ACC Finds EPA’s Draft Formaldehyde IRIS Assessment Problematic

April 12, 2022
ACC calls for a reset following a review of transparency and objectivity issues with EPA’s draft formaldehyde IRIS assessment.

The American Chemistry Council (ACC) is releasing findings from its review of the processes for the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System’s (IRIS) draft formaldehyde assessment that suggest the draft document will fail to meet the agency’s standards for unwavering transparency, scientific integrity and a robust, independent peer review process, according to the organization. 

ACC says the IRIS program’s approach to performing scientific assessments has a troubling history and has been criticized for producing overly conservative reports that are out of step with current science. Utilizing public documents obtained through the Freedom of Information Act (FOIA), ACC’s analysis reportedly reveals what it terms a troubling pattern of process irregularities, lack of independence, bias and conflicts of interest that demonstrates a need for greater scrutiny and transparency. 

ACC says its findings reveal:

  • Key officials involved in the National Academy of Sciences’ (NAS) upcoming review appear to have violated basic standards regarding independence, bias and balance in the peer-review process. For example, the lead NAS staff officer was directly involved in developing the assessment under review while working at EPA.
  • EPA is violating its own IRIS process and policies by ambiguously prioritizing this assessment in 2021 and failing to include critical steps, like a systematic review protocol for formaldehyde to allow peer reviewers and the public to determine if EPA is appropriately evaluating the science.
  • The draft formaldehyde IRIS assessment lacked a thorough formal interagency review to ensure robust participation from all relevant other federal agencies, as well as the public.
  • Industry has consistently called for any formaldehyde assessment to use transparent, science-based standards and has diligently supported peer-reviewed published studies that improve understanding of formaldehyde.

“The IRIS program is not fulfilling its mission. The program has long had deficiencies, especially as it relates to formaldehyde. ACC has consistently called upon EPA to improve the design and conduct of its chemical assessments,” says Chris Jahn, President and CEO, ACC.

“Now, our findings have brought to light what we’ve long known—the draft formaldehyde IRIS assessment is riddled with questionable decisions, poor process and conflicts of interest.”

 “ACC is requesting EPA take immediate steps to ensure that the draft formaldehyde IRIS assessment isn’t used as a risk communication tool, to guide regulations, nor to set policy at any level of government until EPA corrects the process errors and produces a document that meets scientific standards worthy of public confidence,” says Dr. Kimberly Wise White, vice president of regulatory and scientific Affairs, ACC. “Time and time again, we have tried to provide solutions to help the program enhance its scientific integrity and transparency. Our hope is this analysis sheds light on ways the IRIS program can restore its credibility.” 

Immediate steps, according to the organization, include:

  • Imploring EPA to conduct its own investigation to maintain the integrity of its process to assess chemicals and ensure an unbiased formaldehyde IRIS assessment, including whether EPA policies on scientific integrity, peer review, and information quality have been violated and whether these process issues impact EPA’s legal obligations
  • Calling on EPA to release and take comment on the charge questions guiding NAS’s review of the draft formaldehyde IRIS assessment to facilitate greater review transparency
  • Urging NAS to conduct a thorough investigation to ensure an independent, objective review process, including:
  • A reset of the panel nomination process after the public comment period for the charge questions
  • Removal of any potentially biased panel members and NAS staff who lack independence or objectivity from the panel reviewing the draft IRIS assessment
  • Calling on the Office of Management and Budget to conduct a formal interagency review for the draft formaldehyde IRIS assessment before it is released

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