Document ID: EPA-HQ-OPP-2002-0329-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-12-06T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
December
18,
2001
SUBJECT:
Asulam.
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED);
PC
codes
106901;
DP
Barcode
D279592.

FROM:
José
J.
Morales,
Chemist
Reregistration
Branch
III
Health
Effects
Division
(
7509C)

THROUGH:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
III
Health
Effects
Division
(
7509C)

and
Chemistry
Science
Advisory
Council
(
Chem
SAC)
Health
Effects
Division
(
7509C)

and
Jennifer
Tyler
Sherrie
Kinard
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
Health
Effects
Division
(
7509C)

TO:
Demson
Fuller,
Chemical
Review
Manager
Reregistration
Branch
I
Special
Review
and
Reregistration
Division
(
7508C)
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

1
EPA
Reviewer:
,
Date
STUDY
TYPE:
Asulam.
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED).

ACTIVE
INGREDIENT:
Sodium
Asulam
SYNONYMS:
Asulox
®
RESIDUE
OF
CONCERN:
The
qualitative
nature
of
the
residue
in
plants
is
adequately
understood
based
on
sugarcane
metabolism
studies.
The
terminal
residues
of
concern
are
free
and
conjugated
asulam,
sulfanilamide,
N4­
acetylasulam,
and
N4­
acetylsulfanilamide
determined
as
a
common
moiety.

The
qualitative
nature
of
the
residue
in
animals
is
adequately
understood
based
on
acceptable
poultry
and
ruminant
metabolism
studies.
The
terminal
residues
of
concern
are
free
and
conjugated
asulam,
sulfanilamide,
N4­
acetylasulam,
and
N4­
acetylsulfanilamide
determined
as
a
common
moiety.

Executive
Summary
A
chronic
dietary
exposure
assessment
was
requested
to
determine
the
dietary
exposure
estimates
associated
with
the
use
of
asulam
in/
on
sugarcane
to
support
the
Tolerance
Reassessment
Eligibility
Document.
Sugarcane
is
the
only
registered
use
for
this
chemical.

Anticipated
residues
were
calculated
using
field
trial
data.
No
monitoring
data
exist
for
asulam.
In
addition,
estimates
of
percent
crop
treated
(%
CT)
generated
by
BEAD
were
used
to
refine
the
assessment.

Risk
estimates
were
generated
for
chronic
(
longer­
term)
dietary
exposure
using
the
most
recent
version
of
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
,
Version
7.73),
and
toxicological
doses
and
endpoints
selected
by
the
HED
Hazard
Identification
Assessment
Review
Committee
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

2
(
HIARC)
for
asulam
risk
assessments.
The
committee
did
not
select
an
acute
dietary
endpoint
for
asulam.

A
refined
Tier
2/
3
chronic
dietary
risk
assessment
was
conducted
for
all
supported
(
i.
e.,
currently
registered
and
proposed)
asulam
food
uses.
Dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
commodities,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
cPAD1)
for
the
general
U.
S.
population
(<
1%
of
the
cPAD)
and
all
population
subgroups.
The
chronic
dietary
exposure
estimate
for
children
1­
6
years
[
highest
exposed
population
subgroup]
is
1%
of
the
cPAD.

I.
Introduction
Exposure
to
pesticides
can
occur
through
food,
water,
residential
and
occupational
means.
Risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
The
risk
is
expressed
as
a
percentage
of
a
dose
that
could
be
expressed
as
a
daily
or
a
long
term
dose,
to
pose
no
unreasonable
adverse
effects.
This
is
called
the
population
adjusted
dose
(
PAD),
and
is
expressed
as
%
PAD.
References
are
available
on
the
EPA/
pesticides
web
site
which
discuss
the
acute
and
chronic
risk
assessments
in
more
detail:
"
Available
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide",
6/
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.

The
purpose
of
this
memorandum
is
to
summarize
the
results
of
the
dietary
risk
assessment
for
the
general
U.
S.
population
and
various
population
subgroups
resulting
from
exposure
to
asulam
through
food.
This
risk
assessment
is
the
first
dietary
risk
analysis
that
has
been
conducted
for
asulam
under
FQPA.
A
previous
chronic
dietary
risk
assessment
was
done
by
the
former
Science
Analysis
Branch
in
HED
using
DRES
(
E.
Doyle,
1/
3/
95,
no
DP
Barcode).

