Document ID: EPA-HQ-OPP-2004-0317-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-09T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
August
30,
2004
Subject:
Flumetsulam.
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.

DP
Barcode:
D306279
PC
Code:
129016
Chemical
Class:
Triazolopyrimidine
40
CFR
§
:
180.468
From:
Samuel
Ary,
Chemist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

Through:
Sherrie
Kinard,
Chemist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

William
Hazel,
Branch
Chief
(
Acting)
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

To:
Elissa
Reaves,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
2
of
8
Executive
Summary
A
chronic
dietary
(
food
and
water)
risk
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
2.03),
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994
to
1996
and
1998.
The
analysis
was
performed
to
support
the
tolerance
reassessment
eligibility
decision
for
current
uses
and
to
support
the
proposed
tolerance
in/
on
dry
beans
(
Petition
Number:
7F4851).
The
chronic
dietary
exposure/
risk
analysis
was
conducted
using
current
and
proposed
tolerance
values
for
corn
(
forage,
grain,
and
stover),
soybean,
and
dry
beans.

A
conservative
chronic
dietary
(
food
and
water)
assessment
was
performed
using
DEEM­
FCID
 
.
Tolerance
level
residues,
default
processing
factors,
100%
crop
treated,
and
the
highest
estimated
chronic
drinking
water
concentration
were
used
to
conduct
this
Tier
1
(
unrefined)
assessment.
Dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
commodities,
the
chronic
dietary
exposure
estimates
are
below
the
Health
Effects
Division's
(
HED)
level
of
concern
for
all
population
subgroups
at
less
than
1%
of
the
cPAD.

I.
Introduction
Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
For
acute
and
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
a
maximum
acceptable
dose
(
i.
e.,
the
dose
which
HED
has
concluded
will
result
in
no
unreasonable
adverse
health
effects).
This
dose
is
referred
to
as
the
population­
adjusted
dose
(
PAD).
The
PAD
is
equivalent
to
the
reference
dose
(
RfD)
divided
by
the
special
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor.

For
non­
cancer
chronic
exposures,
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
cPAD.
HED
is
generally
concerned
when
estimated
cancer
risk
exceeds
one
in
one
million
(
i.
e.,
the
risk
exceeds
1
x
10­
6).
References
which
discuss
chronic
risk
assessments
in
more
detail
are
available
on
the
EPA
pesticides
web
site:
"
Available
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide,"
June
21,
2000,
web
link:
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf;
or
see
SOP
99.6
(
8/
20/
99).

II.
Residue
Information
Flumetsulam,
N­(
2,6­
difluorophenyl)­
5­
methyl­(
1,2,4)­
triazolo­[
1,5a]­
pyrimidine­
2­
sulfonamide,
is
a
herbicide
in
the
triazolopyrimidine
chemical
class.
The
mode
of
action
of
flumetsulam
is
similar
to
the
sulfonylurea
herbicides,
which
are
acetolactate
synthase
(
ALS)
inhibitors.

Tolerances
have
been
established
under
40
CFR
§
180.468
for
residues
of
flumetsulam
in/
on
field
corn
(
forage,
grain,
and
stover)
and
soybean
at
0.05
ppm.
A
tolerance
of
0.05
ppm
for
dry
beans
is
also
being
proposed.
The
nature
of
residues
in
corn
and
soybeans
is
adequately
delineated
based
on
acceptable
plant
metabolism
studies.
The
HED
Metabolism
Committee
concluded
that
the
residue
of
concern
resulting
from
the
uses
on
field
corn
and
soybeans
is
flumetsulam
per
se
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
3
of
8
(
N.
Dodd,
HED
Metabolism
Committee
Memo,
4/
16/
93
and
N.
Dodd,
Metabolism
Committee
Memo,
4/
26/
93).
Plant
metabolism
studies
for
dry
beans
have
not
been
submitted;
however,
metabolism
data
from
soybeans
may
be
translated
to
dry
beans
because
of
the
similarities
between
the
two
crops.

The
HED
Metabolism
Committee
has
not
determined
the
residue
of
concern
in
livestock;
however,
based
on
the
submitted
data,
the
nature
of
the
residue
in
livestock
(
goats
and
hens)
is
adequately
defined
because
no
detectable
residues
of
flumetsulam
per
se
were
found
in
feed
items.

A
summary
of
the
flumetsulam
tolerance
reassessment
for
field
corn
and
soybeans
and
the
assessment
of
the
proposed
tolerance
for
dry
beans
is
presented
in
Table
1.

