
schools/universities, industry and government. In most cases, the most widely
trusted information sources are those provided by consumer and environmental
groups. The issue is not one of robustness or accuracy of information, but trust.
The role of the media in influencing public perceptions is also significant.
Information provided by a range of media is ‘often misleading, inaccurate, and
incomplete’.[226] The role of the media
in the dissemination of information on gene technology was also criticised in
evidence to the Committee:
I would urge the committee to give weight to the evidence which
has proper scientific basis and reject the myth and misinformation that is
being perpetuated in this debate...If you go around the world...you see the same
messages coming out. The media obviously perpetuates a lot of it, but where it
emanates from I am not too sure.[227]
3.181
Another approach, first
developed and used in Denmark in the mid 1980s, is the consensus conference
which brings together relevant experts and lay people. Other European countries
have adopted the model, modified to fit the local political culture.[228]
3.182
Australia held its first
consensus conference in March 1999 on gene technology in the food chain. Over
nine days, a Lay Panel comprising people with no prior knowledge of the topic
and representing a range of attitudes and values, set questions for a panel of
experts who came from science, industry, environment, religion and public
health. A number of concerns were highlighted as a result of the conference,
including:
-
consumers are mistrustful and cynical;
-
people feel excluded from decision-making;
-
ethical and moral considerations are major
issues;
-
while recognising the perceived benefits people
see technology as serving the interest of a privileged few, that is,
multinational companies;
-
that there should be more caution and less haste
in applying new technologies.[229]
3.183
The Committee notes that the
Lay Panel recommended that better processes to allow public access to
information, which includes varying perspectives, should be established at many
levels, including:
-
the establishment of a gene technology
information office;
-
government sponsored advertising campaigns;
-
toll-free phone lines and Website for consumer
information;
-
public notices on GM issues;
-
information fact sheets; and
-
focused education information and CD Roms.
3.184
The Lay Panel also recommended
that increased consumer representation on existing and future decision making
bodies ‘is absolutely necessary’.[230]
3.185
The Gene Technology Bill
provides for extensive community participation in GMO assessment processes. The
role and composition of the proposed Gene Technology Community Consultative
Group is discussed in Chapter 5.
3.186
In referring to the impact on
public perception of genetic modification with respect to fresh fruit and
vegetables, Australian United Fresh Fruit & Vegetable Association and Fresh
Produce Watch considered that:
Consumer reassurance about safety and environmental effects of
GM fresh produce is the role of Government which has to ensure adequate and
thorough assessment, control, monitoring and the provision of unbiased
information.[231]
3.187
In 1999, the Australian
Government announced the establishment of Biotechnology Australia (BA) with the
aim of consolidating information on, and increasing public awareness about,
biotechnology. The Committee notes that the goal of Biotechnology Australia is
to ensure that Australia captures the benefits arising from the medical,
agricultural and environmental application of biotechnology, while protecting
the safety of people and the environment.[232]
3.188
Biotechnology Australia
developed the National Biotechnology Strategy which was launched in July 2000,
which encapsulates the Commonwealth’s vision for biotechnology:
Consistent with safeguarding human health and ensuring
environment protection, that Australia capture the benefits of biotechnology
for the Australian community, industry and the environment.
3.189
In acknowledging the purpose
for which Biotechnology Australia was established, the Committee accepts that
BA is perceived to have a pro-gene technology bias, notwithstanding its fact
sheet The Arguments For ‘n’ Against
Genetic Manipulation[233] and other
general information provided for the public. A brochure produced by BA for
distribution to Australian supermarkets entitled Genetically Modified Foods - Information and answers to your questions
was described by the Australian Consumers’ Association as a ‘sales brochure for
GM foods’.[234]
3.190
The Committee notes the
conclusions drawn by the recent House of Representatives report, Work in Progress: Proceed with Caution,
which recommended that Biotechnology Australia be established as a statutory
authority to ensure that it is, and is seen to be, independent to overcome the
distrust the consumers have of government agencies.
3.191
The need for a source of
objective information on the benefits and risks of gene technology that
presents both sides of the debate is becoming increasingly urgent.
