Tag Archives: Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries

Building a regulatory framework for nanotechnology in India

For the second time in less than six weeks (the first time is described in my June 13, 2016 posting on India’s draft guidelines for the safe handling of nanomaterials) I’ve stumbled across an article about the need for more nanotechnology safety measures in India. From a June 23, 2016 article by Prateek Sibal for The Wire (Note: Links have been removed),

India ranks third in the number of research publications in nanotechnology, only after China and the US. This significant share in global nanotech research is a result of sharp focus by the Department of Science and Technology (DST) to research in the field in the country. The unprecedented funding of Rs 1,000 crore for the Nano Mission was clearly dictated by the fact that India had missed the bus on the micro-electronic revolution of the 1970s and its attendant economic benefits that countries like China, Taiwan and South Korea continue to enjoy to this day.

At the same time, the success of the Nano Mission is not limited to research but also involves training the required human resource for further advancement in the field. An ASSOCHAM and TechSci Research study reported in 2014: “From 2015 onwards, global nanotechnology industry would require about two million professionals and India is expected to contribute about 25% professionals in the coming years.”

A missing element in India’s march towards becoming a nanotechnology powerhouse is the lack of focus on risk analysis and regulation. A survey of Indian practitioners working in the area of nano-science and nanotechnology research showed that 95% of the practitioners recognised ethical issues in nanotech research. Some of these concerns relate to the possibly adverse effects of nanotechnology on the environment and humans, their use as undetectable weapon in warfare, and the incorporation of nano-devices as performance enhancers in human beings.

One reason for lack of debate around ethical, and public-health and -safety, concerns around new technologies could be the exalted status that science and its practitioners enjoy in the country. A very successful space program and a largely indigenous nuclear program has ensured that policymakers spend much of their time feting achievements of Indian science than discussing the risks associated with new technologies or improving regulation.

After describing some of the studies raising health concerns, Sibal describes the issue for policymakers (Note: Links have been removed),

The challenge that remains in front of policymakers is that of regulating a field where vast areas of knowledge are still being investigated and are unknown. In this situation, over-regulation may end up stifling further development while under-regulation could expose the public to adverse health effects. Further, India’s lack of investment in risk studies only sustains the lull in the policy establishment when it comes to nanotech regulations.

The Energy and Resources Institute has extensively studied regulatory challenges posed by nanotechnology and advocates that an “incremental approach holds out some promise and offers a reconciliation between the two schools- one advocating no regulation at present given the uncertainty and the other propounding a stand-alone regulation for nanotechnology.”

Kesineni Srinivas, the Member of Parliament from Vijayawada, has taken cognisance of the need for incremental regulation in nanotechnology from the view point of public health and safety. (Disclosure: The author worked with the Vijayawada MP on drafting the legislation on nanotechnology regulation, introduced in the winter session of Parliament, 2015.)

In December 2015, Srinivas introduced the Insecticides (Amendment) Bill in the Lok Sabha to grant only a provisional registration to insecticides containing nanoparticles with a condition that “it shall be mandatory for the manufacturer or importer to report any adverse impact of the insecticide on humans and environment in a manner specified by the Registration Committee.” This is an improvement over the earlier process of granting permanent registration to insecticides. However, the fate of the bill remains uncertain as only 14 private member bills have been passed in Parliament since the first Lok Sabha in 1952.

Prateek Sibal will be joining Sciences Po (the Paris Institute of Political Sciences), Paris, as a Charpak Scholar in 2016.

I always appreciate these pieces as they help me to adjust my Canada-, US-, Commonwealth- and European-centric views.

India’s draft guidelines for the safe handling of nanomaterials

I believe this is the first time I’ve seen any guidelines for the safe handling of nanomaterials that are neither from Europe nor from the US. I imagine that’s due to translation issues or lack of publicity rather than a failure to create guidelines.

In any event, Indrani Barpujari, Advisor (Governance) at the Atal Bihari Vajpayee Institute of Good Governance and Policy Analysis, Bhopal, India, has written a commentary on draft regulations for India (from her Draft Guidelines for Safe Handling of Nanomaterials commentary in Economic and Political Weekly, Vol. 51, Issue No. 23, 04 Jun, 2016 ISSN [Online] – 2349-8846 [appears to be open access]),

It is indeed laudable that as a first step towards regulation of nanotechnology in India, the Nano Mission under the Department of Science and Technology has come out with the draft “Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries.” Taking cognisance of the imperative for safe handling of nanomaterials, the Nano Mission has constituted a task force consisting of eminent experts who have prepared this document. Involving the control of matter at the nanoscale, nanomaterials are characterised by small dimensions, large surface area, and high reactivity which while making them amenable to a large variety of applications in various sectors also render them potentially dangerous for human health and environmental safety, with considerable scientific uncertainty regarding the risks. Nanotechnology presents before policymakers a classic case of “Collingridge dilemma” or a “dilemma of control” with policy decisions required to be taken on the basis of uncertain scientific facts and under conditions of some urgency. It is the unique combination of “high expectations and huge uncertainties” (Van Lente 2010) associated with nanotechnology which has provided the required thrust for the current guidelines.

