Document ID: EPA-HQ-OAR-2004-0074-0050
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-01-13T05:00Z

February
5,
2002
Donald
R.
Lynam
Vice
President,
Air
Conservation
Ethyl
Corporation
330
South
Fourth
Street
Richmond,
VA
23219­
4304
Dear
Dr.
Lynam,

On
January
22,
2002,
you
submitted
a
request
to
Joseph
Sopata
of
my
staff
for
a
four
month
extension
for
the
submission
of
the
audited,
peer­
reviewed
draft
final
report
for
the
health
study
entitled,
"
Pharmacokinetics
of
inhaled
manganese
sulfate
in
pregnant
and
lactating
CD
rats",
(
CIIT
(
Chemical
Industry
Institute
of
Toxicology)
Protocol
01003),
as
required
under
the
MMT
Alternative
Tier
2
Health
Effects
Testing
Requirements.
This
protocol
was
approved
by
the
Agency
on
October
26,
2001.

According
to
Schedule
D.
2
in
the
MMT
Alternative
Tier
2
Health
Effects
Testing
Requirements,
the
audited,
peer­
reviewed
draft
final
report
for
the
health
study
entitled,
"
Pharmacokinetics
of
inhaled
manganese
sulfate
in
pregnant
and
lactating
CD
rats",
(
CIIT
Protocol
01003),
is
due
on
November
1,
2002.
In
an
attachment
to
your
request
for
an
extension,
Dr.
David
Dorman
of
CIIT
indicated
that
the
in­
life
phase
of
this
study
could
end
as
late
as
May
8,
2002.
He
also
indicated
that
the
original
schedule
provides
CIIT
with
less
than
6
months
to
complete
the
last
set
of
tissue
analyses
and
submit
an
audited,
peer­
reviewed,
draft
final
report
to
the
Agency.
Because
he
thought
more
time
was
needed,
Dr.
Dorman
asked
you
to
submit
a
request
for
an
extension
of
3
to
4
months
to
the
original
schedule.
You
indicated
that
Ethyl
agrees
with
Dr.
Dorman's
concerns.
Finally,
you
indicated
in
your
request
that
this
extension
would
not
affect
the
scheduled
beginning
of
the
primate
study,
which
requires
that
a
draft
peer­
reviewed
protocol
be
submitted
to
the
Agency
by
April
1,
2002.

We
believe
your
request
for
an
extension
is
reasonable.
This
letter
conveys
the
Agency's
approval
for
a
4
month
extension,
until
March
1,
2003,
to
schedule
D.
2
for
the
submission
of
the
audited,
peer­
reviewed
draft
final
report
for
the
health
study
entitled,
"
Pharmacokinetics
of
inhaled
manganese
sulfate
in
pregnant
and
lactating
CD
rats",
(
CIIT
Protocol
01003).
This
extension
would
also
be
applied
to
schedule
D.
2
for
the
Agency's
submission
of
comments
on
this
draft
final
report
as
well
as
Ethyl's
submission
of
the
final
report
to
EPA.
­
2­

If
you
have
any
questions
concerning
extension
in
the
schedule,
please
contact
Joe
Sopata
of
my
staff
at
(
202)
564­
9034.

Sincerely,

/
s/

Robert
E.
Larson,
Acting
Director
Transportation
and
Regional
Programs
Division
cc:
Monica
Alvarez,
ORD/
OSP
Tim
Backstrom,
OGC
Kevin
Fast,
Hunton
&
Williams