Document ID: EPA-HQ-OPP-2002-0250-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-24T04:00Z

OVERVIEW
OF
FENARIMOL
RISK
ASSESSMENT
Introduction
This
document
presents
an
overview
of
EPA's
human
health
findings
and
conclusions
for
the
fungicide
fenarimol,
as
presented
fully
in
the
documents:"
Fenarimol:
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED),"
dated
February
12,
2002,
and
"
Drinking
Water
Assessment
to
Support
TRED
for
fenarimol,"
dated
August
6,
2001.
The
purpose
of
this
overview
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
this
risk
reassessment
in
order
to
better
understand
the
conclusions
reached
in
the
tolerance
reassessment.
This
overview
was
developed
in
response
to
comments
and
requests
from
the
public,
which
indicated
that
the
risk
assessments
were
difficult
to
understand,
that
they
were
too
lengthy,
and
that
it
was
not
easy
to
compare
the
assessments
for
different
chemicals
due
to
the
use
of
different
formats.

The
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
requires
EPA
to
review
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
FQPA.
In
reviewing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non­
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
The
tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.

FQPA
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non­
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.

EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
the
Tolerance
Reassessment
Decision
(
TRED)
for
fenarimol
because
the
Agency
has
not
yet
initiated
a
comprehensive
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
For
purposes
of
this
risk
assessment,
EPA
has
assumed
that
fenarimol
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
In
the
future,
the
registrant
may
be
asked
to
submit,
upon
EPA's
request
and
according
to
2
a
schedule
determined
by
the
Agency,
such
information
as
the
Agency
directs
to
be
submitted
in
order
to
evaluate
issues
related
to
whether
fenarimol
shares
a
common
mechanism
of
toxicity
with
any
other
substance
and,
if
so,
whether
any
tolerances
for
fenarimol
need
to
be
modified
or
revoked.
The
Agency
has
developed
a
framework
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
was
issued
on
January
16,
2002
(
67
FR
2210­
2214)
and
is
available
from
the
OPP
Website
at:
http://
www.
epa.
gov/
pesticides/
trac/
science/
cumulative_
guidance.
pdf.

The
risk
assessment,
and
documents
pertaining
to
the
Agency's
report
on
FQPA
tolerance
reassessment
progress
and
risk
management
decision
for
fenarimol
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
in
the
public
docket
for
viewing.
The
Agency's
report
on
FQPA
tolerance
reassessment
progress
and
risk
management
decision
for
fenarimol
will
be
announced
in
the
Federal
Register.

Use
Profile
$
Fungicide:
Fenarimol
is
registered
for
treatment
of
apples,
bananas,
cherries,
filberts,
grapes,
pears,
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
and
residential/
recreational
turf.
Fenarimol
is
a
systemic
fungicide
that
inhibits
fungal
growth.

$
Formulations:
Formulated
as
flowable
concentrate
(
2.4%
ai),
granular
(
0.78%
ai,
turf
use
only),
soluble
concentrate
(
11.6%
ai),
and
emulsifiable
concentrates
(
12%
ai).

$
Methods
of
Application:
Granules
can
be
applied
by
hand
or
by
granule
applicator
(
belly
grinder,
push
type
spreader).
Other
formulations
are
applied
by
high
or
low
volume
ground
sprayers.

$
Use
Rates:
The
maximum
rate
for
fruit
and
nut
trees
is
0.09375
lb
ai/
A.
The
maximum
rate
for
ornamentals
is
0.34
lb/
350
gal.
The
maximum
rate
for
turf
is
2.73
lb
ai/
A.

$
Registrants:
Gowan
Company,
Riverdale,
and
Leesco.

