Document ID: EPA-HQ-OPP-2003-0075-0001
Agency: epa
Document Type: Rule
Title: Folpet; Pesticide Tolerance
Posted Date: 2003-03-05T05:00Z

10377
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
paragraph
(
a),
and
by
removing
and
reserving
paragraph
(
b)
as
follows:
§
180.448
Hexythiazox;
tolerances
for
residues.
(
a)
*
*
*

Commodity
Parts
per
million
Date,
dried
fruit
1.0
(
b)
[
Reserved]
*
*
*
*
*
[
FR
Doc.
03
 
5194
Filed
3
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0075;
FRL
 
7296
 
2]

Folpet;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
folpet
(
N­
(
trichloromethylthio)
phthalimide)
in
or
on
hop,
dried
cones.
Makhteshim­
Agan
of
North
America
Inc.
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
March
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0075,
must
be
received
on
or
before
May
5,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
 
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Richard
P.
Keigwin,
Jr.,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7618;
email
address:
keigwin.
richard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111),
Crop
production.
 
Industry
(
NAICS
112),
Animal
production.
 
Industry
(
NAICS
311),
Food
manufacturing.
 
Industry
(
NAICS
32532),
Pesticide
manufacturing.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0075.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml__
00/
Title__
40/
40cfr180_(_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
January
9,
2003
(
68
FR
1182)
(
FRL
 
7287
 
7),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
2E6512)
by
Makhteshim­
Agan
of
North
America
Inc.,
551
Fifth
Ave.,
Suite
1100
New
York,
NY
10176.
That
notice
included
a
summary
of
the
petition
prepared
by
Makhteshim­
Agan
of
North
America
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.191
be
amended
by
establishing
a
tolerance
for
residues
of
the
fungicide
folpet,
(
N
 
(
trichloromethylthio)
phthalimide),
in
or
on
hop
at
120
parts
per
million
(
ppm).
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00033
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10378
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).
III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
folpet
on
hop,
dried
cones
at
100
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.
A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
folpet
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
NOAEL
=
160
milligrams/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
500
mg/
kg/
day
based
on
5
percent
decrease
in
body
weight
870.3150
90
 
Day
oral
toxicity
in
nonrodents
NOAEL
=
<
790
mg/
kg/
day
(
lowest
dose
tested)(
LDT)
LOAEL
=
790
mg/
kg/
day
based
on
decreased
weight
gain
in
males
and
females,
testicular
atrophy
in
males
870.3200
28
 
Day
dermal
toxicity
NOAEL
=
1
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
dermal
irritation;
systemic
toxicity
as
reduced
body
weight
gain
occurred
only
at
doses
greater
than
10
mg/
kg/
day
870.3700
Prenatal
developmental
in
rodents
Crl:
COBS­
CD­(
SD)
BR
strain.
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
60
mg/
kg/
day
based
on
reduced
body
weight
Developmental
NOAEL
=
60
mg/
kg/
day
LOAEL
=
360
mg/
kg/
day
based
on
possible
incomplete
ossification
of
one
or
both
pubes
and/
or
eschia
870.3700
Prenatal
developmental
in
rodents
CD
Rats
Maternal
NOAEL
=
150
mg/
kg/
day
LOAEL
=
550
mg/
kg/
day
based
on
decreased
body
weight
gain,
soft
feces
Developmental
NOAEL
=
<
150
mg/
kg/
day
(
LDT)
LOAEL
=
550
mg/
kg/
day
based
on
small
fetuses,
reduced
ossification
of
interparietal
bone
as
well
as
increase
in
angulated
ribs
870.3700
Prenatal
developmental
in
nonrodents
HY/
CR
Albino
Rabbits
Maternal
NOAEL
=
40
mg/
kg/
day
LOAEL
=
160
mg/
kg/
day
based
on
decrease
in
body
weight
gain
and
food
consumption
Developmental
NOAEL
=
10
mg/
kg/
day
LOAEL
=
40
mg/
kg/
day
based
on
delayed
ossification
of
sternebrae
and
lack
of
ossification
of
caudal
vertebrae
distal
to
caudal
vertebra
15.

870.3700
Prenatal
developmental
in
nonrodents
NZW
Rabbits
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
20
mg/
kg/
day
based
on
decreased
food
consumption
&
body
weight
gain
during
gestation.
At
60
mg/
kg/
day,
decreased
food
consumption
&
body
weight
gain,
hydrocephalus
and
related
skull
malformations.
Developmental
NOAEL
=
10
mg/
kg/
day
LOAEL
=
20
mg/
kg/
day
based
on
Increased
incidence
of
hydrocephalus
&
domed
skull
&
irregularly
shaped
fontanelles
870.3800
Reproduction
and
fertility
effects
Charles
River
Rat
Parental/
Systemic
NOAEL
=
19.1
mg/
kg/
day
in
males;
22.5
mg/
kg/
day
in
females
LOAEL
=
112
mg/
kg/
day
in
males
and
134
mg/
kg/
day
in
females
based
on
diffuse
hyperkeratosis
of
the
non­
glandular
epithelium
of
in
both
sexes
of
both
generations.
Reproductive
NOAEL
=
370
mg/
kg/
day
in
males;
436
mg/
kg/
day
in
females
highest
dose
tested
(
HDT)
Offspring
NOAEL
=
112
mg/
kg/
day
in
males
and
134
mg/
kg/
day
in
females
LOAEL
=
370
mg/
kg/
day
in
males
and
565
mg/
kg/
day
in
females
based
on
lower
pup
body
weights
primarily
in
the
F1
litter
generation
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00034
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10379
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3800
Reproduction
and
fertility
effects
Sprague­
Dawley
Rat
Parental/
Systemic
NOAEL
=
35
mg/
kg/
day
LOAEL
=
160
mg/
kg/
day
based
on
decreased
weight
gain
in
F1
offspring.
Reproductive
NOAEL
=
35
mg/
kg/
day
LOAEL
=
160
mg/
kg/
day
based
on
decreased
fertility
in
males
870.4100
Chronic
toxicity
rodents
Crl:
CD(
SD)
BR
albino
rats
NOAEL
=
10
mg/
kg/
day
LOAEL
=
40
mg/
kg/
day
based
on
ulceration/
erosion,
hyperkeratosis
of
stomach
in
males
and
females
870.4100
Chronic
toxicity
rodents
Fischer
344
Rat
NOAEL
=
25
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
hyperkeratosis
of
nonglandular
epithelium
of
stomach
in
both
sexes.

