C.I. Pigment Violet 29; Revised Draft Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability, Letter Peer Review and Public Comment, 68873-68875 [2020-24032]
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2007–0478, FRL–10016–43–
OMS]
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) has submitted an
information collection request (ICR),
Regulation of Fuels and Fuel Additives:
Gasoline Volatility (EPA ICR Number
1367.13, OMB Control Number 2060–
0178) to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act (PRA). This is a proposed
extension of the ICR, which is currently
approved through December 31, 2020.
Public comments were previously
requested via the Federal Register on
April 1, 2020 during a 60-day comment
period. This notice allows for an
additional 30 days for public comments.
A fuller description of the ICR is given
below, including its estimated burden
and cost to the public. An agency may
not conduct or sponsor and a person is
not required to respond to a collection
of information unless it displays a
currently valid OMB control number.
DATES: Additional comments may be
submitted on or before November 30,
2020.
SUMMARY:
Submit your comments,
referencing Docket ID No. EPA–HQ–
OAR–2007–0478, online using
www.regulations.gov (our preferred
method), by email to a-and-r-docket@
epa.gov, or by mail to: EPA Docket
Center, Environmental Protection
Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC
20460. EPA’s policy is that all
comments received will be included in
the public docket without change
including any personal information
provided, unless the comment includes
profanity, threats, information claimed
to be Confidential Business Information
(CBI), or other information whose
disclosure is restricted by statute.
Submit written comments and
recommendations to OMB for the
proposed information collection within
30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
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FOR FURTHER INFORMATION CONTACT:
James W. Caldwell, Compliance
Division, Office of Transportation and
Air Quality, Mail Code 6406J,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460; telephone number: (202) 343–
9303; fax number: (202) 343–2801;
email address: caldwell.jim@epa.gov.
Information Collection Request
Submitted to OMB for Review and
Approval; Comment Request;
Regulation of Fuels and Fuel
Additives: Gasoline Volatility
(Renewal)
ADDRESSES:
30-day Review—Open for Public
Comments’’ or by using the search
function.
SUPPLEMENTARY INFORMATION:
Supporting documents, which explain
in detail the information that the EPA
will be collecting, are available in the
public docket for this ICR. The docket
can be viewed online at https://
www.regulations.gov or in person at the
EPA Docket Center, EPA West, Room
3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number
for the Docket Center is 202–566–1744.
For additional information about EPA’s
public docket, visit https://www.epa.gov/
dockets.
Abstract: Gasoline volatility, as
measured by Reid Vapor Pressure (RVP)
in pounds per square inch (psi), is
controlled in the spring and summer in
order to minimize evaporative
hydrocarbon emissions from motor
vehicles. RVP is subject to a Federal
standard of 7.8 psi or 9.0 psi, depending
on location. The addition of ethanol to
gasoline increases the RVP by about 1
psi. Gasoline that contains nine volume
percent to 15 volume percent ethanol is
subject to a standard that is 1.0 psi
greater. As an aid to industry
compliance and EPA enforcement, the
product transfer document (PTD), which
is prepared by the producer or importer
and which accompanies a shipment of
gasoline containing ethanol, is required
by regulation to contain a legible and
conspicuous statement that the gasoline
contains ethanol and the percentage
concentration of ethanol. This is
intended to deter the mixing within the
distribution system, particularly in
retail storage tanks, of gasoline which
contains ethanol in the nine to 15
percent range with gasoline which does
not contain ethanol in that range. Such
mixing would likely result in a gasoline
which is in violation of its RVP
standard. Also, a party wishing a testing
exemption, for research on gasoline that
is not in compliance with the applicable
volatility standard, must submit certain
information to EPA. EPA has additional
PTD requirements for gasoline
containing ethanol at 40 CFR 80.1503.
Those requirements are covered in a
separate ICR.
Form Numbers: None.
PO 00000
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68873
Respondents/affected entities: Entities
potentially affected by this action are
those who produce or import gasoline
containing ethanol, or who wish to
obtain a testing exemption.
Respondent’s obligation to respond:
Mandatory per 40 CFR 80.27(d) and (e).
Estimated number of respondents:
2,200 (total).
Frequency of response: On occasion.
Total estimated burden: 1,410 hours
per year. Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $154,030,
includes $10 annualized capital or
operation & maintenance costs.
