[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1093-1094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00169]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0627; FRL-11598-01-OCSPP]


TSCA New Chemicals Program Decision Framework for Hazard 
Identification of Eye Irritation and Corrosion; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of a new document supporting the new chemicals program 
under the Toxic Substances Control Act (TSCA) titled ``New Chemicals 
Program Decision Framework for Hazard Identification of Eye Irritation 
and Corrosion.'' The document provides a decision framework for use by 
the Office of Pollution Prevention and Toxics (OPPT) New Chemicals 
Division (NCD) for identification of eye irritation or corrosion 
hazards for new chemical substances based on prioritization of 
reproducible, human-relevant data. The Framework supports EPA's mandate 
under TSCA to promote the development and implementation of alternative 
test methods and strategies, or New Approach Methodologies

[[Page 1094]]

(NAMs), to reduce, refine or replace vertebrate animal testing and 
provide information of equivalent or better scientific quality and 
relevance for assessing risks of injury to health or the environment.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2023-0627, is available online 
at http://www.regulations.gov. Additional instructions for visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Renee Beardslee, New Chemical Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001: telephone number: 
(202) 564-8787; email address: <a href="/cdn-cgi/l/email-protection#492b2c283b2d3a252c2c673b2c272c2c092c3928672e263f"><span class="__cf_email__" data-cfemail="c9abaca8bbadbaa5acace7bbaca7acac89acb9a8e7aea6bf">[email protected]</span></a>.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: <a href="/cdn-cgi/l/email-protection#8bdfd8c8caa6c3e4ffe7e2e5eecbeefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="c094938381ed88afb4aca9aea580a5b0a1eea7afb6">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. This notice may 
be of specific interest to persons who are or may be interested in risk 
assessments of new chemical substances under TSCA (e.g., submitters of 
TSCA 5 notices, industry, non-governmental organizations (NGOs), and 
academia). Since other entities may also be interested, the Agency has 
not attempted to describe all the specific entities that may be 
affected by this action.

II. What action is the Agency taking?

    EPA is announcing the availability of a new decision framework for 
use by the New Chemicals Division (NCD) of the Office of Pollution 
Prevention and Toxics (OPPT) for identification of eye irritation or 
corrosion hazards for new chemical substances based on prioritization 
of reproducible, human-relevant data. The document supports EPA's 
efforts to develop NAMs that do not require vertebrate animal testing 
and furthers the agency's commitment to reduce and replace the use of 
vertebrate animals in the testing of chemical substances and mixtures.
    TSCA section 4(h)(2)(A) directs EPA to ``promote the development 
and implementation of alternative test methods and strategies to 
reduce, refine, or replace vertebrate animal testing and provide 
information of equivalent or better scientific quality and relevance 
for assessing risks of injury to health or the environment.''
    To incorporate alternative test methods and strategies, or NAMs, 
data for eye irritation and corrosion hazard identification into the 
new chemicals program risk assessment process, NCD developed a 
framework for new chemical risk assessments that prioritizes 
reproducible, human-relevant in vitro data. The Framework is based upon 
existing peer-reviewed literature, accepted Organization for Economic 
Cooperation and Development (OECD) test guidelines, and other existing 
accepted risk assessment approaches.
    NCD is responsible for conducting risk assessments for new chemical 
substances submitted under TSCA section 5 authority. NCD expects 
multiple benefits from the incorporation of this proposed Framework in 
its assessment including: (1) progress towards fulfilling TSCA section 
4(h)(2) statutory requirements; (2) transparency for stakeholders 
regarding EPA's process of hazard identification of eye irritation and 
corrosion for new chemical submissions; (3) clear scientific rationale 
for identification of eye irritation and corrosion hazards for human 
health assessors leading to improved consistency across final new 
chemical risk assessments; and (4) use of the most reproducible, human-
relevant scientific data for decision-making.

III. Does this Framework impose binding requirements?

    This document is not binding on the Agency or any outside parties, 
and the Agency may depart from it where circumstances warrant and 
without prior notice. While EPA has made every effort to ensure the 
accuracy of the discussion in the Framework, the obligations of EPA and 
the regulated community are determined by statutes, regulations, or 
other legally binding documents. In the event of a conflict between the 
discussion in the Framework document and any statute, regulation, or 
other legally binding document, the Framework document will not be 
controlling.

IV. Is this Framework subject to the Paperwork Reduction Act (PRA)?

    This action does not contain any new or revised information 
collections or burden subject to additional OMB approval under the PRA, 
44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). 
Information collection activities contained in the TSCA new chemicals 
program are already approved by OMB under the PRA and are assigned OMB 
Control No. 2070-0038 (EPA ICR No. 1188.14).
    Authority: 15 U.S.C. 2604 et seq.

    Dated: January 3, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-00169 Filed 1-8-24; 8:45 am]
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