Document ID: EPA-HQ-OPPT-2002-0056-0037
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-17T04:00Z

TO:

FROM:

SUBJECT:
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
1
.
WASHINGTON,
D.
C.
20460
January
14,2002
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
John
Schaeffkr
/M
e
t7
CITBKCD
I
DOC­
t
4
Addendum
Moditication
to
ECA
for
1,
l
,2­
Trichloroethane
(TCE)
CAS
NO.
79­
00­
5.

Attached
is
the
signed
addendum
modification
for
the
above­
referenced
project.

N
cr
W
N
48828888815
internet
Address
(URL)
http://
w.
epa.
gov
RecycledlRecyclable
Printed
wlh
Vegetable
011
Based
Inks
on
Recycled
Paper
(Minimum
25%
Postconsumer)
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Dr.
Peter
Voytek
HAP
Task
Force
Manager
P.
O.
Box
331
Millwood,
VA
22646
RE:
Request
for
Modifications
(OPPTS
Docket
#
4219SCI
Dear
Dr.
Voytek:

EPA
is
in.
receipt
of
your
letter
dated
September
14,2001,
requesting
a
modification
to
the
Enforceable
Consent
Agreement
(ECA)
for
l,
l,
2­
Trichloroethane
(TCE),
Specifically
the
request
is
to
amend,
by
45
days,
the
deadlines
for
submitting
a
final
report
for
the
acute
inhalation
toxicity
testing,
and
fgr
submitting
the
pharmacokinetic
data
to
support
model
vahdation
and
verification
of
extrapolation
capabilities.
The
adjustment
in
reporting
deadlines
is
necessary
because
of
a
prior
(EPA­
approved)
change
in
the
dose
levels
for
the.
acute
inhalation
study,
which
occurred
after
the
study
was
ongoing.

EPA
believes
that
this
modification
to
the
test
schedule
is
both
necessary
and
minor
and
will
not
have,
an
adverse
effect
on
the
results
expected
from
the
testing
specified
in
the
ECA
for
TCE.
Therefore,
by
this
letter
EPA
approves
the
HAP
TaskForce
request
that
Table
I
of
the
ECA
be
modified
to
provide
an
additionaI
45
days
for
the
submission
of
the
final
report
for
the
acute
inhalation
toxicity
test
and
the
pharmacokinetics
data.

The
requested
modification
changes
the
ECA
adding
45
days
to
the
following
reporting
requirements
(Table
1):

FROM:
TIER
I
HAPS
Testing
Test
Standard
DeadIine
for
Final
Report
(Months)
Acute
Toxicity
(inhalation)
§.
799.9135
(as
annotated
15
in
Appendix
B.
I)

TO:
TIER
I
HAPS
Testing
Acute
Toxicity
(inhalation)
Test
Standard
3.
799.9135
(as
annotated
in
Appendix
B.
1)
Deadline
for
Final
Report
(Months)
15
(f
45
days)

Internet
Address
(URL)
*
http://
www.
opa.
gov
Recycled/
Recyclable
o
Printed
with
Vegetable
Oil
Based
Inks
o'n
Recycled
Paper
(Minimum
25%
Postconsumer)
and
FROM:
TIER
I
Program
Review
Test
Standard
Deadline
for
Final
Testing
PK/
MECH
data
to
Supportmodel
Appendix
C(
1
­
3)
Report
(Months)
15
validation
and
verification
of
oral­
.

to­
inhalation
extrapolation
for
the
following
data
needs
in
the
F344
rat.....

TO:
PIUMECH
da&
to
support
model
Appendix
C(
1
­3)
vaIidation
and
verification
of
oral­
to­
inhalation
extrapoIation
for
the
following
data
needs
in
the
mouse
.
.
.
.
.
.

TIER
I
Program
Review
Testing
Test
Standard
PK/
MECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalatidn
extrapolation
for
the
following
data
needs
in
the
F344.
rat.....
Appendix
C(
l
­
3)

PK/
MECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalation
extrapolation
for
the
following
data
needs
in,
the
mouse
Appendix
C(
l
­3)
15
(+
4.5
days)

.
.
.
.
.
.
15
Deadline
for
Final
Report
(Months)
15
(+
4.5
days)

This
modification
is
considered
to
be
a
minok
change
for
which
public
comment
is
not
required.
Please
sign
and
return
the
enclosed
addendum
to
the
Enforceable
Consent
Agreement
3
fo;
1,1,2&
chloroethane.
This
signed
document
will
be
submitted
to
the
above
referenced
EPA
Docket.
Please
call
John
Schaeffer
(202­
260­
1266)
or
Richard
Leukroth
(202­
260­
032
1)
if
you
have
any
questions.

Chemical
Control
Division
Attachment
cc:
Docket
OPPTS
42198C
Francisca
Liam
(2225A)
JohnSch~~~~~~~~~~~:,:;
Richard
Leukroth
(7405)
Addendum
Modification
to
ENFORCEABLE
CONSENT
AGREEMENT
FOR
1,1,2­
Trichloroethane
(TCE)
CAS
No.
79­
00­
5
Docket
No.
,OPPTS
­
421986
We
the
undersigned
agree
to
the
change
to
the
Enforceable
Consent
Agreement
for
1,1,2­
Trichoroethane
as
described
in
the
table
below:
Original
Language
(in
Table
1
of
the
ECA):

TIER
I
HAPS
Testing
Test
Standard
Deadline
for
Final
Report
(Months)
Acute
Toxicity
(inhalation)
5.
799.9135
(as
annotated
in
Appendix
B
.
1)
15
.
.
.
.
.
.
.
.
.
.
.
.

TIER
I
Program
Review
Testing
PWMECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalation
extrapolation
for
the
following
data
needs
in
the
F344
rat.....
Test
Standard
Appendix
C(
l
­
3)
Deadline
for
Final
Report
(Months)
15
PWMECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalation
extrapolation
for
the
following
data
needs
in
the
mouse
Appendix
C(
1
­3)
15
.
.
.
.
.
.

New,
Amended,
Language
(in
Table
1
of
the
ECA):

TIER
I
HAPS
Testing
Test
Standard
Deadline
for
Final
Report
(Months)
Acute
Toxicity
(inhalation)
9.
799.9135
(as
annotated
in
Appendix
B.
1)
15
(+
45
days)

a...........

TIER
I
Program
Review
Testing
PUMECH
data
to
support
model
validation
and
verification
of
oral­
to­
inhalation
extrapolation
for
the
following
data
needs
in
the
F344
rat.....
Test
Standard
Appendix
C(
1
­
3)
Deadline
for
Final
Report
(Months)
15
(+
45
days)

PWMECH
data
to
support
model
validation
and
verification
of
oral­
:o­
inhalation
extrapolation
for
the
following
data
needs
in
the
mouse
Appendix
C(
1
­3)
15
(f
45
days)

.
.
.
.
.
.

Charles
M.
Auer,
Director
Chemical
Control
Division
Date
HAP
Task
Force
Sponsor
Representative