1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON
D.
C.,
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
June
8,
2006
SUBJECT:
Formetanate
Hydrochloride,
Addendum
to
the
HED
Revised
Risk
Assessment
for
Formetanate
Hydrochloride
dated
December
23,
2005
A
revised
human
health
risk
assessment
for
formetanate
hydrochloride
(
HCl)
was
issued
in
December
2005
that
included
a
dietary
exposure
assessment
which
incorporated
supported
food
uses
and
drinking
water.
Acute
anticipated
residues
for
all
foods
were
derived
using
field
trial
data.
Based
on
various
concerns
posed
by
stakeholders
during
the
comment
period
about
the
limited
nature
of
the
field
trial
data,
EPA
revised
its
dietary
exposure
assessment
to
incorporate
a
more
robust
residue
data
set
that
included
data
from
the
United
States
Department
of
Agriculture's
Pesticide
Data
Program
(
PDP)

As
a
result,
a
partially
refined
acute
probabilistic
dietary
exposure
assessment
was
conducted
for
all
supported
formetanate
HCl
food
uses
and
for
drinking
water.
Acute
anticipated
residues
for
all
foods
were
derived
using
either
field
trial
data
reflecting
current
maximum
label
rates
and
minimum
Pre­
Harvest
Intervals
(
PHI)
or
PDP
monitoring
data.

Field
trial
data
were
used
to
analyze
stone
fruits,
lemons,
limes,
tangelos
and
juice
(
orange
and
grapefruit).
PDP
data
were
used
to
analyze
apples,
pears,
oranges,
and
grapefruit.
Field
trial
data
were
used
for
orange
and
grapefruit
juice
since
PDP
data
reflect
residues
on
peeled
fruit
and
juice
is
extracted
from
whole
(
unpeeled)
fruit.

Estimated
residues
in
drinking
water
were
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
(
7.68
ppb).
This
eastern
crop
scenario
is
expected
to
provide
conservative
(
protective)
residue
values.

The
resulting
acute
dietary
exposure
and
risk
estimates
for
food
and
water
exceed
EPA's
level
of
concern
for
the
population
subgroups,
Infants
and
Children
1­
2
years
old.
Acute
dietary
(
food
+
water)
exposure
at
the
99.9th
percentile
was
estimated
at
162%
of
the
Acute
Population
Adjusted
Dose
(
aPAD)
for
the
most
highly
exposed
population
2
subgroup
(
infants).
Most
of
the
estimated
acute
exposure
from
food
was
determined
to
result
from
the
late
season
uses
of
formetanate
HCl
on
apples.

Formetanate
HCl
Acute
Dietary
Analysis
(
With
Late
Season
Use
on
Apples)
Population
Exposure
at
99.9th
Percentile
(
mg/
kg)
%
aPAD
General
U.
S.
Population
0.000308
47
All
Infants
(<
1
year
old)
0.001055
162
Children
1­
2
years
old
0.000771
119
Children
3­
5
years
old
0.000607
93
Children
6­
12
years
old
0.000329
51
Youth
13­
19
years
old
0.000183
28
Adults
20­
49
years
old
0.000213
33
Females
13­
49
years
old
0.000217
33
Adults
50+
years
old
0.000216
33
Removing
the
late
season
use
for
apples
resulted
in
a
dietary
risk
of
56%
(
for
food
only)
and
117%
(
food
plus
water)
of
the
aPAD
for
infants,
the
most
highly
exposed
subgroup.
All
other
populations
have
risks
below
EPA's
level
of
concern
(
69%
or
less
of
the
aPAD
occupied
after
late
season
apples
are
removed).

Formetanate
HCl
Acute
Dietary
Analysis
(
Without
Late
Season
Use
on
Apples)
Population
Risks
Without
Late
Season
Applications
on
Apples
(
Food
Only)
Risks
Without
Late
Season
Applications
on
Apples
(
Food
+
Water)
General
U.
S.
Population
25
37
All
Infants
(<
1
year
old)
56
117
Children
1­
2
years
old
56
69
Children
3­
5
years
old
51
64
Children
6­
12
years
old
34
41
Youth
13­
19
years
old
19
25
Adults
20­
49
years
old
16
29
Females
13­
49
years
old
17
31
Adults
50+
years
old
17
29