Changes in estimates: With nearly all
PTDs now being computer generated,
the average time to include the
regulatory language on each PTD has
decreased from one second to 0.1
second. As a result, the total annual
burden has decreased from 12,330 hours
per year to 1,410 hours per year.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020–24129 Filed 10–29–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2018–0604; FRL–10015–
96]
C.I. Pigment Violet 29; Revised Draft
Toxic Substances Control Act (TSCA)
Risk Evaluation; Notice of Availability,
Letter Peer Review and Public
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is announcing the
availability of and soliciting public
comment on a revised draft risk
evaluation of C. I. Pigment Violent 29
under the Toxic Substances Control Act
(TSCA). EPA conducts 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 potentially exposed
or susceptible subpopulations, under
the conditions of use. The draft risk
evaluation has been revised to include
information EPA received from the
manufacturing stakeholders as a result
of a TSCA section 4 order requiring
testing of the chemical substance. EPA
is announcing the opening of a docket
for a 30-day comment period to allow
the public to review the revised draft inlight of the additional information.
SUMMARY:
E:\FR\FM\30OCN1.SGM
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
Concurrently with the public comment,
EPA is announcing the availability of
the risk evaluation for expert letter peer
review.
DATES: Comments must be received on
or before November 30, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA- EPA–HQ–OPPT–2018–
0604, using the Federal eRulemaking
Portal at 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.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Seema
Schappelle, Risk Assessment Division,
Office of Pollution Prevention and
Toxics (7403M), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–8006;
email address: schappelle.seema@
epa.gov.
For peer review information contact:
Dr. Todd Peterson, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–6428; email address:
peterson.todd@epa.gov.
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. General Information
jbell on DSKJLSW7X2PROD with NOTICES
A. What action is the Agency taking?
Subsequent to the publication of the
C.I. Pigment Violet 29 Draft Risk
Evaluation, EPA obtained additional
information, including but not limited
to information submitted in response to
a TSCA section 4 testing order. This
additional information triggered revised
analyses and the selection of a different
analogue for adverse health effects
outcome and dose response. This new
information has been placed in the
public docket. EPA seeks public
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21:10 Oct 29, 2020
Jkt 253001
comment on the Agency’s interpretation
and use of the information and its
revised calculations. Therefore, EPA is
providing 30 days public notice and an
opportunity for comment on this revised
draft risk evaluation prior to publishing
a final risk evaluation (see Unit III.).
EPA is also initiating a letter peer
review of this revised draft risk
evaluation concurrently with the public
comment period (see Unit IV.).
B. Does this action apply to me?
This action is directed to the public
in general. This action may, however, be
of interest to those involved in the
manufacture, processing, distribution,
use, disposal, and/or the assessment of
risks involving chemical substances and
mixtures. 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 C.I.
Pigment Violet 29. 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.
C. What is the Agency’s authority for
taking this action?
TSCA section 6(b) requires that EPA
conduct risk evaluations on existing
chemical substances and identifies the
minimum components EPA must
include in all chemical substance risk
evaluations. 15 U.S.C. 2605(b). The risk
evaluation must not consider costs or
other nonrisk factors. 15 U.S.C.
2605(b)(4)(F)(iii). The specific risk
evaluation process is set out in 40 CFR
part 702 and summarized on EPA’s
website at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluations-existingchemicals-under-tsca.
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 email. If your
comments contain any information that
you consider to be CBI or otherwise
protected, please contact Seema
Schappelle 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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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. 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 the
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 https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluationsexisting-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.
In November 2018, EPA published a
draft risk evaluation, which was subject
to peer review and public comment.
EPA reviewed the peer review report
from the Science Advisory Committee
on Chemicals (SACC) and public
comments, and has revised the risk
evaluation in response to these
comments as appropriate. The public
comments, peer review report, and
EPA’s draft response are in Docket EPA–
HQ–OPPT–2018–0604 at
www.regulations.gov. Prior to the
publication of the draft risk evaluation,
EPA made available the scope and
problem formulation, and solicited
public input on uses and exposure.
