US Ecology, a hazardous waste company with dozens of sites around the U.S., received 11,638,732 pounds of waste containing the firefighting foam known as aqueous film-forming foam, or AFFF, at its facility in Beatty, Nevada, in 2020, according to public reports filed under the Resource Conservation and Recovery Act. The company has also received, and did not report, waste containing AFFF at its facilities in Robstown, Texas, and Grand View, Idaho. It is unclear whether the company’s failure to disclose the waste violated the law or whether it was legal under a loophole in the reporting requirement.

US Ecology referred questions for this story to Republic Services, a waste management company that acquired US Ecology in May. Republic Services did not respond to multiple requests for comment.

AFFF — which has been used for decades by firefighters in the military, airports, and other settings to put out jet fuel fires — contains PFAS chemicals that have been detected in drinking water across the country, as The Intercept was the first to report in 2015. (At the time, PFAS chemicals were known as “PFCs.”) PFAS have also been used to make Teflon and hundreds of other products, and some of the compounds have been shown to cause health problems, including immune deficiency, cancer, liver damage, thyroid disease, decreased fertility, obesity, hormonal irregularities, and high cholesterol.

In 2019, as the public became increasingly aware of the health risks from widespread water and soil contamination from PFAS, Congress passed the National Defense Authorization Act, which required the EPA to add certain PFAS compounds to the Toxics Release Inventory, or TRI, a public EPA database to which companies must legally report if they have “manufactured, processed, or otherwise used” certain chemicals. There are now 180 PFAS compounds on the list.

EPA Loopholes Violate Law

But there are critical gaps in the requirements for reporting PFAS-containing waste, as the massive amount of unreported waste at the Nevada facility suggests. There is a 100-pound reporting threshold for PFAS chemicals — a huge amount considering that even extremely low levels can cause health problems. The agency recently acknowledged the threat when it set dramatically lower safety thresholds for levels of PFOA, PFOS, and two other PFAS compounds in drinking water in June.

The EPA allows companies to avoid reporting PFAS to the TRI, through a loophole known as the “de minimis exemption,” if the individual PFAS compound makes up less than 1 percent of the total volume of the waste — or .1 percent, in the case of PFOA. But AFFF often contains multiple PFAS chemicals, and even low concentrations of a single compound can add up to extremely dangerous amounts — especially when large quantities are involved, as is the case with the 11 million pounds of AFFF-related waste at the US Ecology facility in Beatty, a small town northwest of Las Vegas.

The loopholes undermine the intent of the Emergency Planning and Community Right-to-Know Act, according to advocates. The law, which was passed after a leak of poisonous gas killed thousands in Bhopal, India, enabled community members and environmental agencies to learn about chemical releases and pollution control measures reported by local companies. “Without it, it’s impossible for regulators to have any idea where they might have hot spots of pollution, where they might have industries where they should be looking into wastewater permitting, where these chemicals are being burned, where you might need to put a fish advisory in place,” said Sonya Lunder, the senior toxics policy adviser at the Sierra Club.

According to Eve Gartner, the managing attorney for the Toxic Exposure and Health Program at Earthjustice, the exemptions violate the letter and spirit of the 1986 law. “The fact that EPA made PFAS subject to these exemptions was an illegal move that was first adopted during the Trump administration and has now unfortunately been replicated two times in the Biden administration,” said Gartner, who sued the EPA in January on behalf of the Sierra Club, the Union of Concerned Scientists, and the National PFAS Contamination Coalition over the issue. “This is not at all what Congress intended.”

In an emailed response to questions from The Intercept, EPA spokesperson Timothy Carroll wrote that the agency plans to address the problem soon. “This fall EPA plans to propose a rulemaking that would classify certain PFAS as ‘chemicals of special concern,’” Carroll wrote. “Such a rule, if finalized, would increase PFAS reporting under TRI by, among other changes, removing the eligibility of the de minimis exemption for PFAS for reporting and supplier notification purposes — reversing the approach set forth by the previous Administration. Until such a rule is finalized, EPA must continue to allow the de minimis exemption.”

Over the past year, Gartner and her staff have compared filings under the Resource Conservation and Recovery Act, which requires reporting of hazardous waste, with records from the TRI. The results showed that several companies that reported receiving hazardous PFAS waste under the law did not report the waste to the TRI. US Ecology had the largest amount of unreported material, according to Earthjustice research, but other companies also reported significant amounts of the compounds under the RCRA and failed to disclose them to the TRI, which requires more detailed and in-depth information.

On August 3, the Sierra Club sent a letter to Republic Services inquiring about the unreported waste and providing records that it says suggest the company violated the TRI’s reporting requirements.

Advocates fear that many other companies may be failing to report PFAS to the TRI. “These chemicals are circulating in products and in ways throughout the United States with almost no tracking and ability to know where they’re going and where their final destination might be,” said Lunder.

Gentle Reminder

The EPA also may have noticed the discrepancy between the RCRA and TRI records, according to emails obtained through a public records request. In one sent to US Ecology in July 2021, a senior chemical engineer at the EPA named Velu Senthil wrote, “Your facility has not submitted any report for Hexafluoropropylene oxide dimer acid to TRI for reporting year 2020, but might have received Hexafluoropropylene oxide dimer acid in excess of processing / otherwise use reporting threshold amounts from one or more TRI facilities for waste management activities such as disposal and/or treatment. Please review and submit new report for Hexafluoropropylene oxide dimer acid for reporting year 2020, if required.”

The email referred to a PFAS compound that was added to the TRI’s list of reportable chemicals in 2020. According to the law, companies may be fined up to $25,000 for each day they are in violation of the Emergency Planning and Community Right-to-Know Act. But Senthil was clear that he didn’t intend to punish them.

“This inquiry does not assume that there is a reporting error,” he wrote in the email. “Rather, EPA would like to provide you an opportunity to review and validate your submission(s) regarding the below observation(s) and make correction(s), if necessary.”

The EPA has given companies the opportunity to review and change their TRI reporting before. As The Intercept previously reported, under President Donald Trump the agency encouraged some facilities that emit ethylene oxide to lower the amounts of releases of the carcinogenic gas that were recorded in the TRI.

But according to Earthjustice’s Gartner, the most alarming aspect of the EPA’s communication with US Ecology about its TRI reporting isn’t the gentle tone or omission of any possible penalties but its failure to mention that the company had also apparently received and failed to report more than 11 million pounds of AFFF-containing waste in addition to the hexafluoropropylene oxide dimer acid.

“When you compare our letter to US Ecology with EPA’s letter to US Ecology, they’re night and day,” said Gartner. “I’m glad they asked about that chemical if they thought maybe there was noncompliance for that chemical. But if EPA was looking at the same RCRA manifests that we were, why didn’t they say anything to US Ecology about receiving 11.6 million pounds of PFAS-contaminated AFFF?”

Enforcement is key to making the TRI meaningful, according to Gartner. “Because if this law is just an empty promise to communities, it’s really not going to do anything. The facilities have to know that if they don’t comply, there will be enforcement,” she said. “So they have to be honest about the level of PFAS they’re manufacturing using and releasing.”

The EPA’s Carroll said the agency is doing all it can to address the PFAS problem.”EPA is leveraging the full range of statutory authorities to confront the human health and ecological risks of PFAS,” Carroll wrote. “These actions include a regulatory process to remove exemptions and exclusions that limit the quality of TRI data, expanded unregulated contaminant monitoring of 29 PFAS in more drinking water systems and at lower levels than ever before, and a commitment to use enforcement tools to better identify and address PFAS releases at facilities.”

Everyone Is Exposed

The discovery that huge amounts of PFAS-contaminated waste are escaping the EPA’s chemical tracking system comes just as the agency has begun to acknowledge the extreme toxicity of these industrial chemicals. The drinking water advisories the agency set in June are just .004 parts per trillion for PFOA and .02 parts per trillion for PFOS — which are roughly 1,000 times lower than the previous standard and below the current limits of detection.

The updated advisories are likely to mean that everyone encounters chemicals at levels above what the EPA has deemed safe. “My guess is that there are no people on the planet who have that kind of low exposure,” said physician and environmental health researcher Philippe Grandjean.

Grandjean, who studies the immune effects of PFAS, has known for years that extremely low levels of the chemicals can be dangerous. In 2008, he noticed a study that showed that mice exposed to the chemicals had decreased immune function. And in 2012, he documented the same phenomenon in children living in the Faroe Islands.

By analyzing the blood of children before and after they were vaccinated for tetanus and diphtheria, he found that those with lower levels of PFAS had stronger responses to vaccinations. His findings, which were published in the peer-reviewed Journal of the American Medical Association in 2012, were striking: Among 7-year-olds who had been vaccinated against diphtheria, higher levels of PFAS were associated with lower levels of antibodies to those diseases. For each doubling of exposure to the chemicals, the risk that the vaccine didn’t take increased two- to four-fold.

The following year, Grandjean calculated that the safety levels for both PFOS and PFOA should be less than 1 part per trillion. Yet until June — more than a decade after Grandjean’s results were first published — the EPA’s official safety threshold sat at 70 parts per trillion.

Deadly Delay

A similar lag has plagued the EPA’s handling of PFAS waste reporting, according to environmental advocates. The agency has taken more than a decade to begin tracking the chemicals around the country, even though it was clear as far back as 1999 that some members of the class were toxic. By 2006, the EPA had helped craft a voluntary agreement with eight companies to phase out the use and production of PFOS and PFOA, two of the best-known PFAS compounds. At the time, the agency issued a press release stating that it was “initiating efforts to add PFOA and related chemicals to the Toxics Release Inventory.” But PFOA and PFOS were first added to the list of reportable chemicals in 2020, more than a decade after the EPA said it had begun the process.

“The failure to list PFAS on the TRI as soon as EPA knew how toxic and persistent they were was a major failure that led to the loss of lives,” said Gartner, who pointed to the EPA’s 2006 announcement that it had begun the process of adding two PFAS compounds to the inventory. “That didn’t actually happen until 2020 — so 14 years of delay in giving communities information about releases of PFOA and PFOS into their drinking water. And that’s unacceptable.”

The post Massive Quantities of PFAS Waste Go Unreported to EPA appeared first on The Intercept.

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.

The graduate student recovered and left the hospital two weeks later. But the incident, which was written up in the journal Emerging Infectious Diseases in 2014, proved scientifically important. Not only did it allow for the identification of the Sosuga virus — a paramyxovirus named for Southern Sudan and Uganda — and the knowledge that the bat virus can infect and sicken people, the woman’s infection also pointed to the dangers posed by the kind of research she was doing: trapping, manipulating, and dissecting animals suspected of being infected with novel disease-causing viruses.

Biosafety experts have long worried over the possibility that scientists seeking dangerous viruses in the wild could inadvertently become infected in the course of either capturing or coming into contact with the saliva, urine, or feces of the animals. The case of the Sosuga virus shows that those concerns are well founded.

Virus hunter Michael Callahan, an infectious disease doctor who has worked for federal agencies on global disease outbreak and the tracking of wildlife pathogens, has vividly described the high risks faced by field researchers. “Squirming, clawed and toothy animals bite and scratch during collection of body fluids. Teeth and talons easily penetrate the thin gloves required to maintain dexterity when handling fragile wildlife,” he wrote in Politico in 2021. “The fact that researchers are not infected every time they do a field collection is a question that continues to stump us.”

With more than 6 million people now dead from Covid-19, the catastrophic potential of a researcher becoming infected with a wildlife pathogen has become inescapable. While the origins of the current pandemic are still unclear, it remains possible that virus hunting could have been the cause. Rocco Casagrande, a biochemist who was hired by the National Institutes of Health’s Office of Science Policy to assess the risks of gain-of-function research, thinks a natural spillover of the virus from animals to people, a lab accident, or what he calls a “prospecting based accident” are equally likely potential causes of the initial outbreak. He imagined the prospecting scenario as “the researchers in Wuhan looking for bat viruses found one and got infected outside of the lab.”

Even as the very real chance remains that the search for new viruses led to this cataclysmic event, scientists hoping to prevent viral outbreaks continue to seek out new bat coronaviruses and other potential pandemic pathogens around the world.

Ask the Bats

The search for pathogens that infect animals is driven by the desire to prevent and prepare for their possible transmission to people. But that work, which spans the globe and is funded in large part by the U.S. government, can sometimes result in human infection — exactly the outcome it is meant to prevent.

Virus hunting — or wildlife disease ecology, as DeeAnn Reeder prefers to call it — is a field that has come under increasing scrutiny during the Covid pandemic. For Reeder, a professor of biology at Bucknell College who led the 2012 expedition on which the graduate student was infected, one of the central purposes of her research in Africa on bats’ immune responses to viruses is to understand how humans might react to the same infectious agents, knowledge she says can protect us if the pathogens jump from animals to humans. “If you want to understand how to survive a coronavirus, or if you want to understand how to survive a filovirus — Ebola fits within that context — you need to ask the bats because they know how to do it,” said Reeder.

Reeder, who put up her first bat net in South Sudan in 2008, continues to do wildlife research in Uganda. No one has previously reported her connection to the work. “I’ve never been contacted by a reporter on that particular story,” Reeder said, after being asked whether the Sosuga virus infection occurred during research on one of her projects. “I’ve always been surprised about that.” Reeder would not confirm the identity of the researcher on her project who was sickened, citing privacy concerns.

The Sosuga case shows that concerns about viral transmission from wild animals to researchers are not just theoretical. It is still unclear exactly how the infection occurred. While the graduate student only occasionally used protective gear when working with animal specimens, when she visited the bat caves she wore a paper Tyvek suit that’s become the hallmark of virus hunters, gum boots, bite-resistant gloves, and even an air-powered respirator known as a PAPR that looks like an astronaut’s helmet. The researcher did not report being bitten or scratched by any of the animals she encountered.

CDC scientists approach Bat Cave in Queen Elizabeth National Park on August 25, 2018, Uganda.“Maybe outside the cave before they put the respirators on, she leaned against a rock that had been peed on, because we know that it could be in the kidneys of this particular bat species,” said Reeder. “But that’s just conjecture, which is the scary part.”

Cowboys and Cowgirls

Reeder carries a card in her wallet she hopes medical professionals will read should she herself wind up in the emergency room with a mysterious infectious disease someday. “It says, ‘Attention medical personnel: I study wildlife disease. Here’s all the things you should test me for should I present to you in the emergency room,’” she explained.

Reeder describes herself and other researchers in her field as “a little bit like cowboys and cowgirls — we go to a foreign place and we catch exotic things.” Yet she’s grown increasingly cautious during her years in the field. “When I first started this work, nobody was wearing PPE. It just wasn’t a thing,” she said. “I thought we were good if I didn’t have my coffee cup on the same table when I was doing dissections.”

Despite her growing concern about biosafety, Reeder has still had a few worrisome interactions with bats herself. “I had one bite me. That big canine tooth went right into my knuckle, and for like two years, whenever it was cold, my knuckle would hurt,” she recently recalled. And in 2017, Reeder was stuck with a needle that had just come out of a bat that she knew could have carried the deadly Ebola virus.

“I was like, wow, OK. So I make notes in my notebook, started counting 21 days, which is the incubation period for Ebola,” said Reeder. “I’m mostly kind of flippant about that. But I can tell you I knew when that 21 days was up.”

Yet even after these experiences, Reeder said there are rare times when she still eschews personal protective equipment: “If I’ve got a live bat, I can’t go into a village and show up in my space suit.”

Most interactions with bats don’t cause disease. But the risk of viral infections remains — and many professional scientists and hobbyists don’t even take the basic precautions to protect themselves from it, according to a study published in 2021 in Biodiversity Data. The authors, who include Reeder, analyzed 759 of the more than 43,000 photos of people holding bats taken that were uploaded since the 1980s to iNaturalist, a popular biodiversity tracking app. While the percentage of the app’s users who wore gloves when they held bats has increased over time, even in 2021, less than half of the people holding bats, both dead and live, were wearing gloves.

“This lack of adherence to even minimal biosafety practices may jeopardize both the safety of the bat and the handler,” the authors concluded.

Reeder said those who continue to openly flout the recommendations to wear protective gear are increasingly met with disapproval within her scientific community. “If somebody is at a conference and they show pictures of themselves in the field not wearing a face mask, and not wearing gloves, even latex gloves, there’s a little bit of criticism,” she said. “A sort of public shaming.”

Ongoing Risk

As a recent report from the World Health Organization makes clear, there is still no definitive proof of how Covid-19 originated. And an infection that occurred during the collection of dangerous new coronaviruses from bats is among the possible explanations for the initial coronavirus outbreak in Wuhan in 2019. There is no question that the National Institutes of Health, which indirectly funded bat coronavirus research at the Wuhan Institute of Virology in China, is still struggling to fully understand the biosafety precautions taken around that research. Yet the U.S. government continues to support similar research around the world, with grants to numerous organizations including EcoHealth Alliance, the NIH grantee that worked with the Wuhan institute.

EcoHealth Alliance, a nonprofit research group based in New York, received a $3.1 million grant in 2014 from the NIH, some of which was spent on the collection of novel bat coronaviruses in rural China. Specifically, the organization awarded a subgrant of some $750,00 to researchers at the Wuhan Institute of Virology. In April 2020, at the request of President Donald Trump, the NIH suspended that grant. But four months later, the NIH awarded EcoHealth Alliance another, larger grant. (The Intercept obtained the grant documents via a Freedom of Information Act lawsuit with the NIH.)

Like the first grant, the second grant — titled “Understanding the Risk of Zoonotic Virus Emergence in Emerging Infectious Disease Hotspots of Southeast Asia” — pays for the collection of what it calls “high zoonotic potential viruses” from remote locations in Southeast Asia. It also funds experiments involving the infection of humanized mice with hybrid viruses created from the new viruses, which are designed to gauge the threat those viruses pose to humans. The grant is funded through 2025.

Other branches of the U.S. government also continue to fund the collection and study of novel viruses that could infect humans, including DEEP VZN, a $125 million project funded by the U.S. Agency for International Development, and the Ecology and Evolution of Infectious Diseases Program, which is jointly funded by NIH, the U.S. Department of Agriculture, and the National Science Foundation.

“Everybody has been just kind of winging it.”

Despite concerns about biosafety lapses in U.S.-funded research in Wuhan and a lack of oversight from both NIH and EcoHealth Alliance, there are no agreed-upon standards for ensuring the safety of ongoing research.

“There is currently very little biosafety guidance specifically for this kind of biological fieldwork,” Filippa Lentzos, a biosecurity expert who works at King’s College London, wrote in an email to The Intercept. “This is a major gap in biorisk management that urgently needs to be addressed both nationally and internationally, not least because this kind of fieldwork is on the rise.”

During the pandemic, David Gillum, assistant vice president for environmental health and safety at Arizona State University, began meeting with a small group of experts over Zoom to discuss biosafety practices for researchers working with bats in the wild. “It’s guidance on what to wear as personal protective equipment, what vaccinations should you have before you go to a certain area, what medications should you bring,” said Gillum. The group’s recommendations are expected to be published soon in the journal Applied Biosafety. Up until now, he said, “Everybody has been just kind of winging it.”

While Gillum and other biosafety experts say they hope national and international field work guidelines will ultimately be put in place, they expect the process to take years.

In the absence of such clear recommendations — and with institutions coming up with their own varied approaches to biosafety — a range of researchers face the risk of infection from pathogens in wildlife, according to Casagrande, the biochemist. “And that includes people specifically trying to find viruses but also people who aren’t,” he said. “Plenty of biologists who work with wildlife also don’t take precautions. And many times they get infected by things.”

A Fine Balance

While the pandemic has sparked a debate about the safety of studying dangerous viruses, most scientists agree on the need for at least some viral surveillance. To Reeder, the emergence of SARS-CoV-2 has made the value of her work only clearer. “Our understanding of the extraordinary diversity of SARS-related coronaviruses in bats in Southeast Asia is really critical for our pandemic preparedness, for our ability to predict what’s going to bind to human receptors,” she said. “We need to understand what’s there.”

As she sees it, that benefit is worth whatever risk it entails. And, in the case of the graduate student infected with the Sosuga virus, the cost wasn’t great. The virus didn’t kill her — and, critically, it didn’t spread from her to other people. Looking ahead, Reeder said, improved adherence to protective gear should protect against future viral jumps from animals to researchers.

“I think you just do your best, right?” said Reeder. “You try to look for those gaps. You put your gloves on, then you put your Tyvek suit on over those, and then you take Gorilla tape, and you wrap your wrist with Gorilla tape to make sure that you don’t have a gap as you move your arms,” she said, noting that colleagues in the field tend to help one another. “You can call each other out on stuff. You know, ‘Hey, it looks like your mask has slipped.’ But it’s never perfect, and this case just sort of illustrates that for us.”

The case of the woman who was infected working with bats in Uganda also taught Reeder how, at least that time, luck was on her side: “This could have been really, really ugly.”

The post Infection of Wildlife Biologist Highlights Risks of Virus Hunting appeared first on The Intercept.

The decision, written by Supreme Court Chief Justice John Roberts and joined by conservative Justices Clarence Thomas, Samuel Alito, Amy Coney Barrett, Neil Gorsuch, and Brett Kavanaugh, finds that the EPA does not have the authority to impose caps on carbon emissions by mandating a shift to cleaner energy sources. The ruling means that Congress, rather than the EPA and its staff of scientific experts, will handle the critical task of curbing greenhouse gas emissions.

“Today, the Court strips the EPA of the power Congress gave it to respond to ‘the most pressing environmental challenge of our time,’” Justice Elena Kagan wrote in a dissenting opinion joined by Justices Sonia Sotomayor and Stephen Breyer. “Whatever else this Court may know about, it does not have a clue about how to address climate change. Yet the Court today prevents congressionally authorized agency action to curb power plants’ carbon dioxide emissions. The Court appoints itself—instead of Congress or the expert agency—the decisionmaker on climate policy. I cannot think of many things more frightening.”

A number of energy magnates and fossil fuel trade groups pushed for the case that could kneecap the agency and boost their profits. But perhaps no one did more to bring West Virginia v. Environmental Protection Agency to the Supreme Court — or ensure that ultraconservative justices would be on the bench to decide in the companies’ favor — than Charles Koch.

The billionaire energy executive who reigns over Koch Industries is known for playing the long game. He bought up pipelines in advance of the fracking boom — and waited calmly until they delivered billions in profits. He invested in obscure, failing companies even though he knew that it would take years before they could add to his bottom line. And he has been cautious as he’s ventured into new markets — his empire now includes glass, pulp and paper, chemicals, agricultural products, and commodities trading — making small acquisitions to see if they’d be profitable before gradually taking over.

Such patience and strategic use of his enormous wealth have benefited Koch handsomely. His net worth has steadily climbed to more than $60 billion. Koch Industries, which makes more than half of its money from fossil fuels and owns refineries, petrochemical plants, and thousands of miles of oil and gas pipelines, is now the second-biggest privately held company in the country.

The Kochtopus

To ensure further growth of his riches even as science showed that the continued use of fossil fuels would accelerate climate disaster, Koch has funneled some of his vast fortune into an extraordinary network of political front groups, lobbying efforts, think tanks, and activist networks that aim to stifle climate action. For decades, the Kochtopus, as some call his many-tentacled political influence machine, has sought to undermine not just the environmental regulation in Koch Industries’ path but also the science and philosophy of government on which it is based.

