Bio-Diversity And The Challenges

"There are many factors responsible for the loss of biodiversity, which is occurring at a very alarming rate. If humanity is to avoid becoming once again a spices consisting of scattered group practicing subsistence agriculture, dramatic steps will be necessary. Conservation programmes are one such step in this direction, but the problem lies in their implementation. And hence through public awareness, change in the attitude of the people is required.

Moreover improvements in technologies do to some extent solve problems of extinction but to solely rely on them may be dangerous, because every technology not only provides certain benefits but also involves risks, and hence the effort should be towards regulation of these technologies so that benefits are enjoyed and dangers are avoided. Emphasis should also be laid upon the regeneration aspect."

The concept of biodiversity had its origin in mid 1980 though the earth and the evolution processes are very ancient phenomenon. The most acceptable definition of Bio-diversity is the one held by the Convention of Biological Diversity (CBD), which was signed by more than 150 nations in 1992 at Rio-De-Janeiro. It defines: "Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems".
Biodiversity may be defined as the sum total of species richness that is the number of species of plants, animals and microorganisms occurring in a given habitat. It includes diversity of forms right from the molecular unit to the individual organism, and then on to the population, community, ecosystem, landscape and biospheric levels.

In the simplest sense, biodiversity may be of the following types:
Genetic Diversity: (Diversity within species): it refers to the variation of genes within species. A species can have varieties and each variety its own genes or genetic makeup. This constitutes distinct population of the same species or genetic variation within population or varieties within a species. Diversity of genes within a species increases its ability to adapt to disease, pollution and other changes in environment.

Species Diversity: (Diversity between species): it refers to the variety of species within a region. Such diversity could be measured on the basis of number of species in a region.

Ecosystem Diversity: In a ecosystem, there may exist different landforms, each of which supports different and specific vegetation. Ecosystem diversity in contrast to genetic and specific diversity is difficult to measure since the boundaries of the community which constitute the various sub ecosystems are elusive.
All these three levels are linked and constitute a gene pool. The 1992, United Nations Conference on Environment and Development at Rio put Biological Diversity on the International agenda by signing the Convention on Biological Diversity. This Convention addresses many issues ranging from forests, agriculture to Intellectual Property Rights. Before signing CBD, a lot of preparations were done. In August 1988, the United Nations Environment Programme (UNEP) convened a high level panel of experts to advise it whether a global biodiversity convention was timely, and if so what should it include. UNEP then convened a series an inter-governmental meetings to develop the CBD. CBD was then signed at Rio. India is signatory to CBD and ratified it in 1993.

The Convention, in contrast far from a neutral document, is amply revealed by its objectives as below:
".....the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of the genetic resources, including by appropriate access to genetic resources and by appropriate transfer for relevant technologies, taking into account al rights over those resources and technologies and by appropriate funding."

The Loss of Diversity:

Discussions of the current extinction crisis all to often focus on the fates of the prominent endangered species, and in many cases on deliberate over exploitation by human beings as the cause of the endangerment. The time has come, however, to focus public attention on a number of more of more obscure and (to most people) unpleasant truths, such as the following:
(i) The primary cause of the decay of organic diversity is not direct human exploitation or malevolence, but the habitat destruction that inevitable results from the expansion of human populations and human activities.

(ii) Many of the less cuddly, less spectacular organisms that Homo sapiens is wiping out are more important to the human future than are most of the publicized endangered species. People need plants and insects more than they need leopards and whales.

(iii) Other organisms have provided humanity with the very basis of civilization in the form of crops, domestic animals, a wide range of industrial products, and many important medicines. Nonetheless, the most important anthropocentric reason for preserving diversity is the role that microorganisms, plants and animals play in providing free ecosystems services, without which society in its present form could not persist.

(iv) The loss of genetically distinct populations within species is, at the moment, at least as important a problem as the loss of entire species. Once a specie is reduced to a remnant, its ability to benefit humanity ordinarily declines greatly, and its total extinction in the relatively near future becomes much more likely. By the time an organisms is recognized as endangered it is often too late to save it.

(v) Extrapolation of the current trends in the reduction of diversity implies a denouement for civilization within the net 100 years comparable to a nuclear winter.
(vi) Arresting the loss of diversity will be extremely difficult. The traditional "just set aside a preserve" approach is almost certain to be inadequate because of certain factors such as runaway human population growth, acid rains, and climate change induced by human beings. A quasi-religious transformation leading to the appreciation of the diversity for its own sake, apart from the obvious direct benefits to humanity, may be required to save other organisms and ourselves.
This utter dependence of organisms on appropriate environments is what makes ecologist so certain that today's trends of habitat destruction and modification- especially in the high diversity tropical forest (where atleast one half of all human species are believed to dwell)-are an infallible recipe for biological impoverishment. Those politicians and social scientist who have questioned the extent of current extinctions are simply displaying their deep ignorance of ecology; habitat modification and destruction and extinction of populations and species go hand in hand.

The extirpation of populations and species or organisms exerts its primary impact on society through the impairment of ecosystems services. All plants, animals, and micro organisms exchange gases with their environments and are thus directly or indirectly involved in maintaining the mix of gases in the atmosphere. Changes in that mix (such as increase in carbon di-oxide) can lead to rapid climate change and in turn agricultural disaster. As Physicist John Holdren put it, a carbon dioxide induced climatic change could lead to the deaths by famine of as many as a billion people before 2020. Destroying forests deprives humanity not only of the timber but also of dependable freshwater supplies and further more increases the danger of floods. Natural ecosystems maintain a vast genetic library that has already provided people with countless benefits and had the potential for providing many more. The basic point is that organisms most of which are obscure to non-biologist play roles in eco systems that are essential to civilization. When a population playing a certain role is wiped out, ecosystems services suffer, even if many other populations of the same organism are still extant.

What will happen if the current decimation of the organic diversity continues? Crop yields will be more difficult to maintain in the face of the climatic change, soil erosion, loss of dependable water supplies, decline of pollinators, and even more serious assaults by pests. Conversion of productive land to wasteland will accelerate, deserts will expand more. Air pollution will increase, and local climate will become harsher. Humanity will have to forego many of the direct economic benefits it might have withdrawn from the earth's once well-stocked genetic library. Life expectancies will be lowered due to development of more incurable diseases. Humanity will bring upon itself consequences depressingly similar to those expected from a nuclear winter . Barring a nuclear conflict, it appears that civilization will disappear some time before the end of the next century-not with a bang but with a whimper.

Challenges To Biological Diversity:

Unfortunately losses of animal and plants species are restricted neither to temperate zone urban areas nor to the developed world. Urban impacts on biological diversity reach their most devastating in the third world. Although the full extent of this urban environmental degradation is virtually impossible to convey, its underlying causes are comparatively simple to identify. With few exceptions, losses for naturally occurring biological diversity are incidental to human activities. Thus, urban areas are effectively synonymous with ecosystem disruption and the erosion of biological diversity. Natural habitats are replaced directly by houses, condominiums, hotels and malls as well as by streets, highways and utilities that support them. Historically, urban areas were the first regions subjected to local overkill of wildlife for food, fur and feathers and through misdirected predator control programs. They were also the first to experience logging and weed eradication programs. The biological diversity of urban areas has been among the most severely affected by the introduction of animal species, which prey on native animal populations, compete for limited resources and act as vectors for novel diseases and parasites to which native organisms can be particularly susceptible.

