Document ID: EPA-HQ-OPP-2004-0032-0024
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-28T04:00Z

Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
1
  
57
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
12/
16/
2005
SUBJECT:
Formetanate
Hydrochloride:
Revised
Acute
Probabilistic
and
Chronic
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision.

PC
Code:
097301
DP
Barcode:
D323946
REVIEWER:
Susan
Stanton,
Environmental
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

THROUGH:
Thurston
Morton,
Chemist
Danette
Drew,
Chemist
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
Health
Effects
Division
(
7509C)

and
Catherine
Eiden,
Branch
Chief
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

TO:
Demson
Fuller,
Chemical
Review
Manager
Reregistration
Branch
2
Special
Review
and
Reregistration
Division
(
7508C)

Executive
Summary
The
purpose
of
this
memorandum
is
to
revise
the
risk
estimates
of
the
previous
dietary
exposure
assessment
for
formetanate
hydrochloride,
dated
4/
28/
03
(
D.
Drew;
DP
Barcode
D289012),
and
its
addendum,
dated
6/
4/
03
(
D.
Drew,
DP
Barcode
D290559).
This
revision
incorporates
recent
changes
made
to
the
acute
and
chronic
Population
Adjusted
Doses
(
PADs).
It
also
incorporates
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
2
  
57
updated
percent
crop
treated
information
and
is
based
on
residue
data
from
field
trials
only.
The
previous
dietary
risk
estimates
were
based
on
PDP
monitoring
data
or,
where
such
data
were
not
available,
on
field
trial
data.
HED
has
since
determined
that
the
available
PDP
monitoring
data
for
formetanate
hydrochloride
should
not
be
used
to
assess
dietary
exposure,
since
they
do
not
reflect
the
lower
rates
and
longer
PHIs
specified
in
the
10/
99
Memorandum
of
Agreement
(
MOA)
between
the
registrant
and
the
EPA.
Finally,
this
assessment
incorporates
estimated
drinking
water
residues
directly
into
the
dietary
exposure
estimates
in
accordance
with
HED's
current
policy.

Acute
probabilistic
and
chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
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
analyses
were
performed
to
support
the
reregistration
eligibility
decision.

Acute
Dietary
Exposure
Results
and
Characterization
A
Tier
3,
acute
probabilistic
dietary
exposure
assessment
was
conducted
for
all
supported
formetanate
food
uses
and
drinking
water.
Acute
anticipated
residues
for
all
foods
were
derived
using
field
trial
data
reflecting
current
maximum
label
rates
and
minimum
PHIs.
Anticipated
residues
were
further
refined
using
percent
crop
treated
(%
CT)
data
where
appropriate,
following
the
guidance
provided
in
HED's
SOP
99.6
(
Classification
of
Food
Forms
with
Respect
to
level
of
Blending;
8/
20/
99),
and
available
processing
factors.
Where
processing
data
were
not
available,
DEEM
7.81
default
processing
factors
were
assumed.

Estimated
residues
in
drinking
water
were
provided
by
EFED
(
Revised
Tier
II
Drinking
Water
Assessment
for
Formetanate
HCL;
DP
Barcode289182;
Ibrahim
Abdel­
Saheb;
03/
27/
03)
and
incorporated
directly
into
the
acute
assessment.
The
assessment
was
conducted
using
the
full
distribution
of
estimated
residues
in
surface
water
generated
by
the
PRZM­
EXAMS
model
for
the
North
Carolina
apple
crop
scenario,
the
crop
scenario
resulting
in
the
highest
estimated
peak
surface
water
concentration.

The
resulting
acute
dietary
exposure
estimates
for
food
and
water
exceed
HED's
level
of
concern
for
the
U.
S.
population
and
all
reported
population
subgroups
at
the
99.9th
percentile
of
exposure.
Formetanate
acute
dietary
exposure
(
food
+
water)
at
the
99.9th
percentile
was
estimated
at
0.005424
mg/
kg/
day
for
the
U.
S.
population
(
830%
of
the
aPAD)
and
0.016665
mg/
kg/
day
(
2600%
of
the
aPAD)
for
the
most
highly
exposed
population
subgroup
(
infants).
Most
of
the
estimated
acute
exposure
was
determined
to
result
from
the
late
season
uses
of
formetanate
hydrochloride
on
apples,
pears,
oranges
and
grapefruit
(
particularly
apples,
and
to
a
lesser
extent,
pears).
When
the
late
season
uses
are
excluded
from
the
assessment,
estimated
dietary
exposure
(
food
+
water)
is
below
HED's
level
of
concern
for
the
U.
S.
population
(
32%
of
the
aPAD)
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
3
  
57
110%
of
the
aPAD.
Drinking
water
is
the
largest
contributor
to
overall
dietary
exposure
when
late
season
uses
are
excluded.
A
separate
analysis
of
acute
exposure
to
formetanate
hydrochloride
from
drinking
water
alone
resulted
in
exposure
estimates
equivalent
to
28%
of
the
aPAD
for
the
overall
U.
S.
population
and
110%
of
the
aPAD
for
infants.
Chronic
Dietary
Exposure
Results
and
Characterization
A
refined,
Tier
3
chronic
dietary
exposure
assessment
was
also
conducted
for
the
supported
food
uses
of
formetanate
hydrochloride
and
drinking
water.
Anticipated
residues
were
derived
using
field
trial
data,
incorporating
%
CT
data
in
accordance
with
the
guidance
for
chronic
assessments
in
HED's
1/
25/
99
memorandum,
ChemSAC
decision
re:
calculation
of
anticipated
residues,
and
available
processing
factors.
Where
processing
data
were
not
available,
DEEM
7.81
default
processing
factors
were
assumed.

For
the
chronic
assessment,
a
single
point
estimate
(
0.08
ppb)
of
formetanate
hydrochloride
residues
in
surface
water
was
used
to
assess
exposure
from
drinking
water.
The
estimated
surface
water
concentration
represents
the
90th
percentile
annual
mean
concentration
generated
by
the
PRZM­
EXAMS
model
for
the
Pennsylvania
apple
crop
scenario,
the
crop
scenario
resulting
in
the
highest
estimated
annual
mean
concentration.

Chronic
dietary
exposure
estimates
based
on
these
assumptions
are
below
HED's
level
of
concern
for
the
U.
S.
population
and
all
population
subgroups.
Formetanate
hydrochloride
mean
dietary
exposure
(
food
+
water)
is
estimated
at
0.000032
mg/
kg/
day
for
the
U.
S.
population
(
4.9%
of
the
cPAD)
and
0.000180
mg/
kg/
day
(
28%
of
the
cPAD)
for
the
most
highly
exposed
population
subgroup
(
infants,
<
1
yr.
old).
When
late
season
uses
on
apples,
pears,
oranges
and
grapefruit
are
excluded,
estimated
chronic
dietary
exposure
represents
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
1.3%
of
the
cPAD.
Chronic
dietary
exposure
from
drinking
water
alone
is
estimated
to
be
less
than
1%
of
the
cPAD
for
all
populations.

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.
This
is
the
population
adjusted
dose
(
PAD),
which
HED
has
concluded
will
result
in
no
unreasonable
adverse
health
effects.
The
PAD
is
the
Reference
Dose
(
RfD)
divided
by
the
special
FQPA
Safety
Factor.
Dietary
risk
is
expressed
as
a
percentage
of
the
PAD.
For
acute
and
noncancer
chronic
exposures,
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.
References
which
discuss
the
acute
and
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",
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).
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
4
  
57
II.
Residue
Information
The
residue
chemistry
of
formetanate
hydrochloride
is
discussed
in
Formetanate
Hydrochloride:
HED
Revised
Residue
Chemistry
Chapter
of
the
RED:
Summary
of
Analytical
Chemistry
and
Residue
Data;
DP
Barcode
289010;
D.
Drew;
03/
27/
03.

Tolerances
are
established
for
residues
of
formetanate
hydrochloride
per
se
in
or
on
apple;
pear;
peach;
nectarine;
orange;
lemon;
lime;
grapefruit;
and
tangerine.
In
general,
the
submitted
residue
data
for
these
crops
do
not
satisfy
the
requirements
for
the
number
of
field
trials,
and
additional
field
trials
are
required.
At
such
time
as
the
additional
field
trials
are
received
and
deemed
adequate,
the
tolerances
will
be
reevaluated.

The
results
of
the
alfalfa,
lemon
and
orange
seedling
metabolism
studies
indicate
that
the
metabolic
pathway
in
plants
is
similar
with
resulting
metabolites
containing
the
formamidine
moiety.
Parent
formetanate
was
the
only
compound
identified
in
the
extractable
radioactivity
in/
on
peaches.
The
majority
of
the
terminal
residue
in
plants
consists
mainly
of
parent
compound,
and
formetanate
residues
are
found
mainly
on
the
surface
(
peel)
of
fruit.
Formetanate
HCl
is
the
residue
of
concern
to
be
included
in
the
tolerance
expression
and
the
dietary
risk
assessment
for
food
and
drinking
water.

No
detectable
residues
of
parent
formetanate
HCl
were
found
in
milk,
fat,
muscle,
kidney
and
liver
of
ruminants.
Two
potentially
cholinesterase­
inhibiting
metabolites
(
3­
formamidophenyl
methylcarbamate
and
3­
aminophenyl
methylcarbamate)
found
in
dairy
milk,
liver
and
kidney
have
been
determined
not
to
be
of
significant
toxicological
concern
based
on
an
in
vitro
study
(
J.
Doherty,
12/
10/
98,
DP
barcode
D249197;
and
MARC
decisions
1/
12/
99,
D252123
and
3/
15/
99,
D254395).
Therefore,
no
tolerances
are
required
for
formetanate
HCl
and
its
metabolites
for
milk
and
the
fat,
meat
and
meat
byproducts
of
cattle,
goat,
horse
and
sheep
(
40
CFR
180.6(
a)(
3)).
No
formetanate
HCl
tolerances
are
required
for
poultry
or
hog
commodities
as
there
are
no
registered
uses
on
poultry
or
swine
feed
items.
Therefore,
no
livestock
commodities
need
to
be
included
in
the
dietary
risk
assessment
for
formetanate
HCl.

Residue
Data
used
for
Acute
and
Chronic
Assessments:

Food
Residues:

Anticipated
residues
for
formetanate
HCl
in
foods
were
derived
in
accordance
with
established
Agency
policies
and
guidance
for
chronic
and
acute
dietary
exposure
assessments.
Chronic
anticipated
residues
were
generally
based
on
the
mean
residue
from
field
trials
conducted
at
the
maximum
label
rate
and
minimum
PHI
with
appropriate
adjustments
for
percent
crop
treated
and
residue
concentration/
reduction
from
processing.
For
the
acute
assessment,
residue
distribution
files
(
RDFs)
were
generated
based
on
field
trial
data
and
maximum
percent
crop
treated
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
5
  
57
information.
A
certain
number
of
"
zero"
residue
values
were
included
to
account
for
the
untreated
portion
of
the
crop,
and
residues
equal
to
½
the
method
Limit
of
Quantitation
(
LOQ)
were
assigned
to
field
trial
samples
with
no
detectable
residues
in
accordance
with
guidance
in
HED
SOP
99.6
(
Classification
of
Food
Forms
with
Respect
to
Level
of
Blending
(
8/
20/
99)).
Percent
crop
treated
(%
CT)
data
were
provided
by
the
Biological
and
Economic
Analysis
Division
(
Screening
Level
Usage
Analysis
(
SLUA),
11/
17/
05;
as
modified
by
the
email
communication
from
Jihad
Alsadek
to
Danette
Drew,
11/
21/
05,
attached).

Formetanate
HCl
is
generally
applied
to
fruit
trees
as
an
early
season
treatment
(
i.
e.,
before
petal
fall
on
apples,
pears,
peaches
and
nectarines;
and
before
citrus
fruit
reaches
one
inch
in
diameter).
However,
late
season
uses
are
permitted
on
apples,
pears,
Valencia
oranges
and
grapefruit
as
follows:
On
apples
and
pears,
a
second,
later
season,
application
may
be
made
to
control
stink
bugs,
lygus
bugs
and
pear
rust
mites
in
CA,
OR,
WA
and
ID
with
prior
State
approval.
No
PHI
is
specified
for
this
late
season
use.
On
grapefruit
and
Valencia
oranges,
if
unharvested
fruit
are
present
from
the
previous
crop,
an
application
may
be
made
to
the
new
crop,
provided
a
30­
day
PHI
is
observed
for
the
unharvested
crop.
Field
trial
data
reflecting
these
late
season
uses
showed
considerably
higher
residues
than
those
reflecting
only
early
season
uses.
To
assess
the
impact
of
the
late­
season
uses
on
dietary
exposure,
separate
acute
and
chronic
assessments
were
conducted
­
one
based
on
late­
season
field
trial
data
and
one
based
on
early­
season
field
trial
results
only.
Both
assessments
were
conducted
for
food
alone
and
for
food
plus
drinking
water.

