NANOTECHNOLOGY is acknowledged as an emerging technology with huge potential for usage in various significant sectors such as agriculture, healthcare services and the fertilizer industry. The Government of India had focused on and invested in the field of nanotechnology as early as 2001 with the Department of Science and Technology (DST) launching the Nano Science and Technology Initiative and more recently the Nano Mission. The erstwhile Planning Commission also encouraged research and development funding in the field of nano-science.

Even though the public funded research and development in the domain of nanotechnology has been quite robust and almost a decade old, it is worth noting that regulatory and the legal framework pertaining to nanotechnology is still at a nascent stage. The Indian experience in dealing with other emerging and high technology sectors such as outer space and biotechnology is no different so far as creating an effective regulatory and legal framework is concerned. The need for regulatory clarity is pertinent for market oriented private investment and participation and also for creating a platform for innovation and commercialization. The risk an emerging nanotechnology poses to the environment and human health also needs concerted attention from a legal and regulatory perspective.

Nanotech involves dealing with materials at the nano-scale level. It is due to the fact that ‘at the nano-scale, common materials often have different physico-chemical properties than in bulk form’¹ and can leverage the beneficial characteristic features of those materials. For example, silver acquires an antimicrobial character and silicon attains the character of a good conductor at the nano-scale. The commercialization possibility of nano-materials by leveraging the special character they may acquire at nano-scale too is significant. The growing use in drug delivery mechanisms and the potential as nano-biosensors is a good rationale for pushing research and development in the field of nanotechnology.

 

The Department of Science and Technology serves as the nodal agency for the promotion of nanotechnology research and development in India. The Nano Science and Technology Initiative was launched in 2001 to boost research and development, infrastructure and manpower.² In 2007 with the launch of the Nano Mission, a monetary allocation of around 1000 crore rupees was earmarked for research and product development.³ The Nano-mission also emphasizes the need for industry participation through the Public Private Partnership model. In the eleventh plan period, the Planning Commission placed emphasis on nano-biotechnology and nano-medicine. The Department of Electronics and Information Technology have also started a nano electronics initiative.⁴

Even though nanotechnology has got requisite support for research and product development, less attention has been given to the need for a regulatory framework to tackle environmental and health risks arising out of nanotechnology – critical given the scientific uncertainty regarding the impact of certain nano-materials on human health and environment. With day-to-day advancement in commercial application of nanotechnology, the regulation of risk has also become a challenge. An appropriate example is the advent of 3-D print technology. The human health risk factor is perceived to be high in the use of 3-D printers as they might expose users to toxic nanoparticles.

The regulatory scenario in India to comprehensively deal with the environmental health safety risk posed by nanotechnology is yet to evolve. India does not have any nanotechnology specific regulation, barring the recent ‘Guidelines and Best Practices for Safe Handling of Nano-materials in Research Laboratories and Industries’ formulated by the Department of Science and Technology.⁵ The availability of consumer commercial products in the Indian market such as washing machines, water purifiers, detergents and textiles using nanotechnology further underscores the urgency of evolving a regulatory framework.

 

The present environmental and waste management law would be important for the purpose of nanotechnology environmental risk regulation. This would include the application of the following legislations. Environment Protection Act, 1986 which acts as an umbrella legislation for pollution control, prevention of hazards and provides the central government overarching powers to act in regard for environmental pollution. A hazardous substance is defined in the Environmental Protection Act, 1986 as ‘any substance or preparation which, by reason of its chemical or physico-chemical properties or handling, is liable to cause harm to human beings, other living creatures, plant, micro-organism, property or the environment.’⁶ This definition is wide enough to bring nanotechnology as a hazardous substance under the regulatory ambit of the Environmental Protection Act, 1986.

The Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 2008, are also important for the purpose of dealing with nanotechnology waste. India does not have any specific law dealing with toxic chemicals such as the United State’s Toxic Substances Control Act. But the Environment Protection Act, 1986 provides ample power to the central government to draft subordinate legislation for regulating chemical substances in India.

