Nanotechnology Law for Commercialization of Nano-Enabled Products

Abstract

Ilise L Feitshans JD

This presentation begins with a very short overview of the emerging laws of nanotechnology and then moves forward to study the key trends in emerging nanoregulations. Now that nanomaterials are becoming part of the global codification of nanoregulations hundreds of emerging laws have begun to sprout like mushrooms in unexpected places all over the globe. Surrounding these mushrooms is a vague and treacherous swamp of new laws draft laws and pre-existing laws. Additionally there are rules emerging from powerful opinion leaders who have expertise but not regulatory authority, such as some USA federal government agencies and the World Health Organization (WHO). This overview of the emerging nanoregulations explores USA OSHA and EU REACh and NIOSH RELs (Recommended Exposure Limits) for carbon nanotubes and nanofibers, NIOSH documents such as TiO2 guidance for nanomaterials and an entire webpage full of sound approaches to nanomaterials should remove many questions about the methods for best practices but leaves legal authority unclear because NIOSH is not an enforcement authority and the concept of RELs itself does not appear anywhere in the OSH Act that created NIOSH. So too, WHO guidelines for workplace exposure to nanomaterials are an unprecedented well intended application of precautionary principles even though no data yet exists demonstrating a link between exposure to manufactured nanomaterials in the workplace and proven harm and WHO has no enforcement authority. This trend towards prevention in face of unquantifed risk is important. This presentation will examine what this means from the global health standpoint, regarding nanotechnology; what does this mean for global health law and governance of science and emerging technologies? This presentation concludes that the new nanomaterial rules focus on problems that haven’t happened yet but that experts believe are likely to occur. This unprecedented preventive phenomenon in nanoregulations impacts risk assessment, quality assurance for compliance and inevitably the acceptaable methods for preventing corporate or professional liability. Therefore nanoregulation is a dynamic process that will influence many health laws around the world.

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