Document ID: EPA-HQ-OPPT-2003-0012-0107
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-06-03T04:00Z

Ward
Penberthy
06/
03/
2003
07:
50
AM
To:
Mary
Dominiak/
DC/
USEPA/
US@
EPA
cc:
Charles
Auer/
DC/
USEPA/
US@
EPA,
(
bcc:
Mary
Dominiak/
DC/
USEPA/
US)
Subject:
Updated
Materials
for
PFOA
Meeting,
June
6,
2003
To
Interested
Parties
and
Meeting
Attendees:

Attached
please
find
an
amended
draft
agenda
and
a
revised
list
of
interested
parties
for
the
upcoming
public
meeting,
to
be
held
June
6,
2003,
on
the
enforceable
consent
agreement
(
ECA)
development
process
for
perfluorooctanoic
acid
(
PFOA)
and
fluorinated
telomers.
These
documents
replace
earlier
versions
transmitted
on
May
21,
2003
(
OPPT­
2003­
0012­
0056).

The
revised
list
of
groups
and
individuals
registered
as
interested
parties
for
the
purpose
of
participating
in
or
monitoring
the
ECA
negotiations
includes
parties
whose
requests
for
status
at
the
meeting
were
delayed
by
EPA's
mail
processing
system.
The
amended
draft
agenda
indicates
time
granted
to
the
five
parties
who
specifically
requested
the
ability
to
make
brief,
three­
to­
five
minute
opening
statements.
The
amended
agenda
also
clarifies
that
members
of
the
public
who
did
not
register
as
interested
parties
will
be
given
preference
during
the
half­
hour
public
comment
period
near
the
close
of
the
meeting,
since
interested
parties
will
be
able
to
participate
in
the
earlier
discussions
during
the
meeting.

Additional
groups
and
individuals
who
did
not
request
interested
party
status
have
also
indicated
that
they
will
attend
the
meeting.
Other
Federal
partners
may
also
participate,
including
the
U.
S.
Consumer
Product
Safety
Commission.
Meeting
attendees
other
than
interested
parties
are
not
required
to
notify
the
Agency
in
advance,
but
prior
notice
will
expedite
security
processing
into
the
EPA
building.

Also
attached
to
this
message
is
a
copy
of
an
enforceable
consent
agreement
previously
concluded
by
the
Agency.
Every
ECA
is
unique.
This
sample
ECA
is
provided
solely
as
an
example
of
the
level
of
detail
and
the
type
of
information
generally
contained
in
a
simple
ECA
for
a
single
chemical.
EPA
anticipates
that
ECAs
concluded
through
this
process
on
PFOA
and
telomers
will
involve
different
testing
and
reflect
significantly
greater
complexity.
New
ECAs
will
also
include
additional
standard
language
addressing
information
quality
issues.

Participants
and
meeting
attendees
are
reminded
that
the
meeting
on
June
6,
2003
will
begin
at
noon
and
conclude
at
5:
00
PM.
You
are
also
reminded
that
photo
identification
will
be
required
for
access
to
the
meeting
location.

If
you
have
questions
concerning
this
meeting,
please
contact
Mary
Dominiak
by
telephone
at
202­
564­
8104,
or
by
email
at
dominiak.
mary@
epa.
gov.

Sincerely,

Ward
Penberthy
Associate
Director
Chemical
Control
Division
MIBK
ECA
Example.
pdAmended
Interested
Parties
List
Amended
6­
6­
03
draft
agenda.
PUBLIC
MEETING
Enforceable
Consent
Agreement
Development
for
Perfluorooctanoic
acid
(
PFOA)
and
Fluorinated
Telomers
Location:
Environmental
Protection
Agency
(
EPA),
East
Bldg.
Rm.
1153
1201
Constitution
Ave.,
NW,
Washington,
DC
20460
Date:
Friday,
June
6,
2003;
12:
00
PM
­
5:
00
PM
Draft
Agenda
12:
00
­
12:
30
Introduction
of
Participants
 
Opening
Remarks
and
ECA
Process
(
EPA)
 
Charles
M.
Auer,
Director
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)

