Office of Inspector General U.S. Environmental Protection Agency At a Glance 23-E-0013 March 7, 2023 Why We Did This Evaluation The U.S. Environmental Protection Agency Office of Inspector General conducted this evaluation to determine whether the EPA followed applicable policies and procedures to develop and publish the January 19, 2021 perfluorobutane sulfonic acid toxicity assessment. Two weeks after publication, the EPA removed the toxicity assessment from its website, citing political interference and Scientific Integrity Policy Violations. The EPA republished the toxicity assessment in April 2021. The EPA's Scientific Integrity Policy, established in 2012, states that science is the backbone of the EPA's decision-making and that the Agency depends on the integrity of its science to protect human health and the environment. All EPA employees—including scientists, managers, and political appointees—must follow the Scientific Integrity Policy. This evaluation supports an EPA mission-related effort: • Operating efficiently and effectively. This evaluation addresses a top EPA management challenge: • Safeguarding scientific integrity. Address inquiries to our public affairs office at (202) 566-2391 or OIG WEBCOMMENTS@epa.gov. List of OIG reports. The EPA's January 2021 PFBS Toxicity Assessment Did Not Uphold the Agency's Commitments to Scientific Integrity and Information Quality What We Found The EPA's actions left the public vulnerable to potential negative impacts on human health. The EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 perfluorobutane sulfonic acid, or PFBS, toxicity assessment. During final clearance, a political appointee directed that a last-minute review 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 toxicity ranges. 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 may have been less costly but also less protective of human health. 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. Without updates to policies and procedures, the Agency cannot fulfill its commitment to scientific integrity and information quality. Recommendations and Planned Agency Corrective Actions We make a total of five recommendations in this report: • Three to the assistant administrator for Research and Development to reduce procedural confusion and strengthen existing policies, procedures, and guidance by clarifying if and when comments expressing scientific disagreement can be expressed; making clear if and when toxicity ranges are acceptable; and using the OIG as a resource for high-profile scientific integrity concerns that relate to political interference or that assert risk to human health or the environment. • One to the assistant administrator for Mission Support to update policies and procedures on environmental information quality to require additional quality assurance reviews for EPA products. • One to the deputy administrator to strengthen the EPA's culture of scientific integrity, transparency, and accountability of political leadership actions when changes occur as a result of policy decisions. The EPA disagreed with all five recommendations, which remain unresolved. Noteworthy Achievement In fiscal year 2022, the Scientific Integrity Program and the OIG increased the frequency of their meetings from quarterly to every two weeks to facilitate timely communication of scientific integrity issues and discuss appropriate action. ------- |