Chee Yoke Ling
A southern perspective

Biodiversity in its interactive complexity embodies ecological, social, economic, cultural, ethical and spiritual values. It supports the livelihoods of millions of people in the South, be it in the forest, on farms or in coastal and riverine ecosystems. Those millions of farmers, fisher communities and indigenous peoples are producers, consumers and conservers at the same time. They have, and continue to, contribute to the knowledge and evolution of biodiversity. Seen in this perspective, corporate and public sector scientists are merely consumers of the products of these communities, which are raw materials in the industrial system (Shiva, 1993).

The objectives of the Convention on Biological Diversity are,inter alia, "the conservation of biological diversity and the sustainable use of its components". To be mutually reinforcing, conservation and sustainable use means that biodiversity can only be conserved if production itself is based on the principle of preserving diversity. Conversely, it is diversity that ensures a sustainable base for production. By reducing biodiversity to economic values that serve an industrial system, and then justifying its protection by those terms, undesirable consequences will follow:

* the ongoing primary causes of large-scale destruction of biodiversity will continue (habitat destruction due to internationally financed development projects and replacement by monocultures)

* utilitarian cost-benefit analysis becomes the dominant approach for conservation, primarily serving corporate interests (wild reserves are set aside and capital-intensive ex situ germplasm collections, especially of domesticated species, replace on-farm conservation)

* technology, especially from the North, is promoted as a tool for conservation (while in most cases it is technology that destroys or threatens biodiversity).

This will further worsen already inequitable North-South relations. Thus, use of 'components' of biodiversity has to satisfy ecological and social criteria, not just commercial objectives. Any attempt at economic valuation must necessarily encompass the economies of different sectors in society, formal and informal. However, the limits of such valuation have to be recognised, too - what economic value does one attach to the ecological functions of species and the cultural and spiritual values of biodiversity of communities which in turn ensure the conservation of that diversity? The Biodiversity Convention acknowledges the intrinsic, ecological, social, economic, cultural values of biodiversity and its components as well as the importance of biodiversity for evolution and for maintaining life sustaining systems of the biosphere. It also recognises the close and traditional dependence of indigenous and local communities on biological resources, as well as traditional knowledge, innovations and practices related to the conservation and sustainable use of biodiversity.

It is crucial that this Convention does not go the way of the Climate Change Convention where 'economic valuation' has valued the life of one Northerner to be equivalent to 15 people from the South, and in the name of 'efficiency' the burden of adjustment is shifting rapidly from the industrial North (which is primarily responsible for global warming) to the South.


The history of market-oriented, resource-using industries is not one of conservation of biodiversity and sustainability. Biodiversity in the South has been primarily destroyed by the international financing of projects that include dams, mining, highways, large-scale cattle ranching, aquaculture and coastal land reclamation. Such activities constituted the first round of biodiversity destruction in the North, and spread with the expansion (often imposition) of the same economic development model to almost the entire world.

Monoculture in agriculture and forestry promoted by transnational corporations, international research institutions and the World Bank also destroys biodiversity. The industrial production paradigm regards biodiversity as raw material, measuring 'productivity', 'improvements' and 'increased yield' from a market, corporate perspective. The result, whether in the Green Revolution, forestry or aquaculture, are a loss of diversity which in turn drastically reduces the resources needed by Southern communities and sparks off ecological instabilites (e.g. pests, disease).

For example, the Green Revolution in Asia displaced other crops which provided nutrition and maintained soil fertility. In South-east Asia, fish farming in wet rice cultivation fields disappeared, and with it an important source of protein, biological control of insects and natural fertiliser. The monoculture of dwarf varieties of wheat and rice reduced the straw that farmers traditionally used for fodder and fertilising the soil.

As biodiversity is reduced, vulnerability of the agricultural and forestry systems to pests and disease escalates. Monocultures of these varieties based on a narrow genetic base then makes for large scale susceptibility to such hazards.

A central feature of diverse systems is their low external input production because diverse systems have multiple outputs and yields, much of which flows back into the system. This diversity in turn ensures that communities have diverse livelihoods. On the other hand, uniform production systems depend on high external inputs and external markets. Entire populations are thus in a vulnerable situation, faced with an ecologically unstable production base and an economically unstable commodity market.

