2.1 Methodology

2.1.1 A method for determining the underlying ethic of environmental laws

The general method for discovering the underlying environmental ethic of any piece of environmental legislation is statutory interpretation of the language of the statute and regulations. Analysis of statutory language to discover an environmental ethic involves a range of legal and non-legal tasks viz (i) legal analysis in the form of statutory interpretation but also (ii) elaboration of values embedded within that language from which (iii) plausible justifications are derived (Flournoy, 2003).

Determination of an environmental ethic within a regulatory regime is also not limited to an analysis of statutory language. Rather, determination of the ethics and values expressed through social institutions involves consideration of not only statutory sources but also mechanisms of implementation including guidelines, operational manuals and exercise of discretionary powers.

2.1.2 A method for determining the environmental values underpinning the Gene Technology Act 2000

Following this general method, the method adopted in this paper to consider values underpinning the Gene Technology Act 2000 is to analyse statutory language of the Act itself and also to examine values that emerge from the law in action, as implemented within discretionary frameworks in public administration (such as reflected in the Risk Analysis Framework, [RAF]), April 2009).

Subjecting the wording of the entire Gene Technology Act 2000 and the Gene Technology Regulations, the implementation procedures and the actions of the Office of the Gene Technology Regulator (OGTR) to analysis would be an immense project. Consequently, a single primary operative section, section 56 has been selected as a preliminary starting point for analysis of the values underpinning the Act.

Section 56 is a very important section as it creates the primary statutory obligation on the Regulator not to issue a licence unless satisfied as to risk management. Interpreting this important section of the Act, in context, requires consideration of other core concepts of the Gene Technology Act 2000, such as the Object of the Act (section 3), the definition of ‘environment’ and other key concepts within the legislation. This analysis also considers the RAF (April 2009) as a core document of relevance to implementation of the Gene Technology Act 2000. The inquiry could be expanded to consider individual Risk Assessment and Risk Management Plans (RARMPs). Other sources that could be considered as part of an expanded inquiry are the historical context (including the operation of the Genetic Manipulation Advisory Committee and impetus for regulatory reform), the explanatory memorandum to the Gene Technology Act 2000 and documented public consultation both prior to enactment of the Gene Technology Act 2000 and also as part of the review of the Act (2005 - 2006). Since all of these sources are highly relevant to determining the values and motivation behind the legislative scheme, and have not yet all been incorporated, the statutory analysis that follows should be regarded as a starting point.

2.2 Analysis

2.2.1 Section 56, Gene Technology Act 2000

Section 56 (1) provides:

      “The Regulator must not issue the licence unless the Regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect:
      the health and safety of people; and
      the environment.”

The thematic structure of the analysis that follows picks up on the fundamental elements of Section 56 which are:
      What can decision-makers consider? What is included and excluded from the Regulator’s consideration?
      the definition of “environment”, and
      the obligation “to protect”, and
      the obligation to “manage risk.”

The latter three elements namely “environment”, “to protect” and “manage risk” appear not only in section 56, but are also duplicated in section 3, the Objects of the Act.
      “Section 3: Object of Act

      The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.”
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2.2.2 What can decision-makers consider? What is included and excluded from consideration?

One notable feature of mainstream environmental law (such as in environmental impact assessment) is that economic and social considerations are consistently placed in direct competition with environmental objectives (including for example in some conceptions of ecologically sustainable development). The Environment Protection and Biodiversity Conservation Act 1999 (the ‘EPBC Act’) makes it mandatory for the decision-maker to consider the economic and social impact of a development as well as environmental considerations1

In contrast, section 56 of the Gene Technology Act 2000, consistent with the remainder of the Gene Technology Act 2000, does not allow consideration of economic and social considerations in decision-making by the Gene Technology Regulator when issuing a licence. This means that issues relating to trade and benefits of gene technology are outside the scope of the Act. This is clearly expressed in the RAF (April 2009, page 16) which states: “…Certain issues, such as impacts on trade, social and cultural effects, as well as benefits that may be derived from gene technology or food labelling, are outside the scope of the analysis.”

It was also noted in the earlier version of the RAF (November 2007, para 46) that extensive stakeholder consultation “…made it clear that the community wanted the regulatory system to focus exclusively on the evaluation of risks to human health and safety and the environment. This was to prevent economic considerations (eg, cost-benefit analyses, market access and agricultural trade implications), from compromising the regulatory system’s focus upon the scientific evaluation of risks and the protection of human health and safety and the environment”. When compared to all other environmental laws this feature of the Gene Technology Act 2000 is a significant privileging or elevation of environmental values over economic and social benefits and values.