12:
30
­
12:
55
Opening
Statements
by
Interested
Parties
(
3
to
5
minutes
each)
°
Center
for
Regulatory
Effectiveness
°
Little
Hocking
Water
Association
°
Environmental
Working
Group
°
DuPont
°
Telomer
Research
Program
12:
55
­
1:
10
Overview
of
EPA
Preliminary
Framework
Document
for
ECA
Data
Development
for
PFOA
and
Telomers
°
Telomer
Data
Needs
°
Fluoropolymer
Data
Needs
°
Rationales
for
Proposed
Fate
Testing
and
Monitoring/
Sampling
1:
10
­
2:
00
General
Discussion
Among
EPA
and
Interested
Parties
of
Data
Needs
for
Identifying
PFOA
Sources
and
Pathways
of
Exposure
2:
00
­
2:
10
Break
2:
10
­
4:
00
Identification
and
Discussion
Among
EPA
and
Interested
Parties
of
ECA
Opportunities
and
Approaches
°
ECA
Topics
Amenable
to
Quick
Resolution
°
Telomer
ECAs
°
Fluoropolymer
ECAs
°
Other
Additional
ECA
Opportunities?

4:
00
­
4:
20
Next
Steps
4:
20
­
4:
50
Public
Comment
(
Open
mike:
maximum
time
3
minutes
per
speaker)
Members
of
the
public
not
registered
as
Interested
Parties
will
be
given
preference,
since
Interested
Parties
can
participate
in
earlier
discussions.

4:
50
­
5:
00
OPPT
Closing
Remarks
U.
S.
EPA
Amended
"
Interested
Parties"
List
for
June
6,
2003
Meeting
June
2,
2003
List
of
"
Interested
Parties"
for
PFOA
and
Telomer
ECA
Negotiations
As
of
this
date,
the
following
groups
and/
or
individuals
have
requested
status
as
"
interested
parties"
for
the
purpose
of
monitoring
or
participating
in
ECA
negotiations
on
PFOA
and
fluorinated
telomers.
Please
be
advised
that,
due
to
security
delays
in
the
processing
of
mail
to
Federal
facilities,
additional
"
interested
party"
registrations
may
be
received
between
this
date
and
the
June
6,
2003
meeting.
Updated
lists
will
be
provided
as
needed
at
and
before
the
meeting.
Additional
parties
may
attend
as
observers
without
providing
prior
notice
to
the
Agency.

3M
Advanced
Polymer,
Inc.
AGA
Chemicals
American
Council
on
Science
and
Health
American
Chemistry
Council
American
Fiber
Manufacturers
Association,
Inc.
Asahi
Glass
Co.,
Ltd.
Asahi
Glass
Fluoropolymers
USA,
Inc.
ATOFINA
Chemicals,
Inc.
Bennett
&
Williams
(
Environmental
Consultants)
Chamber
of
Commerce
of
the
Mid­
Ohio
Valley
Ciba
Specialty
Chemicals
Corporation
Clariant
GmbH
Daikin
America
Dainippon
Ink
&
Chemicals
Davis,
Pickering
&
Co.,
Inc.
Department
of
the
Navy
DuPont
DuPont
Textiles
and
Interiors,
Inc.
Dyneon
Environmental
Health
Research
Foundation
Environmental
Working
Group
Fire
Fighting
Foam
Coalition
Vicky
Gheen
(
Private
Citizen)
Hughes
Associates,
Inc.
International
Imaging
Industry
Association
Little
Hocking
Water
Association,
Inc.
Miteni
S.
p.
A.
Mitsubishi
International
Corporation
Ohio
Environmental
Protection
Agency
Ohio
River
Valley
Water
Sanitation
Commission
OMNOVA
Solutions
Parkersburg­
Wood
County
Area
Development
Corporation
Rich
Purdy
Regenerative
Products
Solvay
Solexis,
Inc.
Society
of
the
Plastics
Industry/
Fluoropolymer
Manufacturers
Group
Telomer
Research
Program
Tennant
Rentals
The
Area
Roundtable
The
Carpet
and
Rug
Institute
The
Center
for
Regulatory
Effectiveness
Tuppers
Plains­
Chester
Water
District
United
Bank,
West
Virginia
University
of
Pennsylvania
Medical
Center
W.
L.
Gore
&
Associates,
Inc.
Walki
Wisa
Ltd.
West
Virginia
Class
Action
Plaintiffs
West
Virginia
Department
of
Environmental
Protection
ENFORCEABLE
CONSENT
AGREEMENT
FOR
METHYL
ISOBUTYL
KETONE
September
14,
1998
ENFORCEABLE
CONSENT
AGREEMENT
FOR
METHYL
ISOBUTYL
KETONE
Docket
No.
OPPTS­
42205B
TABLE
OF
CONTENTS
I.
Introduction
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.1
II.
Chemical
Subject
to
the
ECA
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
III.
Obligation
of
Signatory
Companies
and
Role
of
the
Ketones
Panel
of
the
Chemical
Manufacturers
Association
(
CMA)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
IV.
Purpose
and
Scope
of
the
Testing
Program
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.2
V.
Standards
for
Conducting
Testing
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
2
VI.
Submission
of
Study
Plans
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
3
VII.
Modifications
to
the
Enforceable
Consent
Agreement
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
...
.
.
.
.
.
3
VIII.
Failure
to
Comply
with
the
Enforceable
Consent
Agreement
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
IX.
EPA
Monitoring
of
Enforceable
Consent
Agreement
Testing
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
X.
Submission
of
Data
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
XI.
Publication
and
Disclosure
of
Test
Results
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
XII.
Confidentiality
of
Information
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
­
i­

