Document ID: EPA-HQ-OPP-2002-0237-0001
Agency: epa
Document Type: Rule
Title: Cyromazine; Pesticide Tolerance
Posted Date: 2002-12-06T05:00Z

72585
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
3.
Section
63.1344
is
amended
by
revising
paragraph
(
a)(
3)
to
read
as
follows:

§
63.1344
Operating
limits
for
kilns
and
inline
kiln/
raw
mills.

(
a)
*
*
*
(
3)
If
the
in­
line
kiln/
raw
mill
is
equipped
with
an
alkali
bypass,
the
applicable
temperature
limit
for
the
alkali
bypass
specified
in
paragraph
(
b)
of
this
section
and
established
during
the
performance
test,
with
or
without
the
raw
mill
operating,
is
not
exceeded.
*
*
*
*
*
4.
Section
63.1349
is
amended
by
adding
new
paragraph
(
e)(
3)
to
read
as
follows:

§
63.1349
Performance
testing
requirements.

*
*
*
*
*
(
e)
*
*
*
(
3)
In
preparation
for
and
while
conducting
a
performance
test
required
in
paragraph
(
e)(
1)
of
this
section,
a
source
may
operate
under
the
planned
operational
change
conditions
for
a
period
not
to
exceed
360
hours,
provided
that
the
conditions
in
paragraphs
(
e)(
3)(
i)
through
(
iv)
of
this
section
are
met.
The
source
shall
submit
temperature
and
other
monitoring
data
that
are
recorded
during
the
pretest
operations.
(
i)
The
source
must
provide
the
Administrator
written
notice
at
least
60
days
prior
to
undertaking
an
operational
change
that
may
adversely
affect
compliance
with
an
applicable
standard
under
this
subpart,
or
as
soon
as
practicable
where
60
days
advance
notice
is
not
feasible.
Notice
provided
under
this
paragraph
shall
include
a
description
of
the
planned
change,
the
emissions
standards
that
may
be
affected
by
the
change,
and
a
schedule
for
completion
of
the
performance
test
required
under
paragraph
(
e)(
1)
of
this
section,
including
when
the
planned
operational
change
period
would
begin.
(
ii)
The
performance
test
results
must
be
documented
in
a
test
report
according
to
paragraph
(
a)
of
this
section.
(
iii)
A
test
plan
must
be
made
available
to
the
Administrator
prior
to
testing,
if
requested.
(
iv)
The
performance
test
must
be
conducted,
and
it
must
be
completed
within
360
hours
after
the
planned
operational
change
period
begins.
*
*
*
*
*
5.
Section
63.1350
is
amended
by:
a.
Adding
paragraphs
(
a)(
4)(
v)
through
(
vii);
b.
Revising
paragraph
(
c)(
2)(
i);
c.
Revising
paragraph
(
d)(
2)(
i);
and
d.
Revising
paragraph
(
e)
introductory
text.
The
revisions
and
additions
read
as
follows:

§
63.1350
Monitoring
requirements.

