[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6322-6323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01229]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0604; FRL-10017-50]


C.I. Pigment Violet 29; Final Toxic Substances Control Act (TSCA) 
Risk Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final Toxic Substances Control Act (TSCA) risk 
evaluation of C.I. Pigment Violet 29. The purpose of conducting risk 
evaluations under TSCA 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, without 
consideration of costs or other nonrisk factors. EPA has determined 
that specific conditions of use of C.I. Pigment Violet 29 present an 
unreasonable risk of injury to health or the environment. For those 
conditions of use for which EPA has found an unreasonable risk, EPA 
must move to address that unreasonable risk through risk management 
measures enumerated in TSCA. EPA has also determined that specific 
conditions of use do not present unreasonable risk of injury to health 
or the environment. For those conditions of use for which EPA has found 
no unreasonable risk to health or the environment, the Agency's 
determination is a final Agency action and is issued via order in the 
risk evaluation.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2018-0604, is available online 
at http://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Please review the visitor instructions and additional 
information about the docket available at http://www.epa.gov/dockets.
    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, Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-8006; email address: schappelle.seema@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. 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 or may be interested in risk 
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq. 
Since other entities may also be interested in this final risk 
evaluation, the EPA has not attempted to describe all the specific 
entities that may be affected by this action.

B. 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 nonrisk 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 provide 
instruction on chemical substances that must undergo evaluation, the 
minimum components of a TSCA risk evaluation, and the timelines for 
public comment and completion of the risk evaluation. TSCA also 
requires that EPA operate in a manner that is consistent with the best 
available science, make decisions based on the weight of the scientific 
evidence and consider reasonably available information. 15 U.S.C. 
2625(h), (i), and (k). TSCA section 6(i) directs that a determination 
of ``no unreasonable risk'' shall be issued by order and considered to 
be a final Agency action, while a determination of ``unreasonable 
risk'' is not considered to be a final Agency action. 15 U.S.C. 
2605(i).
    The statute identifies the minimum components for 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 exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant 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 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed 
within a specified timeframe and provide an opportunity for public 
comment on a draft risk evaluation prior to publishing a final risk 
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.4.1 of the final risk evaluation for C.I. Pigment 
Violet 29 constitutes the order required under TSCA section 6(i)(1), 
and the ``no unreasonable risk'' determinations in that subsection are 
considered to be a final Agency action effective on the date

[[Page 6323]]

of issuance of the order. In conducting risk evaluations, ``EPA will 
determine whether the chemical substance presents an unreasonable risk 
of injury to health or the environment under each condition of use 
within the scope of the risk evaluation . . . .'' 40 CFR 702.47. Under 
EPA's implementing regulations, ``[a] determination by EPA that the 
chemical substance, under one or more of the conditions of use within 
the scope of the risk evaluation, does not present an unreasonable risk 
of injury to health or the environment will be issued by order and 
considered to be a final Agency action, effective on the date of 
issuance of the order.'' 40 CFR 702.49(d). For purposes of TSCA section 
19(a)(1)(A), the date of issuance of the TSCA section 6(i)(1) order for 
C.I. Pigment Violet 29 shall be at 1:00 p.m. Eastern time (standard or 
daylight, as appropriate) on the date that is two weeks after the date 
when this notice is published in the Federal Register, which is in 
accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the 
chemical substance identified in Unit II. In this risk evaluation EPA 
has made unreasonable risk determinations on some of the conditions of 
use within the scope of the risk evaluation for this chemical. For 
those conditions of use for which EPA has found an unreasonable risk of 
injury to health or the environment, EPA must initiate regulatory 
action to address those risks through risk management measures 
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required 
to be provided publicly with each risk evaluation, which is available 
online at http://www.regulations.gov in the dockets identified. 40 CFR 
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID 
No. EPA-HQ-OPPT-2016-0725);
     Draft risk evaluation, revised draft risk evaluation and 
final risk evaluation (in Docket ID No. EPA-HQ-OPPT-2018-0604);
     All notices, determinations, findings, consent agreements, 
and orders (in Docket ID No. EPA-HQ-OPPT-2018-0604);
     Any information required to be provided to the Agency 
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0725 and Docket 
ID No. EPA-HQ-OPPT-2018-0604);
     A nontechnical summary of the risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2018-0604);
     A list of the studies, with the results of the studies, 
considered in carrying out each risk evaluation (Risk Evaluation for 
C.I. Pigment Violet 29) in Docket ID No. EPA-HQ-OPPT-2018-0604);
     The final peer review report, including the response to 
peer review and public comments received during peer review (in Docket 
ID No. EPA-HQ-OPPT-2018-0604); and
     Response to public comments received on the draft scope, 
the draft risk evaluation and revised draft risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2018-0604).

II. TSCA Risk Evaluation

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.
    Prior to the publication of this final risk evaluation, a draft 
risk evaluation and a revised draft risk evaluation were subject to 
peer review and public comment. EPA reviewed the peer review reports 
from the Science Advisory Committee on Chemicals (SACC), a Letter Peer 
Review, and public comments and has supplemented the risk evaluation in 
response to these comments as appropriate. 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, the peer review report, and the public comments are in 
Docket EPA-HQ-OPPT-2018-0604 at http://www.regulations.gov. 
Additionally, information about the scope, problem 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.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2021-01229 Filed 1-19-21; 8:45 am]
BILLING CODE 6560-50-P


