Regulatory Supervision of Emerging Technologies A Case for Nanotechnology in India Regulatory supervision of emerging technologies is seen as unfriendly to business ventures entering uncharted areas. However, technologies like nanotechnology should be supervised as they pose potential environmental risks and health hazards. The initial investments into research in such technologies are public-funded and, hence, it is important to consider questions of efficiency in resource allocation, the need for transparency and public involvement in decision-making. NUPUR CHOWDHURY
M
uch of history has been witness to the largely ambivalent role of the state in encouraging and adopting technological revolutions. The role of the state has ranged from outright rejection and suppression of such technological advances to that of state patronage being extended to the scientific stalwarts on the verge of important breakthroughs. Through much of the 20th century, however, there was a gradual trend towards securing public investment in new and emerging technologies that held out hope of securing geopolitical aims and ambitions. For instance, nuclear technology was one such coveted and highly visible illustration of public sector investment in a new technology. An important characteristic of this trend was that this phenomenon was largely limited to Europe, the US and Japan. In the developing countries, at the time of the fervour of post-independence, the technological upgradation that took place was driven by foreign investments and aid depending on geopolitical considerations, (i e, either the US or the Soviets) to which they belonged. Thus, the main aim of the developing countries was to secure the transfer of technology by signing bilateral science and technology agreements. Adaptation of non-indigenous technologies was the primary aim of the public scientific establishment. In India, this trend was largely reflected within the post-independence scientific establishment. The government was an
4730
ardent investor in fundamental research that was essentially carried out in the premier scientific educational establishments. Public sector investment in research was mostly driven towards capacity building without any strategic link between the investment made and the scientific results generated.
Regulating ICTs, Biotechnologies The boom in information and communication technology (ICT) has been largely driven by private sector funding – though the initial impetus came from the government. Within the telecom sector, the government, for instance, set up a specialised regulatory body to address the concerns relating to pricing, efficiency and competition aspects of supplying and consuming telecom products and services. This kind of strong regulatory posturing has, however, not been reflected in other important sectors involving emerging technologies – like that of biotechnology. In biotechnology, it has largely been the private sector that has driven market-based solutions. In biotechnology, though the government did take the essential first steps by providing a statutory framework (the notification1 was passed way back in 1989) for regulating the burgeoning sector in terms of its environmental and other health impacts, it did not take the followup steps to functionalise the regulatory infrastructure. One of the reasons for its go-slow approach to regulations was so as not to appear to be seen as sending out the wrong
signals to wary investors. This is despite the fact that especially in the case of biotechnology, there has been considerable criticism of its lack of transparency and lethargy in setting up of regulatory institutions and structures which would be charged with overseeing this potentially harmful technology. In the sphere of biotechnology applications, despite regulations being formulated at an early stage, unfortunately there has been little practical implementation. This has been primarily because the government has yet to invest in the development of a robust risk assessment, management and governance structure.2 Public involvement (in terms of interaction and discussions) on the development and application of the regulatory governance structure has been negligible. In fact, the risk discourse within the government regulation of emerging technologies could be characterised by a defensive reaction to the widespread criticism (and in one case, a legal challenge) that was made at the point of providing project approvals given to the Bt cotton seeds. In the case of nanotechnology, there is a serious apprehension of a similar situation arising. The government should therefore take an early lead in involving civil society in the deliberations over a future framework for nanotechnology governance this country, specifically the risk assessment, managements and mitigation framework. This would mean that the present attempts of the government to engage with the public in terms of the science and society interface programme that is currently in place would have to be extended and, to some extent, reoriented in terms of its exclusive focus on promotion of rural and indigenous technologies. This would substantially be in conformity with the current legislative trend of making the government more transparent by way of empowering the public with the right to information.3 The Right to Information Act and the public policies that support its functioning are a revolutionary step forward in terms of enabling the establishment of a framework of statutory rights which could be instrumental in opening up the hitherto closed-up scientific establishments to public debates and criticism. This is imperative especially in the case of new scientific technologies (like nanotechnology, for
Economic and Political Weekly
Electronic copy available at: http://ssrn.com/abstract=1105655
November 18, 2006
instance), which may have far-reaching consequences for society.