(
a)
*
*
*
(
4)
*
*
*
(
v)
The
requirement
to
conduct
Method
22
visible
emissions
monitoring
under
this
paragraph
shall
not
apply
to
any
totally
enclosed
conveying
system
transfer
point,
regardless
of
the
location
of
the
transfer
point.
``
Totally
enclosed
conveying
system
transfer
point''
shall
mean
a
conveying
system
transfer
point
that
is
enclosed
on
all
sides,
top,
and
bottom.
The
enclosures
for
these
transfer
points
shall
be
operated
and
maintained
as
total
enclosures
on
a
continuing
basis
in
accordance
with
the
facility
operations
and
maintenance
plan.
(
vi)
If
any
partially
enclosed
or
unenclosed
conveying
system
transfer
point
is
located
in
a
building,
the
owner
or
operator
of
the
portland
cement
plant
shall
have
the
option
to
conduct
a
Method
22
visible
emissions
monitoring
test
according
to
the
requirements
of
paragraphs
(
a)(
4)(
i)
through
(
iv)
of
this
section
for
each
such
conveying
system
transfer
point
located
within
the
building,
or
for
the
building
itself,
according
to
paragraph
(
a)(
4)(
vii)
of
this
section.
(
vii)
If
visible
emissions
from
a
building
are
monitored,
the
requirements
of
paragraphs
(
a)(
4)(
i)
through
(
iv)
of
this
section
apply
to
the
monitoring
of
the
building,
and
you
must
also
test
visible
emissions
from
each
side,
roof
and
vent
of
the
building
for
at
least
1
minute.
The
test
must
be
conducted
under
normal
operating
conditions.
*
*
*
*
*
(
c)
*
*
*
(
2)
*
*
*
(
i)
Perform
daily
visual
opacity
observations
of
each
stack
in
accordance
with
the
procedures
of
Method
9
of
appendix
A
to
part
60
of
this
chapter.
The
Method
9
test
shall
be
conducted
while
the
affected
source
is
operating
at
the
representative
performance
conditions.
The
duration
of
the
Method
9
test
shall
be
at
least
30
minutes
each
day.
*
*
*
*
*
(
d)
*
*
*
(
2)
*
*
*
(
i)
Perform
daily
visual
opacity
observations
of
each
stack
in
accordance
with
the
procedures
of
Method
9
of
appendix
A
to
part
60
of
this
chapter.
The
Method
9
test
shall
be
conducted
while
the
affected
source
is
operating
at
the
representative
performance
conditions.
The
duration
of
the
Method
9
test
shall
be
at
least
30
minutes
each
day.
*
*
*
*
*
(
e)
The
owner
or
operator
of
a
raw
mill
or
finish
mill
shall
monitor
opacity
by
conducting
daily
visual
emissions
observations
of
the
mill
sweep
and
air
separator
PMCD
of
these
affected
sources
in
accordance
with
the
procedures
of
Method
22
of
appendix
A
to
part
60
of
this
chapter.
The
Method
22
test
shall
be
conducted
while
the
affected
source
is
operating
at
the
representative
performance
conditions.
The
duration
of
the
Method
22
test
shall
be
6
minutes.
If
visible
emissions
are
observed
during
any
Method
22
visible
emissions
test,
the
owner
or
operator
must:
*
*
*
*
*

[
FR
Doc.
02
 
30844
Filed
12
 
5
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0237;
FRL
 
7274
 
8]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
cyromazine
in
or
on
bean,
dry
at
3.0
parts
per
million
(
ppm).
The
Interregional
Research
Project
Number
4
(
IR­
4),
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
DATES:
This
regulation
is
effective
December
6,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0237,
must
be
received
on
or
before
February
4,
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:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
epa.
gov@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00033
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72586
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111,
112,
311,
32532),
e.
g.,
Crop
production,
Animal
production,
Food
manufacturing,
and
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
 
2002
 
0237.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
July
17,
2002
(
67
FR
4697)
(
FRL
 
7185
 
6),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
0E6219)
by
IR­
4.
The
notice
included
a
summary
of
the
petition
prepared
by
Novartis
Crop
Protection
Inc.,
Greensboro,
NC
27419,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.414
be
amended
by
establishing
a
tolerance
for
residues
of
the
insecticide
cyromazine,
(
N­
cyclopropyl­
1,3,5­
triazine­
2,4,6­
triamine),
in
or
on
dry
bean
(
except
cowpea)
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
cyromazine
on
dry
bean
at
0.3
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
their
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
cyromazine
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
 
rat
NOAEL
=
3.0
(
milligram/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
30
mg/
kg/
day
based
on
alteration
in
the
liver
weight
changes
in
males
VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00034
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72587
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3150
90­
Day
oral
toxicity
 
dog
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
25
mg/
kg/
day
based
on
alteration
in
liver
weight
in
males
870.3200
21­
Day
dermal
toxicity
NOAEL
=
>
2,010
mg/
kg/
day
LOAEL
=
>
2,010
mg/
kg/
day.
No
dermal
irritation
was
noted.
No
treatment
related
systemic
toxicity
was
noted.

