Occupational Safety and Health Enforcement (U.S.)

Although environmental, health, and safety (EHS) issues have been of abiding public concern in the United States since the U.S. National Nanotechnology Initiative (NNI) was announced in January 2000, occupational safety and health enforcement has developed slowly because of uncertainty on the questions of nanotechnology's novelty and its experimental status. Nanomaterials are hazardous both when derived from materials that are toxic in bulk and from materials nontoxic in bulk, but that become dangerous in ultrafine or aerosol form. The discipline of nanotoxicology can be traced to at least the late 1980s and early 1990s, when Günter Oberdörster found that metal oxide nanoparticles had greater inflammatory effects on lung tissue than larger particles of the same substances. This was confirmed in subsequent work by Oberdörster and colleagues in 1992 and 1994, D. Lison and colleagues in 1997, N. Tran and colleagues in 1999 and 2000, and J. Brown and colleagues in 2002.

Occupational safety research was not a primary consideration of the architects of the NNI. The first such work was done outside of the National Science and Technology Council's Nanoscale Science, Engineering and Technology (NSET) subcommittee, the formal coordination machinery of the NNI. This was pioneered by the National Institute for Occupational Safety and Health (NIOSH), a division of the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention (CDC). In 2004, NIOSH established a Nanotechnology Research Center (NTRC) using re-programmed internal funds ($3.0 million in fiscal year (FY) 2005, $3.7 million in FY 2006, and $4.6 million in [Page 611]FY 2007). The following year, the President's Council of Advisors on Science and Technology (PCAST) identified the workplace as among the highest nanotechnology EHS priorities, noting that exposure was greatest during manufacturing.

To be sure, the NSET had studied these issues since 2003. Only in 2005, however, did the subcommittee formally institute the Nanotechnology Environment and Health Implications (NEHI) body. An interagency working group designed to facilitate cooperation among NNI agencies in understanding EHS issues, the NEHI identified Human and Environmental Exposure Assessment (HEEA) as one of five research categories, with NIOSH as the chief coordinating agency. In the NTRC's early years, researchers felt constrained by budget limitations. Indeed, only $1.1 million of the $68 million spent on 246 NNI EHS projects in FY 2006 was devoted to HEEA. Nevertheless, by 2007 the NTRC had published more than 70 papers. One of its initial findings established the harmful pulmonary effects in mice of inhaling after inhaling carbon nanotubes.

By mid-decade, critics were calling for modifying old regulations or creating new ones to accommodate nanotechnology. This was complicated by the unique qualities of nanomaterials and the circumstances in which they were then produced. Although the Toxic Substances Control Act (TSCA) required manufacturers to notify the Environmental Protection Agency (EPA) about chemicals they wished to manufacture, it largely exempted materials made in quantities of 11 tons or less. In the early 2000s, many, if not most, makers of nanomaterials, especially academic laboratories, produced batches far smaller than that. Yet, existing aerosol mapping techniques worked best in manufactories employing continuous processes, not batch methods. Moreover, many nanomaterials were existing chemicals of smaller particle size, raising a regulatory quandary for EPA.

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