$
Use
Summary:
Total
annual
domestic
use
averages
approximately
61,000
thousand
pounds
of
active
ingredient.
The
largest
markets,
in
terms
of
total
pounds
active
ingredient
are
apples
(
33%),
nursery
outdoors
(
20%),
turf
for
lawn
(
16%),
and
turf
for
golf
courses
(
12%).
The
remaining
usage
is
primarily
on
raisin
and
wine
grapes,
almonds,
cherries,
hazelnuts,
and
pears.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
apples
(
25%),
sweet
cherries
(
13%),
tart
cherries,
wine
grapes,
and
hazelnuts
(
9%
each),
and
table
grapes
(
8%).
3
Human
Health
Risk
Assessment
Acute
Dietary
Risk
(
Food)

No
appropriate
endpoint
was
identified
in
the
toxicological
data
base
to
estimate
risk
from
a
single
dose
administration
of
fenarimol.
Therefore,
an
acute
dietary
exposure
assessment
was
not
performed.

Chronic
Dietary
Risk
(
Food)

(
For
a
complete
discussion,
see
section
4.2
of
the
Human
Health
Risk
Assessment)

Chronic
dietary
risk
is
calculated
by
using
the
average
consumption
value
for
food
and
average
residue
values
on
those
foods
over
a
70­
year
lifetime.
A
risk
estimate
that
is
less
than
100%
of
the
chronic
RfD
(
the
dose
at
which
an
individual
could
be
exposed
over
the
course
of
a
lifetime
and
no
adverse
health
effects
would
be
expected)
does
not
exceed
the
Agency's
level
of
concern.
The
cPAD
is
the
chronic
reference
dose
(
cRfD)
adjusted
for
the
FQPA
Safety
Factor.

Chronic
risk
estimates
from
exposures
to
food
do
not
exceed
the
Agency's
level
of
concern.
The
chronic
dietary
(
food
only)
risk
estimate
is
<
1%
of
the
cPAD,
for
the
U.
S.
Population
and
all
subpopulations.
This
is
not
surprising
based
on:
the
lack
of
detectable
residues
for
many
commodities
in
the
FDA
monitoring
data;
no
residues
expected
in
milk,
poultry
and
hogs;
and,
low
anticipated
residues
for
cattle
meat,
fat,
and
meat
by­
products.

$
The
toxicity
endpoint
for
the
chronic
dietary
assessment
is
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
based
on
the
results
of
a
rat
reproduction
study
(
NOAEL
=
0.6
mg/
kg/
day).
These
effects
were
observed
at
1.2
mg/
kg/
day
(
LOAEL).

$
The
Uncertainty
Factor
is
100x;
10x
for
inter­
species
variation
and
10x
for
intra­
species
extrapolation.

$
The
10x
FQPA
Safety
Factor
has
been
reduced
to
3x
for
chronic
exposure
scenarios
to
account
for
the
potential
increased
sensitivity
of
young
organisms
to
the
hormonal
effects
elicited
by
fenarimol's
inhibition
of
aromatase.

$
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996­
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
4
available,
were
used.
There
were
no
PDP
monitoring
data
available
for
fenarimol.

$
The
chronic
Population
Adjusted
Dose
(
cPAD)
is
0.002
mg/
kg/
day
(
chronic
RfD
0.006
mg/
kg/
day
÷
3x
FQPA
safety
factor).

$
Drinking
Water
Dietary
Risk
(
For
a
complete
discussion,
see
section
4.3
of
the
Human
Health
Risk
Assessment)

Drinking
water
exposure
to
pesticides
can
occur
through
groundwater
and
surface
water
contamination.
EPA
considers
both
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
either
modeling
or
actual
monitoring
data,
if
available,
to
estimate
those
risks.
To
determine
the
maximum
allowable
contribution
of
treated
water
allowed
in
the
diet,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food,
then
calculates
a
"
drinking
water
level
of
comparison"
(
DWLOC)
to
determine
whether
modeled
or
monitoring
concentrations
exceed
this
level.

