United States
Environmental
Protection Agency
Office of Enforcement
and Compliance
Assurance (2201 A)
EPA 325-F-08-002
Enforcement Alert
Volume 9, Number 4
Office of Civil Enforcement
August 2008
Failure to Report Chemical Risks
Can Result in Major Fines
Section 8(e) of the Toxic Substances Control Act
Those who manufacture, import.
process or distribute chemical substances
or chemical mixtures have a clear duty to
notify the United States Environmental
Protection Agency (EPA) when they
obtain any information that their chemical
substances or chemical mixtures present
a substantial risk to public health or the
environment.
Failure to timely report this critical
information is a serious violation of
the law because it prevents EPA from
determining what actions may be
necessary to understand and manage
these potential risks. Penalties imposed
for failing to report can be significant, up
to $32,500 a day for each violation.
Effective management of potential
risks to public health and the environment
from chemical substances and chemical
mixtures is tied to reporting requirements
in the Toxic Substance Control Act
(TSCA). Section 8(e) of TSCA is
particularly important: essentially, it
establishes an early warning system to
immediately inform EPA and the public of
possible risks associated with chemicals.
Health concerns can include cancer, birth
defects or serious impairment of normal
activities.
Enforcement of Section 8(e)
EPA takes enforcement of Section 8(e)
requirements seriously, as exemplified by
the settlement between the Agency and
E.I. DuPont de Nemours and Company
puPont). The company paid a $10.25
Public health and
environmental protections
rely on timely reporting
of substantial risk
information.
million penalty, the largest administrative
penalty in EPA's history, for failing
to report risk information regarding
the synthetic chemical substance
perfluorooctanoic acid (PFOA) and
related perfluorochemicals. The case
underscores the importance of prompt
reporting of Section 8(e) substantial
risk information. PFOA has caused
developmental and other adverse effects
in laboratory animals.
The information withheld by
DuPont demonstrated placenta! transfer
of PFOA from human mothers to their
babies during pregnancy, and the levels
of PFOA found in a newborn and a two-
year old. As a result of this and other
information, EPA is investigating the
effects of human exposure to PFOA and
related perfluorochemicals. Although
our investigation is on-going, EPA has
sought voluntary commitments and
taken regulatory chemical management
activities intended to reduce release of.
and exposure to, these chemicals while
the Agency's assessment process is
underway.
The E. I. du Pont de Nemours and
Company Settlement
PFOA is used in the manufacture of
fluoropolymers, which impart desirable
properties such as oil, stain, grease and
water repellency, and fire resistance.
Fluoropolymers are used to provide non-
stick surfaces on cookware, including
some TeflonŽ products, and to create
waterproof, breathable membranes
for clothing. The chemicals are very
persistent in the environment.
http://www.epa.gov/compliance/resources/newsletters/civil/enfalert/index.html
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Enforcement Alert
DuPont obtained
information regarding
substantial health risks
posed by PFOA at its
Washington Works Plant
in Wood County, West
Virginia, in connection with
its use in the manufacture
of fluoropolymers.
DuPont observed
PFOA in blood samples
taken from pregnant
workers at the Washington
Works facility and found
at least one woman had
transferred the chemical to her fetus.
DuPont also detected the chemical in
drinking water supplies in West Virginia
and Ohio communities near the facility,
and knew that PFOA was in these
water supplies at a greater level than
the company's guidelines indicated
would be without any effect on people.
DuPont also had information regarding
blood levels of PFOA in individuals
living near the Washington Works
Plant.
EPA discovered that the company
had obtained substantial risk information
showing three other perfluorinated
chemical substances to be highly toxic
when inhaled. The Agency learned of
this information from a third party.
In its administrative complaint, EPA
alleged that DuPont violated Section
8(e) for failing to report information it
had obtained. In settlement, DuPont paid
the record-setting penalty and agreed to
come into compliance with the law. The
company also agreed to undertake two
Supplemental Environmental Projects,
worth $6.25 million, aimed at protecting
and enhancing public health and the
environment.
Under one of the Supplemental
Environmental Projects, DuPont is
investigating the potential of nine of
the company's fluorotelomer-based
products to break down and form
PFOA. The information developed
should help industry, scientists, the
public and EPA examine possible sources
of PFOA in the environment and routes of
human exposure to the chemical. In the
second project, DuPont is fostering science
laboratory curriculum changes in Wood
County schools to reduce risk to children's
health through exposure chemicals and
enhance use of safer chemicals.
