33125
Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
Region
VII,
901
N.
5th
Street,
Kansas
City,
Kansas
66101.

SUPPLEMENTARY
INFORMATION:
This
proposed
settlement
is
intended
to
resolve
the
liability
of
Saveway
Petroleum
at
the
Great
Lakes
Container
Corporation
Superfund
Site
in
St.
Louis,
Missouri.
Great
Lakes
Container
Corporation
is
a
former
drum
reclamation
company
who
operated
at
the
Site
from
1976
to
1985.
The
same
business
was
operated
as
Northwestern
Cooperage
from
the
1950'
s
to
1976
and
then
operated
as
Great
Lakes
Container
Corporation.
EPA
conducted
a
time­
critical
removal
completed
in
1998
that
consisted
primarily
of
soil
and
drum
removal.
The
EPA
incurred
costs
of
approximately
$
9,127,244.30.
The
hazardous
substances
at
this
Site
consisted
primarily
of
lead
and
polychlorinated
biphenyls.
Liability
is
based
on
the
theory
that
de
minimis
parties
arranged
for
disposal
of
hazardous
substances
at
the
Site
by
shipping
drums
for
reclamation
coated
with
paint
containing
lead.
The
de
minimis
parties
either
admitted
that
they
sent
drums
for
reclamation
to
the
Site
or
EPA
had
separate
evidence
to
prove
that
de
minimis
parties
sent
drums
for
reclamation
to
the
Site.
This
settlement
is
being
offered
to
Saveway
because
it
is
liable
for
no
more
than
one
quarter
a
percent
(.
25%)
of
EPA's
past
costs
at
the
Site.
The
majority
of
de
minimis
parties
are
each
required
to
pay
$
4,839.44
or
$
5,133.72
depending
on
whether
the
party
was
required
to
pay
prejudgment
interest.
Other
settlements
made
for
six
de
minimis
parties
varied
from
$
3,794.19
to
$
22,856.56
because
more
volumespecific
information
was
available
for
them
allowing
EPA
to
refine
the
calculation.
The
amount
and
toxicity
of
hazardous
substances
contributed
by
Saveway
was
minimal
as
compared
to
other
parties'
shares
of
hazardous
substances.
The
EPA
determined
this
amount
to
be
Saveway's
fair
share
of
liability
based
on
the
amount
of
hazardous
substances
generated
and
disposed
of
at
the
Site
and
the
volume
of
waste
contributed.
However,
because
Saveway
has
demonstrated
an
inability
to
pay,
it
will
not
be
required
to
pay
any
of
EPA's
past
costs
at
the
Site.
As
a
result,
Saveway
has
agreed
to
provide
access
to
EPA
and
maintain
records
for
five
(
5)
years.
The
settlement
also
includes
contribution
protection
from
lawsuits
by
other
potentially
responsible
parties
as
provided
for
under
section
122(
g)(
5)
of
CERCLA,
42
U.
S.
C.
9622(
g)(
5).
The
de
minimis
settlement
provides
that
EPA
covenants
not
to
sue
Saveway
for
response
costs
at
the
Site
or
for
injunctive
relief
pursuant
to
sections
106
and
107
of
CERCLA
and
section
7003
of
the
Resource
Conservation
and
Recovery
Act
of
1976,
as
amended
(
RCRA),
42
U.
S.
C.
6973.
The
settlement
contains
a
reopener
clause
which
nullifies
the
covenant
not
to
sue
if
any
information
becomes
known
to
EPA
that
indicates
that
Saveway
no
longer
meets
the
criteria
for
a
de
minimis
settlement
set
forth
in
section
122(
g)(
1)(
A)
of
CERCLA,
42
U.
S.
C.
9622(
g)(
1)(
A).
The
United
States
maintains
the
ability
to
bring
an
action
in
the
event
that
the
financial
information
provided
by
Saveway
was
false.
The
covenant
not
to
sue
does
not
apply
to
the
following
matters:
(
a)
Claims
based
on
the
future
arrangement
for
disposal
or
treatment
of
any
hazardous
substance,
pollutant,
or
contaminant
at
the
Site
after
the
effective
date
of
the
de
minimis
settlement;
(
b)
Criminal
liability;
or
(
c)
Liability
for
damages
or
injury
to,
destruction
of,
or
loss
of
the
natural
resources
and
for
the
costs
of
any
natural
resource
damage
assessments.
The
de
minimis
settlement
will
become
effective
upon
the
date
which
the
EPA
issues
a
written
notice
to
Saveway
that
the
statutory
public
comment
period
has
closed
and
that
comments
received,
if
any,
do
not
require
modification,
of
or
EPA
withdrawal
from
the
settlement.