In each case, technology has been applied to transform biodiversity, such technology being designed for maximum output of selected products and is centrally controlled. The new biotechnologies are the current phase of the technological 'miracle'. These promise to further reduce the genetic base for production, and genetically engineered organisms bring with them new hazards and threats to biodiversity, the environment and health.

The destruction of biodiversity and livelihoods, social and cultural systems saw the phenomenal growth of the agri-chemical industry that profited from the globalisation of monocultures. This gave rise to a small number of powerful corporations in the North, which could assert tremendous influence on their national governments. The results were national policies in the North that perpetuated (and subsidised) unsustainable production, and policies in global institutions (such as the World Bank, GATT/WTO, commodities fora) that viewed the South as a reservoir of raw material for exploitation. This situation is in danger of worsening as genetic resources (increasingly, microorganisms) are targetted for exploitation with the use of new technologies, especially genetic engineering. The expansion in the scope of patenting and the globalisation of US patent regimes, through the GATT/Uruguay Round agreement on Trade-Related Intellectual Property Rights, threatens to deepen the North-South chasm. The knowledge of Southern communities on medicinal values of biological resources, and the rights of farmers to use and innovate seed varieties are at stake.

At the same time, the loss of and threats to biodiversity caused by the external debt burden of the South, structural adjustment policies prescribed by the World Bank and IMF and low commodity prices have yet to be addressed -- these assert tremendous pressure to exploit natural resources and erode biodiversity.


The concept of common heritage of mankind has shifted to the notion of national sovereignty over biological resources and access to genetic resources on "mutually agreed terms" and the "fair and equitable sharing of benefits" from use of biodiversity under the Convention. The second meeting of the Conference of the Parties this November in Jakarta will begin discussion on these issues.

Access to genetic resources includes access to the wilds (forest, marine, soil organisms) and domesticated resources. Regulating access is considered by a number of countries, given that the South-North flows have been free in the past or stolen. The concept of "mutually agreed terms", however, needs to be clear. Experience convinces many of us that we cannot leave these vital issues to the market place and pure contractual arrangement among private parties or even between governments and private parties because the more powerful corporations and their agents in bio-prospecting will inevitably broker inequitable contracts. Minimum standards set by law will thus be necessary.

Underlying the question of access and benefit sharing is who controls the genetic resources. Rights of communities, the role of states and the interests of corporations are in conflict and needs to be addressed first. Benefits from biodiversity are also not confined to profits from commercialisation. The sustaining of lives and livelihoods of communities in the South outside the marketplace and the ecological functions of diverse species are unquantifiable benefits. Thus while mechanisms for, and terms of, benefit sharing of commercial profits are put in place, the wider benefits derived from biological resources need to be part of the goal of conserving biodiversity.

Resolving the economic inequities that result in billions of dollars of net South-North flows through debt repayments, unfair trading terms and repatriation of investment returns and royalty payments would also be critical to relieve pressure on resource exploitation and ensure sharing of benefits in a more structural way.

A matter of great concern is the collections of agricultural germplasm found in the international collections of the CGIAR. The UN Food and Agriculture Organisation Commission on Plant Genetic Resources is in the midst of renegotiating the non-legally binding International Undertaking on Plant Genetic Resources. At its last session in July 1995, governments on the Commission affirmed national sovereignty over PGR and had intense debates on defining access to in situ and ex situ PGR and the definition of farmers' rights and plant breeders' rights. The fate of the extensive collections of the CGIAR centres, made before the entry into force of the Biodiversity Convention, is also a key issue.(Consent from the country of origin is required for use of germplasm collected after the enforcement of the Convention.) Agreements in 1994 brought those collections under the auspices of the FAO and the Commission is to give policy guidance regarding the collections. Discussions are ongoing in the CGIAR and the Commission on approaches to facilitate access to PGR and the on the equitable sharing of of results of research and development and of benefits arising from the commercial exploitation of those resources. Economic assessment of the contribution of germplasm to varieties is proposed by the CGIAR for determining benefit-sharing. Farmers' rights and IPRs will be central in the debate.

Although the agreements forbid the Centres from claiming legal ownership over the germplasm and from seeking intellectual property rights over the resources or related information, the fear is that IPRs will be claimed by corporations that use the germplasm from the CG Centres.

