ILMA Compoundings April 2017 - 45

WASHINGTON LANDSCAPE

EPA Publishes Final
Nanoscale Reporting Rule
By Daniel Bryant

he Environmental Protection
Agency (EPA) published its
final nanoscale-reporting rule
on Jan. 12. Ultimately, the agency
wants to determine if nanoscale materials interact with the environment
and/or human health in a manner
that is different from non-nanoscale
materials. This reporting rule is the
threshold step EPA will utilize to determine whether additional information or action is needed for specific
nanoscale materials.
The final rule outlines two significant requirements. One is a retrospective reporting requirement for companies that manufactured or processed
chemicals on the Toxic Substances
Control Act (TSCA) Inventory in the
nano form between May 12, 2014,
and May 12, 2017. Those businesses
must report that activity to EPA by
May 12, 2018.
The second requirement is a prospective reporting obligation for those
companies that intend to manufacture
or process a nano form of a substance
on TSCA after May 12, 2017. Those
entities must notify EPA 1351 days
before first manufacture or processing.
The reporting requirements are
predicated upon EPA's definitions
for specific terms and descriptions
for certain processes. In general,2 the
reporting requirement attaches if a
company manufactured or processed
chemical substances,3 which are solids
at 25 degrees Celsius and standard
atmospheric pressure, that are manufactured or processed in a form where

processors from reporting obligations
if total sales (including that of its
parent company) are less than $11
million per year or if nanoscale materials are manufactured or processed
expressly for research and development
(R&D) purposes.
Even though the reporting deadline
for historical nanoscale data is not
until 2018, ILMA members should
review the final rule now in conjunction with their specific product lines
(potentially with in-house chemists)
to ascertain whether they must report
to EPA.
1. The final rule states that if a person has not
formed an intent to manufacture or process the
discrete form at least 135 days prior to commencing, the entity or person must file within 30 days of
the intent to process or manufacture.
2. EPA clarified in the final rule that "trace amounts"

any particles, including aggregates and
agglomerates, are in the size range of
1 to 100 nanometers (nm) in at least
one dimension and that are manufactured or processed to exhibit one or
more unique4 and novel properties.
The final rule mandates that the
information be reported electronically
through the agency's Central Data Exchange. Covered entities must provide
EPA with information including the
specific chemical identity, production
volume, methods of manufacture
and processing, exposure and release
information, and currently available
information pertaining to any environmental or health effects.
Importantly for ILMA members,
the rule exempts manufacturers and

- that is, substances that contain less than 1 percent of particles from 1 to 100nm by weight - need
not be reported.

3. Chemical substance means any organic or
inorganic of particular molecular identity, including
any combination of such substances occurring in
whole or in part as a result of a chemical reaction
or occurring in nature and any element or combined radical.
4. "Unique and novel properties" means any
size-dependent properties that vary from those
associated with other forms or sizes of the same
chemical substance, and such properties are a reason that the chemical substance is manufactured
or processed in that form or size.

Bryant serves as regulatory
counsel to ILMA through
Bassman, Mitchell, Alfano &
Leiter Chtd. He may be
reached at 202-386-7670 or dbryant@bmalaw.net.

ILMA Compoundings April 2017

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