Nanotechnology Applications Nanotechnology is one of the most rapidly developing fields of technological applications. One of the most important differences between nanotechnology applications and those of the other technologies is that the former is a platform technology (ETC Group 2005), in that it has the potential to influence almost every sector and stage of manufacturing process. There have been a few studies4 that have highlighted the potential adverse impacts that might result from nanotechnology applications resulting from the toxicity of such materials. Further, nanotechnology also has the potential of application to manufacturing chains and across scientific disciplines, and thus has the potential for physical disruptions across manufacturing processes. There have been studies5 which predict that the nanotech applications will in future reduce the dependence on natural rubber. Such kind of an impact would be felt in several south-east countries where rubber is a main export product. Thus consequences of nanotech applications would not only potentially include environmental and health aspects, but also more general societal impacts relating to labour dislocation and more extensive concerns of livelihood disruption, etc. Nanotechnology refers to the manipulation of substances at the nano scale. There are some substances that are naturally occurring nano particles. However, nanotechnology per se refers to the deliberate human intervention – at the nano scale to produce substances, which react in a manner different from their physio-chemical qualities at their naturally occurring size. Thus, at a nano scale a material could well be a good conductor of electricity – while in its naturally occurring size it is not. In this context, therefore, questions of toxicity and environmental impacts are relevant and important. If at a nano scale materials act differently – the odds are in favour of it also reflecting differential levels of toxicity, conductivity, etc. This task is especially relevant due to the exponential expansion of the applications of nanotechnology from hardware products to that of beauty products and including clothing (which entails direct human exposure). Thus we have a situation in which the applications of this technology has far Economic and Political Weekly
outreached the levels of information we have on the toxic and other impacts of this technology on human health and the environment. There is, therefore, a critical asymmetry of information.
Question of Regulation The obvious next question that pertains to the regulation of such a technology is what should be the subject of regulation. In this case it would be helpful to differentiate between nanotechnology as a process, as a set of materials (as in nano materials) and products containing such nano materials. Experts like Davies and Maynard have contended that it is the latter two – i e, nano materials and products containing such materials that need to be regulated. However, a case could also be made for regulation of nanotechnology per se as is practised at the laboratory level primarily in terms of ensuring health safety aspects of laboratory professionals and addressing the concerns of environmental impacts that might result from such experimentation. In terms of nano materials and application, regulations would apply at several stages. At the manufacturing stage, the manufacturers of such nano materials would be liable for ensuring the health and safety of the workers – in terms of security from occupational hazards and also in terms of safe disposal of potentially polluting wastes that may result from the manufacturing process. In the case of products using such nano material, the primary legal directive would be in terms of specifying the standards and degrees of permitted which is safe. In the sphere of nanotechnogy research and investment in India, the government of India is consciously pursuing a private sector-friendly approach to investment and has taken several steps to encourage private-public sector investment in this technology. 6 In this context too the government has similarly postponed regulatory initiatives largely on the argument that the technology is still in its nascent stage and there is lack of information as to its potential harmful effects. This makes for an interesting comparison with that of regulation of genetechnology. In the case of the latter, India has developed a regulatory regime (although inadequate) quite early, and therefore, one could logically raise the question, why then in the case of nanotechnology, it has taken
a wait and watch approach. One of the reasons could lie in the essential differences in the nature of the technologies. The other could well be in the government’s keenness not to appear to be overtly regulatory as was perceived by many private investors within the biotechnology sector. Nanotechnology is not subject specific but is essentially a combination technology that essentially refers to physical or chemical properties of any substance at a nano scale. It is therefore inherently difficult to identify subject criteria to regulate such a technological revolution.
