In a memo sent to senior EPA staff yesterday, the Office of Research and Development (currently led by Jennifer Orme-Zavaleta) announced that its Integrated Risk Information System (IRIS) program will resume the risk assessment for the hazardous air pollutant formaldehyde. It will still need to move forward with a check of the latest literature, peer review, interagency review, and public comment, which will take some time, but it is essential that EPA gets the science right so that it can finally take action to end dangerous exposures to this carcinogen.
Formaldehyde is a colorless, flammable chemical widely used in building materials, medicinal and personal care products, and furnishings. Fumes from these products can be harmful to human health, especially when they accumulate indoors at high concentrations. According to EPA’s 2018 National Air Toxics Assessment (NATA) data, formaldehyde is one of the three air pollutants responsible for over 90 percent of the cancer risk related to air pollution in over a hundred census tracts that have pollution above the 100 per million threshold. Acute exposure can lead to nausea, headaches, and eye, nose, throat and skin irritation, even asthma exacerbation. Chronic exposure has been linked to cancers in humans, including cancers of the nose and throat, lymphomas, and leukemia. In 2004, the International Agency for Research on Cancer concluded that formaldehyde is a human carcinogen, and the U.S. Department of Health and Human Services listed it is as a known human carcinogen in 2011. Despite the large body of scientific evidence on its cancer risk, EPA still only lists formaldehyde as a “probable human carcinogen” (Group B1).
As a result of industry and political interference spanning decades, EPA has been unable to update its own scientific assessment, stalling progress and the potential to better protect the public from this harmful chemical. If it weren’t for political interference, at this point in 2021, the formaldehyde assessment that has been supposedly complete since 2017 should have already been through peer review and available to the public. The resulting risk estimate that is likely to acknowledge the cancer risk of inhalation of formaldehyde could have already been influencing regulators’ decisions to tighten emissions standards to protect those bearing the brunt of the exposure, which are largely communities of color. At this point the public could have had more trust in the scientific integrity of the EPA had it released this long-awaited and long-suppressed scientific document. We have waited far too long for the EPA to make the updated science on formaldehyde available, and it is welcome news that under the Biden administration, EPA is committing to move forward with this assessment.
A history of political interference in formaldehyde science
At UCS we have been following the formaldehyde assessment saga for a very long time, and today’s news is encouraging. Interference and steamrolling progress on this assessment has been taking place since the Obama administration, when extensive lobbying from the American Chemistry Council (ACC) and a review by the National Academies resulted in the reworking of a 2010 draft assessment. The IRIS program had been making slow progress on the draft assessment for years and was supposedly ready to the move to the next stage of peer review and public comment as early as 2017. The assessment then got stuck in the political muck and mire of the Trump administration’s chemicals office, led by former ACC staffer, Nancy Beck. In our Disinformation Playbook, we have tracked how the chemical industry, when faced with the truth about the harms of their products, have launched unfair and inaccurate criticism of the IRIS office and campaigns to delay the release of EPA scientific documents to sow disinformation and delay science-based safeguards. Under the Trump administration, government officials with chemical industry ties used this same playbook to undermine the work of their own agencies and sideline advice from career scientists.
The reason Administrator Wheeler gave for suspending the assessment was that it was not a priority of the agency’s program areas. Yet, documents we obtained through FOIA revealed the opposite. Scientists from the Office of Air and Radiation division wrote to Jennifer Orme-Zavaleta at the Office of Research and Development (ORD) in 2017: “As you know, we have a strong interest in this review and are anxious to see it completed,” she wrote (our emphasis added). “OAR regularly provides input to ORD on which hazardous air pollutants (HAP) the program office believes may be critical in shaping its regulations, and we have consistently identified formaldehyde as a priority. Having a current cancer unit risk estimate for formaldehyde is critical for the agency’s air toxics program for use in 1) the National Air Toxics Assessment (NATA), 2) the Clean Air Act (CAA) Section 112 Risk and Technology Review (RTR) rulemakings, 3) evaluation of potential risks from on-road and nonroad mobile sources regulated under relevant sections of the CAA and 4) regional and local-scale risk assessment.” Further, a 2019 GAO report revealed that senior officials at EPA interfered with the ability of IRIS career staff to continue work on or issue critical scientific assessments on the health risks associated with exposures to environmental contaminants, including formaldehyde. The GAO report does not name the individuals involved with stalling the assessment releases, but states that they were in leadership positions.
I hope that EPA plans to accept our 2019 request for a scientific integrity investigation, since questions still remain about how former ORD head David Dunlap, who previously worked at Koch Industries—which has a stake in the chemical’s production—delayed his recusal to weigh in on related decisions. We also know ACC was continuing to meet with EPA and lobby hard against making a link between formaldehyde exposure and leukemia, using industry-funded data. The voices of industry should not have been prioritized over the voices of EPA scientists and experts committed to meeting the agency’s mission. Ultimately, EPA’s scientific integrity policy “prohibits all EPA employees, including scientists, managers, and other Agency leadership, from suppressing, altering, or otherwise impeding the timely release of scientific information,” which should have insulated this study from interference. In order to prevent future delay of this study and others, EPA must expose the truth about what occurred and change internal practices to fill in the cracks.
The next piece of the process is important
The output of the IRIS office is not just important for federal policymaking, but its assessments and associated toxicity values are used by state environmental and public health agencies, as well as community groups, to assess and address local risks to public health. This scientific expertise guides action that is essential to protect public health nationwide, especially in communities of color bearing the unacceptable burden of cumulative chemical exposures. The finalization of the formaldehyde assessment should be grounded in the best available science, completed without delay, and promptly incorporated into and relied upon to expediently set health-protective standards.
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