870.3700
Developmental
toxicity
in
rodents
 
rat
Maternal
NOAEL
=
100
mg/
kg/
day
LOAEL
=
300
mg/
kg/
day
based
on
clinical
signs
(
red
or
clear
nasal
discharge)
and
decrease
body
weights
Developmental
NOAEL
=
300
mg/
kg/
day
LOAEL
=
600
mg/
kg/
day
highest
dose
tested
(
HDT)
based
on
increased
incidence
of
minor
skeletal
variations
870.3700
Developmental
toxicity
in
non­
rodents
 
rabbit
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
30
mg/
kg/
day
based
on
reduced
body
weight
Developmental
NOAEL
=
>
60
mg/
kg/
day
(
HDT)
LOAEL
was
not
established
870.3800
2
 
Generation
reproduction
 
rat
Parental/
Systemic
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
based
on
decreased
body
weights
that
were
associated
with
decreased
food
efficiency
Reproductive
NOAEL
=
>
150
mg/
kg/
day
LOAEL
=
Not
determined.
No
effects
were
noted
on
reproductive
parameters
at
HDT
Offspring
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
based
on
decreased
body
weights
at
birth
and
through
weaning
870.4100
Chronic
oral
toxicity
 
dogs
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
75.0
mg/
kg/
day
based
on
alteration
in
the
hematological
parameters
(
hemoglobin
and
hermatocrit)

870.4300
Combined
chronic/
carcinogenicity
 
rats
NOAEL
=
0.75
mg/
kg/
day
LOAEL
=
7.5
mg/
kg/
day
based
on
based
on
decreased
body
weight
There
is
no
evidence
of
carcinogenicity.

870.4200
Carcinogenicity
 
mice
NOAEL
=
7.5
mg/
kg/
day
LOAEL
=
50.0
mg/
kg/
day
based
on
decreased
body
weight
There
is
no
evidence
of
carcinogenicity
Mammalian
chromosomal
aberration
Negative
for
mutagenicity
in
Chinese
hamster
study
870.5100
Mutagenic
 
point
mutation
Salmonella
typhimurium
Negative
results
for
point
mutations
in
TA1537,
TA98,
TA100,
with
and
without
activation
870.5450
Mutagenic
 
dominant
lethal
 
mouse
Negative
mutagen
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
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
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
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
VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00035
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72588
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
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
cyromazine
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CYROMAZINE
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
General
population
including
infants
and
children
Not
Applicable
(
NA)
NA
An
appropriate
end
point
attributable
to
a
single
dose
(
exposure)
was
not
observed
in
oral
toxicity
studies.

Chronic
dietary
All
populations
NOAEL
=
7.5
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.075
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD/
FQPA
SF
=
0.075
mg/
kg/
day
6­
Month
Feeding
 
dog
LOAEL
=
75
mg/
kg/
day
based
on
alterations
in
hematological
parameters
[
hematocrit,
and
hemoglobin
(
males)],
body
weight
and
body
weight
gain
decreases
and
increase
in
several
organ
weights
Incidental
oral
Short­
term
(
1
to
30
days)
(
Residential)
NOAEL
=
10
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
 
rabbit
study.
LOAEL
=
30
mg/
kg/
day
based
on
decreases
in
body
weight
gain
and
food
consumption.

Incidental
Oral
Intermediate­
term
(
1
to
6
months)
(
Residential)
NOAEL
=
7.5
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential)
6­
Month
feeding
 
dog
LOAEL
=
75
mg/
kg/
day
based
on
alterations
in
hematological
parameters
[
hematocrit,
and
body
weight
gain
decreases
and
increase
in
several
organ
weights].

Dermal
(
any
time
period)
(
Residential)
NA
NA
Dermal
risk
assessments
were
not
performed
since
no
hazard
was
identified
via
dermal
exposure
there
are
no
concerns
for
pre­/
post­
natal
toxicity
and
dermal
exposure
is
not
expected
since
there
are
no
registered
residential
uses.

