Notice2024-31571
Formaldehyde; Risk Evaluation Under the Toxic Substances Control Act (TSC); Notice of Availability
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Published
January 3, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use. The Agency used the best available science to prepare this final risk evaluation and has determined, based on the weight of scientific evidence, that formaldehyde presents an unreasonable risk of injury to human health. Under TSCA, EPA must initiate risk management actions to address the unreasonable risk.
Full Text
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<title>Federal Register, Volume 90 Issue 2 (Friday, January 3, 2025)</title>
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[Federal Register Volume 90, Number 2 (Friday, January 3, 2025)]
[Notices]
[Pages 316-318]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31571]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0438; FRL-11608-04-OCSPP]
Formaldehyde; Risk Evaluation Under the Toxic Substances Control
Act (TSC); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of the final risk evaluation under the
Toxic Substances Control Act (TSCA) for formaldehyde. The purpose of
risk evaluations under TSCA is to determine whether a chemical
substance presents an unreasonable risk of injury to health or the
environment, without consideration of costs or non-risk factors,
including unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by EPA,
under the conditions of use. The Agency used the best available science
to prepare this final risk evaluation and has determined, based on the
weight of scientific evidence, that formaldehyde presents an
unreasonable risk of injury to human health. Under TSCA, EPA must
initiate risk management actions to address the unreasonable risk.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0438, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jeffery Putt, Existing Chemical Risk
Management Division (7404M), Office of Pollution Prevention and Toxics,
[[Page 317]]
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-3703; email address:
<a href="/cdn-cgi/l/email-protection#4e28213c232f222a2b26372a2b1a1d0d0f0e2b3e2f60292138"><span class="__cf_email__" data-cfemail="781e170a1519141c1d10011c1d2c2b3b39381d0819561f170e">[email protected]</span></a>.
For general information: 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#a2f6f1e1e38feacdd6cecbccc7e2c7d2c38cc5cdd4"><span class="__cf_email__" data-cfemail="37636474761a7f58435b5e59527752475619505841">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. 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 (defined under
TSCA section 3(9) to include import), processing, distribution in
commerce, use, and disposal of formaldehyde, related industry trade
organizations, non-governmental organizations with an interest in human
and environmental health, state and local governments, Tribal Nations,
and/or those interested in the assessment of risks involving chemical
substances and mixtures regulated under TSCA. As such, the Agency has
not attempted to describe all the specific entities that this action
might apply to. If you need help determining applicability, consult the
technical contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
The Agency conducted this risk evaluation under TSCA section 6, 15
U.S.C. 2605, which requires that EPA conduct risk evaluations on
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. Each risk
evaluation must be conducted consistent with the best available
science, be based on the weight of the scientific evidence, and
consider reasonably available information, pursuant to 15 U.S.C.
2625(h), (i), and (k). See also the implementing procedural regulations
at 40 CFR part 702.
C. What action is the Agency taking?
EPA is announcing the availability of the final risk evaluation
under TSCA for formaldehyde. The purpose of risk evaluations under TSCA
is to determine whether a chemical substance presents an unreasonable
risk of injury to health or the environment, without consideration of
costs or non-risk factors, including unreasonable risk to potentially
exposed or susceptible subpopulations identified as relevant to the
risk evaluation by EPA, under the conditions of use. EPA has used the
best available science to prepare this final risk evaluation and based
on the weight of scientific evidence, determined that formaldehyde
poses unreasonable risk to human health. Upon a determination of
unreasonable risk, EPA must initiate risk management action as required
pursuant to 15 U.S.C 2605(a) to address the unreasonable risk.
For more information about the TSCA risk evaluation process for
existing chemicals, go to <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca</a>.
II. Background
A. What is formaldehyde?
Formaldehyde is a colorless, flammable gas at room temperature and
has a strong odor. Formaldehyde is found nearly everywhere. People and
animals produce and release formaldehyde. Formaldehyde is produced when
organic material including leaves, plants, and woodchips decay.
Formaldehyde is also produced and released into the air from combustion
activities like burning fuel (e.g., exhaust from cars, airplanes), gas/
wood burning (furnaces and stoves), and forest fires, burning candles,
and smoking. Finally, formaldehyde is released into the air from
industrial and commercial operations when produced or used to make many
products or articles including composite wood products and other
building materials, plastics, pesticides, paints, adhesives, and
sealants. Industry uses formaldehyde due to its ability to combine and
react with many other chemical substances and make resilient structures
that are widely used in manufacturing. Information from the 2016
Chemical Data Reporting (CDR) for formaldehyde indicates that the
reported production volume is between 1 billion and 5 billion pounds
per year (manufacture and import).