3.192
The Committee notes that a 1998
postal survey of attitudes to genetic engineering and food conducted by the
Consumer Science Program at CSIRO Health Sciences and Nutrition, Adelaide,
found that most respondents would trust information provided to them by CSIRO
scientists. Among the least trusted were government agencies, food
manufacturers and the companies using the new technologies, with the news media
rated last.[235]
3.193
The Committee acknowledges the
valuable contribution that CSIRO is making to gene technology research and
awareness. CSIRO currently conducts three main gene technology public awareness
activities:
Gene Technology
Information Program
3.194
This program was established in
1998 to provide balanced and factual information on the benefits and risks of
gene technology, which brought together a number of activities previously run
by individual Divisions of CSIRO as well as initiating new activities
including:
-
participating in the Biotechnology Australia
public awareness program (since 1999) [BA website: http://www.isr.gov.au/ba/];
-
providing background scientific information to
the media;
-
producing radio interviews with scientists in
the Sci Files CSIRO radio series
[CSIRO education website: http://www.csiro.au/];
-
sponsoring and helping organise Australia’s
First Consensus Conference on Gene Technology in the Food Chain, Canberra,
March 1999 [website: http://www.austmus.gov.au/consensus/];
-
organising National Science Briefings for
members of parliaments in Canberra, Adelaide and Melbourne on the subject of
gene technology;
-
producing six short video clips about gene
technology research as part of CSIRO’s Australia Advances television series
(funded by BA);
-
organising a special gene technology feature in
the science magazine The Helix
[magazine website: http://www.csiro.au/helix/dhthehelix.html];
-
launching a website providing scientific
information about gene technology in Australia [http://genetech.csiro.au/]
(funded by BA); and
-
piloting a public telephone enquiry service for
Biotechnology Australia (funded by BA).
CSIRO Plant Industry
communication activities
3.195
In 1993 the CSIRO Division of
Plant Industry coordinated the production of ‘Will Pigs Fly?’, an exhibition
that toured eastern Australia for two years explaining the potential uses of
gene technology in Australia. An associated teachers education kit was also
produced and distributed to schools. Other activities include:
-
organisation of the Australian Academy of
Science’s Science and Industry Forum on Gene Technology at the Maritime Museum,
Sydney [Science and Industry Forum web site:
http://science.org.au/industry/industry.htm];
-
organisation of the inaugural Discovery Lecture ‘Frontiers of Plant
Biology’ [website: http://www.pi.csiro.au/Events/Events.htm];
-
hosting gene technology briefing sessions;
-
preparation of the paper Future Opportunities for Biotechnology in Australia: Field Crops,
Horticulture and Forestry (commissioned by BA);
-
coordination of a series of seven Cross Country stories on gene technology
covering major CSIRO sectors, which form the basis of CSIRO’s Australia Advances series 7 [website:
http://www.csiro.au/promos/ozadvances/];
-
provision of speakers at major forums/events
including Australian Science Communicators ‘Science in the Pub’, the First
Australian Consensus Conference on Gene Technology in the Food Chain, the
National Farmers Federation Annual Horticulture Conference, University of the
Third Age, Food Congress 2000, Seed Industry Association of Australia; and
-
coordination of the CSIRO Discovery Centre Gene Technology Exhibit.
The Green Machine
Science Education Centre
3.196
The Green Machine opened in mid
1993 and is part of a national network of CSIRO Science Education Centres. It
is currently operated as a joint venture between the ACT Department of
Education and Community Services, the Australian National University and CSIRO
Education, with support from CSIRO Plant Industry and the Catholic Education
Office. Its flagship program is Gene
Technology in Australia - a workshop presented during Science Festival Week
which enables school students and adults to extract DNA from peas and ask
questions about the technology [website: http://www.csiro.au/greenmachine/main.html].
3.197
Another program run under the
auspices of the Green Machine is the Industry
Link program, a joint initiative of CSIRO Education and CSIRO Plant
Industry. Laboratory and lecture sessions aim to give industry groups and the general
public an understanding of fundamental concepts in science. It currently has
one course, the Industry Link Plant Gene Technology Workshop, which focuses on
explaining plant gene technology in simple terms.
3.198
The Committee is cautious about
suggestions that the CSIRO should be the primary Australian disseminator of
public information on gene technology,[236]
noting that Biotechnology Australia has utilised CSIRO’s expertise as part of
its public awareness program.
3.199
The Committee is concerned that
CSIRO’s objectivity may have been compromised by its increasing reliance on
funding from industry to support its research, and perceived vested interest
in, and enthusiasm for, biotechnology. It concurs with the view that there must
be substantial consumer and medical input, as well as the inclusion of a range
of other views, regardless of who ultimately issues the material.[237]
3.200
Ms Lisa McDermott observed:
Many people don’t get a chance to read newspapers or read
notices of submissions but if the information is brought to people’s attention,
they will get involved...All opportunities for public input...on GE as well as
other matters that effect consumers should be made by way of an announcement on
ABC Radio, Triple J (for younger audiences) and ABC television during prime time.