However, the Trade-related Intellectual Property Rights (TRIPs) Agreement of the GATT/Uruguay Round negotiations has pulled countries into an international obligation to accord IPRs, especially patents and plant breeders' rights, in a more sweeping manner than ever seen before so that ownership of life becomes legal. Farmers' rights under the FAO Undertaking are being reformulated, but the agribusiness, via Northern governments (especially the US) are aggressively pushing for a definition of plant breeders' rights that will amount to patents. The fact that patent lawyers, including a number from corporations, form the majority of the US official delegation makes it clear that ownership of the commercial products derived from these ex situ collections is of paramount importance to industry.

The issue before governments and citizens is the extent to which a strict enforceable IPR regime will undermine or even negate the Convention's objective of fair and equitable sharing of benefits. The Convention obliges Parties to ensure that IPRs are supportive of and do not run counter to the objectives of the Convention [Article 16(5)]. The US, though not a Party to the Convention, has from the beginning rejected this provision. (It was one of the reasons for the Bush Administration to refuse to sign the Convention in 1992, the other being the call for a biosafety protocol.) The Group of 77 and China have been calling for a study by the Convention Secretariat to examine the implications of IPRs on the implementation of the Convention. Not surprisingly, there has been strong resistance from the North. Given the current power relations, in the event of a conflict between TRIPs and the Convention, we can expect TRIPs to override. Already, bilateral pressure, even threats of unilateral trade sanctions, is directed at key Southern countries to ensure that patent laws are passed or amended to comply with TRIPs.

Patents were originally conceived to protect the interests of inventors of industrial products. They are a legal construct, not an inherent right. It would be more appropriate to call this protection a 'privilege'. As in other IPRs, there have always been restrictions, largely in terms of time scale (usually 20 years), which seek to balance between the interests of the inventor and the public. The exclusivity related to the commercial use of the invention. Another fundamental principle reflected in many national laws, where they exist, was the prohibition on proprietary rights over plants, animals and other living organisms as a matter of ethics. Most laws in the industrialised countries were adopted in the post-World War II period, the rationale being that in developing economies, competition was crucial and patents would be a disincentive. Ironically, the then President of Ciba Geigy at the turn of this century was a leading critic of patent laws.

Countries of the South that entered the global market later had the choice to adopt IPR laws in accordance with the needs of national development priorities. Thus India passed a Patent Act in 1970 that excluded product patents in pharmaceuticals and agriculture as well as all methods of agriculture and horticulture from patentability. This was in the health, nutrition and livelihood interests of its citizens.

The TRIPs agreement has for the first time put in place an international obligatory system which extends IPR protection to life forms, and national laws have to be passed accordingly. It will open the way for private ownership of life forms, undermine public interest in health and food security, and deny the rights of communities to their knowledge and use of biological resources.

Recognition of the knowledge, innovations and practices of indigenous and local communities is found in the Biodiversity Convention. The concept of 'farmers' rights' in the FAO International Undertaking on Plant Genetic Resources is currently being hotly debated and reformulated by the Commission on Plant Genetic Resources.

The 'commons' of communities, be they forest, seeds or knowledge on the conservation and use of biological resources, have been systematically encroached and denied. Thus moves to recognise the knowledge systems of communities were welcomed. However, the TRIPs regime threatens the realisation of community intellectual rights. There are attempts now to formulate the principles and legal regimes for protecting the intellectual rights of communities, based on the common values that underlie the diversity of societies and cultures, especially in the South, that are ecological and life-sustaining.[1]

In many countries, Parliaments are not even aware of the full implications of patent legislation laid before them. The state of affairs where international decisions are made by a minority of powerful countries, resulted in agreements such as TRIPs. If we value democracy, then we must ensure its operation at all levels. These issues of vital importance which, if decided within closed negotiation rooms, can result in national laws and policies that adversely transforms entire societies, must necessarily be matters for public discussion and feedback. The GATT Uruguay Round negotiations were among the most untransparent in international relations, and should not be repeated. Democracy at the international level is crucial if a new North-South relations is envisaged.

In light of this, the issue before governments is the extent to which a strict enforceable IPR regime will undermine or even negate equitable sharing of benefits under the Biodiversity Convention.


The assumption that technology conserves biological diversity and ensures sustainable use of resources is highly questionable. It has been technology from the industrial North that is responsible for most biodiversity loss -- the Green Revolution, commercial fish trawling, hydropower projects, to name a few. On the other hand, appropriate technologies developed by Southern peoples are not recognised as such.