Fluoropolymers, created from
PFOA, have thousands of
important manufacturing and
industrial uses. These products
are not themselves PFOA. EPA
has no information that routine
use of household or other
products using fluoropolymers,
such as non-stick cookware or
all weather clothing, poses a
concern. For further information,
see: http://www.epa.gov/opptintr/
pfoa/ pubs/pfoainfo. htm
The Value of Voluntary
Compliance
EPA also seeks to bring companies
into compliance with Section 8(e)
through self-audits of their reporting
practices, immediate disclosure to EPA
of any Section 8(e) violations found and
correction of its violations. An audit
agreement with EPA assists companies
that either suspect or do not know
whether they are in violation of federal
law. In the context of Section 8(e), this
tool helps ensure that EPA receives all
substantial risk information obtained by
a company, regardless of prior failures
to timely submit it.
EPA's Audit Policy, formally
titled "Incentives for Self-Policing:
Discovery, Disclosure, Correction and
Prevention of Violations," safeguards
human health and the environment
by providing several major incentives
for regulated entities to voluntarily
come into compliance with federal
environmental laws and regulations.
The incentives include significant
penalty reductions or penalty waivers.
The 3M Company Settlement
3M Company, another large
chemical manufacturer, made use of a
compliance incentive offered by EPA.
In accordance with a corporate-wide
audit agreement with the Agency, 3M
reviewed its compliance with Section
8(e), as well as with other sections of
TSCA, at 28 of its business units and
facilities with respect to a variety of
chemicals, including PFOA. As part of
the agreement, 3M disclosed to EPA
and corrected 234 violations of Section
8(e) and ten other TSCA violations
it discovered. 3M also paid a civil
administrative penalty of $1.52 million
to resolve all 244 violations.
Information about EPA's various
compliance incentives and
self-disclosure programs can be
found at http://www.epa.gov/
compliance/incentives/index.html
Section 8(e) Information -
Launching Global Protection
The Section 8(e) information EPA
received from DuPont and 3M underlies
the Agency's continuing efforts to identify
and develop the scientific information
needed to fully understand how people
are being exposed to PFOA and what, if
any, concerns the exposure may pose. It
is now known that PFOA and related
August 2008
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Enforcement Alert
chemicals are found worldwide
in low levels and in the blood of the
general United States population.
As part of EPA's efforts, in early
2006 the Agency initiated its 2010/15
PFOA Stewardship Program, inviting
companies to reduce PFOA releases and
its presence in products by 95 percent
no later than 2010, and to work toward
eliminating these sources of exposure
five years after that, but no later than
2015. The commitments applicable to
the companies' operations worldwide.
EPA's PFOA Stewardship Program is
resulting in global change. All eight of
the major companies using PFOA and
related chemicals in their manufacturing
processes signed up for the Program. As
of 2008, all eight have reported significant
drops in the release of these chemicals,
putting the industry on target to meet both
the 2010 and 2015 goals worldwide.
The change is measurable. In 2007,
the Centers for Disease Control and
Prevention reported that their analysis of
human blood levels of PFOA collected
in 2003-2004 showed a 25 percent
reduction from levels found in samples
collected in 1999-2000. CDC attributed
this decline largely to EPA's efforts on
PFOA. Additional reduction are expected
as further progress is made by industry
under EPA's PFOA Stewardship Program.
EPA is continuing to investigate the
risk to humans posed by PFOA and
related chemicals. Voluntary activities
by industry are also underway to help
resolve the existing uncertainties and fill
remaining data gaps.
Meeting Reporting
Requirements
Section 8(e) requires immediate
notification when any information is
obtained that "reasonably supports the
conclusion that [a chemical] substance
or mixture presents a substantial risk of
injury to health or the environment..."
EPA views "substantial risk of
injury to health or the environment" to
be a risk of considerable concern based
on the seriousness of the effect and the
probability of its occurrence. These two
criteria are differentially weighted for
different types of effects.
For example, some health effects are so
serious that relatively little weight is given
to the extent of exposure. In this situation,
the mere fact that a particular chemical
is in commerce constitutes sufficient
evidence of exposure. In contrast, other
types of health or environmental effects
must involve, or be accompanied by,
the potential for significant levels of
exposure.
