P-F-B-S PODCAST TRANSCRIPT

ASHLEY: Hello! Welcome to this podcast by the Office of Inspector General for the U.S. Environmental Protection Agency. My name is Ashley Gonzalez, and with me is Alicia Buchanan, a program analyst with the OIG. Thanks for joining me today, Alicia. 

ALICIA: Thanks for having me, Ashley!

ASHLEY: Your team just issued a new report related to P-FAS and P-F-B-S. Can you tell us about these chemicals – what they are and where they exist?

ALICIA: Of course. P-FAS stands for per- and polyfluoroalkyl substances, and P-F-B-S stands for perfluorobutane sulfonic acid. There are thousands of P-FAS chemicals, and P-F-B-S is just a type of P-FAS. P-FAS can be found in almost every U.S. home and business, as they are widely used in commercial and consumer products, such as stain- and water-resistant coatings and food packaging. P-FAS are also widely used in the firefighting, construction, aerospace, and electronics industries, to name a few. 

ASHLEY: If these chemicals are so useful, why is there so much attention on them? 

ALICIA: Well, some P-FAS may be toxic and certain levels of exposure may cause adverse health effects, such as abnormal fetal development, cancer, and liver damage. P-FAS are slow to break down, which means they can accumulate over time in people, animals, and the environment. That’s why they are known as “forever chemicals.” The Agency for Toxic Substances and Disease Registry says that -quote - most people in the United States have been exposed to P-FAS and have P-FAS in their blood – end quote.
Now there’s some indication that P-F-B-S, which is a newer, short-chain type of P-FAS, may be less toxic and less likely to accumulate over time than the older, longer-chain P-FAS. That said, P-F-B-S is ubiquitous. For example, it has been detected in surface water, wastewater, and drinking water. And animal toxicity studies have shown that oral P-F-B-S exposure causes some adverse health effects. So, exposure to P-F-B-S remains a concern.

ASHLEY: Your report focuses more on process – specifically, how EPA developed and published its toxicity assessment for P-F-B-S. Right?

ALICIA: Yes, that’s correct, although the process has environmental implications. A toxicity assessment is important because it describes potential health effects associated with a given chemical, and then specifies how much of that chemical can be present in the environment without likely causing those effects. That level is called the toxicity value. So, for example, at a contaminated site, EPA and other stakeholders would look to see whether the level of a certain chemical exceeds its toxicity value, and if it does, they would implement clean-up activities.

ASHLEY: Interesting. So the P-F-B-S toxicity assessment should help EPA protect human health and the environment from adverse levels of P-F-B-S. But the title of the OIG’s report indicates that there may have been issues with the process that resulted in lapses in scientific integrity and information quality.

ALICIA: That’s right. EPA’s toxicity assessments typically undergo an established review process, but we found that EPA deviated from that process for the P-F-B-S toxicity assessment. And this deviation happened very late in the development process – in fact, just before the assessment was originally supposed to be published in October 2020. 

ASHLEY: What happened as a result of this process deviation? 

ALICIA: Before the process deviation occurred, EPA’s Office of Chemical Safety and Pollution Prevention had not expressed any scientific disagreement with the toxicity values originally presented. And that office had looked at the assessment twice as part of the established review process. However, as EPA was preparing the P-F-B-S toxicity assessment for publication, a political appointee in that office ordered EPA scientists to review the assessment again. After this third, last-minute review, the Office of Chemical Safety and Pollution Prevention took a different position – that the toxicity values were too stringent – and proposed less stringent toxicity values.

ASHLEY: How did EPA reconcile this last-minute change?

ALICIA: The EPA administrator at the time decided to include both the more and less stringent toxicity values. In other words, when EPA published the P-F-B-S toxicity assessment in January 2021, it included toxicity ranges instead of single toxicity values. However, neither the less stringent values nor the ranges had gone through the review process. 

ASHLEY: What are the consequences of not having those ranges or values reviewed? 

ALICIA: There are implications in terms of information quality and scientific integrity, as well as possible harm to human health and the environment. It’s important to note that we did not find evidence that any stakeholders used the January 2021 PFBS toxicity assessment, and EPA retracted it after just three weeks. However, it is possible that parties charged with cleaning up PFBS contamination – if they accessed that version of the toxicity assessment – could have selected a less stringent value within the range. While any clean ups based on the less stringent value may have been less costly – they also may have been insufficient. If so, public health could have been adversely impacted. 

ASHLEY: What are some of the other potential implications you mentioned related to scientific integrity and information quality?
Alicia: Yes. First, when EPA doesn’t have significant changes to its products reviewed, it risks losing the public’s confidence in them. In addition, the EPA scientists who helped develop the toxicity assessment declined to be listed as authors due to the changes made; instead, EPA was listed as the general author. A – quote unquote – ghost authorship reduces transparency and diminishes scientific integrity because it’s unclear who at the Agency assumes responsibility for that product. And, finally, even though two EPA employees presented concerns related to scientific integrity before the January 2021 P-F-B-S toxicity assessment was published, those concerns weren’t addressed, nor were they shared with the OIG. Following publication of the toxicity assessment, the OIG received a hotline complaint outlining some of the issues you and I are discussing, and our team learned more details during the course of our evaluation. 
It's important to add that, almost three years ago, in May 2020, the OIG recommended that EPA develop procedures to address concerns about violations of its Scientific Integrity Policy, including those involving senior leaders. EPA agreed but, to date, has not finalized such procedures. 

ASHLEY: You mentioned earlier that EPA retracted the P-F-B-S toxicity assessment three weeks after publishing it in January 2021. The OIG’s report says that EPA cited “political interference” as a reason for the retraction. Did your team find that to be the case?

ALICIA: No, we didn’t. When EPA asserted “political interference,” that term was not defined in EPA policies and procedures. EPA officials also did not inform the OIG of potential political interference at the time the events occurred, nor did the Scientific Integrity Program consider there to be a formal allegation of a Scientific Integrity Policy violation involving a high-profile issue or senior official. 

ASHLEY: But even though the OIG’s evaluation did not support EPA’s claims of political interference, it sounds like we did find several process-oriented issues for EPA to address.

ALICIA: Yes. We made five recommendations to address the issues you and I have been discussing, as well as other issues explained in our report. 

ASHLEY: One final question, Alicia. Did EPA ever republish the P-F-B-S toxicity assessment after retracting it?

Alicia: Yes, it did. In April 2021, EPA published an updated toxicity assessment that included single toxicity values.

ASHLEY: Thank you so much for lending us your time and expertise today, Alicia. And thank you, listeners, for checking out our podcast. For more information on this and other EPA OIG reports, visit our website at www.epa.gov/oig.