N-Methylpyrrolidone (NMP); Draft Toxic Substances Control Act (TSCA) Risk Evaluation and TSCA Science Advisory Committee on Chemicals (SACC) Meeting; Notice of Availability, Public Meeting, and Request for Comment, 60087-60090 [2019-24349]
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60087
TABLE III—TEST INFORMATION RECEIVED FROM 08/01/2019 TO 08/31/2019—Continued
Case No.
Received date
Type of test information
Chemical substance
(G) Halogenophosphoric acid
metal salt.
(G) 2-Propenoic acid, 2-alkyl-,
2-(dialkylamino)alkyl ester,
polymer with alpha-(2-alkyl1-oxo-2-alken-1-yl)-omegamethoxypoly(oxy-1,2alkanediyl).
(G) Methyl modified lactam.
P–16–0543 ..............................
8/9/2019
Exposure Monitoring Report ....................................................
P–18–0027 ..............................
8/28/2019
Fish acute toxicity test, freshwater and marine (OECD Test
Guideline 203), Special Considerations—Tests with Aquatic and Sediment-Dwelling Fauna and Aquatic Microcosms,
Fish Acute Toxicity Mitigated by Humic Acid.
P–18–0141 ..............................
8/14/2019
P–18–0141 ..............................
8/21/2019
P–18–0203 ..............................
8/7/2019
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD Test
Guideline 422), Reproduction/Developmental Toxicity
Screening Test (OECD Test Guideline 421), Repeated
Dose 28-day Oral Toxicity Study in Rodents (OECD Test
Guideline 407), Acute Inhalation Toxicity (OECD Test
Guideline 403).
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD Test
Guideline 422), Reproduction/Developmental Toxicity
Screening Test (OECD Test Guideline 421), Repeated
Dose 28-day Oral Toxicity Study in Rodents (OECD Test
Guideline 407).
Partition Coefficient (n-octanol/water), HPLC Method (OECD
Test Guideline 117).
P–19–0137 ..............................
8/19/2019
If you are interested in information
that is not included in these tables, you
may contact EPA’s technical
information contact or general
information contact as described under
FOR FURTHER INFORMATION CONTACT to
access additional non-CBI information
that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: October 29, 2019.
Pamela Myrick,
Director, Information Management Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2019–24287 Filed 11–6–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2019–0236; FRL–10001–
87]
N-Methylpyrrolidone (NMP); Draft
Toxic Substances Control Act (TSCA)
Risk Evaluation and TSCA Science
Advisory Committee on Chemicals
(SACC) Meeting; Notice of Availability,
Public Meeting, and Request for
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is announcing the
availability of and soliciting public
comment on the draft Toxic Substances
SUMMARY:
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Modified Activated Sludge, Respiration Inhibition Test for
Sparingly Soluble Chemicals (OECD Test Guideline 209),
In Vitro Mammalian Chromosome Aberration Test (OECD
Test Guideline 473).
Control Act (TSCA) risk evaluation of NMethylpyrrolidone (NMP). The purpose
of the risk evaluation process under
TSCA is to determine, upon issuance of
a final risk evaluation, 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. EPA is also
submitting the same document to the
TSCA Science Advisory Committee on
Chemicals (SACC) for peer review and
is announcing that there will be an inperson public meeting of the TSCA
SACC to consider and review the draft
risk evaluation. Preceding the in-person
meeting, there will be a preparatory
virtual public meeting for the panel to
consider the scope and clarity of the
draft charge questions for the peer
review.
DATES:
Virtual Meeting: The preparatory
virtual meeting will be held on
November 12, 2019, from 1:00 p.m. to
approximately 4:00 p.m. (EST). You
must register online on or before
November 12, 2019, to receive the
webcast meeting link and audio
teleconference information. Submit your
written comments for the preparatory
virtual meeting, or request time to
present oral comments, on or before
10:00 a.m. on November 12, 2019.
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(G) Methyl modified lactam.
(G) Trialkyl alkanal, polymer
with alkylalkanal and phenol.
(G) Alkyl oligomeric reaction
products.