Koch’s lobbyists and political operatives helped kill a 2009 bill aimed at tackling climate change through a cap-and-trade system that could have cut into his companies’ profits. While the mounting findings of climate scientists led other titans of industry to begin adjusting their business plans to lower carbon emissions, Koch-funded groups were among the first climate denialists, flatly lying about the well-documented planetary trend of global warming and then schooling lawmakers on the alternate reality they had crafted. Koch also pioneered the attack on Republicans from the right, pushing the party into its current extremism.

Today’s Supreme Court decision marks perhaps the biggest payoff yet for Koch’s decades of plotting against environmental regulations — and the most devastating loss for everyone else. Three of the extremist judges who joined the decision — Gorsuch, Barrett, and Kavanaugh — wound up on the Supreme Court in large part because of Koch’s activism and contributions.

Americans for Prosperity, an astroturf political group founded by Charles Koch and his brother David, conducted extraordinary campaigns to put all three judges on the highest bench. To support Kavanaugh’s nomination, the group reached out to more than 1.2 million Americans through mail, phone calls, and knocking on doors, according to a flyer released by the organization. The group also pushed hard for Barrett, whose father worked for Shell and the American Petroleum Institute, a powerful trade group for the oil and gas industry. And it campaigned for Gorsuch, whose mother presided — disastrously — over the EPA under President Ronald Reagan. Charles Koch is also closely connected to Leonard Leo, co-chair of the Federalist Society, a conservative organization Koch has supported directly and through his family foundation.

The case itself can also be tied directly to Koch. The challengers are 27 Republican attorneys general, who were supported by the Koch-funded Republican Attorneys General Association. At least four Koch-funded entities have filed amicus briefs in the case: the Cato Institute, which was co-founded by Charles Koch; the Competitive Enterprise Institute; the New Civil Liberties Alliance; and Americans for Prosperity. Another foundation that filed an amicus brief, the Landmark Legal Foundation, denied receiving Koch funding, though Jane Mayer reports in her book “Dark Money” that Koch helped subsidize it.

Taking Aim at the EPA

Koch’s antipathy for the EPA began with the founding of the agency in 1970. “It is the one regulatory agency that is on his ass every single day and has authority over all his operations,” said Christopher Leonard, author of “Kochland,” a history of Koch Industries and its political activities. “Every single day this agency is like a traffic cop clocking Koch’s speed on the highway. The EPA is sending agents to inspect Koch’s facilities. The EPA is monitoring the level of pollution coming out of spillways from Koch facilities. Koch has to employ almost buildings full of lawyers just to document their air emissions every year from their refineries, from their natural gas plants, from the Georgia-Pacific plant.”

The original case was about the Clean Power Plan, the Obama administration’s effort to limit carbon emissions from power plants, which are the second-largest source of U.S. greenhouse gas emissions. But that plan no longer exists, having been struck down by the Trump administration. Nor does its Trump-era replacement. In practical terms, the ruling will hamstring the Biden administration, which has pledged to cut greenhouse gas emissions 50 percent economywide by 2030. The administration is in the process of crafting its own rule affecting power plant emissions, which is expected next year.

“The decision takes off the table the approach that was used in the Clean Power Plan, the most efficient, effective way to address these emissions,” said Kirti Datla, director of strategic legal advocacy at Earthjustice. While the Biden administration will still be able to take less sweeping steps to limit carbon, such as requiring emissions controls on individual power plants, “this makes their job much harder,” Datla said.

Now Congress, rather than the EPA’s environmental experts, will be responsible for drafting the highly technical plan for limiting emissions from power plants. The regulatory process is expected to be far slower and less effective, which, according to Lisa Graves, executive director of True North Research, was exactly the point of the suit.

“These politicians in black robes know full well that, with Mitch McConnell in a leadership position doing the bidding of Koch and the oil and gas industry, this Congress will not pass any substantial climate change mitigation legislation,” said Graves, adding that the timing of the decision couldn’t be worse. “Now and in the coming years are the only window we have to really stem the tide of the truly devastating climate changes that are underway.”

Broader Implications

The motivations for the West Virginia case go beyond the individual and corporate pursuit of financial gain. “They’re doing it to make more money. But it’s also bigger in the sense they want to cripple the federal government,” said Leonard.

Indeed, the effects of the ruling will likely far surpass the EPA’s ability to limit carbon emissions from power plants. “It’s going to trim back the sets of regulations that they even consider,” said Leonard. “It’s a slow pushback of the EPA and a diminishment of its power over time.”

The West Virginia decision will also likely chasten other federal agencies, according to Datla. “It sends a signal to agencies that if they’re approaching big problems for the first time under their statutory authority, or if they’re tackling an existing problem, but using kind of a new approach, that either the court is going to be skeptical, or at the very least, somebody is going to bring a challenge based on all of the language that is in this opinion.”

Ironically, the decision that weakens the federal government follows on the heels of Dobbs v. Jackson Women’s Health Organization, the ruling that overturned Roe v. Wade and vastly extended the reach of the state to control what people can do with their bodies. That decision, too, grew out of seeds that Charles Koch planted years ago. But the profound step backward for reproductive freedom seems to have been an incidental result of the billionaire’s effort to grow his fortune.

One of Koch’s most effective policy creations is the American Legislative Exchange Council, a right-wing activist network that drafts model state legislation, which is then introduced around the country. “Koch funded ALEC to do stuff like deregulate the utilities industry,” said Leonard. “But what animated ALEC was anti-abortion laws.” Indeed, the grassroots network Koch created took up the issue even as he himself was indifferent about it.

“Koch doesn’t care at all about Roe v. Wade. Religious and cultural issues have zero relevance to him,” said Leonard, who added that Koch saw the abortion issue as a “sideshow.”

In contrast, Koch cares profoundly about West Virginia v. EPA. “This decision represents the culmination of years of attacks by Koch-funded groups on these rules,” Graves said. “It is a win for Charles Koch and the multibillion-dollar oil and gas industry and a huge loss for the American people.”

Update: July 1, 2022

This article has been updated to reflect the Landmark Legal Foundation’s denial that it has ever received Koch funding.

The post How Charles Koch Purchased the Supreme Court’s EPA Decision appeared first on The Intercept.

Sachs and Harrison are hardly the first to suggest that SARS-CoV-2 might have been created in a lab. Since its genetic sequence was first published in February 2020, scientists have puzzled over the furin cleavage site, an area on the virus’s spike that allows it to be cleaved by a protein on the membrane of human cells and makes the coronavirus particularly dangerous to people. Once split, the virus releases its genetic material into the cell and reproduces. While attaching to cells and spike cleavage is part of how all coronaviruses work, SARS-CoV-2 is the only one of its class, sarbecoviruses, that can use furin for the cleavage.

As with past discussion of a possible lab origin of SARS-CoV-2, this latest theory has already been met with considerable pushback. Even some scientists who are open to the idea that a lab accident could have sparked the pandemic remain unconvinced by the particular trail of evidence laid out by Sachs and Harrison.

The journal article offers a scientific road map for how this unusual sequence of amino acids could have made its way into the furin cleavage site, or FCS, of the virus. Sachs and Harrison acknowledge that the sequence could have arisen naturally. But they also lay out another possibility: that scientists might have purposefully inserted this particular string of amino acids into a bat coronavirus in the course of their work. They focus particularly on scientists who submitted an unfunded grant proposal to a division of the Defense Department called the Defense Advanced Research Projects Agency, or DARPA, laying out plans to insert a furin cleavage site into a bat coronavirus.

“We do not know whether the insertion of the FCS was the result of natural evolution — perhaps via a recombination event in an intermediate mammal or a human — or was the result of a deliberate introduction of the FCS into a SARS-like virus as part of a laboratory experiment,” Sachs and Harrison write. “We do know that the insertion of such FCS sequences into SARS-like viruses was a specific goal of work proposed by the EHA-WIV-UNC partnership within a 2018 grant proposal (“DEFUSE”) that was submitted to the US Defense Advanced Research Projects (DARPA).”

EHA is a reference to EcoHealth Alliance, a nonprofit research group based in New York City that has received more than $118 million in grants and contracts from federal agencies. WIV, or the Wuhan Institute of Virology, is a Chinese research organization that collaborated with EcoHealth Alliance in the past and was listed as a subcontractor on the DARPA grant. UNC is mentioned because Ralph Baric, a molecular biologist at the University of North Carolina, Chapel Hill, was to have conducted part of the work pitched to DARPA. The grant proposal touted Baric’s “two-decade track record of reverse engineering [coronavirus] and other virus spike proteins.”

The intent of the DARPA proposal was to prevent emerging pathogenic threats, but the work, if conducted, could have created a novel virus capable of infecting humans. “We will introduce appropriate human-specific cleavage sites and evaluate growth potential in [a type of mammalian cell commonly used in microbiology] and [human airway epithelial cell] cultures,” the proposal stated.

Several scientists interviewed about the DARPA proposal in September told The Intercept that scientists often begin research before seeking funding and thus that some of the experiments described in the proposal could have already been completed. But when asked about that possibility in an interview, Peter Daszak, the president of EcoHealth Alliance, rejected it: “The DARPA proposal was not funded. Therefore, the work was not done. Simple.”

A Rational Choice

As Sachs and Harrison note, the part of a protein on the cell membrane that shares its amino acid sequence with the bat coronavirus is critical for lung function. Known as an epithelial sodium channel-alpha, or ENaC-alpha, it is found in human airway cells, as well as in human kidneys and colons. Intriguingly, like SARS-CoV-2, ENaC-alpha, which facilitates the absorption of fluid in cells, is also activated by the unusual furin cleavage site. Harrison, a physiologist affiliated with Columbia’s Department of Molecular Pharmacology and Therapeutics, studies ion channels, the larger category to which ENaC-alpha belongs.

Other scientists have already pointed out the match between the amino acid series in the furin cleavage site of SARS-CoV-2 and the ENaC-alpha found in human airways. In 2020, a team from the biomedical company Nference suggested that the overlap between the virus and the sequence found in human lungs is part of the reason that Covid-19 is so damaging to the respiratory system. Those scientists described the sequence as having evolved naturally.

Sachs and Harrison, in contrast, suggest that researchers may have inserted the string of amino acids into a bat coronavirus precisely because of its known importance to lung function. “For a research team assessing the pandemic potential of SARS-related coronaviruses, the FCS of human ENaC — an FCS known to be efficiently cleaved by host furin present in the target location (epithelial cells) of an important target organ (lung), of the target organism (human) — might be a rational, if not obvious, choice of FCS to introduce into a virus in order to alter its infectivity, in line with other work performed previously,” they write.

Such a choice, they point out, would have been in keeping with another viral research project on which EcoHealth Alliance, the Wuhan Institute of Virology, and UNC’s Baric collaborated: a 2014 grant from the National Institute of Allergy and Infectious Diseases that involved increasing the transmissibility and pathogenicity of bat coronaviruses.

Growing List of Coincidences

The intriguing theory of viral engineering hinges on two observations: that the amino acid sequences match and that experts in both the ENaC-alpha furin cleavage site and the insertion of genetic sequences into bat coronaviruses happen to work at the same academic institution: the University of North Carolina, Chapel Hill.

Baric, whose work aims to prevent and create treatments for viral outbreaks, has previously inserted segments of DNA and RNA into viruses and created an infectious clone of SARS using his own patented “No See’m” method of inserting genetic materials without a trace. He has also collaborated on coronavirus research with scientists from a center for lung studies at UNC-Chapel Hill who are knowledgeable about ENaC-alpha. In one 2016 study, the scientists created a new virus using the spike of a bat coronavirus that had been isolated and characterized by the Wuhan Institute of Virology. The experiment found that the new virus “replicated efficiently” in human airway cells that were cultured in a lab.

In another paper, published a year earlier, Baric, along with the Wuhan Institute of Virology’s Shi Zhengli and a lung expert at UNC-Chapel Hill’s lung institute, described creating a hybrid virus using a SARS-like virus from a bat and a “mouse-adapted” coronavirus. The new virus caused mice to get sicker than those exposed to the original virus. The goal of these experiments was to prepare for the possibility that a virus might jump naturally from animals to humans, as SARS had in 2003. But even before the pandemic, the experiment drew criticism from other scientists, who were concerned because the researchers had created a virus that was able to spread in humans.

Sachs and Harrison note that the scientists who co-authored the DARPA grant proposal would have been aware of research on coronavirus furin cleavage sites, including one 2006 experiment in which a furin cleavage site was inserted into a coronavirus. “The research team would also have some familiarity with the FCS sequence and the FCS-dependent activation mechanism of human ENaC, which was extensively characterized at UNC,” they write.

“The list of coincidences is getting verrrrrrrrrrry long.”

Still, both the overlap in the amino acid sequence and the fact that experts in the furin cleavage site of the ENaC-alpha and insertion of genetic material into bat coronaviruses work at the same university could be coincidental, as Harrison and Sachs acknowledge. Some virologists, though, say that the coincidence strains credulity.

“Could be,” Richard Ebright, a molecular biologist at Rutgers University, wrote in an email to The Intercept when asked about the possibility that these things are both chance occurrences. “But the list of coincidences is getting verrrrrrrrrrry long.”

Ebright, a proponent of investigating the origin of SARS-CoV-2 and of investigating both natural-spillover and research-related-spillover, whom Harrison and Sachs thank “for helpful commentary on the manuscript,” spelled out some of the other Covid coincidences that he considers questionable, including its initial outbreak in a city that, well before 2019, had already been pegged as a biosafety risk. Ebright also noted Wuhan’s 1,000-mile distance from the nearest wild bats that carry the type of SARS-related coronaviruses that caused the pandemic. And he pointed to the particular coding of the amino acids in the furin cleavage site of SARS-CoV2.

“The sequence encoding the FCS of the pandemic virus contained two consecutive CGG arginine codons,” Ebright explained in his email. (A codon, or a combination of three nucleotides, supplies the genetic code for a single amino acid, though most amino acids can be represented by multiple different codons. Each nucleotide is represented by a letter — for RNA, either A, C, U, or G.) “This codon usage is unusual for a natural bat SARS-related coronaviruses (for which fewer than 1 in 30 arginine codons are CGG) but is optimal for humans (for which most arginine codons are CGG codons).”

Still, Ebright said that at first he didn’t see the identical amino acid sequences as particularly suspicious. “I had known for more than a year that there was a perfect match to an eight-amino acid sequence present in human ENaC. What I had not known was that the sequence was known to be a functional furin cleavage site and that it was a sequence extensively studied at UNC,” he said. “The crucial point that the ENaC sequence was a known functional site, not just that there happens to be a match to a protein that happens to be in humans. … That suddenly turned it from what I thought to be largely irrelevant to being a logical and obvious choice to proceed.”

Ralph Baric and the University of North Carolina did not immediately respond to requests for comment.

Name Calling

Other scientists dismiss the idea that the ENaC sequence might have been purposefully inserted into a coronavirus. Scientists who are already convinced that the new coronavirus emerged naturally are unlikely to be persuaded by Sachs and Harrison’s article, which appears in the opinion section of the esteemed journal. Over the past year, many scientists involved in the debate over the origins of the pandemic have settled into an increasingly acrimonious, coarse, and unyielding opposition.

Some proponents of the natural origin theory became particularly dismissive of those open to the possibility of a lab leak after the February release of two pre-print studies mapping the early spread of the virus at the Huanan market in Wuhan. Angela Rasmussen, one of a team of virologists who worked on the project, described it on Twitter as “dispositive evidence of a zoonotic origin” that will “drive those with personal interest in the lab leak hypothesis out of their goddam minds.” In another tweet, Rasmussen referred to proponents of the lab-leak theory as a “pack of ghouls, who through gullibility, stupidity, & conspiracist thinking have decided this is their thing despite zero expertise.”

Although the pre-prints had not been peer-reviewed and may have simply illustrated the spread of the virus rather than its original outbreak, the New York Times ran a front-page story about them that quoted an epidemiologist as saying that the origins debate “has been settled with a very high degree of evidence.” The story, which was announced by a push notification from the paper, also noted a lack of direct evidence for a lab leak.

Meanwhile, Kristian Andersen, another co-author of the pre-prints and a virologist at the well-regarded Scripps Research Institute, used the “poop” emoji to criticize a deeply researched article by Katherine Eban about EcoHealth Alliance. On Twitter, Andersen tarred Eban, New York Times columnist Zeynep Tufekci, and others reporting on biosafety issues that could have led to the release of SARS-CoV-2 as “deep in conspiracy theories” and on the other side of “a clear split” from journalists who dismiss the possibility of a lab origin, whom Andersen referred to as “science-based.”

Even some scientists who have been vocal about the possibility that the pandemic may have been sparked by research have expressed skepticism about the theory suggested by Harrison and Sachs. “The pandemic virus might have been genetically engineered. However, this could have been done in various ways not limited to the specific theory by Harrison and Sachs. I’m not convinced that their hypothesis is the most plausible one,” said Alina Chan, a scientist who laid out a number of possible routes for how the coronavirus might have emerged through research-related incidents in her recent book “Viral: The Search for the Origin of Covid-19.”

“There’s no need for them to go hunting inside the human protein catalogue to look for cleavage sites to put into viruses.”

While she is open to the possibility that the furin cleavage site might have been purposefully inserted into the coronavirus, Chan said there was no reason to think that researchers would mine humans for such material. “These scientists literally had access to hundreds of SARS-like viruses and sequences,” said Chan, referring to the vast collection of coronaviruses from bats and other animals that researchers amassed at the Wuhan Institute of Virology. “There’s no need for them to go hunting inside the human protein catalogue to look for cleavage sites to put into viruses.”

Jack Nunberg, a virologist at the University of Montana, was also not immediately persuaded by the theory of engineering suggested by Sachs and Harrison. “It’s possible,” Nunberg said of the idea that the ENaC segment was inserted into a bat coronavirus as part of research designed to gauge the pandemic potential of a virus. “But I don’t find their evidence on ENaC compelling because furin cleavage sites have a lot of common amino acids, and therefore it may just have happened by chance.”

Others say that the article adds noteworthy information to the public conversation about the origins of the pandemic. “The defenders of the natural origin indicate that the virus on which this type of experiment could have been done — the backbone — has never been published and that specialists in the furin cleavage sites would have chosen a more commonly used furin cleavage site like RARR rather than PRRAR. The Proceedings of the National Academy of Sciences article contradicts this argument and indicates that specialists knew that the RRAR’SVAS site was efficiently cleaved by furin,” Etienne Decroly, director of virology research at the Aix-Marseille Université in France, wrote in an email to The Intercept.

Decroly added, “It is impossible to decide on the basis of the information currently available and it is urgent that the WHO Special Advisory Group for the Origins of Novel Pathogens investigate this question.”

On the suggestion of an investigation, Nunberg is in agreement. “You can’t argue with that,” he told The Intercept. “Who’s going to argue for burying one’s head in the sand?”

For their part, Sachs and Harrison emphasize that they’re not saying laboratory manipulation was involved in the emergence of the pandemic virus, only “that it could have been.” They also give a nod to other possibilities, including that an airborne virus might have infected a laboratory worker. Rather than argue that any of these conceivable scenarios happened, they present the clues of the matching amino acid sequences to argue for an independent and transparent scientific investigation of the U.S.-based evidence related to the origins of the virus.

Among the institutions that Sachs and Harrison list as possibly having “knowledge of the detailed activities that were underway in Wuhan and in the United States” are the National Institutes of Health; the Defense Threat Reduction Agency, which has provided grant funding to EcoHealth Alliance; the Department of Homeland Security; DARPA; the U.S. Agency for International Development, which funded the $200 million PREDICT program that catalogued potential pandemic viruses; and the University of California, Davis, which participated in that program.

The authors suggest that EcoHealth Alliance and UNC may have particularly important untapped resources. “The exact details of the fieldwork and laboratory work of the EHA-WIV-UNC partnership, and the engagement of other institutions in the US and China, has not been disclosed for independent analysis,” they write. “The precise nature of the experiments that were conducted, including the full array of viruses collected from the field and the subsequent sequencing and manipulation of those viruses, remains unknown.”

A Reversal

The publication in the prestigious Proceedings of the National Academy of Sciences marks a reversal of sorts for Sachs, the chair of the Lancet Covid-19 Commission who, in November 2020, appointed Daszak, the EcoHealth Alliance president, to lead a task force to investigate the origins of the pandemic. Earlier that year, Daszak had signed on to a public statement published in The Lancet on behalf of scientists who said they “condemn conspiracy theories suggesting that COVID-19 does not have a natural origin.”

Yet that early certainty about the pandemic’s origins — and the sense of shared civic responsibility among members of the Lancet task force — soon disintegrated. In February 2021, emails revealed that Daszak coordinated the public statement in The Lancet tamping down suspicions of a lab leak. And by June 2021, Sachs was expressing his openness to the possibility of a lab origin, writing that NIH-funded research at the Wuhan Institute of Virology “deserves scrutiny under the hypothesis of a laboratory-related release of the virus.” Three months later, he disbanded the task force that had been organized to “carefully scrutinize the origin of the SARS-CoV-2 virus” in the hopes of preventing future disease outbreaks, explaining that he had concerns that several members of the commission had conflicts of interest because of their ties to EcoHealth Alliance.

After leading the mainstream scientific inquiry into the origins of the pandemic, Sachs is now skewering it. “A steady trickle of disquieting information has cast a darkening cloud over the agency,” he and Harrison write of the NIH, going on to accuse the entire federal government of not doing enough to explore the possible role of its grantees in the emergence of SARS-CoV-2 and investigate “overlooked details” such as the matching amino acid sequences.

Noting that the NIH has insisted that “the pandemic virus could not have resulted from the work sponsored by” the agency, Sachs and Harrison write that “blanket denials from the NIH are no longer good enough.”

Update: May 19, 2022

This article has been updated to clarify the opinions expressed by Richard Ebright and Alina Chan.

The post Jeffrey Sachs Presents Evidence of Possible Lab Origin of Covid-19 appeared first on The Intercept.

BlueTriton — which owns Poland Spring, Pure Life, Splash, Ozarka, and Arrowhead, among many other brands — is estimated to contribute hundreds of millions of pounds of plastic to U.S. landfills each year. BlueTriton used to be known as Nestlé Waters North America, which was bought by the private equity firm One Rock Capital Partners in March 2021. The company, which has a history of draining aquifers to get the water that it encases in polluting plastic, owns about a third of bottled water brands in the U.S. Yet with sleek, green — and blue — PR materials, BlueTriton markets itself as a solution to the problems of plastic waste and water.

“Water is at the very core of our sustainable efforts to meet the needs of future generations,” BlueTriton declares on its website, spelling out its promise for sustainable stewardship over a picture of pine trees, pristine water, and clouds. The company’s Instagram account is similarly nature-oriented and wholesome, filled with green-tinged images of people hiking and enhancing the native trout population.

