Formaldehyde and EPA – time for a change

The 30-year story of the U.S. Environmental Protection Agency (EPA) attempting to regulate formaldehyde reads like a tragic relationship that may finally be changing. Formaldehyde is a chemical commonly found in building materials, insulation, furniture, and clothing, and shown to have negative health effects related to asthma and fertility.

EPA’s doomed attempts to regulate formaldehyde formally began in 1990, when EPA’s Integrated Risk Information System (IRIS) program released its first assessment of formaldehyde health risks. The assessment identified the potential harmful health effects of formaldehyde related to weight gain and gastrointestinal tract issues and classified it as a probable human carcinogen. In 1998, EPA initiated a reassessment of formaldehyde—but alas, this assessment never came to be. The EPA released a draft report in 2010 which was heavily criticized by the National Academy of Sciences (NAS) and ultimately led to the suspension of the assessment in 2018.

But there was still a chance. After all, EPA had the authority to regulate formaldehyde under the Clean Air Act and so it could at least regulate the harmful chemical and to some extent, protect the public. Unfortunately, a powerful conglomeration of furniture manufactures intervened. Industry doesn’t have the power to stop regulatory efforts, but they know how to sabotage regulations from within. They manipulated the cost-benefit evaluation for the regulation to falsely show that the costs of implementing the regulation would outweigh the health and economic benefits. After considerable industry pressure, the White House Office of Management and Budget (OMB) “redlined” EPA’s estimated monetary benefits related to preventing asthma and infertility, causing the benefits to drop from $278 million to $48 million per year (Figure 1).

Figure 1: The White House Office of Management and Budget’s version of EPA’s cost-benefit evaluation for its formaldehyde regulation showing how they “redlined” out asthma and female reproductive toxicity

Although the rationale for this “redlining bloodbath” was never explicitly stated, it was likely related to questions surrounding the association between formaldehyde exposure and asthma outcomes. This is a page from industry’s well-worn playbook for striking down regulations that impact their bottom line—they cast doubt on the scientific underpinnings supporting associations between chemical exposures and human health outcomes. Luckily, environmental health researchers have been catching on to industry and creating their own playbook which highlights front and center the effectiveness of systematic review methods to quash questions about the validity of review conclusions and health risks.

Why conduct a systematic review of the evidence for formaldehyde? A systematic review follows pre-specified, consistently applied, and transparent rules to reduce bias and document how scientific data is integrated to address a specific review question. Furthermore, a comprehensive evaluation of the most up-to-date scientific information could inform a more reliable evaluation of the monetized benefits of reducing asthma in the U.S.

In our review, we screened almost 5,000 unique references and identified 90 studies published up to April 2020 that evaluated human exposures to formaldehyde with outcomes related to asthma. Following our protocol, we evaluated studies for internal validity (i.e., risk of bias) and compared to pre-defined criteria to evaluate the quality and strength of the evidence, taking into consideration factors such as consistency, precision, publication bias, and whether there was evidence of a dose-response relationship.

Review authors concluded there was “sufficient evidence of toxicity” for associations between exposure to formaldehyde and asthma diagnosis and symptoms for both children and adults. A meta-analysis of the data revealed that every 10 ug/m3 increase in formaldehyde exposure increased the odds of childhood asthma diagnosis by 20% (OR=1.20, 95% CI [1.02, 1.41] and the odds of exacerbating existing childhood asthma by 8% (OR=1.08, 96% CI [0.92, 1.28]).

Furthermore, our economic evaluation revealed that EPA’s proposed rule on pressed wood would have resulted in 2,805 fewer asthma cases, leading to a total economic benefit of $210 million dollars each year. So, the OMB’s monetized benefits value of $48 million would actually increase to $258 million dollars! That’s a whole lot of economic benefit—but even more importantly, a whole lot of asthma cases avoided.

So, what does the future hold for EPA and formaldehyde? In 2021 the new political administration gave us hope—EPA has initiated steps to resume efforts to complete its long-abandoned formaldehyde reassessment. Although it may be too early to toast, the future looks bright and promising. After all, it has been a longtime coming.

For more information on EPA’s systematic review methods:

Dr. Lam’s co-authors for the formaldehyde and asthma paper include Patrice Sutton, Natalyn Daniels, and Drs. Michael Cabana, Mark Dickie, Charles Griffiths, Erica Koustas, Amy Padula, Hanna Vesterinen, Evans Whitaker, and Tracey Woodruff.

About the author

Dr. Juleen Lam is an Assistant Professor in the Department of Health Sciences at California State University, East Bay. She has a joint research affiliation with the University of California, San Francisco. Dr. Lam’s research interests include environmental epidemiology, evaluation of population exposures to environmental contaminants, assessment and communication of environmental risks, and reproductive/developmental health. She has been involved in developing systematic review methods for environmental health data for over a decade and has been a pivotal part in implementing, publishing, and disseminating these approaches in both academic and government settings. She currently serves as a member of the US EPA’s Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability Subcommittee.