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Tuesday, 7 November 2000
Page: 19291

Senator STOTT DESPOJA (Deputy Leader of the Australian Democrats) (8:17 PM) —I rise to speak on behalf of the Democrats in a debate on an issue that I have been waiting for for some time in this chamber, and that is the regulation of genetic technologies. The Gene Technology Bill 2000, the Gene Technology (Consequential Amendments) Bill 2000 and the Gene Technology (Licence Charges) Bill 2000 set up a regulatory system to oversee so-called gap GMOs which do not fall within the six Commonwealth bodies and schemes that currently oversee genetically modified organism, or GMO, regulation.

While the Democrats believe that GMOs require effective isolation, risk management and independent assessment for environmental release, the extent to which the Gene Technology Bill 2000 achieves this we consider highly questionable. I would like to firstly acknowledge, as did Senator Sherry, the agreement reached between the Tasmanian and Commonwealth governments allowing an appeal provision for state governments if a state's concern regarding a gene technology regulation issue was not taken into account. The Democrats welcome this announcement as an indication that the government is open to the market and environmental needs of states and territories and will be assessing the details of the proposal to determine the extent of state and territory appeal powers to enable self-determination with respect to the application of gene technologies.

The Democrats announced back in June this year support for an opt-out provision for the states and territories wanting to make their own determination with respect to GMOs and the extent to which they are pursued by local industries. The fact that the bill did not provide for states and territories to determine their own regulatory system or pursue areas of natural advantage within agricultural markets, we believe, was a large flaw within the proposed system. Australia's best bet for future markets remains in the pursuit of clean and green technologies and industries. There is no doubt that GE free will be a market differential and Australia cannot afford to deal itself out of this market so early in the biotechnology revolution.

The Democrats have always acknowledged that a moratorium would have to be carefully considered, as we do not oppose every aspect or application of this genetic technology. Indeed, we are aware of the dazzling, as I have described it previously, or the potential benefits of the genetic technology. In fact, the Democrats do not see a moratorium on this potentially beneficial technology as a viable or appropriate regulatory option at a federal level. A blanket ban on the technology may hinder innovative Australian research in the pursuit of positive bio-remediation applications, including bacteria that, for example, eat oil slicks or waste cements. At the same time, I recognise that states have differing industry bases and market advantages. States such as the aforementioned Tasmania or my home state of South Australia should be able to promote GE-free industries state wide if desired.

Australia as a mega diverse and isolated landmass and Tasmania in particular have a natural advantage to cater for GM-free products. We have the ultimate buffer zones: the Pacific and the Indian oceans, or Bass Strait in the case of Tasmania. There is no doubt that we should be using this market advantage and appealing to food markets like Japan and the EU, who of course are paying premium prices for GMO-free products. The issue of GM-free governments and communities is not an issue for legislation but an issue of providing scope within the current regulatory regime for choice. This is more an issue for labelling, adequate segregation and isolated production processes and testing rather than specific address under the current regulatory proposal for genetically modified organisms.

There are several areas of improvement that the Democrats see as essential for the implementation of a successful and effective GM regulatory system. As stated in our additional comments to the Senate Community Affairs References Committee report, A cautionary tale: fish don't lay tomatoes, on the Gene Technology Bill 2000, the Democrats see two factors as integral to the establishment of an effective gene technology regulatory system: one that will ensure community confidence and one that will ensure independent public information and education. They are the two key areas that will ensure that members of the public have faith in these technologies and they will do so through a public awareness and education process or campaign.

Community confidence is, however, reliant on several multidimensional factors. Firstly, confidence is intrinsically linked to public opinion and perception. It was a quite valuable contribution for Senator Sherry to talk about the impact of the survey that he and other members have done in Tasmania to get a sense of how people are feeling about these technologies. Whether they are informed perceptions, it does not really matter; the point is that these are people's perceptions in relation to labelling or other aspects of gene technology. I do not think that legislators, or scientists for that matter, or even regulatory regimes can afford to ignore those current levels of understanding or perception. The Australian public will have a much greater faith in a multimember body than in a one-person show. The Democrats support the recommendation of the Senate Community Affairs References Committee for the establishment of a three-person team to share the responsibilities of the Regulator of Gene Technologies. It is also a case, of course, of having an independent team in this particular position.

While I have reservations about stipulating or excluding certain persons from the position of regulator, or part of the team of regulators as the case may be, I also believe that certain career choices or extended periods may have an impact on the independence of the office of the regulator, perceived or otherwise. Community confidence is also linked to having punitive penalties, random spot checks; scientific risk assessment; environmental risk assessment, at least to the standing of the EPBC Act; and, of course, public involvement. The Australian Democrats believe that the community consultative group should be a committee of standing and funding equal to the technical advisory committee and the ethics committee. The recommendation of the Senate Community Affairs References Committee inquiry to require cross-membership among committees to facilitate balanced regulation of GMOs is also supported by the Australian Democrats.

