The theory behind the EPA’s decision not to calculate the risk of repeated exposure to certain corrosive chemicals — or to remove information about those risks — is that after the unpleasantness of the first exposure, people will avoid contact with the chemical in the future. But according to the group of health assessors who have been providing The Intercept with insider accounts of corruption in the EPA’s chemical assessment process over the past year, this logic is flawed for many reasons. Perhaps the most significant problem is that people may not actually experience or notice any effect from an initial exposure — either because the chemical has been incorrectly deemed corrosive or because it is corrosive only at concentrations higher than the levels to which people are exposed. Neither circumstance has any bearing on whether the chemical presents other risks. Workers may also be forced to have repeated contact with chemicals to stay employed.

“They’re trying to say that if a chemical is corrosive, people will just avoid it, which is nonsense,” said William Irwin, an EPA toxicologist who is among the small group of scientists that has been calling attention to flaws in the agency’s assessment of new chemicals. “That’s not the way things work. People have to do their jobs.”

In some cases, according to the complaint, high-level EPA staff members have argued against the calculation or mention of chemicals’ systemic risks based on the idea that workers will be protected from their dangers because they will wear personal protective equipment. But according to Sarah Gallagher, one of the whistleblowers and a human health assessor in the EPA’s Office of Pollution Prevention and Toxics, that’s not a safe assumption.

“PPE gives some protection, but it is often not complete, and some chemicals can sneak through gloves. In order to get the best protection, you need to ensure that the chemical does not readily break down the gloves so that they lose protectiveness,” said Gallagher. “There are tests for that, but my understanding is that the New Chemicals Division is not ensuring the right gloves are used for new chemicals.”

In an emailed response to questions from The Intercept, Timothy Carroll, the EPA’s deputy press secretary, confirmed that, for some corrosive chemicals, assessments do not include health effects beyond the corrosivity. “When occupational exposures from a chemical EPA finds to be highly corrosive are expected to occur, meaning it would immediately burn the skin/lungs, chronic effects that could occur from prolonged exposure to that chemical would not be expected to occur and therefore the risk assessment would quantify the corrosivity risk alone.” But in other cases, the EPA does consider other health risks, according to Carroll. “In cases where a chemical is not expected to be sufficiently corrosive to support an assumption that prolonged exposures would not occur or there are non-occupational uses that are described in the [pre-manufacture notice] or reasonably foreseeable that could result in prolonged or repeated exposures, EPA would characterize risks beyond corrosivity.”

Carroll’s email also said that the agency had recently changed its approach to addressing personal protective equipment, such as respirators and gloves, in chemical assessments. “In order to ensure that neither prolonged nor repeated exposures to the chemical would occur when the chemical begins to be manufactured, EPA would require the use of PPE or other measures during the risk management phase for that substance,” said Carroll. “This is a shift away from the last Administration’s policy of assuming that workers always have access to and correctly use PPE. Under the Biden Administration, in conducting initial risk assessments for new chemicals, EPA does not assume workers are utilizing PPE when calculating risks.” When the EPA does require PPE, it issues a special order that limits that production and use of the chemical, according to Carroll.

A Single Exposure

Another hole in what the whistleblowers have called the “burned-finger hypothesis” is that, for some chemicals, a single exposure can cause irreversible effects. So even if someone’s eyes or skin are irritated or burned on a first encounter, other serious harms could already have occurred. Consider a new chemical whose assessment was finalized in March: The company that submitted the chemical for review did not provide the agency with studies of its reproductive health effects. So, as is often the case, the health assessors had to resort to studies of structurally similar chemicals, or analogues, which often have similar health effects, to glean any information about the risks it might pose.

Studies of one analogous chemical showed that a single exposure could cause mice to “resorb” — or essentially miscarry — their fetuses. In fact, just hours after a single exposure to the chemical, more than 63 percent of pregnant mice experienced fetal death. Yet the risk assessment of the new chemical, which was finalized on March 7, did not mention the study or the possibility that the new chemical might cause miscarriage in humans. Instead, it noted that “the corrosiveness of the new chemical substance” limited repeated exposures — and found the chemical “not likely” to present an unreasonable risk to health.

While the assessment did not calculate or note the miscarriage risk on the grounds that the chemical’s corrosivity would cause people to avoid coming into contact with it, the whistleblowers also determined that workers exposed to it would probably not experience any skin damage — and thus were unlikely to realize that it was corrosive.

Like the vast majority of the other chemicals being reviewed by the EPA’s new chemicals program and described in this series, the information regarding that chemical was submitted to the agency as confidential business information. Although the health assessors know the product’s exact structure and name, they could suffer severe penalties if they made that information public.

Cancer Risk

The health effects that are omitted from assessment on the grounds that chemicals are corrosive include cancer. This was the case for a compound that the New Chemicals Division was reviewing in March 2021. There were clear reasons to suspect that the chemical, which is to be used to produce other chemicals, was a carcinogen. And information submitted by the company made it clear that workers and people living near the factories where it is used could be exposed. But the assessment, which has not yet been finalized, does not include the calculations of any systemic health risks, in part because the chemical was known to irritate the eyes and skin. Instead, the assessment notes that the “corrosivity of the new chemical substance may be protective of any potential systemic effects.”

This chemical was also submitted to the EPA without any heath data, so the health assessors had to resort to analogues to glean information about the risks it might pose. When they did, they found that the structure alone raised serious concerns. Similar chemicals cause cancer, liver effects, and neurotoxicity. The whistleblowers then used a close analogue — a chemical called benzyl chloride that the EPA had deemed a “probable human carcinogen” in 2008 — to gauge the likelihood that the new compound might cause cancer. The results were alarming: One out of every 118 people exposed would be expected to develop cancer. In comparison, the EPA usually considers one cancer in every 100,000 people exposed the upper limit of acceptability.

But rather than using benzyl chloride to predict the carcinogenicity of the new chemical, without explanation the assessment relied on another analogue to gauge the new chemical’s cancer risk, as the whistleblowers point out in their complaint. That chemical had not been subject to a repeated-dose carcinogenicity study, which the agency requires for assessing the likelihood that a chemical will cause cancer.

If the EPA did not want to base its assessment of the new chemical on benzyl chloride, the analogue that had already been found to be a probable carcinogen, it could have asked the company to perform its own cancer studies on the new chemical. Or it could have searched for another appropriate analogue that had been assessed for its cancer-causing potential. Or, if it didn’t obtain adequate evidence of its safety, the agency could have prohibited the company from using the chemical. Instead, the latest version of the assessment deemed this chemical, too, “not likely to present an unreasonable health risk.”

Fundamentally Inaccurate

In March 2020, Gallagher, the human health assessor, found that another chemical presented risks to workers. Experiments showed that one analogous chemical caused rats to have tremors and behave aggressively. Another analogue caused reproductive effects in male rats and mice. Information about both hazards were included in a version of the assessment that was finalized on April 8, 2020.

But a month later, a manager in the New Chemicals Division created a new assessment. In this version, the information about the hazards had been deleted. Instead, in a section of the document headed “workers,” the document explained: “Risks were not evaluated for workers via repeated dermal exposures because dermal exposures are not considered likely due to the corrosivity of the new chemical substance.”

“It’s not just that we did the calculations. We did the calculations and found risks, and then they got rid of them.”

According to the whistleblowers, this statement is false. “It is intentionally misleading for EPA to put into a report that we did not calculate risk when we did,” said Martin Phillips, a chemist and human health assessor who works in the EPA’s Office of Pollution Prevention and Toxics. “It’s lying about what we did. It’s not just that we did the calculations. We did the calculations and found risks, and then they got rid of them and said that we didn’t calculate them. It’s fundamentally inaccurate.”

According to Public Employees for Environmental Responsibility, the organization that’s representing the whistleblowers, the statements may be a violation of the law. “I hope that the inspector general evaluates whether these false statement are violations of the criminal statute,” said Kyla Bennett, director of science policy for PEER. “EPA is not allowed to make knowingly materially false statements.”

To further complicate the assessment, a quick check of the pH of the chemical done by Gallagher revealed that it was neither acidic nor basic enough to cause skin damage. In other words, the chemical wasn’t corrosive after all. Gallagher repeatedly raised the issue with her colleagues after she made the discovery, but the assessment was not corrected. It was finalized on May 29, 2020.

In the emailed response to questions from The Intercept, the EPA’s Carroll wrote, “EPA is committed to ensuring the highest level of scientific integrity across the agency and takes seriously all allegations of violations of scientific integrity. Additionally, EPA is committed to fostering a healthy work environment that promotes respect between all levels of staff, supports work-life balance, provides for an open exchange of differing scientific and policy views, and achieves our mission of protecting human health and the environment. Where scientists identify a difference in scientific opinion, EPA has a transparent process that allows for expression, elevation, and resolution.”

The email went on to say, “The agency will fully cooperate with any and all future investigation by the Office of Inspector General.” The EPA inspector general is currently investigating numerous complaints previously filed by the whistleblowers.

An Ongoing Problem

For at least two years, the whistleblowers have repeatedly argued against the use of corrosivity to dismiss other health hazards — a strategy they say is in keeping with other EPA efforts to make dangerous chemicals seems safer than they are. Since The Intercept began reporting on their complaints more than a year ago, the EPA has taken several important steps to improve the regulation of new chemicals.

But according to the whistleblowers, the dismissal of serious health concerns with the mention of corrosivity continues. Just two weeks ago, Kyoungju Choi, a toxicologist in the New Chemicals Division, was asked to assess a compound. She noted that an analogue had developmental and reproductive effects on rats. But per the instructions of a senior staff member in her division, she was offered the option of dismissing these hazards because the chemical is corrosive.

“Then there would have been no other hazards,” said Choi. Although she felt pressure to dismiss the health concerns, Choi opted instead to lay them out in the document. While the assessment is still in draft form, she is hopeful that her warning will survive the EPA’s fraught assessment process and go on to protect workers and their children from harm.

The post EPA Whistleblowers Provide New Evidence of Ongoing Failure to Assess Dangerous Chemicals appeared first on The Intercept.

For some of the 29 staff members who responded to the survey, those intertwined stressors appear to have turned work into a form of agony. “When I joined the [New Chemicals Division in the Office of Pollution Prevention and Toxics], my expectation was very high because I was standing in the core sector to protect the American public and environment,” one agency employee wrote. “But now I am failing all my excitement for the EPA, my duties, environmental justice for the public, and even as a human being. I am so exhausted and worn out due to the harsh environment.”

“Staff has been told to leave the room when they expressed a scientific opinion which was contrary to management.”