A true assessment of technology options in all aspects -- environmental, health, social, economic, biodiversity impact, and ethical/moral implications where relevant -- is necessary before a choice is made. The Convention provides that access to and transfer of technology, including biotechnology, should be technology that is relevant to the conservation and sustainable use of biodiversity or make use of genetic resources and do not cause significant damage to the environment [Article 16(2)]. Accordingly, any transfer of technology should be assessed prior to its transfer.

Such assessment has to be transparent and public. For example, a diversity of seed varieties and technologies and agricultural systems built on traditional or indigenous knowledge are available for sustainable agriculture. Yet genetically engineered seeds are being promoted by the same companies that profited from the Green Revolution, while intellectual property rights regimes for agribusiness are contorted against logic and in denial of the intellectual contributions and rights of communities, especially in the South. Biotechnology, be it tissue culture or genetic enginnering, in effect narrows the genetic base of biological resources and leads to increased genetic vulnerability.

However, even where the technology is appropriate, the issue of IPRs arises. Recognising this, the Convention obliges States to* ensure that intellectual property rights are supportive of and do not run counter to the objectives of the Convention [Article 16(5)].

Of concern to many of us is genetic engineering. The central issues relating to this new biotechnology are biosafety, the patenting of life forms, labelling as well as liability and compensation. The Biodiversity Convention has provisions which obliges State Parties to:

* consider the need for, and modalities of, a biosafety protocol [Article 19(3)];

Article 14(2) is a weak provision requiring the Conference of the Parties to examine, on the basis of studies to be carried out, the issue of liability and redress, including restoration and compensation, for damage to biodiversity, except where such liability is a purely internal matter. A meeting of government-nominated experts met in July 1995 to examine the issue of biosafety, and identified elements that could be considered for a protocol. There was no agreement on the issue of liability and compensation, with major opposition from a few Northern countries.

The issue of labelling is being debated in the Codex Alimentaris committee, now assigned the task by the World Trade Organisation. Again, there is strong opposition for biotechnology products to be labelled, led by the United States. Genetically engineered seeds and plants are not within the purview of the Codex body. An important step for States to take, nationally and internationally (particularly since the target market for biotechnology products is predominantly global) is to put in place legal requirements for full labelling of genetically engineered organisms and products containing GEOs.


In the twenty years since scientists at the Asilomar conference in the United States warned that "there is serious concern that some of [the] artificial recombinant DNA molecules could prove biologically hazardous", the biotechnology industry has grown tremendously. With it has faded the call of Asilomar that scientists should voluntarily defer from certain experiments involving recombinant DNA molecules. The expansion in research, small-scale and increasingly large-scale field tests involving the release of genetically modified organisms, as well as industry's eagerness to commercialise biotechnology products, have resulted in a disturbing number of exaggerated or unsubstantiated claims and economic promises. In many cases, the scientific basis of those claims has been flawed. Thus, there is growing concern among the public, and within the scientific community, that this rapid expansion has not been matched by national and international efforts to properly assess, monitor, regulate and control genetic engineering and its application.

This concern is further strengthened as the quest for sustainable development becomes more urgent in the face of escalating global environmental problems and erosion of biological diversity, worsening poverty in many parts of the South and unsustainable consumption and production in the North. The promotion of genetic engineering and its application is in danger of diverting countries, especially of the South, from truly sustainable development options while glorifying the new biotechnology as the next round of "technological fix-it miracle". Past and continuing experiences of technology in the areas of chemicals and nuclear power beg us to be cautious and more importantly, to ensure that there is wide and open public discourse and debate to the development of new technologies which threaten to pervade our lives. The new biotechnology is intruding into the physical frontiers of nature and human beings in an unprecedented way -- be it scientific paradigms, the social-cultural fabric of human societies or the jurisprudence of law.

At present there are no legally binding international instruments to specifically regulate genetic engineering and genetically engineered organisms.

Two sets of voluntary guidelines, which have not been formally adopted by any inter-governmental body, exist. The first is the Voluntary Code of Conduct for the Release of Organisms into the Environment, prepared by the Secretariat of the United Nations Industrial Development Organisation (UNIDO) and finalised in 1991, which is highly inadequate.