The claims were a bridge too far for the environmental group Earth Island Institute, which sued BlueTriton in August, arguing that its misleading sustainability claims violate a local Washington, D.C., law known as the Consumer Protection Procedures Act, which is designed to prevent “deceptive trade practices.” In response, the company defended its green self-promotion by explaining that everyone should realize that the claims are meaningless nonsense.

“Many of the statements at issue here constitute non-actionable puffery,” BlueTriton’s attorneys wrote in a motion to dismiss the case submitted to a D.C. court in March. “BlueTriton’s representation of itself as ‘a guardian of sustainable resources’ and ‘a company who, at its core, cares about water’ is vague and hyperbolic,” the attorneys continued. “Because these statements are ‘couched in aspirational terms,’ they cannot serve as the basis for Plaintiff’s CPPA claim.”

Dirty Business

When BlueTriton picked a new logo in April 2021, it explained its choice on Instagram as a nod to its commitment to nature and environmentalism. “Triton is a god of the sea in classical Greek mythology,” the company wrote. “Combined with the color blue, representing water, the new name and logo reflect our role as a guardian of sustainable resources and a provider of fresh water.”

Several of its brands go even further, suggesting that they are helping address the plastic problem because the bottles can in principle be recycled. BlueTriton brands Poland Spring, Ozarka, and Zephyrhills Water advertise that “We use #1PET plastic, which can be used over and over again!” Pure Life water boasts that all its bottles are “100% recyclable … and can be used for new bottles and all sorts of new, reusable things.” Deer Park claims that its recyclable bottles help “keep plastic out of landfills” and that the company “care[s] about you & our planet.”

In truth, there is overwhelming evidence that recycling cannot solve the plastic problem. Since the 1950s, only 9 percent of plastic produced has been recycled, while the vast majority of plastic waste is either landfilled or incinerated. Six times more plastic waste is burned than recycled in the United States. Packaging, including the PET bottles that BlueTriton brands describe as recyclable, account for more than half the plastic that winds up in landfills.

As the complaint notes, plastic pollution is now so widespread that the average person is drinking more than 1,700 tiny bits of plastic in a week’s worth of drinking water — the equivalent of an entire credit card. Microplastics are found in 94.4 percent of tap water samples in the U.S. and may be an even bigger problem in bottled water, despite bottled water companies marketing their product as pollution-free. One BlueTriton brand, Pure Life, had twice the level of plastic fibers as tap water.

Meanwhile, as BlueTriton touts itself as a solution to America’s water problems, it has been caught extracting water from the national forest without authorization. The practice of tapping into natural water supplies has been shown to drain aquifers and rivers, taking water from plants and animals as well as public drinking water reserves.

Empty Promises

With rising public awareness of the role played by bottled water companies in the plastic pollution crisis, companies have publicly pledged to do better. In 2008, Nestlé Waters North America committed to recycling 60 percent of PET bottles by 2018. The company proudly announced its intentions in its first corporate citizenship report (which is no longer available online). But when the deadline came and its recycling rate was still less than half of its goal — just 28.9 percent, according to a 2020 report by the Changing Markets Foundation — the company just issued another pledge rather than dwelling on its failure to meet the earlier one.

The loud announcement of lofty goals for plastic recycling followed by the quiet failure to meet them is part of a larger pattern. Since at least 1990, Coca-Cola has made repeated promises on the plastics front, including commitments to use more recycled plastic, recover and refill more of its bottles, and incorporate more plant-based materials. The company, which has fought against efforts that would reduce plastic waste and recently hired Bill Nye to help clean up its image, regularly rolls out these goals with much fanfare and rarely, if ever, meets them. Coca-Cola did not respond to an inquiry for this story.

The distances between PR and reality are particularly pronounced around pledges to increasingly rely on recycled plastic, which is far more expensive to use than new plastic. According to Beyond Plastics, 10 major corporations — including L’Oréal, Unilever, Nestlé, and PepsiCo — had promised vast reductions in their dependence on virgin plastic while continuing to rely on new plastic. The environmental advocacy organization based its findings on 2019 data, the most recent available.

BlueTriton, which does not publicly list a media contact and provides no way for reporters to ask questions, did not respond to an inquiry from The Intercept for this article (which was conveyed through a message left with the sales department). But in its filing that asks the court to dismiss the greenwashing suit, the company argues that some of its brands have taken several steps that show they are genuinely sustainable. It says that Pure Life, for instance, has converted the cooling towers in its bottling plants to reuse water that was previously discharged. And that company is also “reduc[ing] the amount of plastic in our 0.5 liter bottles by over 40%” and “improving our production processes to reduce the amount of water needed to make one liter of Pure Life® purified water.” One Rock Capital Partners, the private equity firm that bought Nestlé Waters North America, also did not respond to an inquiry from The Intercept.

“They’re admitting that they use these sustainability commitments just as marketing tools.”

Sumona Majumdar, general counsel at the Earth Island Institute, dismissed those claims. “You can’t claim to be a sustainable company while using plastic as your primary packaging,” said Majumdar. “Maybe there was a time when, as a company, you might have thought our plastic is getting recycled and getting turned back into plastic. But at this point, everybody knows that’s not true.”

Majumdar counts the company’s executives among those who clearly understand that they are contributing to the plastic waste crisis — even as their spin suggests otherwise.

“When you look at their Instagram feeds and their statements about sustainability, it seems like a fait accompli. But in this brief they filed, they’re admitting that they use these sustainability commitments just as marketing tools,” said Majumdar. “It’s just to get consumers to buy their goods, and not because they actually intend to follow through with their promises.”

The post Bottled Water Giant BlueTriton Admits Claims of Recycling and Sustainability Are “Puffery” appeared first on The Intercept.

Chemours, a chemical company that was spun off from DuPont in 2015, made the case for GenX as an environmental good in response to a toxicity assessment of the chemical that the Environmental Protection Agency finalized in October. The EPA document set a safety threshold for GenX based on studies showing that it causes liver effects in rats, including cancerous tumors. But in a March 18 request for correction, Chemours’ attorneys asked the agency to weaken its threshold, arguing that GenX is necessary for the country’s transition away from fossil fuels.

“Chemours’s chemistries are critical to achieving the United States’ energy transition and decarbonization ambitions,” attorneys from the firm Arnold & Porter wrote, going on to note that GenX is used in the process of creating compounds called fluoropolymers, which are used to make lithium-ion batteries used in electric cars, membranes used for water purification, and hydrogen from renewable sources.

The company, which makes GenX in its plant in Fayetteville, North Carolina, and uses the chemical at its facilities in New Jersey and West Virginia, also insisted that continued domestic production is important for U.S. energy independence: “There are often no domestically manufactured alternative replacement products available for these mission-critical applications.”

According to Chemours, which reported net sales of $6.3 billion last year, restrictions on GenX are not just a threat to the company’s bottom line. Noting that “fluoropolymers are used in every car, airplane, cellphone, as well as semiconductor and computer chips” and are also used in the production of “the vast majority of prescription drugs,” the company’s attorneys argued that the “EPA’s Toxicity Assessment, unless corrected, has the potential to cause significant harm to Chemours as well as to the broader United States economy.”

In recent years, as the climate crisis has escalated, fossil fuel companies have responded with a flurry of greenwashing, false pledges, and branded content that inaccurately absolves oil and gas from responsibility for climate change. Even in this context, Chemours’ attempt to position its toxic chemical as a solution to energy and water problems has struck some environmental advocates as remarkably cynical. They object to the company’s pitting of one environmental cause against another and scoff at the notion that GenX, one of a class of chemicals that has caused one of the most widespread and persistent pollution problems in recent history, is truly helping address the spiraling climate catastrophe.

“Chemours currently manufactures PFAS by using and releasing potent greenhouse gas chemicals such as HCFC-22. They are clearly part of the climate pollution problem, not the solution,” said Laurie Valeriano, executive director of the advocacy group Toxic-Free Future. “A clean energy future includes safer products made without emissions of potent greenhouse gases and hazardous chemicals.”

Toxic History

Veterans of the battle over PFAS contamination find the company’s claims about the environmental and economic benefits of GenX familiar. “This is the same kind of argument we’ve been hearing for several decades now,” said Rob Bilott, an attorney who sued DuPont over another toxic PFAS chemical, PFOA, in 1999. The company had used PFOA for decades to make Teflon and other products — and spent years defending it as an industrial necessity. DuPont only agreed to phase it out in 2006 after Bilott shared voluminous evidence with the EPA showing that exposure to the chemical led to cancers, liver damage, and immune effects — and only after the company had selected a substitute: GenX.

“It’s just remarkable to see how the spin continues, trying to implicate these chemicals with products that will resonate with consumers,” said Bilott. “They’re trying to create fear that by actually regulating these chemicals that present a public health threat, you’re going to force people to make choices about these products.”

“It’s just remarkable to see how the spin continues, trying to implicate these chemicals with products that will resonate with consumers.”

Bilott knows firsthand about such efforts to fend off regulation, having first discovered the documents showing that DuPont (along with 3M, which first created PFOA) had known about the environmental and health harms of PFOA for decades and had hidden the evidence from the public and regulators. The EPA fined DuPont $10.5 million over its deception — the biggest penalty in the agency’s history at the time. But the punishment came too late to protect health and the environment. By the time the fine was levied, PFOA had already contaminated the drinking water of some 80,000 people living near a DuPont plant in West Virginia. The exposure was later found to have caused a local increase of kidney and testicular cancer in the exposed population.

GenX emerged from complex negotiations between the EPA and DuPont over the phaseout of PFOA. While the environmental agency was slapping the chemical manufacturer on the hand for withholding evidence of the harms of that chemical, it also agreed to allow the company almost a decade to phase in its replacement. During the back-and-forth between the company and the agency in 2006, DuPont had insisted that the EPA give its substitute compound “timely review and approvals.” By then, the company already had evidence that GenX had some of the same effects as PFOA on lab animals. DuPont’s own studies, submitted to the EPA between 2006 and 2013, showed that the replacement chemical caused liver and kidney damage; developmental effects, including early deliveries and delays in genital development; immune suppression; and cancerous tumors in both the liver and pancreas, as The Intercept first reported in 2016.

Despite the alarming evidence of harm, the EPA went ahead with the timely approval of GenX as DuPont had requested, issuing a consent order in 2009 that acknowledged that the replacement chemical could present the same risks as PFOA — including cancer, systemic toxicity, and reproductive toxicity — while allowing DuPont and, after 2015, Chemours to make GenX at its North Carolina plant. In the following years, as the company was releasing its new product into the Cape Fear River and into the air through its stacks, DuPont was also quietly handing over additional research to the EPA that showed that the toxicity profile of its new chemical in fact did match that of its old one — and that in some cases, GenX was even more toxic than PFOA. The January 2022 toxicity assessment that drew on these studies set a safety threshold that was considerably lower than that of PFOA. The EPA says that it is currently reviewing the PFOA standard and plans to issue a drinking water health advisory for GenX based on the assessment this spring.

But as with PFOA, these regulatory steps, taken 16 years after DuPont submitted its first GenX study to the EPA, came too late to protect the public. Residents of the Wilmington, North Carolina, area have already spent decades drinking water laced with the compound, which was released into the Cape Fear River as a byproduct of other processes before DuPont began producing it in 2009. In 2019, as news of the contamination spread, Chemours entered into a consent order with the North Carolina Department of Environmental Quality and the environmental group Cape Fear River Watch, in which it agreed to provide replacement drinking water to residents whose water has been contaminated with GenX.

Escaping Financial Responsibility

As the company freely admitted in its March request for correction, a change to the safety threshold set in the EPA’s toxicity assessment could relieve the company of some of its legal obligations under that consent order. In the agreement, the level of GenX in drinking water that triggers Chemours’ responsibility to provide clean water “is subject to adjustment based on an ‘applicable EPA health advisory,’” as the lawyers note. “An EPA health advisory for [GenX] could therefore substantially affect Chemours’s obligations under the North Carolina Consent Order.” Because the new level set by the EPA is more protective than the one set by North Carolina, Chemours could face additional financial obligations in North Carolina if its petition fails. If it succeeds, the company could wind up spending less, since it would be responsible for providing fewer people with clean water.

Even if the EPA denies Chemours’ request for correction, drinkers of the contaminated water are already being forced to pick up hundreds of millions of dollars in costs to purify it. Brunswick is one of two counties in North Carolina that recently increased water rates to cover the cost of new systems installed to filter out PFAS. “Brunswick County is a poor, rural county, and people there are now paying to put in a reverse osmosis plant for their water treatment to PFAS specifically because Chemours won’t,” said Johnsie Lang, a scientist who has studied GenX. Lang, who lives in the county, saw her own monthly water bill rise from $130 to $180 in March.

The request for correction comes at a time when Chemours is facing increasing costs in North Carolina. The consent order requires the company to provide clean water to households whose water is contaminated above a certain level. “But they had no idea how big their plume was. At first, it looked like there would probably be like 100 or less houses,” said Lang. But more than 6,000 now qualify. “And the number is still growing. I think they thought they were done, that they spent the money they wanted to spend.”

Chemours paid over $100 million for technology that reduces air emissions of GenX by 99.99 percent, as the consent order required. But the company has also been fined by the state Department of Environmental Quality for at least 16 violations of the consent order and related regulations, including exceeding the air emissions limit, disposing of waste improperly, and releasing more PFAS into water than allowed. And while the amount of GenX released from the North Carolina plant has clearly been reduced, shorter-chain PFAS have been found in water around the state — including on beaches and in home gutters, some as far as 80 miles from the plant.

Testicular and Liver Cancer

It is not unusual for companies to challenge EPA science that threatens to reduce profits. Nor is it uncommon for such companies to offer a range of criticisms in the hope that at least one might prevail. In the case of GenX, Chemours has argued not only that the chemical is essential to halt the climate crisis, but also that the science used to calculate the safety threshold is flawed. In the request for correction, the company’s lawyers claimed that the EPA failed to consider epidemiological data released by the North Carolina Department of Health and Human Services in 2017 and that “NCDHHS concluded that rates of liver and other cancers are generally lower in North Carolina counties with exposures to [GenX] the rates reported in the U.S. general population, in the state of North Carolina, and in North Carolina counties without alleged exposure to [GenX].”

Asked to confirm this finding, a North Carolina health agency representative said that Chemours’ interpretation of its data was not accurate. “NCDHHS did not conclude that rates of liver and other cancers are generally lower in North Carolina counties with exposures to [GenX] than the rates reported in the U.S. general population, in the state of North Carolina, or in North Carolina counties without alleged exposure” to GenX, Catie Armstrong, a spokesperson for the department, wrote in an email to The Intercept. Armstrong also noted that while overall cancer rates in the four counties studied were similar, in New Hanover County rates of testicular cancer were elevated over a 20-year period and rates of liver cancer were higher over a five-year period. The cancer rates collected by the health department are descriptive, Armstrong said, and “only a comprehensive research study can provide information about whether a specific exposure might be associated with increased rates of cancer.”

For local advocates have who been asking for such a detailed epidemiological study of people who drank contaminated water in the area, most explicitly in a petition local environmental groups submitted to the EPA in October 2020, the company’s misinterpretation of incomplete data is particularly galling. “One of the big pushes in our petition is for a comprehensive epidemiological study for people in that portion of North Carolina,” said Bob Sussman, an attorney representing the environmental groups that submitted the petition, which also demands health and environmental studies of 54 PFAS compounds that Chemours emitted in the area. “Chemours’ misrepresentation of a study that in fact shows increases in liver tumors in PFAS-impacted areas is disturbing and of a piece with the company’s resistance to conducting the research requested in the petition.”

Another Chemours strategy that is vexing for clean water advocates is its argument that the EPA is incorrectly applying “uncertainty factors” in its calculation of the safety standard for GenX. The agency uses the numbers, which make safety thresholds more protective, to compensate for gaps in knowledge about the effects of chemicals. Chemours says that the EPA has inappropriately inflated the uncertainty factors, resulting in a threshold that’s too low. But Sussman pointed out that the agency used the factors because the company didn’t provide studies that show definitively how the chemical affects people.

“In our petition, we say that we need all this additional testing on GenX. And here’s Chemours coming in and not even addressing the central point — that we don’t have the data we need,” said Sussman. “What I would say to Chemours is, if you don’t like these uncertainty factors, then you better go out and do some testing.”

Locked In

Environmental scientists agree with Chemours on at least one point: that GenX is now used to make fluoropolymers that wind up in a wide range of products, including, as the company’s attorneys pointed out to the EPA, computer chips, light-weight vehicles, and “piping and vessels to protect employees from harsh chemicals.” Such economic facts are irrelevant to the science about the chemical — and have no place in a toxicity assessment, according to Linda Birnbaum, who directed the National Institute of Environmental Health Sciences and served as the country’s chief toxicologist until 2019. Still, said Birnbaum, “the issue that they raised — that PFAS are everywhere — that’s absolutely true. The point is that it’s a bad thing.”

The thornier question is how to make those products without using such dangerous chemicals. Some manufacturers have already begun to create fluoropolymers without PFAS — one did so back in 2008. Still, a full transition away from GenX will take time, according to Mark Rossi, executive director of Clean Production Action. “If it’s currently necessary in the moment, I would say it’s not necessary in the long run,” said Rossi. “If you said, from today, you have to be out of all PFAS in manufacturing in five to 10 years, I’d say that’s a reasonable timeline.”

“The issue that they raised — that PFAS are everywhere — that’s absolutely true. The point is that it’s a bad thing.”

While the nonessential uses of PFAS could easily be immediately stopped, the gradual phaseout from more critical products will take both commitment and investment as well as time, according to Zhanyun Wang. “Nonfluorinated alternatives exist, but they require innovation,” said Wang, a scientist at the Swiss Federal Laboratories for Materials Science and Technology, known as EMPA. “Until you train the next generation of scientists, they always follow the same chemistry.”

The public has frustratingly little say over whether the production of our cellphones, cars, and allergy medicines involves the contamination of the environment. “The companies always say that they are customer-driven,” said Wang. “But if you think about it, it’s actually the companies deciding for us.”

Climate activists refer to the phenomenon of a polluting industry doubling down on nonsustainable practices that are profitable in the short term — and catastrophic in the long term — as “lock-in.” Ironically, with its challenge to the EPA, Chemours is using the promise of helping fight the lock-in of fossil fuels to justify further locking in the use of PFAS, arguing that its own environmental contaminants are essential and immutable.

Chemours declined to answer a question about the relevance of the economic arguments to the toxicity assessment. Instead, it provided The Intercept with an emailed statement that said, in part, “We support science-based regulation that is protective of public health and the environment, and we are committed to manufacturing our advanced chemistries responsibly — including by working to achieve our ambitious corporate responsibility goals.”

The post Chemours Claims Toxic PFAS Chemical GenX Protects the Climate 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.

But the EPA wrote that it would not be changing its assessment, which found that chloroprene was “likely to be carcinogenic to humans” and set a safety threshold for inhalation based on the chemical’s effects on the nervous, immune, and respiratory systems. The letter also suggested that Denka had misused the agency’s process for making requests for correction, or RFCs.

“The RFC process is intended to provide a mechanism to correct errors where the disseminated product does not meet information quality standards,” wrote Maureen R. Gwinn, acting assistant administrator in the EPA’s Office of Research and Development, which contains the Integrated Risk Information System, or IRIS, the division of the agency that does independent chemical assessments. “But the Denka submission does not identify errors in the 2010 IRIS assessment.”

Buying Time

In the strictest sense, Denka lost its appeal, which would have changed the scientific record on chloroprene and cleared some of the cloud that has hung over its cancer alley plant. But with its request for correction, as well as past lobbying to change the EPA’s science on chloroprene, the company has succeeded in extending the time in which the plant continues to emit the chemical at levels the EPA has shown to be dangerous. Denka did not respond to questions for this article.

For decades, St. John residents have felt that they have borne a disproportionate burden of cancers, respiratory distress, immune dysfunction, and other illnesses due to emissions from the plant, which DuPont opened in 1964 and sold to Denka in 2015. The smell of the plant’s emissions hung over the small community by the Mississippi River. People noticed their respiratory issues improved when they were away from home — and worsened when they returned. And they all knew several people who had died an early death from cancer.

But official recognition of the dangers of chloroprene lagged far behind their health problems. The International Agency for Research on Cancer classified chloroprene as “possibly carcinogenic to humans” in 1999. Six years later, a National Toxicology Program report found the chemical was “reasonably anticipated to be a human carcinogen.” The 2010 IRIS assessment based its probable carcinogen finding on research showing that lab animals exposed to chloroprene developed cancers of the thyroid, lung, kidney, liver, mammary gland, and forestomach, as well as evidence that chloroprene exposure was associated with higher rates of lung cancer, liver cancer, and leukemia in people.

Still, it wasn’t until 2015, when the EPA’s National Air Toxics Assessment used the threshold IRIS set to estimate local cancer risk, that the agency quantified the impact of chloroprene exposure in St. John. The report put the risk of cancer from air pollution in one census tract near the plant at 777 per 1 million people — by far the highest in the country at the time. In 2018, when the next NATA report was released (which reflected an updated assessment of another carcinogen present in St. John called ethylene oxide), the estimated cancer risk from air pollution in St. John climbed to 1,505 in a million — once again well above the cancer risk from air pollution anywhere else in the country.

Industry-Funded Research

Denka has said that, since acquiring the plant in 2015, it has reduced its chloroprene emissions by 85 percent under a voluntary agreement with Louisiana’s Department of Environmental Quality. The company has repeatedly pointed out the $35 million it spent on technology to achieve these reductions. But Denka has not lowered its emissions all the way down to the level the EPA deemed safe. Instead, Denka hired scientists who painted a rosier picture of chloroprene, which is emitted during the production of the synthetic rubber neoprene. The company commissioned the science-for-hire firm Ramboll to come up with an alternate model. According to Denka’s July 2021 request for correction, use of this new model would result in a safety threshold for chloroprene that is “approximately two orders of magnitude below” the one the EPA set in 2010.

In its request for correction, the company also repeatedly referred the federal agency to a 2021 analysis of mortality patterns in workers exposed to chloroprene authored by biostatistician Gary Marsh, which found that there was no link between chloroprene exposure and the risk of death from liver or lung cancer. Marsh declared “no conflicts of interest” in the study, which was published in the Journal of Occupational and Environmental Medicine. Yet, according to his curriculum vitae, he has been paid more than $800,000 by the International Institute of Synthetic Rubber Producers, a trade group that represents Denka, to study the effects on workers exposed to the chemical since 2000. In a note in the study directly above his claim of no conflicts of interest, Marsh declared that the trade group “sponsored this research, but the design, conduct, analysis and conclusions are those of the authors.”

Asked about Marsh’s apparent conflict of interest, Stacie Yuhasz, managing editor of the Journal of Occupational and Environmental Medicine, wrote that “if the Author(s) signed off on ‘no conflicts,’ we have to accept that at the time since we have no way to confirm or deny.” In an email, Marsh told The Intercept that his receipt of hundreds of thousands of dollars from the industry association representing manufacturers, including Denka, did not constitute a conflict of interest. “Conflict of interest relates to other financial or other connections with sponsors of which I had none,” Marsh wrote.

