Formaldehyde; Risk Evaluation Under the Toxic Substances Control Act (TSC); Notice of Availability, 316-318 [2024-31571]
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316
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
TABLE 2—REGISTRANT REQUESTING VOLUNTARY TERMINATION OF USE
EPA Company No.
Company name and address
93182 ..............................................
Gharda Chemicals International, Inc., 4032 Crockers Lake Blvd., Suite 818, Sarasota, FL 34238.
III. Public Comments
A. Summary of Comments Received
EPA received two comments in
response to the notice that published in
the Federal Register of September 16,
2024 (89 FR 75546) (FRL–12246–01–
OCSPP). The comments are in the
docket for this action and are briefly
summarized here.
Neither of the comments specifies the
product listed in Table 1 of Unit II. One
comment was submitted by a private
citizen supporting the cancellation of
the pesticide. The other comment stated
that the proposed provisions for using
existing stocks for food uses until June
30, 2025, would subject workers,
bystanders, and consumers to health
risks, and were not consistent with
FIFRA.
lotter on DSK11XQN23PROD with NOTICES1
B. EPA Response to Comments
This cancellation action is responsive
to the registrant’s request to cancel a
specific use. In response to both
commenters, under FIFRA section 6(f),
registrants may, at any time, seek to
cancel their products or seek to amend
their registrations to terminate specific
uses. Under that provision of the statute,
EPA provides an opportunity for public
comment and then acts on the request.
Cancellation of other products or uses
that are not requested by the registrant
occurs under other provisions of FIFRA,
which is beyond the scope of this action
and EPA’s authority in FIFRA section
6(f).
EPA has determined that the existing
stocks provisions are not inconsistent
with the purposes of FIFRA given the
limited number of existing stocks and
the limited time allowed for the use of
existing stocks outlined in Unit VI. EPA
has determined that neither comment
merited denial of the registrant’s request
for use termination.
IV. The Cancellation Order
Pursuant to FIFRA section 6(f) (7
U.S.C. 136d(f)(1)), EPA hereby approves
the requested amendment to terminate
asparagus for Pilot 15G Chlorpyrifos
Agricultural Insecticide. Accordingly,
the Agency hereby orders that the use
on asparagus is terminated for Pilot 15G
Chlorpyrifos Agricultural Insecticide.
This Order terminating the asparagus
use is effective January 3, 2025. Any
distribution, sale, or use of existing
stocks of Pilot 15G Chlorpyrifos
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18:01 Jan 02, 2025
Jkt 265001
Agricultural Insecticide in a manner
inconsistent with any of the provisions
for disposition of existing stocks set
forth in Unit VI will be a violation of
FIFRA.
V. What is the Agency’s authority for
taking these actions?
Section 6(f)(1) of FIFRA (7 U.S.C.
136d(f)(1)) provides that a registrant of
a pesticide product may at any time
request that any of its pesticide
registrations be cancelled or amended to
terminate one or more registered uses.
FIFRA further provides that, before
acting on the request, EPA must publish
a notice of receipt of any such request
in the Federal Register and provide a
public comment period. EPA has
provided the requisite notice and public
comment period. Two comments were
submitted to which EPA has responded
above.
VI. Provisions for Disposition of
Existing Stocks
Existing stocks for the product
identified in this document are those
stocks of registered pesticide product
that are currently in the United States
and that were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
EPA has determined that the following
existing stocks provisions are not
inconsistent with the purposes of FIFRA
given the limited number of existing
stocks and the limited time allowed for
use of the existing stocks outlined
below:
• Sale and distribution of existing
stocks of Pilot 15G Chlorpyrifos
Agricultural Insecticide (EPA Reg. No.
93182–8) is permitted until April 30,
2025;
• Use of existing stocks of Pilot 15G
Chlorpyrifos Agricultural Insecticide
(EPA Reg. No. 93182–8) on food or feed
must be consistent with the product
labeling. Such use is permitted until
June 30, 2025;
• Use of existing stocks of Pilot 15G
Chlorpyrifos Agricultural Insecticide
(EPA Reg. No. 93182–8) for non-food
purposes is permitted until existing
stocks are exhausted, as long as such
use is in accordance with the labeling.
After these dates, all respective sale,
distribution, and use of existing stocks
is prohibited, except for sale and
distribution for export consistent with
FIFRA section 17 (7 U.S.C. 136o) and for
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proper disposal in accordance with state
regulations.
Authority: 7 U.S.C. et seq.
Dated: December 17, 2024.