870.4100
Chronic
toxicity
rodents
NOAEL
=
12
mg/
kg/
day
in
males;
15
mg/
kg/
day
in
females
LOAEL
=
81
mg/
kg/
day
in
males
and
100
mg/
kg/
day
in
females
based
on
an
increase
in
incidence
and
severity
of
hyperkeratosis
of
the
esophagus
and
nonglandular
epithelium
of
the
stomach.

870.4100
Chronic
toxicity
dogs
NOAEL
=
10
mg/
kg/
day
LOAEL
=
60
mg/
kg/
day
based
on
decreased
food
consumption
&
body
weight
gain;
decreased
serum
cholesterol
and
serum
proteins
870.4200
Carcinogenicity
rats
Crl:
CD(
SD)
BR
albino
rats
NOAEL
=
Not
achieved.
LOAEL
=
10
mg/
kg/
day
on
increased
incidence
of
C­
cell
adenoma
&
carcinoma
of
thyroid
in
males
&
intrietical
cell
tumors
of
testes
870.4200
Carcino­
genicity
rats
Fischer
344
Rat
NOAEL
=
50
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
on
increased
benign
fibroepithelial
tumor
of
the
mammary
glands
&
C­
cell
adenoma
of
the
thyroid
No
evidence
of
carcinogenicity
870.4200
Carcinogenicity
mice
B6C3F1
Strain
NOAEL
=
Not
achieved.
LOAEL
=
150
mg/
kg/
day
based
on
duodenal
carcinoma
and
stomach
papilloma
both
sexes;
malignant
lymphoma
in
high
dose
females
only
Evidence
of
carcinogenicity
870.4200
Carcinogenicity
mice
CD­
1
Mice
NOAEL
=
Not
achieved.
LOAEL
=
150
mg/
kg/
day
based
on
a
dose
related
increase
in
incidence
of
intestinal
adenomas
and
adenocarcinomas
in
both
sexes
Evidence
of
carcinogenicity
870.5195
Mutagenic­
Lymphoma
Mutation
in
L5178Y/
TK
mouse
lymphoma
cells
Positive
for
forward
mutations
in
L5178Y/
TK
mouse
lymphoma
cells.
Higher
concentration
necessary
in
the
presence
of
S­
9
fraction
870.5275
Mutagenic­
Sex
Link
Recessive
in
Drosophilia
Positive
for
sex
linked
recessive
lethals
870.5300
Mutagenic­
In
vivo
Cytogenetic
toxicity
in
Mouse
No
effect
on
the
incidence
of
coat
color
spots
­
negative
for
mutations.
Significant
pup
mortality
at
all
doses
levels.
Decreased
survival
of
pups
during
lactation.
Increased
melanocyte
toxicity
in
pups
at
4310
ppm,
decreased
weight
gain
in
dams
at
4310.

870.5300
Mutagenic­
In
Vivo
Cytogenetic
in
Mouse
Decreases
in
the
number
and
percentage
of
live
born
pups;
maternal
weight
gain
870.5375
Mutagenic­
Chromosome
Aberration
in
Rats
Not
a
clastogen
at
the
HDT.
No
measure
of
cytotoxicity
in
bone
marrow.
Dose
used
not
supported
by
evidence
that
the
HDT
was
a
maximum
tolerated
dose.

870.5380
Cytogenetics
Chromosome
Aberration
in
Chinese
hamster
ovary
cells
Folpet
was
tested
up
to
toxicity
in
non­
activated
(
2.5
µ
g/
mL)
&
activated
Chinese
hamster
ovary
cells
(
CHO)
(
25.7
&
75.0
µ
g/
mL)
in
10
&
20
hour
assays.
Results:
There
was
a
10­
30
fold
difference
in
toxicity
sensitivity.
The
test
article
induced
chromosomal
aberrations
at
marginally
cytotoxic
concentrations
of
0.75
µ
g/
mL
in
the
non­
activated
system,
and
0.26
µ
g/
mL
in
the
10
hour
activ.
assay,
but
required
25.0
µ
g/
mL
in
the
20
hour
activation
assay.

870.5395
Mutagenic
Micronucleus
Assay
in
the
Mouse
(
CD­
1)
No
evidence
of
mutagenicity.

870.5450
Mutagenic­
Dominant
Lethal
Test
in
the
Mouse
Negative
for
mutation
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00035
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10380
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5500
Mutagenic­
Reverse
Mutation
Positive
direct
acting
mutagen.
Both
batches
tested
were
equally
mutagenic.
Effect
of
metabolic
activation
not
assessed.