Asked about the ethics of receiving the industry funding without declaring a conflict of interest, David Michaels, former director of the Occupational Safety and Health Administration, disagreed with the journal editor’s position. “Sponsorship of a study, especially by a party with a strong financial interest in the outcome, presents a basic and undeniable conflict of interest,” wrote Michaels, who explored industry manipulation of data in his book “The Triumph of Doubt: Dark Money and the Science of Deception.” “The author is being paid for the study, and no doubt recognizes that finding a result unfavorable to the sponsor will mean no more money will likely come from that sponsor.”

Chloroprene Emissions on the Rise

While Denka has been using industry-funded science to push back against the EPA’s 2010 assessment, it has allowed its St. John plant to continue to emit the chemical at levels well above the limit it set. Indeed, the most recent data collected by air monitors installed near the Denka plant show that, in January 2022, levels of chloroprene were higher than at any other point over the last two years. Near the levee at the Mississippi River, the level of the chemical reached 30.1 micrograms per cubic meter on January 17, more than 150 times the EPA’s threshold of 0.2 micrograms per cubic meter. The level of the carcinogen measured by a monitor on the western edge of the factory was 24.3 micrograms per cubic meter, more than 121 times the threshold set in 2010. That monitor is less than half a mile from the Fifth Ward Elementary School, whose student body is more than 90 percent children of color.

For St. John residents, the ongoing exposure of children to a well-studied carcinogen amounts to a deadly indifference.

For St. John residents whose children, grandchildren, and neighbors attend the school, the ongoing exposure of children to a well-studied carcinogen amounts to a deadly indifference. “We’ve got little children going to that school and playing in that playground,” said Robert Taylor. “The air conditioners suck the contamination into the classrooms.” Taylor has lost dozens of friends and relatives to cancer. His nephew, who is in his mid-30s and lives along the fence line of the plant, was diagnosed with stage 4 cancer this winter. That nephew’s brother, who grew up in the same house, died of cancer several years ago. And Taylor’s daughter, Raven, has been bedridden for more than a decade with an autoimmune condition likely related to the pollution.

These ongoing losses — and the knowledge that another generation of young people in St. John was likely to be burdened with disproportionate rates of cancer — sparked Taylor to co-found the group Concerned Citizens of St. John, which has been fighting against industrial pollution in the area. Yet, more than five years since its inception, more than 500 children are still attending school in a carcinogenic cloud.

The Biden administration was the first to pay any significant attention to the plight of St. John. In November, EPA Administrator Michael Regan visited St. John and spoke with Taylor and other locals, including Geraldine Watkins, as part of his “Journey to Justice” tour through Mississippi, Louisiana, and Texas. “Meeting with Mr. Regan from EPA gave me a real uplift at the thought that, possibly, here is somebody that cares about people in a small community surrounded by industry,” said Watkins. “But people are still getting sick in the community and dying.”

In January, Regan wrote to the CEOs of both DuPont and Denka, emphasizing his support for the students at Fifth Ward Elementary and encouraging the executives to take voluntary action. “As a parent, I remain extremely concerned about the over 500 children at the elementary school,” Regan wrote. “I strongly urge you to listen to the community’s concerns and actively partner with community members to develop and implement community-based projects that reduce risk, increase awareness of local air quality, and ensure children have a safe place in which to learn and grow.”

Later that month, the EPA announced it would be investing more than $600,000 in additional monitoring at the Denka plant in St. John, as well as several other cancer alley locations. In an emailed statement, the EPA said that it would be publicly releasing the results of the air monitoring in St. John in the coming weeks.

Taylor, who was heartened by Regan’s visit and the EPA’s decision to do more monitoring, is nevertheless frustrated by the fact that his community is still exposed to chloroprene at levels that EPA scientists determined were dangerous more than a decade ago.

“Where’s the enforcement? We have higher pollution than we did two years ago.”

“The new administration seems to be pretty aggressive about monitoring. But the question is: What do they do with it?” said Taylor. “There haven’t been any steps to force them to stop. Where’s the enforcement? We have higher pollution than we did two years ago. And still nobody is doing anything to take that burden off us and stopping this company from flooding us with poisons.”

The time and resources the EPA recently put into considering Denka’s request for correction might have further prolonged the delay before the company is forced to bring its emissions down to safe levels. Instead of relitigating the assessment of chloroprene, which the EPA’s Gwinn noted was supported by years of “rigorous independent peer review and comment,” the handful of scientists who work in IRIS might have been working on some of the many other chemicals still on their agenda, including arsenic, chloroform, and formaldehyde.

Gwinn’s letter, which was stern at points, seemed intent on preventing industry from making future requests for correction in other cases where the science is accurate: “This courtesy review substantially exceeds EPA’s commitment toward addressing an RFC and should not be interpreted as setting a precedent for any future RFC request.”

The post EPA Rejects Denka’s Request to Weaken Assessment of Chloroprene appeared first on The Intercept.

Those documents have shown that in its efforts to head off and prepare for a pandemic, EcoHealth Alliance oversaw an experiment in which researchers intentionally made coronaviruses more pathogenic and transmissible. One grant report contained evidence that the research group also did an experiment with infectious clones of MERS, another deadly virus. While none of the experiments described in the grant materials released so far could have sparked the current pandemic, the documents raise serious questions about biosafety and oversight at NIH. Early in the grant, research on certain coronaviruses was subject to a U.S. government ban, but notes on communications between NIH staffers and EcoHealth Alliance obtained by The Intercept showed that the federal agency allowed Daszak to take the lead in shaping a plan to evade that moratorium.

Meanwhile, a grant proposal published by the internet research group DRASTIC last September showed that in 2018 EcoHealth Alliance applied for funding from the Defense Advanced Research Projects Agency, or DARPA, to look for novel furin cleavage sites in bat coronaviruses. According to the proposal, which was not funded, EcoHealth planned to insert furin cleavage sites into the spikes of SARS-related viruses — an idea that drew attention because scientists had already noted that such a site is unique in the subclass of viruses to which SARS-CoV-2 belongs.

The Intercept repeatedly sought comment from EcoHealth Alliance on these revelations. EcoHealth initially responded. In September 2021, a spokesperson denied that the organization had conducted the research on the deadly MERS virus that was described in the NIH proposal. After documents obtained via FOIA later showed that such research had in fact been done, Daszak stated that the spokesperson had been misinformed. EcoHealth Alliance then stopped responding to The Intercept’s questions. In late February, Daszak replied to email inquiries and offered to talk. He spoke with us on March 1. In a wide-ranging interview conducted over Zoom, he addressed questions that have swirled around EcoHealth Alliance for the past two years, defended his organization against what he characterized as unjust accusations, and railed against the questioning he has faced from congressional Republicans, the NIH, and news organizations, including The Intercept.

This interview has been edited for length and clarity.

Responding to the Outbreak

We’re curious when you first heard about the outbreak in Wuhan.

If you look at my Twitter account, you’ll see a tweet on New Year’s Eve of 2019 —

But before the tweet, what was the moment when you first learned about it?

It was a couple of days before that. We heard from our contacts in China that something was going on, that there were cases of a disease in Wuhan. I think it was December 30. We looked on Chinese social media and found the rumors about it there. But we heard from many scientists in China.

Many of the virologists and other scientists we speak to say that we don’t have enough information to determine whether Covid-19 emerged from natural spillover or as a result of research. Do you agree with that?

Do I agree that it’s possible that Covid-19 emerged through a lab leak? Of course. It’s been widely reported that we shut down discussion on that. But in the WHO report, which I was part of — and in fact I led the animal environmental side for the WHO side — we state that it’s extremely unlikely. We don’t state that it’s impossible it came from the lab. Of course it’s possible.

One of the many reasons that the origin of Covid-19 became such a sensitive and divisive issue was the sense, based on your communications about the Lancet letter, that you orchestrated a response among scientists and then made an effort to distance yourself from that effort. Do you want to say anything about that episode?

You said, “One of the reasons why this has become so divisive is because of the Lancet thing.” You could say that about many things. It’s because we didn’t release the DARPA proposal. It’s because we didn’t release our emails. It’s because, early on, we said very strongly that this came from nature, and that this lab leak stuff is preposterous. The real reason this has become so divisive is because it’s being used politically. That’s it.

Scientists disagree over an issue where there’s no definitive proof. And for this issue, there’s no definitive proof. And there may never be. But what we do know is the weight of evidence points strongly to emergence from farmed wildlife in China.

Since the WHO report even, there are something like 12 scientific papers that have been published or put up online from good scientists pointing towards that origin. And I’ve looked at every single document that’s come out of the folks who are trying to show it came out of the lab, and there is no evidence yet for that. It’s all about implied motives, databases that were taken offline, people that aren’t on a website, or innuendo around something. Any one of those things can be explained by the normal process of doing science.

Controversial Research

Did EcoHealth Alliance or the Wuhan Institute of Virology, through its partnership with EcoHealth Alliance, ever insert a furin cleavage site into a bat coronavirus genetic sequence?

Of course we did not do that. I really don’t understand how that could be a question at this point — it’s beyond the pale. That’s not in our plans and it’s not any of our reports, so of course we didn’t do that.

But isn’t it the case that you submitted a grant proposal to DARPA to do so?

We did submit a proposal to DARPA. I’ve not checked through the one that’s online that it’s the correct document. What I do know is it was widely reported that DARPA rejected that because there were concerns about safety issues. That is absolutely untrue. The document that allegedly is DARPA’s response, their review of our proposal, I’ve never seen that before. It was never sent to us. I don’t know if it’s real.

DARPA had a process by which people who didn’t get funded could do an interview with them to find out why they didn’t get funded. So I did that. Never once did they mention any concerns or issues around safety; never once did they mention gain-of-function. The reason they told us it was rejected was because the amount we asked for was too much for them. They couldn’t afford it. They actually encouraged us to resubmit in different ways. We then had protracted conversations with them about funding specific parts of it. They liked the proposal.

Was any of the work described in that proposal completed prior to its submission? We were told by multiple sources that when you submit a grant, that at least some of the work would have been done.

When you write a grant proposal and propose to do a new line of research, which is what we did, we would not be doing that research before we submit the proposal. That’s not how it works.

When we asked if you had ever inserted a furin cleavage site to a coronavirus, you responded with outrage. But that is what was described in the DARPA proposal.

No. What you said is, did we insert a furin cleavage site? And what I said was, of course not! If we had done that work with the Wuhan Institute of Virology, it would have been published by now. It would have been made public in our reports to the NIH. The DARPA proposal was not funded. Therefore, the work was not done. Simple.

But you acknowledge that you proposed to DARPA to insert a furin cleavage site?

I refute that that was the goal of the DARPA proposal. The idea was not to insert a furin cleavage site in a virus to see what happens. That’s not what was proposed. The proposal was to look for those polybasic cleavage sites in nature because we knew that that was the potential to make a virus more able to infect people and move from person to person. If we found mutations around that polybasic cleavage site that looked like it could be evolvable, the idea was then that Ralph Baric’s lab at UNC would do some work to see how evolvable that site was. So that work never happened. The proposal was not funded.

Did you find any of these cleavage sites in naturally occurring viruses that you collected?

The proposal was not funded so we didn’t do that work. We’ve not found polybasic cleavage sites. However, they are in many coronaviruses from bats. Papers from Europe show mutations around that cleavage site that suggest strongly that that furin cleavage site could evolve very easily in nature. I’m sure there are viruses out there with it. I’m convinced that it could have easily evolved during the first stages of the pandemic, as the virus got from bats, perhaps into an intermediate host in a wildlife farm, or into people.

Did you resubmit the proposal?

We had conversations with them over many months about bits they would like to fund or they wanted to fund. We did not get funded. We did not do the work.

So you didn’t think the DARPA proposal was relevant to the investigation into the origin of the pandemic?

A proposal that was not funded and work that was never done is not relevant to the origins of Covid. Of course not!

When asked if you had done this work with the furin cleavage site, you said no.

For the furin cleavage site, you should really ask Ralph Baric. He wrote that section of the DARPA grant.

So you’re saying that that would be a good question for Ralph Baric, whether he has done any of these insertions?

I don’t know what Ralph Baric has done. But I doubt that he would go ahead and do that work without the funding.

Some virologists were dismayed to see the insertion of furin cleavage sites in this proposal.

I don’t know why anyone would be dismayed at that because furin cleavage sites were first researched in influenza viruses. And it’s well known that that’s something you should look for if you’re interested in virulence factors. Second, there’s actually a published paper from way before our proposal was submitted, way before the pandemic, where a group actually inserted a furin cleavage site into SARS-CoV-1. So we were right to look for that. And I think the proposal stands as a valid and actually quite predictive effort to understand the risk of viruses. You’ve got to look at the big picture of why we do this research. We’re not doing it as a sort of academic interest, “what would happen if you put a cleavage site there?” No. This work is done to say: What viruses are there out there in the wild that have the potential to emerge in people? And can we do something to stop them? Develop vaccines, develop therapies, stop people making contact with those animals.

Your grant, “Understanding the Risk of Bat Coronavirus Emergence,” included an experiment using humanized mice. Were other humanized mouse experiments conducted by you and/or WIV?

Not by us, no.

What about by WIV?

Well, you need to talk to WIV about what else they were doing. We were doing one line of work with them.

Were you aware of any?

No, of course. I’d tell you if I was aware.

Were there viruses from elsewhere in Southeast Asia that were sent to the WIV?

No. This is a commonly put about story that’s simply not true. WIV did not receive viruses from all around the world.

How many actual viruses do they have?

WIV does not have the biggest collection of viruses from bats in the world. There’s 20,000 bat samples, something like that, tiny fecal pellets from bats.

Right now I don’t know exactly how many bat coronaviruses are in culture and freezers at the WIV. But from our work, I know that out of the SARS-related coronavirus, they were only ever able to culture a handful. I think three cultures. It’s not easy to do.

In November 2019, you tweeted that you had identified over 50 novel SARS-related coronaviruses, including some that cause SARS-like signs in mice and didn’t respond to monoclonal antibodies.

Yes.

What are these 50 viruses? And are they public?

This is a complex thing that’s been widely misinterpreted. It’s actually quite simple. What we had were hundreds of genetic sequences of coronaviruses from bats. We published them in that paper. They’re not all new viruses. As we went through the sequence data and analyzed it, we refined what you might call a new virus versus a known virus. That’s all. It’s scientists refining and analyzing.

One ongoing point of contention between you and NIH is about lab notebooks and the communications around experiments.

NIH has made a bunch of requests that are completely reasonable, that we’ve dealt with very quickly and sent them the information that they required. And in many cases, NIH had the information already. What’s happening here is you’ve got an office of the director that’s dealing directly with us and completely cutting out the program staff who’ve got all the data they need. NIH has also asked us for a number of things which to any balanced and independent reviewer are impossible for us to supply.

Clearly in coming up with Year 4 and 5 progress reports, EcoHealth Alliance had information and draft reports on these humanized mouse experiments. Did you share those with NIH?

Of course not. You don’t share draft reports. You share the final report.

Here’s what happens, it’s a very standard procedure: We are subcontracting to a lab in China to do some work. Every year we have to file a report to NIH to tell them what we’ve done for the year, how we’ve spent the money, and whether we’ve achieved the goals of the grant. So, we contact our subcontractees and we say, “Send us the information. Let us know what successes you’ve had this year and whether you’ve had problems and issues. Put it all in a report and send it to us.” And then we use that to produce a report for NIH. That’s why there are some editing issues around that. We move them around a bit, and we send a final report. A draft report is just a worse written version of the final report. There’s no special information that’s got intelligence value or anything.

Then why not share them?

We’ve not been asked for a draft report by anybody.

You’ve been colleagues with Shi Zhengli, the Chinese bat coronavirus expert who directs the Center for Emerging Infectious Diseases at the Wuhan Institute of Virology, since 2005?

Yes.

So is it the kind of relationship where you would be generally aware of all the work that she was involved in? Can you say a little bit about what your level of awareness of other stuff she was doing?

We were aware of most of the stuff she was doing. Of course. These people weren’t hiding anything from us. They are scientists.

I’ve sat through dozens of meetings with people from Wuhan Institute of Virology, where they talk openly about unpublished work. And, by the way, RaTG13 was one of the sequences in a paper published — in I think 2015. So they weren’t hiding anything from us.

Early on, after she learned about the outbreak, Shi said she was worried that somehow a virus might have leaked from her lab. A lot of people we speak to — virologists who do this kind of work — are the ones who seem most in touch with that possibility, that this stuff happens.

Very specifically, it happens when you have cultures of viruses in flasks, and you’re then doing experiments with high concentrations of virus. It rarely happens if ever from an animal sample, especially a saliva sample from a bat. What Shi Zhengli was saying at that time was, “Oh, no, it’s a coronavirus. I need to go back and check on those viruses that we’ve got and see: Is it one of them?” And she did, and it wasn’t. That’s what any reasonable person would do.

You implied in early 2020 that RaTG13 was not fully sequenced by WIV until late 2019 or later. And then afterwards, Shi revealed that it had actually been fully sequenced in 2018. When and how did you first learn about the true date that this virus was sequenced?

I don’t actually know the true date of when this virus was sequenced. I didn’t see an interview with Zhengli where she said, “We sequenced it in 2018.” I don’t know when and I don’t think they ever got the full genome. There are parts of that virus that aren’t correctly sequenced. Bear in mind, RaTG13 was not from a sample collected under the NIH grant. So we didn’t have any oversight on that or any knowledge of it.

Missing Data

Did you have access to the Wuhan Institute of Virology’s database of viral samples and sequences that went offline in September 2019?

I’ve never actually seen the database. I’ve seen pages of it from the internet, Twitter, chats. But I’ve never looked at the database.

Did your staff have access to it?

No. We didn’t need to! We had all the data we needed. Some folks find this missing database indicative of a cover-up or something. When we were in Wuhan [with the WHO mission] in the Institute of Virology, I said, “Why did you take the database offline?” And their response was, “We took it offline before the outbreak. We were then getting hacking attempts, hundreds, thousands of hacking attempts. So we decided it wouldn’t be wise to put it back up.” Now, you may not believe them. But it is a perfectly reasonable explanation. And I think people should try and go for the most likely reasonable explanation for these things.

So why did they take it offline in September 2019?

They told us — and it’s in the WHO report — that they were trying to update it to make it modern. WIV was trying to present itself like a globally significant virology institute, and it is. But when you look at Chinese websites, they can be really old and stuffy and clunky. What they were trying to do, they told us, was to make it interactive so that you can click on something and a map would show. They were trying to make it fit in with the national databases.

I find it quite ironic that the focus on the database of WIV is so intense, whereas what actually happened was we took the data and, with China, put the data into the NIH’s own database to make it public. That’s a great win for the U.S.

In April 2020, you wrote in an email, “It’s extremely important that we don’t have these sequences as part of our PREDICT release to Genbank at this point. As you may have heard, these were part of a grant just terminated by NIH. … Having them as part of PREDICT will being [sic] very unwelcome attention to UC Davis, PREDICT and USAID.” Why did you think that publishing these sequences would bring unwelcome attention?

Because we just had our grant terminated by NIH.

So you didn’t think it would be important to release this data, given that there was a pandemic?

Those sequences were released publicly by publishing them in a scientific paper, which is what scientists do. The email that you’re reading out is not about whether sequences should be made public; it’s about whether sequences should be made public via a USAID mechanism or via publishing through the NIH mechanism. And what I was saying to the UC Davis team that ran PREDICT was that these are NIH-funded sequences and should be reported through the NIH system. It’s really that simple.

And which paper were they reported in?

Latinne et al, published in Nature Communications. We were struggling to get that paper out. It was very, very difficult, once the pandemic started, to keep communication with Chinese scientists. The utmost priority as a scientist is to get the data published, not to upload it into some database that’s going to take months to go through. And by the way, that database is somewhere on the USAID government system. It’s very difficult to find. The paper had already been submitted for publication, and the sequences were uploaded into GenBank, the NIH system. And then once the papers were accepted, they became public. And that’s exactly what we did.

Are there sequences that have not been made public?

To my mind, there are no sequences of SARS-related coronaviruses that have not been made public. Some people think there are still viruses that are SARS-related that haven’t been put in GenBank. That’s not true. We’ve uploaded all of the SARS-related coronavirus sequences, or we’ve reported them to NIH, or we’ve published them in scientific papers. And in fact, for most of them, we’ve done all the above. We had them all uploaded before the pandemic. Most of them anyway.

You were on the WHO mission to investigate the origins of SARS-CoV-2. When the NIH grant documents were released, it was a surprise to many people that animal experiments were being done at Wuhan University. If you knew this information, did you share it?

It wasn’t a surprise to NIH because the NIH knew about them.

Right. But did you share that information with the WHO committee or with others who were investigating the origins?

The Wuhan University BSL-3 facility is what we’re talking about. They do humanized mouse work. That was not looked at by the WHO origins group. It’s a BSL-3 lab that had humanized mice under BSL-3 conditions. It’s highly unlikely to be the source of the Covid-19 outbreak.

Did you mention it to the committee?

I mentioned all my work to the committee, of course. We talked about it, for sure.

The Challenges of Public Scrutiny

Dr. Michael Lauer at the NIH has repeatedly asked you for biosafety records from the WIV and said that he has been unable to get some of them.

He says that, but it’s not true. We’ve supplied everything we could possibly supply on the issues that they’ve asked for.

In one of his letters to you, Lauer asked about the biosafety oversight of the work at WIV. In your response to him, you wrote that it consisted of semiannual meetings with the lead investigator and assessments of compliance with all conditions of the award. Biosafety experts have said that this falls short of the level of oversight one would want for this kind of work. You mentioned in an exchange with Lauer that you were offering to pay from EcoHealth’s own coffers for additional biosafety measures. Why did you offer to do this? Did you feel that the biosafety oversight was adequate?

We’re talking about a world-class virology lab run by the Chinese government that is probably the best virology lab in China, and China is very good at virology. It’s very efficiently run, and the biosafety conditions are very good. Just because people think that Covid-19 might have come from WIV doesn’t mean that therefore our oversight of biosafety wasn’t sufficient. We did everything normal in oversight of that lab.

Then why did you suggest these additional measures, if the others were already adequate?

Because I was worried that they were going to terminate our other grants. This is the key driving force for every action we’ve taken since April 24, 2020. I don’t know why people don’t realize that.

Once NIH shows you that it’s willing to terminate your funding and kick people out of a job and put your whole organization under pressure simply because a single politician tells them to, then you start worrying about every other grant and contract that NIH controls. We live in fear that they’re going to do similar abrupt terminations with no cause and no rationale and no logic.

What I was doing then was saying to Michael Lauer, please be reasonable. We’re trying to do everything we can, within the normal bounds of what organizations do. We probably have the best biosafety and field teams in the world.

We’re overcompliant and yet still being accused of lack of compliance.

On February 24, House Energy and Commerce Committee Republicans sent a letter to NIH alleging that it is “highly suspicious” that EcoHealth reported the humanized mouse experiment results over two years, and suggesting that more work may have been done that was not reported. How would you respond to that?

