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EPA’s draft risk evaluation for formaldehyde preliminarily finds that formaldehyde poses an unreasonable risk to human health.

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The draft risk evaluation preliminarily concludes formaldehyde does not pose a risk to the environment.&nbsp;

EPA is on track to initiate risk management actions that could potentially augment formaldehyde regulations under the Toxic Substances Control Act in the next few years.&nbsp;

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On March 15, 2024, the United States Environmental Protection Agency (EPA) released the draft risk evaluation for formaldehyde for public comment and peer review.<a href="#_ftn1" id="_ftnref1">[1]</a> The draft risk evaluation was promulgated pursuant to EPA’s authority under the Toxic Substances Control Act (TSCA) and makes a preliminary finding that formaldehyde poses an unreasonable risk to human health. But EPA acknowledged two significant caveats to this preliminary finding: (1) that the risk findings “may not apply to everyone, everywhere”; and (2) that the new risk estimates may not be reflective of real-life exposure scenarios in the workplace, outdoor air, or indoors and in homes.<a href="#_ftn2" id="_ftnref2">[2]</a>

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Pending input from stakeholders, EPA may initiate risk management actions that could change formaldehyde regulation under TSCA within the next few years.&nbsp;

Formaldehyde is a colorless, flammable gas that is naturally occurring and essential for human metabolism.<a href="#_ftn3" id="_ftnref3">[3]</a> It also has pervasive commercial application; formaldehyde is an essential component in several commercial products, including resins used in the manufacture of composite wood products, building materials and insulation, semiconductors, automobiles, fertilizers and pesticides, a plethora of household products, and certain preservatives.<a href="#_ftn4" id="_ftnref4">[4]</a>

Given its ubiquitous presence in the environment, there are numerous sources of potential exposure to formaldehyde. For example, formaldehyde occurs naturally in a variety of meats, fruits and vegetables and is a byproduct of forest fires and the normal metabolic processes in humans.<a href="#_ftn5" id="_ftnref5">[5]</a> According to the Centers for Disease Control and Prevention, exposure to formaldehyde at high concentrations can irritate the skin, throat, lungs and eyes.<a href="#_ftn6" id="_ftnref6">[6]</a>

EPA classifies formaldehyde as a “probable human carcinogen” and a “high priority chemical.”<a href="#_ftn7" id="_ftnref7">[7]</a> As such, formaldehyde is subject to extensive federal regulation. Under the TSCA, EPA is authorized to require reporting, recordkeeping and testing, as well as implement restrictions relating to products that contain formaldehyde.<a href="#_ftn8" id="_ftnref8">[8]</a> The TSCA also permits EPA to regulate significant new uses of formaldehyde and formaldehyde emissions from composite wood products.<a href="#_ftn9" id="_ftnref9">[9]</a> The Resource Conservation and Recovery Act permits EPA to control commercial chemical products and other wastes containing formaldehyde from the “cradle to the grave,” including generation, transportation, storage and disposal.<a href="#_ftn10" id="_ftnref10">[10]</a> Formaldehyde is also subject to regulation under the Clean Water Act and the Clean Air Act.<a href="#_ftn11" id="_ftnref11">[11]</a>&nbsp; &nbsp;

Some states have adopted regulations concerning formaldehyde. For example, in 2007 the California Air Resources Board approved a regulation reducing formaldehyde emissions from composite wood products.<a href="#_ftn12" id="_ftnref12">[12]</a>

Risk Evaluation Findings

Under TSCA, EPA is required to evaluate the risks formaldehyde poses to the environment and to people.

In the recent risk analysis, EPA preliminarily concluded that formaldehyde does not pose a risk to the environment.<a href="#_ftn13" id="_ftnref13">[13]</a> This appears to be due in large part to the fact that formaldehyde does not bioaccumulate in environmental media— that is, its physical and chemical properties do not allow it to persist in water, sediment or soil.<a href="#_ftn14" id="_ftnref14">[14]</a> Thus, the recent draft risk evaluation focuses exclusively on the effect of formaldehyde on people.

