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.
Formaldehyde: The Real Story
Process Irregularities & Bias Found in EPA’s Draft Formaldehyde IRIS Assessment
FOIA Request Identifies — in EPA’s Own Words and Emails — Concern About Lack of Reform and Failure to Address Previous NASEM Recommendations Prior to Release of Latest Draft Formaldehyde Assessment
Year after year, industry has repeatedly called on the U.S. Environmental Protection Agency (EPA) to reform its Integrated Risk Information System (IRIS) program before issuing another draft formaldehyde assessment. Still, the IRIS program remains deficient.
A Freedom of Information Act (FOIA) request has now validated what the troubled history of the draft formaldehyde IRIS assessment has long indicated—despite calls from industry and scientific experts, the EPA’s next draft assessment on formaldehyde will likely, again, fail to meet adequate standards for scientific rigor and impartiality.
Public documents obtained through the Freedom of Information Act (FOIA) reveal a troubling pattern of process irregularities, bias, and conflicts of interest — demonstrating the need for greater scrutiny and transparency.
What ACC Is Doing Now
Until EPA corrects the process errors and produces a document that meets scientific standards worthy of public confidence, ACC is urging EPA to take immediate steps to ensure the draft formaldehyde IRIS assessment isn’t used as a risk communication tool, to guide regulations, or to set policy at any level of government, in addition to:
- Imploring EPA to conduct its own investigation to maintain the integrity of its process to assess chemicals and ensure an unbiased formaldehyde IRIS assessment.
- Calling on EPA to release the charge questions guiding NAS’s review of the draft formaldehyde IRIS assessment to the public to facilitate greater review transparency.
- Urging NAS to conduct a thorough investigation of the ad-hoc committee charged with reviewing EPA’s draft formaldehyde IRIS assessment to ensure an independent, objective review process, including:
- A reset of the panel nomination process after a public comment on the charge questions; and
- Removal of any panel members and NAS staff with potential conflicts of interest or the appearance thereof.
- Calling on the Office of Management and Budget to conduct a formal interagency review for the draft formaldehyde IRIS assessment before it is released.
What ACC Found
Key officials involved in the National Academy of Sciences’ (NAS) upcoming review appear to have violated basic standards regarding impartiality, 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.
Conflict of Interest
- NASEM Conflict of Interest Certification
- EPA Human Health Risk Assessment Fact Sheet
- NAS Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde (2011)
- NAS Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens (2014)
- The New York Times, Weed Killer, Long Cleared
- All Documents Archive Notes Mail; pages 6-7
- In Defense of Scientific Integrity: Examining The IARC Monograph Programme and Glyphosate Review (2018)
- Reuters, Exclusive: WHO cancer agency asked experts to withhold weedkiller documents
- The Risk-Monger, The Corruption of IARC 3/4: The Glyphosate Gameplan
- Reuters, In glyphosate review, WHO cancer agency edited out “non-carcinogenic” findings
- The Risk-Monger, Is IARC Fit for Purpose?
In at least one version, the EPA team working on the draft formaldehyde IRIS assessment was accused by a staff scientist to have manipulated scientific outcomes to advance unsupported conclusions.
Advocating for Conclusions Not Supported by the Weight of Evidence
EPA’s decision to prioritize formaldehyde for IRIS review in March 2021 lacked transparency, a clear scientific basis for conducting this assessment versus other agency priorities, and a formal nomination process.
Decisions Based on Politics, Not Science
The draft formaldehyde IRIS assessment lacked a thorough formal science consultation to ensure robust participation from all relevant federal agencies, as well as the public.
Shortcutting Transparency & Stakeholder Engagement
- The George Washington University, Regulatory Studies Center, Comment on The Office of Management and Budget‘s Draft 2010 Report to Congress on the Benefits and Costs of Federal Regulations
- Written Testimony of Richard A. Williams, Ph.D. Director of Policy Studies, Mercatus Center at George Mason University
Premature Transmission of Documents
Why It Matters
- A robust review of formaldehyde must objectively evaluate the best available science.
- IRIS assessments can lead to unnecessary public alarm if they fail to undergo a “reality check” to ensure the risk values make sense.
- Formaldehyde is a critical facet of everyday life and a core building block of the U.S. chemical industry. Restrictive regulation of formaldehyde will cause harm up and down the supply chain—including to consumers and producers.
- Formaldehyde supports employment for nearly 1 million workers and generates over half a trillion dollars in sales in the United States.
- Put simply, smart policymaking should create solutions, not problems.
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.