One respondent offered a description of meetings with companies at which risk assessors don’t speak “since they are too afraid.” Another noted that “staff has been told to leave the room when they expressed a scientific opinion which was contrary to management.” And others said that they faced retaliation for raising scientific concerns with their superiors. One staff member reported becoming physically ill in response to the stress in the new chemicals division. In an interview about the workplace, another staff member mentioned that “People are made to cry regularly.”

Although the report was redacted to protect the names of individuals, it nevertheless conveyed a pointed mistrust and fear of particular staff members. “On the conference calls with companies, the Risk Assessors are afraid to talk when [redacted] is there,” one person noted in a one-on-one interview, going on to say that “[redacted] is very hostile and makes false complaints about the Risk Assessors.” Another said, “People are fearful of [redacted].” Even the agency’s effort to solicit the employees’ thoughts and feelings on their work culture, which was done as part of a larger effort to address scientific integrity problems at the agency, didn’t escape fears of retaliation from co-workers. “There was very little participation in one of the listening sessions because [redacted] buddy was logged on to spy,” one staff member noted.

Despite the clear tensions, the responses also show that many employees have retained their enthusiasm for the agency’s mission, which includes protecting public health and the environment from toxic chemicals. “I know that the work I do protects myself and others to ensure that my family, my community, and the greater world can have access to clean safe water, air, and land to thrive on,” one worker wrote. “This brings me immense joy to serve them in this way.”

“Most staff believe that they are not protecting the public and decisions favor industry instead.”

Others lamented the gulf between the agency’s mission and the reality of their jobs. “If I take a moment and step back to look at what the work I am doing might accomplish, I take pride in it,” wrote one staff member quoted in the report. “Yet, this becomes very hard to recognize in the day-to-day. While I can draft an inspiring/impressive blurb about my work, the daily tasks and pace of work can quickly make the highlight reel of my work feel like a complete distortion of the truth.”

Several respondents blamed chemical companies for souring the environment within the agency and suggested that “New managers need to be brought in for OPPT without ties to the industry.” Asked “what makes you feel good about your work and workplace?” one staff member answered, “Not much. OPPT is chaos. Most staff believe that they are not protecting the public and decisions favor industry instead.”

Survey Underscores Whistleblower Allegations

Indeed, many of the responses in the report underscore allegations made by the whistleblowers, who, since July, have been providing The Intercept, the EPA Inspector General, and members of Congress with detailed evidence that some managers and high-level officials within the division of new chemicals have interfered with dozens of assessments. Together the information they have shared — including screenshots of emails, internal reports, and draft chemical assessments — have outlined a pattern of industry influence in the division, in which risk assessors were pressured to minimize or omit the potential harms of chemicals. In several cases, the documents show, managers changed and deleted the risk assessors’ findings when they refused to do it themselves.

While five Ph.D. scientists who worked in the division of new chemicals have supplied the bulk of that evidence, the newly released survey, which the EPA refers to as a “climate assessment,” provides a broader look into the experience of workers in the division. In addition to getting 29 responses to its written questionnaire, the Federal Consulting Group also conducted 13 listening sessions and 10 individual interviews as part of its assessment. (Because some employees may have participated in interviews as well as surveys and listening groups, the total number of participants is unclear.)

The new report, which contains more extensive notes on the listening sessions and interviews as well as direct quotes from the surveys, lays out a range of frustrations felt by workers and reveals a throughline of distrust that appears to divide the staff working on new chemicals. At least one respondent seemed to blame the whistleblowers for the dysfunctional environment. “We are unable to get anything done because we are acutely aware that our meetings are more than likely being recorded without our knowledge and consent,” the person wrote, possibly referring to an audio recording (made by a consultant) of a meeting in which high-priority “hair-on-fire” cases were discussed. Others described being pressured by higher-level staff members to change their scientific findings. Asked “what is impeding your ability to get work done,” one staff member wrote, “Management that micromanages and interferes with staff risk assessments. Assessments were put through multiple rounds of review with the sole purpose of eroding risk finding.” Another responded that “Managers from the Branch Chief level up to the [assistant administrator] level force technical experts to do unethical or illegal things and block scientific information from being released if it says something they don’t like.”

In its depiction of scientists who feel mistrustful of their superiors and unable to properly do their jobs, the new report parallels the findings of a 2020 survey by the U.S. Office of Personnel Management. In that survey, which was conducted well before the whistleblowers came forward with their allegations, only 41 percent of 181 staff members of the agency’s Office of Pollution Prevention and Toxics, which contains the New Chemicals Division, agreed with the statement that “I can disclose a suspected violation of any law, rule or regulation without fear of reprisal.” And a mere 18 percent of respondents to the 2020 survey agreed with the statement that “My organization’s senior leaders maintain high standards of honesty and integrity.”

Public Employees for Environmental Responsibility, or PEER, which has been representing the whistleblowers and submitted the Freedom of Information Act Request for the internal report, said that the newly released document vindicated the group’s clients. “It supports everything they’ve been saying about morale, bullying, and catering to industry,” said Kyla Bennett, director of science policy at PEER. Bennett also criticized the EPA for not voluntarily making the report public: “The fact that EPA did not give this information to the employees is disheartening.”

In an emailed response to questions from The Intercept, the EPA emphasized its intention to resolve the issues roiling the Office of Chemical Safety and Pollution Prevention: “OCSPP is committed to ensuring the highest level of scientific integrity across the office and takes seriously all allegations of violations of scientific integrity. Additionally, OCSPP is committed to fostering a healthy work environment that promotes respect between all levels of staff, supports work-life balance, provides for an open exchange of differing scientific and policy views, and achieves our mission of protecting human health and the environment.”

Overworked and Under-Resourced

The pressures on the scientists who assess chemicals appears to be intensified by a lack of resources. In October, EPA Assistant Administrator Michal Freedhoff told members of the House Energy and Commerce Committee that the EPA has less than 50 percent of the resources necessary to implement the new chemicals program as Congress had intended. The EPA also blamed its failure to publicly post the risk reports for 1,240 chemicals on a lack of resources. The internal report paints a grim picture of the experience of trying to perform complex scientific evaluations on new chemicals without enough staff or resources.

“We have a handful of human health assessors responsible for all of the new chemicals cases, which means each one might have over a hundred cases they need to keep track of at a given time,” one employee wrote. “That’s too much work and quality can suffer as a result.” Asked what are the most critical things that need to be addressed to improve the organization, one staff member responded “about 4 times as many people as we currently have.”

Part of the problem seems to stem from the increased demands on assessors due to the 2016 update of the Toxic Substance Control Act, also known as the Lautenberg Act. “We are woefully understaffed given the 2016 mandate,” is how one respondent described the crush of work. “Lautenberg requires us to make a risk assessment finding for all cases (400-500 a year) whereas before 2016 we would only need to do so for ~20% of the cases received.”

If funded, the 2023 budget for the EPA, which President Joe Biden released this week, would address some of the problem. The president requested $11.881 billion for the agency, which includes $124 million for “efforts to deliver on the promises made to the American people by the bipartisan Lautenberg Act.” That money would pay for 449 full-time employees and “support EPA-initiated chemical risk evaluations and protective regulations in accordance with statutory timelines,” according to a statement from EPA Administrator Michael Regan.

It’s hard to imagine these basic documents, which are meant to provide clear, written instructions on how to perform routine activities, causing unrest. Yet according to one EPA employee who was quoted in the climate assessment, even writing SOPs has proven a source of painful contention about how to deal with industry involvement. “We can’t write SOPs because we might forget a reference that the American Chemistry Council might have wanted to be included and if they ask for us to include a reference that we didn’t at the start then the whole thing has to be thrown out and we have to perform a sacrifice to redeem ourselves in the eyes of some unknown god,” wrote the employee. The American Chemistry Council is a trade group that represents many chemical companies.

In January, the EPA released a memo about the climate assessment, in which it summarized the findings in the survey and acknowledged that the employees had expressed fear, anger, frustration, and disappointment about working in the New Chemicals Division. In the memo, Freedhoff also reiterated her commitment to “taking the appropriate actions to address any inappropriate behaviors in the workplace” in certain circumstances, including in response to recommendations from the inspector general. Freedhoff also reaffirmed her commitment to taking actions in response to substantiated cases of harassment, scientific integrity violations, and recommendations from the inspector general in a February interview with The Intercept.

In its statement to The Intercept, the EPA once again underscored Freedhoff’s commitment to resolving the problems within the New Chemicals Division, which is part of the Office of Chemical Safety and Pollution Prevention. “Dr. Freedhoff is focused on fostering a collaborative workplace environment that enables OCSPP staff to better work together to protect human health and the environment and return to long-standing practices and procedures that may have been disregarded by the previous Administration,” the statement read.

The EPA also noted some recent changes the agency has made to support scientific integrity and strengthen the new chemicals program. Among the new efforts are a program to streamline the review of new chemicals; a partnership with the Office of Research and Development to modernize the review process; and the appointment of Stan Barone as the new science policy adviser in the Office of Chemical Safety and Pollution Prevention.

For some, the changes are already too late. Throughout the report, survey respondents and interviewees mention former colleagues who have left the unpleasant work circumstances to take other jobs. “People leave due to the bad upper management, feeling happy that they no longer have to deal with terrible management and then convincing others to leave,” one worker wrote. Another tied the departures to the division’s scientific integrity problems, writing, “The staff knows that their only recourse, when confronted with unethical or illegal actions by management, is to leave.”

Others were clear that they hoped to follow their co-workers out the door. Asked “what is your greatest hope going forward?” one employee responded, “That I find a new job as soon as possible.” Another wrote: “Willing to take a lateral or move to a different agency to escape this broken organization.”

Yet still others seemed committed to finding a way to keep doing science at the agency, affirming their allegiance to their work at the New Chemicals Division, if not its current workplace cultures. “I want to have a safe working place without being bullied, discriminated against,” one scientist wrote. Another agreed, expressing the desire to continue doing the work but with one big caveat: “That I no longer have to fear that management interference could result in a decision or assessment that I worked on/contributed to harming human health and the environment.”

The post Internal EPA Report Describes “Incredibly Toxic Work Environment” in New Chemicals Division appeared first on The Intercept.

All three EPA officials have played a significant role in pressuring scientists to downplay the risks posed by products the agency is assessing, according to voluminous documentation the whistleblowers have provided to The Intercept and the EPA inspector general over the past eight months. Henry serves as the deputy director for programs in the agency’s Office of Pollution Prevention and Toxics, which includes the New Chemicals Division, and Camacho is a branch chief responsible for chemical assessment in a division of the same office. Stedeford, an attorney and toxicologist, served as a senior science adviser in the agency’s Office of Pollution Prevention and Toxics until May, when he left to work at Bergeson & Campbell, a law firm that helps chemical companies navigate the regulatory process.

