[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]
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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.
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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 http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
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 http://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 http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702,
subpart B will be followed for the first ten chemical substances
undergoing risk evaluation to the maximum extent practicable.
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]
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