Draft TSCA Risk Evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29); Notice of Availability, 57473-57475 [2018-24972]
Download as PDF
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
Mason’s Dam
(1) A 15-foot-high, 86-foot-long rock
masonry dam impounding a reservoir
with a storage capacity of approximately
1,621 acre-feet at an elevation of 188
feet above sea level; (2) a concrete inlet
structure; (3) a manually operated
butterfly gate regulating flow from the
inlet structure to the penstock; (4) a 3foot-diameter, 350-foot-long steel
penstock; (5) a 266-square-foot concrete
powerhouse containing two Kaplan
turbines and generating units with a
licensed capacity of 100 kW; (6) a 300foot-long, 12-kilovolt (kV) transmission
line; and (7) appurtenant facilities.
Mason’s Development generates when
flows in excess of 5 cfs are available and
when an operator is present.
Kelly Dam
(1) A 15-foot-high, 135-foot-long
masonry gravity dam impounding a
reservoir with a storage capacity of
approximately 200 acre-feet at an
elevation of approximately 159 feet
above sea level; and (2) three 3-foothigh, 2.5-foot-wide manually operated
butterfly gates.
Mill Dam
(1) A 6-foot-tall, 70-foot-wide masonry
dam impounding a reservoir with a
storage capacity of approximately 7
acre-feet at an elevation of
approximately 128 feet above sea level;
(2) a concrete inlet structure; (3) a trash
sluice with wooden stop logs; (4) a
powerhouse containing a Francis-type
turbine and generator unit with a
licensed capacity of 75 kW; (5) a 60foot-wide concrete spillway; and (6) an
approximately 100-foot-long, 12-kV
transmission line. The penstock used to
deliver water to the powerhouse has
been removed due to deterioration and
subsequent leakage; thus, the
powerhouse is not operating.
khammond on DSK30JT082PROD with NOTICES
CMP Dam
(1) A 21-foot-high, 231-foot-long
buttress dam impounding a reservoir
with a storage capacity of approximately
72 acre-feet at an elevation of
approximately 109 feet above sea level;
(2) a manually operated low-level water
release lift gate; (3) a manually operated
lift gate regulating flow to the penstock;
(4) a 5-foot-diameter, 1,200-foot-long
steel penstock; (5) a 300-square-foot
concrete and timber powerhouse with a
Kaplan-type turbine and generator unit
with a licensed capacity of 200 kW; (6)
a 42-foot-long spillway; and (7) an
approximately 500-foot-long, 12-kV
transmission line. The penstock used to
deliver water to the powerhouse is
currently out of service due to damage,
VerDate Sep<11>2014
16:53 Nov 14, 2018
Jkt 247001
deterioration, and subsequent leakage;
thus, the powerhouse is not operating.
m. Copies of the applications are
available for review at the Commission
in the Public Reference Room or may be
viewed on the Commission’s website at
https://www.ferc.gov using the eLibrary
link. Enter the docket number excluding
the last three digits in the docket
number field to access the document.
For assistance, contact FERC Online
Support. Copies are also available for
inspection and reproduction at the
address in item h above.
All filings must (1) bear in all capital
letters the title COMMENTS, REPLY
COMMENTS, RECOMMENDATIONS,
TERMS AND CONDITIONS, or
PRESCRIPTIONS; (2) set forth in the
heading the name of the applicant and
the project number of the application to
which the filing responds; (3) furnish
the name, address, and telephone
number of the person submitting the
filing; and (4) otherwise comply with
the requirements of 18 CFR 385.2001
through 385.2005. All comments,
recommendations, terms and conditions
or prescriptions must set forth their
evidentiary basis and otherwise comply
with the requirements of 18 CFR 4.34(b).
Agencies may obtain copies of the
applications directly from the applicant.
Each filing must be accompanied by
proof of service on all persons listed on
the service list prepared by the
Commission in this proceeding, in
accordance with 18 CFR 4.34(b), and
385.2010.
