[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]
[[Page 26464]]
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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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