EPA’s documents and the public
comments are in Docket EPA–HQ–
OPPT–2016–0725. Additionally,
information about the scope, problem
E:\FR\FM\30OCN1.SGM
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
formulation, and draft risk evaluation
phases of the TSCA risk evaluation for
this chemical is available at https://
www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluationpigment-violet-29-anthra219-def6510
jbell on DSKJLSW7X2PROD with NOTICES
B. What is C.I. Pigment Violet 29?
C.I. Pigment Violet 29 (Anthra[2,1,9def:6,5,10-d’e’f’] diisoquinoline1,3,8,10(2H,9H)-tetrone) is a perylene
derivative used to color materials and as
an intermediate for other perylene
pigments. C.I. Pigment Violet 29 is
currently manufactured (including
imported), processed, distributed, used,
and disposed of as part of industrial,
commercial, and consumer conditions
of use. Leading applications for C.I.
Pigment Violet 29 include use as an
intermediate to create or adjust color of
other perylene pigments, incorporation
into paints and coatings used primarily
in the automobile industry,
incorporation into plastic and rubber
products used primarily in automobiles
and industrial carpeting, use in
merchant ink for commercial printing,
and use in consumer watercolors and
artistic color.
C. What additional information has
been gathered?
In the draft risk evaluation for C.I.
Pigment Violet 29, published in
November 2018, EPA preliminarily
concluded C.I. Pigment Violet 29 does
not present an unreasonable risk of
injury to human health or the
environment. During the peer review of
the draft risk evaluation, members of the
SACC highlighted uncertainties in the
draft evaluation, specifically concerning
C.I. Pigment Violet 29’s solubility and
occupational worker inhalation
exposure.
In response to the SACC comments, in
February 2020, EPA issued a TSCA
section 4(a)(2) order to two companies,
a manufacturer and an importer of C.I.
Pigment Violet 29, requiring the
development of information necessary
to decrease uncertainty in the risk
evaluation. The tests ordered by EPA
were tailored to address critical
uncertainties highlighted by SACC and
public comments and were capable of
being conducted in a relatively short
time period. Section 4 of TSCA
authorizes EPA to issue rules, orders, or
consent agreements to require the
development of new information that is
necessary to, among other things,
perform a risk evaluation under TSCA
section 6(b) or prioritize a chemical
substance under TSCA section 6(b)
(subject to certain limitations). The EPA
test orders required laboratory tests
confirming the solubility of C.I. Pigment
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21:10 Oct 29, 2020
Jkt 253001
Violet 29. The other test order required
worker respirable dust monitoring of
C.I. Pigment Violet 29 in the
manufacturing facility. This information
has been received and incorporated into
the revised draft risk evaluation.
The test order information combined
with additional particle size information
received from the manufacturers had a
significant impact on EPA’s analysis of
the potential exposure and health effects
of PV29. As a result of this updated
analysis, the revised draft risk
evaluation now shows unreasonable risk
for 8 out of 14 conditions of use.
Because this important new data had a
significant impact on EPA’s risk
evaluation and ultimately the risk
determinations, the Agency feels it is
important that the public have the
opportunity to provide input on this
new information and analysis before the
risk evaluation is finalized.
III. Request for Comment
The docket associated with this
request contains the Revised Draft Risk
Evaluation, a document that responds to
comment received from both the public
and peer reviewers on the Draft Risk
Evaluation, the SACC Peer Review
Report, supplemental files to support
the Revised Draft Risk Evaluation, and
Charge Questions for the letter peer
review.
EPA is seeking public comment on,
and information relevant to, the revised
draft risk evaluation; in particular,
commenters are encouraged to provide
comment in-light-of the charge
questions supplied to the peer
reviewers.
IV. Letter Peer Review
The inclusion of the additional test
ordered scientific information resulted
in significant changes to the evaluation,
including assumptions and models, and
ultimately resulted in changes to EPA’s
risk characterization for this chemical
substance. EPA feels it is important that
independent, scientific experts have the
opportunity to provide input on this
new information and analysis before the
risk evaluation is finalized, and EPA
will conduct an independent expert
peer review in the form of a letter peer
review simultaneous to the period of
solicitation for public comment. Peer
reviewers will be provided the identical
information made available to the
public and will be asked to review the
revised draft risk evaluation in-light-of
the charge questions posted in the same
docket. EPA will consider public and
peer review comments as it finalizes the
risk evaluation.