II.
Toxicological
Information
In
a
previous
meeting
(
March
19,
1998),
the
Health
Effects
Division's
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
met
to
evaluate
the
toxicology
data
base
for
asulam
and
to
select
doses
and
endpoints
for
the
human
health
risk
assessment.
The
HIARC
met
again
on
November
13,
2001
for
a
revisit
of
asulam
for
toxicological
endpoint
selection
for
use
in
occupational/
residential
exposure
risk
assessments.
In
addition,
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
asulam
was
re­
evaluated.

The
FQPA
Safety
Factor
Committee
met
on
12/
10/
01
to
evaluate
both
the
hazard
and
exposure
databases
and
recommended
that
the
10x
FQPA
Safety
Factor
for
asulam
be
retained.
A
summary
of
the
doses
and
endpoints
relevant
to
dietary
exposure
assessment
are
presented
in
Table
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

3
I.

Table
I.
Summary
of
Toxicological
Dose
and
Endpoints
for
Asulam
for
Use
in
Dietary
Exposure
Assessment
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
An
appropriate
endpoint
attributable
to
a
single
dose
was
not
identified.

Chronic
Dietary
all
populations
NOAEL=
[
36
]
mg/
kg/
day
UF
=
[
100
]
Chronic
RfD
=
[
0.36
]
mg/
kg/
day
FQPA
SF
=
[
10x
]
cPAD
=
chronic
RfD
/
FQPA
SF
=
[
0.036
]
mg/
kg/
day
Combined
Chronic
Toxicity/
Oncogenicity
in
the
rat.
The
LOAEL
was
180
mg/
kg/
day
based
on
hyperplastic
changes
in
the
adrenal
medulla
and
in
thyroid
follicular
cells
of
males.

Cancer
The
Carcinogenicity
Peer
Review
Committee
classified
asulam
as
a
"
Group
C,"
possible
human
carcinogen.

III.
Residue
Information
Asulam
Use:

A
tolerance
is
established
for
negligible
residues
of
asulam
per
se
in/
on
sugarcane
at
0.1
ppm
[
40
CFR
§
180.360].
HED
has
recommended
that
the
tolerance
expression
be
revised
to
include
all
metabolites
containing
the
sulfanilamide
moiety.
An
adequate
enforcement
method
is
available
for
the
determination
of
combined
residues
of
asulam
and
all
metabolites
containing
the
sulfanilamide
moiety
in/
on
sugarcane.

HED's
recommendations
as
to
tolerance
reassessment
are
summarized
below:

Tolerance
Reassessment
for
Asulam
1.
The
existing
tolerance
of
0.1
ppm
for
asulam
residues
on
sugar
cane
established
in
40
CFR
§
180.360
has
been
reassessed.
HED
recommends
the
tolerance
be
raised
to
1.0
ppm;
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

4
2.
HED
recommends
a
tolerance
of
30
ppm
for
asulam
residues
in
molasses
from
sugar
cane
be
established
in
40
CFR
§
180.360;

3.
HED
recommends
a
tolerance
of
0.05
ppm
for
asulam
residues
in
milk,
and
meat
and
fat
from
cattle,
goats,
hogs,
horses,
and
sheep
be
established
in
40
CFR
§
180.360;

4.
HED
recommends
a
tolerance
of
0.2
ppm
for
asulam
residues
in
meat
byproducts
from
cattle,
goats,
hogs,
horses,
and
sheep
be
established
in
40
CFR
§
180.360;

5.
Because
there
are
no
poultry
feed
items
associated
with
asulam's
use,
tolerances
on
poultry
tissues
and
eggs
are
not
warranted.

Chronic
Assessment:

There
are
no
available
monitoring
data
for
asulam.
Residue
data
were
reviewed
in
the
following
document:

"
Asulam
(
List
A,
Case
0265,
Chemical
106901/
02).
Sugarcane
Field
Trials.
CBRS
No.
16299.
DP
Barcode
D219787.
S.
Funk.
2/
22/
96."

