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ACC Calls for Action After EPA Releases Draft Formaldehyde IRIS Assessment Without Addressing Transparency and Objectivity Issues

EPA Decision to Release Assessment is Troubling Amidst Process Irregularities, Conflicts of Interest and Potential Bias

Charlotte Anthony

WASHINGTON (April 14, 2022) — Today, the Environmental Protection Agency (EPA) released its draft Integrated Risk Information System (IRIS) assessment on formaldehyde for public comment. The American Chemistry Council (ACC) strongly objects to this decision, as it follows several unheeded calls by industry and lawmakers to address clear process deficiencies and potential issues of bias that undermine public confidence in the assessment. 

Year after year, ACC has met with IRIS staff to provide briefings on new scientific findings and to urge for transparency and scientific reliability in the process. Just last week, ACC released an analysis of public documents, obtained through the Freedom of Information Act (FOIA), that revealed a troubling pattern of process irregularities, potential issues of bias and conflicts of interest. ACC called on EPA to take immediate steps to address these concerns and are disappointed that, despite repeated calls for change, EPA is instead choosing to move forward with releasing its assessment. 

With ACC’s concerns unaddressed, ACC is even more troubled by the possibility that EPA’s draft formaldehyde IRIS assessment could be used as a risk communication tool, to guide regulations or to set policy at any level of government.

For decades, industry has invested tens of millions of dollars in research and development on the safety of products that use formaldehyde. ACC is dedicated to contributing to the public discourse on formaldehyde and is committed to any assessment used to guide regulation considers the full weight of scientific evidence. We are carefully reviewing the full assessment and plan to submit public comment by June 13. 

“In August 2021, we urged EPA to ensure the draft formaldehyde IRIS assessment relies on the best available data in an objective, transparent way. Last month, we again stressed the importance of independent, sound science. And, just last week, we called on EPA to address process irregularities and transparency concerns,” said Dr. Kimberly Wise White, Vice President of Regulatory & Scientific Affairs, ACC. “We are disappointed that, despite our repeated requests for EPA to address these concerns prior to releasing its draft, the agency has decided to move forward without taking the steps necessary to ensure the assessment is scientifically-sound and worthy of public confidence.” 

“We have waited more than a decade for EPA to address the 2011 NAS recommendations on the draft formaldehyde IRIS assessment. We are concerned that this assessment is shrouded in bias, conflict of interest, and process irregularities,” said Chris Jahn, President and CEO, ACC.

Chris Jahn, President & CEO, American Chemistry Council
We are disappointed the draft formaldehyde IRIS assessment has moved forward when there are serious doubts that it will meet the Agency’s commitment to unwavering transparency, scientific integrity, and a robust peer review process. We are carefully reviewing the draft assessment in full and intend to issue public comment in the coming weeks.

In the interim, EPA must take steps to address process irregularities and concerns regarding bias and impartiality. Moreover, consistent with its commitment to transparency, responsible risk communication and peer review, EPA must also ensure that federal and non-federal users of IRIS do not rely on a draft, non-peer-reviewed assessment.

Immediate steps EPA can take include:

  • Deploying all tools at its disposal to discourage the use of the draft assessment including through commitment to not using draft, non-peer-reviewed material in any agency activities (including risk evaluation activities under the amended Toxic Substances Control Act); updating the draft assessment to include disclaimers; and discouraging governmental and non-governmental entities from using information in draft reports that are undergoing peer review
  • Conducting 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
  • Releasing and taking 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 Office of Management and Budget to conduct a formal interagency review for the draft formaldehyde IRIS assessment 

For more details about ACC’s analysis of public documents related to the draft formaldehyde IRIS assessment, please visit our website at AmericanChemistry.com/TheRealStory.

American Chemistry Council

The American Chemistry Council (ACC) represents the leading companies engaged in the multibillion-dollar business of chemistry. ACC members apply the science of chemistry to make innovative products, technologies and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health, safety and security performance through Responsible Care®; common sense advocacy addressing major public policy issues; and health and environmental research and product testing. ACC members and chemistry companies are among the largest investors in research and development, and are advancing products, processes and technologies to address climate change, enhance air and water quality, and progress toward a more sustainable, circular economy.

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