The U.S. Environmental Protection Agency (EPA) Office of
Inspector General (OIG) announced on March 7, 2023, that EPA did not
follow the typical intra-agency review and clearance process during
the development and publication of the January 2021 perfluorobutane
sulfonic acid (PFBS) toxicity assessment. OIG conducted its
evaluation to determine whether EPA followed applicable policies
and procedures to develop and publish the PFBS toxicity assessment.
OIG notes that two weeks after publication, EPA removed the
toxicity assessment from its website, citing political interference
and Scientific Integrity Policy violations. EPA republished the
toxicity assessment in April 2021.
According to OIG, EPA did not follow the typical intra-agency
review and clearance process during the development and publication
of the January 2021 toxicity assessment. OIG states that 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." The changes included
replacing single toxicity values with "unprecedented toxicity
ranges." Users of the toxicity assessment, including 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, EPA lacked policies and
procedures to address these concerns. According to OIG, without
updates to policies and procedures, EPA cannot fulfill its
commitment to scientific integrity and information quality.
OIG made five recommendations:
- 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 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; and
- One to the Deputy Administrator to strengthen EPA's culture of scientific integrity, transparency, and accountability of political leadership actions when changes occur as a result of policy decisions.
OIG notes that "EPA disagreed with all five recommendations, which remain unresolved."
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