Nanotech Research Nanotech research in India is still at a nascent stage and conservative estimates put it around a good decade behind that in the US and Europe. The authorities therefore feel that it far too early to focus on regulation when the research is still at an experimental and laboratory stage. They are, however, aware of the potential health impacts of nanotech agricultural products and the ethical issues underlying their usage. The present regulatory posture can be suitably described as that of an open door policy of subsidising public research and encouraging publicprivate partnership in nanotech ventures. The nanotechnology research initiative has been largely a fundamental science programme focusing primarily on equipment research. Research at the nano level has been carried out at government research institutes for sometime now, not within the larger confines of a dedicated research programme, but as part of the various disciplines of fundamental research sponsored by government funding. The Nanoscience and Technology Initiative (NSTI) was launched as a national programme by the department of science and technology in October 2001. The programme is focused on primarily three aspects, i e, investment in fundamental research programmes initiated at government research laboratories, human resource development in terms of organisation of symposiums and training workshops for research scholars on nanotech research, and lastly, facilitating public-private industry partnerships focusing on commercialisation of nanotech research. Within the government, nanotechnology research is carried out by three
November 18, 2006
Electronic copy available at: http://ssrn.com/abstract=1105655
4731
departments, viz, the department of science and technology (DST), the Defence Research and Development Organisation (DRDO) and the department of biotechnology (DBT). Amongst the three it is the DST that is overseeing the disbursement of research funds and activities under the NSTI. The DST is therefore responsible for the overall coordination of nano initiatives undertaken through government funding in the country. Given the disparate and sometimes competitive nature of governmental departmental structure it is still unclear as to how much reviewing authority of DST holds over those nano programmes that are funded directly or are undertaken by the research institutes working under the departmental supervision of the DRDO and the DBT. This lack of jurisdiction would to an extent impact on the functioning and would act as an impediment to the regulatory authority in undertaking a more proactive role. The research funded under the NSTI focuses on four specific areas of research; viz, nano materials for surface coating purposes, nano metallurgy, nanosensors (like electronic application devices) and nano drug delivery systems. The choice of these four areas reveals a distinct plan on the part of the government to focus and direct our research energies in the sectors wherein nanotech research (in the west) has been able to produce significant results in terms of commercially successful products or product enhancements. Policy planning in terms of identification of sectors for research investment has therefore primarily been guided by the potential or the possibility of commercialisation. Observers have suggested that some of these areas identified for research investment are important sectors since they would considerably enhance India’s present capacity and leadership in some significant industries. The Indian generic drug manufacturers are a case in point, wherein they would be able to add premium to their generic drugs by supplying them along with state-of-the-art nano scale drug delivery systems. Within the government, nanotechnology is seen as holding the promise of spectacular development and growth, much like that of information technology. This kind of an overt commercialisation focus could possibly lead to a climate where research into the environmental and
4732
safety aspects of nanotechnology could be neglected. Some observers have also warned of the potential disruptive effects of nanotechnology on the commodity markets of the south7 by providing costeffective alternatives to the natural goods like rubber, etc. This is also an area of research that requires attention, especially since natural commodities form a significant part of India’s exports. The nanotech research supportive of product innovation of natural raw materials, is imperative for securing future markets for natural commodities. Some research institutes have used considerable flexibility afforded to them under the fundamental research programme of the government. The S N Bose Centre, Kolkata, for instance, has experimented with nanotechnology in enhancements of jute products.8 Currently, the research funded by the government on nanotechnology amounts to around Rs 23 crore per annum.9 Public sector investments are the primary drivers of investments in nanotechnology and there is an approximately 1:5 ratio between public and private sector investment in business ventures on nanotech applications. Under the NSTI, therefore a conscious effort has been made to reallocate funds earmarked under the soft loan scheme of the Technology Board and fund disbursement units of Technology Information, Forecasting
and Assessment Council (TIFAC) to finance nanotech ventures.
