The EPA’s Toxic Substances Control Act: What you must know

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Courtesy of Bergeson & Campbell, P.C.

Does the nanoscale substance you are producing or using require approval under the U.S. Environmental Protection
Agency’s (EPA) Toxic Substances Control Act (TSCA)? It does if it’s new. But what exactly is “new?”

Nanotechnology innovators face challenges in commercializing their products-and pre-manufacture notification
(PMN) requirements under the TSCA, the federal law governing chemical substances, is one of them. The EPA
considers nanoscale materials that meet the TSCA definition of “chemical substance” to be “new”-and thus subject to
PMN requirements-if they are not listed on the TSCA Inventory, a listing of chemicals in commerce.

The cost and timing of satisfying PMN requirements are difficult to predict and inject uncertainty into an already
uncertain business environment. So let’s look at the EPA’s general approach to determining whether a nanoscale
substance is “new” for TSCA purposes based on EPA guidance issued on July 12, 2007 (see for details).

It’s chemistry

Materials that have structures 1nm to 100nm long are generally referred to as engineered nanoscale materials or
substances. Those that meet the TSCA definition of “chemical substance” are subject to TSCA because they may
exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part,
“any organic or inorganic substance of a particular molecular identity.”

A threshold question for nanoscale material developers to answer before moving to commercial manufacture is
whether their new materials are “new.” If a nanoscale material is listed on the TSCA Inventory, it is considered
“existing,” and it is not subject to new chemical reporting requirements. If it is not Inventory-listed, EPA considers the
substance “new” and, unless a PMN exemption applies, the manufacturer must submit a PMN to the EPA at least 90
days before commencing commercial manufacture or import. (PMN exemptions important for nano innovations
include the exemption for chemical substances having no separate commercial purpose; the polymer exemption; and
the research and development exemption.)

A PMN requires information on the submitter’s identity, the chemical substance’s identity, production volume, uses,
exposures, and environmental fate. Data need not be produced, but must be submitted if available. If the PMN
submitter does not hear from the EPA within 90 days of PMN submission, then it may commence manufacture or
import of the substance after submission of a Notice of Commencement of Manufacture or Import (NOC). Submission
of the NOC adds the substance to the Inventory and changes the status of the substance from a “new” substance to
an “existing” one.

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