Law

Health and Safety Regulation

In any given jurisdiction at the national, supranational. or local level, there is also an issue of which institution should take the lead in regulating nanotechnology. In jurisdictions such as the United States, with a strong separation of powers doctrine, nanotechnology regulation could be initiated by either the legislative (i.e., U.S. Congress) or the executive (i.e., regulatory agencies such as the Environmental Protection Agency or the Food and Drug Administration) branches of government. Similarly, in the European Union (EU), different regulatory impetus may emerge from the Commission, the Council, or the European Parliament. A related issue is whether nanotechnology regulation should be undertaken under existing regulatory authorities by existing institutions, or whether new regulatory authorities and/or institutions are needed. Many jurisdictions (e.g., EU, Australia, the United States) have undertaken “gap analyses” to determine whether existing regulatory authorities are sufficient to govern nanotechnology risks or whether new statutes or regulations are needed. While these analyses have generally all found that existing authorities are sufficient to cover nanotechnology in the near term, there are growing strains and pressures for new or amended statutes and regulations to address some of the unique regulatory issues presented by nanotechnology.

Another aspect of this same issue is whether nanotechnology regulation can be parceled out to various existing agencies covering different nanotechnology products and exposures (e.g., environmental exposures, occupational [Page 395]exposures, consumer products, drugs and medical devices), or whether all nanotechnology regulation should be consolidated into a single new regulatory entity specifically created to oversee nanotechnology. To date, no jurisdiction has created a new regulatory agency or institution specifically to regulate nanotechnology; rather nations are relying (at least initially) on existing institutions and instruments to regulate nanotechnology.

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