Camacho, Henry, Stedeford, and Stedeford’s employer, Bergeson & Campbell, did not respond to multiple inquiries related to this article, including emails to Camacho’s and Henry’s EPA email addresses, and Stedeford’s work address and to his employer. The EPA press office said that, because of a pending investigation by the EPA Inspector General, “Drs. Henry and Camacho do not have a comment at this time.”

The whistleblowers, all scientists with doctorates who worked in a division of the EPA that assesses the hazards of new chemicals, have alleged that these agency officials pushed them to expedite the approval of certain high-priority chemical submissions at the behest of industry. Their complaints to the EPA inspector general, which they also submitted to members of Congress, have contained specific records to back their allegations.

The first complaint, filed in June, explained that all four whistleblowers experienced having chemical hazards they identified — including developmental toxicity, neurotoxicity, mutagenicity, and/or carcinogenicity — removed from assessments. According to a complaint they submitted to the EPA inspector general in early August, the whistleblowers met with opposition from all three named officials in their effort to accurately account for exposure to certain chemicals. On one occasion, according to the complaint, Stedeford revised a report, changing a finding of neurotoxicity after speaking to a representative of the company that made the chemical. Another of their complaints, submitted to the inspector general in late August, described Camacho as deleting hazards from an assessment without the permission of the scientist who worked on it to make the chemical seem less hazardous. And in a complaint filed with the inspector general in November, the whistleblowers documented the case of a chemical used in paint, caulk, ink, and other products that posed health risks, including the risk of cancer. In the latter case, a risk assessor noted the hazards in the assessment, but Henry changed the document to say that the “EPA did not identify risk” for the chemical.

Screenshot of an EPA draft assessment of a paint containing PCBTF, a chemical that has been shown to cause cancer. The initial assessment identified the health hazards associated with the chemical. But a version that whistleblowers say was revised by Tala Henry, deputy director for programs in the EPA’s Office of Pollution Prevention and Toxics, strikes the specific health risks and concludes that the “EPA did not identify a hazard.”

Michal Freedhoff, assistant administrator of the EPA’s Office of Chemical Safety and Pollution Prevention, which includes the New Chemicals Division, told The Intercept that she is ready and willing to respond to cases of wrongdoing. “I am fully committed to taking appropriate actions in response to substantiated cases of harassment, scientific integrity violations, and recommendations from the inspector general,” Freedhoff said in a telephone interview.

Tim Whitehouse, PEER’s executive director, said the organization made the decision to release the documents containing the detailed allegations and officials’ names in part because of a threat Freedhoff reportedly made during a Zoom meeting she held in January with environmentalists who work on toxic chemicals, which Henry also attended. During the meeting, Freedhoff told representatives of environmental organizations that if they publicly suggested individual EPA staff members had been influenced by industry they would no longer be welcome at the regular meetings with the agency, according to several people who were on the call. Freedhoff said that criticism about the individual agency officials was causing her staff to have low morale and that while she welcomed substantive policy suggestions, personnel matters and internal agency disputes were off limits. PEER stated that all “confidential business information” was redacted from the complaints prior to being released to The Intercept.

In the interview, Freedhoff acknowledged making the statement to the advocates but said that her intent was not to stifle criticism. “It’s not about being disagreed with,” said Freedhoff. “It’s about being personally attacked, having the agency be personally attacked, and having individual staff and managers be personally attacked. And I think there’s a really big difference between a personal attack and a substantive disagreement.”

Freedhoff, who joined the EPA in January 2021, described her stance as supportive of agency employees who are still reeling from interference with environmental regulation that was rampant during the Trump administration. “I think the staff, both career and managers, just went through what is probably the four worst years of their professional careers,” she said. “I’m not going to have my staff, after all that they’ve been through, sit through meetings with people who are calling them corrupt.”

Some who were aware of Freedhoff’s comments said they found them disturbing. “This was just a very naked threat to deny access to people who say things she doesn’t like,” said one environmental advocate who attended the January meeting.

“This was just a very naked threat to deny access to people who say things she doesn’t like.”

Kyla Bennett, PEER’s director of science policy, said that she believed Freedhoff was choosing to support some of her staff members at the expense of others. “Freedhoff is assistant administrator for OCSPP. That includes staff and managers. Our clients are her staff too. But she has clearly chosen a side,” she said. Bennett added that she saw the interference with dozens of chemical assessments that the whistleblowers have documented as both a substantive issue and a personnel issue.

Freedhoff’s comments to the advocates came weeks after six major environmental organizations sent a letter to her and EPA Administrator Michael Regan in December asking them to make several changes in response to The Intercept’s reporting on the whistleblowers’ allegations. While acknowledging that the agency had already taken steps to improve scientific integrity in the chemical assessment process, the green groups, including the Natural Resources Defense Council, the Environmental Defense Fund, the Center for Environmental Health, and Earthjustice, argued that the EPA hadn’t gone far enough. The letter asked the agency leaders to clearly condemn and immediately halt the “improper practices” laid out by the whistleblowers. The environmental advocates also asked Freedhoff and Regan to commit to immediately removing staff from supervisory roles “where the evidence shows that they engaged in serious misconduct that failed to conform to EPA scientific integrity principles or otherwise violated agency policies.”

Noting that the EPA had not spoken out about the conduct described by the whistleblowers since the allegations were first made in early July, the representatives of the environmental organizations asked Freedhoff and Regan to take a stand against corruption of the handling of pre-manufacture notifications, also known as PMNs.

“We urge that EPA staff be sent a clear message that the alleged actions will no longer be tolerated, that scientific misconduct in the PMN program will no longer be rewarded and that the overriding goal of PMN reviews will be public health and environmental protection, not rapid approval of new chemicals in order to placate industry submitters,” the letter stated.

“If EPA is serious about scientific integrity, it can’t just sit on its hands.”

Under President Joe Biden, the EPA has repeatedly emphasized its commitment to investigating violations of scientific integrity. But the administration’s fight to clean up the agency has been met with criticism for its reluctance to punish wrongdoers. Accountability has again proved to be a sticking point in the case of the whistleblowers, three of whom were removed from their positions in the agency’s New Chemicals Division during the Trump administration after speaking up about the pressure they faced to downplay chemical risks. Meanwhile, the agency staff who have been accused of interfering with science have been allowed to stay in their jobs in that same division.

Freedhoff defended her choice not to remove the accused officials from their posts by contrasting her decision with the last administration’s handling of staff they saw as problematic. “The previous leadership would remove staff and managers from the roles, divert them to other parts of the agency or OCSPP, or marginalize people who raised concerns about policy decisions, and that honestly left the entire workforce, both the staff and managers, feeling completely unsafe and unprotected,” she said. “I can’t just remove people, staff or managers, from their roles without a normal, standard EPA personnel process.”

But one former senior EPA official who asked not to be identified by name said that transferring managers who have been the subject of well-documented complaints that they interfered with the regulatory process is not comparable to the Trump administration’s removal of scientists who were trying to do their jobs. “I don’t see how you could equate the two situations,” said the former official. “Based on the whistleblower complaints, there are credible and detailed claims with documentation that supervisors engaged in violations of scientific integrity. If EPA is serious about scientific integrity, it can’t just sit on its hands.”

PEER’s Bennett said that delaying action until the conclusion of an investigation by the inspector general has allowed the manipulation of the assessment process to continue and has left the whistleblowers vulnerable to ongoing retaliation. “We are so grateful for the IG’s deep dive into these very complicated allegations. But because we’ve given them so much information, it’s going to take them a lot of time to do it justice and come up with a conclusion,” said Bennett. “In the meantime, while they are investigating, these problems are continuing unabated, which is affecting the public health of every American. And it’s making our clients miserable.” Since coming forward with their allegations, the whistleblowers have been denied advancement within the agency and excluded from opportunities to serve on certain committees and interesting projects. “They are treated as pariahs,” said Bennett.

Asked whether she was aware of any retaliation against the whistleblowers, Freedhoff declined to answer.

Bennett also noted that Freedhoff still works very closely with Henry and that her comments clarified the need for the organization to take additional steps to protect the whistleblowers. “We were working under the mistaken assumption that the Biden administration would take some kind of action to ensure that American health was protected and that our clients were protected until such time as the IG made a final determination,” she said. “But because Dr. Freedhoff so firmly sided with her managers before the IG has come to a conclusion, we felt we had no choice.”

Freedhoff has the daunting task of both reversing the environmental rollbacks made under President Donald Trump and addressing the corruption of the regulatory process that was widespread under the last administration. In some cases, she has been quick to act: In February 2021, the EPA pulled the assessment of the PFAS compound PFBS, citing breaches of scientific integrity. And in March of last year, just seven weeks after she joined the agency, Freedhoff sent an email to staff in the Office of Chemical Safety and Pollution Prevention announcing that “political interference” had also compromised the integrity of the registration of the pesticide dicamba and a risk evaluation of the chemical TCE.

Notably, she made these announcements before the EPA’s Office of Inspector General released its final report on political interference in the dicamba registration process. Freedhoff has taken a sharply different approach to the whistleblowers.

“I want to know why Freedhoff admitted flat out that the dicamba, TCE, and PFBS assessments were tainted by violations of the Scientific Integrity Policy within a month or two of starting but the whistleblowers’ allegations are ‘just differences of opinion,’” said a current EPA staffer, who asked to remain anonymous because of fears of retaliation. “There is no way she was handed a finalized IG report on those three decisions on her first day in office. What gives with the double standard?”

Freedhoff said that in the cases of PFBS, dicamba, and TCE, she and her staff had been very involved in presenting evidence of interference to the inspector general. “We all knew what that report was going to say because it was based on stories that my staff had told the IG,” she said. “They were public already. They weren’t under litigation themselves at the time, and most importantly, the interference in question wasn’t directed by anybody who remained employed at the agency.”

Some environmental advocates said they were sympathetic to Freedhoff’s situation. “She’s juggling a lot — really wanting to fix things, having a staffing crisis, having all these ongoing investigations, and trying to get done all she wants to get done,” said Lori Ann Burd, environmental health program director at the Center for Biological Diversity. Burd, along with several other environmental advocates who work closely with the EPA, also said that Freedhoff has been responsive to their substantive concerns.

