Jul 05, 2021, 19:10 pm
Written by: Sharon Lerner for The Intercept
July 2, 2021
Managers and career staff in the Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention tampered with the assessments of dozens of chemicals to make them appear safer, according to four scientists who work at the agency. The whistleblowers, whose jobs involve identifying the potential harms posed by new chemicals, provided The Intercept with detailed evidence of pressure within the agency to minimize or remove evidence of potential adverse effects of the chemicals, including neurological effects, birth defects, and cancer.
On several occasions, information about hazards was deleted from agency assessments without informing or seeking the consent of the scientists who authored them. Some of these cases led the EPA to withhold critical information from the public about potentially dangerous chemical exposures. In other cases, the removal of the hazard information or the altering of the scientists’ conclusions in reports paved the way for the use of chemicals, which otherwise would not have been allowed on the market.
This is the first of a series of articles based on the four whistleblowers’ highly detailed allegations, which were supported by dozens of internal emails with supervisors, meeting summaries, and other documents. Together, the evidence they provided shows a pattern in which the EPA failed to follow the law that oversees chemical regulation, particularly the Toxic Substances Control Act, or TSCA, and depicts a workplace in which EPA staffers regularly faced retribution for following the science.
The four EPA staff members, who hold doctorates in toxicology, chemistry, biochemistry, and medicinal chemistry, said that they told colleagues and supervisors within the agency about the interference with their work. Each of the scientists also filed complaints with either the EPA’s inspector general or the Office of Science Integrity, which has pledged to investigate corruption within the agency. But because most of their concerns remained unaddressed months after they disclosed them — and because, in each case, the altering of the record presented a potential risk to human health — the scientists said they felt compelled to make their complaints public.
Maybe the Hazards Will Go Away
Elyse Osterweil, one of the four scientists, said she was at first reluctant to speak up about the intense pressure she faced from her supervisors to remove references to potential toxicity from the assessments of new chemicals. The assessments, which use animal studies to gauge a chemical’s potential risk to humans, can lead the agency to place limits on its use — or to ban it entirely. In the case of one substance that Osterweil was reviewing in February of this year, the animal studies suggested serious potential for harm. Rats exposed to a single dose of the chemical had become lethargic, lost weight, and had trouble moving. Some became comatose, and others died.
A chemist named Martin Phillips faced similar pushback when he was assessing a mixture of compounds in January of 2020. One component of the product, which was to be used in cleaning solutions, is a chemical that caused birth defects and miscarriage in experiments on rats. Phillips and another risk assessor noted the developmental effects in the chemical’s hazard assessment, which must by law then be added to the chemical’s safety data sheet, a document the Occupational Safety and Health Administration uses to communicate risk to workers. But the company that had submitted the product for approval balked at the requirement. And the day after the assessment Phillips wrote was finalized, a representative of the company who had recently worked in the same division of the EPA met with several of Phillips’s colleagues and his supervisor, whom she had known from her time at the agency. Phillips wasn’t invited to attend the meeting. The following day, another assessment of the chemical was uploaded into the EPA’s computer system without Phillips’s consent or knowledge. The new version omitted the information about the birth defects and miscarriages.
When he learned of the new assessment, Phillips asked that the original one be restored. The meeting that followed was hostile, with a senior science adviser in the office calling Phillips “passive aggressive” for being so concerned about the assessment. While some information about the chemical was restored in the assessment after Phillips complained about its removal, the warning about its potential to cause developmental toxicity, which would alert pregnant people to these harms, never made it into the safety data sheet.
Phillips had his work revised without his knowledge on other occasions too. In one case in 2019, he was asked to assess a chemical even though the manufacturer had not submitted studies. Phillips followed the EPA’s written guidance for such situations and used toxicity numbers for the class to which the chemical belongs. When he plugged in the proper values, Phillips calculated that the likely exposures to the chemical would exceed the agency’s safety limit by more than 15,000 times. Three months after he submitted the document with this conclusion, he noticed that a new assessment of the chemical had been uploaded to the EPA’s computer system. In this new assessment, which deviated from guidelines, the assessor found that the chemical posed only a slight risk and that workers who used the material could mitigate the danger by wearing protective gear.
The second assessment, which found the chemical not likely to pose harm, was finalized in August of 2020.
Siding with the Company
All four scientists said the pressure to downplay the risk of chemicals increased during their time in the division.
Gallagher protested changes in multiple risk assessments between March and June of 2020. Her supervisors asked her to represent the developmental effects of one chemical, which included the reduction of fetal weight in animal studies, as effects on the pregnant people. Such a mischaracterization would mean that the risk the chemical poses to a developing human fetus would not be reflected by its safety data sheet. Gallagher refused to make the change.
