Document ID: EPA-HQ-OPP-2002-0344-0001
Agency: epa
Document Type: Notice
Title: Cyprodinil; Pesticide Tolerance
Posted Date: 2003-02-05T05:00Z

5839
Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
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
exemption
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.

XII.
Submission
to
Congress
and
the
Comptroller
General
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:
January
16,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
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:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.

2.
Section
180.1150
of
subpart
D
is
revised
to
read
as
follows:

§
180.1150
6­
Benzyladenine;
exemption
from
the
requirement
of
a
tolerance.

(
a)
The
plant
growth
regulator
6­
benzyladenine
is
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
fruit­
thinning
agent
at
an
application
rate
not
to
exceed
30
grams
of
active
ingredient
per
acre
in
or
on
apples.
(
b)
6­
Benzyladenine
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in
or
on
apples
at
 
182
grams
of
active
ingredient
per
acre
per
season,
and
in
or
on
pistachio
at
 
60
grams
of
active
ingredient
per
acre
per
season
when
used
in
accordance
with
the
Experimental
Use
Permit
73049
 
EUP
 
2.
The
temporary
exemption
from
a
tolerance
will
expire
on
January
31,
2005.
[
FR
Doc.
03
 
2431
Filed
2
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0344;
FRL
 
7289
 
7]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
cyprodinil
in
or
on
the
bushberry
subgroup,
caneberry
subgroup,
juneberry,
lingonberry,
pistachio,
salal
and
watercress.
The
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
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
February
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0344,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
besubmitted
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:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
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:
 
Crop
production
(
NAICS
Code
111)
 
Animal
production
(
NAICS
Code
112)
 
Food
manufacturing
(
NAICS
Code
311)
 
Pesticide
manufacturing
(
NAICS
Code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
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5840
Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
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
 
2002
 
0344.
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
May
1,
2002
(
67
FR
21671)(
FRL
 
6833
 
4),
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
pesticide
petitions
(
PP
2E6359,
2E6365,
2E6377
and
2E6393)
by
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Syngenta
Crop
Protection,
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.532
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
cyprodinil,
4­
cyclopropyl­
6­
methyl­
Nphenyl
2­
pyrimidinamine,
in
or
on
the
caneberry
subgroup
at
10.0
parts
per
million
(
ppm)
(
2E6393),
watercress
at
20
ppm
(
2E6365),
pistachio
at
0.07
ppm
(
2E6377)
and
the
bushberry
subgroup,
lingonberry,
juneberry,
and
salal,
at
3.0
ppm
(
2E6359).
IR­
4
subsequently
revised
the
petition
to
propose
the
following
tolerances
for
cyprodinil
residues
in
or
on
the
caneberry
subgroup
at
10.0
parts
per
million
(
ppm),
watercress
at
20
ppm,
pistachio
at
0.10
ppm
and
the
bushberry
subgroup,
lingonberry,
juneberry,
and
salal,
at
3.0
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
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
cyprodinil
on
the
caneberry
subgroup
at
10.0
parts
per
million
(
ppm),
watercress
at
20
ppm,
pistachio
at
0.10
ppm
and
the
bushberry
subgroup,
lingonberry,
juneberry,
and
salal,
at
3.0
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
cyprodinil
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effectlevel
(
LOAEL)
from
the
toxicity
studies
reviewed.

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Federal
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/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
mouse
NOAEL
=
73.3/
103
(
male/
female
(
m/
f))
milligram/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
257/
349
(
m/
f)
mg/
kg/
day
based
on
histopathological
changes
in
the
liver
(
m/
f)

870.3100
90
 
Day
oral
toxicity
rat
NOAEL
=
3.14
(
mg/
kg/
day)
LOAEL
=
19
mg/
kg/
day
based
on
increasedtubular
kidney
lesions
in
males
870.3150
90
 