Great effects on biological diversity in urban areas also can result from the less direct sources, including many of the air and water borne pollutants that imperil human health. Toxic by-products of the industrial production have been found to disrupt natural ecosystems . Air borne pollutants are especially insidious, since they expand the reach of urban blight far beyond city limits. More subtle impacts on biological diversity result from the over drafting local aquifers, dropping water tables and ground subsidence. This wide array of obvious and subtle factors contribute to the disruption of the ecosystem function, the decoupling of interactions among species, and the disappearance of populations or organisms from urban locales. Why should that concern us? Because losses of just a few populations can result in a great destabilization of natural ecological communities an, as a consequence, in a decrement in the ability to those communities to provide a wide array of services.

The arguments for protecting biological diversity in urban areas seem straightforward, but the implementation of conservation programs in urban areas is among the most difficult problems faced by the environmentalist. Some areas are so disturbed that functioning, naturally occurring ecosystems are no longer identifiable, whereas other urban habitats remain effectively undisturbed. Open spaces in inner cities often support only species that are particularly well adapted to human impact. Such areas are nearly always small and extremely isolated, and their maintenance and enhancement demand extensive and continuous hands-on management. The conservations goals in such areas must usually aim at maximizing biological diversity to the extent possible rather than preserving all remaining resident species.

The single greatest threat to the biological diversity of relatively intact natural communities in and around urban areas in the destruction of natural habitats and their conversion to other uses. The paving over of natural habitats as urban activities sprawl outward destroys and fragments remnant functioning ecosystems. The redistribution of water through channelisation and impoundment of flowing waters, and the draining of some wetlands and the flooding of others, destroys undeveloped habitat areas. Decreases in local biological diversity resulting from losses of habitat area and insularization of habitat remnants are compounded by the more subtle effects of fragmentation. Losses of single, specific microhabitats within an otherwise undisturbed habitat can cause the local extinction of certain species.

Disruption of even narrow corridors of natural habitat between large habitat patches can lead to losses of species. Vast differences in temperature, humidity, light availability and wind exposure exist between forest edges and interiors and affect habitat suitability for some species. In addition, losses of certain species due to any one or more causes can affect closely associated species sometimes leading ultimately to secondary extinction events.

In light if these basic ecological facts, conservation of the full range of urban biological diversity necessitates the protection of the largest possible expanses of natural habitat. Yet, that simple prescription is usually impossible to fill in urban areas, where the forces acting to decrease the size of remaining natural habitats are greatest.

These conflicting pressures interact to determine urban conservation policy and to force biologists to justify the sizes of biological reserves. Economic and political considerations in urban areas make preservation participation difficult. Land costs are high because of high demand, and the vast majority of the urban space is the private property. The few publicly owned open spaces are subject to intensive, varied uses, many of which are incompatible with preserving biological diversity. Local political institutions usually favor development over preservation.

The Endangered Species Act with its mandate outlawing the "take" of any endangered species is the best tool for protecting biological diversity in urban areas of this country. Efforts to conserve the full extent of biological diversity by using the Endangered Species Act must target species that are most susceptible to habitat loss. The protection of extinction prone species can be the key to facilitating the conservation of biological diversity in urban areas. In the urban United States, three groups must interact to assist the Endangered Species Act in protecting biological diversity. Field Biologist must aid in the identification and survey of potential umbrella species. Conservation organizations must use that information and citizen petitions to get appropriate umbrella species protected via the endangered list. In response, the office of Endangered Species will have to reassess listing priorities.

Can this urban biological diversity be protected? Overpopulation, chronic poverty, and fuel shortages in the third world create unrelenting pressures to exploit all available local resources. These pressures certainly will become more overwhelming in the future. Our urban centers can be viewed as bellwethers of our global environmental fate. Our success at meeting the challenges of protecting biological diversity in urban areas is a good measure of out commitment to protect functioning ecosystems worldwide. If we cannot act as responsible stewards in our own backyards, the long-term prospects for biological diversity in the rest of this planet are grim indeed.

The Need For Conservation:

In 1997, at the U.N. Special Session of the General Assembly to Review and Appraise the Implementation of Agenda 21, it was acknowledged that five years after the UNCED the state of the global environment had continued to deteriorate and significant environmental problems remain deeply embedded in the socio-economic fabric of countries in all regions. This assessment indicated that, in terms of the condition of the global environment, things were not on course and were in fact worsening. There remains an urgent need for the conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising from the utilization of components of genetic resources. The threat to biodiversity stems mainly from habitat destruction, over-harvesting, pollution and the inappropriate introduction of foreign plants and animals.

To conserve the biodiversity, the immediate task will be to devise and enforce time bound programme for saving plant and animal species as well as habitats of biological resources. Traditionally conservation has been polarized into two separate approaches that is ex-situ and in-situ. The ecologists and conservationist prefer in-situ conservation while the agriculturist and species oriented biologist prefer the former.

In-situ Conservation: In situ conservation refers to protection of zones and areas of high biological diversity. These areas described as natural ecosystems, will protect species with minimum human interference. Since most of the threatened organisms occur as components of biotic communities in open sites, restoring them in such habitats through judicious protection measures is required.

Scientific studies in regard to in situ conservation should focus on the following lines:

1. Applied research for conservation of living resources
2. Interlinkages between plant and animal species;
3. Quantitative assessment of the conservation status of the species;
4. Multiplication and restoration of endangered, rare and endemic species using biotechnology;
5. Assessment of the impact of exotic species on the ecosystem
6. The possible climatic change and its impact on the biodiversity;
7. Primary production and cycling of nutrients in the soil.

Ex-situ Conservation:

India has done commendably well as far as ex-situ conservation of crop genetic resources is concerned. It has also taken up such work on livestock, poultry and fish genetic resources. However, there is a need to develop facilities for long and medium term conservation through:

1. of genetic enhancement centers for producing good quality seeds;
2. Enhancement in the existing Zoos and botanical garden network;
3. Seed-gene banks;
4. Pollen and spores banks;
5. Tissue culture gene bank;
6. Captive breeding in zoological gardens; and
7. In-vivo and in-vitro preservation.

Both these conservation methods should be given equal importance as measures in biodiversity conservation. Release of genetically modified organisms should be regulated at national and international level, and there should be adequate dissemination of information about such release by the respective countries.
The conservation of Biodiversity is a global responsibility.

In its Status Report to the U.N. Commission on Sustainable Development, India stated that:
..national action regarding conservation and sustainable use of biodiversity and equitable sharing of benefits arising out of the utilization of genetic resources demands appropriate actions on the part of international community.

The international community would then have to respond accordingly. The principle of "common and differentiated responsibility" established at UNCED has not yet fully taken hold in the relations between Northern and Southern governments. The Report of the U.N. Secretary General on "Implementing Agenda 21", in its part F, dealing with Sustainable management of ecosystems and biodiversity, articulates the range of activities required in the sector.

The degradation of natural ecosystems may, in some cases, be moving towards critical thresholds beyond which natural resilience is destroyed and recovery becomes difficult or even impossible. Commitments should be made and initiatives agreed upon to halt and reverse the current degradation of the natural environment by:
1: Site-specific research is necessary to advance the understanding of the ecosystem composition. Improving indicators and data on land degradation and improvement in order to assess and manage those processes and their impacts;
2: Defining intellectual property rights relating to biological resources in order to ensure that benefits derived from the use of genetic material are equitably shared;
3: Fully implementing the Global Programme of Action for the Protection of the Marine Environment from Land-based Activities, which is currently hampered by the lack of funding and the need for large investments to address land-based sources of pollution;
4: Improving the management of marine and coastal protected areas and increasing their number since protected reserves (or no-take areas) have been shown to increase the diversity and productivity of marine organisms;
5: Integrating agriculture with other aspects of land management and ecosystem conservation in order to promote both environmental sustainability and agricultural production;
6: Improving policies and laws to allow for a more systematic approach to sustainable mountain development, addressing such issues as property rights, economic incentives, political empowerment and the preservation of cultural heritage in an integrated manner;
7: Resolving issues of illegal, unregulated and unreported fishing and overcapacity of fishing vessels;
8: Enhancing cooperation, coordination and synergies among international organizations and instruments related to forests, in the framework of the Collaborative Partnership on Forests;
9: Managing man-made and natural disaster risks, with an emphasis on pre-disaster preparedness, mitigation, vulnerability assessments, adaptation strategies and other measures to reduce human and economic losses.
10:Monitoring to detect major changes in the status of the biological diversity.