This is a simple issue of Chinese nationals writing a report and then us drafting our report to NIH. So there’s a word in there where they say we continued the studies. That doesn’t mean they continued infecting mice with new viruses. No. What it means is they continued doing the research on the one experiment that they’ve done. And that continuation is a lot of work. So they did all the pathology, which means at the end of the experiment, you take all the mice, and you look at every organ in the body. You do detailed microscopical analysis. It takes months. So that’s why it dragged on because you’ve got months of after-the-experiment analysis. And we included the mortality data as part of the pathology data. That’s completely normal.

The House Energy and Commerce Republicans don’t write to us, they write to NIH. Sometimes we hear about it, sometimes we don’t. NIH doesn’t copy us on their responses. Then eventually we get a letter from NIH asking questions, which we always respond to, always within the timeframe and always refuting any allegations with evidence. So that’s what we’ve done.

The latest letter from the House Energy and Commerce Republicans accused us of being overfunded, effectively having two grants to do the same thing. It’s simply not true. The USAID PREDICT grant has completely different goals to the NIH coronavirus grant. For instance, PREDICT looks for between seven and 18 different viral families within samples, not just coronaviruses. NIH is focused solely on coronaviruses. So the goals are different.

The agencies do, as a standard procedure, a review of a grantee’s other proposals to see if there’s overlap between them, because they don’t want to fund the same thing twice. This is absolutely refutable with documentary evidence.

What’s your understanding of the Republicans’ motivation?

Any bipartisan requests for information from the House or the Senate, we’ve responded to. We’ve been working with the U.S. government since the pandemic began to get information to them about every single aspect of this pandemic, including unpublished data. The politicians who are attacking us probably don’t realize or know or care, in some cases. When there’s a request from one side of the political spectrum, we try not to respond to that. We’ve had hundreds of questions sent to us by letter, including requests for thousands of pages of documents. We don’t have the staff to do that. And bear in mind our grant has been terminated and now suspended. We don’t have access to funding. We don’t have the staff to do this work. It’s a horrible, cruel irony that, on the one hand, your funding is cut; and on the other hand, there are now outrageously huge number of demands for us to do work to show data from that funding that’s been cut.

Don’t you have ongoing funding for two other NIH projects?

Yes. Well, you can’t use that money.

What have you been asked to get by NIH that you feel you can’t get?

There are a whole series of things that we’ve been unable to get. A vial of virus. Information on a person that was removed from the website (I did ask them that, and they gave us an explanation, which is perfectly reasonable). NIH asked us for an inspection of the WIV. Every right-minded person on the planet realizes that the World Health Organization asked for an inspection of that lab, and we did go into the lab and ask questions and go around the facilities. For NIH to say that I should organize a U.S.-only, NIH-based or National Academy-based inspection of the lab facilities is a request that is way beyond what’s possible. You know, you can’t go into CDC as a foreigner and do an inspection of the lab.

NIH writing to us saying, “We demand that you do this,” puts us in jeopardy and it’s a security risk. If I was to take that letter from NIH and go to the Beijing airport and say, “I’m here to do this,” I would be arrested and put in jail and probably put on trial, in the same way that scientists from China have come to the U.S. and tried to take vials of virus back to China and been arrested and convicted. NIH doing this is clearly a way for them to try to get the public behind a decision they made that was political about terminating our grant. Ever since that decision, we’ve been put under similar pressure over and over again. The Republicans write to NIH with some fairly outrageous accusations. NIH responds and says, “Don’t worry, we will go and make EcoHealth do this, this, this, and this.”

I don’t think that those questions are posed to truly get to the bottom of the origins of Covid. While the House Republicans are putting pressure on NIH for tiny bits of administrative information, scientists are going out and finding that actually things are really pointing towards a natural origin. And meanwhile, we’re left refuting each one of those allegations. They’re all false. There’s no substance to them at all.

A good proportion of the public have been pushed by misinformation to believe a narrative — and this narrative is repeated daily — that gain-of-function work was funded by Tony Fauci as a back channel to China, and EcoHealth funneled funds to China. Those stories are very beguiling, they sort of make you feel, “Ah! I knew it.” But actually, there’s not a grain of truth to them. Every single action that EcoHealth Alliance has taken has been things that scientists do in the normal course of doing their work.

Closing down that line of research means we lose eyes and ears on the ground in China. And it doesn’t benefit us from a public health point of view or a national security point of view. It’s a huge mistake.

The post Peter Daszak Answers Critics and Defends Coronavirus Research 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.

One of hundreds of redacted pages the NIH sent to The Intercept this week in response to a Freedom of Information Act lawsuit.

The “lab-leak” hypothesis is bolstered by a long history of accidents at facilities that study pathogens and the fact that one such laboratory that specializes in coronaviruses, the Wuhan Institute of Virology in China, is located in the very city where the pandemic first began. As many have noted, China has not been forthcoming with information that could help us understand the origins of the pandemic, blocking access to a cave that may hold important clues, taking a database of information about coronaviruses offline, and refusing requests for records from the World Health Organization.

But the U.S. government, which funded some of the coronavirus research at the Wuhan Institute of Virology through a New York-based research organization called EcoHealth Alliance, has also withheld information that could provide insight into the origins of the pandemic. The Intercept filed a Freedom of Information Act request in September 2020 for grants the NIH provided to the Wuhan Institute of Virology. At the time, only summaries of the research were publicly available. The NIH initially refused to provide the documents. It was only after The Intercept sued the federal agency that it agreed to provide thousands of pages of relevant materials.

Some of these releases have proven newsworthy. The grant proposals received in an initial batch of documents in September revealed that scientists working under the grant in Wuhan were engaged in what most knowledgeable experts we consulted described as gain-of-function experiments, in which scientists created mutant bat coronaviruses and used them to infect “humanized mice.” The mutant viruses proved more pathogenic and transmissible in the mice than the original viruses. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, denied that the U.S. had funded gain-of-function work in Wuhan.

Communications received by The Intercept in December provided insight into the agency’s ongoing and largely unsuccessful efforts to obtain records pertaining to the biosafety of the work conducted at the Wuhan Institute of Virology. And another grant proposal from EcoHealth Alliance that we received from the NIH clarified the extent to which ongoing work now funded by the U.S. government is similar to the work under the now-suspended bat coronavirus grant that has raised so many biosafety red flags and questions. We also learned that in 2020 the FBI sought documents related to the U.S.-funded coronavirus research in Wuhan.

But the most recent batch of documents, which the NIH sent The Intercept on Tuesday, underscores an ongoing lack of transparency at the agency. Even as members of Congress and scientists call for additional information that could shed light on the origins of the pandemic, 292 of 314 pages — more than 90 percent of the current release — were completely redacted. Besides a big gray rectangle that obscures any meaningful text, the pages show only a date, page number, and the NIAID logo. The remaining pages also contain significant redactions.

Even when the redactions are technically justifiable under the Freedom of Information Act, public agencies typically have the discretion to release documents anyway. In this inquiry, which could help us understand the how this pandemic began — and how we might avoid future outbreaks — the presumption should be to give the public as much as information as possible, not the least.

The NIH still had more than 1,400 pages of relevant documents in its possession when it issued the almost entirely redacted release to The Intercept. Despite broad bipartisan agreement about the need to better understand whether research could have led to the deadliest disease outbreak in recent history, the agency appears to have no urgency to make this critical information public.

The post NIH Sent The Intercept 292 Fully Redacted Pages Related to Virus Research in Wuhan appeared first on The Intercept.

People living in Merrimack, in southern New Hampshire, had rates of thyroid cancer that were higher than the national average between 2005 and 2014. The authors also found that Merrimack residents had higher rates of thyroid, colon, and prostate cancer, when compared to several nearby towns that did not have high levels of PFAS contamination, as well as a higher risk of all cancers when compared to the relatively unexposed communities.

Merrimack is home to a Saint-Gobain factory that produces PFAS-lined glass and fabrics. Previously, the factory had been operated by the chemical company ChemFab, which Saint-Gobain acquired in 2000.

In 2016, two of Merrimack’s public drinking water wells were found to contain the toxic compound PFOA, a type of PFAS, in amounts above the Environmental Protection Agency’s 70 parts per trillion safety threshold. In 2019, the agency found 190 PFAS compounds in the air emissions coming out of the plant’s stack, most of which had never been identified before.

According to the new paper, the level of PFOA in the blood of Merrimack residents was almost three times the 2015-2016 national average — and higher for people who drank more water.

The EPA has recently taken several steps to limit exposure to PFOA, which has been shown to cause kidney cancer and other health problems, but the vast majority of PFAS compounds remain unregulated.

Nancy Murphy, a retired nurse who lives in Merrimack and whose family drank PFAS-contaminated water for years, has been asking for research on the health effects of the PFOA pollution since it was discovered in 2016. Murphy’s 36-year-old daughter is sick with a number of conditions, including hypothyroidism and polycystic ovarian syndrome, both of which have been linked to PFAS exposure. Her 32-year-old son, who runs marathons, has elevated cholesterol, which is also linked to PFAS, and her youngest son also has a serious thyroid condition. Both Murphy’s husband and brother-in-law, who also lived in Merrimack, have developed prostate cancer, which has also been linked to PFOA exposure — as did her father, who also had kidney cancer.

“Can I say that PFAS definitely caused these things? I certainly can’t,” said Murphy. “But, man, there’s an awful lot of things that make me wonder.”

Murphy, who helped found a local advocacy group to fight the pollution and now serves on the Merrimack town council, has spent years asking for more research on how the chemicals have affected her town. “The pushback was unbelievable,” said Murphy. “It was, ‘Oh, you’re fearmongers,’ or ‘You’re going to ruin the property values.’”

In contrast to the new findings, a 2018 cancer incidence report from the New Hampshire Department of Health and Human Service that compared Merrimack’s cancer rates to those of the state found that “none of the cancers in Merrimack, NH, occurred in significantly higher numbers than would be expected.” In December, the state released an updated report that found that the number of kidney cancers between 2009 and 2018 in Merrimack is higher than would be expected “in a town of similar size in New Hampshire” but warned there was insufficient evidence to link the cancers to any exposure.

“It shows how important picking a comparison group is,” toxicologist Linda Birnbaum said of the Environmental Health Insights study. “If you say, we’re going to pick another economically and socially matched community, well, that all sounds great. But if they’ve got the same exposures you do, you’re not going to be measuring anything.” Birnbaum, who retired as director of the National Institute for Environmental Health Sciences in 2019, has studied the toxicity of PFAS chemicals extensively and has noted that the EPA’s safety threshold for PFOA in drinking water did not reflect the evidence that extremely low levels of the chemical can cause cancer.

Mindi Messmer, who was serving in the New Hampshire state legislature when the state’s first study of cancer rates in Merrimack came out, had similar thoughts about the health department’s decision to compare Merrimack’s cancer rates with those of the entire state. “We suspected that using that as comparator group wasn’t really appropriate,” said Messmer. “The cancer rates of the state are really driven by the high population centers in southern New Hampshire, which also happen to be highly exposed to PFAS.” Indeed, PFAS contamination has been measured in a 65-square mile area around the Merrimack plant.

In 2020, Messmer and several health researchers decided to embark on a study that would compare the town’s cancer rates to those of the nation, as well as to those of comparable towns in New Hampshire, Vermont, and Maine that do not have notable PFAS contamination. The study also compares Merrimack’s cancer rates with those of Bennington, Vermont — another town where considerable levels of PFAS have been measured in drinking water.

In addition to identifying relatively high local rates of prostate and thyroid cancers, which researchers have previously linked to PFAS, their study also found elevated levels of bladder cancer, colon cancer, esophageal cancer, and mesothelioma, which are not known to be caused by the chemicals. Messmer said she did not know why those cancer rates were higher but added that the elevated bladder cancer numbers may reflect local arsenic contamination, which is naturally occurring in the area.

“I suspect that there’s a confluence of mixtures of chemicals and naturally occurring contaminants that are causing these high rates of cancers,” said Messmer, adding that the findings show the need for more research.

Birnbaum agrees. Although the new study shows clear differences in the cancer rates in certain towns, “All you know is what their exposure in the water is. You don’t have any blood levels from the people,” said Birnbaum. “But it could very well be that this would be the kind of point where people will say, OK, there’s enough data that we should go in and do another study.”

Voluminous research has already shown links between PFAS and a wide range of health effects, including weakened immune response, reproductive difficulties, hormonal imbalances, and obesity. The cancers that have been clearly linked to the chemicals include testicular cancer, kidney cancer, prostate cancer, and, in mice, pancreatic cancer.

Although it is now clear that thousands of sites in the U.S. have been contaminated, surprisingly few studies have looked at the cancer rates in these toxic hot spots. Studies of people who lived near a DuPont plant that released PFOA into the public water supply in West Virginia and Ohio, conducted between 2005 and 2013, showed that exposure to the chemical was “more probably than not” linked to elevated rates of testicular and kidney cancer, cholesterol, thyroid disease, preeclampsia, and ulcerative colitis, which can lead to rectal cancer.

“The more people they contaminate, the harder it is for those of us exposed to prove the harm from that exposure.”

Robert Bilott, the attorney who led the class-action litigation that led to the creation of the panel of epidemiologists who conducted the studies of the effects of PFOA near the West Virginia plant, expressed frustration at the ongoing challenges of demonstrating the health impacts of the chemicals, which have been used in firefighting foam, nonstick coatings, and hundreds of other products.

“It’s infuriating that the more these PFAS manufacturers contaminate the planet, the more difficult it is to do effective human health studies, as there are fewer and fewer ‘uncontaminated’ populations to compare to,” said Bilott. “It’s as if, the more people they contaminate, the harder it is for those of us exposed to prove the harm from that exposure.”

Messmer, who now runs the nonprofit group New Hampshire Science and Public Health and serves on a state commission on the public health impacts of PFAS, said that she and others focused on cleaning up and preventing PFAS pollution in the state have run into considerable resistance. “The opposition for certain comes from lawyers hired by Saint-Gobain,” said Messmer.

Saint-Gobain did not respond to inquiries for this story.

Messmer also pointed to a recent session of the State Senate’s Energy and Natural Resource Committee during which Jodi Grimbilas, a lobbyist representing the American Chemistry Council, compared PFAS to berries. While the legislators discussed the possibility of regulating the chemicals as a class, Grimbilas said that PFAS are like berries: While some are poisonous, others, like strawberries, blueberries, and raspberries, are “good.”

Murphy is pushing for more research to elucidate the precise relationship between the illnesses in her family members and the PFAS compounds in Merrimack’s air and water. “My kids grew up here. I have grandchildren who live here now. We’re talking about three generations of people who have been harmed by polluters here,” she said. “And [the polluters] don’t give a rat’s ass.”

The post New Hampshire Town Polluted With PFAS Has Elevated Cancer Rates appeared first on The Intercept.

Around the globe, the scientists who study the animal origins of infectious diseases are treated with similar reverence. In its documentary “Virus Hunters,” National Geographic tells the story of an American band of researchers who risk their lives in search of bats carrying Ebola in an abandoned Liberian mine shaft. “You are getting aerosolized urine, aerosolized feces, but also, if you’re killing the bats, you’re then exposed directly to their blood as well,” professor Christopher Golden says as the animals screech around him and eerie music plays in the background. The risk, it seems, is part of what makes these anti-outbreak efforts so thrilling — and the people who perform them so heroic.

As the world enters its third year ravaged by a novel coronavirus that may have originated in bats, the endeavor to learn more about SARS-CoV-2 and other pathogens like it is particularly urgent. Much of the success we have had in responding to the Covid pandemic so far has its roots in studying coronaviruses. Recent research on MERS and human cold viruses enabled scientists to develop vaccines for SARS-CoV-2 in record time, and the genetic sequencing of viruses that have jumped from animals to people has helped scientists design Covid treatments. Yet it is not at all clear that tracking down virus-infected wildlife in remote locations, to which the U.S. devotes a substantial share of research dollars, has helped us prepare for our current crisis.

Still, over the past two decades, fears of bioterrorism have increased U.S. funding for a particularly aggressive subgenre of viral surveillance that entails hunting and studying previously unknown viruses in wildlife. “Outbreak prediction,” as it’s sometimes called, pushes beyond the tracking of diseases that affect people, which public health officials have relied on for decades to understand the scope and causes of epidemics. The new viral research aims to find the most dangerous pathogens before they jump to humans. Proponents of this approach — which involves hunting viruses in remote locations as well as transporting, storing, and sometimes experimenting on the most dangerous pathogens — say it’s necessary to prevent the next outbreak.

But others warn that the ongoing pursuit of deadly viruses that have yet to infect people is unlikely to prevent infectious diseases from emerging or help us cope with them when they do. Instead, they say, there are several ways this research could set off the next pandemic — and could have, in fact, led to this one.

Yet virus hunting and related activities have somehow escaped the level of scrutiny that some biosecurity experts feel they should have. “A lab leak in people’s minds means a building and something seeping out,” said Filippa Lentzos, a social scientist at King’s College London who studies the threat posed by biological agents. “But far too little of our pandemic origin discussion has been focused on that fieldwork point. There are really, really high risks involved in this kind of research.”

One Health

Most infectious diseases that have recently emerged in humans can be traced back to wild animals. There are about 1 billion of these “zoonotic infections” each year, as well as millions of deaths, according to the World Health Organization. Fruit bats are the natural hosts of the Nipah virus, which can cause brain swelling, seizures, comas, and ultimately death in humans. The Zika virus, which causes babies to be born with very small heads and other potentially deadly birth defects, was first isolated in a rhesus monkey. MERS, the coronavirus that causes the deadly Middle East respiratory syndrome, has been traced to camels from Saudi Arabia. And HIV infected chimpanzees before it jumped species and went on to kill some 36 million people worldwide.

The SARS coronavirus, which began infecting people in southern China in 2002, also originated in animals. The spread of SARS was brought under control in 2003, at which point it was already clear that humans had been exposed through contact with masked palm civets sold in wet markets. It was more than a decade before researchers found the SARS virus in horseshoe bats living in a remote cave in China’s Yunnan province. Peter Daszak, president of a New York-based research group called EcoHealth Alliance, and Shi Zhengli, director of the Center for Emerging Infectious Diseases at the Wuhan Institute of Virology, were among the researchers who found the virus in bats. Daszak and Shi had worked together since at least 2014, and finding SARS in bats gave additional credence to the exhaustive sampling and cataloging of viruses they employed. By pinpointing the origin of the SARS virus, which spread from bats to civets to humans, they were able to underscore the dangers of the wildlife trade, which presents an ongoing viral threat.

But Daszak didn’t need the extra feather in his cap. By 2017, when he helped solve the SARS origin puzzle, he already had tens of millions of dollars in U.S. government grants under his belt, much of it from the National Institutes of Health and the Department of Defense. He sat on the editorial boards of scientific journals and was advising science organizations around the world, including the U.S. Global Change Research Program and the Australian Biosecurity Cooperative Research Centre for Emerging Infectious Disease. He was also a member of the WHO’s Blueprint Pathogen Prioritization Committee.

A British parasitologist who had begun his career studying frogs, Daszak went to work for a conservation group called the Wildlife Trust in 2001. The organization then focused mostly on endangered species. But Daszak, who became its director in 2010 and helped rebrand the group as EcoHealth Alliance, shifted the organization’s emphasis toward an idea known as “one health.” The concept, which has gained ground in public health circles in recent years, recognizes that the health of humans, animals, and plants is inextricably linked.

EcoHealth’s rebranding allowed it to incorporate research on how the climate crisis and other emerging environmental factors were driving disease outbreaks. Through the interdisciplinary lens of “one health,” EcoHealth Alliance began studying the ecological and health effects of oil and gas extraction in Liberia, tracing the impacts of forcing wild animals from their habitats and into greater contact with humans, which in turn opened the possibility of animal-borne infections. The group also quantified the health costs of deforestation in Malaysia, showing that chopping down trees to make room for palm oil plantations has given rise to an increase in malaria infections.

The broader framing was helpful in the search for funding too. “We go to foundations and say, ‘Look, you’ve been trying to stop the wildlife trade in China for 20 years. You’ve put all this money into this. If you have a health angle to that, it really does work,’” Daszak said in a May 2020 interview with virologist Vincent Racaniello. “That’s the argument we use.”

EcoHealth Alliance’s funding from the U.S. government, which Daszak has said makes up some 80 percent of its budget, has also grown in recent years. Since 2002, according to an Intercept analysis of public records, the organization has received more than $118 million in grants and contracts from federal agencies, $42 million of which comes from the Department of Defense. Much of that money has been awarded through programs focused not on health or ecology, however, but on the prevention of biowarfare, bioterrorism, and other misuses of pathogens.

It might seem odd that an organization focused on naturally occurring organisms would receive such funding. But it also makes a certain amount of sense, as the Wildlife Trust pointed out in a 2008 grant proposal to the NIH, which The Intercept obtained through a Freedom of Information Act lawsuit. Even microbes found in wild animals could become weapons if they fell into the wrong hands, noted the proposal for the grant, titled “Risk of Viral Emergence from Bats.” The work entailed studying the Hendra and Nipah viruses. “HeV and NiV are not only novel discoveries, they are also BSL4 agents that possess several biological features that make them highly adaptable for use as bioterror agents,” the grant proposal explained, referring to biosafety level 4 laboratories that work with the most dangerous microorganisms.

A proposal for a grant that the Defense Threat Reduction Agency, a division of the Defense Department, awarded EcoHealth Alliance in 2017 takes a slightly different angle. The bat coronavirus research the organization and its partners planned to conduct in Jordan, Turkey, Pakistan, and Georgia would fill a dangerous data gap on viruses, EcoHealth argued in the proposal for “Understanding the Risk of Bat-Borne Zoonotic Disease Emergence in Western Asia,” which The Intercept obtained through a separate Freedom of Information Act lawsuit. “Viral emergence, both nefarious and natural, poses a significant threat to global security,” the proposal explains. “The current regional gap in capabilities to conduct research and facilitate early detection of bat borne diseases in Western Asia severely weakens our ability to counter the threats of biological weapons of mass destruction.”

In part, the justification for harnessing the “one health” concept to defend one nation-state from another seems to be that if U.S. scientists don’t learn about these viruses, someone else will. These projects were described as efforts to make the world safer: to alert people in the surrounding area to a new disease before it hits and to create treatments and potentially vaccines that could prevent it. But in the throes of the current pandemic, the risk calculus behind this decision is coming under new scrutiny.

With more than 5 million people dead from a disease that could have been unleashed as the result of research, this scientific attempt at staving off worldwide calamity is being reappraised as a double-edged sword.

Tooth and Claw

Virtually every part of the work of outbreak prediction can result in an accidental infection. Even with the best of intentions, scientists can serve as vectors for the viruses they hunt — and as a result, their work may put everyone else’s lives on the line along with their own. Seeking out animals and pathogens in areas where they might not have otherwise come into contact with people is especially risky, as is sending viruses from these locations to more densely populated urban areas such as Wuhan, where scientists sent samples of bat coronaviruses collected under a grant from the NIH. “There is immense danger when you go into remote areas in a highly intrusive fashion, directly seeking viral samples, and return those samples to laboratories where then they are tested for pandemic potential,” said Richard Ebright, a molecular biologist at Rutgers University.