The
highest
residue
found
for
a
use
pattern
of
2
X
3.34
lbs.
a.
i./
A
and
a
100
day
PHI
is
0.213
ppm.
Correction
for
loss
in
storage
gives
a
residue
value
of
0.71
ppm.
Thus,
an
appropriate
tolerance
for
the
combined
residue
of
asulam
and
sulfanilamide­
containing
metabolites
in/
on
sugarcane
is
1
ppm.

Asulam
residues
concentrate
in
blackstrap
molasses
by
a
factor
of
about
48X
(
S.
Funk,
CBRS
None,
DP
Barcode
None,
01/
21/
95).
Molasses
is
considered
to
be
ready­
to­
eat
as
an
animal
feed
item.
Therefore,
a
tolerance
of
30
ppm
(
48
X
0.167
HAFT
ppm
/
0.30)
would
be
appropriate
for
asulam
residues
in
molasses
[
the
highest
average
field
trial
residue
(
2
X
3.34
lbs.
a.
i./
A,
100
day
PHI)
is
0.167
ppm,
and
this
value
is
corrected
for
70%
loss
in
storage].

Table
II
(
09/
95)
lists
"
molasses"
as
a
processed
commodity,
and
"
molasses"
encompasses
both
blackstrap
and
human
food
molasses.
Most
molasses
mixtures
are
prepared
from
A­
strike
sugar
and
would
be
expected
to
contain
pesticide
residue
equal
or
less
in
concentration
than
those
of
refined
sugar.
Because
Table
II
does
not
distinguish
animal
feed
blackstrap
from
human
molasses,
the
chronic
residue
value
calculated
for
blackstrap
should
be
used
in
dietary
exposure
analysis
for
human
molasses.

Sugarcane
and
sugarcane
molasses
are
considered
blended
commodities
(
HED
SOP
99.6,
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

5
8/
20/
99).

The
anticipated
residues
for
chronic
dietary
risk
assessment
are
presented
in
Table
II.

Table
II.
Asulam
Anticipated
Residues
for
Chronic
Dietary
Risk
Assessment
Commodity
Asulam
and
Sulfanilamide­
Containing
Metabolites
Existing
Tolerance
(
ppm)
Revised
Tolerance
(
ppm)
Chronic
Anticipated
Residue
(
ppm)

Sugar3
0.1
1
0.51
Molasses
None
30
242,4
1
The
average
of
the
average
residues
for
mainland
trials,
corrected
for
70%
loss,
or
0.126
/
0.30
=
0.42.
Percent
crop
treated
(
42%)
was
not
incorporated
in
the
calculations.
2
The
chronic
anticipated
residue
for
sugar
(
0.5
ppm)
multiplied
by
the
concentration
factor
for
processing
from
cane
to
blackstrap,
48,
or
48
X
0.5
=
24,
and
rounded
to
two
significant
figures.
Percent
crop
treated
(
42%)
was
not
incorporated
in
the
calculations.
3
No
significant
concentration
(
1
­
1.3X)
occurred
in
processing
cane
into
refined
sugar.
4
The
highest
average
field
trial
result
(
HAFT)
multiplied
by
the
48X
concentration
factor
for
the
conversion
of
cane
to
blackstrap
molasses.
Blackstrap
molasses,
defined
as
the
final
strike
residue
or
C
molasses
from
conventional
sugarcane
processing,
is
not
a
significant
human
food
item.
However,
these
values
should
be
used
for
human
molasses,
prepared
from
A­
strike
sugar.

Animal
Commodity
Tolerances
The
reassessed
tolerance
of
1
ppm
for
asulam
in
sugarcane
yields
a
maximum
ruminant
diet
of
4
ppm
asulam,
resulting
from
ingestion
of
molasses
(
10%
diet,
tolerance
30
ppm,
75%
dry
matter).

Based
on
the
5
ppm
feeding
study
level
(
See
Table
III
below)
and
the
results
of
the
animal
metabolism
study,
the
anticipated
residues
in
animal
commodities
are
summarized,
as
follows
in
Table
IV:
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

6
Table
III.
Asulam
Residues
from
Feeding
Study
Commodity
Asulam
and
Sulfanilamide­
Containing
Metabolites
5
ppm
Diet
(
1.2X)
50
ppm
Diet
(
12X)
20
ppm
Radiolabeled2
(
7
days)

Milk1
<
0.025
0.11
0.021
Fat
<
0.05
<
0.05
<
0.005
Kidney
0.12
0.34
0.162
Liver
<
0.05
0.08
0.090
Muscle
<
0.05
<
0.05
<
0.005
1
The
residue
plateaued
in
milk
on
day
13.
2
TRR,
including
all
radiolabeled
residue.

