In April 2022, U.S. Environmental Protection Agency (EPA) released a draft toxicological assessment of formaldehyde under the Integrated Risk Information System (IRIS). The updated draft assessment conclusions are similar to the heavily criticized, including by peer reviewers in 2011, previous draft where EPA alleged certain adverse health effects at extremely low doses not supported by high quality data. The draft assessment concludes that human exposure to formaldehyde at extremely low doses causes a variety of adverse health effects. These conclusions are based on very little new evidence and grounded on a few key studies that are of questionable quality. Since 2011, new groundbreaking research and robust data have emerged that seriously challenge certain aspects of EPA’s IRIS 2022 draft conclusions. Therefore, unbiased, independent scientific review of the draft Formaldehyde assessment is of critical importance and the assessment and peer review process would be strengthened by welcoming input from experts well-versed in these formaldehyde-specific scientific and data quality issues.
However, this process has not followed accepted EPA practices for peer reviews, information quality, and risk assessment. For example, EPA only allowed for an abbreviated period for review by other federal agencies. The interagency review was followed by a written short public comment period, for which requests for additional time were denied. EPA provided the draft assessment to the National Academies of Science, Engineering and Medicine (NASEM), for review. However, NASEM has not provided sufficient opportunities for public comment and participation. Recently, NASEM held two truncated one-hour oral public comment sessions, limiting scientific debate and discussion that could highlight key concerns with the draft assessment and resolve past NASEM recommendations. The opportunity for greater public participation is important because consistent fundamental concerns about the scientific conclusions and assessment process have been raised by a number of experts, authors of key studies, former government officials, a bipartisan group of Members of Congress and important stakeholders across a variety of fields.
In fact, of the submissions provided ahead of the June 13, 2022 EPA deadline for public comment on the draft assessment, only a handful were supportive of EPA while the remainder raised fundamental concerns about the draft assessment and/or highlighted procedural concerns, including the insufficient opportunity for public comment.
Most recently, the National Academies of Sciences, Engineering, and Medicine (NASEM) held a one hour virtual meeting late in the afternoon of December 22. Despite the holiday timing, a dozen experts provided critical comments, limited to three minutes per presentation, to the Committee. This builds on the concerns regarding foundational scientific errors and lack of engagement raised by all 17 speakers during a public comment opportunity on October 12, 2022. Among the nearly 30 presenters who have highlighted major scientific issues are authors of key studies, former government officials and experts who have previously served as reviewers on EPA’s formaldehyde assessments, including:
In addition, former officials from the EPA and Small Business Administration highlighted significant process concerns with the assessment. Most concerning, several experienced scientists were excluded from the opportunity to comment.
Additional regulation of formaldehyde that is not supported by high quality toxicology and epidemiology studies, including EPA’s reliance on particular studies that contain methods and conclusions out of step with the scientific community, would be detrimental to a variety of industries and the communities they serve. Formaldehyde supports nearly one million workers and generates over half a trillion dollars in sales in the U.S. as a critical resource for the automotive, construction, medical, agricultural industries and more. A draft assessment, not backed by science and a robust process while inconsistent with conclusions reached by other competent authorities creates risks of vast disruptions to supply chains and would require the use of more costly and/or lower reliability chemical alternatives, which are not readily available for some common uses.
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