2.2.3 Definition of “environment”

What is the environment that the Regulator is obliged to consider and “protect”?

The starting point is an examination of the text of the Gene Technology Act 2000 and the text of the RAF (April 2009). Statutory interpretation of “environment” for the purposes of the Gene Technology Act 2000 is assisted by inclusion of a definition within Section 10 of the Act which states:
      “Environment includes:
      (a) ecosystems and their constituent parts; and
      (b) natural and physical resources; and
      (c) the qualities and characteristics of locations, places and areas.2

The RAF (April 2009) provides some examples of environmental components that will be considered in environmental risk assessment. On pg. 5, following discussion of the definition of the environment, it is noted:
      “Risk to the environment includes consideration of effects on biotic and abiotic components of the environment”.
Biotic components include reduced “biodiversity” and abiotic components include “soil, water, or air”.

So far, there is nothing remarkable about this characterisation of the environment when compared to other environmental regulation (including the EPBC Act) – many of which refer to biodiversity in similar terms. But what kind of bio-diverse environment is envisaged?

One of the common assumptions made about environmental policy and law is that it seeks to protect and maintain the environment in a pristine ‘natural’ or unmodified (by humans) state. However, closer scrutiny of general environmental policy and law reveals that it seeks to satisfy a range of competing social, economic and environmental interests – and ultimately only provides limited environmental guarantees.

Arguably, the Gene Technology Act 2000 also does not use the pristine environment as its reference point for protection. Indeed, the Gene Technology Act 2000 refers, in its definition, to “natural and physical resources” expressly acknowledging that in the Gene Technology Act 2000, as in other environmental law statutes, the environment is a resource. Furthermore, on a globe populated by seven billion people it is very difficult to find an unmodified environment – and Australia is no exception. While it is of course a question of degree, one only needs to consider increased atmospheric carbon dioxide levels or increased seasonal UV levels due to the hole in the ozone layer over the Antarctic to appreciate how difficult it is to find an environment that remains unmodified by human activities. This policy and regulatory landscape is a very important context when considering the environmental ethics or philosophy that underpin provisions of the Gene Technology Act 2000. The Relevance of the Agricultural Environmental Baseline to the meaning “Environment” within the Gene Technology Act 2000

In the preceding section it was noted that much of the environment is modified by humans. One such modified environment is the agricultural environment. This is an important ‘environment’ or context for the purposes of the Gene Technology Act 2000 because many current gene technology applications for intentional release, such as genetically-modified cotton and genetically-modified canola, do have distinct agricultural applications.

Agricultural activities are relatively unregulated in Australia – at least in terms of direct regulation. Landowners have historically had a free choice as to any agricultural enterprise adopted – although, indirectly, some forms of regulation may have a large bearing. For example, at State level, the siting of intensive agriculture such as feedlots will invoke development approvals and pollution controls; growing of irrigated crops will invoke water licensing regulation; and land clearing will require development approval. At the Federal level the Australian Pesticides and Veterinary Medicines Authority regulates insect resistant genetically-modified organisms as agricultural products (‘plant pesticides’) and considers product efficacy (i.e., the emergence of insect resistance). If regarded as a “matter of national environmental significance” the activity would need Federal approval pursuant to the EPBC Act. So, although there is some indirect regulation and also some properties are managed more sustainably than others, environmental regulatory obligations are limited and the agricultural environment is, generally speaking, a highly modified environment.

What then, does the Gene Technology Act 2000 suggest as the relevant baseline environment? Section 15 AA of the Acts Interpretation Act 1901 (Cth) permits recourse to the purpose section of a statute to assist with interpretation of a provision (such as section 56). In section 3 (Object of Act) the Gene Technology Act 2000 refers to the risks “posed by or as a result of gene technology”.
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As noted in the RAF (April 2009; page 19):
      “In particular, the Regulator identifies risks posed by or as a result of gene technology by using comparative risk assessment methodology. Therefore risks posed by a particular GMO need to be considered in relation to the parent organism in the receiving environment. For example, non-GM crop species already present risks to the health of people (for example, gluten in wheat or allergens in soybeans or peanuts) or to the environment (for example, some pasture species have a degree of weediness). These risks associated with the parent organism form part of the baseline against which the GMO is assessed to determine whether gene technology has increased the level of risks or poses additional risks.”

Because genetically-modified organisms are currently being released in agricultural environments, a number of agricultural examples will be utilised to illustrate the scope of the Gene Technology Act 2000 and OGTR deliberations.

