[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86558-86560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28872]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0236; FRL-10017-18]
n-Methylpyrrolidone (NMP); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of n-Methylpyrrolidone (NMP). The purpose of conducting risk
evaluations under TSCA is to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment
under the conditions of use, including an unreasonable risk to a
relevant potentially exposed or susceptible subpopulation, without
consideration of costs or other nonrisk factors. EPA has determined
that specific conditions of use of NMP present an unreasonable risk of
injury to health. For those conditions of use for which EPA has found
an unreasonable risk, EPA must take regulatory action to address that
unreasonable risk through risk management measures enumerated in TSCA.
EPA has also determined that specific conditions of use do not present
unreasonable risk of injury to health or the environment. For those
conditions of use for which EPA has found no unreasonable risk to
health or the environment, the Agency's determination is a final Agency
action and is issued via order in the risk evaluation.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0236, is available online
at http://www.regulations.gov or in-person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room are closed to visitors
with limited exceptions. The EPA/DC staff continue to provide remote
customer service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Seema Schappelle, Office of
Pollution Prevention and Toxics (7403M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-8006; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 86559]]
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. This action may
be of interest to persons who are or may be interested in risk
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq.
Since other entities may also be interested in this final risk
evaluation, the EPA has not attempted to describe all the specific
entities that may be affected by this action.
B. What is EPA's authority for taking this action?
TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk
evaluations to ``determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator,
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements
applicable to this process, including provisions that provide
instruction on chemical substances that must undergo evaluation, the
minimum components of a TSCA risk evaluation, and the timelines for
public comment and completion of the risk evaluation. TSCA also
requires that EPA operate in a manner that is consistent with the best
available science, make decisions based on the weight of the scientific
evidence and consider reasonably available information. 15 U.S.C.
2625(h), (i), and (k). TSCA section 6(i) directs that a determination
of ``no unreasonable risk'' shall be issued by order and considered to
be a final Agency action, while a determination of ``unreasonable
risk'' is not considered to be a final Agency action. 15 U.S.C.
2605(i).
The statute identifies the minimum components for all chemical
substance risk evaluations. For each risk evaluation, EPA must publish
a document that outlines the scope of the risk evaluation to be
conducted, which includes the hazards, exposures, conditions of use,
and the potentially exposed or susceptible subpopulations that EPA
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further
provides that each risk evaluation must also: (1) Integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance, including information that is relevant
to specific risks of injury to health or the environment and
information on relevant potentially exposed or susceptible
subpopulations; (2) describe whether aggregate or sentinel exposures
were considered and the basis for that consideration; (3) take into
account, where relevant, the likely duration, intensity, frequency, and
number of exposures under the conditions of use; and (4) describe the
weight of the scientific evidence for the identified hazards and
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through
(v). Each risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
The statute requires that the risk evaluation process be completed
within a specified timeframe and provide an opportunity for public
comment on a draft risk evaluation prior to publishing a final risk
evaluation. 15 U.S.C. 2605(b)(4)
Subsection 5.1.1 of the final risk evaluation for NMP constitutes
the order required under TSCA section 6(i)(1), and the ``no
unreasonable risk'' determinations in that subsection are considered to
be a final Agency action effective on the date of issuance of the
order. In conducting risk evaluations, ``EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of use within the scope of the
risk evaluation . . . .'' 40 CFR 702.47. Under EPA's implementing
regulations, ``[a] determination by EPA that the chemical substance,
under one or more of the conditions of use within the scope of the risk
evaluation, does not present an unreasonable risk of injury to health
or the environment will be issued by order and considered to be a final
Agency action, effective on the date of issuance of the order.'' 40 CFR
702.49(d). For purposes of TSCA section 19(a)(1)(A), the date of
issuance of the TSCA section 6(i)(1) order for NMP shall be at 1:00
p.m. Eastern time (standard or daylight, as appropriate) on the date
that is two weeks after the date when this notice is published in the
Federal Register, which is in accordance with 40 CFR 23.5.