XIII.
Responsibilities
of
the
Companies
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
XIV.
Severability
of
Enforceable
Consent
Agreement
Provisions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
XV.
Final
Agency
Action
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
XVI.
Public
Record
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
5
XVII.
Effectiveness
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
6
XVIII.
Rights
of
the
Companies
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
6
XIX.
Identity
of
the
Companies
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
6
XX.
Signatures
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
7
TABLE
1:
Required
Testing,
Test
Standards,
Reporting
and
Other
Requirements
for
Methyl
Isobutyl
Ketone
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
12
Appendix
1:
Protocol:
An
Inhalation
Two­
Generation
Reproductive
Toxicity
Study
of
Methyl
Isobutyl
Ketone
(
MIBK)
in
Rats
(
WIL
Study
No:
WIL­
186007)

­
ii­
1
I.
INTRODUCTION
Under
the
authority
of
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA),
15
U.
S.
C.
2603,
the
United
States
Environmental
Protection
Agency
(
EPA),
Eastman
Chemical
Company,
Celanese,
Ltd.,
Shell
Chemical
Company,
and
Union
Carbide
Corporation
(
hereinafter
collectively
"
the
Companies")
enter
into
the
following
enforceable
consent
agreement
(
ECA).
This
ECA
takes
effect
on
the
date
of
publication
of
the
notice
in
the
Federal
Register
announcing
the
issuance
of
the
testing
consent
order
(
Order)
that
incorporates
this
ECA.

In
EPA's
proposed
test
rule
for
hazardous
air
pollutants
(
HAPs)
published
on
June
26,
1996
(
61
FR
33178),
amended
on
December
24,
1997
(
62
FR
67466)
and
on
April
21,
1998
(
63
FR
19694),
EPA
invited
the
submission
of
alternative
testing
proposals
for
HAP
chemicals
that
would
provide
the
data
needs
identified
by
EPA
in
the
proposed
HAPs
rulemaking
via
an
ECA
process.
This
ECA
resulted
from
negotiations
conducted
as
a
part
of
an
ECA
process
for
the
HAPs
chemical
methyl
isobutyl
ketone
(
63
FR
32656).
The
official
record
for
this
ECA
Action,
including
the
public
version,
is
established
under
EPA
docket
control
number
OPPTS­
42205B.
The
procedures
for
ECA
negotiations
are
described
at
40
CFR
790.22(
b).

II.
CHEMICAL
SUBJECT
TO
THE
ECA
The
subject
of
this
ECA
is
the
chemical
substance
methyl
isobutyl
ketone,
CAS
No.
108­
10­
1.
The
methyl
isobutyl
ketone
to
be
tested
shall
be
as
pure
as
can
be
reasonably
attained,
but
shall
be
at
least
99
percent
pure.

III.
OBLIGATION
OF
SIGNATORY
COMPANIES
AND
ROLE
OF
THE
KETONES
PANEL
OF
THE
CHEMICAL
MANUFACTURERS
ASSOCIATION(
CMA)

A.
Testing
shall
be
sponsored
by
the
Companies,
which
are
responsible
for
complying
with
this
ECA.

B.
The
Companies
recognize
that
to
implement
this
ECA,
EPA
will
issue
and
publish
in
the
Federal
Register
an
Order
under
section
4
of
TSCA
that
incorporates
the
terms
of
this
ECA.
The
Companies
agree
that
all
terms
of
this
ECA
shall
take
effect
on
the
date
of
publication
of
the
notice
in
the
Federal
Register
announcing
the
issuance
of
the
Order
that
incorporates
this
ECA,
and
all
applicable
time
periods
shall
be
treated
as
beginning
on
that
publication
date.