In-Person Meeting: The in-person
meeting will be held on December 5–6,
2019, from 8:00 a.m. to approximately
6:00 p.m. (EST) on the first day, and
8:00 a.m. to 12:30 p.m. on the second
day. Any comments submitted on the
draft risk evaluation on or before
November 26, 2019, will be provided to
the SACC for their consideration before
the meeting. Comments received after
November 26, 2019, and prior to the oral
public comment period during the
meeting will be available to the SACC
for their consideration during the
meeting. Please submit requests to
present oral comments during the inperson meeting on or before December
3, 2019, to be included on the meeting
agenda. All comments received by the
end of the comment period will be
considered by EPA.
Comments: All comments on the draft
risk evaluation must be received on or
before January 6, 2020.
For additional instructions, see Unit
III. of the SUPPLEMENTARY INFORMATION.
ADDRESSES:
Virtual Meeting: Please visit https://
www.epa.gov/tsca-peer-review to
register.
In-Person Meeting: The in-person
meeting will be held at the Hyatt
Regency Crystal City, 2799 Jefferson
Davis Highway, Arlington, VA.
Additional meeting information can be
found on the TSCA SACC website at
https://www.epa.gov/tsca-peer-review.
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Comments: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2019–0236 by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPPT Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
Requests to present oral comments
and requests for special
accommodations. Submit requests for
special accommodations, or requests to
present oral comments during the
virtual meeting and/or the in-person
peer review meeting, to the Designated
Federal Official (DFO) listed under FOR
FURTHER INFORMATION CONTACT by the
deadline identified in the DATES section.
FOR FURTHER INFORMATION CONTACT:
TSCA SACC Meeting: Dr. Todd
Peterson, DFO, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–6428; email address:
peterson.todd@epa.gov.
Draft Risk Evaluation: Dr. Stan
Barone, Office of Pollution Prevention
and Toxics (7403M), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–1169;
email address: barone.stan@epa.gov.
SUPPLEMENTARY INFORMATION:
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
required to conduct testing and those
interested in risk evaluations of
chemical substances under TSCA, 15
U.S.C. 2601 et seq. Since other entities
may also be interested in these draft risk
evaluations, the EPA has not attempted
to describe all the specific entities that
may be affected by this action.
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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).
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 on
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)–(ii) and (iv)–(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 last no longer than
three years, with a possible additional
six-month extension. 15 U.S.C.
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2605(b)(4)(G). The statute also requires
that the EPA allow for no less than a 30day public comment period on the draft
risk evaluation, prior to publishing a
final risk evaluation. 15 U.S.C.
2605(b)(4)(H).
C. What action is EPA taking?
EPA is announcing the availability of
and seeking public comment on the
draft risk evaluation of the chemical
substances identified in Unit II. EPA is
seeking public comment on all aspects
of the draft risk evaluation, including
any preliminary conclusions, findings,
and determinations, and the submission
of any additional information that might
be relevant to the draft risk evaluation,
including the science underlying the
draft risk evaluation and the outcome of
the systematic review associated with
the chemical substances. This 60-day
comment period on the draft risk
evaluation satisfies TSCA section
6(b)(4)(H), which requires EPA to
‘‘provide no less than 30 days public
notice and an opportunity for comment
on a draft risk evaluation prior to
publishing a final risk evaluation,’’ and
40 CFR 702.49(a), which states that
‘‘EPA will publish a draft risk
evaluation in the Federal Register, open
a docket to facilitate receipt of public
comment, and provide no less than a 60day comment period, during which time
the public may submit comment on
EPA’s draft risk evaluation.’’ In addition
to any new comments on the draft risk
evaluation, the public should resubmit
or clearly identify any previously filed
comments, modified as appropriate, that
are relevant to the draft risk evaluation
and that the submitter feels have not
been addressed. EPA does not intend to
respond to comments submitted prior to
the release of the draft risk evaluation
unless they are clearly identified in
comments on the draft risk evaluation.