Every sphere of research on biodiversity and its conservation-biological, economic and cultural-will require activities across ecological zones. Each developing country should build their own competent researchers and develop solid institutions. The task ahead at the 2002 WSSD in Johannesburg is to move the protection of developing nations' biodiversity rights beyond the paper protections of the CBD.

There have also been attempts at preparing Community/ Peoples Biodiversity Registers (CBRs/PBRs) in several parts of India, a process and product, which is yet to be given formal recognition by the State. The CBRs not only serve as local directories of biological resources but, in their making, a valuable process for community management of biological resources. There are also other several ongoing efforts at community-based conservation (CBC), some of which even find mention in India's submission to the WTO which seek to highlight how trade negatively impacts local control over biological resources and their knowledge. An important process oriented activity under the CBD is the making of the National Biodiversity and Strategy Action Plan (NBSAP) in which the country's largest ever exercise in environment and development planning is involving tens of thousands of people in making 75 local, state, regional, and thematic action plans .

If humanity is to avoid becoming once again a spices consisting of scattered group practicing subsistence agriculture, dramatic steps will be necessary. They can only be briefly outlined here. Simply setting aside preserves in the remaining relatively undisturbed ecosystems will no longer suffice. In most parts of the planet such areas are too scarce, and rapid climatic changes may make those preserves impossible to maintain . Areas already greatly modified by the human activities must be made more hospitable for other organisms, for example the spewing of toxins into the environment must be abated. Above all, the growth of the human population must be halted, since it is obvious that if the scale of the human activities continues to increase for even a few more decades, the extinction of the much of the earth's biota cannot be avoided. Reducing that scale will be an especially difficult task, since it means that the environmental impacts of the rich must be enormously curtailed to permit the poor a chance for reasonable development.

Although improvements in the technologies use to support human life and the affluence can of course help to ameliorate the extinction crisis, and to a limited extent technologies can substitute for the lost ecosystems services, it would be dangerous miscalculation to look to technology for the answer . Only an intensive effort to make those improvements and substitutions, combined with a revolution in attitudes towards other people, population growth, the purpose of human life, and the intrinsic value of organic diversity, is likely to prevent the worst catastrophe ever to befall the human lineage. Curiously, scientific analysis points towards the need for the quasi-religious transformation of contemporary cultures.

We must begin this formidable effort by increasing public awareness of the urgent need for action. People everywhere should understand the importance of loss of bio diversity. The geological record can tell us much about the catastrophic mass extinctions in the past. That, and more intensive studies of the living biota, can provide hints about what we might expect in the future. At the present time, data's on the rate and direction of biodiversity loss remain sparse and often uncertain. As a result, estimates of the rate of loss, including the number and variety of species that are disappearing, vary greatly. More over scientist have also differed in their predictions of the eventual impact that will result from the diminishing diversity.

Biotechnology:

Modern biotechnology is found to offer the mankind the potential of enormous benefit-including healthier and longer life with plenty of water and food. Modern day biotechnology deals generally with molecular biology and specifically with genetic engineering. Basically biotechnology concerns 'techniques' for using the properties of living things to make products or services. Thus the OCED defines biotechnology to be "the application of scientific and engineering principles to processing of materials by biological agents to produce food and services. According to the CBD biotechnology "means any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use. The Indian 1989 Hazardous Microorganisms Rules defines biotechnology as to mean "the application of scientific and engineering principles to the processing of materials by biological agents to produce goods and services". Thus the modern biotechnology involves scientific techniques on living things for commercial exploitation. The technique include:
a) Selecting natural strains of organisms that carry desirable traits;
b) Making hybrids by fusing cells from different parental sources;
c) Using chemicals and radiation to create mutant strains or genetically engineered plants, animal, and microorganisms to produce specific phenotype characteristic.

Like most modern technologies, biotechnology cannot be confined within the borders of a single state. Indeed the techniques of genetic manipulation are so simple and relatively inexpensive that the Third World countries may easily claim a share of the important discoveries that are certain to result. The next decade is therefore, likely to witness intense competition among nations of leadership roles in the development of new biotechnologies.

Benefits:
'Agriculture: Perhaps the most immediate benefits from biotechnology will flow from its agricultural uses. Through relatively simple genetic engineering techniques, scientist can create biological pesticides that are highly selective and therefore not as likely to cause adverse environmental side effects as chemical pesticides. Genetic modification techniques can also be applied directly to plants to improve yields. For example, scientists should soon be able to create plants that have a higher resistance to diseases and drought. In addition to increasing yields, genetic engineering can increase crop quality by enhancing nutritional value, flavor and processability. The development of agricultural biotechnologies will be of particular interest to developing countries, where agriculture is often a mainstay of the economy and where the pressure of past land use is rapidly reducing the capacity of existing technologies to increase yields. Biotechnology has the potential greatly to improve the productivity of land by reducing the quantities of water and energy necessary to raise a given crop while at the same time preserving essential soil nutrients. It may well be that new products of biotechnology will become essential to the survival of some 3rd world countries as population pressures relentlessly demand greater agricultural production from fewer natural resources.

'Public Health: Genetic engineering techniques can be used to manufacture live animal vaccines to protect human beings from vector borne diseases. Scientist are also attempting genetically to modify mosquitoes to make them incapable of transmitting diseases such as malaria and yellow fever.

Mineral Development:

Genetically altered microorganisms are capable of leaching metals from low grade ores and thereby enhance recovery of such metals such as copper etc. Unlike traditional metal recovery techniques, biotechnology does not require high temperatures and pressures, and it is significantly less polluting. Similar technologies might also be used to mine deposits that are otherwise unreachable. Bioengineered microorganisms might also be used to facilitate crude oil recovery from marginal wells. Microorganisms could be designed to lower viscosity of the oil in place and to increase underground pressure by generating carbon dioxide.

Pollution Control: The very first genetically engineered microorganisms to receive a patent in the US was designed to digest crude oil into less toxic substances. Microorganisms already play a prominent role in water pollution control technology, and genetic engineering techniques have an enormous potential both for enhancing the efficiency of the existing pollution destroying bugs and for producing new microorganisms that are capable of rendering toxic pollutants in drinking water harmless.

As with many modern technological developments, the enormous benefits of biotechnology will not come without corresponding social and environmental risks. Biotechnology has a dualistic character. On the one hand, it offers developing countries new ways of solving a number of major constraints and it also can contribute to their economic independence. On the other hand, its application and use can cause social, economic and ecological problems.

Risks:

Substitution of traditional commodities:

Using biotechnology it has become possible to produce substitutes for some traditional commodities. This development threatens those countries that depend heavily on the export of few commodities. As commodities become extremely interchangeable, the processing companies (which are mainly located in the industrialized countries) have a wider choice of material. Because of their economically weak position and narrow export base, developing countries will suffer from the loss of export markets for one or more commodities, and this can have serious adverse consequences for their development.