Data
Translation:

Field
trial
and
%
CT
data
were
available
for
apples,
pears,
peaches,
nectarines,
oranges,
grapefruit
and
lemons.
The
data
for
lemons
were
translated
to
both
limes
and
tangerines,
based
on
fruit
size
similarities.
Because
residues
are
found
primarily
on
the
surface
of
fruits,
size
(
i.
e.,
surface­
tovolume
ratio)
was
considered
more
important
than
taxonomic
similarity
within
the
citrus
group
for
the
purposes
of
residue
data
translation.

Analytical
Methods
and
LOQs
Used
in
the
Assessments:

Two
analytical
methods
were
used
to
determine
residues
in/
on
collected
field
trial
samples.
One
method
(
HPLC/
UV)
is
a
single
analyte
method
which
measured
only
parent
formetanate
HCl;
the
other
method
(
GC/
ECD)
is
a
common
moiety
method,
slightly
modified
from
PAM
Volume
II
enforcement
Method
I,
which
measured
parent
and
several
metabolites
convertible
to
3­
aminophenol.
The
LOQ
of
the
single
analyte
method
is
0.1
ppm
for
nectarines
and
0.03
ppm
for
apples,
pears,
peaches
and
citrus.
The
LOQ
of
the
common
moiety
method
is
0.02
ppm
for
all
crops.
In
cases
where
residues
were
non­
detectable
using
both
methods,
HED
assigned
the
sample
a
residue
value
equal
to
½
the
LOQ
of
the
common
moiety
method
(
0.01ppm),
based
on
the
conclusion
that
residues
of
parent
formetanate
could
not
be
any
greater
than
the
combined
residues
of
parent
and
its
metabolites.
In
cases
where
residues
were
non­
detectable
using
the
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
6
  
57
single
analyte
method
but
detectable
using
the
common
moiety
method,
HED
assigned
the
sample
a
residue
value
equal
to
½
the
LOQ
of
the
single
analyte
method
(
0.05ppm
for
nectarines
and
0.015
ppm
for
other
crops),
since
the
residue
of
concern
consists
of
parent
formetanate
HCl
only.
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
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57
Processing
Factors:

Processing
data
indicate
that
residues
in
apple
juice
are
reduced
by
a
factor
of
0.31x
compared
to
fresh
apples
(
MRID
00077702,
memo
8/
13/
70,
PP0F0961).
This
factor
was
applied
to
both
apple
and
pear
juice.
Similarly,
a
processing
factor
of
0.03x,
based
on
a
citrus
processing
study
(
MRID
00077702),
was
applied
to
grapefruit,
lemon,
orange,
lime
and
tangerine
juice
in
the
acute
and
chronic
assessments.
A
40x
concentration
factor
for
citrus
peel
was
calculated
from
the
same
study.
DEEM
default
processing
factors
of
8x
for
dried
apples,
6.25x
for
dried
pears
and
7x
for
dried
peaches
were
assumed
in
the
absence
of
processing
data
for
these
commodities.

The
data
and
residue
estimates
(
or
RDFs)
used
in
the
acute
and
chronic
dietary
assessments
are
summarized
in
Table
1.
anate
Hydrochloride
Dietary
Exposure
Assessment
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57
and
Residue
Estimates
Used
in
Dietary
Analyses
Anticipated
Residue
Estimates
(
ppm)

s
Classification1
Data
Source
No.
of
Samples
No.
of
Detectable
Residues
(
single
analyte
method)
LOD3
%
CT
Processing
Factors
Acute
(
AR,
RDF2)
Chro
h,
ked,
NB/
PB
FT
2
2
N/
A
5%
Ave
5%
Max
0.31
(
juice)
'
Apples
5%
CT
;
FT
(
late
season
apps)
TOTALZ=
38
0.704
0.787
0.037
B
FT
2
2
N/
A
5%
Ave
5%
Max
8
0.0373
0.037
h,
ked,
NB/
PB
FT
6
0
4@
0.01
2@
0.015
5%
Ave
5%
Max
0.31
(
juice)
'
Apples
5%
CT
;
FT
(
pre­
petal
fall
apps)
TOTALZ=
114
0.01
0.01
0.01
0.01
0.015
0.015
0.000
B
FT
6
0
4@
0.01
2@
0.015
5%
Ave
5%
Max
8
0.000583
0.000
anate
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h,
ked,
NB/
PB
FT
2
2
N/
A
5%
Ave
5%
Max
0.31
(
juice)
'
Pears
5%
CT
;
FT
(
late
season
apps)
TOTALZ=
38
0.917
1.01
0.048
B
FT
2
2
N/
A
5%
Ave
5%
Max
6.25
0.048
0.048
h,
ked,
NB/
PB
FT
4
0
0.01
5%
Ave
5%
Max
0.31
(
juice)
'
Pears
5%
CT
;
FT
(
pre­
petal
fall
apps)
TOTALZ=
76
0.01
0.01
0.01
0.01
0.000
B
FT
4
0
0.01
5%
Ave
5%
Max
6.25
0.0005
0.000
h,
ked,
NB/
PB
FT
6
0
0.01
5%
Ave
5%
Max
1
(
juice)
'
Peaches
5%
CT
;
FT
DATA;
NB/
PB
TOTALZ=
114
TOTALLOD=
6
LODRES=
0.01
0.000
B
FT
6
0
0.01
5%
Ave
5%
Max
7
0.0005
0.000
NB
FT
26
0
20@
0.01
6@
0.05
46%
Ave
46%
Max
not
applicable
'
Nectarines
46%
CT
;
FT
DATA;
NB
TOTALZ=
31
TOTALFREQ=
2
20,
0.01
6,
0.05
0.008
anate
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ked,

NB/
PB
FT
2
2
N/
A
1%
Ave
2.5%
Max
0.03
(
juice)
40
(
peel)
'
Oranges
2.5%
CT
;
FT
(
Overcropping
w/
30­
day
PHI)
TOTALZ=
78
0.338
0.234
0.002
ked,

NB/
PB
FT
2
0
0.015
1%
Ave
2.5%
Max
0.03
(
juice)
40
(
peel)
'
Oranges
2.5%
CT
;
FT
(
early
season
269­
day
PHI)
TOTALZ=
78
0.015
0.015
0.000
ked,
NB/
PB
FT
2
2
N/
A
1%
Ave
5%
Max
0.03
(
juice)
'
Grapefruit
5%
CT
;
FT
(
Overcropping
w/
30­
day
PHI)
TOTALZ=
38
0.0605
0.0478
0.000
h,
ked,
NB/
PB
FT
2
0
0.01
1%
Ave
5%
Max
0.03
(
juice)
'
Grapefruit
5%
CT
;
FT
(
early
season
215­
day
PHI)
TOTALZ=
38
0.01
0.01
0.000
anate
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ked
on),

on)
NB/
PB
FT
2
0
0.01
10%
Ave
15%
Max
0.03
(
juice)
40
(
lemon
peel)
'
Lemons/
Limes/
Tangerines/
Tangelos;
15%
CT
;
FT
(
early
season
207­
day
PHI)
TOTALZ=
11
0.01
0.01
0.001
cation
of
blended
(
B),
partially
blended
(
PB),
not
blended
(
NB).
te
RDFs
are
shown
(
1st
line
wraps
in
some
cases
due
to
limited
column
width
in
the
table).
ples
where
residues
were
non­
detectable
using
both
methods,
½
the
LOQ
of
the
common
moiety
method
(
0.01ppm)
was
used.
For
samples
where
residues
were
non­
d
e
single
analyte
method
but
detectable
using
the
common
moiety
method,
½
the
LOQ
of
the
single
analyte
method
(
0.05ppm
for
nectarines
and
0.015
ppm
for
other
cro
applicable,
since
there
are
no
non­
detectable
residues.
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The
field
trial
data
used
to
develop
the
RDFs
are
limited
in
terms
of
the
number
of
trials
and
samples,
with
only
2
samples
available
for
many
crops
at
the
relevant
PHIs.
As
noted
previously,
additional
field
trials
are
being
required
to
support
the
existing
tolerances
and
confirm
dietary
exposure
estimates
based
on
the
limited
trials.
Despite
the
limited
nature
of
the
field
trial
data,
HED
believes
it
is
unlikely
that
the
analyses
based
on
these
data
underestimate
dietary
exposure.
Field
trials
are
conducted
at
maximum
application
rates
and
minimum
PHIs
and
resulting
residues
represent
the
high
end
of
the
range
of
residues
likely
to
be
found
at
the
"
farm
gate".
Residues
in
foods
"
as
eaten"
(
i.
e.,
after
storage,
processing,
cooking,
peeling,
etc.)
are
likely
to
be
much
lower.

USDA's
Pesticide
Data
Program
(
PDP),
at
HED's
request,
collected
and
analyzed
oranges,
apples
and
nectarines
for
residues
of
formetanate
HCl
in
2000
and
2001;
and
HED
used
the
2001
data
in
its
previous
2003
dietary
exposure
assessment.
Although
these
data
were
collected
after
the
10/
99
MOA
which
mandated
lower
application
rates
and
longer
PHIs,
the
registrant
argued
that
the
PDP
data
did
not
reflect
these
label
changes,
since
most
of
the
formetanate
HCl
product
in
the
channels
of
trade
at
the
time
still
bore
labeling
with
the
previously
approved
rates
and
PHIs.
Therefore,
the
registrant
recommended
that
field
trial
data
reflecting
current
label
rates
and
PHIs
be
used
to
assess
dietary
exposure.
HED
considered
the
registrant's
arguments
and
agreed
to
reassess
dietary
exposure
using
the
available
field
trial
data.

Drinking
Water
Residues:

Reference:
Revised
Tier
II
Drinking
Water
Assessment
for
Formetanate
HCL;
DP
Barcode
289182;
Ibrahim
Abdel­
Saheb;
03/
27/
03)

The
Tier
II
screening
models
PRZM
and
EXAMS
with
the
Index
Reservoir
and
Percent
Crop
Area
adjustment
(
IR­
PCA
PRZM/
EXAMS)
were
used
to
determine
estimated
surface
water
concentrations
of
formetanate
HCL.
Modeling
results
are
shown
in
Table
2.

Table
2.
Estimated
environmental
concentrations
in
surface
water
for
formetanate
HCL
use
on
apples
in
NC,
PA,
and
OR.

model
EECs
(
µ
g/
L)

NC
PA
OR
Surface
water/
peak
(
90th
percentile
annual
daily
max.)
7.68
6.76
6.83
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Surface
water/
90th
percentile
annual
mean)
0.06
0.08
0.04
Surface
water/
36­
year
overall
mean
0.04
0.04
0.03
use(
s)
modeled
1
application
@
1.15
lb
ai/
acre,
aerial
application
PCA
0.87
Since
the
NC
apple
scenario
resulted
in
the
highest
estimated
peak
concentration
in
surface
water
(
7.67
ppb),
HED
selected
this
scenario
for
the
acute
analysis.
Rough,
preliminary
calculations
indicated
that
water
exposure
would
likely
exceed
HED's
level
of
concern
for
acute
exposure;
therefore,
HED
asked
EFED
to
provide
the
entire
distribution
of
estimated
daily
exposure
values
from
the
PRZM­
EXAMS
run
for
this
worst­
case
crop
scenario.
This
distribution
was
then
incorporated
in
the
acute
probabilistic
exposure
analyses.

For
the
chronic
assessment,
HED
selected
the
highest
annual
mean
EEC
for
surface
water
based
on
the
PA
apple
crop
scenario
(
0.08
ppb)
and
incorporated
it
as
a
point
estimate
in
the
chronic
analyses.

III.
DEEM­
FCID
 
Program
and
Consumption
Information
Formetanate
HCl
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
2.02),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
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
EPA­
defined
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.
Consumption
data
are
averaged
for
the
entire
U.
S.
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
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.
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
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.
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For
acute
exposure
assessments,
individual
one­
day
food
consumption
data
are
used
on
an
individual­
by­
individual
basis.
The
reported
consumption
amounts
of
each
food
item
can
be
multiplied
by
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
deterministic
(
Tier
1
or
Tier
2)
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
(
Tier
3/
4)
assessment.
The
resulting
distribution
of
exposures
is
expressed
as
a
percentage
of
the
aPAD
on
both
a
user
(
i.
e.,
those
who
reported
eating
relevant
commodities/
food
forms)
and
a
per
capita
(
i.
e.,
those
who
reported
eating
the
relevant
commodities
as
well
as
those
who
did
not)
basis.
In
accordance
with
HED
policy,
per
capita
exposure
and
risk
are
reported
for
all
tiers
of
analysis.
However,
for
tiers
1
and
2,
significant
differences
in
user
vs.
per
capita
exposure
and
risk
are
identified
and
noted
in
the
risk
assessment.

IV.
Toxicological
Information
Formetanate
HCl
is
a
carbamate
insecticide
whose
toxic
effect
of
concern
is
cholinesterase
inhibition
(
ChEI).
In
order
to
evaluate
the
appropriate
point
of
departure
(
PoD)
for
cholinesterase
inhibition,
EPA
performed
a
benchmark
dose
(
BMD)
analysis.
ChEI
data
from
the
comparative
ChE
study
in
rat
were
analyzed:

The
estimated
dose
at
which
10%
ChE
is
observed
(
BMD10)
and
the
lower
95%
confidence
intervals
(
BMDL10)
were
estimated
by
fitting
the
ChE
data
to
an
exponential
dose­
response
model
using
generalized
nonlinear
least
squares.
The
BMDL10
was
selected
because
it
is
generally
at
or
near
the
limit
of
sensitivity
for
discerning
a
statistically
significant
decrease
in
ChE
activity
across
the
blood
and
brain
compartments
and
is
a
response
level
close
to
the
background
ChE.

