Excerpt: "This is a strategy to avoid risk assessment; and hence a strategy for deregulation of the biotechnology industry in India and outsourcing genetic pollution and health risks to India's ecosystem and the Indian public."
Outsourcing Ecological and Health Risks & Reducing Scientists to Bio-coolies for Industry
Dr. Vandana Shiva condemns India's New Biotechnology Development Strategy
India has emerged as a major global player in the outsourcing of information technology (IT) related activities from the developed world. Now, its New Biotechnology Development Strategy ("India’s biotech future", accompanying article) is proposing an outsourcing of biotechnology related activities. It states in no uncertain terms: "Biotech can deliver the next wave of technological change that can be as radical and even more pervasive than that brought about by IT."
There is however a major difference between IT and biotechnology. The latter deals with the manipulation of life forms at the genetic level through genetic engineering (and at the atomic level when combined with nanotechnology). The engineering of life is inherently linked to ecological and health risks. Outsourcing biotechnology is therefore the outsourcing of risk; and this is clearly admitted in the introduction:
"The Indian Biotechnology sector is gaining global visibility and is being tracked for emerging investment opportunities. Human capital is perceived to be the key driver for global competitiveness. Added to this is a decreasing appetite for risk capital in developed countries, which has led to a decline in the biotechnology sector in these regions where survival lifelines are being provided by the lower cost research environs of the developing world such as India."
GMOs: hope vs hype
Biotechnology is defined as a "technology of hope", despite the repeated failure of the only commercialized product of agricultural biotechnology, Bt-cotton:
"Biotechnology, globally recognized as a rapidly emerging and far-reaching technology, is aptly described as the "technology of hope" for its promising of food, health and environmental sustainability."
Bt-cotton is genetically engineered cotton, which contains genes taken from a soil bacterium (Bacillus thuringiensis) to produce toxins in the plant to reduce infestation by American bollworm. It has promoter genes to create high-doses of the toxin, which are released in all parts of the plant during the entire life span of the crop.
The history of Bt-cotton in India is a story of lies, legal violations and connivance between multinational corporations and governmental authorities. It began in March 1995, with MAHYCO, a collaborator with Monsanto, importing 100 grams of Bt cottonseed after obtaining permission from Review Committee of Genetic Manipulation (RCGM) in the Department of Biotechnology, and not from the Genetic Engineering Advisory Committee (GEAC). Under the Environment (Protection) Act 1986, the GEAC is the only body that can grant permission for importing genetically engineered substances (seeds in the present case). Therefore the import of Bt gene into India was illegal (For details of the illegal import, trials and seed multiplication, see the publication by Vandana Shiva, Seeds of Suicide, Navdanya, New Delhi, 2000)
In 1998, Monsanto-MAHYCO started large-scale multi-centric, open field trials in 40 acres at 40 locations spread over nine states; also without the permission from GEAC even though it is the sole agency to grant permission for large-scale open field trials of GMOs under the 1989 Rules.
The Bt-cotton failure forced the government to not renew permission for planting in the Southern states where it had been planted for the past 5 years. Instead the government has cleared Bt-cotton for Northern states.
The Research Foundation for Science, Technology and Ecology was forced to initiate a case against Monsanto-Mahyco and the government because the trails and clearances have violated all Biosafety Laws and Rules framed under the Environmental Protection Act (1986) for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms and Genetically Engineered Organisms or Cells, 1989.
The failure of Bt. Cotton has pushed farmers into debt, and in some cases to suicide. For small farmers, biotechnology is clearly not a technology of hope.
Besides the social costs, there are serious ecological risks associated with GM crops.
At a time when the negative experience with genetically engineered crops should be leading to a strengthening of biosafety regulation, the strategy is calling for a total deregulation of biotechnology. The deregulation is proposed through two processes.
First, the current multi-tiered biosafety regulation in which the Ministry of Environmental has final authority for clearance is to be replaced by a single window clearance under the Department of Biotechnology.
A new National Biotechnology Authority has been proposed to cover agricultural products and GMOs, pharmaceuticals and drugs, transgenic food and feed and transgenic animal/aquaculture. This effectively marginalises health and environmental risk assessment.
Second, the case-by-case approach in risk assessment is to be replaced effectively by reinventing the discredited principle of substantial equivalence. The Strategy states:
"It is recommended that an event that has already undergone extensive biosafety tests should not be treated as a new event if it is in a changed background containing the tested and biosafety evaluated "event"."