You may also register online at https://
www.ferc.gov/docs-filing/
esubscription.asp to be notified via
email of new filings and issuances
related to this or other pending projects.
For assistance, contact FERC Online
Support.
n. A license applicant must file no
later than 60 days following the date of
issuance of this notice: (1) A copy of the
water quality certification; (2) a copy of
the request for certification, including
proof of the date on which the certifying
agency received the request; or (3)
evidence of waiver of water quality
certification.
o. Procedural schedule: The
applications will be processed
according to the following schedule.
Revisions to the schedule will be made
as appropriate.
Commission issues EA—June 2019
Comments on EA due—July 2019
Dated: November 8, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018–24886 Filed 11–14–18; 8:45 am]
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57473
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0604; FRL–9986–45]
Draft TSCA Risk Evaluation for Colour
Index (C. I.) Pigment Violet 29 (PV29);
Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is announcing the
availability of and seeking public
comment on the draft Risk Evaluation
for Colour Index (C. I.) Pigment Violet
29 (PV29) and associated documents
developed under EPA’s existing
chemical substance process under the
Toxic Substances Control Act (TSCA).
The purpose of the risk evaluation is to
determine whether a chemical
substance presents an unreasonable risk
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
these same documents to the TSCA
Science Advisory Committee on
Chemicals (SACC) which will peer
review the draft risk evaluation, and
EPA will provide the peer review
meeting details in a separate Federal
Register notice. All comments
submitted on the draft risk evaluation in
response to this Notice of Availability
will be provided to the TSCA SACC
peer review panel, which will have the
opportunity to consider the comments
during its discussions. In addition, the
subsequent Federal Register notice
providing details on the peer review
meeting will explain the process for
submitting information and views to the
peer review panel. EPA will consider
the public comments on the draft risk
evaluation submitted in response to this
Notice of Availability, along with peer
reviewer comments and
recommendations, to finalize the risk
evaluation.
SUMMARY:
Comments must be received on
or before January 14, 2019.
ADDRESSES: Submit your written
comments, identified by docket
identification (ID) number EPA–HQ–
OPPT–2018–0604, 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.
DATES:
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57474
Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
• Mail: OPPT Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Dawson, Office of Pollution
Prevention and Toxics (7403M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–0331; email address:
dawson.jeffrey@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
khammond on DSK30JT082PROD with NOTICES
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 interested in
risk evaluations of existing chemical
substances under the Toxic Substances
Control Act (TSCA). Since other entities
may also be interested in this draft risk
evaluation, the Agency has not
attempted to describe all the entities
that may be interested in this action.
B. What action is the agency taking?
EPA is announcing the availability of
and seeking public comment on the
draft Risk Evaluation for Colour Index
(C. I.) Pigment Violet 29 (PV29) and
associated documents, which is
available at the docket identified by ID
No. EPA–HQ–OPPT–2018–0604 at
https://www.regulations.gov. EPA is
providing 60 days for public comment
on all aspects of this draft risk
evaluation, including any conclusions,
findings, determinations, and the
submission of any additional
information that might be relevant to the
science underlying the risk evaluation
and the outcome of the systematic
review associated with C.I. Pigment
Violet 29. 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.’’
In addition to any new comments on
the draft risk evaluation, the public
should resubmit or clearly identify at
this time any previously filed
comments, modified as appropriate, that
are relevant to this risk evaluation and
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16:53 Nov 14, 2018
Jkt 247001
that the submitter feels have not been
addressed. EPA does not intend to
further respond to comments submitted
prior to the release of this draft risk
evaluation.
All comments on the draft risk
evaluation in response to this Notice of
Availability, and all information and
views submitted to the peer review
panel as directed in the subsequent
Federal Register notice announcing the
TSCA SACC panel meeting, are being
directed to the same docket, identified
by docket ID No. EPA–HQ–OPPT–2018–
0604 at https://www.regulations.gov. As
such, comments submitted or
resubmitted during this 60-day period
will be provided to the TSCA SACC for
consideration during their peer review.