EPA is also submitting the draft risk
evaluation and associated supporting
documents to the TSCA SACC for peer
review and announcing the meeting for
the peer review panel. All comments
submitted to the dockets on the draft
risk evaluation by the deadline
identified in the DATES section will be
provided for consideration to the TSCA
SACC peer review panel, which will
have the opportunity to consider the
comments during its discussions.
D. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
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you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Draft 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
process under TSCA, following
prioritization and before risk
management. As these chemicals are
part of the first ten chemical substances
undergoing risk evaluation, these
chemical substances were not required
to go through prioritization (81 FR
91927, December 19, 2016) (FRL–9956–
47). The purpose of risk evaluation 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
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-ofscientific-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 https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluationsexisting-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, will be followed for the first
ten chemical substances undergoing risk
evaluation to the maximum extent
practicable.
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B. What is NMP?
N-methylpyrrolidone (NMP), also
called N-methyl-2-pyrrolidone, or
1-methyl-2-pyrrolidone, is a chemical
that is widely used during the
manufacture and production of
polymers, pharmaceuticals,
agrichemicals and petroleum products.
Information from the 2016 Chemical
Data Reporting (CDR) for NMP indicates
the reported production volume is more
than 160 million lbs/year (manufacture
and import).
Information about the problem
formulation and scope phases of the
TSCA risk evaluation for this chemical
is available at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluation-nmethylpyrrolidone-nmp-0.
III. TSCA SACC
A. What is the purpose of the TSCA
SACC?
The TSCA SACC was established by
EPA in 2016 and operates in accordance
with the Federal Advisory Committee
Act (FACA), 5 U.S.C. Appendix 2 et seq.
The TSCA SACC provides expert
independent scientific advice and
consultation to the EPA on the scientific
and technical aspects of risk
assessments, methodologies, and
pollution prevention measures and
approaches for chemicals regulated
under TSCA.
The TSCA SACC is comprised of
experts in: Toxicology; human health
and environmental risk assessment;
exposure assessment; and related
sciences (e.g., synthetic biology,
pharmacology, biotechnology,
nanotechnology, biochemistry,
biostatistics, physiologically based
pharmacokinetic modelling (PBPK)
modeling, computational toxicology,
epidemiology, environmental fate, and
environmental engineering and
sustainability). When needed, the
committee will be assisted in their
reviews by ad hoc participants with
specific expertise in the topics under
consideration.
B. How can I access the TSCA SACC
documents?
EPA’s background documents, related
supporting materials, and draft charge
questions to the TSCA SACC are
available on the TSCA SACC website
and in the docket established for the
specific chemical substances. In
addition, EPA will provide additional
background documents (e.g., TSCA
SACC members participating in this
meeting and the meeting agenda) as the
materials become available. You may
obtain electronic copies of these
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60089
documents, and certain other related
documents that might be available, in
the docket at https://www.regulations.gov
and the TSCA SACC website at https://
www.epa.gov/tsca-peer-review.
After the public meeting, the TSCA
SACC will prepare meeting minutes
summarizing its recommendations to
EPA. The meeting minutes will be
posted on the TSCA SACC website and
in the relevant docket.
C. What do I need to know about the
TSCA SACC public meetings?
The focus of the public meeting is to
peer review EPA’s draft risk evaluation.
After the peer review process, EPA will
consider peer reviewer comments and
recommendations, and public
comments, in finalizing the risk
evaluation. The draft risk evaluation
contains: Discussion of chemistry and
physical-chemical properties;
characterization of conditions of use;
environmental fate and transport
assessment; human health exposures;
environmental hazard assessment; risk
characterization; risk determination;
and a detailed description of the
systematic review process developed by
the Office of Pollution Prevention and
Toxics to search, screen, and evaluate
scientific literature for use in the risk
evaluation process.
D. How do I participate in the public
meetings?
You may participate in the public
meetings by following the instructions
in this unit. To ensure proper receipt by
EPA, it is imperative that you identify
the corresponding docket ID number in
the subject line on the first page of your
request.
1. Preparatory virtual meeting. The
preparatory virtual meeting will be
conducted via webcast and telephone.
