ACC’s Formaldehyde Panel: Potential EPA Midnight Actions on Formaldehyde Risk Prioritizing Political Timelines Over Requirement to Use Best Available Science

EPA Rushing Forward with Formaldehyde TSCA Risk Evaluation and Future Onerous Regulation Despite Widespread Scientific, Stakeholder Criticisms

WASHINGTON (November 5, 2024) - Despite the level of major scientific, legal, federal agency, state, Congressional, public and peer reviewer concerns raised this year, the Environmental Protection Agency (EPA) is rushing forward to issuing a final Toxic Substances Control Act (TSCA) risk evaluation for formaldehyde by the end of the year which would require risk management, including potential bans or unachievable workplace standards, within two years. The American Chemistry Council's Formaldehyde Panel transmitted a detailed letter to EPA outlining these major scientific and procedural concerns. The Panel issued the following statement:

"Unfortunately, EPA is on a path to ignoring the concerns of scientists and stakeholders by rushing forward with a deeply flawed assessment of formaldehyde. Issuing a midnight TSCA risk evaluation in late December 2024 would demonstrate EPA's continued disregard for statutory requirements on scientific quality, peer review, and engagement with public and interagency comments. Government agencies like Department of Defense, Department of Agriculture, the Centers for Disease Control, and the Small Business Administration and EPA-selected expert peer reviewers have raised concerns about the shortened timeline, scientific shortcomings, and potential devastating effects of a flawed risk assessment. Despite these concerns, EPA is expected to barrel forward with a rushed process that could bind a future Administration to unnecessary regulations on this building block chemistry rather than a commitment to regulate based on the best available science, as required by TSCA."

"Any assessment of formaldehyde must begin with the best available science. Formaldehyde is a natural part of our world and, through decades of responsible innovation and regulation, is essential to critical applications for housing, agriculture, transportation, lifesaving vaccines, and national security."

"We have met with the EPA to express our concerns about this broken process and have sent a letter outlining substantial comments from a diverse group of stakeholders, experts, and peer reviewers. These comments raise major issues with the 2024 Draft Risk Evaluation for Formaldehyde as well as the deeply flawed underlying assessment of formaldehyde developed by EPA's Integrated Risk Information System (IRIS). We urge the EPA to listen to these important voices and prioritize policy over politics on this critical issue, which affects industries ranging from affordable housing to agriculture and modern healthcare. This letter outlines EPA's requirement under its own regulations, to respond to peer review, interagency, and stakeholder comments on the draft risk evaluation. EPA should go back to the scientific drawing board on formaldehyde instead of pursuing unaccountable lame duck actions that threaten the U.S. economy and key sectors that support health, safety and national security."

Background:

In recent months, numerous scientists and stakeholders have raised concerns about this timeline.

For instance, the U.S. Department of Defense (DoD) requested more time during the interagency review process for the Integrated Risk Information System (IRIS) formaldehyde assessment and was denied by EPA:

• "Since the SACC review is not available yet, DoD requests this IRIS interagency review be extended to provide additional time to consider SACC comments as they pertain to the IRIS assessment. Ultimately this will ensure a more robust and scientifically and legally defensible IRIS risk assessment, TSCA risk evaluation, and any subsequent EPA rulemakings for formaldehyde…."
• "Because the draft IRIS formaldehyde assessment formed the basis of the now publicly available TSCA Formaldehyde risk evaluation, it is important that the IRIS final assessment is reviewed in the context of both the NASEM report and the SACC report. This is important from multiple perspectives including…Ensuring that the SACC technical concerns regarding the IRIS assessment are addressed so that the toxicity assessment of formaldehyde is deemed by the SACC to be scientifically sound and appropriate for evaluating risk in the TSCA context and development of existing chemical exposure limits that will determine unreasonable risk from use of mission critical products that support defense and US critical infrastructure."

The U.S. Small Business Administration (SBA) raised similar concerns about the absence of meaningful engagement.

• This included a request to extend the public comment period on the Draft Formaldehyde Risk Evaluation noting that the 60-day comment period "does not give small entities enough time to analyze both the draft risk assessment and associated materials" and that "[i]t is vital to obtain small entity input early in the regulatory process, at the draft risk assessment stage, rather than wait for an eventual proposed rule."
• These formaldehyde-specific concerns were also reflected in SBA comments on the risk evaluation process, where the Administration argued that the absence of robust interagency review for risk evaluation "create a significant risk that the resulting risk management regulations will impose unnecessary and duplicative burdens on small businesses with minimal public health benefits" and that "it is not a good use of EPA's resources to duplicate the effort an expertise of these other federal offices."

The U.S. Department of Agriculture (USDA) noted the following:

• "Given the significance and ubiquity of formaldehyde in commerce and in production, and the sheer volume of information contained in this review, USDA would note that the time provided for review was very short. USDA requests a more formal process to address issues related to this chemical…"
• "USDA also requests additional interagency conversations to discuss potential implications of this draft toxicological review on future regulatory actions for formaldehyde…"
• "USDA notes that formaldehyde is both directly and indirectly very important in agriculture, including in applications that themselves impact human and environmental health (positively). If those uses are threatened due to an overly conservative toxicological assessment of formaldehyde, that assessment could have a net adverse impact on human health and the environment."

The Agency for Toxic Substances and Disease Registry (ATSDR), part of the Centers for Disease Control, commented as well:

• ATSDR "disagrees with the lack of response to these other bullets (e.g., failing to incorporate relevant literature, use of uncertainty factors, lack of transparency) as they do impact the formaldehyde specific assessment.…This issue could detract [from] the confidence in the entire" assessment.
• "It is suggested that EPA convene discussions from the larger scientific community (such as scientific international workshops, panels, or other non-governmental panels/reports) regarding the issue of mode of action and the impact that it could have on evidence findings in systematic review…"
• "It is recommended that EPA allow for another round of interagency, peer review, and public commenting on this ToxReview to provide the scientific community time to assess whether they agree with this methodology …. This sentiment is echoed by public commenters."

These stakeholder concerns have been echoed by EPA's Science Advisory Committee on Chemicals (SACC). During its 4-day meeting, comments from peer reviewers made clear that EPA had imposed upon them a timeline that did not allow adequate and independent peer review. In response, while not directly disputing that the driver was the timeline rather than an accurate evaluation, EPA acknowledged that the feedback from the SACC might cause the Agency to reevaluate its ability to meet a December deadline.

To read the Formaldehyde Panel letter to EPA, click here.

For more details on the SACC review, click here.

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