Table
3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Formetanate
HCl
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
­
U.
S.
Population
and
All
Subgroups
BMDL10=
0.065
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.00065
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
0.00065
mg/
kg/
day
Comparative
cholinesterase
study
in
the
rat
BMDL10
=
0.065
mg/
kg/
day,
based
on
cholinesterase
inhibition.

Chronic
Dietary
­
U.
S.
Population
BMDL10=
0.065
mg/
kg/
day
UF
=
100
FQPA
SF
=
1X
Comparative
cholinesterase
study
in
the
rat
Formetanate
Hydrochloride
Dietary
Exposure
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Table
3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Formetanate
HCl
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
and
All
Subgroups
Chronic
RfD
=
0.00065
mg/
kg/
day
cPAD
=
0.00065
mg/
kg/
day
BMDL10
=
0.065
mg/
kg/
day,
based
on
cholinesterase
inhibition.

Cancer
Classified
"
Not
likely
to
be
a
human
carcinogen"

V.
Results/
Discussion
As
stated
above,
for
acute
and
chronic
assessments,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
PAD.
The
DEEM­
FCID
 
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
26
population
subgroups.
The
results
reported
in
Tables
4
through
8
and
Tables
10
and
11
are
for
the
general
U.
S.
Population,
all
infants
(<
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.

Results
of
Acute
Dietary
Exposure
Analysis
Results
in
Tables
4
(
food
+
water,
including
late
season
uses),
5
(
food
+
water,
without
late
season
uses),
6
(
food
only,
including
late
season
uses),
7
(
food
only,
without
late
season
uses)
and
8
(
water
only)
are
reported
at
the
95th,
99th
and
99.9th
percentiles
of
exposure.

The
acute
dietary
exposure
estimates
for
food
and
water
exceed
HED's
level
of
concern
for
the
U.
S.
population
and
all
reported
population
subgroups
at
the
99.9th
percentile
of
exposure.
Formetanate
acute
dietary
exposure
(
food
+
water)
at
the
99.9th
percentile
was
estimated
at
0.005424
mg/
kg/
day
for
the
U.
S.
population
(
830%
of
the
aPAD)
and
0.016665
mg/
kg/
day
(
2600%
of
the
aPAD)
for
the
most
highly
exposed
population
subgroup
(
infants).
Most
of
the
estimated
acute
exposure
was
determined
to
result
from
the
late
season
uses
of
formetanate
hydrochloride
on
apples,
pears,
oranges
and
grapefruit
(
particularly
apples,
and
to
a
lesser
extent,
pears).
When
the
late
season
uses
are
excluded
from
the
assessment,
estimated
dietary
exposure
(
food
+
water)
is
below
HED's
level
of
concern
for
the
U.
S.
population
(
32%
of
the
aPAD)
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
110%
of
the
aPAD.
Drinking
water
is
the
largest
contributor
to
overall
dietary
exposure
when
late
season
uses
are
excluded.
A
separate
analysis
of
acute
exposure
to
formetanate
hydrochloride
from
drinking
water
alone
resulted
in
exposure
estimates
equivalent
to
28%
of
the
aPAD
for
the
overall
U.
S.
population
and
110%
of
the
aPAD
for
infants.
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
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Analyses
were
also
conducted
for
food
alone
(
with
and
without
late
season
uses).
Estimated
exposure
to
formetanate
hydrochloride
at
the
99.9th
percentile
from
food
alone
exceeds
HED's
level
of
concern
for
all
populations
when
the
late
season
uses
are
included
(
840%
of
the
aPAD
for
the
U.
S.
population
and
2600%
of
the
aPAD
for
infants)
but
is
below
HED's
level
of
concern
for
all
populations
when
they
are
excluded
from
consideration
(
17%
and
41%
of
the
aPAD
for
the
U.
S.
population
and
infants,
respectively).

At
the
99th
percentile,
estimated
exposure
due
to
the
late
season
uses
of
formetanate
HCl
still
exceeds
HED's
level
of
concern
for
the
U.
S.
population
and
all
infants'
and
children's
subgroups.
Estimated
combined
food
and
drinking
water
exposure
is
below
HED's
level
of
concern
for
all
populations
when
the
late
season
uses
are
excluded.
Estimated
exposure
from
all
food
uses
(
including
late
season
uses)
and
drinking
water
is
below
HED's
level
of
concern
at
the
95th
percentile
of
exposure.
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
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57
Table
4.
Results
of
Acute
Dietary
Exposure
Analysis:
Food
+
Water,
Including
Late
Season
Uses
on
Apples,
Pears,
Oranges
and
Grapefruit
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.000014
2.1
0.000820
130
0.005424
830
All
Infants
(<
1
year
old)
0.000067
10
0.006212
960
0.016665
2600
Children
1­
2
years
old
0.000111
17
0.005861
900
0.013953
2100
Children
3­
5
years
old
0.000073
11
0.004433
680
0.010942
1700
Children
6­
12
years
old
0.000031
4.7
0.001892
290
0.005939
910
Youth
13­
19
years
old
0.000008
1.3
0.000182
28
0.002722
420
Adults
20­
49
years
old
0.000008
1.2
0.000222
34
0.002329
360
Females
13­
49
years
old
0.000010
1.5
0.000232
36
0.002596
400
Adults
50+
years
old
0.00065
0.000014
2.2
0.000631
97
0.002560
390
Table
5.
Results
of
Acute
Dietary
Exposure
Analysis:
Food
+
Water,
Without
Late
Season
Uses
on
Apples,
Pears,
Oranges
and
Grapefruit
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.000002
0.28
0.000045
6.9
0.000209
32
All
Infants
(<
1
year
old)
0.000014
2.2
0.000146
23
0.000706
110
Children
1­
2
years
old
0.000018
2.7
0.000120
19
0.000355
55
Children
3­
5
years
old
0.000010
1.6
0.000101
16
0.000345
53
Children
6­
12
years
old
0.000003
0.48
0.000058
8.9
0.000232
36
Youth
13­
19
years
old
0.000001
0.12
0.000027
4.2
0.000142
22
0.00065
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Table
5.
Results
of
Acute
Dietary
Exposure
Analysis:
Food
+
Water,
Without
Late
Season
Uses
on
Apples,
Pears,
Oranges
and
Grapefruit
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Adults
20­
49
years
old
0.000001
0.18
0.000032
5.0
0.000180
28
Females
13­
49
years
old
0.000001
0.19
0.000033
5.1
0.000177
27
Adults
50+
years
old
0.000003
0.39
0.000036
5.5
0.000184
.28
Table
6.
Results
of
Acute
Dietary
Exposure
Analysis:
Food
Only,
Including
Late
Season
Uses
on
Apples,
Pears,
Oranges
and
Grapefruit
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.000008
1.3
0.000826
130
0.005461
840
All
Infants
(<
1
year
old)
0.000045
7.0
0.006121
940
0.016725
2600
Children
1­
2
years
old
0.000091
14
0.005918
910
0.013976
2200
Children
3­
5
years
old
0.000055
8.5
0.004421
680
0.010859
1700
Children
6­
12
years
old
0.000021
3.2
0.001917
290
0.005970
920
Youth
13­
19
years
old
0.000004
0.66
0.000159
24
0.002724
420
Adults
20­
49
years
old
0.000004
0.55
0.000160
25
0.002312
360
Females
13­
49
years
old
0.000004
0.64
0.000182
28
0.002575
400
Adults
50+
years
old
0.00065
0.000006
0.95
0.000628
97
0.002568
400
Table
7.
Results
of
Acute
Dietary
Exposure
Analysis:
Food
Only,
Without
Late
Season
Uses
on
Apples,
Pears,
Oranges
and
Grapefruit
Population
Subgroup
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Formetanate
Hydrochloride
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Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.000000
0.04
0.000023
3.5
0.000113
17
All
Infants
(<
1
year
old)
0.000001
0.13
0.000104
16
0.000266
41
Children
1­
2
years
old
0.000004
0.68
0.000100
15
0.000243
37
Children
3­
5
years
old
0.000002
0.26
0.000080
12
0.000219
34
Children
6­
12
years
old
0.000001
0.09
0.000039
6.0
0.000126
19
Youth
13­
19
years
old
0.000000
0.02
0.000010
1.5
0.000051
7.8
Adults
20­
49
years
old
0.000000
0.02
0.000016
2.5
0.000069
11
Females
13­
49
years
old
0.000000
0.03
0.000019
2.9
0.000082
13
Adults
50+
years
old
0.00065
0.000000
0.05
0.000020
3.1
0.000067
10
Table
8.
Results
of
Acute
Dietary
Exposure
Analysis:
Water
Only,
Based
on
NC
Apple
Crop
Scenario
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.000000
0.01
0.000017
2.7
0.000184
28
All
Infants
(<
1
year
old)
0.000000
0.02
0.000045
6.9
0.000687
110
Children
1­
2
years
old
0.000000
0.01
0.000025
3.8
0.000289
44
Children
3­
5
years
old
0.000000
0.01
0.000024
3.7
0.000261
40
Children
6­
12
years
old
0.000000
0.01
0.000016
2.5
0.000183
28
Youth
13­
19
years
old
0.000000
0.01
0.000011
1.8
0.000136
21
Adults
20­
49
years
old
0.000000
0.01
0.000017
2.6
0.000173
27
Females
13­
49
years
old
0.000000
0.01
0.000016
2.5
0.000173
27
Adults
50+
years
old
0.00065
0.000000
0.01
0.000019
2.9
0.000173
27
A
Critical
Exposure
Contribution
(
CEC)
Analysis
was
conducted
to
determine
the
foods
contributing
most
heavily
to
acute
exposure
at
the
99.9th
percentile
of
exposure.
Table
9
below
Formetanate
Hydrochloride
Dietary
Exposure
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summarizes
the
results
of
this
analysis.
Note
that
this
analysis
considered
all
food
uses,
including
the
late
season
uses
on
apples,
pears,
oranges
and
grapefruit.

Table
9.
Major
Food
Contributors
to
Formetanate
HCl
Acute
Exposure
at
the
99.9th
Percentile
(
The
numbers
in
parentheses
indicate
the
food's
approximate
contribution
as
a
percent
of
total
exposure.)

U.
S.
Population
All
Infants1
Children,
1­
2
Years
Old
Apples
(
84)
Apples
(
74)
Apples
(
85)

Pears
(
14)
Pears
(
25.6)
Pears
(
15)

Oranges
(
1.7)
Oranges
(
0.05)
Oranges
(
0.13)

Drinking
Water
(
0.03)
Drinking
Water
(
0.01)

1
The
population
subgroup
with
the
highest
estimated
acute
dietary
exposure.

The
results
of
the
CEC
analysis
indicate
that
most
of
the
estimated
acute
dietary
exposure
is
due
to
the
late
season
uses
on
apples
and,
to
a
lesser
extent,
pears.
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Results
of
Chronic
Dietary
Exposure
Analysis
Chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
the
U.
S.
population
and
all
population
subgroups.
Formetanate
hydrochloride
mean
dietary
exposure
(
food
+
water)
is
estimated
at
0.000032
mg/
kg/
day
for
the
U.
S.
population
(
4.9%
of
the
cPAD)
and
0.000180
mg/
kg/
day
(
28%
of
the
cPAD)
for
the
most
highly
exposed
population
subgroup
(
infants,
<
1
yr.
old).
When
late
season
uses
on
apples,
pears,
oranges
and
grapefruit
are
excluded,
estimated
chronic
dietary
exposure
represents
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
1.3%
of
the
cPAD.
Chronic
dietary
exposure
from
drinking
water
alone
is
estimated
to
be
less
than
1%
of
the
cPAD
for
all
populations.

The
results
of
the
chronic
dietary
exposure
assessment
are
presented
below
in
Tables
10
and
11.