But others said they were disturbed by Freedhoff’s attempt to prohibit certain critics from attending meetings. “It’s very, very problematic,” said the former EPA senior official who asked to remain anonymous. “It’s part of the agency’s environmental protection mission to hear from all stakeholders, including those that offer critical feedback.”

One of the environmental advocates present at the January meeting took issue with Freedhoff’s characterization of her statements as defending EPA staff members. “I believe it is a false characterization,” said the advocate, who asked to remain anonymous because of fears of retaliation. “None of the environmental groups who were at the meeting and who signed on to that letter have attacked anyone at EPA personally. Freedhoff is creating a false issue here and trying to seize the high ground.” Instead, the advocate said, “the real broader issue is of Freedhoff not liking criticism and not liking people saying that some EPA actions favored the interests of industry over communities.”

Documents published with this article:

Regulatory Capture of EPA’s Chemical Assessment Process

EPA’s Failure to Consider Toxicity of PCBTF

Deleting and Altering Hazards

Modification of Scientific Data in the New Chemicals Division

Update: March 2, 2022

This article has been updated with comments from an environmental advocate who was present at the January meeting with Freedhoff and disputed her characterization of her comments.

The post Documents Reveal Identities of Three EPA Officials Who Downplayed Chemical Hazards appeared first on The Intercept.

While the assessor worked in the EPA’s New Chemicals division, and the particular paint he was assessing was new, PCBTF is not. The most widely used solvent in the coatings and adhesives industry, PCBTF has been added to products since the 1960s and can be found in ink, caulk, cleaners, stain removal products, polyurethane finishes, primer, graffiti remover, paint for cars, steel and concrete, and garage floors. The chemical has also been used to make other chemicals, including dyes, pharmaceuticals, and pesticides. Each year, between 10 and 50 million pounds of PCBTF are used in the U.S., according to the most recent data from the EPA, and countless workers are exposed at both paint and car manufacturing plants.

PCBTF is on a list of “green” compounds preferred by the EPA because, when used instead of some other solvents, it can help reduce ozone levels. However, while that designation boosts the use of PCBTF, it doesn’t take into account its health effects. Nor has the EPA assessed PCBTF under the updated Toxic Substances Control Act, as is the case for the vast majority of chemicals now in use. In fact, because it was introduced before the Toxic Substances Control Act was passed in 1976, the safety of the compound had not been reviewed at all. Rather, PCBTF was grandfathered in, along with more than 60,000 chemicals that were on the market before the law took effect.

While the EPA had not assessed the safety of PCBTF, other scientists had done so. From a quick search, the toxicologist was able to find concerning evidence of its harms dating back decades. In a 1983 study of 4,000 workers exposed to PCBTF at an Occidental Chemical Corporation plant in Niagara, New York, researchers documented elevated rates of stomach and respiratory cancers. A 2009 report from the National Toxicology Program cited those findings as well as studies showing that mice exposed to the chemical developed liver cancer. The report also noted experiments that had shown the chemical to cause tremors and hyperactivity in rats, as well as lung problems in pups who had been exposed in the womb.

Six months before the case of the new paint landed on the toxicologist’s desk, California had listed PCBTF under Proposition 65, a law that requires public warnings for carcinogenic chemicals. The state’s Office of Environmental Health Hazard Assessment had made the decision based on evidence that the chemical had caused liver tumors in both male and female mice. And just one month before he began considering the new paint, the International Agency for Cancer Research had deemed PCBTF a likely human carcinogen.

In an emailed response to questions for this story, EPA spokesperson Lindsay Hamilton wrote, “While one can accurately state that many of the chemicals that were grandfathered into the 1976 law may pose risks and remain unrestricted under TSCA [Toxic Substances Control Act], the PMN [premanufacture notification] substance subject to this inquiry was not handled inappropriately or inconsistently with TSCA.”

Just a Solvent

The toxicologist found himself in a bind. He felt he should incorporate the information about PCBTF into his assessment. After all, the law requires the agency to determine whether each new chemical substance presents an unreasonable risk to human health or the environment. His job as a human health assessor was to flag chemicals and products that posed an unreasonable risk; surely workers and consumers who breathed in the paint — and thus PCBTF — were facing a risk. When he asked his colleagues, they agreed that the assessment should include the dangers of the solvent.

Yet one official, who holds a senior leadership role in the agency, felt that the dangers of PCBTF should not be mentioned in the assessment. In a December 18, 2019, email she described the chemical as “just a solvent there as a part of making it,” according to screenshots of the email that the whistleblowers shared with The Intercept. (In the hopes of minimizing retaliation against them, the whistleblowers are choosing not to disclose the official’s name.)

Although consumers and workers would be exposed to the chemical regardless of the manufacturers’ intentions, she argued that because PCBTF was not intended to be an ingredient in the final product, its health effects should not be considered in the assessment.

At a meeting that same day, the official, who holds a higher rank within the agency than all the others engaged in the discussion, pointed the scientists to a memo — or rather, she threw it at them, as several of the whistleblowers recently recalled. The 1985 memo addressed when the EPA should assess the risk from a new chemical substance. The official saw it as evidence that PCBTF should not be considered when assessing the paint and told the toxicologists assembled at the meeting to “Read it. Follow it.”

In response to questions from The Intercept, the EPA’s Hamilton referred The Intercept to the same memo and said that it supported the idea that the substance fell under the polymer exemption, which allows manufacturers to avoid submitting certain chemicals for assessment. In this case, however, the company had not opted to submit the product for an exemption but rather for a review.

Most of the scientists who do assessments interpreted the memo differently, pointing out in discussions with the official that some sections seemed to support the inclusion of PCBTF in the assessment and noting that others laid out the possibility of referring the compound to the Existing Chemicals program for assessment. The memo also specified other actions to be taken if the New Chemicals division did not assess the product.

“There’s a final paragraph stating that if there is nothing done, if we’re not going to do the review ourselves, at a bare minimum, the risk managers should be communicating what we found to the chemical company so that they know that they have to take some sort of action,” said Sarah Gallagher, a human health assessor in the Office of Pollution Prevention and Toxics and one of five agency scientists who expressed their support for including the dangers of PCBTF in the assessment of the new paint.

“It does seem that we need to be concerned about the risk of the new chemical plus existing chemicals that pose risk,” one of the toxicologists on the EPA staff wrote in an email to her colleagues. “I think the human health assessors need to feel comfortable that we are doing our best to protect public health.”

Another concurred, noting that “several of us spoke to [New Chemicals Management Branch] in mid-October about this and they supported assessing residuals, impurities” for risk assessments.

By the time they were debating how to handle the assessment of the product that contains PCBTF, tensions between staff who assess the safety of new chemicals and their managers had already reached a point of divisionwide discomfort, with those responsible for writing chemical assessments routinely feeling pressured to dismiss or downplay health hazards they found. They had previously come into conflict with this particular agency leader, who had discouraged them on multiple occasions from noting evidence of the dangers of chemicals in assessments and even, in a few cases, deleted the information they had included in documents without asking or informing them.

In the case of PCBTF, the scientists found themselves once again trying to convince their superior to allow them to do their jobs. They did not succeed.

Delete All References

In a version of the document entered into the division’s computer system on December 17, the toxicologist had included the information about PCBTF, noting that the chemical can be absorbed through the lungs, gastrointestinal tract, and skin. He also identified cancer as one of its hazards, along with liver, kidney, lung, and adrenal gland effects, and calculated the cancer risk associated with precise amounts of the paint. But the next day, hours after the contentious meeting in which the official had tossed the memo, she inserted a note into the assessment, asking the assessor to delete all references to PCBTF.

The toxicologist did not delete the information, so the official did so herself. On December 18, she posted an updated version of the assessment that crossed out the list of PCBTF’s effects and the exposure levels above which it could be expected to cause cancer. In its place, the official inserted a new sentence: “For the new chemical substance (polymer), EPA did not identify a hazard.” The next day, she signed off on the document she had changed, publicly declaring that the agency had found that it did not pose a hazard.

The removal of the scientifically accurate warning that could have prevented people from getting cancer left the scientists who do chemical assessments feeling powerless to do their jobs — and unable to win an argument at the agency on its scientific merits. “You’ve got multiple people saying, hey, this deserves more careful consideration. But she made a call, overrode everybody, shut it down, and we never talked about it again,” said Martin Phillips, a chemist and human health assessor who was involved in the debate over PCBTF.

“Their question is, ‘How little can we get away with? What can we get off our plate?’”

The EPA is both underfunded and subject to specific laws about how assess chemicals, yet Phillips said it could have taken several possible actions to alert the public about the paint. “But the conversation is not, ‘What can we do within these limitations?’” he said. “Instead their question is, ‘How little can we get away with? What can we get off our plate?’”

According to Phillips, the resistance to incorporating the information about the carcinogen into the assessment is in keeping with a larger ethos within the agency of downplaying the harms of chemicals. “When new information comes in that shows that something is less toxic than what we thought, that gets used right away,” he said. “But if it shows that there are new concerns that we weren’t aware of before, suddenly the level of scrutiny goes way up.”

Failure to Follow the Law

Had the original assessment been finalized, the company that made the paint would have been required to include the cancer information in its safety data sheet. That document can guide factory policy, encouraging the use of masks, gloves, and other protective gear, although many consumers and workers are exposed to dangerous chemicals despite the warnings.

The failure to protect workers from exposure to this carcinogen shows that an update to the Toxic Substances Control Act, which passed in 2016, is not working as intended, according to David Michaels, who headed the Occupational Safety and Health Administration during the Obama administration. “The EPA is supposed to be considering whether workers’ exposures could be toxic,” said Michaels. “This is a failure of EPA to follow the law.”

In its statement, the EPA’s Hamilton emphasized the agency’s commitment to following the science in environmental regulation. “Restoring scientific integrity has been a top priority across the Agency since the beginning of the Biden-Harris Administration. Significant efforts are underway to understand and address concerns that have been raised. We are continuing to make improvements to the program and are cooperating fully with the ongoing IG investigation,” she wrote. “EPA’s new chemicals program has been engaging in targeted, all-hands-on deck efforts to catalogue, prioritize and improve its procedures, recordkeeping and decision-making practices related to review and management of new chemicals under TSCA.”

Hamilton noted several steps the agency has already taken to improve scientific integrity, including implementing new processes for scientists to elevate their concerns and get a review wherever there’s disagreement; providing a series of scientific integrity trainings for the entire Office of Chemical Safety and Pollution Prevention; and hiring an independent contractor to identify potential workplace barriers and opportunities for organizational improvement within the office.

If they had the knowledge that the new paint causes cancer, auto body and detailing shops, car manufacturers, as well as other companies and consumers might choose to use another one in its place. But the product is now commercially available without the warning that would give the public at least a chance to make that informed choice.