C. What is the Agency’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 non-risk 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 direct which chemical substances
must undergo evaluation, the
development of criteria for
manufacturer-requested evaluations, the
minimum components of an Agency
risk evaluation, and the timelines for
public comment and completion of the
risk evaluation. The law also requires
that EPA operate in a manner that is
consistent with the best available
science and make decisions based on
the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i).
The statute identifies the minimum
components EPA must include in 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 exposure
for the conditions of use of the chemical
substance, including information on
specific risks of injury to health or the
environment and information on
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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 exposure. 15 U.S.C.
2605(b)(4)(F)(i), and (iii)–(v). The risk
evaluation must not consider costs or
other non-risk factors. 15 U.S.C.
2605(b)(4)(F)(ii).
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 Agency 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).
D. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit CBI
information to EPA through
regulations.gov or via email. If your
comments contain any information that
you consider to be CBI or otherwise
protected, please contact the DFO listed
under FOR FURTHER INFORMATION
CONTACT to obtain special instructions
before submitting your comments.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
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. The purpose of risk
evaluation is to determine whether a
chemical substance presents an
unreasonable risk 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 non-risk factors, use scientific
information and approaches in a
manner that is consistent with the
requirements in TSCA for the best
available science, and ensure decisions
are based on the weight-of-scientificevidence.
E:\FR\FM\15NON1.SGM
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Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
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 our website at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluations-existingchemicals-under-tsca. As explained the
in the preamble to EPA’s procedural
final rule (82 FR 33726, July 20, 2017)
(FRL–9964–38), the specific regulatory
process set out in 40 CFR part 702 will
be followed for the first ten chemical
substances undergoing risk evaluation
to the maximum extent practicable.
B. What is Pigment Violet 29?
Pigment Violet 29 (Anthra[2,1,9def:6,5,10-d′e′f′] diisoquinoline1,3,8,10(2H,9H)-tetrone) (pigment violet
29) is a perylene derivative used to color
materials and as an intermediate for
other perylene pigments. The pigment is
utilized as an intermediate to create or
adjust the color of other pigments, as
well as in commercial paints, coatings,
plastics, and rubber products. C.I.
Pigment Violet 29 is an organic pigment
that has a low solubility, low volatility,
is expected to be highly persistent and
has low bioaccumulation potential in
fish and other animals.
Information about the problem
formulation and scope phases of the risk
evaluation for this chemical is available
at https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/riskevaluation-pigment-violet-29-anthra219def6510.
khammond on DSK30JT082PROD with NOTICES
C. Purpose of the TSCA SACC
The TSCA SACC was established by
EPA to support activities under TSCA,
15 U.S.C. 2601 et seq., the Pollution
Prevention Act (PPA), 42 U.S.C. 13101
et seq., and other applicable statutes.
The TSCA SACC provides expert
independent scientific advice and
recommendations to the EPA on the
scientific and technical aspects of risk
assessments, methodologies, and
pollution prevention measures and
approaches for chemicals regulated
under TSCA. Given the SACC’s
expertise, EPA is submitting the draft
risk evaluation and related documents
to the TSCA SACC for peer review and
scheduling a public meeting for the
panel’s discussion of those materials.
Consistent with EPA’s peer review
policy and requirements associated with
the Federal Advisory Committee Act
(FACA), 5 U.S.C Appendix 2 et seq.,
EPA will announce the TSCA SACC
public meeting and provide related
details about that meeting in a future
Federal Register notice.
Authority: 15 U.S.C. 2601 et seq.
VerDate Sep<11>2014
16:53 Nov 14, 2018
Jkt 247001
Dated: November 9, 2018.
Nancy B. Beck,
Deputy Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
[FR Doc. 2018–24972 Filed 11–14–18; 8:45 am]
BILLING CODE 6560–50–P
57475
address, include the contact person’s
name, division, and mail code. The
division to contact is listed at the end
of each application summary.
