NASEM Meetings Highlight Broad Scientific Criticism for EPA’s Draft Formaldehyde Assessment

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.

This criticism has come from:

•  Authors of studies fundamental to the scientific literature on formaldehyde, including the more than 70 important studies, reviews and responses excluded by EPA’s assessment, like those from Dr. Leslie Recio, Chief Scientific Officer, ScitoVation (bio), Dr. Robert Golden, ToxLogic LLC, and Stewart Holm, Chief Scientist, American Forest & Paper Association and American Wood Council and Drs. Debra Kaden and Peder Wolkoff (bio). There were additional critical comments on the assessment process from a member of the 2010 NASEM review committee as well as a lifetime member of the National Academy of Medicine.
• Other federal agencies including White House Office of Management and Budget, Small Business Administration, Agency for Toxic Substances and Disease Registry and Department of Defense.
• A bipartisan group of two dozen Members of Congress, including leaders on key House and Senate appropriations, science, oversight, energy and natural resources committees. See here, here, here, here, here and here.
• Major trade associations and stakeholder groups including ACC, the U.S. Chamber of Commerce, American Veterinary Medical Association, European Chemical Industry Council (Cefic), Composite Panel Association, Independent Lubricant Manufacturers Association, American Feed Industry Association as well as a number of agricultural groups and Louisiana Chemical Association. In addition, a number of important U.S.-based companies have voiced their concerns in the public comment and peer review process.

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:

• Dr. Richard Albertini (bio), Emeritus Professor of Medicine at the University of Vermont
• Dr. Paolo Boffetta (bio), Professor at Stony Brook University Cancer Center, NY and the University of Bologna
• Dr. Harvey Checkoway (bio), Professor, Family Medicine and Public Health, University of California, San Diego and member of the 2010 NRC Committee to Review EPAs Draft IRIS Assessment of Formaldehyde
• Dr. Rory Conolly (bio), Adjunct Professor, Institute for Integrative Toxicology, Michigan State University; retired from U.S. Environmental Protection Agency in 2020; Senior Managing Consultant at Ramboll
• Dr. Tony Cox (bio), President of Cox Associates; served on many National Academies, World Health Organization, EPA, USDA and other agency committees and advisory boards
• Dr. Pamela Dalton (bio), Principal Investigator and Full Member, Monell Chemical Senses Center
• Dr. Bernhard Gadagbui (bio), Senior Toxicologist, Toxicology Excellence For Risk Assessment
• Dr. John Graham (bio), Indiana University and former Director, White House Office of Information and Regulatory Affairs
• Dr. Kun Lu (bio), Associate Professor, Scientific Director, UNC Biomarker Mass Spectrometry Facility, Department of Environmental Sciences and Engineering, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
• Ms. Heather Lynch (bio), Supervising Health Scientist, Stantec
• Dr. Gary Marsh (bio), Professor Emeritus, Biostatistics, University of Pittsburgh; Founder, Center for Occupational Biostatistics & Epidemiology, Biostatistics
• Dr. Kenneth Mundt (bio), University of Massachusetts Amherst; Senior Principal Health Scientist at Stantec
• Dr. Thomas Starr (bio), Adjunct Associate Professor, University of North Carolina; Principal with TBS Associates
• Mr. Bill Thompson (bio), Senior Epidemiology Consultant, Stantec
• Dr. Chad Thompson (bio), Senior Managing Scientist, ToxStrategies

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. The recordings of the October 12th, December 22th, and January 30th public meetings video are also available.

Why this matters:

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.