You may participate in the preparatory
virtual meeting by registering to join the
webcast. You may also submit written
comments or request time for oral
comments.
i. Registration. You must register to
participate in the preparatory virtual
meeting. To participate by listening or
making a comment during this meeting,
please go to the EPA website to register:
https://www.epa.gov/tsca-peer-review.
Registration online will be confirmed by
an email that will include the webcast
meeting link and audio teleconference
information.
ii. Written comments. Written
comments for consideration during the
preparatory virtual meeting should be
submitted, using the instructions in
ADDRESSES and this unit, on or before
the date set in the DATES section.
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iii. Oral comments. Requests to make
brief oral comments to the TSCA SACC
during the preparatory virtual meeting
should be submitted when registering
online or with the DFO listed under FOR
FURTHER INFORMATION CONTACT on or
before noon on the date set in the DATES
section. Oral comments before the TSCA
SACC during the preparatory virtual
meeting are limited to approximately 5
minutes due to the time constraints of
this virtual meeting.
2. In-person meeting. You may
participate in the in-person public
meeting by attending and by providing
written or oral comments. The in-person
meeting may also be webcast. Please
refer to the TSCA SACC website at
https://www.epa.gov/tsca-peer-review for
information on how to access the
webcast. Please note that for the inperson meeting, the webcast is a
supplementary public process provided
only for convenience. If difficulties arise
resulting in webcasting outages, the inperson meeting will continue as
planned.
i. Seating at the meeting. Seating at
the meeting will be open and on a firstcome basis.
ii. Written comments. To provide the
TSCA SACC the time necessary to
consider and review your comments,
written comments must be submitted by
the date set in the DATES section and
using the instructions in the ADDRESSES
section and this unit. Comments
received after the date set in the DATES
section and prior to the end of the oral
public comment period during the
meeting will still be provided to the
TSCA SACC for their consideration.
iii. Oral comments. To be included on
the meeting agenda, submit your request
to make brief oral comments at the inperson meeting to the DFO listed under
FOR FURTHER INFORMATION CONTACT on or
before the date set in the DATES section.
The request should identify the name of
the individual making the presentation,
the organization (if any) the individual
will represent, and any requirements for
audiovisual equipment. Oral comments
before TSCA SACC during the in-person
meeting are limited to approximately 5
minutes unless prior arrangements have
been made. In addition, each speaker
should bring 30 copies of the comments
and presentation for distribution by the
DFO to the TSCA SACC at the meeting.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 4, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019–24349 Filed 11–6–19; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL DEPOSIT INSURANCE
CORPORATION
Notice of Termination of Receiverships
The Federal Deposit Insurance
Corporation (FDIC or Receiver), as
Receiver for each of the following
insured depository institutions, was
charged with the duty of winding up the
affairs of the former institutions and
liquidating all related assets. The
Receiver has fulfilled its obligations and
made all dividend distributions
required by law.
NOTICE OF TERMINATION OF RECEIVERSHIPS
Fund
Receivership name
City
10052 ................................................
10094 ................................................
10497 ................................................
American Sterling Bank ...................
Mutual Bank .....................................
Allendale County Bank ....................
Sugar Creek .....................................
Harvey ..............................................
Fairfax ..............................................
The Receiver has further irrevocably
authorized and appointed FDICCorporate as its attorney-in-fact to
execute and file any and all documents
that may be required to be executed by
the Receiver which FDIC-Corporate, in
its sole discretion, deems necessary,
including but not limited to releases,
discharges, satisfactions, endorsements,
assignments, and deeds. Effective on the
termination dates listed above, the
Receiverships have been terminated, the
Receiver has been discharged, and the
Receiverships have ceased to exist as
legal entities.
(Authority: 12 U.S.C. 1819).
Dated at Washington, DC, on November 4,
2019.
Annmarie H. Boyd,
Assistant Executive Secretary.
[FR Doc. 2019–24340 Filed 11–6–19; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL DEPOSIT INSURANCE
CORPORATION
Update To Notice of Financial
Institutions for Which the Federal
Deposit Insurance Corporation Has
Been Appointed Either Receiver,
Liquidator, or Manager
Federal Deposit Insurance
Corporation.