The draft guidelines, basically intended as standard operating procedure (SOP) for handling nanomaterials in research laboratories and industries, prescribe a combination of engineering controls, work practices and personal protective equipment as part of a robust exposure control strategy. These lay down the process for identifying hazards, taking note of the specific effect of surface chemistry, shape, size and morphology on toxicity caused to various organs. These address the potential exposure pathways and concomitant safety measures to mitigate the same. While prescribing certain best practices for handling nanomaterials generally, the guidelines also lay down another set of best practices specifically pertaining to the making and handling of nanopowders and use of products relating to food and healthcare. A precautionary approach is advocated with detailed life cycle assessment and strong binding procedures with respect to stakeholder involvement for various players while formulating best practices in the food sector particularly.

While the draft guidelines as a first step cover reasonable ground, it may be relevant to look at these in the context of the discourse on nanotechnology regulation abroad as well as in India. The focus of modern “risk societies” being more on “manufactured risks” or risks which are the product of human activity (Giddens 1999), governments, particularly in the developed world, are increasingly realising the need for risk-based regulation, to address potential risks from emerging technologies like nanotechnology, while promoting their development. Preliminary steps have been taken to regulate nanotechnology despite the admitted difficulty in doing so owing to the scientific uncertainty regarding its risks and limited amenability to traditional risk management approaches (Schummer and Pariotti 2008).

Thus, it may be surmised that the developed world’s engagement with nanotechnology to harness its benefits has been characterised by an almost unprecedented focus on regulating its risks and developing an anticipatory governance framework, taking on board different stakeholders including the public and incorporating societal concerns. On the other hand, with an almost single-minded focus on promotion in the initial years, the official pursuit of nanotechnology in India has not accorded much priority to its potential risks with the result than a large number of nano-based products are already out in the markets, without any regulation (Barpujari 2011a). In India, the government is the primary promoter of nanotechnology, pursued under the mission on nanoscience and technology (Nano Mission) with a huge budget outlay targeted at the development of nano-applications and creating adequate infrastructural and human capabilities for this purpose.

The Indian scientific establishment has high expectations from nanotechnology, with the technology expected to help meet the development needs of the country, while also positioning India as a forerunner in the global arena. Srivastava and Chowdhury (2008) observe that Indian scientists at the helm of affairs perceive that Indian science should not lose out on this opportunity to establish itself as a global leader and that it should not “miss the bus” as it did during the previous semiconductor revolution. Sahoo and Deshpande Sarma’s (2010) survey on risk perceptions among thirty scientists working in public-funded scientific institutions/laboratories indicate that Indian scientists are not very much perturbed by the risks of nanotechnology, and few take special precautions while working with nanomaterials, while very few are interested in taking up risk research.

The fact that the policy establishment is yet to take into serious consideration the potential risks of the technology is also evident from the low priority accorded to risk research, which should precede regulation. A very small number of projects are being publicly funded to look into toxicity issues, and there is almost no engagement with the social sciences and humanities, as evidenced by the lack of government funding for such studies.

At the same time, it must be acknowledged that different stakeholders in India particularly policy researchers, civil society actors and research institutions pursuing risk research have been persistently making the case for nanotechnology regulation in the country and taken the lead in charting the way ahead. It is acknowledged that problems in developing risk-based regulation are particularly compounded for a developing country like India, owing to a lack of resources, expertise and regulatory mandate. The absence of regulation, it is anticipated, would be even worse as in the event of some of the risks materialising, developing countries would be ill-equipped to handle and mitigate these (Barpujari 2011b).

Particularly noteworthy is a regulatory matrix for India developed by TERI [The Energy and Resources Institute] (2009) comprising several central legislation, rules and notifications which could have relevance for regulation of environmental risks, occupational health and safety risks arising from nanotechnology development and applications in India. Another report (TERI 2012) has provided leads for adopting a precautionary approach and developing an anticipatory regulatory framework for nanotechnology in the South Asian region, taking the particular case of India, Pakistan and Sri Lanka.

Vajpayee offers more insight with her suggestions for “The Way Ahead” and I strongly suggest reading her commentary if you’re interested in a perspective from South Asia. There’s also a list of references at the end of the commentary, should you wish to explore further.