Day
oral­
toxicity
­
dog
NOAEL
=
210/
232
(
m/
f)
mg/
kg/
day
LOAEL
=
560/
581
mg/
kg/
day
based
on
lowerbody­
weight
gains
and
decreased
food
consumption
inboth
sexes
870.3200
Carcinogenicity
­
mice
NOAEL
=
16.1
mg/
kg/
day
LOAEL
=
212.4
mg/
kg/
day
based
on
a
dose­
related
increase
in
the
incidence
of
focal
and
multifocal
hyperplasia
of
the
exocrine
pancreas
in
males
No
evidence
of
carcinogenicity
870.3700
Prenatal
developmental
­
rat
Maternal
NOAEL
=
200
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
lower
body­
weight/
body­
weight
gain
and
reduced
food
consumption
Developmental
NOAEL
=
200
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
lowermean
fetal
weights
and
increased
incidence
of
delayedossification
870.3700
Prenatal
developmental
­
rabbit
Maternal
NOAEL
=
150
mg/
kg/
day
LOAEL
=
400
mg/
kg/
day
based
on
decreasedbody­
weight
gain
Developmental
NOAEL
=
150
mg/
kg/
day
LOAEL
=
400
mg/
kg/
day
based
on
slight
increase
of
litters
showing
extra
(
13th)
ribs
870.3800
Reproduction
and
fertility
effects
­
rat
Parental/
Systemic
NOAEL
=
81
mg/
kg/
day
LOAEL
=
326
mg/
kg/
day
based
on
lowerbody­
weights
in
the
F0
females
during
the
pre­
matingperiod.
Reproductive/
Developmental
NOAEL
=
81mg/
kg/
day
LOAEL
=
326
mg/
kg/
day
based
on
decreasedpup
weights
(
F1
and
F2)

870.4100
Chronic
toxicity
dogs
NOAEL
=
65.63/
67.99
(
m/
f)
mg/
kg/
day
LOAEL
=
449.25/
446.3
(
m/
f)
mg/
kg/
day
based
on
lower
body­
weight
gains
and
decreased
food
consumption
and
food
efficiency
870.4300
Chronic
toxicity/
Carcinogenicity(
feeding)
­
rat
NOAEL
=
2.7
mg/
kg/
day
LOAEL
=
35.6
mg/
kg/
day
based
on
degenerative
liver
lesions
(
spongiosis
hepatis)
in
males
No
evidence
of
carcinogenicity
870.5265
and
870.5100
Gene
Mutation
In
a
reverse
gene
mutation
assay
withSalmonella
typhimurium/
Escherichia
coli,
cyprodinil
was
negative
up
to
concentrations
( 
1,250
µ
g/
plate
+/­
S9)
that
produced
reproducible
cytotoxicity
for
the
majority
of
strains.
Compound
insolubility
was
reported
at
 
313
µ
g/
plate.

870.5300
Gene
Mutation
In
a
Chinese
hamster
V79
cell
HGPRT
forward
gene
mutation
assay,
cyprodinil
was
negative
up
to
cytotoxic
concentrations
( 
96.0
µ
g/
mL
with
S9)
( 
24
µ
g/
mL
without
S9).

870.5375
Cytogenetics/
In
vitro
Chromosomal
Aberration
In
an
in
vitro
assay
for
chromosome
aberrations
in
Chinese
hamster
ovary
(
CHO)
cells,
cyprodinil
gave
negative
results
up
tocytotoxic
concentrations
( 
50
µ
g/
mL
without
S9,
18
 
or
42
 
hour
cell
harvest
or
 
25
µ
g/
mL
with
S9,
18
 
hour
cell
harvest)
or
to
the
highest
subcytotoxic
concentration
(
50
µ
g/
mL
with
S9,
42
 
hour
cell
harvest).

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TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5395
Cytogenetics/
In
vivo
bone
marrow
micronucleus
In
an
in
vivo
bone
marrow
micronucleus
assay,
cyprodinil
was
negative
when
administered
orally
(
gavage)
at
5,000
mg/
kg(
HDT)
to
both
sexes
of
Tif:
MAGF
mice.
No
signs
of
overt
toxicity
or
clear
evidence
of
cytotoxicity
for
the
target
organ
were
noted
at
any
dose
or
sacrifice
time.

870.5550
Unscheduled
DNA
Synthesis
In
an
Unscheduled
DNA
Synthesis(
UDS)
assay
in
primary
rat
hepatocytes,
cyprodinil
was
negative
up
to
a
cytotoxic
concentration
(
80
µ
g/
mL).

