Document ID: EPA-HQ-OPPT-2002-0056-0052
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-10-02T04:00Z

UNIlED
STATES
ENViRONMENTAL
PROTECTION
AGENCY
(tl
WASHINGTON,
D.
C.
20460
Septetrber
18,
2002
PREfl
PtSUOCEAND
TOXIC
SUBSTANCES
Dr.
Peter
Voytck
HAP
Task
Force
Manager
P.
O.
Box
331
Miliwood,
VA
22646
RE:
TCE
ECA
Modifications
(OPPTS
Docket
#
42198C1
Dear
Dr.
Voytek:

I
want
to
acknowledge
the
receipt
ofthe
HAP
Task
Force
Tier
I
Program
Review
Testing
reports
entitled:
"Phannacokinetics
of
1,1
.2­
Trichloroethane
in
Rats
and
Mice"
and
`Physiologically
Based
Pharmacokinetic
Model
Development,
Simulations,
and
Sensitivity
Analysis
for
Repeated
Exposure
to
1.1
.2­
Trichloroethane."
Meeting
this
commitment
under
the
TSCA
Section
4
Enforceable
Consent
Agreement
(LiCA)
for
1,1,2­
Trichioroethane
(ICE)
is
clearly
a
commendable
accomplishment
for
the
HAP
Task
Force.
In
addition.
I
want
to
thank
you
for
previewing
the
PKJMECH
data
and
model
development
described
in
these
reports
during
the
technical
consultation
meeting
held
at
the
EPA
laboratory
ftcilities
in
RTP
on
August
13~
h~

Your
presentations
helped
EPA
scientists
focus
on
important
aspects
ofthe
findings
described
in
these
reports.
EPA's
receipt
ofthese
reports
was
announced
in
the
Federal
Register
on
April
10,
2002(
67
FR
17429);
April
12,
2002(
67
FR
17996);
and
August
14.2002(
67
FR
53001).

This
is
also
an
important
milestone
for
EPA
within
the
TCE
ECA
process.
The
receipt
of
these
reports
triggers
the
EPA
Program
Review
segment
ofthe
ICE
ECA
alternative
testing
program.
The
purpose
ofthe
EPA
Program
Review
was
outlined
in
Part
VI.
C.
ofthe
TCE
ECA.
As
previously
noted,
the
use
of
PKJMECH
data
to
support
quantitative
mute­
to­
mute
extrapolation
is
a
new
approach
for
EPA's
Office
ofPollution
Prevention
and
Toxics
(OPPT).
Clearly.
it
is
important
that
EPA
apply
the
most
sound
scientific
criteria
in
conducting
this
review
and
in
reaching
the
pivotal
decision
regarding
the
application
ofdata
from
these
reports
for
the
Tier
II
testing
segment
ofthe
ECA.
A
description
of'the
possible
outcomes
ofthe
EPA
Program
Review
is
provided
in
Part
VII
ofthe
TCE
ECA
document.

R.
cycIsdlR.
cyclsbl.
.Pitilsdwth
V.
gsis,
I.
CII
Sned
1*
1w
0*
100%
Scycled
P~
nr(
40%
Postconsuflhsv)
FPA~
sability
to
perform
the
Program
Review
function
is
proving
to
he
more
resource
intensive
than
originally
anticipated.
This
is
clue
partially
to
the
fact
that
this
is
the
first
instance
in
which
an
EPA
determination
is
needed
regarding
the
reliance
on
a
model
to
develop
data
under
a
TSCA
LCA.
and
also
because
there
have
been
important
policy
changes
at
EPA
since
the
ECA
was
put
in
place
which
directly
impact
science
decisions.
(i)
f
particular
consideration
is
the
impact
of
new
peer
review
requirements
on
many
aspects
of
EPA
s
science
decision
making.
As
a
result,
I
now
find
that
m
Office
is
not
only
embarking
on
a
Program
Review
of
the
science
described
in
the
ECA
hut
also
a
possible
peer
review
of
the
Program
Review
decision
called
fhr
under
the
[CA.
This
new
aspect
of
the
Program
Review
decision
places
additional
emphasis
on
opportunities
for
public
participation
in
the
review
process.
for
example,
a
Federal
Register
notice
announcing
the
TEE
Program
Review
will
he
published
beibre
the
end
of
this
month.
Ihis
notice
solicits
public
comment
on
the
fLAP
Task
Force
Tier
I
Program
Review
reports.
Comments
received
through
this
notice
are
expected
to
infbrm
EPA's
Program
Review
decision.

