[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Pages 26464-26466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09369]



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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0502; FRL-10008-63]


Perchloroethylene; Draft Toxic Substances Control Act (TSCA) Risk 
Evaluation and TSCA Science Advisory Committee on Chemicals (SACC) 
Meetings; Notice of Availability, Public Meetings, and Request for 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of and soliciting public 
comment on the draft Toxic Substances Control Act (TSCA) risk 
evaluation of perchloroethylene. 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 two virtual public 
meetings of the TSCA SACC, with participation by phone and webcast 
only, and no in-person gathering. The first virtual public meeting will 
be a preparatory meeting for the SACC to consider the scope and clarity 
of the draft charge questions for the peer review. This will be 
followed by the peer review public virtual meeting for the SACC to 
consider and review the draft risk evaluation. 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.

DATES: 
    Preparatory Virtual Meeting: Will be held on May 5, 2020, from 1:00 
p.m. to approximately 4:00 p.m. (EDT). You must register online on or 
before May 5, 2020, to receive the webcast meeting link and audio 
teleconference information. Submit your comments for the preparatory 
virtual meeting, or request time to present oral comments, on or before 
noon, May 1, 2020.
    Peer Review Public Virtual Meeting: Will be held on May 26-29, 
2020, from 10:00 a.m. to approximately 5:00 p.m. (EDT) (as needed, 
updated times for each day may be provided in the meeting agenda that 
will be posted in the docket at http://www.regulations.gov and the TSCA 
SACC website at http://www.epa.gov/tsca-peer-review). You must register 
online to receive the webcast meeting link and audio teleconference 
information. To make oral comments during the peer review virtual 
public meeting, please register by noon on May 20, 2020, to be included 
on the meeting agenda. Any written comments submitted on the draft risk 
evaluation on or before May 20, 2020, will be provided to the TSCA SACC 
committee for their consideration before the meeting. Comments received 
after May 20, 2020, and prior to the oral public comment period during 
the meeting will be available to the SACC for their consideration 
during the meeting. 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 July 6, 2020. For additional instructions, see 
Unit III. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: 
    Virtual Meetings: Please visit http://www.epa.gov/tsca-peer-review 
to register. You must register online to receive the webcast meeting 
link and audio teleconference information for participation.
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0502, using the Federal eRulemaking Portal 
at 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.
    Docket: Docket materials are publicly available online at https://www.regulations.gov under docket ID number EPA-HQ-OPPT-2019-0502. 
Please note, that due to the public health emergency, the EPA Docket 
Center and Reading Room was closed to public visitors on March 31, 
2020, and there is a temporary suspension of mail delivery to EPA 
(including hand deliveries). Our Docket Center staff will continue to 
provide customer service via email, phone, and webform. For further 
information on EPA Docket Center services, docket contact information 
and the current status of the EPA Docket Center and Reading Room, 
please visit 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 meetings 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: Tamue Gibson, DFO, Office 
of Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-7642; 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 this draft 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).
    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

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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)-(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 substance 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 risk evaluation and the outcome of the systematic review 
associated with the chemical substance. 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 
docket 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 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 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 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 perchloroethylene?

    Perchloroethylene has a wide range of uses, including production of 
fluorinated compounds, and as a solvent in dry cleaning and vapor 
degreasing. A variety of consumer and commercial products use 
perchloroethylene such as adhesives (arts and crafts, as well as light 
repairs), aerosol degreasing, brake cleaners, aerosol lubricants, 
sealants, stone polish, stainless steel polish and wipe cleaners. 
Perchloroethylene is subject to federal and state regulations and 
reporting requirements. Leading applications of perchloroethylene 
include manufacturing, solvents for cleaning and degreasing, 
lubricants, adhesives and sealants, cleaning and furniture care 
products. EPA evaluated the conditions of use associated with the 
manufacturing, processing, distribution in commerce, industrial, 
commercial and consumer use and disposal of perchloroethylene. The 
yearly aggregate production volume ranged from 388 to 324 million 
pounds between 2012 and 2015.
    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-perchloroethylene.

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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 
substance. 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 the 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 meetings 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 or 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.
    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. Peer review public virtual meeting. The peer review public 
virtual meeting will be conducted via webcast and telephone. You may 
participate in the peer review public virtual meeting by registering to 
join the webcast. You may also submit written or oral comments.
    i. Registration. You must register to participate in the peer 
review public 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. To provide the TSCA SACC the time necessary 
to consider and review your comments, written comments for 
consideration during the peer review public virtual meeting should be 
submitted, using the instructions in ADDRESSES and this unit, on or 
before the date set in the DATES section. 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, requests 
to make brief oral comments to the TSCA SACC during the peer review 
public 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. The request should identify 
the name of the individual making the presentation, and the 
organization (if any) the individual will represent. Oral comments 
before the TSCA SACC during the peer review public virtual meeting are 
limited to approximately 5 minutes. In addition, each speaker should 
email their comments and presentation to the DFO listed under FOR 
FURTHER INFORMATION CONTACT, preferably, at least 24 hours prior to the 
oral public comment period.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2020-09369 Filed 5-1-20; 8:45 am]
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