It would only take a few minutes of broadcasters’ time and it is important
community information that I’m sure everyone would wish to know.[238]
3.201
The Committee also notes
comments made by virologist, Professor Adrian Gibbs, who considered that
universities would be better placed to provide information on gene technology:
That
is their role. I think that is why the public pays taxes for universities to be
established. They rely upon universities to try and tell them exactly what the
truth is, even if it hears a thousand voices all telling different versions of
the truth. CSIRO is very much a corporate body. It is a single body. It has a
long history of looking after itself. I believe that, therefore, it is not the
only appropriate body and funding should be supplied to other bodies. I
believe, in fact, there should be a plurality of sources of information, and
that will keep everybody honest.[239]
3.202
The Committee is aware that various organisations[240] provide information on different
aspects of gene technology, but considers it vital to establish a ‘one-stop’
shop for independent, objective and factual information on what is an
increasingly controversial issue.
3.203
The Committee considers
that measures in the Bill will improve consumer confidence in the regulation of
GMOs, but suggests that information on the pros and cons of gene technology
must be disseminated to the public by a body that is, and is seen to be,
independent from the commercial interests associated with the biotechnology
industry.
3.204
In this regard, both CSIRO,
although widely and highly respected as a research and education organisation,
and the newly established Biotechnology Australia, should be provided with
additional support to ensure that the widest possible views are incorporated
into publications and other information made available to the public on gene
technology.
3.205
The Committee also supports the
use of other forms of communication, including television, radio and the
Internet, to ensure the widest possible exposure to arguments both in favour
and against the developing technology. The importance of these arguments being
presented in an understandable format was also emphasised in evidence:
I also think those up-to-date scientists... must be prepared to
communicate [information] in the language that ordinary people can understand.
If they do not, they will never win the trust of the Australian people.[241]
3.206
The Committee agrees with the
view expressed by the Tasmanian Government that ‘it is essential that the GTR
continue to monitor consumer and public confidence in the Office of the GTR and
that the Government respond to any emerging concerns with regard to the
regulation’.[242]
Recommendation
The Committee RECOMMENDS that an independent organisation
conduct a national public education campaign to provide information on the
benefits and risks of gene technology, drawing on, but not limited to, the
expertise of scientists, primary producers, academics and consumer
organisations.
3.207
While the Bill covers the
regulation of all GMOs, by far the greatest concern expressed in evidence was
in relation to the regulation of GMOs that were or may become part of the food
chain. An AC Nielson Futures study conducted in April 2000 found that 68 per
cent of respondents were not happy about eating GM food.[243]
3.208
The Institute of Public Affairs
argued, however:
With regard to the protection of people’s health and safety, the
new products have undergone greater testing prior to release than any previous
food technology. Indeed, although all plant and animal food we now consume has
been the creation of human induced cross breeding, no previous food has ever
been subject to the oversight required of GM foods.[244]
3.209
The NSW Farmers’ Association
also pointed to recent safety measures announced by ANZFA:
...we believe that the measures recently announced by ANZFA...and
used by it to assess five genetically modified products are adequate to address
consumers’ food safety concerns. ANZFA measures carefully assess whether
genetic modification gives rise to products containing residual DNA and whether
that residual DNA or any other alteration in the composition of the GM product
give rise to additional allergenic or toxicity problems.[245]
3.210
Surveys conducted by Consumer
Science Program between 1994 and 1999 show little change in community attitudes
over the period with a slight lessening of support for genetically engineered
foods based primarily on:
-
concerns with the involvement of large
corporations;
-
increased availability of information on the
subject;
-
fear of science and technology taking over; and
-
concern with environmental and health effects.[246]
3.211
Australian consumer concerns
about GM food is mirrored overseas, particularly in the United Kingdom, Western
European countries and Japan, with similar trends emerging in New Zealand,
South Korea and the United States.[247]
3.212
The National Farmers’
Federation observed public confidence, may in part, be lacking because of less
than obvious benefits to the consumer:
One of the barriers to consumer acceptance at this stage appears
to be the fact that there is currently little discernible benefit to consumers
in the products on shelves. Many of the biotechnological characteristics
developed so far benefit agricultural inputs, for example they may be drought
resistant or salt tolerant. However, it is difficult for those benefits to be
extrapolated to the finished product, so that consumers can see [and taste] the
benefits as well.[248]
3.213
However, Dr Tribe of the
Australian Biotechnology Association argued that acceptance of GM food will