ACTION: Update listing of financial
institutions in liquidation.
AGENCY:
Federal Deposit Insurance Corporation.
Notice is hereby given that
the Federal Deposit Insurance
SUMMARY:
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State
MO
IL
SC
Termination
date
11/1/2019
11/1/2019
11/1/2019
Corporation (Corporation) has been
appointed the sole receiver for the
following financial institutions effective
as of the Date Closed as indicated in the
listing below.
SUPPLEMENTARY INFORMATION: This list
(as updated from time to time in the
Federal Register) may be relied upon as
‘‘of record’’ notice that the Corporation
has been appointed receiver for
purposes of the statement of policy
published in the July 2, 1992, issue of
the Federal Register (57 FR 29491). For
further information concerning the
identification of any institutions which
have been placed in liquidation, please
visit the Corporation website at
www.fdic.gov/bank/individual/failed/
banklist.html, or contact the Manager of
Receivership Oversight at RO@fdic.gov
or at Division of Resolutions and
Receiverships, FDIC, 1601 Bryan Street,
Suite 34100, Dallas, TX 75201–3401.
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]]>Agencies
[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60087-60090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24349]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0236; FRL-10001-87]
N-Methylpyrrolidone (NMP); Draft Toxic Substances Control Act
(TSCA) Risk Evaluation and TSCA Science Advisory Committee on Chemicals
(SACC) Meeting; Notice of Availability, Public Meeting, and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing the availability of and soliciting public
comment on the draft Toxic Substances Control Act (TSCA) risk
evaluation of N-Methylpyrrolidone (NMP). The purpose of the risk
evaluation process under TSCA is to determine, upon issuance of a final
risk evaluation, 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. EPA is also submitting the same document
to the TSCA Science Advisory Committee on Chemicals (SACC) for peer
review and is announcing that there will be an in-person public meeting
of the TSCA SACC to consider and review the draft risk evaluation.
Preceding the in-person meeting, there will be a preparatory virtual
public meeting for the panel to consider the scope and clarity of the
draft charge questions for the peer review.
DATES:
Virtual Meeting: The preparatory virtual meeting will be held on
November 12, 2019, from 1:00 p.m. to approximately 4:00 p.m. (EST). You
must register online on or before November 12, 2019, to receive the
webcast meeting link and audio teleconference information. Submit your
written comments for the preparatory virtual meeting, or request time
to present oral comments, on or before 10:00 a.m. on November 12, 2019.
In-Person Meeting: The in-person meeting will be held on December
5-6, 2019, from 8:00 a.m. to approximately 6:00 p.m. (EST) on the first
day, and 8:00 a.m. to 12:30 p.m. on the second day. Any comments
submitted on the draft risk evaluation on or before November 26, 2019,
will be provided to the SACC for their consideration before the
meeting. Comments received after November 26, 2019, and prior to the
oral public comment period during the meeting will be available to the
SACC for their consideration during the meeting. Please submit requests
to present oral comments during the in-person meeting on or before
December 3, 2019, to be included on the meeting agenda. All comments
received by the end of the comment period will be considered by EPA.
Comments: All comments on the draft risk evaluation must be
received on or before January 6, 2020.
For additional instructions, see Unit III. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES:
Virtual Meeting: Please visit https://www.epa.gov/tsca-peer-review
to register.
In-Person Meeting: The in-person meeting will be held at the Hyatt
Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA.
Additional meeting information can be found on the TSCA SACC website at
https://www.epa.gov/tsca-peer-review.
[[Page 60088]]
Comments: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0236 by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPPT Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
Requests to present oral comments and requests for special
accommodations. Submit requests for special accommodations, or requests
to present oral comments during the virtual meeting and/or the in-
person peer review meeting, to the Designated Federal Official (DFO)
listed under FOR FURTHER INFORMATION CONTACT by the deadline identified
in the DATES section.
FOR FURTHER INFORMATION CONTACT:
TSCA SACC Meeting: Dr. Todd Peterson, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-6428; email address: [email protected].