Short­
term
inhalation
(
1
to
30
days)
(
Residential)
Oral
NOAEL=
10
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
 
rabbit
study
LOAEL
=
30
mg/
kg/
day
based
on
decreases
in
body
weight
gain
and
food
consumption
Intermediate­
term
inhalation
(
1
to
6
months)
(
Residential)
Oral
study
NOAEL
=
7.5
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
6­
Month
feeding
 
dog
study
LOAEL
=
75.0
mg/
kg/
day
based
on
alterations
in
hematological
parameters
[
hematocrit,
and
hemoglobin
(
males)],
body
weight
and
body
weight
gain
decreases
and
increase
in
several
organ
weights.

Long­
term
inhalation
(>
6
months)
(
Residential)
Oral
study
NOAEL=
7.5
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
6­
Month
feeding
 
dog
study
LOAEL
=
75.0
mg/
kg/
day
based
on
alterations
in
hematological
parameters
[
hematocrit,
and
hemoglobin
(
males)],
body
weight
and
body
weight
gain
decreases
and
increase
in
several
organ
weights.

Cancer
NA
NA
Based
on
weight­
of­
the­
evidence,
classified
in
Category
E
``
no
evidence
of
carcinogenicity
in
humans''

*
The
reference
to
the
Food
Quality
Protection
Act
Safety
Factor
(
FQPA
SF)
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.414)
for
the
residues
of
cyromazine,
in
or
on
a
variety
of
raw
agricultural
commodities.
There
are
currently
tolerances
for
cyromazine
use
on
a
number
of
food
crops
including
cucurbits,
leafy
vegatables,
onions,
lima
beans,
pepper,
potato,
and
tomato.
Tolerances
exist
as
well
for
livestock
commodities.
Cyromazine
is
generally
used
on
terrestrial
crops
as
a
foliar
spray
throughout
the
growing
season,
although
for
onions
it
is
used
as
a
seed
treatment
and
for
poultry
it
is
used
as
a
feed­
through
to
control
flies
breeding
VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00036
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72589
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
in
poultry
waste.
There
are
no
existing
or
pending
residential
uses
of
cyromazine.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
cyromazine
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.
An
endpoint
was
not
identified
for
acute
dietary
exposure
and
risk
assessment
because
no
effects
were
observed
in
oral
toxicity
studies
including
developmental
toxicity
studies
in
rats
or
rabbits
that
could
be
attributable
to
a
single
dose
(
exposure).
Therefore,
an
acute
dietary
exposure
assessment
was
not
performed.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
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:
Chronic
dietary
exposure
estimates
are
based
on
tolerance
level
residues
for
plant
and
poultry
commodities
and
on
anticipated
residue
estimates
for
ruminant
commodities.
Dietary
exposure
estimates
are
also
factored
by
the
estimated
(
weighted
average)
usage
of
cyromazine,
or
``
percent
crop
treated''
(
PCT)
data.
iii.
Cancer.
Cyromazine
is
classified
into
Group
E
(
non­
carcinogen)
based
on
carcinogenicity
studies
in
rats
and
mice
following
long­
term
dietary
administration.
A
quantified
carinogenic
risk
estimate
is
not
appropriate
for
cyromazine.
iv.
Anticipated
residue
and
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.
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.
Cantaloupe
0.3%;
cucurbits
0.1%;
lettuce
2.6%;
leafy
vegetables,
other
9.4%;
celery
14.2%;
spinach
6.0%;
onions
2.4%;
pepper
5.3%;
peppers,
bell
9.0%;
tomatoes
5.8%;
tomatoes,
fresh
22.2%;
and
watermelon
1.5%.
The
Agency
believes
that
the
three
conditions
listed
in
this
unit
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.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
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
cyromazine
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
cyromazine
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
cyromazine.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
Model/
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
screeninglevel
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
high­
end
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
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
exceed
human
health
levels
of
concern.

VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00037
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72590
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
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
%
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
cyromazine
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
cyromazine
for
chronic
exposures
are
estimated
to
be
16
parts
per
billion
(
ppb)
for
surface
water
and
5.0
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).
Cyromazine
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.''
Cyromazine
is
a
member
of
the
triazine
class
of
chemicals.
EPA
evaluated
available
scientific
evidence
to
determine
whether
a
common
mechanism
of
toxicity
exists
among
certain
triazine­
containing
pesticides.
Based
on
the
available
weight­
ofevidence
cyromazine
can
not
be
grouped
with
other
triazines
based
on
a
common
mechanism
of
toxicity.
EPA
determined
that
only
atrazine,
simazine,
propazine,
and
their
specified
degradants
could
be
grouped
based
a
common
mechanism
of
toxicity
for
disruption
of
the
hypothalamicpituitary
gonadal
(
HPG)
axis.
For
purposes
of
this
tolerance
action,
EPA
has
concluded
that
cyromazine
does
not
have
a
common
mechanism
of
toxicity
with
other
triazine­
containing
compounds.
If
additional
data
become
available
to
support
its
inclusion
in
a
common
mechanism
group,
these
data
will
be
considered.
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
ten­
fold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
pre­
natal
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.
Pre­
natal
and
post­
natal
sensitivity.
The
developmental
and
reproductive
toxicity
data
from
a
pre­
natal
developmental
study
in
rats,
a
pre­
natal
developmental
study
in
rabbits,
and
a
2­
generation
reproductive
toxicity
study
in
rats,
did
not
indicate
increased
susceptibility
of
young
rats
on
rabbits
to
un
urero
and/
or
post­
natal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
cyromazine
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10x
safety
factor
to
protect
infants
and
children
should
be
reduced
to
1x.
The
FQPA
factor
was
reduced
based
on
reliable
data
supporting
the
following
weight­
ofevidence
considerations:
i.
There
are
no
data
deficiencies
and
hence
there
are
no
residual
uncertainties
for
pre­
and/
or
post­
natal
exposure,
and
no
additional
traditional
SFs
are
needed
with
regard
to
the
completeness
of
the
cyromazine
toxicity
data
base;
ii.
There
is
no
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
with
cyromazine;
iii.
There
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
cyromazine;
and
iv.
There
are
also
no
residual
uncertainties
identified
in
the
exposure
data
bases.
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.
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
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.
There
were
no
toxicological
effects
attributable
to
a
single
exposure
(
dose)
observed
in
the
oral
toxicity
studies.
A
dose
and
an
endpoint
for
an
acute
RfD
was
not
selected.
Therefore,
acute
risk
from
exposure
to
cyromazine
is
not
expected.

VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00038
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72591
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
cyromazine
from
food
will
utilize
2.0%
of
the
cPAD
for
both
males
and
females
of
the
U.
S.
population,
and
4.0%
of
the
cPAD
for
children
1
 
6
years
old,
subpopulation
at
greatest
exposure.
There
are
no
residential
uses
for
cyromazine
that
result
in
chronic
residential
exposure
to
cyromazine.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
cyromazine
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
cyromazine
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
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
CYROMAZINE
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

Males
0.075
2.0
16
5
2,550
Female
0.075
2.0
16
5
2,200
Children
0.075
4.0
16
5
700
3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Cyromazine
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.
4.
Aggregate
cancer
risk
for
U.
S.
population.
Cyromazine
has
been
classified
as
a
chemical
showing
``
no
evidence
of
carcinogenicity
in
humans.''
The
Agency
concludes
that
pesticidal
uses
of
cyromazine
are
not
likely
to
pose
a
carcinogenic
risk
to
humans.
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
cyromazine
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Analytical
methods,
AG­
408
and
AG­
417,
as
listed
in
the
Food
and
Drug
Administration's
Pesticide
Analytical
Manual
(
PAM)
II,
are
adequate
for
tolerance
enforce
purposes.

