Issue



Legal association points to EPA as nano regulator


09/01/2006







By Richard Acello

An American Bar Association committee of attorneys has concluded that no major changes are required in statutes to bring nanotech products and processes under the jurisdiction of the Environmental Protection Agency.

Lynn Bergeson, chair of the ABA’s Section of Environment, Energy and Resources (SEER) and a partner at the Washington, D.C., firm of Bergeson & Campbell, says the panel’s review was spurred by the increasing use of nanotech in everyday products.

“Products such as food packaging materials are starting to involve nanotech,” Bergeson said. “Our hope is that the technology is applied with eyes wide open and with a good deal of common sense.”

From March through May of this year, more than a hundred SEER attorneys were organized into seven teams to consider whether the EPA’s current statutory authority was sufficient to bring nanotech products within its purview. The SEER attorneys produced seven papers on topics ranging from whether regulation of nanotech materials is included in the Clean Water Act to regulation of nanoscale materials under the Toxic Substances Control Act. The complete set of papers can be found at www.abanet.org/environ/nanotech. The SEER committee has already briefed EPA General Counsel Ann Klee on its work.

“Our goal was to provide scholarly, balanced reviews of these statutes to see if they provide EPA with the authorization to address nanotech products, and the answer is yes, they do,” Bergeson said.

While the ABA report finds existing statutes sufficient to regulate nanotech products, agencies may need to revise and update their regulatory schemes to include nanotech products.

“The devil is in the details,” Bergeson said. “There’s a lot we don’t know that involves data development, the retooling of screening procedures, and (EPA) needs to get a handle on that stuff, but we don’t need a new law. These laws are very elastic and well-suited to address nanotech issues and risks. Some of the regulatory programs will need to be amended, some tweaked and some re-thought to deal with nanotech.”

In addition to the EPA’s set of water, air and hazardous material legislation, nanotech products may be subject to regulation by other federal agencies. For example, nanotech manufacturers are subject to rules of the Occupational Health and Safety Administration (OSHA), and may be subject to regulation by the Food and Drug Administration (FDA), among others.

A tricky issue for regulators may be how much they’re likely to know about the potential risks of a nanotech product before it has been introduced into the stream of commerce.

“It’s a combination of EPA and the manufacturing sector and the user community appreciating that there are unknowns,” said Bergeson. “So if you don’t know, you minimize exposures, make sure (workers) are wearing the appropriate clothing and equipment, and minimize potential troubles through waste and shipment, using an abundance of caution.”

Europe has also been wrestling with nanotech regulation issues and appears to be leaning toward a model of nanotech regulation that involves more government oversight than in the United States. One issue for both European and U.S. regulators is whether nanotech products should be subject to government approval before they enter the stream of commerce. Pre-approval by the FDA is part of the government’s regulatory scheme for new drugs, but not for most products.

Bergeson counseled nanotech-related businesses to apply the technology prudently and to manage risks associated with nanotech “as you would any other business risk, but don’t ignore it.”

The seven briefing documents prepared by the American Bar Association’s Section of Environment, Energy, and Resources were as follows:

  1. CAA (Clean Air Act) Nanotechnology Briefing Paper
  2. CERCLA (Comprehensive Environmental Response, Compensation and Liability Act) Nanotechnology Issues
  3. CWA (Clean Water Act) Nanotechnology Briefing Paper
  4. EMS (Environmental Management Systems)/Innovative Regulatory Approaches
  5. The Adequacy of FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) to Regulate Nanotechnology-Based Pesticides
  6. RCRA (Resource Conservation and Recovery Act) Regulation of Wastes from the Production, Use, and Disposal of Nanomaterials
  7. Regulation of Nanoscale Materials under the Toxic Substances Control Act

The full text of each white paper and additional information about the SEER’s nanotechnology project is available online at www.abanet.org/environ/nanotech.