SUPPLEMENTARY INFORMATION:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
[EPA–HQ–OPP–2018–0576; FRL–9985–70]
producer, food manufacturer, or
pesticide manufacturer. The following
Pesticide Product Registration;
list of North American Industrial
Receipt of Applications for New Uses
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
AGENCY: Environmental Protection
provides a guide to help readers
Agency (EPA).
determine whether this document
ACTION: Notice.
applies to them. Potentially affected
SUMMARY: EPA has received applications entities may include:
to register new uses for pesticide
• Crop production (NAICS code 111).
products containing currently registered
• Animal production (NAICS code
active ingredients. Pursuant to the
112).
Federal Insecticide, Fungicide, and
• Food manufacturing (NAICS code
Rodenticide Act (FIFRA), EPA is hereby
311).
providing notice of receipt and
• Pesticide manufacturing (NAICS
opportunity to comment on these
code
32532).
applications.
Comments must be received on
or before December 17, 2018.
ADDRESSES: Submit your comments,
identified by the Docket Identification
(ID) Number and the File Symbol or
EPA Registration Number of interest as
shown in the body of this document, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), main telephone number: (703)
305–7090, email address:
RDFRNotices@epa.gov. The mailing
address for each contact person is:
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001. As part of the mailing
DATES:
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B. 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 as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Registration Applications
EPA has received applications to
register new uses for pesticide products
containing currently registered active
ingredients. Pursuant to the provisions
of FIFRA section 3(c)(4) (7 U.S.C.
136a(c)(4)), EPA is hereby providing
notice of receipt and opportunity to
comment on these applications. Notice
of receipt of these applications does not
imply a decision by the Agency on these
applications.
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Agencies
[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Notices]
[Pages 57473-57475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24972]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0604; FRL-9986-45]
Draft TSCA Risk Evaluation for Colour Index (C. I.) Pigment
Violet 29 (PV29); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing the availability of and seeking public
comment on the draft Risk Evaluation for Colour Index (C. I.) Pigment
Violet 29 (PV29) and associated documents developed under EPA's
existing chemical substance process under the Toxic Substances Control
Act (TSCA). The purpose of the risk evaluation is to determine whether
a chemical substance presents an unreasonable risk 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 these same documents to the TSCA Science Advisory
Committee on Chemicals (SACC) which will peer review the draft risk
evaluation, and EPA will provide the peer review meeting details in a
separate Federal Register notice. All comments submitted on the draft
risk evaluation in response to this Notice of Availability will be
provided to the TSCA SACC peer review panel, which will have the
opportunity to consider the comments during its discussions. In
addition, the subsequent Federal Register notice providing details on
the peer review meeting will explain the process for submitting
information and views to the peer review panel. EPA will consider the
public comments on the draft risk evaluation submitted in response to
this Notice of Availability, along with peer reviewer comments and
recommendations, to finalize the risk evaluation.
DATES: Comments must be received on or before January 14, 2019.
ADDRESSES: Submit your written comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0604, 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.
[[Page 57474]]
Mail: OPPT Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Jeffrey Dawson, Office of Pollution
Prevention and Toxics (7403M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-0331; 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 interested in risk evaluations of
existing chemical substances under the Toxic Substances Control Act
(TSCA). Since other entities may also be interested in this draft risk
evaluation, the Agency has not attempted to describe all the entities
that may be interested in this action.
B. What action is the agency taking?
EPA is announcing the availability of and seeking public comment on
the draft Risk Evaluation for Colour Index (C. I.) Pigment Violet 29
(PV29) and associated documents, which is available at the docket
identified by ID No. EPA-HQ-OPPT-2018-0604 at https://www.regulations.gov. EPA is providing 60 days for public comment on all
aspects of this draft risk evaluation, including any conclusions,
findings, determinations, and the submission of any additional
information that might be relevant to the science underlying the risk
evaluation and the outcome of the systematic review associated with
C.I. Pigment Violet 29. 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.''