As I have stated before in this place, the main issue that gene technologies raise and that must be addressed by any effective regulatory system is the issue of the unknown—that is, the unknown effects, unknown consequences and, therefore, unknown risks. No-one knows what will be the extent or degree of effect of horizontal gene transfers of intended and unintended genetic manipulations on, say, human health and the environment. Therefore, central to this pursuit is the fact that responsible application and uptake of this technology are probably the only and best ways that we can appease public concern about the bill. The public must be taken with this technology—informed and included in the formation and instigation of responsible gene technology regulations. One way that the Democrats believe this could best be facilitated would be with the inclusion of citizen juries—that is, representative, deliberative democracy forums, when deemed appropriate by a community consultative committee, in the regulative process for issues of specific public concern.

I imagine there are a few people here who recall the consensus conference of last year and what a productive community process that was—involving all stakeholders whether representatives of multinationals or agrimultinationals like Monsanto, right through to representatives of gene ethics groups, the consumer association or just your average punter. Members of the community were involved in that process and all sides learnt from those deliberations. Under the mechanism, recommendations of the jury would be put forward to the regulator body. After consideration, in cases where the outcomes of such consultative procedures are not implemented by the regulator, the reason is widely publicised for public information and justification. This process is usually via a media conference. In places like the United Kingdom the process has been used for many years for public input into varying aspects of public policy and regulatory systems.

The Democrats have reservations about many aspects of the regulatory regime that the Gene Technology Bill establishes. I have stated before on behalf of the Democrats my support and preference for a one-stop shop for gene technology regulation—not a replication of a mega regulatory body such as the United States Food and Drug Administration, which some groups were supporting for the Australian context, but a body which does not cause unnecessary complications and increasingly theoretical delineation between GMO products with the development of this technology. The Australian community deserves an easily identifiable and accountable Commonwealth regulatory body overseeing a coordinated approach to gene technology regulation—not one that just adds another level of paperwork on top of the disparate bodies and schemes that already oversee gene technology. I am glad this is vaguely amusing to the chair.

The Democrats therefore welcome the recommendation of the Senate Community Affairs References Committee to review the system after three years. We believe this should be a minimum requirement, and that the recommendation to investigate the feasibility of a one-stop shop is essential to the determination of the most effective regulatory system for genetic technologies in Australia. I acknowledge that the Gene Technology Bill 2000 is not the answer to the wide range of inadequacies in the current regulatory system and that many of the guarantees that the community requires to feel safe about this technology are not provided for by the current regulatory system or that proposed by the Gene Technology Bill and its cognate bills.

The Democrats believe that this bill can be improved significantly to work towards the regulatory system the Australian community deserves and requires—though further review and reform are required to protect public health and environmental safety from GM0s and to earn public confidence. Effective isolation, opt-out provisions and precautionary requirements are the best way to contain our new biological knowledge and to support its appropriate application. Genetic technologies and the environment do not have to be—and should not be—enemies. Scientists and the community are recognising that there is much more to this debate than the notion of Frankenstein foods. And while I do not discount such concerns, I do not want to see a situation where the potential for this technology is disregarded due to community concern regarding these first generation GM products, agricultural products in particular. It is our responsibility to provide for the community a regulatory system that works towards this particular outcome. I believe that, with the incorporation of the recommendations contained in the Senate Community Affairs References Committee report—specific exemptions for states and territories, and the environment minister to approve any GMOs for environmental release—we can work towards such an outcome. I have previously put on record my concerns about the lack of the precautionary principle in the objectives of the ANZFA or the independent testing of GM0s released and have expanded these in the Democrats' additional comments in the committee report in the light of new findings by the Public Health Association, which I am sure the chamber is aware of by now and which the Democrats refer to in their additional comments to the Senate Community Affairs References Committee's report.

With respect to the issue of risk assessment, I would like to focus now on the commitment given to the Senate on behalf of the government by the Minister for the Environment and Heritage, Senator Hill, during the passage of the Environment Protection and Biodiversity Conservation Bill 1999 on 22 June 1999. He said:

... 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—

That is, 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.

The bill currently does not provide for this. Instead, under section 50(3) it states:

The Regulator must seek advice on matters relevant to the preparation of the risk assessment and the risk management plan from:

... ... ...

the Environment Minister ...