870.7485
Metabolism
and
pharmacokinetics
Single
oral
doses
(
0.5
or
100
mg/
kg
bw)
of
phenyl
or
pyrimidyl­
radiolabelled
cyprodinil
(
purity
 
98%)
were
administered
toTif:
RAIf(
SPF)
rats,
with
one
low­
dose
group
receiving
unlabelled
cyprodinil
(
purity
 
99%)
for
2
weeks
prior
to
treatment
with
radiolabelled
compound.
Absorption
was
very
rapid
(
tcmax=
0.3
hours)
with
rapid
clearance
(
tcmax/
2=
1.2
hours).
A
minimum
of
75%
of
the
administered
dose
was
absorbed.
Excretion
was
rapid
and
almost
complete,
with
urine
as
the
principle
route
of
excretion
(
48
 
68%),
and
>
90%
of
the
administered
dose
detected
in
the
urine
and
feces
within
48
hours.
Excretion,
distribution
and
metabolite
profiles
were
essentially
independent
of
dose
level,
pretreatment,
and
type
of
label,
although
there
were
some
quantitative
differences
sex­
dependent
qualitative
differences
in
two
urinary
metabolite
fractions.

870.7485
Metabolism
and
pharmacokinetics
Excreta
(
Group
D1
and
D2)
and
bile
(
Group
G1)
from
radiolabelled
cyprodinil­
treated
Tif:
RAIf(
SPF)
rats
were
used
to
characterize,
isolateand
identify
cyprodinil
metabolites
Eleven
metabolites
were
isolated
from
urine,
feces
and
bile,
and
the
metabolic
pathways
in
the
rat
were
proposed.
All
urinary
and
biliary
metabolites
(
with
the
exception
of
7U)
were
conjugated
with
glucuronic
acid
or
sulfonated,
and
excreted.
Cyprodinil
was
almostcompletely
metabolized
by
hydroxylation
of
the
phenyl
ring
(
position
4)
or
pyrimidine
ring
(
position
5),
followed
by
conjugation.
An
alternative
pathwayinvolved
oxidation
of
the
phenyl
ring
followed
by
glucuronic
acid
conjugation.
A
quantitative
sex
difference
was
observed
with
respect
to
sulfonation
ofthe
major
metabolite
that
formed
6U.
The
monosulfate
metabolite
(
1U)
was
predominant
in
females,
whereas
equal
amounts
of
mono­
and
disulfate
(
6U)
conjugates
were
noted
in
males.
Most
of
the
significant
metabolites
in
feces
were
exocons
of
biliary
metabolites
(
2U,
3U,
1G).
These
were
assumed
to
be
deconjugated
in
the
intestines,
partially
reabsorbed
into
the
generalcirculation,
conjugated
again,
and
eliminated
renally.
The
major
metabolic
pathways
of
cyprodinil
were
not
significantly
influenced
by
the
dose,
treatment
regimen,
or
sex
of
the
animal.

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
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
adverse
effects
of
concern
are
identified
(
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
intraspecies
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
factor
(
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
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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
cyprodinil
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CYPRODINIL
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
females
13
 
50years
of
age
Developmental
NOAEL
=
150
mg/
kg/
day
UF
=
100
Acute
RfD
=
1.5
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
÷
FQPA
SF
=
1.5
mg/
kg/
day
Developmental
Toxicity
­
rabbit
Developmental
LOAEL
=
400
mg/
kg/
day
based
on
slight
increase
of
litters
showing
extra
ribs
(
13th).

Chronic
Dietary
all
populations
NOAEL=
2.7
UF
=
100
Chronic
RfD
=
0.03
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.03
mg/
kg/
day
2
 
Year
Chronic
Toxicity/
Carcinogenicity­
rat
LOAEL
=
35.6
mg/
kg/
day
based
on
degenerative
liver
lesions
(
spongiosis
hepatis)
in
males.

