A new report from the National Academies of Sciences, Engineering, and Medicine has backed a 2022 U.S. Environmental Protection Agency draft toxicological risk assessment review that found formaldehyde to be a human carcinogen linked to cancers such as leukemia.
The Aug. 9 report was challenged by the American Chemistry Council (ACC) that claimed numerous flaws with the EPA's review process and the report from NASEM.
"Overall, the report finds that EPA’s draft assessment follows the advice of prior National Academies reports and that the agency’s findings on hazard and quantitative risk are supported by the evidence identified in the document. The report recommends that EPA revise the document to ensure that users can find and follow the methods used in each step of its assessment for each health outcome.
The National Academies’ committee was not asked to conduct its own hazard risk assessment of formaldehyde and does not address any broader aspects of the IRIS program. In addition, the committee was not asked to provide a recommendation for a safe level of formaldehyde exposure for humans.
The study — undertaken by the Committee on the Review of EPA’s 2022 Draft Formaldehyde Assessment — was sponsored by the U.S. Environmental Protection Agency.
Formaldehyde is present in a variety of products including plywood adhesives, abrasive materials, insulation, pesticides, and embalming fluids. Major sources of anthropogenic emissions include household furnishings and building materials, motor vehicle exhaust, manufacturing plants that produce or use formaldehyde or substances that contain it (e.g., glues), and tobacco smoke.
The EPA’s assessment, according to Chemical and Engineering News, cites evidence that inhaling formaldehyde causes nasopharyngeal cancer, sinonasal cancer, and myeloid leukemia in ,humans. If finalized, the IRIS assessment will serve as a benchmark for future formaldehyde-related regulations.
Chemistry group's objections
The American Chemistry Council, however, voiced strong concerns about the EPA Draft Formaldehyde Assessment
citing a lack of transparency and independence in the peer review process that "clouds [the] EPA’s regulatory process."
The National Academies of Sciences, Engineering, and Medicine (NASEM) report, the ACC said, did not address the validity of the toxicity values in EPA’s 2022 draft IRIS assessment.
“These values are significantly out of step with international authorities, such as global health agencies and regulators, including the World Health Organization (WHO) and the European Chemicals Agency, which have used decades of scientific evidence by universities and independent scientists to support a safe threshold for formaldehyde exposure and no causal association with leukemia,” the statement read. “The IRIS program’s disregard for current best available science, methodological norms, and process requirements should not be used for regulatory decision-making. Using it could unnecessarily cause unjustified public alarm and lead to inaccurate risk assessment and risk management decisions, as well as other unintended, adverse effects.”
The ACC also objected to the limited scope of the NASEM review, criticized the EPA for not following its own risk assessment protocols, and said the systematic review fails to appropriately integrate over 40 years of peer-reviewed scientific evidence.
“Any assessment of formaldehyde must begin with best available science and the undeniable fact that formaldehyde is an ever-present part of the natural world that, through decades of responsible innovation and regulation, has become essential to goods including sustainable wood products, electric vehicles, and lifesaving vaccines and medical devices.
“For over a year, ACC has repeatedly expressed concerns with the EPA and NASEM and their failure to comply with specific transparency, balance, and independence requirements in the peer review process as laid out in the Federal Advisory Committee Act (FACA).
The ACC filed a complaint July 20 in the United States District Court for the District of Columbia that it says outlines the fundamental failure of this review process to follow the law and basic standards for scientific integrity, independent peer review, and governmental transparency.”
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