Industrialization of Agriculture:

Much of the current biotechnological plant research is carried out by multinationals and is aimed mainly at large scale, commercial agriculture. The technology developed is adapted to the needs of this type of agriculture. More than 75% of agricultural production in developing countries, however, is on a small scale. The currently available biotechnology is not adapted to the needs of the small producers or their limited ability to invest and is thus unsuitable for them. The large commercial producers will be able to make use of the technology, thus increasing their productions, but that of the small farmers would remain the same. Increased production will lead to lower prices, which is good for the general public but bad for small farmers. This may lead to even more migration to the over crowded cities, where there is no prospect for work.

Another problem associated with the industrialization of agriculture is that more and more crops are being sown with the same genetic base. The narrowing of the genetic base of the main commercial and food crops increases the risk from diseases and pests because the whole plant population becomes equally susceptible to disease and environmental stresses. This genetic erosion threatens the world supply of food and plant improvement research, which is based on genetic diversity.

Privatization of Knowledge and Technology:

The idea of patents on products and processes in microorganisms goes against the principle of free availability of natural genetic resources. At both the national and international level there is still no clear definition of which new developments might be covered by patent law. Patenting in advanced countries will jeopardize these countries export markets and small scale food production, and that as a result the gap between he third worlds countries and the west and between the developing countries themselves will widen. Moreover, biotechnological research in industrialized countries ignores any possible consequences for developing countries.

'Effects on People and the Environment: In many cases the application of biotechnology will involve the introduction of new or modified organisms into the areas where they were not found in the same form or to the same extent. The effect of this might include the following:
1: disease in people, animals and plants;
2: disturbance of ecosystem;
3: transfer of new genetic properties to other species; and
4: decrease of genetic diversity.

Very little is known about the possible risks of introducing genetically modified organism (GMO'S) into the environment. Living organisms reproduce and, once released, they are hard to control. The effects may be irreversible. In developing countries, the infrastructure is not strong enough for effective production of biotechnology-generated products. A further constraint is the weak distribution and marketing networks. The problem of mass poverty in the 3rd world is essentially one of rural poverty. Biotechnology applications in rural areas can contribute to poverty alleviation if they are accompanied by widespread gains in the purchasing power of the poor through the creation of increase employment opportunities in rural areas.

The International Dimensions:

There can be little doubt from the foregoing that the development of the deliberate release biotechnologies in the foreseeable future will have important international dimensions. Although it may already be too late to implement an international solution to the anticipated problems posed by the future worldwide spread of biotechnologies (given the slow pace at which international institutions move), it is worth while to explore the international aspects of biotechnology and to ask whether international solutions mat be appropriate. One consideration is since citizens and the environment in one country can be harmed by biotechnologies originating in another country, an international approach to regulating deliberate release biotechnologies is required.|

Since most responsible scientist agree that at least some kinds of release of genetically engineered microorganisms into the environment, most countries in which deliberate releases are likely to occur will probably erect some form of regulatory programme for health and environmental protection. At the same time, it is unlikely that all countries will erect identical regulatory regimes. Multinational corporations will play the predominant role in the international development and marketing of such technologies and a multinational company that faces stringent regulatory requirements in one country may be tempted to conduct field testing and marketing in a country with less stringent regulations.

The only way to prevent transnational "forum shopping" is to achieve international uniformity through international law. Either an international liability regime must be capable of dissuading multinational companies from seeking out the least capable regulators or an international agreement must provide for some minimum level of health and environmental protection in all countries in which companies are likely to conduct field tests, erect manufacturing facilities or otherwise expose humans and the environment to genetically modified plants and microorganisms. A uniform international regulatory regime will be more attractive to companies attempting to market novel biotechnologies.

The implications of biotechnology applications seems to be quite significant. Development of commercial biotechnology though possess certain remedies to the worldwide problems in varied fields it also possess certain problems. It has actual and potential risks to human beings and plant life as well as environment. Fears have arisen over unknown toxins, antibiotics resistance, and genetic pollution. In addition to these general fears of the world as a whole, the third world countries have expressed their concern over development of commercial biotechnology. The third world countries have already expressed their fear and concern over "Bio-Colonialism" and "Bio-Piracy".

Apart from scientific and political concerns of biotechnology, there are also concerns founded on ethical and religious grounds for example interference with nature and God Designs. All these concern cumulatively suggest the need for the regulation of biotechnology. Moreover, any unregulated, unbridled development could cause chaos in the society that is why jurisprudentially it is said that law has to be responsive to not only to the social economic and political but also to the technological developments/changes that take place in the society/community.

Regulating Biotechnology: The Basic Issues:

he need for regulating biotechnology has been felt a decade ago. However currently there is not a single particular institution created for the exclusive purpose of regulating biotechnology and products of biotechnology . It is simply because biotechnology issue is not simply one issue at all but a complex matrix of issues that touch upon scientific, political, social, ethical and economic concerns and hardly any international institutions has the scope, the resilience, the political support or expertise to provide and support a comprehensive framework for the regulation of biotechnology. The various concerns expressed regarding biotechnology and biotechnology products essentially revolve around 2 basic questions: "Is it safe?" and "Is it good?". It has been found that the question "is biotechnology safe?" further breaks down into 2 sub questions:
1. How does one regulate biotechnology to protect human health and plants and animals for human consumption?
2. How does one regulate biotechnology to protect against threats to environment; and the question "Is biotechnology good" also breaks into two parts:
How does one regulate biotechnology to balance socio-economic interest?
Need we establish some ethical boundaries for manipulating life?

Thus with respect to the second aspect "Is it safe"? question the biosafety regulations assume greater significance. In other words the biosafety regulations/rules provide the necessary answer to the question, from the environmental perspective how one can regulate biotechnology?

Bio-safety:
Generally speaking 'Biosafety' is an all embracing term referring to safety measures relating to potential or actual adverse effects on the conservation and sustainable use of biological diversity including risks to human health, arising as a consequence of the application of the modern biotechnology . Thus incidentally biosafety measures can operate so as to regulate the biotechnology and its products. The safety measures may, for example, include a ban on the biotechnology product or its import, based on the risks assessment- risk assessment for releasing genetically modified organisms (GMO's) into the environment and the risk management requirements once the GMO is in the environment; the Bio labeling (to indicate that the product is a product of biotechnology).

The Bio-safety Protocol:

The first protocol under the framework of 1992 UN Convention on Biological Diversity (CBD) was conducted when the parties to the CBD negotiated over the course of 5 years and then adopted on Jan 29, 2000 The Cartegena Protocol on Bio safety to the Convention on Biological Diversity . The biosafety Protocol by means of 40 articles and 3 annexes aims at creating an international framework for addressing the environmental risks and effects of some products of biotechnology.

The objective of Biosafety Protocol is:

"To contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and specifically focusing on trans-boundary movement."
Thus the biosafety protocol is concerned with the safety of living modified organisms (LMO's) resulting from the modern biotechnology that may have adverse effects on conservation and sustainable use of biological diversity including risks to human health.

Obligations:
Under Art.2 (2) of the Protocol a general obligation to ensure that the development, handling, transport, use, transfer and release of GMOs is done in such a manner that it prevents or reduces the risks to biological diversity including risks to human health, is imposed. This general obligation of bio safety protection is realized at two levels. Firstly by imposing certain general obligations like duty t co-operate in relation to GMO matters (Art 16 (5) ), specifically in research on the socio-economic impact of the GMOs (Art 26) and to make financial provisions for national operations aimed at the implementation of the Protocol (Art. 28 (1) ). At the second level the biosafety protection is ensured by insisting upon risk assessment, risk management, transparency and import measures.

