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.

To receive this newsletter electronically,
    see www.epa.gov/compliance/
  resources/newsletters/civil/enfalert/
             index.html.

 Office of Civil Enforcement: Director,
          Walker B. Smith

  Editor, Office of Civil Enforcement:
        Melissa Page Marshall

   Please send all address and name
  changes or subscription requests to:
         ncepiwo@one.net

Document Number: EPA 325-F-08-002
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August 2008

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