C.
The
Companies
are
members
of
the
Ketones
Panel
of
the
Chemical
Manufacturers
Association
(
hereinafter,
referred
to
as
the
CMA
Ketones
Panel)
which
is
an
association
of
manufacturers
and
processors
of
methyl
isobutyl
ketone.
The
CMA
Ketones
Panel
shall
be
responsible
for
coordinating
and
administering
testing
under
this
ECA
and
communicating
with
EPA
about
study
plans,
protocols,
test
standards,
and
other
aspects
of
the
testing
program.
In
performing
these
functions,
the
CMA
Ketones
Panel
will
be
acting
as
the
agent
of
the
2
Companies
for
purposes
of
compliance
and
communication
with
EPA.
EPA
and
the
Companies
recognize
that,
except
for
its
role
as
agent
as
specified
in
this
ECA,
the
CMA
Ketones
Panel
has
no
legal
responsibility
for
complying
with
this
ECA.
Responsibility
for
complying
with
the
ECA
rests
at
all
times
with
the
Companies
as
individual
entities.

IV.
PURPOSE
AND
SCOPE
OF
THE
TESTING
PROGRAM
A.
The
purpose
of
the
testing
program
specified
in
this
ECA
is
to
supplement
available
information
and
to
further
characterize
the
potential
for
reproductive
effects
of
methyl
isobutyl
ketone
from
inhalation
exposures.

B.
EPA
believes
that
the
studies
specified
in
Table
1
and
described
in
Appendix
1
to
this
ECA,
will
generate
data
needed
by
EPA
to
determine
whether
methyl
isobutyl
ketone
presents
an
unreasonable
risk
of
injury
to
human
health
from
inhalation
exposures.

C.
The
Companies,
through
the
CMA
Ketones
Panel,
shall
jointly
conduct
or
provide
for
the
performance
of
the
testing
program
specified
in
this
ECA.
This
testing
program
shall
consist
of:
1)
conducting
the
reproductive
effects
testing
by
inhalation
exposure
listed
in
Table
1
in
accordance
with
the
test
standards
specified
in
Table
1
and
described
in
Appendix
1
("
Test
Standards");
and
2)
submitting
the
reports
and
documents
specified
in
Table
1
in
accordance
with
the
deadlines
set
forth
in
Table
1.

D.
EPA
will
not
finalize
the
testing
requirements
for
reproductive
effects
for
methyl
isobutyl
ketone
as
specified
in
the
proposed
HAPs
test
rule,
as
amended,
because
such
testing
will
be
conducted
under
this
ECA.
However,
EPA
will
continue
the
process
to
finalize
the
proposed
HAPs
test
rule
for
the
other
studies
specified
for
methyl
isobutyl
ketone,
viz.:
acute
inhalation
testing,
including
pulmonary
alveolar
macrophage
function
testing,
and
immunotoxicity
testing.
Prior
to
finalizing
the
HAPs
rulemaking,
EPA
will
take
into
consideration
the
public
comments
received
regarding
the
proposed
testing
requirements
for
methyl
isobutyl
ketone
that
are
not
included
in
this
ECA.

V.
STANDARDS
FOR
CONDUCTING
TESTING
A.
Testing
shall
be
conducted
in
accordance
with
the
Test
Standards
listed
in
Table
1
and
described
in
Appendix
1
to
this
ECA.