The second is the draft International Technical Guidelines for Safety in Biotechnology. These were prepared by the Departments of Environment of the Netherlands and the United Kingdom in 1993, and subsequently adopted by the Secretariat of the United Nations Environment Programme (UNEP) in 1995. Six regional consultations of government-designated experts on these Guidelines have been held by UNEP between March and July. The promotion of these Guidelines has been a matter of controversy since the Guidelines were 'floated' by the Netherlands and the UK just as the call for a legally binding biosafety protocol was being made by the vast majority of Governments which are Parties to the Biodiversity Convention. The May 1995 meeting of the UNEP Governing Council stated that UNEP's sponsorship of these consultations should avoid prejudging the consideration on the need for and modalities of a biosafety protocol under the Convention.

Therefore, the Convention provides the first opportunity for a comprehensive international law on biosafety. One of the four Experts Panels set up by UNEP in 1992 (to assist the Contracting Parties on key issues) dealt with the need for and modalities of a biosafety protocol. The majority of this UNEP Panel IV recommended such a protocol. At the second meeting of the Intergovernmental Committee of the Convention, and then at the first meeting of the Conference of the Parties in November 1994, the overwhelming majority of countries called for immediate work to begin on a protocol. An ad hoc open-ended working group of experts was set up by the Conference of the Parties, which met in July 1995 in Madrid. Again, the majority recommendation was for a protocol. Elements for a protocol were also identified, but there was no consensus on issues relating to socio-economic factors (of particular concern is the substitution of biotechnology products for natural commodities which may devastate many Southern economies), liability and compensation as well as finance. It will be left to the Conference of the Parties, when it meets in November 1995, to decide on whether steps for immediate negotiations will be initiated. We hope that Germany (and the European Union as a whole) supports the setting up of a negotiation process at that meeting.

Meanwhile, the international debate on the benefits, hazards and risks of genetic engineering and its application also intensified at the third session of the Commission on Sustainable Development in May 1995. The CSD is an inter-governmental body under the UN, set up in 1992 to follow up on the implementation of the principles of the Summit Declaration on Environment and Development, and Agenda 21 which is the programme of action for sustainable development. In reviewing the implementation of Chapter 16 of Agenda 21 (Environmentally Sound Management of Biotechnology), the Commission called for a balanced and objective approach to biotechnology, stressing that while benefits accrue from biotechnology, "Future reports should place a stronger emphasis, including more information and proposals, on the ecological, safety, health and socio-economic and ethical aspects of the application of biotechnology and the commercialisation of biotechnology products, with particular reference to genetic engineering, including genetically modified organisms when human genetic material is involved. Such reports should take into account existing uncertainties and the most recent findings of the science of genetics" (Chairman's Decision on Chapter 16 of Agenda 21, para. 1, 1995).

The Commission pointed to the precautionary principle which makes the safe handling of biotechnology a "high priority", and also emphasised the special vulnerability of developing countries in the absence of a global framework for bioisafety. The legal supremacy of the Convention on Biological Diversity was reiterated when the Commission stated that work on the development of possible international voluntary technical biosafety guidelines should not pre- judge the result of the ongoing work on a protocol under the Convention.

This consensus of States reflected in the Chairman's Decision represented a significant shift in the risk/benefit analysis of the new biotechnology. Chapter 16 as originally drafted was regarded by many NGOs and scientists as being too glowing on the promises of the technology and inadequate on the hazards and risks. Some fundamental scientific assumptions underlying the Chapter were also questionable, especially in the light of new understanding of genetics. Moreover, recent scientific findings since 1992 required that governments in the Commission review their position. NGOs, scientists and a number of government delegations were therefore shocked at a Secretariat paper prepared by UNIDO which uncritically promoted biotechnology with highly exaggerated and misleading claims. However, the United States supported the document and instead very strongly objected to the inclusion of references to, inter alia,

* the application of the precautionary approach in dealing with GEOs;

* concerns that without proper regulation, the release of GEOs might take place in the South without due consideration for the environment in those countries;

* the lack of an internationally agreed framework for regulating the safe handling and transfer of biotechnology (the US, though not a Party to the Convention on Biological Diversity, has been obstructing immediate work on a biosafety protocol);

* the knowledge, innovations and practices of indigenous and local communities;

* feasible and up-to-date standards for intellectual property rights related to biotechnology.

The stance of the US, to only highlight the importance of biotechnology and marginalise the perils, was an isolated one, and the final report reflected the major shift by Governments towards a position of more caution and assessment.