Dated:
May
22,
2003.
James
B.
Gulliford,
Regional
Administrator,
Region
VII.
[
FR
Doc.
03
 
13565
Filed
6
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0010;
FRL
 
7300
 
6]

1,2­
Ethylene
Dichloride;
Final
Enforceable
Consent
Agreement
and
Testing
Consent
Order
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
Under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA),
EPA
has
issued
a
testing
consent
order
(
Order)
that
incorporates
an
enforceable
consent
agreement
(
ECA)
with
the
Dow
Chemical
Company,
Vulcan
Materials
Company,
Occidental
Chemical
Corporation,
Oxy
Vinyls,
LP,
Georgia
Gulf
Corporation,
Westlake
Chemical
Corporation,
PPG
Industries,
Inc.,
and
Formosa
Plastics
Corporation,
U.
S.
A.
The
Companies
are
members
of
the
Hazardous
Air
Pollutant
(
HAP)
Task
Force,
which
represents
the
manufacturers
of
1,2­
ethylene
dichloride
(
EDC).
The
Companies
have
agreed
to:
Conduct
toxicity
testing,
develop
pharmacokinetics
and
mechanistic
test
data,
and
develop
a
computational
dosimetry
model
for
quantitative
route­
to­
route
extrapolations
of
dose­
response
for
EDC
for
acute,
subchronic,
developmental,
reproductive
and
neurotoxicity
effects
that
were
identified
in
a
proposed
test
rule
for
hazardous
air
pollutants.
This
notice
announces
the
ECA
and
Order
for
EDC
and
summarizes
the
terms
of
the
ECA.

DATES:
The
effective
date
of
the
ECA
and
Order
is
May
13,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
For
technical
information
contact:
Richard
Leukroth
or
John
Schaeffer,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8157;
fax
number:
(
202)
564
 
4765;
e­
mail
address:
ccd.
citb@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

This
announcement
is
directed
to
the
public
in
general.
However,
as
described
in
Unit
IV.,
this
ECA
and
Order
may
affect
others
in
that
EPA
has
initiated
rulemaking
under
TSCA
section
12(
b)
(
62
FR
67038,
December
23,
1997)
(
FRL
 
5762
 
8).
When
finalized,
that
rulemaking
will
require
all
persons
who
export
or
intend
to
export
EDC
to
comply
with
the
export
notification
regulations
at
40
CFR
part
707,
subpart
D.
Although
others
may
be
affected
by
subsequent
actions
related
to
this
announcement,
this
ECA
and
Order
only
applies
to
those
Companies
that
are
specifically
named
in
this
ECA
and
Order.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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3
7:
09AM
33126
Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2003
 
0010.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
the
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
A.
What
is
EDC?

EDC
is
used
as
a
chemical
intermediate
principally
in
the
production
of
vinyl
chloride,
but
also
vinylidene
chloride,
1,1,1­
trichloroethane,
trichloroethylene,
tetrachloroethylene,
aziridines,
and
ethylene
diamines.
It
is
also
used
as
a
solvent.
An
estimated
77,111
workders
are
exposed
to
EDC
(
Ref.
1).
The
Chemical
Abstract
Service
Registry
Number
(
CAS
No.)
for
EDC
is
107
 
06
 
2.
B.
Why
Does
EPA
Need
Health
Effects
Data
on
EDC?

EPA
proposed
health
effects
testing
under
TSCA
section
4(
a)
for
a
number
of
hazardous
air
pollutants
(``
HAPs''
or
``
HAP
chemicals''),
including
EDC
(
61
FR
33178,
June
26,
1996)
(
FRL
 
4869
 
1),
as
amended
at
62
FR
67466,
December
24,
1997
(
FRL
 
5742
 
2)
and
63
FR
19694,
April
21,
1998
(
FRL
 
5780
 
6).
In
the
original
HAPs
proposal,
the
Agency
made
preliminary
findings
for
EDC
(
61
FR
33178,
33190,
33191;
and
Ref.
1)
that:
1.
EDC
may
present
an
unreasonable
risk
of
injury
to
health.
2.
EDC
is
or
will
be
produced
in
substantial
quantities,
and
there
is
or
may
be
substantial
human
exposures
to
the
chemical.
3.
There
are
insufficient
data
to
determine
or
predict
the
effects
of
activities
on
human
health
involving
EDC.
4.
Testing
is
necessary
to
develop
health
effects
data
for
EDC.
The
HAPs
rule,
as
amended,
proposed
testing
of
EDC
for
acute
toxicity,
subchronic
toxicity,
developmental
toxicity,
reproductive
effects
toxicity,
and
neurotoxicity
(
61
FR
33178,
33198,
June
26,
1996;
62
FR
67466,
67483,
December
24,
1997).

