How Biden’s team rushed to dump a Trump-era PFAS assessment

By E.A. Crunden | 09/01/2021 12:46 PM EST

Trump administration appointees interfered with development of a toxicity assessment for a "forever chemical" and made changes that were "not scientifically sound," documents obtained by E&E News through the Freedom of Information Act show. Claudine Hellmuth/E&E News (illustration); EPA (document); unclelkt/Pixabay (hand)

Trump-era EPA appointees engaged in "considerable political level interference" on an assessment for a controversial "forever chemical," documents obtained by E&E News indicate.

But the Biden administration wasted no time in yanking that document, moving to scrub the assessment of alterations made by political appointees and restore language advocated by EPA career scientists shortly after the president’s inauguration.

At issue is a toxicity assessment for PFBS, part of the per- and polyfluoroalkyl substances family. PFBS is a replacement chemical for PFOS — one of the two most well-studied and controversial PFAS, due to health risks like cancer. The replacement compound, a surfactant, is used in manufacturing processes and to make stain-resistant coatings for various consumer items like clothes, among other purposes.

Documents obtained under the Freedom of Information Act shed light on the agency back-and-forth over the toxicity assessment for PFBS, released in the last days of the Trump administration, only to be clawed back as soon as Biden took office. Staff conversations show the process of withdrawing and replacing the document came after a contentious publication process that saw significant input from political appointees, in a breach with agency processes.

In an email sent Jan. 21, shortly after Biden’s inauguration, then-head of EPA’s Office of Research and Development Jennifer Orme-Zavaleta conveyed wishes that the PFBS assessment be removed.

"During the rush of the last administration to complete various tasks, there was a PFAS assessment on PFBS along with an internal deliberative memo from [the EPA chemicals office] that apparently were posted Tuesday," she wrote to Jane Nishida, then-acting EPA administrator, in an email marked with a "high" importance level.

In January, anonymous EPA staffers raised concerns that the assessment had been politically compromised (Greenwire, Jan. 14).

As Biden took office, leadership in the research office and the Office of Chemical Safety and Pollution Prevention immediately requested that the assessment and related documents be taken down at once, Orme-Zavaleta said. "The materials posted are not supported by ORD or OCSPP career scientists and violate the Agency’s scientific integrity policy. We will work to correct the document, brief new leadership then follow up with [the Office of Public Affairs] on the correct release."

At the heart of the controversy was a significant shift from a draft assessment, which offered a reference dose — or an indicator of how much individuals can be exposed to a chemical before experiencing adverse health impacts.

A key component of deriving that reference dose are uncertainty factors, which are applied to reflect data limitations. For the PFBS assessment, uncertainty factors were crucial, given a lack of information around areas like immunotoxicity and mammary gland development. But the new document refuted any database deficiency and shifted the reference dose to a range.

While the assessment was a science, rather than regulatory, document, critics worried the change would allow for industry and government to cherry pick numbers when setting threshold levels. An EPA spokesperson confirmed to E&E News that the Biden administration "immediately began working with EPA’s career scientists and staff" to withdraw and replace the document.

Orme-Zavaleta, who recently retired, meanwhile said the document published under Trump reflected "considerable political level interference" and became "a poster child for why it’s critical to have scientific integrity policies in federal government."

Pushback on a Trump EPA priority

The PFBS assessment was a priority for the Trump administration, and former Deputy Assistant Administrator for Science Policy David Dunlap highlighted the issue as a major focus.

EPA originally planned to publish the assessment in late October 2020. But the schedule was delayed amid last-minute comments and concerns about the uncertainty factors from the Office of Pollution Prevention and Toxics.

A December document reviewed by E&E News showed that Office of Chemical Safety and Pollution Prevention Deputy Assistant Administrator David Fischer — a former official with the American Chemistry Council, which represents PFAS manufacturers and has lobbied extensively against a crackdown on the chemicals — asked senior toxicologists to review the Office of Research and Development’s PFBS work. Fischer’s office countered ORD’s findings regarding uncertainty factors for chronic and subchronic reference doses.

Fischer did not respond to a request for comment. But EPA confirmed to E&E News that the process became bogged down by his office’s previous political leadership, in a deviation from regular practices.

In early January, leading up to posting the assessment, Office of Pollution Prevention and Toxics Deputy Director Tala Henry shared a draft with officials, noting it included proposed in-line edits supporting a range of uncertainty factors. She commented that former EPA Administrator Andrew Wheeler had requested the inclusion of those edits. Conversations indicate officials sought to publish the assessment in advance of a Wheeler PFAS-centric interview.

Orme-Zavaleta confirmed to E&E News that political leadership decided to modify ORD’s peer-reviewed assessment in keeping with Wheeler’s preferences and that she did not learn of the changes until January. She called the back-and-forth "one of the more infuriating experiences I have ever encountered."