These
changes,
some
of
which
have
occurred
since
the
TCE
ECA
was
signed
and
were
previously
unforseen,
add
an
element
of
uncertainty
to
the
deadline
schedule
described
in
Table
I
of
the
ECA
document.
As
a
result
the
originally
anticipated
three
(3)
month
time
frame
for
EPA
to
complete
the
Program
Review
is
no
longer
feasible.
At
this
time
it
is
not
possible
to
predict
how
long
the
Program
Review
process
may
take
hut
we
anticipate
that
it
could
he
as
long
as
eight
(8)
months
from
the
date
of
this
letter.
\evertheless.
I
have
asked
all
EPA
reviewers
and
project
staff'
to
make
this
a
high
priority
and
redouble
their
efforts
to
complete
this
Program
Review
activity
as
SOOfl
as
possible.
I
remain
hopelltl
that
the
time
frame
can
he
shortened
by
diligent
eflbrts
on
the
part
of
all
those
involved
in
the
process.
As
a
result
of
these
unfbrseen
elements
which
need
to
be
incorporated
into
the
Program
Review
process.
EPA
finds
it
necessary
to
modif
the
deadlines
for
the
Tier
II
testing
and
route—
to—
route
extrapolation
reports.
The
niodihecl
deadlines
fbr
these
[CA
deliverables
~viIt
be
based
on
when
the
EPA
Program
Review
activity
is
completed
and
communicated
to
the
I­
lAP
Task
Force.

EPA
believes
that
moclitications
to
the
test
schedule
as
described
in
the
attached
Addendum
to
the
TCF
[CA
are
both
necessary
and
minor
and
will
not
have
an
adverse
effect
on
the
results
expected
from
the
testing
specified
in
the
[CA.
In
addition.
EPA
believes
that
this
modification
is
a
minor
change
tbr
which
public
comment
is
not
required.
Iherefore.
by
this
letter.
EPA
is
informing
the
I
lAP
Task
Force
that
Table
I
of
the
ECA
needs
to
he
modified
to
provide
additional
dine
fbi'
the
Agency
to
complete
the
Program
Review
activity.
On
completion
of
EPA's
Program
Review.
EPA
will
inform
the
F
lAP
lask
Force
of
the
outcome
and
reset
the
deadlines
fbr
Tier
II
HAP
Testing
and
Extrapolation
Reporting
as
described
in
the
enclosed
Addendum
to
the
[CA.
Please
sign
and
return
the
enclosed
Addendum
to
the
Enforceable
Consent
Agreement
for
1,1,2­
trichloroethane
to
me
by
September
30,
2002.
This
signed
document
will
be
submitted
to
the
above
referenced
EPA
Docket.
Please
call
John
Schaeffer
(202­
260­
1266)
or
Richard
Leukroth
(202­
260­
0321)
if
you
have
any
questions.