Table
IV.
Asulam
Anticipated
Residues
for
Animal
Commodities
Commodity
Asulam
and
Sulfanilamide­
Containing
Metabolites
Initial
Tolerance
(
ppm)
Reassesse
d
Tolerance
(
ppm)
Anticipated
Residue1
(
ppm)

Milk
None
0.05
0.025
Cattle,
meat
None
0.05
0.05
Cattle,
mbyp
None
0.2
0.12
Cattle,
fat
None
0.05
0.05
Goats,
meat
None
0.05
0.05
Goats,
mbyp
None
0.2
0.12
Goats,
fat
None
0.05
0.05
Hogs,
meat
None
0.05
0.05
Hogs,
mbyp
None
0.2
0.12
Hogs,
fat
None
0.05
0.05
Horses,
meat
None
0.05
0.05
Horses,
mbyp
None
0.2
0.12
[
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~

[
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/
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7
Horses,
fat
None
0.05
0.05
Sheep,
meat
None
0.05
0.05
Sheep,
mbyp
None
0.2
0.12
Sheep,
fat
None
0.05
0.05
1
Anticipated
residue
for
determination
of
human
dietary
risk.
Percent
crop
treated
(
42%)
was
not
incorporated
in
the
calculations.

Percent
Crop
Treated
Information:

Based
on
pesticide
usage
information
mainly
for
1992
through
2000
for
agriculture
and
1994
through
1999
for
non­
agriculture,
total
annual
domestic
usage
of
sodium
asulam
is
approximately
1.3
million
pounds
active
ingredient
(
a.
i.)
allocated
by
site
mainly
to
sugarcane
(
95%),
lawn
care
operators
and
sod
farms
(
2%
each)
and
institutional
turf
(
1%).
The
average
percent
crop
treated
for
sugarcane,
the
only
registered
agricultural
crop,
is
about
42%.
States
of
most
usage
are
Florida,
Louisiana
and
Texas
(
A.
Halvorson,
7/
25/
01).
This
information
was
incorporated
into
the
dietary
assessment.

IV.
DEEM
 
Program
and
Consumption
Information
Asulam
chronic
dietary
exposure
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
software
Version
7.73,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII),
1989­
1992.
The
1989­
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"
person
days"
of
data.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(
e.
g.,
apples­
cooked/
canned
or
wheat­
flour)
by
recipe
translation
files
internal
to
the
DEEM
software.
Consumption
data
are
averaged
for
the
entire
US
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.

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

HED
notes
that
there
is
a
degree
of
uncertainty
in
extrapolating
exposures
for
certain
population
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

8
subgroups
from
the
general
U.
S.
population
which
may
not
be
sufficiently
represented
in
the
consumption
surveys,
(
e.
g.,
nursing
and
non­
nursing
infants
or
Hispanic
females).
Therefore,
risks
estimated
for
these
population
subgroups
were
included
in
representative
populations
having
sufficient
numbers
of
survey
respondents
(
e.
g.,
all
infants
or
females,
13­
50
years).

V.
Results/
Discussion
Exposures
>
100%
of
the
cPAD
exceed
HED's
level
of
concern.
That
is,
estimated
exposures
above
this
level
are
of
concern,
while
estimated
exposures
at
or
below
this
level
are
not
of
concern.
The
DEEM
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
26
population
subgroups.
The
results
reported
in
Table
V
are
for
the
U.
S.
Population
(
total),
all
infants
(<
1
year
old),
children
1­
6,
children
7­
12,
females
13­
50,
males
13­
19,
males
20+,
and
seniors
55+
years
of
age.
The
results
for
the
other
population
subgroups
are
not
reported
in
Table
V.
This
is
because
the
numbers
of
respondents
in
the
other
subgroups
were
not
sufficient,
and
thus
the
exposure
estimates
for
these
subgroups
contained
higher
levels
of
uncertainty.
However,
the
respondents
in
these
subgroups
were
also
part
of
larger
subgroups
which
are
listed
in
Table
V.
For
example,
nursing
and
non­
nursing
infants
are
included
in
all
infants.
The
subgroups
which
are
broken
down
by
region,
season,
and
ethnicity
are
also
not
included.

