WASHINGTON (August 5, 2024) – The American Chemistry Council’s (ACC) Formaldehyde Panel issued the following statement on the Scientific Advisory Committee on Chemicals (SACC) report on the Environmental Protection Agency’s (EPA) Draft Toxic Substances Control Act (TSCA) Risk Evaluation for formaldehyde, which is based on a 2022 draft assessment under EPA’s Integrated Risk Information System (IRIS):
The report highlights fundamental flaws that demonstrate that the draft risk evaluation fails to meet TSCA’s scientific standards and process requirements. EPA’s peer reviewers echoed important concerns we have previously raised, including the failure to incorporate dozens of high-quality studies as well as assessments by authoritative bodies like the World Health Organization and European Union, that have been raised by other peer reviewers, scientific experts, and the public for over a decade.
The SACC peer reviewers found that the TSCA program’s reliance on a draft IRIS assessment inappropriate, in particular the report stated:
- On chronic noncancer endpoints: “Concerns were raised by some Committee members regarding studies selected by ORD IRIS for chronic non-cancer hazards. These studies are mainly observational and unreliable for identifying a point of departure. The studies identified by ORD IRIS for the weight of evidence for chronic human health non-cancer hazard do not adequately address the chosen endpoint.”
- On cancer endpoints: “Many Committee members recommended not using the IUR published in the 2022 Draft Formaldehyde IRIS assessment” with these members recommending use of “a mode of action approach where there is a threshold concentration below which no cancer is anticipated.”
As ACC has previously noted, “Any assessment of formaldehyde must begin with the best available science and the 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 contributing to a sustainable future for wood products, electric vehicles, agriculture, lifesaving vaccines, and medical devices. If EPA continues on its current path, formaldehyde manufacturing and many of its downstream uses would be severely restricted or potentially banned in the U.S.”
The SACC also raised several issues regarding the peer review and risk evaluation development process, similar to issues raised repeatedly by the American Chemistry Council – For example:
- Failure to address past peer review recommendations, with the Committee noting that EPA received extensive comments from the National Academies of Science, Engineering, and Medicine and EPA’s Human Studies Review Board and “the current draft does not… reflect these comments.”
- Reliance on a draft IRIS assessment, noting that “[t]his document is heavily based on the Draft IRIS document, which has not been finalized, making it difficult to understand” the selection of health values.
- Failure to incorporate best available science from authoritative bodies, with the SACC describing that “EPA does not appear to have reviewed the work of other regulatory bodies to refine their methodology,” including the European Union, World Health Organization, and Germany. Incorporating “international standards and guidelines,” the report notes, would “achieve greater credibility, consistency in regulation, and acceptance” as well as “ensure exposure limits are consistent with the best available science.”
- Failure to coordinate and consult with other parts of EPA or other federal agencies, identifying this as an “area in which the Committee felt strongly that the evaluation could benefit” from such cooperation and the resolution of differing perspectives.
- A rushed process with limited public interaction, with the Committee acknowledging “that timelines, information complexities, concerns from numerous stakeholders, and budgetary constraints further complicate the implementation of this” risk evaluation.
- Failure to use a transparent process for systematic review and use of weight scientific evidence, with key studies, peer reviews, and authoritative assessments identified as being excluded from EPA’s TSCA risk evaluation and IRIS assessment.
Formaldehyde remains a critical building block for essential U.S. applications including agriculture, food safety, medical devices, semiconductors, automobiles/electric vehicles, and affordable housing. Formaldehyde technologies have broad roles in the economy, supporting 987,000 jobs and $552.7 billion in sales in 2022 in the United States.