(a) Agricultural Sustainability

Cotton has been grown for several decades in the Australian agricultural sector in an unmodified form (subject, of course, to modification through traditional plant breeding) (see further ‘The Biology and ecology of cotton (Gossypium hirsutum) in Australia’ (OGTR website). Current agricultural practices, including, for example, the use of insecticides in cotton growing have detrimental environmental impacts, having a detrimental impact on non-target species. Insecticide use and consequently its negative environmental effect will be changed by the growing of genetically-modified cotton (cotton containing an insecticide). In addition, the mere fact that cotton crops are grown at all, e.g., irrigated cotton, have a significant environmental impact. This is starkly illustrated by the example of the environmental effects of growing any type of irrigated cotton in the Murray-Darling Basin. Arguments have been made that the OGTR should look at the environmental impact of cotton growing per se rather than simply the environmental impact of genetically-modified cotton. However, such an approach to the Gene Technology Act 2000 would not be consistent with the assessment of risks that are “…posed by or as a result of gene technology…” as required by the Gene Technology Act 2000 (s 3).

(b) Harmfulness to other Organisms – target and non-target

Does the Gene Technology Act 2000 oblige the protection of native invertebrates or other native organisms such as plants as part of the ecosystem or environment it seeks to protect? What if a genetically-modified organism has a detrimental effect on native species (e.g., native invertebrates that are considered pests to agriculture)? Indeed, in some agricultural applications of gene technology the aim of the genetically-modified organism, such as an insecticidal agricultural plant, will be the mortality of such invertebrates. Furthermore, what if the genetically-modified organism that has an indirect detrimental effect on native species, e.g., native vertebrates (birds) that feed on the invertebrates? Is such ‘collateral damage’ part of the risk to the environment that has to be managed or avoided?

Thus, statutory interpretation of the definition of the “environment” assisted by Section 3 of the Gene Technology Act 2000 (and as interpreted by the OGTR in the RAF (April 2009)) suggests that the agricultural environmental baseline or environmental ‘status quo’ is very relevant. This is also a pragmatic and consistent approach. First, it seems reasonable to recognise that the current environment is an environment that has been modified by humans. Secondly, as noted above, elevation or tolerance of agricultural values is consistent with the philosophy underpinning other forms of well-accepted environmental regulation.

2.2.4 Obligation “to protect”

- Statutory Guidance in the Gene Technology Act 2000
Another important feature to expand our understanding of the ethical bases or values embedded in the Gene Technology Act 2000 is the obligation “to protect” the environment. Mandatory statutory provisions prevent the Regulator from issuing a license unless satisfied that risks can be managed in a manner that will “protect …the environment” (sections 56 (1) and also 51(2) (a)). “Protect” is not defined in the Act.

In the absence of a definition of “protect” within the Gene Technology Act 2000 recourse to a dictionary for the purposes of statutory interpretation is permitted (State Chamber of Commerce v Commonwealth (1987) 163 CLR 329 at 348). The Australian Oxford Dictionary (1999) defines “protect” as “keep safe; defend; guard”. But what does this mean in terms of statutory environmental protections?

What does the notion “to protect” require? Is this protection offered by the regime(s) protection of the species, ecosystem or community or of individuals of the species, ecosystem or community? Again, comparison with other environmental laws is useful as a starting point.
      Comparisons with the EPBC Act.
Regardless of the fact that the word “protection” is contained in the title to the Environment Protection and Biodiversity Conservation Act 1999, the level of protection that this statute can provide is arguable. This is because, as noted above, the decision-maker under the EPBC Act is not only authorised, but is required, to take into account economic and social considerations as well as environmental matters.

But the legislation does provide indirectly a higher level of protection for some individuals – those that are members of threatened or endangered species or communities. Regulatory regimes, such as the EPBC Act (and equivalent legislation in all States and Territories) do recognise the so-called threatened or endangered species or ecological communities, and these ‘species’ or ‘communities’ may be given a higher level of protection. And, if the species or community is threatened, then the individuals of the species or community (or the individual communities) will be protected in order to protect the species or community.