The whistleblowers are not allowed to disclose its name or anything else about the paint.

Meanwhile, the whistleblowers are not allowed to disclose its name or anything else about the paint because, as is almost always the case, the manufacturers submitted those details to the agency as confidential business information. The EPA staffers could face disciplinary action, including losing their jobs, if they disclosed those details. They can identify PCBTF without penalty because the science showing its carcinogenicity is public.

The case of the mysterious paint points to even bigger problems in the EPA’s chemical regulation. The paint is not the only product that contains PCBTF, yet none of the safety data sheets reviewed by The Intercept for several products that contain it identified the risk of cancer. And PCBTF is hardly the only chemical for which the EPA has failed to update regulations based on the most recent science.

“We never go back and review these cases and put on new restrictions for their use,” said Gallagher, the human health assessor at the Office of Pollution Prevention and Toxics.

A division of the agency’s Office of Chemical Safety and Pollution Prevention is tasked with updating the assessment of existing chemicals. But so far it has only begun reviewing a tiny fraction of the chemicals in use. In December 2019, as the paint case was moving its way through the agency, the EPA was choosing 20 dangerous substances to be evaluated under the updated chemicals law, but those “high priority” assessments are still not finalized. According to Hamilton, those assessments are expected to take three and a half years to be completed. At that rate, it will take the agency more than 7,000 years to review the more than 40,000 chemicals now in use.

Meanwhile, there is no clear way to ensure that the agency updates its assessments — or even informs anyone — when it learns about the harms of a chemical. Even when manufacturers provide the EPA with clear evidence that their products present a serious threat to health and the environment, the agency almost never makes the public aware of that information. In the case of 1,240 chemicals that were the subject of “substantial risk reports” that manufacturers sent to the EPA since January 2019, the agency has failed to update its public database and has not even made the reports available through the computer systems most frequently used by chemical assessors. According to Hamilton, the single person who had been responsible for posting the reports to the EPA’s public database retired in December 2018, and the agency has not had the funds to replace them. “The Biden-Harris Administration has asked for significantly more resources for this program in the 2022 budget,” she wrote.

For the EPA assessors who brought the case of the paint to the attention of The Intercept and filed a report about it with the EPA’s inspector general, the overarching difficulty of protecting people from toxic chemicals makes this particular failure all the more galling. The vast majority of substances never come before EPA toxicologists for review, so the public has no opportunity to learn if they cause cancer and other health problems.

Yet in this case, the agency scientists were being asked to weigh in on a product that poses a clear danger, and they weren’t allowed to inform the public. A high-ranking official in an agency that is supposed to protect human health and the environment stood in their way, an experience they found familiar, frustrating — and baffling.

“Why would someone hear that there’s a cancer risk for workers and not even let people know about it?” asked Gallagher. “Why would they think that that’s something that can just be ignored?”

The post EPA Official Prevented Staff From Warning Public About Widely Used Carcinogen appeared first on The Intercept.

During this time, chemical companies have continued to submit the critical studies to the agency, according to two EPA staff members with knowledge of the matter. Since January 2019, the EPA has received at least 1,240 reports documenting the risk of chemicals’ serious harms, including eye corrosion, damage to the brain and nervous system, chronic toxicity to honeybees, and cancer in both people and animals. PFAS compounds are among the chemical subjects of these notifications.

An EPA spokesperson acknowledged the problem in an emailed response to questions from The Intercept. “Due to overarching (staff and contractor) resource limitations, the agency was not able to continue the regular publication of 8(e) submissions in ChemView, a very manual process, after 1/1/2019.” The statement went on to note: “The TSCA program is underfunded. The previous Administration never asked Congress for the necessary resources to reflect the agency’s new responsibilities under amended TSCA. These shortfalls have implications that matter to all stakeholders, not just industry.” Despite the funding challenges, the EPA pledged to try to rectify the situation.

The Black Hole

Not only has the agency kept all but one of these reports from the public, but it has also made them difficult for EPA staff to access, according to the two agency scientists, who are choosing to remain anonymous because of concerns about possible retribution. The substantial risk reports have not been uploaded to the databases used most often by risk assessors searching for information about chemicals, according one of the EPA scientists, who has worked closely with the 8(e) statements. They have been entered only into an internal database that is difficult to access and search. As a result, little — and perhaps none — of the information about these serious risks to health and the environment has been incorporated into the chemical assessments completed during this period.

“The fact that these studies aren’t being included means there’s a very good chance there are some chemical assessments where we should have reached different conclusions,” said another EPA staff member who is familiar with the chemical assessment process. The information comes in the wake of evidence of dysfunction and corruption in the EPA’s Office of Pollution Prevention and Toxics that five whistleblowers have provided to The Intercept, the EPA inspector general, and members of Congress since July. All five remain employed by the agency and are working with Public Employees for Environmental Responsibility, or PEER, an organization that represents whistleblowers.

According to the emailed response from the agency, “EPA routinely uses all studies submitted to the agency, including 8e submissions, in TSCA new and existing chemical risk evaluations.” The statement acknowledged the difficulty of using the internal database, called CIS, on which the reports were loaded. “Some aspects of navigating CIS may be cumbersome, especially for assessors with less experience in doing so, and EPA has developed plans and proposals for updates and modernization, but their implementation has been hindered by a lack of resources,” it said.

The 1976 Toxic Substances Control Act clearly intended for the EPA to act on the information sent in by industry. And according to an agency spokesperson, each 8(e) submission is promptly reviewed and evaluated to determine the degree of concern that should be attached to it as well as recommendations for appropriate follow-up actions.

But the two EPA staff members who spoke with The Intercept said that the reports do not trigger an immediate response. “I would think most people in the public would assume that when we would get these reports, we give them incredible scrutiny and say, ‘Oh no! What are we going to do about this?’ But basically, they are just going into a black hole,” said one of the two scientists. “We don’t look at them. We don’t evaluate them. And we don’t check to see if they change our understanding of the chemical.”

In its response to The Intercept, the EPA disputed the scientists’ description of the process. “This is not a factual representation of how EPA deals with TSCA 8(e) submissions,” the agency spokesperson wrote, going on to say that agency staff do review the submissions to determine the “degree of concern.”

For decades, companies routinely claimed that much of the information in an 8(e) report could be declared confidential business information, allowing them to strike the name of the chemical from the report and making it impossible to address the harm. In 2010, the Obama administration changed course, announcing that it would begin reviewing the confidentiality claims and, if they were not legitimate, publicly post the reports along with compounds’ names.

The chemical industry pushed back against the policy, arguing that forcing companies to reveal the names of their compounds was a violation of their intellectual property rights. And close observers of the industry believe that pressure from companies that held this view was likely what led the Trump EPA to decide to stop publicly posting the reports.

“It is not easy to keep selling your chemicals when people know they likely cause cancer or other serious disease.”

“It is not easy to keep selling your chemicals when people know they likely cause cancer or other serious disease,” said Eve Gartner, an attorney who manages the toxic exposure and health program at Earthjustice. “It makes perfect sense that in an EPA that was largely controlled by industry, chemical manufacturers would lobby to get EPA to stop releasing significant risk studies, and EPA would agree to keep this basic health and safety information secret.”

Gartner said it’s harder to understand why the Biden administration, which has repeatedly expressed its commitment to scientific integrity, has not already fixed the problem and made this backlogged health and safety information available to the public.

As the scientists who spoke with The Intercept see it, part of the explanation may be budgeting constraints. The Biden EPA was left with a situation that puts public health at risk and is expensive to fix. “The Trump administration created this huge backlog for them, and then it became just this intractable problem,” said one of the EPA scientists, who added that several other staff members have expressed concern about the problem.

In its response to The Intercept, the EPA spokesperson said the agency is planning to address the problem. “The Biden-Harris Administration has asked for significantly more resources for this program in the 2022 budget request to ensure we’re meeting our obligations under TSCA, most importantly protecting human health and the environment. In the future, as resources allow, EPA will continue to strive to make TSCA 8(e) reports publicly available in ChemView in the interest of increased transparency.”

While the Trump EPA stopped posting the 8(e) reports, it was also putting more resources into accommodating the companies the agency regulates, fast-tracking the approval of chemicals they considered high priority, pressuring risk assessors to downplay or ignore the risks presented by chemicals, and creating digital tools to ease the regulatory experience. “Together it shows EPA cares more about industry and getting their products out than it does about protecting human health and the environment,” said Kyla Bennett, director of science policy at PEER.

Toxics, the Next Generation

Even before 2019, when the EPA was making the risk reports from industry publicly available, the agency did not always respond to the information in them with any urgency. In 2016, The Intercept reported on 16 8(e) reports that DuPont submitted to the EPA between 2006 and 2013. The reports detailed the potential dangers of GenX, a then-unknown PFAS compound that the company had introduced to replace another chemical in the same class, PFOA, which had been found to cause thyroid disease, cancers, and other health problems.

The studies showed that the replacement compound caused many of the same health problems in lab tests that the original chemical did, including cancer and reproductive problems. Although the studies were in the ChemView database, the EPA appeared to be unaware of them. The agency had made no public announcements about the information and had taken no actions to protect public health. As an agency employee said of the 8(e) reports to The Intercept at the time, “A lot of them do just get filed away.”

In 2019, The Intercept used the ChemView database to find 40 new PFAS compounds that had been the subject of 8(e) reports. Among the health effects listed in the animal studies the companies sent the agency were neurotoxicity; developmental toxicity; decreased conception; severe convulsions; bleeding in the lungs; tooth problems; post-natal loss; hair loss; depression of sperm function; abnormal development of skulls, ribs, and pelvises; and testicular, pancreatic, and kidney cancers. Despite the concerning reports, all 40 PFAS compounds were allowed onto the market and remain unregulated.

Last week, more than 15 years after DuPont submitted the first of those reports and more than five years after The Intercept first reported on them, the EPA took action on GenX using the 8(e) reports. On October 25, the agency released new toxicity assessments that found two closely related chemicals, both known as GenX, to be very toxic. The assessments were based largely on the information that DuPont sent the EPA in 8(e) reports years earlier. They also included information from a letter Chemours sent the EPA as an 8(e) report in March, which noted that approximately 80 percent of blood samples taken from workers at one of its plants outside the U.S. had tested positive for one of the two GenX compounds.

In the years between the EPA’s receipt of the information about GenX’s toxicity and the assessment, the chemical was released into the drinking water of more than 1 million people in North Carolina.