Ebright has been outspoken about the risks involved in “gain-of-function” research, in which researchers tweak viruses to make them more infectious or pathogenic. Ebright has called research that EcoHealth was conducting to enhance dangerous viruses — which The Intercept documented through materials obtained via an ongoing lawsuit with the NIH — “reckless.” But he is also concerned about the work that happens both before and after gain-of-function experiments. “Every aspect of that work plan, from beginning to end, entails risks,” he said.

The virus hunting itself is particularly perilous. The work of catching and taking biological samples from animals is inherently messy and dangerous. “Squirming, clawed and toothy animals bite and scratch during collection of body fluids. Teeth and talons easily penetrate the thin gloves required to maintain dexterity when handling fragile wildlife. And overhead, angry bats release a fine patina of virus-laden urine aerosols,” as infectious disease specialist Michael Callahan recently wrote in Politico of his virus-hunting expeditions. “The fact that researchers are not infected every time they do a field collection is a question that continues to stump us.”

“Every aspect of that work plan, from beginning to end, entails risks.”

In fact, some scientists have been infected in the course of virus hunting, including two researchers in Asia whom Callahan notes were recorded as having lab-acquired infections despite having contracted a disease when exposed to the pathogen during field collection. Because it took several days for their symptoms to appear, the researchers had already returned from their virus-hunting expedition to work in the lab by the time they realized that they were sick.

Scientists may become infected even when they’re not doing particularly dangerous experiments with pathogens, as an analysis of the spread of the Marburg virus in the Journal of Infectious Diseases made clear. The Marburg virus, which causes an often fatal hemorrhagic fever and infects bats and monkeys as well as humans, was spread through three different labs in the 1960s. Workers in the labs became infected with the virus after having direct contact with the blood, organs, and cell cultures from infected monkeys.

Even the seemingly straightforward reproduction of the virus in the lab, a step scientists often need to take before assessing its pathogenicity or analyzing its genetic makeup, entails danger, according to molecular biologist Alina Chan. “Just the act of trying to isolate and grow up the virus for studies involves making large volumes, far more than found in a bat,” said Chan, who emphasized that workers don’t need to be directly involved in producing the virus to be at risk. “The presence of a sample alone can result in accidental contamination.”

Lab workers can become infected through all sorts of routine encounters with lab animals. This was apparently the case when a researcher who worked on SARS-CoV-2 in Taiwan contracted Covid in early December 2021. The lab worker was infected in a biosafety level 3 lab that employs equipment and precautions meant to prevent such transmissions. But according to a report from Taiwan’s Central Epidemic Command Center, she had broken several rules by failing to wear proper protective gear, handling infected mice outside biosafety cabinets, and removing her mask before the rest of her protective gear.

And while Taiwan has advanced health security measures in place — and the facility where the lab worker was recently infected was part of Taiwan’s top research institution and used state-of-the-art equipment — many other facilities do not have the latest equipment, including negative pressure systems, HEPA filters, biosafety cabinets, and sewage incinerators. And those that do have biosafety level 4 labs, which offer the greatest containment of bio-agents, are often located in urban centers like Wuhan.

The 9/11 Funding Surge

Our vulnerability to bioterrorism was brought home by the anthrax-laced letters that were mailed just after 9/11, the first of which was sent less than a week after the Twin Towers fell. The handwritten phrase “Death to America” was part of what fueled suspicions that the letters, addressed to senators and members of the media, had been sent by a Muslim terrorist. Over the next few months, 22 people were infected by anthrax sent through the mail. Five of the recipients died from exposure to the bacteria. Although the letters stopped arriving within a month, their impact on the U.S. government’s approach to research on biological agents continues to this day.

In 2002, the National Institute of Allergy and Infectious Diseases, a somewhat sleepy division of the NIH that had its roots in studying tick-borne diseases, announced that it would be receiving an extraordinary $1.5 billion funding increase. Much of the new funding would be spent defending the United States against bioterrorism, or the intentional release of dangerous viruses and other pathogens. The NIAID focused its new efforts on the most dangerous “Category A agents,” which include the bubonic plague, smallpox, viruses that cause hemorrhagic fevers, and anthrax. But the federal institute was also seeking a broader understanding of microbes and would try to genetically sequence “virtually any potential pathogens,” as NIAID Director Anthony Fauci, who began serving in that role in 1984, said at the time.

That year, some of the NIH’s new funding went to Daszak and the Wildlife Trust to study the Nipah and Hendra viruses the group had identified as “BLS4 agents.” In 2008, the NIAID provided the group with another grant to study the Nipah virus as well as bat viruses. Ultimately, the NIAID would award more than $15 million to the group.

After the anthrax attacks, additional funding to combat biological threats came from the Department of Homeland Security and the Department of Defense, which expanded the U.S. Army Medical Research Institute of Infectious Diseases, a division of the Army that had conducted biological weapons research in Fort Detrick, Maryland, since 1969.

The Defense Threat Reduction Agency, whose mission is to counter and deter weapons of mass destruction and other emerging threats, funded EcoHealth Alliance’s bat research in western Asia and has awarded nine grants to the group to study a number of dangerous viruses and diseases, including henipaviruses in Malaysia, Rift Valley fever in South Africa, Crimean-Congo hemorrhagic fever in Tanzania, avian influenza in Jordan, and high-risk pathogens in Liberia.

Other grants paid for the tracking of specific flu viruses that had already been transmitted through animals to cause human disease. Biodefense concerns had sparked disease surveillance in the past, including during the Korean War, when the Centers for Disease Control and Prevention created its Epidemic Intelligence Service to track the spread of infectious diseases. But after the anthrax letters, funding was increasingly directed toward the pursuit of pathogens that had not yet infected humans.

In 2008, after conducting thousands of interviews and creating a new Chemical Biological Sciences division, the FBI announced that it had solved what it had begun calling the “Amerithrax case.” The person who sent the letters, the FBI said, was not a Muslim terrorist after all, but Bruce Ivins, a microbiologist who had worked at the Army’s biodefense laboratory in Fort Detrick and had devoted much of his career to trying to thwart bioterrorism. Ivins, who had been experiencing mental health problems, killed himself after learning that the federal government was planning to file charges against him. But even after the evidence of the external bioweapons threat faded — and the internal threat posed by researchers working on bioterrorism was made frighteningly clear — large-scale U.S. funding for biodefense projects around the world has continued.

Predicting the Viral Future

By 2017, Daszak, Shi, and many of their colleagues had already pressed beyond studying past outbreaks into predicting future ones. The work involves mapping hotspots of potentially dangerous zoonotic diseases, trapping and sampling animals and analyzing the viruses that infect them, and then studying the viruses they find to determine which have the greatest potential to infect people. The ultimate goal is to create an open-source atlas of potential pandemic pathogens, complete with genetic sequencing information and a ranked list of the organisms that present the greatest threat.

In scope and ambition, the work is not unlike trying to predict the weather by studying individual raindrops. According to an article Daszak himself co-authored in Science, there are an estimated 631,000 to 827,000 undiscovered viruses capable of infecting humans circulating in birds and mammals — so many that it would take a global army of scientists decades to track them all down.

The U.S. Agency for International Development is another unlikely funder of viral research. Historically focused on providing economic aid to low-income countries, it began giving out grants for projects that could counter the threat of bioterrorism after 9/11, including Predict, a 10-year project launched in 2009 that would ultimately cost more than $210 million. Through the program, scientists in 35 countries collected samples from more than 160,000 bats, rodents, birds, and other animals. The work led to the identification of more than 1,100 previously unknown viruses and involved training scientists in more than 60 labs.

Predict had some clear benefits. Stephen Morse, who co-directed the first five years of the program, said that it left countries where the research took place better prepared to respond to outbreaks. “You don’t just fly in and take samples and test them using high-tech equipment,” said Morse, now a professor of epidemiology at Columbia University. “You try to work with local people to build the capacity in the countries where you’re working. And I think that’s the morally, ethically, as well as scientifically good thing to do.”

In an emailed response to questions from The Intercept, a spokesperson for USAID wrote that “USAID is building on previous efforts by expanding its global health security portfolio to help partner countries prepare for future health threats. This includes investing in risk reduction as well as discovering and understanding the risk of unknown viruses.”

While helping advance science in partner countries, such international aid is also sometimes seen as securing national security interests. As Callahan, the infectious disease physician, who has worked on global outbreaks for three federal agencies, has noted, an important part of the U.S. government’s international work on biological agents over the past decades has been securing and rooting out bioweapons in foreign labs through a program known as “cooperative threat reduction.”

After the anthrax letters, cooperative threat reduction efforts were also increased. The U.S. sent infectious disease specialists and bioweapons experts to the former Soviet Union to help repurpose bioweapons labs and retrain the scientists who work in them. U.S. biosafety experts were also dispatched to countries in Africa, Asia, and the Middle East.

The Forecasting Fallacy

Predict may have also served the similar purpose of allowing U.S. scientists to keep an eye on viral research in other countries. Yet as a predictive tool, it was of little value. Even Morse described its ability to enable scientists to anticipate and prevent disease outbreaks based on the enormous amount of data they collected as “aspirational.”

“The problem,” said Morse, “is then, how do you decide which ones to pay attention to?”

Many other scientists have pointed to the same foundational problem. Alexander Kekulé, director of the Institute of Medical Microbiology at the University of Medicine in Halle, Germany, thinks that it is important to study viruses and has spent his career doing so. But he said that no amount of data on viruses will allow scientists to anticipate how they will behave in the future. “It’s almost impossible to predict which virus will spill over and when and how,” said Kekulé. “It’s science fiction to do this. To look to see if a virus might become dangerous is so arbitrary. Why should nature follow your path?”

“To look to see if a virus might become dangerous is so arbitrary. Why should nature follow your path?”

The sheer number of potentially dangerous viruses that have yet to infect humans also makes it unlikely that a catalog of the viral universe could help create countermeasures to treat and prevent the spread of the new diseases, according to Kevin Esvelt, a biotechnologist and assistant professor at the Massachusetts Institute of Technology Media Lab. “There are so many viruses out there that we’d be lucky to prevent a single pandemic,” said Esvelt, who points to the difficulty of deciding which of the many viruses to target. “As for vaccines, forget about it. Are we really going to infect unvaccinated volunteers with a virus that hasn’t yet infected any human and might never do so and then do it again for dozens of different pathogens?”

Dennis Carroll, who designed and led Predict, defended the program. While Carroll, who has a doctorate in biomedical research, called the criticisms about its inability to predict the viral future “legitimate,” he also said that wasn’t the real point of the program. “It’s more about forecasting than predicting,” said Carroll. “It’s fool’s gold to think that you’re going to predict which is the next virus. But you can begin forecasting where that emergence is most likely to occur,” he said, and the hope is that such information can be used to change human behaviors that might lead to an outbreak. “I probably never should have named Predict ‘Predict,’” he added.

Other researchers have observed that rapid viral evolution would quickly render any collected data obsolete. “New variants of RNA viruses appear every day,” biologist Edward C. Holmes and his colleagues wrote in Nature in 2018. “This speedy evolution means that surveys would need to be done continuously to be informative.” Holmes, a professor at the University of Sydney, dubbed the idea that scientists could prevent the next pandemic by genetically characterizing all viruses the “forecasting fallacy” and urged his fellow researchers to focus on more cost-effective approaches to mitigate disease outbreaks.

Kekulé points to the recent failure of the scientific community to anticipate the delta variant of SARS-CoV-2 to underscore the futility of outbreak prediction. “It was clear that there would be a variant which is a little bit more effective,” Kekulé said. “But how would the virus do this? What is the exact mechanism? No one knew.” Similarly, the close scrutiny of the Ebola virus that followed its jump to humans in West Africa in 2013 did not enable researchers to prevent or better respond to its reemergence in 2018. And many scientists who were carefully tracking flu viruses were nevertheless surprised by the emergence of the swine flu in 2009.

But perhaps the best indicator that viral surveillance won’t prevent future pandemics is that it didn’t prevent the current one, which, as many have noted, first arose in a city that is home to multiple labs engaged in studying dangerous coronaviruses, including the Wuhan Institute of Virology. “Despite the fact that they had been conducting intensive surveillance and characterization of SARS-like coronaviruses, they failed to identify the SARS-like coronavirus, SARS-CoV-2, that jumped into humans right where they were doing their studies,” said Jesse Bloom, who studies the evolution of viruses with a particular focus on the flu at the Fred Hutchinson Cancer Center.

Bloom, who thinks that it’s valuable to understand the diversity of viruses in nature, also acknowledges the alternate possibility: that the Wuhan Institute of Virology did know about SARS-CoV-2 and it somehow escaped from its laboratory and went on to cause the pandemic. “In either case, that particular line of research wasn’t productive,” he noted, going on to point out the problematic premise underlying the pursuit of any previously unknown dangerous virus: “Either this virus is an animal virus and it can’t actually infect humans, in which case the entire rationale for the research is undermined because the rationale for this research is to predict the next pandemic virus,” said Bloom, “or, if it is actually the next pandemic virus and you’re collecting it and bringing it back to a lab and studying it, there’s some risk that if something goes wrong, it could cause a pandemic.”

No Need For Engineering

The $3.1 million grant that EcoHealth Alliance received from the NIAID in 2014 to study bat coronaviruses was also meant to anticipate and avert future outbreaks. The proposal described the project as a “predictive, proactive approach to combating the most high profile group of emerging pathogens.” Shi and five other Chinese scientists were co-investigators on the project, which involved catching bats in caves; taking samples of their blood, urine, and feces; transporting them to the Wuhan Institute of Virology; and subjecting them to various experiments to gauge the dangers they pose to humans.

The increasingly heated debate over the origins of SARS-CoV-2 has recently centered on those experiments. The Intercept has reported that under the NIH grant to study bat coronaviruses, the Wuhan Institute of Virology and EcoHealth Alliance created mutant versions of bat coronaviruses that were both more transmissible and more virulent than the original viruses. The majority of scientists we interviewed said that one experiment documented in records we obtained fit the NIH’s own definition of gain-of-function research, which had been a source of consternation within the scientific community for years before the pandemic.

But as a microbiologist named James LeDuc recognized early in 2020, all sorts of activities besides gain-of-function experiments could have led SARS-CoV-2 to leap from bats to humans. LeDuc was clearly worried about such activities when he emailed a colleague at the Wuhan Institute of Virology, Yuan Zhiming, in early February of last year. As the first U.S. cases were being reported in Washington state and Wuhan was still under lockdown, LeDuc suggested that Yuan and others at the institute conduct their own investigation into whether the new coronavirus might have escaped from its main campus or the newly constructed biosafety labs, according to emails obtained by U.S. Right to Know.

Then serving as director of the biosafety level 4 Galveston National Laboratory in Texas, LeDuc had previously worked on infectious diseases for the WHO, the CDC, and the United States Army Medical Research Institute of Infectious Diseases at Fort Detrick — and had trained scientists in biosafety procedures when the biosafety level 4 lab opened in Wuhan. And his list of questions for Yuan demonstrated his deep knowledge of the potential perils of viral research: Where were the coronavirus stocks stored? How many people had access to them? Were any of them disgruntled? Were exhaust air filtration systems working correctly? What about autoclaves and waste stream disinfection systems? Were biological safety cabinets used and appropriately certified? Was the waste stream properly managed?

LeDuc, who did not receive a response from his colleague, remained convinced that researchers could have caused the outbreak. “It is certainly possible that a lab accident was the source of the epidemic,” he wrote to another scientist named Philip Russell in April 2020. A physician and Army major who had also worked on biodefense, Russell agreed: “I have no doubt that Zheng Li Shi is a brilliant scientist and very charming. That does not rule out the possibility that one of the many bat coronaviruses isolated in the Wuhan lab infected a technician who walked out the door. No need for engineering the virus.”

The Laos Connection

Recently released communications between the NIH and EcoHealth Alliance hint at one plausible way that virus hunters might have aided the movement of SARS-CoV-2 from animals to people. A pre-print of a paper being considered for publication in Nature, released in September, described the discovery of three coronaviruses that were more than 95 percent identical to SARS-CoV-2 — the closest relatives yet discovered — in horseshoe bats found in the wild in northern Laos. The findings were presented by a team of researchers from the Pasteur Institute and the National University of Laos, and were received by many in the scientific community, as additional evidence that the pandemic began through a natural spillover from animal hosts.

But emails between EcoHealth Alliance and the NIH, which were released via a public records request and lawsuit by the White Coat Waste Project in November, raise questions about that conclusion. While the researchers had said that they planned to sample bats only in China in their grant proposal, the emails show that the group had actually written to the NIH about plans to conduct several “free-ranging bat surveys” during field trips to Laos — where the close viral relatives of SARS-CoV-2 were found — as well as in Vietnam, Myanmar, and Cambodia. All samples were to be tested at the Wuhan Institute of Virology, according to a 2016 email Daszak sent to the NIH.

Gilles Demaneuf, a data scientist and researcher who works with the group of Covid-19 researchers known as DRASTIC — Decentralized Radical Autonomous Search Team Investigating Covid-19 — which has been conducting an online investigation into the possibility of a lab leak, said that the emails’ reference to sampling in Laos made him more inclined to think that the pandemic was caused by research-related work.

“There was a concerted effort to actually take some of these samples from Vietnam, Myanmar, Cambodia, Laos and bring them to the Wuhan Institute of Virology,” said Demaneuf. “That’s a big change because now we have a direct link between Laos and the Wuhan Institute of Virology.”

The Intercept reached out to six of the scientists EcoHealth Alliance listed as viral sampling collaborators in its letter to the NIH, including Watthana Theppangna, who was listed as the group’s in-country contact in Laos, to get additional information about the sampling trips, like the number and dates of trips and the kind and number of animals sampled. Only one of the researchers, Dr. Veasna Duong of the Pasteur Institute in Cambodia, responded, saying that she did not have the requested information.

EcoHealth Alliance did not respond to The Intercept’s questions for this story. But Daszak did speak with Science’s Jon Cohen in November, telling him that he and his organization have broken no rules and “done nothing wrong.” On Twitter, EcoHealth Alliance insisted that it did not follow through with its plan to perform bat surveys in Laos, though it did seek and receive permission from the NIH to do so. “No work was ever conducted in Laos as a part of this collaborative research project,” the organization tweeted in November. The NIH did not answer questions for this article.

“Cowboy Country”

As outbreak prediction has grown from an idea into a well-funded research field, another danger has emerged. When the global hunt for potential pandemic pathogens began almost two decades ago, only a handful of people were able to create viruses from their genomic sequences. In the intervening years, technological advances have made it vastly easier to construct viruses, and now thousands of scientists can do so. The shift means that a ranked list of the most potentially destructive viruses would be available to an expanding group of people who, with little effort and expenditure, could use that information to create viruses capable of causing massive suffering and death.

Ironically, this also means that the NIAID’s funding for virus research, which ballooned because of bioterrorism fears, has inadvertently resulted in what could be a bioterror arsenal if it fell into the wrong hands.

“Creating a ranked-order list of every pandemic-capable pathogen we can find makes sense only if you assume that no one would ever dream of misuse.”

“A credible pandemic-capable virus on the level of SARS-CoV-2 is a weapon of mass destruction, one that can be assembled in a minimal lab for just a few thousand dollars in synthetic DNA and reagents,” said Esvelt, of the MIT Media Lab. While acknowledging the small possibility that the characterization and ranking of viruses that could infect humans might help address future pandemics, Esvelt believes that no benefit would be worth the possible costs.

“Creating a ranked-order list of every pandemic-capable pathogen we can find makes sense only if you assume that no one would ever dream of misuse,” he said.

Carroll, who directed Predict, acknowledged that a scientist could use the genetic sequence of a dangerous virus malevolently but said that risk already exists. “We don’t need to find some new virus in order to elevate that risk.” Even so, he recognized the more general concern. “If you go out and cavalierly begin collecting and characterizing these viruses, there’s inherent risk attached to that. And you have to be accountable for that risk.”

Given the numerous routes through which virus research can cause catastrophe, ensuring its safety requires keeping a close and constant eye on equipment, research practices, and anyone who has contact with biological samples in the field and the lab. Yet such oversight is all but impossible from afar.

Documents obtained in December by The Intercept as part of its litigation with the NIH reveal new details about EcoHealth Alliance’s monitoring of biosafety issues at the Wuhan Institute of Virology. In an April 23, 2021 letter to NIH Deputy Director for Extramural Research Michael Lauer, Daszak stated that such monitoring consisted of “semi-annual meetings with the lead investigator and assessments of compliance against all conditions of the award.”

Presented with Daszak’s description of its biosafety oversight, Lentzos, the biological threat researcher, said, “I don’t think that’s appropriate at all — every half a year — when you’re talking about really fast-paced, high-risk work.” She said that there should be ongoing bio-risk management as scientists design, carry out, and review research. “Formal assessments need to be regular, but, in addition, whenever unexpected results arise or any biosafety lapses occur, these need to be relayed straight away without delay.”

Lentzos also expressed concern about the NIH’s apparent lack of oversight. “It’s not clear how NIH is doing risk assessment or whether they’re completely outsourcing it to the grantees,” she said. “It seems a little bit of a free-for-all, like cowboy country.”

Indeed, more than 7,000 miles from the lab it was funding, the NIH operated at an even greater remove than EcoHealth Alliance. In April 2020, the NIH suspended the bat coronavirus grant, offering only that the “NIH does not believe that the current project outcomes align with the program goals and agency priorities,” as Lauer wrote to Daszak. At the time, the decision was condemned as being unscientific, both because President Donald Trump had ordered it and because it recognized the possibility of a lab leak, then considered by many — including Daszak — to be an outlandish conspiracy theory. Yet more than a year later, the agency was still struggling to understand what biosafety protocols had been in place at the Wuhan Institute of Virology while the agency-funded research was underway, as the recently released correspondence between Daszak and Lauer makes clear.

For months, Lauer had been asking Daszak for a series of documents, including monitoring, safety, and audit reports. And while the organization supplied many of the requested documents, it appeared unable to find several that related directly to the Wuhan Institute of Virology’s inner workings. Throughout the spring of 2021, Daszak seemed hopeful that he might persuade the NIH to reinstate the bat coronavirus grant. Its cancellation had taken a toll on EcoHealth Alliance staff, particularly Daszak himself, as he explained to Lauer in an April 25 email. “During the last 12 months we have been the subject of a growing series of horrific attacks in the press, and via online conspiracy theorists, and physically (including a white powder letter delivered to my home address).”

Daszak said he hoped that the NIH would correct course by reinstating the bat coronavirus grant — which, he reminded Lauer, could both help prevent “future spillover events” and offer “a critical opportunity for the USA to have eyes and ears on the ground in a country that has seen two coronaviruses emerge and spread globally in the past 2 decades,” as he explained in his April 25 email, concluding that “we await your decision on this suspension with great interest and remain at-the-ready to continue this work, as do our collaborators in China.”

As part of his pitch, Daszak told Lauer that EcoHealth Alliance had begun to shore up its biosafety operations in China after the bat coronavirus grant was canceled. “We have contracted with a leading lab biosafety contractor based in Southeast Asia [redacted] who has extensive experience commissioning, accrediting and auditing BSL-2,-3, and -4 labs, and has worked for over a decade at the BSL-4,” Daszak wrote in an April 23 letter to Lauer. “We will be using their services where appropriate for foreign lab subcontractees to assess lab biosafety procedures and conduct audits, including following the full reinstatement of [the bat coronavirus grant].” EcoHealth Alliance also hired someone to ensure the safety of virus hunting and other activities that take place outside the lab, writing that “we have appointed a Senior Field Veterinarian who will oversee all EcoHealth Alliance fieldwork in the region and ensure continued compliance with biosafety when conducting animal capture, sampling and sample handling.”