In addition to any new comments on the draft risk evaluation, the
public should resubmit or clearly identify at this time any previously
filed comments, modified as appropriate, that are relevant to this risk
evaluation and that the submitter feels have not been addressed. EPA
does not intend to further respond to comments submitted prior to the
release of this draft risk evaluation.
All comments on the draft risk evaluation in response to this
Notice of Availability, and all information and views submitted to the
peer review panel as directed in the subsequent Federal Register notice
announcing the TSCA SACC panel meeting, are being directed to the same
docket, identified by docket ID No. EPA-HQ-OPPT-2018-0604 at https://www.regulations.gov. As such, comments submitted or resubmitted during
this 60-day period will be provided to the TSCA SACC for consideration
during their peer review.
C. What is the Agency'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 non-risk 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 direct which
chemical substances must undergo evaluation, the development of
criteria for manufacturer-requested evaluations, the minimum components
of an Agency risk evaluation, and the timelines for public comment and
completion of the risk evaluation. The law also requires that EPA
operate in a manner that is consistent with the best available science
and make decisions based on the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i).
The statute identifies the minimum components EPA must include in
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 exposure for the conditions of use
of the chemical substance, including information on specific risks of
injury to health or the environment and information on 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 exposure. 15 U.S.C.
2605(b)(4)(F)(i), and (iii)-(v). The risk evaluation must not consider
costs or other non-risk factors. 15 U.S.C. 2605(b)(4)(F)(ii).
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
Agency 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).
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or via email. If your comments contain any information
that you consider to be CBI or otherwise protected, please contact the
DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Background
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. The purpose of risk evaluation is to determine whether a
chemical substance presents an unreasonable risk 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 non-risk factors, use scientific information
and approaches in a manner that is consistent with the requirements in
TSCA for the best available science, and ensure decisions are based on
the weight-of-scientific-evidence.
[[Page 57475]]
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 our website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained the in the preamble to EPA's procedural final
rule (82 FR 33726, July 20, 2017) (FRL-9964-38), the specific
regulatory process set out in 40 CFR part 702 will be followed for the
first ten chemical substances undergoing risk evaluation to the maximum
extent practicable.
B. What is Pigment Violet 29?
Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d'e'f'] diisoquinoline-
1,3,8,10(2H,9H)-tetrone) (pigment violet 29) is a perylene derivative
used to color materials and as an intermediate for other perylene
pigments. The pigment is utilized as an intermediate to create or
adjust the color of other pigments, as well as in commercial paints,
coatings, plastics, and rubber products. C.I. Pigment Violet 29 is an
organic pigment that has a low solubility, low volatility, is expected
to be highly persistent and has low bioaccumulation potential in fish
and other animals.
Information about the problem formulation and scope phases of the
risk evaluation for this chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-pigment-violet-29-anthra219-def6510.
C. Purpose of the TSCA SACC
The TSCA SACC was established by EPA to support activities under
TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention Act (PPA), 42
U.S.C. 13101 et seq., and other applicable statutes. The TSCA SACC
provides expert independent scientific advice and recommendations to
the EPA on the scientific and technical aspects of risk assessments,
methodologies, and pollution prevention measures and approaches for
chemicals regulated under TSCA. Given the SACC's expertise, EPA is
submitting the draft risk evaluation and related documents to the TSCA
SACC for peer review and scheduling a public meeting for the panel's
discussion of those materials. Consistent with EPA's peer review policy
and requirements associated with the Federal Advisory Committee Act
(FACA), 5 U.S.C Appendix 2 et seq., EPA will announce the TSCA SACC
public meeting and provide related details about that meeting in a
future Federal Register notice.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 9, 2018.
Nancy B. Beck,
Deputy Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2018-24972 Filed 11-14-18; 8:45 am]
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