C. What action is EPA taking?
EPA is announcing the availability of the risk evaluation of the
chemical substance identified in Unit II. In this risk evaluation EPA
has made unreasonable risk determinations on some of the conditions of
use within the scope of the risk evaluation for this chemical. For
those conditions of use for which EPA has found an unreasonable risk of
injury to health or the environment, EPA must initiate regulatory
action to address those risks through risk management measures
enumerated in 15 U.S.C. 2605(a).
EPA also is announcing the availability of the information required
to be provided publicly with each risk evaluation, which is available
online at http://www.regulations.gov in the dockets identified. 40 CFR
702.51. Specifically, EPA has provided:
The scope document and problem formulation (in Docket ID
No. EPA-HQ-OPPT-2016-0743);
Draft risk evaluation, and final risk evaluation (in
Docket ID No. EPA-HQ-OPPT-2019-0236);
All notices, determinations, findings, consent agreements,
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0236);
Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0743 and Docket
ID No. EPA-HQ-OPPT-2019-0236);
A nontechnical summary of the risk evaluation (in Docket
ID No. EPA-HQ-OPPT-2019-0236);
A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for N-
methylpyrrolidone (NMP)) in Docket ID No. EPA-HQ-OPPT-2019-0236);
The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
ID No. EPA-HQ-OPPT-2019-0236); and
Response to public comments received on the draft scope
and the draft risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0236).
II. TSCA Risk Evaluation
A. What is EPA's risk evaluation process for existing chemicals under
TSCA?
The risk evaluation process is the second step in EPA's existing
chemical review process under TSCA, following prioritization and before
risk management. As this chemical is one of the first ten chemical
substances undergoing risk evaluation, the chemical substance was not
required to go through prioritization (81 FR 91927, December 19, 2016)
(FRL-9956-47). The purpose of conducting risk evaluations is to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use,
including an unreasonable risk to a relevant potentially exposed or
susceptible subpopulation. As part of this process, EPA must evaluate
both hazard and exposure, not consider costs or other nonrisk factors,
use reasonably available information and approaches in a
[[Page 86560]]
manner that is consistent with the requirements in TSCA for the use of
the best available science, and ensure decisions are based on the
weight of the scientific evidence.
The specific risk evaluation process that EPA has established by
rule to implement the statutory process is set out in 40 CFR part 702
and summarized on EPA's website at http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B is being followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
Prior to the publication of this final risk evaluation, a draft
risk evaluation was subject to peer review and public comment. EPA
reviewed the report from the peer review committee and public comments
and has amended the risk evaluation in response to these comments as
appropriate. The public comments, peer review report, and EPA's
response to comments is in Docket ID No. EPA-HQ-OPPT-2019-0236. Prior
to the publication of the draft risk evaluation, EPA made available the
scope and problem formulation, and solicited public input on uses and
exposure. EPA's documents and the public comments are in Docket ID No.
EPA-HQ-OPPT-2016-0743. Additionally, information about the scope,
problem formulation, and draft risk evaluation phases of the TSCA risk
evaluation for this chemical is available at EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-n-methylpyrrolidone-nmp-0.
B. What is n-Methylpyrrolidone (NMP)?
n-Methylpyrrolidone (CASRN 872-50-4), also called n-methyl-2-
pyrrolidone, or 1-methyl-2-pyrrolidone, is a water-miscible, organic
solvent that is often used as a substitute for halogenated solvents.
NMP is widely used in the chemical manufacturing, petrochemical
processing and electronics industries, and in semiconductor fabrication
and lithium ion battery manufacturing {FMI, 2015, 3827469{time} . In
the commercial sector, NMP is primarily used for producing and removing
paints, coatings and adhesives. Other applications include use in
solvents, reagents, sealers, inks and grouts, industrial, commercial
and consumer uses and disposal. CDR data shows that the total aggregate
production volume for NMP decreased slightly from 164 to 160 million
pounds between 2012 and 2015.
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-28872 Filed 12-29-20; 8:45 am]
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