B.
International
Residue
Limits
There
are
currently
no
codex,
Canadian
or
Mexican
limits
for
residues
of
cyromazine
on
dry
bean.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
cyromazine,
(
Ncyclopropyl
1,3,5­
triazine­
2,4,6­
triamine),
in
or
on
dry
bean
(
except
cowpea)
at
3.0
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
the
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
 
0237
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
February
4,
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
VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00039
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72592
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
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
 
0237,
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.
Regulatory
Assessment
Requirements
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.
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
VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00040
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1
72593
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Rules
and
Regulations
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
November
15,
2002.
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
180.414
is
amended
by
alphabetically
adding
a
commodity
to
the
table
in
paragraph
(
a)(
1)
to
read
as
follows:

§
180.414
Cyromazine,
tolerances
for
residues.
(
a)
*
*
*
(
1)
*
*
*

Commodity
Parts
per
million
Bean,
dry,
except
cowpea
........
3.0
*
*
*
*
*

*
*
*
*
*

[
FR
Doc.
02
 
30839
Filed
12
 
5
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
EMERGENCY
MANAGEMENT
AGENCY
44
CFR
Part
64
[
Docket
No.
FEMA
 
7797]

Suspension
of
Community
Eligibility
AGENCY:
Federal
Emergency
Management
Agency,
FEMA.
ACTION:
Final
rule.

SUMMARY:
This
rule
identifies
communities,
where
the
sale
of
flood
insurance
has
been
authorized
under
the
National
Flood
Insurance
Program
(
NFIP),
that
are
suspended
on
the
effective
dates
listed
within
this
rule
because
of
noncompliance
with
the
floodplain
management
requirements
of
the
program.
If
the
Federal
Emergency
Management
Agency
(
FEMA)
receives
documentation
that
the
community
has
adopted
the
required
floodplain
management
measures
prior
to
the
effective
suspension
date
given
in
this
rule,
the
suspension
will
be
withdrawn
by
publication
in
the
Federal
Register.
EFFECTIVE
DATES:
The
effective
date
of
each
community's
suspension
is
the
third
date
(``
Susp.'')
listed
in
the
third
column
of
the
following
tables.
ADDRESSES:
If
you
wish
to
determine
whether
a
particular
community
was
suspended
on
the
suspension
date,
contact
the
appropriate
FEMA
Regional
Office
or
the
NFIP
servicing
contractor.
FOR
FURTHER
INFORMATION
CONTACT:
Edward
Pasterick,
Division
Director,
Risk
Communication
Division,
Federal
Insurance
and
Mitigation
Administrator,
500
C
Street,
SW.;
Room
411,
Washington,
DC
20472,
(
202)
646
 