One month later, she was reassigned to another office.
Even after her transfer, documents she had written while in the Office of Chemical Safety and Pollution Prevention continued to be altered, including an assessment of a PFAS compound. Because there was limited information available about the chemical, she had looked to studies of similarly structured compounds, as is EPA policy. In this case, one of the closest analogues was PFOA, an industrial chemical that poses both cancer and developmental risks, as Gallagher noted in her assessment. But one of her former supervisors had instructed another scientist to remove her reference to PFOA from the assessment and replace it with another, less toxic chemical to gauge its safety. The change resulted in a 33-fold underestimation of the compound’s risk, according to Gallagher.
William Irwin, another of the four whistleblowers, who has worked at the EPA for over 11 years as a toxicologist, was also moved out of the office after repeatedly resisting pressure to change his assessments to favor industry. Irwin said that while it had seemed obvious that the pressure stemmed from chemical companies, the science adviser in the office made the point irrefutably clear during an argument over one particular chemical assessment.
Phillips was also transferred in September 2020. Meanwhile, Osterweil continues to work in the office, where she said disputes over chemical assessments and retaliation against her have continued unabated.
The ongoing issues are evidence that the pressures on chemical assessors within the EPA’s Office of Chemical Safety and Pollution Prevention have persisted even under the Biden administration, according to Kyla Bennett, director of science policy at Public Employees for Environmental Responsibility, or PEER, an organization that provides support to whistleblowers and helped the scientists draft their disclosure document.
On Monday, PEER submitted its complaint to the EPA inspector general; Michal Freedhoff, assistant administrator for the EPA’s Office of Chemical Safety and Pollution Prevention; and Khanna, asking that they conduct an audit to identify risk assessments that were altered without the knowledge or consent of the risk assessor; investigate apparent violations of the EPA’s records management policy, in which documents were altered; and evaluate the process that allowed these changes to be made and remain uncorrected.
Khanna provided a statement to The Intercept applauding the whistleblowers.
While such complaints are usually kept confidential, by Tuesday many mangers in the Office of Chemical Safety and Pollution Prevention had somehow obtained a copy of the whistleblowers’ allegations.
For the whistleblowers, the release of their names is just the latest battle in a war they’ve been waging for years.
For Gallagher, a scientist with expertise in chemistry and toxicology, the combative turn of her career has been a surprise.
https://theintercept.com/2021/07/02/epa-...leblowers/
July 2, 2021
Managers and career staff in the Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention tampered with the assessments of dozens of chemicals to make them appear safer, according to four scientists who work at the agency. The whistleblowers, whose jobs involve identifying the potential harms posed by new chemicals, provided The Intercept with detailed evidence of pressure within the agency to minimize or remove evidence of potential adverse effects of the chemicals, including neurological effects, birth defects, and cancer.
On several occasions, information about hazards was deleted from agency assessments without informing or seeking the consent of the scientists who authored them. Some of these cases led the EPA to withhold critical information from the public about potentially dangerous chemical exposures. In other cases, the removal of the hazard information or the altering of the scientists’ conclusions in reports paved the way for the use of chemicals, which otherwise would not have been allowed on the market.
This is the first of a series of articles based on the four whistleblowers’ highly detailed allegations, which were supported by dozens of internal emails with supervisors, meeting summaries, and other documents. Together, the evidence they provided shows a pattern in which the EPA failed to follow the law that oversees chemical regulation, particularly the Toxic Substances Control Act, or TSCA, and depicts a workplace in which EPA staffers regularly faced retribution for following the science.
Quote:“The Office of Chemical Safety and Pollution Prevention is broken,” the scientists wrote in a statement they provided to The Intercept and Rep. Ro Khanna, D-Calif., chair of the House Committee on Oversight and Reform. “The entire New Chemicals program operates under an atmosphere of fear — scientists are afraid of retaliation for trying to implement TSCA the way Congress intended, and they fear that their actions (or inactions) at the direction of management are resulting in harm to human health and the environment.”
The four EPA staff members, who hold doctorates in toxicology, chemistry, biochemistry, and medicinal chemistry, said that they told colleagues and supervisors within the agency about the interference with their work. Each of the scientists also filed complaints with either the EPA’s inspector general or the Office of Science Integrity, which has pledged to investigate corruption within the agency. But because most of their concerns remained unaddressed months after they disclosed them — and because, in each case, the altering of the record presented a potential risk to human health — the scientists said they felt compelled to make their complaints public.
