Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers


On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

The updated analysis is based on a totally new analysis of scientific studies about formaldehyde, including research published after 2010. The current analysis differs from EPA’s previous findings in that it incorporates studies using new technologies that can measure smaller doses of formaldehyde. The health concerns discussed in the EPA’s updated analysis are largely the same as previously published, including increased risk of tumors in the head, neck, and sinuses; leukemia; decreased pulmonary function; asthma; and allergies. The report also addresses the possibility that inhaling formaldehyde can delay pregnancy and cause spontaneous abortion.

The focus of the EPA report is on environmental exposure and formaldehyde as a hazardous air pollutant. However, formaldehyde is also used to make thousands of products and other chemicals used for adhesives, paint, insulation, plywood, dishwashing liquids, permanent press fabrics, paper products, medicines, embalming fluid, makeup, and other goods. As such, manufacturers should be aware of the potentially immense impact of EPA’s analysis on tort litigation.

Manufacturers are not strangers to formaldehyde litigation. For example, in 2018, Virginia-based Lumber Liquidators agreed to pay $36 million to resolve class action lawsuits alleging that the company sold formaldehyde-laced laminate flooring imported from China to consumers. The level of formaldehyde in the imported laminate was alleged to have exceeded emission standards adopted by the federal government.

For now, the updated analysis is merely in draft form and has yet to undergo scientific review by the National Academies of Sciences, Engineering, and Medicine. The EPA is accepting public comments on the updated analysis through June 13, 2022.


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About the Author: Jenna R. Lawson

Jenna Lawson helps clients prevent and resolve product liability disputes. She defends companies in product liability litigation around the country, including federal multidistrict litigation (MDLs).

About the Author: Jim Frederick

With a sophisticated background leading litigation, Jim Frederick defends innovative life sciences companies in pharmaceutical and medical device product liability, mass tort and consumer fraud lawsuits. Jim also represents clients in commercial litigation and appellate matters. A former Assistant U.S. Attorney in the District of Maryland, Jim wields his background investigating and prosecuting civil and criminal fraud cases to inform his defense strategy for clients.

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