3098.
SUPPLEMENTARY
INFORMATION:
The
NFIP
enables
property
owners
to
purchase
flood
insurance
which
is
generally
not
otherwise
available.
In
return,
communities
agree
to
adopt
and
administer
local
floodplain
management
aimed
at
protecting
lives
and
new
construction
from
future
flooding.
Section
1315
of
the
National
Flood
Insurance
Act
of
1968,
as
amended,
42
U.
S.
C.
4022,
prohibits
flood
insurance
coverage
as
authorized
under
the
National
Flood
Insurance
Program,
42
U.
S.
C.
4001
et
seq.;
unless
an
appropriate
public
body
adopts
adequate
floodplain
management
measures
with
effective
enforcement
measures.
The
communities
listed
in
this
document
no
longer
meet
that
statutory
requirement
for
compliance
with
program
regulations,
44
CFR
part
59
et
seq.
Accordingly,
the
communities
will
be
suspended
on
the
effective
date
in
the
third
column.
As
of
that
date,
flood
insurance
will
no
longer
be
available
in
the
community.
However,
some
of
these
communities
may
adopt
and
submit
the
required
documentation
of
legally
enforceable
floodplain
management
measures
after
this
rule
is
published
but
prior
to
the
actual
suspension
date.
These
communities
will
not
be
suspended
and
will
continue
their
eligibility
for
the
sale
of
insurance.
A
notice
withdrawing
the
suspension
of
the
communities
will
be
published
in
the
Federal
Register.
In
addition,
the
Federal
Emergency
Management
Agency
has
identified
the
special
flood
hazard
areas
in
these
communities
by
publishing
a
Flood
Insurance
Rate
Map
(
FIRM).
The
date
of
the
FIRM
if
one
has
been
published,
is
indicated
in
the
fourth
column
of
the
table.
No
direct
Federal
financial
assistance
(
except
assistance
pursuant
to
the
Robert
T.
Stafford
Disaster
Relief
and
Emergency
Assistance
Act
not
in
connection
with
a
flood)
may
legally
be
provided
for
construction
or
acquisition
of
buildings
in
the
identified
special
flood
hazard
area
of
communities
not
participating
in
the
NFIP
and
identified
for
more
than
a
year,
on
the
Federal
Emergency
Management
Agency's
initial
flood
insurance
map
of
the
community
as
having
flood­
prone
areas
(
section
202(
a)
of
the
Flood
Disaster
Protection
Act
of
1973,
42
U.
S.
C.
4106(
a),
as
amended).
This
prohibition
against
certain
types
of
Federal
assistance
becomes
effective
for
the
communities
listed
on
the
date
shown
in
the
last
column.
The
Administrator
finds
that
notice
and
public
comment
under
5
U.
S.
C.
553(
b)
are
impracticable
and
unnecessary
because
communities
listed
in
this
final
rule
have
been
adequately
notified.
Each
community
receives
a
6­
month,
90­
day,
and
30­
day
notification
addressed
to
the
Chief
Executive
Officer
that
the
community
will
be
suspended
unless
the
required
floodplain
management
measures
are
met
prior
to
the
effective
suspension
date.
Since
these
notifications
have
been
made,
this
final
rule
may
take
effect
within
less
than
30
days.
National
Environmental
Policy
Act.
This
rule
is
categorically
excluded
from
the
requirements
of
44
CFR
Part
10,
Environmental
Considerations.
No
environmental
impact
assessment
has
been
prepared.
Regulatory
Flexibility
Act.
The
Administrator
has
determined
that
this
rule
is
exempt
from
the
requirements
of
the
Regulatory
Flexibility
Act
because
the
National
Flood
Insurance
Act
of
1968,
as
amended,
42
U.
S.
C.
4022,
prohibits
flood
insurance
coverage
unless
an
appropriate
public
body
adopts
adequate
floodplain
management
measures
with
effective
enforcement
measures.
The
communities
listed
no
longer
comply
with
the
statutory
requirements,
and
after
the
effective
date,
flood
insurance
will
no
longer
be
available
in
the
communities
unless
they
take
remedial
action.
Regulatory
Classification.
This
final
rule
is
not
a
significant
regulatory
action
under
the
criteria
of
section
3(
f)
of
Executive
Order
12866
of
September
30,
1993,
Regulatory
Planning
and
Review,
58
FR
51735.
Paperwork
Reduction
Act.
This
rule
does
not
involve
any
collection
of
information
for
purposes
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
Executive
Order
12612,
Federalism.
This
rule
involves
no
policies
that
have
federalism
implications
under
Executive
Order
12612,
Federalism,
October
26,
1987,
3
CFR,
1987
Comp.;
p.
252.
Executive
Order
12778,
Civil
Justice
Reform.
This
rule
meets
the
applicable
standards
of
section
2(
b)(
2)
of
Executive
Order
12778,
October
25,
1991,
56
FR
55195,
3
CFR,
1991
Comp.;
p.
309.

List
of
Subjects
in
44
CFR
Part
64
Flood
insurance,
Floodplains.

VerDate
0ct<
31>
2002
12:
56
Dec
05,
2002
Jkt
200001
PO
00000
Frm
00041
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
06DER1.
SGM
06DER1