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68875
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020–24032 Filed 10–29–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2020–0262; FRL–10013–
38–OMS]
Information Collection Request
Submitted to OMB for Review and
Approval; Comment Request;
Asbestos Abatement Worker
Protection (Renewal)
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) has submitted an
information collection request (ICR),
Asbestos Abatement Worker Protection
(EPA ICR Number 1246.14, OMB
Control Number 2070–0072) to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act. This is a proposed
extension of the ICR, which is currently
approved through December 31, 2020.
Public comments were previously
requested via the Federal Register on
May 20, 2020 during a 60-day comment
period. This notice allows for an
additional 30 days for public comments.
A fuller description of the ICR is given
below, including its estimated burden
and cost to the public. An agency may
not conduct or sponsor and a person is
not required to respond to a collection
of information unless it displays a
currently valid OMB control number.
DATES: Additional comments may be
submitted on or before November 30,
2020.
ADDRESSES: Submit your comments,
referencing Docket ID No. EPA–HQ–
OPPT–2020–0262 to EPA online using
www.regulations.gov (our preferred
method), or by mail to: EPA Docket
Center, Environmental Protection
Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC
20460. EPA’s policy is that all
comments received will be included in
the public docket without change
including any personal information
provided, unless the comment includes
profanity, threats, information claimed
to be Confidential Business Information
(CBI), or other information whose
disclosure is restricted by statute.
Submit written comments and
recommendations to OMB for the
SUMMARY:
E:\FR\FM\30OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68873-68875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24032]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0604; FRL-10015-96]
C.I. Pigment Violet 29; Revised Draft Toxic Substances Control
Act (TSCA) Risk Evaluation; Notice of Availability, Letter Peer Review
and Public Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing the availability of and soliciting public
comment on a revised draft risk evaluation of C. I. Pigment Violent 29
under the Toxic Substances Control Act (TSCA). EPA conducts 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 potentially exposed or susceptible subpopulations,
under the conditions of use. The draft risk evaluation has been revised
to include information EPA received from the manufacturing stakeholders
as a result of a TSCA section 4 order requiring testing of the chemical
substance. EPA is announcing the opening of a docket for a 30-day
comment period to allow the public to review the revised draft in-light
of the additional information.
[[Page 68874]]
Concurrently with the public comment, EPA is announcing the
availability of the risk evaluation for expert letter peer review.
DATES: Comments must be received on or before November 30, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA- EPA-HQ-OPPT-2018-0604, using the Federal eRulemaking
Portal at 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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Seema Schappelle, Risk Assessment Division, Office of Pollution
Prevention and Toxics (7403M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8006; email address: [email protected].
For peer review information contact: Dr. Todd Peterson, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-6428; email address: [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. General Information
A. What action is the Agency taking?
Subsequent to the publication of the C.I. Pigment Violet 29 Draft
Risk Evaluation, EPA obtained additional information, including but not
limited to information submitted in response to a TSCA section 4
testing order. This additional information triggered revised analyses
and the selection of a different analogue for adverse health effects
outcome and dose response. This new information has been placed in the
public docket. EPA seeks public comment on the Agency's interpretation
and use of the information and its revised calculations. Therefore, EPA
is providing 30 days public notice and an opportunity for comment on
this revised draft risk evaluation prior to publishing a final risk
evaluation (see Unit III.). EPA is also initiating a letter peer review
of this revised draft risk evaluation concurrently with the public
comment period (see Unit IV.).
B. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, use, disposal, and/or the assessment of risks
involving chemical substances and mixtures. 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
C.I. Pigment Violet 29. 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.
C. What is the Agency's authority for taking this action?
TSCA section 6(b) requires that EPA conduct risk evaluations on
existing chemical substances and identifies the minimum components EPA
must include in all chemical substance risk evaluations. 15 U.S.C.
2605(b). The risk evaluation must not consider costs or other nonrisk
factors. 15 U.S.C. 2605(b)(4)(F)(iii). The specific risk evaluation
process is set out in 40 CFR part 702 and summarized on EPA's website
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.
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 email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact Seema
Schappelle 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. 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 the
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 https://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.