EPA interprets the term "immediately"
to mean that a company or individual has
30 calendar days from the date it obtained
substantial risk information in which to
report to EPA.
The Section 8(e) 30-day reporting
deadline does not apply to information
on emergency incidents of environmental
contamination, which should be reported
to the EPA Administrator or by telephone
to the National Response Center at (800)
424-8802 as soon as a company has
knowledge of the incident. This early
notification of chemical emergencies is
also required by the Comprehensive
Environmental Response, Compensation
and Liability Act (Superfund) and the
Emergency Planning and Community
Right-to-Know Act.
What should I do if I'm unsure whether
I have information that should be reported
under Section 8(e)?
Companies and others unsure whether
information should be reported under
Section 8(e) should promptly report the
information to EPA as a "For Your
Information" (FYI) submission. EPA
reviews both Section 8(e) and FYI
submissions to determine whether the
information submitted is Section 8(e)
substantial risk information.
For more information and guidance
about the Section 8(e) substantial risk
reporting requirement, visit: http://www.
epa.gov/opptintr/tsca8e/
How is Section 8(e) substantial risk
information used?
Section 8(e) substantial risk
information is extremely valuable in
hazard identification, risk assessment
and risk management activities, both
within and outside of EPA. Within
EPA, the Office of Pollution Prevention
and Toxics screens all Section 8(e)
submissions to identify chemicals for
further assessment or testing, and refers
pertinent information to other EPA
offices. Section 8(e) information is also
made available outside of the Agency
to state and local governments, the
public and other stakeholders, such as
public interest groups and the chemical
industry, subject to confidential business
information considerations.
Where should I send Section 8(e)
substantial risk information?
Information you wish to submit
should be sent by certified mail or in any
Disclaimer: This document attempts to clarify in plain language some EPA provisions. Nothing in the Enforcement Alert revises or replaces any
regulatory provision in the cited part, any other part of the Code of Federal Regulations, the Federal Register, the Toxic Substances Control Act or
any previously expressed policy or interpretation. For more information go to: www.epa.gov/compliance
August 2008
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Enforcement Alert
other manner that provides you with verification of EPA's receipt. You should send
Section 8(e) substantial risk information (and FYI information) to:
Document Processing Center (7407M)
Attn: Section 8(e)
U. S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460-0001
For courier service:
EPA East - Room 6428
1201 Constitution Avenue, N.W.
Washington, DC 20004-3302
Companies submitting substantial risk information containing Confidential Business
Information must follow the Agency's procedures for submitting such information at
40 C.F.R. Part 2 and EPA's TSCA Section 8(e) website: http://www.epa.gov/opptintr/
tscaSe/.
Is there an obligation to conduct risk assessments under Section 8(e)?
No. Preparation of a qualitative or quantitative risk assessment based on new
toxicity or exposure data is not required under Section 8(e).
Do contractors, consultants and independent laboratories have a Section 8(e)
reporting responsibility?
If an entity does not manufacture, process or distribute in commerce TSCA chemical
substances or mixtures, it does not have a Section 8(e) reporting responsibility. Its
client manufacturers, processors and distributors are responsible for reporting such
information.
How should a company submit 8(e) information on different chemicals, as may
happen as a result of a self-audit?
Separate submissions should be made for each chemical substance or mixture. For
example, including more than one study report per submission relating to a particular
chemical substance or mixture is acceptable; submitting studies on different chemical
substances or mixtures in a single 8(e) submission is not. Similarly, FYI submissions
should also be provided separately for each chemical substance or mixture.
For questions on TSCA Section 8(e) substantial risk reporting, contact the TSCA
Hotline at (202) 554-1404. For more information regarding EPA's case against
DuPont, and the 3M corporate-wide audit agreement, contact Tony Ellis (202)
564-4167, Office of Civil Enforcement.
Enforcement Alert
Enforcement Alert is published
periodically by EPA's Office of
Enforcement and Compliance
Assurance, Office of Civil Enforcement,
to inform the public and regulated
community about environmental
enforcement issues, trends and
significant enforcement actions.
This information should help the
regulated community avoid violations
of federal environmental law. Please
reproduce and share this publication.
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Office of Civil Enforcement: Director,
Walker B. Smith
Editor, Office of Civil Enforcement:
Melissa Page Marshall
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Document Number: EPA 325-F-08-002
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August 2008
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