Table
10.
Results
of
Chronic
Dietary
Exposure
Analysis
for
Food
(
including
Late
Season
Uses)
and
Drinking
Water
Food
Drinking
Water
Food
+
Drinking
Water
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Exposure
(
mg/
kg/
day)
%
cPAD
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.000030
4.7
0.000002
0.3
0.000032
4.9
All
Infants
(<
1
year
old)
0.000174
27
0.000006
0.9
0.000180
28
Children
1­
2
years
old
0.000171
26
0.000003
0.4
0.000173
27
Children
3­
5
years
old
0.000119
18
0.000002
0.4
0.000121
19
Children
6­
12
years
old
0.000050
7.7
0.000002
0.2
0.000052
8.0
Youth
13­
19
years
old
0.000014
2.2
0.000001
0.2
0.000016
2.4
Adults
20­
49
years
old
0.000013
1.9
0.000002
0.2
0.000014
2.2
Females
13­
49
years
old
0.000014
2.2
0.000002
0.2
0.000016
2.4
Adults
50+
years
old
0.00065
0.000018
2.8
0.000002
0.3
0.000020
3.0
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Table
11.
Results
of
Chronic
Dietary
Exposure
Analysis
for
Food
(
without
Late
Season
Uses)
and
Drinking
Water
Food
Drinking
Water
Food
+
Drinking
Water
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Exposure
(
mg/
kg/
day)
%
cPAD
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.000001
0.1
0.000002
0.3
0.000002
0.4
All
Infants
(<
1
year
old)
0.000003
0.5
0.000006
0.9
0.000009
1.3
Children
1­
2
years
old
0.000003
0.5
0.000003
0.4
0.000006
0.9
Children
3­
5
years
old
0.000002
0.4
0.000002
0.4
0.000005
0.7
Children
6­
12
years
old
0.000001
0.2
0.000002
0.2
0.000003
0.4
Youth
13­
19
years
old
0.000000
0.0
0.000001
0.2
0.000002
0.2
Adults
20­
49
years
old
0.000000
0.1
0.000002
0.2
0.000002
0.3
Females
13­
49
years
old
0.000000
0.1
0.000002
0.2
0.000002
0.3
Adults
50+
years
old
0.00065
0.000001
0.1
0.000002
0.3
0.000002
0.3
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VI.
Discussion
of
Uncertainties
This
dietary
assessment
for
formetanate
HCl
includes
estimated
exposure
from
food
and
drinking
water.
A
characterization
of
the
uncertainties
for
each
of
these
components
is
provided
separately
below:

Food:

The
assessment
for
food
incorporates
partially
refined
anticipated
residue
estimates
for
all
commodities
that
were
derived
from
field
trial
data
adjusted
to
account
for
the
percent
crop
treated
and,
in
some
cases,
reduction/
concentration
during
processing.
Although
the
field
trial
data
are
limited
in
terms
of
the
number
of
trials
and
residue
samples,
it
is
still
likely
that
these
data
result
in
overestimates
of
dietary
exposure
to
formetanate,
since
they
reflect
maximum,
rather
than
typical,
usage.
The
availability
and
use
of
monitoring
data
reflecting
current
use
patterns
and/
or
additional
residue
processing
information
(
cooking,
peeling,
etc.)
would
have
resulted
in
a
more
refined
estimate
of
dietary
exposure.
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Percent
crop
treated
data
were
provided
by
BEAD
for
all
commodities.
The
%
CT
estimates
are
screening
level
estimates.
More
refined
%
CT
estimates
would
result
in
more
refined
estimates
of
dietary
exposure.

Drinking
Water:

1.
Actual
monitoring
data
are
not
available
to
estimate
residues
of
formetanate
HCl
in
drinking
water.
The
availability
and
use
of
monitoring
data
would
have
resulted
in
a
more
refined
estimate
of
drinking
water
exposure
to
formetanate
HCl.

2.
PRZM­
EXAMS
surface
water
modeling
data
were
used
probabilistically
in
the
acute
analysis
and
deterministically
in
the
chronic
analysis.
The
estimates
were
partially
refined
in
that
they
took
into
consideration
crop­
specific
percent
cropped
area
(
PCA).
Although
the
PRZMEXAMS
models
provide
more
refined
estimates
of
surface
water
residues
than
the
Tier
1
FIRST
model,
the
drinking
water
inputs
may
be
considered
conservative
for
the
following
reasons.

·
The
model
results
assume
that
applications
will
be
made
at
maximum
application
rates
every
year
for
30
years.

·
The
PRZM­
EXAMS
models
are
based
on
an
actual
reservoir/
watershed
system
in
Illinois
which
is
known
to
be
a
highly
vulnerable
configuration.

2.
The
PRZM­
EXAMS
results
were
based
on
a
single
application
to
apples
at
the
maximum
application
rate
(
1.15
lbs.
a.
i./
A);
as
such,
they
do
not
take
into
consideration
potential
lateseason
applications
that
are
allowed
under
certain
circumstances.
Since
typically
only
a
single
application
is
made,
and
considering
the
conservative
nature
of
the
other
model
assumptions,
it
is
unlikely
that
the
PRZM­
EXAMS
results
based
on
a
single
application
underestimate
drinking
water
residues.

VII.
Conclusions
Acute
probabilistic
and
chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
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.
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
25
  
57
The
resulting
acute
dietary
exposure
estimates
for
food
and
water
exceed
HED's
level
of
concern
for
the
U.
S.
population
and
all
reported
population
subgroups
at
the
99.9th
percentile
of
exposure.
Formetanate
acute
dietary
exposure
(
food
+
water)
at
the
99.9th
percentile
was
estimated
at
0.005424
mg/
kg/
day
for
the
U.
S.
population
(
830%
of
the
aPAD)
and
0.016665
mg/
kg/
day
(
2600%
of
the
aPAD)
for
the
most
highly
exposed
population
subgroup
(
infants).
Most
of
the
estimated
acute
exposure
was
determined
to
result
from
the
late
season
uses
of
formetanate
hydrochloride
on
apples,
pears,
oranges
and
grapefruit
(
particularly
apples,
and
to
a
lesser
extent,
pears).
When
the
late
season
uses
are
excluded
from
the
assessment,
estimated
dietary
exposure
(
food
+
water)
is
below
HED's
level
of
concern
for
the
U.
S.
population
(
32%
of
the
aPAD)
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
110%
of
the
aPAD.
Drinking
water
is
the
largest
contributor
to
overall
dietary
exposure
when
late
season
uses
are
excluded.
A
separate
analysis
of
acute
exposure
to
formetanate
hydrochloride
from
drinking
water
alone
resulted
in
exposure
estimates
equivalent
to
28%
of
the
aPAD
for
the
overall
U.
S.
population
and
110%
of
the
aPAD
for
infants.

Chronic
dietary
exposure
estimates
are
below
HED's
level
of
concern
for
the
U.
S.
population
and
all
population
subgroups.
Formetanate
hydrochloride
mean
dietary
exposure
(
food
+
water)
is
estimated
at
0.000032
mg/
kg/
day
for
the
U.
S.
population
(
4.9%
of
the
cPAD)
and
0.000180
mg/
kg/
day
(
28%
of
the
cPAD)
for
the
most
highly
exposed
population
subgroup
(
infants,
<
1
yr.
old).
When
late
season
uses
on
apples,
pears,
oranges
and
grapefruit
are
excluded,
estimated
chronic
dietary
exposure
represents
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
subgroups,
except
infants,
whose
estimated
exposure
represents
1.3%
of
the
cPAD.
Chronic
dietary
exposure
from
drinking
water
alone
is
estimated
to
be
less
than
1%
of
the
cPAD
for
all
populations.

VIII.
List
of
Attachments
I.
Acute
Input
and
Results
Files
·
Food
+
Water,
including
Late
Season
Uses
(
includes
CEC
analysis)
·
Food
+
Water,
without
Late
Season
Uses
·
Food
only,
including
Late
Season
Uses
·
Food
only,
without
Late
Season
Uses
·
Drinking
Water
only
II.
Chronic
Input
and
Results
Files
·
Food
+
Water,
including
Late
Season
Uses
(
includes
CEC
analysis)
·
Food
+
Water,
without
Late
Season
Uses
·
Food
only,
including
Late
Season
Uses
·
Food
only,
without
Late
Season
Uses
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
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57
·
Drinking
Water
only
III.
Percent
Crop
Treated
Memorandum
and
related
email
correspondence
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
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57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
FORMETANATE
HYDROCHLORIDE
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Food
and
Water
with
Late
Season
Uses.
R98
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
51:
30/
8
Reference
dose:
aRfD
=
0.00065
mg/
kg
bw/
day
NOEL
=
0.065
mg/
kg
bw/
day
Comment:
Formetanate
Acute
Food
and
Water
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
and
NC
apple
water
scenario.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
apple
early
season
NB
PB.
RDF
2
6
apple
late
season
NB
PB.
RDF
3
6
grapefruit
early
season
NB
PB.
RDF
4
6
grapefruit
late
season
overcrop
NB
PB.
RDF
5
6
Lemons_
Limes_
Tangerines_
Tangelos
NB
PB.
RDF
6
6
nectarines
NB.
RDF
7
6
oranges
early
season
NB
PB.
RDF
8
6
oranges
late
season
overcrop
NB
PB.
RDF
9
6
peaches
NB
PB.
RDF
10
6
pear
early
season
NB
PB.
RDF
11
6
pear
late
season
NB
PB.
RDF
12
6
water_
NC
apple
scenario.
rdf
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­
­­­­­­
11000070
11
Apple,
fruit
with
peel
1.000000
1.000
1.000
2
11000080
11
Apple,
peeled
fruit
1.000000
1.000
1.000
2
11000081
11
Apple,
peeled
fruit­
babyfood
1.000000
1.000
1.000
2
11000090
11
Apple,
dried
0.037300
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.037300
8.000
1.000
11000100
11
Apple,
juice
1.000000
0.310
1.000
2
11000101
11
Apple,
juice­
babyfood
1.000000
0.310
1.000
2
11000110
11
Apple,
sauce
1.000000
1.000
1.000
2
11000111
11
Apple,
sauce­
babyfood
1.000000
1.000
1.000
2
10001800
10
Grapefruit
1.000000
1.000
1.000
4
10001810
10
Grapefruit,
juice
1.000000
0.030
1.000
4
10001990
10
Lemon
1.000000
1.000
1.000
5
10002000
10
Lemon,
juice
1.000000
0.030
1.000
5
10002001
10
Lemon,
juice­
babyfood
1.000000
0.030
1.000
5
10002010
10
Lemon,
peel
1.000000
40.000
1.000
5
10002060
10
Lime
1.000000
1.000
1.000
5
10002070
10
Lime,
juice
1.000000
0.030
1.000
5
10002071
10
Lime,
juice­
babyfood
1.000000
0.030
1.000
5
12002300
12
Nectarine
1.000000
1.000
1.000
6
10002400
10
Orange
1.000000
1.000
1.000
8
10002410
10
Orange,
juice
1.000000
0.030
1.000
8
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
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Barcode:
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57
10002411
10
Orange,
juice­
babyfood
1.000000
0.030
1.000
8
10002420
10
Orange,
peel
1.000000
40.000
1.000
8
12002600
12
Peach
1.000000
1.000
1.000
9
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
9
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
9
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
9
11002660
11
Pear
1.000000
1.000
1.000
11
11002661
11
Pear­
babyfood
1.000000
1.000
1.000
11
11002670
11
Pear,
dried
0.048000
6.250
1.000
11002680
11
Pear,
juice
1.000000
0.310
1.000
11
11002681
11
Pear,
juice­
babyfood
1.000000
0.310
1.000
11
10003690
10
Tangerine
1.000000
1.000
1.000
5
10003700
10
Tangerine,
juice
1.000000
0.030
1.000
5
86010000
O
Water,
direct,
all
sources
1.000000
1.000
1.000
12
86020000
O
Water,
indirect,
all
sources
1.000000
1.000
1.000
12
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
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PC
Code:
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57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file:
Formetanate
Acute
Food
and
Water
with
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
12­
01­
2005/
09:
08:
24
Residue
file
dated:
12­
01­
2005/
07:
51:
30/
8
NOEL
(
Acute)
=
0.065000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
1000
MC
list
in
residue
file
MC
seed
=
100
Run
Comment:
"
Formetanate
Acute
Food
and
Water
using
FT
data,
including
late
s
eason
uses
on
apples/
pears/
oranges/
grapefruit
and
NC
apple
water
scenario."
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000014
2.08
4813
0.000820
126.22
79
0.005424
834.47
11
All
infants:
0.000067
10.23
977
0.006212
955.74
10
0.016665
2563.88
3
Children
1­
2
yrs:
0.000111
17.13
583
0.005861
901.73
11
0.013953
2146.62
4
Children
3­
5
yrs:
0.000073
11.23
890
0.004433
681.98
14
0.010942
1683.33
5
Children
6­
12
yrs:
0.000031
4.73
2112
0.001892
291.03
34
0.005939
913.67
10
Youth
13­
19
yrs:
0.000008
1.28
7832
0.000182
27.99
357
0.002722
418.78
23
Adults
20­
49
yrs:
0.000008
1.17
8570
0.000222
34.14
292
0.002329
358.32
27
Adults
50+
yrs:
0.000014
2.16
4625
0.000631
97.04
103
0.002560
393.86
25
Females
13­
49
yrs:
0.000010
1.50
6656
0.000232
35.76
279
0.002596
399.36
25
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
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PC
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57
U.
S.
Environmental
Protection
Agency
DEEM­
FCID
Acute
Critical
Exposure
Contribution
Analysis
(
Ver
2.02)
CSFII
1994­
98
Residue
file
=
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Food
and
Water
with
Late
Se
Acute
report
=
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
acute
food
and
water
with
late
season
uses.
AC7
Date
and
time
of
analysis:
12­
01­
2005
09:
02:
24
Daily
totals
for
food
and
foodform
consumption
used.
Adjustment
factor
#
2
not
used.
Minimum
exposure
contribution
=
10%
Monte
Carlo
Iterations
=
1000
Seed
=
100
CEC
records
generated
for
first
98
iterations.
Exposures
divided
by
body
weight
Subpopulations:
1
U.
S.
Population
2
All
infants
3
Children
1­
2
yrs
================================================================================
U.
S.
Population
Low
percentile
for
CEC
records:
99
Exposure
(
mg/
day)
=
0.000820
High
percentile
for
CEC
records:
100
Exposure
(
mg/
day)
=
0.056056
Number
of
actual
records
in
this
interval:
68315
Critical
foods/
foodforms
for
this
population
(
as
derived
from
these
records):
N=
number
of
appearances
in
all
records
(
including
duplicates)
%=
percent
of
total
exposure
for
all
records
(
including
duplicates)

