EPA Withheld Reports of Substantial Risk Posed by 1,240 Chemicals

The Environmental Protection Agency has withheld information from the public since January 2019 about the dangers posed by more than 1,200 chemicals. By law, companies must give the EPA any evidence they possess that a chemical presents “a substantial risk of injury to health or the environment.” Until recently, the agency had been making these reports — known as 8(e) reports, for the section of the Toxic Substances Control Act that requires them — available to the public. In 2017, for instance, the EPA posted 481 substantial risk reports from industry on ChemView, a searchable public database of chemical information maintained by the agency. And in 2018, it added another 569 8(e) reports to the site. But since 2019, the EPA has only posted one of the reports to its public website.

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.

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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.

The Chemours facility at the Fayetteville Works plant, where the chemical known as GenX is produced, is seen on June 15, 2018, near Fayetteville, N.C.

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.”