Nanotechnology Update: And the Beat Goes On
June 6, 2007
Robert Rhodes - Atlanta
Public and private interest in environmental, health and safety (EHS) aspects of nanotechnology has accelerated since the publication of our last update on this topic.1 Significant developments in connection with governments and nongovernmental organizations in the United States2 are outlined below.
EPA
In February 2007, EPA issued its final Nanotechnology White Paper3 revising the draft version that had been issued in early 2006. This document announces a step by step process, i.e., in fiscal years 2007 and 2008, EPA will focus on “environmental fate, transport, transformation and exposure; monitoring and detection methods” and in fiscal years 2009 and 2010, agency resources will be shifted to focus on toxicity issues. The ultimate goal, according to the white paper, is to develop an adequate knowledge base to support the formulation of an effective risk communication and management program for engineered nanomaterials by fiscal years 2011/2012.
In addition to its ongoing research initiative, in November 2006, EPA decided that it would regulate as a pesticide nanoscale silver used in washing machines as an antibacterial agent. Shortly thereafter, the Natural Resources Defense Council urged EPA to broaden this decision to include a requirement that all consumer products containing silver at the nanoscale level be reviewed under the Federal Insecticide, Fungicide and Rodenticide Act. This focus upon nanoscale silver was recently underscored when the National Toxicology Program published a notice requesting comments on whether it should subject certain chemicals and metals, including nanoscale gold and silver, to toxicology analysis.4
As this update was going to press, the Project on Emerging Technologies5 issued a report urging immediate assumption of nanotechnology oversight responsibility by EPA. The report6 set out specific recommendations including what the authors believe are needed amendments to the Toxic Substances Control Act.
NIOSH
On February 27, 2007, the National Institute for Occupational Safety and Health issued a report titled: Progress Toward Safe Nanotechnology in the Workplace.7 The report discusses research activities carried out by the NIOSH Nanotechnology Research Center since its establishment in 2004. The report states that specific data gaps remain that will need to be addressed by additional research and also notes that new funding beyond current NIOSH budgetary levels will be required to fill the gaps.
FDA
There has been little formal action related to nanotechnology EHS by the Food and Drug Administration following a broad-based nanotechnology task force meeting hosted by the agency in October 2006. Simultaneous with that meeting, however, the Project on Emerging Nanotechnologies issued a report asserting that FDA had inadequate funding and uncertain legal authority to carry out appropriate nanotechnology oversight.
Legislatures
At the federal congressional level, the Joint Economic Committee released a report on March 22, 2007, entitled: Nanotechnology: The Future is Coming Sooner Than You Think.8 Among other things, the report recommended establishment of a labeling requirement on consumer products disclosing the presence of nanomaterials.
Although no comprehensive federal laws have yet been proposed relating to the control of nanotechnology, it is interesting to note that the City of Berkeley, California, has enacted a city ordinance mandating certain reporting and other requirements on businesses that use nanomaterials. There is a concern that other state and local governments may begin to consider such actions in the absence of any specific federal regulatory activity.
NGOs
Finally, since our last update, a number of nongovernmental organizations have weighed in on the issue of nanotechnology, ranging from an insurance company outlining best EHS practices for nanotechnology companies seeking coverage to a representative of the AFL-CIO advocating the establishment of a core worker safety training program for the nanotechnology industry. Several environmental and technology consulting firms have also issued reports and commentaries.
Of particular note is the joint effort by Environmental Defense and DuPont in issuing on February 26 a draft document entitled: Nano Risk Framework.9 This environmental interest group and major chemical company seek comment on a strategy that emphasizes risk assessment carried out during the entire life cycle of a material. The draft document also identifies key data that would need to be obtained or developed and suggests guidance on techniques for monitoring exposures.
The draft framework was strongly criticized in an open letter issued on April 12 by a coalition of labor unions, environmental interest groups and other NGOs. This coalition characterized the draft framework as “fundamentally flawed” because it interpreted the document as recommending voluntary self regulation by industry as opposed to active governmental regulatory oversight. Environmental Defense denied any such intention.
In summary, the EHS nano debate continues and may be heating up. Stay tuned.
For more information, e-mail Robert L. Rhodes, Jr. at rob.rhodes@hklaw.com or call toll free, 1-888-688-8500.
1 “Nanotechnology Update: Small Particles Getting Big Attention,” Holland & Knight Environment Newsletter, Fourth Quarter 2006, available at /id24660/publicationid1858/returnid31/.
2 This article is limited to a discussion of nanotechnology EHS developments in this country. Be aware, however, that at least an equivalent amount of attention is being given to this issue internationally.
3 http:www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-white-paper-final-february-2007.pdf.
4 72 Fed. Reg. 14,816 (March 29, 2007).
5 A joint effort by the Wilson Center for International Scholars and Pew Charitable Trusts.
6 EPA and Nanotechnology: Oversight for the 21st Century (http:www.nanotechproject.org/124/52307-epa-and-nanotechnology-oversight-for-the-21st-century ).
7 http:www.cdc.gov/niosh/docs/2007-123/pdfs/2007-123.pdf.
8 http:www.house.gov/jec/publications/110/nanotechnology_03-22-07.pdf .
9 http://nanoriskframework.com/page.cfm?tagID=1081 .