[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43847-43850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10999]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0073; FRL-11760-02-OCSPP]


Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP); 
Science Advisory Committee on Chemicals (SACC) Peer Review of Draft 
Documents; Notice of SACC Meeting; Availability; and Request for 
Comment

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is 
announcing the availability of and soliciting public comment on the 
draft manufacturer-requested risk evaluation for Di-isodecyl Phthalate 
(DIDP) and the draft physical chemical, fate, and hazard assessments 
for Di-isononyl Phthalate (DINP) prepared under the Toxic Substances 
Control Act (TSCA). The draft documents will also be submitted to the 
Science Advisory Committee on Chemicals (SACC) for peer review. EPA is 
also announcing that there will be two virtual public meetings of the 
SACC: On July 23, 2024, for the SACC to consider the scope and clarity 
of the draft charge questions for the peer review; and on July 30-
August 2, 2024, for the SACC to consider the draft documents and public 
comments for peer review.

DATES: 

Virtual Preparatory Public Meeting

    Comments: Submit written comments on the scope and clarity of the 
charge questions on or before noon (12:00 p.m. EDT) on July 19, 2024.
    Registration: To request time to present oral comments, you must 
register by noon (12:00 p.m. EDT) on July 19, 2024. For those not 
making oral comments, registration will remain open through the end of 
the meeting on July 19, 2024.
    Meeting date: July 23, 2024, 1 p.m. to 4 p.m. (EDT).

Virtual Peer Review Public Meeting

    Comments: Submit comments on or before July 19, 2024.
    Registration: To request time to present oral comments, you must 
register by noon, July 26, 2024. For those not making oral comments, 
registration will remain open through the end of the meeting.
    Meeting dates: July 30-August 2, 2024, 10 a.m. to 5 p.m. (EDT).

Special Accommodations

    To allow sufficient time for EPA to process your request before the 
applicable meeting, please submit your requests at least ten business 
days in advance of the meeting.
    See unit III. of SUPPLEMENTARY INFORMATION.

ADDRESSES: 
    Comments: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2024-0073, through 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. Additional 
instructions on commenting and visiting the docket is available at 
https://www.epa.gov/dockets.
    Meeting registration: For information and instructions on how to 
register and access these virtual public meetings, please refer to the 
SACC website at https://www.epa.gov/tsca-peer-review. After 
registering, you will receive the webcast and streaming service meeting 
links and audio teleconference information.
    Special accommodation requests: To request accommodation for a 
disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT.

[[Page 43848]]


FOR FURTHER INFORMATION CONTACT: 
    SACC peer review: The Designated Federal Official (DFO) is Dr. Alaa 
Kamel, Mission Support Division (7602M), Office of Program Support, 
Office of Chemical Safety and Pollution Prevention, Environmental 
Protection Agency; telephone number: (202) 564-5336 or SACC main office 
number: (202) 564-8450; email address: [email protected].
    Draft documents: Todd Coleman, Existing Chemicals Risk Management 
Division (7404M), Office of Pollution Prevention and Toxics, Office of 
Chemical Safety and Pollution Prevention, Environmental Protection 
Agency; telephone number: (202) 564-1208; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    EPA is announcing the availability of and soliciting public comment 
on the draft risk evaluation for DIDP and the draft physical chemical, 
fate, and hazard assessments for DINP. EPA is also announcing a virtual 
peer review public meeting on July 30-August 2, 2024, for the SACC to 
consider and review the draft documents. A virtual preparatory public 
meeting will be held on July 23, 2024, for the SACC to consider and ask 
questions regarding the scope and clarity of the draft charge 
questions. This document provides instructions for accessing the 
materials, submitting written comments, and registering to provide oral 
comments and attend the public meetings.

B. What is the Agency's authority for taking this action?

    EPA established the SACC in 2016 in accordance with the TSCA, 15 
U.S.C. 2625(o), to provide independent advice and expert consultation 
with respect to the scientific and technical aspects of issues relating 
to the implementation of TSCA. The SACC operates in accordance with the 
Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports 
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.

C. Does this action apply to me?

    This action is directed to the public in general and may be of 
particular interest to those involved in the manufacture, processing, 
distribution, and disposal of the subject chemical substance, and/or 
those interested in the assessment of risks involving chemical 
substances and mixtures regulated under TSCA (including members of at-
risk communities, non-governmental organizations (NGOs), Federal, 
State, and local officials). Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be interested.

D. What should I consider as I submit my comments to EPA?

    1. Submitting CBI. Do not submit CBI to EPA through email or 
https://www.regulations.gov. If you wish to include CBI in your 
comment, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT to obtain special instructions before submitting that 
information.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see https://www.epa.gov/dockets/commenting-epa-dockets. 
See also the instructions in unit III.C.

