Notice2024-00169
TSCA New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion; Notice of Availability
Primary source
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Published
January 9, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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 (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.
Full Text
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<title>Federal Register, Volume 89 Issue 6 (Tuesday, January 9, 2024)</title>
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[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1093-1094]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Additional instructions for visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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]
BILLING CODE P
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