Problem Formulations for the Risk Evaluations To Be Conducted Under the Toxic Substances Control Act, and General Guiding Principles To Apply Systematic Review in TSCA Risk Evaluations; Notice of Availability, 26998-27000 [2018-12520]
Download as PDF
26998
Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
OMB. The actual number of claims
submitted under Section 312 is slightly
lower than the estimate provided in the
previous ICR. The burden hours and
costs may be revised based on the actual
trade secret claim submissions received
for Section 313 reports. The compliance
deadline for section 313 report is July 1,
2018. EPA will revise the burden and
costs prior to submitting the package to
OMB.
Dated: May 24, 2018.
Becki Clark,
Deputy Director, Office of Emergency
Management.
[FR Doc. 2018–12505 Filed 6–8–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9979–08-Region 6]
Underground Injection Control
Program; Hazardous Waste Injection
Restrictions; Petition for Exemption
Reissuance—Class I Hazardous Waste
Injection; U. S. Ecology Texas (USET)
Robstown, Texas
Environmental Protection
Agency (EPA).
ACTION: Notice of a final decision on a
UIC no migration petition reissuance.
AGENCY:
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Dated: May 18, 2018.
James R. Brown,
Associate Director, Safe Drinking Water
Branch.
[FR Doc. 2018–12508 Filed 6–8–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0210; FRL–9978–40]
Notice is hereby given that a
reissuance of an exemption to the Land
Disposal Restrictions, under the 1984
Hazardous and Solid Waste
Amendments to the Resource
Conservation and Recovery Act, has
been granted to USET for two Class I
hazardous waste injection wells located
at their Robstown, Texas facility. The
company has adequately demonstrated
to the satisfaction of the EPA by the
petition reissuance application and
supporting documentation that, to a
reasonable degree of certainty, there will
be no migration of hazardous
constituents from the injection zone for
as long as the waste remains hazardous.
This final decision allows the
underground injection by USET of the
specific restricted hazardous wastes
identified in this exemption reissuance,
into Class I hazardous waste injection
wells WDW–278 and WDW–279 until
December 31, 2030, unless the EPA
moves to terminate this exemption or
other petition condition limitations are
reached. Additional conditions
included in this final decision may be
reviewed by contacting the EPA Region
6 Ground Water/UIC Section. A public
notice was issued March 29, 2018, and
the public comment period closed on
May 15, 2018, and no comments were
SUMMARY:
received. This decision constitutes final
Agency action and there is no
Administrative appeal. This decision
may be reviewed/appealed in
compliance with the Administrative
Procedure Act.
DATES: This action is effective as of May
18, 2018.
ADDRESSES: Copies of the petition
reissuance and all pertinent information
relating thereto are on file at the
following location: Environmental
Protection Agency, Region 6, Water
Division, Safe Drinking Water Branch
(6WQ–S), 1445 Ross Avenue, Dallas,
Texas 75202–2733.
FOR FURTHER INFORMATION CONTACT:
Philip Dellinger, Chief Ground Water/
UIC Section, EPA—Region 6, telephone
(214) 665–8324.
Problem Formulations for the Risk
Evaluations To Be Conducted Under
the Toxic Substances Control Act, and
General Guiding Principles To Apply
Systematic Review in TSCA Risk
Evaluations; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is publishing and taking
comments on the problem formulation
documents for the first 10 chemical
substances undergoing risk evaluation
under the Toxic Substances Control Act
(TSCA). Comments received will inform
the development of draft risk evaluation
documents for these 10 chemical
substances. The 10 problem formulation
documents announced in this document
refine the scope documents published
in June 2017 and are an additional
interim step, prior to publication of the
draft risk evaluations. EPA is also
publishing and taking comments on a
document entitled: ‘‘Application of
Systematic Review in TSCA Risk
Evaluations,’’ which sets out general
principles to guide EPA’s application of
systematic review for TSCA risk
evaluations. The Office of Pollution
Prevention and Toxics (OPPT) generally
intends to apply systematic review
principles in the development of risk
evaluations under TSCA. The
SUMMARY:
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systematic review document includes a
structured process of identifying,
evaluating and integrating evidence for
both the hazard and exposure
assessments developed during the TSCA
risk evaluation process. This document
may be revised periodically. EPA
welcomes public input on the
document.