Her emails show that she pushed back, arguing Wheeler "did not have complete information" in making his request. The PFBS assessment had previously been considered final.

"The type of changes OCSPP proposes would require us to go through the whole process of intra/inter-agency review [and workgroup efforts] … which will take anywhere from 6-8 months," she said.

But a day later, Wheeler’s senior adviser, Taylor Hoverman, announced the process would move forward. The agency’s political leadership negotiated a fast-tracked review through the Office of Management and Budget that is not typically part of EPA’s processes for toxicity assessments. Soon afterward, EPA published the document.

‘Very unusual’ levels of input

Multiple political appointees kept a close eye on the PFBS assessment process. In one instance, the Department of Defense gave EPA feedback disputing the agency’s approach to uncertainty factors. Former career staff said those comments came as part of an interagency review process and in response to language inserted by Fischer. Emails show Dunlap wound up editing EPA’s response to the Department of Defense, taking an active role in shaping the final product. He continued asking for updates on the status of the assessment as it proceeded.

Orme-Zavaleta said the level of involvement was irregular. "David Dunlap was engaging in the decision making process for PFBS without consulting with or including anyone else from ORD," she said. "I am also not aware of any other [EPA administrator] weighing in on a science decision in an assessment before."

Betsy Southerland, a former longtime EPA top scientist, said Dunlap’s level of involvement was "very unusual." She said an official at Dunlap’s level would not typically have edited a technical document as he did.

"[Deputy assistant administrators] certainly keep track of the progress on high-priority projects and ensure work is done on schedule and following all peer-reviewed guidance and standard processes, but rarely if ever rewrite documents since they are generally not subject matter experts," Southerland said.

Kyla Bennett, who directs science policy for Public Employees for Environmental Responsibility, meanwhile expressed alarm. The conversations, she said, "prove what we always suspected — Trump Administration political appointees improperly manipulated science at EPA," adding the revelations were "disturbing."

Dunlap did not respond to a request for comment.

Career staff, meanwhile, were unhappy with the changes imposed by political officials. EPA senior science adviser Louis D’Amico voiced harsh criticism in an email sent on Jan. 6.

"This is precedent setting, and flies completely in the face of legitimate and necessary separation between risk assessment and risk management," he told Orme-Zavaleta and Samantha Jones, the acting associate director for health at EPA’s National Center for Environmental Assessment.

"A decision to release a ‘range of values’ in EPA assessments should be discussed across the agency, including program offices and regions."

Jones agreed in a response email, also taking issue with changes stating that the individual value generated for PFBS would be dependent on "the needs of the program office and in the type of risk assessment being performed," including for the general population.

That note, Jones said, "should NOT be in a scientific foundational document. It would go into the risk assessment by the program."

A speedy reversal

Only a day after Biden took office, EPA staff began the process of taking down the PFBS assessment.

In a Feb. 9 email, EPA science communications specialist Kacey Fitzpatrick linked the issue more clearly to former Administrator Wheeler, saying the changes made to the PFBS assessment were at "political direction" and "not scientifically sound."

"Administrator Wheeler determined that uncertainty factors were policy, not scientific judgements. … This is contrary to long-standing risk assessment practices based on National Academy of Sciences (NAS) guidance," Fitzpatrick wrote to Carolyn Hubbard, ORD’s science communications director, in an email laying out the agency’s response. "This constitutes a violation of the agency’s Scientific Integrity Policy and the documents have been removed from the EPA website while the agency completes its review."

The old document was pulled that same day (E&E News PM, Feb. 9).

Two months later, EPA released its replacement — one Orme-Zavaleta said in a statement "fixes errors in the version issued earlier this year, was developed by EPA career scientists, and upholds the values of scientific integrity" (Greenwire, April 8).

The new assessment set a chronic reference dose of 300 parts per trillion per day, along with a subchronic dose of 1,000 ppt per day. That reference dose is much stricter than the 2018 Trump EPA’s original chronic dose recommendation of 10,000 ppt per day with a subchronic range from 40,000 ppt to 100,000 ppt.

That replacement didn’t mark the end of the saga. EPA’s Office of Inspector General said in June that it would probe the agency’s decisionmaking regarding the assessment (Greenwire, June 16). At the time, EPA said it was "committed to upholding scientific integrity" and would support and assist the review.

For her part, Orme-Zavaleta said the PFBS assessment published under Biden "could have been a good news story" if released under Trump, offering the administration a significant action at a time of mounting focus on PFAS. Instead, the release of the compromised assessment eroded faith in an agency that prides itself on science-based decisions.

"Scientific integrity, coupled with sound external peer review and quality assurance procedures are critical for ensuring public trust," she said. "When these measures break down or are manipulated, it erodes public trust and jeopardizes our ability to protect public health and the environment, which first and foremost is EPA’s mission."