A panel of top US scientists has backed a US Environmental Protection Agency draft toxicological risk assessment review that found formaldehyde, a chemical with broad industrial uses, to be a human carcinogen. However, the Aug. 9 report, by the US National Academy of Sciences (NAS), was challenged by the American Chemistry Council (ACC), a trade association, even before it was publicly released.
The NAS review was commissioned by the EPA to assess the draft risk assessment, which was completed more than a year ago and was conducted through the agency’s Integrated Risk Information System (IRIS) program. The EPA’s assessment 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.
The EPA’s assessment of formaldehyde has long been challenged by industry. The EPA began a health risk assessment for the chemical in 1985 and first proposed it as a probable human carcinogen in 1989, according to the NAS.
The EPA assessment, the academy report notes, “follows the advice of prior National Academies committees, and its findings on hazard and quantitative risk are supported by the evidence identified.” However, the academy recommends that the 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 did not conduct its own risk assessment of formaldehyde, and its report does not assess the IRIS program more broadly, as it was not asked to do so. In addition, the committee was not asked to provide a recommendation for a safe level of formaldehyde exposure for humans.
Overall, the academy report concluded that the EPA should “complete a revised document without delay.”
The ACC takes issue with limitations in the review process used by the EPA and the NAS and with the studies that the EPA used to support its draft risk assessment determination, according to a complaint it filed in July in the US District Court for the District of Columbia.
The EPA and the NAS did not rely on best available science, methodological norms, and process requirements, the ACC says, and its risk assessment should not be used to make regulations. The academy’s review was also too limited, the trade association says, and did not seek or review alternative opinions on the EPA’s formaldehyde assessment.
Using the EPA assessment, the ACC says, could unnecessarily cause public alarm and lead to inaccurate risk assessment and risk management decisions, as well as other unintended effects.
Much could turn on the formaldehyde risk assessment and subsequent regulation. By volume, formaldehyde is one of the nation’s highest-production chemicals. It is used in many wood products, such as cabinets, furniture, flooring, and particle board, as well as in permanent press clothing, cosmetics, paints, glues, and many household and consumer products. The ACC says formaldehyde-containing products support nearly 1 million workers and generate over half a trillion dollars in annual US sales.