DATES: Comments on the problem
formulations must be received on or
before July 26, 2018.
EPA specifically requests comments
on the Application of Systematic Review
in TSCA Risk Evaluations document for
45 days after date of publication in the
Federal Register. In addition, because
this document is a living document
which may be revised periodically. EPA
welcomes public input on this
document at any time.
ADDRESSES: Submit your comments,
identified by the appropriate docket
identification (ID) numbers as provided
in Unit IV., 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. When submitting
comments, please be as specific as
possible, and please include any
supporting data or other information.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 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 in general is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information on the
Problem Formulation documents
contact: Christina Motilall, Risk
Assessment Division, Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–1287;
email address: motilall.christina@
epa.gov.
For technical information on
Application of Systematic Review in
TSCA Risk Evaluations contact: Iris
Camacho, Risk Assessment Division,
Office of Pollution Prevention and
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–1229; email address:
TSCA-systematicreview@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by
this action if you manufacture (defined
under TSCA to include import), process,
distribute in commerce, use or dispose
of any of the 10 chemical substances
identified in this document for risk
evaluation, or any future existing
chemical substances undergoing risk
evaluation under TSCA. This action
may be of particular interest to entities
that are regulated under TSCA (e.g.,
entities identified under North
American Industrial Classification
System (NAICS) codes 325 and 324110,
among others). Since other entities may
also be interested, the Agency has not
attempted to describe all the specific
entities and corresponding NAICS codes
for entities that may be interested in or
affected by this action.
II. What is the Agency’s authority for
this action?
As amended in June 2016, TSCA
requires that EPA prioritize and
evaluate existing chemical substances
and manage identified risks (15 U.S.C.
2605). TSCA section 6(b) specifies the
requirements for risk evaluation.
III. Background
A. The First 10 Chemical Substances for
Risk Evaluations Under TSCA
On December 19, 2016 (81 FR 91927)
(FRL–9956–47), EPA released its
designation of the first 10 chemical
substances for risk evaluations under
TSCA. EPA’s designation of the first 10
chemical substances constituted the
initiation of the risk evaluation process
for each of these chemical substances,
pursuant to the requirements of TSCA
section 6(b)(4).
On June 22, 2017, EPA released scope
documents for the first 10 chemical
substances (see 82 FR 31592, July 7,
2017) (FRL–9963–57). Each scope
document includes the hazards,
exposures, conditions of use, and the
potentially exposed or susceptible
subpopulations that EPA expects to
consider in the risk evaluation.
EPA has prepared a Response to
Comments document addressing
overarching comments received on the
scope documents, which is available in
the docket (see docket ID number EPA–
HQ–OPPT–2017–0736). Chemical
substance-specific comments on the
scope documents are addressed in the
respective problem formulation
documents.
B. Systematic Review
In the development of TSCA risk
evaluations, the Agency generally
intends to apply systematic review
principles. EPA described systematic
review in the preamble of the final rule
Procedures for Chemical Risk
Evaluation Under the Amended Toxic
Substances Control Act (82 FR 33726,
July 20, 2017), and in the preamble of
the proposed rule (82 FR 7562, January
19, 2017) (FRL–9957–75). EPA intends
to apply systematic review to prespecify the criteria, methods/approaches
for data collection, data evaluation and
data integration to meet the TSCA
science standards. TSCA requires EPA
to make scientific decisions in a manner
consistent with the best available
science and base decisions on the
weight of the scientific evidence.
Supplemental documents to the scope
documents of the first 10 chemical
Chemical No.
26999
substances, published in June 2017 (e.g.,
Strategy for Conducting Literature
Searches for Asbestos: Supplemental
Document to the TSCA Scope
Document, CASRN: 1332–21–4) already
document the initial methods for
identifying, compiling and screening
publicly available information. These
data collections and screening activities
are described in the Strategy for
Conducting Literature Searches
document and the Bibliography
document supporting each of the TSCA
scope documents for the first ten
chemical substances.