III.
ECA
Development
and
Conclusion
A.
How
is
EPA
Going
to
Obtain
Health
Effects
Testing
on
EDC?

In
the
proposed
HAPs
test
rule,
as
amended,
EPA
invited
the
submission
of
proposals
regarding
the
performance
of
pharmacokinetics
studies
that
would
permit
extrapolation
from
oral
data
to
predict
risk
from
inhalation
exposure.
Such
proposals
could
provide
the
scientific
basis
for
alternative
testing
to
the
testing
proposed
and
form
the
basis
for
developing
needed
HAPs
data
via
ECAs
(
61
FR
33178,
33189,
June
26,
1996;
62
FR
67466,
67474,
December
24,
1997).
EPA
uses
ECAs
to
accomplish
testing
where
a
consensus
exists
among
EPA,
affected
manufacturers
and/
or
processors,
and
interested
members
of
the
public
concerning
the
need
for
and
scope
of
testing
(
40
CFR
790.1(
c)).
The
procedures
for
ECA
development
are
described
at
40
CFR
790.22(
b).
In
response
to
EPA's
request
for
proposals
for
ECAs,
the
HAP
Task
Force
submitted
a
proposal
for
alternative
testing
that
included
physiologicallybased
pharmacokinetics
(
PBPK)
studies
and
computational
modeling
to
inform
route­
to­
route
extrapolations
of
doseresponse
for
EDC
on
November
22,
1996
(
Ref.
2).
EPA
responded
to
this
proposal
on
June
26,
1997
(
Ref.
3),
indicating
that
the
HAP
Task
Force
alternative
approach
offered
sufficient
merit
to
proceed
with
discussions
for
developing
an
ECA
for
EDC.
Consequently,
EPA
issued
a
document
which
was
published
in
the
Federal
Register
of
December
19,
1997
(
62
FR
66626)
(
FRL
 
5763
 
1),
soliciting
interested
parties
to
monitor
or
participate
in
these
discussions.
EPA
held
a
public
meeting
to
develop
an
ECA
for
EDC
on
January
12,
1998.
Representatives
of
the
Companies
and
other
interested
parties
attended
this
meeting.
The
participants
reached
consensus
on
the
general
scope
of
the
testing
to
be
required
under
the
ECA.
Following
the
public
meeting,
the
HAP
Task
Force
submitted
(
March
19,
1999)
a
revised
proposal
for
a
testing
program
(
Ref.
4).
On
February
13,
2001,
EPA
responded
to
the
HAP
Task
Force
with
comments
on
the
revised
proposal
and
by
initiating
a
draft
ECA
for
consideration
by
the
HAP
Task
Force
(
Ref.
5).
A
final
version
of
the
ECA
was
later
circulated
to
the
HAP
Task
Force
for
signature,
and
returned
to
EPA
for
signature.
On
February
3,
2003,
EPA
received
the
ECA
signed
by
the
Companies.
On
May
13,
2003,
EPA
signed
the
ECA
and
accompanying
Order
(
Ref.
6).

