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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 [www.gpo.gov]
[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 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
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