Certain
provisions
of
the
Test
Standards
are
considered
to
be
mandatory
and
are
referred
to
as
"
requirements."
These
requirements
are
identified
by
the
use
of
the
word
"
shall"
in
the
text
of
the
Test
Standard.
Provisions
that
are
not
mandatory,
and
are
therefore
only
recommended,
are
identified
by
the
use
of
"
should"
statements.
In
the
event
such
"
should"
provisions
are
not
followed,
the
Companies
will
not
be
deemed
by
EPA
to
be
in
violation
of
this
ECA
and
will
not
be
subject
to
penalties
or
other
enforcement
actions,
as
described
in
Part
X.
of
this
ECA.
EPA
3
will
use
its
professional
judgment
to
determine
the
scientific
adequacy
and
validity
of
the
test
results,
and
any
repeat
testing
that
is
determined
by
EPA
to
be
necessary
will
be
required
either
under
a
subsequent
ECA
or
pursuant
to
a
rule
promulgated
under
section
4(
a)
of
TSCA,
15
U.
S.
C.
2603(
a).
In
addition,
for
the
purpose
of
this
ECA,
the
words
"
will"
and
"
must,"
if
they
appear
in
the
Test
Standards,
are
considered
equivalent
to
the
word
"
shall"
and
therefore
delineate
a
test
requirement
to
be
followed
or
met.

B.
The
Companies,
through
the
CMA
Ketones
Panel,
and
EPA
will
consult
in
a
good
faith
effort
to
consider
the
need
for
Test
Standard
modifications
if
either
EPA
or
the
Companies
desire
such
modifications.
Modifications
to
this
ECA
shall
be
governed
by
40
CFR
790.68
(
see
Part
IX.
of
this
ECA).

C.
All
testing
required
by
this
ECA
shall
be
conducted
in
accordance
with
the
EPA
Good
Laboratory
Practice
(
GLP)
Standards
contained
in
40
CFR
part
792.

D.
All
final
reports
must
be
submitted
by
the
Companies
to
EPA
by
the
dates
specified
in
Table
1
unless
otherwise
authorized
by
EPA
pursuant
to
40
CFR
790.68.
Interim
status
reports
for
testing
shall
be
submitted
by
the
Companies
to
EPA
every
six
months
beginning
six
months
from
the
effective
date
of
this
ECA,
until
the
final
report
is
submitted.

VI.
SUBMISSION
OF
STUDY
PLANS
The
Companies,
through
the
CMA
Ketones
Panel,
shall
submit
a
study
plan
to
EPA
for
each
test
conducted
pursuant
to
this
ECA
in
accordance
with
40
CFR
790.62.
The
principal
sponsor
of
the
testing
(
as
defined
in
40
CFR
790.3)
must
submit
a
study
plan
prior
to
the
initiation
of
testing.
The
study
plan
must
be
submitted
prior
to
initiating
testing,
but
does
not
need
to
be
submitted
45
days
prior
to
the
initiation
of
testing
as
specified
at
40
CFR
790.62(
a).
The
initiation
of
testing
is
the
date
on
which
the
administration
of
the
test
substance
begins
in
accordance
with
the
protocol.
The
content
of
the
study
plan
submitted
to
EPA
shall
comply
with
40
CFR
790.62(
b).
Modifications
to
the
study
plan
shall
be
governed
by
the
procedures
of
40
CFR
790.62(
c).
The
study
plan
shall
become
part
of
the
official
record
(
Docket
Control
Number
OPPTS­
42205B).

VII.
MODIFICATIONS
TO
ENFORCEABLE
CONSENT
AGREEMENT
Modifications
to
this
ECA,
if
any,
shall
be
made
according
to
the
procedures
contained
in
40
CFR
790.68.
4
VIII.
FAILURE
TO
COMPLY
WITH
THE
ENFORCEABLE
CONSENT
AGREEMENT
The
Companies
acknowledge
that
a
violation
of
the
requirements
of
this
ECA
shall
constitute
a
"
prohibited
act"
under
section
15(
1)
of
TSCA,
15
U.
S.
C.
2614(
1),
and
shall
trigger
all
provisions
applicable
to
a
section
15
violation.
In
addition,
noncompliance
with
any
term
of
this
ECA
by
any
Company
shall
constitute
conduct
"
in
violation
of
this
Act"
under
section
20(
a)(
1)
of
TSCA,
15
U.
S.
C.
2619(
a)(
1),
and
could
result
in
a
citizen's
civil
action.