IV. What action is the Agency taking?
A. Problem Formulation Documents
To refine the scope documents, EPA
is publishing and taking public
comment on problem formulation
documents for the first 10 chemical
substances. As indicated in the scope
documents, time constraints resulted in
scope documents that were not as
refined or specific as future scope
documents are anticipated to be. The 10
problem formulation documents
announced in this document are an
additional interim step, prior to
publication of the draft risk evaluations,
that refine the scope documents. These
refinements may apply to the conditions
of use, hazards, exposures, and the
potentially exposed or susceptible
subpopulations EPA expects to consider
in the risk evaluation. EPA has
incorporated scope document comments
specific to each chemical substance into
the respective problem formulation
document. While EPA does not intend
to revise these problem formulation
documents, comments and information
provided will inform the development
of the draft risk evaluation documents.
The following table identifies the
docket ID numbers and EPA contact for
each of the 10 problem formulations
that EPA is taking comments on.
Docket ID No.
Agency contact
EPA–HQ–OPPT–2016–0736
1-Bromopropane ..................................................
1,4-Dioxane ..........................................................
Carbon Tetrachloride ...........................................
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Asbestos ...............................................................
EPA–HQ–OPPT–2016–0741
EPA–HQ–OPPT–2016–0723
EPA–HQ–OPPT–2016–0733
Cyclic Aliphatic Bromide Cluster (HBCD) ............
Methylene Chloride ..............................................
N-Methylpyrrolidone (NMP) ..................................
Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d′e’f′]
diisoquinoline-1,3,8,10(2H,9H)-tetrone).
Tetrachloroethylene (also known as
perchloroethylene).
Trichloroethylene (TCE) .......................................
EPA–HQ–OPPT–2016–0735
EPA–HQ–OPPT–2016–0742
EPA–HQ–OPPT–2016–0743
EPA–HQ–OPPT–2016–0725
Robert Courtnage, courtnage.robert@epa.gov, 202–566–
1081.
Ana Corado, corado.ana@epa.gov, 202–564–0140.
Cindy Wheeler, wheeler.cindy@epa.gov, 202–566–0484.
Stephanie Jarmul, jarmul.stephanie@epa.gov, 202–564–
6130.
Sue Slotnick, slotnick.sue@epa.gov, 202–566–1973.
Ana Corado, corado.ana@epa.gov, 202–564–0140.
Ana Corado, corado.ana@epa.gov, 202–564–0140.
Hannah Braun, braun.hannah@epa.gov, 202–564–5614.
EPA–HQ–OPPT–2016–0732
Tyler Lloyd, lloyd.tyler@epa.gov, 202–564–4016.
EPA–HQ–OPPT–2016–0737
Toni Krasnic, krasnic.toni@epa.gov, 202–564–0984.
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
EPA invites the public to provide
additional comment and information
that would be useful in conducting the
risk evaluation for each of the 10
chemical substances.
B. The Application of Systematic
Review in TSCA Risk Evaluations
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Authority: 15 U.S.C. 2601 et seq.
Dated: May 31, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant
Administrator, Office of Chemical Safety and
Pollution Prevention.
BILLING CODE 6560–50–P
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Federal Advisory Committee Act;
Communications Security, Reliability,
and Interoperability Council
Federal Communications
Commission.
ACTION: Notice of public meeting.
AGENCY:
The Application of Systematic Review
in TSCA Risk Evaluations document is
a supplemental publication which sets
out general principles to guide EPA’s
application of systematic review in the
risk evaluation process for the first 10
chemical substances that EPA initiated
on December 19, 2016, as well as future
assessments. It also provides the
intended strategy for assessing the
quality of information that the Agency
plans to use for the TSCA risk
evaluations.
The Agency intends to implement a
structured process of identifying,
evaluating and integrating evidence for
both the hazard and exposure
assessments developed during the TSCA
risk evaluation process. As needed, EPA
will develop new approaches and
methods to address specific assessment
needs for the relatively large and diverse
chemical space under TSCA. Hence, the
Agency will document the progress of
implementing systematic review in the
draft risk evaluations and through
revisions of this document and
publication of supplemental documents.
The systematic review document
provides the general expectations for
evidence integration. Further additional
information will be published with the
publication of the draft TSCA risk
evaluations.
Ultimately, the goal is to establish a
pragmatic systematic review process
that generates high quality, fit-forpurpose risk evaluations that rely on the
best available science and the weight of
the scientific evidence within the
context of TSCA.
This document is a living document
which may be revised periodically. EPA
welcomes public input on this
document at any time.
