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ACC Challenges Lack of Independence, Transparency for Peer Review of EPA’s Draft Formaldehyde IRIS Assessment

Improper EPA Control Over National Academies’ Review of Formaldehyde Assessment Violates the Federal Advisory Committee Act and Undermines NASEM Scientific Review

Charlotte Anthony

WASHINGTON (July 20, 2023) — The American Chemistry Council (ACC), on behalf of a workgroup of members, today announced it has filed a legal action against the U.S. Environmental Protection Agency (EPA) and the National Academies of Sciences, Engineering, and Medicine (NASEM). The complaint seeks to have NASEM follow basic principles of independence, transparency, and sound science in accordance with its legal obligations as part of its reviewing EPA’s draft assessment of formaldehyde. The action was filed in the United States District Court for the District of Columbia. 

The Federal Advisory Committee Act (“FACA”) requires that a federal agency meet specific transparency, balance, and independence requirements in the peer review process. It prohibits a federal agency like the EPA from managing or exercising control over a review. FACA also requires that committee members reviewing EPA’s work disclose any conflicts of interest, the public be permitted to comment on proposed committee members, and that certain information is made available to the public. The complaint outlines numerous violations of these requirements. Over the last 18 months, ACC and other stakeholders have documented these violations in over a dozen letters, written comments, presentations, and other materials sent to EPA and NASEM. 

ACC issued the following statement on the challenge: 

“For over a year, ACC has repeatedly expressed concerns with the EPA and NASEM and their failure to comply with FACA legal requirements. Today’s complaint outlines the fundamental failure of this review process to follow the law and basic standards for scientific integrity, independent peer review, and governmental transparency. 

“We have the highest respect for NASEM and believe it should adhere to the highest standard for objective, scientific peer review. Unfortunately, this review process has included numerous FACA violations, including improper EPA influence, conflicts of interest on the committee, a lack of technical balance, and failure to meet transparency obligations or provide meaningful opportunities for public comment. Notable examples include: 

  • NASEM appointed Committee members and utilized key staff with apparent conflicts of interest, principally with EPA and its IRIS Program which the Committee is tasked with critiquing.
  • NASEM’s Study Director was previously an EPA senior manager with direct involvement with the IRIS program, the formaldehyde assessment under review, and the assessment authors.
  • NASEM’s Study Director directly engaged with senior EPA officials regarding who to select to serve on the Committee.
  • The Committee excluded entire categories of needed expertise in critical scientific disciplines and lacks members with diverse backgrounds and experiences.
  • ACC repeatedly attempted to present key scientific information to Committee members but NASEM outright declined to provide any meaningful opportunities for public engagement.
  • NASEM failed to make available to the public written materials presented to the Committee.

“A NASEM 2011 Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehydewas highly critical of the EPA’s draft assessment of formaldehyde and laid out several recommendations to improve the IRIS assessment process which still have yet to be implemented by the EPA. In support of NASEM’s recommendations, ACC completed numerous research projects to fill perceived data needs. As a result, since 2010 over 50 peer-reviewed publications on various key formaldehyde-related topics have been added to the literature to inform the formaldehyde assessment and underscore its safe use.

“Unfortunately, this subsequent review appears to be designed to evade this additional information and the fundamental scientific and methodological issues identified in the 2011 NASEM review. An impartial and transparent review of this assessment is critical to achieving science-based regulations protecting human health and the environment.

“Formaldehyde is extensively regulated to protect human health and the environment. Decades of scientific data support a safe level of formaldehyde exposure at current regulatory levels. And due to decades of innovation, this compound has become an ingredient in lifesaving medical devices, vaccines and antimicrobials that keep us healthy. It is also a critical chemical building block for affordable housing, sustainable wood products, agriculture, and electric vehicles.

“Given the many benefits of formaldehyde, federal and local policymakers must make regulatory decisions based on all available data. Instead, the U.S. EPA is determined to ignore 40 years of peer-reviewed studies and all available scientific evidence and follow a deeply flawed IRIS assessment rubber-stamped by NASEM as the basis for regulation.

“ACC urges NASEM to develop a fair and balanced Committee, allow for meaningful public input, and carefully consider and transparently address the available scientific information to inform their review of the 2022 draft formaldehyde assessment. Our concerns are shared by prominent scientists, members of Congress, former government officials and advisors, other federal agencies, and numerous stakeholder groups.”

ACC has also made all science and information available to the NASEM committee members and continues to urge them to thoroughly review the information and remedy the FACA deficiencies identified in the complaint. 

Amended Complaint Filed 9/15/23 

PI Motion Filed 10/13/23

Reply Filed 12/4/23

Supplemental Filing to Address EPA Intent to Defer to IRIS and NASEM Report 1/10/24


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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