To obtain this recognition, and higher level of protection, threatened species or ecological communities must be expressly listed or described in a Schedule to the EPBC Act. However, listing of a species in this manner does not guarantee its protection or preservation. Rather, the higher level of protection is simply that there will be a higher level of environmental impact assessment prior to making a discretionary decision (which also expressly incorporates social and economic considerations). Thus, the general approach in environmental law is to provide a higher level of procedural scrutiny in the assessment of potential harm for individuals of a threatened species or ecological community. If a community or species is considered to be of sufficient ‘worth’, then an area will be gazetted as a Nature reserve, National Park or even a World Heritage Area. Creation of nature reserves potentially accords/affords a higher level of protection within these areas. However, the protection of threatened species or ecological communities in off-reserve locations (pursuant to the EPBC Act) is never guaranteed since the decision-maker is also required to take economic and social considerations into account in determining management plans for listed species and communities. Thus, the effect of the legislation is that decision-makers conduct a more intense scrutiny of the potential impact of a proposed development on threatened species or ecological communities but the protection of such species/communities is not guaranteed.

The Gene Technology Act 2000 contains a higher duty of protection when compared to other environmental law statutes
It is clear that the express obligation to “protect”, combined with the exclusion of economic and social considerations from section 56 of the Gene Technology Act 2000 creates a much higher duty to protect, than is provided by mainstream environmental risk assessment.

The RAF (April 2009) provides considerable insight to the interpretation of environmental protection by the OGTR – and that interpretation is consistent with the general approach in environmental law described above, particularly in relation to differential treatment of individuals versus treatment of species or communities. For example, (p 30) it is noted that:

“Harm to humans is usually considered at the level of an individual, whereas harm to the environment is usually considered at the level of populations, species or communities.”

In terms of values underpinning implementation of the Gene Technology Act 2000, this analysis suggests that, consistent with the EPBC Act, individual organisms are not valued whereas entire groupings of entities are valued. This is consistent with current regulatory approaches to biodiversity conservation which, as discussed above, focus on habitat and ecosystem protection rather than protection of individuals.

This discussion of the EPBC Act serves to highlight how different the Gene Technology Act 2000 is from mainstream environmental law in a couple of very important ways. The Gene Technology Act 2000 obliges the OGTR not to take economic and social interests into account (for example, trade related aspects are excluded from consideration). Similarly, the OGTR cannot consider benefits – presumably, also, not being able to consider the environmental benefits of gene technology.
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2.2.5 The obligation to “manage risk”

One further difference between the Gene Technology Act 2000 and mainstream environmental law is that the obligation to manage risk appears prominently in the Gene Technology Act 2000 and in other risk assessment regimes that originate in the health and agriculture portfolios (therapeutic goods approval, chemicals regulation, quarantine, etc) whereas environmental law remains silent on ‘risk’. Nonetheless, despite the absence of any express reference to risk in statements of goals or obligations in mainstream environmental law, these regimes are, in effect, managing environmental risk. The significance of this difference between the two ‘environmental’ regimes deserves further analysis.

Likewise, it should be noted that while the statutory language in the Gene Technology Act 2000 excludes economic and social considerations, the Act does require the management of risk. All processes of risk analysis require judgments about what is an 'acceptable risk' and this has the potential to inject value-laden judgments. The Risk Analysis Framework to the Gene Technology Act 2000 does provide some indication as to the values that have been adopted by the OGTR when assessing and managing the risks of gene technology. This document explains how the risks to human health, safety and the environment are assessed through a comparative methodology which expressly adopts the modified environmental baseline as the relevant environmental reference point (as explained in above).

3.0 Conclusion

As foreshadowed, this represents an initial examination of key statutory language within the Gene Technology Act 2000 and some contextual documents, for the purposes of gleaning values embedded in the regulatory regime. The inquiry could be expanded in scope to include a more detailed analysis of the RAF and analysis of additional contextual material such as the RARMPs.

The discussion has simply attempted to elicit some of the values underpinning the Gene Technology Act 2000 and compared them to mainstream environmental laws enacted ostensibly for the purpose of protecting the environment. The Gene Technology Act 2000 does have some features that make it a much stronger and more ‘protective’ regime than mainstream environmental law. This is perhaps because some of the features of the regime have originated in the health risk assessment portfolios rather than the environmental portfolio. If the Minister administering the EPBC Act decided to destroy the last remaining individual or population of a species by allowing a development on the basis of social or economic considerations it would be within his/her authority to do so. However, the Gene Technology Regulator would not be at liberty either to take these factors into account in making a decision, or to knowingly permit environmental harm as an outcome.


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1See for example, the Environment Protection and Biodiversity Conservation Act 1999 (Cth), section 136(1)(b).

2As noted in the RAF (April 2009, para 43) this definition is less inclusive than the definition of the environment contained within the Environment Protection and Biodiversity Conservation Act 1999 (Cth). That definition includes social, economic and cultural matters whereas they are not included here under the Gene Technology Act 2000. This point has been discussed above.

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