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

[Anti-Imperialist News]

theintercept.com
<https://theintercept.com/2021/11/01/epa-toxic-chemicals-reports-withheld/> EPA
Withheld Reports of Substantial Risk Posed by 1,240 Chemicals
Sharon Lerner <https://theintercept.com/staff/sharonlerner/> - November 1
2021
------------------------------

*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
<https://chemview.epa.gov/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
<https://theintercept.com/collections/bad-chemistry/> 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
<https://theintercept.com/series/epa-exposed/> 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
<https://www.federalregister.gov/documents/2010/01/21/2010-1105/claims-of-confidentiality-of-certain-chemical-identities-submitted-under-section-8e-of-the-toxic>,
the Obama administration changed course, announcing
<https://www.federalregister.gov/documents/2010/01/21/2010-1105/claims-of-confidentiality-of-certain-chemical-identities-submitted-under-section-8e-of-the-toxic>
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
<https://www.documentcloud.org/documents/21092272-2070_01202012-1> 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
<https://theintercept.com/2021/08/04/epa-hair-on-fire-chemicals-leaked-audio/>
, pressuring risk assessors
<https://theintercept.com/2021/07/02/epa-chemical-safety-corruption-whistleblowers/>
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.

[image: This photo taken Friday, June 15, 2018 near Fayetteville, N.C.
shows the Chemours Company's PPA, or Polymer Processing Aid facility at the
Fayetteville Works plant where the chemical known as GenX is produced. The
chemical has been found in the Cape Fear River, a source of drinking water
for much of the southeastern part of the state. (AP Photo/Gerry Broome)]

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.

Photo: Gerry Broome/AP
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
<https://theintercept.com/2016/03/03/new-teflon-toxin-causes-cancer-in-lab-animals/>
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 <https://theintercept.com/series/the-teflon-toxin/>.

The studies
<https://www.documentcloud.org/documents/2746960-GenX8eFilings.html> 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
<https://theintercept.com/2019/09/19/epa-new-pfas-chemicals/> 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
<https://www.documentcloud.org/documents/6385529-89010000317-375724.html>;
developmental
toxicity <https://www.documentcloud.org/documents/6385547-65545-80-4-1.html>
; decreased conception
<https://www.documentcloud.org/documents/6386505-68298-12-4-Decreased-Conception.html>
; severe convulsions
<https://www.documentcloud.org/documents/6413943-Severe-Convulsions.html>;
bleeding
<https://www.documentcloud.org/documents/6413961-Lung-Hemorrhage.html> in
the lungs; tooth problems
<https://www.documentcloud.org/documents/6421801-Teeth-DuPont-11-10.html>;
post-natal
loss <https://www.documentcloud.org/documents/6413982-Post-Natal-Loss.html>
; hair loss
<https://www.documentcloud.org/documents/6386507-70969-47-0-Alopecia-and-Death.html>
; depression of sperm function
<https://www.documentcloud.org/documents/6414185-Depression-of-Sperm-Production.html>;
abnormal development of skulls, ribs, and pelvises
<https://www.documentcloud.org/documents/6244606-skull-and-ribs.html>; and
testicular, pancreatic, and kidney cancers
<https://www.documentcloud.org/documents/6386506-Testicular-Cancer-68259-11-0.html>.
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
<https://www.epa.gov/chemical-research/human-health-toxicity-assessments-genx-chemicals>
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
<https://www.documentcloud.org/documents/21093350-chemours-tsca-fyi-letter-3-17-2021-v2>
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
<https://www.dominos.com/en/pages/tracker/#!/track/order/>, 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.”
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