Nanoscale materials manufacturers are well advised to monitor closely developments in the EPA's chemical reporting processes.

On July 12, 2007, the U.S. Environmental Protection Agency (EPA) released its concept paper for the nanoscale materials stewardship program under tsca (concept paper), which outlines epa's initial thinking on the design and development of the nanoscale materials stewardship program (nmsp). EPA also released its tsca inventory status of nanoscale substances – general approach (TSCA Inventory Paper), which sets forth EPA's “general approach” to defining nanoscale mater-ials as new or existing under the Toxic Substances Control Act (TSCA).

EPA initiated its nanoscale materials regulatory explorations under TSCA on June 23, 2005, when it convened a public meeting to seek views on the feasibility of a voluntary program to obtain information on existing nanoscale materials. Following that meeting, EPA asked the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) to assist the Office of Pollution Prevention and Toxics (OPPT) with developing an approach to assessing potential risks from nanoscale materials. The newly created Interim Ad Hoc Work Group on Nanoscale Materials (Work Group) was tasked with providing input to NPPTAC on targeted issues. In September 2005, the Work Group presented NPPTAC with its Overview of Issues for Consideration (Overview of Issues) document, which was formally submitted to EPA on Nov. 22, 2005.   

The Overview of Issues document outlined a “basic program” and a more “in-depth program.”  Participants in the basic program would submit information to EPA on existing information on selected nanoscale materials. Those in the in-depth program would also submit such information, but also agree to conduct testing on certain nanoscale materials.

Concept Paper for the NMSP
OPPT officially responded to NPPTAC’s Overview of Issues in July 2007 in the form of the Concept Paper. OPPT issued at the same time its TSCA Inventory Paper, discussed separately below. EPA developed the Concept Paper “to outline [EPA’s] initial thinking on the design and development” of the NMSP. Similar to the NPPTAC proposal, EPA’s proposed program has a “basic program” that would request the reporting of “all known or reasonably ascertainable information regarding specific nanoscale materials,” and an “in-depth program” in which additional data would be developed and submitted to EPA over a longer timeframe.

The in-depth program would be informed by the basic program’s results, and would involve a subset of information reported under the basic program “in a greater amount of detail.” Roughly one year after commencement of the basic program, EPA may publish an interim report summarizing “the types of data available, the reasons some data were reported as not being available, additional data that would be needed for a better risk assessment and any activities for which data are being used.” Two years after the launch of the NMSP, EPA will issue a more detailed evaluation of the program and “determine the future direction of the basic reporting phase as well as in-depth data development.”

Key Issues
Three key issues have emerged with regard to the NMSP.  The first is a general concern noted by several commenters regarding the perceived lack of urgency on EPA’s part to initiate the voluntary program.  Environmental Defense (ED), for example, and others expressed concern over the fact that the NPPTAC proposal was issued in 2005, and the Concept Paper is quite similar in scope, only lacking certain key elements included in the NPPTAC proposal.

A second concern expressed by stakeholders is the absence of any consideration by EPA of developing mandatory TSCA reporting requirements.  ED urged EPA to issue a TSCA Section 8(a) rule and withdraw its support for a voluntary approach. ED criticized the NPPTAC document’s proposal for the identification of a “near-term need” to provide a combination of voluntary and regulatory approaches to address the potential risks of nanoscale materials.

A third concern is the absence of timetables by which participants would sign up and submit information, and a time by which EPA would agree to assess and report on the information submitted. The Concept Paper states only that OPPT “may” publish an interim report approximately a year after initiation of the basic reporting phase of the NMSP and a more detailed evaluation of the program two years after initiation.

TSCA Inventory Paper
A threshold question that nanoscale material manufacturers must ask before commencing commercial manufacturing is whether the nanoscale material is new and thus subject to TSCA reporting requirements, or “existing” and thus not subject to reporting.  Whether a chemical substance is new is a function of its listing on the TSCA Inventory, a listing of chemicals in commerce. If the substance is not listed on the inventory, EPA considers the substance “new” and in most cases, the manufacturer must submit a PMN to EPA at least 90 days before commencing commercial manufacture or import.

In its recent guidance, EPA reaffirms its policy not to use particle size to distinguish, for inventory purposes, substances that are known to have the same molecular identity. Importantly, EPA states that substances have different molecular identities when they have different molecular formulas; have the same molecular formulas but different atom connectivities; have the same molecular formulas and atom connectivities but different spatial arrangements of atoms; have the same types of atoms but different crystal lattices; are different allotropes of the same element; or have different isotopes of the same elements.

EPA concludes the TSCA Inventory Paper by reiterating what has been its mantra for some time now: manufacturers or importers of nanoscale substances are “encourage[d] … to contact the [OPPT] New Chemicals Program to arrange a pre-notice consultation or to submit a request for an inventory search under the bonafide intent to manufacture provisions.”

Nanoscale material manufacturers are well advised to monitor closely developments in this regard. How EPA fashions the NMSP, and its further guidance on TSCA inventory issues will have significant impacts on domestic chemical manufacturers for years to come.

Lynn L. Bergeson is a managing director of Bergeson & Campbell P.C., a Washington, D.C., law firm focusing on chemical, pesticide and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation and associated business issues. She is also president of The Acta Group L.L.C. and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, UK. Bergeson is legal counsel to the American Chemistry Counsel Nanotechnology Panel. She can be reached at 202-557-3800.