870.5500
Mutagenic­
DNA
Repair
Test
Positive
for
DNA
damage
without
metabolic
activation.

870.5550
Unscheduled
DNA
Synthesis
in
WI
38
Fibroblasts:
Positive
in
the
presence
of
metabolic
activation
only.

870.5500
Reverse
Mutation
Positive
for
reverse
mutations
in
Salmonella
TA100,
TA1535
&
TA1538,
&
in
E.
coli
WP2.
Rat
liver
S­
9
had
no
effect
on
mutagenicity
870.5575
Mutagenic­
Recomb/
Convers
Assay
Positive
for
recombinants
with/
without
metabolic
activity.

870.6200
Acute
neurotoxicity
screening
battery
Not
available.

870.6200
Subchronic
neurotoxicity
screening
battery
Not
available.

870.6300
Developmental
neurotoxicity
Not
available.

870.7485
Metabolism
and
pharmacokinetics
Doses:
50
and
5,000
ppm.
Results:
The
5,000
ppm
level
had
been
shown
to
cause
the
tumors
in
mice
but
not
in
rats.
The
studies
suggested
that
folpet
was
tumorigenic
in
the
mouse
and
not
in
the
rat
because:
Greater
intake
in
the
mouse
and
greater
target
tissue
exposure
to
active
metabolites
that
the
mouse
could
not
detoxify;
greater
local
effects
on
mouse
upper
gastrointestinal
tract;
and
greater
reliance
by
the
mouse
on
glutathione
for
detoxification
of
folpet.

870.7485
Metabolism
and
pharmacokinetics
C14­
Folpet
was
administered
orally
to
Sprague­
Dawley
rats
in
3
studies:
1.
Single
dose
of
10
mg/
kg;
2.
Single
dose
of
500
mg/
kg;
and
3.
On
day
15,
10
mg/
kg
of
C14­
Folpet
after
14
consecutive
days
of
unlabeled
folpet
at
10
mg/
kg.
Samples
were
examined
for
radioactivity
for
up
to
120
hours
post
C14­
dosing.
Results:
1.
Single
C14­
Folpet
at
10
mg/
kg
was
absorbed
>
90%
of
the
dose,
there
was
rapid
urinary
excretion
and
by
120
hours,
there
was
little
detactable
radioactivity.
2.
Single
C14­
Folpet
at
500
mg/
kg
was
about
60%
absorbed
with
the
urinary
excretion
rate
being
slower
that
after
the
10
mg/
kg
dose
(
possibly
due
to
rate­
limiting
absorption).
3.
Single
C14­
Folpet
at
10
mg/
kg
following
14
daily
non­
labeled
doses
of
10
mg/
kg
yielded
results
similar
to
those
observed
after
a
single
c14
dose.
4.
No
accumulation
of
folpet
was
detected
during
the
5
days
after
dosing;
concentrations
of
radioactivity
in
measured
tissues
were
generally
below
the
limit
of
detection
at
10
mg/
kg
or
were
detected
at
very
low
levels
at
500
mg/
kg.
5.
Phthalamic
acid
was
determined
to
be
the
single
active
metabolite
found
in
urine
&
it
was
suggested
that
its
formation
from
Folpet
may
have
been
by
trichloro­
methylthio
groups
loss
and
hydrolytic
cleavage
of
the
maleimide
ring.
At
10
mg/
kg,
the
major
fecal
metabolite
was
phthalamic
acid
and
at
500
mg/
kg,
the
radioactivity
was
primarily
associated
with
unchanged
C14­
folpet
(
assumed
to
be
unabsorbed
test
article).

870.7600
Dermal
penetration
Doses:
C14­
Folpet
was
administered
dermally
to
male
doses
of
10,
1,
0.1,
and
0.01
mg/
rat
(
200
uL
volume
of
test
suspension
to
18.9
cm2
of
clipped
skin)
for
up
to
24
hours.
Blood,
urine,
feces,
carcass
and
skin
radioactivity
was
measured
(
up
to
24
hrs).
Results:
1.
Rapid
absorption
into
the
skin
and
carcass;
2.
Low
blood
levels;
3.
Primary
excretion
by
urine
with
rate
apparently
inversely
related
to
quantity
applied
and
4.
Minor
bile
involvement
in
excretion
as
little
in
feces.

VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00036
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10381
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
the
LOAEL
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factors
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
folpet
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
FOLPET
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
50
years
of
age)
NOAEL
=
10
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.1
mg/
kg/
day
Developmental
Toxicity
Study
in
Rabbits
LOAEL
=
20
mg/
kg/
day
based
on
an
increased
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations
Chronic
Dietary
(
All
populations)
NOAEL
=
9
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.09
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.09
mg/
kg/
day
Chronic
Toxicity
Study
in
Rat
LOAEL
=
35
mg/
kg/
day
based
on
hyperkeratosis/
acanthosis
and
ulceration/
erosion
of
non­
glandular
stomach
epithelium
in
both
sexes
Short­
Term
Dermal
(
1
to
7
days)
(
Residential)
oral
study
NOAEL=
10
mg/
kg/
day
(
dermal
absorption
rate
=
2.7%)
LOC
for
MOE
=
100
(
Residential)
Developmental
Toxicity
Study
in
Rabbits
LOAEL
=
20
mg/
kg/
day
based
on
an
increased
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations
Intermediate­
Term
Dermal
(
1
week
to
several
months)
(
Residential)
oral
study
NOAEL
=
10
mg/
kg/
day
(
dermal
absorption
rate
=
2.7%
LOC
for
MOE
=
100
(
Residential)
Developmental
Toxicity
Study
in
Rabbits
LOAEL
=
20
mg/
kg/
day
based
on
an
increased
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations
Short­
Term
Inhalation
(
1
to
7
days)
(
Residential)
oral
study
NOAEL=
10
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Developmental
Toxicity
Study
in
Rabbits
LOAEL
=
20
mg/
kg/
day
based
on
an
increased
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations
Intermediate­
Term
Inhalation
(
1
week
to
several
months)
(
Residential)
oral
study
NOAEL
=
10
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Developmental
Toxicity
Study
in
Rabbits
LOAEL
=
20
mg/
kg/
day
based
on
an
increased
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations
Cancer
(
oral,
dermal,
inhalation)
Cancer
potency
factor
(
Q1*)
is
1.86
x
10­
3.
Based
on
increased
incidences
of
adenomas
and
carcinomas
in
the
duodenum
of
male
and
female
mice
in
two
strains
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00037
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10382
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.191)
for
the
residues
of
folpet,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
folpet
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model­
Food
Commodity
Intake
Database
(
DEEMFCIDTM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
Anticipated
residues
for
most
commodities
and
percent
crop
treated
for
many
commodities.
For
hop,
the
dietary
exposure
analysis
assumed
tolerance
level
residues
and
100
percent
crop
treated.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
Food
Commodity
Intake
Database
(
DEEM
FCID
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998]
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
Anticipated
residues
for
most
commodities
and
percent
crop
treated
for
many
commodities.
For
hop,
the
dietary
exposure
analysis
assumed
tolerance
level
residues
and
100
percent
crop
treated.
iii.
Cancer.
In
conducting
this
cancer
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
Food
Commodity
Intake
Database
(
DEEMFCIDTM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
Anticipated
residues
for
most
commodities
and
percent
crop
treated
for
many
commodities.
For
hop,
the
dietary
exposure
analysis
assumed
tolerance
level
residues
and
100
percent
crop
treated.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
The
Agency
did
use
anticipated
residue
calculations
in
conducting
its
risk
assessment.
These
calculations
are
based
upon
submitted
field
trial
data
and
could
be
further
refined
through
the
use
of
monitoring
data.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
PCT
information
as
follows.
The
only
registered
food
use
of
folpet
in
the
United
States
is
avocados
grown
in
Florida.
According
to
data
available
from
the
United
States
Department
of
Agriculture's
National
Agricultural
Statistics
Service,
California
accounted
for
89
percent
of
avocado
production
in
the
United
States,
followed
by
Florida
at
nearly
11
percent
and
Hawaii
at
approximately
0.1
percent.
Therefore,
the
Agency
has
assumed
that
only
11
percent
of
the
U.
S.
avocado
crop
is
treated
with
folpet.
As
stated
earlier,
for
the
hop
use,
the
Agency
assumed
100
percent
crop
treated
even
though
imports
of
hop
accounted
for
less
than
50
percent
of
the
crop
consumed
in
the
United
States,
based
upon
data
available
from
the
Hop
Growers
of
American
2001
Statistical
Report.
For
all
other
commodities
(
except
hops
and
avocados),
the
Agency
assumed
a
maximum
percent
crop
treated
value
of
1%
for
each
commodity
(
i.
e.,
apple,
cranberry,
cucumber,
grape,
lettuce,
melon,
onion,
strawberry,
and
tomato)
based
upon
information
derived
through
an
analysis
of
import
and
domestic
production
data
available
from
the
United
States
Department
of
Agriculture
for
the
years
1995
through
1999
and
adjusted
for
the
countries
in
which
folpet
is
registered.
The
Agency
believes
that
the
three
conditions
listed
in
Unit
III.
have
been
met.
With
respect
to
Condition
1,
PCT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
In
using
these
data,
the
Agency
also
took
into
account
the
specific
countries
where
folpet
is
registered.
In
the
case
of
avocados,
the
Agency
based
its
PCT
estimate
on
the
volume
of
the
avocado
crop
grown
in
the
United
States,
utilizing
data
from
the
U.
S.
Department
of
Agriculture.
For
all
potentiallytreated
commodities,
EPA
used
estimated
maximum
PCT
assumptions
in
conducting
both
the
acute
and
chronic
dietary
exposure
assessments.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00038
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10383
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
folpet
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
folpet
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
folpet.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
folpet
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E..
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
folpet
for
acute
exposures
are
estimated
to
be
309
parts
per
billion
(
ppb)
for
surface
water
and
0.83
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.62
ppb
for
surface
water
and
0.83
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Folpet
is
currently
registered
for
use
as
an
additive
in
paints
and
stains
for
use
both
occupationally
and
by
the
homeowner.
Four
major
exposure
scenarios
for
homeowner
handlers
using
folpet
containing
paints
and
stains
labeled
for
pesticidal
use
and
three
major
scenarios
for
homeowners
using
folpet
containing
products
not
labeled
for
pesticidal
use
were
evaluated.
The
highest
exposure
level
for
combined
inhalation
and
dermal
exposures
were
based
upon
a
homeowner
applying
a
ready­
to­
use
stain
formulation
with
an
airless
sprayer.
This
exposure
level
was
used
to
estimate
the
short­
and
intermediate­
term
risks
for
folpet.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
folpet
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
folpet
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
folpet
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).
Captan
and
folpet
share
a
common
metabolite,
thiophosgene,
which
the
Agency
believes
to
be
responsible
for
the
carcinogenic
effects
of
these
compounds.
Thiophosgene
is
a
highly
reactive,
short­
lived
compound.
Studies
indicate
that
thiophosgene
causes
local
irritation
of
the
site
with
which
it
comes
in
contact,
and
is
believed
to
cause
tumors
through
irritation
of
the
duodenum.
Because
they
are
so
shortlived
thiophosgene
residues
cannot
be
quantified.
Without
measurable
residues
of
the
common
metabolite,
it
is
difficult
to
relate
exposures
of
captan
to
those
of
folpet
since
the
formation
of
thiophosgene
may
be
different
for
both
compounds.
However,
assuming
that
the
carcinogenic
effects
observed
in
both
pesticides
are
due
solely
to
the
metabolite
thiophosgene,
the
Agency
believes
it
is
reasonable
to
add
the
estimate
cancer
risks
from
the
individual
aggregate
risks
from
both
folpet
and
captan
to
obtain
a
worst­
case
estimate.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
data
provided
no
indication
of
increased
susceptibility
in
two
prenatal
developmental
toxicity
studies
in
rats
following
in
utero
or
in
the
two
(
2)
2
 
