Regulation and Legislation

Regulation of nanomaterials is very much in the early stages, with decisions complicated by the remaining unanswered questions related to the risks of exposure to nanomaterials. The focus of this chapter is on the existing legislations currently used for regulation of nanomaterials, including the Toxic Substances Control Act (TSCA) and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). As described in the earlier chapters, nanomaterials are produced for a variety of uses, and the main parameters that make them so appealing in some applications may also make them potentially more hazardous to human health and the environment (the so-called nanomaterials paradox). Human health effects associated with exposure to nanomaterials during manufacturing or use in consumer products are not well investigated or known. There is a lack of information on the effects of the nanomaterials as compared to many of the macro-scale materials. There have been some occupational exposure studies performed, but these are small-scale studies limited to a particular production method or use of a specific nanomaterial. These data limitations impact the ability to assess adequately the risks associated with nanomaterials, making it difficult to evaluate nanomaterials beyond a case-by-case basis. Many of the existing standards for regulation described here are based on materials in their macro-scale forms but these may not be sufficient to protect against the nanoscale counterparts.