Biotechnology

In biotechnology more than in any other area, lack of knowledge of hazards cannot be treated as safety. Restraint and caution is therefore considered the only wise strategy for unleashing powerful technologies with potentially serious risks in a context of near total ignorance.

For Third World countries, a special danger exists for being used as a testing ground and as guinea pigs.

In addition, the uncertainties for the South are aggravated by the fact that the governments of the South want access to the new technologies of the North. In their haste to get access to the new technologies, the Southern governments could unwittingly place themselves and their people and environment in this role of testing ground.

Therefore, to increase the benefits from the new technologies and to reduce their negative impacts, the Third World needs to rapidly evolve a method to assess biotechnology on the basis of ecological, social and economic impact.

Transfer of technology, an important issue for the South, needs to be negotiated within such an assessment framework, so that socially desirable transfer of technology can take place while undesirable and hazardous transfer can be prevented.

In the area of the environmentally safe biotechnologies, it is important to have criteria of demarcation between technologies and products that are dangerous and unnecessary and those that safe and desirable. This requires comparison and evaluation amongst different technology options, and the treatment of the new biotechnologies as merely one among many available alternatives to reach the same objective. In the final analysis, technology assessment and choice demands that technology be treated as what it is, a means and not an end in itself.

Biotechnology and Biodiversity

There is a prevalent misconception that biotechnology development will automatically lead to biodiversity conservation. The main problem with viewing biotechnology as a miracle solution to the biodiversity crisis is related to the fact that biotechnologies are, in essence, technologies for the breeding of uniformity in plants and animals. Biotech corporations do talk of contributingto genetic diversity. As John Duesing of Ciba-Geigy states, 'Patent protection will serve to stimulate the development of competing and diverse genetic solutions with access to these diverse solutions ensured by free market forces at work in biotech ecology and seed industries'. However, the 'diversity' of corporate strategies and the diversity of life forms on this planet are not the same thing, and corporate competition can hardly be treated as a substitute for nature's evolution in the creation of genetic diversity.

Corporate strategies and products can lead to diversification of commodities; they cannot enrich nature's diversity. This confusion between commodity diversification and biodiversity conservation finds its parallel in raw material diversification. Although breeders draw genetic materials from many places as raw material input, the seed commodity that is sold back to farmers is characterized by uniformity. Uniformity and monopolistic seed supplies go hand in hand. When this monopolizing control is achieved through the molecular mind, destruction of diversity becomes more accelerated.As Jack Kloppenburg has warned, 'Though the capacity to move genetic material between species is a means for introducing additional variation, it is also a means for engineering genetic uniformity across species.

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Considerations from the International Biosafety Workshop
held on 23 and 24 February, 1997

The importance of biosafety arises from the need to ensure that the costs of the use and release of genetically engineered organisms (GEOs) are not higher than the benefits for which they are designed.
Since India is a biodiversity rich region, the risks of negative ecological impact on our biodiversity, our environment and agriculture are higher than in industrialised countries which have less complex ecosystems as well as more uniform production systems. The scientific basis for biosafety assessment is an economic as well as an environmental imperative for a country like India. Only on the basis of biosafety can the full and positive potential of biotechnlogy be realised.
In the absence of biosafety assessment, there are no mechanisms available for assessing risks and hence the costs against which all biotechnology development must be weighed. Biosafety is essential for safe and sustainable biotechnology development both because without biosafety there will be no public acceptability and without it, in certain cases the environmental and public health risks could outweigh the benefits.

Biosafety and risk assessment aims to identify and estimate risks to the environment or to human health that may accompany the release or use of a genetically engineered organism (GEO). Although a desirable GEO (or its products) would confer demonstrable benefit, its application should not:

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burden human health,
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inhibit agriculture or other human activities,
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endanger survival of other organisms, except when an injurious organism is intended to be suppressed or eliminated,
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reduce the effectiveness of existing products,
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endanger organisms that are in centers of origin of crops or other cultivated organisms,
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preclude future applications of any technology.

Risk-assessment is too often considered 'science-based' largely because data are collected beore regulatory decisions are made. Science-based risk assessment, hopwever, should:

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use accepted scientific reasoning and ecological principles.
* be open, intelligible and accountable to the scientific community.
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be a PROCESS of case-specific evaluation built upon a clear understanding of modern ecological concepts and on sound experimental design and inerpretation. It is inappropriate to conclude that whole categories of GEOs are commercially safe simply because 'nothing unexpected happened' in numerous laboratory and contained field tests.
* recognise that the technology is new and developing and its applications are not yet fully understood.
* evaluate GEOs not only for their commercial traits but for intended and unintended ecological effects.
* build for foundations of risk assessment on solid scientific ground and not on limited and short term data. Since the ecological knowledge that evolves from biosafety assessment is necessary for building capacity for biodiversity conservation, biosafety assessment should be viewed in the positive context of scientific capacity building and not in the negative context of "regulatory burdens"
* Since the ecological impacts of the commercial release of GEOs is requires a wider and different expertise on the the basis of which the GEOsare developed, biosafety assessments need to be based on wide scientific particiation of the larger scientific community to draw on all the disciplines required for ecological impact assessment. Experetise required for impact analysis has to comoplement the knowledge based of biotechnology for through biosafety.

A science based biosafety policy and assessment framework requires on the one hand that we do not declare as an article of faith that there are no risk involved. Risk need to be scientifically and empirically assessed. A 'don't see' policy generates ignorance about risks. It does not help avoid risks. On the other hand, the early assumptions that the only form of ecological risks are "biohazards" in the form of hazardous and infectious organisms are also scientifically uniformed. The ecological risks can include invasiveness, displacement of indigeneous biodiversity, undermining of agricultural production through the creation of the new ests, diseases ande weeds. A scientifically sound biosafety framework requires the integration of the infectious diseases model, the exotic species model and the domestidated crop model.

Thus, a credible system of risk assessment, based on modern scientific principles, must be implemented at the design stage for GEOs as well as during their development commercialization and when post-commercial monitoring is indicated. Several suggestions have been offered concerning systems for anticipating the long-term impact and consequences of genetically-engineered organisms,including the suggestions of the African group negotiating the biosafety protocol in the Convention on Biological Diversity and scientists who evolved the biosafety framework at the Puget-Sound workshop. These science based biosafety frameworks need to be built on and adapted for the Indian context with wide participation of the scientific community.