Table
1.
Tolerance
Summary
for
Flumetsulam.

Commodity
Established/
Proposed
Tolerance
(
ppm)
Recommended
Tolerance
(
ppm)
Comments
(
correct
commodity
definition)

Corn,
field,
forage
0.05
(
established)
0.05
None
Corn,
field,
grain
0.05
(
established)
0.05
None
Corn,
field,
stover
0.05
(
established)
0.05
None
Soybean
0.05
(
established)
0.05
None
Bean,
dry
0.05
(
proposed)
0.05
None
III.
Drinking
Water
Data
The
values
used
in
the
dietary
risk
assessment
were
provided
by
the
Environmental
Fate
and
Effects
Division
(
EFED)
in
the
following
memo:
"
Drinking
Water
Assessment
for
Flumetsulam
for
Uses
on
Field
Corn
and
Soybeans"
(
J.
Lin
and
S.
Syslo,
D301361,
5/
19/
04).
Water
residues
were
incorporated
in
the
DEEM­
FCID
 
into
the
food
categories
"
water,
direct,
all
sources"
and
"
water,
indirect,
all
sources".

The
estimated
drinking
water
concentrations
from
surface
water
sources
were
calculated
using
Tier
II
PRZM
(
Pesticide
Root
Zone
Model)
and
EXAMS
(
Exposure
Analysis
Modeling
System).
Based
on
the
modeling
results
for
surface
water
derived
drinking
water,
the
Mississippi
corn
scenario
predicts
the
highest
one
in
ten
year
peak
concentration
of
2.03
ppb,
whereas
the
North
Dakota
corn
scenario
gives
the
highest
one
in
ten
year
annual
mean
concentration
of
0.59
ppb,
and
overall
annual
mean
concentration
of
0.34
ppb.

The
estimated
ground
water
concentrations
were
calculated
using
the
Tier
I
SCI­
GROW
(
Screening
Concentration
In
Ground
Water)
model.
The
estimated
chronic
drinking
water
concentration
from
ground
water
sources
is
0.823
ppb.
The
highest
chronic
drinking
water
concentration
(
0.823
ppb)
was
used
for
the
dietary
analysis.

IV.
DEEM­
FCID
 
Program
and
Consumption
Information
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
4
of
8
A
chronic
dietary
exposure
assessment
was
conducted
for
flumetsulam
using
DEEM­
FCID
 
,
Version
2.03,
which
incorporates
consumption
data
from
USDA's
CSFII,
1994­
1996
and
1998.
The
1994­
96,
98
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
EPAdefined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
For
chronic
exposure
assessments,
consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups.
Based
on
analysis
of
the
1994­
96,
98
CSFII
consumption
data,
which
took
into
account
dietary
patterns
and
survey
respondents,
HED
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(
less
than
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
adults
20­
49,
females
13­
49,
and
adults
50+
years
old.

For
chronic
dietary
exposure
assessment,
an
estimate
of
the
residue
level
in
each
food
or
foodform
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form
to
produce
a
residue
intake
estimate.
The
resulting
residue
intake
estimate
for
each
food/
food
form
is
summed
with
the
residue
intake
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.

V.
Toxicological
Information
On
March
24,
1993,
the
HED
RfD/
Peer
Review
Committee
evaluated
the
toxicology
database
for
flumetsulam
and
selected
Reference
Doses
(
RfDs)
and
toxicological
endpoints
for
acute
and
chronic
dietary
exposure
risk
assessments
(
G.
Ghali,
RfD/
Peer
Review
Committee
Memo,
3/
24/
93).
There
are
no
studies
that
identify
an
acute
hazard
based
on
toxic
effects
observed
following
a
single
oral
exposure
(
dose)
of
flumetsulam.
Therefore,
a
dose
and
endpoint
are
not
proposed
for
the
general
population
including
infants
and
children
or
females
13­
49
years
of
age.
Flumetsulam
has
been
classified
as
a
"
Group
E"
pesticide
(
evidence
of
non­
carcinogenicity
to
humans).
The
toxicity
endpoints
pertinent
for
human
risk
assessment
are
summarized
below
in
Table
2
(
E.
Reaves,
D306277,
8/
31/
04).

Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Flumetsulam.

Exposure
Scenario
Dose
(
mg/
kg/
day)
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Endpoint
for
Risk
Assessment
Acute
Dietary
(
Females
13­
50
years
of
age)
Not
applicable.
No
hazard
identified.
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Flumetsulam.

