Science and Research
John Voumard, Inquiry Chair
© Commonwealth of Australia, 2000
ISBN 0642547157
5.1 The Inquiry's terms of reference require the scheme under s301 of the Environmental Protection and Biodiversity Conservation Act 1999 to take into account:
5.2 In considering this aspect of the Inquiry's terms of reference, the Inquiry was assisted by its expert reference group member, Ms Katherine Wells, an environmental lawyer, formerly of the Environment Defenders' Office, Sydney.
5.3 The Inquiry also made particular efforts to ensure environmental organisations had an opportunity to contribute. I wrote to key environmental organisations and the Inquiry Secretariat sent notices to about 50 organisations with responsibility for, or an interest in, environmental issues, drawing on a comprehensive mailing list provided by Environment Australia and from other sources. About 15 submissions focused on environmental issues, although environment issues were raised in most submissions. The Australian Conservation Foundation and the Environmental Defenders Office Network also made oral presentations via telephone hook-up at the Canberra hearing in which they expanded on their submissions.
5.4 Several submissions expressed concern about wildlife (particularly kangaroo) harvesting. However, wildlife harvesting is outside the terms of reference of the Inquiry and, accordingly, the Inquiry has not addressed this issue. I would also observe that wildlife harvesting is more appropriately dealt with (and, indeed, has been dealt with) in other forums.
5.5 Another issue raised in several submissions was that Australia's patent laws should not allow patenting of living organisms, whether modified or not. Again, this issue is outside the terms of reference of the Inquiry and, accordingly, the Inquiry has not addressed it.
5.6 The major issue raised in the submissions which focused on environmental issues was the need for environmental assessment of bioprospecting and when and how this should be carried out.
5.7 However, the Australian Conservation Foundation and the Environmental Defenders Office Network (particularly through their presentations at the hearings) also made valuable contributions to the Inquiry's consideration of a possible scheme for implementation under s301 of the EPBC Act.
5.8 In its submission, the Australian Conservation Foundation suggested the following (not exclusive) principles for a scheme of control of access to biological resources.12 In the Foundation's view, the scheme should:
5.9 The Environmental Defenders Office Network submission supported similar principles, particularly concerning the need for environmental assessment. The Inquiry broadly supports these principles. The proposed access scheme is designed to reflect these principles, as well as ensure that the decision-making process is equitable, transparent and accountable.
5.10 Many submissions commented on the importance of ensuring that bioprospecting is conducted in an environmentally sensitive manner, but the article by Professor David Farrier and Linda Tucker, Centre for Natural Resources Law and Policy, Faculty of Law, Wollongong University was one of few to present evidence about the possible adverse environmental impacts of bioprospecting. Farrier and Tucker observed that:
While the initial screening of biological material collected by bioprospectors may not involve significant amounts of biological material, larger quantities of samples which show useful biological activity must then be collected for detailed chemical and biological investigation. If large amounts of an organism have to be collected to isolate a particular chemical, or to determine its structure, this may undermine the claim to sustainable use.
5.11 The submission referred to an article by Mary Garson 13 which argues that the Convention on Biological Diversity 'has played a role in encouraging a more environmentally sensitive approach'. According to Garson,
research groups and non-governmental organisations have now compiled guidelines for collection and these typically include a requirement to collect no more than is strictly necessary. Developments in bioprospecting practices and technology -- particularly increased sensitivity to the bioassays that test for bioactivity of compounds -- have led to continuing reductions in the impact of prospecting and harvesting.
5.12 Farrier and Tucker commented, however, that,
obtaining enough material is only the first stage of the process. Even if the initial prospecting is low impact, the nexus with sustainable use will be broken if subsequent product development demands quantities of material which can only be obtained by mining the resource.