Draft Risk Evaluation: Dr. Stan Barone, Office of Pollution
Prevention and Toxics (7403M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-1169; email address: [email protected].
SUPPLEMENTARY INFORMATION:
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 required to conduct testing
and those interested in risk evaluations of chemical substances under
TSCA, 15 U.S.C. 2601 et seq. Since other entities may also be
interested in these draft risk evaluations, 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).
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 on 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)-(ii) and (iv)-(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 last no
longer than three years, with a possible additional six-month
extension. 15 U.S.C. 2605(b)(4)(G). The statute also requires that the
EPA allow for no less than a 30-day public comment period on the draft
risk evaluation, prior to publishing a final risk evaluation. 15 U.S.C.
2605(b)(4)(H).
C. What action is EPA taking?
EPA is announcing the availability of and seeking public comment on
the draft risk evaluation of the chemical substances identified in Unit
II. EPA is seeking public comment on all aspects of the draft risk
evaluation, including any preliminary conclusions, findings, and
determinations, and the submission of any additional information that
might be relevant to the draft risk evaluation, including the science
underlying the draft risk evaluation and the outcome of the systematic
review associated with the chemical substances. This 60-day comment
period on the draft risk evaluation satisfies TSCA section 6(b)(4)(H),
which requires EPA to ``provide no less than 30 days public notice and
an opportunity for comment on a draft risk evaluation prior to
publishing a final risk evaluation,'' and 40 CFR 702.49(a), which
states that ``EPA will publish a draft risk evaluation in the Federal
Register, open a docket to facilitate receipt of public comment, and
provide no less than a 60-day comment period, during which time the
public may submit comment on EPA's draft risk evaluation.'' In addition
to any new comments on the draft risk evaluation, the public should
resubmit or clearly identify any previously filed comments, modified as
appropriate, that are relevant to the draft risk evaluation and that
the submitter feels have not been addressed. EPA does not intend to
respond to comments submitted prior to the release of the draft risk
evaluation unless they are clearly identified in comments on the draft
risk evaluation.
EPA is also submitting the draft risk evaluation and associated
supporting documents to the TSCA SACC for peer review and announcing
the meeting for the peer review panel. All comments submitted to the
dockets on the draft risk evaluation by the deadline identified in the
DATES section will be provided for consideration to the TSCA SACC peer
review panel, which will have the opportunity to consider the comments
during its discussions.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that
[[Page 60089]]
you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then
identify electronically within the disk or CD-ROM the specific
information that is claimed CBI. In addition to one complete version of
the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Draft 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 process under TSCA, following prioritization and before risk
management. As these chemicals are part of the first ten chemical
substances undergoing risk evaluation, these chemical substances were
not required to go through prioritization (81 FR 91927, December 19,
2016) (FRL-9956-47). The purpose of risk evaluation 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 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-
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 https://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, will be followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
B. What is NMP?
N-methylpyrrolidone (NMP), also called N-methyl-2-pyrrolidone, or
1-methyl-2-pyrrolidone, is a chemical that is widely used during the
manufacture and production of polymers, pharmaceuticals, agrichemicals
and petroleum products. Information from the 2016 Chemical Data
Reporting (CDR) for NMP indicates the reported production volume is
more than 160 million lbs/year (manufacture and import).
Information about the problem formulation and scope phases of the
TSCA risk evaluation for this chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-n-methylpyrrolidone-nmp-0.
III. TSCA SACC
A. What is the purpose of the TSCA SACC?
The TSCA SACC was established by EPA in 2016 and operates in
accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C.
Appendix 2 et seq. The TSCA SACC provides expert independent scientific
advice and consultation to the EPA on the scientific and technical
aspects of risk assessments, methodologies, and pollution prevention
measures and approaches for chemicals regulated under TSCA.
The TSCA SACC is comprised of experts in: Toxicology; human health
and environmental risk assessment; exposure assessment; and related
sciences (e.g., synthetic biology, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic modelling (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). When needed, the committee will be assisted in their
reviews by ad hoc participants with specific expertise in the topics
under consideration.