Exposure
Scenario
Dose
(
mg/
kg/
day)
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Endpoint
for
Risk
Assessment
5
of
8
Acute
Dietary
(
General
population
including
infants
and
children)
Not
applicable.
No
hazard
identified.

Chronic
Dietary
(
All
populations)
NOAEL=
100
mg/
kg/
day
UF
=
100
Chronic
RfD
=
1
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
1
mg/
kg/
day
Chronic
feeding,
dog
LOAEL
=
500
mg/
kg/
day
based
on
renal
inflammatory
and
atrophic
changes
secondary
to
renal
calculi
and
hepatic
effects
(
inflammation,
focal
necrosis,
biliary
stasis)

Cancer
(
oral,
dermal,
inhalation)
Flumetsulam
is
classified
as
Group
E
(
Evidence
of
non­
carcinogenicity
for
humans)
(
6/
23/
93).
Not
mutagenic.

UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose,
RfD
=
reference
dose.

VI.
Results/
Discussion
As
stated
above,
for
a
chronic
assessment,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
cPAD.
The
DEEM­
FCID
 
analysis
estimates
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
chronic
dietary
exposure
analysis
results
reported
in
Table
3
for
the
general
U.
S.
population,
all
infants
(
less
than
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
females
13­
49,
adults
20­
49,
and
adults
50+
years.
The
resulting
food
exposure
estimates
are
below
HED's
level
of
concern
for
all
population
subgroups,
less
than
1%
of
the
cPAD.

Table
3.
Summary
of
Chronic
Dietary
(
food
and
water)
Exposure
and
Risk
for
Flumetsulam.

Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
1
0.000113
less
than
1
All
Infants
(
less
than
1
year
old)
0.000219
less
than
1
Children
1­
2
years
old
0.000223
less
than
1
Children
3­
5
years
old
0.000244
less
than
1
Children
6­
12
years
old
0.000181
less
than
1
Youth
13­
19
years
old
0.000135
less
than
1
Adults
20­
49
year
old
0.000094
less
than
1
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
Table
3.
Summary
of
Chronic
Dietary
(
food
and
water)
Exposure
and
Risk
for
Flumetsulam.

Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
6
of
8
Adults
50+
years
old
0.000066
less
than
1
Females
13­
49
year
old
0.000092
less
than
1
VII.
Conclusions
A
chronic
dietary
(
food
and
water)
risk
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
2.03),
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
The
analysis
was
performed
to
support
the
tolerance
reassessment
eligibility
decision
for
current
uses
and
to
support
the
proposed
tolerance
in/
on
dry
beans
(
Petition
Number:
7F4851).
The
chronic
dietary
exposure/
risk
analysis
was
conducted
using
current
and
proposed
tolerance
values
for
corn
(
forage,
grain,
and
stover),
soybean,
and
dry
beans.
Also,
default
processing
factors,
100%
crop
treated
for
all
commodities,
and
the
highest
estimated
chronic
drinking
water
concentration
were
used
to
conduct
this
Tier
1
(
unrefined)
assessment.

This
assessment
concludes
that
for
all
supported
commodities,
the
chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
all
population
subgroups
at
less
than
1%
of
the
cPAD.

VI.
List
of
Attachments
Attachment
1.
Chronic
Residue
Input
File.
Attachment
2.
Chronic
Results
File.
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
7
of
8
RDI:
S.
Ary
(
8/
24/
04);
S.
Kinard
(
8/
27/
04);
W.
Hazel
(
8/
30/
04).

