Nanotechnology - Health and Risk Management Concerns

Posted on March 9, 2010 by Michael Rodburg

In June last year insurance giant Zurich issued a report of the work of its Emerging Risks Group study begun in 2006. The report stated that the risks with the greatest potential to affect Zurich and its customers are those associated with nanotechnology.

Similarly, an alphabet soup of regulators—foreign and domestic—is wrestling with largely unknown and largely theoretical risks. The human health and environmental alarms have been sounded by numerous commentators, without yet meaningful, documented empirical observation or controlled studies of human health and safety issues or environmental concerns. Regulation in a factual vacuum is potentially counterproductive and can stifle one of the 21st century’s most promising new technologies. But no one wants “another asbestos” or to have stood by silent in the spring while nanobots consume an ecosystem. This blog will skim the surface of an increasingly deeper and broader pond.

What is Nanotechnology?

Nanotechnology involves the manipulation of matter at the near atomic or nanometer scale--a nanometer is one billionth of a meter; a standard sheet of paper is 100,000 nanometers thick. Materials composed of or including devices and systems with components at the nanometer scale represent fundamentally new molecular organizations with highly different and potentially unpredictable properties and functions compared to their macromolecular cousins. The technology has found uses in a wide variety of commercial products including wound dressings, pregnancy tests, toothpastes, lubricants, paints, nonstick coatings, tennis racquets, air filters and many other products. In each of these products, the nano scale materials exhibit dramatically different characteristics than would be true of those materials at normal scale.  For example, gold is an excellent conductor of heat and electricity but simply reflects ordinary light. Properly structured gold nano particles absorb light and can actually convert light into heat (which, in turn, can be used for cutting purposes in thermal scalpels).  Nano sized particles of titanium dioxide provide UV protection while remaining transparent. Nano scale materials in thin films applied to eyeglasses, computer displays and cameras make them water repellant, anti-reflective or give them other useful physical characteristics.

 

Potential Health Issues

The primary human health concern for the extremely small size of nano materials is that they may be introduced into and affect the body in ways completely different than their bulkier macro cousins. See, e.g., Special Report, Nanotechnology: Benefits vs Toxic Risks, Functional Foods And Nutraceuticals (Feb. 2007) ("nanosized particles were found to traverse through lung tissue in unexpected ways, gaining access to blood and lymphatic systems"). 

The potential for different human health related characteristics such as enhanced adhesion, reactivity and absorption means that current methodologies for risk assessment simply are not applicable and safety data drawn from non-nano counterpart materials may be irrelevant.  See, Fischer Nanotechnology -- Scientific and Regulatory Challenges, 19 Villanova Envt. L. J. 315 (2008). For example, when inhaled, nano particles are deposited more efficiently and deeply into the respiratory tract than non-nano materials, and these nano materials may evade human body defense mechanisms that trap larger particles. In addition, nano materials themselves have sometimes been the subject of problematic animal studies. See Lynn, Size Matters: Regulating Nanotechnology 31 Harv. Envtl. L. Rev. 349 (2007).

Moreover, ordinary risk management tools may also simply “not work” in the presence of nano materials. For example, the use of facial masks designed for non-nano aerosols may not be effective for nano sized particles.

Nanotechnology concerns have been heightened by an article published in the European Respiratory Journal in which researchers reported that seven (7) young women suffered permanent lung damage following months of unprotected exposures to fumes and smoke containing nano particles in spray painting operations in China. The researchers concluded that the patients' illnesses appeared to be a "nanomaterial -- related disease.” While the results of this study have been questioned, the legitimacy of concerns with respect to high level environmental exposures to these materials remains. 

Regulatory Focus

An intense regulatory focus on developing an appropriate scientific basis for ensuring that nano materials do not present unreasonable human health concerns is underway. See e.g., Dept. of Health and Human Services, Approaches To Safe Nanotechnology - Managing The Health And Safety Concerns Associated With Engineered Nanomaterials (March 2009).  Giving further impetus to these concerns is the fact that there is a high concentration of nanotechnology applications in pharmaceutical, food and cosmetics applications, industry segments with direct and immediate human interactions. Every agency with jurisdiction over human and environmental health and safety has found or certainly will find reason to explore regulation. The USEPA has begun to issue rules about handling of and exposure to nano forms of alumina, silica and silver; the California Department of Toxic Substances is considering controls on carbon nanotubes. We can expect initiatives over time from the FDA and OSHA.

Insurance Company Reaction

For its part, the insurance industry has focused on product liability concerns. Insurance industry studies have expressed significant reservations about liability issues associated with nano materials. See Lloyd's of London Emerging Risks Team Report, Nanotechnology - Recent Developments, Risks and Opportunities (2007).  Indeed, one insurance carrier (Continental Western Insurance Group) has gone so far as to impose nano-technology exclusions in their standard CGL policies - notwithstanding the fact that no such claims have yet been presented. 

Conclusion

It is clear that nanotechnology offers tremendous scientific and commercial opportunities in the future. These opportunities, however, are likely to be accompanied by health and safety based product liability and environmental risks, and those risks need to be taken into account in the development and exploitation of these products.

This blog is based in part on a more expansive article: Michael Dore, Nanotechnology - Evaluate The Products Liability Risks, 198 N.J.L.J. 866 (December 14, 2009)



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