 

The Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 and the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996 were formulated to regulate the use of hazardous chemicals. At present, there is no clarity whether nano-materials can be brought within the ambit of these chemical regulation rules, indicating the need for taking a fresh look at the chemical regulation rules to have clear identification and definition of nano-materials as hazardous chemicals.⁷ Note that the existing environmental laws do not comprehensively meet the standards of care required for regulating risk arising out of nanotechnology. The institutional mechanism for monitoring and implementing the chemical laws in India are the respective State Pollution Control Boards, overseen by the Central Pollution Control Board. However, the SPCBs and CPCB are currently not equipped to monitor risk arising out of nano-materials.

Depending on the application of nanotechnology to various products, the following legislations would be applicable. In pharmaceuticals, the Drug and Cosmetics Act, 1940 would be applicable. Further, the Insecticide Act, 1968 too could be applicable, even though these legislations are yet to specify the standard of care needed to tackle risks that nanoparticles could pose to human health and the environment. Moreover, existing legislation fails to meet the need for constant monitoring by ensuring information collection from producers of products with nano-particles.

 

In 2015, a proposed amendment to the Insecticide Act, 1968 attempted to regulate the nano-insecticides by only providing provisional registration and creating an obligation of information reporting in case of ‘any adverse consequences of the use of insecticides on human health, animals and environment.’⁸ From a food safety and risk regulation perspective, the Food Safety and Standard Authority of India (FSSAI) has also issued Food Safety and Standards (Contaminants, Toxins and Residues) Regulations in 2011. But these or other regulations regarding packaging do not provide any specific reference to nanoparticles and application of nanotechnology.

It is relevant to note that fresh occupation health and safety regulations would be important for regulating exposure to nanomaterials at industrial units and research laboratories. ‘Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries’, formulated by the Department of Science and Technology, provides a detailed framework towards the safe handling and disposal of nanoparticles, which would be significant from an occupational health and safety perspective.

 

The Nano Mission emphasizes the PPP as a model for evolving research and development in the nanotechnology sector. The level of industrial confidence for participating and investing in nanotechnology would depend on clarity in the regulatory framework applicable to this technology. Lack of regulatory clarity pertaining to emerging technologies such as nanotechnology may lead to a stagnation in research and development.

The biotechnology sector in India witnessed a similar scenario, resulting in stagnation due to the lack of a proper regulatory and institutional framework. Even though the Rules for Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Engineered Organisms or Cells, 1989 served as the basis for biotechnology regulation, the failure to transit to an evolved framework such as the proposed Biotechnology Regulatory Authority of India shows lack of regulatory clarity. The absence of a regulatory and institutional mechanism to address the capacity to monitor, ensure adequate information gathering and dissemination, and communication regarding risks associated with biotechnology, has led to a lack of public confidence in India. Risk communication to the society and evolving a dialogue from a public participation perspective is significant to ensure that emerging technologies are accepted as important for national development.⁹

The opposition to genetically modified technology in agriculture and food, especially products such as BT-brinjal and BT-cotton, is largely a result of lack of regulatory clarity and proper governmental measures to generate and disseminate reliable scientific information. The WHO Darkar Statement on Manufactured Nanomaterials, 2008 has emphasized ‘making information on use and risks associated with the lifecycle of manufactured nano-materials readily accessible, strengthening capacity of civil society to effectively participate in decision making related to manufactured nano-materials.’¹⁰

 

Towards this end, India should learn from the regulatory experience of both the EU and United States. Rather than allowing for controversies regarding human health and adverse environmental impact to emerge, it is pertinent that India bring in incremental risk regulation based on information collection by ex-ante product registration requirement. Incremental risk regulation based on the information availability is understood to be a better practice in nanotechnology regulation rather than a total ‘wait and watch’ approach. Further, incremental regulation would be helpful in tackling unwanted obstacles calling for an extreme approach of a moratorium on nanotechnology research and commercial product development on the basis of associated risk.

The United States has adopted a decentralized approach towards regulation of nanotechnology. The Environment Protection Agency, Food and Drug Administration, Occupational Health and Safety Administration and Consumer Product Safety Commissioner are provided with the regulatory oversight responsibility for nanotechnology regulation. The absence of similar comprehensive regulatory authorities in the consumer and occupation health sector in the Indian context need to be highlighted. The Food Safety and Standards Authority and the Central Pollution Control Board could be identified as the relevant bodies for the purpose of food safety regulation and environmental risk regulation in India.