There is no stipulation for the minister to incorporate or act on such advice. Similarly, the regulator may consult relevant Commonwealth authorities or agencies on any aspect of an application when considering a licence application. The Australian Democrats maintain that review and assessment at least to the standing of environmental impact assessment under the EBPC Act are required and that the environment minister must approve all GMOs for environmental release.

The bill as it stands sets out low risk and exemption categories for certain types of genetically modified organisms. Exempt dealings are specified by the regulations, and I should acknowledge that the draft regulations were made available only in August of this year. Low risk dealings are defined within the draft regulations as including a dealing involving a host/vector system not mentioned as a host/vector system in part 2 of schedule 1 if:

(a) the host or vector is capable of causing disease in human beings, other animals, plants or fungi; and

(b) the donor DNA is fully characterised and will not increase the virulence of the host or vector; and the dealing is not a dealing listed in Part 2 of Schedule 2; and the dealing does not involve an intentional release of the GMO into the environment.

And similarly for a dealing involving a host/vector system mentioned in part 2 of schedule 1 if the gene inserted is:

(a) a pathogenic determinant; and,

(b) uncharcterised DNA from a micro-organism capable of causing disease in human beings, other animals or plants; or

(c) an oncogene; and the dealing

(d) is not a dealing listed in Part 2 of Schedule 2 and

(e) does not involved an intentional release of the GMO into the environment.

While that may sound like gobbledegook, they are the regulations that will be before the chamber. While I recognise that such manipulations are undertaken in contained laboratory facilities and that donor DNA of such host/vector systems are sequenced and mapped, I believe that such manipulations still pose a risk greater than that reflected in the bill and the corresponding draft regulations. So-called `low risk' GMOs may still be transported, and the risk of an unintentional release for the potential manipulations covered by the above definitions must be considered significant. The Democrats very strongly believe that there should be truly random spot checks by the Office of the Gene Technology Regulator and that this should be treated with significant precaution.

The reason GMOs are topical and require specific regulation is that we simply do not know enough about them. Therefore, the classification of low risk and exempt GMO dealings is somewhat paradoxical. The Democrats have similar concerns for exempt dealings. Differing classifications of GMOs provide for further complications and costs, further subcategories and the risk of loopholes for sidestepping adequate precautionary measures for GMO regulation. The Democrats believe that regulatory and risk differentiation between GMO applications is a weakness and a complexity that must be addressed.

Current manipulation techniques involve the insertion of genetic material randomly and do not provide a precise or chosen location for insertion. The Democrats believe that the imprecise nature of this technology—and I do not think anyone would doubt that—and the nascence of the science pose possible dangers which are not reflected in the low risk and exempt classifications under the bill. I restate: the parliament has a responsibility not only to protect Australia from health and environmental risks but also, more importantly, to address the Australian community's concerns about the technology as it exists now, beyond the purely technical. We cannot predict what the extent of the impact of this technology will be on our society or indeed what benefits it will bring, though we can act now to provide the level of assurance that Australians and the scientific community need to pursue sustainable and beneficial uses of this technology.

I note the comments by Senator Forshaw on behalf of the opposition in this place last night with respect to the allegations made by you, Madam Acting Deputy President Knowles, that non-government senators were acting through the committee process to hold up this very important piece of legislation. On behalf of the Democrats I would like to register our concern regarding the late circulation of the draft regulations underpinning this very important legislation. While the Interim Office of the Gene Technology Regulator has been willing—and I would like to place that on the record—to assist in any such inquiries, such tight time frames assisted neither the considerations of the Community Affairs References Committee's inquiry nor the task of this place as a house of review to assess the proposed regulatory system. In fact, the Democrats and I have argued probably more strongly than just about anyone in this place to deal with this bill or at least some regulatory system in relation to genetic technologies. We have had no interest in holding up this process—in fact, we are glad that it has finally got this far, but not without sufficient review or analysis.

Finally I would like to draw attention to the need for the incorporation of the precautionary principle in the objectives and licensing provisions of the bill. The Democrats support incorporation of the precautionary principle in keeping with the definition contained within the EPBC Act at section 391, which states:

The precautionary principle is that lack of full scientific certainty should not be used as a reason for postponing a measure to prevent degradation of the environment where there are threats of serious or irreversible environmental damage.

There is no more pressing area of environmental concern which requires such an approach than the regulation of current gene technologies. I am glad to see that it has finally reached a point of debate in the chamber. I look forward to the committee stage. I urge members of the government to support the valuable recommendations in the Senate Community Affairs References Committee majority report. And I do urge the chamber to consider the Democrat amendments to which I referred as a means of improving and value adding the bill that is before us.