“This science-based final assessment marks a critical step in the process of establishing a national drinking water health advisory for GenX chemicals and provides important information to our partners that can be used to protect communities where these chemicals are found,” said Radhika Fox, EPA assistant administrator for water, when announcing the finalized assessment.

Yet in the years between the EPA’s receipt of the information about GenX’s toxicity and the assessment, the chemical was released into the drinking water of more than 1 million people in North Carolina. As happened with PFOA and many of the new PFAS compounds introduced after GenX, the chemical was allowed to contaminate the environment and harm countless people — all while the EPA sat on information about its dangers.

A Toxic Pizza Tracker

In 2019, some of the EPA staff members who had been entering the 8(e) reports into the EPA’s public database were reassigned to another project. To help chemical companies track the progress of their products as they move through the approval process, the agency created an online tool that it refers to internally as a “pizza tracker,” which was launched later that year. According to a strategic plan of the Office of Pollution Prevention and Toxics, work on the pizza tracker is expected to continue through 2024.

While acknowledging that it prioritized the chemical tracking process and “that resources used to sanitize and post 8(e) submissions to ChemView … were reduced and eventually stopped,” the EPA denied that funding was “shifted specially” from posting the 8(e) reports to funding the pizza tracker.

Like the Domino’s app, the chemical-tracking tool is user-friendly, allowing companies to quickly and conveniently access information about their products as they move through the regulatory process. The two EPA scientists say that in order to protect public health, risk assessors need to be able to see the industry reports with the same ease. And, they say, taking resources away from protecting the public from health and environmental hazards while directing them toward the  improvement of industry’s experience of being regulated betrays misplaced priorities.

“The whole concept of a pizza tracker is that you’re delivering an order to a customer,” said one of the EPA scientists. “But the companies are not our clients, the public is.”

The post EPA Withheld Reports of Substantial Risk Posed by 1,240 Chemicals appeared first on The Intercept.

The announcement comes after The Intercept reported extensively on allegations of corruption from five whistleblowers within the New Chemicals Division, which is part of the Office of Pollution Prevention and Toxics, and detailed extensive problems within the Office of Pesticide Programs.

The whistleblowers have provided detailed evidence of interference with the assessment of dozens of new chemicals submitted to the agency by companies planning to introduce them to market. The scientists documented intense pressure within the agency to downplay or remove evidence of the potential harms caused by chemicals, including neurological effects, birth defects, and cancer. They also reported that their findings were altered or deleted from assessments without their knowledge.

The EPA described its planned effort to shore up scientific integrity at the New Chemicals Division as “a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOPs), decision-making and record-keeping practices related to review and management of new chemicals under the Toxic Substances Control Act.” The agency’s “New Chemicals Advisory Committee,” one of the two new internal advisory groups, will review scientific and science policy issues related to new chemical submissions.

“Strong, sound science underpins confidence in our decision-making among the public that we serve. Today’s announcements are the latest in a series of steps OCSPP is taking to reaffirm our commitment to scientific integrity and restore the public trust,” said Michal Freedhoff, assistant administrator of the EPA’s Office of Chemical Safety and Pollution Prevention. Since taking office, President Joe Biden has repeatedly expressed his intention to root out the influence of industry on environmental policy, which had flourished during the previous administration.

But Tim Whitehouse, executive director of Public Employees for Environmental Responsibility, the organization representing the whistleblowers, is skeptical that the proposed changes will adequately address the extensive problems at the agency if the EPA doesn’t also punish staff members found to have violated scientific integrity.

“While these processes and procedures can improve the situation within the offices, they cannot change the culture within the agency,” said Whitehouse. “The core problem at EPA that needs to be addressed is that mid-level managers who violate scientific integrity rules and policies need to be held accountable. And that does not appear to be happening.”

The manipulation of chemical assessments that the whistleblowers have brought to light is only a part of a larger problem at the agency, according to Whitehouse. “I would hope that senior managers and political leaders in EPA reach out and personally meet with and talk to, not just our clients, but the dozens and dozens of people that have filed scientific integrity complaints against their management,” he said.

The EPA inspector general is currently investigating the allegations made by the whistleblowers.

The post EPA Plans to Clean Up Troubled Chemical and Pesticide Programs appeared first on The Intercept.

The scientists’ disclosure laid out allegations of corruption within the EPA’s New Chemicals Division and provided detailed evidence that managers and high-level agency officials had deliberately tampered with numerous chemical assessments, sometimes deleting hazards from them and altering their conclusions. The environmental group Public Employees for Environmental Responsibility, or PEER, which is representing the whistleblowers, submitted the complaint to Michal Freedhoff, the assistant administrator of the EPA’s Office of Pollution Prevention and Toxics, the office that contains the New Chemicals Division, as well as to the EPA inspector general, Rep. Ro Khanna, and The Intercept.

The four scientists who worked in the division decided to speak up about the behavior they had witnessed because they feared it could have public health consequences. And they hoped that by carefully documenting and making public their allegations they would spark a thorough investigation and bring an end to the problems. Such complaints are usually kept confidential, but by the next day staff members named in the disclosure had received the document, and within three days the named employees met over Zoom to discuss how to respond — developments that may have compromised the investigation, according to legal experts.

That’s Not the Way It’s Done

At 5:54 p.m. on Monday, June 28, Tim Whitehouse, PEER’s executive director, sent the scientists’ disclosure to Freedhoff. At 5:57, Freedhoff forwarded the document to six people, including Carol Ann Siciliano, who was then the EPA’s deputy science integrity officer; Mark Hartman, deputy director for management of the Office of Pollution Prevention and Toxics, which includes the program featured in the complaint; and Tala Henry, deputy director for programs of the Office of Pollution Prevention and Toxics, whom the complaint describes as having played a role in approving multiple chemicals that had not been properly assessed. Siciliano and Hartman were not implicated in the whistleblower complaint.

On June 29, Henry asked Siciliano to send the complaint to everyone who was named in it, and Siciliano complied later that day. By June 30, a meeting of several of the people named in the complaint had been arranged. Siciliano noted in her email that she believed the allegations entitled the scientists who submitted them to whistleblower protections and that, under the law, “retaliation against whistleblowers is a prohibited personnel practice.”

While the sharing of the disclosure widely within the agency was not a violation of law, several experts in the handling of whistleblower complaints said it was troubling. “The way this was rushed through — to do it at the end of the workday, and then by the next day already to be sending it around to everybody who’s mentioned in it, that’s insane,” said Adam Arnold, environmental counsel at the Government Accountability Project. “That shows a complete lack of process.”

Liz Hempowicz, director of public policy at the Project on Government Oversight, said the EPA’s response seemed defensive. “When there’s a whistleblower disclosure, the agency’s prerogative should be to get to the bottom of the complaint and address any systemic issues coming out of it, not ‘How do we protect our own?’” said Hempowicz. “These actions definitely strike the tone of ‘How do we protect our own?’ versus ‘How do we get to the bottom of this?’”

When they decided to lay out the problems within the New Chemicals Division, PEER and the whistleblowers chose not to publicly name the EPA staff members. “That is primarily because we are not judge and jury,” said Kyla Bennett, PEER’s director of science policy, who has been working closely with the scientists who came forward. “We are presenting evidence. We don’t know why people did what they did or who was doing it for corrupt purposes or who just didn’t know any better or was pressured into doing something that they didn’t want to do.”

“When there’s a whistleblower disclosure, the agency’s prerogative should be to get to the bottom of the complaint and address any systemic issues coming out of it, not ‘How do we protect our own?’”

The group sent the complaint to the EPA inspector general on June 28, asking for an investigation based on the evidence it provided. Specifically, PEER asked for an audit to identify risk assessments that were altered without the knowledge or consent of the risk assessors who wrote them. The group also requested a review of cases in which comments in documents had been erased to see if they violated the EPA’s records management policy and an evaluation of the process “that allowed these improper changes to be made and remain uncorrected.” The same day, the group sent the disclosure to Khanna, chair of the House Oversight Committee’s environment subcommittee, and to the EPA’s Freedhoff.

But sharing the document with the named staff members within the agency and holding a meeting with them to discuss it may have made it harder for the inspector general to investigate. “The secondary transmission to everybody who’s named and then the meeting with all of them, that speaks to me of potentially interfering with an inspector general investigation, which is a big problem,” said Hempowicz.

PEER’s Bennett agreed. “An analogy would be if there’s a murder investigation. You don’t go to all of the people who you think might have done it and give them all the evidence you’ve collected and say, ‘This is what we’re thinking,’” said Bennett. “That’s just not the way it’s done. How do we know they weren’t using that meeting to get their stories straight?”

“Serious Shit”

In an emailed response to questions from The Intercept, the EPA affirmed its commitment to scientific integrity and detailed its efforts to safeguard whistleblowers. “EPA is committed to protecting employee rights, including the important right of all employees to be free from retaliation for whistleblowing. In April 2021, Administrator Regan reaffirmed this commitment by issuing an email to all employees reminding staff of the whistleblower protections available to every federal employee.”

While the EPA did not respond to the comments of Hempowicz, Arnold, or Bennett suggesting that the agency mishandled the disclosure, the statement did describe a new effort to address issues raised by the whistleblowers’ allegations. The agency is hiring an independent contractor to conduct a “workplace climate assessment” within the New Chemicals Division, which has allowed dozens of new chemicals onto the market since the first whistleblower complaint was filed. According to the EPA’s statement, the assessment effort will be expanded to other parts of Office of Chemical Safety and Pollution Prevention over the coming months.

“Participation in this effort is completely voluntary and confidentiality of the information and the identity of individuals participating in this assessment will be protected to the greatest extent possible. OCSPP leadership will use the feedback collected through this effort to understand, evaluate, and, if necessary, make changes in OCSPP’s work practices and culture in order to promote collaboration and enhance the science that OCSPP uses in our program decision making.”

In a training session for EPA staff held yesterday, officials also described an effort to “triage” some of the many scientific integrity complaints within the agency and said that certain staff members would help with the effort. Within OCSPP, the point person was Tala Henry, the same person named in the whistleblower complaint as one of the officials who manipulated chemical assessments. The EPA did not immediately respond to an inquiry about Henry’s involvement in the scientific integrity process.

The EPA statement emphasized the agency’s commitment to the protection of whistleblowers and stated that after receiving the complaint it was immediately shared with the inspector general. “I am committed to ensuring that these matters are reviewed and evaluated fully,” said Freedhoff.

The records released under the Freedom of Information Act by the EPA also show that many others within the agency understood the gravity of the whistleblowers’ allegations. A July 1 inquiry to the press office from The Intercept asking questions about the disclosure was forwarded to at least 20 officials before the agency responded later that day.

