Document ID: EPA-HQ-OPP-2004-0317-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-02-04T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
November
23,
2004
MEMORANDUM
SUBJECT:
PHASE
2
OF
THE
INTERIM
PUBLIC
PARTICIPATION
PROCESS.
The
Health
Effects
Division's
Response
to
Comments
on
EPA's
FQPA
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
for
Flumetsulam
09/
04.
PC
Code:
129016,
DP
Barcode
D306237,
TXR
0052949.

FROM:
Elissa
Reaves,
Ph.
D.
Toxicologist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

TO:
Mika
Hunter,
Chemical
Review
Manager
Special
Review
Branch
Special
Review
and
Reregistration
Division
(
7504C)

The
attached
document
titled,
"
HED's
Response
to
Comments
for
Flumetsulam,"
was
generated
in
the
Phase
2
Period
of
the
Interim
Public
Participation
Process
(
FR
Notice
09/
24/
04)
to
address
comments
submitted
by
Dow
AgroSciences
(
DAS)
to
the
Agency
following
the
Phase
1
Period
of
the
FQPA
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
on
Flumetsulam
09/
04.
The
attached
document
is
the
Agency's
Health
Effects
Division's
(
HED)
response
to
those
comments.
This
response
includes
input
from
Samual
Ary
(
Residue
Chemistry
and
Dietary
Assessment)
and
Elissa
Reaves
(
Toxicology).
1
November
23,
2004
HED'S
RESPONSE
TO
COMMENTS
FOR
FLUMETSULAM
I.
Introduction
The
following
is
HED's
response
to
comments
on
the
TRED
for
flumetsulam,
generated
in
response
to
the
comments
submitted
to
the
public
docket
by
Dow
AgroSciences
(
DAS)
in
Phase
2
of
the
Interim
Public
Participation
Process.
Some
of
the
responses
serve
as
clarification
or
a
restatement
of
Agency
policies
and
guidance
and
it
is
hoped
that
this
will
provide
a
greater
understanding
of
the
Agency's
position
and
procedures
on
these
matters.
During
Phase
1,
The
Agency's
TRED
on
flumetsulam
was
posted
along
with
support/
background
information
in
the
Federal
Register
on
September
24,
2004
under
Docket
Detail
OPP­
2004­
0317;
FRL­
7680­
7.
The
registrant
was
given
30
days
to
respond
to
error
correction
to
the
Agency
in
writing.
Comments
concerning
the
rationale
behind
Agency
decisions
on
endpoint
selection,
an
error
for
a
referenced
feeding
study;
and
a
chronic
dietary
risk
expression
were
submitted.

Responses
to
specific
issues
raised
in
the
comments
can
be
found
below.

II.
Analytical
and
Residue
Chemistry
Dow
AgroSciences
has
no
corrections
or
comments
on
this
document.

III.
Dietary
(
Food)
Assessment
Rationale
behind
the
chronic
dietary
risk
expressed
as
"<
1%
of
the
cPAD".

HED
acknowledges
that
the
risk
is
<
0.01%
of
the
cPAD
for
chronic
dietary
exposure
assessment.
However,
it
is
current
HED
policy
to
report
findings
as
less
than
1%
when
results
are
1%
or
less.
Therefore,
"<
1%
of
the
cPAD"
will
remain
in
the
TRED.

IV.
Toxicology
Toxicology
Endpoint
for
Inhalation
Exposure;
The
endpoint(
s)
for
short­
term
studies
are
based
on
the
same
chronic
feeding
dog
study
(
MRID
41952103)
as
used
to
determine
intermediate
and
long­
term
(>
6
months)
endpoints.

HED
acknowledges
that
a
90­
day
oral
toxicity
study
both
in
the
rat
and
mouse
are
available
for
flumetsulam.
However,
based
on
the
toxicological
profile
for
flumetsulam,
the
dog
is
the
most
sensitive
species
with
the
most
robust
response
to
compound
exposure.
The
NOAEL
for
the
90­
day
rat
and
mouse
studies
are
250
mg/
kg/
day
and
5000
mg/
kg/
day,
respectively.
The
NOAEL
2
November
23,
2004
for
the
chronic
dog
study
is
100
mg/
kg/
day,
and
therefore,
yields
the
most
health
protective
dose
for
all
durations
of
the
inhalation
risk
assessment.
The
chronic
dog
study
is
therefore
acceptable
for
all
durations
of
the
inhalation
risk
assessment.

A
Developmental
Study
Referenced
as
A
Rat
Study
is
Actually
a
Rabbit
Study;
and
Reference
to
Several
Errors
in
an
Associated
Data
Table.

The
developmental
study
(
MRID
412623213/
41615301)
in
the
Toxicology
Profile
Table
of
the
flumetsulam
TRED
document
is:
1)
an
acceptable/
guideline
Rat
study
with
dose
levels
of
0,
100,
500,
or
1000
mg/
kg/
day;
2)
the
test
species
according
to
the
submitted
study
is
Fischer
344
Rats;
3)
the
gestation
days
are
GD
6­
15
and
not
GD
7­
19;
4)
the
maternal
NOAEL
is
500
mg/
kg/
day
and
not
5000
mg/
kg/
day;
and
5)
effects
on
the
cecum
and
kidney
weights
were
established
at
1000
mg/
kg/
day
and
not
5000
mg/
kg/
day.
These
errors
will
be
corrected
in
the
Toxicology
Profile
Table.

V.
Drinking
Water
Assessment
Dow
AgroSciences
has
no
corrections
or
comments
on
this
document.

VI.
FQPA
Assessment
Dow
AgroSciences
has
no
corrections
or
comments
on
this
document.