Regulatory Imperatives The government’s position is overwhelmingly guided by the prospect of massive growth impacts of nanotech research – the perceived potential of which is expected to even greater than what has been delivered by the information technology boom. The research programme has been deliberately kept at the level of a fundamental science programme though directed largely at the four sectors noted above. It is still at a very nascent stage and therefore the government views regulation of the technology as premature and has consciously adopted a wait and watch policy. The issue of regulation is also seen as potentially problematic at this stage since it could act as a disincentive for the private sector to invest in nanotechnology. The government is not unaware of the moral, ethical and environmental dimensions of nanotech research. It has made public statements10 to this effect and has plans to set up an expert body within the government with the mandate of deliberating on these aspects of research and investment. This is welcome. But given the state’s history of organising policy committees with an overwhelming representation of government bureaucrats, it is
INDIA FOUNDATION FOR THE ARTS I F A India Foundation for the Arts (IFA), an independent, grant-making organisation supporting scholars and artists nationwide invites proposals for grants to be made under its arts research and documentation programme. While the programme has in the past supported a range of projects under the broad head of ‘research and documentation’, it is now focused on two main themes. 1) Research and documentation that critically investigates the making of cultural traditions. 2) Research and documentation that seek to put in place or use new methodologies for studying contemporary arts practices. Scholars, artists and groups who are interested in working on either of these two themes are welcome to apply. For details and application requirements (in English and some other Indian languages) write to Madhuban Mitra, India Foundation for the Arts, Tharangini, 12 th Cross, Raj Mahal Vilas Extension, Bangalore – 560 080; Tel/fax: 080 - 23610584/23610583; e-mail:
[email protected]. You can also download further details about the programme from our website www.indiaifa.org The last date for receiving completed applications is January 31, 2007.
Economic and Political Weekly
November 18, 2006
suspect as to how far these efforts would yield a substantive deliberation in terms of participation of cross section of stakeholders (including industrialists, scientists, academicians, policy experts, etc) within the larger civil society.
Conclusion It would be instructive to outline a few of the regulatory imperatives that should necessarily be included within any governance structure for any new and emerging technology. The first concern in emerging technologies with unknown environmental and health impacts is to put in place adequate structures to carry out risk assessment procedures and ensure laws and policies that would address the liability and redress issues inherent in the application of such potentially harmful technology. The second would be to ensure that investments in such new technologies are adequately focused towards developing usages that would generate public goods like a clean environment. A general review of the current structure of legislation, government rules and judicial prescriptions reveals that there is a possibility of regulating nanotechnology within this structure. Further there exist established legal principles (viz, the precautionary principle and absolutely liability) which need to be internalised within the regulatory regime. The present legislative structure however needs to be thoroughly rationalised in order to be made applicable to nanotechnology. The contribution of the current structure lies not in its applicability but rather in serving as a huge reservoir of regulatory experience that has been developed through the application and implementation of this structure. The drafting of legislation, rules or regulations to govern nanotechnology would necessarily benefit immensely from the different aspects of regulatory governance that have been functioning in the protection of health and environment. Lastly, one cannot but reiterate the need for transparency and public involvement in the design and implementation of any regulatory structure that is to be developed in the near future. This is imperative for several different reasons. First, because unlike other emerging technologies, nanotechnological applications could potentially touch all aspects of our lives and secondly this technology has the Economic and Political Weekly
potential to adversely affect environment and health, and there should therefore be an extensive public deliberation on all aspects of risk assessment and management underlying nanotechnological applications. This calls for a change in the traditional framework of scientific policymaking from that of an essentially bureaucratic enterprise to that of a more participatory and consensual process of scientific policy-making. EPW Email:
[email protected]
Notes 1 Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, Ministry of Environment and Forests Notification, Issued on December 5, 1989 under the Environment Protection Act 1986.
November 18, 2006
2 Note for instance the government’s transference of the responsibility to carry out risk assessments in the case of Bt cotton seeds to the producer (Monsanto Biotech). 3 Right to Information Act 2005, passed by the Indian legislature and received presidential approval on June 15, 2005. 4 Maynard 2005, Oberdorster 2005 and Thomas 2005. 5 South Centre Report – ETC Group. 6 Re Science and Technology Policy Statement 2003. 7 ETC Group; Potential Impacts of Nano-Scale Techlologies on Commodity Markets: The Implications for Commodity Dependent Developing Countries, South Centre, November 2005. 8 Presentation of Mitra of S N Bose Centre; made at the Indo Nanotechnology Conclave, attended by the author on February 23, 2006. 9 Information given by V Rao Aiyagiri, director, SERC, department of science and technology, in a personal meeting with the author. 10 Presentation made by P Asthana (scientist SERC, DST) at the India Nanotechnology Conclave, February 22-23, 2006, New Delhi.
4733