Cancer
(
oral,
dermal,
inhalation
Classification:
``
not
likely
to
be
carcinogenic
tohumans''

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
tothe
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.352)
for
the
residues
of
cyprodinil,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
cyprodinil
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
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
insert
1989
 
1992
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:
100%
crop
treated
(
PCT)
and
tolerance­
level
residues
for
cyprodinil
on
all
treated
crops.
This
assessment
was
a
Tier
I
analysis.
However,
the
only
acute
endpoint
identified
was
for
the
population
subgroup
females
13
 
50
years
old
based
on
a
slight
increase
of
litters
showing
extra
ribs
(
13th).
No
effects
that
could
be
attributed
to
a
single
exposure
were
observed
(
no
end
point
was
chosen)
for
any
other
population
subgroup,
including
the
general
U.
S.
population;
therefore,
an
acute
dietary
assessment
for
the
general
U.
S.
population
or
other
subgroups
was
not
conducted.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
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:
100%
crop
treated
(
PCT)
and
tolerancelevel
residues
for
cyprodinil
on
all
treated
crops.
This
assessment
was
a
Tier
I
analysis.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
cyprodinil
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
cyprodinil.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCIGROW
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
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.

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Rules
and
Regulations
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
percent
of
reference
dose
or
percent
of
population
adjusted
dose.
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
cyprodinil
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
cyprodinil
for
acute
exposures
are
estimated
to
be
32
parts
per
billion
(
ppb)
for
surface
water
and
0.04
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
6
ppb
for
surface
water
and
0.04
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).
Cyprodinil
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
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
cyprodinil
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,
cyprodinil
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
cyprodinil
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).

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.
There
is
no
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
followingin
utero
exposure
in
the
developmental
studies
with
cyprodinil.
There
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
cyprodinil.
3.
Conclusion.
With
the
exception
of
missing
21/
28
 
day
dermal­
toxicity
and
28
 
day
inhalation­
toxicity
studies
in
rats,
there
is
a
complete
toxicity
data
base
for
cyprodinil
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Since
there
are
no
residential
uses
for
cyprodinil
the
only
exposure
route
to
infants
and
children
is
the
oral
route,
for
which
the
toxicity
and
exposure
data
base
is
complete.
Therefore
dermal
and
inhalationtoxicity
studies,
are
not
needed
to
assess
risk
to
infants
and
children
and
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
should
be
reduced
to
1X.
The
FQPA
10X
safety
factor
is
removed
because:
 
i.
There
are
currently
no
registered
or
proposed
residential(
nonoccupational
uses
of
cyprodinil.
 
ii.
There
was
no
evidence
(
qualitative
or
quantitative)
of
increased
susceptibility
in
the
developmental
rat
or
rabbit
study
following
in
utero
exposure
or
in
the
two­
generation
reproduction
study
following
pre­
or
post­
natal
exposure.
 
iii.
There
was
also
no
evidence
of
a
neurodevelopmental
effect
in
the
rat
or
rabbit
developmental
toxicity
studies
or
in
the
rat
two­
generation
reproductivetoxicity
study.
 
iv.
There
are
no
data
deficiencies
for
pre­
and/
or
post­
natal
exposure
and
hence
there
are
no
residual
uncertainties.
 
v.
Food
and
drinking
water
exposure
assessments
will
notunderestimate
the
potential
exposure
for
all
populations,
including
infants
and
children.

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
as
used
by
the
USEPA
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,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
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,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
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Regulations
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
cyprodinil
will
occupy
<
1%
of
the
aPAD
for
the
subpopulation
females
13
 
50
years
old,
the
only
population
for
whom
an
effect
attributable
to
an
acute
exposure
could
be
observed.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
cyprodinil
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
CYPRODINIL
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
13
 
50
years
old
1.5
<
1.0
32
0.04
44,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
cyprodinil
from
food
will
utilize
7.4%
of
the
cPAD
for
the
U.
S.
population,
24%
of
the
cPAD
for
all
infants
(<
1
year
old)
and
22%
of
the
cPAD
for
children
1
 
6
years
old.
There
are
no
residential
uses
for
cyprodinil
that
result
in
chronic
residential
exposure
to
cyprodinil.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
cyprodinil
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
cyprodinil
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
CYPRODINIL
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.03
7.4
6
0.04
970
All
Infants
(<
1
year
old)
0.03
24
6
0.04
230
Children
1
 
6
years
old
0.03
22
6
0.04
230
Children
7
 
12
years
old
0.03
9.1
6
0.04
270
Females
13
 
50years
old
0.03
5.3
6
0.04
1,000
3.
Short­
and
intermediate­
term
risk.
Short­
and
intermediate­
term
aggregate
exposure
take
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Cyprodinil
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Cyprodinil
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
based
on
the
results
of
a
carcinogenicity
study
in
mice
and
the
combined
chronic
toxicity
and
carcinogenicity
study
in
rats.
Therefore,
cyprodinil
is
not
expected
to
pose
a
cancer
risk
to
humans.
6.
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
cyprodinil
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
results
of
Multiresidue
Method
testing
of
cyprodinil
and
its
metabolite
CGA
 