E. How can I stay informed about SACC activities?

    You may subscribe to the following listserv for alerts regarding 
this and other SACC-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.

II. Background

A. What is the purpose of the SACC?

    The SACC provides independent 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. The SACC is composed of experts in 
toxicology; environmental risk assessment; exposure assessment; and 
related sciences (e.g., synthetic biology, pharmacology, biotechnology, 
nanotechnology, biochemistry, biostatistics, physiologically based 
pharmacokinetic (PBPK) modeling, computational toxicology, 
epidemiology, environmental fate, and environmental engineering and 
sustainability). The SACC currently consists of 18 members. When 
needed, the committee will be assisted by ad hoc reviewers with 
specific expertise in the topics under consideration.

B. Why is EPA conducting these risk evaluations?

    TSCA requires EPA to conduct risk evaluations on prioritized 
chemical substances and allows chemical manufacturers to request an 
EPA-conducted risk evaluation of a chemical substance (or category of 
chemical substances) using the procedures established in 40 CFR 702.37. 
TSCA also identifies the minimum components EPA must include in all 
chemical substance risk evaluations. EPA received manufacturer requests 
to conduct risk evaluations for DIDP and DINP, both as categories of 
chemical substances, and subsequently granted and initiated risk 
evaluations for both of them. The purpose of conducting risk 
evaluations is to determine whether a chemical substance presents an 
unreasonable risk to human health or the environment under the 
Conditions of Use (COUs). These evaluations include assessing 
unreasonable risks to relevant potentially exposed or susceptible 
subpopulations. As part of this process EPA: (1) Integrates hazard and 
exposure assessments using the best available science that is 
reasonably available to assure decisions are based on the weight of the 
scientific evidence, and (2) Conducts peer review for risk evaluation 
approaches that have not been previously peer reviewed. For more 
information about the three stages of EPA's process for ensuring the 
safety of existing chemicals (i.e., prioritization, risk evaluation, 
and risk management), go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals.

C. Why is EPA evaluating the risks from DIDP and DINP?

    On May 24, 2019, EPA received requests to conduct risk evaluations 
for DIDP and DINP from ExxonMobil Chemical Company, Evonik Corporation, 
and Teknor Apex, through the American Chemistry Council's High 
Phthalates Panel (ACC HPP). In December 2019, EPA notified ACC HPP that 
the Agency had granted their manufacturer requested risk evaluations.
    DIDP is a common chemical name for the category of chemical 
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-diisodecyl ester (CASRN 26761-40-0) and 
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich 
(CASRN 68515-49-1). Both CASRNs contain mainly C10 dialkyl phthalate 
esters.
    DINP is a common chemical name for the category of chemical 
substances that includes the following substances: 1,2-
benzenedicarboxylic acid, 1,2-isononyl ester (CASRN 28553-12-0) and 
1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C9-rich 
(CASRN 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate 
esters. Both DIDP and DINP are primarily used as a plasticizer in 
polyvinyl chloride (PVC) in consumer, commercial, and industrial 
applications.

[[Page 43849]]

    DIDP and DINP are both structurally phthalates, and therefore many 
aspects of physical-chemical (p-chem) properties and exposure (to 
humans and ecological species) are similar, described further in the 
draft physical chemical and fate assessments for both chemical 
substances. Because of the similar exposure and physical chemical 
properties of DIDP and DINP, EPA is developing these individual risk 
evaluations in parallel, and similarly the SACC peer review of the 
methods and novel analyses for the draft risk evaluations will occur 
concurrently. Both DIDP and DINP have extremely low water solubility 
and will be preferentially sorbed into sediments, soils, and suspended 
solids in surface water and wastewater. Both are expected to be 
persistent in anaerobic environments. Under indoor settings, DIDP and 
DINP are expected to partition to airborne particles and are expected 
to have extended lifetime compared to outdoor settings.
    For both DIDP and DINP, liver and developmental toxicity are 
indicated as the most sensitive and robust non-cancer hazards. However, 
these two phthalates differ in several important respects regarding 
their human health hazard profiles. For DIDP, the developmental 
toxicity is not characterized by androgen insufficiency, and data are 
insufficient to determine the carcinogenicity. For DINP, developmental 
toxicity results in androgen insufficiency (phthalate syndrome), and 
the effects on the liver include cancer. Therefore, because of these 
hazard differences, EPA is requesting peer review on the draft hazard 
assessment of DINP ahead of issuing the risk evaluation of DINP.

