[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 http://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 
http://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: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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.

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 http://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 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, 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 http://www.regulations.gov and the TSCA SACC website at http://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: 
http://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 http://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


