Document ID: EPA-HQ-OPP-2002-0250-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-24T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
August
1,
2002
CERTIFIED
MAIL
Cindy
Baker
Gowan
Company
370
S.
Main
Street
PO
Box
5569
Yuma,
AZ
85366­
5569
Dear
Ms.
Baker:

This
is
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
EPA
or
the
Agency)
"
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Fenarimol",
which
was
approved
on
August
1,
2002.
A
Notice
of
Availability
of
this
tolerance
reassessment
decision
will
be
published
in
the
Federal
Register
(
FR).

The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
EPA
to
reassess
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
the
FQPA,
which
was
in
August
of
1996.
In
reassessing
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.
Once
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
Fenarimol
was
registered
prior
to
FQPA
enactment.
Therefore,
the
tolerances
need
to
be
reassessed
to
meet
the
FQPA
standard.

The
Agency
has
evaluated
the
dietary
risk
associated
with
fenarimol
and
has
determined
that
there
is
a
reasonable
certainty,
with
appropriate
mitigation,
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
fenarimol
when
considering
dietary
exposure
and
all
other
non­
occupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.

Residential
postapplication
exposure
was
of
concern
for
children
and
infants
from
incidental
ingestion
of
fenarimol
product
applied
in
residential
settings.
To
mitigate
this
risk
the
registrant
has
agreed
to
remove
the
residential
uses
from
their
labels
until
they
conduct
a
special
developmental
toxicity
study
that
will
assess
for
possible
effects
of
fenarimol
on
the
adult
and
juvenile
rat
hormonal
systems.
Once
these
data
are
submitted
and
reviewed,
the
Agency
will
make
a
determination
regarding
the
acceptability
of
the
residential
uses.
2
For
chronic
drinking
water
risk
from
surface
water,
potential
(
average)
Estimated
Environmental
Concentrations
(
EECs)
of
fenarimol
(
84
ppb)
exceeds
the
chronic
Drinking
Water
Level
of
Comparison
(
DWLOC)
for
all
populations.
The
84
ppb
value
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.
Infants
and
children,
the
most
sensitive
population
subgroups
would
still
exceed
the
chronic
DWLOC
of
20.
However,
the
chronic
EECs
were
estimated
using
Tier
I
modeling
and
only
slightly
exceed
the
DWLOC.
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
to
refine
the
chronic
surface
and
ground
water
drinking
water
risk
assessments.

FQPA
requires
that
EPA
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
reason
for
considering
other
substances
is
because
of
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
other
substances
individually.
EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
review
of
fenarimol,
because
the
Agency
has
not
determined
that
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
If
EPA
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
fenarimol,
then
a
cumulative
risk
assessment
will
be
conducted
that
includes
fenarimol
once
the
final
framework
EPA
will
use
for
conducting
cumulative
risk
assessments
is
available.
Further,
EPA
is
in
the
process
of
developing
criteria
for
characterizing
and
testing
endocrine
disrupting
chemicals
and
plans
to
implement
an
Endocrine
Disruptor
Screening
Program.
Fenarimol
will
be
reevaluated
at
that
time
and
additional
studies
may
be
requested.

The
Agency's
human
health
findings
for
the
pesticide
fenarimol,
are
summarized
in
the
enclosed
Fenarimol
Overview
and
Fenarimol
Summary
of
the
risk
assessments.
The
risk
assessments
and
other
documents
pertaining
to
the
fenarimol
tolerance
reassessment
decision
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
are
in
the
public
docket
for
viewing.

The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.
In
addition,
available
residue
chemistry
data
support
the
establishment
of
a
0.02
ppm
permanent
tolerance
for
fenarimol
residues
in
filberts
under
40
CFR
180.421
(
a).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
fenarimol.
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
available,
were
used
in
the
assessment.
There
were
no
PDP
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
nondetectable
(
below
the
method
limit
of
detection,
or
LOD)
in
all
1996­
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
nondetectable
(<
LOD)
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
Chronic
dietary
risks
from
exposure
do
not
exceed
the
Agency's
level
of
concern.
3
Table
1
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]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]

4
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
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.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]

5
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.

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.
6
Table
2
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
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.

Note
that
you
will
be
sent
a
Section
3(
c)(
2)(
B)
Data­
Call­
In
(
DCI)
letter
under
the
Federal
Insecticide,
Fungicide,
Rodenticide
Act
(
FIFRA)
in
a
separate
mailing.
If
you
have
questions
on
this
document,
please
contact
the
Chemical
Review
Manager,
Tom
Myers,
at
(
703)
308­
8589.

Sincerely,

Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Enclosures:
"
Fenarimol
Overview"
and
"
Fenarimol
Summary"