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ACC Reiterates Strong Concerns About EPA Draft Formaldehyde Assessment

Lack of transparency and independence in the peer review process clouds EPA’s regulatory process

Charlotte Anthony

WASHINGTON (August 9th, 2023) — Today, the American Chemistry Council (ACC) issued the following statement on the just-released report from the National Academies of Sciences, Engineering, and Medicine (NASEM) on EPA’s 2022 draft assessment of formaldehyde.

“ACC reiterates its strong concerns about the EPA’s 2022 draft formaldehyde assessment and echoes the NASEM Committee’s concerns regarding the assessment’s lack of transparency and replicability that raise serious questions about the underlying science used to develop it.

“Importantly, NASEM did not address the validity of the toxicity values in EPA’s 2022 draft IRIS assessment. These values are significantly out of step with international authorities, such as global health agencies and regulators, including the World Health Organization (WHO) and the European Chemicals Agency, which have used decades of scientific evidence by universities and independent scientists to support a safe threshold for formaldehyde exposure and no causal association with leukemia. The IRIS program’s disregard for current best available science, methodological norms, and process requirements should not be used for regulatory decision-making. Using it could unnecessarily cause unjustified public alarm and lead to inaccurate risk assessment and risk management decisions, as well as other unintended, adverse effects.

“ACC objects to the limited scope of the NASEM review, which threatens the independence of the peer review process. First, the NASEM Committee acknowledges that they were not tasked with conducting an independent hazard evaluation or dose-response assessment for formaldehyde exposure. Additionally, the Committee acknowledges they were not charged with commenting on other interpretations of scientific information relevant to the draft assessment, nor were they permitted to review alternative opinions on EPA’s formaldehyde assessment.

“The Committee also criticized the EPA for not following its own IRIS risk assessment protocols while highlighting an overall lack of transparency regarding the evidence and methods used by the EPA to arrive at their assessment, both of which are critical for EPA to ensure its findings are supported by the scientific evidence.

“Additionally, the systematic review fails to appropriately integrate over 40 years of peer-reviewed scientific evidence. In fact, the committee found that EPA ‘does not satisfactorily follow recommendations for problem formulation’ and systematic review which are ‘essential to ensure transparency.’ Ultimately, EPA and NASEM Committee's review of EPA's 2022 Draft IRIS Formaldehyde Assessment unjustifiably ignored more than 50 key studies published in recent years.

“Any assessment of formaldehyde must begin with best available science and the undeniable fact that formaldehyde is an ever-present part of the natural world that, through decades of responsible innovation and regulation, has become essential to goods including sustainable wood products, electric vehicles, and lifesaving vaccines and medical devices.

“ACC is not alone in highlighting concerns with this formaldehyde assessment, with broad scientific criticism from authors of key studies, other federal agencies, Members of Congress, former government officials and advisors, and numerous stakeholder groups. It’s no wonder, then, that the current review has precluded questions about the IRIS process as well as whether prior peer review recommendations were fully addressed.

“For over a year, ACC has repeatedly expressed concerns with the EPA and NASEM and their failure to comply with specific transparency, balance, and independence requirements in the peer review process as laid out in the Federal Advisory Committee Act (FACA).

“ACC, on behalf of a workgroup of members, has filed a complaint in the United States District Court for the District of Columbia that outlines the fundamental failure of this review process to follow the law and basic standards for scientific integrity, independent peer review, and governmental transparency.

“Formaldehyde is extensively regulated to protect human health and the environment. Decades of scientific evidence support a safe level of formaldehyde exposure at current regulatory levels. Given the many benefits of formaldehyde, federal and local policymakers must make regulatory decisions based on all of the available science.

”EPA must take the time to fully evaluate and address all of NASEM’s recommendations as well as scientific considerations that have been raised by other peer review and regulatory bodies.”

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.