While the improvements in the oversight of its lab and fieldwork in China were clearly offered up to assuage any concerns that the NIH might have about reinstating the grant, the decision to bolster its biosafety practices could also be interpreted as an admission of its previous inadequacy.

It is not clear how the NIH, which had apparently never asked EcoHealth Alliance to put any of these higher-level precautions in place before, saw Daszak’s pitch. But the agency did not restore the funding for the bat coronavirus grant. And on June 11, the inspector general of the Department of Health and Human Services launched an audit “to determine whether: (1) the National Institutes of Health (NIH) monitored grants to EcoHealth Alliance in accordance with Federal regulations and (2) EcoHealth Alliance used and managed its NIH grant funds in accordance with Federal requirements.”

Yet on the very same day in June that the audit was launched, the NIAID awarded the second year’s funding of an even larger grant the agency had given EcoHealth in August 2020 — after the earlier grant had been terminated. A month later, Lauer sent a letter noting that he still had not received the Wuhan Institute of Virology’s “records validating expenditures specific to [the bat coronavirus grant] as well as any and all monitoring, safety, and financial reports specific to [the grant] that WIV submitted to you.” Lauer reminded Daszak that the grant terms had specified that the NIH “must have the right of access to any documents” and that the right “applies not only to awardee records, but also to subawardee records.” If a grantee doesn’t comply with the terms of a grant, it can withhold funding for other projects, Lauer noted in his letter.

The NIH does not appear to have withheld any of EcoHealth Alliance’s new funding.

Doubling Down

The new NIAID grant, titled “Understanding Risk of Zoonotic Virus Emergence in Emerging Infectious Disease Hotspots of Southeast Asia,” provides $7.5 million for researchers to track down, sample, store, and collect viruses obtained from animals throughout Thailand, Singapore, and Malaysia. The proposal, obtained by The Intercept through FOIA litigation, details much of the same work that was underway through the suspended bat virus grant. As with the previous grant, Daszak is the principal investigator.

The new grant, which is funded through 2025, seeks to identify and rank the spillover risk of the most dangerous viruses from wildlife, including bats, in remote locations. EcoHealth Alliance is also using this funding to build chimeric, or hybrid, viruses from SARS- and MERS-like bat coronaviruses, as it did under the grant that was suspended. This time, however, the scientists are using a pangolin virus rather than a bat virus to serve as the “backbone” of their chimeras.

The new grant attempts to tighten the oversight of anything that might be considered gain-of-function research. Both the NIH and EcoHealth Alliance said that work done under the canceled bat coronavirus did not qualify for review under HHS guidelines known as P3CO, which have been in place to guard against the risk posed by federally funded gain-of-function research since 2017. But under the new grant, “building chimeras based on SARS-CoV-1, SARS-CoV-2, and MERS-CoV may be subject to the DHHS P3CO Framework and must be submitted to NIAID for review and approval prior to the work commencing.” In other words, there may be a better chance that guidelines meant to safeguard against the dangers of the research will be effective — but there’s still no guarantee. The new grant also requires EcoHealth to give the NIAID detailed descriptions of its plans and the expected changes “prior to further altering the mutant viruses.”

But scientists who have been concerned about the possibility that the bat coronavirus grant may have led to the pandemic remain concerned that the research paid for through this next round of funding may involve some of the same risks. Instead of sending viral samples to the Wuhan Institute of Virology, which is not a partner on this project, the scientists will send the collected samples, including relatives of the Hendra virus and the Nipah virus, to the National Emerging Infectious Diseases Laboratories in Boston and the University of North Carolina at Chapel Hill, both of which operate the highest-level biosafety labs.

“It’s good it’s not going to China now. But it doesn’t need to be brought here to my home,” said Chan, the molecular biologist, who lives in Boston. “Why don’t we just keep the virus characterization local?”

“It’s good it’s not going to China now. But it doesn’t need to be brought here to my home.”

Along with the new grant, the NIH also gave Daszak his own research center. The South East Asia Research Collaboration Hub is one of 10 Centers for Research in Emerging Infectious Diseases that the NIAID created in 2020 at a cost of $82 million over five years. Some of these new projects entail potentially dangerous research. In Malaysia and Thailand, scientists are now searching for novel viruses in bats, rodents, and primates, according to the website of the CREID network. In Ethiopia, similar work is being conducted on camels and bats. In Nigeria and Sierra Leone, scientists are isolating the Lassa mammarenavirus, which causes a deadly hemorrhagic fever, and plan to ship the virus samples to a biosafety level 4 lab at the University of Texas Medical Branch in Galveston. Another project, taking place in “North America,” is simply described as “Engineering of reverse genetics for SARS-CoV-2 and testing of mutant viruses in cell culture and animal models.”

In April, the NIAID also launched another network of research sites. The Centers of Excellence for Influenza Research and Response will give out $24 million in contracts in its first year for the study of emerging viruses of pandemic potential and SARS-CoV-2 as well as flu viruses. The NIH did not answer questions about what measures have been implemented to ensure biosafety under these new efforts.

Additional federal funding for outbreak prediction is also on the way. In October, USAID, which closed out the Predict project in 2019, announced that it would be spending $125 million to scale up the agency’s previous efforts to identify and understand unknown viral threats through a new project called Discovery & Exploration of Emerging Pathogens – Viral Zoonoses, or Deep VZN. Like Predict, Deep VZN will conduct sampling in select countries in Africa, Asia, and Latin America; the project aims to strengthen the detection and characterization of previously unknown viruses and promises that the data and information it gathers will play a critical role in developing diagnostics, medicines, and vaccines. The project has already awarded a $10 million grant to Washington State University.

In an emailed statement in response to questions from The Intercept, a USAID spokesperson wrote that “USAID is working to detect and prevent future outbreaks by discovering and sequencing new viruses. These efforts help lead to better understanding of whether a new virus can infect humans, whether a human can fight off the virus, and how well the virus can replicate in humans. This information is critical to understanding whether new viruses have the potential to spillover and infect humans.” The USAID statement also said, “Our comprehensive global health security portfolio, including DEEP VZN, works to ensure systems are in place to prevent avoidable outbreaks; detect threats early; and respond rapidly and effectively when outbreaks occur” and that the agency ensures compliance with all safety protocols and procedures.

Protective suits hang in the lab at Boston University high security research lab in Boston on January 04, 2012.

The Global Virome

Meanwhile, Daszak and Carroll are leading an even more ambitious outbreak prediction effort. The Global Virome Project plans to find and map the genomes of more than 500,000 viruses around the world at a cost of roughly $1.2 billion. Carroll, who previously directed the NIAID’s emerging pandemic threats program, refers to the 10-year, $200 million Predict project that he oversaw as a mere “pilot project” for the new endeavor.

As with Predict, the rationale for the Global Virome Project is to track down potential pathogens so that we can prepare treatments and vaccines before the diseases emerge and “kick your door in,” as Carroll explained to Kaiser Health News in a 2020 interview. But Carroll bristles at criticism that the project is overly broad. “The work that I’m advocating isn’t about identifying and characterizing every virus on the planet,” he told The Intercept, emphasizing that the research focuses on global hotspots where viruses found in wildlife would be most likely to infect people. “It’s trying to be a lot smarter about risk and future risk.”

A 2017 State Department cable from the American Embassy in Beijing offers another reason why the U.S. government might want to invest in the project: to maintain U.S. dominance over China in the field of viral research. “Absent U.S. government leadership in GVP agenda-setting, governance, and funding the Chinese government could likely take a leading position in this potentially path breaking endeavor undermining years of USG leadership and considerable investment in this critical field of public health,” the cable states. “The Chinese government has shown strong interest in the Global Virome Project and is not shy about expressing interest in funding projects where Chinese scientists will take a lead.” Indeed, China and Thailand both launched partner virome projects before the pandemic, and the State Department cable, obtained via a public records request by U.S. Right to Know, notes that the Chinese Academy of Sciences had already allocated funding for the project. In an interview, Carroll said that both the Thai and Chinese virome projects are now “on hold.”

The scientists behind the Global Virome Project emphasize its potential to help the world prepare for future pandemics. In an email to The Intercept, Edward Rubin, a physician and geneticist who serves on the project’s board, wrote that the collection of viruses on a massive scale has already put scientists on a path to developing a universal flu vaccine and could potentially help with the development of a similar vaccine for coronaviruses: “This theoretically might be vaccine specific not only for a single coronavirus family but effective against different families of coronaviruses: SARS, MERS, COVID-19 and its variants.”

While Carroll told The Intercept that he and others are “still negotiating” possible federal support for the Global Virome Project, the 2017 State Department cable suggests that the U.S. had already begun funding the project. “Significant USG support for GVP-related research already exists, including the Ecology and Evolution of Infectious Diseases Program, which is jointly supported by NIH, USDA and [National Science Foundation].”

Asked about the cable, Carroll said, “Further development of GVP has been disrupted by the Covid-19 pandemic. Issues of sample ownership remain to be resolved.”

Even as it was getting underway, U.S. officials saw a possible hitch in the plan. “General view is that we do not want China to take a leadership role in isolation in fear of their reluctance to share data,” Rubin wrote to his colleagues in 2017 about a gathering of international officials to discuss the Global Virome Project. Similarly, the State Department cable described the project as having several “significant challenges” and unresolved questions. “Who will own the samples that are collected from many countries? Where will they be analyzed? Will all the GVP data be freely available to the public?” the cable asked in a section titled, “Like all risky endeavors, failure is a possibility.”

While acknowledging the possibility of failure, the State Department document did not explore what that failure might look like. At the time, it might have seemed unlikely that a lack of oversight of this well-intentioned endeavor could lead to grave global consequences. And it would have been hard to accurately weigh — or even imagine — the scale of worldwide misery, death, and economic disruption that hung in the balance.

The world has shifted in other ways around this massive global undertaking. While the pandemic can make the exhaustive search for dangerous viruses seem all the more necessary, unanswered questions about the origins of SARS-CoV-2 underscore the profound implications of the biosecurity concerns voiced in the State Department cable. The Global Virome Project got its start at a time when scientists from China and the U.S. could work together in a way that felt constructive. But now, as tensions over the origins of the pandemic escalate, it’s hard to imagine such cooperation — and hard to imagine that the U.S. will ever have full access to all the viral research funded through NIH grants at the Wuhan Institute of Virology.

“We’re missing the entire period of 2016 to 2019. What viruses and sequences did they find?”

Chief among the missing data are the genetic sequences of viruses the Wuhan Institute of Virology and EcoHealth Alliance collected between 2016 and 2019. A 2020 paper that Shi, Daszak, and others published in Nature, which cited the bat coronavirus grant as one of its funding sources, includes only viral samples collected through 2015. The sequences of viruses collected under the grant since then have yet to become public.

“We’re missing the entire period of 2016 to 2019. What viruses and sequences did they find?” asked Chan, who had similar questions about the projects underway through the new Centers for Research in Emerging Infectious Diseases. Is there any way to ensure transparency and accountability around the viruses and information they collect?

Meanwhile, the fate of the China Virome Project, which was begun in the hopes of working in conjunction with the Global Virome Project, is unclear. Rather than collaborating on health security, the U.S. and China are now positioned to operate as competing superpowers in a biological arms race, engaged in separate efforts to hunt down the world’s most dangerous viruses.

Skirting Safeguards

Even the experts who see the global pursuit of the most dangerous potential pandemic pathogens as dangerous folly agree that basic research on viruses must continue. The challenge is how to do that safely — and ensure that safety measures cover all areas of research that pose risk.

The shortfalls of recent efforts to shore up the safety of viral research are now becoming clear. The U.S. instituted a carefully thought-out moratorium on gain-of-function research — but the policy specifically carved out an exemption for hunting coronaviruses. “The research funding pause would not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses,” as the 2014 HHS document made clear. Similarly, the P3CO guidelines that HHS issued in 2017 apply only to “enhanced potential pandemic pathogens” — and not viruses that have not been altered, even though they may also be dangerous.

And as happened in the case of EcoHealth Alliance, even the best-laid policies can be evaded by powerful scientists. Daszak and Fauci, two powerful leaders in their field, were able to work together to skirt safeguards the U.S. government imposed on gain-of-function research, which might have otherwise prevented experiments that were conducted at the Wuhan Institute of Virology, as The Intercept has previously reported.

Related

NIH Officials Worked With EcoHealth Alliance to Evade Restrictions on Coronavirus Experiments

The U.S. government does have some strict safety protocols in place for working with dangerous pathogens. Virus hunters are required to report any bites or scratches that happen during sampling and train workers in emergency response. But such rules are only as strong as whoever is enforcing them — and they may be increasingly difficult to enforce.

While countries across the globe are taking part in this research, there are no international standards for bio-risk management. Several of the scientists interviewed for the piece, including Carroll of the Global Virome Project, emphasized the urgent need for such oversight. Without it, the level of attention to the possible dangers of the work varies widely throughout the world. Some partners may not agree with the U.S. government about when such facilities should be used, as was the case with the Wuhan Institute of Virology, which had a biosafety level 4 lab but did much of its work on coronaviruses through the NIAID grant in a much less protective biosafety level 2 lab.

“You can say, ‘You have to have this and this equipment in place,’ but it’s harder to ask for certain ways of operating,” said Lentzos, who added that in many countries it is difficult for scientists working on viruses to honestly discuss risk. “Some of this work is taking place in cultures where openness, transparency, and admitting mistakes is not encouraged at all. In fact, the opposite is encouraged.”

An even more vexing challenge to keeping this work safe is the persistent impulse to push past the bounds of acceptability, which can drive researchers around the world to conduct risky gain-of-function experiments or press into the world’s most remote bat caves. According to Lentzos, the pressure to transgress those norms is built into the profession of science. “You have to push the envelope,” she said. “That’s what gets recognition, not just peer recognition, but that’s what gets funding. That’s what gets publication.”

In other words, it’s simply all too human to gravitate toward the most dangerous science — just as it’s only human to have all sorts of accidents once you do.

Documents published with this article:

Risk of Viral Emergence from Bats

Understanding Risk of Zoonotic Virus Emergence in Emerging Infectious Disease Hotspots of Southeast Asia

The Ecology, Emergence and Pandemic Potential of Nipah Virus in Bangladesh

Understanding the Risk of Bat-Borne Zoonotic Disease Emergence in Western Asia

Communications related to “Understanding the Risk of Bat Coronavirus Emergence”

HHS Inspector General Notice of Audit

Year 2 Award Notice Understanding Risk of Zoonotic Virus Emergence in EID Hotspots of Southeast Asia

Documents previously published by The Intercept:

Understanding the Risk of Bat Coronavirus Emergence

Understanding Risk of Zoonotic Virus Emergence in Emerging Infectious Disease Hotspots in Southeast Asia

The post How the Pursuit of Unknown Viruses Risks Triggering the Next Pandemic 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.

Just seven months later, Valeriano, who was by then pregnant with her first child, got what felt at the time like a significant victory: The EPA announced that it planned to grant the group’s request and issued a proposed rule that would add DINP to the toxics inventory. Once the rule was finalized, companies would have to report their DINP emissions to the public database, and communities living nearby would know how much of the chemical was being released into their surroundings. In the federal register, the agency noted the science driving its decision: “The toxicity data clearly indicates that DINP is known to cause or can reasonably be anticipated to cause cancer and other serious or irreversible chronic liver, kidney, and developmental toxicity in humans.”

Yet more than 20 years later, the EPA has yet to make good on its promise to add DINP to the list of chemicals. It never finalized the rule, and in the intervening years, companies have continued to churn out DINP and other chemicals in its class in astounding amounts without disclosing how much individual plants make and emit. Between 2012 and 2015, as much as 500 million pounds of DINP was made or imported each year, according to the most recent numbers available from the EPA. Companies add DINP to hundreds of products in place of another phthalate called DEHP that is being phased out because it causes cancer, birth defects, and reproductive difficulties. Over the last decade, blood levels of chemicals the body forms as it breaks down DINP have climbed in the U.S., while those of DEHP have gone down.

Although it has been promoted as a “green alternative” to DEHP, DINP causes many of the same problems as the chemical it so often replaces. In addition to the cancer and hormone disruption that sparked Valeriano’s claim 21 years ago, we now know more about how DINP affects the sexual development of children. It decreases sperm motility, increases malformations of the testes and other organs, and makes boys with relatively high levels of exposure to the chemical more likely to be infertile later in life. Experiments on lab rats also showed that those that were exposed to DINP in the womb had “reproductive malformations” and developed traits usually seen in females, including female-like nipples. DINP has also been linked to high blood pressure and insulin resistance, which can lead to diabetes.

In fact, the entire group of phthalates — an estimated half-billion pounds of which are made and used in the U.S. each year — seem to cause a similar constellation of health problems. Although not every chemical has the same profile, most of the ones that have been studied appear to damage the development of the male reproductive system. Studies of various phthalates have shown them to cause birth defects, fertility problems in people who can become pregnant, miscarriage, testicular cancer, kidney cancer, and liver cancer. Exposure to the chemicals in the womb or early childhood has also been linked to learning, attention, and behavior problems, lower IQ, memory problems, and autism, rates of which have recently reached record highs.

The Lawsuits

Yet efforts to compel the EPA and the Food and Drug Administration to limit phthalate exposure have been stuck in limbo for years, as the companies that make the chemicals continue to insist that they’re safe. While the Consumer Product Safety Commission and Congress banned the use of eight phthalates in children’s toys, the Food and Drug Administration still allows those same chemicals to be used in food production. Now environmental groups are pushing back, calling on the courts to force both agencies to finally act on their years-old promises to regulate the chemicals.

In September, Earthjustice sued the EPA on behalf of communities living near facilities that import or manufacture large amounts of DINP in an effort to force the agency to finally add the chemical to the Toxics Release Inventory. The legal action comes as the EPA is beginning an assessment of DINP, which cannot be done properly without the emissions information, according to Katherine O’Brien, the Earthjustice attorney handling the case.

“We are very concerned about how EPA is going to identify the fenceline communities and do a lawful and comprehensive risk evaluation without TRI data,” said O’Brien. “The idea that the manufacturers can get in there by requesting a risk evaluation before EPA has the data that really we believe are necessary to support that is very troubling.”

An EPA spokesperson said that the agency was unable to comment on the DINP lawsuit because it is under active litigation.

Meanwhile, on December 7, Earthjustice sued the FDA on behalf of the Center for Food Safety, the Learning Disabilities Association of America, the Environmental Defense Fund, and other environmental groups, demanding that the agency take action on phthalates. This, too, is a repeated request. In 2016, the groups asked the agency to revoke its approval of 28 phthalates used in food packaging and processing materials, such as conveyor belts, tubing used in dairies, and gloves used by workers in food processing facilities and restaurant kitchens. But the FDA has yet to act on the 2016 petition.

The suit notes that “ingestion of food and drinks contaminated by phthalates is the primary way that most people in the United States — including children — are exposed to most phthalates” and asks the court to remedy the FDA’s “years-long unreasonable delay” and make the the agency take action on its 2016 petition within 60 days.

An FDA spokesperson said that the agency does not comment on active litigation.

Everywhere Chemicals

Exposure to phthalates is practically unavoidable. The chemicals easily leach out of products, which helps explain how they can move so easily from equipment into processed food, such as instant macaroni and cheese and fast food, and why virtually all Americans — including newborns — have some phthalates in their blood. In addition to their role as “plasticizers,” phthalates are added to fragrances to make them linger in the air and can be found in shoes, medical tubing, insulation, shower curtains, garden hoses, car interiors, fabrics, floor coverings, building materials, playground and sports equipment, cleaning products, ink, electronics, fabrics, and personal care products.

“We have the forever chemicals, and now we have the everywhere chemicals,” said Maricel Maffini, a researcher who has studied endocrine-disrupting chemicals for 15 years, said of phthalates. “The exposure is constant.”

“We have the forever chemicals, and now we have the everywhere chemicals. The exposure is constant.”

Although everyone is exposed, people of color tend to have the highest levels of the chemicals. According to the National Biomonitoring Program, Black, Hispanic, and Asian people in the U.S. had higher levels than white people for 9 out of 10 phthalates for which data was reported.

Patients also appear to be particularly vulnerable because phthalates can leach from IV bags and medical tubing into blood. Infants have been shown to be exposed while hospitalized in neonatal intensive care units. According to a recent study, DEHP increased the likelihood of drug resistance and relapse in breast cancer patients.

Because the effects of the chemicals can be additive, the European Food Safety Authority recently decided to regulate DINP and DEHP together, setting a maximum exposure level for a group of four phthalates. Yet in the U.S., phthalates have simply been swapped out for one another in manufacturing for years.

The Stealth Phthalate

While the regulatory agencies have yet to catch up with DINP, more phthalates have been introduced, including DPHP, a compound Mike Belliveau refers to as the “stealth phthalate.”

“It’s just not regulated at all,” said Belliveau, executive director of the environmental group Defend Our Health, who has been tracking phthalates for decades. “When we first started asking for it to be analyzed five years ago, the labs didn’t even have the reference standard in stock.”

While the state of California has listed six phthalates, including DINP, under Proposition 65, which warns of the dangers of chemicals that cause cancer, birth defects, and reproductive harm, it has no listing for DPHP. Nor has the European Chemical Agency yet regulated DPHP, although it is assessing the chemical as a potential endocrine disruptor.

“When we first started asking for it to be analyzed five years ago, the labs didn’t even have the reference standards in stock.”

DPHP also has yet to undergo any formal review or approval from the EPA or FDA. Although it has not been widely studied, initial animal experiments show that it is similarly toxic to other phthalates — causing decreased weight, lesions on the liver, and shrinking of the thyroid gland. Nevertheless, DPHP’s use is on the increase.

Companies that make phthalates — along with the American Chemistry Council, which represents them — have insisted for years that the chemicals pose no threat. ExxonMobil, one of the manufacturers of phthalates, has lobbied hard against the ban on the use of the chemicals in toys. Despite the mounting evidence, the company insisted to both the Consumer Product Safety Commission and Congress that phthalates were safe for children. ExxonMobil and other manufacturers in the American Chemistry Council have also pushed to slow or stop regulation of phthalates at the EPA.

In response to questions for this article, ExxonMobil spokesperson Todd Spitler wrote in an email that “DINP is a safe and critical plasticizer used and broadly found in a large variety of construction, automotive and healthcare products that consumers depend on every day.” Spitler also wrote, “As a manufacturer of DINP, we take stringent precautions to protect the safety and health of our employees, customers, the public, as well as the environment.”

While fighting to be able to continue making the chemicals behind the scenes, companies appear reluctant to be publicly linked to phthalates or admit how much they make or use. Every one of the 30 companies mentioned in the EPA’s most recent use report for DINP declined to disclose how much they use or make, claiming that the amounts are confidential business information. Nevertheless, the use report is clear that DINP is produced at several sites, including a BASF plant in Pasadena, Texas; an Arkema plant in Wauwatosa, Wisconsin; a Teknor Apex plant in Brownsville, Tennessee; and a Vectra Corp. plant in Franklin, Pennsylvania.

