ILMA Compoundings June 2017 - 12

INDUSTRY RUNDOWN

International Insight
New Pre-import
Responsibilities for
Nanoscale Material
Reporting
By James Eggenschwiler

t's no secret that the U.S. Environmental Protection
Agency (EPA) and other chemical regulators around the
world have been struggling to cope with the evaluation of
potential hazards posed by nanoscale materials. The subject
has sparked considerable controversy, enough so that no
major market has yet developed a comprehensive approach
to identifying and managing the potential risks.
That being said, the EPA published on March 7 a final
rule that initiates a notification process for nanoscale forms
of Toxic Substances Control Act (TSCA) Inventory-listed
(or "existing") substances. This new rule affects all chemical
manufacturers, importers and processors. Although the final
rule was intended to be effective May 12, the effective date
has since been delayed to Aug. 14.
WHO IS AFFECTED?
Although this new rule also places the same requirements
on U.S. manufacturers of the same category of nanoscale
materials, this discussion will approach the topic from an
importer's perspective.
The new rule has been issued pursuant to EPA's authority under TSCA Section 8(a). Under TSCA, importers are
considered manufacturers, and the "importer" is the person
primarily liable for the payment of duties on commodities imported. This can include the consignee, importer of
record or other substantive parties (including owners and
transferees, depending on the circumstances). In addition,
agents of these parties may also be held responsible. In any
event, the EPA's overriding intent is to assign responsibility
to the primary responsible party for the import.
The term "processor" under TSCA includes anyone who
prepares a chemical substance or mixture (after the manufacturer of the substance) for distribution in commerce. The
nature of activities can range from formulating mixtures

JUNE 2017

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to repackaging the substance as a product. This term adds
important understanding of the breadth of this rule. EPA's
purpose is to capture information about the nanoscale material that will enter U.S. commerce, regardless of the method
for that entry. Formulators are viewed by EPA as just one of
several avenues of market entry.
WHAT IS COVERED?
Generally speaking, the rule covers chemical substances that
are manufactured or processed to form any particles, including aggregates and agglomerates, that are 1-100 nanometers
in at least one dimension and are manufactured or processed
to exhibit one or more unique and novel properties. To the
extent that similar substances are characterized by distinctions
in "unique and novel properties," the importer must evaluate
whether separate notifications must be made for each, based
on EPA guidance. The rule provides definitions and guidance
on how to evaluate discrete forms of the same substance.
The rule also provides general and specific exemptions.
Specific exemptions cover certain biological materials,
substances that dissociate completely in water to form ions
with a size of less than 1 nm, and substances in forms that
contain less than 1 percent by weight of any particles in the
range of 1-100 nm. General exemptions include the TSCA
Section 8(a) reporting exemptions, including the research
and development (R&D) exemption. A final exemption
worth mention is an import entity exemption for any small
importer with sales of less than $11 million per year.
A NEW ROUTINE
The advent of this rule significantly increases the responsibility to and potential interaction with EPA by all chemical
importers. Until now, importer interactions with EPA (as part
of the normal process) have been typically handled through
their Customhouse Broker in the context of TSCA Import
Certifications, and the responsibility of the importer has
been limited to the accuracy of that certification. That will no
longer be the case where nanoscale ingredients are included in
the imported product. Now, chemical importers must add a
new routine to their process that affirmatively screens for the
presence of nanoscale ingredients in the materials they import
and includes direct reporting responsibility to EPA when
nanoscale ingredients or materials are involved.
In those instances where product manufacturers tout their
use of nanoscale substances and the performance benefits
they provide, importer screening will be less involved. However, many manufacturers or intermediary suppliers remain

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ILMA Compoundings June 2017

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