Environmental Policy Alert, June 7, 2006


[Rachel's introduction: Environmental Defense (ED), a major U.S. environmental organization, has petitioned U.S. Environmental Protection Agency (EPA) to regulate nanotechnology under the Toxic Substances Control Act TSCA). TSCA is widely acknowledged as one of the least-effective government regulations ever written. ED's petition could signal a rift between ED and some of its partners in the chemical industry. On the other hand, it might be viewed as ED asking EPA to throw their Brer Rabbit friends into the regulatory briar patch.]

A key environmental group, Environmental Defense (ED), is calling on EPA to issue guidance and possibly initiate a rulemaking regulating nanomaterials as new chemicals under the Toxic Substances Control Act (TSCA) in an effort targeting recent chemical industry arguments that the agency lacks authority under the toxics law to regulate the materials.

The group sent a letter May 22 to EPA's general counsel arguing that engineered nanomaterials are "new" substances under TSCA, which would mean industry would have to submit information to the agency in a pre- manufacture notice (PMN) on the makeup of a nanomaterial. Such an application can slow the process of bringing a product to market, but allows EPA to review and assess the potential for risks from a new material and allows the agency to limit use of, and exposure to, the material. Relevant documents are available on InsideEPA.com.

The dispute suggests a breakdown in joint efforts by the group and the American Chemistry Council (ACC) to develop consensus policies on nanomaterials. But ED and DuPont officials are still working on a joint nanotech policy process, sources say.

Nanotechnology is an emerging technology that is expected to have widespread uses in industry, medicine and consumer products. But activists are concerned about the potential risks to the environment and human health, and industry officials have called for a regulatory framework to limit future liabilities posed by nanomaterials. The unique makeup of the materials, however, poses challenges to EPA in determining how to regulate the technology and whether current statutes and regulations can adequately apply to nanomaterials.

EPA's general counsel is expected to release later this year a guidance on the scope of EPA's authority under TSCA to regulate nanomaterials and what materials require PMNs. EPA sources were unavailable for comment.

ACC and ED issued a joint statement last year at an EPA-convened public meeting on nanotechnology in which the two organizations outlined common principles for developing policies for the emerging technology. The statement called for, among other things, increased government investment in research on nanotechnology; development of international standardized testing protocols; regulation of nanomaterials in a "transparent process" that will minimize risks to human health and the environment; and a "multi-stakeholder dialogue" that will "assure the development of an effective program for nanoscale materials."

But last March, ACC's Nanotechnology Panel sent a document to EPA arguing that the definition of a "chemical substance" under TSCA limits the information EPA can seek on a chemical's makeup. This would minimize the volume of PMNs industry may have to submit before brining a nanotechnology product to market.

In its response to ACC's document, ED argues that it is "entirely consistent with both the language of TSCA and EPA's own regulations and practice to designate engineered nanomaterials as 'new' substances under TSCA and thus subject to PMN review, even where a material has a chemical structure that is identical to a substance already included on the [TSCA] Inventory, unless the nanomaterial's chemical and physical properties are demonstrably identical to an existing conventional substance with the same chemical structure."

The letter also argues that EPA can consider a broad range of information when it defines a "chemical substance" under TSCA, refuting a number of statements the ACC panel makes. The environmentalists point to a number of longstanding agency practices under which it considers factors beyond the basic chemical structure to define a substance.

"In short, EPA can and routinely does consider factors beyond chemical structure in order to define a chemical substance, and it does so in particular when chemical structure alone is insufficient," the letter says. "Engineered nanomaterials are perfect examples of such chemical substances: Their enhanced or novel properties, which in many cases are a direct function of the means by which they are produced, are what make them new, giving them their own molecular identify and distinguishing them from existing chemical substances possessing the same molecular structure. To ignore such factors would be to ignore the very nano-ness of engineered nanomaterials."

Meanwhile, ED and DuPont in recent weeks have been seeking verbal comment from scientists, industry and others on how to move forward with a framework for the development, production, use and disposal of nanomaterials that "identifies, manages and reduces potential risks across all lifecycle phases."

The framework, which was first outlined last year, hopes to identify potential hazards; assess the potential for exposure to such materials; demonstrate the application of the framework on at least one nanotechnology product; apply the framework to all of Dupont's involvement in nanotechnology; and promote the principles of the framework so that it will adopted broadly by government, industry, public interest groups and others.