generation
reproduction
studies
in
rats.
Two
developmental
toxicity
studies
in
rabbits
are
also
available.
In
a
study
with
New
Zealand
rabbits,
folpet
caused
an
increase
in
the
incidence
of
hydrocephalus
in
fetuses
and
with
the
associated
dome
skull
and
irregularlyshaped
fontanelles
at
the
mid
and
high
dose
groups
in
the
presence
of
maternal
toxicity.
Both
fetal
and
litter
incidences
of
this
malformation
were
increased
in
a
dose­
related
manner.
There
were
no
toxicological
effects
noted
on
litter
size,
resorptions,
sex
ratio,
or
number
of
skeletal
malformations.
For
maternal
toxicity,
the
NOAEL
was
10
mg/
kg/
day
and
the
LOAEL
was
20
mg/
kg/
day,
based
on
decreased
body
weight
gain
and
food
consumption.
For
developmental
toxicity,
the
NOAEL
was
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00039
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10384
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
10
mg/
kg/
day
and
the
LOAEL
was
20
mg/
kg/
day,
based
upon
an
increase
in
the
number
of
fetuses
and
litters
with
hydrocephaly
and
related
skull
malformations.
Although
the
developmental
malformations
(
hydrocephaly)
and
associated
maternal
toxicity
occur
at
similar
doses,
such
effects
are
toxic
manifestations
as
a
result
of
exposure.
In
order
to
determine
the
critical
period
of
treatment
for
the
occurrence
of
hydorcephaly
and
other
treatmentrelated
fetal
anomalies
observed
in
the
above
study,
another
developmental
toxicity
study
was
conducted
with
the
same
strain
of
rabbit
with
the
highest
dose
group
(
60
mg/
kg/
day)
receiving
folpet
on
gestation
days
7­
9,
10­
12,
13­
15,
or
16­
18.
The
incidence
of
hydrocephalus
was
higher
than
historical
or
concurrent
controls,
but
lower
than
in
the
previous
study.
The
maternal
toxicity
noted
was
a
doserelated
decreased
food
consumption
and
variable
decrease
in
body
weight
gain.
Significantly
increased
incidence
of
irregularly­
shaped
fontanelles
and
slightly
increased
incidences
of
angulated
hyoid
alae
were
noted
in
the
60
mg/
kg/
day
dose
group.
In
a
second
rabbit
developmental
toxicity
study,
HY/
CR
strain
rabbits
received
folpet
on
gestation
days
7
through
19.
For
maternal
toxicity,
the
NOAEL
was
40
mg/
kg/
day
and
the
LOAEL
was
160
mg/
kg/
day,
based
on
decreased
body
weights
and
food
consumption
as
well
as
clinical
signs.
For
developmental
toxicity,
the
NOAEL
was
10
mg/
kg/
day
and
the
LOAEL
was
40
mg/
kg/
day,
based
on
delayed
ossification
of
the
sternebrae.
There
was
no
evidence
of
hydrocephaly
observed
in
this
study
at
dose
levels
greater
than
in
the
previous
study.
In
addition,
the
Agency
examined
the
available
studies
for
captan,
the
structural
analog
of
folpet,
and
determined
that
there
was
no
indication
of
increased
susceptibility
of
rabbits
or
hamsters
to
pre­
or
post­
natal
exposure
to
captan.
In
prenatal
developmental
toxicity
studies
in
rabbits
and
hamsters
and
reproduction
studies
in
the
rat,
all
conducted
using
captan
as
the
test
material,
toxicity
to
the
offspring
occurred
at
equivalent
or
higher
doses
than
maternal
toxicity.
3.
Conclusion.
i.
There
is
a
complete
toxicity
data
base
for
folpet
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
Agency
has
determined
that
the
FQPA
Safety
Factor
can
be
reduced
to
1X
based
upon
the
following
weight­
of­
theevidence
considerations:
a.
There
was
no
evidence
of
quantitative
or
qualitative
susceptibility
in
two
developmental
toxicity
studies
in
the
rat;
b.
There
was
no
evidence
of
enhanced
suspectibility
to
the
pups
in
two
different
2
 