Food
N
Percent
Food
Name
­­­­­­­­
­­­­­
­­­­­­­
­­­­­­­­­­­­
­
11000070
21601
29.82%
Apple
fruit
with
peel­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000100
16408
24.80%
Apple
juice­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000110
6186
11.18%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Boiled
11000111
2868
7.36%
Apple
sauce­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
2952
5.01%
Pear­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000101
2786
4.34%
Apple
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002661
1332
3.80%
Pear­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
3269
3.59%
Pear­
Cooked;
Canned;
Cook
Meth
N/
S
11000100
4185
3.31%
Apple
juice­
Cooked;
Canned;
Cook
Meth
N/
S
10002400
2418
1.71%
Orange­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000081
1348
1.48%
Apple
peeled
fruit­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002681
420
0.76%
Pear
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11000100
402
0.67%
Apple
juice­
Uncooked;
Frozen;
Cook
Meth
N/
S
11002660
1167
0.57%
Pear­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000080
556
0.38%
Apple
peeled
fruit­
Cooked;
Fresh
or
N/
S;
Baked
11000110
116
0.21%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
Formetanate
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DP
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11000070
199
0.18%
Apple
fruit
with
peel­
Cooked;
Fresh
or
N/
S;
Baked
11002680
198
0.12%
Pear
juice­
Cooked;
Canned;
Cook
Meth
N/
S
11000090
213
0.09%
Apple
dried­
Uncooked;
Dried;
Cook
Meth
N/
S
11000080
85
0.08%
Apple
peeled
fruit­
Cooked;
Canned;
Cook
Meth
N/
S
86020000
159
0.06%
Water
indirect
all
sources­
Uncooked;
Dried;
Cook
Meth
N/
S
86010000
223
0.05%
Water
direct
all
sources­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11002680
81
0.04%
Pear
juice­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000070
62
0.04%
Apple
fruit
with
peel­
Cooked;
Fresh
or
N/
S;
Fried
11002670
104
0.03%
Pear
dried­
Uncooked;
Dried;
Cook
Meth
N/
S
11000110
51
0.02%
Apple
sauce­
Cooked;
Canned;
Cook
Meth
N/
S
86020000
55
0.02%
Water
indirect
all
sources­
Cooked;
Dried;
Cook
Meth
N/
S
86020000
39
0.01%
Water
indirect
all
sources­
Cooked;
Canned;
Cook
Meth
N/
S
11000110
25
0.01%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Baked
12002300
42
0.01%
Nectarine­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000080
27
0.01%
Apple
peeled
fruit­
Cooked;
Fresh
or
N/
S;
Fried
11000070
15
0.01%
Apple
fruit
with
peel­
Uncooked;
Cured
etc;
Cook
Meth
N/
S
10001800
38
0.01%
Grapefruit­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000080
16
0.01%
Apple
peeled
fruit­
Cooked;
Frozen;
Baked
11000110
12
0.01%
Apple
sauce­
Cooked;
Frozen;
Baked
11000080
23
0.01%
Apple
peeled
fruit­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
86020000
50
0.01%
Water
indirect
all
sources­
Cooked;
Dried;
Boiled
10002410
24
0.00%
Orange
juice­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
10002420
6
0.00%
Orange
peel­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
86020000
31
0.00%
Water
indirect
all
sources­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
10002420
6
0.00%
Orange
peel­
Cooked;
Canned;
Cook
Meth
N/
S
10002410
7
0.00%
Orange
juice­
Uncooked;
Frozen;
Cook
Meth
N/
S
86020000
13
0.00%
Water
indirect
all
sources­
Cooked;
Fresh
or
N/
S;
Boiled
11000080
3
0.00%
Apple
peeled
fruit­
Cooked;
Dried;
Boiled
10002420
2
0.00%
Orange
peel­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
86020000
7
0.00%
Water
indirect
all
sources­
Uncooked;
Frozen;
Cook
Meth
N/
S
86020000
3
0.00%
Water
indirect
all
sources­
Cooked;
Canned;
Boiled
11000110
1
0.00%
Apple
sauce­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
10002420
1
0.00%
Orange
peel­
Cooked;
Fresh
or
N/
S;
Boiled
11000100
2
0.00%
Apple
juice­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000100
2
0.00%
Apple
juice­
Cooked;
Fresh
or
N/
S;
Fried/
baked
11000090
2
0.00%
Apple
dried­
Cooked;
Fresh
or
N/
S;
Baked
12002600
1
0.00%
Peach­
Cooked;
Canned;
Cook
Meth
N/
S
11002680
1
0.00%
Pear
juice­
Uncooked;
Frozen;
Cook
Meth
N/
S
================================================================================
All
infants
Low
percentile
for
CEC
records:
99
Exposure
(
mg/
day)
=
0.006212
High
percentile
for
CEC
records:
100
Exposure
(
mg/
day)
=
0.056056
Number
of
actual
records
in
this
interval:
2769
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
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Code:
097301
    
32
  
57
Critical
foods/
foodforms
for
this
population
(
as
derived
from
these
records):
N=
number
of
appearances
in
all
records
(
including
duplicates)
%=
percent
of
total
exposure
for
all
records
(
including
duplicates)

Food
N
Percent
Food
Name
­­­­­­­­
­­­­­
­­­­­­­
­­­­­­­­­­­­
­
11000111
1162
42.14%
Apple
sauce­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002661
641
22.38%
Pear­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11000101
357
12.65%
Apple
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11000100
257
7.20%
Apple
juice­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000110
162
7.02%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Boiled
11000081
143
3.36%
Apple
peeled
fruit­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002681
52
1.40%
Pear
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
31
1.15%
Pear­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000070
30
0.77%
Apple
fruit
with
peel­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11002660
24
0.69%
Pear­
Cooked;
Canned;
Cook
Meth
N/
S
11000100
20
0.65%
Apple
juice­
Cooked;
Canned;
Cook
Meth
N/
S
11000110
9
0.34%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
10002400
2
0.05%
Orange­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000080
2
0.04%
Apple
peeled
fruit­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
2
0.03%
Pear­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
86020000
2
0.01%
Water
indirect
all
sources­
Uncooked;
Dried;
Cook
Meth
N/
S
================================================================================
Children
1­
2
yrs
Low
percentile
for
CEC
records:
99
Exposure
(
mg/
day)
=
0.005861
High
percentile
for
CEC
records:
100
Exposure
(
mg/
day)
=
0.046894
Number
of
actual
records
in
this
interval:
4209
Critical
foods/
foodforms
for
this
population
(
as
derived
from
these
records):
N=
number
of
appearances
in
all
records
(
including
duplicates)
%=
percent
of
total
exposure
for
all
records
(
including
duplicates)

Food
N
Percent
Food
Name
­­­­­­­­
­­­­­
­­­­­­­
­­­­­­­­­­­­
­
11000100
1510
36.66%
Apple
juice­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000070
1130
23.51%
Apple
fruit
with
peel­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000110
610
14.43%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Boiled
11002660
281
7.01%
Pear­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11000111
200
4.21%
Apple
sauce­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
160
3.91%
Pear­
Cooked;
Canned;
Cook
Meth
N/
S
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
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11000101
135
3.02%
Apple
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002661
106
2.52%
Pear­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11002681
35
1.51%
Pear
juice­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11000100
67
1.45%
Apple
juice­
Uncooked;
Frozen;
Cook
Meth
N/
S
11000100
57
0.90%
Apple
juice­
Cooked;
Canned;
Cook
Meth
N/
S
11000081
28
0.36%
Apple
peeled
fruit­
babyfood­
Cooked;
Canned;
Cook
Meth
N/
S
11000110
8
0.14%
Apple
sauce­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
10002400
15
0.13%
Orange­
Uncooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
11002680
8
0.12%
Pear
juice­
Cooked;
Canned;
Cook
Meth
N/
S
11002660
3
0.01%
Pear­
Cooked;
Fresh
or
N/
S;
Cook
Meth
N/
S
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
34
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
FORMETANATE
HYDROCHLORIDE
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Food
and
Water­
NO
Late
Season
Uses.
R98
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
50:
54/
8
Reference
dose:
aRfD
=
0.00065
mg/
kg
bw/
day
NOEL
=
0.065
mg/
kg
bw/
day
Comment:
Formetanate
Acute
Food
and
Water
(
NC
apple
scenario)
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
apple
early
season
NB
PB.
RDF
2
6
apple
late
season
NB
PB.
RDF
3
6
grapefruit
early
season
NB
PB.
RDF
4
6
grapefruit
late
season
overcrop
NB
PB.
RDF
5
6
Lemons_
Limes_
Tangerines_
Tangelos
NB
PB.
RDF
6
6
nectarines
NB.
RDF
7
6
oranges
early
season
NB
PB.
RDF
8
6
oranges
late
season
overcrop
NB
PB.
RDF
9
6
peaches
NB
PB.
RDF
10
6
pear
early
season
NB
PB.
RDF
11
6
pear
late
season
NB
PB.
RDF
12
6
water_
NC
apple
scenario.
rdf
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­­­­
11000070
11
Apple,
fruit
with
peel
1.000000
1.000
1.000
1
11000080
11
Apple,
peeled
fruit
1.000000
1.000
1.000
1
11000081
11
Apple,
peeled
fruit­
babyfood
1.000000
1.000
1.000
1
11000090
11
Apple,
dried
0.000583
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.000583
8.000
1.000
11000100
11
Apple,
juice
1.000000
0.310
1.000
1
11000101
11
Apple,
juice­
babyfood
1.000000
0.310
1.000
1
11000110
11
Apple,
sauce
1.000000
1.000
1.000
1
11000111
11
Apple,
sauce­
babyfood
1.000000
1.000
1.000
1
10001800
10
Grapefruit
1.000000
1.000
1.000
3
10001810
10
Grapefruit,
juice
1.000000
0.030
1.000
3
10001990
10
Lemon
1.000000
1.000
1.000
5
10002000
10
Lemon,
juice
1.000000
0.030
1.000
5
10002001
10
Lemon,
juice­
babyfood
1.000000
0.030
1.000
5
10002010
10
Lemon,
peel
1.000000
40.000
1.000
5
10002060
10
Lime
1.000000
1.000
1.000
5
10002070
10
Lime,
juice
1.000000
0.030
1.000
5
10002071
10
Lime,
juice­
babyfood
1.000000
0.030
1.000
5
12002300
12
Nectarine
1.000000
1.000
1.000
6
10002400
10
Orange
1.000000
1.000
1.000
7
10002410
10
Orange,
juice
1.000000
0.030
1.000
7
10002411
10
Orange,
juice­
babyfood
1.000000
0.030
1.000
7
10002420
10
Orange,
peel
1.000000
40.000
1.000
7
12002600
12
Peach
1.000000
1.000
1.000
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
35
  