It is of the interest to know that the precautionary principle as contained in Art. 15 of CBD is incorporated in the risk assessment. Risk management refers to the maintenance of mechanisms and strategies to manage and control risks that have become known as a consequence of risk assessments. Coming to transparency framework, it comprises the Advanced Informed Agreement Procedure (AIA procedure). This procedure deals with (a) intentional [Art. 7] and unintentional [Art. 17] transboundary movements of GMO's. (b) GMO's intended to be introduced into the environment (Art.7) and GMO's intended for direct use as food or feed or for processing (Art 11). Another aspect of the transparency measures is that the Bio safety Clearing- House is to facilitate "the exchange of scientific, technical, environmental and legal information and experience with the LMO's. Thus the Bio safety Protocol provides a regulatory framework for GMO's. The regulatory framework though could be only for a limited purpose namely transboundary movement of the GMO's assumes grater significance as it encompasses bio-safety provisions.

Indian 1989 Hazardous Micro Organisms Rules (Bio Safety rules):

In exercise of the powers conferred by the Environment Protection Act, 1986 and with a view to protect the environment, nature and health in connection with the application of gene technology and micro organisms, the Govt. of India has made the Rules for the manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells. The rules cover biotechnology products developed using techniques like cell hybridization and genetic engineering or by any such other gene technologies (Rules 2(3)). Various competent authorities have been created to ensure and supervise the compliance of the safety measures like Recombinant DNA advisory Committee; Review Committee on Genetic Manipulation; Institutional Bio safety Committee; Genetic Engineering Approval Committee; State Biotechnology Co-ordination Committee; District level committee.

The implications of biotechnology and biotechnology products are alarming. Biotechnology, like any other branch of science brings both good and evil. To curb these evil effects and at the same time to derive benefits to the mankind, biotechnology has to be regulated because it may even pose threat to our own survival. In this context only bio safety measures to some extent assume significance. The Bio safety measures basically address the environmental concerns of the biotechnology and bioproducts/GMO's/LMO's. At the international level the Bio-safety Protocol governs the transboundary movements of GMOs. At the national level by the 1989 Hazardous Microorganisms Rules, an attempt is made to regulate the manufacture, import and storage of LMO's. The import, export, transport manufacture, process, uses or sales of LMOs can only be dome with the approval of the Genetic Engineering Approval Committee. The discharge of the GMOs can be prohibited in specific areas. Deliberate and unintentional release of the GMOs even for the experimental purposes except in special cases is totally prohibited. Food products containing LMOs cannot except with the approval of the above-mentioned committee (GEAC).

However there are some facts that undermine these rules effectiveness. The Protocol only covers LMOs and its application is limited only to the effect of LMOs on conservation of biological diversity. The Protocol is silent about non-living genetically modified products like food products prepared from genetically modified grains, clothes manufactured from genetically modified cotton. All pharmaceuticals are excluded from the purview of the Protocol. The Indian 1989 Act though cover GMOs, genetically modified products, pharmaceuticals, food stuffs etc, the primary object of the Rules is to protect the environment, nature an health and not regulating biotechnology and biotechnology products. The Indian Bio safety Rules employs Polluter pays principle and prior intimation/ notification to realize its objects.

The Bio safety Protocol's, import restrictions can overlap generally with the provisions of WTO that is concerned with liberal trade and specifically with Agreement on Sanitary and Phytosanitary measures (SPS Agreement), an agreement on technical barriers to trade (TBT Agreement). The biosafety import ban could also be potentially conflicting with free liberal trade. In this context it is of interest to note that the Indian 1989 Rules was brought up into force in 1993 before WTO came into force in 1995. The legal position of the 1989 Rules in WTO era is not clear. If the rules run counter to free trade then they have to be suitably altered to be consistent with the WTO provisions. Regulating biotechnology is not a simple easy task, as many socio-economic issues are involved in regulating it. The fact that many of the socio-economic issues/ questions, for example the questions as to right to development and inter generational equity, the rights of indigenous people, the farmers right, environmental protection, ethical and moral question- are not unique to biotechnology alone still worsens the problem. Any attempt to regulate biotechnology may in effect turn out to be finding answers to these global socio-economic questions. Till the comprehensive legal regime regulating biotechnology emerges, the Bio safety regulations could be of some help.

New Threats To Biodiversity And Related Rights

Biotechnological processes use life forms or derivatives thereof, to make or modify products or processes for specific use. Under IPR's, transformed microorganisms, plants and animals can be patented and become exclusive private property. The North has always used Third World Germplasm as a freely available resource and modified it. The advanced capitalist nations wish to retain free access to the developing worlds storehouse of genetic diversity, while the South like to have the proprietary varieties of the North's industry declared a similarly public good.

The overall result is that genetic resources of the South are normally freely available without charge, while those based on Southern genetic resources but developed in the North are becoming subject to the monopoly control by private companies. Northern countries are not only putting enormous political pressures on developing countries to accept uniform patent laws through GATT/WTO and other mechanisms, they are also refusing to make clear commitments to developing countries on access to biotechnology and other associated technologies. In the new economic order, there are two nascent developments, interconnected as they are, which are of serious concern to biodiversity and related rights in India. These are intellectual property rights relating to biological resources and the impact of genetic engineering on agriculture.

On January 1, 1995, the WTO was established and the TRIPs agreement came into force. TRIPs specifically require all governments to provide for patents for all inventions . The WTO is backed by economically strong developed countries. Most of the multilateral trade agreements within the WTO have been negotiated at the urging and for the benefit of corporate interests in developed countries. For instance, the TRIPs Agreement was drafted with significant input from Intellectual Property Committee (a coalition of twelve major U.S. corporations), Keidanren (a federation of economic organizations in Japan) and the Union of Industrial and Employees Confederation (the official spokesperson for European Business and Industry). As such, the agreement was basically fashioned to meet the commercial interests of multinational companies based in these countries.

Most of the economically strong developed countries have a vested interest in keeping in line with the WTO provisions, primarily to retain market access to and control over bio-resources of the developing countries that these set of rules provides. The negotiations were a package deal, wherein the developing countries had little space to pick and choose elements that would be acceptable. And neither does the WTO allow for any reservations. Nelson Mandela, former President of South Africa, commenting on the results of the GATT Uruguay Round, said: "The developing countries were not able to ensure that the rules accommodated their realities... it was mainly the preoccupations and problems of the advanced industrial economies that shaped the agreement." Mandela added that rules applied uniformly are not necessarily fair because of the different circumstances of members.

The TRIPs agreement of the WTO requires member states to accept IPRs over microorganisms, micro-biological processes and plant varieties . This core requirement and provision is antithetical to India's cultural and economic interests. It also puts at risk the community-based public domain knowledge of biological resources. Article 27.3(b) of TRIPs is of particular concern to developing countries, in as much as it to mandatorily requires for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. This article was a major coup for biotechnology and agrotech corporations in that it provides broad international patent protection for engineered bioresources.

With respect to patent systems for seeds, article 27 of the TRIPS Agreement provides that the "member countries shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof". In the same Article, it is also provided that the provision of this sub-paragraph shall be reviewed 4 years after the date of entry into force of the WTO agreement. Though for the time being, choice of evolving the system of protection of plant varieties is left to each country, the obligatory provision is that the sui generis system (meaning a system of its own) must be effective. The transitional arrangement provided in art.65 of the TRIPS agreement allow a developing countries a period of 5 years to establish their own system of plant breeders right (PBR's) which means that there was no obligation to evolve the system as such till 2000 AD. Further, it could also be interpreted from Article 65(4) that "those developing countries who do not extend product patent protection to areas of technology not so protectable in their countries could delay the application of the provision on product patent by an additional 5 years".