Chronic
Dietary
Exposure
Analysis
Table
V.
Results
of
Chronic
Dietary
Exposure
Analysis
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
total)
0.036
0.000157
<
1%

All
Infants
(<
1
year)
0.036
0.000300
<
1%

Children
1­
6
years
0.036
0.000449
1%

Children
7­
12
years
0.036
0.000275
<
1%

Females
13­
50
years
0.036
0.000107
<
1%

Males
13­
19
years
0.036
0.000185
<
1%

Males
20+
years
0.036
0.000105
<
1%
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
9
Seniors
55+
years
0.036
0.000087
<
1%

VI.
Discussion
of
Uncertainties
This
tier
2/
3
dietary
risk
assessment
is
the
most
refined
to
date
for
asulam.
However,
there
are
some
uncertainties
associated
with
this
assessment
as
follows:

C
Residue
Issues
No
available
residue
data
exist
for
asulam.
The
anticipated
residues
were
calculated
using
field
trial
data.
The
anticipated
residues
were
adjusted
by
percent
crop
treated
data
provided
by
BEAD.
Tolerances
for
this
chemical
were
based
on
quantifiable
residues
found
in
the
field
trials.
Also,
the
residue
values
from
the
field
trials
were
adjusted
for
70%
loss
in
storage.
This
would
tend
to
overestimate
the
exposure
of
asulam
in
sugarcane.

Use
of
molassess
AR
in
the
assessment:
the
molassess
AR
is
based
on
residues
expected
in
the
animal
feed
"
black­
strap"
molassess.
These
residues
are
expected
to
overestimate
residues
in
human
food
molassess.

C
Processing
Factors
DEEM
default
processing
factors
for
dry
beef
were
used.

C
DEEM
Uncertainties
HED
notes
that
there
is
a
degree
of
uncertainty
in
extrapolating
exposures
for
certain
population
subgroups
which
may
not
be
sufficiently
represented
in
the
consumption
surveys,
(
e.
g.,
nursing
and
non­
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

10
nursing
infants
or
Hispanic
females).
Therefore,
risks
estimated
for
these
subpopulations
were
included
in
representative
populations
having
sufficient
numbers
of
survey
respondents
(
e.
g.,
all
infants
or
females,
13­
50
years).

VII.
Conclusions
A
Tier
2/
3
chronic
dietary
risk
assessment
was
conducted
for
all
supported
asulam
food
uses.
Dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(<
1%
of
the
cPAD)
and
all
population
subgroups.
The
chronic
dietary
exposure
estimate
for
children
1­
6
years
(
the
highest
exposed
population
subgroup)
is
1.2%
of
the
cPAD.

Table
VI.
Summary
of
Dietary
Exposure
and
Risk
for
Asulam
Population
Subgroup**
Chronic
Dietary
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
total)
0.000157
<
1%

All
Infants
(<
1
year)
0.000300
<
1%

Children
1­
6
years
0.000449
1%

Children
7­
12
years
0.000275
<
1%

Females
13­
50
0.000107
<
1%

Males
13­
19
0.000185
<
1%

Males
20+
years
0.000105
<
1%

Seniors
55+
0.000087
<
1%

cc:
Jose
Morales
(
RRB3),
RRB3
Reading
File
RDI:
C.
Eiden
(
12/
18/
01);
J.
Tyler
(
12/
18/
01);
S.
Kinard
(
12/
17/
01)
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