Under
the
penalty
provisions
of
section
16
of
TSCA,
15
U.
S.
C.
2615,
and
the
Federal
Civil
Penalties
Inflation
Adjustment
Act
of
1990,
28
U.
S.
C.
2461
note,
as
amended
by
the
Debt
Collection
Improvement
Act
of
1996,
31
U.
S.
C.
3701
note,
as
implemented
by
61
FR
69360
(
December
31,
1996),
a
non­
complying
Company
could
be
subject
to
a
civil
penalty
of
up
to
$
27,500
per
violation,
with
each
day
in
violation
potentially
constituting
a
separate
violation
under
section
15.
Knowing
or
willful
violations
may
lead
to
the
imposition
of
criminal
penalties
or
a
fine
of
not
more
than
$
27,500
for
each
day
of
violation,
or
to
imprisonment
for
up
to
1
year,
or
both.
In
addition,
EPA
could
enforce
this
ECA
pursuant
to
section
17
of
TSCA,
15
U.
S.
C.
2616,
by
seeking
an
injunction
to
compel
adherence
to
the
requirements
of
this
ECA.

IX.
EPA
MONITORING
OF
ENFORCEABLE
CONSENT
AGREEMENT
TESTING
EPA
may
monitor
the
testing
conducted
under
this
ECA,
including
laboratory
inspections
and
study
audits,
as
permitted
under
section
11
of
TSCA,
15
U.
S.
C.
2610.

X.
SUBMISSION
OF
DATA
All
data
submitted
to
EPA
under
this
ECA
shall
be
identified
by
the
Docket
Number:
OPPTS­
42205B,
the
name:
methyl
isobutyl
ketone,
and
the
CAS
Number:
108­
10­
1.
Six
(
6)
copies
of
all
submissions
under
this
ECA
shall
be
provided
to
EPA
at
the
address
specified
in
40
CFR
790.5(
b).

XI.
PUBLICATION
AND
DISCLOSURE
OF
TEST
RESULTS
All
results
of
testing
conducted
pursuant
to
this
ECA
will
be
announced
to
the
public
by
EPA
in
accordance
with
the
procedures
specified
in
section
4(
d)
of
TSCA,
15
U.
S.
C.
2603(
d).
Disclosure
by
EPA
of
data
generated
by
such
testing
will
be
governed
by
section
14
of
TSCA,
15
U.
S.
C.
2613(
b),
and
40
CFR
part
2.

XII.
CONFIDENTIALITY
OF
INFORMATION
Any
claims
of
confidentiality
for
information
submitted
under
this
ECA
shall
be
made
under
the
terms
of
40
CFR
790.7.
If
no
claim
of
confidentiality
is
made
by
the
submitter
of
the
information
at
the
time
of
submission,
the
information
will
be
deemed
by
EPA,
in
accordance
with
40
CFR
790.7,
to
be
public,
and
may
be
made
available
to
the
public
without
further
notice
5
to
the
submitter.
Information
claimed
as
confidential
will
be
treated
in
accordance
with
the
procedures
in
40
CFR
part
2
established
pursuant
to
section
14
of
TSCA,
15
U.
S.
C.
2613.

XIII.
RESPONSIBILITIES
OF
THE
COMPANIES
A.
The
Companies
are
bound
by
the
terms
of
this
ECA
and
the
provisions
of
40
CFR
790.62
and
790.65.

B.
As
indicated
in
Part
II
of
the
ECA,
the
subject
of
this
ECA
is
methyl
isobutyl
ketone.
The
Companies
shall
comply
with
the
notification
requirements
of
section
12(
b)(
1)
of
TSCA,
15
U.
S.
C.
2611(
b)(
1),
and
40
CFR
part
707,
subpart
D,
if
they
export
or
intend
to
export
methyl
isobutyl
ketone.
Any
other
person
who
exports
or
intends
to
export
methyl
isobutyl
ketone
will
be
subject
to
these
export
notification
requirements
upon
promulgation
of
an
export
notification
rule
for
methyl
isobutyl
ketone
under
section
12(
b)(
1)
of
TSCA.

C.
If
methyl
isobutyl
ketone
becomes
subject
to
a
rule
promulgated
under
TSCA
section
5(
a)(
2),
15
U.
S.
C.
2604(
a)(
2),
governing
significant
new
uses
of
methyl
isobutyl
ketone,
then
the
Companies
shall
be
subject
to
the
data
submission
requirements
imposed
by
section
5(
b)(
1)(
A)
of
TSCA,
15
U.
S.
C.
2604(
b)(
1)(
A),
as
if
the
testing
under
this
ECA
had
been
required
by
a
TSCA
section
4
test
rule.

