Document ID: EPA-HQ-OPPT-2018-0604-0001
Agency: epa
Document Type: Notice
Title: Draft Toxic Substances Control Act Risk Evaluations: Colour Index Pigment Violet 29
Posted Date: 2018-11-15T05:00Z

[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]

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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.

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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: 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.

[[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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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 http://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 http://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 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. 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]
 BILLING CODE 6560-50-P