EPA preliminarily found that formaldehyde presents an unreasonable risk of injury to human health.<a href="https://www.bakerlaw.com/insights/47740/#_ftn15" target="_blank" rel="noreferrer noopener">[15]</a>&nbsp;“EPA’s TSCA existing chemical risk evaluations must determine whether a chemical substance does or does not present unreasonable risk under its&nbsp;conditions of use.”<a href="https://www.bakerlaw.com/insights/47740/#_ftn16" target="_blank" rel="noreferrer noopener">[16]</a>&nbsp;EPA evaluated 62 different conditions of use for formaldehyde using many different exposure scenarios at different exposure levels. EPA reached different preliminary conclusions under these various conditions of use for worker and indoor air exposure scenarios.

However, the bigger takeaway is the uncertainty accompanying the finding.&nbsp;EPA acknowledges the complex toxicology and exposure profiles for formaldehyde and “that the evaluation of formaldehyde hazard and exposure is challenging.”<a href="https://www.bakerlaw.com/insights/47740/#_ftn17" target="_blank" rel="noreferrer noopener">[17]</a>&nbsp;For example, EPA acknowledges the “unique challenge associated with this evaluation” of distinguishing between human exposure to naturally occurring formaldehyde and to formaldehyde involved in commercial activities and products.<a href="https://www.bakerlaw.com/insights/47740/#_ftn18" target="_blank" rel="noreferrer noopener">[18]</a>&nbsp;Similarly, this draft risk evaluation required EPA to isolate exposure to sources not regulated under TSCA (e.g., pesticides).<a href="https://www.bakerlaw.com/insights/47740/#_ftn19" target="_blank" rel="noreferrer noopener">[19]</a>

EPA is accepting public comments on the draft risk evaluation until May 14, 2024. The draft risk evaluation will also be submitted to the Science Advisory Committee on Chemicals for peer review, with a virtual peer review public meeting scheduled for May 20-23, 2024.

If at the end of the risk evaluation process EPA determines that formaldehyde presents an unreasonable risk to human health or the environment, it must immediately start the risk management process to reduce or eliminate these risks. The risk management process requires EPA to issue a proposed risk management rule no later than one year after the date the final risk evaluation is published, and a final risk management rule one year thereafter.<a href="#_ftn20" id="_ftnref20">[20]</a> The final risk management rule may include one or a combination of several actions, including prohibiting or limiting the manufacture or distribution of formaldehyde, requiring adequate minimum warnings and instructions, and regulating how formaldehyde is used or disposed of.<a href="#_ftn21" id="_ftnref21">[21]</a>

Notwithstanding the uncertainties highlighted in the draft risk evaluation, EPA has indicated it considers formaldehyde a high-priority chemical. As of the time of this writing, formaldehyde is undergoing a hazard assessment in EPA’s Integrated Risk Information System program and a risk assessment under the Federal Insecticide, Fungicide, and Rodenticide Act.<a href="#_ftn22" id="_ftnref22">[22]</a> Companies involved in the production, distribution and use of formaldehyde may expect increasing regulatory pressures in the near future.

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<a href="#_ftnref1" id="_ftn1">[1]</a> Risk Evaluation for Formaldehyde, United States Environmental Protection Agency, https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-formaldehyde&nbsp;(last updated March 15, 2024).

<a href="#_ftnref2" id="_ftn2">[2]</a> See Executive Summary of the Draft Risk Evaluation for Formaldehyde, United States Environmental Protection Agency 2 (March 2024), chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.epa.gov/system/files/documents/2024-03/formaldehyde-draft-re-executive-summary-public-release-hero-march2024.pdf (“Executive Summary”) (“[T]hese risks result from specific activities using, and products containing, formaldehyde and therefore may not apply to everyone, everywhere. Also, the draft risk evaluation points out uncertainties in these findings that could cast doubt on whether all risk estimates presented in this draft evaluation— even though the values are based on the best available scientific information—are reflective of real-life exposure to formaldehyde in the workplace, outdoor ambient air, and inside homes and other indoor situations.”).

