Tiny particles are drawing big interest

Regulatory Editor Lynn Bergeson discusses how a voluntary program aims at responsible development of nanotechnology in this month's Compliance Advisor column.

By Lynn Bergeson, regulatory editor

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A public meeting to discuss the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA) was held by the U.S. Environmental Protection Agency (EPA) on August 2. Chemical manufacturers and processors will be affected by this program, and EPA’s growing number of TSCA and related program announcements about nanoscale materials.

What was discussed

Nanotechnology is rapidly evolving and cuts across virtually all manufacturing sectors. Some predict that “nano” will eventually be dropped because it will become redundant. The federal government is interested in and supportive of societal advances offered by this technology, but equally cognizant of potential adverse human health and environmental impacts that these tiny particles may invite.

The NMSP, launched by EPA on October 18, 2006, is a voluntary program that EPA’s Office of Pollution Prevention and Toxics (OPPT) will manage under the TSCA. EPA’s goal is “to implement TSCA in a way that enables responsible development of nanotechnology and realizes its potential environmental benefits, while applying sound science to assess and, where appropriate, manage potential risks to human health and the environment presented by nanoscale materials.” EPA says developing the program will help meet this goal “by generating information and providing a sound, scientific basis for risk assessment and risk management.”

After introductory remarks by James Gulliford, EPA assistant administrator for Prevention, Pesticides and Toxic Substances, Charles Auer, OPPT director, and Jim Willis, OPPT’s director of the Chemical Control Division, various organizations presented their views. Among those commenting were the American Chemistry Council Nanotechnology Panel (ACC NP), Environmental Defense (ED), Consumers Union, the NanoBusiness Alliance (NbA), the International Council on Nanotechnology (ICON), and Dr. J. Clarence Davies of the Project on Emerging Nanotechnologies (PEN).

ED, in a statement by Dr. Richard A. Denison, withdrew its NMSP support, contending that “[w]hile a voluntary program [for nanoscale materials] made sense as a starting point two years ago when first proposed [by NPPTAC], . . . it no longer does.” ED urged EPA instead “to move expeditiously to develop and implement mandatory reporting rules applicable to all companies producing, importing and handling engineered nanoscale materials,” and indicated that if the NMSP nevertheless proceeds, “it should not supplant or delay development of mandatory reporting rules.” On EPA’s draft document on the TSCA Inventory status of engineered nanoscale substances, ED strongly disagreed with EPA’s proposed approach and reiterated its long-held view that nanoscale versions of existing (i.e., Inventory-listed) chemicals should be deemed “new chemicals” for purposes of TSCA Section 5. Consumers Union also was fairly critical of the NMSP.

Dr. Shaun Clancy, of the ACC NP, supported the “basic elements of the NMSP” and stated that submitting information through the Program will “enable EPA to develop a better perspective in understanding the range of nanoscale materials in commerce and their volumes.” Similarly, Sean Murdock, of the NbA, said the Alliance supports the concept and commended EPA on the “overall program design.”

Given the strong response by some in the non-governmental organization community, NMSP supporters will need to redouble their efforts to show that a voluntary program can achieve EPA’s short-term goal of collecting meaningful and robust information and data on nanoscale materials. Some have been quick to point out that the United Kingdom’s voluntary program, launched in 2006, has attracted a relatively modest number of participants, certainly less than the government expected. Some fear that a tepid response will invite regulatory measures unsupported by some stakeholders, including a TSCA Section 8(a) rule, seeking production information, and/or a TSCA Section 8(d) rule, seeking health and safety studies and information.

EPA is expected to send letters to CEOs of companies believed to be engaged in the production and/or use of nanoscale materials urging them to participate in the NMSP. This will place enhanced pressure on companies and other recipients, to participate and encourage a favorable response to the program. Carefully consider the significant advantages of a voluntary nanoscale program. Absent a robust voluntary response, EPA will have no choice but to pursue more formal, and perhaps less appealing, regulatory measures to obtain the information it needs to ensure the responsible development of nanotechnology.


By Lynn Bergeson, regulatory editor. She is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. Contact her at lbergeson@putman.net. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.

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