Upon reading the allegations, several staff members marveled at the problems the EPA was likely to soon face as a result. “I mean this is serious shit,” wrote Susanna Blair, a special assistant within the Office of Pollution Prevention and Toxics. Alison Pierce, chief of staff of the Office of Pollution Prevention and Toxics, seemed to share her assessment. “Thanks for the heads up,” Pierce wrote in an email after receiving the document. “This is going to be rough.”

The post EPA Officials Exposed Whistleblowers Three Minutes After Receiving Confidential Complaint appeared first on The Intercept.

The EPA gauges the potential risk posed by a chemical using two measures: how toxic the agency considers it and how much of the substance the public will likely be exposed to. Whistleblowers from the EPA’s New Chemicals Division have already provided The Intercept with evidence that managers and other officials were pressuring them to assess chemicals to be less toxic than they actually are — and sometimes removing references to their harms from chemical assessments.

Now new documents, including meeting summaries, internal emails, and screenshots from the EPA’s computer system, along with interviews with whistleblowers and other EPA scientists, show that the agency’s New Chemicals Division has avoided calculating the exposure to — and thus the risk posed by — hundreds of chemicals and have repeatedly resisted calls to change that policy even after scientists have shown that it puts the public at risk.

Call It “Negligible”

Since 1995, the EPA has operated under the assumption that chemicals emitted below certain cutoff levels are safe. Whether a toxic chemical is emitted through the smokestacks of an industrial plant, via leaks in its machinery, or from a leaky landfill into groundwater, the agency requires scientists to quantify the precise risk posed by the chemical only if the release (and thus likely human exposure) reaches certain thresholds. If the releases from both smokestacks and leaks are below the thresholds, the chemical is given a pass. In recent years, however, scientists have shown that some of the chemicals allowed onto the market using this loophole do in fact present a danger, particularly to the people living in “fence-line communities” near industrial plants.

In 2018, several EPA scientists became worried that the use of these exposure thresholds could leave the public vulnerable to health risks. Their concern was heightened by an email that a manager in the Office of Pollution Prevention and Toxics sent in October of that year, instructing the scientists to change the language they used to classify chemicals that were exempted from risk calculation because they were deemed to have low exposure levels. Up to that point, they had described them in reports as “below modeling thresholds.” From then on, the manager explained, the scientists were to include the words “expects to be negligible” — a phrase that implies there’s no reason for concern.

Several scientists who worked on calculating chemical risks believed that there was in fact reason for concern and that the use of the thresholds leaves the public vulnerable to health effects, including cancer. And after being instructed to refer to exposures they hadn’t actually measured or modeled as “negligible,” the scientists proposed dropping or lowering the cutoffs and running the calculations for each individual chemical — a task that would add only minutes to the assessment process. But the managers refused to heed their request, which would have not only changed how chemicals were assessed moving forward but would have also had implications for hundreds of assessments in the past.

“They told us that the use of the thresholds was a policy decision and, as such, we could not simply stop applying them,” one of the scientists who worked in the office explained to The Intercept.

The issue resurfaced in May 2020 when a scientist presented the case of a single chemical the agency was then considering allowing onto the market. Although it fell into the “negligible” category using the cutoffs that had been set decades previously, when the scientists calculated the exposure levels using an alternate EPA model, which is designed to gauge the risk of airborne chemicals, it became clear that the chemical did pose a risk of damaging the human nervous system. The chemical is still going through the approval process.

In February, a small group of scientists reviewed the safety thresholds set by the EPA for all of the 368 new chemicals submitted to the agency in 2020. They found that more than half could pose risks even in cases in which the agency had already described exposure as “negligible” and thus had not calculated specific risk. Again, the scientists brought the exposure threshold issue to the attention of managers in the New Chemicals Division, briefing them on their analysis and requesting that the use of the outdated cutoffs be stopped. But they received no response to their proposal. Seven months later, the thresholds remain in use and the risk posed by chemicals deemed to have low exposure levels is still not being calculated and included in chemical assessments, according to EPA scientists who spoke with The Intercept.

The internal struggles over exposure present yet another example of managers and senior staff working to undermine the agency’s mission, according to the EPA scientists. “Our work on new chemicals often felt like an exercise in finding ways to approve new chemicals rather than reviewing them for approval,” said one of two scientists who filed new disclosures to the EPA inspector general on August 31 about the issue. The detailed account of corruption within the New Chemicals Division that four whistleblowers previously submitted to members of Congress, the EPA inspector general, and The Intercept also included information on the ongoing problems caused by the use of the exposure thresholds.”

“It all comes down to money.”

“It all comes down to money,” said Kyla Bennett, director of science policy for Public Employees for Environmental Responsibility, or PEER, the organization representing the whistleblowers, who pointed out that risk values above the agency’s accepted cutoffs require the EPA to impose limits that may make a chemical harder to use — and sell. “Companies don’t want warning labels, they don’t want restrictions.”

It’s unclear why some senior staff and managers within the EPA’s New Chemicals Division seem to feel an obligation not to burden the companies they regulate with restrictions. “That’s the $64,000 question,” said Bennett, who pointed out that EPA staffers may enhance their post-agency job prospects within the industry if they stay in the good graces of chemical companies. She also noted that managers’ performance within the division is assessed partly based on how many chemicals they approve. “The bean counting is driving their actions,” said Bennett. “The performance metrics should be, how many chemicals did you prevent from going onto the market, rather than how many did you get onto the market.”

In response to questions about this story, the EPA referred The Intercept to a statement it provided for two recent stories based on disclosures from whistleblowers at the agency. That statement said, in part, “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.”

Failure to Calculate Cancer Risks

For some chemically induced health problems, such as eye irritation, there may be low levels of exposure that are safe. But the idea that even extremely poisonous substances are harmless in tiny amounts has become complicated since the Swiss scientist Paracelsus first introduced it more than 500 years ago. Cancer is one of the conditions that can result from even minuscule exposures. Since at least 2005, the agency’s cancer guidelines have instructed scientists to assume that there is no safe level of agents that are “DNA-reactive” and have “direct mutagenic activity.”

Yet managers within the New Chemicals Division have inappropriately dismissed the risk of cancer based on the assumption that a chemical would be diluted in the air, according to evidence presented by the whistleblowers. This was the case for at least two chemicals assessed this year. One, which the EPA deemed “not likely to present an unreasonable risk of harm” in March, is used as a component of adhesives. Another, a dialkyl sulfate — part of a class of chemicals known to cause cancer in animals — was one of 13 similar new chemical submissions the agency received between June 2020 and August 2021.

EPA managers took several steps to make the dialkyl sulfate chemical appear safer than it really is, according to one of the disclosures provided to the inspector general in late August. Because they didn’t have sufficient testing of the substance itself, the scientist assessing it chose a closely related compound to gauge its risks. But a manager replaced that analogue, which causes miscarriages in animal experiments, with another, less harmful chemical, which allowed the agency to officially dismiss concerns about harms to the developing human fetus, according to the whistleblowers.

“You don’t always find risk when you look for it. But they’re not even trying.”

Information about exposure was also added to the assessment of the dialkyl sulfate compound without the knowledge of the scientist who wrote it. The assessment calculated that the chemical posed a cancer risk and acknowledged that it might cause genotoxicity, or damage to the genes, which can lead to cancer. But according to a change that a manager in the division made in June without the scientist’s knowledge, genotoxicity is not a concern “due to the dilution of the chemical substance in the media.”

The New Chemicals Program also dismissed the need to assess the cancer risk for the entire class of chemicals on the grounds that they would likely react with water in the air, forming a less toxic compound that would not pose a risk to people in the surrounding community. The whistleblowers disagree, noting evidence that related compounds can remain in the air for at least eight days.

“The Agency is failing to calculate potential cancer risks to the general population based on the fallacy that a chemical is expected to be ‘diluted’ in the air,” they wrote. While the EPA has not officially calculated the potential cancer risk of all the recently submitted chemicals in this class, one of the whistleblowers has done so and found that some of them do pose a significant cancer risk. “You don’t always find risk when you look for it,” the scientist said. “But they’re not even trying.”

The post New Evidence of Corruption at EPA Chemicals Division appeared first on The Intercept.

The only problem? The science didn’t show that the chemical was safe.

Irwin, who has a doctorate in biochemistry and molecular biology and three board certifications in toxicology and has worked at the EPA for 12 years, was asked to greenlight the chemical in May 2020. But he had already found reason to be concerned about the chemical’s effects on developing fetuses. Because the manufacturer hadn’t submitted any health studies, he had found an analog — a structurally similar chemical to help predict its effects. That compound was bisphenol A, or BPA, an additive to plastics that is well known to cause reproductive problems as well as immune and neurological effects. Irwin had noted his concerns and a lack of studies that could allay them. His work on the assessment, a document that determines if and how a chemical is allowed to be used, also pointed out that workers faced risks from both breathing and touching the chemicals.

Hair on Fire

But because the chemical fell into a category known within his division as “hair-on-fire” cases, high-priority situations in which manufacturers object to scientists’ findings that their chemicals pose hazards, the conclusions Irwin reached in the assessment were scrutinized and ultimately changed. After he refused to sign off on the altered findings, a higher-ranked employee in the division took over the case and used a different — and, according to Irwin, scientifically inappropriate — approach that allowed the agency to avoid calculating the developmental risks posed by the chemical. On June 15, 2020, the agency posted the final risk assessment of the chemical, which minimized risks to the general population and didn’t calculate the risks to workers that Irwin had highlighted.

Because of confidentiality claims by the manufacturers, Irwin and his colleagues who spoke with The Intercept felt that they were legally bound not to reveal the names of this and other chemicals mentioned in this story.

As The Intercept reported in the first installment of this series, managers within the EPA have pressured health assessors to minimize and downplay the risks posed by chemicals for use even when there is clear evidence that they present harms. That reporting was based on extensive information provided by four whistleblowers — Elyse Osterweil, Martin Phillips, Sarah Gallagher, and William Irwin — who worked as health hazard assessors in the new chemicals division of the agency. This article is based on new information from those whistleblowers along with one additional EPA risk assessor, who has recently come forward but has chosen to remain anonymous because of fear of retaliation.

Through documents, interviews, and a written disclosure that they provided exclusively to The Intercept, the EPA inspector general, and select members of Congress, these government scientists have detailed some extreme examples of interference with the scientific evaluation of chemical safety. Working with Public Employees for Environmental Responsibility, also known as PEER, an environmental group that helps whistleblowers, they laid out the process through which industry exerts particular pressure in “hair-on-fire” cases — sometimes through members of Congress — to expedite the approval of chemicals or minimize their restrictions.

