An
equal
opportunity
employer
July
30,
2004
Suzanne
Rudzinski
Director,
Transportation
and
Regional
Programs
Division
USEPA
Headquarters
6406J
Ariel
Rios
Building
1200
Pennsylvania
Avenue,
N.
W.
Washington,
D.
C.
20460
RE:
Interim
Progress
Report
#
10
 
Fuels
and
Fuel
Additives
Health
Effects
Testing
Regulation;
Pursuant
to
Section
211(
b)(
2)
and
211(
e)
of
the
Clean
Air
Act.

Dear
Ms.
Rudzinski:

The
American
Petroleum
Institute
(
API),
on
behalf
of
the
Section
211(
b)
Research
Group
(
RG)
is
submitting
this
interim
report
describing
the
progress
of
the
testing
program
set
forth
in
the
Alternative
Tier
2
provisions
of
the
testing
regulation.

In
the
January
1,
2003
 
July
15,
2004
period
since
submitting
Interim
Progress
Report
#
9
to
the
Agency,
the
RG
has
accomplished
the
following:

1.
Toxicology
Testing1
Baseline
Gasoline
Vapor
Condensate
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
 
Revisions
to
the
first
draft
report
in
response
to
EPA
and
independent
peer
reviewers
comments
completed.
These
revisions
included
revised/
additional
statistical
evaluations
as
agreed
between
EPA
and
the
RG.
Second
draft
report
submitted
to
the
EPA
for
review
and
acceptance.
Agency
response
to
this
second
draft
will
be
used
to
guide
the
RG
actions
on
remaining
subchronic
reports
which
also
required
the
same
enhancement
of
statistical
evaluation.
The
RG
does
not
anticipate
receiving
any
additional
Agency
or
independent
peer
reviewer
comments
on
the
reports
for
the
Gasoline/
MTBE,
Gasoline/
Ethanol,
Gasoline/
TAME,
and
Gasoline/
ETBE
subchronic
reports.
Accordingly,
they
too
will
be
finalized
pending
acceptance
of
the
Baseline
Gasoline
report.
 
Two­
generation
reproductive
study
 
Revisions
to
draft
report
are
in
progress
in
response
to
EPA
and
independent
peer
reviewer
comments.

1
All
studies
conducted
in
rats,
unless
otherwise
noted
1220
L
Street,
Northwest
Washington,
DC
20005­
4070
Tel
202­
682­
8344
Fax
202­
682­
8270
E­
mail
twerdokl@
api.
org
Lorraine
E.
Twerdok,
Ph.
D.,
DABT
Manager,
Health
Sciences
Suzanne
Rudzinski
July
30,
2004
Page
2
of
6
 
Rat
and
mouse
developmental
toxicity
studies
(
2)
­
Revisions
to
draft
reports
are
in
progress
in
response
to
EPA's
and
independent
peer
reviewer
comments.
 
Chronic
study
 
Preparation
of
draft
report
in
progress.

Gasoline/
MTBE
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Revisions
to
draft
report
are
in
progress
in
response
to
EPA
and
independent
peer
reviewer
comments.
 
Two­
generation
reproductive
study­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Rat
and
mouse
developmental
toxicity
studies
(
2)
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Chronic
 
Preparation
of
draft
report
in
progress.

Gasoline/
Ethanol
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Revisions
to
draft
report
are
in
progress
in
response
to
EPA
and
independent
peer
reviewer
comments.
 
One­
generation
reproductive
toxicity
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Developmental
toxicity
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
was
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.

Gasoline/
TAME
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Revisions
to
draft
report
are
in
progress
in
response
to
EPA
and
independent
peer
reviewer
comments.
 
One­
generation
reproductive
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Developmental
toxicity
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.

Gasoline/
ETBE
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Revisions
to
draft
report
are
in
progress
in
response
to
EPA
and
independent
peer
reviewer
comments.
 
One­
generation
reproductive
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Developmental
toxicity
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
Suzanne
Rudzinski
July
30,
2004
Page
3
of
6
Gasoline/
DIPE
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Draft
report
was
received
and
circulated
to
the
EPA,
RG
Toxicology
Committee
and
Independent
Peer
Reviewers
for
comments.
 
One­
generation
reproductive
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Developmental
toxicity
study
 
Due
to
the
planned
closure
of
the
laboratory
(
ExxonMobil
BioSciences,
Inc.)
that
conducted
the
first
(
flawed)
study,
a
second
laboratory
(
Huntingdon
Life
Sciences)
was
selected
to
conduct
the
repeat
study.