B.
What
Testing
Does
the
ECA
for
EDC
Require?
The
EDC
ECA
alternative
testing
program
has
four
segments
as
follows:
Tier
I
HAPs
Testing,
Tier
I
Program
Review
Testing,
EPA
Program
Review,
and
Tier
II
Testing.
This
is
described
in
Table
1
in
this
unit
and
includes
the
following
testing,
reporting,
and
review
activities:
1.
Tier
I
HAPs
Testing.
This
testing
consists
of
endpoint
testing,
conducted
by
inhalation
exposure,
that
EPA
deemed
necessary
to
meet
certain
data
needs
identified
in
the
proposed
HAPs
test
rule,
as
amended,
and
includes
acute
toxicity
with
bronchoalveolar
lavage
(
BAL)
and
histopathology,
and
acute
neurotoxicity
testing.
These
tests
will
be
conducted
under
a
combined
protocol
as
described
in
Appendix
D.
1
of
the
ECA.
2.
Tier
I
Program
Review
Testing.
Under
this
segment
of
the
EDC
ECA
alternative
testing
program,
the
Companies
will
conduct
studies
to
extend
the
computational
dosimetry
model
of
D'Souza
et
al.
(
1987;
1988;
Refs.
7
and
8)
in
order
to
apply
the
model
to
the
specific
health
effects
endpoints
for
EDC
listed
in
the
ECA,
validate
the
model,
and
verify
the
model's
ability
to
perform
quantitative
route­
to­
route
extrapolations
of
doseresponse
In
addition,
the
Companies
will
sponsor
development
of
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Notices
pharmacokinetics
and
mechanistic
(
PK/
MECH)
data
to
support
the
application
of
the
model
for
the
endpoints
listed
under
Tier
II
of
the
EDC
ECA.
Specifically,
the
PK/
MECH
testing
will
develop
data
to
inform:
i.
Oral­
to­
inhalation
extrapolation
of
subchronic
toxicity
data
reported
by
Daniel,
et
al.
(
1994;
Ref.
9)
relevant
to
corn
oil
gavage.
ii.
Oral­
to­
inhalation
extrapolation
of
subchronic
neurotoxicity
data
relevant
to
drinking
water
exposure
of
a
study
to
be
conducted
under
Tier
II
Testing.
iii.
Oral­
to­
inhalation
extrapolation
of
reproductive
effects
testing
conducted
under
Tier
II
Testing
and
each
dosing
paradigm
of
studies
reported
by
Alumot
et
al.
(
1976;
Ref.
10),
Rao,
et
al.
(
1980;
Ref.
11)
and
Lane
et
al.
(
1982;
Ref.
12).
In
addition,
the
Companies
will
provide
model
simulations
with
point
and
uncertainty
estimates
of
internal
dose
metrics
(
parent
chemical
peak
and
area
under
the
curve
(
AUC)
concentrations
in
blood
and
brain,
and
24­
hour
total
glutathione­
dependent
metabolism)
in
rats
and
humans
to
inform
quantitative
route­
to­
route
extrapolations
of
dose­
response.
These
simulations
will
be
used
to
evaluate
the
acceptability
of:
Subchronic
neurotoxicity
testing
of
oral
exposure
via
drinking
water
in
rats,
extant
oral
subchronic
toxicity
data
of
Daniel
et
al.
(
1994;
Ref.
9)
in
rats
via
corn
oil
gavage,
and
reproductive
toxicity
testing
of
oral
exposure
via
drinking
water
in
rats.
3.
EPA
Program
Review.
Model
development
and
data
from
Tier
I
Program
Review
Testing
are
subject
to
an
EPA
Program
Review.
It
is
essential
to
the
success
of
the
EDC
ECA
alternative
testing
program
for
EPA
to
ensure
that
the
model
and
the
PK/
MECH
data
used
to
support
the
routeto
route
extrapolations
of
dose­
response
are
of
the
highest
quality.
The
purpose
of
the
EPA
Program
Review
will
be
to
determine:
i.
Whether
it
is
feasible
and
appropriate
to
apply
Tier
I
Program
Review
Testing
data
and
data
from
other
studies
acceptable
to
EPA
to
support
computational
route­
to­
route
extrapolations
of
dose­
response
for
endpoints
listed
in
the
Tier
II
Testing
segment
of
the
ECA.
ii.
Whether
the
data
from
the
Tier
I
Program
Review
Testing
segment
provide
a
sufficient
basis
for
conducting
the
endpoint
testing
and/
or
the
computational
route­
to­
route
extrapolations
for
the
dose­
responses
specified
in
the
Tier
II
Testing
segment.
iii.
The
nature
and
scope
of
any
additional
work
that
may
be
required
before
Tier
II
Testing
and
application
of
the
EDC
model
for
route­
to­
route
extrapolation
of
dose­
response
reporting
(
e.
g.,
development
of
additional
PK/
MECH
data,
modification
to
the
EDC
model).
4.
Tier
II
Testing
and/
or
Extrapolation
Reporting.
This
segment
of
the
EDC
ECA
alternative
testing
program
consists
of
endpoint
testing
by
drinking
water
exposure
for
subchronic
neurotoxicity
and
reproductive
toxicity.
The
reproductive
effects
toxicity
testing
is
intended
to
confirm
studies
reported
by
Alumot
et
al.
(
1976;
Ref.
10),
Rao
et
al.
(
1980;
Ref.
11),
and
Lane
et
al.
(
1982;
Ref.
12),
and
provide
data
needed
on
fertility
index,
gestation
index,
gross
necropsy,
organ
weight,
histopathology,
estrous
cycle,
sperm
evaluation,
vaginal
opening,
and
preputial
separation
as
described
in
the
ECA.
This
segment
will
also
include
application
of
the
EDC
model
for
quantitative
route­
to­
route
extrapolation
reporting
(
oral
to
inhalation)
for
Tier
II
endpoint
testing
(
subchronic
neurotoxicity
and
reproductive
toxicity)
and
similar
computational
extrapolation
reporting
for
extant
subchronic
toxicity
reported
by
Daniel
et
al.
(
1994;
Ref.
9).
Testing
conducted
under
this
ECA
will
allow
EPA
to
characterize
certain
potential
health
hazards
resulting
from
inhalation
exposure
to
EDC.
The
following
Table
1
sets
forth
the
required
testing,
test
standard,
and
reporting
requirements
under
the
ECA
for
EDC.