generation
reproduction
studies
in
the
rat;
c.
Folpet
is
not
a
cholinesterase
inhibitor
and,
therefore,
comments
made
at
the
June
26­
27,
2002
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
Scientific
Advisory
Panel
(
SAP)
meeting
on
the
Determination
of
the
Appropriate
FQPA
Safety
Factor(
s)
in
the
Organophosphorous
Pesticide
Cumulative
Risk
Assessment:
Susceptibility
and
Sensitivity
to
the
Common
Mechanism,
Acetylcholinesterase
Inhibition
should
not
influence
this
uncertainty
factor
decision.
d.
There
is
inconsistency
between
the
two
available
developmental
toxicity
studies
in
the
rabbit.
When
tested
at
lower
doses,
there
is
a
concern
for
hydrocephaly.
However,
when
this
study
was
repeated
in
the
same
strain
of
rabbit
at
higher
dose
levels,
no
evidence
of
hydrocephaly
was
observed.
Nevertheless,
for
purposes
of
risk
assessment,
the
Agency
has
selected
the
developmental
NOAEL
of
10
mg/
kg/
day
from
the
rabbit
developmental
study
in
which
hydrocephaly
was
observed
as
the
endpoint
for
evaluating
acute
risk.
e.
Other
than
the
one
rabbit
developmental
toxicity
study,
there
are
no
other
signs
from
the
available
toxicology
database
of
a
concern
for
neurotoxic
effects.
f.
Furthermore,
the
Agency's
exposure
assumptions
are
conservative.
The
assessment
assumes
that
all
hops
consumed
in
the
United
States
are
treated
with
folpet.
In
addition,
the
analysis
presumes
that
all
avocados
grown
in
Florida
are
treated
with
this
fungicide.
The
percent
crop
treated
data
for
the
imported
commodities
assumed
that
all
crop
exported
to
the
U.
S.
from
countries
in
which
folpet
is
registered
are
treated
with
this
chemical.
Therefore,
a
figure
of
1%
crop
treated
was
assumed
for
the
following
commodities:
Apple,
cranberry,
cucumber,
grape,
lettuce,
melon,
onion,
strawberry,
and
tomato.
ii.
The
Agency
has
also
determined
that
a
developmental
neurotoxicity
study
for
folpet
is
not
warranted
based
upon
the
following
considerations:
a.
Although
hydrocephalus
was
observed
in
one
developmental
toxicity
study
in
the
rabbit,
it
occurred
at
maternally
toxic
doses
and
was
only
seen
in
one
species;
b.
No
alterations
to
the
fetal
nervous
system
were
seen
in
the
developmental
rat
studies
at
the
same
doses
that
induce
hydrocephaly
in
rabbits;
c.
Although
there
are
no
acute
or
subchronic
neurotoxicity
studies
available,
there
is
no
evidence
of
neurotoxicity
or
neuropathology
in
adult
animals
in
any
of
the
studies;
d.
The
available
data
indicate
that
the
developmental
neurotoxicity
study
would
have
to
be
tested
at
dose
levels
higher
than
150
mg/
kg/
day
because
no
developmental
toxicity
was
observed
in
rats
at
2,000
mg/
kg/
day.
In
addition,
given
the
results
in
the
2
 
generation
reproduction
study
(
NOAEL
of
168
mg/
kg/
day),
it
is
anticipated
that
in
order
to
elicit
any
fetal
nervous
system
abnormalities
in
the
developmental
neurotoxicity
study,
the
selected
dose
levels
would
have
to
be
higher
than
160
mg/
kg/
day.
e.
Since
the
dose
level
selections
for
the
developmental
neurotoxicity
study
would
be
greater
than
160
mg/
kg/
day,
the
resultant
NOAEL
would
be
either
comparable
to,
or
higher
than,
the
doses
currently
used
in
the
risk
assessment.
The
NOAEL
of
10
mg/
kg/
day
selected
for
the
acute
reference
dose
and
the
residential
exposure
and
risk
assessments
is
seventeen
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
The
NOAEL
of
9
mg/
kg/
day
selected
for
the
chronic
reference
dose
is
nineteen
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
Therefore,
it
is
unlikely
that
the
developmental
neurotoxicity
study
would
change
the
current
doses
used
for
overall
risk
assessments.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00040
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10385
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
as
used
by
the
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
folpet
will
occupy
<
1
%
of
the
aPAD
for
females
13
years
and
older.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
folpet
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
FOLPET
Population
Subgroup
aPAD
(
mg/
kg/
day)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females,
13­
49
years
old
0.1
<
1
309
0.83
2,800
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
folpet
from
food
will
utilize
less
than
1%
of
the
cPAD
for
all
population
subgroups
within
the
United
States.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
folpet
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
folpet
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
FOLPET
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.09
<
1%
0.62
0.83
3,100
All
Infants
0.09
<
1%
0.62
0.83
900
Children,
1­
2
years
0.09
<
1%
0.62
0.83
900
Females,
13­
49
years
0.09
<
1%
0.62
0.83
2,700
Adults,
50+
years
0.09
<
1%
0.62
0.83
3,100
3.
Short­
term
and
intermediate­
term
risk.
Short­
term
and
intermediate­
term
aggregate
exposures
take
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Folpet
is
currently
registered
for
use
that
could
result
in
short­
term
and
intermediate­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
and
intermediate­
term
exposures
for
folpet.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
and
intermediate­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
370.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
shortterm
and
intermediate­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
folpet
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
or
intermediate­
term
aggregate
exposures
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENTS
FOR
SHORT­
TERM
AND
INTERMEDIATE­
TERM
EXPOSURES
TO
FOLPET
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
DWLOC
(
ppb)

