August 09 ElectroIndustry - 18

Electroindustry News › Applying the Brakes to an Emerging Technology: Nanotechnology under the Legal and Regulatory Microscope The threat of fire in the nineteenth century led to a new regulatory era in zoning laws and building codes, and the development of new fire protection technologies. Asbestos, regarded as the gold standard of fire protection materials, was promoted and even required in codes and standards because of its ability to act as a fire retardant and withstand heat, and rapidly new applications were found for this “miracle mineral.” As its use expanded, a darker side of this material began to emerge: serious illness and death from exposure to the tiny fibers that make up asbestos were reported. The products liability toll for industrial enterprises that exploited the miracle mineral brought many companies to bankruptcy and a ripple effect across the economy impacted insurers, workers, and even businesses only remotely touched by asbestos. which there is little practical experience. Importantly, product liability law generally recognizes that useful products may be legally marketed even though there are risks of harm associated with its use or consumption. While courts generally do not recognize an independent legal duty in tort law to test a product, they do recognize that a failure to test can lead to a failure to design a reasonably safe product. Regulatory law sometimes steps in to enhance foreseeability as a precondition to bringing a new product to market by imposing rigorous testing requirements. Food and drug law is a well-known example of this type of regulation. The more risk-averse “precautionary approach” challenges our traditional product liability/risk-utility assessment because it instructs that when there is scientific or technical uncertainty about the health and safety of a product or compound, don’t put it on the market until it is proven safe. Nanotech materials are roughly half the size of the diameter of DNA. The benefits of engineered nanomaterials flow from their size. But that is also the source of health and safety concerns. Their miniscule size enables the particles to be more easily passed through membranes to tissue and organs. Some research suggests that naturally-occurring ultrafine particles can affect toxicity as much as chemical composition. While there is general agreement that there is a dearth of toxicity data about engineered nanomaterials and there are no standardized test protocols for testing nanomaterial toxicity, some say there are already enough red flags related to their chemical reactivity, solubility, and potential for cellular damage to warrant a go-slow approach. The EPA has started wading into the regulatory waters. In January 2008, it announced that as a general rule, certain nanosize materials regulated under the Toxic Substances Control Act (TSCA) may need to be treated as “new” chemical substances—not existing substances—if their molecular identity is not identical to a substance already on the TSCA Inventory. In brief, size is not necessarily a big deal according to this guidance, and producers of nanosized materials chemically identical to larger materials already on the list do not need to report they are making the nanomaterial. Later that year, EPA published a notice endeavoring to clarify whether Engineered nanomaterials, already finding commercial applications in hundreds of products now on the market, are believed to offer significant societal benefits. But both non-governmental and governmental organizations have The lens of product liability law, with its advocated that some investment be focus on the foreseeability of harm, is allocated to improving our understanding not always a sharp regulatory tool when of the risks that nanoparticles may it comes to addressing the development present. Public funds have been of novel products or compounds with allocated for this effort to such agencies as the Environmental The “precautionary approach” Protection Agency (EPA), Food and challenges our traditional product Drug Administration, Consumer Product liability/risk-utility assessment Safety Commission, and Occupational Safety and because it instructs that when Health Administration. there is scientific uncertainty But some groups are advocating for about the safety of a product, precautionary control of untested and potentially don’t put it on the market until harmful nanomaterials you prove it is safe. before products are brought to market, citing the lessons from asbestos. NEMA electroindustry 18 • August 09

August 09 ElectroIndustry

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