232449
have
been
forwarded
to
the
Food
and
Drug
Administration
(
FDA).
Cyprodinil
was
tested
according
to
the
FDA
Multiresidue
protocols
(
Protocols
C,
D,
and
E),
and
acceptable
recoveries
were
obtained
for
cyprodinil
fortified
in
apples
at
0.50
ppm
using
Protocol
D.
The
petitioner
is
proposing
the
Method
AG
 
631A
as
a
tolerance
enforcement
method
for
residues
of
cyprodinil
in/
on
the
subject
crops.
This
method,
entitled
``
Analytical
Method
for
the
Determination
of
Residues
of
CGA
 
219417
in
Crops
by
High
Performance
Liquid
Chromatography
With
Column
Switching,''
is
a
reissue
of
Methods
AG
 
631
and
REM
141.01.
The
method
includes
confirmatory
procedures
using
gas
chromatography/
nitrogen/
phosphorus
detector
(
GC/
NPD).
The
method
has
successfully
undergone
radiovalidation
using
14C­
labeled
tomato
samples
and
independent
laboratory
validation.
In
addition,
the
method
has
been
the
subject
of
acceptable
Agency
petition
method
validations
on
stone
fruits
and
almond
nutmeat
and
hulls.

B.
International
Residue
Limits
There
are
no
Mexican,
Canadian
or
Codex
maximum
residue
limits
established
for
cyprodinil
in/
on
caneberries,
bushberries,
pistachios
and
watercress,
and
thus
no
compatibility
issues
to
be
reconciled.

C.
Conditions
The
Agency
is
requiring
as
conditions
for
registration
the
following:
An
acceptable
21/
28
 
day
dermal­
toxicity
study
in
rats
(
GLN
870.3200).
A
28
 
day
inhalation­
toxicity
study
in
rats
(
GLN
870.3465)

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
cyprodinil
on
the
caneberry
subgroup
at
10.0
ppm,
watercress
at
20
ppm,
pistachio
at
0.10
ppm
and
the
bushberry
subgroup,
lingonberry,
juneberry,
and
salal,
at
3.0
ppm.

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2003
/
Rules
and
Regulations
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
 
2002
 
0344
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
April
7,
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.
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
 
2002
 
0344,
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
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Federal
Register
/
Vol.
68,
No.
24
/
Wednesday,
February
5,
2003
/
Rules
and
Regulations
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.
Submission
to
Congress
and
the
Comptroller
General
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:
January
24,
2003.
Peter
Caulkins,
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:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.

2.
Section
180.532
is
amended
by
adding
alphabetically
the
following
commodities
to
the
table
in
paragraph
(
a)(
1)
to
read
as
follows:

§
180.532
Cyprodinil;
tolerances
forresidues.

(
a)
*
*
*
(
1)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Bushberry
subgroup
13B
3.0
Caneberry
subgroup
13A
10
*
*
*
*
*
Juneberry
........................
3.0
Lingonberry
.....................
3.0
Pistachio
.........................
0.10
*
*
*
*
*
Salal
................................
3.0
Watercress
......................
20
*
*
*
*
*
[
FR
Doc.
03
 
2771
Filed
2
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0355;
FRL
 
7285
 
9]

Thiophanate
Methyl;
Pesticide
Tolerance
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
residues
of
thiophanate
methyl
and
its
metabolite
(
methyl
2­
benzimidazoyl
carbamate
(
MBC))
in
or
on
mushrooms.
This
action
is
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
mushroom
spawn.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
thiophanate
methyl
in
this
food
commodity.
The
tolerance
will
expire
and
is
revoked
on
December
31,
2004.
DATES:
This
regulation
is
effective
February
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0355,
must
be
received
on
or
before
April
7,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Andrea
Conrath,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9356;
e­
mail
address:
conrath.
andrea@
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:
 
Crop
producers
(
NAICS
111)
 
Animal
producers
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)

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