The
DWLOCs
represent
the
maximum
contribution
to
the
human
diet
(
in
ppb
or
µ
g/
L)
that
may
be
attributed
to
residues
of
a
pesticide
in
drinking
water
after
dietary
exposure
is
subtracted
from
the
aPAD
or
cPAD.
Risks
from
drinking
water
are
assessed
by
comparing
the
DWLOCs
to
the
estimated
environmental
concentrations
(
EECs)
in
surface
water
and
groundwater.
Drinking
water
modeling
is
considered
to
be
an
unrefined
assessment
and
provides
high­
end
estimates.
Modeling
provides
a
screening­
level
assessment,
using
conservative
assumptions
to
estimate
high­
end
average
concentrations
(
EECs)
of
fenarimol
in
surface
water
and
groundwater.

$
An
acute
toxicity
endpoint
was
not
identified,
therefore,
an
acute
drinking
water
exposure
assessment
was
not
required.

$
Comparison
of
the
chronic
DWLOCs
with
the
chronic
EECs,
average
concentrations
of
fenarimol
in
surface
water
are
greater
than
the
DWLOCs
for
all
populations
indicating
a
concern
based
on
the
application
rate
to
turf.

$
The
chronic
surface
water
value
of
84
ppb
includes
all
residential
uses
and
the
golf
course
use
of
fenarimol.
However,
with
the
residential
uses
removed
from
the
label
a
correction
factor
of
.31
can
be
applied
to
the
84
ppb
surface
water
number
to
account
for
the
use
of
fenarimol
only
on
tees,
greens,
and
fairways
on
golf
courses.
This
would
reduce
the
chronic
EEC
to
26
ppb.

$
For
groundwater,
the
EECs
are
below
the
DWLOCs
for
all
populations
indicating
that
chronic
exposure
to
fenarimol
in
ground
water
is
not
of
concern.
5
Table
1
Fenarimol
­
Comparison
of
Chronic
DWLOC
and
EEC
Calculations
(
turf
uses)

Population
Subgroup
Chronic
DWLOC
Estimated
Environmental
Concentrations
Surface
Water
(
Chronic)
(
ppb)
Ground
Water
(
SCI­
GROW)
(
ppb)

U.
S.
Population
70
ppb
84
ppb
(
with
residential
and
golf
course
turf
uses)

26
ppb
(
with
residential
uses
removed
and
only
golf
course
use
remaining)
16
Females
13
­
50
yrs
60
ppb
Children
1­
6
yrs
20
ppb
All
Infants
20
ppb
$
Estimated
drinking
water
concentrations
for
ground
water
are
based
on
the
SCI­
GROW
model,
which
is
a
Tier
I
assessment
that
provides
a
high­
end
estimate.

$
Estimated
drinking
water
concentrations
for
surface
water
are
based
on
the
FIRST
model,
which
is
a
Tier
I
assessment
that
also
provides
a
high­
end
estimate.

$
The
use
of
fenarimol
on
turf
was
modeled
for
both
ground
water
and
surface
water.
The
turf
use
has
the
highest
application
rate
of
2.7
lbs
ai/
A.
The
turf
use
comprises
28%
or
approximately
17,000
lbs
of
the
total
fenarimol
use
of
61,000
lbs
applied
annually.
About
9800
lbs
are
used
on
lawns
and
about
7000
lbs
are
used
on
golf
course
turf.

$
Model
estimates
can
be
refined
when
additional
fate
data
become
available.

$
For
chronic
risk
to
surface
water,
the
EEC
of
84
ppb
is
above
the
chronic
DWLOCs
of
70
ppb
for
general
population,
60
ppb
for
females
13­
50
years
old,
and
20
ppb
for
infants
and
children
1­
6
years,
indicating
that
chronic
exposure
to
fenarimol
in
surface
water
may
be
of
concern
for
residential
turf
uses.

$
Removing
the
residential
turf
uses
from
the
labels
and
with
only
the
golf
course
use
remaining
would
reduce
the
chronic
surface
water
DWLOC
to
26
ppb.

