Environmental Policy Alert  [Printer-friendly version]
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

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.