ExxonMobil also produces DINP at its plant in Baton Rouge, Louisiana, though it declares the very name of its company confidential in the EPA document. (Although the parent company is listed as “CBI,” the site gives the address of the ExxonMobil plant.) While it is illegal to claim a company name as confidential, companies often do it in an effort to obscure their responsibility, according to Belliveau. “They just want to hide the ball,” he said.

According to an EPA spokesperson, ExxonMobil withdrew its claim that the company name was CBI, but did so after the most recent use report was released in 2016.

Such reporting shenanigans make it impossible for people living near plants to know if they might be exposed to additional phthalates from local contamination in their environment, in addition to whatever amount they get simply from living amid countless products that contain them. If Earthjustice prevails in its suit, people living near the plants that produce DINP will have more information soon, at least about that one chemical. The EPA and Earthjustice are now discussing a possible settlement.

For Valeriano, who filed the request to the EPA to add DINP to the Toxics Release Inventory 21 years ago, a victory would be bittersweet. While she and other environmentalists have been waiting for the EPA to act, Valeriano went on to have three children — all of whom are now adults. “During that time, we have all had continued ongoing exposures,” she said. “It’s way past time to act.”

Update: December 7, 2021, 3:58 ET

This article has been updated with comments from the EPA and the FDA.

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Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called “Understanding the Risk of Bat Coronavirus Emergence.” The notes were taken by congressional staff who transcribed the emails.

EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as “chimeras.”

The plans triggered concerns at NIH. Two staff members — Jenny Greer, a grants management specialist, and Erik Stemmy, a program officer handling coronavirus research — wrote to EcoHealth Alliance to say that the experiments “appear to involve research covered under the pause,” referring to a temporary moratorium on funding for gain-of-function research that would be reasonably anticipated to make MERS and SARS viruses more pathogenic or transmissible in mammals. Generally, gain-of-function research involves manipulating viruses to give them new attributes; it becomes of concern to the government when the altered viruses appear likely to cause more severe disease or spread more easily among humans.

One of the experiments proposed by EcoHealth Alliance involved making chimeras from the MERS virus. The other experiment used chimeras developed from bat viruses related to SARS. The researchers went on to infect the genetically engineered mice with the altered viruses.

Initially, NIH staff appeared intent on enforcing the funding pause. The two administrators requested additional information from EcoHealth Alliance within 15 days and noted that the next round of funding would be withheld until the information was received. They also asked the group to provide a detailed description of changes that would allow the researchers to pursue their aims without conducting the dangerous experiments.

Agency staff adopted language that EcoHealth Alliance crafted to govern its own work.

But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work. The agency inserted several sentences into grant materials describing immediate actions the group would take if the viruses they created proved to become more transmissible or disease-causing as the result of the experiments.

Although the experiments demonstrate a lack of oversight and present dangers to public health, according to several scientists contacted by The Intercept, none of the viruses involved in the work are related closely enough to SARS-CoV-2 to have sparked the pandemic.

Serious Risks

In December 2017, the funding for some gain-of-function research was resumed under carefully constructed guidelines for “Potential Pandemic Pathogen Care and Oversight,” or P3CO — but the language suggested by Daszak helped the group evade this oversight as well. In July 2018, NIAID program officers decided that the experiments on humanized mice — which had been conducted a few months earlier — would get a pass from these restrictions as long as EcoHealth Alliance immediately notified appropriate agency officials according to the circumstances that the group had laid out.

While it is not unusual for grantees to communicate with their federal program officers, the negotiation of this matter did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. “The discussions reveal that neither party is taking the risks sufficiently seriously,” said Bloom. “MERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn’t also be considered a pandemic risk.”

“The NIH is bending over backward to help people it’s funded.”

“It’s absolutely outrageous,” said Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris. “The NIH is bending over backward to help people it’s funded. It isn’t clear that the NIH is protecting the U.S. taxpayer.”

The NIH did not respond to questions about the communications with Daszak. EcoHealth Alliance did not immediately respond to questions.

In a written response to questions submitted in September and October, an NIH spokesperson told The Intercept that the rule that was supposed to trigger a stop to the research was added “out of an abundance of caution.” Similarly, in a letter sent to the House Committee on Oversight and Reform last month, NIH principal deputy director Lawrence Tabak called the rule “an additional layer of oversight,” implying that the agency had devised the rule itself. But the notes reviewed by The Intercept show that the language was inserted at Daszak’s suggestion and that the NIH and EcoHealth Alliance worked together to evade additional oversight.

Daszak responded to the NIH on June 8, 2016, arguing that, because EcoHealth Alliance’s proposed hybrid viruses were significantly different from the SARS virus, which was already known to infect humans, the experiments were not gain-of-function research and should not be restricted.

Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, “has never been demonstrated to infect humans or cause human disease,” according to the transcribed emails. And he said that previous research “strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals.” The NIH would go on to accept these arguments.

But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic. “The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,” said Bloom. “Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?”

The NIH has not made the correspondence public. Instead, the agency arranged for an “in camera” review for select congressional staff. The staffers were allowed to read and take notes on printed copies of the written exchange — an unusual approach for grant communications that are in the public interest. The Intercept reviewed notes taken by congressional staff.

“Given the importance and interest in this topic, it’s important for the NIH to be fully transparent about the research they support and how they make crucial decisions about the regulation of research on potential pandemic pathogens,” said Bloom.

The Escape Clause

Regulating risky research is the NIH’s role. But Daszak gave his group a way out. If the recombinant viruses grew more quickly than the original viruses on which they were based, he suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer. Specifically, he suggested a threshold beyond which his researchers would not go: If the novel SARS or MERS chimeras showed evidence of enhanced virus growth greater than 1 log (or 10 times) over the original viruses and grow more efficiently in human lung cells, the scientist would immediately stop their experiments with the mutant viruses and inform their NIAID program officer.

In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were “not reasonably anticipated” to “have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,” the administrators concluded, according to the transcribed emails.

The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: “Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.”

But when the scientists conducted the experiments in 2018, one of the chimeric viruses grew at a rate that produced a viral load of log 4 — or 10,000 times — greater than the parent virus. Even so, the work was allowed to proceed.

Despite the careful wording meant to assure the agency that the research would be immediately halted if it enhanced the viruses’ pathogenicity or transmissibility, EcoHealth violated its own rule and did not immediately report the concerning results to NIH, according to the letter from NIH’s Tabak.

In a letter sent to NIH on October 26, Daszak insisted EcoHealth Alliance did comply with all the requirements of its NIH grant, pointing out that the group reported the results of its experiment in its year four progress report, which it submitted to the agency in April 2018 — and that no one at the agency responded to the description of the experiment. “At no time did program staff indicate to us that this work required further clarification or secondary review,” he wrote.

Daszak also argued in the letter that the viral growth reported in the year four progress report did not correspond to the viral growth outlined in the rule he himself had devised. “The experiment we reported to NIH actually shows genome copies per gram not viral titer.”

Daszak emphasized that the growth of the chimeric viruses in the genetically engineered mice was enhanced only in the early part of the experiment. “By day 6-8, there was no discernably significant difference among the different viral types,” he wrote.

Yet virologists contacted by The Intercept dismissed both the distinction between viral titer and viral growth and the focus on the latter part of the mouse experiment, when the rate of growth between the viruses had evened out.

“I don’t agree with their interpretation,” said Wain-Hobson, of the Pasteur Institute. He described the EcoHealth Alliance’s response as “hairsplitting” and said that viral growth inevitably peters out. “Every growth of a virus comes to a plateau. This has been known since time immemorial,” said Wain-Hobson. “They have chosen this interpretation because it suits them.”

NIH officials have previously stated unequivocally that the agency did not fund any gain-of-function research in Wuhan. “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology,” said Anthony Fauci, the head of the NIAID, during a Senate hearing in May. Fauci is scheduled to testify before the Senate health committee tomorrow morning.

In its statement to The Intercept, an NIH spokesperson wrote, “the Agency did not support the kind of ‘gain of function’ research warranting the additional and unique P3CO oversight identified by stakeholders during extensive prior policy development. To claim otherwise is incorrect and irresponsible.” And in his letter last month, Tabak reiterated the claim that the research was not gain-of-function.

But the correspondence with Daszak makes clear that at least some at the agency were concerned that EcoHealth Alliance’s proposed experiments met the criteria for gain-of-function research of concern as early as 2016.

According to Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of federal oversight of gain-of-function research, the fact that the NIH allowed EcoHealth Alliance to write its own rules is further evidence of the NIH’s regulatory failure. “This is like the teacher giving you the opportunity to write your own homework problem and grade your own homework when you turn it in. Then you decide the teacher is so lenient, there’s no need to hand it in,” said Ebright. “The oversight process clearly failed.”

Beyond the question of oversight, others question whether these experiments should be conducted at all.

“In addition to the legalistic questions of whether EcoHealth and NIH were adhering to current guidelines,” said Bloom, “we urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”

The post NIH Officials Worked With EcoHealth Alliance to Evade Restrictions on Coronavirus Experiments 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.

In September, The Intercept received two grant proposals by EcoHealth Alliance that were submitted to the NIH. One of the proposals, “Understanding the Risk of Bat Coronavirus Emergence,” detailed troubling and potentially dangerous research conducted with bat coronaviruses in Wuhan, China. But the first release of the documents, which The Intercept received more than a year after it requested them, did not include the progress report for the grant’s fifth and final funding year.

Yesterday, the NIH provided that missing report for the period ending May 2019, which was inexplicably dated August 2021. That summary of the group’s work includes a description of an experiment the EcoHealth Alliance conducted involving infectious clones of MERS-CoV, the virus that caused a deadly outbreak of Middle East respiratory syndrome in 2012. MERS has a case-fatality rate as high as 35 percent, much higher than Covid-19’s. The scientists swapped out the virus’s receptor-binding domain, or RBD, a part of the spike protein that enables it to enter a host’s cells, according to the report. “We constructed the full-length infectious clone of MERS-CoV, and replaced the RBD of MERS-CoV with the RBDs of various strains of HKU4-related coronaviruses previously identified in bats from different provinces in southern China,” the scientists wrote.

“Changing the receptor binding site on MERS is sort of crazy,” wrote Jack Nunberg, a virologist and director of the Montana Biotechnology Center at the University of Montana, in an email to The Intercept after reviewing the documents. “Although these new chimeric viruses may retain properties of the MERS-CoV genetic backbone, engineering of a known human pathogen raises new and unpredictable risks beyond those posed by their previously reported studies using a non-pathogenic bat virus backbone.” The researchers’ intent, which some scientists consider integral to defining gain-of-function, remains unclear.

“In the very same report, they showed data that one of their chimeric SARS-like viruses caused more severe disease in a humanized animal model than the original virus,” said Alina Chan, a Boston-based molecular biologist and co-author of the upcoming book “Viral: The Search for the Origin of Covid-19.” “After seeing that result, why did they do similar work using the MERS human pathogen?”

The Intercept previously asked EcoHealth Alliance about work on MERS-CoV referenced in sections of the grant that NIH released in September. At the time, EcoHealth spokesperson Robert Kessler insisted that the group had not conducted the work. “The MERS work proposed in the grant is suggested as an alternative and was not undertaken,” Kessler wrote in an email in September. Kessler did not respond to a query The Intercept sent yesterday about the apparent falsity of his previous statement.

The work with the MERS virus complicates EcoHealth Alliance’s previous claims that the research covered in the grant had not involved work with “potential pandemic pathogens,” or viruses, bacteria, and microorganisms that carry a likely risk of uncontrollable spread between humans. Kessler had previously told The Intercept that “All the other viruses studied under this grant are bat viruses, not human viruses.” But MERS is known to infect and spread in humans, and was specifically designated under the NIH’s former pause on funding gain-of-function research of concern.

Other questions arise from the group’s experiments with bat coronaviruses. As The Intercept previously reported, the EcoHealth Alliance grant proposals released in September contained descriptions of an experiment on mice that had been genetically engineered to contain an enzyme receptor found in human cells. These “humanized mice” were infected with bat coronaviruses containing parts of other viruses. At certain times during the experiment, the mutant viruses reproduced far more quickly in the mice than the original bat virus on which they were based and were also somewhat more pathogenic, leading several experts to conclude that they fit the NIH’s definition of gain-of-function research.

The federal government temporarily paused such gain-of-function research involving potential pandemic pathogens in 2014, though it was resumed in 2017, when the Department of Health and Human Services introduced guidelines known as P3CO, which were meant to safeguard against the risk of disease outbreak.

In September, The Intercept asked the NIH whether anyone at the agency was aware of the humanized mouse experiments and whether, after they resulted in evidence of enhanced virus growth greater than 1 log over the parental backbone strain, the grantees were made to “stop all experiments with these viruses and provide the NIAID Program Officer and Grants Management Specialist, and Wuhan Institute of Virology Institutional Biosafety Committee with the relevant data and information related to these unanticipated outcomes,” as the grant had specifically required. We also asked why that research was not subject to either the temporary pause or the P3CO guidelines.

In response, NIH spokesperson Elizabeth Deatrick wrote, “The PI [principal investigator] reported these results in the year 4 progress report and grant renewal application. The research described was reviewed, and was determined not subject to the 2014-2017 Gain-of-Function Research Funding Pause or to the P3CO Framework.”

Yet in a letter sent to Rep. James Comer, R-Ky., yesterday, NIH Principal Deputy Director Lawrence Tabak seemed to suggest that the agency had not been aware of the problematic research. “EcoHealth failed to report this finding right away, as was required by the terms of the grant,” Tabak wrote to Comer, the ranking member of the House Committee on Oversight and Reform, which also received a copy of the annual progress report from the bat coronavirus grant yesterday.

While critical of EcoHealth Alliance, Tabak also seemed to suggest that there was nothing alarming about the research, which he referred to as “limited experiments.” After acknowledging that some of the humanized mice that were infected with the mutant viruses became sicker than those infected with the original viruses, he said the scientists had not been intent on that outcome. “As sometimes occurs in science, this was an unexpected result of the research, rather than something the researchers set out to do.”

Tabak also emphasized, as The Intercept has previously reported, that the viruses studied in the mouse experiments were so evolutionarily distant from SARS-CoV-2 that they could not have mutated into the virus that caused the Covid-19 pandemic. That view was echoed in a brief analysis of the research that NIH posted to its website yesterday.

Also among the documents NIH released to The Intercept yesterday was the original version of an annual report from the fourth year of the bat coronavirus grant. The version released to The Intercept in September indicated that it had been submitted in 2020, after the pandemic began and more than two years after it was due. The two versions appear to be almost identical, though they include different reference publications. NIH has not yet released communications around the grant that may explain why the document was updated.

According to Tabak’s letter, the NIH has demanded additional information from EcoHealth Alliance. “EcoHealth is being notified that they have five days from today to submit to NIH any and all unpublished data from the experiments and work conducted under this award,” he wrote. “Additional compliance efforts continue.”

“This is a pattern of dishonesty,” said Chan, the molecular biologist and “Viral” author. “It should be clear now that we cannot take the word of conflicted parties in the search for the origin of Covid-19,” she added. “It is urgently important that the public and investigators gain full access to all EcoHealth documents relating to research conducted in Wuhan.”

Update: October 21, 2021, 2:33 p.m. ET

This story has been updated to clarify a statement by Jack Nunberg and include an additional comment from Alina Chan.

The post EcoHealth Alliance Conducted Risky Experiments on MERS Virus in China appeared first on The Intercept.

“This comprehensive, national PFAS strategy will deliver protections to people who are hurting by advancing bold and concrete actions that address the full life cycle of these chemicals,” said EPA Administrator Michael Regan, who appeared in North Carolina, where he previously served as secretary of the North Carolina Department of Environmental Quality, to launch the plan. “Let there be no doubt that EPA is listening, we have your back, and we are laser-focused on protecting people from pollution and holding polluters accountable.”

The EPA document lays out an accelerated timeline for various steps to regulate, remediate, and conduct research on PFAS, a class of chemicals used to make nonstick pans, firefighting foam, and hundreds of other products. The agency committed to designating two of the best-known chemicals in the class, PFOA and PFOS, as hazardous under the Comprehensive Environmental Response, Compensation, and Liability Act by the summer of 2023. By that fall, the agency plans to set enforceable drinking water limits on those same two compounds. The EPA has pledged to finalize a risk assessment for PFOA and PFOS in sludge by the winter of 2024.

But environmental advocates and people living in contaminated communities criticized the plan for containing more promises and planned actions than concrete policies. “I first wrote to U.S. EPA March 6, 2001, asking and urging the agency to take action to protect people from PFOA in public drinking water,” said Robert Bilott, an attorney who represented some 80,000 people whose drinking water was polluted with PFOA from a DuPont plant in West Virginia. “It is now 20 years later, and we are still waiting for them to actually do it, as opposed to announcing plans to do it years in the future.”

“We’ve had two prior action plans, which went nowhere, so it’s frustrating because there’s no actual actions being announced as opposed to plans,” said Bilott, who noted that the EPA acknowledged that the fulfillment of its commitments is contingent upon appropriations.

How Many Chemicals?

The road map, which was produced by the EPA Council on PFAS created earlier this year, attempts to broaden the agency’s focus on the thousands of chemicals in the class. The document lays out plans to sample for 29 PFAS compounds in water systems in 2024 and 2025. And the agency will soon begin to publish toxicity assessments for seven PFAS compounds, including GenX, which was introduced as a substitute for PFOA.

The EPA also plans to subdivide the thousands of PFAS compounds based on their toxicity, chemical structure, and the techniques used to remove them from the environment, according to the document. The agency will then identify the gaps in research about these compounds and, in some cases, require the companies that make the chemicals to conduct and fund the research themselves.

“This is a big deal,” said Betsy Southerland, a scientist who worked at the EPA for 33 years. “Finally, this is going to be used to get the industry people rather than the federal government and academics to have to fill in all the critical missing data.” The agency could then use the information to regulate all the chemicals within the category. But the process of restricting or banning uses for a single category would take at least seven years, even if it begins immediately, Southerland said.

Critics pointed out that several of the planned regulatory steps focused on only PFOS and PFOA and said that the EPA fell short of regulating PFAS chemicals as a class, an approach environmental groups have advocated because it would speed up the process and bypass the cycle of replacing one toxic chemical with another.

“They have the option under the Toxic Substances Control Act of saying that PFAS comprise a class and are going to be treated as a class, but they’re not doing that,” said Robert Sussman, an attorney representing six environmental groups that have petitioned the EPA to require testing of 54 PFAS compounds released by a former DuPont plant, now owned by DuPont spinoff Chemours. The plant has released hundreds of PFAS compounds into North Carolina’s Cape Fear River, which supplies drinking water to 1.5 million people. Although the plan said that the agency would issue its first round of orders for companies to do toxicity testing by the end of this year, Sussman expressed skepticism that it would meet the demands of the environmental groups he’s representing.

“There’s nothing in the road map that increases my confidence that EPA is going to require the testing that we’ve asked for,” said Sussman. “Just in the Cape Fear watershed, we’re dealing with hundreds of compounds. We need to be getting a handle on what people are exposed to in the real world.”

More PFAS Still Coming

While emphasizing the agency’s commitment to safeguarding communities from PFAS contamination, the road map makes it clear that the EPA does not plan to remove compounds that entered the market through a loophole that allows them to bypass a thorough safety review. Instead, the agency document cites an existing program meant to encourage companies to voluntarily withdraw the approvals the EPA has previously granted them through these loopholes. So far no companies have chosen to do so.

Nor will the agency prevent all new compounds in the class from entering the market, promising only to “apply a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter commerce.”

“It just says ‘rigorous review process,’” said Eve Gartner, managing attorney for the Toxic Exposure and Health Program at Earthjustice. “But we’ve seen that the rigorous review process that has been in place for a long time has resulted in in hundreds of PFAS being approved.”

“Since we also know the process has been corrupted by industry influence, how can we trust this supposedly rigorous review process for PFAS?”

Gartner also pointed to recent evidence of corruption within the EPA presented by whistleblowers in the agency’s New Chemicals Division. “Since we also know the process has been corrupted by industry influence, how can we trust this supposedly rigorous review process for PFAS? The only answer is to say no new PFAS will be approved,” said Gartner. “It’s disappointing that EPA is not just closing the door on any new PFAS.”

For some who have been directly affected by the chemicals, the road map is just the latest disappointment with regulators who have failed to protect them from the poisonous chemicals. “From a community perspective, this all should have been done yesterday,” said Emily Donovan, co-founder of Clean Cape Fear, an alliance of advocacy groups organized around the PFAS contamination in North Carolina.

Donovan, who has collected foam samples from local beaches that have tested positive for PFAS made by Chemours and has dozens of PFAS in her drinking water, doesn’t have the patience for the EPA’s extended timeline. “I’m grateful for the work on PFOA and PFOS, but we can’t stop there,” said Donovan. “The level of total PFAS in our tap water keeps rising, and at the very minimum, EPA should be doing toxicity analysis on those compounds ASAP.”

Meanwhile, as the EPA was launching its “PFAS Strategic Roadmap” with fanfare yesterday, it also released its “National PFAS Testing Strategy,” quietly posting the document on its website. The much awaited testing plan is intended to gather information about the toxicity of thousands of PFAS compounds that have not been studied and has been a focal point of interest for communities exposed to the chemicals.

The EPA began its search for testing candidates with 6,504 PFAS compounds, which it subdivided by category, ultimately identifying only 24 chemicals to be tested. While the agency emphasized to the press that it would be making the polluter pay for such toxicity research, for more than half of the PFAS categories — 32 of 56 — there’s no “identifiable manufacturer,” according to the testing plan, making such accountability impossible.

What’s more, the EPA testing plan is based on a definition of PFAS that scientists have already criticized as “too narrow.” The PFAS testing plan refers only to “chemicals with at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated,” as opposed to a broader definition that was adopted by the Organization for Economic Cooperation and Development. As a result, it would leave out important chemicals that are released in large volumes — including some of the new coolant chemicals produced by Chemours and other companies and trifluoroacetic acid, or TFA, a toxic, persistent water contaminant that’s created when the coolants break down.

In the testing plan, the EPA does not commit to doing any particular test but instead lists tests for carcinogenicity, prenatal developmental toxicity, and reproductive toxicity on the third of three tiers under the heading “Potential Tests.”

Sussman, who represents PFAS-affected community groups in North Carolina, was dismayed by the testing plan. “Slicing and dicing the PFAS category into 24 subcategories and then conducting a multi-phased testing program on 24 compounds is not an efficient or expeditious way to regulate commercial uses of PFAS,” said Sussman. “The EPA strategy also fails to recognize that communities are not interested in testing as an academic exercise but want information that helps them understand the risks of harm from the PFAS they’ve actually been exposed to in the real world.”

Update: October 19, 2021, 2:30 p.m. ET

This article has been updated with details about the EPA’s national testing strategy, which was posted to the EPA website but went unmentioned in the release of the “PFAS Strategic Roadmap.”

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