D. What is the topic of the planned SACC peer review?

    EPA is submitting the draft risk evaluation of DIDP, draft physical 
chemical, fate, and hazard assessments of DINP, and associated 
supporting documents to the SACC for peer review, along with the public 
comments received. The draft risk evaluation for DIDP includes analyses 
of physical chemical properties, the fate and transport in the 
environment, exposure to workers, consumers and general population 
including potentially exposed or susceptible subpopulations (PESS), 
releases to the environment, environmental hazard and risk 
characterization for terrestrial and aquatic species, and human health 
hazard and risk characterization for workers, consumers, and the 
general population. The draft assessments of DINP includes analyses of 
physical chemical properties, the fate and transport in the 
environment, environmental hazard for terrestrial and aquatic species, 
human health non-cancer hazards, and human health cancer hazards.
    EPA is not developing charge questions for all aspects of the draft 
documents but is instead focusing its charge to the SACC on specific 
scientific areas that need peer review. Many of the methods and 
analyses used in these evaluations are not novel and have been reviewed 
in the development of the tools, used in various agency work products 
or in previous TSCA assessments (e.g., systematic review, consumer 
exposure model (CEM), American Meteorological Society (AMS)/EPA 
Regulatory Model (AERMOD), point source calculator (PSC), etc.). Also, 
EPA is not soliciting comments on uses of these phthalates that are 
outside the scope of TSCA (e.g., personal care products, cosmetics, 
food contact materials, medical devices); those uses will be addressed 
as appropriate within the cumulative risk assessment.
    As a result of the similarities in conditions of use, chemical 
properties, and data availability between DIDP and DINP, the methods 
and approaches used to assess DIDP apply to DINP. Nonetheless, these 
two chemicals differ most in their human health hazard profiles and 
therefore SACC is requested to review these novel analyses for DINP. 
Any relevant recommendations from this SACC review on DIDP will be also 
considered in the development of the final risk evaluations for both 
DIDP and DINP. By taking the DIDP risk evaluation and DINP hazard 
assessments to peer review in this manner, EPA will obtain the 
necessary independent review and advice for the DINP risk evaluation.
    EPA continues to work on risk evaluations of additional high-
priority substance phthalates, in addition to the cumulative risk 
assessment (CRA) for the phthalates. The subsequent five individual 
risk evaluations and the CRA are not part of this peer review but will 
be brought to the SACC for peer review at a future date.

III. Public Meeting of the SACC

A. What is the purpose of the virtual peer review public meeting(s)?

    EPA is planning two virtual public meetings: (1) A preparatory 
public meeting for the SACC to consider and ask questions regarding the 
scope and clarity of the draft charge questions; and (2) a public 
meeting for the SACC to consider and review the draft documents. These 
public meetings are part of the SACC peer review of the Agency's 
methods and novel analyses for the draft evaluations of the risks from 
the phthalates DIDP and DINP to inform risk management decisions under 
TSCA. EPA expects to ask the SACC to consider and review this DIDP 
draft risk evaluation and DINP assessments. The agenda for these 
meetings will be posted in the docket and the SACC website.
    To participate in these virtual public meetings, you must register 
online to receive the webcast and streaming service meeting links and 
audio teleconference information for each meeting. Online registration 
will be available beginning approximately one month prior to the 
meeting, and remain open through the end of the meeting. To make oral 
comments during one of these meetings, follow the instructions in unit 
III.C.
    Recommendations from this SACC review and public comments will be 
considered in the development of the final risk evaluation for DIDP and 
DINP. The Agency will be seeking SACC review of its data analyses and 
methodologies relevant to human health hazard and exposure analyses 
that have not been previously peer reviewed.

B. How can I access the documents?

    The manufacturer-requested draft risk evaluation for DIDP, draft 
assessments for DINP, and related documents, including background 
documents, related supporting materials, and draft charge questions, 
are available in the docket. As additional background materials become 
available, EPA will include those additional background materials 
(e.g., SACC members and consultants participating in this meeting and 
the meeting agenda) in the docket and through links on the SACC website 
at https://www.epa.gov/tsca-peer-review.
    After the public meeting, the SACC will prepare the meeting minutes 
and a final report document summarizing its recommendations to the EPA, 
which will also be available in the docket and through the SACC 
website.

C. How can I provide comments?

    To ensure proper receipt of comments, it is imperative that you 
identify docket ID No. EPA-HQ-OPPT-2024-0073 in the subject line on the 
first page of your comments and follow the instructions in this 
document.
    1. Written comments. Submit written comments by the deadlines set 
in the DATES section of this document and as described in the ADDRESSES 
section of this document.

[[Page 43850]]

    2. Oral comments. To request time to present oral comments during 
one of the virtual public meetings, you must register online by the 
deadlines set in the DATES section of this document. Oral comments 
during the virtual public meetings are limited to 5 minutes. In 
addition, each speaker should submit a written copy of their oral 
comments and any supporting materials (e.g., presentation slides) to 
the DFO prior to the meetings for distribution to the SACC.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.

    Dated: May 15, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-10999 Filed 5-17-24; 8:45 am]
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