XIV.
SEVERABILITY
OF
ENFORCEABLE
CONSENT
AGREEMENT
PROVISIONS
In
the
event
that
one
or
more
provisions
of
this
ECA
are
determined
by
a
court
decision
to
be
unenforceable,
the
remaining
provisions
of
this
ECA
will
not
be
presumed
to
be
valid,
and
EPA
will
either
initiate
a
rulemaking
proceeding
to
require
testing
or
publish
in
the
Federal
Register
the
reasons
for
not
initiating
such
a
proceeding.

XV.
FINAL
AGENCY
ACTION
Issuance
of
this
ECA
by
EPA
constitutes
final
EPA
action
for
purposes
of
5
U.
S.
C.
704.

XVI.
PUBLIC
RECORD
EPA
has
established
a
public
record
which
will
contain
this
ECA,
the
Order
that
incorporates
this
ECA,
the
Federal
Register
notice
announcing
issuance
of
the
Order
incorporating
this
ECA,
and
any
and
all
relevant
information,
subject
to
the
confidentiality
provisions
of
section
14(
b)
of
TSCA
and
40
CFR
part
2.
The
official
record
for
this
ECA,
including
the
public
version,
which
does
not
include
any
information
claimed
as
CBI,
has
been
established
under
docket
control
number
OPPTS­
42205B.
6
XVII.
EFFECTIVENESS
This
ECA
may
be
signed
in
separate
counterparts.
This
ECA
shall
not
be
effective
unless
signed
by
each
of
the
Companies
and
by
EPA.
This
ECA
shall
take
effect
on
the
date
of
publication
of
the
Federal
Register
notice
announcing
the
issuance
of
the
Order
that
incorporates
this
ECA.

XVIII.
RIGHTS
OF
THE
COMPANIES
By
signing
this
ECA,
the
Companies
waive
their
right
to
challenge
EPA's
authority
to
assess
penalties
for
violations
of
the
terms
of
this
ECA.
This
waiver
does
not
affect
any
other
rights
that
the
Companies
may
have
under
TSCA,
including
the
right
to
dispute
the
amount
of
any
penalty
or
to
dispute
factually
whether
a
violation
of
the
terms
of
this
ECA
has
occurred.

XIX.
IDENTITY
OF
THE
COMPANIES
The
Companies
subject
to
this
ECA
are:

Eastman
Chemical
Company
Celanese,
Ltd.

Shell
Chemical
Company
Union
Carbide
Corporation
7
XX.
SIGNATURE
TEST
SPONSOR
Eastman
Chemical
Company
Date:
Marc
G.
Schurger
Director
of
Product
Safety
and
Stewardship
Eastman
Chemical
Company
200
South
Wilcox
Drive
P.
O.
Box
431
Building
280W
Kingsport,
TN
37662­
5280
8
XX.
SIGNATURE
TEST
SPONSOR
Celanese,
Ltd.

Date:
Debra
B.
Phillips
Coordinator,
Product
Stewardship
Celanese,
Ltd.
1601
West
LBJ
Freeway
Dallas,
TX
75234
9
XX.
SIGNATURE
TEST
SPONSOR
Shell
Chemical
Company
Date:
Don
Roche
Business
Manager,
Americas
One
Shell
Plaza
Room
1780
P.
O.
Box
4320
Houston,
TX
77252
10
XX.
SIGNATURE
TEST
SPONSOR
Union
Carbide
Corporation
Date:
Neal
A.
Wyhs
Business
Director,
Solvents
and
Intermediates
39
Old
Ridgebury
Road
Danbury,
CT
06817­
0001
11
XX.
SIGNATURE
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
Date:
Lynn
R.
Goldman,
M.
D.,
Assistant
Administrator
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
U.
S.
Environmental
Protection
Agency
401
M
Street
SW
Washington,
DC
20460
1
Number
of
months
after
the
effective
date
of
the
testing
consent
order
that
incorporates
this
ECA.

2
This
column
shows
the
number
of
interim
reports
required.
Interim
reports
are
required
every
6
months
from
the
effective
date
of
this
ECA.

12
Table
1.
REQUIRED
TESTING,
TEST
STANDARDS,
REPORTING
AND
OTHER
REQUIREMENTS
FOR
METHYL
ISOBUTYL
KETONE
HAPs
Testing
Test
Standard
Deadline
for
Final
Report1
(
Months)
Interim
Reports2
Required
(
Number)

Reproductive
effects
testing
by
inhalation
(
rats)
§
799.9380
(
as
modified
in
Appendix
1)
29
4