Maybe the Hazards Will Go Away
Elyse Osterweil, one of the four scientists, said she was at first reluctant to speak up about the intense pressure she faced from her supervisors to remove references to potential toxicity from the assessments of new chemicals. The assessments, which use animal studies to gauge a chemical’s potential risk to humans, can lead the agency to place limits on its use — or to ban it entirely. In the case of one substance that Osterweil was reviewing in February of this year, the animal studies suggested serious potential for harm. Rats exposed to a single dose of the chemical had become lethargic, lost weight, and had trouble moving. Some became comatose, and others died.
Quote:“Usually with this type of acute study, there are no effects,” said Osterweil. “So this was a red flag to me that we needed further information.” But when Osterweil said in a meeting that she needed more data to complete her hazard assessment report, one of her supervisors responded with a series of questions. “She kept asking me, ‘Look at the data, look at the data, look at it again, tell me what you see,’” Osterweil said of her supervisor. “I knew she wanted me to make the hazards go away, and she even said that: ‘Why don’t you take a look at the actual study data again, and maybe the hazards will go away?’”
Although she knew she didn’t have enough information to say that the chemical didn’t pose a risk, Osterweil seriously considered giving in to the pressure to deem it safe. “There was a time when I thought, ‘Well, maybe I should let this one go and just pick my battles,’” she said. “But I just couldn’t.”
A chemist named Martin Phillips faced similar pushback when he was assessing a mixture of compounds in January of 2020. One component of the product, which was to be used in cleaning solutions, is a chemical that caused birth defects and miscarriage in experiments on rats. Phillips and another risk assessor noted the developmental effects in the chemical’s hazard assessment, which must by law then be added to the chemical’s safety data sheet, a document the Occupational Safety and Health Administration uses to communicate risk to workers. But the company that had submitted the product for approval balked at the requirement. And the day after the assessment Phillips wrote was finalized, a representative of the company who had recently worked in the same division of the EPA met with several of Phillips’s colleagues and his supervisor, whom she had known from her time at the agency. Phillips wasn’t invited to attend the meeting. The following day, another assessment of the chemical was uploaded into the EPA’s computer system without Phillips’s consent or knowledge. The new version omitted the information about the birth defects and miscarriages.
When he learned of the new assessment, Phillips asked that the original one be restored. The meeting that followed was hostile, with a senior science adviser in the office calling Phillips “passive aggressive” for being so concerned about the assessment. While some information about the chemical was restored in the assessment after Phillips complained about its removal, the warning about its potential to cause developmental toxicity, which would alert pregnant people to these harms, never made it into the safety data sheet.
Phillips had his work revised without his knowledge on other occasions too. In one case in 2019, he was asked to assess a chemical even though the manufacturer had not submitted studies. Phillips followed the EPA’s written guidance for such situations and used toxicity numbers for the class to which the chemical belongs. When he plugged in the proper values, Phillips calculated that the likely exposures to the chemical would exceed the agency’s safety limit by more than 15,000 times. Three months after he submitted the document with this conclusion, he noticed that a new assessment of the chemical had been uploaded to the EPA’s computer system. In this new assessment, which deviated from guidelines, the assessor found that the chemical posed only a slight risk and that workers who used the material could mitigate the danger by wearing protective gear.
The second assessment, which found the chemical not likely to pose harm, was finalized in August of 2020.
Quote:“So it went from being over 15,000 times over the safe dose to you just need to wear a dust mask and you’ll be fine,” said Phillips.
Siding with the Company
All four scientists said the pressure to downplay the risk of chemicals increased during their time in the division.
Quote:“We started getting increasing pressure to use the wrong exposure metrics,” said Sarah Gallagher, who joined the Office of Pollution Prevention and Toxics, which is within Office of Chemical Safety and Pollution Prevention, in May 2019. (The Office of Chemical Safety and Pollution Prevention is also home to the Office of Pesticide Programs.)
Gallagher protested changes in multiple risk assessments between March and June of 2020. Her supervisors asked her to represent the developmental effects of one chemical, which included the reduction of fetal weight in animal studies, as effects on the pregnant people. Such a mischaracterization would mean that the risk the chemical poses to a developing human fetus would not be reflected by its safety data sheet. Gallagher refused to make the change.
One month later, she was reassigned to another office.
Even after her transfer, documents she had written while in the Office of Chemical Safety and Pollution Prevention continued to be altered, including an assessment of a PFAS compound. Because there was limited information available about the chemical, she had looked to studies of similarly structured compounds, as is EPA policy. In this case, one of the closest analogues was PFOA, an industrial chemical that poses both cancer and developmental risks, as Gallagher noted in her assessment. But one of her former supervisors had instructed another scientist to remove her reference to PFOA from the assessment and replace it with another, less toxic chemical to gauge its safety. The change resulted in a 33-fold underestimation of the compound’s risk, according to Gallagher.