[FR Doc. 2018–12520 Filed 6–8–18; 8:45 am]
FEDERAL COMMUNICATIONS
COMMISSION
In accordance with the
Federal Advisory Committee Act, this
notice advises interested persons that
the Federal Communications
Commission’s (FCC or Commission)
Communications Security, Reliability,
and Interoperability Council (CSRIC) VI
will hold its fifth meeting.
DATES: June 29, 2018.
ADDRESSES: Federal Communications
Commission, Room TW–C305
(Commission Meeting Room), 445 12th
Street SW, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Jeffery Goldthorp, Designated Federal
Officer, (202) 418–1096 (voice) or
jeffery.goldthorp@fcc.gov (email); or
Suzon Cameron, Deputy Designated
Federal Officer, (202) 418–1916 (voice)
or suzon.cameron@fcc.gov (email).
SUPPLEMENTARY INFORMATION: The
meeting will be held on June 29, 2018,
from 1:00 p.m. to 5:00 p.m. in the
Commission Meeting Room of the
Federal Communications Commission,
Room TW–C305, 445 12th Street SW,
Washington, DC 20554.
The CSRIC is a Federal Advisory
Committee that will provide
recommendations to the FCC regarding
best practices and actions the FCC can
take to help ensure the security,
reliability, and interoperability of
communications systems. On March 19,
2017, the FCC, pursuant to the Federal
Advisory Committee Act, renewed the
charter for the CSRIC for a period of two
years through March 18, 2019. The
meeting on June 29, 2018, will be the
fifth meeting of the CSRIC under the
current charter. The FCC will attempt to
accommodate as many attendees as
possible; however, admittance will be
limited to seating availability. The
Commission will provide audio and/or
video coverage of the meeting over the
internet from the FCC’s web page at
https://www.fcc.gov/live. The public may
submit written comments before the
meeting to Jeffery Goldthorp, CSRIC
Designated Federal Officer, by email to
jeffery.goldthorp@fcc.gov or U.S. Postal
Service Mail to Jeffery Goldthorp,
Associate Bureau Chief, Public Safety
and Homeland Security Bureau, Federal
Communications Commission, 445 12th
Street SW, Room 7–A325, Washington,
DC 20554.
SUMMARY:
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Open captioning will be provided for
this event. Other reasonable
accommodations for people with
disabilities are available upon request.
Requests for such accommodations
should be submitted via email to
fcc504@fcc.gov or by calling the
Consumer & Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (tty). Such requests should
include a detailed description of the
accommodation needed. In addition,
please include a way the FCC can
contact you if it needs more
information. Please allow at least five
days’ advance notice; last-minute
requests will be accepted, but may be
impossible to fill.
Federal Communications Commission.
Marlene Dortch,
Secretary.
[FR Doc. 2018–12490 Filed 6–8–18; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL COMMUNICATIONS
COMMISSION
[OMB 3060–1113]
Information Collection Being
Submitted for Review and Approval to
the Office of Management and Budget
Federal Communications
Commission.
ACTION: Notice and request for
comments.
AGENCY:
As part of its continuing effort
to reduce paperwork burdens, and as
required by the Paperwork Reduction
Act (PRA) of 1995, the Federal
Communications Commission (FCC or
the Commission) invites the general
public and other Federal agencies to
take this opportunity to comment on the
following information collection.
Comments are requested concerning:
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
the accuracy of the Commission’s
burden estimate; ways to enhance the
quality, utility, and clarity of the
information collected; ways to minimize
the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology; and ways to
further reduce the information
collection burden on small business
concerns with fewer than 25 employees.