57
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
9
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
9
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
9
11002660
11
Pear
1.000000
1.000
1.000
10
11002661
11
Pear­
babyfood
1.000000
1.000
1.000
10
11002670
11
Pear,
dried
0.000500
6.250
1.000
11002680
11
Pear,
juice
1.000000
0.310
1.000
10
11002681
11
Pear,
juice­
babyfood
1.000000
0.310
1.000
10
10003690
10
Tangerine
1.000000
1.000
1.000
5
10003700
10
Tangerine,
juice
1.000000
0.030
1.000
5
86010000
O
Water,
direct,
all
sources
1.000000
1.000
1.000
12
86020000
O
Water,
indirect,
all
sources
1.000000
1.000
1.000
12
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
36
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file:
Formetanate
Acute
Food
and
Water­
NO
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
12­
01­
2005/
08:
35:
43
Residue
file
dated:
12­
01­
2005/
07:
50:
54/
8
NOEL
(
Acute)
=
0.065000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
1000
MC
list
in
residue
file
MC
seed
=
100
Run
Comment:
"
Formetanate
Acute
Food
and
Water
(
NC
apple
scenario)
using
FT
da
ta,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit."
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000002
0.28
35241
0.000045
6.89
1451
0.000209
32.17
310
All
infants:
0.000014
2.22
4499
0.000146
22.51
444
0.000706
108.63
92
Children
1­
2
yrs:
0.000018
2.74
3648
0.000120
18.54
539
0.000355
54.60
183
Children
3­
5
yrs:
0.000010
1.57
6387
0.000101
15.53
643
0.000345
53.07
188
Children
6­
12
yrs:
0.000003
0.48
20646
0.000058
8.94
1118
0.000232
35.62
280
Youth
13­
19
yrs:
0.000001
0.12
85348
0.000027
4.23
2365
0.000142
21.85
457
Adults
20­
49
yrs:
0.000001
0.18
55404
0.000032
4.99
2002
0.000180
27.76
360
Adults
50+
yrs:
0.000003
0.39
25718
0.000036
5.51
1814
0.000184
28.26
353
Females
13­
49
yrs:
0.000001
0.19
53428
0.000033
5.14
1945
0.000177
27.21
367
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
37
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
FORMETANATE
HYDROCHLORIDE
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Food
with
Late
Season
Uses.
R98
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
52:
10/
8
Reference
dose:
aRfD
=
0.00065
mg/
kg
bw/
day
NOEL
=
0.065
mg/
kg
bw/
day
Comment:
Formetanate
Acute
Food
only
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
apple
early
season
NB
PB.
RDF
2
6
apple
late
season
NB
PB.
RDF
3
6
grapefruit
early
season
NB
PB.
RDF
4
6
grapefruit
late
season
overcrop
NB
PB.
RDF
5
6
Lemons_
Limes_
Tangerines_
Tangelos
NB
PB.
RDF
6
6
nectarines
NB.
RDF
7
6
oranges
early
season
NB
PB.
RDF
8
6
oranges
late
season
overcrop
NB
PB.
RDF
9
6
peaches
NB
PB.
RDF
10
6
pear
early
season
NB
PB.
RDF
11
6
pear
late
season
NB
PB.
RDF
12
6
water_
NC
apple
scenario.
rdf
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­­­­
11000070
11
Apple,
fruit
with
peel
1.000000
1.000
1.000
2
11000080
11
Apple,
peeled
fruit
1.000000
1.000
1.000
2
11000081
11
Apple,
peeled
fruit­
babyfood
1.000000
1.000
1.000
2
11000090
11
Apple,
dried
0.037300
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.037300
8.000
1.000
11000100
11
Apple,
juice
1.000000
0.310
1.000
2
11000101
11
Apple,
juice­
babyfood
1.000000
0.310
1.000
2
11000110
11
Apple,
sauce
1.000000
1.000
1.000
2
11000111
11
Apple,
sauce­
babyfood
1.000000
1.000
1.000
2
10001800
10
Grapefruit
1.000000
1.000
1.000
4
10001810
10
Grapefruit,
juice
1.000000
0.030
1.000
4
10001990
10
Lemon
1.000000
1.000
1.000
5
10002000
10
Lemon,
juice
1.000000
0.030
1.000
5
10002001
10
Lemon,
juice­
babyfood
1.000000
0.030
1.000
5
10002010
10
Lemon,
peel
1.000000
40.000
1.000
5
10002060
10
Lime
1.000000
1.000
1.000
5
10002070
10
Lime,
juice
1.000000
0.030
1.000
5
10002071
10
Lime,
juice­
babyfood
1.000000
0.030
1.000
5
12002300
12
Nectarine
1.000000
1.000
1.000
6
10002400
10
Orange
1.000000
1.000
1.000
8
10002410
10
Orange,
juice
1.000000
0.030
1.000
8
10002411
10
Orange,
juice­
babyfood
1.000000
0.030
1.000
8
10002420
10
Orange,
peel
1.000000
40.000
1.000
8
12002600
12
Peach
1.000000
1.000
1.000
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
38
  
57
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
9
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
9
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
9
11002660
11
Pear
1.000000
1.000
1.000
11
11002661
11
Pear­
babyfood
1.000000
1.000
1.000
11
11002670
11
Pear,
dried
0.048000
6.250
1.000
11002680
11
Pear,
juice
1.000000
0.310
1.000
11
11002681
11
Pear,
juice­
babyfood
1.000000
0.310
1.000
11
10003690
10
Tangerine
1.000000
1.000
1.000
5
10003700
10
Tangerine,
juice
1.000000
0.030
1.000
5
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
39
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file:
Formetanate
Acute
Food
with
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
12­
01­
2005/
08:
49:
04
Residue
file
dated:
12­
01­
2005/
07:
52:
10/
8
NOEL
(
Acute)
=
0.065000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
1000
MC
list
in
residue
file
MC
seed
=
100
Run
Comment:
"
Formetanate
Acute
Food
only
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000008
1.26
7909
0.000826
127.04
78
0.005461
840.21
11
All
infants:
0.000045
6.98
1432
0.006121
941.75
10
0.016725
2573.09
3
Children
1­
2
yrs:
0.000091
13.93
717
0.005918
910.52
10
0.013976
2150.12
4
Children
3­
5
yrs:
0.000055
8.54
1171
0.004421
680.15
14
0.010859
1670.54
5
Children
6­
12
yrs:
0.000021
3.24
3089
0.001917
294.90
33
0.005970
918.53
10
Youth
13­
19
yrs:
0.000004
0.66
15207
0.000159
24.47
408
0.002724
419.13
23
Adults
20­
49
yrs:
0.000004
0.55
18178
0.000160
24.63
405
0.002312
355.66
28
Adults
50+
yrs:
0.000006
0.95
10532
0.000628
96.60
103
0.002568
395.04
25
Females
13­
49
yrs:
0.000004
0.64
15594
0.000182
28.04
356
0.002575
396.11
25
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
40
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
FORMETANATE
HYDROCHLORIDE
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Food
­
NO
Late
Season
Uses.
R98
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
50:
18/
8
Reference
dose:
aRfD
=
0.00065
mg/
kg
bw/
day
NOEL
=
0.065
mg/
kg
bw/
day
Comment:
Formetanate
Acute
Food
only
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
apple
early
season
NB
PB.
RDF
2
6
apple
late
season
NB
PB.
RDF
3
6
grapefruit
early
season
NB
PB.
RDF
4
6
grapefruit
late
season
overcrop
NB
PB.
RDF
5
6
Lemons_
Limes_
Tangerines_
Tangelos
NB
PB.
RDF
6
6
nectarines
NB.
RDF
7
6
oranges
early
season
NB
PB.
RDF
8
6
oranges
late
season
overcrop
NB
PB.
RDF
9
6
peaches
NB
PB.
RDF
10
6
pear
early
season
NB
PB.
RDF
11
6
pear
late
season
NB
PB.
RDF
12
6
water_
NC
apple
scenario.
rdf
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­­­­
11000070
11
Apple,
fruit
with
peel
1.000000
1.000
1.000
1
11000080
11
Apple,
peeled
fruit
1.000000
1.000
1.000
1
11000081
11
Apple,
peeled
fruit­
babyfood
1.000000
1.000
1.000
1
11000090
11
Apple,
dried
0.000583
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.000583
8.000
1.000
11000100
11
Apple,
juice
1.000000
0.310
1.000
1
11000101
11
Apple,
juice­
babyfood
1.000000
0.310
1.000
1
11000110
11
Apple,
sauce
1.000000
1.000
1.000
1
11000111
11
Apple,
sauce­
babyfood
1.000000
1.000
1.000
1
10001800
10
Grapefruit
1.000000
1.000
1.000
3
10001810
10
Grapefruit,
juice
1.000000
0.030
1.000
3
10001990
10
Lemon
1.000000
1.000
1.000
5
10002000
10
Lemon,
juice
1.000000
0.030
1.000
5
10002001
10
Lemon,
juice­
babyfood
1.000000
0.030
1.000
5
10002010
10
Lemon,
peel
1.000000
40.000
1.000
5
10002060
10
Lime
1.000000
1.000
1.000
5
10002070
10
Lime,
juice
1.000000
0.030
1.000
5
10002071
10
Lime,
juice­
babyfood
1.000000
0.030
1.000
5
12002300
12
Nectarine
1.000000
1.000
1.000
6
10002400
10
Orange
1.000000
1.000
1.000
7
10002410
10
Orange,
juice
1.000000
0.030
1.000
7
10002411
10
Orange,
juice­
babyfood
1.000000
0.030
1.000
7
10002420
10
Orange,
peel
1.000000
40.000
1.000
7
12002600
12
Peach
1.000000
1.000
1.000
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
41
  
57
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
9
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
9
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
9
11002660
11
Pear
1.000000
1.000
1.000
10
11002661
11
Pear­
babyfood
1.000000
1.000
1.000
10
11002670
11
Pear,
dried
0.000500
6.250
1.000
11002680
11
Pear,
juice
1.000000
0.310
1.000
10
11002681
11
Pear,
juice­
babyfood
1.000000
0.310
1.000
10
10003690
10
Tangerine
1.000000
1.000
1.000
5
10003700
10
Tangerine,
juice
1.000000
0.030
1.000
5
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
42
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file:
Formetanate
Acute
Food
­
NO
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
12­
01­
2005/
08:
05:
18
Residue
file
dated:
12­
01­
2005/
07:
50:
18/
8
NOEL
(
Acute)
=
0.065000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
1000
MC
list
in
residue
file
MC
seed
=
100
Run
Comment:
"
Formetanate
Acute
Food
only
using
FT
data,
without
late
season
u
ses
on
apples/
pears/
oranges/
grapefruit"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000000
0.04
241930
0.000023
3.53
2833
0.000113
17.42
573
All
infants:
0.000001
0.13
74553
0.000104
15.94
627
0.000266
40.96
244
Children
1­
2
yrs:
0.000004
0.68
14702
0.000100
15.44
647
0.000243
37.36
267
Children
3­
5
yrs:
0.000002
0.26
38076
0.000080
12.23
817
0.000219
33.63
297
Children
6­
12
yrs:
0.000001
0.09
110167
0.000039
5.98
1672
0.000126
19.34
517
Youth
13­
19
yrs:
0.000000
0.02
451367
0.000010
1.49
6698
0.000051
7.79
1283
Adults
20­
49
yrs:
0.000000
0.02
496028
0.000016
2.48
4037
0.000069
10.68
936
Adults
50+
yrs:
0.000000
0.05
190886
0.000020
3.08
3242
0.000067
10.27
973
Females
13­
49
yrs:
0.000000
0.03
374803
0.000019
2.85
3509
0.000082
12.55
797
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
43
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
Acute
analysis
for
FORMETANATE
HCL
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Acute
Water
Only
­
NC
apple.
R98
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
52:
54/
8
Reference
dose:
aRfD
=
0.00065
mg/
kg
bw/
day
NOEL
=
0.065
mg/
kg
bw/
day
Comment:
Formetanate
acute
­
water
only
based
on
NC
apple
PRZM
EXAMS
distribution
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
RDL
indices
and
parameters
for
Monte
Carlo
Analysis:
Index
Dist
Parameter
#
1
Param
#
2
Param
#
3
Comment
#
Code
­­­­­
­­­­
­­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­­
­­­­­­­­­­
1
6
water_
NC
apple
scenario.
rdf
EPA
Crop
Food
Name
Def
Res
Adj.
Factors
RDL
Comment
Code
Grp
(
ppm)
#
1
#
2
Pntr
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­
­­­­­­­
86010000
O
Water,
direct,
all
sources
1.000000
1.000
1.000
1
86020000
O
Water,
indirect,
all
sources
1.000000
1.000
1.000
1
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
44
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
FORMETANATE
HCL
(
1994­
98
data)
Residue
file:
Formetanate
Acute
Water
Only
­
NC
apple.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
12­
01­
2005/
09:
29:
23
Residue
file
dated:
12­
01­
2005/
07:
52:
54/
8
NOEL
(
Acute)
=
0.065000
mg/
kg
body­
wt/
day
Daily
totals
for
food
and
foodform
consumption
used.
MC
iterations
=
1000
MC
list
in
residue
file
MC
seed
=
100
Run
Comment:
"
Formetanate
acute
­
water
only
based
on
NC
apple
PRZM
EXAMS
dist
ribution"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
Exposure
%
aRfD
MOE
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­
­­­­­­­­
U.
S.
Population:
0.000000
0.01
945355
0.000017
2.67
3747
0.000184
28.34
352
All
infants:
0.000000
0.02
559343
0.000045
6.88
1452
0.000687
105.75
94
Children
1­
2
yrs:
0.000000
0.01
727996
0.000025
3.79
2641
0.000289
44.46
224
Children
3­
5
yrs:
0.000000
0.01
714576
0.000024
3.67
2726
0.000261
40.08
249
Children
6­
12
yrs:
0.000000
0.01>
1000000
0.000016
2.54
3941
0.000183
28.15
355
Youth
13­
19
yrs:
0.000000
0.01>
1000000
0.000011
1.76
5669
0.000136
20.95
477
Adults
20­
49
yrs:
0.000000
0.01
982684
0.000017
2.56
3907
0.000173
26.61
375
Adults
50+
yrs:
0.000000
0.01
799366
0.000019
2.94
3401
0.000173
26.62
375
Females
13­
49
yrs:
0.000000
0.01>
1000000
0.000016
2.48
4028
0.000173
26.66
375
9
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
45
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
1994­
98
data
Residue
file:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
and
Water
with
Late
Season
Uses.
R98
Adjust.
#
2
NOT
used
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
09:
58:
33/
8
Reference
dose
(
RfD)
=
0.00065
mg/
kg
bw/
day
Comment:
Formetanate
Chronic
Food
and
Water
(
PA
apple
scenario)
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­
­
11000070
11
Apple,
fruit
with
peel
0.037300
1.000
1.000
11000080
11
Apple,
peeled
fruit
0.037300
1.000
1.000
11000081
11
Apple,
peeled
fruit­
babyfood
0.037300
1.000
1.000
11000090
11
Apple,
dried
0.037300
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.037300
8.000
1.000
11000100
11
Apple,
juice
0.037300
0.310
1.000
11000101
11
Apple,
juice­
babyfood
0.037300
0.310
1.000
11000110
11
Apple,
sauce
0.037300
1.000
1.000
11000111
11
Apple,
sauce­
babyfood
0.037300
1.000
1.000
10001800
10
Grapefruit
0.000542
1.000
1.000
10001810
10
Grapefruit,
juice
0.000542
0.030
1.000
10001990
10
Lemon
0.001000
1.000
1.000
10002000
10
Lemon,
juice
0.001000
0.030
1.000
10002001
10
Lemon,
juice­
babyfood
0.001000
0.030
1.000
10002010
10
Lemon,
peel
0.001000
40.000
1.000
10002060
10
Lime
0.001000
1.000
1.000
10002070
10
Lime,
juice
0.001000
0.030
1.000
10002071
10
Lime,
juice­
babyfood
0.001000
0.030
1.000
12002300
12
Nectarine
0.008850
1.000
1.000
10002400
10
Orange
0.002860
1.000
1.000
10002410
10
Orange,
juice
0.002860
0.030
1.000
10002411
10
Orange,
juice­
babyfood
0.002860
0.030
1.000
10002420
10
Orange,
peel
0.002860
40.000
1.000
12002600
12
Peach
0.000500
1.000
1.000
12002601
12
Peach­
babyfood
0.000500
1.000
1.000
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
0.000500
1.000
1.000
12002621
12
Peach,
juice­
babyfood
0.000500
1.000
1.000
11002660
11
Pear
0.048000
1.000
1.000
11002661
11
Pear­
babyfood
0.048000
1.000
1.000
11002670
11
Pear,
dried
0.048000
6.250
1.000
11002680
11
Pear,
juice
0.048000
0.310
1.000
11002681
11
Pear,
juice­
babyfood
0.048000
0.310
1.000
10003690
10
Tangerine
0.001000
1.000
1.000
10003700
10
Tangerine,
juice
0.001000
0.030
1.000
86010000
O
Water,
direct,
all
sources
0.000080
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.000080
1.000
1.000
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
46
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
and
Water
with
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
12­
01­
2005/
10:
22:
25
Residue
file
dated:
12­
01­
2005/
09:
58:
33/
8
Reference
dose
(
RfD,
Chronic)
=
.00065
mg/
kg
bw/
day
COMMENT
1:
Formetanate
Chronic
Food
and
Water
(
PA
apple
scenario)
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000032
4.9%