Females,
13­
49
years
370
100
0.62
0.83
2,200
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00041
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10386
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
4.
Aggregate
cancer
risk
for
U.
S.
population.
The
aggregate
cancer
risk
(
food
plus
residential)
from
exposure
to
folpet
is
estimated
to
be
7.2
x
10­
8.
Assuming
a
negligible
risk
level
of
1.0
x
10­
6,
the
cancer
DWLOC
would
be
15
ppb.
Based
on
the
FIRST
and
SCIGROW
models
the
EECs
for
chronic
exposures
to
folpet
are
estimated
to
be
0.62
ppb
for
surface
water
and
0.83
ppb
for
ground
water,
significantly
lower
than
the
DWLOC.
As
discussed
in
Unit
III.
C.
4.,
captan
and
folpet
share
a
common
metabolite,
thiophosgene,
which
the
Agency
believes
to
be
responsible
for
the
carcinogenic
effects
of
these
compounds.
Thiophosgene
is
a
highly
reactive,
short­
lived
compound.
Studies
indicate
that
thiophosgene
causes
local
irritation
of
the
site
with
which
it
comes
in
contact,
and
is
believed
to
cause
tumors
through
irritation
of
the
duodenum.
Because
they
are
so
shortlived
thiophosgene
residues
cannot
be
quantified.
Without
measurable
residues
of
the
common
metabolite,
it
is
difficult
to
relate
exposures
of
captan
to
those
of
folpet
since
the
formation
of
thiophosgene
may
be
different
for
both
compounds.
However,
assuming
that
the
carcinogenic
effects
observed
in
both
pesticides
are
due
solely
to
the
metabolite
thiophosgene,
the
Agency
believes
it
is
reasonable
to
add
the
estimate
cancer
risks
from
the
individual
aggregate
risks
from
both
folpet
and
captan
to
obtain
a
worst­
case
estimate.
For
captan,
the
estimated
cancer
risk
for
the
U.
S.
population
from
exposure
to
food
only
is
1.26
x
10­
7.
As
discussed
above,
the
estimate
cancer
risk
(
food
only)
from
exposure
to
folpet
is
7.2
x
10­
8.
If
these
two
risk
estimates
are
added
together,
the
total
estimated
cancer
risk
is
2.0
x
10­
7.
Assuming
a
negligible
cancer
risk
in
the
range
of
1.0
x
10­
6
to
3.0
x
10­
6,
the
smallest
cancer
DWLOC
would
be
11
ppb.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
for
chronic
exposures
to
folpet
are
estimated
to
be
0.62
ppb
for
surface
water
and
0.83
ppb
for
ground
water.
The
EECs
for
chronic
exposure
to
captan
are
estimated
to
be
4
ppb
for
surface
water
and
1
ppb
for
groundwater.
The
combined
EECs
for
chronic
exposure
to
captan
plus
folpet
are
5
ppb
for
surface
water
and
2
ppb
for
groundwater,
both
below
the
DWLOC
of
11
ppb.
5.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
folpet
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
adequate
gas
chromatography/
electron
capture
detector
(
GC/
ECD)
analytical
method
is
available
for
enforcing
tolerances
of
folpet
in
or
on
plant
commodities.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
No
CODEX
MRLs
exist
for
folpet
on
hop.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
folpet,
(
N
 
(
trichloromethylthio)
phthalimide),
in
or
on
hop,
dried
cones
at
120
ppm.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0075
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
May
5,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.

VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00042
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10387
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0075,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
February
25,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00043
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1
10388
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Rules
and
Regulations
Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.
2.
Section
180.191
is
amended:
i.
By
designating
the
existing
text
as
paragraph
(
a)
and
adding
a
heading,
and
alphabetically
adding
a
commodity
to
the
table
in
newly
designated
paragraph
(
a);
and
ii.
By
adding
and
reserving
with
headings
paragraphs
(
b),
(
c),
and
(
d)
to
read
as
follows:

§
180.191
Folpet;
tolerances
for
residues.
(
a)
General.
*
*
*

Commodity
Parts
per
million
*
*
*
*
*

Hop,
dried
cones
1201
*
*
*
*
*

1
There
are
no
U.
S.
registrations
on
hop,
dried
cones
as
of
February
14,
2003
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
03
 
5192
Filed
3
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
73
Radio
Broadcasting
Services;
Clarendon,
TX
CFR
Correction
In
Title
47
of
the
Code
of
Federal
Regulations,
Parts
70
to
79,
revised
as
of
October
1,
2002,
in
§
73.202(
b),
on
page
108,
the
Table
of
FM
Allotments
is
amended
under
Texas
by
adding
Clarendon,
Channel
257C2.

[
FR
Doc.
03
 
55507
Filed
3
 
4
 
03;
8:
45
am]

BILLING
CODE
1505
 
01
 
D
DEPARTMENT
OF
THE
INTERIOR
Fish
and
Wildlife
Service
50
CFR
Part
17
RIN
1080
 
AI17
Endangered
and
Threatened
Wildlife
and
Plants;
Final
Rule
to
List
the
Columbia
Basin
Distinct
Population
Segment
of
the
Pygmy
Rabbit
(
Brachylagus
idahoensis)
as
Endangered
AGENCY:
Fish
and
Wildlife
Service,
Interior.
ACTION:
Final
rule.

SUMMARY:
We,
the
U.
S.
Fish
and
Wildlife
Service
(
Service),
determine
endangered
status
for
the
Columbia
Basin
distinct
population
segment
of
the
pygmy
rabbit
(
Brachylagus
idahoensis)
pursuant
to
the
Endangered
Species
Act
of
1973,
as
amended
(
Act).
This
population
consists
of
fewer
than
30
wild
individuals
in
Douglas
County,
Washington,
and
a
small
captive
population.
The
Columbia
Basin
pygmy
rabbit
is
imminently
threatened
by
recent
decreases
in
its
population
size
and
distribution
that
have
caused
it
to
be
susceptible
to
the
combined
influence
of
catastrophic
environmental
events,
habitat
degradation
and
fragmentation,
disease,
predation,
demographic
limitations,
and
loss
of
genetic
heterogeneity.
We
find
that
these
threats
constitute
a
significant
risk
to
the
wellbeing
of
the
Columbia
Basin
pygmy
rabbit
and,
as
such,
make
the
protective
measures
afforded
by
the
Act
immediately
available
with
publication
of
this
final
rule.
DATES:
This
rule
becomes
effective
on
March
5,
2003.
ADDRESSES:
The
complete
file
for
this
final
rule
is
available
for
inspection,
by
appointment,
during
normal
business
hours
at
the
U.
S.
Fish
and
Wildlife
Service,
Upper
Columbia
Fish
and
Wildlife
Office,
11103
East
Montgomery
Drive,
Spokane,
Washington
99206.