The Commission may not conduct or
sponsor a collection of information
unless it displays a currently valid
SUMMARY:
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Agencies
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 26998-27000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12520]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0210; FRL-9978-40]
Problem Formulations for the Risk Evaluations To Be Conducted
Under the Toxic Substances Control Act, and General Guiding Principles
To Apply Systematic Review in TSCA Risk Evaluations; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is publishing and taking comments on the problem
formulation documents for the first 10 chemical substances undergoing
risk evaluation under the Toxic Substances Control Act (TSCA). Comments
received will inform the development of draft risk evaluation documents
for these 10 chemical substances. The 10 problem formulation documents
announced in this document refine the scope documents published in June
2017 and are an additional interim step, prior to publication of the
draft risk evaluations. EPA is also publishing and taking comments on a
document entitled: ``Application of Systematic Review in TSCA Risk
Evaluations,'' which sets out general principles to guide EPA's
application of systematic review for TSCA risk evaluations. The Office
of Pollution Prevention and Toxics (OPPT) generally intends to apply
systematic review principles in the development of risk evaluations
under TSCA. The systematic review document includes a structured
process of identifying, evaluating and integrating evidence for both
the hazard and exposure assessments developed during the TSCA risk
evaluation process. This document may be revised periodically. EPA
welcomes public input on the document.
DATES: Comments on the problem formulations must be received on or
before July 26, 2018.
EPA specifically requests comments on the Application of Systematic
Review in TSCA Risk Evaluations document for 45 days after date of
publication in the Federal Register. In addition, because this document
is a living document which may be revised periodically. EPA welcomes
public input on this document at any time.
ADDRESSES: Submit your comments, identified by the appropriate docket
identification (ID) numbers as provided in Unit IV., 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. When submitting comments, please
be as specific as possible, and please include any supporting data or
other information.
Mail: Document Control Office (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 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 in general is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information on the Problem Formulation documents
contact: Christina Motilall, Risk Assessment Division, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-1287; email address: [email protected].
For technical information on Application of Systematic Review in
TSCA Risk Evaluations contact: Iris Camacho, Risk Assessment Division,
Office of Pollution Prevention and
[[Page 26999]]
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-1229; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined under TSCA to include import), process, distribute in
commerce, use or dispose of any of the 10 chemical substances
identified in this document for risk evaluation, or any future existing
chemical substances undergoing risk evaluation under TSCA. This action
may be of particular interest to entities that are regulated under TSCA
(e.g., entities identified under North American Industrial
Classification System (NAICS) codes 325 and 324110, among others).
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities and corresponding NAICS
codes for entities that may be interested in or affected by this
action.
II. What is the Agency's authority for this action?
As amended in June 2016, TSCA requires that EPA prioritize and
evaluate existing chemical substances and manage identified risks (15
U.S.C. 2605). TSCA section 6(b) specifies the requirements for risk
evaluation.
III. Background
A. The First 10 Chemical Substances for Risk Evaluations Under TSCA
On December 19, 2016 (81 FR 91927) (FRL-9956-47), EPA released its
designation of the first 10 chemical substances for risk evaluations
under TSCA. EPA's designation of the first 10 chemical substances
constituted the initiation of the risk evaluation process for each of
these chemical substances, pursuant to the requirements of TSCA section
6(b)(4).
On June 22, 2017, EPA released scope documents for the first 10
chemical substances (see 82 FR 31592, July 7, 2017) (FRL-9963-57). Each
scope document includes the hazards, exposures, conditions of use, and
the potentially exposed or susceptible subpopulations that EPA expects
to consider in the risk evaluation.
EPA has prepared a Response to Comments document addressing
overarching comments received on the scope documents, which is
available in the docket (see docket ID number EPA-HQ-OPPT-2017-0736).
Chemical substance-specific comments on the scope documents are
addressed in the respective problem formulation documents.
B. Systematic Review
In the development of TSCA risk evaluations, the Agency generally
intends to apply systematic review principles. EPA described systematic
review in the preamble of the final rule Procedures for Chemical Risk
Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726,
July 20, 2017), and in the preamble of the proposed rule (82 FR 7562,
January 19, 2017) (FRL-9957-75). EPA intends to apply systematic review
to pre-specify the criteria, methods/approaches for data collection,
data evaluation and data integration to meet the TSCA science
standards. TSCA requires EPA to make scientific decisions in a manner
consistent with the best available science and base decisions on the
weight of the scientific evidence.
Supplemental documents to the scope documents of the first 10
chemical substances, published in June 2017 (e.g., Strategy for
Conducting Literature Searches for Asbestos: Supplemental Document to
the TSCA Scope Document, CASRN: 1332-21-4) already document the initial
methods for identifying, compiling and screening publicly available
information. These data collections and screening activities are
described in the Strategy for Conducting Literature Searches document
and the Bibliography document supporting each of the TSCA scope
documents for the first ten chemical substances.