11
VIII.
Attachments
U.
S.
Environmental
Protection
Agency
Ver.
DEEM
Chronic
analysis
for
ASULAM
1989­
92
Residue
file:
C:\
My
DEEM\
Asulam\
chronic.
RS7
Adjust.
#
2
Analysis
Date
12­
10­
2001
Residue
file
dated:
12­
10­
2001/
15:
36:
Reference
dose
(
RfD)
=
0.036
mg/
kg
bw/
day
Comment:
Chronic
Run
for
the
TRED
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­
Food
Crop
RESIDUE
Adj.
Factors
Comment
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
283
O
Sugar­
cane
0.500000
1.000
0.420
284
O
Sugar­
cane/
molasses
13­
Baked
24.000000
1.000
0.420
98­
Refined
24.000000
1.000
0.420
318
D
Milk­
nonfat
solids
0.025000
1.000
0.420
319
D
Milk­
fat
solids
0.025000
1.000
0.420
321
M
Beef­
meat
byproducts
0.120000
1.000
0.420
322
M
Beef­
other
organ
meats
0.120000
1.000
0.420
323
M
Beef­
dried
0.050000
1.920
0.420
324
M
Beef­
fat
w/
o
bones
0.050000
1.000
0.420
325
M
Beef­
kidney
0.120000
1.000
0.420
326
M
Beef­
liver
0.120000
1.000
0.420
327
M
Beef­
lean
(
fat/
free)
w/
o
bones
0.050000
1.000
0.420
328
M
Goat­
meat
byproducts
0.120000
1.000
0.420
329
M
Goat­
other
organ
meats
0.120000
1.000
0.420
330
M
Goat­
fat
w/
o
bone
0.050000
1.000
0.420
331
M
Goat­
kidney
0.120000
1.000
0.420
332
M
Goat­
liver
0.120000
1.000
0.420
333
M
Goat­
lean
(
fat/
free)
w/
o
bone
0.050000
1.000
0.420
334
M
Horsemeat
0.050000
1.000
0.420
335
M
Rabbit
0.050000
1.000
0.420
336
M
Sheep­
meat
byproducts
0.120000
1.000
0.420
337
M
Sheep­
other
organ
meats
0.120000
1.000
0.420
338
M
Sheep­
fat
w/
o
bone
0.050000
1.000
0.420
339
M
Sheep­
kidney
0.120000
1.000
0.420
340
M
Sheep­
liver
0.120000
1.000
0.420
341
M
Sheep­
lean
(
fat
free)
w/
o
bone
0.050000
1.000
0.420
342
M
Pork­
meat
byproducts
0.120000
1.000
0.420
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

12
343
M
Pork­
other
organ
meats
0.120000
1.000
0.420
344
M
Pork­
fat
w/
o
bone
0.050000
1.000
0.420
345
M
Pork­
kidney
0.120000
1.000
0.420
346
M
Pork­
liver
0.120000
1.000
0.420
347
M
Pork­
lean
(
fat
free)
w/
o
bone
0.050000
1.000
0.420
398
D
Milk­
based
water
0.025000
1.000
0.420
424
M
Veal­
fat
w/
o
bones
0.050000
1.000
0.420
425
M
Veal­
lean
(
fat
free)
w/
o
bones
0.050000
1.000
0.420
426
M
Veal­
kidney
0.120000
1.000
0.420
427
M
Veal­
liver
0.120000
1.000
0.420
428
M
Veal­
other
organ
meats
0.120000
1.000
0.420
429
M
Veal­
dried
0.050000
1.920
0.420
430
M
Veal­
meat
byproducts
0.120000
1.000
0.420
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

13
U.
S.
Environmental
Protection
Agency
Ver.
DEEM
Chronic
analysis
for
ASULAM
(
1989­
92
Residue
file
name:
C:\
My
DEEM\
Asulam\
chronic.
RS7
Adjustment
factor
#
2
used.
Analysis
Date
12­
10­
2001/
15:
41:
38
Residue
file
dated:
12­
10­
2001/
15:
36:
16/
8
Reference
dose
(
RfD,
Chronic)
=
.036
mg/
kg
bw/
day
COMMENT
1:
Chronic
Run
for
the
TRED
==============================================================================
=
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000157
0.4%

U.
S.
Population
(
spring
season)
0.000156
0.4%
U.
S.
Population
(
summer
season)
0.000160
0.4%
U.
S.
Population
(
autumn
season)
0.000161
0.4%
U.
S.
Population
(
winter
season)
0.000152
0.4%

Northeast
region
0.000153
0.4%
Midwest
region
0.000170
0.5%
Southern
region
0.000155
0.4%
Western
region
0.000150
0.4%

Hispanics
0.000173
0.5%
Non­
hispanic
whites
0.000156
0.4%
Non­
hispanic
blacks
0.000156
0.4%
Non­
hisp/
non­
white/
non­
black
0.000158
0.4%