FOR
FURTHER
INFORMATION
CONTACT:
Christopher
Warren,
at
the
address
listed
above
(
telephone
509/
891
 
6839;
facsimile
509/
891
 
6748;
electronic
mail:
chris_
warren@
fws.
gov).

SUPPLEMENTARY
INFORMATION:

Background
The
pygmy
rabbit
(
Brachylagus
idahoensis)
is
a
member
of
the
family
Leporidae,
which
includes
hares
and
rabbits.
The
species
has
been
placed
in
a
number
of
genera
since
it
was
first
classified
in
1891
as
Lepus
idahoensis
(
Washington
Department
of
Fish
and
Wildlife
(
WDFW)
1995a).
In
1904,
it
was
reclassified
and
placed
in
the
genus
Brachylagus.
In
1930,
it
was
again
reclassified
and
placed
in
the
genus
Sylvilagus.
More
recent
examination
of
dentition
(
Hibbard
1963)
and
analysis
of
blood
proteins
(
Johnson
1968)
suggest
that
the
pygmy
rabbit
differs
significantly
from
species
within
either
the
Lepus
or
Sylvilagus
genera.
The
pygmy
rabbit
is
now
generally
considered
to
be
within
the
monotypic
genus
Brachylagus,
and
classified
as
B.
idahoensis
(
Green
and
Flinders
1980a;
WDFW
1995a).
There
are
no
recognized
subspecies
of
the
pygmy
rabbit
(
Dalquest
1948;
Green
and
Flinders
1980a).
The
pygmy
rabbit
is
the
smallest
Leporid
in
North
America,
with
mean
adult
weights
from
375
to
about
500
grams
(
0.83
to
1.1
pounds),
and
lengths
from
23.5
to
29.5
centimeters
(
cm)
(
9.3
to
11.6
inches
(
in))
(
Orr
1940;
Janson
1946;
Wilde
1978;
Gahr
1993;
WDFW
1995a;
T.
Katzner,
Arizona
State
University,
pers.
comm.
2002).
Females
tend
to
be
slightly
larger
than
males.
Pygmy
rabbits
undergo
an
annual
molt.
During
summer,
their
overall
color
is
slate­
gray
tipped
with
brown.
Their
legs,
chest,
and
nape
(
back
of
neck)
are
tawny
cinnamon­
brown,
their
bellies
are
whitish,
and
the
entire
edges
of
their
ears
are
pale
buff.
Their
ears
are
short
(
3.5
to
5.2
cm
(
1.4
to
2.0
in)),
rounded,
and
thickly
furred
outside.
Their
tails
are
small
(
1.5
to
2.4
cm
(
0.6
to
0.9
in)),
uniform
in
color,
and
nearly
unnoticeable
in
the
wild
(
Orr
1940;
Janson
1946;
WDFW
1995a).
The
pygmy
rabbit
is
distinguishable
from
other
Leporids
by
its
small
size,
short
ears,
gray
color,
small
hind
legs,
and
lack
of
white
on
the
tail.
Pygmy
rabbits
are
typically
found
in
areas
of
tall,
dense
sagebrush
(
Artemisia
spp.)
cover,
and
are
highly
dependent
on
sagebrush
to
provide
both
food
and
shelter
throughout
the
year
(
Orr
1940;
Green
and
Flinders
1980a;
WDFW
1995a).
The
winter
diet
of
pygmy
rabbits
is
comprised
of
up
to
99
percent
sagebrush
(
Wilde
1978),
which
is
unique
among
Leporids
(
White
et
al.
1982).
During
spring
and
summer
in
Utah,
their
diet
consists
of
roughly
51
percent
sagebrush,
39
percent
grasses
(
particularly
native
bunch­
grasses,
such
as
Agropyron
spp.
and
Poa
spp.),
and
10
percent
forbs
(
an
herb
other
than
grass)
(
Green
and
Flinders
1980b).
There
is
evidence
that
pygmy
rabbits
preferentially
select
native
grasses
as
forage
during
this
period
in
comparison
to
other
available
foods.
In
addition,
total
grass
cover
relative
to
forbs
and
shrubs
may
be
reduced
within
the
immediate
areas
occupied
by
pygmy
rabbits
as
a
result
of
its
use
as
a
food
source
during
spring
and
summer
(
Green
and
Flinders
1980b).
The
specific
diets
of
pygmy
rabbit
populations
likely
change
depending
on
the
region
occupied
(
T.
Katzner,
pers.
comm.
2002).
The
pygmy
rabbit
is
believed
to
be
one
of
only
two
Leporids
in
North
America
that
digs
its
own
burrows
(
Nelson
1909;
Green
and
Flinders
1980a;
WDFW
1995a),
the
other
being
the
volcano
rabbit
(
Romerolagus
diazi)
found
in
central
Mexico
(
Durrell
and
Mallinson
1970).
Pygmy
rabbit
burrows
VerDate
Jan<
31>
2003
18:
49
Mar
04,
2003
Jkt
200001
PO
00000
Frm
00044
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
05MRR1.
SGM
05MRR1