follow the same path as genetically modified pharmaceuticals. In relation to
the acceptance of GM pharmaceuticals, he stated:
Perhaps
it is related to the fact that, once tangible benefits from gene technology
became obvious around 1982, the anti-GMO people gave up claiming that medicine
was dangerous in this area because the record showed that tangible benefits
would occur. And I hazard a guess that, since agriculture is lagging behind by
about 10 years in the implementation of this technology, once clear-cut examples
of obvious benefits to the consumer-such as golden rice-reach the market place,
you might see quite different attitudes. The historical snap shot we are
looking at at the present time may change when demonstration of what is going
to happen takes place. So that is one factor.[249]
3.214
Some applications of genetic
engineering do appear to have greater public acceptance including in the areas
of pharmaceuticals, pollution control, waste management and cut flowers.[250] Public confidence in the regulation
of pharmaceuticals is also perceived by the public to be more stringent and the
benefits more tangible than the current regulatory arrangements for GM food. An
explanation of this view was expressed by the Organic Federation of Australia:
...we see pharmaceutical [gene technology] as not involving the
release of live organisms, so the risk is much less; it provides medicines
which are taken in small quantities for short periods of time when people are
in a compromised position. We believe that the use of gene technology in those
circumstances is warranted. In terms of food, it does involve the release of
live organisms...[251]
3.215
While public acceptance is
higher where either the exposure of an individual to a GMO has been for medical
treatment or where genetically modified plants are not destined for the food
chain, particular concerns are felt in relation to the use of bacteria and
viruses in gene technology, and transgenic organisms, that is, cross species
transfer of genes, for example transferring fish genes into tomatoes.[252]
3.216
Mr Kinnear of the Organic Federation of Australia
stated:
When
we insert a piece of DNA somewhere, there are other consequences in doing that.
We may disrupt other genes on either side, we may turn on or off, or...you
actually cause other genes that are already there to express proteins or cause
proteins to build up in much higher concentrations than have ever existed
before in that tomato plant, for example. So that tomato which we are used to
is changing in its protein nutrient status...we are dealing with unknown
quantities here. Perhaps 999 out of 1,000 of these products might be fine, and
history may tell us that they are fine, but we have to really carefully
consider our duty of care. How many generations should we think down the track?
Are we here for another 100 years, or are we here for 1,000 years, and what are
the implications of our activities?[253]
3.217
Mr Burgess from the SA Farmers Federation
indicated that while the organisation did not, as yet, have a policy position
on cross species genetic modification, for example, the transferring of a
salmon gene into a strawberry:
...if
the scientific evidence supports it, given that there are, say, three million
genes in a single strand of DNA, to introduce a minor amount of 15 to 20 genes
from another species is not going to change the whole organism so dramatically
as to be a major problem. But there are ethical issues...that will need to be
handled.[254]
3.218
The National Farmers’
Federation commented that ‘more needs to be done to ensure consumers are
exercising informed choice and are not being led by media scare campaigns, for
example “Frankenstein foods”’.[255]
3.219
The Committee considers that a
combination of tighter regulation provided by the Gene Technology Bill and a
national education campaign to inform the community about the benefits, risks
and measures designed to control the development and adoption of new gene
technologies, will improve consumer confidence.
3.220
The Committee is also conscious
that any proposed changes to the Bill made at this stage would require
agreement from the States and Territories to ensure a truly national scheme,
and that anything less may adversely impact on consumer confidence in the
regulatory process.[256]
3.221
The Committee considers that
the Gene Technology Bill provides an adequate regulatory regime to ensure the
protection of the health and safety of people and the environment, and includes
public reporting provisions that should help to enhance consumer confidence in
the regulation of the development and adoption of new and existing gene
technologies. However, the Committee considers that some of the proposed
regulatory arrangements and reporting provisions require strengthening, and has
made recommendations to improve the Bill in this and subsequent chapters.
Review of gene technology legislation
3.222
While the Committee supports
the Bill, it is likely that in establishing the new national regulatory scheme,
the Regulator will experience problems in implementing certain aspects of, and
ensuring compliance with, the new regulatory system. The IOGTR advised the
Committee that it is proposed that the Ministerial Council undertake a
comprehensive review of the legislative scheme no later than 5 years after the
commencement of the scheme.[257]
However, the Committee considers that given the fundamental importance of the
issues involved, the timeframe, in which the proposed review is to take place,
is too long.
Recommendation
The Committee RECOMMENDS that the
operation of the Act should be independently reviewed after three years to
ensure that its objects are being met.