GEOs in Northern countries will result in the testing of such GEOs in the South, which is already occuring. Some countries are meanwhile developing their biotechnology sector, and accordingly realise that biosafety regulations are necessary. However, in almost all cases, national regulations do not address the issue of export of GEOs, especially to the South. It is this vacuum in the international dimension that requires urgent action.

At the same time, new scientific findings make it necessary for existing national regulations to be reviewed, especially in the North where current laws are often held out to be sufficient. Three significant cases are:

* A genetically engineered soil bacterium klebsiella planticola unpredictably reduced mycorrhizal fungi in the root system (necessary for nutrient uptake and plant growth) while converting agriculture waste to ethanol would have slipped the USA regulations if independent scientists had not conducted extra tests not required by law. The wholly inadequate procedures for assessment of impacts on soil systems and the food web was exposed, not only in the US case but in other existing national laws and international guidelines;

* In 1994, research scientists in Denmark reported strong evidence that an oilseed rape plant genetically engineered to be herbicide tolerant transmitted its transgene to a weedy natural relative. This transfer can take place in just two generations of the plant, and can make the wild relative become a more aggressive weed. The scientists also warned that as the gene for herbicide resistance is likely to be transferred to the weed, this herbicide strategy will be useless after a few years. In response to the Danish findings, the governments of Denmark and Norway have acted against the commercial planting of the engineered plant, but the UK government has approved its marketing.

* GEOs which are currently designed for commercial release are designed to be robust and vigorous. They may migrate, mutate and multiply. This self-replicating nature of genetic material and lateral spread through ecosystems result in an intrinsically unstable and unpredictable situation. In contrast, laboratory strains of GEOs are supposedly not designed to survive in an open environment. demonstrating as incorrect the earlier assumptions that GEOs do not survive and spread from containment.

However, increasing evidence has emerged demonstrating the viability of engineered organisms supposedly unable to survive outside laboratory conditions. These organisms have been found to survive in waste water and sludge, soils and aquatic ecosystems. Ostensibly "crippled" microorganisms have evidently managed to survive and compete with indigenous microorganisms. DNA persistance in laboratories, waste water treatment plants, aquatic systems, soils and digestive systems of mammals has also been shown in a series of experiments. DNA ingested with food is not completely broken down in the gastro-intestinal tract, and is even found in the blood stream and white blood cells. The long term ecosystem effects of these surprise survivals are unknown.

A process of reviewing and strengthening standards and criteria for assessing genetic engineering and its application is thus urgent and neccesary.

A shocking report that will be publicly released on 21 September (significantly on the day of this seminar), confirms the fundamental flaws and omissions in the US regulatory system, and the promotion of biotechnology based on ignorance and scientific dishonesty by a body that is mandated by law to be responsible for risk assessment. Entitled The Imminent and Premature Commercial Release of Genetically Engineered Bacteria, it is prepared by a number of current professional employees of the US Environmental Protection Agency, based on the assessment of an application in 1994.[2]

They are biological, ecological and human health scientists whose expertise ranges from agricultural marketing to pharmacology. Driven by deep concern that the first authorisation of the widespread commercial release of a genetically engineered microorganism may soon take place, these scientists warn that the EPA lacks a sound process to assess risks and benefits of such releases as well as preparedness for the biotechnology revolution.

In this case, the EPA conducted a risk assessment of a genetically engineered bacteria, Rhizobium meliloti RMBPC-2, which will be used as a seed inoculant to increase yields in alfalfa and other legumes, through better performance in nitrogen-fixing. (Alfalfa is consumed by livestock and humans). A naturally-occuring nitrogen-fixing strain has been engineered by Research Seeds Inc. to contain genetic information from 6 "donor" bacteria from 5 genera. One of the genes of overarching concern to EPA scientists is from Shigella flexneri, a bacterium that causes dysentry and infantile gastroenteritis (inflammation of the stomach and intestine) in humans. It confers antibiotic resistance and is solely used as a "marker gene" - its utility as a marker, according to the report, is questionable and an important uncertainty in the risk assessment, in addition to the risk of confering of such resistance to the new species.

Field tests were conducted in 1993. The report reveals that the conclusions of the assessment are based on incomplete data, opinion and unsubstantiated presumptions, even though there are potential hazards to the environment, public health and agriculture, including: promotion of weed species, biodiversity loss, adverse impact on soil system (including fertility), antibiotic resistance, possible pathogenicity or toxicity, genetic transfer to human beings, uncharacterised DNA, genetic stability and transfer in agriculture.[3]

Concerns and queries from some EPA scientists themselves were brushed aside. The EPA failed to follow its own mandatory guidance on characterising the uncertainties of its assessment or consult with its own experts on how best to assess the risks.