TABLE
1.
 
REQUIRED
TESTING,
TEST
STANDARD,
AND
REPORTING
REQUIREMENTS
FOR
EDC
Testing
Segment
Required
testing
Test
standard
Deadline
for
final
report1
(
Months)

Tier
I
HAPs
Testing.
Acute
toxicity,
with
BAL
and
histopathology
(
inhalation).
40
CFR
799.9135
(
as
annotated
in
ECA
Appendix
D.
1).
18
Acute
neurotoxicity
(
inhalation).
40
CFR
799.9620
(
as
annotated
in
ECA
Appendix
D.
1).
18
Tier
I
Program
Review
Testing.
PK/
MECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalation
extrapolation
of
dose­
response
for
the
following
data
needs
in
the
F344
rat:
ECA
Appendix
C
(
1
 
4).
21
a.
Subchronic
toxicity.
b.
Subchronic
neurotoxicity.
c.
Reproductive
toxicity.
PBPK
model
simulations.
ECA
Appendix
C
(
1
 
5).
21
Tier
II
Testing
and/
or
Extrapolation
Reporting.
Subchronic
toxicity
route­
to­
route
extrapolation
of
dose­
response
(
oral
Tier
II
Testing
to
inhalation)
of
a
study
reported
by
Daniel
et
al.
(
1994).
ECA
Appendix
C.
2
and
C.
6.
36
Subchronic
neurotoxicity
(
oral).
40
CFR
799.9620
(
as
annotated
in
ECA
Appendix
D.
2).
42
Subchronic
neurotoxicity
route­
to­
route
extrapolation
of
dose­
response
(
oral
Tier
II
Testing
to
inhalation).
ECA
Appendix
C.
3
and
C.
6.
52
Reproductive
toxicity
(
oral).
40
CFR
799.9380
(
as
annotated
in
ECA
Appendix
D.
3).
42
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/
Notices
TABLE
1.
 
REQUIRED
TESTING,
TEST
STANDARD,
AND
REPORTING
REQUIREMENTS
FOR
EDC
 
Continued
Testing
Segment
Required
testing
Test
standard
Deadline
for
final
report1
(
Months)

Reproductive
toxicity
route­
to­
route
extrapolation
of
dose­
response
(
oral
data
to
inhalation,
including
Tier
II
Testing
and
extant
studies
reported
by
Alumot
et
al.
(
1976),
Rao
et
al.
(
1980),
and
Lane
et
al.
(
1982)).
ECA
Appendix
C.
4
and
C.
6.
52
1
Number
of
months
after
the
effective
date
of
the
Order
that
incorporates
this
ECA
when
the
final
report
is
due.
In
addition,
every
6
months
from
the
effective
date
of
the
Order
until
the
end
of
the
ECA
testing
program,
interim
reports
describing
the
status
of
all
testing
to
be
performed
under
this
ECA
must
be
submitted
by
the
Companies
to
EPA.

