ILMA Compoundings May 2017 - 45

WASHINGTON LANDSCAPE

TSCA Reform
Implementation Proceeds
By Daniel Bryant

ongress amended the Toxic
Substances Control Act (TSCA)
last June, and lawmakers directed the Environmental Protection Agency (EPA) to promulgate several rules to
implement key provisions of the law.
The Inventory Reset, Risk Prioritization
and Risk Evaluation rules are mandated
to be published in the Federal Register
(FR) by June 22, 2017.
THE INVENTORY RESET RULE
The revised TSCA requires that EPA
determine what chemicals on the
TSCA inventory are currently being
manufactured and processed, and designate all substances as either "active"
or "inactive" in U.S. commerce. To
effectuate that requirement, EPA has
proposed a retrospective electronic
notification requirement for chemical
substances on the TSCA inventory
that were manufactured or imported
for non-exempt commercial purposes
during the 10-year period ending June
21, 2016. The agency also proposes
to accept voluntary notifications for
chemical substances that were processed during the same period.
Under the proposed rule, chemical
manufacturers (and importers) would
have to notify EPA within 180 days after
the final rule is published in the FR.
Processors would have the option to
report up to 360 days after publication.
This additional time allows processors
to review the information received and
published and ascertain whether any
substances important to them are absent.

PRIORITIZATION RULE
EPA also was required by Congress to
publish a rule establishing its internal,
risk-based procedures for the prioritization of existing chemicals as either
"high-priority substances"1 for risk evaluation or "low-priority substances"2 for

which risk evaluations are not warranted
at the time. Prioritization is the initial
phase of the new procedure for existing
chemical reviews, and EPA is proposing
four steps: pre-prioritization, initiation,
proposed designation and final designation, which must be completed for a single substance in a 9-12-month period.
During the pre-prioritization stage,
EPA will seek to gather available information and "prescreen" the substances
against criteria outlined in the law.
Then, during the "initiation" phase,
EPA will post a notice in the FR and
allow for public comment. Once all
relevant information and data are submitted, EPA will make a preliminary
determination that a chemical is high3
or low priority and will publish that
proposed designation in the FR. Once
comments are reviewed, EPA will make
its final designation.4

CONCLUSION
ILMA submitted comments on all
three proposed rules. The Association
and other groups' comments can be
reviewed in the public dockets at
www.regulations.gov. EPA expects to
publish final versions of these rules by
its June 22 deadline. ILMA members
should review the final rules, particularly the Inventory Reset, to ensure
that no new obligations are created for
their companies.
Additionally, it is advisable to keep
an eye out, as EPA will also propose
an industry "fees rule" in the coming
months that will assist the agency
in implementing the legislation and
offset costs to administer the statute.
There are concerns that the fees will be
onerous and will require that companies generate mass sets of data at
considerable time and cost.

RISK EVALUATION RULE
Another proposed rule sets forth the
procedures and methods EPA is proposing to use in conducting risk evaluations
for chemicals, building upon the current
risk assessment process. EPA will initially
develop a scoping document that will
provide an overview of the work the agency intends to undertake on the chemical,
and it will subsequently be made available
for public review and comment. EPA will
then proceed with the full risk evaluation and publish its draft in the FR and
allow for public comment. The final risk
evaluation will be published as soon as
practicable after comments are considered, but not to exceed the statutory
deadline of three years (with a potential
six-month extension) from when the evaluation commenced. The final evaluation
will analyze whether the substance poses
an unreasonable risk. If so, the agency will
proceed to risk management.

1 "High-priority substance" means a chemical
substance, without consideration of costs or other
non-risk factors, may present an unreasonable risk
of injury to health or the environment because of a
potential hazard and a potential route of exposure
under the conditions of use, including an unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant by EPA.
2 "Low-priority substance" means a chemical
substance that does not meet the standard for
a high-priority substance.
3 EPA will default to a high-priority designation
where data is lacking.
4 A high-priority designation does not mean that
the chemical substance presents an unreasonable
risk to human health or the environment; rather, it
means that EPA intends to conduct a risk evaluation on the substance.

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.

http://www.regulations.gov

ILMA Compoundings May 2017

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