With regard to the "risk benefit analysis", the report esposes that this will not be the weighing of risks against the benefits of the proposed product to society. Instead, it will be a "risk market potential analysis" in which the risks to society will be weighed against whether the company can get sales revenue from the product. According to the report, 'Because efficacy is not considered a benefit, a product which is useless but which sells can still be considered "beneficial" ... The market potential analysis which was submitted along with the risk assessment ... is fatally flawed'.

Among the recommendations of the concerned scientists are:

* EPA should regulate products of biotechnology to protect human health and the environment, not to promote those products;

* EPA should move cautiously, waiting until it has in place a good method to determine how, when and which new creatures could safely be released into the environment before granting any approvals. EPA should assemble experts from inside and outside of the agency to advise it on how best to assess the risks associated with this emerging technology;

* Risk management policies should clearly define how risks are to be incorporated into its cost-benefit analysis of applications for the release of genetically organisms. This should address the issue of whether ANY risk will be acceptable if a product is not clearly efficacious and beneficial to the public in addition to the manufacturer.

* Legislation should be prepared which gives EPA clear authority to regulate living organisms as such (the current Toxic Substances Control Act was designed for new chemicals), and address the unique properties of living organisms;

* EPA should research on the fate and transport, containment and eradication of, and gene transfer to and from genetically engineered organisms;

* EPA should coordinate, with the European Union and other countries, a moratorium on releases until common safeguards (risk assessment guidance, containment and control) can be established.

This latest report, following a number of cases proving the fundamental inadequacies and laxity of the US regulatory system[4], is significant because US laws are projected to the South as sufficient (even too stringent), and the US is actively putting obstacles to international initiatives on a legally binding biosafety protocol while aggressively pushing for extensive patent protection for biotechnology products in order to confer monopolistic markets on corporations. The threat of unilateral trade sanctions under US trade law, the notorious Super 301 provision, has been unashamedly used to make Southern governments legislate patent laws that are against the public interest of the South.

On the other hand, some European states, have been strong allies of the South in pressing for international regulation and national laws and safety assessment capacity-building. Norway and Denmark are leading European voices, and their recent rejection of applications to market herbicide-tolerant oilseed rape in their respective countries are bold and encouraging steps. Germany is one of the countries with a comparatively stringent regulatory system and there are fears from citizens' groups, especially in the South, over corporate pressure on the Government to deregulate, just as scientific findings are calling for even more strict and comprehensive laws. Further, the experience of existing regulatory bodies in countries such as the US where safety and honesty are sacrificed for the interests of corporations shows an unhealthy trend.


Conservation of biodiversity goes beyond the setting aside of resource pools for the exploitation by industry. North-South relations that will conserve biodiversity and sustain ecosystems and human lives have to address the structural inequities at the international level, and replace current trends of bio-piracy and commercialised reductionist approaches to conservation with a new order based on ecological, equitable and ethical values. Consumption patterns and lifestyles need to be compatible with the sustaining of biodiversity. At the national level, the state has to be protective, in the interest of peoples' needs and the long-term sustainability of resources and diversity (biological and cultural), and not only serve the corporate exploitation of resources. It has also to check and reverse the trend, especially in the North, of market monopolies and monocultures and IPR regimes that perpetuate these.

Biodiversity can be a key link in forging new North-South relations. The question is whether those relations will be rooted in sustainability and justice or a deepening of biodiversity destruction and inequities.

In that respect we hope that Germany will stand on the side of sustainability and North-South solidarity, and consider the following calls by growing coalitions of citizens' groups, scientists, religious groups and NGOs:

* A moratorium on releases of genetically engineered organisms and products containing GEOs;

* Immediate negotiations on an international legally-binding biosafety protocol, which includes a ban on the export of GEOs and products containing GEOs, especially to the South, for testing or releases when such activities are prohibited in the exporting or importing countries;

* There should be no patenting of life forms, and the letter and spirit of legislatures (European Parliament, India) that has rejected such patents should be maintained and spread, and build towards an amendment of the relevant provisions of the TRIPs agreement when it is reviewed in four years' time.

© Friedrich Ebert Stiftung | technical support | net edition fes-library | März 1998

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