U.
S.
Population
(
spring
season)
0.000032
4.9%
U.
S.
Population
(
summer
season)
0.000026
4.1%
U.
S.
Population
(
autumn
season)
0.000037
5.6%
U.
S.
Population
(
winter
season)
0.000034
5.2%

Northeast
region
0.000036
5.5%
Midwest
region
0.000032
5.0%
Southern
region
0.000027
4.1%
Western
region
0.000037
5.7%

Hispanics
0.000037
5.7%
Non­
hispanic
whites
0.000031
4.8%
Non­
hispanic
blacks
0.000028
4.4%
Non­
hisp/
non­
white/
non­
black
0.000041
6.2%

All
infants
(<
1
year)
0.000180
27.7%
Nursing
infants
0.000114
17.5%
Non­
nursing
infants
0.000205
31.5%
Children
1­
6
yrs
0.000131
20.2%
Children
7­
12
yrs
0.000047
7.2%

Females
13­
19
(
not
preg
or
nursing)
0.000017
2.6%
Females
20+
(
not
preg
or
nursing)
0.000017
2.6%
Females
13­
50
yrs
0.000019
3.0%
Females
13+
(
preg/
not
nursing)
0.000031
4.7%
Females
13+
(
nursing)
0.000026
4.0%

Males
13­
19
yrs
0.000014
2.2%
Males
20+
yrs
0.000015
2.3%
Seniors
55+
0.000021
3.2%

Children
1­
2
yrs
0.000173
26.6%
Children
3­
5
yrs
0.000121
18.6%
Children
6­
12
yrs
0.000052
8.0%
Youth
13­
19
yrs
0.000016
2.4%
Adults
20­
49
yrs
0.000014
2.2%
Adults
50+
yrs
0.000020
3.0%
Females
13­
49
yrs
0.000016
2.4%
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
47
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
1994­
98
data
Residue
file:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
and
Water­
NO
Late
Season
Uses.
R98
Adjust.
#
2
NOT
used
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
09:
57:
03/
8
Reference
dose
(
RfD)
=
0.00065
mg/
kg
bw/
day
Comment:
Formetanate
Chronic
Food
and
water
(
PA
apple
scenario)
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­
­
11000070
11
Apple,
fruit
with
peel
0.000583
1.000
1.000
11000080
11
Apple,
peeled
fruit
0.000583
1.000
1.000
11000081
11
Apple,
peeled
fruit­
babyfood
0.000583
1.000
1.000
11000090
11
Apple,
dried
0.000583
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.000583
8.000
1.000
11000100
11
Apple,
juice
0.000583
0.310
1.000
11000101
11
Apple,
juice­
babyfood
0.000583
0.310
1.000
11000110
11
Apple,
sauce
0.000583
1.000
1.000
11000111
11
Apple,
sauce­
babyfood
0.000583
1.000
1.000
10001800
10
Grapefruit
0.000100
1.000
1.000
10001810
10
Grapefruit,
juice
0.000100
0.030
1.000
10001990
10
Lemon
0.001000
1.000
1.000
10002000
10
Lemon,
juice
0.001000
0.030
1.000
10002001
10
Lemon,
juice­
babyfood
0.001000
0.030
1.000
10002010
10
Lemon,
peel
0.001000
40.000
1.000
10002060
10
Lime
0.001000
1.000
1.000
10002070
10
Lime,
juice
0.001000
0.030
1.000
10002071
10
Lime,
juice­
babyfood
0.001000
0.030
1.000
12002300
12
Nectarine
0.008850
1.000
1.000
10002400
10
Orange
0.000150
1.000
1.000
10002410
10
Orange,
juice
0.000150
0.030
1.000
10002411
10
Orange,
juice­
babyfood
0.000150
0.030
1.000
10002420
10
Orange,
peel
0.000150
40.000
1.000
12002600
12
Peach
0.000500
1.000
1.000
12002601
12
Peach­
babyfood
0.000500
1.000
1.000
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
0.000500
1.000
1.000
12002621
12
Peach,
juice­
babyfood
0.000500
1.000
1.000
11002660
11
Pear
0.000500
1.000
1.000
11002661
11
Pear­
babyfood
0.000500
1.000
1.000
11002670
11
Pear,
dried
0.000500
6.250
1.000
11002680
11
Pear,
juice
0.000500
0.310
1.000
11002681
11
Pear,
juice­
babyfood
0.000500
0.310
1.000
10003690
10
Tangerine
0.001000
1.000
1.000
10003700
10
Tangerine,
juice
0.001000
0.030
1.000
86010000
O
Water,
direct,
all
sources
0.000080
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.000080
1.000
1.000
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
48
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
and
Water­
NO
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
12­
01­
2005/
10:
13:
56
Residue
file
dated:
12­
01­
2005/
09:
57:
03/
8
Reference
dose
(
RfD,
Chronic)
=
.00065
mg/
kg
bw/
day
COMMENT
1:
Formetanate
Chronic
Food
and
water
(
PA
apple
scenario)
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000002
0.4%

U.
S.
Population
(
spring
season)
0.000002
0.4%
U.
S.
Population
(
summer
season)
0.000003
0.4%
U.
S.
Population
(
autumn
season)
0.000002
0.3%
U.
S.
Population
(
winter
season)
0.000002
0.3%

Northeast
region
0.000002
0.4%
Midwest
region
0.000002
0.4%
Southern
region
0.000002
0.3%
Western
region
0.000003
0.4%

Hispanics
0.000003
0.4%
Non­
hispanic
whites
0.000002
0.4%
Non­
hispanic
blacks
0.000002
0.3%
Non­
hisp/
non­
white/
non­
black
0.000003
0.5%

All
infants
(<
1
year)
0.000009
1.3%
Nursing
infants
0.000004
0.6%
Non­
nursing
infants
0.000010
1.6%
Children
1­
6
yrs
0.000005
0.7%
Children
7­
12
yrs
0.000003
0.4%

Females
13­
19
(
not
preg
or
nursing)
0.000002
0.2%
Females
20+
(
not
preg
or
nursing)
0.000002
0.3%
Females
13­
50
yrs
0.000002
0.3%
Females
13+
(
preg/
not
nursing)
0.000003
0.4%
Females
13+
(
nursing)
0.000003
0.4%

Males
13­
19
yrs
0.000002
0.2%
Males
20+
yrs
0.000002
0.3%
Seniors
55+
0.000002
0.3%

Children
1­
2
yrs
0.000006
0.9%
Children
3­
5
yrs
0.000005
0.7%
Children
6­
12
yrs
0.000003
0.4%
Youth
13­
19
yrs
0.000002
0.2%
Adults
20­
49
yrs
0.000002
0.3%
Adults
50+
yrs
0.000002
0.3%
Females
13­
49
yrs
0.000002
0.3%
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
49
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
1994­
98
data
Residue
file:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
with
Late
Season
Uses.
R98
Adjust.
#
2
NOT
used
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
54:
05/
8
Reference
dose
(
RfD)
=
0.00065
mg/
kg
bw/
day
Comment:
Formetanate
Chronic
Food
only
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­
­
11000070
11
Apple,
fruit
with
peel
0.037300
1.000
1.000
11000080
11
Apple,
peeled
fruit
0.037300
1.000
1.000
11000081
11
Apple,
peeled
fruit­
babyfood
0.037300
1.000
1.000
11000090
11
Apple,
dried
0.037300
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.037300
8.000
1.000
11000100
11
Apple,
juice
0.037300
0.310
1.000
11000101
11
Apple,
juice­
babyfood
0.037300
0.310
1.000
11000110
11
Apple,
sauce
0.037300
1.000
1.000
11000111
11
Apple,
sauce­
babyfood
0.037300
1.000
1.000
10001800
10
Grapefruit
0.000542
1.000
1.000
10001810
10
Grapefruit,
juice
0.000542
0.030
1.000
10001990
10
Lemon
0.001000
1.000
1.000
10002000
10
Lemon,
juice
0.001000
0.030
1.000
10002001
10
Lemon,
juice­
babyfood
0.001000
0.030
1.000
10002010
10
Lemon,
peel
0.001000
40.000
1.000
10002060
10
Lime
0.001000
1.000
1.000
10002070
10
Lime,
juice
0.001000
0.030
1.000
10002071
10
Lime,
juice­
babyfood
0.001000
0.030
1.000
12002300
12
Nectarine
0.008850
1.000
1.000
10002400
10
Orange
0.002860
1.000
1.000
10002410
10
Orange,
juice
0.002860
0.030
1.000
10002411
10
Orange,
juice­
babyfood
0.002860
0.030
1.000
10002420
10
Orange,
peel
0.002860
40.000
1.000
12002600
12
Peach
0.000500
1.000
1.000
12002601
12
Peach­
babyfood
0.000500
1.000
1.000
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
0.000500
1.000
1.000
12002621
12
Peach,
juice­
babyfood
0.000500
1.000
1.000
11002660
11
Pear
0.048000
1.000
1.000
11002661
11
Pear­
babyfood
0.048000
1.000
1.000
11002670
11
Pear,
dried
0.048000
6.250
1.000
11002680
11
Pear,
juice
0.048000
0.310
1.000
11002681
11
Pear,
juice­
babyfood
0.048000
0.310
1.000
10003690
10
Tangerine
0.001000
1.000
1.000
10003700
10
Tangerine,
juice
0.001000
0.030
1.000
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
50
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
with
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
12­
01­
2005/
10:
18:
13
Residue
file
dated:
12­
01­
2005/
07:
54:
05/
8
Reference
dose
(
RfD,
Chronic)
=
.00065
mg/
kg
bw/
day
COMMENT
1:
Formetanate
Chronic
Food
only
using
FT
data,
including
late
season
uses
on
apples/
pears/
oranges/
grapefruit
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000030
4.7%

U.
S.
Population
(
spring
season)
0.000030
4.6%
U.
S.
Population
(
summer
season)
0.000025
3.8%
U.
S.
Population
(
autumn
season)
0.000035
5.4%
U.
S.
Population
(
winter
season)
0.000032
4.9%

Northeast
region
0.000034
5.2%
Midwest
region
0.000031
4.7%
Southern
region
0.000025
3.8%
Western
region
0.000035
5.4%

Hispanics
0.000035
5.4%
Non­
hispanic
whites
0.000030
4.6%
Non­
hispanic
blacks
0.000027
4.1%
Non­
hisp/
non­
white/
non­
black
0.000038
5.9%

All
infants
(<
1
year)
0.000174
26.8%
Nursing
infants
0.000112
17.2%
Non­
nursing
infants
0.000198
30.5%
Children
1­
6
yrs
0.000129
19.9%
Children
7­
12
yrs
0.000045
7.0%