In November 2018, EPA published a draft risk evaluation, which was
subject to peer review and public comment. EPA reviewed the peer review
report from the Science Advisory Committee on Chemicals (SACC) and
public comments, and has revised the risk evaluation in response to
these comments as appropriate. The public comments, peer review report,
and EPA's draft response are in Docket EPA-HQ-OPPT-2018-0604 at
www.regulations.gov. Prior to the publication of the draft risk
evaluation, EPA made available the scope and problem formulation, and
solicited public input on uses and exposure. EPA's documents and the
public comments are in Docket EPA-HQ-OPPT-2016-0725. Additionally,
information about the scope, problem
[[Page 68875]]
formulation, and draft risk evaluation phases of the TSCA 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
B. What is C.I. Pigment Violet 29?
C.I. Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d'e'f']
diisoquinoline-1,3,8,10(2H,9H)-tetrone) is a perylene derivative used
to color materials and as an intermediate for other perylene pigments.
C.I. Pigment Violet 29 is currently manufactured (including imported),
processed, distributed, used, and disposed of as part of industrial,
commercial, and consumer conditions of use. Leading applications for
C.I. Pigment Violet 29 include use as an intermediate to create or
adjust color of other perylene pigments, incorporation into paints and
coatings used primarily in the automobile industry, incorporation into
plastic and rubber products used primarily in automobiles and
industrial carpeting, use in merchant ink for commercial printing, and
use in consumer watercolors and artistic color.
C. What additional information has been gathered?
In the draft risk evaluation for C.I. Pigment Violet 29, published
in November 2018, EPA preliminarily concluded C.I. Pigment Violet 29
does not present an unreasonable risk of injury to human health or the
environment. During the peer review of the draft risk evaluation,
members of the SACC highlighted uncertainties in the draft evaluation,
specifically concerning C.I. Pigment Violet 29's solubility and
occupational worker inhalation exposure.
In response to the SACC comments, in February 2020, EPA issued a
TSCA section 4(a)(2) order to two companies, a manufacturer and an
importer of C.I. Pigment Violet 29, requiring the development of
information necessary to decrease uncertainty in the risk evaluation.
The tests ordered by EPA were tailored to address critical
uncertainties highlighted by SACC and public comments and were capable
of being conducted in a relatively short time period. Section 4 of TSCA
authorizes EPA to issue rules, orders, or consent agreements to require
the development of new information that is necessary to, among other
things, perform a risk evaluation under TSCA section 6(b) or prioritize
a chemical substance under TSCA section 6(b) (subject to certain
limitations). The EPA test orders required laboratory tests confirming
the solubility of C.I. Pigment Violet 29. The other test order required
worker respirable dust monitoring of C.I. Pigment Violet 29 in the
manufacturing facility. This information has been received and
incorporated into the revised draft risk evaluation.
The test order information combined with additional particle size
information received from the manufacturers had a significant impact on
EPA's analysis of the potential exposure and health effects of PV29. As
a result of this updated analysis, the revised draft risk evaluation
now shows unreasonable risk for 8 out of 14 conditions of use. Because
this important new data had a significant impact on EPA's risk
evaluation and ultimately the risk determinations, the Agency feels it
is important that the public have the opportunity to provide input on
this new information and analysis before the risk evaluation is
finalized.
III. Request for Comment
The docket associated with this request contains the Revised Draft
Risk Evaluation, a document that responds to comment received from both
the public and peer reviewers on the Draft Risk Evaluation, the SACC
Peer Review Report, supplemental files to support the Revised Draft
Risk Evaluation, and Charge Questions for the letter peer review.
EPA is seeking public comment on, and information relevant to, the
revised draft risk evaluation; in particular, commenters are encouraged
to provide comment in-light-of the charge questions supplied to the
peer reviewers.
IV. Letter Peer Review
The inclusion of the additional test ordered scientific information
resulted in significant changes to the evaluation, including
assumptions and models, and ultimately resulted in changes to EPA's
risk characterization for this chemical substance. EPA feels it is
important that independent, scientific experts have the opportunity to
provide input on this new information and analysis before the risk
evaluation is finalized, and EPA will conduct an independent expert
peer review in the form of a letter peer review simultaneous to the
period of solicitation for public comment. Peer reviewers will be
provided the identical information made available to the public and
will be asked to review the revised draft risk evaluation in-light-of
the charge questions posted in the same docket. EPA will consider
public and peer review comments as it finalizes the risk evaluation.
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-24032 Filed 10-29-20; 8:45 am]
BILLING CODE 6560-50-P