William Irwin, another of the four whistleblowers, who has worked at the EPA for over 11 years as a toxicologist, was also moved out of the office after repeatedly resisting pressure to change his assessments to favor industry. Irwin said that while it had seemed obvious that the pressure stemmed from chemical companies, the science adviser in the office made the point irrefutably clear during an argument over one particular chemical assessment.
Quote:“At one point, he was shouting at me to change it,” Irwin said of the science adviser, who was urging him to eliminate hazards noted in the assessment. “He basically was siding with the company, shouting at me that ‘the company went apeshit when they saw this document.’” Irwin replied, “Well, that’s the assessment.”
Irwin didn’t make the changes. “I actually added extra hazards to it,” he said. “It was also a carcinogen.” Several months after that encounter, the antagonism stopped when Irwin was transferred out of the office. The scientist saw the move as a last resort for his managers. “I have three board certifications in toxicology, so it was hard for them to say, ‘William, you’re stupid,’ and so instead they just kicked me out of the program.”
Phillips was also transferred in September 2020. Meanwhile, Osterweil continues to work in the office, where she said disputes over chemical assessments and retaliation against her have continued unabated.
The ongoing issues are evidence that the pressures on chemical assessors within the EPA’s Office of Chemical Safety and Pollution Prevention have persisted even under the Biden administration, according to Kyla Bennett, director of science policy at Public Employees for Environmental Responsibility, or PEER, an organization that provides support to whistleblowers and helped the scientists draft their disclosure document.
Quote:“The problems in OCSPP are not due solely to the Trump administration and its appointees,” said Bennett. “The issues faced by our clients occurred before Trump took office, during the Trump years, and continue now.”
On Monday, PEER submitted its complaint to the EPA inspector general; Michal Freedhoff, assistant administrator for the EPA’s Office of Chemical Safety and Pollution Prevention; and Khanna, asking that they conduct an audit to identify risk assessments that were altered without the knowledge or consent of the risk assessor; investigate apparent violations of the EPA’s records management policy, in which documents were altered; and evaluate the process that allowed these changes to be made and remain uncorrected.
Khanna provided a statement to The Intercept applauding the whistleblowers.
Quote:“Clean, cancer-free air and water still isn’t a given in our country,” Khanna wrote. “I will continue to monitor this situation and ensure that these scientists’ concerns are addressed to ensure that toxic or harmful chemicals are not going out to the market without the appropriate health and safety warnings. I am so proud of the work of our Environmental Subcommittee is doing to create a healthier world.”
Quote:Asked about the complaint, the EPA wrote in an email that “This Administration is committed to investigating alleged violations of scientific integrity. It is critical that all EPA decisions are informed by rigorous scientific information and standards. As one of his first acts as Administrator, Administrator Regan issued a memorandum outlining concrete steps to reinforce the agency’s commitment to science.
“EPA takes seriously all allegations of violations of scientific integrity. EPA’s scientific integrity official and scientific integrity team members will thoroughly investigate any allegation of violation of EPA’s scientific integrity policy that they receive and work to safeguard EPA science. Additionally, EPA is currently reviewing agency policies, processes, and practices to ensure that the best available science and data inform Agency decisions. EPA is committed to fostering a culture of evaluation and continuous learning that promotes an open exchange of differing scientific and policy positions. Additionally, retaliation against EPA employees for reporting violations alleged to have occurred will not be tolerated in this administration. EPA leadership are reviewing these complaints, and any appropriate action will be taken.”
While such complaints are usually kept confidential, by Tuesday many mangers in the Office of Chemical Safety and Pollution Prevention had somehow obtained a copy of the whistleblowers’ allegations.
Quote:“The fact that EPA released our clients’ names is inappropriate and troubling,” said Bennett. “They’ve been put in an incredibly uncomfortable situation. This gives the managers the chance to circle the wagons trying to go after them.”
For the whistleblowers, the release of their names is just the latest battle in a war they’ve been waging for years.
For Gallagher, a scientist with expertise in chemistry and toxicology, the combative turn of her career has been a surprise.
Quote:“Like a lot of us who are in this, we came to work at the EPA because I wanted to preserve the environment for our children’s children,” said Gallagher. “It’s infuriating that I have to push back against managers to do that.”
https://theintercept.com/2021/07/02/epa-...leblowers/