$
Surface
water
modeling
for
drinking
water
uses
a
percent
cropped
area
factor
(
PCA).
The
PCA
represents
the
fraction
of
a
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
having
a
PCA
factor
for
a
particular
crop
a
default
PCA
of
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.

$
For
chronic
risk
to
groundwater,
the
EEC
of
16
is
below
the
chronic
DWLOCs
of
70
ppb
for
general
population,
60
ppb
for
females
13­
50
years
old,
and
20
ppb
for
infants
and
children
1­
6
years,
indicating
that
chronic
exposure
to
fenarimol
in
ground
water
is
not
of
6
concern.

$
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
refine
the
assessment.

$
Very
limited
water
monitoring
data
are
available
for
fenarimol.

Residential
Risk
The
registrants
have
agreed
to
add
prohibitions
on
the
labels
indicating
that
fenarimol
products
are
not
for
use
or
sale
to
homeowners.
Also,
the
registrants
have
agreed
to
delete
residential
uses
from
end­
use
labels
until
data
are
developed
to
further
clarify
potential
risk
to
children.
The
following
summary
is
provided
to
outline
the
rationale
for
deleting
this
use
as
an
interim
mitigation
measure.

Residential
Postapplication
Risk
$
For
the
short­
term
(
1­
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia
(
difficult
labor),
an
indicator
of
hormonal
effects,
observed
in
a
special
nonguideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
LOAEL
is
used
an
additional
3x
uncertainty
factor
was
applied
in
addition
to
the
10x
interspecies,
10x
intraspecies,
and
3x
FQPA
factor.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
900
does
not
exceed
the
Agency's
level
of
concern
for
these
risk
assessments.

$
Increasing
the
minimum
retreatment
interval
on
residential/
recreational
turf
from
7
to
30
days
would
eliminate
the
residential
postapplication
intermediate­
term
exposure
scenarios.
This
is
based
on
chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
which
estimates
that
the
dissipation
of
fenarimol
is
approximately
8%
per
day.

$
Only
short­
term
risks
from
residential
postapplication
dermal
and
incidental
oral
exposures
are
anticipated
and
were
estimated
for
fenarimol.
No
intermediate­
or
long­
term
exposure
scenarios
are
anticipated
due
to
proposed
labeling
changes.
Postapplication
inhalation
exposures
are
not
anticipated
because
the
vapor
pressure
of
fenarimol
is
low
(
2.2
x
10­
7
mmHg).

$
A
5%
dermal
absorption
factor
was
derived
from
a
monkey
study.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
radioactivity
not
accounted
for,
a
value
of
5%
is
appropriate.

$
The
scenarios
assessed
for
the
purpose
of
determining
risk
estimates
included
adults
and
7
children
performing
high­
contact
play
or
work
activities
on
treated
lawns,
and
adults
mowing
lawns
or
golfing.
Small
children
(
toddlers)
were
also
assessed
for
incidental
oral
exposure
from
hand­
to­
mouth
activities
while
playing
on
a
treated
lawn.
Some
of
these
exposures
were
combined,
where
it
was
deemed
reasonably
likely
that
activities
would
cooccur

$
Risk
estimates
for
short­
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
(
e.
g.
playing)
on
day
zero
following
application
exceed
the
Agency's
estimated
level
of
concern,
i.
e.
result
in
MOEs
<
900
for
children
(
MOE
=
660).
Risk
estimates
for
short­
term
dermal
contact
with
fenarimol
residues
on
treated
turf
on
the
day
of
treatment
do
not
exceed
the
level
of
concern
for
adults
during
the
low
contact
activities
of
grass
mowing
(
MOE
=
27,000)
or
golfing
(
MOE
=
14,000).

