"Proposed national regulatory system for genetically modified organisms:
How should it work?"
Please note that the paper to which these comments are a response may be accessed: here.
GENERAL ISSUES
We have sympathy with the thrust of the changes proposed in the above paper. We see the paper as a response to public concern about a new series of products, and a need for reassurance that the products are safe.
Even so, we do have concerns that the proposals may be excessive regulation. Regulation should be tailored in response
- first to the level of risk of the untoward occurring;
- secondly to the degree that the incentives in the remedies of the normal operations of law inadequately encourage appropriate care; and
- thirdly to the degree that a government expert body can be better informed of dangers and how to avoid them than commercial organisations.
Our concerns are in the context of the clear scientific advice that the GM techniques are benign or at least pose no greater threat than the "natural" genetic modification referred to in section 2.5 (p.16) of the paper. In this respect, we may wish to provide further comment as the proposal progresses to advise about the level of oversight it entails.
We would expect these matters to be rigorously assessed under regulatory review and national competition policies that have been implemented by all Australian jurisdictions and agreed by COAG.
The legislative or alternative regulatory vehicle through which the proposals are implemented should also be sunsetted. This is of particular relevance to GM technology since its wide adoption is relatively new. The technology's risks may be recognised as being negligible and the rationale for special, or indeed any, regulatory control would then disappear.
SPECIFIC MATTERS
There are four specific matters covered by the paper where we would wish to offer advice at this stage. These are:
- the relationship of the proposed Gene Technology Advisory Committee (GTAC) with the existing Genetic Manipulation Advisory Committee (GMAC);
- the definition of what constitutes GM products for the purpose of the legislation;
- the appropriate administrative arrangements; and
- the suggested provision for jurisdictions to be able to "opt out" of an approval.
THE CREATION OF GTAC
Our understanding is that GTAC will be introduced as part of a process under which the existing voluntary scrutiny, where GMAC plays a key role, is transformed into a mandatory system of approval. The information before us does not indicate that GMAC is to be replaced and not continued in some form. We suggest this be made clear to avoid perceptions of excessive regulation.
THE DEFINITION OF GM PRODUCTS
GM products will only be approved where they are safe. This has led some jurisdictions to adopt a criteria of "substantially equivalent" as a criteria beyond which regulatory approval may be required. With respect to food, Australian and New Zealand Health Ministers have indicated that they wish to adopt a more stringent regulatory approach than this. That disposition reflects the view that the public wish to be informed, even if the products they consume are safe.
In this respect, the public concern appears to be well publicised anxieties that GM products will be developed containing genes introduced from alien species. Pig genes in GM tomato paste is a case often cited.
It is uncontroversial that GM, through traditional breeding techniques, is the pathway through which most modern foods and pharmaceuticals were developed. Much of the new technology simply seeks to promote and expedite this approach. Genetic modification within a genus is a test tube way of following traditional breeding techniques.
It follows that the definition of GM products falling under the regulatory oversight of the GTR should exclude those products that involve modification solely within an existing species. Indeed, the exclusion could be wider than this since traditional breeding measures sometimes succeed in introducing new genes from related species.
Confining the regulatory oversight to where genes are introduced from a different species will reduce the regulatory costs and improve the regulatory focus both to the Government and industry. It will do so while leaving oversight with those product modifications that pose risks not seen with traditional breeding techniques.
ADMINISTRATIVE ARRANGEMENTS
The foregoing raises the question of appropriate ministerial control over the regulations.
The proposal does not specify the composition of the Ministerial Council which is to oversee the GTR. It does argue that the Council should not be permitted to override any individual decision on an organism by the GTR, a position we strongly support.
It further argues GTAC members should be appointed by the Commonwealth Minister for Health (following consultation with other Commonwealth and State Ministers).
The composition of the Ministerial Council requires further consideration. Health Ministers oversee human safety and would have strong claims to carriage of the issues; yet the GM controls are often concerned with requirements to provide the appropriate level of public information. They may also have a bearing on environmental matters and they clearly have a major influence on agriculture and other branches of industry policy.
It is important to avoid having the authority of Health Ministers extended beyond that of their ostensible expertise.
OPT OUT PROVISIONS
The proposal under section 4.9 addresses the possibility that a state or territory could opt out of allowing sale of a product that had been approved by the GTR. Such a proposal has far-reaching implications for the Australian Constitution (s.92 freedom of trade) and for the mutual recognition provisions of CER with New Zealand.
It would set a precedent that could undermine co-operative federalism and should be dismissed from any further discussion drafts.
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