C.
What
are
the
Uses
for
the
Test
Data
for
EDC?

EPA
would
use
the
data
obtained
from
testing
to
implement
several
provisions
of
section
112
of
the
Clean
Air
Act
(
CAA),
including
the
determination
of
residual
risk,
the
estimation
of
the
risks
associated
with
accidental
releases
of
chemicals,
and
other
HAP
risk
assessments.
EPA
will
also
use
the
data
from
this
ECA
to
fulfill
part
of
the
Tier
I
Testing
portion
of
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP).
(
For
more
information
about
VCCEP,
see:
http://
www.
epa.
gov/
chemrtk/
vceep/.)
In
addition,
the
data
will
be
used
by
other
Federal
agencies
(
e.
g.,
the
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR),
the
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH),
the
Occupational
Safety
and
Health
Administration
(
OSHA),
and
the
Consumer
Product
Safety
Commission
(
CPSC))
in
assessing
chemical
risks
and
in
taking
appropriate
actions
within
their
programs
(
see
the
proposed
HAPs
test
rule
at
61
FR
33178,
33179,
June
26,
1996).

D.
Does
the
ECA
for
EDC
Meet
all
the
Testing
Requirements
for
EDC
that
were
Contained
in
the
Proposed
Test
Rule?

In
the
proposed
HAPs
test
rule,
as
amended,
EPA
proposed
testing
of
EDC
for
acute,
subchronic,
developmental,
and
reproductive
effects
and
neurotoxocity
by
the
inhalation
route
of
exposure.
The
ECA
alternative
testing
program
for
EDC
requires
inhalation
testing
for
acute
toxicity
and
acute
neurotoxicity,
and
oral
drinking
water
testing
for
subchronic
neurotoxicity
and
reproductive
effects
toxicity.
The
ECA
requires
the
development
of
PK/
MECH
data
to
support
computational
PBPK
modeling
to
inform
quantitative
routeto
route
extrapolations
of
dose­
response
(
oral
to
inhalation)
for
the
endpoints
of
subchronic
toxicity,
subchronic
neurotoxicity,
and
reproductive
effects
toxicity
as
described
in
the
ECA.
During
discussions
to
develop
this
ECA,
EPA
concluded
that
the
developmental
toxicity
studies
reported
by
Rao
et
al.
(
1980;
Ref.
11),
in
rabbits,
and
Payan
et
al.
(
1995;
Ref.
13),
in
rats,
adequately
fulfill
the
HAPs
rulemaking
testing
requirement
for
developmental
toxicity
testing
for
EDC
and,
therefore,
the
ECA
does
not
require,
and
the
final
HAPs
test
rule
will
not
require
this
testing.
In
addition,
the
ECA
does
not
require,
and
the
final
HAPs
test
rule
will
not
require,
macrophage
function
testing
(
a
component
of
EPA's
acute
toxicity
test
gudeline
40
CFR
799.9135)
because
EPA
considers
existing
data
by
Sherwood
et
al.
(
1987;
Ref.
14)
adequate
to
fulfill
this
aspect
of
the
acute
testing
need.
Furthermore,
the
Tier
I
HAPs
Testing
endpoints
(
acute
toxicity
and
acute
neurotoxicity)
will
not
be
included
in
the
final
HAPs
test
rule
because
the
route
of
testing
to
be
conducted
under
this
ECA
is
identical
to
that
specified
in
the
HAPs
rulemaking.
Finally,
depending
on
the
outcome
of
EPA's
Program
Review,
the
Agency
anticipates
that
the
balance
of
the
testing
for
EDC
that
was
contained
in
the
proposed
HAPs
test
rule,
as
amended,
will
also
not
be
included
in
the
final
HAPs
test
rule
because
the
Companies
will
conduct
equivalent
testing
as
Tier
II
Testing
and
Extrapolation
Reporting
under
this
ECA
alternative
testing
program
for
EDC.
Therefore,
EPA
anticipates
the
fulfilling
of
all
of
the
health
effects
testing
requirements,
identified
in
the
HAPs
proposed
rule,
as
amended,
by
implementing
the
ECA
and
Order.
The
issuance
of
the
ECA
and
Order
constitutes
final
EPA
action
for
purposes
of
5
U.
S.
C.
704.

E.
What
if
EPA
Should
Require
Additional
Health
Effects
Testing
on
EDC?
If
EPA
decides
in
the
future
that
it
requires
additional
health
effects
data
on
EDC,
the
Agency
will
initiate
a
separate
action.