Short-term inhalation exposure to high levels of formaldehyde can
cause sensory irritation such as eye and respiratory irritation. Short-
term skin contact can cause sensitization. Exposure over longer periods
can also cause respiratory effects and cancer. The complex toxicology
and exposure profiles for formaldehyde presented unique challenges for
this evaluation. As required under TSCA section 6(b)(4)(A), EPA
evaluated the risks from formaldehyde under its conditions of use,
including the intended, known and reasonably foreseen circumstances
under which the chemical is manufactured, processed, distributed in
commerce, used or disposed of. EPA did not evaluate risk from sources
of formaldehyde exposure excluded from TSCA jurisdiction.
B. Risk Evaluation of Formaldehyde
In December 2019, EPA designated formaldehyde as a High Priority
Substance for risk evaluation under TSCA (Ref 1.). A draft scope of the
formaldehyde risk evaluation was published in April 2020 (Ref 2.) and
after receiving public comment, EPA issued the final scope of the
formaldehyde risk evaluation in September 2020 (Ref 3.). In March 2024,
EPA released a draft risk evaluation for public comment and scientific
peer review (Ref 4.).
EPA leveraged work products and resources across the agency in its
development of the draft risk evaluation under TSCA, including
consideration of hazard information from EPA's Integrated Risk
Information System (IRIS) Toxicological Review of Formaldehyde-
Inhalation. A draft version of the IRIS document was published in April
2022 and finalized in August 2024. The draft IRIS document was the
subject of external peer review by the National Academies of Sciences,
Engineering, and Medicine (NASEM).
In addition, EPA leveraged multiple federal advisory committees and
their reports to support the external peer review of formaldehyde
during the TSCA risk evaluation process, including NASEM, the Human
Studies Review Board (HSRB) and the TSCA Science Advisory Committee on
Chemicals (SACC).
The final formaldehyde risk evaluation comprises a series of
technical support documents. Each document contains sub-assessments
that inform adjacent, ``downstream'' documents. These documents address
comments from both the public and peer reviewers. The components of the
risk evaluation, including (but not limited to) each technical support
document and responses to peer review and public comments, are
available in the docket.
III. Unreasonable Risk Determination
EPA has determined that formaldehyde presents an unreasonable risk
of injury to human health under the conditions of use. The unreasonable
risk to human health presented by formaldehyde is due to non-cancer
effects in workers and consumers from acute dermal and inhalation
exposures, and due to cancer effects in workers from long-term
inhalation exposure.
EPA did not identify risk of injury to the environment that would
contribute
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to the unreasonable risk determination for formaldehyde.
Consistent with the statutory requirements of TSCA section 6(a),
EPA will propose risk management regulatory actions to the extent
necessary so that formaldehyde no longer presents an unreasonable risk
under the conditions of use. The Agency expects to focus its risk
management action on the TSCA conditions of use that significantly
contribute to the unreasonable risk. However, it should be noted that,
under TSCA section 6(a), EPA is not limited to regulating the specific
activities found to contribute significantly to unreasonable risk and
may select from among a suite of risk management approaches based on
requirements in TSCA section 6(a) related to manufacture (including
import), processing, distribution in commerce, commercial use, and
disposal as part of its regulatory options to address the unreasonable
risk. As a general example, EPA may regulate upstream activities (e.g.,
processing, distribution in commerce) to address downstream activities
(e.g., consumer uses) contributing significantly to unreasonable risk,
even if the upstream activities do not contribute significantly to the
unreasonable risk.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register.
84 FR 71924, December 30, 2019 (FRL-10003-15).
2. EPA. Draft Scopes of the Risk Evaluations to be Conducted for
Seven Chemical Substances under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 22733, April 23,
2020 (FRL-10008-05).
3. EPA. Final Scopes of the Risk Evaluations To Be Conducted for
Twenty Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. 85 FR 55281, September 4,
2020 (FRL-10013-90).
4. EPA. Formaldehyde; Draft Risk Evaluation Peer Review by the
Science Advisory Committee on Chemicals (SACC); Notice of
Availability, Public Meetings and Request for Comment. Federal
Register. 89 FR 18933, March 15, 2024 (FRL-11608-03-OCSPP).
5. EPA. Formaldehyde; Draft Risk Evaluation Peer Review by the
Science Advisory Committee on Chemicals (SACC); Request for
Nominations of ad hoc Expert Reviewers. Federal Register. 88 FR
88910, December 26, 2023 (FRL-11608-01-OCSPP).
Authority: 15 U.S.C. 2601 et seq.
Dated: December 30, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-31571 Filed 1-2-25; 8:45 am]
BILLING CODE 6560-50-P
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