Document ID: EPA-HQ-OPPT-2018-0604-0091
Agency: epa
Document Type: Notice
Title: C.I. Pigment Violet 29; Revised Draft Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability, Letter Peer Review and Public Comment
Posted Date: 2020-10-30T04:00Z

[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: 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

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]
BILLING CODE 6560-50-P