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Did EPA Dismiss Recommendations from the National Academy of Sciences and Its Own Best Practices in its Draft Formaldehyde Assessment?

Formaldehyde is among the chemicals undergoing renewed evaluation by the federal government to implement the first new rules under the amended Toxic Substances Control Act (TSCA) in over a generation. If adopted, the new limits would have sweeping ramifications for their manufacturing and application in the U.S. that would paradoxically not improve public health.

This won’t result in meaningful public health improvements because if the final rule over-regulates the production of this important compound by setting exposure limits well below the safe thresholds set by other countries with more sensible regulations, manufacturers would move production overseas, taking with them nearly one million American jobs and $70 billion in payroll costs.

Shipping production overseas would have a ripple effect, further complicating the supply chain for companies who rely on formaldehyde to make essential products that keep Americans safe, including the automotive, agriculture, and medical industries.

The National Academies of Science, Engineering and Medicine (NASEM) review of the U.S. Environmental Protection Agency’s (EPA) 2022 draft toxicological assessment of formaldehyde under the Integrated Risk Information System (IRIS), an EPA subunit designed to identify and characterize perceived hazards, continues to move forward despite mounting evidence of flawsthe review process.

ACC has catalogued a variety of issues related to lack of transparency, independence, and public participation in this peer review which could raise legal and scientific quality concerns. One significant area of NASEM’s closed process has been severely curtailed opportunities for meaningful public comment. This includes repeated denials by NASEM to hold an information-gathering session. In March of this year, NASEM denied a request to hold an information-gathering session, arguing that “other interpretations of scientific information relevant to the hazards and risks of formaldehyde” or “to review alternative opinions of EPA’s formaldehyde assessment” is out of the scope of their review.

Scientists who have been studying formaldehyde science for decades should be allowed to inform the rulemaking committee. Instead, NASEM is ignoring this expertise, despite the numerous and significant flaws in the draft assessment that have previously been highlighted. ACC and its Formaldehyde Panel have repeatedly raised concerns about the absence of a robust and independent scope of a review, issues identified even prior to the release of the draft assessment or the selection of peer reviewers.

A flawed process benefits no one – not the public that the regulations will impact, nor the scientists tasked with facilitating an impartial and fair review process that follows experts' facts and guidance. However, NASEM appears content with moving forward.

The best available science must support new formaldehyde regulations to avoid unintentionally damaging the U.S. economy. By excluding these expert voices, NASEM is putting various industries at risk that support nearly one million workers and generate over half a trillion dollars in sales in the U.S. as a critical resource for the automotive, construction, medical and agriculture industries.

Instead, we urge NASEM to use a more inclusive approach to ensure that new regulations reflect the numerous peer-reviewed studies about formaldehyde. 

EPA Ignores NASEM 2011 Recommendations

If NASEM and EPA are excluding the expertise of independent scientists and key stakeholders, will these bodies at least fully evaluate whether this updated assessment of formaldehyde fully addresses the numerous critiques and recommendations identified by NASEM in 2011 for the previous draft? In 2011, NASEM delivered recommendations to improve the IRIS regulatory process and these recommendations included deriving the reference concentration and the unit risk estimates; as well as improving the IRIS assessment for formaldehyde, and the IRIS development process.

Unfortunately, NASEM has failed to follow its advice, which counters its mission statement to “provide independent, objective advice to inform policy with evidence, spark progress and innovation and confront challenging issues for the benefit of society.”

The ACC’s Formaldehyde Panel has sent a letter to NASEM outlining our concerns to demonstrate how the EPA has yet to fully implement, or respond at all too many of NASEM’s 2011 recommendations.

Of note, the EPA has publicly answered some of NASEM’s questions stemming from the 2011 recommendations with incorrect and confusing claims about the responsiveness of the 2022 draft IRIS assessment to the 2011 recommendations. ACC has previously catalogued how EPA and NASEM’s failure to assess whether these prior peer review recommendations were fully addressed runs afoul of legal requirements, EPA guidelines, and direction from Congress.

Ultimately, the EPA’s failure to fully address all recommendations of the 2011 NASEM report has serious legal, scientific, policy, and procedural implications for its use and imperils the scientific foundation of the 2022 draft IRIS assessment.

EPA Fails to Follow IRIS Handbook

The IRIS assessment development process has been a significant focus of multiple NASEM committees, starting from the 2011 NASEM review of the previous 2010 draft IRIS formaldehyde assessment.

As we’ve detailed in a separate analysis to NASEM, the EPA deviated from its own IRIS Handbook , finalized on December 22, 2022, in developing the 2022 draft assessment for formaldehyde. None of the NASEM top recommendations for the IRIS handbook are reflected in the 2022 draft assessment, the process for inclusion and exclusion of studies diverges from the handbook. In addition, the EPA’s integration judgment for myeloid leukemia does not incorporate inferences from available scientific information.

And, despite internal guidance related to formaldehyde regulations, the EPA failed to develop an IRIS assessment plan, systematic review protocol or convene a public science meeting during the development of the 2022 draft assessment.

The EPA’s deviations from its IRIS handbook are not trivial or inconsequential. IRIS assessments inform both EPA risk assessment and risk management decisions. They are also relied upon by federal, state, local, and tribal agencies, as well as community organizations and agencies in other countries.

Given that EPA has been developing the IRIS formaldehyde assessment for over two decades, the Panel would have expected the most recent 2022 Draft Assessment to reflect the best available systematic review approaches and best available science, including the Tier 1 recommendations offered by the NASEM Committee that peer-reviewed the draft IRIS Handbook. Regrettably, that is not the case.

Why This Is Important

Formaldehyde is an extensively regulated material, and government regulations have set standards protecting human health and the environment for years. Likewise, the industry has instituted strict safety precautions for many years. Together, these actions allow for safer production, storage, handling and use of this critical all-natural compound.  

We are committed to working with the EPA to find newer and better ways of ensuring the health of people and our communities comes first.

Yet, regulation for the sake of regulation ignores the evidence. Given the broad network of stakeholders involved, the EPA owes it to other agencies, American industries and consumers to incorporate the best available science and recommendations to ensure a well-informed regulatory process. Failure to follow past peer review recommendations or EPA’s own guidelines likely renders this assessment of formaldehyde as failing to achieve the best available science and unfit for regulatory purposes. 

American Chemistry Council

The American Chemistry Council’s mission is to advocate for the people, policy, and products of chemistry that make the United States the global leader in innovation and manufacturing. To achieve this, we: Champion science-based policy solutions across all levels of government; Drive continuous performance improvement to protect employees and communities through Responsible Care®; Foster the development of sustainability practices throughout ACC member companies; and Communicate authentically with communities about challenges and solutions for a safer, healthier and more sustainable way of life. Our vision is a world made better by chemistry, where people live happier, healthier, and more prosperous lives, safely and sustainably—for generations to come.

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