Opinions differ as to whether seeds could be treated as 'products'. 10-year period is a long time and the developing countries can watch the development in the world to take the best advantage of any favorable conditions that might emerge.

Though no specific model has been suggested in the TRIPS text, there are models available in the UPOV convention 1990. The other agreement that is closely related to WTO TRIPs Agreement Article 27.3(b) is the International Convention For the Protection of New Plant Varieties ("UPOV"). It has no developing country as its member. In view of this, the model which has emerged in the UPOV convention for plant variety legislation is suitable mainly in the socio-economic context of the industrialized countries. The farmers in these countries do not have much role over plant breeding or seed supply as in the case of the developing countries, where farmers themselves are engaged in the seed production and they are also the main source of seeds to other fellow farmers. Almost about 65% of the seed requirement is met through the exchange system, which has been prevalent in countries like India.

In the past, UPOV protected farmer's interest by allowing them to save protected varieties of seeds. This protection to farmers was retained in the amendment to the UPOV in 1978. The breeders also enjoyed exemption for free access to protected varieties, for use in further research and for breeding other varieties. However, UPOV Convention 1991 has removed the exemptions available under 1978 convention. Breeders and preachers will have to pay royalty to the plant breeder right holder to use the protected variety for breeding new varieties.

UPOV is primarily designed to protect the patent rights of agrotech companies and disallows farmers to save seeds at the farm level. The "protected variety" may still be used as an initial source of variation for the creation of new varieties but such "new varieties" increasingly under the control of corporate breeders cannot be marketed or sold without the plant breeders' rights' holder allowing it. This undercuts the rights and welfare of the majority of the farming population in India. So far we are concerned, seeds are also not patentable in India today, and we do not have any intention in changing this system. The extension of IPR's to plant varieties either in the form of patents or in the form of plant breeders rights is bound to result in increased in prices of seeds, greater domination of agriculture by multinational companies and slower diffusion of new varieties. Provisions of international trade law, such as those in the TRIPs and UPOV, serve to disenfranchise local communities and contradict the biodiversity rights recognized in the CBD. More specifically, these trade law provisions are not compatible with the CBD's protection of the biodiversity rights of indigenous and local communities.

The biodiversity crisis in India and other developing countries is heightened by the fact that the international trade agreements are being implemented at a much faster pace than can be matched by any possible safeguards in domestic law and policy for biodiversity and related rights of the people. Since 1995 (post-WTO) several IPR-related legislation have been enacted in India, most of which bolster the interests of multinational biotech/agrotech corporations.

The most controversial legislative development, however, has been the amendments to the 1970 India Patent Act. By an amendment enacted in 1999, provision was made for grant of exclusive marketing rights on drugs and agrochemicals, a sector hitherto reserved for government in the interest of keeping pricing and supply in check. In an era of biotechnology where drugs, pharmaceuticals and agrochemicals are derived from biological sources, patent issues in medicine and agriculture necessarily involve issues of biodiversity.

The 1999 amendment to the Patent Act was pushed through despite protests from citizens and non-governmental organization (NGOs) who pointed out that the rush to make domestic legislation TRIPs-compliant jeopardized the health and agriculture sectors of the country, and was unwarranted particularly when there is a review provision in TRIPs that countries like India must avail of to highlight the problems faced in implementation. This resulted in NGOs filing a writ petition in public interest in the Supreme Court of India, challenging the amendment as unconstitutional and against national interest. There is also a second amendment, which seeks to introduce product patents in India, which is poised for clearance by the Parliament. The Court has allowed the petitioners to withdraw the abovementioned case with the liberty to file a fresh writ petition, if necessary, after this subsequent second amendment is made.

Another sector of biodiversity that has been vulnerable to the change in patent law and policy is that of agricultural biodiversity. The Indian agriculture sector has been opened up to international trade as per the dictates of the WTO. This has meant, among other things, reorientation of cropping patterns for export markets, entry of global corporations in the seed, food processing and packaging sectors and industrialization of agriculture with the introduction of potentially hazardous technologies, such as genetic engineering.

India issued its first ever National Agriculture Policy in 2000. On the one hand, the policy expressly remarks how the situation for Indian farmers would deteriorate in the wake of integration of agricultural trade in the global system. On the other hand, however, it continues to focus on promoting "value addition" and accelerating the growth of agrobusiness. This policy also does little to address the problem of the economic marginalization of small-scale, diverse food production systems that conserve farmers' varieties of crops, which form the genetic pool for food and agriculture in the future. On the contrary the policy inter alia seeks to give special attention "...to development of new crop varieties, particularly of food crops, with higher nutritional value through adoption of biotechnology particularly, genetic modification.

There are legitimate biosafety concerns arising from this focus on the development of new crop varieties. As the Government of India itself admits in the second report to the CBD, there are not adequate mechanisms in the country to deal with this potentially hazardous technology. For instance, open field trials of Monsanto's transgenic cotton have been allowed by the Government of India's Department of Biotechnology without proper approval of the Genetic Engineering Approval Committee of the Ministry of Environment and Forests.

As per scientific fundamentals, in an ecosystem you can always intervene and change something, but there is no way of knowing what all the downstream effects will be or how it might effect the environment. The risks associated with open field trials involving transgenic material are those arising from the understanding of reproduction and multiplication inherent to living organisms. Releases of genetically engineered organisms may trigger irreversible changes with the elements of the natural environment that they come in contact with, as against when they are kept in closed containment whereby such an interaction is not possible. Highlighting the possible risks to human and ecological health, as well as the need of clear jurisdiction in the biotechnology and regulatory system a writ petition was filed in the Indian Supreme Court challenging these open field trials.

The matter is still pending before the apex court. In the meanwhile, transgenic Bt cotton was found to be growing in the Western State of Gujarat late last year without the Center or the State governments having given permission for the same. With such an apparent by-pass of the regulatory system, posing risks to the natural environment and divided Center and State opinions on the manner in which it should be dealt with, the debate on whether India should adopt transgenics in agriculture has been rekindled anew.

Principle 15 of the Rio Declaration provides that when there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for proposing cost-effective measures to prevent environmental degradation. This approach is commonly referred to as the precautionary principle. Because of the reproduction and multiplication inherent to living organisms, releases of genetically engineered organisms can have an irreversible negative impact on the environment. As reiterated by Justice M.J. Rao of the India Supreme Court: "...there is nothing to prevent decision makers from assessing the record and concluding there is inadequate information on which to reach a determination. If it is not possible to make a decision with some confidence, then it makes sense to err on the side of caution and prevent activities that may cause serious or irreparable harm. An informed decision can be made at a later stage when additional data is available or resources permit further research."

As early as the time of adoption of the CBD, India had taken the position that the "focus of studies... relating to liability and compensation should be on subjects as biotechnology products, the environmental aspects of genetically modified organisms..." These issues remain unresolved. Also, the issue of a ban on Genetic Use Restriction Technologies (GURTs), more commonly known as Terminator and Traitor technologies has often been raised in the CBD. However, many have been left disappointed with the outcome of the Conference of Parties, which did not take a strong stand on this issue.

Genetically modified organisms and intellectual property go together. The law of patents allows private ownership at the level of the gene. In other words, IPR law under TRIPs legitimizes the patenting of life forms and biodiversity. Today transgenic crops are the "intellectual property".of the multinational corporations, such as Monsanto, which are marketing the technology to countries in the Third World. Monsanto has been very loud and public in its claims against farmers who used its patented seeds, even if this use was accidental. Multinational agro-business firms such as Monsanto have been aggressively pushing their products into India not only through the regular trade route, but also by dumping food and seeds with GMOs as food aid in disaster areas, as well as in nutritional programmes.

