United States: Formaldehyde – What It Is And Why Manufacturers Should Be Paying Attention

Companies using formaldehyde in their operations should be aware of recent developments with the potential to substantially impact litigation concerning this substance. With regulations significantly reducing permissible levels of exposure on the horizon, many current uses of formaldehyde are likely to come under increased scrutiny from both regulators and plaintiffs' lawyers.

Formaldehyde is an organic compound and pungent colorless gas made of carbon, hydrogen, and oxygen. The substance is used in a variety of industries, including the manufacturing of plywood, house shingles and other roofing products, laminated beams, carpets, and fabrics. Formaldehyde is also used in adhesive and sealants, pesticides, paper manufacturing, various petrochemical processes and products, leather, apparel items, and personal care products.¹ Regulatory scrutiny of formaldehyde dates back more than 30 years, with the chemical first being categorized by the US Environmental Protection Agency (EPA) as a "probable" human carcinogen in 1989.² The EPA subsequently completed a draft toxicological assessment under its Integrated Risk Information System (IRIS) in 2010 concluding that formaldehyde was in fact carcinogenic to humans, but that assessment faced significant methodological criticisms from the esteemed National Academy of Sciences (NAS). The US Department of Health and Human Services also concluded in 2011 that formaldehyde was a known human carcinogen.³

More recently, in April 2022, the EPA released a new draft IRIS assessment that had been revised to account for comments from the NAS and recent scientific developments.⁴ That assessment concludes formaldehyde inhalation causes nasopharyngeal cancer and myeloid leukemia in humans.⁵ The assessment also concludes that nasopharyngeal cancer risk increases above background level exposures at a lifetime exposure of 1 microgram per cubic meter (or 0.001 parts per million (ppm)) of formaldehyde,⁶ which is orders of magnitude lower than the current Occupational Safety and Health Administration permissible exposure limit of 0.75 ppm calculated over an eight-hour time-weighted average.⁷ It also is well below the formaldehyde indoor air range of 0.02–4 ppm from the ATSDR.⁸

NAS has taken a markedly different view of the EPA's more recent findings. In August of 2023, the NAS released its Review of EPA's 2022 Draft Formaldehyde Assessment (EPA 2022 Draft Assessment) and found the "overall organization of the information on cancer effects of formaldehyde is appropriate and commensurate with prior recommendations from the NRC [National Research Council, principal operating agency for NAS]."⁹ NAS also found the "focus on respiratory tract cancers and cancer of the lymphohematopoietic system, but not other cancer types, is appropriate and justified."¹⁰ The NAS conclusions regarding causation of lymphohematopoietic cancers, which includes various types of leukemia, marked a departure from its assessment of the EPA's 2010 draft assessment in which NAS concluded there was a lack of support for such conclusions.¹¹ The NAS notably also found that the assessment "adequately and transparently evaluates the scientific evidence" in its dose-response analysis.¹²

Both the cancer causation conclusions and the dose response analysis in the EPA 2022 Draft Assessment are significant. At .001 ppm, the EPA's dose-response analysis would render many residences and offices containing products that release formaldehyde unsafe, with air levels in such locations capable of exceeding 0.03 ppm.¹³ This includes emissions from certain wood floor finishes, pressed wood and wood-based products, and certain wallpaper and wood-based products.¹⁴ Even before the current assessment, the EPA found that formaldehyde emissions were among the most significant toxic air pollutants contributing to cancer risk in the United States.¹⁵ Accordingly, with the implementation of more stringent regulations, all industrial and commercial emitters of formaldehyde are likely to come under increased scrutiny.

Public comment is now closed on the EPA 2022 Draft Assessment, making publication of a final assessment by the EPA imminent, which, in turn, can form the basis for significant regulatory changes concerning formaldehyde.¹⁶ As we have seen in similar contexts involving other allegedly carcinogenic substances, when exposure levels associated with potential risk are significantly lowered by regulatory agencies, efforts to further regulate or outright ban the at-issue chemicals often soon follow.¹⁷ This situation then presents fertile ground for litigation and lawsuits concerning cancer diagnoses, medical monitoring, and failure to warn. Already, plaintiff lawyers have had success litigating in this area, with a prominent example being a recent US$1 million verdict in Alameda County Superior Court, California, against a clothing company brought by flight attendants claiming they developed rashes, headaches, and breathing problems due to trace contamination of formaldehyde in their uniforms.¹⁸

Any company that uses formaldehyde in its operations or that manufactures products containing formaldehyde should be mindful of these developments and the potential for regulations and litigation impacting their business.

Footnotes

1 U.S. Env't Prot. Agency, Risk Evaluation of Formaldehyde (last updated Dec. 6, 2023).

2 U.S. Env't Prot. Agency, Off. of Air & Radiation, Report to Congress on Indoor Air Quality, Volume II: Assessment and Control of Indoor Air Pollution (1989).

3 Agency for Toxic Substances & Disease Registry (ATSDR), Formaldehyde – ToxFAQs (CAS # 50-00-0), https://www.atsdr.cdc.gov/toxfaqs/tfacts111.pdf.

4 See NAS Review of EPA's 2010 Draft Formaldehyde Assessment, 4.

5 EPA 2022 Draft Assessment, 129–30.

6 NAS Review of EPA's 2022 Draft Formaldehyde Assessment, 103–04.

7 See 29 C.F.R. § 1910.1048(c).

8 ATSDR, supra note 3.

9 NAS Review, supra note 6, at 87.

10 Id.

11 NAS Review, supra note 4, at 108–10.

12 Id. at 104.

13 U.S. Consumer Prod. Safety Comm'n, An Update on Formaldehyde, Publ'n 725 (2016 Revision), 2.

14 Id. at 3.

15 U.S. Env't Prot. Agency, Our Nation's Air: Status and Trends Through 2010 (Feb. 2012), 19.

16 There is currently litigation pending seeking to enjoin the EPA from relying on the conclusions of the NAS Review of the EPA 2022 Draft Assessment in formulating new regulations (Am. Chemistry Council, Inc. v. Nat'l Acad. of Scis., 23-cv-2113 (D.D.C.)).

17 See, e.g., David A. Fusco et al., Ethylene Oxide: The Litigation Risks and Regulatory Issues Ahead, K&L GATES HUB (July 26, 2021), https://www.klgates.com/Ethylene-Oxide-The-Litigation-Risks-and-Regulatory-Issues-Ahead-7-26-2021; David A. Fusco et al., PFAS Litigation: Who's Next?, K&L GATES HUB (Apr. 13, 2023), https://www.klgates.com/PFAS-Litigation-Whos-Next-4-13-2023.

18 David Koenig, Jury sides with American Airlines flight attendance who said uniforms made them sick, USA TODAY (Nov. 3, 2023), https://www.usatoday.com/story/travel/airline-news/2023/11/03/american-airlines-uniform-chemical-lawsuit/71439513007/.

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