5.13 In this context, they further commented that, 'replication in the laboratory of the biological material required for product development is legitimate, and entirely desirable where the alternative is unsustainable mining of wild strands'. Farrier and Tucker referred to the argument of one author that the focus should be on carrying out syntheses of bioactive chemicals isolated from nature or using them as lead compounds to trigger the design and synthesis of analogues.14 However, some novel chemicals may be either too structurally complex or too expensive to produce synthetically, and in these circumstances management of wild strands or farming of the resource are the only alternatives.15
5.14 At the Canberra hearing, the Australian Conservation Foundation's legal adviser, Michael Kerr, also made useful comments about environmental impact assessment:
... it is critical that a thorough assessment of the environmental impacts of the granting of access takes place. Given that it is the intention of the Commonwealth to establish this scheme within the Environment Protection and Biodiversity Conservation Act, which is the Commonwealth's newest and most central piece of environmental protection legislation, it would be ludicrous to argue that environmental assessment is not relevant. In any event, it is my understanding of the Act that environmental impact assessment will be required under the Act's existing trigger mechanisms ... the trigger mechanisms that I am referring to are at s23 and s26 of the EPBC Act ...
Section 23 requires an environmental assessment of an action in a Commonwealth marine area that has, will have, or is likely to have, a significant impact on the environment. Now, s26 is similar to that trigger mechanism but applies to Commonwealth land, and ... require[s] an environmental assessment.
So, for example, if a proponent or a bioprospector requests access to biological resources in a Commonwealth area and that access will have or is likely to have a significant impact on the environment, an environmental assessment must take place in any event under the existing triggers of the EPBC Act ... the threshold question that then arises is, 'when might access to biological resources be deemed to have a significant impact on the environment?', because that wording, 'significant impact', is a threshold question for all triggers. Now, it is our recommendation to this Inquiry that two things might be done to assist the appropriate authority in the task of determining what might be a significant impact.
Firstly, the regulations enacted under s301 which are the subject of this Inquiry could give guidance as to when access is likely to have a significant impact or, secondly, there are some guidelines for determining significance under the Act which are currently being drafted by the Government. And these guidelines could have specific reference to situations when access is likely to have a significant impact. In any event, it is our own view that anything above the initial collection of a biological resource for scientific analysis would have a significant impact on the environment and would require an environmental assessment to take place under the provisions of the EPBC Act.
5.15 Don Anton of the Environmental Defenders Office Network made similar comments at the Canberra hearing:
There are various gradations of assessment in the EPBC Act, but I would tend to echo what [the Australian Conservation Foundation] indicated, most of these would require an assessment simply so we would know, if nothing else, whether the use, the access to ... particular biological resource, will be environmentally sound.
5.16 The Queensland Government said that most primary biodiscovery collections involve relatively small samples sizes of less than 100 grams per species and, provided the target species are readily available with a sustainable population in the target area, are not considered threatened or endangered, and proper collection methods are used, the environmental impact may be minimal. Secondary collections of a specific species, conducted after a lead has been identified, may first require an environmental impact and species distribution analysis to determine the viability and ecological sustainability of the proposed second or any subsequent collection.
5.17 The Australian Institute of Marine Science suggested that all access must be undertaken on a sustainable basis:
5.18 The Institute added that, 'In order to secure a level of confidence and certainty to attract industrial research support, generic conditions of secondary access should be set out at the time of permission for primary collection'.
5.19 Some submissions referred to the possibility of developing guidelines or collecting protocols for bioprospecting. Professor Helene Marsh, Professor of Environmental Science, James Cook University, and Chair, National Committee for the Environment, drew the Inquiry's attention to the report of a 1998 study by the Australian Science, Technology and Engineering Council entitled Environmental Research Ethics: National Principles and Guidelines for the Ethical Conduct of Research in Protected and Environmentally Sensitive Areas.
5.20 Dr Jane Fromont, Curator of Marine Invertebrates, Department of Aquatic Zoology, Western Australian Museum, referred specifically to the paucity of information on marine invertebrate fauna, especially in the waters off Western Australia, as an argument for the importance of 'any collection for use as a resource [being] undertaken with precautionary concepts as fundamental to the project'.