Meanwhile there has been as increase in the spending in developed countries on research and development in crop biotechnologies for application in agricultural practices in the developing countries. The lack of technical knowledge in developing countries is a matter of grave concern when dealing with potentially hazardous technologies. The most pressing concern, however, is the imbalance of negotiating strength between the corporations that pioneered transgenic crops on the one hand, and farmers, scientists and governments in poor countries on the other.

There is the concern that wide use of transgenics in agriculture would reduce the diversity of crop species grown and so reduce the gene pool. The gene pool has already been reduced to some extent by modern farming techniques and it is feared that the availability of GE crops would aggravate the problem.

Many Indian farmers--generally the small and marginal--never adopted the intensive practices used in many developed nations, such as heavy reliance on pesticides and chemical fertilizers. These farmers still use traditional seeds that can be saved from one crop to plant the next. Those farmers may get smaller yields and profits than their corporate counterpart, but because they use free seeds--and, often, little or no chemical fertilizers or pesticides--they rarely take on debt. If GE seeds become the norm traditional seeds might become hard to find, or the latter could get contaminated by GE crops in neighboring fields due to possible crosspollination. Then the big multinationals would control the market for seeds--the most basic source of a farmer's livelihood and, indeed, his/her life. In this scenario, Indian agriculture would increasingly become a subsidiary of agro-business corporations in the North.

Food and agriculture systems are going through major transformations worldwide with serious ramifications on biodiversity. If the CBD is to check this, it must strengthen its programme work on agricultural biodiversity, a task begun at the COP3. The CBD has asked with reference to the WTO Committee on Trade and Environment ("CTE") to develop better appreciation of the relationship between trade and agricultural biodiversity.

Per the 1994 WTO Agreement on Agriculture (AOA), the member countries - both developed and developing - are obliged to gradually open up their agricultural sectors to world trade by removing all the trade distortions. For instance, India was compelled to remove quantitative restrictions on imports of several agricultural goods with effect from April 1, 2001. Previously, imports have been restricted by countries on various grounds for environmental and ethical reasons and reasons of public order - so as also to protect the small and unorganized sector that would be adversely affected by an influx of imports. India, as a member of WTO, is now required to implement various agreements and provisions pertaining to agriculture. These include commitments on reduce domestic support, increase market access, reduce export subsidies.

A major area of concern is the impact of the western-styled IPR system promoted by the WTO. CBD's COP has also sought cooperation from the WTO in the context of IPRs and particularly in the context of benefit sharing. In its submissions to CTE, India has proposed that under its terms of reference the CTE (Committee of Trade and Environment)) should deal with: (a) the relationship between the provisions of the CBD and those of the TRIPs Agreement; and (b) suggestions on reconciliation of any contradictions therein, in line with the CBD provisions or within the same overall objective of conservation of biological resources with sustainable development. India has also offered some suggestions to reconcile the contradictions here abovementioned. For instance, at the CTE in 2000, India raised the issue of biopiracy of traditional knowledge, reiterating "patent applicants should be required to disclose the source of origin of the biological material utilized in their invention under the TRIPS Agreement and should also be required to obtain prior informed consent (PIC) of the country of origin."

The WTO has not yet responded to these demands, and there here is no visible attempt by the WTO to re-orient the IPR regime accordingly. On the contrary, recent decisions by WTO dispute panels has insisted on TRIPs compliance by developing countries. Similarly, there is also no indication that reviews of the TRIPs Agreement are giving consideration to any fundamental change in the international IPR regime.

Issues of traditional knowledge are discussed in a number of international fora including the CBD, the FAO (U.N. Food and Agricultural Organization) and the U.N. Economic Social and Cultural Organization (UNESCO), the World Intellectual Property Organization (WIPO), the WTO's TRIPS Council and the CTE. Herein it is crucial to keep the CBD central, for the opportunities that it provides to developing countries.

In the present trade dominant paradigm, there is also the risk of the CBD being invoked by corporate interests to bolster their IPR claims, and developing world governments need to be wary of such attempts. Mere utilization and value addition to indigenous bioresources cannot be considered a vehicle for economic growth of developed countries, which possess the larger portion of the world's bio-assets.

This is manifested in the debate on access and benefit sharing (ABS) in the CBD. Currently, under the auspices of the CBD, a Working Group is discussing the development of Draft International Guidelines on Access and Benefit-Sharing. In India, a national regime to manage these access issues has been proposed in the Biological Diversity Bill . The Bill envisages the setting up of a National Biodiversity Authority, which would process access and also effect the sharing of benefits arising from such access granted. Importantly, this national access legislation recognizes the rights, customary laws, and practices of indigenous peoples and local communities.

Biopiracy:

By 2050, the world is expected to have 9 billion people - as against 6 billion today. The tragedy is that while the biggest sources of biodiversity are in tropical countries, they are the least informed about what they possess, leading to charges of "bio-piracy" against industrial countries which plunder these resources and make extortionate profits on them.

Biopiracy can refer to

1. Unauthorized use of biological resources
e.g., plants, animals, organs, microorganisms, genes;
2. Unauthorized use of traditional communities' knowledge on biological resources;
3. Unequal share of benefits between a patent holder and the indigenous community whose resource and/or knowledge has been used;
4. Patenting of biological resources with no respect to patentable criteria (novelty, non-obviousness and usefulness).

In under-developed countries, farmers breed crop varieties adapted to their local soil/climate conditions over several decades. Local plant breeders improve varieties through a circular model: selective breeding, release of the variety, and use of the seeds for further selection. Traditional varieties are not fixed genetic structures, but rather dynamic structures, resulting from collective efforts over generations. Most of the time, improvement and use of crops cannot be separated.

An interesting variety may be locally known for its particular properties and identified by a local name, but rarely patented. This may be explained by several facts: the crop does not show the quality of stability and homogeneity required, patenting is a long and expensive process, the selection of the crop is a community work, hence no single holder can be identified, etc.

Given the international market potential, an agricultural biotechnological company can decide to ask the indigenous community of the biodiversity-rich country for information on interesting crops availability. Discovering that this variety and its characteristics appeal to a market in developed countries, the company acquires samples of it. The firm, then, genetically engineers a close substitute from the original natural variety, adding an improvement (e.g., pest resistance), and keeping the natural variety's desirable characteristics.

As a genetically engineered variety, the new crop can be patented and its name copyrighted. Companies, in particular, are quick to apply for a patent on the collected resource or the new products, so as to prevent competitors from using them. The biotechnological company may license production of the crop in any suitable country, and even export the product in the source-country, in which case the improved variety comes into competition with the traditional one. The company may even ask for the intellectual protection of the modified variety in the original country in order to prevent both seeds from co-existsting, and the natural variety from being sold under the traditional name. In the latter case, the source-country loses its rights to produce or use the original variety for any further breeding.

The implications for the source-country are various:
-Possible necessity for the farmers to use the new patented variety, implying increasing dependence on the company owning the seed, especially in case of monopoly;
-Prohibition of the use of the seed for any further breeding;
-Loss of biodiversity resulting from increased monoculture, monospecies culture and lack of access to seed stocks;
-Possible financial loss when fair agreement on benefit sharing between the source country and the company was not achieved.
-Possible loss of traditional community knowledge, with limited compensation.