Sincerely,

/1
(~
c~
~~~­­

Charles
M.
Auer
Acting
Director
Chemical
Control
Division
Enclosure
cc:
Docket
OPPTS
42198C
Francisca
Liam
(2225A)
John
Schaeffer
(7405)
Richard
Leukroth
(7405)
~ç~
o
si~

,,~

Ui
Addend
urn
Modifi
cation
to
ENFORCEABLE
CONSENT
FOR
1,1
,2­
Trichloroethane
(TCE)
CAS
No.
79­
00­
5
Docket
No.
OPPTS
­
42198C
AGREEMENT
September
15,
2002
This
modification
changes
the
reporting
requirements
described
in
lable
I
of
the
ICE
[CA
as
follows:

Enforceable
Consent
Agreement
for
1,1
,2­
Trichloroethane
Modification
Tier
11
HAP
Testing
Test
Standard
Final
Report
I)
eadline
from
~
Acute
Neurotox!
cit\
(Oral)
799
9~
79(
as
annotated
~

Appendix
D3)
36
months
from
the
date
of
the
[CA
Order
Acute
~eurotox
ic
1k
(Oral)
709.9620
(as
annotated
ir
Appendix
03)
months
from
notiOcation
of
EPA
Pro
ram
Reviexs
completion
From
~
Fo
Route­
to­
route
extrapolation
reporting
of
acute
neurotoxicity
`
Appendix
C
39
months
from
the
date
of
the
[CA
Order
Route—
to—
route
extrapolation
reportino
of
acute
neurotoxicity
Appendix
C
12
months
ftorn
notification
of
EPA
Program
Review
completion
From
1u
Suhchronic
Neurotoxicit~
(oral)
§
799.9620
(as
annotated
~
Appendix
1)
3)
42
months
from
the
date
of
the
[CA
Order
Suhchronic
Neurotoxicity
(oral)
§
799.9620
(as
annotated
frt
Appendix
1)
3)
I
5
months
from
not~
ftcation
of
EPA
Program
Rex
iew
completion
From
lo
Route—
to—
route
extrapolation
reporting
of
subchromc
tieurOtoxicily
Appendix
C
45
months
trom
the
date
ot
the
[CA
Order
Route—
to—
route
extrapolation
reportino
of
suhchronic
neurotoxicity
Appendix
C
1
8
months
from
notification
of
EPA
Program
Review
completion
From
1
0
Developmental
fox
iC]
tV
(°`~)
x'~
7999370
(as
annotated
n
Appendix
1)
4)
48
months
from
the
date
of
the
[CA
Order
Developmental
foxicitv
(oral)
§
7999370
(as
antiotated
in
Appendix
1)
4)
21
months
from
notification
of
EPA
Program
Rex'iexx
co
nip
let
ion
1mm
~

lu
Route­
to­
route
extrapolation
reporting
of
Ccx
clopinental
toxicit\
Append
ix
C
5
I
months
front
(lie
date
of
the
[CA
Order
Route­
to­
route
extrapolation
Appenei\
C
24
months
from
tiotiheatioti
reporting
oldex
elopmenntal
of
EPA
Program
Rex
ie~
toxic
Er
completion
6
Enforceable
Consent
Agreement
for
1,1,2­
Trichforoethane
continued
Modification
Tier
ii
HAP
Testing
I
Test
Standard
Final
Report
l)
eadtine
From
In
Reproductive
toxicit)
(orah
§
7999380
(as
annotated
in
Appendix
05)
5—)
months
from
thc
date
of
the
[(
IA
Order
Reproductive
toxic~
tv(
oral)
§
7999380
(as
ant~
otatedin
Appendix
D5)
27
months
froni
notification
of
EPA
Program
Review
completion
From
lo
Route­
to­
route
extrapolation
reporting
of
reproductive
toxicity
Appendix
C
57
trtonths
from
the
date
of
the
ECA
Order
Route—
to—
route
extrapolation
reporting
of
reproductive
toxicity
Appendix
(1
30
months
from
tiotification
of
[PA
Program
Review
completion
From
.

In
Route­
to—
route
extrapolation
reporting
of
extant
tiimunotox~
citvdata
Appendix
C
33
months
from
the
date
of
the
[CA
Order
Route—
to—
route
extrapol
at
ion
reporting
of
extant
innmnunotox
icit~
data
Appendix
C
6
months
from
not
ificat
iou
of
[PA
Program
Reviex~
cotiip
letion
From
Route­
to—
route
extrapolation
repotting
of
extant
carcinoeenicimv
data
10
Route—
to—
route
extrapolation
reportitig
of
extant
carcinogen
icity
data
Appendix
C
30
months
from
the
date
of
the
[CA
Order
Appendix
C
3
months
from
notification
of
EPA
Program
Review
completion
We
the
undersigned
agree
these
changes
to
the
Enforceable
Consent
Agreement
for
I
,l
,2­

Trichoroethane
as
descri
bed
in
the
table
above:

7
,`~

c~~­~

Peter
`voviek
Date
Charles
M.
Auer,
Acting
Di
rector
Date
Chemical
Cotitrol
Division
H,\
P
Task
Force
Sponsor
Representative