The EPA Office of Inspector General (OIG) recently issued a report that found the Agency didn’t follow the typical intra-agency review and clearance process during the development and publication of the January 2021 perfluorobutane sulfonic acid (PFBS) toxicity assessment.

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During the final clearance process for the assessment, a Trump political appointee ordered a last-minute review to be conducted of the uncertainty factors used to calculate toxicity values, resulting in a scientific disagreement that caused delay, confusion, and significant changes to the near-final, peer-reviewed work product.  These changes included replacing single toxicity values with unprecedented (less protective) toxicity ranges.

PFBS is one of thousands of per- and polyfluoroalkyl substances (PFAS), which are known as “forever chemicals” due to their resistance to breaking down over time in human bodies and the environment. The Agency for Toxic Substances and Disease Registry states that “most people in the [U.S.] have been exposed to PFAS and have PFAS in their blood.”

“Exposure to some PFAS above certain levels may increase the risk of adverse health effects, including abnormal fetal development, cancer, liver damage, immune effects, thyroid effects, and cholesterol changes,” the OIG report says.

Although the OIG report concluded that there was no evidence that anyone relied on the less protective values in the altered report, users of the PFBS toxicity assessment—for example, regulated entities cleaning up PFBS contamination—could have selected a less stringent value within this range, which would have put human health at risk.

“While EPA staff expressed scientific integrity concerns about the last-minute review and risks to public health, the EPA lacked policies and procedures to address these concerns,” the OIG report continues. “Without updates to policies and procedures, the Agency cannot fulfill its commitment to scientific integrity and information quality.”

The OIG report contained the following suggestions to correct the issue:

• Recommendations for the EPA assistant administrator for research and development to:
• Develop or update existing policies, procedures, or guidance to specify whether and under which applicable circumstances comments expressing scientific disagreement can be provided for a scientific product that has undergone all peer reviews and required developmental steps set forth in applicable actions or project plans.
• Develop or update existing policies, procedures, or technical documents to specify whether reference dose ranges are acceptable in toxicity assessments. If acceptable, specify circumstances under which reference dose ranges may be applied.
• Update the EPA’s Scientific Integrity Policy to require that the OIG be immediately notified of scientific integrity concerns, including advice queries and allegations, that relate to political interference or that assert risks to human health or the environment.
• A recommendation for the EPA assistant administrator for mission support to update EPA policies and procedures on environmental information quality to require additional quality assurance reviews for EPA products that undergo major changes to scientific results or conclusions after quality assurance reviews have been completed.
• A recommendation for the EPA deputy administrator to develop or update existing policies, procedures, or guidance to require policymakers and decision officials to uphold transparency through timely, formal communication of decisions and the scientific bases to change results or conclusions of a scientific product to originating authors in the absence of peer review.

According to the OIG report, the EPA disagreed with the findings and stated the report “mischaracterized the events surrounding the changes made to the scientific conclusions presented in the October 2020 PFBS toxicity assessment as deviations from Agency processes rather than violations of the EPA’s Scientific Integrity Policy.”

“Further, the EPA stated that political interference was the underlying cause of the cascading sequence of events,” the report adds. “We note that the Agency determined in its February 9, 2021 press release that the January 2021 toxicity assessment was compromised by political interference, which constituted a violation of the Scientific Integrity Policy. As the policy prohibits alteration of scientific findings and conclusions, we agree that a scientific integrity violation occurred when the ‘redline markup’ changes were accepted by someone in the Office of the Administrator at the time. We further note, however, that this report describes the findings from our evaluation of policies and procedures, not an investigation into potential misconduct.

“The Agency’s benefit of hindsight in attributing all breakdowns to political interference obscures the fact that our recommendations, when considered collectively, seek to improve the efficiency and effectiveness in the EPA’s scientific integrity and information quality programs.”

All five OIG recommendations currently remain unresolved.