5.21 Don Anton of the Environmental Defenders Office Network also specifically referred to the precautionary principle:
... in deciding whether or not to grant a permit or to enter into a contract, it is important that the precautionary principle which applies under s391 of the EPBC Act in decision-making by the Minister also apply in relation to decision-making with respect to determinations about whether a permit should issue and whether or not a contract should be entered into.
5.22 In general, scientific analysis of an organism's genetic and biochemical make-up requires only a small amount of material, such as bark, flowers, leaves or seed, usually about 100 grams or less. A simple re-collection to confirm earlier findings and the continued availability and identity of the specimen initially collected should require no greater amount than the original collection.
5.23 This may lead policymakers to conclude that there are unlikely to be significant environmental impacts. However, there are three problems to consider,
5.24 The collection method may have adverse consequences, for example, the use of vehicles, the location of campsites, the number of people, or the nature of disturbance to the location may damage particularly sensitive areas. Lack of knowledge about the ecosystem may result in unintended losses of biodiversity. At the same time, the nature of the species and the ecosystem in which it is to be collected needs to be considered. For example, 100 grams of some species may constitute an unacceptably high and damaging number of individuals, whereas 100 grams of a large common species will be inconsequential. Collection methods may result in the inadvertent collection of rare or endangered species or put them at risk.
5.25 In the light of these considerations, the Inquiry considers that environmental assessment of bioprospecting proposals may be required in some situations.
5.26 Environmental assessment would be done under existing triggers in the Act. These are
5.27 The Minister has approved 'Administrative guidelines for determining whether an action has, will have, or is likely to have a significant impact on a matter of national environmental significance under the EPBC Act' (ss12, 16, 18, 20 and 23 above).
5.28 The Inquiry considers that these guidelines will need to be amended to indicate that, in some circumstances, bioprospecting may have a significant impact on the environment and would therefore require environmental assessment and approval before an access permit could be approved.
5.29 The revised guidelines should take into account that:
5.30 Bioprospecting collecting, at any stage, is likely to have a significant impact if:
5.31 When drafting the revised guidelines, as well as considering the criteria for significance described above, consideration should be given to the work of the Australian Institute of Marine Science and the Great Barrier Reef Marine Park Authority in developing a tiered approach to collecting samples for biodiscovery programs. The Authority's submission to the Inquiry noted:
The Authority is aware of concerns regarding certainty of access to biological resources within the Marine Park. However, the sustainability of an activity is a fundamental criteria in the assessment of its acceptability. Frequently, there is a very low level of knowledge about the biology and ecology of many of the organisms targeted in collections. This makes it difficult to assess the impacts of a collection regime on the viability or conservation status of many species or populations.
Recognising that the risk of environmental impacts increases with the intensity and scale of collecting, the Authority is currently formulating a tiered approach aimed at facilitating reasonable access to biological material for biodiscovery programs while ensuring that activities do not compromise the sustainability of resources.
5.32 There is some synergy in the tiers proposed by both the Authority and the Institute. In summary, they are:
5.33 The Inquiry considered that this tiered approach provides useful insights into the levels of environmental assessment appropriate at different stages of the bioprospecting collection process. It also considered that to eliminate undesirable delays in the research and development process, it may be possible, in some circumstances, to avoid a permit assessment process before activating a tier 2 collection.
5.34 To achieve this, the Inquiry considered that it may be possible to include both tier 1 and tier 2 activities within the initial bioprospecting collecting permit, provided the tier 2 collection is restricted to an additional quantity of the same as that allowed in tier 1, and strict permit conditions are imposed under which the applicant may proceed with the tier 2 re-collection.
5.35 The success of such an approach would rely, amongst other things, on the adequacy of information provided in the permit application.
5.36 Revising the guidelines will close a significant gap as far as the environmental regulation of access to biological resources is concerned. Subsequent publication of the revised guidelines will also provide certainty for the owners of biological resources and for industry.
5.37 The Inquiry considers that the States should take into account the criteria for significance and the tiered approach outlined above when developing their positions on this topic. This would help develop a more consistent national approach, as recommended by many submissions.
