Regulating Emerging Technologies : NANOTECH

In an industrial gold rush that mirrors the semiconductor and biotech booms, Silicon Valley is rapidly emerging as the centre for a host of new nanotechnologies. Nanotech is more than a single new industrial sector: It is transforming fields as diverse as electronics, medicine, environmental remediation, and solar energy, and it is already ubiquitous in a wide range of consumer products. By manipulating commonly used materials such as carbon, silver, gold, and polymers on the atomic and molecular levels, nanotech is exploiting the distinctive properties that many materials display at this extremely tiny scale.

At the forefront of the nano boom is the so-called “clean tech” movement, applying nanotechnology to address global warming, the need for clean water, and other environmental problems. These include the development of new solar technologies, energy-efficient products, environmental monitoring techniques, and water treatments.

The situation today looks strikingly similar to that of the electronics industry in the early 1980s, when new “clean” manufacturing processes resulted in widespread groundwater pollution throughout Santa Clara County. The responses of industry, government, and environmental agencies to that crisis were woefully inadequate, due to major information and technology gaps.

The nanotech boom too, in a similar manner, is generating an unprecedented number of new processes and materials that pose unknown potential environmental and health hazards. Unfortunately, U.S. regulatory policy has changed very little since the 1980s, and we now face similar gaps in our ability to protect public and environmental health. A 2006 study requested by California state legislators characterised these gaps in the environmental regulatory framework as follows:

Data Gaps: Lack of data on industrial materials, including their health impacts, environmental toxicity, and monitoring.

Technology Gaps: Lack of technologies and protocols for environmental and health monitoring, detection, and remediation.

Safety Gaps: Lack of coordinated, publicly available information about specific chemicals and materials, including where they are being produced and used.

Although some progress is being made toward addressing these policy gaps, it is critical that we work towards the development of comprehensive state and federal chemical policies that protect public and environmental health. These policies should incorporate the “precautionary principle” as applied to recent environmental policy in the European Union. This principle requires those who advocate the use of new chemicals or processes to prove their safety, rather than requiring communities or workers to prove their dangers. Nanotech policies also need to address the impacts of nano materials throughout their life cycles, from manufacturing through use and end-of-life disposal. We need to ensure that this new industrial revolution continues to benefit the regional, state, and national economies.

From Richard Feynman, the Nobel Prize winning physicist, who was among the first to realise that many commonly used materials exhibit entirely new and potentially useful characteristics at what we now call the “nanoscale”, the epicentre now seems to have shifted over to much of the San Francisco Bay Area, the region already being a leading incubator for nanotechnology enterprises. The entrepreneurial spirit, abundant venture capital, and highly educated population at the Silicon Valley here make it ideal for the cultivation of new technologies, and there are at least 111 active nanotech companies and research facilities in the San Francisco Bay Area.

But the excitement and buzz surrounding this emerging industrial sector are only now being tempered by growing caution about its potential human and environmental hazards. New materials and processes are being rapidly developed and marketed without the regulatory and safety frameworks needed to protect human and environmental health.

This situation is strikingly similar to that of the early days of the electronics industry in Silicon Valley, when new manufacturing processes touted as “clean industry” resulted in widespread groundwater pollution throughout the region. In 1981, the discovery of industrial chemical leaks from underground storage tanks at IBM and Fairchild Camera and Instrument led to an investigation of storage tanks at all the major companies in Silicon Valley. Leakage was pervasive. Today Silicon Valley is still home to 29 “Superfund” sites (highly contaminated sites designated for clean-up under the federal 1980 Comprehensive Environmental Response, Compensation and Liability Act or CERCLA), and 179 contaminated groundwater locations that are the legacy of the industry’s infancy.

Just as there were few regulations in the 1980s to address the dangers of electronics manufacturing chemicals, we now face a regulatory system that is outdated and ill-equipped to handle increasingly diverse and complex nano materials and processes.

THE CHALLENGES OF REGULATING NANOTECH

Nano materials present an entirely new set of issues and regulatory concerns that are not addressed by the regulatory framework that was developed almost 40 years ago (and is still largely in place). In the 1970s, legislators could not anticipate the need to regulate engineered materials that are valued precisely because they are incredibly small. The 1976 federal Toxic Substances Control Act (TSCA) and other statutory and regulatory frameworks continue to regulate chemicals based on volume, typically exempting small quantities of materials. In addition, although materials at the nanoscale have properties that are completely different from their more common “bulk” forms, the current regulatory framework does not recognise them as new materials that require new evaluation.

Fortunately, we have an opportunity to learn from the past. Nanotech start-ups and established businesses are in a position to push for better understanding of the hazards of their industry. The industry is relatively new and still has a chance to work proactively rather than retroactively.

As we approach the regulation of these new technologies, it is important that we address potential hazards throughout the life cycle of nano materials. Life cycle analysis can assess both the short-term economic value of a technology, as well as the longer-term societal and environmental impacts. This approach is especially valuable with emerging products and markets, enabling regulators to address potential challenges and problems early in the product development process.

There are encouraging signs that legislators are beginning to address this need. In 2004, California State Senator Byron Sher, chair of the Senate Environmental Quality Committee, and Assembly member John Laird, chair of the Assembly Committee on Environmental Safety and Toxic Materials, requested a study to address public and environmental health concerns, and to explore how to build long-term health and environmental safety into the design, production, and use of chemicals.

This 2006 report, Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation, found that the existing environmental regulatory system is incapable of responding to developments in a proactive, deliberative way. The report concludes that chemical policy represents one of the major challenges of the 21st century, and that reorienting the existing approach to chemical regulations will require a long-term commitment to the development of a modern, comprehensive chemicals policy that includes the following goals:

Close the Data Gap: Ensure that chemical producers generate, distribute, and communicate information on chemical toxicity, ecotoxicity, uses, and other key data.

Close the Technology Gap: Support research, development, technical assistance, entrepreneurial activity, and education in green chemistry science and technology.

Close the Safety Gap: Strengthen government tools for identifying, prioritising, and mitigating chemical hazards.

The rapid expansion of patents and publications related to nanotechnology’s commercial applications far outstrips the amount of research related to its potential risks. From 1998 and 2007, the total number of research publications investigating nanotechnology was approximately 33,430; but only 656 of those addressed nanotoxicology and the potential risks related to these new materials and processes.

Nanotoxicology research is critical because, just as the unique properties of nanomaterials are difficult to predict from the properties of their bulk form, the health hazards of nanoscale materials can be equally unpredictable. In the past, we have failed to anticipate the dangers of many widely used materials, including DDT, asbestos, benzene, and, more recently, flame retardants. Nanotech arguably presents even greater risk than these past “wonder” materials because, unlike them, it is not limited to one material or class of materials. Rather, it is platform technology cross-cutting many industries, and it will soon be ubiquitous in manufacturing.