All
infants
(<
1
year)
0.000300
0.8%
Nursing
infants
0.000075
0.2%
Non­
nursing
infants
0.000394
1.1%
Children
1­
6
yrs
0.000449
1.2%
Children
7­
12
yrs
0.000275
0.8%
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

14
Females
13­
19
(
not
preg
or
nursing)
0.000147
0.4%
Females
20+
(
not
preg
or
nursing)
0.000092
0.3%
Females
13­
50
yrs
0.000107
0.3%
Females
13+
(
preg/
not
nursing)
0.000130
0.4%
Females
13+
(
nursing)
0.000120
0.3%

Males
13­
19
yrs
0.000185
0.5%
Males
20+
yrs
0.000105
0.3%
Seniors
55+
0.000087
0.2%
Pacific
Region
0.000144
0.4%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

15
Quantitative
Usage
Analysis
for
Sodium
Asulam
Case
No.
265
PC
Code
No.
106902
Date:
7­
25­
01
Analyst:
Alan
Halvorson
Based
on
pesticide
usage
information
mainly
for
1992
through
2000
for
agriculture
and
1994
through
1999
for
non­
agriculture,
total
annual
domestic
usage
of
sodium
asulam
is
approximately
1.3
million
pounds
active
ingredient
(
a.
i.)
allocated
by
site
mainly
to
sugarcane
(
95%),
lawn
care
operators
and
sod
farms
(
2%
each)
and
institutional
turf
(
1%).
The
average
percent
crop
treated
for
sugarcane,
the
only
registered
agricultural
crop,
is
about
42%,
while
its
average
use
rate
per
acre
is
2.5
pounds
a.
i.
per
application
and
3.0
pounds
a.
i.
per
year.
States
of
most
usage
are
Florida,
Louisiana
and
Texas.

Sodium
Asulam
Case
#:
265
AI
#:
106902
EPA
QUANTITATIVE
USAGE
ANALYSIS
Analyst:
Alan
Halvorson
7­
25­
01
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­
Acres
Acres
Treated
(
000)
%
Crop
Treated
Lb
AI
Appl'd
(
000)
Avg
Applic
Rates/
Acre
States
of
Most
Usage
(
000)
­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­
(%
of
total
lb
ai
Site
Grown
Est
Est
Est
lb
ai/
#
appl/
lb
ai/
used
by
these
states)
Avg
Max
Avg
Max
Avg
Max
year
year
appl
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­

Sugarcane
939
398
498
42%
53%
1,211
1,513
3.04
1.2
2.46
FL
LA
TX
100%
Lawn
Care
Operators(*)
­
­
­
­
­
26
40
­
­
­
FL
100%
Sod
Farms
­
­
­
­
­
21
32
­
­
­
FL
(
most)
Institutional
Turf(**)
­
­
­
­
­
17
25
­
­
­
­
Ornamentals
­
­
­
­
­
3
4
­
­
­
FL
TX
­
Golf
Courses
­
­
­
­
­
2
3
­
­
­
FL
GA
­
TOTAL
1,280
1,600
FL
LA
97%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­

NOTES
ON
TABLE
DATA
­­­­­­­­­­­­­­­­­­­
­
Usage
data
primarily
cover
1992
­
2000
for
agriculture
and
1994
­
1999
for
non­
agriculture.
­
Calculations
of
the
above
numbers
may
not
appear
to
agree
with
each
other
because
they
are
displayed
as
rounded.
[
D279592]
~
DRAFT
~

[
Asulam
/
106901]

16
­
A
dash(­)
indicates
that
information
is
not
readily
available
or
is
not
applicable.

CROP/
SITE
GROUPS
AND
DEFINITIONS
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
(*)
Lawn
care
operators
make
applications
to
commercial,
not
residential,
turf.
(**)
Institutional
turf
consists
of
maintained
turf
of
educational
facilities,
cemeteries
and
parks.

DATA
SOURCES
­­­­­­­­­­­­
­
US
EPA,
proprietary
data,
1994
­
2000.
­
NCFAP,
circa
1992.

cc:
Include
typical
reviewer
information
here.
Include
one
copy
for
(
HED
Staff/
CEB1),
where
staff
=
Mohsen
Sahafeyen
or
LaShonia
Richardson).
Include
names
of
secondary
reviewers
and
review
dates.