<a href="#_ftnref3" id="_ftn3">[3]</a> Formaldehyde Occurs Naturally and Is All Around Us, American Chemistry Council, https://www.americanchemistry.com/chemistry-in-america/chemistries/formaldehyde (last visited March 21, 2024).

<a href="#_ftnref4" id="_ftn4">[4]</a> Facts About Formaldehyde, United States Environmental Protection Agency, https://www.epa.gov/formaldehyde/facts-about-formaldehyde (last updated March 6, 2024).

<a href="#_ftnref5" id="_ftn5">[5]</a> Formaldehyde Occurs Naturally and Is All Around Us, American Chemistry Council, https://www.americanchemistry.com/chemistry-in-america/chemistries/formaldehyde (last visited March 21, 2024).

<a href="#_ftnref6" id="_ftn6">[6]</a> Formaldehyde, Centers for Disease Control and Prevention, https://www.cdc.gov/niosh/topics/formaldehyde/default.html (last updated June 21, 2019).

<a href="#_ftnref7" id="_ftn7">[7]</a> Formaldehyde, IRIS Assessment, United States Environmental Protection Agency, https://iris.epa.gov/ChemicalLanding/&amp;substance_nmbr=419#status (last visited March 21, 2024); Draft Human Health Risk Assessment for Formaldehyde, United States Environmental Protection Agency (March 2024), chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.epa.gov/system/files/documents/2024-03/formaldehyde-draft-re-human-health-risk-assessment-public-release-hero-march-2024.pdf (“Draft Human Health Risk Assessment”).

<a href="#_ftnref8" id="_ftn8">[8]</a> Laws and Regulations Concerning Formaldehyde, United States Environmental Protection Agency, https://www.epa.gov/formaldehyde/laws-and-regulations-concerning-formaldehyde (last updated May 22, 2023).

<a href="#_ftnref9" id="_ftn9">[9]</a> Id.

<a href="#_ftnref10" id="_ftn10">[10]</a> Id.

<a href="#_ftnref11" id="_ftn11">[11]</a> Id.

<a href="#_ftnref12" id="_ftn12">[12]</a> Composite Wood Products Airborne Toxic Control Measure, California Air Resources Board, https://ww2.arb.ca.gov/our-work/programs/composite-wood-products-program (last visited March 21, 2024).

<a href="#_ftnref13" id="_ftn13">[13]</a> See Executive Summary at 3.&nbsp;

<a href="#_ftnref14" id="_ftn14">[14]</a> Id.; see also Health and Environment, Toxic Use Reduction Institute, https://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Formaldehyde_Fact_Sheet/Formaldehyde_Facts/Health_and_Environment (last updated Jan. 14, 2022).

<a href="#_ftnref15" id="_ftn15">[15]</a> See Executive Summary at 2.

<a href="#_ftnref16" id="_ftn16">[16]</a> Id. at 2 (emphasis in original).&nbsp;

<a href="#_ftnref17" id="_ftn17">[17]</a> See id. at 6–7.

<a href="#_ftnref18" id="_ftn18">[18]</a> See id. at 2, 3.&nbsp;

<a href="#_ftnref19" id="_ftn19">[19]</a> See id.

<a href="#_ftnref20" id="_ftn20">[20]</a> Risk Management for Existing Chemicals Under TSCA, United States Environmental Protection Agency, https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca#:~:text=If%20at%20the%20end%20of,to%20the%20risk%20management%20process (last updated Jan. 29, 2024).

<a href="#_ftnref21" id="_ftn21">[21]</a> Id.

<a href="#_ftnref22" id="_ftn22">[22]</a> See Draft Human Health Risk Assessment at 16.

EPA Takes Next Step Toward New Formaldehyde Regulations

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