5.38 Decisions about whether environmental assessment is needed and, if so, what level of assessment (s87 of the Act), will need to be made on a case-by-case basis, with the bioprospecting proposal being assessed against the revised guidelines.
5.39 It should be noted that a lengthy environmental assessment process would not necessarily be required even if the Minister considered a proposal to have a significant environmental impact. Once an action is referred to the Minister under the Act, the Minister has the following environmental assessment choices:
5.40 The Inquiry anticipates that assessment on preliminary documentation may often provide a satisfactory means of assessing the environmental significance of the proposed bioprospecting.16
5.41 The Inquiry also notes the proposal in the Australian Institute of Marine Science submission, that collecting activities in tiers 1 and 2, in the model outlined above, be accompanied by the cost-effective collection of appropriate distribution and abundance data to anticipate and support informed assessment of proposals of tier 2 and 3 activities respectively.
5.42 In addition to the environmental assessment requirements discussed above, the access permit system will provide an important source of environmental control, in particular through application of environmental permit conditions. To this end, the regulations will require certain environmental permit conditions to be mandatory, including conditions that the bioprospector comply with collection protocols attached to the permit.
5.43 The access permit system will also include the following safeguards. When considering whether or not to issue a permit, the Minister will be required to consider the precautionary principle. He or she will also be required to be satisfied that the collection protocols attached to the permit provide adequate levels of environmental protection. In addition, it will be an offence, with significant penalties, to fail to obtain a permit when one is necessary, or to contravene permit conditions.
5.44 The permit system is discussed in more detail in Chapter 2.
Recommendation
|
5.45 Some submissions commented on the need for further taxonomic work in Australia. For example, the Tasmanian Conservation Trust recommended that inventory and taxonomic work be given a high priority while the Australian Research Council commented on the need for an increased rate of species identification and description, a need that could be met by increased funding to agencies engaged in taxonomic work.
5.46 The Queensland Government said that bioprospecting has significantly enhanced the discovery and documentation of Australia's biodiversity -- for some phyla most of our knowledge has been gained from biodiscovery -- yet this outcome has not always been a mandatory permitting requirement.
5.47 To maximise potential scientific outcomes, Queensland recommended there be a strict requirement that representative samples of all taxa obtained from biodiscovery are lodged with an appropriate State or Commonwealth CITES-accredited museum, together with appropriate collection data and any other information that may contribute to furthering the scientific knowledge of Australian biodiversity. Lodged specimens must be of sufficient quality for this purpose. A good quality example of a specimen is one that includes taxonomically representative issues that have been fixed and preserved or otherwise treated by a method appropriate to the taxonomic grouping.
5.48 Ideally, there should also be further 'encouragement' for bioindustries to perform some level of taxonomic sorting of these collections, to make them more relevant and accessible to the scientific community.
5.49 The Australian Conservation Foundation also addressed ways in which benefits to the environment could flow from an access regime under s301 of the EPBC Act:
... any access scheme should ensure that the benefits arising from a grant of access flow to the environment ... this could be achieved by making it a condition of access that, for instance, an identified level of information about the process of modifying or using the resource is provided to the authorising body for use in a public database.
5.50 Some submissions raised the possibility of establishing national approaches to biodiversity conservation arising from access and benefit-sharing agreements. For example, the Australian Conservation Foundation suggested at the hearings that 'perhaps an identified percentage of the monetary benefits gained from the access [could be] placed into an environmental fund, managed by independent trustees, for conservation purposes'.
5.51 The Inquiry discussed this idea at some length but considered that, at this point,
5.52 a preferable approach was to attempt to ensure that at least some benefits under the contract were used to promote biodiversity in the area covered by the contract.
5.53 The Inquiry considered that potential providers of biological resources would be more sympathetic to such an approach because it would ensure that all benefits under the contract would flow to them, even if indirectly in some cases. Accordingly, I have simply recommended that the Minister consider the proposal to establish a national environment fund.