IV.
Other
Impacts
of
the
ECA
for
EDC
The
issuance
of
the
ECA
and
Order
under
TSCA
section
4
subjects
the
Companies
that
signed
the
ECA
to
export
notification
requirements
under
TSCA
section
12(
b)(
1),
as
set
forth
at
40
CFR
part
707,
subpart
D,
if
they
export
or
intend
to
export
EDC.
In
the
12(
b)
proposal
published
in
the
Federal
Register
of
December
23,
1997
(
62
FR
67038)
(
FRL
 
5762
 
8),
EPA
proposed
to
amend
40
CFR
799.5000
by
adding
EDC
to
the
list
of
chemicals
subject
to
testing
consent
orders.
The
listing
of
a
chemical
substance
at
40
CFR
799.5000
serves
as
notification
to
all
persons
who
export
or
intend
to
export
the
chemical
substance
that:
1.
The
chemical
substance
is
the
subject
of
an
ECA
and
Order.
2.
EPA's
export
notification
regulations
at
40
CFR
part
707,
subpart
D,
apply
to
those
exporters
who
have
signed
the
ECA,
as
well
as
those
exporters
who
have
not
signed
the
ECA
(
40
CFR
799.19).
When
a
final
rule
based
on
the
proposed
rule
is
published
in
the
Federal
Register,
all
persons
who
export
or
who
intend
to
export
EDC
will
be
subject
to
export
notification
requirements.

V.
Paperwork
Reduction
Act
The
ECA
and
Order
announced
in
this
notice
do
not
contain
any
information
collection
requirements
that
require
additional
approval
by
the
Office
of
Management
and
Budget
(
OMB)
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.
The
information
collection
requirements
related
to
test
rules
and
ECAs
issued
under
TSCA
section
4
have
already
been
approved
by
OMB
under
OMB
control
number
2070
 
0033
(
EPA
ICR
No.
1139).
The
one­
time
public
burden
for
this
collection
of
information
is
estimated
to
be
approximately
3,364
hours
total
(
Ref.
15).
Under
the
PRA,
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection
it
includes
the
time
needed
to
review
instructions;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
agency
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3,
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/
Notices
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

VI.
References
1.
U.
S.
EPA,
OPPT.
I.
Ethylene
Dichloride
(
107
 
06
 
2).
Pp
24
 
27
In:
``
TSCA
Section
4
Findings
for
21
Hazardous
Air
Pollutants:
A
Supporting
Document
for
Proposed
Hazardous
Air
Pollutants
(
HAPs)
Test
Rule.''
(
June
25,
1996).
2.
The
HAP
Task
Force.
Letter
from
Peter
E.
Voytek
to
Charles
M.
Auer
with
attachment
entitled:
``
Proposal
for
Pharmacokinetics
Study
of
Ethylene
Dichloride,
November
22,
1996.''
(
November
22,
1996).
3.
U.
S.
EPA.
Letter
from
Charles
M.
Auer
to
Peter
E.
Voytek
with
attachment
entitled:
``
Preliminary
EPA
Technical
Analysis
of
Proposed
Industry
Pharmacokinetics
(
PK)
Strategy
for
Ethylene
Dichloride,
June,
1997.''
(
June
26,
1997).
4.
The
HAP
Task
Force.
Letter
from
Peter
E.
Voytek
to
Charles
M.
Auer,
U.
S.
EPA.
(
March
19,
1999).
5.
U.
S.
EPA.
Letter
from
Charles
M.
Auer
to
Peter
E.
Voytek,
HAP
Task
Force,
Re:
ECA
Development
of
Ethylene
Dichloride
(
EDC)
(
OPPTS
42197C,
with
attachment:
``
EDC
ECA
 
DRAFT,
dated
February,
2001.''
(
February
13,
2001).
6.
Final
Enforceable
Consent
Agreement
for
Ethylene
Dichloride
and
Accompanying
Testing
Consent
Order,
signed
by
EPA
on
May
13,
2003.
7.
D'Souza,
R.
W.,
Francis,
W.
R.,
Bruce
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D.,
and
Andersen,
M.
E.
Physiologically
based
phamacokinetic
model
for
ethylene
dichloride
and
its
application
in
risk
assessment.
Pp
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In:
Pharmacokinetics
in
Risk
Assessment.
National
Academy
Press.
Washington,
D.
C.
(
1987).
8.
D'Souza,
R.
W.,
Francis,
W.
R.,
and
Andersen,
M.
E.
Physiological
model
for
tissue
glutathione
depletion
and
increased
resynthesis
after
ethylene
dichloride
exposure.
Journal
of
Pharmacology
and
Experimental
Therapeutics
245(
2):
563
 