In the European Union context, there has been a strong push for voluntary codes of safety standards by manufacturers and researchers, which advocate a strong precautionary principle approach.¹¹ In contrast, this degree of emphasis on the precautionary principle as a strong basis for nanotechnology regulation is not evident in the US; the ‘mandatory labelling and pre-market safety assessment requirements’ in the EU are far more stringent. Similarly, the introduction of a comprehensive chemical law by way of the REACH Directive (Registration, Evaluation, Authorization and Restriction of Chemicals Directive) places a clear responsibility on manufactures to share information with regulatory agencies with specified reporting requirements.

India, however, is yet to formulate a well articulated nanotechnology regulation policy. Even though the National Environmental Policy, 2006 as well as the Supreme Court have affirmed the precautionary principle as a powerful environmental regulation tool in India, the extent to which it could be applicable to emerging technology regulation is not clearly articulated.

 

By judiciously drawing upon both the strong precautionary principle approach of the European Union and the weak precautionary approach in the United States, India needs to initiate a dialogue based on multi-stakeholder participation for evolving a robust regulatory framework. The critical institutional mechanism for regulation should be anchored within the Nano Mission. Except for the regulation of nano-materials from a food safety perspective, which the Food Safety and Standards Authority of India must oversee, it is important that there exist a mechanism for ex-ante product review required for gauging the risk within the Nano Mission. For environmental risk regulation regarding nanotechnology, a coordinated approach between the Nano Mission and the Central Pollution Control Board would be required. The regulatory tools such as the ‘pre-market review and authorization, post-market monitoring and labelling, product recalls and adverse event reporting’ which are currently used by the European Union nanotechnology regulation in an effective manner could be utilized by the Nano Mission. Finally the various legislations that have relevance for nanotechnology would need to be harmonized for the purpose of allowing the Nano Mission to act as a nodal regulatory institution. In a long-term perspective, a comprehensive legislation is needed, enabling the Nano Mission to bring forth incremental regulations based on evidence.

 

In order to ensure that India emerges as a favoured destination for commercial product development using nanotechnology, we need immediate action to create a nanotechnology regulatory policy, providing clear road-maps for evolving a legal and regulatory framework. Such a step would be important for other emerging technology regulations in India as well, teaching us the way to integrate new technology in a safe manner while suitably protecting the health and well-being of Indian citizens.

 

Footnotes:

1. Rober Falker and Nico Jaspers, ‘Regulating Nanotechnologies: Risk, Uncertainty and the Global Governance Gap’, Global Environmental Politics 30(55), 2012.

2. Amit Kumar, ‘Nanotechnology Development in India: An Overview’, RIS Discussion Paper, available at http://ris.org.in/images/RIS_images/pdf/DP%20193%20Amit% 20Kumar.pdf

3. Nano-Mission Website, available at http://nanomission.gov.in

4. Nanotechnology Initiatives, Ministry of Electronics and Information Technology, http://meity.gov.in/content/nanotechnology-initiative-division

5. Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries, available at http://nanomission.gov.in/What_new/Draft_ Guidelines_and_Best_Practices.pdf

6. Section 2(e) of the Environmental Protection Act, 1986.

7. Regulatory Challenges Posed by Nanotechnology Developments in India. The Energy Research Institute, available at http://www.teriin.org/nano-uploads/D6_ Regulatory_challenges_April_2010.pdf

8. Insecticide Amendment Bill, 2015, available at http://164.100.47.4/BillsTexts/LSBillTexts/Asintroduced/3032LS.pdf

9. Nanotechnology Risk Governance: Policy Paper by International Risk Governance Council, available at https://www.irgc.org/IMG/pdf/PB_nanoFINAL2_2_.pdf

10. WHO Darkar Statement on Manufactured Nanomaterials 2008, available at http://www. who.int/ifcs/documents/forums/forum6/f6_finalreport_en.pdf

11. EU Code of Conduct for Responsible Nanosciences and Nanotechnologies, available at ec.europa.eu/research/science-society/.../pdf.../nanocode-apr09_en.pdf