Recommendation
|
5.54 The Australian Conservation Foundation and the Australian Institute of Marine Science 17 were among the few organisations which specifically considered how a scheme under s301 of the EPBC Act could operate. In particular, the Australian Conservation Foundation explained, at the hearing, how it saw the requirement for environmental assessment relating to the subsequent benefit-sharing contract between the parties:
... we do see a benefit in maintaining some aspects of a contractual approach ... we advocate ... a dual approach combining both ... a permit system and the contractual system. For instance, we recommend that a permit ... should be required at the initial access stage ... a bioprospector must obtain an access permit from the appropriate authority before access is permitted in the first instance.
... the permit for access would only be granted after an appropriate level of environmental assessment takes place under the provisions of the EPBC Act, for example, and also would specifically identify, I would imagine, the biological resource that might be accessed to ensure that no endangered species are collected, for example. They are two specifications that might be listed in the permit.
But the permit could then specify -- and this is where the dual approach comes in, that a benefit-sharing contract must then be entered into between the bioprospector, the Government and other specified parties ...
But we recommend perhaps that the regulations enacted under s301 of the EPBC Act could then provide from there regulatory guidance as to what the content of the benefit-sharing contract might be and such specifications might be that there be a creation of a public register to detail information concerning the biological resource.
5.55 In response to this proposal I commented that it closely paralleled the Inquiry's thinking to date on how a scheme under s301 could operate.
5.56 The Environment Institute of Australia supports the view that Environment Australia, in administering the EPBC Act, needs to establish an inter-agency section which can undertake liaison and monitoring and enforce compliance by all federal government agencies, corporations and business enterprises with the access regulations.
5.57 The Tasmanian Conservation Trust said that it would like to see a Biodiversity Screening Centre established as a major institution in recognition of:
the profound and far-reaching changes which the biotechnology 'revolution' will engender in Australian commercial, social, cultural and environmental life.
5.58 Such a Centre would establish and manage the institutional arrangements necessary to secure and ensure the equitable sharing of the rental value of sustainable development and use of Australia's biological resources.
5.59 The Australian Conservation Foundation supported the need for a national approach and a national system.
5.60 The Tasmanian Conservation Trust, on behalf of the World Wide Fund For Nature (Australia), the Humane Society International (Australia) and the Tasmanian Conservation Trust, stated that Commonwealth legislation will only go part of the way to meeting the Commonwealth's outstanding obligation in ratifying the Convention on Biological Diversity. The Commonwealth has a responsibility, in international law, to ensure a regime is established to allow control of biological resources throughout all areas subject to the jurisdiction of Australian governments. It was suggested, therefore that the Commonwealth's legislation be developed:
5.61 The Australian Conservation Foundation queried the appropriateness of implementing such a scheme through regulations as they are more easily amended and subject to lower levels of parliamentary scrutiny. It preferred amendments to the EPBC Act.
5.62 The Tasmanian Conservation Trust said that Australia stands to benefit most by ensuring an equitable flow of benefits to both users and owners of biological resources.
5.63 The Trust also put the view that policies, laws and institutions should 'enhance the capacity of the Commonwealth to ensure that the full rental value of the use of Australian biological resources, including genetic resources, is captured by Australian governments, landholders, companies and most importantly Indigenous communities'. The biotechnology industry must 'pay the rent' for access and use of resources.
5.64 The Tasmanian Conservation Trust said that an equitable regime has the potential to make a substantial contribution to the process of reconciliation.
5.65 The Australian Conservation Foundation put the view that recognition of Indigenous rights in international legal instruments and crucial issues for implementing Article 8(j) for Indigenous people involves recognition of:
5.66 According to the Tasmanian Conservation Trust, registers of custodians of biological resources and associated knowledge are needed to ensure, where possible, eligible beneficiaries of benefit sharing arrangements can be identified and legal sanctions applied to anyone trying to use these resources without sharing the benefits.
5.67 In developing the proposed scheme in Chapter 2, I have given careful consideration to the issues discussed in this chapter.
5.68 The proposed scheme takes into account the major concerns and suggestions in the submissions from environmental interests, in particular:
