On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance: The Current State of Federal, State, and International Regulation.” Speakers came from all sectors, including private law firms and industry.
Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.
1. Size. It really is all about size. Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation. Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.
2. Progress. Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology. There is a pervasive concern about the prevalence of these technologies and the paucity of studies.
3. Fragmentation. Attention to the potential issues raised by nanotechnology continues to be highly fragmented. There has been intensely focused attention to some issues, but others remain to be addressed.
For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products. Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.” Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials. Other applications are pending for registration of pesticides containing nanomaterials. EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product. Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide. But risks assessment lags behind. According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”
Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar). But progress in one area does not necessarily mean progress elsewhere. The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches. And standardization remains a debatable issue in itself.
4. Industry Uncertainty. Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful. The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.
5. Bottom Line. The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.
Other speakers at the webinar included representatives of:
Nanotechnologies Industries Association, Brussels, Belgium
Chemical Control Division, Office of Pollution Prevention and Toxics, EPA
U.S. Consumer Product Safety Commission
California Nanotechnology Initiative
California Department of Toxic Substances Control
Environmental Defense Fund, Inc.
. . . and several attorneys in private practice