B. How can I access the TSCA SACC documents?
EPA's background documents, related supporting materials, and draft
charge questions to the TSCA SACC are available on the TSCA SACC
website and in the docket established for the specific chemical
substances. In addition, EPA will provide additional background
documents (e.g., TSCA SACC members participating in this meeting and
the meeting agenda) as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available, in the docket at https://www.regulations.gov and the TSCA SACC website at https://www.epa.gov/tsca-peer-review.
After the public meeting, the TSCA SACC will prepare meeting
minutes summarizing its recommendations to EPA. The meeting minutes
will be posted on the TSCA SACC website and in the relevant docket.
C. What do I need to know about the TSCA SACC public meetings?
The focus of the public meeting is to peer review EPA's draft risk
evaluation. After the peer review process, EPA will consider peer
reviewer comments and recommendations, and public comments, in
finalizing the risk evaluation. The draft risk evaluation contains:
Discussion of chemistry and physical-chemical properties;
characterization of conditions of use; environmental fate and transport
assessment; human health exposures; environmental hazard assessment;
risk characterization; risk determination; and a detailed description
of the systematic review process developed by the Office of Pollution
Prevention and Toxics to search, screen, and evaluate scientific
literature for use in the risk evaluation process.
D. How do I participate in the public meetings?
You may participate in the public meetings by following the
instructions in this unit. To ensure proper receipt by EPA, it is
imperative that you identify the corresponding docket ID number in the
subject line on the first page of your request.
1. Preparatory virtual meeting. The preparatory virtual meeting
will be conducted via webcast and telephone. You may participate in the
preparatory virtual meeting by registering to join the webcast. You may
also submit written comments or request time for oral comments.
i. Registration. You must register to participate in the
preparatory virtual meeting. To participate by listening or making a
comment during this meeting, please go to the EPA website to register:
https://www.epa.gov/tsca-peer-review. Registration online will be
confirmed by an email that will include the webcast meeting link and
audio teleconference information.
ii. Written comments. Written comments for consideration during the
preparatory virtual meeting should be submitted, using the instructions
in ADDRESSES and this unit, on or before the date set in the DATES
section.
[[Page 60090]]
iii. Oral comments. Requests to make brief oral comments to the
TSCA SACC during the preparatory virtual meeting should be submitted
when registering online or with the DFO listed under FOR FURTHER
INFORMATION CONTACT on or before noon on the date set in the DATES
section. Oral comments before the TSCA SACC during the preparatory
virtual meeting are limited to approximately 5 minutes due to the time
constraints of this virtual meeting.
2. In-person meeting. You may participate in the in-person public
meeting by attending and by providing written or oral comments. The in-
person meeting may also be webcast. Please refer to the TSCA SACC
website at https://www.epa.gov/tsca-peer-review for information on how
to access the webcast. Please note that for the in-person meeting, the
webcast is a supplementary public process provided only for
convenience. If difficulties arise resulting in webcasting outages, the
in-person meeting will continue as planned.
i. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
ii. Written comments. To provide the TSCA SACC the time necessary
to consider and review your comments, written comments must be
submitted by the date set in the DATES section and using the
instructions in the ADDRESSES section and this unit. Comments received
after the date set in the DATES section and prior to the end of the
oral public comment period during the meeting will still be provided to
the TSCA SACC for their consideration.
iii. Oral comments. To be included on the meeting agenda, submit
your request to make brief oral comments at the in-person meeting to
the DFO listed under FOR FURTHER INFORMATION CONTACT on or before the
date set in the DATES section. The request should identify the name of
the individual making the presentation, the organization (if any) the
individual will represent, and any requirements for audiovisual
equipment. Oral comments before TSCA SACC during the in-person meeting
are limited to approximately 5 minutes unless prior arrangements have
been made. In addition, each speaker should bring 30 copies of the
comments and presentation for distribution by the DFO to the TSCA SACC
at the meeting.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 4, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-24349 Filed 11-6-19; 8:45 am]
BILLING CODE 6560-50-P