$
EPA
assessed
short­
term
exposure
of
small
children
from
incidental
episodic
ingestion
of
fenarimol
granules
following
application
to
residential
lawns.
The
risk
calculations
indicate
that
ingestion
of
fenarimol
granules
(
MOE
=
220)
exceed
the
level
of
concern
(
MOEs
<
900).
However,
EPA
considers
the
incidental
episodic
risk
of
ingestion
of
fenarimol
granules
to
be
unlikely
given
the
small
particle
size
of
fenarimol
granules
and
the
low
percentage
of
active
ingredient
(
0.78%).
Approximately
93%
of
the
product
has
a
particle
diameter
range
of
0.594
to
0.841
mm,
with
the
remaining
7%
in
the
0.841
to
2
mm
size.
The
granules
are
white
in
color.
If
evenly
distributed,
individual
grains
would
be
difficult
to
pick
up,
or
even
to
see
when
applied
on
a
lawn.
Therefore,
this
product
would
be
difficult
for
a
small
child
to
grasp
and
then
mouth
or
ingest.

$
EPA
also
assessed
short­
term
exposures
to
small
children
from
incidental
episodic
ingestion
of
residues
following
application
to
residential
lawns.
The
risk
calculations
for
small
children's
non­
dietary
hand­
to­
mouth
activities
(
MOE
=
860)
indicate
that
risks
exceed
the
level
of
concern
(
MOEs
<
900).
Incidental
ingestion
of
soil
(
MOE
=
260,000)
and
incidental
turfgrass
mouthing
(
MOE
=
3400)
did
not
exceed
the
level
of
concern
(
MOEs
<
900).
The
small
children's
combined
oral
hand­
to­
mouth
scenarios
(
except
granular
ingestion)
also
exceeds
the
level
of
concern
(
MOE
=
690).
When
risk
estimates
to
small
children
from
short­
term
dermal
exposures
are
combined
with
risk
estimates
from
all
incidental
oral
exposures
(
except
episodic
ingestion
of
fenarimol
granules)
the
combined
short­
term
risk
estimate
exceeds
the
level
of
concern
(
MOE
=
340).

$
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available.
A
dissipation
rate
of
8%
daily
was
derived
from
this
data
and
translated
to
residential
application.
The
Residential
SOPs
were
utilized
to
estimate
initial
residues
(
i.
e.
DAT
0
residues)
based
on
application
rate
and
to
estimate
contact
rates
with
turf.
The
data
show
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
Therefore,
due
to
the
variability
of
the
study
transfer
efficiency
data,
the
poor
quality
of
the
study
itself,
and
because
no
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study,
a
5%
transfer
efficiency
8
rate
was
used
for
risk
assessment
purposes.
Additional
TTR
data
would
allow
further
refinement
of
the
exposure
estimate.
Aggregate
Risk
(
For
a
complete
discussion,
see
section
5.0
of
the
Human
Health
Risk
Assessment)

$
The
aggregate
risk
assessment
for
fenarimol
examines
the
combined
risk
from
exposure
through
food,
drinking
water,
and
residential
exposure
where
applicable.

$
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
aggregate
risk
assessment
is
not
required.

$
Based
on
agreements
with
the
registrant
regarding
amendments
(
i.
e.,
removal
of
residential
uses)
to
product
labels,
the
Agency
anticipates
neither
residential
handler
nor
residential
postapplication
exposure
to
children.
Consequently,
these
scenarios
were
not
included
in
an
aggregate
risks
assessment.

$
Since
the
residential
uses
are
being
removed
from
the
labels
only
the
short­
term
dermal
postapplication
exposures
for
adult
golfers
was
combined
with
the
average
dietary
(
food
&
water)
exposures
in
a
short­
term
aggregate
risk
assessment.
The
aggregate
risk
estimate
for
the
postapplication
short­
term
dermal
exposure
scenario
of
golfing
did
not
exceed
the
Agency's
level
of
concern.
The
exposure
from
food
is
zero
for
adults;
therefore,
the
aggregate
risk
estimates
include
only
dermal
and
water
exposures.
The
short­
term
DWLOCs
are
calculated
to
be
1267
ppb
for
adult
males
and
1086
ppb
for
adult
females
which
are
well
above
the
estimated
EECs
for
ground
(
16
ppb)
and
surface
water
(
26
ppb),
and
indicate
that
combined
short­
term
dietary
(
food
&
water)
and
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.