568.
1988.
9.
Daniel,
F.
B.,
Robinson,
M.,
Olson,
G.
R.,
York,
R.
G.,
and
Condie,
L.
W.
Ten
and
ninety­
day
toxicity
studies
of
1,2­
dichloroethane
in
Sprague­
Dawley
rats.
Drug
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17:
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Alumot,
E.,
Nachtomi,
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Holstein,
P.,
Bondi,
A.,
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Herzberg,
M.
Tolerance
and
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daily
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fumigants
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Food,
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14:
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(
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11.
Rao,
K.
S.,
Murray,
J.
S.,
Deacon,
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John,
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A.,
Calhoun,
L.
L.,
and
Young,
J.
T.
Teratogenicity
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reproduction
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in
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inhaling
ethylene
dichloride.
Banbury
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(
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12.
Lane,
R.
W.,
Riddle,
B.
L.,
and
Borzelleca,
J.
F.
Effects
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dichloroethane
and
1,1,1­
trichloroethane
in
drinking
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on
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Toxicology
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13.
Payan,
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Saillenfait,
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M.,
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Fabry,
J.
P.,
Langonne,
I.,
and
Sabate
J.
P.
Assessment
of
the
developmental
toxicity
and
placental
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of
the
1,2­
dichloroethane
in
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Fundamental
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14.
Sherwood,
R.
L.,
O'Shea,
W.,
Thomas,
P.
T.,
Ratajczak,
H.
V.,
and
Aranyi,
C.
Effects
of
inhalation
of
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dichloride
on
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defenses
of
mice
and
rats.
Toxicology
and
Applied
Pharmacology
91:
491
 
496.
1987.
15.
U.
S.
EPA,
OPPTS.
``
Burden
Estimates
for
the
Enforceable
Consent
Agreement
for
Ethylene
Dichloride.''
(
January
31,
2002).

List
of
Subjects
Environmental
protection,
Hazardous
chemicals.

Dated:
May
13,
2003.
Stephen
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
13721
Filed
6
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2002
 
0067;
FRL
 
7287
 
4]

TSCA
Section
8(
e);
Notification
of
Substantial
Risk;
Policy
Clarification
and
Reporting
Guidance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
is
hereby
finalizing
revisions
to
certain
parts
of
EPA's
``
Statement
of
Interpretation
and
Enforcement
Policy;
Notification
of
Substantial
Risk''
(
policy
statement)
issued
March
16,
1978,
concerning
the
reporting
of
``
substantial
risk''
information
pursuant
to
section
8(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA).
EPA
is
making
these
revisions
after
having
considered
public
comments
that
were
solicited
in
1993
and
1995.
Specifically,
the
revisions
address
the
reporting
of
information
on
the
release
of
chemical
substances
to,
and
the
detection
of
chemical
substances
in,
environmental
media,
the
reporting
deadline
for
written
``
substantial
risk''
information,
and
the
circumstances
under
which
certain
information
need
not
be
reported
to
EPA
under
section
8(
e)
of
TSCA.
EPA
is
republishing
the
policy
statement
in
its
entirety
in
this
document,
including
both
those
portions
of
the
policy
statement
that
are
revised
and
those
portions
that
are
not
affected
by
any
revisions.
Since
the
policy
statement
was
published
in
1978,
this
republication
is
intended
to
ensure
that
a
single
reference
source
for
the
TSCA
section
8(
e)
policy
and
guidance
is
easily
available
to
the
regulated
community
and
other
interested
parties.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Richard
Hefter,
Chief,
High
Production
Volume
Chemicals
Branch,
Risk
Assessment
Division,
Office
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
7649;
e­
mail
address:
hefter.
richard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
manufacture,
process,
import,
or
distribute
in
commerce
chemical
substances
and
mixtures.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Chemical
manufacturers,
processors,
and
distributors
(
NAICS
325)
 
Petroleum
refiners
and
distributors
(
NAICS
324)
 
Manufacturers
of
plastic
parts
and
components
(
NAICS
325211)
 
Paints
and
coatings
and
adhesive
manufacturing
(
NAICS
3255)
 
Cleaning
compounds
and
similar
products
manufacturing
(
NAICS
3256)
 
Electronics
manufacturing
(
NAICS
334
and
335)
 
Automobiles
manufacturing
(
NAICS
3361)

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2003
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