Attachment
1.
Chronic
Food
Residue
Input
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FLUMETSULAM
1994­
98
data
Residue
file:
C:\
Documents
and
Settings\
sary\
Desktop\
Flumetsulam\
flumetsulam.
chronic.
R98
Adjust.
#
2
NOT
used
Analysis
Date
08­
30­
2004
Residue
file
dated:
08­
30­
2004/
17:
14:
27/
8
Reference
dose
(
RfD)
=
1
mg/
kg
bw/
day
Comment:
Food
and
Water
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
06030300
6C
Bean,
black,
seed
0.050000
1.000
1.000
06030320
6C
Bean,
broad,
seed
0.050000
1.000
1.000
06030340
6C
Bean,
cowpea,
seed
0.050000
1.000
1.000
06030350
6C
Bean,
great
northern,
seed
0.050000
1.000
1.000
06030360
6C
Bean,
kidney,
seed
0.050000
1.000
1.000
06030380
6C
Bean,
lima,
seed
0.050000
1.000
1.000
06030390
6C
Bean,
mung,
seed
0.050000
1.000
1.000
06030400
6C
Bean,
navy,
seed
0.050000
1.000
1.000
06030410
6C
Bean,
pink,
seed
0.050000
1.000
1.000
06030420
6C
Bean,
pinto,
seed
0.050000
1.000
1.000
15001200
15
Corn,
field,
flour
0.050000
1.000
1.000
15001201
15
Corn,
field,
flour­
babyfood
0.050000
1.000
1.000
15001210
15
Corn,
field,
meal
0.050000
1.000
1.000
15001211
15
Corn,
field,
meal­
babyfood
0.050000
1.000
1.000
15001220
15
Corn,
field,
bran
0.050000
1.000
1.000
15001230
15
Corn,
field,
starch
0.050000
1.000
1.000
15001231
15
Corn,
field,
starch­
babyfood
0.050000
1.000
1.000
15001240
15
Corn,
field,
syrup
0.050000
1.000
1.000
15001241
15
Corn,
field,
syrup­
babyfood
0.050000
1.000
1.000
15001250
15
Corn,
field,
oil
0.050000
1.000
1.000
15001251
15
Corn,
field,
oil­
babyfood
0.050000
1.000
1.000
06003470
6
Soybean,
seed
0.050000
1.000
1.000
06003480
6
Soybean,
flour
0.050000
1.000
1.000
06003481
6
Soybean,
flour­
babyfood
0.050000
1.000
1.000
06003490
6
Soybean,
soy
milk
0.050000
1.000
1.000
06003491
6
Soybean,
soy
milk­
babyfood
or
in
0.050000
1.000
1.000
06003500
6
Soybean,
oil
0.050000
1.000
1.000
06003501
6
Soybean,
oil­
babyfood
0.050000
1.000
1.000
86010000
O
Water,
direct,
all
sources
0.000823
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.000823
1.000
1.000
Flumetsulam
Dietary
Exposure
Assessment
DP
Barcode:
306279
8
of
8
Attachment
2.
Chronic
Results
File.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FLUMETSULAM
(
1994­
98
data)
Residue
file
name:
C:\
Documents
and
Settings\
sary\
Desktop\
Flumetsulam\
flumetsulam.
chronic.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
08­
30­
2004/
17:
14:
54
Residue
file
dated:
08­
30­
2004/
17:
14:
27/
8
Reference
dose
(
RfD,
Chronic)
=
1
mg/
kg
bw/
day
COMMENT
1:
Food
and
Water
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000113
0.0%

U.
S.
Population
(
spring
season)
0.000114
0.0%
U.
S.
Population
(
summer
season)
0.000117
0.0%
U.
S.
Population
(
autumn
season)
0.000110
0.0%
U.
S.
Population
(
winter
season)
0.000110
0.0%

Northeast
region
0.000098
0.0%
Midwest
region
0.000118
0.0%
Southern
region
0.000113
0.0%
Western
region
0.000120
0.0%

Hispanics
0.000139
0.0%
Non­
hispanic
whites
0.000108
0.0%
Non­
hispanic
blacks
0.000122
0.0%
Non­
hisp/
non­
white/
non­
black
0.000112
0.0%

All
infants
(<
1
year)
0.000219
0.0%
Nursing
infants
0.000070
0.0%
Non­
nursing
infants
0.000275
0.0%
Children
1­
6
yrs
0.000232
0.0%
Children
7­
12
yrs
0.000175
0.0%

Females
13­
19
(
not
preg
or
nursing)
0.000118
0.0%
Females
20+
(
not
preg
or
nursing)
0.000077
0.0%
Females
13­
50
yrs
0.000101
0.0%
Females
13+
(
preg/
not
nursing)
0.000097
0.0%
Females
13+
(
nursing)
0.000105
0.0%

Males
13­
19
yrs
0.000152
0.0%
Males
20+
yrs
0.000091
0.0%
Seniors
55+
0.000064
0.0%

Children
1­
2
yrs
0.000223
0.0%
Children
3­
5
yrs
0.000244
0.0%
Children
6­
12
yrs
0.000181
0.0%
Youth
13­
19
yrs
0.000135
0.0%
Adults
20­
49
yrs
0.000094
0.0%
Adults
50+
yrs
0.000066
0.0%
Females
13­
49
yrs
0.000092
0.0%