IV. What action is the Agency taking?
A. Problem Formulation Documents
To refine the scope documents, EPA is publishing and taking public
comment on problem formulation documents for the first 10 chemical
substances. As indicated in the scope documents, time constraints
resulted in scope documents that were not as refined or specific as
future scope documents are anticipated to be. The 10 problem
formulation documents announced in this document are an additional
interim step, prior to publication of the draft risk evaluations, that
refine the scope documents. These refinements may apply to the
conditions of use, hazards, exposures, and the potentially exposed or
susceptible subpopulations EPA expects to consider in the risk
evaluation. EPA has incorporated scope document comments specific to
each chemical substance into the respective problem formulation
document. While EPA does not intend to revise these problem formulation
documents, comments and information provided will inform the
development of the draft risk evaluation documents.
The following table identifies the docket ID numbers and EPA
contact for each of the 10 problem formulations that EPA is taking
comments on.
----------------------------------------------------------------------------------------------------------------
Chemical No. Docket ID No. Agency contact
----------------------------------------------------------------------------------------------------------------
Asbestos............................ EPA-HQ-OPPT-2016-0736 Robert Courtnage,
[email protected],
202-566-1081.
1-Bromopropane...................... EPA-HQ-OPPT-2016-0741 Ana Corado,
[email protected], 202-564-
0140.
1,4-Dioxane......................... EPA-HQ-OPPT-2016-0723 Cindy Wheeler,
[email protected], 202-
566-0484.
Carbon Tetrachloride................ EPA-HQ-OPPT-2016-0733 Stephanie Jarmul,
[email protected],
202-564-6130.
Cyclic Aliphatic Bromide Cluster EPA-HQ-OPPT-2016-0735 Sue Slotnick,
(HBCD). [email protected], 202-
566-1973.
Methylene Chloride.................. EPA-HQ-OPPT-2016-0742 Ana Corado,
[email protected], 202-564-
0140.
N-Methylpyrrolidone (NMP)........... EPA-HQ-OPPT-2016-0743 Ana Corado,
[email protected], 202-564-
0140.
Pigment Violet 29 (Anthra[2,1,9- EPA-HQ-OPPT-2016-0725 Hannah Braun,
def:6,5,10-d'e'f'] diisoquinoline- [email protected], 202-
1,3,8,10(2H,9H)-tetrone). 564-5614.
Tetrachloroethylene (also known as EPA-HQ-OPPT-2016-0732 Tyler Lloyd,
perchloroethylene). [email protected], 202-
564-4016.
Trichloroethylene (TCE)............. EPA-HQ-OPPT-2016-0737 Toni Krasnic,
[email protected], 202-
564-0984.
----------------------------------------------------------------------------------------------------------------
[[Page 27000]]
EPA invites the public to provide additional comment and
information that would be useful in conducting the risk evaluation for
each of the 10 chemical substances.
B. The Application of Systematic Review in TSCA Risk Evaluations
The Application of Systematic Review in TSCA Risk Evaluations
document is a supplemental publication which sets out general
principles to guide EPA's application of systematic review in the risk
evaluation process for the first 10 chemical substances that EPA
initiated on December 19, 2016, as well as future assessments. It also
provides the intended strategy for assessing the quality of information
that the Agency plans to use for the TSCA risk evaluations.
The Agency intends to implement a structured process of
identifying, evaluating and integrating evidence for both the hazard
and exposure assessments developed during the TSCA risk evaluation
process. As needed, EPA will develop new approaches and methods to
address specific assessment needs for the relatively large and diverse
chemical space under TSCA. Hence, the Agency will document the progress
of implementing systematic review in the draft risk evaluations and
through revisions of this document and publication of supplemental
documents. The systematic review document provides the general
expectations for evidence integration. Further additional information
will be published with the publication of the draft TSCA risk
evaluations.
Ultimately, the goal is to establish a pragmatic systematic review
process that generates high quality, fit-for-purpose risk evaluations
that rely on the best available science and the weight of the
scientific evidence within the context of TSCA.
This document is a living document which may be revised
periodically. EPA welcomes public input on this document at any time.
Authority: 15 U.S.C. 2601 et seq.
Dated: May 31, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2018-12520 Filed 6-8-18; 8:45 am]
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