Females
13­
19
(
not
preg
or
nursing)
0.000016
2.4%
Females
20+
(
not
preg
or
nursing)
0.000015
2.4%
Females
13­
50
yrs
0.000018
2.7%
Females
13+
(
preg/
not
nursing)
0.000029
4.5%
Females
13+
(
nursing)
0.000024
3.6%

Males
13­
19
yrs
0.000013
2.0%
Males
20+
yrs
0.000013
2.0%
Seniors
55+
0.000019
2.9%

Children
1­
2
yrs
0.000171
26.3%
Children
3­
5
yrs
0.000119
18.3%
Children
6­
12
yrs
0.000050
7.7%
Youth
13­
19
yrs
0.000014
2.2%
Adults
20­
49
yrs
0.000013
1.9%
Adults
50+
yrs
0.000018
2.8%
Females
13­
49
yrs
0.000014
2.2%
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
51
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
1994­
98
data
Residue
file:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
­
NO
Late
Season
Uses.
R98
Adjust.
#
2
NOT
used
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
07:
53:
29/
8
Reference
dose
(
RfD)
=
0.00065
mg/
kg
bw/
day
Comment:
Formetanate
Chronic
Food
only
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­
­
11000070
11
Apple,
fruit
with
peel
0.000583
1.000
1.000
11000080
11
Apple,
peeled
fruit
0.000583
1.000
1.000
11000081
11
Apple,
peeled
fruit­
babyfood
0.000583
1.000
1.000
11000090
11
Apple,
dried
0.000583
8.000
1.000
11000091
11
Apple,
dried­
babyfood
0.000583
8.000
1.000
11000100
11
Apple,
juice
0.000583
0.310
1.000
11000101
11
Apple,
juice­
babyfood
0.000583
0.310
1.000
11000110
11
Apple,
sauce
0.000583
1.000
1.000
11000111
11
Apple,
sauce­
babyfood
0.000583
1.000
1.000
10001800
10
Grapefruit
0.000100
1.000
1.000
10001810
10
Grapefruit,
juice
0.000100
0.030
1.000
10001990
10
Lemon
0.001000
1.000
1.000
10002000
10
Lemon,
juice
0.001000
0.030
1.000
10002001
10
Lemon,
juice­
babyfood
0.001000
0.030
1.000
10002010
10
Lemon,
peel
0.001000
40.000
1.000
10002060
10
Lime
0.001000
1.000
1.000
10002070
10
Lime,
juice
0.001000
0.030
1.000
10002071
10
Lime,
juice­
babyfood
0.001000
0.030
1.000
12002300
12
Nectarine
0.008850
1.000
1.000
10002400
10
Orange
0.000150
1.000
1.000
10002410
10
Orange,
juice
0.000150
0.030
1.000
10002411
10
Orange,
juice­
babyfood
0.000150
0.030
1.000
10002420
10
Orange,
peel
0.000150
40.000
1.000
12002600
12
Peach
0.000500
1.000
1.000
12002601
12
Peach­
babyfood
0.000500
1.000
1.000
12002610
12
Peach,
dried
0.000500
7.000
1.000
12002611
12
Peach,
dried­
babyfood
0.000500
7.000
1.000
12002620
12
Peach,
juice
0.000500
1.000
1.000
12002621
12
Peach,
juice­
babyfood
0.000500
1.000
1.000
11002660
11
Pear
0.000500
1.000
1.000
11002661
11
Pear­
babyfood
0.000500
1.000
1.000
11002670
11
Pear,
dried
0.000500
6.250
1.000
11002680
11
Pear,
juice
0.000500
0.310
1.000
11002681
11
Pear,
juice­
babyfood
0.000500
0.310
1.000
10003690
10
Tangerine
0.001000
1.000
1.000
10003700
10
Tangerine,
juice
0.001000
0.030
1.000
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
52
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Food
­
NO
Late
Season
Uses.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
12­
01­
2005/
10:
01:
22
Residue
file
dated:
12­
01­
2005/
07:
53:
29/
8
Reference
dose
(
RfD,
Chronic)
=
.00065
mg/
kg
bw/
day
COMMENT
1:
Formetanate
Chronic
Food
only
using
FT
data,
without
late
season
uses
on
apples/
pears/
oranges/
grapefruit
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000001
0.1%

U.
S.
Population
(
spring
season)
0.000001
0.1%
U.
S.
Population
(
summer
season)
0.000001
0.1%
U.
S.
Population
(
autumn
season)
0.000001
0.1%
U.
S.
Population
(
winter
season)
0.000001
0.1%

Northeast
region
0.000001
0.1%
Midwest
region
0.000001
0.1%
Southern
region
0.000001
0.1%
Western
region
0.000001
0.1%

Hispanics
0.000001
0.1%
Non­
hispanic
whites
0.000001
0.1%
Non­
hispanic
blacks
0.000001
0.1%
Non­
hisp/
non­
white/
non­
black
0.000001
0.1%

All
infants
(<
1
year)
0.000003
0.5%
Nursing
infants
0.000002
0.3%
Non­
nursing
infants
0.000003
0.5%
Children
1­
6
yrs
0.000003
0.4%
Children
7­
12
yrs
0.000001
0.2%

Females
13­
19
(
not
preg
or
nursing)
0.000000
0.1%
Females
20+
(
not
preg
or
nursing)
0.000001
0.1%
Females
13­
50
yrs
0.000001
0.1%
Females
13+
(
preg/
not
nursing)
0.000001
0.1%
Females
13+
(
nursing)
0.000001
0.1%

Males
13­
19
yrs
0.000000
0.0%
Males
20+
yrs
0.000000
0.1%
Seniors
55+
0.000001
0.1%

Children
1­
2
yrs
0.000003
0.5%
Children
3­
5
yrs
0.000002
0.4%
Children
6­
12
yrs
0.000001
0.2%
Youth
13­
19
yrs
0.000000
0.0%
Adults
20­
49
yrs
0.000000
0.1%
Adults
50+
yrs
0.000001
0.1%
Females
13­
49
yrs
0.000000
0.1%
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
53
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
1994­
98
data
Residue
file:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Water
only
­
PA
apple
scenario.
R98
Adjust.
#
2
NOT
used
Analysis
Date
12­
01­
2005
Residue
file
dated:
12­
01­
2005/
10:
28:
45/
8
Reference
dose
(
RfD)
=
0.00065
mg/
kg
bw/
day
Comment:
Formetanate
Chronic
Water
only
(
PA
apple
scenario)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Food
Crop
Residue
Adj.
Factors
Comment
EPA
Code
Grp
Food
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­
­
86010000
O
Water,
direct,
all
sources
0.000080
1.000
1.000
86020000
O
Water,
indirect,
all
sources
0.000080
1.000
1.000
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
54
  
57
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
FORMETANATE
HYDROCHLORIDE
(
1994­
98
data)
Residue
file
name:
C:\
DEEMFCID\
formetanteFT\
Dec.
2005
Assessment\
Formetanate
Chronic
Water
only
­
PA
apple
scenario.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
12­
01­
2005/
10:
29:
45
Residue
file
dated:
12­
01­
2005/
10:
28:
45/
8
Reference
dose
(
RfD,
Chronic)
=
.00065
mg/
kg
bw/
day
COMMENT
1:
Formetanate
Chronic
Water
only
(
PA
apple
scenario)
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.000002
0.3%

U.
S.
Population
(
spring
season)
0.000002
0.3%
U.
S.
Population
(
summer
season)
0.000002
0.3%
U.
S.
Population
(
autumn
season)
0.000002
0.3%
U.
S.
Population
(
winter
season)
0.000002
0.3%

Northeast
region
0.000002
0.2%
Midwest
region
0.000002
0.3%
Southern
region
0.000002
0.2%
Western
region
0.000002
0.3%

Hispanics
0.000002
0.3%
Non­
hispanic
whites
0.000002
0.3%
Non­
hispanic
blacks
0.000002
0.2%
Non­
hisp/
non­
white/
non­
black
0.000002
0.3%

All
infants
(<
1
year)
0.000006
0.9%
Nursing
infants
0.000002
0.3%
Non­
nursing
infants
0.000007
1.1%
Children
1­
6
yrs
0.000002
0.4%
Children
7­
12
yrs
0.000002
0.2%

Females
13­
19
(
not
preg
or
nursing)
0.000001
0.2%
Females
20+
(
not
preg
or
nursing)
0.000002
0.3%
Females
13­
50
yrs
0.000002
0.3%
Females
13+
(
preg/
not
nursing)
0.000002
0.3%
Females
13+
(
nursing)
0.000002
0.4%

Males
13­
19
yrs
0.000001
0.2%
Males
20+
yrs
0.000002
0.2%
Seniors
55+
0.000002
0.3%

Children
1­
2
yrs
0.000003
0.4%
Children
3­
5
yrs
0.000002
0.4%
Children
6­
12
yrs
0.000002
0.2%
Youth
13­
19
yrs
0.000001
0.2%
Adults
20­
49
yrs
0.000002
0.2%
Adults
50+
yrs
0.000002
0.3%
Females
13­
49
yrs
0.000002
0.2%
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
55
  
57
Tuesday,
November
15,
2005
13:
14
Screening
Level
Estimates
of
Agricultural
Uses
of
formetanate
Sorted
Alphabetically
Crop
Lbs.
A.
I.
Percent
Crop
Ttd.
Avg.
Max.
1
Alfalfa
9,000
<
1
<
2.5
2
Apples
20,000
5
5
3
Grapefruit
4,000
<
1
5
4
Grapes
1,000
<
1
<
2.5
5
Lemons
10,000
10
15
6
Nectarines
(
NCFAP
'
97)
40,000
60
7
Oranges
20,000
<
1
<
2.5
8
Peaches
5,000
5
5
9
Pears
2,000
5
5
10
Prunes
&
Plums
1,000
<
1
<
2.5
______________________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
56
  
57
Email:
Jihad
Alsadek/
DC/
USEPA/
US
To
Danette
Drew/
DC/
USEPA/
US@
EPA
11/
21/
2005
10:
49
AM
Danette,
I
would
use
the
46
percent
nectarine
treated
in
03,
97
NCFAP
is
too
old
to
use.
I
checked
CA
data
for
previous
years
and
found
out
amount
of
nectarine
acres
treated
with
formetanate
are
falling,
see
my
explanation
in
a
footnote
for
CA
Data
file
attached
below
to
replace
the
old
file
that
I
sent
you
a
while
ago.
Art
Grube,
our
programmer,
is
working
on
providing
CA
data
rather
then
NCFAP
when
there
are
no
data
form
Doane
and/
or
USDA/
NASS.
thanks,
jihad.

Jihad
Alsadek,
PhD.,
Economist
CM2­
Rm.
911FF
Usage
and
Label
Use
Team
(
ULUT)
Science
Information
and
Analysis
Branch
(
SIAB)
Biological
and
Economic
Analysis
Division
(
BEAD)
Office
of
Pesticide
Programs
(
OPP)
United
States
Environmental
Protection
Agency
(
USEPA)
1200
Pennsylvania
Avenue,
NW,
7503C
Washington,
D.
C.
20460­
0001
Phone:
(
703)
308­
8140
Fax:
(
703)
308­
8091
Email:
alsadek.
jihad@
epa.
gov
Formetanate
Hydrochloride
Dietary
Exposure
Assessment
DP
Barcode:
D323946
PC
Code:
097301
    
57
  
57
Department
of
Pesticide
Regulation
2003
Annual
Statewide
Pesticide
Use
Report
Indexed
by
Chemical
Agricultural
Amount
Unit
Chemical
Commodity
Pounds
Applied
Applications
Treated
Type
FORMETANATE
HYDROCHLORIDE
ALFALFA
1,394.9960
37
2,199.50
A
APPLE
813.2800
20
76.00
A
GRAPEFRUIT
14.9500
2
13.00
A
LEMON
21.3900
3
19.00
A
N­
GRNHS
PLANTS
IN
CONTAINERS0.6327
7
0.28
A
0.0656
3
30,000.00
S
TOTALPOUNDSONTHISCOMMODITY
0.6983
N­
OUTDR
PLANTSINCONTAINERS
43.2768
11
30.95
A
NECTARINE1
16,819.5176
1,348
16,836.69
A
ORANGE
7,902.4955
266
7,562.33
A
PEACH
317.2091
38
389.23
A
PEAR
39.2582
7
96.16
A
PLUM
102.8100
14
110.00
A
TANGERINE
910.1376
20
1,057.50
A
Chemical
Total
28,419.5791
1,779
Prepared
by:
Jihad
Alsadek,
703­
308­
8140
Monday,
June
19,
2006
1
99
percent
of
nectarines
are
grown
in
California
for
fresh,
and
1­
2
percent
are
processed.
In
2003­
2004,
36,500
acres
are
grown
,
hence
percent
nectarines
treated
with
formetanate
will
be
approximately
46%
(
16,837/
36,500*
100),
compared
to
60%
cited
by
National
Center
for
Food
and
Agricultural
Policy
(
NCFAP),
which
is
too
old
to
be
used
in
risk
assessment.
Amount
treated
are
on
the
decline
side,
23,518
acres
treated
in
01,
and
20,712
treated
with
formetanate
in
2002.