During the last decades, an erosion of biodiversity was observed. The majority of the actors estimated that the first cause of biodiversity erosion was the lack or the wrong definition of the rights of ownership. The (CBD) entered into force in 1994. It gave sovereign national rights over biological resources. One of the advantages of it was that it would enable southern countries to better benefit from their resources and traditional knowledge. Under these new rules, it is expected that bioprospecting implies a prior informed consent, and must result in a share of the benefits between the biodiversity-rich country and the prospecting firm. However, some critics believe that the CBD has failed to establish appropriate regulations to prevent biopiracy.

Research costs and benefit sharing

Some companies argue that under-developed countries are themselves guilty of piracy. They believe that the southern countries do not have adequate and efficient intellectual property protection laws, and say they are losing millions of dollars per year because of lack of respect of patents. These companies have been applying pressure for the strengthening of intellectual property issues within the WTO.

Companies say access to biological resources allow them to develop new products that could help solve food and health essential issues. They also argue that research; development and commercialization authorizations have a cost that must be balanced by the protection of the resulting product. Patents offer this much needed revenue and favour innovation.

One of the solutions suggested to solve this North-South disagreement was to define bilateral contracts between source-country and pharmaceutical or seed companies. These contracts of bioprospecting lay down the rules of benefit sharing, and can potentially bring substantial royalties to southern countries.
What defense is there against biopiracy practices?

The agreement can result in high potential benefits for the source-country. However, there are several reasons why this usually does not happen:
1. Bilateral contracts are not always respected, or they do not propose a fair trade. By admitting that the principle of compensation of the populations is retained, which amount could be an equitable and realistic remuneration? How could the rights be redistributed?
2. Lack of awareness of the potential value of the products;
3. Very few of the samples collected actually lead to a new profitable product;
4. Lost ownership in case of genetic modification;
5. Majority of concerned species to be found in several countries at the same time, thus preventing some of them from taking advantage of the product, or diluting the benefits for all;
6. Protection of collective knowledge doesn't fit within the legal systems of IPR protection (e.g. patents, copyrights, trademarks);
7. Finally, most bioprospecting is made by directly using the genetic resources stored in seed banks.

Some options considered by southern countries include:
1. Documentation of traditional knowledge;
2. Registration and innovation system;
3. Easier and less expensible patenting system;
4. Development of a sui generis system;
5. Development of own research;
6. Creation of alliances of source-countries.

In 1993, 500,000 Indian farmers demonstrated against the General Agreement on Tariffs and Trade. In a Charter of Farmers' rights, they stated their wish to protect their right to produce, reproduce and modify seeds and plants.

Conclusion:
As the world moves further into the 21st century, there is no question that its biodiversity is under threat from several sources. Perhaps the greatest of them all is the sheer ignorance of what it comprises. Put simply, biodiversity refers to the number of species of wild plants and animals a country possesses. The UN has a Convention on Biological Diversity in place since 1993, which has been signed by most countries, but the protection it offers to countries to protect their natural resources remains largely on paper. One of the biggest threats to biodiversity is the conversion of forestland to produce more crops. While it is true that the bulk of the food grown by 2050 will come from increasing the productivity of existing farm land, an additional 120 million hectares will have to be brought under the plough in developing countries in the next 30 years, according to the Food and Agriculture Organization. The International Union for Conservation of Nature estimates that as many as 350 species of birds, or 3.5 per cent of such fauna, may be extinct in 50 years; birds are a vital indicator of the vitality of the ecosystems. Another danger is to the marine ecosystem, largely due to reckless over fishing.

One of the little known, and highly controversial, hazards is due to global warming, which is already changing ecosystems at an alarming rate. The Inter-governmental Panel on Climate Change, which consists of 2,500 scientists from around the world, estimates that the average global surface temperature will be up to 2 degrees Celsius higher in 2050, and atmospheric accumulation of carbon dioxide will be much higher too. As some areas grow hotter while others become cooler or wetter, not to mention the widespread inundation of low-lying coastal areas, flora and fauna are exposed to drastic changes. A final threat emanates from the genetically modified (GM) crops, which narrow the number of plants being grown on farms. Biodiversity offers considerable promise for food, medicine and fiber.

To conserve the biodiversity, the immediate task will be to devise and enforce time bound programme for saving plant and animal species as well as habitats of biological resources. In addition to this formidable efforts to increase public awareness. People everywhere should understand the importance of loss of bio diversity. Development of commercial biotechnology though possess certain remedies to the worldwide problems in varied fields it also possess certain problems. The third world countries have already expressed their fear and concern over "Bio-Colonialism" and "Bio-Piracy". All these concern cumulatively suggest the need for the regulation of biotechnology.

Northern countries are not only putting enormous political pressures on developing countries to accept uniform patent laws through GATT/WTO and other mechanisms, they are also refusing to make clear commitments to developing countries on access to biotechnology and other associated technologies. India, as a member of WTO, is now required to implement various agreements and provisions pertaining to agriculture. These include commitments on reduce domestic support, increase market access, reduce export subsidies. Mere utilization and value addition to indigenous bioresources cannot be considered a vehicle for economic growth of developed countries, which possess the larger portion of the world's bio-assets and therefore appropriate measures have to be taken under the Convention on Biological Diversity to protect against these dangers so that the Convention fulfills its objectives.

Regeneration of land and water, which are degraded to abysmally low levels of productivity over more than 60% of India's area. This cannot be done by centralised bureaucracies, but by empowering and providing resources to rural and urban communities. The amazing regeneration of forests under joint forest management over millions of hectares, or of wetlands through decentralized water harvesting, despite inadequate power-sharing in such programmes, is proof enough of the capacity of communities to make miracles happen.

Indeed, such regeneration is potentially India's single biggest source of employment, as highlighted by the Planning Commission some years back. With this, the government could tackle three critical issues at the same time: the ecological crisis, raging unemployment, and the declining productivity of our land. There are considerable resources being put into 'wastelands development' and watershed programmes today, but these need to be much more in the hands of local people, and need to emphasize local solutions building on available indigenous knowledge, planting or regeneration of local species, and sensitivity to indigenous farming practices.

Bibliography
Books Referred:

• Alexander Gillespie, Environmental Law Policy and Ethics, 1997 edition, Oxford University Press.
• Hunter David, Salzman James; International Environmental Law and Practice, 2nd edition, 2002, New York Foundation Press
• Dwivedi O.P., India's Environmental Policies, Programmes and Stewardship, 1997 edition, Macmillan Press Ltd.
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• Gunther Handl, Year Book of International Environmental Law, Vol. 1, 1990, Graham and Trotman.
• Mathur Purohit, Biotechnology: fundamentals and Applications, 1999 edition, Botanica Publications.
• Francioni Francesco, Scovazzi Tullio, "International Responsibility for Environmental Harm", 1991 Edition, Graham and Trotman Publications.
• Kumar H.D., "Modern Concepts of Bio Technology", 1997 edition, Vikas Publishing House.
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• Wilson E.O., Bio Diversity, 6th edition, 1990, National Academy Press.
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Journals referred:

• Gadgil Madhav, "The Bio-Diversity Act, 2002: An Act for the New Millennium", J. Biosci, Vol.28, No.2, March 2003, Indian Academy of Sciences.
• Dr. Ambrose A. David, "Regulating Biotechnology: The Bio Safety Regulations", Journal of Indian Legal Thought, Vol.1, 2003.
• Olivette Rivera-Torres, "The Biosafety Protocol And The WTO", Vol XXVI, No.2, Spring 2003, Boston College International And Comparative Law Review.

Internet Sources:

• www.art.man.ac.uk/PLANNING/CURE/LIFE
• www.regenwm.org/rwmImages/events/regeneration
• www.barnsley.gov.uk/service/regeneration/bio diversity

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Article 21 of Indian Constitution- A Mandate To Pollution Free Environment

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