$
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
ground
water.

$
Excluding
the
residential
use,
the
EEC
for
surface
water
(
26
ppb)
slightly
exceeds
the
DWLOC
for
children
under
6.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
The
surface
water
EEC
is
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).

Occupational
and
Ecological
Risk
$
Because
fenarimol
is
under
review
for
tolerance
reassessment
only,
no
occupational
or
ecological
risk
assessment
was
not
conducted.
9
Tolerance
Reassessment
Summary
(
For
a
complete
discussion,
see
Fenarimol,
Product
and
Residue
Chemistry
Chapter
for
the
Tolerance
Reassessment
Eligibility
Decision,
dated
10/
18/
2001.)

The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.

Table
2
Tolerance
Reassessment
Summary
For
Fenarimol.

Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]

Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)

Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]

Apples
0.1
0.1
[
Apple]

Cattle,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Cattle,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.

Cattle,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]

Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.

Goat,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Goat,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.

Goat,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]

Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]

10
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Horse,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.

Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]

Horse,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)

Pears
0.1
0.1
[
Pear]

Pecans
0.1
0.02
[
Pecan]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
pecans.

Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Sheep,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.

Sheep,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).

Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]

Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)

Bananas
1
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
bananas.

Cherries
1.0
1.0
[
Cherry]

Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]

11
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.

Grapes
0.2
0.1
[
Grape]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
grapes.

Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.

Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.

Tolerance
to
be
Established
Under
40
CFR
§
180.421(
a)(
1)

Filberts
not
applicable
0.02
Residue
chemistry
data
support
the
establishment
of
a
0.02
ppm
tolerance
for
filberts.

1
For
tolerance
reassessment
purposes,
the
banana
tolerance
is
counted
as
two
tolerances
to
reflect
the
baseline
count
determined
at
the
start
of
FQPA
(
bananas
and
bananas,
pulp).

Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
the
Table
below.
The
Table
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.

Table
3
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.

Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)

Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.

Artichoke
globe
0.1
­­

Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)

Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)

Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)

12
Grapes
0.3
0.1
Hops,
dry
5
­­

Melons,
except
watermelon
0.05
­­

Peach
0.5
­­

Pecan
0.02
(*)
0.02
(*)

Peppers,
sweet
0.5
­­

Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
­­

1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.

Fenarimol
Data
Gaps
The
following
confirmatory
data
requirements
have
been
initially
identified
by
the
Agency:

Environmental
Fate
Data:

835.1230
Sediment
and
Soil
Adsorption/
Desorption
for
parent
and
degradates
835.2240
Direct
Photolysis
Rate
of
Parent
and
Degradates
in
Water
835.2410
Photodegradation
of
Parent
and
Degradates
in
Soil
835.4300
Aerobic
Aquatic
Metabolism
for
parent
and
degradates
835.4400
Anaerobic
Aquatic
Metabolism
for
parent
and
degradates
835.6100
Terrestrial
Field
Dissipation
Product
and
Residue
Chemistry
Data:

Additional
data
are
required
concerning
enforcement
analytical
methods,
stability,
storage
stability,
pH,
UV/
Visible
absorption,
density,
octanol/
water
partition
coefficient,
and
solubility
(
OPPTS
830.1800,
6313,
6317,
7000,
7050,
7300,
7550,
and
7840)
of
the
T/
TGAI.

Storage
stability
data
for
livestock
commodities
are
required
to
support
the
storage
intervals
used
in
the
livestock
feeding
studies.

Toxicology
Data:

870.2500
Primary
Dermal
Irritation
Study
13
870.3465
28­
Day
Subchronic
Inhalation
Study
870.6300
Special
Developmental
Toxicity
Study
in
Rats