In these cases, some EPA managers have worked hand-in-hand with industry to fend off the safety concerns raised by the agency’s own scientists about new chemicals entering the marketplace. While not all of the instances of manipulated chemical assessments were designated “hair on fire,” these high-priority cases have become so common that the division of new chemicals has arranged to have someone always available to oversee them. Since at least January 2021, managers have been on a rotating schedule for “HOF Duty,” as it’s called on internal calendars.

EPA managers use a variety of tactics to persuade staff scientists to change their assessments in these cases, according to the whistleblowers, including emphasizing the displeasure and impatience of the companies that make the chemicals; criticizing the scientists for taking too long to approve chemicals in their performance reviews; and even insinuating that individual assessors will be sued by the chemical manufacturers if they insist on standing by their findings. In several cases in which the whistleblowers refused to make changes, other EPA employees deleted or altered the information in the documents without their approval or knowledge.

So great are the tensions in the new chemicals division that managers recently sought to have their internal computer system revised so that they could automatically override staff scientists in some “hair-on-fire cases,” according to audio obtained by The Intercept. In a November 18, 2020, meeting with information technology contractors who were working on the new chemical review tracking system, managers of the division suggested adding a new button to the interface that with a single click would enable these high-priority cases to bypass scientific review from staff and go straight to management.

“Is there a way to override it all?” a division manager asks at the meeting. “So for example, say there are nine open discussions but then we suddenly had to expedite a case due to some hair-on-fire situation, uh, do we need nine people to go in and close out these discussions for it to move forward or, uh, does, is there an all-powerful person like [name removed] can come in and override everything?”

Ultimately, the division manager and the consultant did settle on just this plan at the end of the meeting. “Yes, we’d, we’d like a button or something, and then we’ll assign whoever that person or persons may be to override everything,” the division manager says. It’s not clear whether the override button has been implemented.

“Okay. Uh, override meaning that this turns to green?” the consultant clarifies.

“Yes.”

“OK, perfect.”

The Chocolate Factory

The EPA has the authority to prevent new chemicals from entering the market if they present an unreasonable risk to human health or the environment. But the agency’s division of new chemicals didn’t do that for any of the 3,835 new chemical applications submitted to the agency between June 22, 2016, and July 1, 2021. In response to questions, the EPA pointed out that, during that period, 3,256 cases were reviewed; of those, 266 were determined to be invalid or incomplete and 11 were required to undergo further testing. But not a single chemical was “prohibited from commercializing,” according to the EPA’s own data. Instead, whether in “hair-on-fire” or regular priority cases, health assessors who identified hazards caused by chemicals routinely faced intense pressure to dismiss or downplay them. According to the whistleblowers, there is a strong expectation that assessors should not just deem chemicals safe but also do so quickly.

The law gives the EPA 90 days to respond to a new chemical submission. But determining whether chemicals are safe can be time-consuming, especially since the assessors often receive very little information about their health effects. In some cases, companies provide only the chemical name and structure without any information on health and safety. To properly vet them, assessors need to find and read through relevant studies and sometimes seek opinions from outside experts. Yet the whistleblowers said they were regularly encouraged to pass even these mysterious chemicals so quickly that they were often unable to thoroughly review them.

“We’re not being given enough time,” said Gallagher, a toxicologist who worked as a human health assessor in the Office of Pollution Prevention and Toxics. “We need time to figure out if there are experts we need to talk to. But we’re being told to get cases done within two days of our hazard meeting.” In addition to evaluating the safety of new chemicals, the assessors say they were increasingly asked to make changes to cases they had already completed. “I got cases I finished four months before, and they would want me to make substantial revisions that were deviations from our process, and it’d be thrown on top of my current work,” said Gallagher, who likened the experience to the “I Love Lucy” episode set in the chocolate factory. “It was speeding up and speeding up, and we had more and more, and we just couldn’t keep up with it.”

Irwin said he regularly had to work on weekends to keep up with the workload and was even asked to hand in two complex assessments by the end of the day immediately after telling his supervisor that he had to go home because he was experiencing severe chest pain.

All four whistleblowers have been reprimanded for not moving quickly enough when reviewing new chemicals. Gallagher’s supervisor told her that she had difficulty “letting go when a decision was made” about a particular chemical. In that case, someone else had changed her assessment, removing information she had included about the chemical’s carcinogenicity.

Irwin’s supervisor cited his refusal to sign off on the assessment of the chemical that was similar to BPA as a reason to downgrade his performance rating in an annual review. And Martin Phillips, another of the whistleblowers, was also criticized for the timeliness of his assessments in his performance review.

Similarly, in a June 21 performance review shared with The Intercept, Elyse Osterweil’s supervisor accused her of having a “pattern of providing late and incomplete work products.” According to Osterweil, these delays were the result of her refusal to capitulate to the pressure to deem certain chemicals as safe based on evidence that they may cause specific harms, including birth defects and cancer. Yet her supervisor pointed out that the missed deadlines “resulted in the Agency being contacted by several outside submitters, on several occasions, to express their dissatisfaction with the timeliness of cases assigned to you.”

Insufficient Data

Assessors can halt or delay approval if they don’t have enough information to declare a chemical as not likely to pose an unreasonable risk. But their superiors often push assessors to find chemicals safe even when they lack the data they need to know that. That was the case with a chemical that was granted conditional approval for manufacture in April 2020 despite the fact that both Gallagher and Phillips said a two-year carcinogenicity study was necessary to assess its cancer-causing potential.

Managers also reassigned a chemical that Gallagher was assessing after she made it clear that she believed it could be dangerous. Gallagher was concerned that the chemical, which is slated to be used as a spray coating for cars, could have respiratory effects on workers who use it. But a supervisor insisted that the assessment describe the chemical as “low risk.” In a March 2020 email, Gallagher was instructed to remove all references to hazards. Gallagher refused; hours later, she was told that the chemical, along with all but one of her other cases, had been reassigned to other assessors. Two months later, the chemical was approved for use and found “not likely to present an unreasonable risk.” Two months after that, Gallagher was removed from the program entirely.

Even when assessors do succeed in getting hazards listed in their assessments, the submitting companies often dispute them. In some cases, companies have resubmitted applications for new chemicals more than 10 times. While the EPA does need to communicate with chemical manufacturers, according to the whistleblowers, some managers regularly talk with company representatives by cellphone and have been heard encouraging their industry colleagues to avoid communicating by email because it is subject to public records requests.

While chemical assessors’ original recommendations to new chemical applications used to be publicly available, that policy changed under the Trump administration. Then-EPA Administrator Scott Pruitt removed information about the process of reviewing new chemicals, including records of meetings with manufacturers and concerns staff scientists have or studies they recommend, from the EPA website. Although President Joe Biden and current EPA Administrator Michael Regan have vowed to prioritize science and root out corruption, this policy remains in place under the current administration. And the whistleblowers contend that the pressure to minimize and remove risks in chemical assessments continues unabated.

In an emailed response to questions about this story, the EPA wrote 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.”

The statement also said that EPA leadership is reviewing these complaints and that any appropriate action will be taken. “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.”

Threats and Intimidation

In June 2020, Osterweil was working on a chemical that she believed could cause severe developmental harms. Her suspicion was based on the molecular structure of a chemical that forms as the body processes the chemical under review — which is associated with effects such as missing bones, clubfoot, and extra fingers. After she submitted her draft report, the manufacturer rebutted her finding. A consultant for the company made repeated calls to EPA about the urgency of changing her report. After one call, the manager of the case called to tell her that the company was considering a lawsuit over her scientific assessment and suggested that they may have to “lawyer up,” which Osterweil took to mean that she might be sued as an individual.

Osterweil, along with Phillips and Gallagher, had already heard vague threats about the wrath of companies angered over their science. In 2019, a manager who was frustrated that they wouldn’t delete a cancer hazard wrote in an email to the three of them that “you all can defend when the companies come in to discuss cancer hazard.”

“Regardless of how good of a scientist you are, they can still ruin your credibility.”

But the threat of being sued as an individual weighed on her. “I was worried that my credibility as a scientist would be marred,” Osterweil said. A single mother, she also feared that she would lose her job. “Regardless of how good of a scientist you are, they can still ruin your credibility.”

The legal threat is just one of the forms of harassment endured by the whistleblowers, who described incidents of shouting, name-calling, and disparagement of their work in front of colleagues.

Irwin described one interaction in which a highly ranked colleague, who also happens to be tall and muscular, was trying to convince him to change the safety threshold of a chemical. “He came to my cube one time, towering over me while I was in my chair,” said Irwin. “He wanted to have a benchmark of two instead of 1,000. And he was shouting at me.” Irwin said he felt threatened and that the intimidation was a key part of the pressure to change scientific findings. “That’s the main mechanism, how they achieve their goal for us to delete hazards — they bully us to do it.”

In the case of the chemical that she believed presented a developmental hazard, Osterweil also faced escalating pressure to use a study done by the manufacturer, which had already been deemed scientifically unacceptable. Although she wasn’t personally sued, by August 2020 the case in which they were told to “lawyer up” was escalated to the level of “hair on fire.” In November, a consultant who worked for the company that submitted the chemical and had previously worked at the EPA arranged a meeting with one of Osterweil’s superiors, who was a personal friend. And on December 21, 2020, when Osterweil was out of the office, an updated assessment of the chemical was uploaded to the agency’s system.

Although she had resolutely refused to change her conclusion about the threat posed by the chemical, the new document dismissed the information Osterweil had inserted about the developmental hazards. Instead, it was deemed unlikely to present an unreasonable risk — making it a “not likely,” in the agency’s parlance. The industry had once again won the battle over a chemical assessment — getting the risks of its product minimized and speeding up the review process. In an email sent by Osterweil’s supervisor that day, she wrote, “Please move this Not Likely expeditiously, as the submitter is anxious.”

In June, after several of the whistleblowers had filed complaints with the EPA’s science adviser and the EPA inspector general, the assessment was again changed, this time to reflect that the chemical “may present an unreasonable risk of injury to health.” It was nevertheless allowed onto the market.

The post Leaked Audio Shows Pressure to Overrule Scientists in “Hair-on-Fire” Cases appeared first on The Intercept.

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 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.

“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. “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. “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 pregnant rats themselves rather than direct effects on the fetus. 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.

“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.”

“He basically was siding with the company.”

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. “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. “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.”

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. “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. “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.”

The post Whistleblowers Expose Corruption in EPA Chemical Safety Office appeared first on The Intercept.