April 28, 2009
Gibson, Dunn & Crutcher’s Environmental Litigation and Mass Tort Group is closely tracking regulatory and legislative activity relating to the regulation of nanotechnology, which is an emerging technology that involves an increasing number of products and businesses. In light of recent activity by Congress, the Environmental Protection Agency (EPA), and the Food and Drug Administration, we expect that a new federal nanotechnology regulatory environment will begin to develop this year. We will provide updates on information and legal issues that might prove useful to nanotechnology stakeholders as regulation and law develops in this area.
This update focuses on the Environmental Protection Agency’s announcement that it will decide on ways to regulate nanoscale materials by the end of the year because, according to the agency, manufacturers have not provided enough information for the agency to understand key characteristics of manufactured nanomaterials.
Nanoscale Materials Stewardship Program vs. Imposed Regulation – a Change in EPA’s Approach May Be on the Horizon
In January of 2008, EPA launched the Nanoscale Materials Stewardship Program (NMSP). The NMSP asks companies to voluntarily submit basic information about nanoscale materials they use, including their chemical and physical properties, hazard information, worker and other human exposure, whether the company releases the materials to the environment, and the company’s risk-management measures.
The NMSP consists of two levels: a “Basic Program” under which manufacturers would provide available data on their nanomaterials to EPA, and an “In-Depth” program under which manufacturers would agree to conduct new research on their nanomaterials.
As of January 2009, 29 companies or trade associations had submitted information to EPA under the basic program, and seven additional firms had pledged to provide basic information. Because of this limited participation in the first year of the NMSP, EPA announced that it will consider ways to regulate nanoscale materials, according to an interim report on the program released January 12, 2009. The agency will consider how best to apply its regulatory authority under the Toxic Substances Control Act (TSCA) to require the submission of data on nanomaterials and to mandate the testing of materials, the agency said in its Nanoscale Materials Stewardship Program: Interim Report. Options available to the agency under TSCA include using the authority provided under Section 8 to require companies to provide information they already have generated. EPA also could use its authority under Section 4 to mandate new testing of chemicals, or EPA could spur companies to generate new information by applying its Significant New Use Rules.
According to a recent statement by Jim Jones, acting assistant EPA administrator for prevention, pesticides, and toxic substances, EPA will decide this year, perhaps in the next six months, how it will compel companies to provide the information it seeks to understand how to evaluate the hazards nanomaterials may pose and how to address them. This announcement comes while EPA considers a petition that calls on the agency to classify nanosilver as a pesticide. This issue extends to the broader questions of whether EPA has the existing regulatory authority and regulatory tools to ensure that use of nanomaterials do not endanger public health and the environment, and whether it should make a regulatory distinction between a chemical substance and its nanoparticle form.
The open questions associated with the classification of nanosilver and EPA’s plans for the NMSP reflect the uncertain state of the agency’s current approach to nanotechnology issues in general, leaving companies already active in this area in a state of ambiguity regarding the regulatory status and implications of their efforts. EPA’s shift away from a voluntary participation program could open the door not only to stricter EPA regulation, but also to a patchwork of local laws that could confuse companies across the nation. In fact, some local governments have already launched their own ordinances seeking information on the use of “nanomaterials.” In 2006, Berkeley, California passed the world’s first nanotechnology ordinance, requiring nanotech firms within city limits to detail what they are producing and what they know about its risks. Cambridge, Massachusetts, which is one of the country’s nanotech hot spots, opted to take a voluntary approach, but is leaving the door open to regulating nanotechnology at the local level.
EPA continues to welcome new participants and information submissions for the NMSP, which will continue until January 2010. EPA’s Nanoscale Materials Stewardship Program could provide a positive benefit for business by helping to shape nanotechnology regulation, which seems to be on the way.
Gibson, Dunn & Crutcher lawyers are available to assist in addressing any questions you may have about these developments. To learn more about the firm’s Environmental Litigation and Mass Tort Practice Group, please contact the Gibson Dunn attorney with whom you work, or any of the following Practice Group Co-Chairs:
Alan N. Bick (949-451-4211, email@example.com)
© 2009 Gibson, Dunn & Crutcher LLP
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