Gasoline/
TBA
Vapor
Condensate:
 
Subchronic
study
(
with
GFAP,
genotoxicity
and
immunotoxicity)
­
Preparation
of
draft
report
in
progress.
 
One­
generation
reproductive
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Developmental
toxicity
study
­
Independent
peer
reviewer
comments,
and
RG
response
to
those
comments
were
submitted
to
the
EPA.
RG
now
awaiting
EPA
comments
on
draft
report.
 
Pharmacokinetic
Studies
on
DIPE,
ETBE,
and
TBA:
 
The
Research
Triangle
Institute
contract
to
conduct
the
studies
was
completed.

2.
Exposure
Screening
Studies
Winter
field
sampling
in
the
Atlanta
and
Chicago
areas
was
concluded.
Sexsmith
Consulting
Services,
LLC,
conducted
a
field
audit
of
the
Atlanta
sampling
effort.

As
requested
by
ORD,
an
interim
data
report
for
the
2002
summer
Houston
and
San
Antonio
sampling
study
was
forwarded
to
EPA.
An
interim
data
report
for
the
2003
summer
sampling
study
in
Atlanta
and
Chicago
was
provided
to
EPA.
A
revised
sampling
schedule
for
summer
Houston
and
San
Antonio
study
and
responses
to
ORD
May,
2004
comments
on
the
2002
Houston
and
San
Antonio
report
were
sent
to
EPA.

In
response
to
a
recent
ORD
request,
the
RG
agreed
to
expand
the
2004
summer
Houston
resampling
study
to
include
all
microenvironments.
The
expanded
summer
Houston
resampling
study
should
begin
in
July
2004.
Responses
to
ORD
comments
on
the
2003
summer
Atlanta­
Chicago
interim
data
report
are
being
prepared.
Suzanne
Rudzinski
July
30,
2004
Page
4
of
6
3.
Miscellaneous
Activities
A
schedule
for
toxicology
draft
reports
due
for
submission
over
the
next
six
months
(
i.
e.,
July
 
December
2004)
is
attached
to
this
progress
report.
This
schedule
is
organized
by
month
draft
reports
are
due,
rather
than
by
test
material.

Please
feel
free
to
contact
me
with
any
questions
you
may
have
regarding
this
information.

Sincerely,

Lorraine
E.
Twerdok,
Ph.
D.,
D.
A.
B.
T.
Manager,
Health
Sciences
Cc:
Joe
Sopata,
EPA
(
via
email)
Monica
Alvarez,
EPA
(
via
email)
Mike
Davis,
EPA
(
via
email)
Stan
Durkee,
EPA
(
via
email)
Tom
Goldsworthy
(
via
email)
Rich
Schlesinger
(
via
email)
211b
Oversight
and
Technical
Committees
211b
Consortium
Members
at
Large
Suzanne
Rudzinski
July
30,
2004
Page
5
of
6
API
Staff
Contacts
for
211(
b)
Research
Group
Activities
Program
Manager
Lorraine
Twerdok
202/
682­
8344
twerdokl@
api.
org
Administrative
Coordinator
Paula
Podhasky
202/
682­
8333
podhaskyp@
api.
org
Toxicology
Report
Coordinator
Matt
Todd
202/
682­
8319
toddm@
api.
org
Toxicologists
Lorraine
Twerdok
202/
682­
8344
twerdokl@
api.
org
Tom
Gray
202/
682­
8480
grayt@
api.
org
Exposure
Assessment
Scientist
Will
Ollison
202/
682­
8262
ollisonw@
api.
org
Financials
Elsie
Barbaza
202/
682­
8329
barbaza@
api.
org
Legal
Alice
Crowe
202/
682­
8249
crowe@
api.
org
Suzanne
Rudzinski
July
30,
2004
Page
6
of
6
CAA
 
211(
b)
Alternative
Tier
II
Toxicity
Study
Draft
Report
Schedule
Draft
Report
Due
to
API
Test
Material
Study
August
2004
Gasoline/
TBA
Vapor
Condensate
Subchronic
August
2004
Gasoline/
MTBE
Vapor
Condensate
Carcinogenicity
September
2004
Baseline
Gasoline
Vapor
Condensate
Carcinogenicity