The "event" referred to is the genetically modified (GM) insert containing the transgene that has landed in a particular location of a given plant genome. The assumption that the transgene will behave in the same manner when introduced into a different plant genome is scientifically flawed. Natural Bt, a soil bacterium is not the same as the Bt Cotton, and the Bt protein in one cotton variety will have different implications for health and environmental safety than the same Bt in another cotton variety; and all the more so, in Bt mustard or potato.
This is a strategy to avoid risk assessment; and hence a strategy for deregulation of the biotechnology industry in India and outsourcing genetic pollution and health risks to India’s ecosystem and the Indian public.
A future of genetically engineered plants, animals and humans
The Strategy proposes to genetic engineer rice, wheat, maize, sorghum, pigeon pea, chick pea, moong bean, ground nut, mustard, soy bean, cotton, sugarcane, potato, tomato, cole crop, banana, papaya, and citrus; in other words, the entire food basket. And the untested genetically engineered foods are to be promoted for consumption by Indians. In addition, the Strategy also proposes to genetic engineer animals, especially buffalo, cattle, sheep and goat. Genetically engineered fish are also a priority, with a focus on carps, tiger shrimp and fresh water prawns.
Not only that. The Strategy also aims to promote human genetic engineering with promise that,
"We will be able to repair some of the damage caused by aging, organ by organ”¦”¦.. The application of nanotechnology in bioengineering together with biotechnology offers a great new range of advanced biomaterials with enhanced functionality; and intertwined with tissue engineering, it has the potential to provide true organ replacement technology of the coming decade."
The nanotechnology applications to be promoted are carbon nanotubes for biosensors, DNA nanowire, bio-molecular chips.
The new biotechnology strategy is rushing headlong to include new technology areas for which independent risk assessment needs to be evolved. As Vicki Colvin, Director of the Centre for Biological and Environmental Nanotechology, Prince University observes:
"In a field with more than 12 000 citations a year, we were stunned to discover no prior research in developing nanomaterials risk assessment models and no toxicology studies devoted to synthetic nanomaterials." (Quoted in The Big Down: From Genome to Atom, ETC group, Jan 2003)
Under a single window clearance, no new assessments for nanotech will be evolved. The technology will thus evolve in a regulatory vacuum. Further, with an "event" treated as equal in all contexts, carbon nanoparticles will be treated as safe because carbon in its naturally occurring forms is safe. However, research at Rice University showed that nanoparticles were accumulating in the livers of lab animals (ETC Report P 24).
As nanoparticles can be taken up by cells, they can enter the food chain. And what makes nanoparticles efficient as drug delivery systems viz., their ability to easily enter the blood strain and even target individual cells due to their small size can also become the reason for the risk of a new form of "nanopollution".
Nanoparticles could reach organs they were not intended to be in, and have impacts that were never assessed. The health and environmental risks need to be assessed before the technology is developed. Instead the new Biotechnology Strategy is planning to introduce nanotechnology below the regulatory radar.
Privatisation of knowledge
Simultaneously with outsourcing risk, the Strategy rests on privatizing India’s intellectual and biodiversity wealth. The 500 000 students trained annually in biological sciences, 17 000 medical practitioners graduating annually from India's Medical Colleges, and 300 000 postgraduates and 1 500 Ph.D.s qualifying in biosciences and engineering each year are the human raw material for the new vision. India's rich biodiversity of agricultural crops and medicinal plants is the biological raw material.
Mobilising India’s scientific talent for the Biotechnology industry is the main objective of "human resource development" in the Strategy.
Visiting professorship and creation of industry-sponsored chairs in partnership with the Department of Biotechnology
Industry research laboratories to be introduced at the school level to create interest in the fields of biotechnology and biology
Public-private partnerships to be encouraged in Ph.D. programmes through creation of the "Bio-Edu-Grid" a network of universities and industries facilitating pooling of resources
Scientists working at universities and research institutions to be allowed to work in industries for commercialization of their research efforts
Dual/adjunct faculty positions: researchers working in university/research institutions to be allowed to hold positions in the industry and vice-versa
Joint salary support: faculty in academic institutions to be paid salaries by industry;
Rapid travel grants to scientists to be approved within two weeks to meet industry collaborators
To facilitate these partnerships with industry, contract research organisations (CROs) and Contract Manufacturing Organisations (CMOs) are being set up. Gene banks and animal testing labs will be set up in partnership with industry. While the Indian public and parliament are working to change TRIPS and amend India's patent laws to exclude patents on life, the Biotechnology Strategy proposes to lobby WTO and the Government of India to include patents on life and patents related to biotechnology.
The biotechnology policy is therefore a radical reorientation of our public education and public research systems to serve the narrow needs of industry, not the broad and diverse needs of society.
In effect, the strategy envisions reducing our biological scientists into "bio-coolies" for the global biotech industry.