On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review. The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.
The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials. This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology. It is a critical step toward reducing risks to human health and the environment. But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.
In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”
The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.
The European Union may be further ahead. On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes. Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years. Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.
Even so, why so slow? Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.
Sources (all by BNA subscription):
225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)
34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)
34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)
