Manufacturing Today - July 2017 - 9

LYNN L. BERGESON | COLUMN BY

Years in the Making
epa seeks comment on draft guidance for nanoscale materials rule

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The U.S. Environmental Protection Agency (EPA) made available
on May 16, 2017, and requested comment on a draft guidance document, "Guidance on EPA's Section 8(a) Information Gathering
Rule on Nanomaterials in Commerce." This column discusses
the draft guidance.

E CONOMY

A LFAB INC.

substance, the importer of the toner
must report. Processors that do not
know about the particle size and other
characteristics of formulations they
process or use must take reasonable
measures to ascertain the information that would determine whether
they are subject to the rule. The supplier is not required to provide any additional information to the processor
but might provide other supporting
information, such as whether the supplier has reported or intends to report
the chemical substance under this
rule. Companies that purchase formulations but do not change or modify those formulations and only use
them are not considered processors
and thus are not required to report.
Each manufacturer and processor in the supply chain must report
"reasonably ascertainable" information on the reportable chemical substance. The draft guidance clarifies
the scope of what would be required
under the "known to or reasonably
ascertainable by" reporting standard. As defined by 40 C.F.R. Section
704.3, the standard means "all information in a person's possession
or control, plus all information that
a reasonable person similarly situated might be expected to possess,
control or know." A submitter must

B UY AMERICAN

The draft guidance provides answers
to questions EPA has received from
manufacturers, including importers
and processors of certain chemical
substances when they are manufactured or processed at the nanoscale,
as described in the Jan. 12, 2017, final Toxic Substances Control Act
(TSCA) Section 8(a) rule. The final
rule requires one-time reporting for
existing discrete forms of certain nanoscale materials and a standing onetime reporting requirement for new
discrete forms of certain nanoscale
materials. The rule was years in the
making and is believed by many to be
somewhat confusing and difficult to
apply to real world settings. The guidance is both a step in the right direction and much needed, but comment
upon it will be essential to make the
guidance more serviceable.
The draft guidance reiterates that
under TSCA, the definition of "manufacture" includes import. In the case
of a company importing a chemical
substance as part of a formulation,
such as ink/toner products, the chemicals in the formulation are subject
to TSCA reporting requirements, including the final rule for nanoscale
materials. If the chemical substance
is imported in a form that meets the
definition of a reportable chemical

ascertain what they know about the
manufacturing, processing and use
of a chemical substance it manufactures (including imports) or processes, without confining its inquiry
to what is known to managerial and
supervisory employees. According
to the draft guidance, a submitter
would also be expected to review other information that the manufacturer (including importer) or processor
may have in its possession. This standard requires that submitters conduct a reasonable inquiry within the
full scope of their organization (not
just the information known to managerial or supervisory employees).
Because the final rule requires
only one-time reporting, a change in
manufacture, processing or use will
not require updating EPA with new
information, unless the change creates a new discrete form of a reportable chemical substance. EPA notes
that the type of process change is not
the criterion for distinguishing new
processing methods from existing
methods. EPA states that any manufacturing or processing change that is
intended to change particle size and
properties would be a process change
that could require new reporting.
EPA states that the purpose of the
final rule is not to create an inventory
of nanoscale material chemical substances in commerce, but rather to
collect information on the manufacture (including importation), processing and industrial, commercial
and consumer uses of certain chemical substances that are nanoscale
materials. EPA notes that it will use
information gathered through the
rule to inform its understanding
about the manufacture, processing
and use of nanoscale substances and
to determine if any further action under TSCA is needed.

JULY 2017 manufacturing-today.com

9


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Table of Contents for the Digital Edition of Manufacturing Today - July 2017

Table of Contents
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Manufacturing Today - July 2017 - Cover3
Manufacturing Today - July 2017 - Cover4
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