ILMA Compoundings June 2017 - 13

silent concerning both nanomaterials and the identity of the
substances included. To prevent slippage, importers must
now seek this information at the front end of the import
pre-purchase process. In those instances where nanomaterial
ingredients are confirmed, the timetable for import must be
carefully determined to allow sufficient time to gather the
required data and submit the report electronically to EPA
within the prescribed time window before import.
NOTIFICATION WINDOWS
Two notification windows are established by the new rule.
First, anyone who has imported a reportable nanoscale
substance between Aug. 14, 2014, and the effective date must
notify EPA concerning each nanoscale substance involved
(not each import of the substance) during that three-year period by Aug. 14, 2018. Where importers already know about
nanoscale materials they imported, meeting the 2018 deadline
should be relatively easy, provided they can obtain requisite
data cooperation from their exporter manufacturers. Greater
difficulty will be experienced by importers who are unaware
of the nanoscale content within their imported materials. Any
importer who has not meticulously tracked this detail must
investigate. This process should begin sooner rather than later
to allow sufficient time to meet the 2018 deadline.
The second notification window is for any import date
that occurs on or within three years after Aug. 14, 2017.
Here, importers must submit the notification to EPA at
least 135 days before the intended date of import, unless the
importer can demonstrate that it formed an intent to import
the related product less than 135 days before the import
date. Where this exception can be shown, the notification
must be submitted to EPA at least 30 days before the import
date. Demonstrating the date on which the intent to import
occurred can be difficult, however, because it does not
automatically track to the purchase order date. Evidence
of intent can be gleaned from correspondence between the
importer and supplier, and R&D evaluation prior to import
might also be interpreted as supporting this intent where
the R&D results are favorable. Care should be exercised by
importers in claiming this exception, because EPA's rejection
of the claim will result in penalties for late compliance.
In addition to the reporting requirement, EPA also
requires recordkeeping concerning all import transactions
involving any nanoscale material content during the three
years from Aug. 14, 2017, and Aug. 14, 2020. This recordkeeping will support EPA compliance auditing concerning

the period and will likely be used to evaluate the potential
need for additional measures.
The same notification windows apply to domestic manufacturers and processors. In those situations, the submittal
time frame is measured against the formation of the intent
to manufacture, or the intent to process, as the case may
be. The first reporting window requires notification for
nanoscale materials manufactured or processed on or after
Aug. 14, 2014. The second reporting window concerns
nanoscale materials manufactured or processed on or during
the three years after Aug. 14, 2017, within the 135 days
prior to commencement of manufacturing or processing,
respectively. The same exception applies with a manufacturer or processor who can demonstrate that the intent was
formed in a shorter period of time, subject to a minimum of
30 days notification before the start of manufacturing
or processing.
HOW AND WHAT TO REPORT
Reporting must occur electronically through EPA's CDX
reporting portal. The information to be reported includes:
* specific chemical identity (including Chemical Index
Name and CAS number, with supporting analytical data)
* import volume
* methods manufacture/processing
* uses
* exposure and release information
* available health and safety information
The requirement for submittal through CDX has a
practical impact: Only U.S. companies with U.S. physical
addresses may submit a notification under the rule. Consequently, many foreign manufacturers will not be able to submit their data directly to EPA through the portal. Neither
are they likely to provide the data to the importer directly.
Those faced with this dilemma should consider working
with a U.S. regulatory trustee (such as Redstone) that can
receive the data directly from the foreign manufacturer in
a confidential environment and submit it to EPA without
disclosing the data to the importer.
Eggenschwiler is an international trade attorney and
director of Global Trade for Redstone Group LLC. He can
be reached at 614-923-7472 or jeggenschwiler@
redstonegrp.com.

13
ILMA Compoundings June 2017

Table of Contents for the Digital Edition of ILMA Compoundings June 2017