Jean Overstreet,
Director, Pesticide Re-Evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2024–31586 Filed 1–2–25; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 https://
www.regulations.gov. Additional
information about dockets generally,
along with instructions for visiting the
docket in-person, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information: Jeffery
Putt, Existing Chemical Risk
Management Division (7404M), Office of
Pollution Prevention and Toxics,
SUMMARY:
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03JAN1
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–3703; email address:
formaldehydeTSCA@epa.gov.
For general information: The TSCAHotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
telephone number: (202) 554–1404;
email address: TSCA-Hotline@epa.gov.
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:01 Jan 02, 2025
Jkt 265001
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 https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca.
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
PO 00000
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Sfmt 4703
317
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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03JAN1
318
Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:01 Jan 02, 2025
Jkt 265001
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).
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
Authority: 15 U.S.C. 2601 et seq.
the offices of the Board of Governors.
Dated: December 30, 2024.
This information may also be obtained
Michal Freedhoff,
on an expedited basis, upon request, by
Assistant Administrator, Office of Chemical
contacting the appropriate Federal
Safety and Pollution Prevention.
Reserve Bank and from the Board’s
[FR Doc. 2024–31571 Filed 1–2–25; 8:45 am]
Freedom of Information Office at
BILLING CODE 6560–50–P
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in paragraph 7 of
FARM CREDIT ADMINISTRATION
the Act.
Sunshine Act Meetings
Comments received are subject to
public disclosure. In general, comments
TIME AND DATE: 10 a.m., Wednesday,
received will be made available without
January 8, 2025.
change and will not be modified to
PLACE: You may observe this meeting in
remove personal or business
person at 1501 Farm Credit Drive,
information including confidential,
McLean, Virginia 22102–5090, or
contact, or other identifying
virtually. If you would like to observe,
information. Comments should not
at least 24 hours in advance, visit
include any information such as
FCA.gov, select ‘‘Newsroom,’’ then
confidential information that would not
select ‘‘Events.’’ From there, access the
be appropriate for public disclosure.
linked ‘‘Instructions for board meeting
Comments regarding each of these
visitors’’ and complete the described
applications must be received at the
registration process.
Reserve Bank indicated or the offices of
STATUS: This meeting will be open to the the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
public.
Street and Constitution Avenue, NW,
MATTERS TO BE CONSIDERED: The
Washington DC 20551–0001, not later
following matters will be considered:
than January 21, 2025.
• Approval of Minutes for December 12,
A. Federal Reserve Bank of Dallas
2024
(Karen Smith, Assistant Vice President,
• Update on Farm Credit System
Mergers & Acquisitions and
Funding Conditions
Enforcement) 2200 North Pearl Street,
CONTACT PERSON FOR MORE INFORMATION: Dallas, Texas 75201–2272. Comments
If you need more information or
can also be sent electronically to
assistance for accessibility reasons, or
Comments.applications@dal.frb.org:
have questions, contact Ashley
1. Stephen J. Lee, as trustee of the
Waldron, Secretary to the Board.
Bastrop Bancshares, Inc. Employee
Telephone: 703–883–4009. TTY: 703–
Stock Ownership Plan (With 401(k)
883–4056.
Provisions) (Amended Effective
November 12, 2024), both of Bastrop,
Ashley Waldron,
Texas; to retain control of voting shares
Secretary to the Board.
of Bastrop Bancshares, Inc., Bastrop,
[FR Doc. 2024–31629 Filed 12–31–24; 11:15 am]
Texas, parent of Bastrop Holdings, Inc.,
BILLING CODE 6705–01–P
Wilmington, Delaware, and thereby
indirectly retain control of voting shares
of The First National Bank of Bastrop,
FEDERAL RESERVE SYSTEM
Bastrop, Texas.
B. Federal Reserve Bank of San
Change in Bank Control Notices;
Francisco
(Joseph Cuenco, Assistant
Acquisitions of Shares of a Bank or
Vice President, Formations &
Bank Holding Company
Transactions) 101 Market Street, San
Francisco, California 94105–1579.
The notificants listed below have
Comments can also be sent
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and electronically to
§ 225.41 of the Board’s Regulation Y (12 sf.fisc.comments.applications@
sf.frb.org:
CFR 225.41) to acquire shares of a bank
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]]>Agencies
[Federal Register Volume 90, Number 2 (Friday, January 3, 2025)]
[Notices]
[Pages 316-318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31571]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
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:
[email protected].
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: [email protected].
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
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
[[Page 318]]
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
